This Week in Washington: Senate Fails to Advance Bill Protecting Abortion Rights After Supreme Court Draft Opinion Leak

Congress

House

Senate

Administration

Other Activity

Proposed Rules

Final Rules

Courts

Reports

Upcoming Hearings

May 17

Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies Hearing: “A Review of the President’s FY 2023 Funding Request and Budget Justification for the National Institutes of Health” 10:00 a.m.

House Committee on Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Hearing: “Fiscal Year 2023 VA Electronic Health Record Modernization Budget Hearing” 10:30 a.m.

May 18

Senate Education, Labor and Pensions Committee Hearing: “Cybersecurity in the Health and Education Sectors” 10:00 a.m.

House Judiciary Committee Hearing: “Revoking Your Rights: The Ongoing Crisis in Abortion Care Access” 10:00 a.m.

House Committee on Homeland Security Subcommittee on Border Security, Facilitation and Operations Hearing: “Examining DHS’s Efforts to Combat the Opioid Epidemic” 2:00 p.m.

May 19

House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Hearing: “Fiscal Year 2023 Budget Request for the Food and Drug Administration” 10:00 a.m.

Senate Special Committee on Aging Hearing: “Mental Health Care for Older Adults: Raising Awareness, Addressing Stigma, and Providing Support” 10:00 a.m.

Congress

House

House Committee on Energy and Commerce Health Subcommittee Advances ARPA-H Bill

On May 11, the House Committee on Energy and Commerce Subcommittee on Health voted to advance the Advanced Research Projects Agency-Health (ARPA-H) Act. The bill would house the new ARPA-H agency within the Department of Health and Human Services (HHS). This differs from HHS’s earlier decision to place ARPA-H in the National Institutes of Health (NIH).

106 House Republicans Call on FDA and President Biden to Act on Baby Formula Shortage

On May 11, Rep. Cathy McMorris Rodgers (R-WA) led a group of 106 House Republicans in a letter to President Biden and Food and Drug Administration Commissioner Califf calling for information on the current baby formula shortage and how the administration plans to address it.

100 House Democrats Call on CMS to Ensure Medicaid Provider Choice for Abortion Providers

On May 10, Reps. Lizzie Fletcher (D-TX) and Cori Bush (D-MO) led a group of 100 House Democrats in a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure calling for CMS to enforce Medicaid’s free choice of provider requirement. The letter claims that a number of states have cut abortion providers out of state Medicaid programs, which violates federal law.

Committees Release Staff Report Detailing Emergent’s Failure to Meet Quality Standards for COVID-19 Vaccines

On May 10, the House Committee on Oversight Reform and the Select Subcommittee on the Coronavirus Crisis released a staff report on their joint investigation of Emergent BioSolutions, Inc.’s COVID-19 vaccine manufacturing failures. The report states that 400 million doses of COVID-19 vaccines were destroyed as a result of Emergent’s failure to meet quality standards at its Bayview facility. In addition, the report states that Emergent executives attempted to hide evidence of contamination to evade government oversight efforts.

Reps. McMorris Rodgers and Pallone Introduce Bill to Reauthorize Mental Health and Substance Abuse Programs

On May 6, Reps. Cathy McMorris Rodgers (R-WA) and Frank Pallone (D-NJ) introduced the Restoring Hope for Mental Health and Well-Being Act of 2022. The bill would reauthorize mental health and substance use disorder programs at the Health Resources and Services Administration (HRSA) and the Substance Abuse and Mental Health Services Administration (SAMHSA).

House Committee on Energy and Commerce Health Subcommittee Advances the Medical User Fee Reauthorization Legislative Package

On May 4, the House Energy and Commerce Committee published the legislative package that would reauthorize the Food and Drug Administration’s (FDA) medical product user fee programs. The legislative package reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA) and the Medical Device User Fee Act (MDUFA), and will allow the FDA to continue collecting fees from drug and medical device manufacturers. Reauthorization of the user fee programs happens every five years.

On May 11, the House Committee on Energy and Commerce Subcommittee on Health voted unanimously to advance the user fee legislation to the full committee.

Reps. Rodgers, Brady, Crapo and Sen. Burr Write to CMS Expressing Concern with Coverage of Drugs to Treat Alzheimer’s Disease

On May 2, Reps. Cathy McMorris Rodgers (R-WA), Kevin Brady (R-TX) and Mike Crapo (R-ID) and Sen. Richard Burr (R-NC) wrote to the Centers for Medicare and Medicaid Services (CMS) expressing their concern with the agency’s decision to restrict coverage of current and future Alzheimer’s treatments. In the letter, the members express concern that this decision could reduce access to drugs to treat Alzheimer’s and could reduce the investment in research and development.

Senate

Sen. Sanders Introduces the Medicare for All Act of 2022

On May 12, Sen. Bernie Sanders (I-VT) introduced the Medicare for All Act of 2022. The bill would guarantee healthcare as a fundamental right to all Americans. The bill was cosponsored by Sens. Tammy Baldwin (D-WI), Richard Blumenthal (D-CT), Cory Booker (D-NJ), Kirsten Gillibrand (D-NY), Martin Heinrich (D-NM), Mazie Hirono (D-HI), Patrick Leahy (D-VT), Ben Ray Luján (D-NM), Ed Markey (D-MA), Jeff Merkley (D-OR), Alex Padilla (D-CA), Brian Schatz (D-HI), Elizabeth Warren (D-MA) and Sheldon Whitehouse (D-RI).

Senate Fails to Pass Bill That Would Codify Abortion Protections

On May 11, the Senate failed to pass a bill that would ensure abortion rights with a vote of 49-51. Sen. Joe Manchin (D-WV) and all Senate Republicans opposed the bill.

Sens. Cassidy and Murphy Introduce Bill to Reauthorize Mental Health and Substance Use Disorder Programs

On May 10, Sens. Bill Cassidy (R-LA) and Chris Murphy (D-CT) introduced the Mental Health Reform Reauthorization Act of 2022. The bill would reauthorize mental health and substance use disorder programs that were created under the Mental Health Reform Act. The programs are currently set to expire in September.

Sens. Schatz and Booker Call on FDA and NIH to Carry Out More Research on the Therapeutic Potential of Psychedelics

On May 10, Sens. Brian Schatz (D-HI) and Cory Booker (D-NJ) wrote to the Food and Drug Administration (FDA) Commissioner Robert Califf and National Institutes of Health (NIH) Acting Director Lawrence Tabak calling for more research into the potential therapeutic uses of psychedelics.

Administration

HHS Awards $16.3 Million to Expand Telehealth in the Title X Family Planning Program

On May 10, the Department of Health and Human Services (HHS) announced it would be awarding $16.3 million in grant funding to support telehealth infrastructure in Title X family planning clinics. The Title X grant program provides family planning and preventive health services.

CMS Approves Extended Medicaid and CHIP Postpartum Coverage in Tennessee and South Carolina

On May 6, the Centers for Medicare and Medicaid Services (CMS) announced that it had approved an extension of Medicaid and Children’s Health Insurance Program (CHIP) coverage for 12 months postpartum in the states of Tennessee and South Carolina.

FDA Approves New Indication for Olumiant to Treat COVID-19

On May 10, the Food and Drug Administration (FDA) announced that it approved a new indication for Olumiant (baricitinib) to treat COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation.

FDA Restricts the Use of the Johnson & Johnson COVID-19 Vaccine

On May 5, the Food and Drug Administration (FDA) announced that it had restricted the use of the Johnson & Johnson COVID-19 vaccine to adults who are either unable or unwilling to receive other COVID-19 vaccine options. This decision comes after the FDA studied the risk of developing blood clots and low platelets, a potentially fatal combination, after receiving the vaccine. Due to the demonstrated risk, the FDA determined that the benefit of the Johnson & Johnson vaccine only outweighs the risk for individuals who cannot or will not receive another form of vaccination.

HRSA Announces $5 Million to Improve Cancer Screening at Community Health Centers

On May 11, the Health Resources and Services Administration (HRSA) announced that $5 million would be made available to help community health centers increase access to cancer screenings.

CDC Announces Meeting of Advisory Committee

On May 10, the Centers for Disease Control and Prevention (CDC) announced that the Advisory Committee on Immunization Practices (ACIP) will hold a meeting on May 19, 2022, from 11 a.m. to 4 p.m. EDT. The meeting is open to the public.

Indian Health Service Receives $5 Million to Address Alzheimer’s Disease

On May 9, the Department of Health and Human Services (HHS) announced that it had allocated $5 million to the Indian Health Service (IHS) to help address Alzheimer’s disease in tribal communities.

Other Activity

GAO Announces MACPAC Appointments and Reappointments

On May 2, the Government Accountability Office (GAO) announced the appointment of four new members and reappointment of two members to the Medicaid and CHIP Payment and Access Commission (MACPAC).

Proposed Rules

FDA Issues Proposed Rules to Ban the Sale of Menthol Cigarettes and Flavored Cigars

On April 28, the Food and Drug Administration (FDA) issued two proposed rules, the “Tobacco Product Standard for Menthol in Cigarettes,” and the “Tobacco Product Standard for Characterizing Flavors in Cigars.” Together, the proposed rules would ban the sale of menthol cigarettes and flavored cigars, citing the need to protect public health, combat youth tobacco use and promote health equity. The FDA will hold listening sessions to discuss the proposed rules on June 13 and 15.

Public comment on both rules will be open until June 6.

CMS Releases FY 2023 Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Rule

On April 18, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year (FY) 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation.” The proposed rule, which is referred to as the FY 2023 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) rule, updates the Medicare fee-for-service payment rates for long-term care hospitals (LTCHs). The rule also establishes new requirements for hospitals and critical access hospitals participating in the Medicare Promoting Interoperability Program. In addition, the proposed rule adds three health equity measures to hospital quality programs.

A CMS fact sheet on the proposed rule can found here.

CMS Releases FY 2023 Skilled Nursing Facilities Prospective Payment System Proposed Rule

On April 15, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program; Long Term Care Facilities to Establish Mandatory Minimum Staffing Levels.” The proposed rule, which is referred to as the fiscal year (FY) 2023 Skilled Nursing Facilities Prospective Payment System (SNF PPS) proposed rule, adds three new measures to the SNF Value-Based Purchasing (VBP) Program. As part of the proposed rule, CMS is seeking public input on how to best establish minimum staffing requirements at nursing homes. CMS is also seeking public comment on how to address staff turnover in nursing homes.

Comments will be accepted until June 10, 2022.

CMS Issues Proposed Rule to Delay Start of Radiation Oncology Model

On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Radiation Oncology (RO) Model.” The proposed rule delays the start of the RO to an undetermined future date that will be determined by future rulemaking.

Comments will be accepted until June 7, 2022.

IRS Publishes Proposed Rule to Address Affordable Care Act “Family Glitch”

On April 7, the Internal Revenue Service (IRS) published a proposed rule titled “Affordability of Employer Coverage for Family Members of Employees.” The proposed rule would make changes to the eligibility for the premium tax credit to ensure that the affordability of employer-sponsored minimum essential coverage for family members of an employee is determined on the employee’s share of the cost of covering themselves and their family members. Currently, regulations define “affordable” employer-based coverage as coverage that is affordable for the employee, not considering whether it is affordable for the employee’s family members. This can lead family members to be ineligible for a premium tax credit, and this situation is referred to as the “family glitch.”

Public comment will be accepted until June 6, 2022.

HHS’ Office for Civil Rights Announces RFI on Security Practices and Monetary Settlements Included in the HITECH Act

On April 6, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced it was seeking public input on two provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, which was amended in 2021. The Request for Information (RFI) will inform the OCR’s policies to support the healthcare industry’s security practices going forward. In addition, the RFI will inform how the OCR will share funds collected from HIPAA rule violation enforcement.

Comments will be accepted until June 6, 2022.

CMS Releases Proposed Rule with Updates for the Inpatient Psychiatric Facilities Prospective Payment System

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Fiscal Year 2023 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update and Quality Reporting.” The proposed rule would make updates to prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF). The proposed rule would also establish a mitigation policy to facilitate the yearly changes in IPF payments. The changes are summarized in this CMS fact sheet. The proposed changes would be in effect from Oct. 1, 2022, to Sept. 30, 2023.

Public comments will be accepted until May 31, 2022.

CMS Releases Proposed Rule to Update the Hospice Wage Index, Payment Rate and Hospice Quality Reporting Requirements

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The proposed rule would establish a mitigation policy to facilitate the yearly changes to the hospice wage index. The proposed rule would also update the hospice wage index, payment rates and aggregate cap amount for Fiscal Year 2023, and make changes to the Hospice Quality Reporting Program (HQRP). The changes are summarized in this CMS fact sheet.

Public comments will be accepted until May 31, 2022.

CMS Releases Proposed Rule to Update Medicare Inpatient Rehabilitation Facility Prospective Payment System and Quality Reporting Program

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the Inpatient Rehabilitation Facility Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program for Fiscal Year 2023. The changes are summarized in this CMS fact sheet.

Public comments will be accepted until May 31, 2022.

FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database

On March 22, the Food and Drug Administration (FDA) issued a notice titled “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database” to establish a public docket and request public comment. The public comments will help the FDA determine how to best prioritize maximum daily exposure (MDE) information for inactive ingredients that are not currently included in the Centers for Drug Evaluation and Research’s Inactive Ingredient Database, as well as if the database should be restructured by removing dosage form information.

Public comments will be accepted until June 21, 2022.

FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements

On Feb. 23, the Food and Drug Administration (FDA) published a proposed rule titled “Medical Devices; Quality System Regulation Amendments.” The proposed rule would amend the Quality System Regulation’s device current good manufacturing practice (CGMP) requirements to align more closely with international device standards.

Public comments are accepted until May 24, 2022.

FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers.” The proposed rule includes proposed national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers.

Public comments are accepted until June 6, 2022.

Final Rules

CMS Releases Reassignment of Medicaid Provider Claims Final Rule

On May 12, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicaid Program; Reassignment of Medicaid Provider Claims.” The final rule authorizes states to make payments to third parties on behalf of individual Medicaid practitioners for whom Medicaid is their primary source of revenue. The rule allows payments for health insurance, skills training and other benefits typical for employees.

CMS Releases Notice of Benefit and Parameters for 2023 Final Rule

On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods.

A CMS fact sheet on the final rule can be found here.

CMS Releases Final Rule for Medicare Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing

On April 14, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicare Program; Maximum Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing Standards.” The rule finalizes the maximum out-of-pocket (MOOP) limits for Medicare Parts A and B services and cost sharing limits for Medicare Parts A and B services. CMS is also requesting public comment on new ways to update cost sharing limits in the future. The regulations go into effect on June 13, 2022.

Final Rule to Change Qualifications for Products to be Considered “Made in America” Released

On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that aims to increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.

The White House Fact Sheet on the final rule can be found here.

SUNSET Final Rule Implementation Delayed

On March 4, the Department of Health and Human Services (HHS) released a final rule to postpone the final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET Final Rule). The SUNSET final rule was first published on Jan. 19, 2021, and was set to go into effect on March 22, 2022. The final rule would establish a new process to review HHS regulations, with automatic expiration of regulations that meet certain circumstances. The final rule will now be delayed further and will go into effect on Sept. 22, 2022.

Courts

Draft Majority Opinion for Supreme Court Abortion Case Leaked

On May 3, Politico reported that it had obtained an initial draft majority opinion from the Supreme Court’s ruling on abortion rights. The draft opinion shows that the Supreme Court has voted to strike down Roe v. Wade, the 1973 decision that made abortion a federally protected right. In the draft opinion, Justice Alito says that the issue of abortion should be returned to the states. It should be noted that the draft opinion is not final.

Reports

GAO Report on FDA’s Efforts to Increase Access to COVID-19 Tests and Future Preparedness

On May 12, the Government Accountability Office (GAO) published a report titled “COVID-19: FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed.” The report notes that the Food and Drug Administration (FDA) granted emergency use authorizations for COVID-19 tests in order to increase availability. The GAO recommends that the FDA develop an enforcement discretion policy for unauthorized tests in future public health emergencies.

GAO Report on VA Healthcare Facilities

On May 12, the Government Accountability Office (GAO) published a report titled “VA Health Care Facilities: Leveraging Partnerships to Address Capital Investment Needs.” The report notes that the Department of Veterans Affairs (VA) needs more healthcare facilities and updated infrastructure to meet its current needs.

NASEM Report on Autoimmune Disease Research at the NIH

On May 10, the National Academies of Sciences, Engineering, and Medicine (NASEM) released a report titled “Enhancing NIH Research on Autoimmune Disease.” The report states that the National Institutes of Health (NIH) needs a strategic plan and funding to better support the coordination of autoimmune disease research. The report recommends that the NIH create an Office of Autoimmune Disease/Autoimmunity Research to better coordinate these efforts.