US Codex
Pub. L.
Notes

Division P — Health Provisions

117th Congress · Approved Mar 15, 2022 · 136 Stat. 49

DIVISION P Health Provisions

TITLE I Public Health

Subtitle A National Disaster Medical System

SEC. 101. Extension of Authority to Make Certain Appointments for National Disaster Medical System.

Section 2812(c)(4)(B) of the Public Health Service Act (42 U.S.C. 300hh–11(c)(4)(B)) is amended by striking “ March 11, 2022” and inserting “ September 30, 2023”.

Subtitle B Synthetic Nicotine

SEC. 111. Fda Authority Over Products Containing Nicotine.

(a)
Tobacco Product Defined.— Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)) is amended—
(1)
in subparagraph (1), by inserting “ , or containing nicotine from any source,” after “ from tobacco”; and
(2)
by adding at the end the following:

“(5) The term ‘tobacco product’ does not mean an article that is a food under paragraph (f), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.”

(b)
Applicability to Certain Products.— Section 901(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) is amended by adding at the end the following: “ This chapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco.”.
(c)
Effective Date.— The amendments made by subsections (a) and (b) shall take effect 30 days after the date of enactment of this Act.
(d)
Submission of Applications for Previously Marketed Products.—
(1)
Transition period for all products.— With respect to a tobacco product that contains nicotine from any source other than tobacco and that was being marketed in the United States within 30 days after the date of enactment of this Act, such product shall not be considered to be in violation of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j) (relating to applications for review of certain tobacco products) during the 60-day period following the date of enactment of this Act.
(2)
Submission of applications.—
(A)
In general.— As a condition for continuing to market a product described in paragraph (1) after the 60-day period specified in such paragraph, during the 30-day period beginning on the effective date specified in subsection (c), the manufacturer shall submit a new tobacco product application under section 910(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)) with respect to such product.
(B)
Transition period.— Except as provided in subparagraph (C), with respect to a tobacco product for which an application is submitted as described in subparagraph (A), the manufacturer of such product may continue to market such product during the 90-day period beginning on the effective date specified in subsection (c).
(C)
Exception.— If the Secretary of Health and Human Services previously denied an application under section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(c)(2)), refused to file an application under section 910(b) of such Act, or withdrew an order under section 910(d) of such Act for a previous version of a tobacco product that used nicotine made or derived from tobacco, such product is not eligible for continued marketing under subparagraph (B).
(3)
End of transition period.— Beginning on the date that is 90 days after the effective date specified in subsection (c), a tobacco product described in paragraph (1) (including such a tobacco product that is the subject of a pending application under section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j)) is in violation of such section 910 if such tobacco product does not have an order in effect under subsection (c)(1)(A)(i) of such section.
(e)
Applicability of Existing Requirements for Tobacco Products.— Effective 30 days after the date of enactment of this Act, with respect to any regulation promulgated or related guidance issued, in whole or part, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) before the date that is 30 days after such date of enactment, the term “tobacco product” shall have the meaning of, and shall be deemed amended to reflect the meaning of, such term as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)), as amended by subsection (a). Products that are tobacco products under such section 201(rr), as so amended, shall be subject to all requirements of regulations for tobacco products. The Secretary of Health and Human Services shall publish a notice in the Federal Register to update the Code of Federal Regulations to reflect such deemed amendment to existing regulations and guidance.
(f)
Technical Achievability.— Section 907(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g(b)(1)) is amended by inserting before the period at the end the following: “ , including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class containing nicotine not made or derived from tobacco and products containing nicotine made or derived from tobacco”.

SEC. 112. Reporting on Tobacco Regulation Activities.

(a)
In General.— For fiscal year 2022 and each subsequent fiscal year for which fees are collected under section 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s), the Secretary of Health and Human Services shall, not later than 180 days after the end of the fiscal year, prepare and submit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, an annual report that contains the information required under subsection (b).
(b)
Required Information.— Each report submitted under subsection (a) shall contain the following information for the previous fiscal year:
(1)
Total annual user fee collections.
(2)
Total amount of fees obligated.
(3)
The amount of unobligated carryover balance from fees collected.
(4)
The amount obligated by the Center for Tobacco Products for each of the following activities:
(A)
Compliance and enforcement.
(B)
Public education campaigns.
(C)
Scientific research and research infrastructure.
(D)
Communications.
(E)
Leadership, management oversight, and administrative services.
(F)
Related overhead activities.
(5)
The numbers of applications, categorized by class of tobacco product and review pathway under sections 905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e; 387j; 387k), that were—
(A)
submitted;
(B)
pending;
(C)
accepted;
(D)
refused to file;
(E)
withdrawn;
(F)
denied;
(G)
authorized for marketing under an order;
(H)
issued a deficiency letter or environmental information request letter; or
(I)
referred to the Tobacco Products Scientific Advisory Committee.
(6)
The number and titles of draft and final guidance documents and proposed and final regulations issued on topics related to the process for the review of tobacco product applications, whether such regulations and guidance documents were issued as required by statute or by other legal or regulatory requirements, and whether the issuance met the deadlines set forth by the applicable statute or other requirements.
(7)
The number and titles of public meetings related to the review of tobacco product applications by the Center for Tobacco Products or other offices or centers within the Food and Drug Administration.
(8)
The number of pre-submission meetings relating to applications under section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j), including the number of meeting requests received, the number of meetings held, and the median amount of time between when such meeting requests were made and when the requests were granted or denied.
(9)
The number of full-time equivalent employees funded pursuant to fees collected under section 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s), including identification of the centers and offices within the Food and Drug Administration in which such positions are located.
(10)
The number of inspections and investigations conducted at domestic and foreign establishments required to register under section 905 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e).
(11)
The total number of compliance and enforcement actions issued or taken with respect to tobacco products, including warning letters, civil money penalties, no-tobacco-sale orders, and other enforcement actions (including seizures, injunctions, and criminal prosecution).
(c)
Public Availability.— The Secretary of Health and Human Services shall make the reports required under this section available to the public on the website of the Food and Drug Administration.
(d)
Limitations.— Reporting under this section shall include best estimates for any reporting category for which the Food and Drug Administration does not have precise calculations. Such best estimates shall be accompanied with an explanatory statement for why the Food and Drug Administration does not have access to, or cannot calculate, the exact figure and a date by which the Food and Drug Administration will update its internal accounting procedures to allow for such reporting. If a category is successfully reported by the Food and Drug Administration with regard to another type of user fee but is provided a best estimate by the Center for Tobacco Products, the explanatory statement shall include information regarding how the Food and Drug Administration will align systems and apply learning across the agency to allow for accurate reporting.

Subtitle C Drug Discount Program

SEC. 121. Eligibility Exception for the Drug Discount Program Due to the Covid–19 Public Health Emergency.

(a)
In General.— Notwithstanding any other provision of law, in the case of a hospital described in subsection (b) that, with respect to cost reporting periods that begin during fiscal year 2020 or a subsequent fiscal year, but do not end after December 31, 2022, does not meet the applicable requirement for the disproportionate share adjustment percentage described in subsection (c) by reason of the COVID–19 public health emergency, but otherwise meets the requirements for being a covered entity under subparagraph (L), (M), or (O) of subsection (a)(4) of section 340B of the Public Health Service Act (42 U.S.C. 256b) and is in compliance with all other requirements of the program under such section, shall be deemed a covered entity for purposes of such section for the period—
(1)
beginning on the date of the enactment of this Act (or, if later, with the first of such cost reporting periods for which the hospital does not so meet such applicable requirement for the disproportionate share adjustment percentage, but otherwise meets all other such requirements for being such a covered entity and of such program); and
(2)
ending with the last of such cost reporting periods (ending not later than December 31, 2022) for which the hospital does not so meet such applicable requirement for the disproportionate share adjustment percentage, but otherwise meets all other such requirements for being such a covered entity and of such program.
(b)
Hospitals.— A hospital described in this subsection is an entity that, on the day before the first day of the COVID–19 public health emergency, was a covered entity described in subparagraph (L), (M), or (O) of subsection (a)(4) of section 340B of the Public Health Service Act participating in the drug discount program under such section.
(c)
Applicable Requirement for Disproportionate Share Adjustment Percentage.— The applicable requirement for the disproportionate share adjustment percentage described in this subsection is—
(1)
in the case of a hospital described in subsection (a) that otherwise meets the requirements under subparagraph (L) or (M) of section 340B(a)(4) of the Public Health Service Act, the requirement under subparagraph (L)(ii) of such section; and
(2)
in the case of a hospital described in subsection (a) that otherwise meets the requirements under subparagraph (O) of such section 340B(a)(4), the requirement with respect to the disproportionate share adjustment percentage described in such subparagraph (O).
(d)
Self-attestation.—
(1)
In general.— A hospital described in subsection (a) that fails to meet the applicable requirement for the disproportionate share adjustment percentage described in subsection (c) shall, within 30 days of such failure, or in the case of a hospital where such failure occurred prior to the date of enactment of this Act but after the start of the COVID-19 public health emergency, within 30 days of the date of enactment, provide to the Secretary of Health and Human Services an attestation that contains information on any actions taken by or other impact on such hospital in response to or as a result of the COVID-19 public health emergency that may have impacted the ability to meet the applicable requirement for the disproportionate share adjustment percentage described in subsection (c).
(2)
Paperwork reduction act.— Chapter 35 of title 44, United States Code, shall not apply to the collection of information provided pursuant to this subsection.
(e)
Definitions.— In this section:
(1)
Covered entity.— The term “covered entity” has the meaning given such term in section 340B(a)(4) of the Public Health Service Act (42 U.S.C. 256b(a)(4)).
(2)
Covid–19 public health emergency.— The term “COVID–19 public health emergency” means 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) on January 31, 2020, with respect to COVID–19 (or any renewal of such declaration).

Subtitle D Maternal Health Quality Improvement

CHAPTER 1 Improvements to Maternal Health Care

SEC. 131. Innovation for Maternal Health.

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 330N of such Act, the following:

“SEC. 330O. INNOVATION FOR MATERNAL HEALTH.

“(a) In General.—The Secretary, in consultation with experts representing a variety of clinical specialties, State, Tribal, or local public health officials, researchers, epidemiologists, statisticians, and community organizations, shall establish or continue a program to award competitive grants to eligible entities for the purpose of—

“(1) identifying, developing, or disseminating best practices to improve maternal health care quality and outcomes, improve maternal and infant health, and eliminate preventable maternal mortality and severe maternal morbidity, which may include—

“(A) information on evidence-based practices to improve the quality and safety of maternal health care in hospitals and other health care settings of a State or health care system by addressing topics commonly associated with health complications or risks related to prenatal care, labor care, birthing, and postpartum care;

“(B) best practices for improving maternal health care based on data findings and reviews conducted by a State maternal mortality review committee that address topics of relevance to common complications or health risks related to prenatal care, labor care, birthing, and postpartum care; and

“(C) information on addressing determinants of health that impact maternal health outcomes for women before, during, and after pregnancy;

“(2) collaborating with State maternal mortality review committees to identify issues for the development and implementation of evidence-based practices to improve maternal health outcomes and reduce preventable maternal mortality and severe maternal morbidity, consistent with section 317K;

“(3) providing technical assistance and supporting the implementation of best practices identified in paragraph (1) to entities providing health care services to pregnant and postpartum women; and

“(4) identifying, developing, and evaluating new models of care that improve maternal and infant health outcomes, which may include the integration of community-based services and clinical care.

“(b) Eligible Entities.—To be eligible for a grant under subsection (a), an entity shall—

“(1) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and

“(2) demonstrate in such application that the entity is capable of carrying out data-driven maternal safety and quality improvement initiatives in the areas of obstetrics and gynecology or maternal health.

“(c) Report.—Not later than September 30, 2025, and every 2 years thereafter, the Secretary shall submit a report to Congress on the practices described in paragraphs (1) and (2) of subsection (a). Such report shall include a description of the extent to which such practices reduced preventable maternal mortality and severe maternal morbidity, and whether such practices improved maternal and infant health. The Secretary shall disseminate information on such practices, as appropriate.

“(d) Authorization of Appropriations.—To carry out this section, there are authorized to be appropriated $9,000,000 for each of fiscal years 2023 through 2027.”

SEC. 132. Training for Health Care Providers.

Title VII of the Public Health Service Act is amended by striking section 763 (42 U.S.C. 294p) and inserting the following:

“SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS.

“(a) Grant Program.—The Secretary shall establish a program to award grants to accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other health professional training programs for the training of health care professionals to improve the provision of prenatal care, labor care, birthing, and postpartum care for racial and ethnic minority populations, including with respect to perceptions and biases that may affect the approach to, and provision of, care.

“(b) Eligibility.—To be eligible for a grant under subsection (a), an entity described in such subsection shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.

“(c) Reporting Requirements.—

“(1) Periodic grantee reports.—Each entity awarded a grant under this section shall periodically submit to the Secretary a report on the status of activities conducted using the grant, including a description of the impact of such training on patient outcomes, as applicable.

“(2) Report to congress.—Not later than September 30, 2026, the Secretary shall submit a report to Congress on the activities conducted using grants under subsection (a) and any best practices identified and disseminated under subsection (d).

“(d) Best Practices.—The Secretary may identify and disseminate best practices for the training described in subsection (a).

“(e) Authorization of Appropriations.—To carry out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2023 through 2027.”

SEC. 133. Study on Improving Training for Health Care Providers.

Not later than 2 years after date of enactment of this Act, the Secretary of Health and Human Services shall, through a contract with an independent research organization, conduct a study and make recommendations for accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other health professional training programs on best practices related to training to improve the provision of prenatal care, labor care, birthing, and postpartum care for racial and ethnic minority populations, including with respect to perceptions and biases that may affect the approach to, and provision of, care.

SEC. 134. Integrated Services for Pregnant and Postpartum Women.

(a)
Grants.— Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 330O of such Act, as added by section 131, the following:

“SEC. 330P. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM WOMEN.

“(a) In General.—The Secretary may award grants for the purpose of establishing or operating evidence-based or innovative, evidence-informed programs to deliver integrated health care services to pregnant and postpartum women to optimize the health of women and their infants, including to reduce adverse maternal health outcomes, pregnancy-related deaths, and related health disparities (including such disparities associated with racial and ethnic minority populations), and, as appropriate, by addressing issues researched under subsection (b)(2) of section 317K.

“(b) Integrated Services for Pregnant and Postpartum Women.—

“(1) Eligibility.—To be eligible to receive a grant under subsection (a), a State, Indian Tribe, or Tribal organization (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act) shall work with relevant stakeholders that coordinate care to develop and carry out the program, including—

“(A) State, Tribal, and local agencies responsible for Medicaid, public health, social services, mental health, and substance use disorder treatment and services;

“(B) health care providers who serve pregnant and postpartum women; and

“(C) community-based health organizations and health workers, including providers of home visiting services and individuals representing communities with disproportionately high rates of maternal mortality and severe maternal morbidity, and including those representing racial and ethnic minority populations.

“(2) Terms.—

“(A) Period.—A grant awarded under subsection (a) shall be made for a period of 5 years. Any supplemental award made to a grantee under subsection (a) may be made for a period of less than 5 years.

“(B) Priorities.—In awarding grants under subsection (a), the Secretary shall—

“(i) give priority to States, Indian Tribes, and Tribal organizations that have the highest rates of maternal mortality and severe maternal morbidity relative to other such States, Indian Tribes, or Tribal organizations, respectively; and

“(ii) shall consider health disparities related to maternal mortality and severe maternal morbidity, including such disparities associated with racial and ethnic minority populations.

“(C) Evaluation.—The Secretary shall require grantees to evaluate the outcomes of the programs supported under the grant.

“(c) Authorization of Appropriations.—There are authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2023 through 2027.”

(b)
Report on Grant Outcomes and Dissemination of Best Practices.—
(1)
Report.— Not later than February 1, 2027, the Secretary of Health and Human Services 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 that describes—
(A)
the outcomes of the activities supported by the grants awarded under the amendments made by this section on maternal and child health;
(B)
best practices and models of care used by recipients of grants under such amendments; and
(C)
obstacles identified by recipients of grants under such amendments, and strategies used by such recipients to deliver care, improve maternal and child health, and reduce health disparities.
(2)
Dissemination of best practices.— Not later than August 1, 2027, the Secretary of Health and Human Services shall disseminate information on best practices and models of care used by recipients of grants under the amendments made by this section (including best practices and models of care relating to the reduction of health disparities, including such disparities associated with racial and ethnic minority populations, in rates of maternal mortality and severe maternal morbidity) to relevant stakeholders, which may include health providers, medical schools, nursing schools, relevant State, Tribal, and local agencies, and the general public.

SEC. 135. Maternal Vaccination Awareness.

In carrying out the public awareness initiative related to vaccinations pursuant to section 313 of the Public Health Service Act (42 U.S.C. 245), the Secretary of Health and Human Services shall take into consideration the importance of increasing awareness and knowledge of the safety and effectiveness of vaccines to prevent disease in pregnant and postpartum women and in infants and the need to improve vaccination rates in communities and populations with low rates of vaccination.

CHAPTER 2 Rural Maternal and Obstetric Modernization of Services

SEC. 141. Improving Rural Maternal and Obstetric Care Data.

(a)
Maternal Mortality and Morbidity Activities.— Section 301(e) of the Public Health Service Act (42 U.S.C. 241) is amended by inserting “ , preventable maternal mortality and severe maternal morbidity,” after “ delivery”.
(b)
Office of Women’s Health.— Section 310A(b)(1) of the Public Health Service Act (42 U.S.C. 242s(b)(1)) is amended by striking “ and sociocultural contexts,” and inserting “ sociocultural (including among American Indians, Native Hawaiians, and Alaska Natives), and geographical contexts,”.
(c)
Safe Motherhood.— Section 317K of the Public Health Service Act (42 U.S.C. 247b–12) is amended—
(1)
in subsection (a)(2)(A), by inserting “ , including improving disaggregation of data (in a manner consistent with applicable State and Federal privacy laws)” before the period; and
(2)
in subsection (b)(2)—
(A)
in subparagraph (L), by striking “ and” at the end;
(B)
by redesignating subparagraph (M) as subparagraph (N); and
(C)
by inserting after subparagraph (L) the following:

“(M) an examination of the relationship between maternal health and obstetric services in rural areas and outcomes in delivery and postpartum care; and”

(d)
Office of Research on Women’s Health.— Section 486(d)(4)(A)(iv) of the Public Health Service Act (42 U.S.C. 287d(d)(4)(A)(iv)) is amended by inserting “ , including preventable maternal mortality and severe maternal morbidity” before the semicolon.

SEC. 142. Rural Obstetric Network Grants.

The Public Health Service Act is amended by inserting after section 330A–1 of such Act (42 U.S.C. 254c–1a) the following:

“SEC. 330A–2. RURAL OBSTETRIC NETWORK GRANTS.

“(a) Program Established.—The Secretary shall award grants or cooperative agreements to eligible entities to establish collaborative improvement and innovation networks (referred to in this section as ‘rural obstetric networks’) to improve maternal and infant health outcomes and reduce preventable maternal mortality and severe maternal morbidity by improving maternity care and access to care in rural areas, frontier areas, maternity care health professional target areas, or jurisdictions of Indian Tribes and Tribal organizations.

“(b) Use of Funds.—Grants or cooperative agreements awarded pursuant to this section shall be used for the establishment or continuation of collaborative improvement and innovation networks to improve maternal and infant health outcomes and reduce preventable maternal mortality and severe maternal morbidity by improving prenatal care, labor care, birthing, and postpartum care services in rural areas. Rural obstetric networks established in accordance with this section may—

“(1) develop a network to improve coordination and increase access to maternal health care and assist pregnant women in the areas described in subsection (a) with accessing and utilizing prenatal care, labor care, birthing, and postpartum care services to improve outcomes in birth and maternal mortality and morbidity;

“(2) identify and implement evidence-based and sustainable delivery models for providing prenatal care, labor care, birthing, and postpartum care services, including home visiting programs and culturally appropriate care models that reduce health disparities;

“(3) develop a model for maternal health care collaboration between health care settings to improve access to care in areas described in subsection (a), which may include the use of telehealth;

“(4) provide training for professionals in health care settings that do not have specialty maternity care;

“(5) collaborate with academic institutions that can provide regional expertise and help identify barriers to providing maternal health care, including strategies for addressing such barriers; and

“(6) assess and address disparities in infant and maternal health outcomes, including among racial and ethnic minority populations and underserved populations in such areas described in subsection (a).

“(c) Definitions.—In this section:

“(1) Eligible entities.—The term ‘eligible entities’ means entities providing prenatal care, labor care, birthing, and postpartum care services in rural areas, frontier areas, or medically underserved areas, or to medically underserved populations or Indian Tribes or Tribal organizations.

“(2) Frontier area.—The term ‘frontier area’ means a frontier county, as defined in section 1886(d)(3)(E)(iii)(III) of the Social Security Act.

“(3) Indian tribes; tribal organization.—The terms ‘Indian Tribe’ and ‘Tribal organization’ have the meanings given the terms ‘Indian tribe’ and ‘tribal organization’ in section 4 of the Indian Self-Determination and Education Assistance Act.

“(4) Maternity care health professional target area.—The term ‘maternity care health professional target area’ has the meaning described in section 332(k)(2).

“(d) Report to Congress.—Not later than September 30, 2026, the Secretary shall submit to Congress a report on activities supported by grants awarded under this section, including—

“(1) a description of activities conducted pursuant to paragraphs (1) through (6) of subsection (b); and

“(2) an analysis of the effects of rural obstetric networks on improving maternal and infant health outcomes.

“(e) Authorization of Appropriations.—There are authorized to be appropriated to carry out this section $3,000,000 for each of fiscal years 2023 through 2027.”

SEC. 143. 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 (f)(3), by adding at the end the following:

“(M) Providers of prenatal, labor care, birthing, and postpartum care services, including hospitals that operate obstetric care units.”

; and

(2)
in subsection (h)(1)(B), by striking “ or prenatal care for high-risk pregnancies” and inserting “ prenatal care, labor care, birthing care, or postpartum care”.

SEC. 144. Rural Maternal and Obstetric Care Training Demonstration.

Subpart 1 of part E of title VII of the Public Health Service Act (42 U.S.C. 294n et seq.) is amended by adding at the end the following:

“SEC. 764. RURAL MATERNAL AND OBSTETRIC CARE TRAINING DEMONSTRATION.

“(a) In General.—The Secretary shall award grants to accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other appropriate health professional training programs, to establish a training demonstration program to support—

“(1) training for physicians, medical residents, fellows, nurse practitioners, physician assistants, nurses, certified nurse midwives, relevant home visiting workforce professionals and paraprofessionals, or other professionals who meet relevant State training and licensing requirements, as applicable, to reduce preventable maternal mortality and severe maternal morbidity by improving prenatal care, labor care, birthing, and postpartum care in rural community-based settings; and

“(2) developing recommendations for such training programs.

“(b) Application.—To be eligible to receive a grant under subsection (a), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.

“(c) Activities.—

“(1) Training for health care professionals.—A recipient of a grant under subsection (a)—

“(A) shall use the grant funds to plan, develop, and operate a training program to provide prenatal care, labor care, birthing, and postpartum care in rural areas; and

“(B) may use the grant funds to provide additional support for the administration of the program or to meet the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or other units necessary to implement such training.

“(2) Training program requirements.—The recipient of a grant under subsection (a) shall ensure that training programs carried out under the grant are evidence-based and address improving prenatal care, labor care, birthing, and postpartum care in rural areas, and such programs may include training on topics such as—

“(A) maternal mental health, including perinatal depression and anxiety;

“(B) substance use disorders;

“(C) social determinants of health that affect individuals living in rural areas; and

“(D) improving the provision of prenatal care, labor care, birthing, and postpartum care for racial and ethnic minority populations, including with respect to perceptions and biases that may affect the approach to, and provision of, care.

“(d) Evaluation and Report.—

“(1) Evaluation.—

“(A) In general.—The Secretary shall evaluate the outcomes of the demonstration program under this section.

“(B) Data submission.—Recipients of a grant under subsection (a) shall submit to the Secretary performance metrics and other related data in order to evaluate the program for the report described in paragraph (2).

“(2) Report to congress.—Not later than January 1, 2026, the Secretary shall submit to Congress a report that includes—

“(A) an analysis of the effects of the demonstration program under this section on the quality, quantity, and distribution of maternal health care services, including prenatal care, labor care, birthing, and postpartum care services, and the demographics of the recipients of those services;

“(B) an analysis of maternal and infant health outcomes (including quality of care, morbidity, and mortality) before and after implementation of the program in the communities served by entities participating in the demonstration; and

“(C) recommendations on whether the demonstration program should be continued.

“(e) Authorization of Appropriations.—There are authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2023 through 2027.”

Subtitle E Fentanyl Scheduling Extension

SEC. 151. Extension of Temporary Order for Fentanyl-Related Substances.

Effective as if included in the enactment of the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act (Public Law 116–114), section 2 of such Act is amended by striking “ March 15, 2022” and inserting “ December 31, 2022”.

Subtitle F Drug-Free Communities

SEC. 161. Waiver of Federal Fund Limitation for the Drug-Free Communities Support Program.

(a)
In General.— Subject to subsection (b), if the Administrator of the Drug-Free Communities Support Program determines that, as a result of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, an eligible coalition is unable to raise the amount of non-Federal funds, including in-kind contributions, agreed to be raised by the coalition for fiscal year 2020, 2021, or 2022 under an agreement entered into with the Administrator pursuant to paragraph (1)(A) or (3) of section 1032(b) of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1532(b)), the Administrator may, notwithstanding such paragraphs, provide to the eligible coalition the grant or renewal grant, as applicable, for that fiscal year only in an amount—
(1)
with respect to an initial grant or renewal grant described under paragraph (1)(A) or (3)(A) of such section, that exceeds the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year;
(2)
with respect to a renewal grant described under paragraph (3)(D)(i) of such section, that exceeds 125 percent of the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year; and
(3)
with respect to a renewal grant described under paragraph (3)(D)(ii) of such section, that exceeds 150 percent of the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year.
(b)
Limitation.— The Administrator may not provide a grant or renewal grant to an eligible coalition in an amount exceeding the amount of funds initially agreed to be provided by the Administrator under the applicable agreement.

TITLE II Medicaid

SEC. 201. Certain Medicaid Extensions for Territories.

(a)
Extending Increased FMAP.— Section 1905(ff) of the Social Security Act (42 U.S.C. 1396d(ff)) is amended—
(1)
in paragraph (2), by inserting “ and for the period beginning January 1, 2022, and ending December 13, 2022” after “ and ending December 3, 2021,” and
(2)
in paragraph (3), by striking “ March 11, 2022” and inserting “ December 13, 2022”.
(b)
Extending Additional Increase for Puerto Rico.— Section 1108(g) of the Social Security Act (42 U.S.C. 1308(g)) is amended by adding at the end the following new paragraph:

“(10) Additional increase for puerto rico for fiscal year 2022.—

“(A) In general.—Notwithstanding the preceding provisions of this subsection, the total amount certified for Puerto Rico for fiscal year 2022 under this subsection shall be increased by $200,000,000 if the Secretary certifies that, with respect to such fiscal year, Puerto Rico’s State plan under title XIX (or a waiver of such plan) establishes a reimbursement floor, implemented through a directed payment arrangement plan, for physician services that are covered under the Medicare part B fee schedule in the Puerto Rico locality established under section 1848(b) that is not less than 70 percent of the payment that would apply to such services if they were furnished under part B of title XVIII during such fiscal year.

“(B) Application to managed care.—In certifying whether Puerto Rico has established a reimbursement floor under a directed payment arrangement plan that satisfies the requirements of subparagraph (A) for fiscal year 2022, the Secretary shall—

“(i) disregard payments made under sub-capitated arrangements for services such as primary care case management; and

“(ii) if the reimbursement floor for physician services applicable under a managed care contract satisfies the requirements of subparagraph (A) for the fiscal year in which the contract is entered into or renewed, such reimbursement floor shall be deemed to satisfy such requirements for the subsequent fiscal year.”

(c)
Puerto Rico Report on Procurement Processes and Standards Used for Contracting Under the Medicaid Program.—
(1)
Report required.— Not later than December 1, 2022, the agency responsible for administering Puerto Rico’s Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) shall submit to Congress a report on the procurement processes and standards used for selecting contracts under Puerto Rico’s Medicaid program.
(2)
Information in report.— The report required under paragraph (1) shall include the following:
(A)
A detailed description of the procurement processes and standards used for selecting contracts under Puerto Rico’s Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), for contracts in effect as of the date of the enactment of this subsection.
(B)
The number of contracts, and a description of such contracts, for an amount greater than $150,000 as of the date of the enactment of this subsection.
(C)
Differences between the procurement processes and standards for selecting contracts in place as of the date of the enactment of this subsection, and the Federal procurement standards (as described in sections 75.327, 75.328, and 75.329 of title 45, Code of Federal Regulations) as of such date.

SEC. 202. Increasing State Flexibility with Respect to Third Party Liability.

(a)
In General.— Section 1902(a)(25)(I) of the Social Security Act (42 U.S.C. 1396a(a)(25)(I)) is amended—
(1)
by amending clause (ii) to read as follows:

“(ii)

(I) accept the State’s right of recovery and the assignment to the State of any right of an individual or other entity to payment from the party for an item or service for which payment has been made under the State plan (or under a waiver of such plan); and

“(II) in the case of a responsible third party (other than the original medicare fee-for-service program under parts A and B of title XVIII, a Medicare Advantage plan offered by a Medicare Advantage organization under part C of such title, a reasonable cost reimbursement plan under section 1876, a health care prepayment plan under section 1833, or a prescription drug plan offered by a PDP sponsor under part D of such title) that requires prior authorization for an item or service furnished to an individual eligible to receive medical assistance under this title, accept authorization provided by the State that the item or service is covered under the State plan (or waiver of such plan) for such individual, as if such authorization were the prior authorization made by the third party for such item or service;”

(2)
in clause (iii)—
(A)
by striking “ respond to any inquiry” and inserting “ not later than 60 days after receiving any inquiry”; and
(B)
by striking “ ; and” at the end and inserting “ , respond to such inquiry; and”; and
(3)
in clause (iv)—
(A)
by striking “ or a failure” and inserting “ a failure”; and
(B)
by inserting after “ the basis of the claim” the following: “ , or in the case of a responsible third party (other than the original medicare fee-for-service program under parts A and B of title XVIII, a Medicare Advantage plan offered by a Medicare Advantage organization under part C of such title, a reasonable cost reimbursement plan under section 1876, a health care prepayment plan under section 1833, or a prescription drug plan offered by a PDP sponsor under part D of such title) a failure to obtain a prior authorization for the item or service for which the claim is being submitted”;
(b)
Effective Date.—
(1)
In general.— Except as provided in paragraph (2), the amendments made by this section shall apply beginning on January 1, 2024.
(2)
Exception if state legislation required.— In the case of a State plan for medical assistance under title XIX of the Social Security Act that the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made under this section, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.

TITLE III Medicare

Subtitle A Telehealth Flexibility Extensions

SEC. 301. Removing Geographic Requirements and Expanding Originating Sites for Telehealth Services.

(a)
In General.— Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—
(1)
in paragraph (4)(C)—
(A)
in clause (i), in the matter preceding subclause (I), by inserting “ clause (iii) and” after “ Except as provided in”; and
(B)
by adding at the end the following new clause:

“(iii) Expanding access to telehealth services.—With respect to telehealth services identified in subparagraph (F)(i) as of the date of the enactment of this clause that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B), the term ‘originating site’ means any site in the United States at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications system, including the home of an individual.”

; and

(2)
in paragraph (7)(A), by inserting “ or, for the period for which clause (iii) of paragraph (4)(C) applies, at any site described in such clause” before the period at the end.
(b)
No Facility Fee for New Sites.— Section 1834(m)(2)(B) of the Social Security Act (42 U.S.C. 1395m(m)(2)(B)) is amended—
(1)
in clause (i), in the matter preceding subclause (I), by striking “ clause (ii)” and inserting “ clauses (ii) and (iii)”; and
(2)
by adding at the end the following new clause:

“(iii) No facility fee for new sites.—With respect to telehealth services identified in paragraph (4)(F)(i) as of the date of the enactment of this clause that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B), a facility fee shall only be paid under this subparagraph to an originating site that is described in paragraph (4)(C)(ii) (other than subclause (X) of such paragraph).”

SEC. 302. Expanding Practitioners Eligible to Furnish Telehealth Services.

Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—
(1)
in paragraph (1), by striking “ (described in section 1842(b)(18)(C))” and inserting “ (as defined in paragraph (4)(E))”; and
(2)
in paragraph (4)(E), by inserting “ and, for the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B), shall include a qualified occupational therapist (as such term is used in section 1861(g)), a qualified physical therapist (as such term is used in section 1861(p)), a qualified speech-language pathologist (as defined in section 1861(ll)(4)(A)), and a qualified audiologist (as defined in section 1861(ll)(4)(B))” after “ section 1842(b)(18)(C)”.

SEC. 303. Extending Telehealth Services for Federally Qualified Health Centers and Rural Health Clinics.

Section 1834(m)(8) of the Social Security Act (42 U.S.C. 1395m(m)(8)) is amended—
(1)
in the header, by striking “ during emergency period”;
(2)
in subparagraph (A), in the matter preceding clause (i), by inserting “ and, during the 151-day period beginning on the first day after the end of such emergency period” after “ During the emergency period described in section 1135(g)(1)(B)”; and
(3)
in subparagraph (B)(i), by striking “ such emergency period” and inserting “ the periods for which subparagraph (A) applies”.

SEC. 304. Delaying the In-Person Requirements under Medicare for Mental Health Services Furnished Through Telehealth and Telecommunications Technology.

(a)
Delay in Requirements for Mental Health Services Furnished Through Telehealth.— Section 1834(m)(7)(B)(i) of the Social Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is amended, in the matter preceding subclause (I), by inserting “ on or after the day that is the 152nd day after the end of the emergency period described in section 1135(g)(1)(B))” after “ telehealth services furnished”.
(b)
Mental Health Visits Furnished by Rural Health Clinics.— Section 1834(y) of the Social Security Act (42 U.S.C. 1395m(y)) is amended—
(1)
in the heading, by striking “ Attending Physician” and inserting “ Certain”;
(2)
by striking “ Hospice Patients.—In the case of” and inserting

“(1) Attending physician services for hospice patients.—In the case of”

; and

(3)
by adding at the end the following new paragraph:

“(2) Mental health visits furnished via telecommunications technology.—In the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-person mental health visit requirements established under section 405.2463(b)(3) of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to the day that is the 152nd day after the end of the emergency period described in section 1135(g)(1)(B)).”

(c)
Mental Health Visits Furnished by Federally Qualified Health Centers.— Section 1834(o)(4) of the Social Security Act (42 U.S.C. 1395m(o)(4)) is amended—
(1)
in the heading, by striking “ attending physician” and inserting “ certain”;
(2)
by striking “ hospice patients.—In the case of” and inserting

“(A) Attending physician services for hospice patients.—In the case of”

; and

(3)
by adding at the end the following new subparagraph:

“(B) Mental health visits furnished via telecommunications technology.—In the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-person mental health visit requirements established under section 405.2463(b)(3) of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to the day that is the 152nd day after the end of the emergency period described in section 1135(g)(1)(B)).”

SEC. 305. Allowing for the Furnishing of Audio-Only Telehealth Services.

Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—
(1)
in paragraph (1), in the first sentence, by striking “ paragraph (8)” and inserting “ paragraphs (8) and (9)”; and
(2)
by adding at the end the following new paragraph:

“(9) Treatment of telehealth services furnished using audio-only telecommunications technology.—The Secretary shall continue to provide coverage and payment under this part for telehealth services identified in paragraph (4)(F)(i) as of the date of the enactment of this paragraph that are furnished via an audio-only telecommunications system during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B). For purposes of the previous sentence, the term ‘telehealth service’ means a telehealth service identified as of the date of the enactment of this paragraph by a HCPCS code (and any succeeding codes) for which the Secretary has not applied the requirements of paragraph (1) and the first sentence of section 410.78(a)(3) of title 42, Code of Federal Regulations, during such emergency period.”

SEC. 306. Use of Telehealth to Conduct Face-To-Face Encounter Prior to Recertification of Eligibility for Hospice Care During Emergency Period.

Section 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)) is amended by inserting “ , and during the 151-day period beginning on the first day after the end of such emergency period” after “ section 1135(g)(1)(B)”.

SEC. 307. Extension of Exemption for Telehealth Services.

(a)
In General.— Subparagraph (E) of section 223(c)(2) of the Internal Revenue Code of 1986 is amended by inserting “ or in the case of months beginning after March 31, 2022, and before January 1, 2023,” after “ December 31, 2021,”.
(b)
Certain Coverage Disregarded.— Clause (ii) of section 223(c)(1)(B) of the Internal Revenue Code of 1986 is amended by inserting “ , or in the case of months beginning after March 31, 2022, and before January 1, 2023,” after “ December 31, 2021”.
(c)
Effective Date.— The amendments made by this section shall take effect on the date of the enactment of this Act.

SEC. 308. Reports on Telehealth Utilization.

(a)
Medpac Report.—
(1)
Study.—
(A)
In general.— The Medicare Payment Advisory Commission (in this subsection referred to as the “Commission”) shall conduct a study on the expansions of telehealth services (as defined in section 1834(m)(4)(F) of the Social Security Act (42 U.S.C. 1395m(m)(4)(F)) under the Medicare program under title XVIII of such Act as a result of the COVID-19 public health emergency described in section 1135(g)(1)(B) of such Act (42 U.S.C. 1320b–5(g)(1)(B)) and the amendments made by sections 301 through 306 of this title.
(B)
Analysis.— The study under subparagraph (A) shall include at least an analysis of each of the following:
(i)
The utilization of telehealth services under the Medicare program, which may include analysis by service, provider type, geographic area (including analysis of the provision of telehealth services by clinicians located in different States than the Medicare beneficiary receiving such services to the extent that reliable data are available), and beneficiary type (including reason of entitlement and such beneficiaries who are also enrolled under a State plan under title XIX of the Social Security Act).
(ii)
Medicare program expenditures on telehealth services.
(iii)
Medicare payment policy for telehealth services and alternative approaches to such payment policy, including for federally qualified health centers and rural health clinics.
(iv)
The implications of expanded Medicare coverage of telehealth services on beneficiary access to care and the quality of care, to the extent reliable data are available.
(v)
Other areas determined appropriate by the Commission.
(2)
Report.— Not later than June 15, 2023, the Commission shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for legislative and administrative action as the Commission determines appropriate.
(b)
Publication of Data.— Beginning July 1, 2022, the Secretary of Health and Human Services shall post on the public website of the Centers for Medicare & Medicaid Services on a quarterly basis data with respect to Medicare claims for telemedicine services, including data on utilization and beneficiary characteristics.
(c)
Office of the Inspector General Report.— Not later than June 15, 2023, the Inspector General of the Department of Health and Human Services shall submit to Congress a report on program integrity risks associated with Medicare telehealth services. Such report shall include recommendations to prevent waste, fraud, and abuse under the Medicare program as appropriate.

SEC. 309. Program Instruction Authority.

Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, including amendments made by, sections 301 through 306 through program instruction or otherwise.

Subtitle B Additional Medicare Provisions

SEC. 311. Revision of the Timing of Medpac Report on Ambulance Cost Data.

Section 1834(l)(17)(F)(i) of the Social Security Act (42 U.S.C. 1395m(l)(17)(F)(i)) is amended by striking “ Not later than March 15, 2023, and as determined necessary by the Medicare Payment Advisory Commission thereafter” and inserting “ Not later than the second June 15th following the date on which the Secretary transmits data for the first representative sample of providers and suppliers of ground ambulance services to the Medicare Payment Advisory Commission, and as determined necessary by such Commission thereafter,”.

SEC. 312. Adjusting Calculation of Hospice Cap Amount under Medicare.

Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C. 1395f(i)(2)(B)) is amended—
(1)
in clause (ii), by striking “ 2030” and inserting “ 2031”; and
(2)
in clause (iii), by striking “ 2030” and inserting “ 2031”.

SEC. 313. Medicare Improvement Fund.

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking “ $99,000,000” and inserting “ $5,000,000”.

TITLE IV Human Services

SEC. 401. Extension of Temporary Assistance for Needy Families and Related Programs.

Activities authorized by part A of title IV (other than under section 403(c) or 418) and section 1108(b) of the Social Security Act shall continue through September 30, 2022, in the manner authorized for fiscal year 2021, and out of any money in the Treasury of the United States not otherwise appropriated, there are hereby appropriated such sums as may be necessary for such purpose.