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Title II — Patients and caregivers

H.R. 6000 · 117th Congress · Nov 17, 2021 · Lineage

II Patients and caregivers

Sec. 201 Educational programs and training for caregivers

Part D of title VII of the Public Health Service Act (42 U.S.C. 294 et seq.) is amended by adding at the end the following:

“760A. Educational programs and training for caregivers

“(a) In general—The Secretary may award grants for educational programs and training for caregivers to learn skills to empower them—

“(1) to be a member of a care team; and

“(2) to complement a clinical visit.

“(b) Types of programs and training—Educational programs and training funded under subsection (a) may include—

“(1) specialized training in medication adherence and injections;

“(2) complementary strategies to ensure adherence to physical, occupational, speech, and habilitative therapy regimens;

“(3) nutritional compliance;

“(4) caregiver psychosocial support (including cognitive-behavioral, supportive, and bereavement counseling);

“(5) caregiver health self-management; and

“(6) other services provided in the home.

“(c) Non-Duplication—The Secretary may not use the same requirements under this section for a grant, contract, or cooperative agreement under the Geriatric Workforce Enhancement Program under section 753 of the Public Health Service Act (42 U.S.C. 294c).

“(d) Caregiver defined—In this section, the term caregiver means an adult family member or other individual who has a significant relationship with, and who provides a broad range of assistance to, an individual with a chronic or other health condition, disability, or functional limitation.

“(e) Authorization of appropriations—To carry out this section, there is authorized to be appropriated $25,000,000 for each of fiscal years 2022 through 2024.”

Sec. 202 Increasing health literacy to promote better outcomes for patients

(a)
In general— Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a request for information to solicit recommendations on ways the Centers for Medicare & Medicaid Services can work with stakeholders of the Federal health care programs (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))) to promote increased patient and family caregiver health literacy, including recommendations for—
(1)
identifying culturally competent, evidence-based interventions that have been proven to improve health literacy in populations served by such programs;
(2)
identifying evidence-based health literacy approaches that can be used by the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), a State plan (or waiver of such plan) under title XIX of such Act (42 U.S.C. 1396 et seq.), a State child health plan (or waiver of such plan) under title XXI of such Act (42 U.S.C. 1397aa et seq.), or health care providers participating in such program under such title XVIII, under a State plan (or waiver of such plan) under such title XIX, or under a State child health plan (or waiver of such plan) under such title XXI, and that—
(A)
have been proven to, or show promise to, reduce costs to individuals enrolled under a State plan (or waiver of such plan) under such title XIX, or under a State child health plan (or waiver of such plan) under such title XXI, respectively, and reduce expenditures under such respective titles; or
(B)
have been proven to increase patient and family caregiver satisfaction or improve the quality of care for at-risk populations, including holistic and non-medication-based forms of care;
(3)
how the Centers for Medicare & Medicaid Services can encourage the use of evidence-based health literacy interventions through payment policies under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), a State plan under title XIX of such Act (42 U.S.C. 1396 et seq.), a State child health plan under title XXI of such Act (42 U.S.C. 1397 et seq.); and
(4)
improving patient and family caregiver health literacy with respect to health insurance, including an understanding of in-network providers, deductibles, co-insurance, co-payments, and differences between payors.

Sec. 203 Increasing diversity in clinical trials

(a)
Updated reporting on inclusion of demographic subgroups— The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—
(1)
not later than 90 days after the date of the enactment of this Act, submit to the Food and Drug Administration, and provide to the Congress, an updated version of the report under section 907(a) of the Food and Drug Administration Safety and Innovation Act (Public Law 115–52); and
(2)
not later than 1 year after the publication of the updated report pursuant to paragraph (1), publish on the website of the Food and Drug Administration, and provide to the Congress, an updated version of the action plan under section 907(b) of such Act.
(b)
GAO study on barriers to participation— Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall—
(1)
complete a study—
(A)
to review how the Department of Health and Human Services addresses barriers to participation by individuals from underrepresented populations in conducting or supporting clinical trials; and
(B)
to formulate recommendations for addressing such barriers; and
(2)
submit a report to the Congress on the results of such study.
(c)
Public awareness campaign— The Secretary of Health and Human Services shall—
(1)
carry out a public awareness campaign to increase awareness and understanding, particularly in minority communities, of—
(A)
upcoming and ongoing clinical trials;
(B)
how to enroll as subjects in such clinical trials; and
(C)
the availability of databases and other resources relevant to clinical trial enrollment, such as ClinicalTrials.gov; and
(2)
in carrying out such campaign, utilize a variety of communication channels, including through use of the explanation of Medicare benefits under section 1806 of the Social Security Act (42 U.S.C. 1395b–7).
(d)
Task force for making ClinicalTrials.gov more user-Friendly—
(1)
In general— The Secretary of Health and Human Services shall convene a permanent task force to propose, on a biennial basis, recommendations for improving ClinicalTrials.gov by making it more user-friendly, including for patients.
(2)
Membership— The membership of the task force shall include representatives of—
(A)
the National Institutes of Health;
(B)
the Food and Drug Administration;
(C)
academic researchers; and
(D)
patient organizations.
(e)
Definition— In this section, the term ClinicalTrials.gov refers to the data bank described in section 402(i) of the Public Health Service Act (42 U.S.C. 282(i)).

Sec. 204 Patient experience data

(a)
Policy— Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amended—
(1)
by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and
(2)
by inserting after subsection (a) the following new subsection:

“(b) Collection, submission, and use of data

“(1) In general—The Secretary shall—

“(A) for any drug for which an exemption is granted for investigational use under section 505(i) of this Act or section 351(a) of the Public Health Service Act, require the sponsor of the drug to collect standardized patient experience data as part of the clinical trials conducted pursuant to such exemption;

“(B) require any application for the approval or licensing of such drug under section 505(b) of this Act or section 351(a) of the Public Health Service Act to include—

“(i) the standardized patient experience data so collected; and

“(ii) such related information as the Secretary may require; and

“(C) consider patient experience data and related information that is submitted pursuant to subparagraph (B) in deciding whether to approve or license, as applicable, the drug involved.

“(2) Applicability—Paragraph (1) applies only with respect to drugs for which a request for an exemption described in paragraph (1)(A) is submitted on or after the date of the enactment of the Cures 2.0 Act, or an application under section 505(b) of this Act or section 351(a) of the Public Health Service Act is filed, as applicable, on or after the day that is 2 years after the date of the enactment of the Cures 2.0 Act.”

(b)
Regulations— Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations to implement section 569C(b) of the Federal Food, Drug, and Cosmetic Act, as added by this section.

Sec. 205 Ensuring coverage for clinical trials under existing standard of care

(a)
Revision to definition of approved clinical trial in individual and group market—
(1)
In general— Subsection (d)(1) of the first section 2709 of the Public Health Service Act (42 U.S.C. 300gg–8) (relating to coverage for individuals participating in approved clinical trials) is amended by adding at the end the following new subparagraph:

“(D) The study or investigation is approved or funded (which may include funding through in-kind contributions) by the Patient Centered Outcomes Research Institute established under section 1181 of the Social Security Act.”

(2)
Effective date— The amendment made by this paragraph shall apply with respect to plan years beginning on or after January 1, 2022.
(b)
Medicare coverage of routine costs associated with certain clinical trials—
(1)
In general— Section 1862(m)(2) of the Social Security Act (42 U.S.C.1395y(m)(2)) is amended, in the matter preceding subparagraph (A), by inserting “(including a trial funded by the Patient Centered Outcomes Research Institute established under section 1181)” after “means a trial”.
(2)
Effective date— The amendment made by this paragraph shall apply with respect to items and services furnished on or after the date of the enactment of this Act.