Sec. 100 Short title
This division may be cited as the “Investing in America’s Health Care During the COVID–19 Pandemic Act”.
Division K — Health Provisions
K Health Provisions
I Medicaid Provisions
Sec. 101 COVID–19-related temporary increase of Medicaid FMAP
In general— Section 6008 of the Families First Coronavirus Response Act (42 U.S.C. 1396d note) is amended—
in subsection (a)—
by inserting “(or, if later, September 30, 2021)” after “last day of such emergency period occurs”; and
by striking “6.2 percentage points.” and inserting “the percentage points specified in subsection (e). In no case may the application of this section result in the Federal medical assistance percentage determined for a State being more than 95 percent.”; and
by adding at the end the following new subsections:
“(f) Specified percentage points—For purposes of subsection (a), the percentage points specified in this subsection are—
“(1) for each calendar quarter occurring during the period beginning on the first day of the emergency period described in paragraph (1)(B) of section 1135(g) of the Social Security Act (42 U.S.C. 1320b-5(g)) and ending on September 30, 2020, 6.2 percentage points;
“(2) for each calendar quarter occurring during the period beginning on October 1, 2020, and ending on September 30, 2021, 14 percentage points; and
“(3) for each calendar quarter, if any, occurring during the period beginning on October 1, 2021, and ending on the last day of the calendar quarter in which the last day of such emergency period occurs, 6.2 percentage points.
“(g) Clarifications
“(1) In the case of a State that treats an individual described in subsection (b)(3) as eligible for the benefits described in such subsection, for the period described in subsection (a), expenditures for medical assistance and administrative costs attributable to such individual that would not otherwise be included as expenditures under section 1903 of the Social Security Act shall be regarded as expenditures under the State plan approved under title XIX of the Social Security Act or for administration of such State plan.
“(2) The limitations on payment under subsections (f) and (g) of section 1108 of the Social Security Act (42 U.S.C. 1308) shall not apply to Federal payments made under section 1903(a)(1) of the Social Security Act (42 U.S.C. 1396b(a)(1)) attributable to the increase in the Federal medical assistance percentage under this section.
“(3) Expenditures attributable to the increased Federal medical assistance percentage under this section shall not be counted for purposes of the limitations under section 2104(b)(4) of such Act (42 U.S.C. 1397dd(b)(4)).
“(4) Notwithstanding the first sentence of section 2105(b) of the Social Security Act (42 U.S.C. 1397ee(b)), the application of the increase under this section may result in the enhanced FMAP of a State for a fiscal year under such section exceeding 85 percent, but in no case may the application of such increase before application of the second sentence of such section result in the enhanced FMAP of the State exceeding 95 percent.
“(h) Scope of application—An increase in the Federal medical assistance percentage for a State under this section shall not be taken into account for purposes of payments under part D of title IV of the Social Security Act (42 U.S.C. 651 et seq.).”
Effective date— The amendments made by subsection (a) shall take effect and apply as if included in the enactment of section 6008 of the Families First Coronavirus Response Act (Public Law 116–127).
Sec. 102 Additional support for Medicaid home and community-based services during the COVID–19 emergency period
Increased FMAP—
In general— Notwithstanding section 1905(b) of the Social Security Act (42 U.S.C. 1396d(b)), in the case of an HCBS program State, the Federal medical assistance percentage determined for the State under section 1905(b) of such Act and, if applicable, increased under subsection (y), (z), or (aa) of section 1905 of such Act (42 U.S.C. 1396d), section 1915(k) of such Act (42 U.S.C. 1396n(k)), or section 6008(a) of the Families First Coronavirus Response Act (Public Law 116–127), shall be increased by 10 percentage points with respect to expenditures of the State under the State Medicaid program for home and community-based services that are provided during the HCBS program improvement period. In no case may the application of the previous sentence result in the Federal medical assistance percentage determined for a State being more than 95 percent.
Definitions— In this section:
HCBS program improvement period— The term HCBS program improvement period means, with respect to a State, the period—
beginning on October 1, 2020; and
ending on September 30, 2021.
HCBS program State— The term HCBS program State means a State that meets the condition described in subsection (b) by submitting an application described in such subsection, which is approved by the Secretary pursuant to subsection (c).
Home and community-based services— The term home and community-based services means home health care services authorized under paragraph (7) of section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)), personal care services authorized under paragraph (24) of such section, PACE services authorized under paragraph (26) of such section, services authorized under subsections (b), (c), (i), (j), and (k) of section 1915 of such Act (42 U.S.C. 1396n), such services authorized under a waiver under section 1115 of such Act (42 U.S.C. 1315), and such other services specified by the Secretary.
Condition— The condition described in this subsection, with respect to a State, is that the State submits an application to the Secretary, at such time and in such manner as specified by the Secretary, that includes, in addition to such other information as the Secretary shall require—
a description of which activities described in subsection (d) that a state plans to implement and a description of how it plans to implement such activities;
assurances that the Federal funds attributable to the increase under subsection (a) will be used—
to implement the activities described in subsection (d); and
to supplement, and not supplant, the level of State funds expended for home and community-based services for eligible individuals through programs in effect as of the date of the enactment of this section; and
assurances that the State will conduct adequate oversight and ensure the validity of such data as may be required by the Secretary.
Approval of application— Not later than 90 days after the date of submission of an application of a State under subsection (b), the Secretary shall certify if the application is complete. Upon certification that an application of a State is complete, the application shall be deemed to be approved for purposes of this section.
Activities to improve the delivery of HCBS—
In general— A State shall work with community partners, such as Area Agencies on Aging, Centers for Independent Living, non-profit home and community-based services providers, and other entities providing home and community-based services, to implement—
the purposes described in paragraph (2) during the COVID–19 public health emergency period; and
the purposes described in paragraph (3) after the end of such emergency period.
Focused areas of HCBS improvement— The purposes described in this paragraph, with respect to a State, are the following:
To increase rates for home health agencies and agencies that employ direct support professionals (including independent providers in a self-directed or consumer-directed model) to provide home and community-based services under the State Medicaid program, provided that any agency or individual that receives payment under such an increased rate increases the compensation it pays its home health workers or direct support professionals.
To provide paid sick leave, paid family leave, and paid medical leave for home health workers and direct support professionals.
To provide hazard pay, overtime pay, and shift differential pay for home health workers and direct support professionals.
To provide home and community-based services to eligible individuals who are on waiting lists for programs approved under sections 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n).
To purchase emergency supplies and equipment, which may include items not typically covered under the Medicaid program, such as personal protective equipment, necessary to enhance access to services and to protect the health and well-being of home health workers and direct support professionals.
To pay for the travel of home health workers and direct support professionals to conduct home and community-based services.
To recruit new home health workers and direct support professionals.
To support family care providers of eligible individuals with needed supplies and equipment, which may include items not typically covered under the Medicaid program, such as personal protective equipment, and pay.
To pay for training for home health workers and direct support professionals that is specific to the COVID–19 public health emergency.
To pay for assistive technologies, staffing, and other costs incurred during the COVID–19 public health emergency period in order to facilitate community integration and ensure an individual’s person-centered service plan continues to be fully implemented.
To prepare information and public health and educational materials in accessible formats (including formats accessible to people with low literacy or intellectual disabilities) about prevention, treatment, recovery and other aspects of COVID–19 for eligible individuals, their families, and the general community served by agencies described in subparagraph (A).
To pay for American sign language interpreters to assist in providing home and community-based services to eligible individuals and to inform the general public about COVID–19.
To allow day services providers to provide home and community-based services.
To pay for other expenses deemed appropriate by the Secretary to enhance, expand, or strengthen Home and Community-Based Services, including retainer payments, and expenses which meet the criteria of the home and community-based settings rule published on January 16, 2014.
Permissible uses after the emergency period— The purpose described in this paragraph, with respect to a State, is to assist eligible individuals who had to relocate to a nursing facility or institutional setting from their homes during the COVID–19 public health emergency period in—
moving back to their homes (including by paying for moving costs, first month’s rent, and other one-time expenses and start-up costs);
resuming home and community-based services;
receiving mental health services and necessary rehabilitative service to regain skills lost while relocated during the public health emergency period; and
while funds attributable to the increased FMAP under this section remain available, continuing home and community-based services for eligible individuals who were served from a waiting list for such services during the public health emergency period.
Reporting requirements—
State reporting requirements— Not later than December 31, 2022, any State with respect to which an application is approved by the Secretary pursuant to subsection (c) shall submit a report to the Secretary that contains the following information:
Activities and programs that were funded using Federal funds attributable to such increase.
The number of eligible individuals who were served by such activities and programs.
The number of eligible individuals who were able to resume home and community-based services as a result of such activities and programs.
HHS evaluation—
In general— The Secretary shall evaluate the implementation and outcomes of this section in the aggregate using an external evaluator with experience evaluating home and community-based services, disability programs, and older adult programs.
Evaluation criteria— For purposes of subparagraph (A), the external evaluator shall—
document and evaluate changes in access, availability, and quality of home and community-based services in each HCBS program State;
document and evaluate aggregate changes in access, availability, and quality of home and community-based services across all such States; and
evaluate the implementation and outcomes of this section based on—
the impact of this section on increasing funding for home and community-based services;
the impact of this section on achieving targeted access, availability, and quality of home and community-based services; and
promising practices identified by activities conducted pursuant to subsection (d) that increase access to, availability of, and quality of home and community-based services.
Dissemination of evaluation findings— The Secretary shall—
disseminate the findings from the evaluations conducted under this paragraph to—
all State Medicaid directors; and
the Committee on Energy and Commerce of the House of Representatives, the Committee on Finance of the Senate, and the Special Committee on Aging of the Senate; and
make all evaluation findings publicly available in an accessible electronic format and any other accessible format determined appropriate by the Secretary.
Oversight— Each State with respect to which an application is approved by the Secretary pursuant to subsection (c) shall ensure adequate oversight of the expenditure of Federal funds pursuant to such increase in accordance with the Medicaid regulations, including section 1115 and 1915 waiver regulations and special terms and conditions for any relevant waiver or grant program.
Non-Application Of The Paperwork Reduction Act— Chapter 35 of title 44, United States Code (commonly referred to as the “Paperwork Reduction Act of 1995”), shall not apply to the provisions of this subsection.
Additional definitions— In this section:
COVID–19 public health emergency period— The term COVID–19 public health emergency period means the portion of the emergency period described in paragraph (1)(B) of section 1135(g) of the Social Security Act (42 U.S.C. 1320b–5(g)) beginning on or after the date of the enactment of this Act.
Eligible individual— The term eligible individual means an individual who is eligible for or enrolled for medical assistance under a State Medicaid program.
Medicaid program— The term Medicaid program means, with respect to a State, the State program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) (including any waiver or demonstration under such title or under section 1115 of such Act (42 U.S.C. 1315) relating to such title).
Secretary— The term Secretary means the Secretary of Health and Human Services.
State— The term State has the meaning given such term for purposes of title XIX of the Social Security Act (42 U.S.C. 1396 et seq.).
Sec. 103 Coverage at no cost sharing of COVID–19 vaccine and treatment
Medicaid—
by striking “and (D)” and inserting “(D)”; and
by striking the semicolon at the end and inserting “; (E) during the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of the Investing in America’s Health Care During the COVID–19 Pandemic Act, a COVID–19 vaccine licensed under section 351 of the Public Health Service Act, or approved or authorized under sections 505 or 564 of the Federal Food, Drug, and Cosmetic Act, and administration of the vaccine; (F) during such portion of the emergency period described in paragraph (1)(B) of section 1135(g), items or services for the prevention or treatment of COVID–19, including drugs approved or authorized under such section 505 or such section 564 or, without regard to the requirements of section 1902(a)(10)(B) (relating to comparability), in the case of an individual who is diagnosed with or presumed to have COVID–19, during such portion of such emergency period during which such individual is infected (or presumed infected) with COVID–19, the treatment of a condition that may complicate the treatment of COVID–19;”.
Prohibition of cost sharing—
In general— Subsections (a)(2) and (b)(2) of section 1916 of the Social Security Act (42 U.S.C. 1396o) are each amended—
in subparagraph (F), by striking “or” at the end;
in subparagraph (G), by striking “; and” and inserting “, or”; and
by adding at the end the following subparagraphs:
“(H) during the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of this subparagraph, a COVID–19 vaccine licensed under section 351 of the Public Health Service Act, or approved or authorized under section 505 or 564 of the Federal Food, Drug, and Cosmetic Act, and the administration of such vaccine, or
“(I) during such portion of the emergency period described in paragraph (1)(B) of section 1135(g), any item or service furnished for the treatment of COVID–19, including drugs approved or authorized under such section 505 or such section 564 or, in the case of an individual who is diagnosed with or presumed to have COVID–19, during the portion of such emergency period during which such individual is infected (or presumed infected) with COVID–19, the treatment of a condition that may complicate the treatment of COVID–19; and”
Application to alternative cost sharing— Section 1916A(b)(3)(B) of the Social Security Act (42 U.S.C. 1396o–1(b)(3)(B)) is amended—
in clause (xi), by striking “any visit” and inserting “any service”; and
by adding at the end the following clauses:
“(xii) During the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of this clause, a COVID–19 vaccine licensed under section 351 of the Public Health Service Act, or approved or authorized under section 505 or 564 of the Federal Food, Drug, and Cosmetic Act, and the administration of such vaccine.
“(xiii) During such portion of the emergency period described in paragraph (1)(B) of section 1135(g), an item or service furnished for the treatment of COVID–19, including drugs approved or authorized under such section 505 or such section 564 or, in the case of an individual who is diagnosed with or presumed to have COVID–19, during such portion of such emergency period during which such individual is infected (or presumed infected) with COVID–19, the treatment of a condition that may complicate the treatment of COVID–19.”
Clarification— The amendments made by this subsection shall apply with respect to a State plan of a territory in the same manner as a State plan of one of the 50 States.
State pediatric vaccine distribution program— Section 1928 of the Social Security Act (42 U.S.C. 1396s) is amended—
in subsection (a)(1)—
in subparagraph (A), by striking “; and” and inserting a semicolon;
in subparagraph (B), by striking the period and inserting “; and”; and
by adding at the end the following subparagraph:
“(C) during the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of this subparagraph, each vaccine-eligible child (as defined in subsection (b)) is entitled to receive a COVID–19 vaccine from a program-registered provider (as defined in subsection (h)(7)) without charge for—
“(i) the cost of such vaccine; or
“(ii) the administration of such vaccine.”
in subsection (c)(2)—
in subparagraph (C)(ii), by inserting “, but, during the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of the Investing in America’s Health Care During the COVID–19 Pandemic Act, may not impose a fee for the administration of a COVID–19 vaccine” before the period; and
by adding at the end the following subparagraph:
“(D) The provider will provide and administer an approved COVID–19 vaccine to a vaccine-eligible child in accordance with the same requirements as apply under the preceding subparagraphs to the provision and administration of a qualified pediatric vaccine to such a child.”
in subsection (d)(1), in the first sentence, by inserting “, including, during the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of the Investing in America’s Health Care During the COVID–19 Pandemic Act, with respect to a COVID–19 vaccine licensed under section 351 of the Public Health Service Act, or approved or authorized under section 505 or 564 of the Federal Food, Drug, and Cosmetic Act” before the period.
CHIP—
In general— Section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c)) is amended by adding at the end the following paragraph:
“(11) Coverage of COVID–19 vaccines and treatment—Regardless of the type of coverage elected by a State under subsection (a), child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income pregnant women (as defined in section 2112(d)) shall include coverage, during the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of this paragraph, of—
“(A) a COVID–19 vaccine licensed under section 351 of the Public Health Service Act, or approved or authorized under section 505 or 564 of the Federal Food, Drug, and Cosmetic Act, and the administration of such vaccine; and
“(B) any item or service furnished for the treatment of COVID–19, including drugs approved or authorized under such section 505 or such section 564, or, in the case of an individual who is diagnosed with or presumed to have COVID–19, during the portion of such emergency period during which such individual is infected (or presumed infected) with COVID–19, the treatment of a condition that may complicate the treatment of COVID–19.”
Prohibition of cost sharing— Section 2103(e)(2) of the Social Security Act (42 U.S.C. 1397cc(e)(2)), as amended by section 6004(b)(3) of the Families First Coronavirus Response Act, is amended—
in the paragraph header, by inserting “a COVID–19 vaccine, COVID–19 treatment,” before “or pregnancy-related assistance”; and
by striking “visits described in section 1916(a)(2)(G), or” and inserting “services described in section 1916(a)(2)(G), vaccines described in section 1916(a)(2)(H) administered during the portion of the emergency period described in paragraph (1)(B) of section 1135(g) beginning on the date of the enactment of the Investing in America’s Health Care During the COVID–19 Pandemic Act, items or services described in section 1916(a)(2)(I) furnished during such emergency period, or”.
in subsection (a)(1)(B), by inserting “, under subclause (XXIII) of section 1902(a)(10)(A)(ii),” after “section 1902(a)(10)(A)(i)”; and
in subsection (b)(5), by adding before the period the following: “, and, effective on the date of the enactment of the Investing in America’s Health Care During the COVID–19 Pandemic Act, must comply with subparagraphs (F) through (I) of subsections (a)(2) and (b)(2) of section 1916 and subsection (b)(3)(B) of section 1916A”.
Effective date— The amendments made by this section shall take effect on the date of enactment of this Act and shall apply with respect to a COVID–19 vaccine beginning on the date that such vaccine is licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or approved or authorized under section 505 or 564 of the Federal Food, Drug, and Cosmetic Act.
Sec. 104 Optional coverage at no cost sharing of COVID–19 treatment and vaccines under Medicaid for uninsured individuals
In general— Section 1902(a)(10) of the Social Security Act (42 U.S.C. 1396a(a)(10) is amended, in the matter following subparagraph (G), by striking “and any visit described in section 1916(a)(2)(G)” and inserting the following: “, any COVID–19 vaccine that is administered during any such portion (and the administration of such vaccine), any item or service that is furnished during any such portion for the treatment of COVID–19, including drugs approved or authorized under section 505 or 564 of the Federal Food, Drug, and Cosmetic Act, or, in the case of an individual who is diagnosed with or presumed to have COVID–19, during the period such individual is infected (or presumed infected) with COVID–19, the treatment of a condition that may complicate the treatment of COVID–19, and any services described in section 1916(a)(2)(G)”.
Definition of uninsured individual—
In general— Subsection (ss) of section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended to read as follows:
“(ss) Uninsured individual defined—For purposes of this section, the term uninsured individual means, notwithstanding any other provision of this title, any individual who is not covered by minimum essential coverage (as defined in section 5000A(f)(1) of the Internal Revenue Code of 1986).”
Effective date— The amendment made by paragraph (1) shall take effect and apply as if included in the enactment of the Families First Coronavirus Response Act (Public Law 116–127).
Clarification regarding emergency services for certain individuals— Section 1903(v)(2) of the Social Security Act (42 U.S.C. 1396b(v)(2)) is amended by adding at the end the following flush sentence:
Inclusion of COVID–19 concern as an emergency condition— Section 1903(v)(3) of the Social Security Act (42 U.S.C. 1396b(v)(3)) is amended by adding at the end the following flush sentence:
Sec. 105 Medicaid coverage for citizens of Freely Associated States
In general— Section 402(b)(2) of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 1612(b)(2)) is amended by adding at the end the following new subparagraph:
“(G) Medicaid exception for citizens of Freely Associated States—With respect to eligibility for benefits for the designated Federal program defined in paragraph (3)(C) (relating to the Medicaid program), section 401(a) and paragraph (1) shall not apply to any individual who lawfully resides in 1 of the 50 States or the District of Columbia in accordance with the Compacts of Free Association between the Government of the United States and the Governments of the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau and shall not apply, at the option of the Governor of Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or American Samoa as communicated to the Secretary of Health and Human Services in writing, to any individual who lawfully resides in the respective territory in accordance with such Compacts.”
in paragraph (1), by striking “or” at the end;
in paragraph (2), by striking the period at the end and inserting “; or”; and
by adding at the end the following new paragraph:
“(3) an individual described in section 402(b)(2)(G), but only with respect to the designated Federal program defined in section 402(b)(3)(C).”
in paragraph (6), by striking “; or” at the end and inserting a comma;
in paragraph (7), by striking the period at the end and inserting “, or”; and
by adding at the end the following new paragraph:
“(8) an individual who lawfully resides in the United States in accordance with a Compact of Free Association referred to in section 402(b)(2)(G), but only with respect to the designated Federal program defined in section 402(b)(3)(C) (relating to the Medicaid program).”
Application to State plans— Section 1902(a)(10)(A)(i) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)(i)) is amended by inserting after subclause (IX) the following:
“(X) who are described in section 402(b)(2)(G) of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 and eligible for benefits under this title by reason of application of such section;”
in subsection (f), in the matter preceding paragraph (1), by striking “subsections (g) and (h) and section 1935(e)(1)(B)” and inserting “subsections (g), (h), and (i) and section 1935(e)(1)(B)”; and
by adding at the end the following:
“(i) Exclusion of medical assistance expenditures for citizens of Freely Associated States—Expenditures for medical assistance provided to an individual described in section 431(b)(8) of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 1641(b)(8)) shall not be taken into account for purposes of applying payment limits under subsections (f) and (g).”
Effective date— The amendments made by this section shall apply to benefits for items and services furnished on or after the date of the enactment of this Act.
Sec. 106 Temporary increase in Medicaid DSH allotments
in subparagraph (A), by striking “and subparagraph (E)” and inserting “and subparagraphs (E) and (F)”; and
by adding at the end the following new subparagraph:
“(F) Temporary increase in allotments during certain public health emergency—The DSH allotment for any State for each of fiscal years 2020 and 2021 is equal to 102.5 percent of the DSH allotment that would be determined under this paragraph for the State for each respective fiscal year without application of this subparagraph, notwithstanding subparagraphs (B) and (C). For each fiscal year after fiscal year 2021, the DSH allotment for a State for such fiscal year is equal to the DSH allotment that would have been determined under this paragraph for such fiscal year if this subparagraph had not been enacted.”
DSH allotment adjustment for Tennessee— Section 1923(f)(6)(A)(vi) of the Social Security Act (42 U.S.C. 1396r–4(f)(6)(A)(vi)) is amended—
by striking “Notwithstanding any other provision of this subsection” and inserting the following:
“(I) In general—Notwithstanding any other provision of this subsection (except as provided in subclause (II) of this clause)”
by adding at the end the following:
“(II) Temporary increase in allotments—The DSH allotment for Tennessee for each of fiscal years 2020 and 2021 shall be equal to $54,427,500.”
Sense of Congress— It is the sense of Congress that a State should prioritize making payments under the State plan of the State under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) (or a waiver of such plan) to disproportionate share hospitals that have a higher share of COVID–19 patients relative to other such hospitals in the State.
Sec. 107 Allowing for medical assistance under Medicaid for inmates during 30-day period preceding release
In general— The subdivision (A) following paragraph (30) of section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is amended by inserting “and except during the 30-day period preceding the date of release of such individual from such public institution” after “medical institution”.
Report— Not later than June 30, 2022, the Medicaid and CHIP Payment and Access Commission shall submit a report to Congress on the Medicaid inmate exclusion under the subdivision (A) following paragraph (30) of section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)). Such report may, to the extent practicable, include the following information:
The number of incarcerated individuals who would otherwise be eligible to enroll for medical assistance under a State plan approved under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) (or a waiver of such a plan).
Access to health care for incarcerated individuals, including a description of medical services generally available to incarcerated individuals.
A description of current practices related to the discharge of incarcerated individuals, including how prisons interact with State Medicaid agencies to ensure that such individuals who are eligible to enroll for medical assistance under a State plan or waiver described in paragraph (1) are so enrolled.
If determined appropriate by the Commission, recommendations for Congress, the Department of Health and Human Services, or States regarding the Medicaid inmate exclusion.
Any other information that the Commission determines would be useful to Congress.
Sec. 108 Medicaid coverage of certain medical transportation
Continuing requirement of medicaid coverage of necessary transportation—
by striking “and including provision for utilization” and inserting “including provision for utilization”; and
by inserting after “supervision of administration of the plan” the following: “, and, subject to section 1903(i), including a specification that the single State agency described in paragraph (5) will ensure necessary transportation for beneficiaries under the State plan to and from providers and a description of the methods that such agency will use to ensure such transportation”.
Application with respect to benchmark benefit packages and benchmark equivalent coverage— Section 1937(a)(1) of the Social Security Act (42 U.S.C. 1396u–7(a)(1)) is amended—
in subparagraph (A), by striking “subsection (E)” and inserting “subparagraphs (E) and (F)”; and
by adding at the end the following new subparagraph:
“(F) Necessary transportation—Notwithstanding the preceding provisions of this paragraph, a State may not provide medical assistance through the enrollment of an individual with benchmark coverage or benchmark equivalent coverage described in subparagraph (A)(i) unless, subject to section 1903(i)(9) and in accordance with section 1902(a)(4), the benchmark benefit package or benchmark equivalent coverage (or the State)—
“(i) ensures necessary transportation for individuals enrolled under such package or coverage to and from providers; and
“(ii) provides a description of the methods that will be used to ensure such transportation.”
Limitation on federal financial participation— Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) is amended by inserting after paragraph (8) the following new paragraph:
“(9) with respect to any amount expended for non-emergency transportation authorized under section 1902(a)(4), unless the State plan provides for the methods and procedures required under section 1902(a)(30)(A); or”
Effective date— The amendments made by this subsection shall take effect on the date of the enactment of this Act and shall apply to transportation furnished on or after such date.
Medicaid program integrity measures related to coverage of nonemergency medical transportation—
Gao study— Not later than two years after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress, a report on coverage under the Medicaid program under title XIX of the Social Security Act of nonemergency transportation to medically necessary services. Such study shall take into account the 2009 report of the Office of the Inspector General of the Department of Health and Human Services, titled “Fraud and Abuse Safeguards for Medicaid Nonemergency Medical Transportation” (OEI–06–07–003200). Such report shall include the following:
An examination of the 50 States and the District of Columbia to identify safeguards to prevent and detect fraud and abuse with respect to coverage under the Medicaid program of nonemergency transportation to medically necessary services.
An examination of transportation brokers to identify the range of safeguards against such fraud and abuse to prevent improper payments for such transportation.
Identification of the numbers, types, and outcomes of instances of fraud and abuse, with respect to coverage under the Medicaid program of such transportation, that State Medicaid Fraud Control Units have investigated in recent years.
Identification of commonalities or trends in program integrity, with respect to such coverage, to inform risk management strategies of States and the Centers for Medicare & Medicaid Services.
Stakeholder working group—
In general— Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Centers for Medicare & Medicaid Services, shall convene a series of meetings to obtain input from appropriate stakeholders to facilitate discussion and shared learning about the leading practices for improving Medicaid program integrity, with respect to coverage of nonemergency transportation to medically necessary services.
Topics— The meetings convened under subparagraph (A) shall—
focus on ongoing challenges to Medicaid program integrity as well as leading practices to address such challenges; and
address specific challenges raised by stakeholders involved in coverage under the Medicaid program of nonemergency transportation to medically necessary services, including unique considerations for specific groups of Medicaid beneficiaries meriting particular attention, such as American Indians and tribal land issues or accommodations for individuals with disabilities.
Stakeholders— Stakeholders described in subparagraph (A) shall include individuals from State Medicaid programs, brokers for nonemergency transportation to medically necessary services that meet the criteria described in section 1902(a)(70)(B) of the Social Security Act (42 U.S.C. 1396a(a)(70)(B)), providers (including transportation network companies), Medicaid patient advocates, and such other individuals specified by the Secretary.
Guidance review— Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Centers for Medicare & Medicaid Services, shall assess guidance issued to States by the Centers for Medicare & Medicaid Services relating to Federal requirements for nonemergency transportation to medically necessary services under the Medicaid program under title XIX of the Social Security Act and update such guidance as necessary to ensure States have appropriate and current guidance in designing and administering coverage under the Medicaid program of nonemergency transportation to medically necessary services.
Nemt transportation provider and driver requirements—
by striking “and” at the end of paragraph (85);
by striking the period at the end of paragraph (86) and inserting “; and”; and
by inserting after paragraph (86) the following new paragraph:
“(87) provide for a mechanism, which may include attestation, that ensures that, with respect to any provider (including a transportation network company) or individual driver of nonemergency transportation to medically necessary services receiving payments under such plan (but excluding any public transit authority), at a minimum—
“(A) each such provider and individual driver is not excluded from participation in any Federal health care program (as defined in section 1128B(f)) and is not listed on the exclusion list of the Inspector General of the Department of Health and Human Services;
“(B) each such individual driver has a valid driver’s license;
“(C) each such provider has in place a process to address any violation of a State drug law; and
“(D) each such provider has in place a process to disclose to the State Medicaid program the driving history, including any traffic violations, of each such individual driver employed by such provider, including any traffic violations.”
Effective date—
In general— Except as provided in clause (ii), the amendments made by subparagraph (A) shall take effect on the date of the enactment of this Act and shall apply to services furnished on or after the date that is one year after the date of the enactment of this Act.
Exception if state legislation required— In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by subparagraph (A), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.
Analysis of t–msis data— Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Centers for Medicare & Medicaid Services, shall analyze, and submit to Congress a report on, the nation-wide data set under the Transformed Medicaid Statistical Information System to identify recommendations relating to coverage under the Medicaid program under title XIX of the Social Security Act of nonemergency transportation to medically necessary services.
II Medicare Provisions
Sec. 201 Holding Medicare beneficiaries harmless for specified COVID–19 treatment services furnished under part A or part B of the Medicare program
In general— Notwithstanding any other provision of law, in the case of a specified COVID–19 treatment service (as defined in subsection (b)) furnished during any portion of the emergency period described in paragraph (1)(B) of section 1135(g) of the Social Security Act (42 U.S.C. 1320b-5(g)) beginning on or after the date of the enactment of this Act to an individual entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) for which payment is made under such part A or such part B, the Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall provide that—
any cost-sharing required (including any deductible, copayment, or coinsurance) applicable to such individual under such part A or such part B with respect to such item or service is paid by the Secretary; and
the provider of services or supplier (as defined in section 1861 of the Social Security Act (42 U.S.C. 1395x)) does not hold such individual liable for such requirement.
Definition of specified COVID–19 treatment services— For purposes of this section, the term specified COVID–19 treatment service means any item or service furnished to an individual for which payment may be made under part A or part B of title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) if such item or service is included in a claim with an ICD–10–CM code relating to COVID–19 (as described in the document entitled “ICD–10–CM Official Coding Guidelines - Supplement Coding encounters related to COVID–19 Coronavirus Outbreak” published on February 20, 2020, or as otherwise specified by the Secretary).
Recovery of cost-Sharing amounts paid by the Secretary in the case of supplemental insurance coverage—
In general— In the case of any amount paid by the Secretary pursuant to subsection (a)(1) that the Secretary determines would otherwise have been paid by a group health plan or health insurance issuer (as such terms are defined in section 2791 of the Public Health Service Act (42 U.S.C. 300gg–91)), a private entity offering a medicare supplemental policy under section 1882 of the Social Security Act (42 U.S.C. 1395ss), any other health plan offering supplemental coverage, a State plan under title XIX of the Social Security Act, or the Secretary of Defense under the TRICARE program, such plan, issuer, private entity, other health plan, State plan, or Secretary of Defense, as applicable, shall pay to the Secretary, not later than 1 year after such plan, issuer, private entity, other health plan, State plan, or Secretary of Defense receives a notice under paragraph (3), such amount in accordance with this subsection.
Required information— Not later than 9 months after the date of the enactment of this Act, each group health plan, health insurance issuer, private entity, other health plan, State plan, and Secretary of Defense described in paragraph (1) shall submit to the Secretary such information as the Secretary determines necessary for purposes of carrying out this subsection. Such information so submitted shall be updated by such plan, issuer, private entity, other health plan, State plan, or Secretary of Defense, as applicable, at such time and in such manner as specified by the Secretary.
Review of claims and notification— The Secretary shall establish a process under which claims for items and services for which the Secretary has paid an amount pursuant to subsection (a)(1) are reviewed for purposes of identifying if such amount would otherwise have been paid by a plan, issuer, private entity, other health plan, State plan, or Secretary of Defense described in paragraph (1). In the case such a claim is so identified, the Secretary shall determine the amount that would have been otherwise payable by such plan, issuer, private entity, other health plan, State plan, or Secretary of Defense and notify such plan, issuer, private entity, other health plan, State plan, or Secretary of Defense of such amount.
Enforcement— The Secretary may impose a civil monetary penalty in an amount determined appropriate by the Secretary in the case of a plan, issuer, private entity, other health plan, or State plan that fails to comply with a provision of this section. The provisions of section 1128A of the Social Security Act shall apply to a civil monetary penalty imposed under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under subsection (a) or (b) of such section.
Funding— The Secretary shall provide for the transfer to the Centers for Medicare & Medicaid Program Management Account from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Trust Fund (in such portions as the Secretary determines appropriate) $100,000,000 for purposes of carrying out this section.
Report— Not later than 3 years after the date of the enactment of this Act, the Inspector General of the Department of Health and Human Services shall submit to Congress a report containing an analysis of amounts paid pursuant to subsection (a)(1) compared to amounts paid to the Secretary pursuant to subsection (c).
Implementation— Notwithstanding any other provision of law, the Secretary may implement the provisions of this section by program instruction or otherwise.
Sec. 202 Ensuring communications accessibility for residents of skilled nursing facilities during the COVID–19 emergency period
in subparagraph (D), by striking “and” at the end;
in subparagraph (E), by striking the period and inserting “; and”; and
by adding at the end the following new subparagraph:
“(F) provide for reasonable access to the use of a telephone, including TTY and TDD services (as defined for purposes of section 483.10 of title 42, Code of Federal Regulations (or a successor regulation)), and the internet (to the extent available to the facility) and inform each such resident (or a representative of such resident) of such access and any changes in policies or procedures of such facility relating to limitations on external visitors.”
COVID–19 provisions—
Guidance— Not later than 15 days after the date of the enactment of this Act, the Secretary of Health and Human Service shall issue guidance on steps skilled nursing facilities may take to ensure residents have access to televisitation during the emergency period defined in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)). Such guidance shall include information on how such facilities will notify residents of such facilities, representatives of such residents, and relatives of such residents of the rights of such residents to such televisitation, and ensure timely and equitable access to such televisitation.
Review of facilities— The Secretary of Health and Human Services shall take such steps as determined appropriate by the Secretary to ensure that residents of skilled nursing facilities and relatives of such residents are made aware of the access rights described in section 1819(c)(3)(F) of the Social Security Act (42 U.S.C. 1395i–3(c)(3)(F)).
Sec. 203 Medicare hospital inpatient prospective payment system outlier payments for COVID–19 patients during certain emergency period
In general— Section 1886(d)(5)(A) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(A)) is amended—
in clause (ii), by striking “For cases” and inserting “Subject to clause (vii), for cases”;
in clause (iii), by striking “The amount” and inserting “Subject to clause (vii), the amount”;
in clause (iv), by striking “The total amount” and inserting “Subject to clause (vii), the total amount”; and
by adding at the end the following new clause:
“(vii) For discharges that have a primary or secondary diagnosis of COVID–19 and that occur during the period beginning on the date of the enactment of this clause and ending on the sooner of January 31, 2021, or the last day of the emergency period described in section 1135(g)(1)(B), the amount of any additional payment under clause (ii) for a subsection (d) hospital for such a discharge shall be determined as if—
“(I) clause (ii) was amended by striking “plus a fixed dollar amount determined by the Secretary”;
“(II) the reference in clause (iii) to “approximate the marginal cost of care beyond the cutoff point applicable under clause (i) or (ii)” were a reference to “approximate the marginal cost of care beyond the cutoff point applicable under clause (i), or, in the case of an additional payment requested under clause (ii), be equal to 100 percent of the amount by which the costs of the discharge for which such additional payment is so requested exceed the applicable DRG prospective payment rate”; and
“(III) clause (iv) does not apply.”
Exclusion from reduction in average standardized amounts payable to hospitals located in certain areas— Section 1886(d)(3)(B) of the Social Security Act (42 U.S.C. 1395ww(d)(3)(B)) is amended by inserting before the period the following: “, other than additional payments described in clause (vii) of such paragraph”.
Implementation— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.
Sec. 204 Coverage of treatments for COVID–19 at no cost sharing under the Medicare Advantage program
In general— Section 1852(a)(1)(B) of the Social Security Act (42 U.S.C. 1395w–22(a)(1)(B)) is amended by adding at the end the following new clause:
“(vii) Special coverage rules for specified COVID–19 treatment services—Notwithstanding clause (i), in the case of a specified COVID–19 treatment service (as defined in section 201(b) of the Investing in America’s Health Care During the COVID–19 Pandemic Act) that is furnished during a plan year occurring during any portion of the emergency period defined in section 1135(g)(1)(B) beginning on or after the date of the enactment of this clause, a Medicare Advantage plan may not, with respect to such service, impose—
“(I) any cost-sharing requirement (including a deductible, copayment, or coinsurance requirement); and
“(II) in the case such service is a critical specified COVID–19 treatment service (including ventilator services and intensive care unit services), any prior authorization or other utilization management requirement.”
Implementation— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.
Sec. 205 Requiring coverage under Medicare PDPs and MA–PD plans, without the imposition of cost sharing or utilization management requirements, of drugs intended to treat COVID–19 during certain emergencies
Coverage requirement—
In general— Section 1860D–4(b)(3) of the Social Security Act (42 U.S.C. 1395w–104(b)(3)) is amended by adding at the end the following new subparagraph:
“(I) Required inclusion of drugs intended to treat COVID–19
“(i) In general—Notwithstanding any other provision of law, a PDP sponsor offering a prescription drug plan shall, with respect to a plan year, any portion of which occurs during the period described in clause (ii), be required to—
“(I) include in any formulary—
“(aa) all covered part D drugs with a medically accepted indication (as defined in section 1860D–2(e)(4)) to treat COVID–19 that are marketed in the United States; and
“(bb) all drugs authorized under section 564 or 564A of the Federal Food, Drug, and Cosmetic Act to treat COVID–19; and
“(II) not impose any prior authorization or other utilization management requirement with respect to such drugs described in item (aa) or (bb) of subclause (I) (other than such a requirement that limits the quantity of drugs due to safety).
“(ii) Period described—For purposes of clause (i), the period described in this clause is the period during which there exists the public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service Act on January 31, 2020, entitled “Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus” (including any renewal of such declaration pursuant to such section).”
Elimination of cost sharing—
Elimination of cost-sharing for drugs intended to treat COVID–19 under standard and alternative prescription drug coverage— Section 1860D–2 of the Social Security Act (42 U.S.C. 1395w–102) is amended—
in subsection (b)—
in paragraph (1)(A), by striking “The coverage” and inserting “Subject to paragraph (8), the coverage”;
in paragraph (2)—
in subparagraph (A), by inserting after “Subject to subparagraphs (C) and (D)” the following: “and paragraph (8)”;
in subparagraph (C)(i), by striking “paragraph (4)” and inserting “paragraphs (4) and (8)”; and
in subparagraph (D)(i), by striking “paragraph (4)” and inserting “paragraphs (4) and (8)”;
in paragraph (4)(A)(i), by striking “The coverage” and inserting “Subject to paragraph (8), the coverage”; and
by adding at the end the following new paragraph:
“(8) Elimination of cost-sharing for drugs intended to treat COVID–19—The coverage does not impose any deductible, copayment, coinsurance, or other cost-sharing requirement for drugs described in section 1860D–4(b)(3)(I)(i)(I) with respect to a plan year, any portion of which occurs during the period during which there exists the public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service Act on January 31, 2020, entitled “Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus” (including any renewal of such declaration pursuant to such section).”
in subsection (c), by adding at the end the following new paragraph:
“(4) Same elimination of cost-sharing for drugs intended to treat COVID–19—The coverage is in accordance with subsection (b)(8).”
Elimination of cost-sharing for drugs intended to treat COVID–19 dispensed to individuals who are subsidy eligible individuals— Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)) is amended—
in paragraph (1)—
in subparagraph (D)—
in clause (ii), by striking “In the case of” and inserting “Subject to subparagraph (F), in the case of”; and
in clause (iii), by striking “In the case of” and inserting “Subject to subparagraph (F), in the case of”; and
by adding at the end the following new subparagraph:
“(F) Elimination of cost-sharing for drugs intended to treat COVID–19—Coverage that is in accordance with section 1860D–2(b)(8).”
in paragraph (2)—
in subparagraph (B), by striking “A reduction” and inserting “Subject to subparagraph (F), a reduction”;
in subparagraph (D), by striking “The substitution” and inserting “Subject to subparagraph (F), the substitution”;
in subparagraph (E), by inserting after “Subject to” the following: “subparagraph (F) and”; and
by adding at the end the following new subparagraph:
“(F) Elimination of cost-sharing for drugs intended to treat COVID–19—Coverage that is in accordance with section 1860D–2(b)(8).”
Implementation— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.
Sec. 206 Medicare special enrollment period for individuals residing in COVID–19 emergency areas
In general— Section 1837(i) of the Social Security Act (42 U.S.C. 1395p(i)) is amended by adding at the end the following new paragraph:
“(5)
“(A) In the case of an individual who—
“(i) is eligible under section 1836 to enroll in the medical insurance program established by this part,
“(ii) did not enroll (or elected not to be deemed enrolled) under this section during an enrollment period, and
“(iii) during the emergency period (as described in section 1135(g)(1)(B)), resided in an emergency area (as described in such section),
“(B) The special enrollment period referred to in subparagraph (A) is the period that begins not later than December 1, 2020, and ends on the last day of the month in which the emergency period (as described in section 1135(g)(1)(B)) ends.”
Coverage period for individuals transitioning from other coverage— Section 1838(e) of the Social Security Act (42 U.S.C. 1395q(e)) is amended—
by striking “pursuant to section 1837(i)(3) or 1837(i)(4)(B)—” and inserting the following:
“(1) section 1837(i)(3) or 1837(i)(4)(B)—”
by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and moving the indentation of each such subparagraph 2 ems to the right;
by striking the period at the end of the subparagraph (B), as so redesignated, and inserting “; or”; and
by adding at the end the following new paragraph:
“(2) section 1837(i)(5), the coverage period shall begin on the first day of the month following the month in which the individual so enrolls.”
Funding— The Secretary of Health and Human Services shall provide for the transfer from the Federal Hospital Insurance Trust Fund (as described in section 1817 of the Social Security Act (42 U.S.C. 1395i)) and the Federal Supplementary Medical Insurance Trust Fund (as described in section 1841 of such Act (42 U.S.C. 1395t)), in such proportions as determined appropriate by the Secretary, to the Social Security Administration, of $30,000,000, to remain available until expended, for purposes of carrying out the amendments made by this section.
Implementation— Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.
Sec. 207 COVID–19 skilled nursing facility payment incentive program
In general— Section 1819 of the Social Security Act (42 U.S.C. 1395i–3) is amended by adding at the end the following new subsection:
“(k) COVID–19 designation program
“(1) In general—Not later than 2 weeks after the date of the enactment of this subsection, the Secretary shall establish a program under which a skilled nursing facility that makes an election described in paragraph (2)(A) and meets the requirements described in paragraph (2)(B) is designated (or a portion of such facility is so designated) as a COVID–19 treatment center and receives incentive payments under section 1888(e)(13).
“(2) Designation
“(A) In general—A skilled nursing facility may elect to be designated (or to have a portion of such facility designated) as a COVID–19 treatment center under the program established under paragraph (1) if the facility submits to the Secretary, at a time and in a manner specified by the Secretary, an application for such designation that contains such information as required by the Secretary and demonstrates that such facility meets the requirements described in subparagraph (B).
“(B) Requirements—The requirements described in this subparagraph with respect to a skilled nursing facility are the following:
“(i) The facility has a star rating with respect to staffing of 4 or 5 on the Nursing Home Compare website (as described in subsection (i)) and has maintained such a rating on such website during the 2-year period ending on the date of the submission of the application described in subparagraph (A).
“(ii) The facility has a star rating of 4 or 5 with respect to health inspections on such website and has maintained such a rating on such website during such period.
“(iii) During such period, the Secretary or a State has not found a deficiency with such facility relating to infection control that the Secretary or State determined immediately jeopardized the health or safety of the residents of such facility (as described in paragraph (1) or (2)(A) of subsection (h), as applicable).
“(iv) The facility provides care at such facility (or, in the case of an election made with respect to a portion of such facility, to provide care in such portion of such facility) only to eligible individuals.
“(v) The facility arranges for and transfers all residents of such facility (or such portion of such facility, as applicable) who are not eligible individuals to other skilled nursing facilities (or other portions of such facility, as applicable).
“(vi) The facility complies with the notice requirement described in paragraph (4).
“(vii) The facility meets the reporting requirement described in paragraph (5).
“(viii) Any other requirement determined appropriate by the Secretary.
“(3) Duration of designation
“(A) In general—A designation of a skilled nursing facility (or portion of such facility) as a COVID–19 treatment center shall begin on a date specified by the Secretary and end upon the earliest of the following:
“(i) The revocation of such designation under subparagraph (B).
“(ii) The submission of a notification by such facility to the Secretary that such facility elects to terminate such designation.
“(iii) The termination of the program (as specified in paragraph (6)).
“(B) Revocation—The Secretary may revoke the designation of a skilled nursing facility (or portion of such facility) as a COVID–19 treatment center if the Secretary determines that the facility is no longer in compliance with a requirement described in paragraph (2)(B).
“(4) Resident notice requirement—For purposes of paragraph (2)(B)(vi), the notice requirement described in this paragraph is that, not later than 72 hours before the date specified by the Secretary under paragraph (3)(A) with respect to the designation of a skilled nursing facility (or portion of such facility) as a COVID–19 treatment center, the facility provides a notification to each resident of such facility (and to appropriate representatives or family members of each such resident, as specified by the Secretary) that contains the following:
“(A) Notice of such designation.
“(B) In the case such resident is not an eligible individual (and, in the case such designation is made only with respect to a portion of such facility, resides in such portion of such facility)—
“(i) a specification of when and where such resident will be transferred (or moved within such facility);
“(ii) an explanation that, in lieu of such transfer or move, such resident may arrange for transfer to such other setting (including a home) selected by the resident; and
“(iii) if such resident so arranges to be transferred to a home, information on Internet resources for caregivers who elect to care for such resident at home.
“(C) Contact information for the State long-term care ombudsman (established under section 307(a)(12) of the Older Americans Act of 1965) for the applicable State.
“(5) Reporting requirement
“(A) In general—For purposes of paragraph (2)(B)(vii), the reporting requirement described in this paragraph is, with respect to a skilled nursing facility, that the facility reports to the Secretary, weekly and in such manner specified by the Secretary, the following (but only to the extent the information described in clauses (i) through (vii) is not otherwise reported to the Secretary weekly):
“(i) The number of COVID–19 related deaths at such facility.
“(ii) The number of discharges from such facility.
“(iii) The number of admissions to such facility.
“(iv) The number of beds occupied and the number of beds available at such facility.
“(v) The number of residents on a ventilator at such facility.
“(vi) The number of clinical and nonclinical staff providing direct patient care at such facility.
“(vii) Such other information determined appropriate by the Secretary.
“(B) Nonapplication of Paperwork Reduction Act—Chapter 35 of title 44, United States Code (commonly known as the “Paperwork Reduction Act”), shall not apply to the collection of information under this paragraph.
“(6) Definition—For purposes of this subsection, the term eligible individual means an individual who, during the 30-day period ending on the first day on which such individual is a resident of a COVID–19 treatment center (on or after the date such center is so designated), was furnished a test for COVID–19 that came back positive.
“(7) Termination—The program established under paragraph (1) shall terminate upon the termination of the emergency period described in section 1135(g)(1)(B).
“(8) Prohibition on administrative and judicial review—There shall be no administrative or judicial review under section 1869, 1878, or otherwise of a designation of a skilled nursing facility (or portion of such facility) as a COVID–19 treatment center, or revocation of such a designation, under this subsection.”
in paragraph (1), in the matter preceding subparagraph (A), by striking “and (12)” and inserting “(12), and (13)”; and
by adding at the end the following new paragraph:
“(13) Adjustment for COVID–19 treatment centers—In the case of a resident of a skilled nursing facility that has been designated as a COVID–19 treatment center under section 1819(k) (or in the case of a resident who resides in a portion of such facility that has been so designated), if such resident is an eligible individual (as defined in paragraph (5) of such section), the per diem amount of payment for such resident otherwise applicable shall be increased by 20 percent to reflect increased costs associated with such residents.”
Sec. 208 Funding for State strike teams for resident and employee safety in skilled nursing facilities and nursing facilities
In general— Of the amounts made available under subsection (c), the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall allocate such amounts among the States, in a manner that takes into account the percentage of skilled nursing facilities and nursing facilities in each State that have residents or employees who have been diagnosed with COVID–19, for purposes of establishing and implementing strike teams in accordance with subsection (b).
Use of funds— A State that receives funds under this section shall use such funds to establish and implement a strike team that will be deployed to a skilled nursing facility or nursing facility in the State with diagnosed or suspected cases of COVID–19 among residents or staff for the purposes of assisting with clinical care, infection control, or staffing.
Authorization of appropriations— For purposes of carrying out this section, there is authorized to be appropriated $500,000,000.
Definitions— In this section:
Nursing facility— The term nursing facility has the meaning given such term in section 1919(a) of the Social Security Act (42 U.S.C. 1396r(a)).
Skilled nursing facility— The term skilled nursing facility has the meaning given such term in section 1819(a) of the Social Security Act (42 U.S.C. 1395i–3(a)).
Sec. 209 Providing for infection control support to skilled nursing facilities through contracts with quality improvement organizations
by striking “The Secretary” and inserting “(1) The Secretary”; and
by adding at the end the following new paragraph:
“(2)
“(A) The Secretary shall ensure that at least 1 contract with a quality improvement organization described in paragraph (1) entered into on or after the date of the enactment of this paragraph and before the end of the emergency period described in section 1135(g)(1)(B) (or in effect as of such date) includes the requirement that such organization provide to skilled nursing facilities with cases of COVID–19 (or facilities attempting to prevent outbreaks of COVID–19) infection control support described in subparagraph (B) during such period.
“(B) For purposes of subparagraph (A), the infection control support described in this subparagraph is, with respect to skilled nursing facilities described in such subparagraph, the development and dissemination to such facilities of protocols relating to the prevention or mitigation of COVID–19 at such facilities and the provision of training materials to such facilities relating to such prevention or mitigation.”
Funding— The Secretary of Health and Human Services shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund (as described in section 1841 of the Social Security Act (42 U.S.C. 1395t)) and the Federal Hospital Insurance Trust Fund (as described in section 1817 of such Act (42 U.S.C. 1395i)), in such proportions as determined appropriate by the Secretary, to the Centers for Medicare & Medicaid Services Program Management Account, of $210,000,000, to remain available until expended, for purposes of entering into contracts with quality improvement organizations under part B of title XI of such Act (42 U.S.C. 1320c et seq.). Of the amount transferred pursuant to the previous sentence, not less that $110,000,000 shall be used for purposes of entering into such a contract that includes the requirement described in section 1862(g)(2)(A) of such Act (as added by subsection (a)).
Sec. 210 Requiring long term care facilities to report certain information relating to COVID–19 cases and deaths
In general— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall, as soon as practicable, require that the information described in paragraph (1) of section 483.80(g) of title 42, Code of Federal Regulations, or a successor regulation, be reported by a facility (as defined for purposes of such section).
Demographic information— The Secretary shall post the following information with respect to skilled nursing facilities (as defined in section 1819(a) of the Social Security Act (42 U.S.C. 1395i–3(a))) and nursing facilities (as defined in section 1919(a) of such Act (42 U.S.C. 1396r(a))) on the Nursing Home Compare website (as described in section 1819(i) of the Social Security Act (42 U.S.C. 1395i–3(i))), or a successor website, aggregated by State:
The age, race/ethnicity, and preferred language of the residents of such skilled nursing facilities and nursing facilities with suspected or confirmed COVID–19 infections, including residents previously treated for COVID–19.
The age, race/ethnicity, and preferred language relating to total deaths and COVID–19 deaths among residents of such skilled nursing facilities and nursing facilities.
Confidentiality— Any information reported under this section that is made available to the public shall be made so available in a manner that protects the identity of residents of skilled nursing facilities and nursing facilities.
Implementation— The Secretary may implement the provisions of this section be program instruction or otherwise.
Sec. 211 Floor on the Medicare area wage index for hospitals in all-urban States
In general— Section 1886(d)(3)(E) of the Social Security Act (42 U.S.C. 1395ww(d)(3)(E)) is amended—
in clause (i), in the first sentence, by striking “or (iii)” and inserting “, (iii), or (iv)”; and
by adding at the end the following new clause:
“(iv) Floor on area wage index for hospitals in all-urban States
“(I) In general—For discharges occurring on or after October 1, 2021, the area wage index applicable under this subparagraph to any hospital in an all-urban State (as defined in subclause (IV)) may not be less than the minimum area wage index for the fiscal year for hospitals in that State, as established under subclause (II).
“(II) Minimum area wage index—For purposes of subclause (I), the Secretary shall establish a minimum area wage index for a fiscal year for hospitals in each all-urban State using the methodology described in section 412.64(h)(4) of title 42, Code of Federal Regulations, as in effect for fiscal year 2018.
“(III) Waiving budget neutrality—Pursuant to the fifth sentence of clause (i), this subsection shall not be applied in a budget neutral manner.
“(IV) All-urban State defined—In this clause, the term all-urban State means a State in which there are no rural areas (as defined in paragraph (2)(D)) or a State in which there are no hospitals classified as rural under this section.”
Waiving budget neutrality—
Technical amendatory correction— Section 10324(a)(2) of Public Law 111–148 is amended by striking “third sentence” and inserting “fifth sentence”.
Waiver— Section 1886(d)(3)(E)(i) of the Social Security Act (42 U.S.C. 1395ww(d)(3)(E)(i)) is amended, in the fifth sentence—
by striking “and the amendments” and inserting “, the amendments”; and
by inserting “, and the amendments made by section 211 of the Investing in America’s Health Care During the COVID–19 Pandemic Act” after “Care Act”.
Sec. 212 Relief for small rural hospitals from inaccurate instructions provided by certain medicare administrative contractors
Section 1886(d)(5) of the Social Security Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end the following new subparagraph:
“(N)
“(i) Subject to clause (ii), in the case of a sole community hospital or a medicare-dependent, small rural hospital with respect to which a medicare administrative contractor initially determined and paid a volume decrease adjustment under subparagraph (D)(ii) or (G)(iii) for a specified cost reporting period, at the election of the hospital, the Secretary of Health and Human Services shall replace the volume decrease adjustment subsequently determined for that specified cost reporting period by the medicare administrative contractor with the volume decrease adjustment initially determined and paid by the medicare administrative contractor for that specified cost reporting period.
“(ii)
“(I) Clause (i) shall not apply in the case of a sole community hospital or a medicare-dependent, small rural hospital for which the medicare administrative contractor determination of the volume decrease adjustment with respect to a specified cost reporting period of the hospital is administratively final before the date that is three years before the date of the enactment of this section.
“(II) For purposes of subclause (I), the date on which the medicare administrative contractor determination with respect to a volume decrease adjustment for a specified cost reporting period is administratively final is the latest of the following:
“(aa) The date of the contractor determination (as defined in section 405.1801 of title 42, Code of Federal Regulations).
“(bb) The date of the final outcome of any reopening of the medicare administrative contractor determination under section 405.1885 of title 42, Code of Federal Regulations.
“(cc) The date of the final outcome of the final appeal filed by such hospital with respect to such volume decrease adjustment for such specified cost reporting period.
“(iii) For purposes of this subparagraph, the term “specified cost reporting period” means a cost reporting period of a sole community hospital or a medicare-dependent, small rural hospital, as the case may be, that begins during a fiscal year before fiscal year 2018.”
Sec. 213 Deeming certain hospitals to be located in an urban area for purposes of payment for inpatient hospital services under the Medicare program
Section 1886(d)(10) of the Social Security Act (42 U.S.C. 1395ww(d)(10)) is amended by adding at the end the following new subparagraph:
“(G)
“(i) For purposes of payment under this subsection for discharges occurring during the 3-year period beginning on October 1, 2020, each hospital located in Albany, Saratoga, Schenectady, Montgomery, or Rensselaer County of New York shall be deemed to be located in the urban area of Hartford-East Hartford-Middletown, Connecticut (CBSA 25540), notwithstanding any other reclassification or redesignation that otherwise would have applied for purposes of the wage index under this paragraph or subparagraphs (B) or (E) of paragraph (8).
“(ii) Any deemed location of a hospital pursuant to clause (i) shall be treated as a decision of the Medicare Geographic Classification Review Board for purposes of paragraph (8)(D).”
Sec. 214 Effective date of Medicare coverage of COVID–19 vaccines without any cost-sharing
Effective as if included in the enactment of the CARES Act (Public Law 116–136; 42 U.S.C. 13951 note), section 3713(d) of such Act is amended by inserting before the period at the end the following: “or authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3)”.
III Private Insurance Provisions
Sec. 301 Special enrollment period through Exchanges
Special enrollment period through Exchanges— Section 1311(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(c)) is amended—
in paragraph (6)—
in subparagraph (C), by striking at the end “and”;
in subparagraph (D), by striking at the end the period and inserting “; and”; and
by adding at the end the following new subparagraph:
“(E) subject to subparagraph (B) of paragraph (8), the special enrollment period described in subparagraph (A) of such paragraph.”
by adding at the end the following new paragraph:
“(8) Special enrollment period for certain public health emergency
“(A) In general—The Secretary shall, subject to subparagraph (B), require an Exchange to provide—
“(i) for a special enrollment period during the emergency period described in section 1135(g)(1)(B) of the Social Security Act—
“(I) which shall begin on the date that is one week after the date of the enactment of this paragraph and which, in the case of an Exchange established or operated by the Secretary within a State pursuant to section 1321(c), shall be an 8-week period; and
“(II) during which any individual who is otherwise eligible to enroll in a qualified health plan through the Exchange may enroll in such a qualified health plan; and
“(ii) that, in the case of an individual who enrolls in a qualified health plan through the Exchange during such enrollment period, the coverage period under such plan shall begin on the first day of the month following the day the individual selects a plan through such special enrollment period.
“(B) Exception—The requirement of subparagraph (A) shall not apply to a State-operated or State-established Exchange if such Exchange, prior to the date of the enactment of this paragraph, established or otherwise provided for a special enrollment period to address access to coverage under qualified health plans offered through such Exchange during the emergency period described in section 1135(g)(1)(B) of the Social Security Act.”
Implementation— The Secretary of Health and Human Services may implement the provisions of (including amendments made by) this section through subregulatory guidance, program instruction, or otherwise.
Sec. 302 Expedited Meeting Of ACIP For COVID–19 Vaccines
In general— Notwithstanding section 3091 of the 21st Century Cures Act (21 U.S.C. 360bbb–4 note), the Advisory Committee on Immunization Practices shall meet and issue a recommendation with respect to a vaccine that is intended to prevent or treat COVID–19 not later than 15 business days after the date on which such vaccine is licensed under section 351 of the Public Health Service Act (42 U.S.C. 262).
Definition— In this section, the term Advisory Committee on Immunization Practices means the Advisory Committee on Immunization Practices established by the Secretary of Health and Human Services pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention.
Sec. 303 Coverage of COVID–19 related treatment at no cost sharing
In general— A group health plan and a health insurance issuer offering group or individual health insurance coverage (including a grandfathered health plan (as defined in section 1251(e) of the Patient Protection and Affordable Care Act)) shall provide coverage, and shall not impose any cost sharing (including deductibles, copayments, and coinsurance) requirements, for the following items and services furnished during any portion of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Social Security Act (42 U.S.C. 1320b–5(g)) beginning on or after the date of the enactment of this Act:
Medically necessary items and services (including in-person or telehealth visits in which such items and services are furnished) that are furnished to an individual who has been diagnosed with (or after provision of the items and services is diagnosed with) COVID–19 to treat or mitigate the effects of COVID–19.
Medically necessary items and services (including in-person or telehealth visits in which such items and services are furnished) that are furnished to an individual who is presumed to have COVID–19 but is never diagnosed as such, if the following conditions are met:
Such items and services are furnished to the individual to treat or mitigate the effects of COVID–19 or to mitigate the impact of COVID–19 on society.
Health care providers have taken appropriate steps under the circumstances to make a diagnosis, or confirm whether a diagnosis was made, with respect to such individual, for COVID–19, if possible.
Items and services related to COVID–19— For purposes of this section—
not later than one week after the date of the enactment of this section, the Secretary of Health and Human Services, Secretary of Labor, and Secretary of the Treasury shall jointly issue guidance specifying applicable diagnoses and medically necessary items and services related to COVID–19; and
such items and services shall include all items or services that are relevant to the treatment or mitigation of COVID–19, regardless of whether such items or services are ordinarily covered under the terms of a group health plan or group or individual health insurance coverage offered by a health insurance issuer.
Enforcement—
Application with respect to PHSA, ERISA, and IRC— The provisions of this section shall be applied by the Secretary of Health and Human Services, Secretary of Labor, and Secretary of the Treasury to group health plans and health insurance issuers offering group or individual health insurance coverage as if included in the provisions of part A of title XXVII of the Public Health Service Act, part 7 of the Employee Retirement Income Security Act of 1974, and subchapter B of chapter 100 of the Internal Revenue Code of 1986, as applicable.
Private right of action— An individual with respect to whom an action is taken by a group health plan or health insurance issuer offering group or individual health insurance coverage in violation of subsection (a) may commence a civil action against the plan or issuer for appropriate relief. The previous sentence shall not be construed as limiting any enforcement mechanism otherwise applicable pursuant to paragraph (1).
Implementation— The Secretary of Health and Human Services, Secretary of Labor, and Secretary of the Treasury may implement the provisions of this section through sub-regulatory guidance, program instruction or otherwise.
Terms— The terms group health plan; “health insurance issuer”; “group health insurance coverage”, and “individual health insurance coverage” have the meanings given such terms in section 2791 of the Public Health Service Act (42 U.S.C. 300gg–91), section 733 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191b), and section 9832 of the Internal Revenue Code of 1986, as applicable.
Sec. 304 Requiring prescription drug refill notifications during emergencies
ERISA—
In general— Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the following new section:
“716. Provision of prescription drug refill notifications during emergencies
“(a) In general—A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, that provides benefits for prescription drugs under such plan or such coverage shall provide to each participant or beneficiary under such plan or such coverage who resides in an emergency area during an emergency period—
“(1) not later than 5 business days after the date of the beginning of such period with respect to such area (or, the case of the emergency period described in section 304(d)(2) of the Investing in America’s Health Care During the COVID–19 Pandemic Act, not later than 5 business days after the date of the enactment of this section), a notification (written in a manner that is clear and understandable to the average participant or beneficiary)—
“(A) of whether such plan or coverage will waive, during such period with respect to such a participant or beneficiary, any time restrictions under such plan or coverage on any authorized refills for such drugs to enable such refills in advance of when such refills would otherwise have been permitted under such plan or coverage; and
“(B) in the case that such plan or coverage will waive such restrictions during such period with respect to such a participant or beneficiary, that contains information on how such a participant or beneficiary may obtain such a refill; and
“(2) in the case such plan or coverage elects to so waive such restrictions during such period with respect to such a participant or beneficiary after the notification described in paragraph (1) has been provided with respect to such period, not later than 5 business days after such election, a notification of such election that contains the information described in subparagraph (B) of such paragraph.
“(b) Emergency area; emergency period—For purposes of this section, an “emergency area” is a geographical area in which, and an “emergency period” is the period during which, there exists—
“(1) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act; and
“(2) a public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service Act.”
Clerical amendment— The table of contents of the Employee Retirement Income Security Act of 1974 is amended by inserting after the item relating to section 714 the following:
PHSA— Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following new section:
“2730. Provision of prescription drug refill notifications during emergencies
“(a) In general—A group health plan, and a health insurance issuer offering group or individual health insurance coverage, that provides benefits for prescription drugs under such plan or such coverage shall provide to each participant, beneficiary, or enrollee enrolled under such plan or such coverage who resides in an emergency area during an emergency period—
“(1) not later than 5 business days after the date of the beginning of such period with respect to such area (or, the case of the emergency period described in section 304(d)(2) of the Investing in America’s Health Care During the COVID–19 Pandemic Act, not later than 5 business days after the date of the enactment of this section), a notification (written in a manner that is clear and understandable to the average participant, beneficiary, or enrollee)—
“(A) of whether such plan or coverage will waive, during such period with respect to such a participant, beneficiary, or enrollee, any time restrictions under such plan or coverage on any authorized refills for such drugs to enable such refills in advance of when such refills would otherwise have been permitted under such plan or coverage; and
“(B) in the case that such plan or coverage will waive such restrictions during such period with respect to such a participant, beneficiary, or enrollee, that contains information on how such a participant, beneficiary, or enrollee may obtain such a refill; and
“(2) in the case such plan or coverage elects to so waive such restrictions during such period with respect to such a participant, beneficiary, or enrollee after the notification described in paragraph (1) has been provided with respect to such period, not later than 5 business days after such election, a notification of such election that contains the information described in subparagraph (B) of such paragraph.
“(b) Emergency area; emergency period—For purposes of this section, an “emergency area” is a geographical area in which, and an “emergency period” is the period during which, there exists—
“(1) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act; and
“(2) a public health emergency declared by the Secretary pursuant to section 319.”
IRC—
In general— Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:
“9816. Provision of prescription drug refill notifications during emergencies
“(a) In general—A group health plan that provides benefits for prescription drugs under such plan shall provide to each participant or beneficiary enrolled under such plan who resides in an emergency area during an emergency period, not later than 5 business days after the date of the beginning of such period with respect to such area (or, the case of the emergency period described in section 304(d)(2) of the Investing in America’s Health Care During the COVID–19 Pandemic Act, not later than 5 business days after the date of the enactment of this section)—
“(1) a notification (written in a manner that is clear and understandable to the average participant or beneficiary)—
“(A) of whether such plan will waive, during such period with respect to such a participant or beneficiary, any time restrictions under such plan on any authorized refills for such drugs to enable such refills in advance of when such refills would otherwise have been permitted under such plan; and
“(B) in the case that such plan will waive such restrictions during such period with respect to such a participant or beneficiary, that contains information on how such a participant or beneficiary may obtain such a refill; and
“(2) in the case such plan elects to so waive such restrictions during such period with respect to such a participant or beneficiary after the notification described in paragraph (1) has been provided with respect to such period, not later than 5 business days after such election, a notification of such election that contains the information described in subparagraph (B) of such paragraph.
“(b) Emergency area; emergency period—For purposes of this section, an “emergency area” is a geographical area in which, and an “emergency period” is the period during which, there exists—
“(1) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act; and
“(2) a public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service Act.”
Clerical amendment— The table of sections for subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:
Effective date— The amendments made by this section shall apply with respect to—
emergency periods beginning on or after the date of the enactment of this Act; and
the emergency period relating to the public health emergency declared by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act on January 31, 2020, entitled “Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus”.
Sec. 305 Improvement of certain notifications provided to qualified beneficiaries by group health plans in the case of qualifying events
Employee Retirement Income Security Act of 1974—
In general— Section 606 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1166) is amended—
in subsection (a)(4), in the matter following subparagraph (B), by striking “under this subsection” and inserting “under this part in accordance with the notification requirements under subsection (c)”; and
in subsection (c)—
by striking “For purposes of subsection (a)(4), any notification” and inserting
“(1) any notification”
by striking “, whichever is applicable, and any such notification” and inserting
“(2) any such notification”
by striking “such notification is made” and inserting
“(3) any such notification shall, with respect to each qualified beneficiary with respect to whom such notification is made, include information regarding any Exchange established under title I of the Patient Protection and Affordable Care Act through which such a qualified beneficiary may be eligible to enroll in a qualified health plan (as defined in section 1301 of the Patient Protection and Affordable Care Act), including—
“(A) the publicly accessible Internet website address for such Exchange;
“(B) the publicly accessible Internet website address for the Find Local Help directory maintained by the Department of Health and Human Services on the healthcare.gov Internet website (or a successor website);
“(C) a clear explanation that—
“(i) an individual who is eligible for continuation coverage may also be eligible to enroll, with financial assistance, in a qualified health plan offered through such Exchange, but, in the case that such individual elects to enroll in such continuation coverage and subsequently elects to terminate such continuation coverage before the period of such continuation coverage expires, such individual will not be eligible to enroll in a qualified health plan offered through such Exchange during a special enrollment period; and
“(ii) an individual who elects to enroll in continuation coverage will remain eligible to enroll in a qualified health plan offered through such Exchange during an open enrollment period and may be eligible for financial assistance with respect to enrolling in such a qualified health plan;
“(D) information on consumer protections with respect to enrolling in a qualified health plan offered through such Exchange, including the requirement for such a qualified health plan to provide coverage for essential health benefits (as defined in section 1302(b) of the Patient Protection and Affordable Care Act) and the requirements applicable to such a qualified health plan under part A of title XXVII of the Public Health Service Act; and
“(E) information on the availability of financial assistance with respect to enrolling in a qualified health plan, including the maximum income limit for eligibility for a premium tax credit under section 36B of the Internal Revenue Code of 1986.”
Effective date— The amendments made by paragraph (1) shall apply with respect to qualifying events occurring on or after the date that is 14 days after the date of the enactment of this Act.
Public Health Service Act—
by striking “In accordance” and inserting the following:
“(a) In general—In accordance”
by striking “of such beneficiary’s rights under this subsection” and inserting “of such beneficiary’s rights under this title in accordance with the notification requirements under subsection (b)”; and
by striking “For purposes of paragraph (4),” and all that follows through “such notification is made.” and inserting the following:
“(b) Rules relating to notification of qualified beneficiaries by plan administrator—For purposes of subsection (a)(4)—
“(1) any notification shall be made within 14 days of the date on which the plan administrator is notified under paragraph (2) or (3) of subsection (a), whichever is applicable;
“(2) any such notification to an individual who is a qualified beneficiary as the spouse of the covered employee shall be treated as notification to all other qualified beneficiaries residing with such spouse at the time such notification is made; and
“(3) any such notification shall, with respect to each qualified beneficiary with respect to whom such notification is made, include information regarding any Exchange established under title I of the Patient Protection and Affordable Care Act through which such a qualified beneficiary may be eligible to enroll in a qualified health plan (as defined in section 1301 of the Patient Protection and Affordable Care Act), including—
“(A) the publicly accessible Internet website address for such Exchange;
“(B) the publicly accessible Internet website address for the Find Local Help directory maintained by the Department of Health and Human Services on the healthcare.gov Internet website (or a successor website);
“(C) a clear explanation that—
“(i) an individual who is eligible for continuation coverage may also be eligible to enroll, with financial assistance, in a qualified health plan offered through such Exchange, but, in the case that such individual elects to enroll in such continuation coverage and subsequently elects to terminate such continuation coverage before the period of such continuation coverage expires, such individual will not be eligible to enroll in a qualified health plan offered through such Exchange during a special enrollment period; and
“(ii) an individual who elects to enroll in continuation coverage will remain eligible to enroll in a qualified health plan offered through such Exchange during an open enrollment period and may be eligible for financial assistance with respect to enrolling in such a qualified health plan;
“(D) information on consumer protections with respect to enrolling in a qualified health plan offered through such Exchange, including the requirement for such a qualified health plan to provide coverage for essential health benefits (as defined in section 1302(b) of the Patient Protection and Affordable Care Act) and the requirements applicable to such a qualified health plan under part A of title XXVII; and
“(E) information on the availability of financial assistance with respect to enrolling in a qualified health plan, including the maximum income limit for eligibility for a premium tax credit under section 36B of the Internal Revenue Code of 1986.”
Effective date— The amendments made by paragraph (1) shall apply with respect to qualifying events occurring on or after the date that is 14 days after the date of the enactment of this Act.
Internal Revenue Code of 1986—
in subparagraph (D)—
in clause (ii), by striking “under subparagraph (C)” and inserting “under clause (iii)”; and
by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and moving the margin of each such subclause, as so redesignated, 2 ems to the right;
by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively, and moving the margin of each such clause, as so redesignated, 2 ems to the right;
by striking “In accordance” and inserting the following:
“(A) In general—In accordance”
by inserting after “of such beneficiary’s rights under this subsection” the following: “in accordance with the notification requirements under subparagraph (C)”; and
by striking “The requirements of subparagraph (B)” and all that follows through “such notification is made.” and inserting the following:
“(B) Alternative means of compliance with requirement for notification of multiemployer plans by employers—The requirements of subparagraph (A)(ii) shall be considered satisfied in the case of a multiemployer plan in connection with a qualifying event described in paragraph (3)(B) if the plan provides that the determination of the occurrence of such qualifying event will be made by the plan administrator.
“(C) Rules relating to notification of qualified beneficiaries by plan administrator—For purposes of subparagraph (A)(iv)—
“(i) any notification shall be made within 14 days (or, in the case of a group health plan which is a multiemployer plan, such longer period of time as may be provided in the terms of the plan) of the date on which the plan administrator is notified under clause (ii) or (iii) of subparagraph (A), whichever is applicable;
“(ii) any such notification to an individual who is a qualified beneficiary as the spouse of the covered employee shall be treated as notification to all other qualified beneficiaries residing with such spouse at the time such notification is made; and
“(iii) any such notification shall, with respect to each qualified beneficiary with respect to whom such notification is made, include information regarding any Exchange established under title I of the Patient Protection and Affordable Care Act through which such a qualified beneficiary may be eligible to enroll in a qualified health plan (as defined in section 1301 of the Patient Protection and Affordable Care Act), including—
“(I) the publicly accessible Internet website address for such Exchange;
“(II) the publicly accessible Internet website address for the Find Local Help directory maintained by the Department of Health and Human Services on the healthcare.gov Internet website (or a successor website);
“(III) a clear explanation that—
“(aa) an individual who is eligible for continuation coverage may also be eligible to enroll, with financial assistance, in a qualified health plan offered through such Exchange, but, in the case that such individual elects to enroll in such continuation coverage and subsequently elects to terminate such continuation coverage before the period of such continuation coverage expires, such individual will not be eligible to enroll in a qualified health plan offered through such Exchange during a special enrollment period; and
“(bb) an individual who elects to enroll in continuation coverage will remain eligible to enroll in a qualified health plan offered through such Exchange during an open enrollment period and may be eligible for financial assistance with respect to enrolling in such a qualified health plan;
“(IV) information on consumer protections with respect to enrolling in a qualified health plan offered through such Exchange, including the requirement for such a qualified health plan to provide coverage for essential health benefits (as defined in section 1302(b) of the Patient Protection and Affordable Care Act) and the requirements applicable to such a qualified health plan under part A of title XXVII of the Public Health Service Act; and
“(V) information on the availability of financial assistance with respect to enrolling in a qualified health plan, including the maximum income limit for eligibility for a premium tax credit under section 36B.”
Effective date— The amendments made by paragraph (1) shall apply with respect to qualifying events occurring on or after the date that is 14 days after the date of the enactment of this Act.
Model notices— Not later than 14 days after the date of the enactment of this Act, the Secretary of the Labor, in consultation with the Secretary of the Treasury and the Secretary of Health and Human Services, shall—
update the model Consolidated Omnibus Budget Reconciliation Act of 1985 (referred to in this subsection as “COBRA”) continuation coverage general notice and the model COBRA continuation coverage election notice developed by the Secretary of Labor for purposes of facilitating compliance of group health plans with the notification requirements under section 606 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1166) to include the information described in paragraph (3) of subsection (c) of such section 606, as added by subsection (a)(1);
provide an opportunity for consumer testing of each such notice, as so updated, to ensure that each such notice is clear and understandable to the average participant or beneficiary of a group health plan; and
rename the model COBRA continuation coverage general notice and the model COBRA continuation coverage election notice as the “model COBRA continuation coverage and Affordable Care Act coverage general notice” and the “model COBRA continuation coverage and Affordable Care Act coverage election notice”, respectively.
Sec. 306 Sooner coverage of testing for COVID–19
Section 6001(a) of division F of the Families First Coronavirus Response Act (42 U.S.C. 1320b–5 note) is amended by striking “beginning on or after” and inserting “beginning before, on, or after”.
Sec. 307 Clarifying scope of coverage requirement for items and services relating to COVID–19
Section 6001 of the Families First Coronavirus Response Act (Public Law 116–127) is amended—
in subsection (b), by striking “subsection (a)” and inserting “subsections (a) and (e)”; and
by adding at the end the following new subsection:
“(e) Scope of coverage requirement—A group health plan and a health insurance issuer offering group or individual health insurance coverage (including a grandfathered health plan (as defined in section 1251(e) of the Patient Protection and Affordable Care Act)) shall provide coverage, without cost sharing and without prior authorization or other medical management requirements, in accordance with subsection (a) for tests, items, and services described in such subsection and furnished to an individual during the emergency period defined in paragraph (1)(B) of section 1135(g) of the Social Security Act (42 U.S.C. 1320b-5(g)), regardless of—
“(1) why such individual sought such tests, items, and services;
“(2) the nature of the clinical assessment that was associated with such tests, items, and services;
“(3) whether such individual was showing symptoms prior to being furnished such tests, items, and services;
“(4) in the case of such tests, whether or not such tests were ordered by a provider;
“(5) the frequency with which such individual is furnished such tests, items, and services; and
“(6) any other review of the encounters or events that preceded or followed the furnishing of such tests, items, and services.”
Sec. 308 Guidance on billing for provider visits associated with COVID–19 testing
The Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury shall jointly issue guidance not later than 30 days after the date of enactment of this Act for purposes of clarifying—
the process for submitting claims for tests, items, and services described in section 6001(a) of the Families First Coronavirus Response Act (Public Law 116–127) to ensure that individuals enrolled in individual or group health insurance coverage or group health plans (including grandfathered health plans (as defined in section 1251(e) of the Patient Protection and Affordable Care Act)) to whom such tests, items, and services are furnished are not subject to cost-sharing (including deductibles, copayments, and coinsurance) or prior authorization or other medical management requirements; and
that providers should not collect cost-sharing amounts from such individuals seeking such tests, items, or services.
Sec. 309 Improvements to transparency of the pricing of diagnostic testing for COVID–19
in subsection (b)—
in the heading, by inserting “and related items and services” after “diagnostic testing for COVID–19”;
in paragraph (1)—
by striking “a diagnostic test for COVID–19” and inserting “a test, item, or service described in section 6001(a) of division F of the Families First Coronavirus Response Act”; and
by striking “such test” and inserting “such test, item, or service”; and
in paragraph (2), by striking “a diagnostic test for COVID–19” and inserting “a test, item, or service described in section 6001(a) of division F of the Families First Coronavirus Response Act”; and
by adding at the end the following new subsections:
“(c) Improvements to transparency policy
“(1) In general—Not later than 30 days after the date of the enactment of this subsection, the Secretary of Health and Human Services shall conduct a survey of providers of the items and services described in section 6001(a) of division F of the Families First Coronavirus Response Act (Public Law 116– 127) regarding the cash prices for such items and services listed by the providers on a public internet website of such provider.
“(2) Representative sample—In carrying out paragraph (1), the Secretary shall survey a sample of providers that is representative of the diversity of sizes, geographic locations, and care settings (such as hospitals, laboratories, and independent freestanding emergency department) in which diagnostic testing for COVID–19 is performed.
“(d) Public report—Not later than 60 days after the date of the enactment of this subsection, the Secretary of Health and Human Services shall publish on the Internet website of the Department of Health and Human Services a report on cash prices for items and services published under subsection (b)(1) during the period beginning on the date of the enactment of this Act and ending on the date of the enactment of this subsection, which shall include—
“(1) the percentage of providers that comply with the publication requirement under such subsection;
“(2) the average cash price for each item and service described in section 6001(a) of division F of the Families First Coronavirus Response Act that is published under such subsection;
“(3) with respect to each such item and service, a comparison of such average cash price to the reimbursement rate under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.); and
“(4) any cash prices published under such subsection that substantially exceed the average cash price for each such item or service and the name of each provider that charges such prices.”
Sec. 310 Grants for Exchange outreach, education, and enrollment assistance
Outreach and education grants to States and navigator enrollment grants to Exchanges to assist eligible individuals—
Outreach and education grants to States—
In general— The Secretary of Health and Human Services shall carry out a program that awards grants to States that provide outreach and educational activities for purposes of informing individuals of the availability of coverage under qualified health plans offered through an Exchange and financial assistance for coverage under such plans (including the informing of eligible individuals of the availability of coverage under qualified health plans offered through an Exchange during the application process for unemployment compensation under State or Federal law).
Consideration of certain needs of population of Exchange— The outreach and educational activities described in subparagraph (A) shall be provided in a manner that is culturally and linguistically appropriate to the needs of the populations being served by the Exchange (including hard-to-reach populations, such as racial and sexual minorities, limited English proficient populations, and young adults).
Applications— To be eligible to receive a grant under this paragraph, a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
Limitation on use of funds— No funds appropriated under paragraph (4)(A) shall be used for expenditures for promoting non-ACA compliant health insurance coverage.
Grant duration and amount—
Duration— Each grant under this paragraph shall be for a 1-year period that begins on the date of the enactment of this Act (which may be renewed for a 1-year period by the Secretary of Health and Human Services).
Amount—
In general— The Secretary of Health and Human Services shall determine the amount of each grant under this paragraph.
Minimum— Each grant under this paragraph shall be for an amount that is at least $500,000 for each 1-year period, and if applicable, at least $500,000 for any 1-year period of renewal.
Navigator enrollment grants through Exchanges—
In general— The Secretary of Health and Human Services shall award grants to Exchanges described in subparagraph (D) for purposes of facilitating the enrollment of individuals in qualified health plans offered through such Exchanges.
Use of funds— Funds made available under a grant made under subparagraph (A) may only be used by such Exchanges to carry out the navigator program described in subsection (i)(1) of such section 1311.
Applications— To be eligible to receive a grant under this paragraph, for purposes of carrying out subparagraph (A), an Exchange described in subparagraph (D) shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
Exchange described— For purposes of this paragraph, an Exchange described in this subparagraph is an Exchange that a State establishes and operates pursuant to section 1311(b)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(b)(1)).
Appropriations— There are appropriated for each of fiscal years 2021 and 2022, to remain available through fiscal year 2023—
$100,000,000 to carry out paragraph (1)(A); and
$100,000,000—
to carry out paragraph (2)(A); and
to carry out the navigator program described in section 1311(i) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(i)) for Exchanges operated by the Secretary pursuant to section 1321(c)(1) of such Act (42 U.S.C. 18041(c)(1))).
Definitions— In this subsection:
Eligible individuals— The term “eligible individual” means, with respect to an Exchange, an individual who is otherwise eligible to enroll through such Exchange.
Exchange— The term “Exchange” means an American Health Benefit Exchange established under section 1311 of the Patient Protection and Affordable Care Act (42 U.S.C. 18031).
Non-ACA compliant health insurance coverage—
In general— The term “non-ACA compliant health insurance coverage” means health insurance coverage, or a group health plan, that is not a qualified health plan.
Inclusion— Such term includes the following:
An association health plan.
Short-term limited duration insurance.
Qualified health plan— The term “qualified health plan” has the meaning given such term in section 1301(a)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18021(a)(1)).
Implementation— The Secretary of Health and Human Services may implement the provisions of this section through subregulatory guidance, program instruction, or otherwise.
Sec. 311 Application of premium tax credit in case of individuals receiving unemployment compensation during the COVID-19 public health emergency
In general— Section 36B of the Internal Revenue Code of 1986, as amended by the preceding provisions of this Act, is amended by redesignating subsection (g) as subsection (h) and by inserting after subsection (f) the following new subsection:
“(g) Special rule for individuals who receive unemployment compensation during COVID-19 public health emergency
“(1) In general—For purposes of the credit determined under this section, in the case of a taxpayer who has received, or has been approved to receive, unemployment compensation for any week during the applicable period, for the taxable year in which such week begins—
“(A) such taxpayer shall be treated as an applicable taxpayer, and
“(B) there shall not be taken into account any household income of the taxpayer in excess of 133 percent of the poverty line for a family of the size involved.
“(2) Applicable period—For purposes of this section, the applicable period is the period that—
“(A) begins on the date of the enactment of this subsection, and
“(B) ends 60 days after the last day of the emergency period described in section 1135(g)(1)(B) of the Social Security Act.
“(3) Reasonable evidence of unemployment compensation—For purposes of this subsection, a taxpayer shall not be treated as having received (or been approved to receive) unemployment compensation for any week unless such taxpayer provides documentation which demonstrates such receipt or approval.
“(4) Unemployment compensation—For purposes of this subsection, the term “unemployment compensation” has the meaning given such term in section 1311(c)(8)(E) of the Patient Protection and Affordable Care Act.”
Effective date— The amendments made by this section shall apply to taxable years beginning after December 31, 2019.
Sec. 312 Increasing accessibility and affordability to qualified health plans for individuals receiving unemployment compensation during the COVID–19 emergency period
Establishment of special enrollment periods for individuals receiving unemployment compensation— Section 1311(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(c)) is amended—
in paragraph (6)—
in subparagraph (C), by striking at the end “and”;
in subparagraph (D), by striking the period at the end and inserting “; and”; and
by adding at the end the following new subparagraph:
“(E) special enrollment periods described in paragraph (8).”
by adding at the end the following new paragraph:
“(8) Special enrollment periods for individuals receiving unemployment compensation
“(A) In general—The special enrollment period described in this paragraph—
“(i) in the case of an individual who becomes eligible for unemployment compensation on any date before January 1, 2021, is the period beginning on the first day on or after such date that the individual is not eligible for minimum essential coverage (as defined in section 5000A(f) of the Internal Revenue Code of 1986) and ending on the later of—
“(I) December 31, 2020; and
“(II) the day that is 60 days after such first day; and
“(ii) in the case of an individual who becomes eligible for unemployment compensation beginning on any date that is on or after January 1, 2021, is the 60-day period beginning on the first day on or after such date that the individual is not eligible for minimum essential coverage.
“(B) Self-attestation—For purposes of this paragraph, eligibility of an individual for unemployment compensation and the date on which such eligibility begins shall be determined by the self-attestation of such individual.
“(C) Exclusion—For purposes of this paragraph, an individual shall not be treated as eligible for minimum essential coverage if—
“(i) such individual is eligible only for coverage described in section 5000A(f)(1)(C) of the Internal Revenue Code of 1986; or
“(ii) such individual would not be treated as eligible for minimum essential coverage pursuant to section 36B(c)(2)(C) of such Code.
“(D) Clarification—Nothing in subparagraph (A) shall be construed to prohibit an individual described in such subparagraph from qualifying for multiple special enrollment periods under such subparagraph.
“(E) Unemployment compensation defined—In this paragraph, the term “unemployment compensation” means, with respect to an individual—
“(i) regular compensation and extended compensation (as such terms are defined by section 205 of the Federal-State Extended Unemployment Compensation Act of 1970);
“(ii) unemployment compensation (as defined by section 85(b) of the Internal Revenue Code of 1986) provided under any program administered by a State under an agreement with the Secretary;
“(iii) pandemic unemployment assistance under section 2102 of the CARES Act;
“(iv) pandemic emergency unemployment compensation under section 2107 of the CARES Act;
“(v) pandemic emergency unemployment extension compensation under section 2107A of the CARES Act;
“(vi) unemployment benefits under the Railroad Unemployment Insurance Act; and
“(vii) trade adjustment assistance under title II of the Trade Act of 1974;”
Requirement for first day of coverage for individuals receiving unemployment compensation enrolling during special enrollment periods— Section 1303 of the Patient Protection and Affordable Care Act (42 U.S.C. 18023) is amended by adding at the end the following new subsection:
“(e) Requirement for first day of coverage for individuals receiving unemployment compensation enrolling during special enrollment periods
“(1) In general—In the case of an individual described in section 1311(c)(8)(A) who enrolls in a qualified health plan through an Exchange during a month during a special enrollment period described in such section, such coverage shall be effective beginning on—
“(A) if such individual was enrolled in minimum essential coverage (other than the qualified health plan enrolled through such a special enrollment period) on the first day of such month, the first day of such month on which the individual is longer so enrolled; and
“(B) if such individual was not enrolled in minimum essential coverage (other than the qualified health plan enrolled through such a special enrollment period) on the first day of such month, the first day of such month.
“(2) Minimum essential coverage defined—In this subsection, the term “minimum essential coverage” has the meaning given such term in section 5000A(f) of the Internal Revenue Code of 1986.”
Model notice and publication of information relating to special enrollment periods and credits for individuals receiving unemployment compensation—
Model notice— The Secretary of Health and Human Services shall make available to States a model notice (which may be sent by mail, email, or electronic means upon the receipt of unemployment compensation (as defined in subparagraph (D) of section 1311(c)(8) of the Patient Protection and Affordable Care Act, as added by subsection (a)) that includes information with respect to the eligibility of individuals described in subparagraph (A) of such section—
to enroll in a qualified health plan offered through an Exchange during a special enrollment period described in section 1311(c)(8)(A) of such Act;
for the premium tax credit under section 36B of the Internal Revenue Code of 1986; and
for any increase to the premium tax credit an individual otherwise receives under section 36B of the Internal Revenue Code of 1986 by reason of subsection (g) of such section.
Publication of information— Section 1311(b) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(b)) by adding at the end the following new paragraph:
“(3) Publication of information relating to a special enrollment period and credits—An Exchange shall, not later than 7 days after the date of the enactment of this paragraph, prominently post on the homepage of the Internet website for such Exchange information with respect to the special enrollment period described in subsection (c)(8)(A) and hyperlinks to information with respect to the eligibility of individuals described in such subsection—
“(A) to enroll in a qualified health plan offered through an Exchange during a special enrollment period described in such subsection;
“(B) for the premium tax credit under section 36B of the Internal Revenue Code of 1986; and
“(C) for any increase to the premium tax credit an individual otherwise receives under section 36B of the Internal Revenue Code of 1986 by reason of subsection (g) of such section.”
Sec. 313 Temporary modification of limitations on reconciliation of tax credits for coverage under a qualified health plan with advance payments of such credit
In general— Section 36B(f)(2)(B) of the Internal Revenue Code of 1986 is amended by adding at the end the following new clause:
“(iii) Temporary modification of limitation on increase—In the case of any taxable year beginning in 2020 or 2021, clause (i) shall be applied—
“(I) by substituting “600 percent” for “400 percent” the first place it appears therein, and
“(II) by substituting the following table for the table contained therein:”
Effective date— The amendment made by this section shall apply to taxable years beginning after December 31, 2019.
Sec. 314 Requirements for COBRA notices relating to the availability of health insurance coverage and assistance
Additional notification requirement for COBRA notices—
In general— In the case of a notice provided under section 606(a)(4) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1166(4)), section 4980B(f)(6)(D) of the Internal Revenue Code of 1986, or section 2206(4) of the Public Health Service Act (42 U.S.C. 300bb–6(4)), with respect to an individual who, during the period described in paragraph (2), becomes entitled to elect COBRA continuation coverage, the requirements of such provisions shall not be treated as met unless such notice includes an additional written notice advising such individual, in clear and understandable language—
that such individual may be eligible for—
a special enrollment period described in section 1311(c)(8)(A) of the Patient Protection and Affordable Care Act; and
a premium tax credit under section 36B of the Internal Revenue Code of 1986 (including a possible increase to such credit by reason of subsection (g) of such section); and
of the existence and potential effects of the temporary modification of limitations on reconciliation of such credits under section 36B(f)(2)(B)(iii) of such Code.
Period described— For purposes of paragraph (1), the period described in this paragraph is the period that—
begins 14 days after the date of the enactment of this Act; and
ends 60 days after the last day of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)).
Form— The requirement of the additional notification under this subsection may be met by amendment of existing notice forms or by inclusion of a separate document with the notice otherwise required.
Model notices— Not later than 14 days after the date of enactment of this Act, with respect to any individual described in paragraph (1), the Secretary of Labor, in consultation with the Secretary of the Treasury and the Secretary of Health and Human Services, shall prescribe models for the additional notification required under this subsection. Such models shall include an estimate of the amount of the monthly premium of a silver-level qualified health plan offered through an Exchange following the application of tax credits under section 36B of the Internal Revenue Code of 1986 for the average individual eligible for the special enrollment period described in paragraph (1)(A)(i).
Outreach by the Secretary of Labor— The Secretary of Labor, in consultation with the Secretary of the Treasury and the Secretary of Health and Human Services, shall provide outreach consisting of public education and enrollment assistance relating to premium assistance, special enrollment periods, and reconciliation modifications described in subsection (a)(1). Such outreach shall target employers, group health plan administrators, public assistance programs, States, consumers, and other entities as determined appropriate by such Secretaries. Information on such premium assistance, special enrollment periods, and reconciliation modifications shall also be made available on the websites of the Departments of Labor, Treasury, and Health and Human Services.
Definitions— In this section:
COBRA continuation coverage— The term COBRA continuation coverage means continuation coverage provided pursuant to part 6 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (other than under section 609), title XXII of the Public Health Service Act, or section 4980B of the Internal Revenue Code of 1986 (other than subsection (f)(1) of such section insofar as it relates to pediatric vaccines), or under a State program that provides comparable continuation coverage. Such term does not include coverage under a health flexible spending arrangement under a cafeteria plan within the meaning of section 125 of the Internal Revenue Code of 1986.
Exchange— The term “Exchange” means an American Health Benefit Exchange established under section 1311 of the Patient Protection and Affordable Care Act.
Group health plan— The term group health plan has the meaning given such term in section 607(1) of the Employee Retirement Income Security Act of 1974.
Qualified health plan— The term “qualified health plan” has the meaning given such term in section 1301(a)(1) of the Patient Protection and Affordable Care Act.
State— The term State includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
Unemployment compensation— The term “unemployment compensation” means, with respect to an individual—
regular compensation and extended compensation (as such terms are defined by section 205 of the Federal-State Extended Unemployment Compensation Act of 1970);
unemployment compensation (as defined by section 85(b) of the Internal Revenue Code of 1986) provided under any program administered by a State under an agreement with the Secretary;
pandemic unemployment assistance under section 2102 of the CARES Act;
pandemic emergency unemployment compensation under section 2107 of the CARES Act;
unemployment benefits under the Railroad Unemployment Insurance Act; and
trade adjustment assistance under title II of the Trade Act of 1974;
IV Application to Other Health Programs
Sec. 401 Prohibition on copayments and cost sharing for TRICARE beneficiaries receiving COVID–19 treatment
In general— Section 6006(a) of the Families First Coronavirus Response Act (Public Law 116–127; 38 U.S.C. 1074 note) is amended by striking “or visits described in paragraph (2) of such section” and inserting “, visits described in paragraph (2) of such section, or medical care to treat COVID–19”.
Effective date— The amendment made by subsection (a) shall apply with respect to medical care furnished on or after the date of the enactment of this Act.
Sec. 402 Prohibition on copayments and cost sharing for veterans receiving COVID–19 treatment furnished by Department of Veterans Affairs
In general— Section 6006(b) of the Families First Coronavirus Response Act (Public Law 116–127; 38 U.S.C. 1701 note) is amended by striking “or visits described in paragraph (2) of such section” and inserting “, visits described in paragraph (2) of such section, or hospital care or medical services to treat COVID–19”.
Effective date— The amendment made by subsection (a) shall apply with respect to hospital care and medical services furnished on or after the date of the enactment of this Act.
Sec. 403 Prohibition on copayments and cost sharing for Federal civilian employees receiving COVID–19 treatment
In general— Section 6006(c) of the Families First Coronavirus Response Act (Public Law 116–127; 5 U.S.C. 8904 note) is amended by striking “or visits described in paragraph (2) of such section” and inserting “, visits described in paragraph (2) of such section, or hospital care or medical services to treat COVID–19”.
Effective date— The amendment made by subsection (a) shall apply with respect to hospital care and medical services furnished on or after the date of the enactment of this Act.
V Public Health Policies
Sec. 501 Definitions
In this title:
Except as inconsistent with the provisions of this title, the term Secretary means the Secretary of Health and Human Services.
The term State refers to each of the 50 States and the District of Columbia.
The term Tribal, with respect to a department of health (or health department), includes—
Indian Tribes that—
are operating one or more health facilities pursuant to an agreement under the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5301 et seq.); or
receive services from a facility operated by the Indian Health Services; and
Tribal organizations and Urban Indian organizations.
A Supply Chain Improvements
Sec. 511 Medical Supplies Response Coordinator
In general— The President shall appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of critical medical supplies and equipment related to detecting, diagnosing, preventing, and treating COVID–19, including personal protective equipment, medical devices, drugs, and vaccines.
Qualifications— To qualify to be appointed as the Medical Supplies Response Coordinator, an individual shall be a senior government official with—
health care training, including training related to infectious diseases or hazardous exposures; and
a familiarity with medical supply chain logistics.
Activities— The Medical Supplies Response Coordinator shall—
consult with State, local, territorial, and Tribal officials to ensure that health care facilities and health care workers have sufficient personal protective equipment and other medical supplies;
evaluate ongoing needs of States, localities, territories, Tribes, health care facilities, and health care workers to determine the need for critical medical supplies and equipment;
serve as a point of contact for industry for procurement and distribution of critical medical supplies and equipment, including personal protective equipment, medical devices, testing supplies, drugs, and vaccines;
procure and distribute critical medical supplies and equipment, including personal protective equipment, medical devices, testing supplies, drugs, and vaccines;
establish and maintain an up-to-date national database of hospital capacity, including beds, ventilators, and supplies, including personal protective equipment, medical devices, drugs, and vaccines; and
provide weekly reports to the Congress on gaps in such capacity and progress made toward closing the gaps;
require, as necessary, industry reporting on production and distribution of personal protective equipment, medical devices, testing supplies, drugs, and vaccines and assess financial penalties as may be specified by the Medical Supplies Response Coordinator for failure to comply with such requirements for reporting on production and distribution;
consult with the Secretary and the Administrator of the Federal Emergency Management Agency, as applicable, to ensure sufficient production levels under the Defense Production Act of 1950 (50 U.S.C. 4501 et seq.); and
monitor the prices of critical medical supplies and equipment, including personal protective equipment and medical devices, drugs, and vaccines related to detecting, diagnosing, preventing, and treating COVID–19 and report any suspected price gouging of such materials to the Federal Trade Commission and appropriate law enforcement officials.
Sec. 512 Information to be included in list of devices determined to be in shortage
Section 506J(g)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as added by section 3121 of the CARES Act (Public Law 116–136), is amended by inserting “, including the device identifier or national product code for such device, if applicable” before the period at the end.
Sec. 513 Extended shelf life dates for essential devices
In general— The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506J (21 U.S.C. 356j) the following:
“506K. Extended shelf life dates for essential devices
“(a) In general—A manufacturer of a device subject to notification requirements under section 506J (in this section referred to as an “essential device”) shall—
“(1) submit to the Secretary data and information as required by subsection (b)(1);
“(2) conduct and submit the results of any studies required under subsection (b)(3); and
“(3) make any labeling change described in subsection (c) by the date specified by the Secretary pursuant to such subsection.
“(b) Notification
“(1) In general—The Secretary may issue an order requiring the manufacturer of any essential device to submit, in such manner as the Secretary may prescribe, data and information from any stage of development of the device (including pilot, investigational, and final product validation) that are adequate to assess the shelf life of the device to determine the longest supported expiration date.
“(2) Unavailable or insufficient data and information—If the data and information referred to in paragraph (1) are not available or are insufficient, the Secretary may require the manufacturer of the device to—
“(A) conduct studies adequate to provide the data and information; and
“(B) submit to the Secretary the results, data, and information generated by such studies when available.
“(c) Labeling—The Secretary may issue an order requiring the manufacturer of an essential device to make by a specified date any labeling change regarding the expiration period that the Secretary determines to be appropriate based on the data and information required to be submitted under this section or any other data and information available to the Secretary.
“(d) Confidentiality—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”
Civil monetary penalty— Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended by adding at the end the following:
“(10) Civil monetary penalty with respect to extended shelf life dates for essential devices—If the manufacturer of a device subject to notification requirements under section 506J violates section 506K by failing to submit data and information as required under section 506K(b)(1), failing to conduct or submit the results of studies as required under section 506K(b)(3), or failing to make a labeling change as required under section 506K(c), such manufacturer shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each such violation.”
Emergency use eligible products— Subparagraph (A) of section 564A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(a)(1)) is amended to read as follows:
“(A) is approved or cleared under this chapter, otherwise listed as a device pursuant to section 510(j), conditionally approved under section 571, or licensed under section 351 of the Public Health Service Act;”
Sec. 514 Authority to destroy counterfeit devices
In general— Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended—
in the fourth sentence, by inserting “or counterfeit device” after “counterfeit drug”; and
by striking “The Secretary of the Treasury shall cause the destruction of” and all that follows through “liable for costs pursuant to subsection (c).” and inserting the following: “The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).”.
Definition— Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended—
by redesignating subparagraphs (1), (2), and (3) as clauses (A), (B), and (C), respectively; and
after making such redesignations—
by striking “(h) The term” and inserting “(h)(1) The term”; and
by adding at the end the following:
“(2) The term counterfeit device means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark, imprint, or symbol, or any likeness thereof, or is manufactured using a design, of a device manufacturer, packer, or distributor other than the person or persons who in fact manufactured, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, packer, or distributor.
“(3) For purposes of subparagraph (2)—
“(A) the term manufactured refers to any of the following activities: manufacture, preparation, propagation, compounding, assembly, or processing; and
“(B) the term manufacturer means a person who is engaged in any of the activities listed in clause (A).”
Sec. 515 Reporting requirement for drug manufacturers
Establishments in a foreign country— Section 510(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is amended by inserting at the end the following new paragraph:
“(5) The requirements of paragraphs (1) and (2) shall apply to establishments within a foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of any drug, including the active pharmaceutical ingredient, that is required to be listed pursuant to subsection (j). Such requirements shall apply regardless of whether the drug or active pharmaceutical ingredient undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment or establishments outside the United States prior to being imported or offered for import into the United States.”
Listing of drugs— Section 510(j)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)(1)) is amended—
in subparagraph (D), by striking “and” at the end;
in subparagraph (E), by striking the period at the end and inserting “; and”; and
by adding at the end the following new subparagraph:
“(F) in the case of a drug contained in the applicable list, a certification that the registrant has—
“(i) identified every other establishment where manufacturing is performed for the drug; and
“(ii) notified each known foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of the drug, including the active pharmaceutical ingredient, of the inclusion of the drug in the list and the obligation to register.”
Quarterly reporting on amount of drugs manufactured— Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act (as added by section 3112 of the CARES Act (Public Law 116–136)) is amended by striking “annually” and inserting “once during the month of March of each year, once during the month of June of each year, once during the month of September of each year, and once during the month of December of each year”.
Sec. 516 Recommendations to encourage domestic manufacturing of critical drugs
In general— Not later than 14 days after the date of enactment of this Act, the Secretary shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the “National Academies”) under which, not later than 90 days after the date of entering into the agreement, the National Academies will—
establish a committee of experts who are knowledgeable about drug and device supply issues, including—
sourcing and production of critical drugs and devices;
sourcing and production of active pharmaceutical ingredients in critical drugs;
the raw materials and other components for critical drugs and devices; and
the public health and national security implications of the current supply chain for critical drugs and devices;
convene a public symposium to—
analyze the impact of United States dependence on the foreign manufacturing of critical drugs and devices on patient access and care, including in hospitals and intensive care units; and
recommend strategies to end United States dependence on foreign manufacturing to ensure the United States has a diverse and vital supply chain for critical drugs and devices to protect the Nation from natural or hostile occurrences; and
submit a report on the symposium’s proceedings to the Congress and publish a summary of such proceedings on the public website of the National Academies.
Symposium— In carrying out the agreement under subsection (a), the National Academies shall consult with—
the Department of Health and Human Services, the Department of Homeland Security, the Department of Defense, the Department of Commerce, the Department of State, the Department of Veterans Affairs, the Department of Justice, and any other Federal agencies as appropriate; and
relevant stakeholders, including drug and device manufacturers, health care providers, medical professional societies, State-based societies, public health experts, State and local public health departments, State medical boards, patient groups, health care distributors, wholesalers and group purchasing organizations, pharmacists, and other entities with experience in health care and public health, as appropriate.
Definitions— For the purposes of this section:
The term critical—
with respect to a device, refers to a device classified by the Food and Drug Administration as implantable, life-saving, and life-sustaining; or
with respect to a drug, refers to a drug that is described in subsection (a) of section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) (relating to notification of any discontinuance or interruption in the production of life-saving drugs).
The terms device and drug have the meanings given to those terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
Sec. 517 Failure to notify of a permanent discontinuance or an interruption
Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
“(fff) The failure of a manufacturer of a drug described in section 506C(a) or an active pharmaceutical ingredient of such a drug, without a reasonable basis as determined by the Secretary, to notify the Secretary of a permanent discontinuance or an interruption, and the reasons for such discontinuance or interruption, as required by section 506C.”
Sec. 518 Failure to develop risk management plan
Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 517, is further amended by adding at the end the following:
“(ggg) The failure to develop, maintain, and implement a risk management plan, as required by section 506C(j).”
Sec. 519 National Centers of Excellence in Continuous Pharmaceutical Manufacturing
In general— Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h) is amended to read as follows:
“3016. National Centers of Excellence in Continuous Pharmaceutical Manufacturing
“(a) In general—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—
“(1) shall solicit and, beginning not later than 1 year after the date of enactment of the Investing in America’s Health Care During the COVID–19 Pandemic Act receive requests from institutions of higher education to be designated as a National Center of Excellence in Continuous Pharmaceutical Manufacturing (in this section referred to as a “National Center of Excellence”) to support the advancement and development of continuous manufacturing; and
“(2) shall so designate any institution of higher education that—
“(A) requests such designation; and
“(B) meets the criteria specified in subsection (c).
“(b) Request for designation—A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require. Any such request shall include a description of how the institution of higher education meets or plans to meet each of the criteria specified in subsection (c).
“(c) Criteria for designation described—The criteria specified in this subsection with respect to an institution of higher education are that the institution has, as of the date of the submission of a request under subsection (a) by such institution—
“(1) physical and technical capacity for research and development of continuous manufacturing;
“(2) manufacturing knowledge-sharing networks with other institutions of higher education, large and small pharmaceutical manufacturers, generic and nonprescription manufacturers, contract manufacturers, and other entities;
“(3) proven capacity to design and demonstrate new, highly effective technology for use in continuous manufacturing;
“(4) a track record for creating and transferring knowledge with respect to continuous manufacturing;
“(5) the potential to train a future workforce for research on and implementation of advanced manufacturing and continuous manufacturing; and
“(6) experience in participating in and leading a continuous manufacturing technology partnership with other institutions of higher education, large and small pharmaceutical manufacturers (including generic and nonprescription drug manufacturers), contract manufacturers, and other entities—
“(A) to support companies with continuous manufacturing in the United States;
“(B) to support Federal agencies with technical assistance, which may include regulatory and quality metric guidance as applicable, for advanced manufacturing and continuous manufacturing;
“(C) with respect to continuous manufacturing, to organize and conduct research and development activities needed to create new and more effective technology, capture and disseminate expertise, create intellectual property, and maintain technological leadership;
“(D) to develop best practices for designing continuous manufacturing; and
“(E) to assess and respond to the workforce needs for continuous manufacturing, including the development of training programs if needed.
“(d) Termination of designation—The Secretary may terminate the designation of any National Center of Excellence designated under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 60 days before the effective date of such a termination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.
“(e) Conditions for designation—As a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education enter into an agreement with the Secretary under which the institution agrees—
“(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);
“(2) to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);
“(3) to develop, along with industry partners (which may include large and small biopharmaceutical manufacturers, generic and nonprescription manufacturers, and contract manufacturers) and another institution or institutions designated under this section, if any, a roadmap for developing a continuous manufacturing workforce;
“(4) to develop, along with industry partners and other institutions designated under this section, a roadmap for strengthening existing, and developing new, relationships with other institutions; and
“(5) to provide an annual report to the Food and Drug Administration regarding the institution’s activities under this section, including a description of how the institution continues to meet and make progress on the criteria listed in subsection (c).
“(f) Funding
“(1) In general—The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the National Centers of Excellence designated under this section for the purpose of studying and recommending improvements to continuous manufacturing, including such improvements as may enable the Centers—
“(A) to continue to meet the conditions specified in subsection (e); and
“(B) to expand capacity for research on, and development of, continuing manufacturing.
“(2) Consistency with FDA mission—As a condition on receipt of funding under this subsection, a National Center of Excellence shall agree to consider any input from the Secretary regarding the use of funding that would—
“(A) help to further the advancement of continuous manufacturing through the National Center of Excellence; and
“(B) be relevant to the mission of the Food and Drug Administration.
“(3) Authorization of appropriations—There is authorized to be appropriated to carry out this subsection $100,000,000, to remain available until expended.
“(4) Rule of construction—Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law.
“(g) Annual review and reports
“(1) Annual report—Beginning not later than 1 year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall—
“(A) submit to Congress a report describing the activities, partnerships and collaborations, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section; and
“(B) make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Administration.
“(2) Review of national centers of excellence and potential designees—The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.
“(3) Report on long-term vision of FDA role—Not later than 2 years after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the Congress on the long-term vision of the Department of Health and Human Services on the role of the Food and Drug Administration in supporting continuous manufacturing, including—
“(A) a national framework of principles related to the implementation and regulation of continuous manufacturing;
“(B) a plan for the development of Federal regulations and guidance for how advanced manufacturing and continuous manufacturing can be incorporated into the development of pharmaceuticals and regulatory responsibilities of the Food and Drug Administration; and
“(C) appropriate feedback solicited from the public, which may include other institutions, large and small biopharmaceutical manufacturers, generic and nonprescription manufacturers, and contract manufacturers.
“(h) Definitions—In this section:
“(1) Advanced manufacturing—The term advanced manufacturing means an approach for the manufacturing of pharmaceuticals that incorporates novel technology, or uses an established technique or technology in a new or innovative way (such as continuous manufacturing where the input materials are continuously transformed within the process by two or more unit operations) that enhances drug quality or improves the manufacturing process.
“(2) Continuous manufacturing—The term continuous manufacturing—
“(A) means a process where the input materials are continuously fed into and transformed within the process, and the processed output materials are continuously removed from the system; and
“(B) consists of an integrated process that consists of a series of two or more unit operations.
“(3) Institution of higher education—The term institution of higher education has the meaning given such term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)).
“(4) Secretary—The term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.”
Transition rule— Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h), as in effect on the day before the date of the enactment of this section, shall apply with respect to grants awarded under such section before such date of enactment.
B Strategic National Stockpile improvements
Sec. 531 Equipment maintenance
in subsection (a)(3)—
in subparagraph (I), by striking “; and” and inserting a semicolon;
in subparagraph (J), by striking the period at the end and inserting a semicolon; and
by inserting the following new subparagraph at the end:
“(K) ensure the contents of the stockpile remain in good working order and, as appropriate, conduct maintenance services on such contents; and”
in subsection (c)(7)(B), by adding at the end the following new clause:
“(ix) Equipment maintenance service—In carrying out this section, the Secretary may enter into contracts for the procurement of equipment maintenance services.”
Sec. 532 Supply chain flexibility manufacturing pilot
In general— Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)), as amended by section 531, is further amended by adding at the end the following new subparagraph:
“(L) enhance medical supply chain elasticity and establish and maintain domestic reserves of critical medical supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, and other medical devices (including diagnostic tests)) by—
“(i) increasing emergency stock of critical medical supplies;
“(ii) geographically diversifying production of such medical supplies;
“(iii) purchasing, leasing, or entering into joint ventures with respect to facilities and equipment for the production of such medical supplies; and
“(iv) working with distributors of such medical supplies to manage the domestic reserves established under this subparagraph by refreshing and replenishing stock of such medical supplies.”
Reporting; sunset— Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)) is amended by adding at the end the following:
“(6) Reporting—Not later than September 30, 2022, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the details of each purchase, lease, or joint venture entered into under paragraph (3)(L), including the amount expended by the Secretary on each such purchase, lease, or joint venture.
“(7) Sunset—The authority to make purchases, leases, or joint ventures pursuant to paragraph (3)(L) shall cease to be effective on September 30, 2023.”
Funding— Section 319F–2(f) of the Public Health Service Act (42 U.S.C. 247d–6b(f)) is amended by adding at the end the following:
“(3) Supply chain elasticity
“(A) In general—For the purpose of carrying out subsection (a)(3)(L), there is authorized to be appropriated $500,000,000 for each of fiscal years 2020 through 2023, to remain available until expended.
“(B) Relation to other amounts—The amount authorized to be appropriated by subparagraph (A) for the purpose of carrying out subsection (a)(3)(L) is in addition to any other amounts available for such purpose.”
Sec. 533 Reimbursable transfers from Strategic National Stockpile
Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), as amended, is further amended by adding at the end the following:
“(8) Transfers and reimbursements
“(A) In general—Without regard to chapter 5 of title 40, United States Code, the Secretary may transfer to any Federal department or agency, on a reimbursable basis, any drugs, vaccines and other biological products, medical devices, and other supplies in the stockpile if—
“(i) the transferred supplies are less than 6 months from expiry;
“(ii) the stockpile is able to replenish the supplies, as appropriate; and
“(iii) the Secretary decides the transfer is in the best interest of the United States Government.
“(B) Use of reimbursement—Reimbursement derived from the transfer of supplies pursuant to subparagraph (A) may be used by the Secretary, without further appropriation and without fiscal year limitation, to carry out this section.
“(C) Report—Not later than September 30, 2022, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on each transfer made under this paragraph and the amount received by the Secretary in exchange for that transfer.
“(D) Sunset—The authority to make transfers under this paragraph shall cease to be effective on September 30, 2023.”
Sec. 534 Strategic National Stockpile action reporting
In general— The Assistant Secretary for Preparedness and Response (in this section referred to as the “Assistant Secretary”), in coordination with the Administrator of the Federal Emergency Management Agency, shall—
not later than 30 days after the date of enactment of this Act, issue a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate regarding all State, local, Tribal, and territorial requests for supplies from the Strategic National Stockpile related to COVID–19; and
not less than every 30 days thereafter through the end of the emergency period (as such term is defined in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B))), submit to such committees an updated version of such report.
Reporting period—
Initial report— The initial report under subsection (a) shall address all requests described in such subsection made during the period—
beginning on January 31, 2020; and
ending on the date that is 30 days before the date of submission of the report.
Updates— Each update to the report under subsection (a) shall address all requests described in such subsection made during the period—
beginning at the end of the previous reporting period under this section; and
ending on the date that is 30 days before the date of submission of the updated report.
Contents of report— The report under subsection (a) (and updates thereto) shall include—
the details of each request described in such subsection, including—
the specific medical countermeasures, including devices such as personal protective equipment, and other materials requested; and
the amount of such materials requested; and
the outcomes of each request described in subsection (a), including—
whether the request was wholly fulfilled, partially fulfilled, or denied;
if the request was wholly or partially fulfilled, the fulfillment amount; and
if the request was partially fulfilled or denied, a rationale for such outcome.
Sec. 535 Improved, transparent processes for the Strategic National Stockpile
In general— Not later than January 1, 2021, the Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, shall develop and implement improved, transparent processes for the use and distribution of drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, diagnostic tests, and other medical devices ) in the Strategic National Stockpile under section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) (in this section referred to as the “Stockpile”).
Processes— The processes developed under subsection (a) shall include—
the form and manner in which States, localities, Tribes, and territories are required to submit requests for supplies from the Stockpile;
the criteria used by the Secretary in responding to such requests, including the reasons for fulfilling or denying such requests;
what circumstances result in prioritization of distribution of supplies from the Stockpile to States, localities, Tribes, or territories;
clear plans for future, urgent communication between the Secretary and States, localities, Tribes, and territories regarding the outcome of such requests; and
any differences in the processes developed under subsection (a) for geographically related emergencies, such as weather events, and national emergencies, such as pandemics.
Report to Congress— Not later than January 1, 2021, the Secretary shall—
submit a report to the Committee Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate regarding the improved, transparent processes developed under this section; and
include in such report recommendations for opportunities for communication (by telebriefing, phone calls, or in-person meetings) between the Secretary and States, localities, Tribes, and territories regarding such improved, transparent processes.
Sec. 536 GAO study on the feasibility and benefits of a Strategic National Stockpile user fee agreement
In general— The Comptroller General of the United States shall conduct a study to investigate the feasibility of establishing user fees to offset certain Federal costs attributable to the procurement of single-source materials for the Strategic National Stockpile under section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) and distributions of such materials from the Stockpile. In conducting this study, the Comptroller General shall consider, to the extent information is available—
whether entities receiving such distributions generate profits from those distributions;
any Federal costs attributable to such distributions;
whether such user fees would provide the Secretary with funding to potentially offset procurement costs of such materials for the Strategic National Stockpile; and
any other issues the Comptroller General identifies as relevant.
Report— Not later than February 1, 2023, the Comptroller General of the United States shall submit to the Congress a report on the findings and conclusions of the study under subsection (a).
C Testing and Testing Infrastructure Improvements
Sec. 541 COVID–19 testing strategy
Strategy— Not later than 30 days after the date of the enactment of this Act, the Secretary shall update the COVID–19 strategic testing plan under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Service Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139, 134 Stat. 620, 626–627) and submit to the appropriate congressional committees such updated national plan identifying—
what level of, types of, and approaches to testing (including predicted numbers of tests, populations to be tested, and frequency of testing and the appropriate setting whether a health care setting (such as hospital-based, high-complexity laboratory, point-of-care, mobile testing units, pharmacies or community health centers) or non-health care setting (such as workplaces, schools, or child care centers)) are necessary—
to sufficiently monitor and contribute to the control of the transmission of SARS–CoV–2 in the United States;
to ensure that any reduction in social distancing efforts, when determined appropriate by public health officials, can be undertaken in a manner that optimizes the health and safety of the people of the United States, and reduces disparities (including disparities related to race, ethnicity, sex, age, disability status, socioeconomic status, and geographic location) in the prevalence of, incidence of, and health outcomes with respect to, COVID–19; and
to provide for ongoing surveillance sufficient to support contact tracing, case identification, quarantine, and isolation to prevent future outbreaks of COVID–19;
specific plans and benchmarks, each with clear timelines, to ensure—
such level of, types of, and approaches to testing as are described in paragraph (1), with respect to optimizing health and safety;
sufficient availability of all necessary testing materials and supplies, including extraction and testing kits, reagents, transport media, swabs, instruments, analysis equipment, personal protective equipment if necessary for testing (including point-of-care testing), and other equipment;
allocation of testing materials and supplies in a manner that optimizes public health, including by considering the variable impact of SARS–CoV–2 on specific States, territories, Indian Tribes, Tribal organizations, urban Indian organizations, communities, industries, and professions;
sufficient evidence of validation for tests that are deployed as a part of such strategy;
sufficient laboratory and analytical capacity, including target turnaround time for test results;
sufficient personnel, including personnel to collect testing samples, conduct and analyze results, and conduct testing follow-up, including contact tracing, as appropriate; and
enforcement of the Families First Coronavirus Response Act (Public Law 116–127) to ensure patients who are tested are not subject to cost sharing;
specific plans to ensure adequate testing in rural areas, frontier areas, health professional shortage areas, and medically underserved areas (as defined in section 330I(a) of the Public Health Service Act (42 U.S.C. 254c–14(a))), and for underserved populations, Native Americans (including Indian Tribes, Tribal organizations, and urban Indian organizations), and populations at increased risk related to COVID–19;
specific plans to ensure accessibility of testing to people with disabilities, older individuals, and individuals with underlying health conditions or weakened immune systems; and
specific plans for broadly developing and implementing testing for potential immunity in the United States, as appropriate, in a manner sufficient—
to monitor and contribute to the control of SARS–CoV–2 in the United States;
to ensure that any reduction in social distancing efforts, when determined appropriate by public health officials, can be undertaken in a manner that optimizes the health and safety of the people of the United States; and
to reduce disparities (including disparities related to race, ethnicity, sex, age, disability status, socioeconomic status, and geographic location) in the prevalence of, incidence of, and health outcomes with respect to, COVID–19.
Coordination— The Secretary shall carry out this section—
in coordination with the Administrator of the Federal Emergency Management Agency;
in collaboration with other agencies and departments, as appropriate; and
taking into consideration the State plans for COVID–19 testing prepared as required under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Service Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139; 134 Stat. 620, 624).
Updates—
Frequency— The updated national plan under subsection (a) shall be updated every 30 days until the end of the public health emergency first declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) on January 31, 2020, with respect to COVID–19.
Relation to other law— Paragraph (1) applies in lieu of the requirement (for updates every 90 days until funds are expended) in the second to last proviso under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Service Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139; 134 Stat. 620, 627).
Appropriate congressional committees— In this section, the term appropriate congressional committees means—
the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and
the Committee on Appropriations and the Committee on Health, Education, Labor and Pensions and of the Senate.
Sec. 542 Centralized testing information website
The Secretary shall establish and maintain a public, searchable webpage, to be updated and corrected as necessary through a process established by the Secretary, on the website of the Department of Health and Human Services that—
identifies all in vitro diagnostic and serological tests used in the United States to analyze clinical specimens for detection of SARS–CoV–2 or antibodies specific to SARS–CoV–2, including—
those tests—
that are approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb–3);
that have been validated by the test’s developers for use on clinical specimens and for which the developer has notified the Food and Drug Administration of the developer’s intent to market the test consistent with applicable guidance issued by the Secretary; or
that have been developed and authorized by a State that has notified the Secretary of the State’s intention to review tests intended to diagnose COVID–19; and
other SARS–CoV–2-related tests that the Secretary determines appropriate in guidance, which may include tests related to the monitoring of COVID–19 patient status;
provides relevant information, as determined by the Secretary, on each test identified pursuant to paragraph (1), which may include—
the name and contact information of the developer of the test;
the date of receipt of notification by the Food and Drug Administration of the developer’s intent to market the test;
the date of authorization for use of the test on clinical specimens, where applicable;
the letter of authorization for use of the test on clinical specimens, where applicable;
any fact sheets, manufacturer instructions, and package inserts for the test, including information on intended use;
sensitivity and specificity of the test; and
in the case of tests distributed by commercial manufacturers, the number of tests distributed and, if available, the number of laboratories in the United States with the required platforms installed to perform the test; and
includes—
a list of laboratories certified under section 353 of the Public Health Service Act (42 U.S.C. 263a; commonly referred to as “CLIA”) that—
meet the regulatory requirements under such section to perform high- or moderate-complexity testing; and
are authorized to perform SARS–CoV–2 diagnostic or serological tests on clinical specimens; and
information on each laboratory identified pursuant to subparagraph (A), including—
the name and address of the laboratory;
the CLIA certificate number;
the laboratory type;
the certificate type; and
the complexity level.
Sec. 543 Manufacturer reporting of test distribution
In general— A commercial manufacturer of an in vitro diagnostic or serological COVID–19 test shall, on a weekly basis, submit a notification to the Secretary regarding distribution of each such test, which notification—
shall include the number of tests distributed and the entities to which the tests are distributed; and
may include the quantity of such tests distributed by the manufacturer.
Confidentiality— Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
Failure to meet requirements— If a manufacturer fails to submit a notification as required under subsection (a), the following applies:
The Secretary shall issue a letter to such manufacturer informing such manufacturer of such failure.
Not later than 7 calendar days after the issuance of a letter under paragraph (1), the manufacturer to whom such letter is issued shall submit to the Secretary a written response to such letter—
setting forth the basis for noncompliance; and
providing information as required under subsection (a).
Not later than 14 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph (2) available to the public on the internet website of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (b). The preceding sentence shall not apply if the Secretary determines that—
the letter under paragraph (1) was issued in error; or
after review of such response, the manufacturer had a reasonable basis for not notifying as required under subsection (a).
Sec. 544 State testing report
For any State that authorizes (or intends to authorize) one or more laboratories in the State to develop and perform in vitro diagnostic COVID–19 tests, the head of the department or agency of such State with primary responsibility for health shall—
notify the Secretary of such authorization (or intention to authorize); and
provide the Secretary with a weekly report—
identifying all laboratories authorized (or intended to be authorized) by the State to develop and perform in vitro diagnostic COVID–19 tests;
including relevant information on all laboratories identified pursuant to subparagraph (A), which may include information on laboratory testing capacity;
identifying all in vitro diagnostic COVID–19 tests developed and approved for clinical use in laboratories identified pursuant to subparagraph (A); and
including relevant information on all tests identified pursuant to subparagraph (C), which may include—
the name and contact information of the developer of any such test;
any fact sheets, manufacturer instructions, and package inserts for any such test, including information on intended use; and
the sensitivity and specificity of any such test.
Sec. 545 State listing of testing sites
Not later than 14 days after the date of enactment of this Act, any State receiving funding or assistance under this Act, as a condition on such receipt, shall establish and maintain a public, searchable webpage on the official website of the State that—
identifies all sites located in the State that provide diagnostic or serological testing for SARS–CoV–2; and
provides appropriate contact information for SARS–CoV–2 testing sites pursuant to paragraph (1).
Sec. 546 Reporting of COVID–19 testing results
In general— Every laboratory that performs or analyzes a test that is intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19 shall report daily the number of tests performed and the results from each such test to the Secretary of Health and Human Services and to the Secretary of Homeland Security, in such form and manner as such Secretaries may prescribe. Such information shall be made available to the public in a searchable, electronic format as soon as is practicable, and in no case later than one week after such information is received.
Additional reporting requirements— The Secretaries specified in subsection (a)—
may specify additional reporting requirements under this section by regulation, including by interim final rule, or by guidance; and
may issue such regulations or guidance without regard to the procedures otherwise required by section 553 of title 5, United States Code.
Sec. 547 GAO report on diagnostic tests
GAO study— Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report describing the response of entities described in subsection (b) to the COVID–19 pandemic with respect to the development, regulatory evaluation, and deployment of diagnostic tests.
Entities described— Entities described in this subsection include—
laboratories, including public health, academic, clinical, and commercial laboratories;
diagnostic test manufacturers;
State, local, Tribal, and territorial governments; and
the Food and Drug Administration, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and other relevant Federal agencies, as appropriate.
Contents— The report under subsection (a) shall include—
a description of actions taken by entities described in subsection (b) to develop, evaluate, and deploy diagnostic tests;
an assessment of the coordination of Federal agencies in the development, regulatory evaluation, and deployment of diagnostic tests;
an assessment of the standards used by the Food and Drug Administration to evaluate diagnostic tests;
an assessment of the clarity of Federal agency guidance related to testing, including the ability for individuals without medical training to understand which diagnostic tests had been evaluated by the Food and Drug Administration;
a description of—
actions taken and clinical processes employed by States and territories that have authorized laboratories to develop and perform diagnostic tests not authorized, approved, or cleared by the Food and Drug Administration, including actions of such States and territories to evaluate the accuracy and sensitivity of such tests; and
the standards used by States and territories when deciding when to authorize laboratories to develop or perform diagnostic tests;
an assessment of the steps taken by laboratories and diagnostic test manufacturers to validate diagnostic tests, as well as the evidence collected by such entities to support validation; and
based on available reports, an assessment of the accuracy and sensitivity of a representative sample of available diagnostic tests.
Definition— In this section, the term diagnostic test means an in vitro diagnostic product (as defined in section 809.3(a) of title 21, Code of Federal Regulations) for—
the detection of SARS–CoV–2;
the diagnosis of the virus that causes COVID–19; or
the detection of antibodies specific to SARS–CoV–2, such as a serological test.
Sec. 548 Public health data system transformation
Subtitle C of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh–31 et seq.) is amended by adding at the end the following:
“2823. Public health data system transformation
“(a) Expanding CDC and public health department capabilities
“(1) In general—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
“(A) conduct activities to expand, enhance, and improve applicable public health data systems used by the Centers for Disease Control and Prevention, related to the interoperability and improvement of such systems (including as it relates to preparedness for, prevention and detection of, and response to public health emergencies); and
“(B) award grants or cooperative agreements to State, local, Tribal, or territorial public health departments for the expansion and modernization of public health data systems, to assist public health departments in—
“(i) assessing current data infrastructure capabilities and gaps to improve and increase consistency in data collection, storage, and analysis and, as appropriate, to improve dissemination of public health-related information;
“(ii) improving secure public health data collection, transmission, exchange, maintenance, and analysis;
“(iii) improving the secure exchange of data between the Centers for Disease Control and Prevention, State, local, Tribal, and territorial public health departments, public health organizations, and health care providers, including by public health officials in multiple jurisdictions within such State, as appropriate, and by simplifying and supporting reporting by health care providers, as applicable, pursuant to State law, including through the use of health information technology;
“(iv) enhancing the interoperability of public health data systems (including systems created or accessed by public health departments) with health information technology, including with health information technology certified under section 3001(c)(5);
“(v) supporting and training data systems, data science, and informatics personnel;
“(vi) supporting earlier disease and health condition detection, such as through near real-time data monitoring, to support rapid public health responses;
“(vii) supporting activities within the applicable jurisdiction related to the expansion and modernization of electronic case reporting; and
“(viii) developing and disseminating information related to the use and importance of public health data.
“(2) Data standards—In carrying out paragraph (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as appropriate and in consultation with the Office of the National Coordinator for Health Information Technology, designate data and technology standards (including standards for interoperability) for public health data systems, with deference given to standards published by consensus-based standards development organizations with public input and voluntary consensus-based standards bodies.
“(3) Public-private partnerships—The Secretary may develop and utilize public-private partnerships for technical assistance, training, and related implementation support for State, local, Tribal, and territorial public health departments, and the Centers for Disease Control and Prevention, on the expansion and modernization of electronic case reporting and public health data systems, as applicable.
“(b) Requirements
“(1) Health information technology standards—The Secretary may not award a grant or cooperative agreement under subsection (a)(1)(B) unless the applicant uses or agrees to use standards endorsed by the National Coordinator for Health Information Technology pursuant to section 3001(c)(1) or adopted by the Secretary under section 3004.
“(2) Waiver—The Secretary may waive the requirement under paragraph (1) with respect to an applicant if the Secretary determines that the activities under subsection (a)(1)(B) cannot otherwise be carried out within the applicable jurisdiction.
“(3) Application—A State, local, Tribal, or territorial health department applying for a grant or cooperative agreement under this section shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include information describing—
“(A) the activities that will be supported by the grant or cooperative agreement; and
“(B) how the modernization of the public health data systems involved will support or impact the public health infrastructure of the health department, including a description of remaining gaps, if any, and the actions needed to address such gaps.
“(c) Strategy and implementation plan—Not later than 180 days after the date of enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measures the Secretary will utilize to—
“(1) update and improve applicable public health data systems used by the Centers for Disease Control and Prevention; and
“(2) carry out the activities described in this section to support the improvement of State, local, Tribal, and territorial public health data systems.
“(d) Consultation—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall consult with State, local, Tribal, and territorial health departments, professional medical and public health associations, associations representing hospitals or other health care entities, health information technology experts, and other appropriate public or private entities regarding the plan and grant program to modernize public health data systems pursuant to this section. Activities under this subsection may include the provision of technical assistance and training related to the exchange of information by such public health data systems used by relevant health care and public health entities at the local, State, Federal, Tribal, and territorial levels, and the development and utilization of public-private partnerships for implementation support applicable to this section.
“(e) Report to Congress—Not later than 1 year after the date of enactment of this section, the Secretary shall submit a report to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—
“(1) a description of any barriers to—
“(A) public health authorities implementing interoperable public health data systems and electronic case reporting;
“(B) the exchange of information pursuant to electronic case reporting; or
“(C) reporting by health care providers using such public health data systems, as appropriate, and pursuant to State law;
“(2) an assessment of the potential public health impact of implementing electronic case reporting and interoperable public health data systems; and
“(3) a description of the activities carried out pursuant to this section.
“(f) Electronic case reporting—In this section, the term electronic case reporting means the automated identification, generation, and bilateral exchange of reports of health events among electronic health record or health information technology systems and public health authorities.
“(g) Authorization of appropriations—To carry out this section, there are authorized to be appropriated $450,000,000 to remain available until expended.”
Sec. 549 Pilot program to improve laboratory infrastructure
In general— The Secretary shall award grants to States and political subdivisions of States to support the improvement, renovation, or modernization of infrastructure at clinical laboratories (as defined in section 353 of the Public Health Service Act (42 U.S.C. 263a)) that will help to improve SARS–CoV–2 and COVID–19 testing and response activities, including the expansion and enhancement of testing capacity at such laboratories.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $1,000,000,000 to remain available until expended.
Sec. 550 Core public health infrastructure for State, local, Tribal, and territorial health departments
Program— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a core public health infrastructure program consisting of awarding grants under subsection (b).
Grants—
Award— For the purpose of addressing core public health infrastructure needs, the Secretary—
shall award a grant to each State health department; and
may award grants on a competitive basis to State, local, Tribal, or territorial health departments.
Allocation— Of the total amount of funds awarded as grants under this subsection for a fiscal year—
not less than 50 percent shall be for grants to State health departments under paragraph (1)(A); and
not less than 30 percent shall be for grants to State, local, Tribal, or territorial health departments under paragraph (1)(B).
Use of funds— A State, local, Tribal, or territorial health department receiving a grant under subsection (b) shall use the grant funds to address core public health infrastructure needs, including those identified in the accreditation process under subsection (g).
Formula grants to State health departments— In making grants under subsection (b)(1)(A), the Secretary shall award funds to each State health department in accordance with—
a formula based on population size; burden of preventable disease and disability; and core public health infrastructure gaps, including those identified in the accreditation process under subsection (g); and
application requirements established by the Secretary, including a requirement that the State health department submit a plan that demonstrates to the satisfaction of the Secretary that the State’s health department will—
address its highest priority core public health infrastructure needs; and
as appropriate, allocate funds to local health departments within the State.
Competitive grants to State, local, Tribal, and territorial health departments— In making grants under subsection (b)(1)(B), the Secretary shall give priority to applicants demonstrating core public health infrastructure needs identified in the accreditation process under subsection (g).
Maintenance of effort— The Secretary may award a grant to an entity under subsection (b) only if the entity demonstrates to the satisfaction of the Secretary that—
funds received through the grant will be expended only to supplement, and not supplant, non-Federal and Federal funds otherwise available to the entity for the purpose of addressing core public health infrastructure needs; and
with respect to activities for which the grant is awarded, the entity will maintain expenditures of non-Federal amounts for such activities at a level not less than the level of such expenditures maintained by the entity for the fiscal year preceding the fiscal year for which the entity receives the grant.
Establishment of a public health accreditation program—
In general— The Secretary shall—
develop, and periodically review and update, standards for voluntary accreditation of State, local, Tribal, and territorial health departments and public health laboratories for the purpose of advancing the quality and performance of such departments and laboratories; and
implement a program to accredit such health departments and laboratories in accordance with such standards.
Cooperative agreement— The Secretary may enter into a cooperative agreement with a private nonprofit entity to carry out paragraph (1).
Report— The Secretary shall submit to the Congress an annual report on progress being made to accredit entities under subsection (g), including—
a strategy, including goals and objectives, for accrediting entities under subsection (g) and achieving the purpose described in subsection (g)(1)(A);
identification of gaps in research related to core public health infrastructure; and
recommendations of priority areas for such research.
Definition— In this section, the term core public health infrastructure includes—
workforce capacity and competency;
laboratory systems;
testing capacity, including test platforms, mobile testing units, and personnel;
health information, health information systems, and health information analysis;
disease surveillance;
contact tracing;
communications;
financing;
other relevant components of organizational capacity; and
other related activities.
Authorization of appropriations— To carry out this section, there are authorized to be appropriated $6,000,000,000, to remain available until expended.
Sec. 551 Core public health infrastructure and activities for CDC
In general— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and improve the core public health infrastructure and activities of the Centers for Disease Control and Prevention to address unmet and emerging public health needs.
Report— The Secretary shall submit to the Congress an annual report on the activities funded through this section.
Definition— In this section, the term core public health infrastructure has the meaning given to such term in section 550.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $1,000,000,000, to remain available until expended.
D COVID–19 National Testing and Contact Tracing Initiative
Sec. 561 National system for COVID–19 testing, contact tracing, surveillance, containment, and mitigation
In general— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in coordination with State, local, Tribal, and territorial health departments, shall establish and implement a nationwide evidence-based system for—
testing, contact tracing, surveillance, containment, and mitigation with respect to COVID–19;
offering guidance on voluntary isolation and quarantine of individuals infected with, or exposed to individuals infected with, the virus that causes COVID–19; and
public reporting on testing, contact tracing, surveillance, and voluntary isolation and quarantine activities with respect to COVID–19.
Coordination; technical assistance— In carrying out the national system under this section, the Secretary shall—
coordinate State, local, Tribal, and territorial activities related to testing, contact tracing, surveillance, containment, and mitigation with respect to COVID–19, as appropriate; and
provide technical assistance for such activities, as appropriate.
Consideration— In establishing and implementing the national system under this section, the Secretary shall take into consideration—
the State plans referred to in the heading “Public Health and Social Services Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139); and
the testing strategy submitted under section 541.
Reporting— The Secretary shall—
not later than one month after the date of the enactment of this Act, submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions a preliminary report on the effectiveness of the activities carried out pursuant to this subtitle; and
not later than three months after the end of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, submit to such committees a final report on such effectiveness.
Sec. 562 Grants
In general— To implement the national system under section 561, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, subject to the availability of appropriations, award grants to State, local, Tribal, and territorial health departments that seek grants under this section to carry out coordinated testing, contact tracing, surveillance, containment, and mitigation with respect to COVID–19, including—
diagnostic and surveillance testing and reporting;
community-based contact tracing efforts; and
policies related to voluntary isolation and quarantine of individuals infected with, or exposed to individuals infected with, the virus that causes COVID–19.
Flexibility— The Secretary shall ensure that—
the grants under subsection (a) provide flexibility for State, local, Tribal, and territorial health departments to modify, establish, or maintain evidence-based systems; and
local health departments receive funding from State health departments or directly from the Centers for Disease Control and Prevention to contribute to such systems, as appropriate.
Allocations—
Formula— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall allocate amounts made available pursuant to subsection (a) in accordance with a formula to be established by the Secretary that provides a minimum level of funding to each State, local, Tribal, and territorial health department that seeks a grant under this section and allocates additional funding based on the following prioritization:
The Secretary shall give highest priority to applicants proposing to serve populations in one or more geographic regions with a high burden of COVID–19 based on data provided by the Centers for Disease Control and Prevention, or other sources as determined by the Secretary.
The Secretary shall give second highest priority to applicants preparing for, or currently working to mitigate, a COVID–19 surge in a geographic region that does not yet have a high number of reported cases of COVID–19 based on data provided by the Centers for Disease Control and Prevention, or other sources as determined by the Secretary.
The Secretary shall give third highest priority to applicants proposing to serve high numbers of low-income and uninsured populations, including medically underserved populations (as defined in section 330(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)(3))), health professional shortage areas (as defined under section 332(a) of the Public Health Service Act (42 U.S.C. 254e(a))), racial and ethnic minorities, or geographically diverse areas, as determined by the Secretary.
Notification— Not later than the date that is one week before first awarding grants under this section, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a notification detailing the formula established under paragraph (1) for allocating amounts made available pursuant to subsection (a).
Use of funds— A State, local, Tribal, and territorial health department receiving a grant under this section shall, to the extent possible, use the grant funds for the following activities, or other activities deemed appropriate by the Director of the Centers for Disease Control and Prevention:
Testing— To implement a coordinated testing system that—
leverages or modernizes existing testing infrastructure and capacity;
is consistent with the updated testing strategy required under section 541;
is coordinated with the State plan for COVID–19 testing prepared as required under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Service Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139; 134 Stat. 620, 624);
is informed by contact tracing and surveillance activities under this subtitle;
is informed by guidelines established by the Centers for Disease Control and Prevention for which populations should be tested;
identifies how diagnostic and serological tests in such system shall be validated prior to use;
identifies how diagnostic and serological tests and testing supplies will be distributed to implement such system;
identifies specific strategies for ensuring testing capabilities and accessibility in racial and ethnic minority populations;
identifies specific strategies for ensuring testing capabilities and accessibility in medically underserved populations (as defined in section 330(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)(3))), health professional shortage areas (as defined under section 332(a) of the Public Health Service Act (42 U.S.C. 254e(a))), and geographically diverse areas, as determined by the Secretary;
identifies how testing may be used, and results may be reported, in both health care settings (such as hospitals, laboratories for moderate or high-complexity testing, pharmacies, mobile testing units, and community health centers) and non-health care settings (such as workplaces, schools, childcare centers, or drive-throughs);
allows for testing in sentinel surveillance programs, as appropriate; and
supports the procurement and distribution of diagnostic and serological tests and testing supplies to meet the goals of the system.
Contact tracing— To implement a coordinated contact tracing system that—
leverages or modernizes existing contact tracing systems and capabilities, including community health workers, health departments, and Federally qualified health centers;
is able to investigate cases of COVID–19, and help to identify other potential cases of COVID–19, through tracing contacts of individuals with positive diagnoses;
establishes culturally competent and multilingual strategies for contact tracing, addressing the specific needs of racial and ethnic minority populations, which may include consultation with and support from faith-based, nonprofit, cultural or civic organizations with established ties to the community;
establishes culturally competent and multilingual strategies for contact tracing, addressing the specific needs of medically underserved populations (as defined in section 330(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)(3))), health professional shortage areas (as defined under section 332(a) of the Public Health Service Act(42 U.S.C. 2324 254e(a)));
provides individuals identified under the contact tracing program with information and support for containment or mitigation;
enables State, local, Tribal, and territorial health departments to work with a nongovernmental, community partner or partners and State and local workforce development systems (as defined in section 3(67) of Workforce Innovation and Opportunity Act (29 U.S.C. 3102(67))) receiving grants under section 566(b) of this Act to hire and compensate a locally-sourced contact tracing workforce, if necessary, to supplement the public health workforce, to—
identify the number of contact tracers needed for the respective State, locality, territorial, or Tribal health department to identify all cases of COVID–19 currently in the jurisdiction and those anticipated to emerge over the next 18 months in such jurisdiction;
outline qualifications necessary for contact tracers;
train the existing and newly hired public health workforce on best practices related to tracing close contacts of individuals diagnosed with COVID–19, including the protection of individual privacy and cybersecurity protection; and
equip the public health workforce with tools and resources to enable a rapid response to new cases;
identifies the level of contact tracing needed within the State, locality, territory, or Tribal area to contain and mitigate the transmission of COVID–19; and
establishes statewide mechanisms to integrate regular evaluation to the Centers for Disease Control and Prevention regarding contact tracing efforts, makes such evaluation publicly available, and to the extent possible provides for such evaluation at the county level.
Surveillance— To strengthen the existing public health surveillance system that—
leverages or modernizes existing surveillance systems within the respective State, local, Tribal, or territorial health department and national surveillance systems;
detects and identifies trends in COVID–19 at the county level;
evaluates State, local, Tribal, and territorial health departments in achieving surveillance capabilities with respect to COVID–19;
integrates and improves disease surveillance and immunization tracking;
identifies specific strategies for ensuring disease surveillance in racial and ethnic minority populations; and
identifies specific strategies for ensuring disease surveillance in medically underserved populations (as defined in section 330(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)(3))), health professional shortage areas (as defined under section 332(a) of the Public Health Service Act (42 U.S.C. 254e(a))), and geographically diverse areas, as determined by the Secretary.
Containment and mitigation— To implement a coordinated containment and mitigation system that—
leverages or modernizes existing containment and mitigation strategies within the respective State, local, Tribal, or territorial governments and national containment and mitigation strategies;
may provide for, connect to, and leverage existing social services and support for individuals who have been infected with or exposed to COVID–19 and who are isolated or quarantined in their homes, such as through—
food assistance programs;
guidance for household infection control;
information and assistance with childcare services; and
information and assistance pertaining to support available under the CARES Act (Public Law 116–136) and this Act;
provides guidance on the establishment of safe, high-quality, facilities for the voluntary isolation of individuals infected with, or quarantine of the contacts of individuals exposed to COVID–19, where hospitalization is not required, which facilities should—
be prohibited from making inquiries relating to the citizenship status of an individual isolated or quarantined; and
be operated by a non-Federal, community partner or partners that—
have previously established relationships in localities;
work with local places of worship, community centers, medical facilities, and schools to recruit local staff for such facilities; and
are fully integrated into State, local, Tribal, or territorial containment and mitigation efforts;
identifies specific strategies for ensuring containment and mitigation activities in racial and ethnic minority populations; and
identifies specific strategies for ensuring containment and mitigation activities in medically underserved populations (as defined in section 330(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)(3))), health professional shortage areas (as defined under section 332(a) of the Public Health Service Act (42 U.S.C. 254e(a))), and geographically diverse areas, as determined by the Secretary.
Reporting— The Secretary shall facilitate mechanisms for timely, standardized reporting by grantees under this section regarding implementation of the systems established under this section and coordinated processes with the reporting as required and under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Service Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139, 134 Stat. 620), including—
a summary of county or local health department level information from the States receiving funding, and information from directly funded localities, territories, and Tribal entities, about the activities that will be undertaken using funding awarded under this section, including subgrants;
any anticipated shortages of required materials for testing for COVID–19 under subsection (a); and
other barriers in the prevention, mitigation, or treatment of COVID–19 under this section.
Public listing of awards— The Secretary shall—
not later than 7 days after first awarding grants under this section, post in a searchable, electronic format a list of all awards made by the Secretary under this section, including the recipients and amounts of such awards; and
update such list not less than every 7 days until all funds made available to carry out this section are expended.
Sec. 563 Guidance, technical assistance, information, and communication
In general— Not later than 14 days after the date of the enactment of this Act, the Secretary, in coordination with other Federal agencies, as appropriate, shall issue guidance, provide technical assistance, and provide information to States, localities, Tribes, and territories, with respect to the following:
The diagnostic and serological testing of individuals identified through contact tracing for COVID–19, including information with respect to the reduction of duplication related to programmatic activities, reporting, and billing.
Best practices regarding contact tracing, including the collection of data with respect to such contact tracing and requirements related to the standardization of demographic and syndromic information collected as part of contact tracing efforts.
Best practices regarding COVID–19 disease surveillance, including best practices to reduce duplication in surveillance activities, identifying gaps in surveillance and surveillance systems, and ways in which the Secretary plans to effectively support State, local, Tribal and territorial health departments in addressing such gaps.
Information on ways for State, local, Tribal, and territorial health departments to establish and maintain the testing, contact tracing, and surveillance activities described in paragraphs (1) through (3).
The protection of any personally identifiable health information collected pursuant to this subtitle.
Best practices regarding privacy and cybersecurity protection related to contact tracing, containment, and mitigation efforts.
Best practices related to improving public compliance for isolation and containment measures and reaching medically underserved communities.
Guidance on payment— Not later than 14 days after the date of the enactment of this Act, the Secretary, in coordination with the Administrator of the Centers for Medicare & Medicaid Services, the Director of the Centers for Disease Control and Prevention, and in coordination with other Federal agencies, as appropriate, shall develop and issue to State, local, Tribal, and territorial health departments clear guidance and policies—
with respect to the coordination of claims submitted for payment out of the Public Health and Social Services Emergency Fund for services furnished in a facility referred to in section 562(d)(4)(C);
identifying how an individual who is isolated or quarantined at home or in such a facility—
incurs no out-of-pocket costs for any services furnished to such individual while isolated; and
may receive income support for lost earnings or payments for expenses such as child care or elder care while such individual is isolated at home or in such a facility;
providing information and assistance pertaining to support available under the CARES Act (Public Law 116–136) and this Act; and
identifying State, local, Tribal, and territorial health departments or partner agencies that may provide social support services, such as groceries or meals, health education, internet access, and behavioral health services, to individuals who isolated or quarantined at home or in such a facility.
Guidance on testing— Not later than 14 days after the date of the enactment of this Act, the Secretary, in coordination with the Commissioner of Food and Drugs, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention, and in coordination with other Federal agencies as appropriate, shall develop and issue to State, local, Tribal, and territorial health departments clear guidance and policies regarding—
objective standards to characterize the performance of all diagnostic and serological tests for COVID–19 in order to independently evaluate tests continuously over time;
protocols for the evaluation of the performance of diagnostic and serological tests for COVID–19; and
a repository of characterized specimens to use to evaluate the performance of those tests that can be made available for appropriate entities to use to evaluate performance.
Communication— The Secretary shall identify and publicly announce the form and manner for communication with State, local, Tribal, and territorial health departments for purposes of carrying out the activities addressed by guidance issued under subsections (a) and (b).
Availability to providers— Guidance issued under subsection (a)(1) shall be issued to health care providers.
Ongoing provision of guidance and technical assistance— Notwithstanding whether funds are available specifically to carry out this subtitle, guidance and technical assistance shall continue to be provided under this section.
Sec. 564 Research and development
The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention and in collaboration with the Director of the National Institutes of Health, the Director of the Agency for Healthcare Research and Quality, the Commissioner of Food and Drugs, and the Administrator of the Centers for Medicare & Medicaid Services, shall support research and development on more efficient and effective strategies—
for the surveillance of SARS–CoV–2 and COVID–19;
for the testing and identification of individuals infected with COVID–19; and
for the tracing of contacts of individuals infected with COVID–19.
Sec. 565 Awareness campaigns
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other offices and agencies, as appropriate, shall award competitive grants or contracts to one or more public or private entities, including faith-based organizations, to carry out multilingual and culturally appropriate awareness campaigns. Such campaigns shall—
be based on available scientific evidence;
increase awareness and knowledge of COVID–19, including countering stigma associated with COVID–19;
improve information on the availability of COVID–19 diagnostic testing; and
promote cooperation with contact tracing efforts.
Sec. 566 Grants to State and Tribal workforce agencies
Definitions— In this section:
In general— Except as otherwise provided, the terms in this section have the meanings given the terms in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102).
Apprenticeship; apprenticeship program— The term apprenticeship or apprenticeship program means an apprenticeship program registered under the Act of August 16, 1937 (commonly known as the “National Apprenticeship Act”) (50 Stat. 664, chapter 663; 29 U.S.C. 50 et seq.), including any requirement, standard, or rule promulgated under such Act, as such requirement, standard, or rule was in effect on December 30, 2019.
Contact tracing and related positions— The term contact tracing and related positions means employment related to contact tracing, surveillance, containment, and mitigation activities as described in paragraphs (2), (3), and (4) of section 562(d).
Eligible entity— The term eligible entity means—
a State or territory, including the District of Columbia and Puerto Rico;
an Indian Tribe, Tribal organization, Alaska Native entity, Indian-controlled organizations serving Indians, or Native Hawaiian organizations;
an outlying area; or
a local board, if an eligible entity under subparagraphs (A) through (C) has not applied with respect to the area over which the local board has jurisdiction as of the date on which the local board submits an application under subsection (c).
Eligible individual— Notwithstanding section 170(b)(2) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3225(b)(2)), the term eligible individual means an individual seeking or securing employment in contact tracing and related positions and served by an eligible entity or community-based organization receiving funding under this section.
Secretary— The term Secretary means the Secretary of Labor.
Grants—
In general— Subject to the availability of appropriations under subsection (g), the Secretary shall award national dislocated worker grants under section 170(b)(1)(B) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3225(b)(1)(B)) to each eligible entity that seeks a grant to assist local boards and community-based organizations in carrying out activities under subsections (f) and (d), respectively, for the following purposes:
To support the recruitment, placement, and training, as applicable, of eligible individuals seeking employment in contact tracing and related positions in accordance with the national system for COVID–19 testing, contact tracing, surveillance, containment, and mitigation established under section 561.
To assist with the employment transition to new employment or education and training of individuals employed under this section in preparation for and upon termination of such employment.
Timeline— The Secretary of Labor shall—
issue application requirements under subsection (c) not later than 10 days after the date of enactment of this section; and
award grants to an eligible entity under paragraph (1) not later than 10 days after the date on which the Secretary receives an application from such entity.
Grant application— An eligible entity applying for a grant under this section shall submit an application to the Secretary, at such time and in such form and manner as the Secretary may reasonably require, which shall include a description of—
how the eligible entity will support the recruitment, placement, and training, as applicable, of eligible individuals seeking employment in contact tracing and related positions by partnering with—
a State, local, Tribal, or territorial health department; or
one or more nonprofit or community-based organizations partnering with such health departments;
how the activities described in paragraph (1) will support State efforts to address the demand for contact tracing and related positions with respect to—
the State plans referred to in the heading “Public Health and Social Services Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139);
the testing strategy submitted under section 541; and
the number of eligible individuals that the State plans to recruit and train under the plans and strategies described in subparagraphs (A) and (B);
the specific strategies for recruiting and placement of eligible individuals from or residing within the communities in which they will work, including—
plans for the recruitment of eligible individuals to serve as contact tracers and related positions, including dislocated workers, individuals with barriers to employment, veterans, new entrants in the workforce, or underemployed or furloughed workers, who are from or reside in or near the local area in which they will serve, and who, to the extent practicable—
have experience or a background in industry-sectors and occupations such as public health, social services, customer service, case management, or occupations that require related qualifications, skills, or competencies, such as strong interpersonal and communication skills, needed for contact tracing and related positions, as described in section 562(d)(2)(E)(ii); or
seek to transition to public health and public health related occupations upon the conclusion of employment in contact tracing and related positions; and
how such strategies will take into account the diversity of such community, including racial, ethnic, socioeconomic, linguistic, or geographic diversity;
the amount, timing, and mechanisms for distribution of funds provided to local boards or through subgrants as described in subsection (d);
for eligible entities described in subparagraphs (A) through (C) of subsection (a)(4), a description of how the eligible entity will ensure the equitable distribution of funds with respect to—
geography (such as urban and rural distribution);
medically underserved populations (as defined in section 33(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)));
health professional shortage areas (as defined under section 332(a) of the Public Health Service Act (42 U.S.C. 254e(a))); and
the racial and ethnic diversity of the area; and
for eligible entities who are local boards, a description of how a grant to such eligible entity would serve the equitable distribution of funds as described in paragraph (5).
Subgrant authorization and application process—
In general— An eligible entity may award a subgrant to one or more community-based organizations for the purposes of partnering with a State or local board to conduct outreach and education activities to inform potentially eligible individuals about employment opportunities in contact tracing and related positions.
Application— A community-based organization shall submit an application at such time and in such manner as the eligible entity may reasonably require, including—
a demonstration of the community-based organization’s established expertise and effectiveness in community outreach in the local area that such organization plans to serve;
a demonstration of the community-based organization’s expertise in providing employment or public health information to the local areas in which such organization plans to serve; and
a description of the expertise of the community-based organization in utilizing culturally competent and multilingual strategies in the provision of services.
Grant distribution—
Federal distribution—
Use of funds— The Secretary of Labor shall use the funds appropriated to carry out this section as follows:
Subject to clause (ii), the Secretary shall distribute funds among eligible entities in accordance with a formula to be established by the Secretary that provides a minimum level of funding to each eligible entity that seeks a grant under this section and allocates additional funding as follows:
The formula shall give first priority based on the number and proportion of contact tracing and related positions that the State plans to recruit, place, and train individuals as a part of the State strategy described in subsection (c)(2)(A).
Subject to subclause (I), the formula shall give priority in accordance with section 562(c).
Not more than 2 percent of the funding for administration of the grants and for providing technical assistance to recipients of funds under this section.
Equitable distribution— If the geographic region served by one or more eligible entities overlaps, the Secretary shall distribute funds among such entities in such a manner that ensures equitable distribution with respect to the factors under subsection (c)(5).
Eligible entity use of funds— An eligible entity described in subparagraphs (A) through (C) of subsection (a)(4)—
shall, not later than 30 days after the date on which the entity receives grant funds under this section, provide not less than 70 percent of grant funds to local boards for the purpose of carrying out activities in subsection (f);
may use up to 20 percent of such funds to make subgrants to community-based organizations in the service area to conduct outreach, to potential eligible individuals, as described in subsection (d);
in providing funds to local boards and awarding subgrants under this subsection shall ensure the equitable distribution with respect to the factors described in subsection (c)(5); and
may use not more than 10 percent of the funds awarded under this section for the administrative costs of carrying out the grant and for providing technical assistance to local boards and community-based organizations.
Local board use of funds— A local board, or an eligible entity that is a local board, shall use—
not less than 60 percent of the funds for recruitment and training for COVID–19 testing, contact tracing, surveillance, containment, and mitigation established under section 561;
not less than 30 of the funds to support the transition of individuals hired as contact tracers and related positions into an education or training program, or unsubsidized employment upon completion of such positions; and
not more than 10 percent of the funds for administrative costs.
Eligible activities— The State or local boards shall use funds awarded under this section to support the recruitment and placement of eligible individuals, training and employment transition as related to contact tracing and related positions, and for the following activities:
Establishing or expanding partnerships with—
State, local, Tribal, and territorial public health departments;
community-based health providers, including community health centers and rural health clinics;
labor organizations or joint labor management organizations;
two-year and four-year institutions of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), including institutions eligible to receive funds under section 371(a) of the Higher Education Act of 1965 (20 U.S.C. 1067q(a)); and
community action agencies or other community-based organizations serving local areas in which there is a demand for contact tracing and related positions.
Providing training for contact tracing and related positions in coordination with State, local, Tribal, or territorial health departments that is consistent with the State or territorial testing and contact tracing strategy, and ensuring that eligible individuals receive compensation while participating in such training.
Providing eligible individuals with—
adequate and safe equipment, environments, and facilities for training and supervision, as applicable;
information regarding the wages and benefits related to contact tracing and related positions, as compared to State, local, and national averages;
supplies and equipment needed by the eligible individuals to support placement of an individual in contact tracing and related positions, as applicable;
an individualized employment plan for each eligible individual, as applicable—
in coordination with the entity employing the eligible individual in a contact tracing and related positions; and
which shall include providing a case manager to work with each eligible individual to develop the plan, which may include—
identifying employment and career goals, and setting appropriate achievement objectives to attain such goals; and
exploring career pathways that lead to in-demand industries and sectors, including in public health and related occupations; and
services for the period during which the eligible individual is employed in a contact tracing and related position to ensure job retention, which may include—
supportive services throughout the term of employment;
a continuation of skills training as related to employment in contact tracing and related positions, that is conducted in collaboration with the employers of such individuals;
mentorship services and job retention support for eligible individuals; or
targeted training for managers and workers working with eligible individuals (such as mentors), and human resource representatives;
Supporting the transition and placement in unsubsidized employment for eligible individuals serving in contact tracing and related positions after such positions are no longer necessary in the State or local area, including—
any additional training and employment activities as described in section 170(d)(4) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3225(d)(4));
developing the appropriate combination of services to enable the eligible individual to achieve the employment and career goals identified under paragraph (3)(D)(ii)(I); and
services to assist eligible individuals in maintaining employment for not less than 12 months after the completion of employment in contact tracing and related positions, as appropriate.
Any other activities as described in subsections (a)(3) and (b) of section 134 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3174).
Limitation— Notwithstanding section 170(d)(3)(A) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3225(d)(3)(A)), a person may be employed in a contact tracing and related positions using funds under this section for a period not greater than 2 years.
Reporting by the Department of Labor—
In general— Not later than 120 days of the enactment of this Act, and once grant funds have been expended under this section, the Secretary shall report to the Committee on Education and Labor of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate, and make publicly available a report containing a description of—
the number of eligible individuals recruited, hired, and trained in contact tracing and related positions;
the number of individuals successfully transitioned to unsubsidized employment or training at the completion of employment in contact tracing and related positions using funds under this subtitle;
the number of such individuals who were unemployed prior to being hired, trained, or deployed as described in paragraph (1);
the performance of each program supported by funds under this subtitle with respect to the indicators of performance under section 116 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3141), as applicable;
the number of individuals in unsubsidized employment within six months and 1 year, respectively, of the conclusion of employment in contact tracing and related positions and, of those, the number of individuals within a State, territorial, or local public health department in an occupation related to public health;
any information on how eligible entities, local boards, or community-based organizations that received funding under this subsection were able to support the goals of the national system for COVID–19 testing, contact tracing, surveillance, containment, and mitigation established under section 561 of this Act; and
best practices for improving and increasing the transition of individuals employed in contract tracing and related positions to unsubsidized employment.
Disaggregation— All data reported under paragraph (1) shall be disaggregated by race, ethnicity, sex, age, and, with respect to individuals with barriers to employment, subpopulation of such individuals, except for when the number of participants in a category is insufficient to yield statistically reliable information or when the results would reveal personally identifiable information about an individual participant.
Special rule— Any funds used for programs under this section that are used to fund an apprenticeship or apprenticeship program shall only be used for, or provided to, an apprenticeship or apprenticeship program that meets the definition of such term subsection (a) of this section, including any funds awarded for the purposes of grants, contracts, or cooperative agreements, or the development, implementation, or administration, of an apprenticeship or an apprenticeship program.
Information sharing requirement for HHS— The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall provide the Secretary of Labor, acting through the Assistant Secretary of the Employment and Training Administration, with information on grants under section 562, including—
the formula used to award such grants to State, local, Tribal, and territorial health departments;
the dollar amounts of and scope of the work funded under such grants;
the geographic areas served by eligible entities that receive such grants; and
the number of contact tracers and related positions to be hired using such grants.
Authorization of appropriations— Of the amounts appropriated to carry out this subtitle, $500,000,000 shall be used by the Secretary of Labor to carry out subsections (a) through (h) of this section.
Sec. 567 Application of the Service Contract Act to contracts and grants
Contracts and grants which include contact tracing as part of the scope of work and that are awarded under this subtitle shall require that contract tracers and related positions are paid not less than the prevailing wage and fringe rates required under chapter 67 of title 41, United States Code (commonly known as the “Service Contract Act”) for the area in which the work is performed. To the extent that a nonstandard wage determination is required to establish a prevailing wage for contact tracers and related positions for purposes of this subtitle, the Secretary of Labor shall issue such determination not later than 14 days after the date of enactment of this Act, based on a job description used by the Centers for Disease Control and Prevention and contractors or grantees performing contact tracing for State public health agencies.
Sec. 568 Authorization of appropriations
To carry out this subtitle, there are authorized to be appropriated $75,000,000,000, to remain available until expended.
E Demographic Data and Supply Reporting Related to COVID–19
Sec. 571 COVID–19 reporting portal
In general— Not later than 15 days after the date of enactment of this Act, the Secretary shall establish and maintain an online portal for use by eligible health care entities to track and transmit data regarding their personal protective equipment and medical supply inventory and capacity related to COVID–19.
Eligible health care entities— In this section, the term eligible health care entity means a licensed acute care hospital, hospital system, or long-term care facility with confirmed cases of COVID–19.
Submission— An eligible health care entity shall report using the portal under this section on a biweekly basis in order to assist the Secretary in tracking usage and need of COVID–related supplies and personnel in a regular and real-time manner.
Included information— The Secretary shall design the portal under this section to include information on personal protective equipment and medical supply inventory and capacity related to COVID–19, including with respect to the following:
Personal protective equipment— Total personal protective equipment inventory, including, in units, the numbers of N95 masks and authorized equivalent respirator masks, surgical masks, exam gloves, face shields, isolation gowns, and coveralls.
Medical supply—
Total ventilator inventory, including, in units, the number of universal, adult, pediatric, and infant ventilators.
Total diagnostic and serological test inventory, including, in units, the number of test platforms, tests, test kits, reagents, transport media, swabs, and other materials or supplies determined necessary by the Secretary.
Capacity—
Case count measurements, including confirmed positive cases and persons under investigation.
Total number of staffed beds, including medical surgical beds, intensive care beds, and critical care beds.
Available beds, including medical surgical beds, intensive care beds, and critical care beds.
Total number of COVID–19 patients currently utilizing a ventilator.
Average number of days a COVID–19 patient is utilizing a ventilator.
Total number of additionally needed professionals in each of the following categories: intensivists, critical care physicians, respiratory therapists, registered nurses, certified registered nurse anesthetists, and laboratory personnel.
Total number of hospital personnel currently not working due to self-isolation following a known or presumed COVID–19 exposure.
Access to information related to inventory and capacity— The Secretary shall ensure that relevant agencies and officials, including the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, and the Federal Emergency Management Agency, have access to information related to inventory and capacity submitted under this section.
Weekly report to Congress— On a weekly basis, the Secretary shall transmit information related to inventory and capacity submitted under this section to the appropriate committees of the House and Senate.
Sec. 572 Regular CDC reporting on demographic data
Not later than 14 days after the date of enactment of this Act, the Secretary, in coordination with the Director of the Centers for Disease Control and Prevention, shall amend the reporting under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Service Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139; 134 Stat. 620, 626) on the demographic characteristics, including race, ethnicity, age, sex, gender, geographic region, and other relevant factors of individuals tested for or diagnosed with COVID–19, to include—
providing technical assistance to State, local, and territorial health departments to improve the collection and reporting of such demographic data;
if such data is not so collected or reported, the reason why the State, local, or territorial department of health has not been able to collect or provide such information; and
making a copy of such report available publicly on the website of the Centers for Disease Control and Prevention.
Sec. 573 Federal modernization for health inequities data
In general— The Secretary shall work with covered agencies to support the modernization of data collection methods and infrastructure at such agencies for the purpose of increasing data collection related to health inequities, such as racial, ethnic, socioeconomic, sex, gender, and disability disparities.
Covered agency defined— In this section, the term covered agency means each of the following Federal agencies:
The Agency for Healthcare Research and Quality.
The Centers for Disease Control and Prevention.
The Centers for Medicare & Medicaid Services.
The Food and Drug Administration.
The Office of the National Coordinator for Health Information Technology.
The National Institutes of Health.
Authorization of appropriations— There is authorized to be appropriated to each covered agency to carry out this section $4,000,000, to remain available until expended.
Sec. 574 Modernization of State and local health inequities data
In general— Not later than 6 months after the date of enactment of this Act, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to State, local, and territorial health departments in order to support the modernization of data collection methods and infrastructure for the purposes of increasing data related to health inequities, such as racial, ethnic, socioeconomic, sex, gender, and disability disparities. The Secretary shall—
provide guidance, technical assistance, and information to grantees under this section on best practices regarding culturally competent, accurate, and increased data collection and transmission; and
track performance of grantees under this section to help improve their health inequities data collection by identifying gaps and taking effective steps to support States, localities, and territories in addressing the gaps.
Report— Not later than 1 year after the date on which the first grant is awarded under this section, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate an initial report detailing—
nationwide best practices for ensuring States and localities collect and transmit health inequities data;
nationwide trends which hinder the collection and transmission of health inequities data;
Federal best practices for working with States and localities to ensure culturally competent, accurate, and increased data collection and transmission; and
any recommended changes to legislative or regulatory authority to help improve and increase health inequities data collection.
Final report— Not later than three months after the end of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, the Secretary shall—
update and finalize the initial report under subsection (b); and
submit such final report to the committees specified in such subsection.
Authorization of appropriations— There is authorized to be appropriated to carry out this section $100,000,000, to remain available until expended.
Sec. 575 Tribal funding to research health inequities including COVID–19
In general— Not later than 6 months after the date of enactment of this Act, the Director of the Indian Health Service, in coordination with Tribal Epidemiology Centers and other Federal agencies, as appropriate, shall conduct or support research and field studies for the purposes of improved understanding of Tribal health inequities among American Indians and Alaska Natives, including with respect to—
disparities related to COVID–19;
public health surveillance and infrastructure regarding unmet needs in Indian country and Urban Indian communities;
population-based health disparities;
barriers to health care services;
the impact of socioeconomic status; and
factors contributing to Tribal health inequities.
Consultation, confer, and coordination— In carrying out this section, the Director of the Indian Health Service shall—
consult with Indian Tribes and Tribal organizations;
confer with Urban Indian organizations; and
coordinate with the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health.
Process— Not later than 60 days after the date of enactment of this Act, the Director of the Indian Health Service shall establish a nationally representative panel to establish processes and procedures for the research and field studies conducted or supported under subsection (a). The Director shall ensure that, at a minimum, the panel consists of the following individuals:
Elected Tribal leaders or their designees.
Tribal public health practitioners and experts from the national and regional levels.
Duties— The panel established under subsection (c) shall, at a minimum—
advise the Director of the Indian Health Service on the processes and procedures regarding the design, implementation, and evaluation of, and reporting on, research and field studies conducted or supported under this section;
develop and share resources on Tribal public health data surveillance and reporting, including best practices; and
carry out such other activities as may be appropriate to establish processes and procedures for the research and field studies conducted or supported under subsection (a).
Report— Not later than 1 year after expending all funds made available to carry out this section, the Director of the Indian Health Service, in coordination with the panel established under subsection (c), shall submit an initial report on the results of the research and field studies under this section to—
the Committee on Energy and Commerce and the Committee on Natural Resources of the House of Representatives; and
the Committee on Indian Affairs and the Committee on Health, Education, Labor and Pensions of the Senate.
Tribal data sovereignty— The Director of the Indian Health Service shall ensure that all research and field studies conducted or supported under this section are tribally-directed and carried out in a manner which ensures Tribal-direction of all data collected under this section—
according to Tribal best practices regarding research design and implementation, including by ensuring the consent of the Tribes involved to public reporting of Tribal data;
according to all relevant and applicable Tribal, professional, institutional, and Federal standards for conducting research and governing research ethics;
with the prior and informed consent of any Indian Tribe participating in the research or sharing data for use under this section; and
in a manner that respects the inherent sovereignty of Indian Tribes, including Tribal governance of data and research.
Final report— Not later than three months after the end of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, the Director of the Indian Health Service shall—
update and finalize the initial report under subsection (e); and
submit such final report to the committees specified in such subsection.
Definitions— In this section:
The terms Indian Tribe and Tribal organization have the meanings given to such terms in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).
The term Urban Indian organization has the meaning given to such term in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603).
Authorization of appropriations— There is authorized to be appropriated to carry out this section $25,000,000, to remain available until expended.
Sec. 576 CDC field studies pertaining to specific health inequities
In general— Not later than 90 days after the date of enactment of this Act, the Secretary, acting through the Centers for Disease Control and Prevention, in collaboration with State, local, and territorial health departments, shall complete (by the reporting deadline in subsection (b)) field studies to better understand health inequities that are not currently tracked by the Secretary. Such studies shall include an analysis of—
the impact of socioeconomic status on health care access and disease outcomes, including COVID–19 outcomes;
the impact of disability status on health care access and disease outcomes, including COVID–19 outcomes;
the impact of language preference on health care access and disease outcomes, including COVID–19 outcomes;
factors contributing to disparities in health outcomes for the COVID–19 pandemic; and
other topics related to disparities in health outcomes for the COVID–19 pandemic, as determined by the Secretary.
Report— Not later than December 31, 2021, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate an initial report on the results of the field studies under this section.
Final report— Not later than three months after the end of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, the Secretary shall—
update and finalize the initial report under subsection (b); and
submit such final report to the committees specified in such subsection.
Authorization of appropriations— There is authorized to be appropriated to carry out this section $25,000,000, to remain available until expended.
Sec. 577 Additional reporting to Congress on the race and ethnicity rates of COVID–19 testing, hospitalizations, and mortalities
In general— Not later than 30 days after the date of enactment of this Act, the Secretary shall submit to the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives and the Committee on Appropriations and the Committee on Health, Education, Labor and Pensions of the Senate an initial report—
describing the testing, positive diagnoses, hospitalization, intensive care admissions, and mortality rates associated with COVID–19, disaggregated by race, ethnicity, age, sex, gender, geographic region, and other relevant factors as determined by the Secretary;
including an analysis of any variances of testing, positive diagnoses, hospitalizations, and deaths by demographic characteristics; and
including proposals for evidenced-based response strategies to reduce disparities related to COVID–19.
Final report— Not later than three months after the end of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, the Secretary shall—
update and finalize the initial report under subsection (a); and
submit such final report to the committees specified in such subsection.
Coordination— In preparing the report submitted under this section, the Secretary shall take into account and otherwise coordinate such report with reporting required under section 572 and under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Service Emergency Fund” in title I of division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139; 134 Stat. 620, 626).
F Miscellaneous
Sec. 581 Technical corrections to amendments made by CARES Act
The amendments made by this section shall take effect as if included in the enactment of the CARES Act (Public Law 116–136).
Section 3112 of division A of the CARES Act (Public Law 116–136) is amended—
in subsection (a)(2)(A), by striking the comma before “or a permanent”;
in subsection (d)(1), by striking “and subparagraphs (A) and (B)” and inserting “as subparagraphs (A) and (B)”; and
in subsection (e), by striking “Drug, Cosmetic Act” and inserting “Drug, and Cosmetic Act”.
Section 6001(a)(1)(D) of division F of the Families First Coronavirus Response Act (Public Law 116–127), as amended by section 3201 of division A of the CARES Act (Public Law 116–136), is amended by striking “other test that”.
Subsection (k)(9) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2), as added by section 3221(d) of division A of the CARES Act (Public Law 116–136), is amended by striking “unprotected health information” and inserting “unsecured protected health information”.
Section 3401(2)(D) of division A of the CARES Act (Public Law 116–136), is amended by striking “Not Later than” and inserting “Not later than”.
Section 831(f) of the Public Health Service Act, as redesignated by section 3404(a)(6)(E) and amended by section 3404(a)(6)(G) of division A of the CARES Act (Public Law 116–136), is amended by striking “a health care facility, or a partnership of such a school and facility”.
Section 846(i) of the Public Health Service Act, as amended by section 3404(a)(8)(C) of division A of the CARES Act (Public Law 116–136), is amended by striking “871(b),,” and inserting “871(b),”.
Section 3606(a)(1)(A) of division A of the CARES Act (Public Law 116–136) is amended by striking “In general” and inserting “In general”.
Section 3856(b)(1) of division A of the CARES Act (Public Law 116–136) is amended to read as follows:
“(1) In general—Section 905(b)(4) of the FDA Reauthorization Act of 2017 (Public Law 115–52) is amended by striking “Section 744H(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(e)(2)(B))” and inserting “Section 744H(f)(2)(B) of the Federal Food, Drug, and Cosmetic Act, as redesignated by section 403(c)(1) of this Act,”.”
VI Public Health Assistance
Sec. 601 Definition
In this title, the term “Secretary” means the Secretary of Health and Human Services.
A Assistance to Providers and Health System
Sec. 611 Health Care Provider Relief Fund
In general— Not later than 7 days after the date of enactment of this Act, the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish a program under which the Secretary shall reimburse, through grants or other mechanisms, eligible health care providers for eligible expenses or lost revenues occurring during calendar quarters beginning on or after January 1, 2020, to prevent, prepare for, and respond to COVID–19, in an amount calculated under subsection (c).
Quarterly basis—
Submission of applications— The Secretary shall give applicants a period of 7 calendar days after the close of a quarter to submit applications under this section with respect to such quarter, except that the Secretary shall give applicants a period of 7 calendar days after the date of enactment of this Act to submit applications with respect to the quarters beginning on January 1 and April 1, 2020, if the applicant has not previously submitted an application with the respect to such quarters.
Review and payment— The Secretary shall—
review applications and make awards of reimbursement under this section on a quarterly basis; and
award the reimbursements under this section for a quarter not later than 14 calendar days after the close of the quarter, except that the Secretary shall award the reimbursements under this section for the quarters beginning on January 1 and April 1, 2020, not later than 14 calendar days after the date of enactment of this Act.
Calculation—
In general— The amount of the reimbursement to an eligible health care provider under this section with respect to a calendar quarter shall equal—
the sum of—
100 percent of the eligible expenses, as described in subsection (d), of the provider during the quarter; and
subject to paragraph (3), 60 percent of the lost revenues, as described in subsection (e), of the provider during the quarter; less
any funds that are—
received by the provider during the quarter pursuant to the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Public Law 116–123), the Families First Coronavirus Response Act (Public Law 116–127), the CARES Act (Public Law 116–136), or the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139); and
not required to be repaid.
Carryover— If the amount determined under paragraph (1)(B) for a calendar quarter with respect to an eligible health care provider exceeds the amount determined under paragraph (1)(A) with respect to such provider and quarter, the amount of such difference shall be applied in making the calculation under this subsection, over each subsequent calendar quarter for which the eligible health care provider seeks reimbursement under this section.
Lost revenue limitation— If the amount determined under subsection (e) with respect to the lost revenue of an eligible health care provider for a calendar quarter does not exceed an amount that equals 10 percent of the net patient revenue (as defined in such subsection) of the provider for the corresponding quarter in 2019, the addend under paragraph (1)(A)(ii), in making the calculation under paragraph (1), is deemed to be zero.
Eligible expenses— Subject to subsection (h)(1), expenses eligible for reimbursement under this section include expenses for—
building or construction of temporary structures;
leasing of properties;
medical supplies and equipment including personal protective equipment;
in vitro diagnostic tests, serological tests, or testing supplies;
increased workforce and trainings;
emergency operation centers;
construction or retrofitting of facilities;
mobile testing units;
surge capacity;
retention of workforce; and
such other items and services as the Secretary determines to be appropriate, in consultation with relevant stakeholders.
Lost revenues—
In general— Subject to subsection (h)(1), for purposes of subsection (c)(1)(A)(ii), the lost revenues of an eligible health care provider, with respect to the calendar quarter involved, shall be equal to—
net patient revenue of the provider for the corresponding quarter in 2019 minus net patient revenue of the provider for such quarter; less
the savings of the provider during the calendar quarter involved attributable to foregone wages, payroll taxes, and benefits of personnel who were furloughed or laid off by the provider during that quarter.
Net patient revenue defined— For purposes of paragraph (1)(A), the term net patient revenue, with respect to an eligible health care provider and a calendar quarter, means the sum of—
200 percent of the total amount of reimbursement received by the provider during the quarter for all items and services furnished under a State plan or a waiver of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.);
125 percent of the total amount of reimbursement received by the provider during the quarter for all items and services furnished under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.); and
100 percent of the total amount of reimbursement not described in subparagraph (A) or (B) received by the provider during the quarter for all items and services.
Insufficient funds for a quarter— If there are insufficient funds made available to reimburse all eligible health care providers for all eligible expenses and lost revenues for a quarter in accordance with this section, the Secretary shall—
prioritize reimbursement of eligible expenses; and
using the entirety of the remaining funds, uniformly reduce the percentage of lost revenues otherwise applicable under subsection (c)(1)(A)(ii) to the extent necessary to reimburse a portion of the lost revenues of all eligible health care providers applying for reimbursement.
Application— A health care provider seeking reimbursement under this section for a calendar quarter shall submit to the Secretary an application that—
provides documentation demonstrating that the health care provider is an eligible health care provider;
includes a valid tax identification number of the health care provider or, if the health care provider does not have a valid tax identification number, an employer identification number or such other identification number as the Secretary may accept or may assign;
attests to the eligible expenses and lost revenues of the health care provider, as described in subsection (d), occurring during the calendar quarter;
includes an itemized listing of each such eligible expense, including expenses incurred in providing uncompensated care;
for purposes of subsection (c)(3), attests to whether the amount determined under subsection (e) with respect to the lost revenue of an eligible health care provider for a calendar quarter exceeds an amount that equals 10 percent of the net patient revenue (as defined in such subsection) of the provider for the corresponding quarter in 2019;
includes projections of the eligible expenses and lost revenues of the health care provider, as described in subsection (c), for the calendar quarter that immediately follows the calendar quarter for which reimbursement is sought; and
indicates the dollar amounts described in each of subparagraphs (A) and (B) of subsection (e)(1) and subparagraphs (A), (B), and (C) of subsection (e)(2) for the calendar quarter and any other information the Secretary determines necessary to determine expenses and lost revenue related to COVID–19.
Limitations—
No duplicative reimbursement— The Secretary may not provide, and a health care provider may not accept, reimbursement under this section for expenses or losses with respect to which—
the eligible health care provider is reimbursed from other sources; or
other sources are obligated to reimburse the provider.
No executive compensation— Reimbursement for eligible expenses (as described in subsection (d)) and lost revenues (as described in subsection (e)) shall not include compensation or benefits, including salary, bonuses, awards of stock, or other financial benefits, for an officer or employee described in section 4004(a)(2) of the CARES Act (Public Law 116–136).
No balance billing as condition of receipt of funds—
Protecting individuals enrolled in health plans— As a condition of receipt of reimbursement under this section, a health care provider, in the case such provider furnishes during the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)) (whether before, on, or after, the date on which the provider submits an application under this section) a medically necessary item or service described in subparagraph (A), (B), or (C) of paragraph (3) to an individual who is described in such subparagraph (A), (B), or (C), respectively, and enrolled in a group health plan or group or individual health insurance coverage offered by a health insurance issuer (including grandfathered health plans as defined in section 1251(e) of the Patient Protection and Affordable Care Act (42 U.S.C. 18011(e)) and such provider is a nonparticipating provider, with respect to such plan or coverage or with respect to such item or service, and such plan or coverage and such items and services would otherwise be covered under such plan if furnished by a participating provider—
may not bill or otherwise hold liable such individual for a payment amount for such item or service that is more than the cost-sharing amount that would apply under such plan or coverage for such item or service if such provider furnishing such service were a participating provider with respect to such plan or coverage;
shall reimburse such individual in a timely manner for any amount for such item or service paid by the individual to such provider in excess of such cost-sharing amount;
shall submit any claim for such item or service directly to the plan or coverage; and
shall not bill the individual for such cost-sharing amount until such individual is informed by the plan or coverage of the required payment amount.
Protecting uninsured individuals— As a condition of receipt by a health care provider of reimbursement under this section, if the health care provider furnishes any medically necessary item or service described in subparagraph (A), (B), or (C) of paragraph (3) during the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b-5(g)(1)(B)) (whether before, on, or after, the date on which the provider submits an application under this section) to an uninsured individual who is described in such subparagraph (A), (B), or (C), respectively, the health care provider—
shall submit a claim for purposes of reimbursement, with respect to such item or service—
from the uninsured portal established pursuant to the provider relief fund established through the Public Health and Social Services Emergency Fund under the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116–136), or pursuant to activities authorized under section 2812 of the Public Health Service Act (42 U.S.C. 300hh–11) under the Public Health and Social Services Emergency Fund under the Families First Coronavirus Response Act (Public Law 116–127); or
if applicable, under this section with respect to expenses incurred in providing uncompensated care (as described in subsection (g)(4)) with respect to such medical care); and
if such claim is eligible for such reimbursement—
shall consider the amount of such reimbursement as payment in full with respect to such item or service so furnished to such individual;
may not bill or otherwise hold liable such individual for any payment for such item or service so furnished to such individual; and
shall reimburse such individual in a timely manner for any amount for such item or service paid by the individual to such provider.
Medically necessary items and services described— For purposes of this subsection, medically necessary items and services described in this paragraph are—
medically necessary items and services (including in-person or telehealth visits in which such items and services are furnished) that are furnished to an individual who has been diagnosed with (or after provision of the items and services is diagnosed with) COVID–19 to treat or mitigate the effects of COVID–19;
medically necessary items and services (including in-person or telehealth visits in which such items and services are furnished) that are furnished to an individual who is presumed, in accordance with paragraph (4), to have COVID–19 but is never diagnosed as such; and
a diagnostic test (and administration of such test) as described in section 6001(a) of division F of the Families First Coronavirus Response Act (42 U.S.C. 1320b–5 note) administered to an individual.
Presumptive case of COVID–19— For purposes of paragraph (3)(B), an individual shall be presumed to have COVID–19 if the medical record documentation of the individual supports a diagnosis of COVID–19, even if the individual does not have a positive in vitro diagnostic test result in the medical record of the individual.
Penalty— In the case of an eligible health care provider that is paid a reimbursement under this section and that is in violation of paragraph (1) or (2), in addition to any other penalties that may be prescribed by law, the Secretary may recoup from such provider up to the full amount of reimbursement the provider receives under this section.
Definitions— In this subsection:
Nonparticipating provider— The term nonparticipating provider means, with respect to an item or service and group health plan or group or individual health insurance coverage offered by a health insurance issuer, a health care provider that does not have a contractual relationship directly or indirectly with the plan or issuer, respectively, for furnishing such an item or service under the plan or coverage.
Participating provider— The term participating provider means, with respect to an item or service and group health plan or group or individual health insurance coverage offered by a health insurance issuer, a health care provider that has a contractual relationship directly or indirectly with the plan or issuer, respectively, for furnishing such an item or service under the plan or coverage.
Group health plan, health insurance coverage— The terms group health plan, health insurance issuer, group health insurance coverage, and individual health insurance coverage shall have the meanings given such terms under section 2791 of the Public Health Service Act (42 U.S.C. 300gg–91).
Uninsured individual— The term “uninsured individual” shall have the meaning given such term in the Families First Coronavirus Response Act (Public Law 116–127) for purposes of the additional amount made available under such Act to the Public Health and Social Services Emergency Fund for activities authorized under section 2812 of the Public Health Service Act (42 U.S.C. 300hh–11).
Reports—
Award information— In making awards under this section, the Secretary shall post in a searchable, electronic format, a list of all recipients and awards pursuant to funding authorized under this section.
Reports by recipients— Each recipient of an award under this section shall, as a condition on receipt of such award, submit reports and maintain documentation, in such form, at such time, and containing such information, as the Secretary determines is needed to ensure compliance with this section.
Public listing of awards— The Secretary shall—
not later than 7 days after the date of enactment of this Act, post in a searchable, electronic format, a list of all awards made by the Secretary under this section, including the recipients and amounts of such awards; and
update such list not less than every 7 days until all funds made available to carry out this section are expended.
Inspector General report—
In general— Not later than 3 years after final payments are made under this section, the Inspector General of the Department of Health and Human Services shall transmit a final report on audit findings with respect to the program under this section to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor and Pensions and the Committee on Appropriations of the Senate.
Rule of construction— Nothing in this paragraph shall be construed as limiting the authority of the Inspector General of the Department of Health and Human Services or the Comptroller General of the United States to conduct audits of interim payments earlier than the deadline described in subparagraph (A).
Eligible health care provider defined— In this section:
In general— The term eligible health care provider means a health care provider described in paragraph (2) that provides diagnostic or testing services or treatment to individuals with a confirmed or possible diagnosis of COVID–19.
Health care providers described— A health care provider described in this paragraph is any of the following:
A health care provider enrolled as a participating provider under a State plan approved under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) (or a waiver of such a plan).
A provider of services (as defined in subsection (u) of section 1861 of the Social Security Act (42 U.S.C. 1395x)) or a supplier (as defined in subsection (d) of such section) that is enrolled as a participating provider of services or participating supplier under the Medicare program under title XVIII of such Act (42 U.S.C. 1395 et seq.).
A public entity.
Any other entity not described in this paragraph as the Secretary may specify.
Funding—
Authorization of appropriations— There is authorized to be appropriated for an additional amount to carry out this section $50,000,000,000, to remain available until expended.
Health Care Provider Relief Fund—
Use of appropriated funds—
In general— In addition to amounts authorized to be appropriated pursuant to paragraph (1), the unobligated balance of all amounts appropriated to the Health Care Provider Relief Fund shall be made available only to carry out this section.
Amounts— For purposes of clause (i), the following amounts are deemed to be appropriated to the Health Care Provider Relief Fund:
The unobligated balance of the appropriation of $100,000,000,000 in the third paragraph under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Services Emergency Fund” in division B of the CARES Act (Public Law 116–136).
The unobligated balance of the appropriation under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Services Emergency Fund” in division B of the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139).
Limitation— Of the unobligated balances described in subparagraph (A)(ii), the Secretary may not make available more than $5,000,000,000 to reimburse eligible health care providers for expenses incurred in providing uncompensated care.
Future amounts— Any appropriation enacted subsequent to the date of enactment of this Act that is made available for reimbursing eligible health care providers as described in subsection (a) shall be made available only to carry out this section.
Sec. 612 Public Health Workforce Loan Repayment Program
Part D of title III of the Public Health Service Act (42 U.S.C. 254b et seq.) is amended by adding at the end the following new subpart:
“XIII Public Health Workforce
“340J. Loan Repayment Program
“(a) Establishment—The Secretary of Health and Human Services shall establish a program to be known as the Public Health Workforce Loan Repayment Program (referred to in this section as the “Program”) to assure an adequate supply of and encourage recruitment of public health professionals to eliminate critical public health workforce shortages in local, State, territorial, and Tribal public health agencies.
“(b) Eligibility—To be eligible to participate in the Program, an individual shall—
“(1)
“(A) be accepted for enrollment, or be enrolled, as a student in an accredited academic educational institution in a State or territory in the final semester or equivalent of a course of study or program leading to a public health degree, a health professions degree or certificate, or a degree in computer science, information science, information systems, information technology, or statistics and have accepted employment with a local, State, territorial, or Tribal public health agency, or a related training fellowship, as recognized by the Secretary, to commence upon graduation; or
“(B)
“(i) have graduated, during the preceding 10-year period, from an accredited educational institution in a State or territory and received a public health degree, a health professions degree or certificate, or a degree in computer science, information science, information systems, information technology, or statistics; and
“(ii) be employed by, or have accepted employment with, a local, State, territorial, or Tribal public health agency or a related training fellowship, as recognized by the Secretary;
“(2) be a United States citizen;
“(3)
“(A) submit an application to the Secretary to participate in the Program; and
“(B) execute a written contract as required in subsection (c); and
“(4) not have received, for the same service, a reduction of loan obligations under section 428K or 428L of the Higher Education Act of 1965 (20 U.S.C. 1078–11, 1078–12).
“(c) Contract—The written contract referred to in subsection (b)(3)(B) between the Secretary and an individual shall contain—
“(1) an agreement on the part of the Secretary that the Secretary will repay, on behalf of the individual, loans incurred by the individual in the pursuit of the relevant degree or certificate in accordance with the terms of the contract;
“(2) an agreement on the part of the individual that the individual will serve in the full-time employment of a local, State, or Tribal public health agency or a related fellowship program in a position related to the course of study or program for which the contract was awarded for a period of time equal to the greater of—
“(A) 2 years; or
“(B) such longer period of time as determined appropriate by the Secretary and the individual;
“(3) an agreement, as appropriate, on the part of the individual to relocate to a priority service area (as determined by the Secretary) in exchange for an additional loan repayment incentive amount to be determined by the Secretary;
“(4) a provision that any financial obligation of the United States arising out of a contract entered into under this section and any obligation of the individual that is conditioned thereon, is contingent on funds being appropriated for loan repayments under this section;
“(5) a statement of the damages to which the United States is entitled, under this section for the individual’s breach of the contract; and
“(6) such other statements of the rights and liabilities of the Secretary and of the individual as the Secretary determines appropriate, not inconsistent with this section.
“(d) Payments
“(1) In general—A loan repayment provided for an individual under a written contract referred to in subsection (b)(3)(B) shall consist of payment, in accordance with paragraph (2), for the individual toward the outstanding principal and interest on education loans incurred by the individual in the pursuit of the relevant degree in accordance with the terms of the contract.
“(2) Equitable distribution—In awarding contracts under this section, the Secretary shall ensure—
“(A) a certain percentage of contracts are awarded to individuals who are not already working in public health departments;
“(B) an equitable distribution of funds geographically; and
“(C) an equitable distribution among State, local, territorial, and Tribal public health departments.
“(3) Payments for years served—For each year of service that an individual contracts to serve pursuant to subsection (c)(2), the Secretary may pay not more than $35,000 on behalf of the individual for loans described in paragraph (1). With respect to participants under the Program whose total eligible loans are less than $105,000, the Secretary shall pay an amount that does not exceed ⅓ of the eligible loan balance for each year of such service of such individual.
“(4) Tax liability—For purposes of the Internal Revenue Code of 1986, a payment made under this section shall be treated in the same manner as an amount received under section 338B(g) of this Act, as described in section 108(f)(4) of such Code.
“(e) Postponing obligated service—With respect to an individual receiving a degree or certificate from a health professions or other related school, the date of the initiation of the period of obligated service may be postponed as approved by the Secretary.
“(f) Breach of contract—An individual who fails to comply with the contract entered into under subsection (c) shall be subject to the same financial penalties as provided for under section 338E of the Public Health Service Act (42 U.S.C. 254o) for breaches of loan repayment contracts under section 338B of such Act (42 U.S.C. section 254l–1).
“(g) Definition—For purposes of this section, the term full-time means full-time as such term is used in section 455(m)(3) of the Higher Education Act of 1965.
“(h) Authorization of appropriations—There is authorized to be appropriated to carry out this section—
“(1) $100,000,000 for fiscal year 2021; and
“(2) $75,000,000 for fiscal year 2022.”
Sec. 613 Expanding capacity for health outcomes
In general— The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall award grants to eligible entities to develop and expand the use of technology-enabled collaborative learning and capacity building models to respond to ongoing and real-time learning, health care information sharing, and capacity building needs related to COVID–19.
Eligible entities— To be eligible to receive a grant under this section, an entity shall have experience providing technology-enabled collaborative learning and capacity building health care services—
in rural areas, frontier areas, health professional shortage areas, or medically underserved area; or
to medically underserved populations or Indian Tribes.
Use of funds— An eligible entity receiving a grant under this section shall use funds received through the grant—
to advance quality of care in response to COVID–19, with particular emphasis on rural and underserved areas and populations;
to protect medical personnel and first responders through sharing real-time learning through virtual communities of practice;
to improve patient outcomes for conditions affected or exacerbated by COVID–19, including improvement of care for patients with complex chronic conditions; and
to support rapid uptake by health care professionals of emerging best practices and treatment protocols around COVID–19.
Optional additional uses of funds— An eligible entity receiving a grant under this section may use funds received through the grant for—
equipment to support the use and expansion of technology-enabled collaborative learning and capacity building models, including hardware and software that enables distance learning, health care provider support, and the secure exchange of electronic health information;
the participation of multidisciplinary expert team members to facilitate and lead technology-enabled collaborative learning sessions, and professionals and staff assisting in the development and execution of technology-enabled collaborative learning;
the development of instructional programming and the training of health care providers and other professionals that provide or assist in the provision of services through technology-enabled collaborative learning and capacity building models; and
other activities consistent with achieving the objectives of the grants awarded under this section.
Technology-enabled collaborative learning and capacity building model defined— In this section, the term technology-enabled collaborative learning and capacity building model has the meaning given that term in section 2(7) of the Expanding Capacity for Health Outcomes Act (Public Law 114–270; 130 Stat. 1395).
Authorization of appropriations— There is authorized to be appropriated to carry out this section $20,000,000, to remain available until expended.
Sec. 614 Additional funding for Medical Reserve Corps
Section 2813(i) of the Public Health Service Act (42 U.S.C. 300hh–15(i)) is amended by striking “$11,200,000 for each of fiscal years 2019 through 2023” and inserting “$31,200,000 for each of fiscal years 2021 and 2022 and $11,200,000 for each of fiscal years 2023 through 2025”.
Sec. 615 Grants for schools of medicine in diverse and underserved areas
Subpart II of part C of title VII of the Public Health Service Act is amended by inserting after section 749B of such Act (42 U.S.C. 293m) the following:
“749C. Schools of medicine in underserved areas
“(a) Grants—The Secretary, acting through the Administrator of the Health Resources and Services Administration, may award grants to institutions of higher education (including multiple institutions of higher education applying jointly) for the establishment, improvement, and expansion of an allopathic or osteopathic school of medicine, or a branch campus of an allopathic or osteopathic school of medicine.
“(b) Priority—In selecting grant recipients under this section, the Secretary shall give priority to institutions of higher education that—
“(1) propose to use the grant for an allopathic or osteopathic school of medicine, or a branch campus of an allopathic or osteopathic school of medicine, in a combined statistical area with fewer than 200 actively practicing physicians per 100,000 residents according to the medical board (or boards) of the State (or States) involved;
“(2) have a curriculum that emphasizes care for diverse and underserved populations; or
“(3) are minority-serving institutions described in the list in section 371(a) of the Higher Education Act of 1965.
“(c) Use of funds—The activities for which a grant under this section may be used include—
“(1) planning and constructing—
“(A) a new allopathic or osteopathic school of medicine in an area in which no other school is based; or
“(B) a branch campus of an allopathic or osteopathic school of medicine in an area in which no such school is based;
“(2) accreditation and planning activities for an allopathic or osteopathic school of medicine or branch campus;
“(3) hiring faculty and other staff to serve at an allopathic or osteopathic school of medicine or branch campus;
“(4) recruitment and enrollment of students at an allopathic or osteopathic school of medicine or branch campus;
“(5) supporting educational programs at an allopathic or osteopathic school of medicine or branch campus;
“(6) modernizing infrastructure or curriculum at an existing allopathic or osteopathic school of medicine or branch campus thereof;
“(7) expanding infrastructure or curriculum at existing an allopathic or osteopathic school of medicine or branch campus; and
“(8) other activities that the Secretary determines further the development, improvement, and expansion of an allopathic or osteopathic school of medicine or branch campus thereof.
“(d) Definitions—In this section:
“(1) The term branch campus means a geographically separate site at least 100 miles from the main campus of a school of medicine where at least one student completes at least 60 percent of the student’s training leading to a degree of doctor of medicine.
“(2) The term institution of higher education has the meaning given to such term in section 101(a) of the Higher Education Act of 1965.
“(e) Authorization of appropriations—To carry out this section, there is authorized to be appropriated $1,000,000,000, to remain available until expended.”
Sec. 616 GAO study on public health workforce
In general— The Comptroller General of the United States shall conduct a study on the public health workforce in the United States during the COVID–19 pandemic.
Topics— The study under subsection (a) shall address—
existing gaps in the Federal, State, local, Tribal, and territorial public health workforce, including—
epidemiological and disease intervention specialists needed during the pandemic for contact tracing, laboratory technicians necessary for testing, community health workers for community supports and services, and other staff necessary for contact tracing, testing, or surveillance activities; and
other personnel needed during the COVID–19 pandemic;
challenges associated with the hiring, recruitment, and retention of the Federal, State, local, Tribal, and territorial public health workforce; and
recommended steps the Federal Government should take to improve hiring, recruitment, and retention of the public health workforce.
Report— Not later than December 1, 2022, the Comptroller General shall submit to the Congress a report on the findings of the study conducted under this section.
Sec. 617 Longitudinal study on the impact of COVID–19 on recovered patients
Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:
“404O. Longitudinal study on the impact of COVID–19 on recovered patients
“(a) In general—The Director of NIH, in consultation with the Director of the Centers for Disease Control and Prevention, shall conduct a longitudinal study, over not less than 10 years, on the full impact of SARS–CoV–2 or COVID–19 on infected individuals, including both short-term and long-term health impacts.
“(b) Timing—The Director of NIH shall begin enrolling patients in the study under this section not later than 6 months after the date of enactment of this section.
“(c) Requirements—The study under this section shall—
“(1) be nationwide;
“(2) include diversity of enrollees to account for gender, age, race, ethnicity, geography, comorbidities, and underrepresented populations, including pregnant and lactating women;
“(3) study individuals with COVID–19 who experienced mild symptoms, such individuals who experienced moderate symptoms, and such individuals who experienced severe symptoms;
“(4) monitor the health outcomes and symptoms of individuals with COVID–19, or who had prenatal exposure to SARS–CoV–2 or COVID–19, including lung capacity and function, and immune response, taking into account any pharmaceutical interventions such individuals may have received;
“(5) monitor the mental health outcomes of individuals with COVID–19, taking into account any interventions that affected mental health; and
“(6) monitor individuals enrolled in the study not less frequently than twice per year after the first year of the individual's infection with SARS–CoV–2.
“(d) Public-private research network—For purposes of carrying out the study under this section, the Director of NIH may develop a network of public-private research partners, provided that all research, including the research carried out through any such partner, is available publicly.
“(e) Summaries of findings—The Director of NIH shall make public a summary of findings under this section not less frequently than once every 3 months for the first 2 years of the study, and not less frequently than every 6 months thereafter. Such summaries may include information about how the findings of the study under this section compare with findings from research conducted abroad.
“(f) Authorization of appropriations—There is authorized to be appropriated to carry out this section $200,000,000, to remain available until expended.”
Sec. 618 Research on the mental health impact of COVID–19
In general— The Secretary, acting through the Director of the National Institute of Mental Health, shall conduct or support research on the mental health consequences of SARS–CoV–2 or COVID–19.
Use of funds— Research under subsection (a) may include the following:
Research on the mental health impact of SARS–CoV–2 or COVID–19 on health care providers, including—
traumatic stress;
psychological distress; and
psychiatric disorders.
Research on the impact of SARS–CoV–2 or COVID–19 stressors on mental health over time.
Research to strengthen the mental health response to SARS–CoV–2 or COVID–19, including adapting to and maintaining or providing additional services for new or increasing mental health needs.
Research on the reach, efficiency, effectiveness, and quality of digital mental health interventions.
Research on effectiveness of strategies for implementation and delivery of evidence-based mental health interventions and services for underserved populations.
Research on suicide prevention.
Research coordination— The Secretary shall coordinate activities under this section with similar activities conducted by national research institutes and centers of the National Institutes of Health to the extent that such institutes and centers have responsibilities that are related to the mental health consequences of SARS–CoV–2 or COVID–19.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $200,000,000, to remain available until expended.
Sec. 619 Emergency mental health and substance use training and technical assistance center
Subpart 3 of part B of title V of the Public Health Service Act (42 U.S.C. 290bb–31 et seq.) is amended by inserting after section 520A (42 U.S.C. 290bb–32) the following:
“520B. Emergency mental health and substance use training and technical assistance center
“(a) Establishment—The Secretary, acting through the Assistant Secretary, shall establish or operate a center to be known as the Emergency Mental Health and Substance Use Training and Technical Assistance Center (referred to in this section as the “Center”) to provide technical assistance and support—
“(1) to public or nonprofit entities seeking to establish or expand access to mental health and substance use prevention, treatment, and recovery support services, and increase awareness of such services; and
“(2) to public health professionals, health care professionals and support staff, essential workers (as defined by a State, Tribe, locality, or territory), and members of the public to address the trauma, stress, and mental health needs associated with an emergency period.
“(b) Assistance and support—The assistance and support provided under subsection (a) shall include assistance and support with respect to—
“(1) training on identifying signs of trauma, stress, and mental health needs;
“(2) providing accessible resources to assist individuals and families experiencing trauma, stress, or other mental health needs during and after an emergency period;
“(3) providing resources for substance use disorder prevention, treatment, and recovery designed to assist individuals and families during and after an emergency period;
“(4) the provision of language access services, including translation services, interpretation, or other such services for individuals with limited English speaking proficiency or people with disabilities; and
“(5) evaluation and improvement, as necessary, of the effectiveness of such services provided by public or nonprofit entities.
“(c) Best practices—The Center shall periodically issue best practices for use by organizations seeking to provide mental health services or substance use disorder prevention, treatment, or recovery services to individuals during and after an emergency period.
“(d) Emergency period—In this section, the term emergency period has the meaning given such term in section 1135(g)(1)(A) of the Social Security Act.
“(e) Authorization of appropriations—There is authorized to be appropriated to carry out this section $20,000,000 for each of fiscal years 2021 and 2022.”
Sec. 620 Importance of the blood and plasma supply
in the section heading after “blood” by inserting “and plasma”; and
by inserting after “blood” each time it appears “and plasma”.
Conforming amendment— The item relating to section 3226 in the table of contents in section 2 of the CARES Act (Public Law 116–136) is amended to read as follows:
B Assistance for Individuals and Families
Sec. 631 Reimbursement for additional health services relating to coronavirus
Title V of division A of the Families First Coronavirus Response Act (Public Law 116–127; 134 Stat. 182) is amended under the heading “Department of Health and Human Services—Office of the Secretary—Public Health and Social Services Emergency Fund” by inserting “, or treatment related to SARS–CoV–2 or COVID–19 for uninsured individuals” after “or visits described in paragraph (2) of such section for uninsured individuals”.
Sec. 632 Centers for Disease Control and Prevention COVID–19 response line
In general— During the public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) on January 31, 2020, with respect to COVID–19, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall maintain a toll-free telephone number to address public health queries, including questions concerning COVID–19.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $10,000,000, to remain available until expended.
Sec. 633 Grants to address substance use during COVID–19
In general— The Assistant Secretary for Mental Health and Substance Use of the Department of Health and Human Services (in this section referred to as the “Assistant Secretary”), in consultation with the Director of the Centers for Disease Control and Prevention, shall award grants to States, political subdivisions of States, Tribes, Tribal organizations, and community-based entities to address the harms of drug misuse, including by—
preventing and controlling the spread of infectious diseases, such as HIV/AIDS and viral hepatitis, and the consequences of such diseases for individuals with substance use disorder;
connecting individuals at risk for or with a substance use disorder to overdose education, counseling, and health education; or
encouraging such individuals to take steps to reduce the negative personal and public health impacts of substance use or misuse during the emergency period.
Considerations— In awarding grants under this section, the Assistant Secretary shall prioritize grants to applicants proposing to serve areas with—
a high proportion of people who meet criteria for dependence on or abuse of illicit drugs who have not received any treatment;
high drug overdose death rates;
high telemedicine infrastructure needs; and
high behavioral health and substance use disorder workforce needs.
Definition— In this section, the term emergency period has the meaning given to such term in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B))).
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $10,000,000, to remain available until expended.
Sec. 634 Grants to support increased behavioral health needs due to COVID–19
In general— The Secretary, acting through the Assistant Secretary of Mental Health and Substance Use, shall award grants to States, political subdivisions of States, Indian Tribes and Tribal organizations, community-based entities, and primary care and behavioral health organizations to address behavioral health needs caused by the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19.
Use of funds— An entity that receives a grant under subsection (a) may use funds received through such grant to—
increase behavioral health treatment and prevention capacity, including to—
promote coordination among local entities;
train the behavioral health workforce, relevant stakeholders, and community members;
upgrade technology to support effective delivery of health care services through telehealth modalities;
purchase medical supplies and equipment for behavioral health treatment entities and providers;
address surge capacity for behavioral health needs such as through mobile units; and
promote collaboration between primary care and mental health providers; and
support or enhance behavioral health services, including—
emergency crisis intervention, including mobile crisis units, 24/7 crisis call centers, and medically staffed crisis stabilization programs;
screening, assessment, diagnosis, and treatment;
mental health awareness trainings;
evidence-based suicide prevention;
evidence-based integrated care models;
community recovery supports;
outreach to underserved and minority communities; and
for front line health care workers.
Priority— The Secretary shall give priority to applicants proposing to serve areas with a high number of COVID–19 cases.
Evaluation— An entity that receives a grant under this section shall prepare and submit an evaluation to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, including—
an evaluation of activities carried out with funds received through the grant; and
a process and outcome evaluation.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $50,000,000 for each of fiscal years 2021 and 2022, to remain available until expended.
C Assistance to Tribes
Sec. 641 Improving State, local, and Tribal public health security
in the section heading, by striking “and local” and inserting “, local, and Tribal”;
in subsection (b)—
in paragraph (1)—
in subparagraph (B), by striking “or” at the end;
in subparagraph (C), by striking “and” at the end and inserting “or”; and
by adding at the end the following:
“(D) be an Indian Tribe, Tribal organization, or a consortium of Indian Tribes or Tribal organizations; and”
in paragraph (2)—
in the matter preceding subparagraph (A), by inserting “, as applicable” after “including”;
in subparagraph (A)(viii)—
by inserting “and Tribal” after “with State”;
by striking “(as defined in section 8101 of the Elementary and Secondary Education Act of 1965)” and inserting “and Tribal educational agencies (as defined in sections 8101 and 6132, respectively, of the Elementary and Secondary Education Act of 1965)”; and
by inserting “and Tribal” after “and State”;
in subparagraph (G), by striking “and tribal” and inserting “Tribal, and urban Indian organization”; and
in subparagraph (H), by inserting “, Indian Tribes, and urban Indian organizations” after “public health”;
in subsection (e), by inserting “Indian Tribes, Tribal organizations, urban Indian organizations,” after “local emergency plans,”;
in subsection (g)(1), by striking “tribal officials” and inserting “Tribal officials”;
in subsection (h)—
in paragraph (1)(A)—
by striking “through 2023” and inserting “and 2020”; and
by inserting before the period “; and $690,000,000 for each of fiscal years 2021 through 2024 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5)) and paragraph (8), of which not less than $5,000,000 shall be reserved each fiscal year for awards under paragraph (8)”;
in paragraph (2)(B), by striking “tribal public” and inserting “Tribal public”;
in the heading of paragraph (3), by inserting “for States” after “amount”; and
by adding at the end the following:
“(8) Tribal eligible entities
“(A) Determination of funding amount
“(i) In general—The Secretary shall award at least 10 cooperative agreements under this section, in amounts not less than the minimum amount determined under clause (ii), to eligible entities described in subsection (b)(1)(D) that submits to the Secretary an application that meets the criteria of the Secretary for the receipt of such an award and that meets other reasonable implementation conditions established by the Secretary, in consultation with Indian Tribes, for such awards. If the Secretary receives more than 10 applications under this section from eligible entities described in subsection (b)(1)(D) that meet the criteria and conditions described in the previous sentence, the Secretary, in consultation with Indian Tribes, may make additional awards under this section to such entities.
“(ii) Minimum amount—In determining the minimum amount of an award pursuant to clause (i), the Secretary, in consultation with Indian Tribes, shall first determine an amount the Secretary considers appropriate for the eligible entity.
“(B) Available until expended—Amounts provided to a Tribal eligible entity under a cooperative agreement under this section for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity during the entirety of the performance period, for the purposes for which said funds were provided.
“(C) No matching requirement—Subparagraphs (B), (C), and (D) of paragraph (1) shall not apply with respect to cooperative agreements awarded under this section to eligible entities described in subsection (b)(1)(D).”
by adding at the end the following:
“(l) Special rules related to Tribal eligible entities
“(1) Modifications—After consultation with Indian Tribes, the Secretary may make necessary and appropriate modifications to the program under this section to facilitate the use of the cooperative agreement program by eligible entities described in subsection (b)(1)(D).
“(2) Waivers
“(A) In general—Except as provided in subparagraph (B), the Secretary may waive or specify alternative requirements for any provision of this section (including regulations) that the Secretary administers in connection with this section if the Secretary finds that the waiver or alternative requirement is necessary for the effective delivery and administration of this program with respect to eligible entities described in subsection (b)(1)(D).
“(B) Exception—The Secretary may not waive or specify alternative requirements under subparagraph (A) relating to labor standards or the environment.
“(3) Consultation—The Secretary shall consult with Indian Tribes and Tribal organizations on the design of this program with respect to such Tribes and organizations to ensure the effectiveness of the program in enhancing the security of Indian Tribes with respect to public health emergencies.
“(4) Reporting
“(A) In general—Not later than 2 years after the date of enactment of this subsection, and as an addendum to the biennial evaluations required under subsection (k), the Secretary, in coordination with the Director of the Indian Health Service, shall—
“(i) conduct a review of the implementation of this section with respect to eligible entities described in subsection (b)(1)(D), including any factors that may have limited its success; and
“(ii) submit a report describing the results of the review described in clause (i) to—
“(I) the Committee on Indian Affairs, the Committee on Health, Education, Labor and Pensions, and the Committee on Appropriations of the Senate; and
“(II) the Subcommittee for Indigenous Peoples of the United States of the Committee on Natural Resources, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives.
“(B) Analysis of Tribal public health emergency infrastructure limitation—The Secretary shall include in the initial report submitted under subparagraph (A) a description of any public health emergency infrastructure limitation encountered by eligible entities described in subsection (b)(1)(D).”
Sec. 642 Provision of items to Indian programs and facilities
Strategic National Stockpile— Section 319F–2(a)(3)(G) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)(G)) is amended by inserting “, and, in the case that the Secretary deploys the stockpile under this subparagraph, ensure, in coordination with the applicable States and programs and facilities, that appropriate drugs, vaccines and other biological products, medical devices, and other supplies are deployed by the Secretary directly to health programs or facilities operated by the Indian Health Service, an Indian Tribe, a Tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304)), or an inter-Tribal consortium (as defined in section 501 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5381)) or through an urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), while avoiding duplicative distributions to such programs or facilities” before the semicolon.
Distribution of qualified pandemic or epidemic products to IHS facilities— Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 319F–4 the following:
“319F–5. Distribution of qualified pandemic or epidemic products to Indian programs and facilities
“In the case that the Secretary distributes qualified pandemic or epidemic products (as defined in section 319F–3(i)(7)) to States or other entities, the Secretary shall ensure, in coordination with the applicable States and programs and facilities, that, as appropriate, such products are distributed directly to health programs or facilities operated by the Indian Health Service, an Indian Tribe, a Tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304)), or an inter-Tribal consortium (as defined in section 501 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5381)) or through an urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), while avoiding duplicative distributions to such programs or facilities.”
Sec. 643 Health care access for urban native veterans
Section 405 of the Indian Health Care Improvement Act (25 U.S.C. 1645) is amended—
in subsection (a)(1), by inserting “urban Indian organizations,” before “and tribal organizations”; and
in subsection (c)—
by inserting “urban Indian organization,” before “or tribal organization”; and
by inserting “an urban Indian organization,” before “or a tribal organization”.
Sec. 644 Tribal school Federal insurance parity
Section 409 of the Indian Health Care Improvement Act (25 U.S.C. 1647b) is amended by inserting “or the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2501 et seq.)” after “(25 U.S.C. 450 et seq.)”.
Sec. 645 PRC for native veterans
Section 405(c) of the Indian Health Care Improvement Act (25 U.S.C. 1645) is amended by inserting before the period at the end the following: “, regardless of whether such services are provided directly by the Service, an Indian tribe, or tribal organization, through contract health services, or through a contract for travel described in section 213(b)”.
D Public health assistance to essential workers
Sec. 651 Containment and mitigation for essential workers program
Program— The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Director of the National Institute for Occupational Safety and Health, shall establish a COVID–19 containment and mitigation for essential workers program consisting of awarding grants under subsection (b).
Grants— For the purpose of improving essential worker safety, the Secretary—
shall award a grant to each State health department; and
may award grants on a competitive basis to State, local, Tribal, or territorial health departments.
Use of funds— A State, local, Tribal, or territorial health department receiving a grant under subsection (b) shall use the grant funds—
to purchase or procure personal protective equipment and rapid testing equipment and supplies for distribution to employers of essential workers, including public employers; or
to support the implementation of other workplace safety measures for use in containment and mitigation of COVID–19 transmission among essential workers in their workplaces, including workplaces of public employers.
Formula grants to State health departments— In making grants under subsection (b)(1), the Secretary shall award funds to each State health department in accordance with a formula based on overall population size, essential workers population size, and burden of COVID–19.
Competitive grants to State, local, Tribal, and territorial health departments— In making grants under subsection (b)(2), the Secretary shall give priority to applicants demonstrating a commitment to containing and mitigating COVID–19 among racial and ethnic minority groups who are disproportionately represented in essential worker settings.
No duplicative assistance limitation— The Secretary may not provide, and a State, local, Tribal, or territorial health department, or employer of essential workers may not accept, assistance under this section for containment and mitigation of COVID–19 transmission among essential workers in their workplaces with respect to which—
the State, local, Tribal, or territorial health department, or employer of essential workers receives assistance from other sources for such purposes; or
other sources are obligated to provide assistance to such health department or employer for such purposes.
Technical assistance— In carrying out the program under this section, the Secretary shall provide technical assistance to State, local, Tribal, or territorial health departments.
Report— No later than 90 days after the date of enactment of this Act, and every 90 days thereafter, the Secretary shall submit to the Committee on Energy and Commerce and the Committee on Education and Labor of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the activities funded through this section, including—
the amount expended and the awardees under subsection (b)(1);
the amount expended and the awardees under subsection (b)(2);
the total amount remaining of the amounts appropriated or otherwise made available to carry out this section under subsection (i); and
evaluating the progress of State, local, Tribal, and territorial health departments in reducing COVID–19 burden among essential workers.
Consultation with essential employers, essential workers, and employee representatives of essential workers—
In general— In developing the strategy and program under subsection (a) and in determining criteria for distribution of competitive grants under this section, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Director of the National Institute for Occupational Safety and Health, shall consult in advance with—
employers of essential workers;
representatives of essential workers; and
labor organizations representing essential workers.
Optional advance consultation— A State health department may, before receiving funding through a grant under this section, consult with employers of essential workers, representatives of workers, and labor organizations representing essential workers in determining—
priorities for the use of such funds; and
the distribution of COVID–19 containment and mitigation equipment and supplies.
Definitions— In this section:
The term “essential worker” refers to—
the “essential critical infrastructure workers” identified in the Department of Homeland Security’s “Advisory Memorandum on Ensuring Essential Critical Infrastructure Workers Ability to Work During the COVID–19 Response” released on August 18, 2020 (or any successor document); and
workers included as essential workers in executive orders issued by the Governor of a State.
The term “containment and mitigation” includes the use of—
personal protective equipment;
other protections, including expanding or improving workplace infrastructure through engineering and work practice controls, such as ventilation systems, plexiglass partitions, air filters, and the use of hand sanitizer or sanitation supplies;
access to medical evaluations, testing (including rapid testing), and contact tracing; and
other related activities or equipment recommended or required by the Director of Centers of Disease Control and Prevention or required pursuant to the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq.) or a State plan approved pursuant to section 18 of that Act (29 U.S.C. 667); and
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $2,000,000,000, to remain available until expended.
VII Vaccine Development, Distribution, Administration, and Awareness
Sec. 701 Definitions
In this title:
The term “ancillary medical supplies” includes—
vials;
bandages;
alcohol swabs;
syringes;
needles;
gloves, masks, and other personal protective equipment;
cold storage equipment; and
other products the Secretary determines necessary for the administration of vaccines.
The term “Secretary” means the Secretary of Health and Human Services.
Sec. 702 Vaccine and therapeutic development and procurement
Enhancing development, procurement and manufacturing capacity—
In general— The Secretary shall, as appropriate, award contracts, grants, and cooperative agreements, and, where otherwise allowed by law, enter into other transactions, for purposes of—
expanding and enhancing COVID–19 and SARS–CoV–2 vaccine and therapeutic development and research;
procurement of COVID–19 and SARS–CoV–2 vaccines, therapeutics, and ancillary medical supplies; and
expanding and enhancing capacity for manufacturing vaccines, therapeutics, and ancillary medical supplies to prevent the spread of COVID–19 and SARS–CoV–2 and .
Authorization of appropriations— To carry out this subsection, there is authorized to be appropriated $20,000,000,000 for the period of fiscal years 2021 through 2025, to remain available until expended.
Report on vaccine manufacturing and administration capacity— Not later than December 1, 2020, the Secretary shall submit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor and Pensions and the Committee on Appropriations of the Senate a report detailing—
an assessment of the estimated supply of vaccines and ancillary medical supplies related to vaccine administration necessary to control and stop the spread of SARS–CoV–2 and COVID–19, domestically and internationally;
an assessment of current and future domestic capacity for manufacturing vaccines or vaccine candidates to control or stop the spread of SARS–CoV–2 and COVID–19 and ancillary medical supplies related to the administration of such vaccines, including—
identification of any gaps in capacity for manufacturing; and
the effects of shifting manufacturing resources to address COVID–19;
activities conducted to expand and enhance capacity for manufacturing vaccines, vaccine candidates, and ancillary medical supplies to levels sufficient to control and stop the spread of SARS–CoV–2 and COVID–19, domestically and internationally, including a list and explanation of all contracts, grants, and cooperative agreements awarded, and other transactions entered into, for purposes of such expansion and enhancement and how such activities will help to meet future domestic manufacturing capacity needs;
a plan for the ongoing support of enhanced capacity for manufacturing vaccines, vaccine candidates, and ancillary medical supplies sufficient to control and stop the spread of SARS–CoV–2 and COVID–19, domestically and internationally; and
a plan to support the distribution and administration of vaccines approved or authorized by the Food and Drug Administration to control and stop the spread of SARS–CoV–2 and COVID–19, domestically and internationally, including Federal workforce enhancements necessary to administer such vaccines.
Sec. 703 Vaccine distribution and administration
In general— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
conduct activities to enhance, expand, and improve nationwide COVID–19 and SARS–CoV–2 vaccine distribution and administration, including activities related to distribution of ancillary medical supplies; and
award grants or cooperative agreements to State, local, Tribal, and territorial public health departments for enhancement of COVID–19 and SARS–CoV–2 vaccine distribution and administration capabilities, including—
distribution of vaccines approved or authorized by the Food and Drug Administration;
distribution of ancillary medical supplies;
workforce enhancements;
information technology and data enhancements, including—
enhancements for purposes of maintaining and tracking real-time information related to vaccine distribution and administration; and
enhancements to improve immunization information systems, including patient matching capabilities and the interoperability of such systems, that are administered by State, local, Tribal, and territorial public health departments and used by health care providers and health care facilities; and
facilities enhancements.
Report to Congress— Not later than December 31, 2020, and annually thereafter, the Secretary shall submit a report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate detailing activities carried out and grants and cooperative agreements awarded under this section.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $7,000,000,000 for the period of fiscal years 2021 through 2025, to remain available until expended.
Sec. 704 Stopping the spread of COVID–19 and other infectious diseases through evidence-based vaccine awareness
In general— The Public Health Service Act is amended by striking section 313 of such Act (42 U.S.C. 245) and inserting the following:
“313. Public awareness campaign on the importance of vaccinations
“(a) In general—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other offices and agencies, as appropriate, shall award competitive grants or contracts to one or more public or private entities to carry out a national, evidence-based campaign for increasing rates of vaccination across all ages, as applicable, particularly in communities with low rates of vaccination, to reduce and eliminate vaccine-preventable diseases by—
“(1) increasing awareness and knowledge of the safety and effectiveness of vaccines approved or authorized by the Food and Drug Administration for the prevention and control of diseases, including COVID–19;
“(2) combating misinformation about vaccines; and
“(3) disseminating scientific and evidence-based vaccine-related information.
“(b) Consultation—In carrying out the campaign under this section, the Secretary shall consult with appropriate public health and medical experts, including the National Academy of Medicine and medical and public health associations and nonprofit organizations, in the development, implementation, and evaluation of the campaign under this section.
“(c) Requirements—The campaign under this section shall—
“(1) be a nationwide, evidence-based media and public engagement initiative;
“(2) include the development of resources for communities with low rates of vaccination, including culturally and linguistically appropriate resources, as applicable;
“(3) include the dissemination of vaccine information and communication resources to public health departments, health care providers, and health care facilities, including such providers and facilities that provide prenatal and pediatric care;
“(4) be complementary to, and coordinated with, any other Federal, State, local, or Tribal efforts;
“(5) assess the effectiveness of communication strategies to increase rates of vaccination; and
“(6) not be used for partisan political purposes, or to express advocacy in support of or to defeat any clearly identified candidate, clearly identified ballot initiative, or clearly identified legislative or regulatory proposal.
“(d) Additional activities—The campaign under this section may—
“(1) include the use of television, radio, the internet, and other media and telecommunications technologies;
“(2) include the use of in-person activities;
“(3) be focused and directed to address specific needs of communities and populations with low rates of vaccination; and
“(4) include the dissemination of scientific and evidence-based vaccine-related information, such as—
“(A) advancements in evidence-based research related to diseases that may be prevented by vaccines and vaccine development;
“(B) information on vaccinations for individuals and communities, including individuals for whom vaccines are not recommended by the Advisory Committee for Immunization Practices, and the effects of low vaccination rates within a community on such individuals;
“(C) information on diseases that may be prevented by vaccines; and
“(D) information on vaccine safety and the systems in place to monitor vaccine safety.
“(e) Evaluation—The Secretary shall—
“(1) establish benchmarks and metrics to quantitatively measure and evaluate the campaign under this section;
“(2) conduct qualitative assessments regarding the campaign under this section; and
“(3) prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate an evaluation of the campaign under this section.
“(f) Supplement not supplant—Funds made available to carry out this section shall be used to supplement and not supplant other Federal, State, local, and Tribal public funds provided for activities described in this section.
“(g) Authorization of appropriations—There is authorized to be appropriated to carry out this section $200,000,000 for the period of fiscal years 2021 through 2025.”
Grants to address vaccine-preventable diseases— Section 317 of the Public Health Service Act (42 U.S.C. 247b) is amended—
in subsection (k)—
in paragraph (1)—
in subparagraph (C), by striking “; and” at the end and inserting a semicolon;
in subparagraph (D), by striking the period at the end and inserting a semicolon; and
by adding at the end the following:
“(E) planning, implementation, and evaluation of activities to address vaccine-preventable diseases, including activities—
“(i) to identify communities at high risk of outbreaks related to vaccine-preventable diseases, including through improved data collection and analysis;
“(ii) to pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination;
“(iii) to reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines;
“(iv) to partner with community organizations and health care providers to develop and deliver evidence-based, culturally and linguistically appropriate interventions to increase vaccination rates;
“(v) to improve delivery of evidence-based vaccine-related information to parents and others; and
“(vi) to improve the ability of State, local, Tribal, and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases, including, as appropriate, with local educational agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965); and
“(F) research related to strategies for improving awareness of scientific and evidence-based vaccine-related information, including for communities with low rates of vaccination, in order to understand barriers to vaccination, improve vaccination rates, and assess the public health outcomes of such strategies.”
by adding at the end the following:
“(5) In addition to amounts authorized to be appropriated by subsection (j) to carry out this subsection, there is authorized to be appropriated to carry out this subsection $750,000,000 for the period of fiscal years 2021 through 2025.”
by adding at the end the following:
“(n) Vaccination data
“(1) In general—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and enhance, and, as appropriate, establish and improve, programs and conduct activities to collect, monitor, and analyze vaccination coverage data to assess levels of protection from vaccine-preventable diseases including COVID–19, including by—
“(A) assessing factors contributing to underutilization of vaccines and variations of such factors; and
“(B) identifying communities at high risk of outbreaks associated with vaccine-preventable diseases.
“(2) Authorization of appropriations—There is authorized to be appropriated to carry out this section $50,000,000 for the period of fiscal years 2021 through 2025.”
Supplemental grant funds— Section 330(d)(1) of the Public Health Service Act (42 U.S.C. 254b(d)(1)) is amended—
in subparagraph (F), by striking “and” at the end;
in subparagraph (G), by striking the period at the end and inserting “; and”; and
by adding at the end the following:
“(H) improving access to recommended immunizations.”
Update of 2015 NVAC report— The National Vaccine Advisory Committee established under section 2105 of the Public Health Service Act (42 U.S.C. 300aa–5) shall, as appropriate, update the report entitled, “Assessing the State of Vaccine Confidence in the United States: Recommendations from the National Vaccine Advisory Committee”, approved by the National Vaccine Advisory Committee on June 10, 2015, with respect to factors affecting childhood vaccination.
VIII Other Matters
Sec. 801 Non-discrimination
In general— Notwithstanding any provision of a covered law (or an amendment made in any such provision), no person otherwise eligible shall be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of, programs and services receiving funding under a covered law (or an amendment made by a provision of such a covered law), based on any factor that is not merit-based, such as age, disability, sex (including sexual orientation, gender identity, and pregnancy, childbirth, and related medical conditions), race, color, national origin, immigration status, or religion.
Covered law defined— In this section, the term “covered law” includes—
this Act (other than this section);
title I of division B of the Paycheck Protection Program and Healthcare Enhancement Act (Public Law 116–139);
subtitles A, D, and E of title III of the CARES Act (Public Law 116–136);
division F of the Families First Coronavirus Relief Act (Public Law 116–127); and
division B of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Public Law 116–123).