H. R. 2617—1174 
Sec. 3109. Reauthorization of third-party review program. 
Subtitle B—Drugs and Biologics 
CHAPTER 1—RESEARCH, DEVELOPMENT, AND COMPETITION IMPROVEMENTS 
Sec. 3201. Prompt reports of marketing status by holders of approved applications 
for biological products. 
Sec. 3202. Improving the treatment of rare diseases and conditions. 
Sec. 3203. Emerging technology program. 
Sec. 3204. National Centers of Excellence in Advanced and Continuous Pharma-
ceutical Manufacturing. 
Sec. 3205. Public workshop on cell therapies. 
Sec. 3206. Clarifications to exclusivity provisions for first interchangeable bio-
similar biological products. 
Sec. 3207. GAO report on nonprofit pharmaceutical organizations. 
Sec. 3208. Rare disease endpoint advancement pilot program. 
Sec. 3209. Animal testing alternatives. 
Sec. 3210. Modernizing accelerated approval. 
Sec. 3211. Antifungal research and development. 
Sec. 3212. Advancing qualified infectious disease product innovation. 
Sec. 3213. Advanced manufacturing technologies designation program. 
CHAPTER 2—TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY IMPROVEMENTS 
Sec. 3221. Safer disposal of opioids. 
Sec. 3222. Therapeutic equivalence evaluations. 
Sec. 3223. Public docket on proposed changes to third-party vendors. 
Sec. 3224. Enhancing access to affordable medicines. 
Subtitle C—Medical Devices 
Sec. 3301. Dual submission for certain devices. 
Sec. 3302. Medical Devices Advisory Committee meetings. 
Sec. 3303. GAO report on third-party review. 
Sec. 3304. Certificates to foreign governments. 
Sec. 3305. Ensuring cybersecurity of medical devices. 
Sec. 3306. Bans of devices for one or more intended uses. 
Sec. 3307. Third party data transparency. 
Sec. 3308. Predetermined change control plans for devices. 
Sec. 3309. Small business fee waiver. 
Subtitle D—Infant Formula 
Sec. 3401. Protecting infants and improving formula supply. 
Subtitle E—Cosmetics 
Sec. 3501. Short title. 
Sec. 3502. Amendments to cosmetic requirements. 
Sec. 3503. Enforcement and conforming amendments. 
Sec. 3504. Records inspection. 
Sec. 3505. Talc-containing cosmetics. 
Sec. 3506. PFAS in cosmetics. 
Sec. 3507. Sense of the Congress on animal testing. 
Sec. 3508. Funding. 
Subtitle F—Cross-Cutting Provisions 
CHAPTER 1—CLINICAL TRIAL DIVERSITY AND MODERNIZATION 
Sec. 3601. Diversity action plans for clinical studies. 
Sec. 3602. Guidance on diversity action plans for clinical studies. 
Sec. 3603. Public workshops to enhance clinical study diversity. 
Sec. 3604. Annual summary report on progress to increase diversity in clinical 
studies. 
Sec. 3605. Public meeting on clinical study flexibilities initiated in response to 
COVID–19 pandemic. 
Sec. 3606. Decentralized clinical studies. 
Sec. 3607. Modernizing clinical trials. 
CHAPTER 2—INSPECTIONS 
Sec. 3611. Device inspections. 
Sec. 3612. Bioresearch monitoring inspections. 
Sec. 3613. Improving Food and Drug Administration inspections. 
Sec. 3614. GAO report on inspections of foreign establishments manufacturing 
drugs.
H. R. 2617—1175 
Sec. 3615. Unannounced foreign facility inspections pilot program. 
Sec. 3616. Enhancing coordination and transparency on inspections. 
Sec. 3617. Enhancing transparency of drug facility inspection timelines. 
CHAPTER 3—MISCELLANEOUS 
Sec. 3621. Regulation of certain products as drugs. 
Sec. 3622. Women’s Health Research Roadmap. 
Sec. 3623. Strategic workforce plan and report. 
Sec. 3624. Enhancing Food and Drug Administration hiring authority for scientific, 
technical, and professional personnel. 
Sec. 3625. Facilities management. 
Sec. 3626. User fee program transparency and accountability. 
Sec. 3627. Improving information technology systems of the Food and Drug Admin-
istration. 
Sec. 3628. Reporting on mailroom and Office of the Executive Secretariat of the 
Food and Drug Administration. 
Sec. 3629. Facilitating the use of real world evidence. 
Sec. 3630. Facilitating exchange of product information prior to approval. 
Sec. 3631. Streamlining blood donor input. 
TITLE IV—MEDICARE PROVISIONS 
Subtitle A—Medicare Extenders 
Sec. 4101. Extension of increased inpatient hospital payment adjustment for cer-
tain low-volume hospitals. 
Sec. 4102. Extension of the Medicare-Dependent Hospital program. 
Sec. 4103. Extension of add-on payments for ambulance services. 
Subtitle B—Other Expiring Medicare Provisions 
Sec. 4111. Extending incentive payments for participation in eligible alternative 
payment models. 
Sec. 4112. Extension of support for physicians and other professionals in adjusting 
to Medicare payment changes. 
Sec. 4113. Advancing telehealth Beyond COVID–19. 
Sec. 4114. Revised phase-in of Medicare clinical laboratory test payment changes. 
Subtitle C—Medicare Mental Health Provisions 
Sec. 4121. Coverage of marriage and family therapist services and mental health 
counselor services under part B of the Medicare program. 
Sec. 4122. Additional residency positions. 
Sec. 4123. Improving mobile crisis care in Medicare. 
Sec. 4124. Ensuring adequate coverage of outpatient mental health services under 
the Medicare program. 
Sec. 4125. Improvements to Medicare prospective payment system for psychiatric 
hospitals and psychiatric units. 
Sec. 4126. Exception for physician wellness programs. 
Sec. 4127. Consideration of safe harbor under the anti-kickback statute for certain 
contingency management interventions. 
Sec. 4128. Provider outreach and reporting on certain behavioral health integration 
services. 
Sec. 4129. Outreach and reporting on opioid use disorder treatment services fur-
nished by opioid treatment programs. 
Sec. 4130. GAO study and report comparing coverage of mental health and sub-
stance use disorder benefits and non-mental health and substance use 
disorder benefits. 
Subtitle D—Other Medicare Provisions 
Sec. 4131. Temporary inclusion of authorized oral antiviral drugs as covered part 
D drug. 
Sec. 4132. Restoration of CBO access to certain part D payment data. 
Sec. 4133. Medicare coverage of certain lymphedema compression treatment items. 
Sec. 4134. Permanent in-home benefit for IVIG services. 
Sec. 4135. Access to non-opioid treatments for pain relief. 
Sec. 4136. Technical amendments to Medicare separate payment for disposable 
negative pressure wound therapy devices. 
Sec. 4137. Extension of certain home health rural add-on payments. 
Sec. 4138. Remedying election revocations relating to administration of COVID–19 
vaccines. 
Sec. 4139. Payment rates for durable medical equipment under the Medicare Pro-
gram. 
Sec. 4140. Extending Acute Hospital Care at Home waivers and flexibilities.
H. R. 2617—1176 
Sec. 4141. Extension of pass-through status under the Medicare program for cer-
tain devices impacted by COVID–19. 
Sec. 4142. Increasing transparency for home health payments under the Medicare 
program. 
Sec. 4143. Waiver of cap on annual payments for nursing and allied health edu-
cation payments. 
Subtitle E—Health Care Tax Provisions 
Sec. 4151. Extension of safe harbor for absence of deductible for telehealth. 
Subtitle F—Offsets 
Sec. 4161. Reduction of Medicare Improvement Fund. 
Sec. 4162. Extension of adjustment to calculation of hospice cap amount under 
Medicare. 
Sec. 4163. Medicare direct spending reductions. 
TITLE V—MEDICAID AND CHIP PROVISIONS 
Subtitle A—Territories 
Sec. 5101. Medicaid adjustments for the territories. 
Subtitle B—Medicaid and CHIP Coverage 
Sec. 5111. Funding extension of the Children’s Health Insurance Program and re-
lated provisions. 
Sec. 5112. Continuous eligibility for children under Medicaid and CHIP. 
Sec. 5113. Modifications to postpartum coverage under Medicaid and CHIP. 
Sec. 5114. Extension of Money Follows the Person Rebalancing demonstration. 
Sec. 5115. Extension of Medicaid protections against spousal impoverishment for 
recipients of home and community-based services. 
Subtitle C—Medicaid and CHIP Mental Health 
Sec. 5121. Medicaid and CHIP requirements for health screenings, referrals, and 
case management services for eligible juveniles in public institutions. 
Sec. 5122. Removal of limitations on Federal financial participation for inmates 
who are eligible juveniles pending disposition of charges. 
Sec. 5123. Requiring accurate, updated, and searchable provider directories. 
Sec. 5124. Supporting access to a continuum of crisis response services under Med-
icaid and CHIP. 
Subtitle D—Transitioning From Medicaid FMAP Increase Requirements 
Sec. 5131. Transitioning from Medicaid FMAP increase requirements. 
Subtitle E—Medicaid Improvement Fund 
Sec. 5141. Medicaid improvement fund. 
TITLE VI—HUMAN SERVICES 
Sec. 6101. Jackie Walorski Maternal and Child Home Visiting Reauthorization Act 
of 2022. 
Sec. 6102. Extension of Temporary Assistance for Needy Families Program. 
Sec. 6103. 1-year extension of child and family services programs. 
TITLE I—RESTORING HOPE FOR 
MENTAL HEALTH AND WELL-BEING 
SEC. 1001. SHORT TITLE. 
This title may be cited as the ‘‘Restoring Hope for Mental 
Health and Well-Being Act of 2022’’.
H. R. 2617—1177 
Subtitle A—Mental Health and Crisis Care 
Needs 
CHAPTER 1—CRISIS CARE SERVICES AND 9–8–8 
IMPLEMENTATION 
SEC. 1101. BEHAVIORAL HEALTH CRISIS COORDINATING OFFICE. 
Part A of title V of the Public Health Service Act (42 U.S.C. 
290aa et seq.) is amended by inserting after section 501A (42 
U.S.C. 290aa–0) the following: 
‘‘SEC. 501B. BEHAVIORAL HEALTH CRISIS COORDINATING OFFICE. 
‘‘(a) IN GENERAL.—The Secretary shall establish, within the 
Substance Abuse and Mental Health Services Administration, an 
office to coordinate work relating to behavioral health crisis care 
across the operating divisions and agencies of the Department of 
Health and Human Services, including the Substance Abuse and 
Mental Health Services Administration, the Centers for Medicare 
& Medicaid Services, and the Health Resources and Services 
Administration, and external stakeholders. 
‘‘(b) DUTY.—The office established under subsection (a) shall— 
‘‘(1) convene Federal, State, Tribal, local, and private part-
ners; 
‘‘(2) launch and manage Federal workgroups charged with 
making recommendations regarding issues related to mental 
health and substance use disorder crises, including with respect 
to health care best practices, workforce development, health 
disparities, data collection, technology, program oversight, 
public awareness, and engagement; and 
‘‘(3) support technical assistance, data analysis, and evalua-
tion functions in order to assist States, localities, Territories, 
Indian Tribes, and Tribal organizations in developing crisis 
care systems and identifying best practices with the objective 
of expanding the capacity of, and access to, local crisis call 
centers, mobile crisis care, crisis stabilization, psychiatric emer-
gency services, and rapid post-crisis follow-up care provided 
by— 
‘‘(A) the National Suicide Prevention and Mental 
Health Crisis Hotline and Response System; 
‘‘(B) the Veterans Crisis Line; 
‘‘(C) community mental health centers (as defined in 
section 1861(ff)(3)(B) of the Social Security Act); 
‘‘(D) certified community behavioral health clinics, as 
described in section 223 of the Protecting Access to Medi-
care Act of 2014; and 
‘‘(E) other community mental health and substance 
use disorder providers. 
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized 
to be appropriated to carry out this section $5,000,000 for each 
of fiscal years 2023 through 2027.’’. 
SEC. 1102. CRISIS RESPONSE CONTINUUM OF CARE. 
(a) IN GENERAL.—The Secretary, acting through the Assistant 
Secretary for Mental Health and Substance Use, shall facilitate 
the identification and publication of best practices for a crisis 
response continuum of care related to mental health and substance