Division D — Health care response

S. 3548 · 116th Congress · Mar 19, 2020 · Lineage

D Health care response

I Health provisions

A Addressing supply shortages

I Moving the strategic national stockpile to ASPR

4101. Moving the strategic national stockpile to ASPR

Section 319F–2(a)(1) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(1)) is amended by striking “The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, and in coordination with the Secretary of Homeland Security (referred to in this section as the “Homeland Security Secretary”), shall maintain” and inserting “The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response, and in coordination with the Secretary of Homeland Security (referred to in this section as the “Homeland Security Secretary”), shall maintain”.

II Medical product supplies

4111. National Academies report on America’s medical product supply chain security

(a)

In general— Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the “National Academies”) to examine, and, in a manner that does not compromise national security, report on, the security of the United States medical product supply chain.

(b)

Purposes— The report developed under this section shall—

(1)

assess and evaluate the dependence of the United States, including the private commercial sector, States, and the Federal Government, on critical drugs and devices that are sourced or manufactured outside of the United States, which may include an analysis of—

(A)

the supply chain of critical drugs and devices of greatest priority to providing health care;

(B)

any potential public health security or national security risks associated with reliance on critical drugs and devices sourced or manufactured outside of the United States, which may include responses to previous or existing shortages or public health emergencies, such as infectious disease outbreaks, bioterror attacks, and other public health threats;

(C)

any existing supply chain information gaps, as applicable; and

(D)

potential economic impact of increased domestic manufacturing; and

(2)

provide recommendations, which may include a plan to improve the resiliency of the supply chain for critical drugs and devices as described in paragraph (1), and to address any supply vulnerabilities or potential disruptions of such products that would significantly affect or pose a threat to public health security or national security, as appropriate, which may include strategies to—

(A)

promote supply chain redundancy and contingency planning;

(B)

encourage domestic manufacturing, including consideration of economic impacts, if any;

(C)

improve supply chain information gaps;

(D)

improve planning considerations for medical product supply chain capacity during public health emergencies; and

(E)

promote the accessibility of such drugs and devices.

(c)

Input— In conducting the study and developing the report under subsection (b), the National Academies shall—

(1)

consider input from 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

(2)

consult with relevant stakeholders, which may include conducting public meetings and other forms of engagement, as appropriate, with health care providers, medical professional societies, State-based societies, public health experts, State and local public health departments, State medical boards, patient groups, medical product manufacturers, health care distributors, wholesalers and group purchasing organizations, pharmacists, and other entities with experience in health care and public health, as appropriate.

(d)

Definitions— In this section, the terms device and drug have the meanings given such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

4112. Requiring the strategic national stockpile to include certain types of medical supplies

Section 319F–2(a)(1) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(1)) is amended by inserting “(including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile)” after “other supplies”.

4113. Treatment of respiratory protective devices as covered countermeasures

Section 319F–3(i)(1) of the Public Health Service Act (42 U.S.C. 247d–6d(i)(1)) is amended—

(1)

in subparagraph (B), by striking “or” at the end;

(2)

in subparagraph (C), by striking the period at the end and inserting “; or”; and

(3)

by adding at the end the following:

“(D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared pursuant to section 319.”

III Mitigating emergency drug shortages

4121. Prioritize reviews of drug applications; incentives

Section 506C(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(g)) is amended—

(1)

in paragraph (1), by striking “the Secretary may” and inserting “the Secretary shall, as appropriate”;

(2)

in paragraph (1), by inserting “prioritize and” before “expedite the review”; and

(3)

in paragraph (2), by inserting “prioritize and” before “expedite an inspection”.

4122. Additional manufacturer reporting requirements in response to drug shortages

(a)

Expansion To include active pharmaceutical ingredients— Subsection (a) of section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended—

(1)

in paragraph (1)(C), by inserting “or any such drug that is critical to the public health during a public health emergency determined under section 319 of the Public Health Service Act” after “during surgery”; and

(2)

in the flush text at the end—

(A)

by inserting “, or a discontinuance or an interruption in the manufacture of the active pharmaceutical ingredients of such drug,” before “that is likely”; and

(B)

by adding at the end the following: “Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, as applicable; if an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated medical devices used for preparation or administration included in the finished dosage form is a reason for, or a risk factor in, such discontinuation or interruption; the expected duration of the interruption; and such other information as the Secretary may require.”.

(b)

FOIA exemption— Section 506C(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(d)) is amended by adding at the end the following: “Information provided by a manufacturer to the Secretary under this section shall not be subject to disclosure under section 552 of title 5, United States Code.”.

(c)

Manufacturing contingency plans— Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended by adding at the end the following:

“(j) Manufacturer contingency plans—Each manufacturer of a drug described in subsection (a) or of any active pharmaceutical ingredient or any associated medical devices used for preparation or administration included in the finished dosage form of such a drug, shall maintain contingency and redundancy plans, as applicable, for each establishment in which such drugs or active pharmaceutical ingredients of such drugs are manufactured to help prevent or mitigate interruptions in the supply of the drug or ingredient.”

(d)

Annual notification— Section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e) is amended by adding at the end the following:

“(d) Interagency notification—Not later than 180 days after the date of enactment of this subsection, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.”

(e)

Reporting after inspections— Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) is amended—

(1)

by redesignating paragraphs (1) and (2) and subparagraphs (A) and (B);

(2)

by striking “(b) Upon completion” and inserting “(b)(1) Upon completion”; and

(3)

by adding at the end the following:

“(2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of section 505 for which a notification has been submitted in accordance with section 506C is, or has been in the last 5 years, listed on the drug shortage list under section 506E, or that is described in section 505(j)(11)(A), a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages. Such offices shall ensure timely and effective coordination regarding the reviews of such report and overseeing the alignment of any feedback regarding such report, or corrective or preventative actions, after consideration of the systematic benefits and risks to public health, patient safety, the drug supply and drug supply chain, and timely patient access to such drugs.”

(f)

Effective date— The amendments made by this section and section 4121 shall take effect on the date that is 180 days after the date of enactment of this Act.

4123. GAO report on intra-agency coordination

(a)

In general— Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States 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 report examining the Food and Drug Administration's intra-agency coordination, communication, and decision making in assessing drug shortage risks, and taking corrective action.

(b)

Content— The report shall include—

(1)

consideration of—

(A)

risks associated with violations of current good manufacturing practices;

(B)

corrective and preventative actions with respect to such violations requested by the Food and Drug Administration;

(C)

the effects of potential manufacturing slow-downs or shut-downs on potential drug shortages, including the discontinuance of drug manufacturing and marketing;

(D)

efforts to prioritize review of applications for drugs that the Secretary has determined under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e) to be in shortage; and

(E)

efforts to prioritize inspections of facilities necessary for approval of applications for drugs described in subparagraph (D);

(2)

a description of how the Food and Drug Administration proactively coordinates strategies to mitigate the consequences of the violations, slow-downs, and shut-downs described in paragraph (1) across agencies; and

(3)

an evaluation of changes in relevant Food and Drug Administration practices that such agency has proposed but not yet implemented.

4124. Report

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in coordination with the Commissioner of Food and Drugs and the Administrator of the Centers for Medicare & Medicaid Services, shall develop and 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 report containing recommendations—

(1)

for market-based incentives or other appropriate mechanisms, sufficient to encourage the manufacture of drugs in shortage or at risk of shortage; and

(2)

on how the Emerging Technology Program of the Food and Drug Administration can help facilitate creating or upgrading existing technologies to address drug shortage challenges and promote modern, reliable manufacturing strategies.

4125. Safe harbor provision

(a)

In general— The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 502 (21 U.S.C. 352) the following:

“502A. Safe harbor provision

“(a) In general—The communication of information, consistent with subsection (b), with respect to the use of a drug or device authorized under section 564 provided or distributed to a health care provider, shall not—

“(1) be a basis for treating such drug or device as misbranded under subsection (a) or (f) of section 502, or in violation of section 505, 515, or 564 of this Act or subsection (a) or (k) of section 351(a)(1) of the Public Health Service Act, as applicable; or

“(2) be treated as evidence that such drug or device is misbranded under subsection (a) or (f) of section 502, or in violation of section 505, 513, 515, or 564 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act, as applicable.

“(b) Provision of information

“(1) In general—Any information relating to a use of a drug or device authorized under section 564, or for which a submission under section 564 has been submitted, that—

“(A) is neither false nor misleading, when measured objectively against the information available at the time the statement is made;

“(B) is accompanied, as required, by an appropriate disclaimer, as described in paragraph (2); and

“(C) is based on competent and reliable scientific evidence, as described in subsection (c).

“(2) Disclaimers—For purposes of paragraph (1), such information shall be accompanied, as necessary, by an appropriate disclaimer, including—

“(A) a statement identifying any differences between the information and any labeling of the drug or device;

“(B) a statement identifying contradictory evidence; and

“(C) such other information as may be required by regulation.

“(c) Competent and reliable scientific evidence—In this section, the term competent and reliable scientific evidence means evidence established through scientific methods that are widely accepted by experts in the relevant field and followed pursuant to a clear and well-described protocol, as scientifically appropriate. Evidence may constitute competent and reliable scientific evidence within the meaning of this section—

“(1) regardless of whether it is supported by 2 adequate and well-controlled clinical studies; and

“(2) may include—

“(A) information derived from clinical trials, observational studies, clinical studies or bench tests that describe performance, database reviews, registries, patient utilization projections, and modeling techniques, and the data, inputs, and components of such information;

“(B) information about the effects of a drug or device in subgroups defined by demographic or other variables, including groups defined by race, sex, risk factors, or other variables, such as genomic features or disease severity;

“(C) information related to the emergency use authorization, as applicable; and

“(D) information relating to the safety, effectiveness, or benefit of a use or treatment that is authorized under section 564 for a drug or device, including information regarding—

“(i) health outcomes, patient or caregiver experience, or other quality metrics; and

“(ii) the comparative effectiveness of a drug or device relative to others products, other health care interventions, program and quality improvement interventions, or no intervention.

“(d) Distribution—Information pursuant to subsection (b) may be distributed proactively through written or oral means, or other information platforms, to a health care provider, payor, formulary committee, or other similar entity carrying out responsibilities for making drug coverage, reimbursement, or usage decisions on a population basis.

“(e) Coverage not excluded—The distribution of information that otherwise meets the requirements of this section shall not fail to meet the requirements of subsection (a) because the manufacturer or distributor of the drug or device about which information is being distributed has—

“(1) knowledge that such drug or device is being used by patients or health care practitioners in a manner not described in any labeling of the drug or device, as applicable; or

“(2) objective or subjective intent that such drug or device be used in a manner inconsistent with any labeling, as applicable, of such drug or device.

“(f) Rule of construction—Nothing in this section shall be construed—

“(1) to limit communication not specifically permitted by this section; or

“(2) to alter or expand the authority of the Secretary to enforce the provisions of this Act, except to the extent that the communication of information in accordance with this section is permitted.”

IV Preventing essential medical device shortages

4131. Discontinuance or interruption in the production of medical devices

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506I the following:

“506J. Discontinuance or interruption in the production of medical devices

“(a) In general—A manufacturer of a device that—

“(1) is critical to public health during a public health emergency, including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; or

“(2) for which the Secretary determines that information on potential meaningful supply disruptions of such device is needed during, or in advance of, a public health emergency;

“(b) Timing—A notice required under subsection (a) shall be submitted to the Secretary—

“(1) at least 6 months prior to the date of the discontinuance or interruption; or

“(2) if compliance with paragraph (1) is not possible, as soon as practicable.

“(c) Distribution

“(1) Public availability—To the maximum extent practicable, subject to paragraph (2), the Secretary shall distribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manufacture of devices reported under subsection (a) to appropriate organizations, including physician, health provider, patient organizations, and supply chain partners, as appropriate and applicable.

“(2) Public health exception—The Secretary may choose not to make information collected under this section publicly available pursuant to this section if the Secretary determines that disclosure of such information would adversely affect the public health, such as by increasing the possibility of unnecessary over purchase of product or other disruption of the availability of medical products to patients.

“(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.

“(e) Failure To meet requirements—If a person fails to submit information required under subsection (a) in accordance with subsection (b)—

“(1) the Secretary shall issue a letter to such person informing such person of such failure;

“(2) not later than 30 calendar days after the issuance of a letter under paragraph (1), the person who receives such letter shall submit to the Secretary a written response to such letter setting forth the basis for noncompliance and providing information required under subsection (a); and

“(3) not later than 45 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 (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply.

“(f) Expedited Inspections and Reviews—If, based on notifications described in subsection (a) or any other relevant information, the Secretary concludes that there is, or is likely to be, a shortage of an device, the Secretary shall, as appropriate—

“(1) prioritize and expedite the review of a submission under section 513(f)(2), 515, review of a notification under section 510(k), or 520(m) for a device that could help mitigate or prevent such shortage; or

“(2) prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such shortage.

“(g) Device shortage list

“(1) Establishment—The Secretary shall establish and maintain an up-to-date list of devices that are determined by the Secretary to be in shortage in the United States.

“(2) Contents—For each device included on the list under paragraph (1), the Secretary shall include the following information:

“(A) The category or name of the device in shortage.

“(B) The name of each manufacturer of such device.

“(C) The reason for the shortage, as determined by the Secretary, selecting from the following categories:

“(i) Requirements related to complying with good manufacturing practices.

“(ii) Regulatory delay.

“(iii) Shortage or discontinuance of a component or part.

“(iv) Discontinuance of the manufacture of the device.

“(v) Delay in shipping of the device.

“(vi) Delay in sterilization of the device.

“(vii) Demand increase for the device.

“(D) The estimated duration of the shortage as determined by the Secretary.

“(3) Public availability

“(A) In general—Subject to subparagraphs (B) and (C), the Secretary shall make the information in the list under paragraph (1) publicly available.

“(B) Trade secrets and confidential information—Nothing in this subsection shall be construed to alter or amend section 1905 of title 18, United States Code, or section 552(b)(4) of title 5 of such Code.

“(C) Public health exception—The Secretary may elect not to make information collected under this subsection publicly available if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the device to patients).

“(h) Rule of construction—Nothing in this section shall be construed to affect the authority of the Secretary on the date of enactment of this section to expedite the review of devices under section 515 of the Federal Food, Drug, and Cosmetic Act, section 515B of such Act relating to the priority review program for devices, and section 564 of such Act relating to the emergency use authorization authorities.

“(i) Definitions—In this section:

“(1) Device—The term device means a device (as defined in section 201(h)) that is intended for human use and is subject to sections 510(k), 513(f)(2), 515, or 520(m).

“(2) Meaningful disruption—The term meaningful disruption—

“(A) means a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product;

“(B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a reasonable or short period of time; and

“(C) does not include interruptions in manufacturing of components or raw materials so long as such interruptions do not result in a shortage of finished product and the manufacturer expects to resume operations in a reasonable or short period of time.

“(3) Shortage—The term shortage, with respect to a device, means a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.”

4132. GAO report on intra-agency coordination

(a)

In general— 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 Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report examining the Food and Drug Administration's intra-agency coordination, communication, and decision-making in assessing device shortages and risks associated with the supply of devices, and any efforts by the Food and Drug Administration to mitigate any device shortages or to take corrective actions.

(b)

Content— The report shall include—

(1)

consideration of—

(A)

risks of creating, worsening, or extending a shortage of a device associated with violations of current good manufacturing practices;

(B)

corrective and preventative actions with respect to such violations requested by the Food and Drug Administration;

(C)

the effects of potential manufacturing disruptions or shut-downs on potential device shortages, which may include the discontinuance of device manufacturing and marketing, or the manufacturing of device components or parts;

(D)

efforts to prioritize and expedite the review of submissions for devices that the Secretary has determined under section 506J(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j) to be in shortage; and

(E)

efforts to prioritize inspections of facilities necessary for approval or clearance of devices described in subparagraph (D);

(2)

(3)

an evaluation of changes in relevant Food and Drug Administration practices that such agency has proposed but not yet implemented.

(c)

Definition— In this section, the term device has the meaning given such term under section 506J(i)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 4131.

V Emergency use of laboratory developed tests

4141. Emergency use of laboratory developed tests

(a)

In general— For the time in which the public health emergency under section 319 of the Public Health Service Act (42 U.S.C. 247d) related to the coronavirus (COVID-19), declared by the Secretary of Health and Human Services (referred to in this section as the “Secretary”) on January 31, 2020, is in place (or such other period of time determined by the Secretary), tests intended to diagnose COVID–19 that are described in subsection (b) may be lawfully marketed in accordance with this section.

(b)

Criteria— Tests described in subsection (a) may be lawfully marketed, during the period described in such subsection, if such test—

(1)

is developed in a State that has notified the Secretary of its intention to review tests intended to diagnose COVID-19;

(2)

is developed in a laboratory with a certificate to conduct high-complexity testing pursuant to section 353 of the Public Health Service Act (42 U.S.C. 263a), and the developer of such test—

(A)

is pursuing an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) and provides updates to the Secretary on efforts to pursue such authorization;

(B)

validates such test prior to use;

(C)

notifies the Secretary of the assay validation; and

(D)

includes a statement together with the results of the test that reads: “This test was developed for use as a part of a response to the public health emergency declared to address the outbreak of COVID-19. This test has not been reviewed by the Food and Drug Administration.”; or

(3)

is an in vitro diagnostic test for which the developer of such test meets all of the requirements of subparagraphs (A) through (D) of paragraph (2) with respect to the test.

(c)

Disposition of product— Notwithstanding the termination of a declaration under subsection (b) of section 564 of the Federal Food, Drug, and Cosmetic Act, or a revocation under subsection (g) of such section with respect to a product described in subsection (a), the Secretary shall consult with the developer of such in vitro diagnostic test with respect to the appropriate disposition of such test to ensure that authorization of any in vitro diagnostic test under this section shall continue to be effective to provide for continued use of such product to prevent or detect COVID–19.

(d)

In vitro diagnostic test— In this section, the term in vitro diagnostic test has the meaning given the term in vitro diagnostic product in section 809.3(a) of title 21, Code of Federal Regulations (or successor regulations).

B Access to health care for COVID-19 patients

I Coverage of testing and preventive services

4201. Coverage of diagnostic testing for COVID-19

(a)

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 (42 U.S.C. 18011(b))) shall provide coverage, and shall not impose any cost-sharing (including deductibles, copayments, and coinsurance) requirements or prior authorization or other medical management requirements, for the following items and services furnished during any portion of 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, with respect to COVID-19, beginning on or after the date of the enactment of this Act:

(1)

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 or the diagnosis of the virus that causes COVID–19, and the administration of such an in vitro diagnostic product, that—

(A)

is 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);

(B)

is a clinical laboratory service performed in a laboratory (including a public health laboratory) certified to conduct high-complexity testing pursuant to section 353 of the Public Health Service Act (42 U.S.C. 253a) for which the developer has requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe; or

(C)

is developed in a State that has notified the Secretary of Health and Human Services of its intention to review tests intended to diagnose COVID-19.

(2)

Items and services furnished to an individual during health care provider office visits, urgent care center visits, and emergency room visits that result in an order for or administration of an in vitro diagnostic product described in paragraph (1), but only to the extent such items and services relate to the furnishing or administration of such product or to the evaluation of such individual for purposes of determining the need of such individual for such product.

4202. Pricing of diagnostic testing

(a)

Reimbursement rates— A group health plan or a health insurance issuer providing coverage of items and services described in section 201(a) with respect to an enrollee shall reimburse the provider of the diagnostic testing as follows:

(1)

If the health plan or issuer has a negotiated rate for such service with such provider, such negotiated rate shall apply.

(2)

If the health plan or issuer does not have a negotiated rate for such service with such provider, such plan or issuer shall reimburse the provider in an amount that equals the cash price for such service as listed by the provider on a public internet website.

(b)

Requirement to Publicize Cash Price for Diagnostic Testing for COVID-19—

(1)

In general— Each provider of a diagnostic test for COVID-19 shall make public the cash price for such test on a public internet website of such provider.

(2)

Civil monetary penalties— The Secretary of Health and Human Services may impose a civil monetary penalty on any provider of a diagnostic test for COVID-19 that is not in compliance with paragraph (1) and has not completed a corrective action plan to comply with the requirements of such paragraph, in an amount not to exceed $300 per day that the violation is ongoing.

4203. Rapid coverage of preventive services and vaccines for coronavirus

(a)

In general— Notwithstanding 2713(b) of the Public Health Service Act (42 U.S.C. 300gg–13), the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury shall require group health plans and health insurance issuers offering group or individual health insurance to cover any qualifying coronavirus preventive service, pursuant to section 2713(a) of the Public Health Service Act (42 U.S.C. 300gg–13(a)). The requirement described in this subsection shall take effect with respect to a qualifying coronavirus prevention service on the specified date described in subsection (b)(2).

(b)

Definitions— For purposes of this section:

(1)

Qualifying coronavirus preventive service— The term qualifying coronavirus preventive service means an item, service, or immunization that is intended to prevent or mitigate coronavirus disease 2019 and that is—

(A)

an evidence-based item or service that has in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force; or

(B)

an immunization that has in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved.

(2)

Specified date— The term specified date means the date that is 15 business days after the date on which a recommendation is made relating to the immunization as described in such paragraph.

(3)

Health insurance terms— In this section, 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).

II Support for health care providers

4211. Supplemental awards for health centers

(a)

Supplemental awards— Section 330(r) of the Public Health Service Act (42 U.S.C. 254b(r)) is amended by adding at the end the following:

“(6) Additional amounts for supplemental awards—In addition to any amounts made available pursuant to this subsection, section 402A of this Act, or section 10503 of the Patient Protection and Affordable Care Act, there is authorized to be appropriated, and there is appropriated, out of any monies in the Treasury not otherwise appropriated, $1,320,000,000 for fiscal year 2020 for supplemental awards under subsection (d) for the detection of SARS-CoV-2 or the prevention, diagnosis, and treatment of COVID-19.”

(b)

Application of provisions— Amounts appropriated pursuant to the amendment made by subsection (a) for fiscal year 2020 shall be subject to the requirements contained in Public Law 116–94 for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (42 U.S.C. 254 through 256).

4212. Allowing permanent direct hire of NDMS health care professionals

Section 2812(c)(4) of the Public Health Service Act (42 U.S.C. 300hh–11(c)(4)) is amended to read as follows:

“(4) Certain appointments—If the Secretary determines that the number of intermittent disaster response personnel within the National Disaster Medical System under this section is insufficient to address a public health emergency or potential public health emergency, the Secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant or unfilled positions within such system to the congressional committees of jurisdiction each quarter for which this authority is in effect.”

4213. Telehealth network and telehealth resource centers grant programs

Section 330I of the Public Health Service Act (42 U.S.C. 254c–14) is amended—

(1)

in subsection (d)—

(A)

in paragraph (1)—

(i)

in the matter preceding subparagraph (A), by striking “projects to demonstrate how telehealth technologies can be used through telehealth networks” and inserting “evidence-based projects that utilize telehealth technologies through telehealth networks”;

(ii)

in subparagraph (A)—

(I)

by striking “the quality of” and inserting “access to, and the quality of,”; and

(II)

by inserting “and” after the semicolon;

(iii)

by striking subparagraph (B);

(iv)

by redesignating subparagraph (C) as subparagraph (B); and

(v)

in subparagraph (B), as so redesignated, by striking “and patients and their families, for decisionmaking” and inserting “, patients, and their families”; and

(B)

in paragraph (2)—

(i)

by striking “demonstrate how telehealth technologies can be used” and inserting “support initiatives that utilize telehealth technologies”; and

(ii)

by striking “, to establish telehealth resource centers”;

(2)

in subsection (e), by striking “4 years” and inserting “5 years”;

(3)

in subsection (f)—

(A)

by striking paragraph (2);

(B)

in paragraph (1)(B)—

(i)

by redesignating clauses (i) through (iii) as paragraphs (1) through (3), respectively, and adjusting the margins accordingly;

(ii)

in paragraph (3), as so redesignated by clause (i), by redesignating subclauses (I) through (XII) as subparagraphs (A) through (L), respectively, and adjusting the margins accordingly; and

(iii)

by striking “(1) Telehealth network grants—” and all that follows through “(B) Telehealth networks—”; and

(C)

in paragraph (3)(I), as so redesignated, by inserting “and substance use disorder” after “mental health” each place such term appears;

(4)

in subsection (g)(2), by striking “or improve” and inserting “and improve”;

(5)

by striking subsection (h);

(6)

by redesignating subsections (i) through (p) as subsection (h) through (o), respectively;

(7)

in subsection (h), as so redesignated—

(A)

in paragraph (1)—

(i)

in subparagraph (B), by striking “mental health, public health, long-term care, home care, preventive” and inserting “mental health care, public health services, long-term care, home care, preventive care”;

(ii)

in subparagraph (E), by inserting “and regional” after “local”; and

(iii)

by striking subparagraph (F); and

(B)

in paragraph (2)(A), by striking “medically underserved areas or” and inserting “rural areas, medically underserved areas, or”;

(8)

in paragraph (2) of subsection (i), as so redesignated, by striking “ensure that—” and all that follows through the end of subparagraph (B) and inserting “ensure that not less than 50 percent of the funds awarded shall be awarded for projects in rural areas.”;

(9)

in subsection (j), as so redesignated—

(A)

in paragraph (1)(B), by striking “computer hardware and software, audio and video equipment, computer network equipment, interactive equipment, data terminal equipment, and other”; and

(B)

in paragraph (2)(F), by striking “health care providers and”;

(10)

in subsection (k), as so redesignated—

(A)

in paragraph (2), by striking “40 percent” and inserting “20 percent”; and

(B)

in paragraph (3), by striking “(such as laying cable or telephone lines, or purchasing or installing microwave towers, satellite dishes, amplifiers, or digital switching equipment)”;

(11)

by striking subsections (q) and (r) and inserting the following:

“(p) Report—Not later than 4 years after the date of enactment of the CARES Act, and every 5 years thereafter, the Secretary shall prepare and 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 report on the activities and outcomes of the grant programs under subsection (b).”

(12)

by redesignating subsection (s) as subsection (q); and

(13)

in subsection (q), as so redesignated, by striking “this section—” and all that follows through the end of paragraph (2) and inserting “this section $29,000,000 for each of fiscal years 2021 through 2025.”.

4214. Rural health care services outreach, rural health network development, and small health care provider quality improvement grant programs

Section 330A of the Public Health Service Act (42 U.S.C. 254c) is amended—

(1)

in subsection (d)(2)—

(A)

in subparagraph (A), by striking “essential” and inserting “basic”; and

(B)

in subparagraph (B)—

(i)

in the matter preceding clause (i), by inserting “to” after “grants”; and

(ii)

in clauses (i), (ii), and (iii), by striking “to” each place such term appears;

(2)

in subsection (e)—

(A)

in paragraph (1)—

(i)

by inserting “improving and” after “outreach by”;

(ii)

by inserting “, through community engagement and evidence-based or innovative, evidence-informed models” before the period of the first sentence; and

(iii)

by striking “3 years” and inserting “5 years”;

(B)

in paragraph (2)—

(i)

in the matter preceding subparagraph (A), by inserting “shall” after “entity”;

(ii)

in subparagraph (A), by striking “shall be a rural public or rural nonprofit private entity” and inserting “be an entity with demonstrated experience serving, or the capacity to serve, rural underserved populations”;

(iii)

in subparagraphs (B) and (C), by striking “shall” each place such term appears; and

(iv)

in subparagraph (B)—

(I)

in the matter preceding clause (i), by inserting “that” after “members”; and

(II)

in clauses (i) and (ii), by striking “that” each place such term appears; and

(C)

in paragraph (3)(C), by striking “the local community or region” and inserting “the rural underserved populations in the local community or region”;

(3)

in subsection (f)—

(A)

in paragraph (1)—

(i)

in subparagraph (A)—

(I)

in the matter preceding clause (i), by striking “promote, through planning and implementation, the development of integrated health care networks that have combined the functions of the entities participating in the networks” and inserting “plan, develop, and implement integrated health care networks that collaborate”; and

(II)

in clause (ii), by striking “essential health care services” and inserting “basic health care services and associated health outcomes”; and

(ii)

by amending subparagraph (B) to read as follows:

“(B) Grant periods—The Director may award grants under this subsection for periods of not more than 5 years.”

(B)

in paragraph (2)—

(i)

in the matter preceding subparagraph (A), by inserting “shall” after “entity”;

(ii)

(iii)

in subparagraph (B)—

(I)

in the matter preceding clause (i)—

(aa)

by striking “shall”; and

(bb)

by inserting “that” after “participants”; and

(II)

in clauses (i) and (ii), by striking “that” each place such term appears; and

(iv)

in subparagraph (C), by striking “shall”; and

(C)

in paragraph (3)—

(i)

by amending clause (iii) of subparagraph (C) to read as follows:

“(iii) how the rural underserved populations in the local community or region to be served will benefit from and be involved in the development and ongoing operations of the network;”

(ii)

in subparagraph (D), by striking “the local community or region” and inserting “the rural underserved populations in the local community or region”;

(4)

in subsection (g)—

(A)

in paragraph (1)—

(i)

by inserting “, including activities related to increasing care coordination, enhancing chronic disease management, and improving patient health outcomes” before the period of the first sentence; and

(ii)

by striking “3 years” and inserting “5 years”;

(B)

in paragraph (2)—

(i)

in the matter preceding subparagraph (A), by inserting “shall” after “entity”;

(ii)

in subparagraphs (A) and (B), by striking “shall” each place such term appears; and

(iii)

in subparagraph (A)(ii), by inserting “or regional” after “local”; and

(C)

in paragraph (3)(D), by striking “the local community or region” and inserting “the rural underserved populations in the local community or region”;

(5)

in subsection (h)(3), in the matter preceding subparagraph (A), by inserting “, as appropriate,” after “the Secretary”;

(6)

by amending subsection (i) to read as follows:

“(i) Report—Not later than 4 years after the date of enactment of the CARES Act, and every 5 years thereafter, the Secretary shall prepare and 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 report on the activities and outcomes of the grant programs under subsections (e), (f), and (g), including the impact of projects funded under such programs on the health status of rural residents with chronic conditions.”

(7)

in subsection (j), by striking “$45,000,000 for each of fiscal years 2008 through 2012” and inserting “$79,500,000 for each of fiscal years 2021 through 2025”.

4215. United States Public Health Service Modernization

(a)

Commissioned corps and ready reserve corps— Section 203 of the Public Health Service Act (42 U.S.C. 204) is amended—

(1)

in subsection (a)(1), by striking “a Ready Reserve Corps for service in time of national emergency” and inserting “, for service in time of a public health or national emergency, a Ready Reserve Corps”; and

(2)

in subsection (c)—

(A)

in the heading, by striking “research” and inserting “Reserve Corps”;

(B)

in paragraph (1), by inserting “during public health or national emergencies” before the period;

(C)

in paragraph (2)—

(i)

in the matter preceding subparagraph (A), by inserting “, consistent with paragraph (1)” after “shall”;

(ii)

in subparagraph (C), by inserting “during such emergencies” after “members”; and

(iii)

in subparagraph (D), by inserting “, consistent with subparagraph (C)” before the period; and

(D)

by adding at the end the following:

“(3) Statutory references to reserve—A reference in any Federal statute, except in the case of subsection (b), to the “Reserve Corps” of the Public Health Service or to the “reserve” of the Public Health Service shall be deemed to be a reference to the Ready Reserve Corps.”

(b)

Deployment readiness— Section 203A(a)(1)(B) of the Public Health Service Act (42 U.S.C. 204a(a)(1)(B)) is amended by striking “Active Reserves” and inserting “Ready Reserve Corps”.

(c)

Retirement of commissioned officers— Section 211 of the Public Health Service Act (42 U.S.C. 212) is amended—

(1)

by striking “the Service” each place it appears and inserting “the Regular Corps”;

(2)

in subsection (a)(4), by striking “(in the case of an officer in the Reserve Corps)”;

(3)

in subsection (c)—

(A)

in paragraph (1)—

(i)

by striking “or an officer of the Reserve Corps”; and

(ii)

by inserting “or under section 221(a)(19)” after “subsection (a)”; and

(B)

in paragraph (2), by striking “Regular or Reserve Corps” and inserting “Regular Corps or Ready Reserve Corps”; and

(4)

in subsection (f), by striking “the Regular or Reserve Corps of”.

(d)

Rights, privileges, etc. of officers and surviving beneficiaries— Section 221 of the Public Health Service Act (42 U.S.C. 213a) is amended—

(1)

in subsection (a), by adding at the end the following:

“(19) Chapter 1223, Retired Pay for Non-Regular Service.

“(20) Section 12601, Compensation: Reserve on active duty accepting from any person.

“(21) Section 12684, Reserves: separation for absence without authority or sentence to imprisonment.”

(2)

in subsection (b)—

(A)

by striking “Secretary of Health, Education, and Welfare or his designee” and inserting “Secretary of Health and Human Services or the designee of such secretary”;

(B)

by striking “(b) The authority vested” and inserting the following:

“(b)

“(1) The authority vested”

(C)

by striking “For purposes of” and inserting the following:

“(2) For purposes of”

(D)

by adding at the end the following:

“(3) For purposes of paragraph (19) of subsection (a), the terms Military department, Secretary concerned, and Armed forces in such title 10 shall be deemed to include, respectively, the Department of Health and Human Services, the Secretary of Health and Human Services, and the Commissioned Corps.”

(e)

Technical amendments— Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended—

(1)

in sections 204 and 207(c), by striking “Regular or Reserve Corps” each place it appears and inserting “Regular Corps or Ready Reserve Corps”;

(2)

in section 208(a), by striking “Regular and Reserve Corps” each place it appears and inserting “Regular Corps and Ready Reserve Corps”; and

(3)

in section 205(c), 206(c), 210, and 219, and in subsections (a), (b), and (d) of section 207, by striking “Reserve Corps” each place it appears and inserting “Ready Reserve Corps”.

4216. Limitation on liability for volunteer health care professionals during covid-19 emergency response

(a)

Limitation on liability— Except as provided in subsection (b), a health care professional shall not be liable under Federal or State law for any harm caused by an act or omission of the professional in the provision of health care services during the public health emergency declared by the Secretary of Health and Human Services (referred to in this section as 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, if—

(1)

the professional is providing health care services in response to such public health emergency, as a volunteer; and

(2)

the act or omission occurs—

(A)

in the course of providing health care services;

(B)

in the health care professional’s capacity as a volunteer;

(C)

in the course of providing health care services that are within the scope of the license, registration, or certification of the volunteer, as defined by the State of licensure, registration, or certification; and

(D)

in a good faith belief that the individual being treated is in need of health care services.

(b)

Exceptions— Subsection (a) does not apply if—

(1)

the harm was caused by an act or omission constituting willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the individual harmed by the health care professional; or

(2)

the health care professional rendered the health care services under the influence (as determined pursuant to applicable State law) of alcohol or an intoxicating drug.

(c)

Preemption—

(1)

In general— This section preempts the laws of a State or any political subdivision of a State to the extent that such laws are inconsistent with this section, unless such laws provide greater protection from liability.

(2)

Volunteer Protection Act— Protections afforded by this section are in addition to those provided by the Volunteer Protection Act of 1997 (Public Law 105–19).

(d)

Definitions— In this section—

(1)

the term harm includes physical, nonphysical, economic, and noneconomic losses;

(2)

the term health care professional means an individual who is licensed, registered, or certified under Federal or State law to provide health care services;

(3)

the term health care services means any services provided by a health care professional, or by any individual working under the supervision of a health care professional that relate to—

(A)

the diagnosis, prevention, or treatment of COVID-19; or

(B)

the assessment or care of the health of a human being; and

(4)

the term volunteer means a health care professional who, with respect to the health care services rendered, does not receive compensation or any other thing of value in lieu of compensation, which compensation—

(A)

includes a payment under any insurance policy or health plan, or under any Federal or State health benefits program; and

(B)

excludes receipt of items to be used exclusively for rendering health care services in the health care professional’s capacity as a volunteer described in subsection (a)(1).

(e)

Effective date— This section shall take effect upon the date of enactment of this Act, and applies to a claim for harm only if the act or omission that caused such harm occurred on or after the date of enactment.

(f)

Sunset— This section shall be in effect only for the length of the public health emergency declared by the Secretary of Health and Human Services (referred to in this section as 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.

III Miscellaneous provisions

4221. Confidentiality and disclosure of records relating to substance use disorder

(a)

Conforming changes relating to substance use disorder— Subsections (a) and (h) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) are each amended by striking “substance abuse” and inserting “substance use disorder”.

(b)

Disclosures to covered entities consistent with HIPAA— Paragraph (1) of section 543(b) of the Public Health Service Act (42 U.S.C. 290dd–2(b)) is amended to read as follows:

“(1) Consent—The following shall apply with respect to the contents of any record referred to in subsection (a):

“(A) Such contents may be used or disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained.

“(B) Once prior written consent of the patient has been obtained, such contents may be used or disclosed by a covered entity, business associate, or a program subject to this section for purposes of treatment, payment, and health care operations as permitted by the HIPAA regulations. Any information so disclosed may then be redisclosed in accordance with the HIPAA regulations. Section 13405(c) of the Health Information Technology and Clinical Health Act (42 U.S.C. 17935(c)) shall apply to all disclosures pursuant to subsection (b)(1) of this section.

“(C) It shall be permissible for a patient’s prior written consent to be given once for all such future uses or disclosures for purposes of treatment, payment, and health care operations, until such time as the patient revokes such consent in writing.

“(D) Section 13405(a) of the Health Information Technology and Clinical Health Act (42 U.S.C. 17935(a)) shall apply to all disclosures pursuant to subsection (b)(1) of this section.”

(c)

Disclosures of de-Identified health information to public health authorities— Paragraph (2) of section 543(b) of the Public Health Service Act (42 U.S.C. 290dd–2(b)), is amended by adding at the end the following:

“(D) To a public health authority, so long as such content meets the standards established in section 164.514(b) of title 45, Code of Federal Regulations (or successor regulations) for creating de-identified information.”

(d)

Definitions— Section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) is amended by adding at the end the following:

“(k) Definitions—For purposes of this section:

“(1) Breach—The term breach has the meaning given such term for purposes of the HIPAA regulations.

“(2) Business associate—The term business associate has the meaning given such term for purposes of the HIPAA regulations.

“(3) Covered entity—The term covered entity has the meaning given such term for purposes of the HIPAA regulations.

“(4) Health care operations—The term health care operations has the meaning given such term for purposes of the HIPAA regulations.

“(5) HIPPA regulations—The term HIPAA regulations has the meaning given such term for purposes of parts 160 and 164 of title 45, Code of Federal Regulations.

“(6) Payment—The term payment has the meaning given such term for purposes of the HIPAA regulations.

“(7) Public health authority—The term public health authority has the meaning given such term for purposes of the HIPAA regulations.

“(8) Treatment—The term treatment has the meaning given such term for purposes of the HIPAA regulations.

“(9) Unsecured protected health information—The term unprotected health information has the meaning given such term for purposes of the HIPAA regulations.”

(e)

Use of records in criminal, civil, or administrative investigations, actions, or proceedings— Subsection (c) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2(c)) is amended to read as follows:

“(c) Use of records in criminal, civil, or administrative contexts—Except as otherwise authorized by a court order under subsection (b)(2)(C) or by the consent of the patient, a record referred to in subsection (a), or testimony relaying the information contained therein, may not be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority, including with respect to the following activities:

“(1) Such record or testimony shall not be entered into evidence in any criminal prosecution or civil action before a Federal or State court.

“(2) Such record or testimony shall not form part of the record for decision or otherwise be taken into account in any proceeding before a Federal, State, or local agency.

“(3) Such record or testimony shall not be used by any Federal, State, or local agency for a law enforcement purpose or to conduct any law enforcement investigation.

“(4) Such record or testimony shall not be used in any application for a warrant.”

(f)

Penalties— Subsection (f) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) is amended to read as follows:

“(f) Penalties—The provisions of sections 1176 and 1177 of the Social Security Act shall apply to a violation of this section to the extent and in the same manner as such provisions apply to a violation of part C of title XI of such Act. In applying the previous sentence—

“(1) the reference to “this subsection” in subsection (a)(2) of such section 1176 shall be treated as a reference to “this subsection (including as applied pursuant to section 543(f) of the Public Health Service Act)”; and

“(2) in subsection (b) of such section 1176—

“(A) each reference to “a penalty imposed under subsection (a)” shall be treated as a reference to “a penalty imposed under subsection (a) (including as applied pursuant to section 543(f) of the Public Health Service Act)”; and

“(B) each reference to “no damages obtained under subsection (d)” shall be treated as a reference to “no damages obtained under subsection (d) (including as applied pursuant to section 543(f) of the Public Health Service Act)”.”

(g)

Antidiscrimination— Section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) is amended by inserting after subsection (h) the following:

“(i) Antidiscrimination

“(1) In general—No entity shall discriminate against an individual on the basis of information received by such entity pursuant to an inadvertent or intentional disclosure of records, or information contained in records, described in subsection (a) in—

“(A) admission, access to, or treatment for health care;

“(B) hiring, firing, or terms of employment, or receipt of worker’s compensation;

“(C) the sale, rental, or continued rental of housing;

“(D) access to Federal, State, or local courts; or

“(E) access to, approval of, or maintenance of social services and benefits provided or funded by Federal, State, or local governments.

“(2) Recipients of Federal funds—No recipient of Federal funds shall discriminate against an individual on the basis of information received by such recipient pursuant to an intentional or inadvertent disclosure of such records or information contained in records described in subsection (a) in affording access to the services provided with such funds.”

(h)

Notification in case of breach— Section 543 of the Public Health Service Act (42 U.S.C. 290dd–2), as amended by subsection (g), is further amended by inserting after subsection (i) the following:

“(j) Notification in case of breach—The provisions of section 13402 of the HITECH Act (42 U.S.C. 17932) shall apply to a program or activity described in subsection (a), in case of a breach of records described in subsection (a), to the same extent and in the same manner as such provisions apply to a covered entity in the case of a breach of unsecured protected health information.”

(i)

Regulations—

(1)

In general— The Secretary of Health and Human Services, in consultation with appropriate Federal agencies, shall make such revisions to regulations as may be necessary for implementing and enforcing the amendments made by this section, such that such amendments shall apply with respect to uses and disclosures of information occurring on or after the date that is 12 months after the date of enactment of this Act.

(2)

Easily understandable notice of privacy practices— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate legal, clinical, privacy, and civil rights experts, shall update section 164.520 of title 45, Code of Federal Regulations, so that covered entities and entities creating or maintaining the records described in subsection (a) provide notice, written in plain language, of privacy practices regarding patient records referred to in section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)), including—

(A)

a statement of the patient’s rights, including self-pay patients, with respect to protected health information and a brief description of how the individual may exercise these rights (as required by subsection (b)(1)(iv) of such section 164.520); and

(B)

a description of each purpose for which the covered entity is permitted or required to use or disclose protected health information without the patient’s written authorization (as required by subsection (b)(2) of such section 164.520).

(j)

Rules of construction— Nothing in this title or the amendments made by this title shall be construed to limit—

(1)

a patient’s right, as described in section 164.522 of title 45, Code of Federal Regulations, or any successor regulation, to request a restriction on the use or disclosure of a record referred to in section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)) for purposes of treatment, payment, or health care operations; or

(2)

a covered entity’s choice, as described in section 164.506 of title 45, Code of Federal Regulations, or any successor regulation, to obtain the consent of the individual to use or disclose a record referred to in such section 543(a) to carry out treatment, payment, or health care operation.

(k)

Sense of Congress— It is the sense of the Congress that—

(1)

any person treating a patient through a program or activity with respect to which the confidentiality requirements of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) apply is encouraged to access the applicable State-based prescription drug monitoring program when clinically appropriate;

(2)

patients have the right to request a restriction on the use or disclosure of a record referred to in section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)) for treatment, payment, or health care operations;

(3)

covered entities should make every reasonable effort to the extent feasible to comply with a patient’s request for a restriction regarding such use or disclosure;

(4)

for purposes of applying section 164.501 of title 45, Code of Federal Regulations, the definition of health care operations shall have the meaning given such term in such section, except that clause (v) of paragraph (6) shall not apply; and

(5)

programs creating records referred to in section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)) should receive positive incentives for discussing with their patients the benefits to consenting to share such records.

4222. Nutrition services

(a)

Definitions— In this section, the terms Assistant Secretary, Secretary, State agency, and area agency on aging have the meanings given the terms in section 102 of the Older Americans Act of 1965 (42 U.S.C. 3002).

(b)

Nutrition services transfer criteria— During any portion of the COVID-19 public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), the Secretary shall allow a State agency or an area agency on aging, without prior approval, to transfer not more than 100 percent of the funds received by the State agency or area agency on aging, respectively, and attributable to funds appropriated under paragraph (1) or (2) of section 303(b) of the Older Americans Act of 1965 (42 U.S.C. 3023(b)), between subpart 1 and subpart 2 of part C (42 U.S.C. 3030d–2 et seq.) for such use as the State agency or area agency on aging, respectively, considers appropriate to meet the needs of the State or area served.

(c )

Home-delivered nutrition services waiver— For purposes of State agencies determining the delivery of nutrition services under section 337 of the Older Americans Act of 1965 (42 U.S.C. 3030g), during the period of the COVID–19 public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), the same meaning shall be given to an individual who is unable to obtain nutrition because the individual is practicing social distancing due to the emergency as is given to an individual who is homebound by reason of illness.

(d)

Dietary guidelines waiver— To facilitate implementation of subparts 1 and 2 of part C of title III of the Older Americans Act of 1965 (42 U.S.C. 3030d–2 et seq.) during any portion of the COVID-19 public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), the Assistant Secretary shall waive the requirements for meals provided under those subparts to comply with the requirements of clauses (i) and (ii) of section 339(2)(A) of such Act (42 U.S.C. 3030g–21(2)(A)).

4223. Guidance on protected health information

Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance on the sharing of patients' protected health information pursuant to section 160.103 of title 45, Code of Federal Regulations (or any successor regulations) during the public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID-19, during the emergency involving Federal primary responsibility determined to exist by the President under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5191(b)) with respect to COVID-19, and during the national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et seq.) with respect to COVID-19. Such guidance shall include information on compliance with the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note) and applicable policies, including such policies that may come into effect during such emergencies.

4224. Reauthorization of healthy start program

Section 330H of the Public Health Service Act (42 U.S.C. 254c–8) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1), by striking “, during fiscal year 2001 and subsequent years,”; and

(B)

in paragraph (2), by inserting “or increasing above the national average” after “areas with high”;

(2)

in subsection (b)—

(A)

in paragraph (1), by striking “consumers of project services, public health departments, hospitals, health centers under section 330” and inserting “participants and former participants of project services, public health departments, hospitals, health centers under section 330, State substance abuse agencies”; and

(B)

in paragraph (2)—

(i)

in subparagraph (A), by striking “such as low birthweight” and inserting “including poor birth outcomes (such as low birthweight and preterm birth) and social determinants of health”;

(ii)

by redesignating subparagraph (B) as subparagraph (C);

(iii)

by inserting after subparagraph (A), the following:

“(B) Communities with—

“(i) high rates of infant mortality or poor perinatal outcomes; or

“(ii) high rates of infant mortality or poor perinatal outcomes in specific subpopulations within the community.”

(iv)

in subparagraph (C) (as so redesignated)—

(I)

by redesignating clauses (i) and (ii) as clauses (ii) and (iii), respectively;

(II)

by inserting before clause (ii) (as so redesignated) the following:

“(i) collaboration with the local community in the development of the project;”

(III)

in clause (ii) (as so redesignated), by striking “and” at the end;

(IV)

in clause (iii) (as so redesignated), by striking the period and inserting “; and”; and

(V)

by adding at the end the following:

“(iv) the use and collection of data demonstrating the effectiveness of such program in decreasing infant mortality rates and improving perinatal outcomes, as applicable, or the process by which new applicants plan to collect this data.”

(3)

in subsection (c)—

(A)

by striking “Recipients of grants” and inserting the following:

“(1) In general—Recipients of grants”

(B)

by adding at the end the following:

“(2) Other programs—The Secretary shall ensure coordination of the program carried out pursuant to this section with other programs and activities related to the reduction of the rate of infant mortality and improved perinatal and infant health outcomes supported by the Department.”

(4)

in subsection (e)—

(A)

in paragraph (1), by striking “appropriated—” and all that follows through the end and inserting “appropriated $122,500,000 for each of fiscal years 2020 through 2024.”; and

(B)

in paragraph (2)(B), by adding at the end the following: “Evaluations may also include, to the extent practicable, information related to—

“(i) progress toward achieving any grant metrics or outcomes related to reducing infant mortality rates, improving perinatal outcomes, or reducing the disparity in health status;

“(ii) recommendations on potential improvements that may assist with addressing gaps, as applicable and appropriate; and

“(iii) the extent to which the grantee coordinated with the community in which the grantee is located in the development of the project and delivery of services, including with respect to technical assistance and mentorship programs.”

(5)

by adding at the end the following:

“(f) GAO report

“(1) In general—Not later than 4 years after the date of the enactment of this subsection, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate Committees of Congress a report, concerning the Healthy Start program under this section.

“(2) Evaluation—In conducting the evaluation under paragraph (1), the Comptroller General shall consider, as applicable and appropriate, information from the evaluations under subsection (e)(2)(B).

“(3) Report—The report described in paragraph (1) shall review, assess, and provide recommendations, as appropriate, on the following:

“(A) The allocation of Healthy Start program grants by the Health Resources and Services Administration, including considerations made by such Administration regarding disparities in infant mortality or perinatal outcomes among urban and rural areas in making such awards.

“(B) Trends in the progress made toward meeting the evaluation criteria pursuant to subsection (e)(2)(B), including programs which decrease infant mortality rates and improve perinatal outcomes, programs that have not decreased infant mortality rates or improved perinatal outcomes, and programs that have made an impact on disparities in infant mortality or perinatal outcomes.

“(C) The ability of grantees to improve health outcomes for project participants, promote the awareness of the Healthy Start program services, incorporate and promote family participation, facilitate coordination with the community in which the grantee is located, and increase grantee accountability through quality improvement, performance monitoring, evaluation, and the effect such metrics may have toward decreasing the rate of infant mortality and improving perinatal outcomes.

“(D) The extent to which such Federal programs are coordinated across agencies and the identification of opportunities for improved coordination in such Federal programs and activities.”

C Innovation

4301. Removing the cap on OTA

Section 319L(c)(5)(A)(ii) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)(A)(ii)) is amended to read as follows:

“(ii) Limitations on authority—To the maximum extent practicable, competitive procedures shall be used when entering into transactions to carry out projects under this subsection.”

4302. Extending the priority review program for agents that present national security threats

Section 565A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4a) is amended by striking subsection (g).

4303. Priority zoonotic animal drugs

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 512 the following:

“512A. Priority zoonotic animal drugs

“(a) In general—The Secretary shall, at the request of the sponsor intending to submit an application for approval of a new animal drug under section 512(b)(1) or an application for conditional approval of a new animal drug under section 571, expedite the development and review of such new animal drug if preliminary clinical evidence indicates that the new animal drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.

“(b) Request for designation—The sponsor of a new animal drug may request the Secretary to designate a new animal drug described in subsection (a) as a priority zoonotic animal drug. A request for the designation may be made concurrently with, or at any time after, the opening of an investigational new animal drug file under section 512(j) or the filing of an application under section 512(b)(1) or 571.

“(c) Designation

“(1) In general—Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether the new animal drug that is the subject of the request meets the criteria described in subsection (a). If the Secretary determines that the new animal drug meets the criteria, the Secretary shall designate the new animal drug as a priority zoonotic animal drug and shall take such actions as are appropriate to expedite the development and review of the application for approval or conditional approval of such new animal drug.

“(2) Actions—The actions to expedite the development and review of an application under paragraph (1) may include, as appropriate—

“(A) taking steps to ensure that the design of clinical trials is as efficient as practicable, when scientifically appropriate, such as by utilizing novel trial designs or drug development tools (including biomarkers) that may reduce the number of animals needed for studies;

“(B) providing timely advice to, and interactive communication with, the sponsor (which may include meetings with the sponsor and review team) regarding the development of the new animal drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;

“(C) involving senior managers and review staff with experience in zoonotic or vector-borne disease to facilitate collaborative, cross-disciplinary review, including, as appropriate, across agency centers; and

“(D) implementing additional administrative or process enhancements, as necessary, to facilitate an efficient review and development program.”

D Finance Committee

4401. Exemption for telehealth services

(a)

In general— Paragraph (2) of section 223(c) of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:

“(E) Safe harbor for absence of deductible for telehealth—In the case of plan years beginning on or before December 31, 2021, a plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for telehealth and other remote care services.”

(b)

Certain coverage disregarded— Clause (ii) of section 223(c)(1)(B) of the Internal Revenue Code of 1986 is amended by striking “or long-term care” and inserting “long-term care, or (in the case of plan years beginning on or before December 31, 2021) telehealth and other remote care”.

(c)

Effective date— The amendments made by this section shall take effect on the date of the enactment of this Act.

4402. Inclusion of certain over-the-counter medical products as qualified medical expenses

(a)

HSAs— Section 223(d)(2) of the Internal Revenue Code of 1986 is amended—

(1)

by striking the last sentence of subparagraph (A) and inserting the following: “For purposes of this subparagraph, amounts paid for menstrual care products shall be treated as paid for medical care.”; and

(2)

by adding at the end the following new subparagraph:

“(D) Menstrual care product—For purposes of this paragraph, the term “menstrual care product” means a tampon, pad, liner, cup, sponge, or similar product used by individuals with respect to menstruation or other genital-tract secretions.”

(b)

Archer MSAs— Section 220(d)(2)(A) of such Code is amended by striking the last sentence and inserting the following: “For purposes of this subparagraph, amounts paid for menstrual care products (as defined in section 223(d)(2)(D)) shall be treated as paid for medical care.”.

(c)

Health flexible spending arrangements and health reimbursement arrangements— Section 106 of such Code is amended by striking subsection (f) and inserting the following new subsection:

“(f) Reimbursements for menstrual care products—For purposes of this section and section 105, expenses incurred for menstrual care products (as defined in section 223(d)(2)(D)) shall be treated as incurred for medical care.”

(d)

Effective dates—

(1)

Distributions from savings accounts— The amendment made by subsections (a) and (b) shall apply to amounts paid after December 31, 2019.

(2)

Reimbursements— The amendment made by subsection (c) shall apply to expenses incurred after December 31, 2019.

4403. Treatment of direct primary care service arrangements

(a)

In general— Section 223(c)(1) of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:

“(D) Treatment of direct primary care service arrangements

“(i) In general—A direct primary care service arrangement shall not be treated as a health plan for purposes of subparagraph (A)(ii).

“(ii) Direct primary care service arrangement—For purposes of this paragraph—

“(I) In general—The term direct primary care service arrangement means, with respect to any individual, an arrangement under which such individual is provided medical care (as defined in section 213(d)) consisting solely of primary care services provided by primary care practitioners (as defined in section 1833(x)(2)(A) of the Social Security Act, determined without regard to clause (ii) thereof), if the sole compensation for such care is a fixed periodic fee.

“(II) Limitation—With respect to any individual for any month, such term shall not include any arrangement if the aggregate fees for all direct primary care service arrangements (determined without regard to this subclause) with respect to such individual for such month exceed $150 (twice such dollar amount in the case of an individual with any direct primary care service arrangement (as so determined) that covers more than one individual).

“(iii) Certain services specifically excluded from treatment as primary care services—For purposes of this paragraph, the term primary care services shall not include—

“(I) procedures that require the use of general anesthesia, and

“(II) laboratory services not typically administered in an ambulatory primary care setting.”

(b)

Direct primary care service arrangement fees treated as medical expenses— Section 223(d)(2)(C) is amended by striking “or” at the end of clause (iii), by striking the period at the end of clause (iv) and inserting “, or”, and by adding at the end the following new clause:

“(v) any direct primary care service arrangement.”

(c)

Inflation adjustment— Section 223(g)(1) of such Code is amended—

(1)

by inserting “, (c)(1)(D)(ii)(II),” after “(b)(2),” each place such term appears, and

(2)

in subparagraph (B), by inserting “and (iii)” after “clause (ii)” in clause (i), by striking “and” at the end of clause (i), by striking the period at the end of clause (ii) and inserting “, and”, and by inserting after clause (ii) the following new clause:

“(iii) in the case of the dollar amount in subsection (c)(1)(D)(ii)(II) for taxable years beginning in calendar years after 2020, “calendar year 2019”.”

(d)

Reporting of direct primary care service arrangement fees on w–2— Section 6051(a) of such Code is amended by striking “and” at the end of paragraph (16), by striking the period at the end of paragraph (17) and inserting “, and”, and by inserting after paragraph (17) the following new paragraph:

“(18) in the case of a direct primary care service arrangement (as defined in section 223(c)(1)(D)(ii)) which is provided in connection with employment, the aggregate fees for such arrangement for such employee.”

(e)

Effective date— The amendments made by this section shall apply to months beginning after December 31, 2019, in taxable years ending after such date.

4404. Increasing Medicare telehealth flexibilities during emergency period

Section 1135 of the Social Security Act (42 U.S.C. 1320b–5) is amended—

(1)

in subsection (b)(8), by striking “to an individual by a qualified provider (as defined in subsection (g)(3))” and all that follows through the period and inserting “, the requirements of section 1834(m).”; and

(2)

in subsection (g), by striking paragraph (3).

4405. Enhancing Medicare telehealth services for Federally qualified health centers and rural health clinics during emergency period

Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—

(1)

in the first sentence of paragraph (1), by striking “The Secretary” and inserting “Subject to paragraph (8), the Secretary”;

(2)

in paragraph (2)(A), by striking “The Secretary” and inserting “Subject to paragraph (8), the Secretary”;

(3)

in paragraph (4)—

(A)

in subparagraph (A), by striking “The term” and inserting “Subject to paragraph (8), the term”; and

(B)

in subparagraph (F)(i), by striking “The term” and inserting “Subject to paragraph (8), the term”; and

(4)

by adding at the end the following new paragraph:

“(8) Enhancing telehealth services for Federally qualified health centers and rural health clinics during emergency period

“(A) In general—During the emergency period described in section 1135(g)(1)(B)—

“(i) the Secretary shall pay for telehealth services that are furnished via a telecommunications system by a Federally qualified health center or a rural health clinic to an eligible telehealth individual enrolled under this part notwithstanding that the Federally qualified health center or rural clinic providing the telehealth service is not at the same location as the beneficiary;

“(ii) the amount of payment to a Federally qualified health center or rural health clinic that serves as a distant site for such a telehealth service shall be determined under subparagraph (B); and

“(iii) for purposes of this subsection—

“(I) the term distant site includes a Federally qualified health center or rural health clinic that furnishes a telehealth service to an eligible telehealth individual; and

“(II) the term telehealth services includes a rural health clinic service or Federally qualified health center service that is furnished using telehealth to the extent that payment codes corresponding to services identified by the Secretary under clause (i) or (ii) of paragraph (4)(F) are listed on the corresponding claim for such rural health clinic service or Federally qualified health center service.

“(B) Special payment rule—The Secretary shall develop and implement payment methods that apply under this subsection to a Federally qualified health center or rural health clinic that serves as a distant site that furnishes a telehealth service to an eligible telehealth individual during such emergency period. Such payment methods shall be based on a composite rate that is similar to the payment that applies to payment for comparable telehealth services under the physician fee schedule under section 1848. Notwithstanding any other provision of law, the Secretary may implement such payment methods through program instruction or otherwise.”

4406. Temporary waiver of requirement for face-to-face visits between home dialysis patients and physicians

Section 1881(b)(3)(B) of the Social Security Act (42 U.S.C. 1395rr(b)(3)(B)) is amended—

(1)

in clause (i), by striking “clause (ii)” and inserting “clauses (ii) and (iii)”;

(2)

in clause (ii), in the matter preceding subclause (I), by striking “Clause (i)” and inserting “Except as provided in clause (iii), clause (i)”; and

(3)

by adding at the end the following new clause:

“(iii) The Secretary may waive the provisions of clause (ii) during the emergency period described in section 1135(g)(1)(B).”

4407. Improving care planning for Medicare home health services

(a)

Part A provisions— Section 1814(a) of the Social Security Act (42 U.S.C. 1395f(a)) is amended—

(1)

in paragraph (2)—

(A)

in the matter preceding subparagraph (A), by inserting “, a nurse practitioner or clinical nurse specialist (as such terms are defined in section 1861(aa)(5)) who is working in accordance with State law, or a physician assistant (as defined in section 1861(aa)(5)) under the supervision of a physician, who is” after “in the case of services described in subparagraph (C), a physician”; and

(B)

in subparagraph (C)—

(i)

by inserting “, a nurse practitioner, a clinical nurse specialist, or a physician assistant (as the case may be)” after “physician” the first 2 times it appears; and

(ii)

by striking “, and, in the case of a certification made by a physician” and all that follows through “face-to-face encounter” and inserting “, and, in the case of a certification made by a physician after January 1, 2010, or by a nurse practitioner, clinical nurse specialist, or physician assistant (as the case may be) after a date specified by the Secretary (but in no case later than the date that is 6 months after the date of the enactment of the CARES Act), prior to making such certification a physician, nurse practitioner, clinical nurse specialist, or physician assistant must document that a physician, nurse practitioner, clinical nurse specialist, or physician assistant has had a face-to-face encounter”;

(2)

in the third sentence—

(A)

by striking “physician certification” and inserting “certification”;

(B)

by inserting “(or in the case of regulations to implement the amendments made by section 4407 of the CARES Act, the Secretary shall prescribe regulations, which shall become effective no later than 6 months after the enactment of such Act))” after “1981”; and

(C)

by striking “a physician who” and inserting “a physician, nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant who”; and

(3)

in the fourth sentence, by inserting “, nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant” after “physician”; and

(4)

in the fifth sentence—

(A)

by inserting “or no later than six months after the enactment of this legislation for purposes of documentation for certification and recertification made under paragraph (2) by a nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant,”; and

(B)

by inserting “, nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant” after “of the physician”.

(b)

Part B provisions— Section 1835(a) of the Social Security Act (42 U.S.C. 1395n(a)) is amended—

(1)

in paragraph (2)—

(A)

in the matter preceding subparagraph (A), by inserting “, a nurse practitioner or clinical nurse specialist (as those terms are defined in section 1861(aa)(5)) who is working in accordance with State law, or a physician assistant (as defined in section 1861(aa)(5)) under the supervision of a physician, who is” after “in the case of services described in subparagraph (C), a physician”; and

(B)

in subparagraph (A)—

(i)

in each of clauses (ii) and (iii) of subparagraph (A) by inserting “, a nurse practitioner, a clinical nurse specialist, or a physician assistant (as the case may be)” after “physician”; and

(ii)

in clause (iv), by striking “after January 1, 2010” and all that follows through “face-to-face encounter” and inserting “made by a physician after January 1, 2010, or by a nurse practitioner, clinical nurse specialist, or physician assistant (as the case may be) after a date specified by the Secretary (but in no case later than the date that is 6 months after the date of the enactment of the CARES Act), prior to making such certification a physician, nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant must document that a physician, nurse practitioner, clinical nurse specialist, or physician assistant has had a face-to-face encounter”;

(2)

in the third sentence, by inserting “, nurse practitioner, clinical nurse specialist, or physician assistant (as the case may be)” after physician;

(3)

in the fourth sentence—

(A)

by striking “physician certification” and inserting “certification”;

(B)

by inserting “(or in the case of regulations to implement the amendments made by section 4407 of the CARES Act the Secretary shall prescribe regulations which shall become effective no later than 6 months after the enactment of such Act))” after “1981”; and

(C)

by striking “a physician who” and inserting “a physician, nurse practitioner, clinical nurse specialist, or physician assistant who”;

(4)

in the fifth sentence, by inserting “, nurse practitioner, clinical nurse specialist, or physician assistant” after “physician”; and

(5)

in the sixth sentence—

(A)

by inserting “or no later than six months after the enactment of this legislation for purposes of documentation for certification and recerification made under paragraph (2) by a nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant,” after “January 1, 2019”; and

(B)

by inserting “, nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant” after “of the physician”.

(c)

Definition provisions—

(1)

Home health services— Section 1861(m) of the Social Security Act (42 U.S.C. 1395x(m)) is amended—

(A)

in the matter preceding paragraph (1)—

(i)

by inserting “, a nurse practitioner or a clinical nurse specialist (as those terms are defined in subsection (aa)(5)), or a physician assistant (as defined in subsection (aa)(5))” after “physician” the first place it appears; and

(ii)

by inserting “, a nurse practitioner, a clinical nurse specialist, or a physician assistant” after “physician” the second place it appears; and

(B)

in paragraph (3), by inserting “, a nurse practitioner, a clinical nurse specialist, or a physician assistant” after “physician”.

(2)

Home health agency— Section 1861(o)(2) of the Social Security Act (42 U.S.C. 1395x(o)(2)) is amended—

(A)

by inserting “, nurse practitioners or clinical nurse specialists (as those terms are defined in subsection (aa)(5)), certified nurse-midwives (as defined in subsection (gg)), or physician assistants (as defined in subsection (aa)(5))” after “physicians”; and

(B)

by inserting “, nurse practitioner, clinical nurse specialist, certified nurse-midwife, physician assistant,” after “physician”.

(3)

Covered osteoporosis drug— Section 1861(kk)(1) of the Social Security Act (42 U.S.C. 1395x(kk)(1)) is amended by inserting “, nurse practitioner or clinical nurse specialist (as those terms are defined in subsection (aa)(5)), certified nurse-midwive (as defined in subsection (gg)), or physician assistant (as defined in subsection 1820(aa)(5))” after “attending physician”.

(d)

Home health prospective payment system provisions— Section 1895 of the Social Security Act (42 U.S.C. 1395fff) is amended—

(1)

in subsection (c)(1)—

(A)

by striking “(provided under section 1842(r))”; and

(B)

by inserting “the 1 nurse practitioner or clinical nurse specialist (as those terms are defined in section 1861(aa)(5)), or the physician assistant (as defined in section 1861(aa)(5))” after “physician”; and

(2)

in subsection (e)—

(A)

in paragraph (1)(A), by inserting “or a nurse practitioner or clinical nurse specialist (as those terms are defined in section 1861(aa)(5))” after “physician”; and

(B)

in paragraph (2)—

(i)

in the heading, by striking “Physician certification” and inserting “Rule of construction regarding requirement for certification”; and

(ii)

by striking “physician”.

(e)

Application to Medicaid— The amendments made under this section shall apply under title XIX of the Social Security Act in the same manner and to the same extent as such requirements apply under title XVIII of such Act or regulations promulgated thereunder.

(f)

Effective date— The Secretary of Health and Human Services shall prescribe regulations to apply the amendments made by this section to items and services furnished, which shall become effective no later than six months after the enactment of this legislation. The Secretary shall promulgate an interim final rule if necessary, to comply with the required effective date.

4408. Adjustment of sequestration

(a)

Temporary suspension of Medicare sequestration— During the period beginning on May 1, 2020 and ending on December 31, 2020, the Medicare programs under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) shall be exempt from reduction under any sequestration order issued before, on, or after the date of enactment of this Act.

(b)

Extension of direct spending reductions through fiscal year 2030— Section 251A(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) is amended—

(1)

in subparagraph (B), in the matter preceding clause (i), by striking “through 2029” and inserting “through 2030”; and

(2)

in subparagraph (C), in the matter preceding clause (i), by striking “fiscal year 2029” and inserting “fiscal year 2030”.

4409. Medicare hospital inpatient prospective payment system add-on payment for covid–19 patients during emergency period

(a)

In general— Section 1886(d)(4)(C) of the Social Security Act (42 U.S.C. 1395ww(d)(4)(C)) is amended by adding at the end the following new clause:

“(iv)

“(I) For discharges occurring during the emergency period described in section 1135(g)(1)(B), in the case of a discharge that has a principal or secondary diagnosis of COVID–19, the Secretary shall increase the weighting factor for each diagnosis-related group (with such a principal or secondary diagnosis) by 15 percent.

“(II) Any adjustment under subclause (I) shall not be taken into account in applying budget neutrality under clause (iii).”

(b)

Implementation— Notwithstanding any other provision of law, the Secretary may implement the amendment made by subsection (a) by program instruction or otherwise.

4410. Revising payment rates for durable medical equipment under the Medicare program through duration of emergency period

(a)

Rural and noncontiguous areas— The Secretary of Health and Human Services shall implement section 414.210(g)(9)(iii) of title 42, Code of Federal Regulations (or any successor regulation), to apply the transition rule described in such section to all applicable items and services furnished in rural areas and noncontiguous areas (as such terms are defined for purposes of such section) as planned through December 31, 2020, and through the duration 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)), if longer.

(b)

Areas other than rural and noncontiguous areas— With respect to items and services furnished on or after the date that is 30 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall apply section 414.210(g)(9)(iv) of title 42, Code of Federal Regulations (or any successor regulation), as if the reference to “dates of service from June 1, 2018 through December 31, 2020, based on the fee schedule amount for the area is equal to 100 percent of the adjusted payment amount established under this section” were instead a reference to “dates of service from March 6, 2020, through the remainder of the duration 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)), based on the fee schedule amount for the area is equal to 75 percent of the adjusted payment amount established under this section and 25 percent of the unadjusted fee schedule amount”.

4411. Providing home and community-based services in acute care hospitals

Section 1902(h) of the Social Security Act (42 U.S.C. 1396a(h)) is amended—

(1)

by inserting “(1)” after “(h)”;

(2)

by inserting “, home and community-based services provided under subsection (c), (d), or (i) of section 1915 or under a waiver under section 1115, self-directed personal assistance services provided pursuant to a written plan of care under section 1915(j), and home and community-based attendant services and supports under section 1915(k)” before the period; and

(3)

by adding at the end the following:

“(2) Nothing in this title, title XVIII, or title XI shall be construed as prohibiting receipt of any care or services specified in paragraph (1) in an acute care hospital that are—

“(A) identified in an individual’s person-centered plan of services and supports (or comparable plan of care);

“(B) provided to meet needs of the individual that are not met through the provision of hospital services;

“(C) not a substitute for services that the hospital is obligated to provide through its conditions of participation or under Federal or State law; and

“(D) designed to ensure smooth transitions between acute care settings and home and community-based settings, and to preserve the individual’s functions.”

4412. Treatment of technology-enabled collaborative learning and capacity building models as medical assistance

Section 1915 of the Social Security Act (42 U.S.C. 1396n) is amended by adding at the end the following:

“(m) Technology-enabled collaborative learning and capacity building models

“(1) In general—A State may provide, as medical assistance, a technology-enabled collaborative learning and capacity building model used by a provider participating under the State plan (or a waiver of such plan) without regard to the requirements of section 1902(a)(1) (relating to statewideness), section 1902(a)(10)(B) (relating to comparability), and section 1902(a)(23) (relating to freedom of choice of providers).

“(2) Requirements—A State shall be eligible for Federal financial assistance for providing such medical assistance under the following conditions:

“(A) A participating provider uses the technology-enabled collaborative learning and capacity building model to train health professionals (which may include medical students) in protocols for responding to a public health emergency during an emergency period, including any period relating to an outbreak of coronavirus disease 2019 (COVID–19).

“(B) In accordance with section 1902(a)(25), there are no other third parties liable to pay for the use of such model by a participating provider, including as reimbursement under a medical, social, educational, or other program.

“(C) The State allocates the costs of any part of the use such model which is reimbursable under another federally funded program in accordance with OMB Circular A–87 (or any related or successor guidance or regulations regarding allocation of costs among federally funded programs) under an approved cost allocation program.

“(3) Nonapplication of time limits—Subsection (h) shall not apply to the provision of medical assistance for technology-enabled collaborative learning and capacity building models under this subsection.

“(4) Definitions—In this subsection:

“(A) Emergency period—The term emergency period has the meaning given that term in section 1135(g)(1).

“(B) Technology-enabled collaborative learning and capacity building model—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).”

4413. Encouraging the development and use of DISARM antimicrobial drugs

(a)

Additional payment for DISARM antimicrobial drugs under Medicare—

(1)

In general— 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:

“(M)

“(i)

“(I) In the case of discharges occurring on or after October 1, 2021, and before October 1, 2026, subject to subclause (II), the Secretary shall, after notice and opportunity for public comment (in the publications required by subsection (e)(5) for a fiscal year or otherwise), provide for an additional payment under a mechanism (separate from the mechanism established under subparagraph (K)), with respect to such discharges involving any DISARM antimicrobial drug, in an amount equal to—

“(aa) the amount payable under section 1847A for such drug during the calendar quarter in which the discharge occurred; or

“(bb) if no amount for such drug is determined under section 1847A, an amount to be determined by the Secretary in a manner similar to the manner in which payment amounts are determined under section 1847A based on information submitted by the manufacturer or sponsor of such drug (as required under clause (v)).

“(II) In determining the amount payable under section 1847A for purposes of items (aa) and (bb) of subclause (I), subparagraphs (A) and (B) of subsection (b)(1) of such section shall be applied by substituting “100 percent” for “106 percent” each place it appears and paragraph (8)(B) of such section shall be applied by substituting “0 percent” for “6 percent”.

“(ii) For purposes of this subparagraph, a DISARM antimicrobial drug is—

“(I) a drug—

“(aa) that—

“(AA) is approved by the Food and Drug Administration;

“(BB) is designated by the Food and Drug Administration as a qualified infectious disease product under subsection (d) of section 505E of the Federal Food, Drug, and Cosmetic Act; and

“(CC) has received an extension of its exclusivity period pursuant to subsection (a) of such section; and

“(bb) that has been designated by the Secretary pursuant to the process established under clause (iv)(I)(bb); or

“(II) an antibacterial or antifungal biological product—

“(aa) that is licensed for use, or an antibacterial or antifungal biological product for which an indication is first licensed for use, by the Food and Drug Administration on or after June 5, 2014, under section 351(a) of the Public Health Service Act for human use to treat serious or life-threatening infections, as determined by the Food and Drug Administration, including those caused by, or likely to be caused by—

“(AA) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

“(BB) a qualifying pathogen (as defined under section 505E(f) of the Federal Food, Drug, and Cosmetic Act); and

“(bb) has been designated by the Secretary pursuant to the process established under clause (iv)(I)(bb).

“(iii) The mechanism established pursuant to clause (i) shall provide that the additional payment under clause (i) shall—

“(I) with respect to a discharge, only be made to a subsection (d) hospital that, as determined by the Secretary—

“(aa) is participating in the National Healthcare Safety Network Antimicrobial Use and Resistance Module of the Centers for Disease Control and Prevention or a similar reporting program, as specified by the Secretary, relating to antimicrobial drugs; and

“(bb) has an antimicrobial stewardship program that aligns with the Core Elements of Hospital Antibiotic Stewardship Programs of the Centers for Disease Control and Prevention or the Antimicrobial Stewardship Standard set by the Joint Commission; and

“(II) apply to discharges occurring on or after October 1 of the year in which the drug or biological product is designated by the Secretary as a DISARM antimicrobial drug.

“(iv)

“(I) The mechanism established pursuant to clause (i) shall provide for a process for—

“(aa) a manufacturer or sponsor of a drug or biological product to request the Secretary to designate the drug or biological product as a DISARM antimicrobial drug; and

“(bb) the designation by the Secretary of drugs and biological products as DISARM antimicrobial drugs.

“(II) A designation of a drug or biological product as a DISARM antimicrobial drug may be revoked by the Secretary if the Secretary determines that—

“(aa) the drug or biological product no longer meets the requirements for a DISARM antimicrobial drug under clause (ii);

“(bb) the request for such designation contained an untrue statement of material fact; or

“(cc) clinical or other information that was not available to the Secretary at the time such designation was made shows that—

“(AA) such drug or biological product is unsafe for use or not shown to be safe for use for individuals who are entitled to benefits under part A; or

“(BB) an alternative to such drug or biological product is an advance that substantially improves the diagnosis or treatment of such individuals.

“(III) Not later than October 1, 2021, and annually thereafter through October 1, 2025, the Secretary shall publish in the Federal Register a list of the DISARM antimicrobial drugs designated under this subparagraph pursuant to the process established under clause (iv)(I)(bb).

“(v)

“(I) For purposes of determining additional payment amounts under clause (i), a manufacturer or sponsor of a drug or biological product that submits a request described in clause (iv)(I)(aa) shall submit to the Secretary information described in section 1927(b)(3)(A)(iii).

“(II) The penalties for failure to provide timely information under clause (i) of subparagraph (C) of section 1927(b)(3) and for providing false information under clause (ii) of such subparagraph shall apply to manufacturers and sponsors of a drug or biological product under this section with respect to information under subclause (I) in the same manner as such penalties apply to manufacturers under such clauses with respect to information under subparagraph (A) of such section.

“(vi) The mechanism established pursuant to clause (i) shall provide that—

“(I) except as provided in subclause (II), no additional payment shall be made under this subparagraph for discharges involving a DISARM antimicrobial drug if any additional payments have been made for discharges involving such drug as a new medical service or technology under subparagraph (K);

“(II) additional payments may be made under this subparagraph for discharges involving a DISARM antimicrobial drug if any additional payments have been made for discharges occurring prior to the date of enactment of this subparagraph involving such drug as a new medical service or technology under subparagraph (K); and

“(III) no additional payment shall be made under subparagraph (K) for discharges involving a DISARM antimicrobial drug as a new medical service or technology if any additional payments for discharges involving such drug have been made under this subparagraph.”

(2)

Conforming amendment— Section 1886(d)(5)(K)(ii)(III) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)(ii)(III)) is amended by striking “provide” and inserting “subject to subparagraph (M)(vi), provide”.

(b)

Study and reports on removing barriers to the development of DISARM antimicrobial drugs—

(1)

Study— The Comptroller General of the United States (in this subsection referred to as the “Comptroller General”) shall, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, and the Director of the Centers for Disease Control and Prevention, conduct a study to—

(A)

identify and examine the barriers that prevent the development of DISARM antimicrobial drugs (as defined in section 1886(d)(5)(M)(ii) of the Social Security Act, as added by subsection (a)); and

(B)

develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph (A).

(2)

Report— October 1, 2025, the Comptroller General shall submit to Congress a report containing the preliminary results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

4414. Novel medical products

(a)

Expedited coding of novel medical products— Section 1174(b)(2)(B) of the Social Security Act (42 U.S.C. 1320d–3(b)(2)(B)) is amended by adding at the end the following new clauses:

“(iii) Expedited coding of novel medical products

“(I) In general—Notwithstanding paragraph (1), in the case of a novel medical product (as defined in clause (iv)), the Secretary shall make modifications to the HCPCS code set at least once every quarter.

“(II) Request—Upon the written confidential request of a manufacturer of a novel medical product, the Secretary shall make a determination whether to assign a HCPCS code to such product. Such request may occur on or after the date on which the product receives a designation as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), a breakthrough device under section 515B of such Act (21 U.S.C. 360e–3), or a regenerative advanced therapy under section 506(g) of such Act (21 U.S.C. 356(g)).

“(III) Deadline for determination; notification—The Secretary shall—

“(aa) not later than 180 calendar days after receiving the request of a manufacturer under subclause (II), make a determination under such subclause with respect to the request; and

“(bb) not later than 30 calendar days after making such determination, notify the manufacturer of the determination.

“(IV) Monitoring utilization and outcomes—A HCPCS code assigned under this clause shall allow for the reliable monitoring of utilization and outcomes of the novel medical product as described in clause (vi).

“(V) Effective date of code assignment—If the Secretary makes a determination to assign a HCPCS code to a product under subclause (II), such code—

“(aa) may be assigned within the first quarter after the manufacturer files, with respect to such product, a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), a biological product license application under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), a premarket application under section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)), a report under section 510(k) of such Act (21 U.S.C. 360k), or a request for classification under section 513(f)(2) of such Act (21 U.S.C. 360c(f)(2)); and

“(bb) may not take effect before the date the product is approved, cleared, or licensed by the Food and Drug Administration.

“(VI) Trade secrets and confidential information—No information submitted under subclause (II) 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.

“(iv) Novel medical product defined—For purposes of this subparagraph, the term novel medical product means a drug, biological product, or medical device—

“(I) that has not been assigned a HCPCS code; and

“(II) that has been designated as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), a breakthrough device under section 515B of such Act (21 U.S.C. 360e–3), or a regenerative advanced therapy under section 506(g) of such Act (21 U.S.C. 356(g)).

“(v) HCPCS defined—For purposes of this subparagraph, the term HCPCS means the Healthcare Common Procedure Coding System.

“(vi) Inpatient products—The Secretary shall establish a code modifier within the hospital inpatient prospective payment system under section 1886(d) to track the utilization and outcomes of novel medical products that are assigned a HCPCS code pursuant to the expedited coding process under clause (iii) and are furnished by hospitals in inpatient settings.”

(b)

Coverage determinations for novel medical products— Section 1862(l) of the Social Security Act (42 U.S.C. 1395y(l)) is amended by adding at the end the following new paragraph:

“(7) Coverage pathway for novel medical products

“(A) In general—The Secretary shall facilitate an efficient coverage pathway to expedite a national coverage decision for coverage with evidence development process under this title for novel medical products described in subparagraph (D). The Secretary shall review such novel medical products for the coverage process on an expedited basis, beginning as soon as the Secretary assigns a HCPCS code to the product under clause (iii)(V)(aa) of section 1174(b)(2)(B).

“(B) Determination of coverage with evidence development—Such coverage pathway shall include, with respect to such novel medical products, if the Secretary determines coverage with evidence development is appropriate, issuance of a national coverage determination of coverage with evidence development for a period up to, but not to exceed, 4 years from the date of such determination.

“(C) Modernizing payment options for novel medical products—Not later than 4 years after issuing such national coverage determination, the Secretary shall submit to Congress and to the manufacturer of the novel medical product a report providing options for alternative payment models under this title for the novel medical product or class of such products, which may include the utilization of existing models in the commercial health insurance market. Such report shall include any recommendations for legislation and administrative action as the Secretary determines appropriate to facilitate such payment arrangements.

“(D) Novel medical products described—For purposes of this paragraph, a novel medical product described in this subparagraph is a novel medical product, as defined in clause (iv) of section 1174(b)(2)(B), that is assigned a HCPCS code pursuant to the expedited coding process under clause (iii) of such section.

“(E) Clarification—Nothing in this paragraph shall prevent the Secretary from issuing a noncoverage or a national coverage determination for a novel medical product.”

(c)

Enhancing coordination with the Food and Drug Administration—

(1)

Public Meeting—

(A)

In general— Not later than 12 months after the date of the enactment of this Act, the Secretary shall convene a public meeting for the purposes of discussing and providing input on improvements to coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services in preparing for the availability of novel medical products (as defined in section 1174(b)(2)(B)(iv) of the Social Security Act, as added by subsection (a)) on the market in the United States.

(B)

Attendees— The public meeting shall include—

(i)

representatives of relevant Federal agencies, including representatives from each of the medical product centers within the Food and Drug Administration and representatives from the coding, coverage, and payment offices within the Centers for Medicare & Medicaid Services;

(ii)

stakeholders with expertise in the research and development of novel medical products, including manufacturers of such products;

(iii)

representatives of commercial health insurance payers;

(iv)

stakeholders with expertise in the administration and use of novel medical products, including physicians; and

(v)

stakeholders representing patients and with expertise in the utilization of patient experience data in medical product development.

(C)

Topics— The public meeting shall include a discussion of—

(i)

the status of the drug and medical device development pipeline related to the availability of novel medical products;

(ii)

the anticipated expertise necessary to review the safety and effectiveness of such products at the Food and Drug Administration and current gaps in such expertise, if any;

(iii)

the expertise necessary to make coding, coverage, and payment decisions with respect to such products within the Centers for Medicare & Medicaid Services, and current gaps in such expertise, if any;

(iv)

trends in the differences in the data necessary to determine the safety and effectiveness of a novel medical product and the data necessary to determine whether a novel medical product meets the reasonable and necessary requirements for coverage and payment under title XVIII of the Social Security Act pursuant to section 1862(a)(1)(A) of such Act (42 U.S.C. 1395y(a)(1)(A));

(v)

the availability of information for sponsors of such novel medical products to meet each of those requirements; and

(vi)

the coordination of information related to significant clinical improvement over existing therapies for patients between the Food and Drug Administration and the Centers for Medicare & Medicaid Services with respect to novel medical products.

(D)

Trade secrets and confidential information— No information discussed as a part of the public meeting under this paragraph 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.

(2)

Improving transparency of criteria for Medicare coverage—

(A)

Updating guidance— Not later than 18 months after the public meeting under paragraph (1), the Secretary of Health and Human Services shall update the final guidance entitled “National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development” to improve the availability and coordination of information as described in clauses (iv) through (vi) of paragraph (1)(C), and clarify novel medical product clinical data requirements to meet reasonable and necessary requirements for coverage and payment under title XVIII of the Social Security Act.

(B)

Finalizing updated guidance— Not later than 12 months after issuing draft guidance under subparagraph (A), the Secretary shall finalize the updated guidance.

(d)

Report on coding, coverage, and payment processes under Medicare for new medical products—

(1)

In general— Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall publish a report on the internet website of the Department of Health and Human Services regarding processes under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to the coding, coverage, and payment of medical products described in paragraph (2). Such report shall include the following:

(A)

A description of challenges in the coding, coverage, and payment processes under the Medicare program for medical products described in such paragraph.

(B)

Recommendations to—

(i)

incorporate patient experience data (such as the impact of a disease or condition on the lives of patients and patient treatment preferences) into the coverage and payment processes within the Centers for Medicare & Medicaid Services;

(ii)

decrease the length of time to make national and local coverage determinations under the Medicare program (as those terms are defined in subparagraph (A) and (B), respectively, of section 1862(l)(6) of the Social Security Act (42 U.S.C. 1395y(l)(6)));

(iii)

streamline the coverage process under the Medicare program and incorporate input from relevant stakeholders into such coverage determinations; and

(iv)

identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and State plans under title XIX of the Social Security Act (42 U.S.C. 1396r et seq.) into the Medicare program.

(2)

Medical products described— For purposes of paragraph (1), a medical product described in this paragraph is a medical product, including a drug, biological (including gene and cell therapy and gene editing), or medical device, that has been designated as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), a breakthrough device under section 515B of such Act (21 U.S.C. 360e–3), or a regenerative advanced therapy under section 506(g) of such Act (21 U.S.C. 356(g)).

II Education provisions

4501. Short title

This title may be cited as the “COVID-19 Pandemic Education Relief Act of 2020”.

4502. Definitions

(a)

Definitions— In this title:

(1)

Qualifying emergency— The term qualifying emergency means—

(A)

a public health emergency declared by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d);

(B)

an event for which the President declared a major disaster or an emergency under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5170 and 5191); or

(C)

a national emergency declared by the President under section 201 of the National Emergencies Act (50 U.S.C. 1601 et seq.).

(2)

Institution of higher education— The term institution of higher education has the meaning of the term under section 102 of the Higher Education Act of 1965 (20 U.S.C. 1002).

(3)

Secretary— The term Secretary means the Secretary of Education.

4503. Campus-based aid waivers

(a)

Waiver of non-federal share requirement— Notwithstanding sections 413C(a)(2) and 443(b)(5) of the Higher Education Act of 1965 (20 U.S.C. 1070b–2(a)(2) and 1087–53(b)(5)), with respect to funds made available for award years 2019-2020 and 2020-2021, the Secretary shall waive the requirement that a participating institution of higher education provide a non-Federal share to match Federal funds provided to the institution for the programs authorized pursuant to subpart 3 of part A and part C of title IV of the Higher Education Act of 1965 (20 U.S.C. 1070b et seq. and 1087–51 et seq.).

(b)

Authority to reallocate— Notwithstanding sections 413D, 442, and 488 of the Higher Education Act of 1965 (20 U.S.C. 1070b–3, 1087–52, and 1095), during a period of a qualifying emergency, an institution may transfer up to 100 percent of the institution’s unexpended allotment under section 442 of such Act to the institution’s allotment under section 413D of such Act, but may not transfer any funds from the institution’s unexpended allotment under section 413D of such Act to the institution’s allotment under section 442 of such Act.

4504. Use of supplemental educational opportunity grants for emergency aid

(a)

In general— Notwithstanding section 413B of the Higher Education Act of 1965 (20 U.S.C. 1070b–1), an institution of higher education may reserve any amount of an institution’s allocation under subpart 3 of part A of title IV of the Higher Education Act of 1965 (20 U.S.C. 1070b et seq.) for a fiscal year to award, in such fiscal year, emergency financial aid grants to assist undergraduate or graduate students for unexpected expenses and unmet financial need as the result of a qualifying emergency.

(b)

Determinations— In determining eligibility for and awarding emergency financial aid grants under this section, an institution of higher education may—

(1)

waive the amount of need calculation under section 471 of the Higher Education Act of 1965 (20 U.S.C. 1087kk);

(2)

allow for a student affected by a qualifying emergency to receive funds in an amount that is not more than the maximum Federal Pell Grant for the applicable award year; and

(3)

utilize a contract with a scholarship-granting organization designated for the sole purpose of accepting applications from or disbursing funds to students enrolled in the institution of higher education, if such scholarship-granting organization disburses the full allocated amount provided to the institution of higher education to the recipients.

(c)

Special rule— Any emergency financial aid grants to students under this section shall not be treated as other financial assistance for the purposes of section 471 of the Higher Education Act of 1965 (20 U.S.C. 1087kk).

4505. Federal work-study during a qualifying emergency

(a)

In general— In the event of a qualifying emergency, an institution of higher education participating in the program under part C of title IV of the Higher Education Act of 1965 (20 U.S.C. 1087–51 et seq.) may make payments under such part to affected work-study students, for the period of time (not to exceed one academic year) in which affected students were unable to fulfill the students' work-study obligation for all or part of such academic year due to such qualifying emergency, as follows:

(1)

Payments may be made under such part to affected work-study students in an amount equal to or less than the amount of wages such students would have been paid under such part had the students been able to complete the work obligation necessary to receive work study funds, as a one time grant or as multiple payments.

(2)

Payments shall not be made to any student who was not eligible for work study or was not completing the work obligation necessary to receive work study funds under such part prior to the occurrence of the qualifying emergency.

(3)

Any payments made to affected work-study students under this subsection shall meet the matching requirements of section 443 of the Higher Education Act of 1965 (20 U.S.C. 1087–53), unless such matching requirements are waived by the Secretary of Education.

(b)

Definition of affected work-study student— In this section, the term affected work-study student means a student enrolled at an eligible institution participating in the program under part C of title IV of the Higher Education Act of 1965 (20 U.S.C. 1087–51 et seq.) who—

(1)

received a work-study award under section 443 of the Higher Education Act of 1965 (20 U.S.C. 1087–53) for the academic year during which a qualifying emergency occurred;

(2)

earned Federal work-study wages from such eligible institution for such academic year; and

(3)

was prevented from fulfilling the student’s work-study obligation for all or part of such academic year due to such qualifying emergency.

4506. Adjustment of subsidized loan usage limits

Notwithstanding section 455(q)(3) of the Higher Education Act of 1965 (20 U.S.C. 1087e(q)(3)), the Secretary shall exclude from a student’s period of enrollment for purposes of loans made under part D of title IV of the Higher Education Act of 1965 (20 U.S.C. 1087a et seq.) any semester (or the equivalent) during which the student was unable to remain enrolled in school as a result of a qualifying emergency, if the Secretary is able to administer such policy in a manner that limits complexity and the burden on the student.

4507. Exclusion from Federal Pell Grant duration limit

The Secretary shall exclude from a student’s Federal Pell Grant duration limit under section 401(c)(5) of the Higher Education Act of 1965 (2 U.S.C. 1070a(c)(5)) any semester (or the equivalent) that the student does not complete due to a qualifying emergency if the Secretary is able to administer such policy in a manner that limits complexity and the burden on the student.

4508. Institutional refunds and Federal student loan flexibility

(a)

Institutional waiver— The Secretary may waive the institutional requirement in section 484B of the Higher Education Act of 1965 (20 U.S.C. 1091b) with respect to the amount of grant or loan assistance (other than assistance received under part C of title IV of such Act) to be returned to the title IV programs if a recipient of assistance under title IV of the Higher Education Act of 1965 (20 U.S.C. 1070 et seq.) withdraws from the institution during the payment period or period of enrollment as a result of a qualifying emergency.

(b)

Student waiver— The Secretary may waive the amounts that students are required to return in section 484B of the Higher Education Act of 1965 (20 U.S.C. 1091b) with respect to Federal Pell Grants or other grant assistance if the withdrawals on which the returns are based on withdrawals by students who withdrew from the institution as a result of a qualifying emergency.

(c)

Canceling loan obligation— Notwithstanding any other provision of the Higher Education Act of 1965 (20 U.S.C. 1001 et seq.), the Secretary shall cancel the borrower's obligation to repay the portion of a loan made under part D of title IV of such Act for a recipient of assistance who withdraws from the institution during the payment period as a result of a qualifying emergency.

(d)

Approved leave of absence— Notwithstanding any other provision of law, for purposes of receiving assistance under title IV of the Higher Education Act of 1965 (20 U.S.C. 1070 et seq.), an institution of higher education may, as a result of a qualifying emergency, provide a student with an approved leave of absence that does not require the student to return at the same point in the academic program that the student began the leave of absence if the student returns within the same semester (or the equivalent).

4509. Satisfactory progress

Notwithstanding section 484 of the Higher Education Act of 1965 (20 U.S.C. 1091), in determining whether a student is maintaining satisfactory progress for purposes of title IV of the Higher Education Act of 1965 (20 U.S.C. 1070 et seq.), an institution of higher education may, as a result of a qualifying emergency, exclude from the quantitative component of the calculation any attempted credits that were not completed by such student without requiring an appeal by such student.

4510. Continuing education at affected foreign institutions

(a)

In general— Notwithstanding section 481(b) of the Higher Education Act of 1965 (20 U.S.C. 1088(b)), with respect to a foreign institution, in the case of a public health emergency, major disaster or emergency, or national emergency declared by the applicable government authorities in the country in which the foreign institution is located, the Secretary may permit any part of an otherwise eligible program to be offered via distance education for the duration of such emergency or disaster and the following payment period for purposes of title IV of the Higher Education Act of 1965 (20 U.S.C. 1070 et seq.).

(b)

Eligibility— An otherwise eligible program that is offered in whole or in part through distance education by a foreign institution between March 1, 2020, and the date of enactment of this Act shall be deemed eligible for the purposes of part D of title IV of the Higher Education Act of 1965 (20 U.S.C. 1087a et seq.) for the duration of the qualifying emergency and the following payment period for purposes of title IV of the Higher Education Act of 1965 (20 U.S.C. 1070 et seq.). Not later than June 30, 2020, an institution of higher that uses the authority provided in the previous sentence shall report such use to the Secretary.

(c)

Report— Not later than 180 days after the date of enactment of this Act, and every 180 days thereafter for the duration of the qualifying emergency and the following payment period, the Secretary shall submit to the authorizing committees (as defined in section 103 of the Higher Education Act of 1965 (20 U.S.C. 1003)) a report that identifies each foreign institution that carried out a distance education program authorized under this section.

(d)

Written arrangements—

(1)

In general— Notwithstanding section 102 of the Higher Education Act of 1965 (20 U.S.C. 1002), for the duration of a qualifying emergency and the following payment period, the Secretary may allow a foreign institution to enter into a written arrangement with an institution of higher education located in the United States that participates in the Federal Direct Loan Program under part D of title IV of the Higher Education Act of 1965 (20 U.S.C. 1087a et seq.) for the purpose of allowing a student of the foreign institution who is a borrower of a loan made under such part to take courses from the institution of higher education located in the United States.

(2)

Form of arrangements—

(A)

Public or other nonprofit institutions— A foreign institution that is a public or other nonprofit institution may enter into a written arrangement under subsection (a) only with an institution of higher education described in section 101 of such Act (20 U.S.C. 1001).

(B)

Other institutions— A foreign institution that is a graduate medical school, nursing school, or a veterinary school and that is not a public or other nonprofit institution may enter into a written arrangement under subsection (a) with an institution of higher education described in section 101 or section 102 of such Act (20 U.S.C. 1001 and 1002).

(3)

Report use— Not later than June 30, 2020, an institution of higher that uses the authority described in paragraph (2) shall report such use to the Secretary.

(4)

Report from the secretary— Not later than 180 days after the date of enactment of this Act, and every 180 days thereafter for the duration of the qualifying emergency and the following payment period, the Secretary shall submit to the authorizing committees (as defined in section 103 of the Higher Education Act of 1965 (20 U.S.C. 1003)) a report that identifies each foreign institution that entered into a written arrangement authorized under subsection (a).

4511. National emergency educational waivers

(a)

In general— Notwithstanding any other provision of law, the Secretary of Education may waive any statutory or regulatory provision described under subparagraphs (A) through (C) of subsection (b)(1) if the Secretary determines that such a waiver is necessary and appropriate due to the emergency involving Federal primary responsibility determined to exist by the President under the section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5191(b)) with respect to the Coronavirus Disease 2019 (COVID-19).

(b)

Applicable provisions of law—

(1)

In general— The Secretary of Education may waive any statutory or regulatory requirement (such as those requirements related to assessments, accountability, allocation of funds, and reporting), for which a waiver request is submitted under subsection (c), if the Secretary determines that such a waiver is necessary and appropriate as described in subsection (a), under the following provisions of law:

(A)

The Elementary and Secondary Education Act of 1965 (20 U.S.C. 6301 et seq.).

(B)

The Carl D. Perkins Career and Technical Education Act of 2006 (20 U.S.C. 2301 et seq.).

(C)

The Higher Education Act of 1965 (20 U.S.C. 1001 et seq.).

(2)

Limitation— The Secretary of Education shall not waive under this section any statutory or regulatory requirements relating to applicable civil rights laws.

(c)

Requests for waivers—

(1)

In general— In addition to any provision waived by the Secretary under subsection (a), a State, State educational agency, local educational agency, Indian tribe, or institution of higher education that desires a waiver from any statutory or regulatory provision described under subparagraphs (A) through (C) of subsection (b)(1) that the Secretary has not already waived in accordance with subsection (a), may submit a waiver request to the Secretary in accordance with this subsection.

(2)

Requests submitted— A request for a waiver under this subsection shall—

(A)

identify the Federal programs affected by the requested waiver;

(B)

describe which Federal statutory or regulatory requirements are to be waived; and

(C)

describe how the emergency involving Federal primary responsibility determined to exist by the President under the section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5191(b)) with respect to the Coronavirus Disease 2019 (COVID-19) prevents or otherwise restricts the ability of the State, State educational agency, local educational agency, Indian tribe, or institution of higher education to comply with such statutory or regulatory requirements.

(3)

Secretary approval—

(A)

In general— Except as provided under subparagraph (B), the Secretary of Education shall approve or disapprove a waiver request submitted under paragraph (1) not more than 15 days after the date on which such request is submitted.

(B)

Exceptions— The Secretary of Education may disapprove a waiver request submitted under paragraph (1), only if the Secretary determines that—

(i)

the waiver request does not meet the requirements of this section;

(ii)

the waiver is not permitted pursuant to subsection (b)(2); or

(iii)

the description required under paragraph (2)(C) provides insufficient information to demonstrate that the waiving of such requirements is necessary or appropriate consistent with subsection (a).

(4)

Duration—

(A)

In general— Except as provided in paragraph (B), a waiver approved by the Secretary of Education under this subsection may be for a period not to exceed 1 academic year.

(B)

Extension— The Secretary of Education may extend the period described under subparagraph (A) if the State, State educational agency, local educational agency, Indian tribe, or institution of higher education demonstrates to the Secretary that extending the waiving of such requirements is necessary and appropriate consistent with subsection (a).

(d)

Reporting and publication—

(1)

Notifying congress— Not later than 7 days after granting a waiver under this section, the Secretary of Education shall notify the Committee on Health, Education, Labor, and Pensions of the Senate, the Committee on Appropriations of the Senate, the Committee on Education and Labor of the House of Representatives, and the Committee on Appropriations of the House of Representatives of such waiver.

(2)

Publication— Not later than 30 days after granting a waiver under this section, the Secretary of Education shall publish a notice of the Secretary’s decision in the Federal Register and on the website of the Department of Education.

(3)

IDEA report— Not later than 30 days after the date of enactment of this Act, the Secretary of Education shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and the Committee on Education and Labor and the Committee on Appropriations of the House of Representatives, with recommendations on any additional waivers the Secretary believes are necessary to be enacted into law under the Individuals with Disabilities Education Act (20 U.S.C. 1401 et seq.) and the Rehabilitation Act of 1973 (29 U.S.C. 701 et seq.) to provide limited flexibility to States and local educational agencies to meet the unique needs of students with disabilities during the emergency involving Federal primary responsibility determined to exist by the President under the section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5191(b)) with respect to the Coronavirus Disease 2019 (COVID-19).

4512. HBCU Capital financing

(a)

Deferment period—

(1)

In general— Notwithstanding any provision of title III of the Higher Education Act of 1965 (20 U.S.C. 1051 et seq.), or any regulation promulgated under such title, the Secretary may grant a deferment, for a period of a qualifying emergency to an institution that has received a loan under part D of title III of such Act (20 U.S.C. 1066 et seq.).

(2)

Terms— During the deferment period granted under this subsection—

(A)

the institution shall not be required to pay any periodic installment of principal required under the loan agreement for such loan; and

(B)

the Secretary shall make principal payments otherwise due under the loan agreement.

(3)

Closing— At the closing of a loan deferred under this subsection, terms shall be set under which the institution shall be required to repay the Secretary for the payments of principal made by the Secretary during the deferment, on a schedule that begins upon repayment to the lender in full on the loan agreement.

(b)

Termination date—

(1)

In general— Except as provided in paragraph (2), the authority provided under this section to grant a loan deferment under subsection (a), shall terminate on the date that is the end of the qualifying emergency.

(2)

Duration— Any provision of a loan agreement or insurance agreement modified or waived by the authority under this section shall remain so modified or waived for the duration of the period covered by the loan agreement or insurance agreement.

(c)

Report— Not later than 180 days after the date of enactment of this Act, and every 180 days thereafter during the period beginning on the first day of the qualifying emergency and ending on September 30 of the fiscal year following the end of the qualifying emergency, the Secretary shall submit to the authorizing committees (as defined in section 103 of the Higher Education Act of 1965 (20 U.S.C. 1003)) a report that identifies each institution that received assistance or a waiver under this section.

4513. Temporary relief for federal student loan borrowers

(a)

In general— The Secretary shall suspend all payments due for loans made under part D of title IV of the Higher Education Act of 1965 (20 U.S.C. 1087a et seq.) for 3 months.

(b)

No accrual of interest— Notwithstanding any other provision of the Higher Education Act of 1965 (20 U.S.C. 1001 et seq.), interest shall not accrue on a loan described under subsection (a) for which payment was suspended for the period of the suspension.

(c)

Consideration of payments— The Secretary shall deem each month for which a loan payment was suspended under this section as if the borrower of the loan had made a payment for the purpose of any loan forgiveness program authorized under part D of title IV of the Higher Education Act of 1965 (20 U.S.C. 1087a et seq.) for which the borrower would have otherwise qualified.

(d)

Extension— The Secretary may extend the period of suspension described under subsection (a) for an additional 3 months.

4514. Provisions related to the Corporation for National and Community Service

(a)

Accrual of service hours—

(1)

Accrual through other service hours—

(A)

In general— Notwithstanding any other provision of the Domestic Volunteer Service Act of 1973 (42 U.S.C. 4950 et seq.) or the National and Community Service Act of 1990 (42 U.S.C. 12501 et seq.), the Corporation for National and Community Service shall allow an individual described in subparagraph (B) to accrue other service hours that will count toward the number of hours needed for the individual's education award.

(B)

Affected individuals— Subparagraph (A) shall apply to any individual serving in a position eligible for an educational award under subtitle D of title I of the National and Community Service Act of 1990 (42 U.S.C. 12601 et seq.)—

(i)

who is performing limited service due to COVID-19; or

(ii)

whose position has been suspended or placed on hold due to COVID-19.

(2)

Provisions in case of early exit— In any case where an individual serving in a position eligible for an educational award under subtitle D of title I of the National and Community Service Act of 1990 (42 U.S.C. 12601 et seq.) was required to exit the position early at the direction of the Corporation for National and Community Service, the Chief Executive Officer of the Corporation for National and Community Service may—

(A)

deem such individual as having met the requirements of the position; and

(B)

award the individual the full value of the educational award under such subtitle for which the individual would otherwise have been eligible.

(b)

Availability of funds— Notwithstanding any other provision of law, all funds made available to the Corporation for National and Community Service under any Act, including the amounts appropriated to the Corporation under the headings “Operating Expenses”, “Salaries and Expenses”, and “Office of the Inspector General” under the heading “Corporation for National and Community Service” under title IV of Division A of the Further Consolidated Appropriations Act, 2020 (Public Law 116–94), shall remain available for the fiscal year ending September 30, 2021.

(c)

No required return of grant funds— Notwithstanding section 129(l)(3)(A)(i) of the National and Community Service Act of 1990 (42 U.S.C. 12581(l)(3)(A)(i)), the Chief Executive Officer of the Corporation for National and Community Service may permit fixed-amount grant recipients under such section 129(l) to maintain a pro rata amount of grant funds, at the discretion of the Corporation for National and Community Service, for participants who exited or are serving in a limited capacity due to COVID-19, to enable the grant recipients to maintain operations and to accept participants.

(d)

Extension of terms and age limits— Notwithstanding any other provision of law, the Corporation for National and Community Service may extend the term of service (for a period not to exceed the 1-year period immediately following the end of the national emergency) or waive any upper age limit (except in no case shall the maximum age exceed 26 years of age) for national service programs carried out by the National Civilian Community Corps under subtitle E of title I of the National and Community Service Act of 1990 (42 U.S.C. 12611 et seq.), and the participants in such programs, for the purposes of—

(1)

addressing disruptions due to COVID-19; and

(2)

minimizing the difficulty in returning to full operation due to COVID-19 on such programs and participants.

4515. Workforce response activities

(a)

Administrative costs— Of the total amount allocated to a local area under section 128(b) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3163(b)) and section 133(b) of such Act (29 U.S.C. 3173(b)) and available for administrative costs for program year 2019, not more than 20 percent of the total amount may be used by the local board involved for the administrative costs of carrying out local workforce investment activities under chapter 2 or chapter 3 of subtitle B of title I of such Act (29 U.S.C. 3151 et seq.), if the portion of the total amount that exceeds 10 percent of the total amount as described under section 128(b)(4)(A) of such Act is used to respond to the COVID-19 national emergency.

(b)

Rapid response activities—

(1)

Statewide rapid response— Of the funds available for program year 2019 for statewide activities under section 128(a) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3163(a)), such funds may be used for statewide rapid response activities as described in section 134(a)(2)(A) (29 U.S.C. 3174(a)(2)(A)) for responding to the COVID-19 national emergency.

(2)

Local boards— Of the funds available to a Governor under section 133(a)(2) of such Act (29 U.S.C. 3173(a)(2)) such funds may be released within 30 days to local boards most impacted by the coronavirus at the determination of the Governor for rapid response activities related to responding to the COVID-19 national emergency.

(c)

Definitions— In this section:

(1)

Coronavirus— The term coronavirus means coronavirus as defined in section 506 of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Public Law 116–123).

(2)

COVID-19 national emergency— The term COVID-19 national emergency means the national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et seq.) on March 13, 2020, with respect to the coronavirus.

(3)

WIOA terms— 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).

4516. Technical amendments

(a)

In general—

(1)

Section 6103(a)(3) of the Internal Revenue Code of 1986, as amended by the FUTURE Act (Public Law 116–91), is further amended by striking “(13), (16)” and inserting “(13)(A), (13)(B), (13)(C), (13)(D)(i), (16)”.

(2)

Section 6103(p)(3)(A) of such Code, as so amended, is further amended by striking “(12),” and inserting “(12), (13)(A), (13)(B), (13)(C), (13)(D)(i)”.

(3)

Section 6103(p)(4) of such Code, as so amended, is further amended by striking “(13) or (16)” each place it appears and inserting “(13), or (16)”.

(4)

Section 6103(p)(4) of such Code, as so amended and as amended by paragraph (3), is further amended by striking “(13)” each place it appears and inserting “(13)(A), (13)(B), (13)(C), (13)(D)(i)”.

(5)

Section 6103(l)(13)(C)(ii) of such Code, as added by the FUTURE Act (Public Law 116–91), is amended by striking “section 236A(e)(4)” and inserting “section 263A(e)(4)”.

(b)

Effective date— The amendments made by this section shall apply as if included in the enactment of the FUTURE Act (Public Law 116–91).

III Labor provisions

4601. Limitation on paid leave

Section 110(b)(2)(B) of the Family and Medical Leave Act of 1993 (as added by the Emergency Family and Medical Leave Expansion Act) is amended by striking clause (ii) and inserting the following:

“(ii) Limitation—An employer shall not be required to pay more than $200 per day and $10,000 in the aggregate for each employee for paid leave under this section.”

4602. Emergency Paid Sick Leave Act Limitation

Section 5102 of the Emergency Paid Sick Leave Act (division E of the Families First Coronavirus Response Act) is amended by adding at the end the following:

“(f) Limitations

“(1) In General—An employer shall not be required to pay more than either—

“(A) $511 per day and $5,110 in the aggregate for each employee, when the employee is taking leave for a reason described in paragraph (1), (2), or (3) of section 5102(a); or

“(B) $200 per day and $2,000 in the aggregate for each employee, when the employee is taking leave for a reason described in paragraph (4), (5), or (6) of section 5102(a).

“(2) Expiration of requirement—An employer's requirement to provide paid leave with respect to a specific employee shall expire at the earlier of—

“(A) the time when the employer has paid that employee for paid leave under this section for an equivalent of 80 hours of work; or

“(B) upon the employee's return to work after taking paid leave under this section.”

4603. Regulatory Authorities under the Emergency Paid Sick Leave Act

Section 5111(2) of the Emergency Paid Sick Leave Act (division E of the Families First Coronavirus Response Act) is amended by striking “section 5102(a)(5)” and inserting “paragraphs (4) and (5) of section 5102(a)(5)”.

4604. Unemployment insurance

Section 903(h)(2)(B) of the Social Security Act (42 U.S.C. 1103(h)(2)(B)), as added by section 4102 of the Emergency Unemployment Insurance Stabilization and Access Act of 2020, is amended to read as follows:

“(B) The State ensures that applications for unemployment compensation, and assistance with the application process, are accessible in person, by phone, or online.”

4605. OMB Waiver of Paid Family and Paid Sick Leave

(a)

Family and Medical Leave Act of 1993— Section 110(a) of title I of the Family and Medical Leave Act of 1993 (29 U.S.C. 2611 et seq.) (as added by division C of the Families First Coronavirus Response Act) is amended by adding at the end the following new paragraph:

“(4) The Director of the Office of Management and Budget shall have the authority to exclude for good cause from the requirements under subsection (b) certain employers of the United States Government with respect to certain categories of Executive Branch employees.”

(b)

Emergency Paid Sick Leave Act— The Emergency Paid Sick Leave Act (division E of the Families First Coronavirus Response Act) is amended by adding at the end the following new section:

“5112. Authority to exclude certain employees

“The Director of the Office of Management and Budget shall have the authority to exclude for good cause from the definition of employee under section 5110(1) certain employees described in subparagraphs (E) and (F) of such section, including by exempting certain United States Government employers covered by section 5110(2)(A)(i)(V) from the requirements of this title with respect to certain categories of Executive Branch employees.”

4606. Paid leave for rehired employees

Section 110(a)(1)(A) of the Family and Medical Leave Act of 1993, as added by section 3102 of the Emergency Family and Medical Leave Expansion Act, is amended to read as follows:

“(A) Eligible employee

“(i) In general—In lieu of the definition in sections 101(2)(A) and 101(2)(B)(ii), the term eligible employee means an employee who has been employed for at least 30 calendar days by the employer with respect to whom leave is requested under section 102(a)(1)(F).

“(ii) Rule regarding rehired employees—For purposes of clause (i), the term employed for at least 30 calendar days, used with respect to an employee and an employer described in clause (i), includes an employee who was laid off by that employer not earlier than March 1, 2020, had worked for the employer for not less than 30 of the last 60 calendar days prior to the employee's layoff, and was rehired by the employer.”

4607. Advance refunding of credits

(a)

Payroll credit for required paid sick leave— Section 7001 of division G of the Families First Coronavirus Response Act is amended by inserting after subsection (g) the following new subsection:

“(h) Treatment of deposits—The Secretary of the Treasury (or the Secretary's delegate) shall waive any penalty under section 6656 of the Internal Revenue Code of 1986 for any failure to make a deposit of the tax imposed by section 3111(a) or 3221(a) of such Code if the Secretary determines that such failure was due to the anticipation of the credit allowed under this section.”

(b)

Credit for sick leave for certain self-employed individuals— Section 7002 of division G of the Families First Coronavirus Response Act is amended by inserting after subsection (g) the following new subsection:

“(h) Advancing credit—The Secretary of the Treasury (or the Secretary's delegate) shall issue such forms and instructions as are necessary—

“(1) to allow the advance payment of the credit under subsection (a), subject to the limitations provided in this section, based on such information as the Secretary shall require, and

“(2) to provide for the reconciliation of such advance payment with the amount advanced at the time of filing the return of tax for the taxable year.”

(c)

Payroll credit for required paid family leave— Section 7003 of division G of the Families First Coronavirus Response Act is amended by inserting after subsection (g) the following new subsection:

(d)

Credit for family leave for certain self-employed individuals— Section 7004 of division G of the Families First Coronavirus Response Act is amended by inserting after subsection (e) the following new subsection:

“(f) Advancing credit—The Secretary of the Treasury (or the Secretary's delegate) shall issue such forms and instructions as are necessary—

“(1) to allow the advance payment of the credit under subsection (a), subject to the limitations provided in this section, based on such information as the Secretary shall require, and

“(2) to provide for the reconciliation of such advance payment with the amount advanced at the time of filing the return of tax for the taxable year.”