Health Care Watch: November 12, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 5 – November 12. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On November 7, Ways & Means Health Subcommittee Ranking Member Lloyd Doggett (D-TX) and Rep. Jan Schakowsky (D-IL) led 101 lawmakers in a letter urging the Centers for Medicare & Medicaid Services (CMS) to strengthen and finalize the proposed Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting proposed rule.
On November 8, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight and Investigations Subcommittee Chairman Morgan Griffith (R-VA) sent a letter to the Substance Abuse & Mental Health Services Administration (SAMHSA) to serve as the final notice before issuing a subpoena asking for expenditure information on COVID-19 spending, Suicide Hotline rollout, support for treating serious mental illness, and new Office of Recovery.
On November 9, Energy & Commerce Committee Chair McMorris Rodgers, Health Subcommittee Chairman Guthrie, and Oversight & Investigations Subcommittee Chairman Griffith (R-VA) sent a letter to the Food & Drug Administration (FDA) threatening to issue a subpoena for documents related to significant biosafety or biosecurity risks at FDA facilities.
On November 9, Ways & Means Health Subcommittee Member Brad Wenstrup (R-OH) announced that he would not seek re-election.
On November 11, Speaker Mike Johnson (R-LA) announced plans to consider a two-stepped government funding package which would extend funding certain Departments through January 19 and others through February 2. It remains to be seen whether this plan can pass the House and Senate Democrats have already voiced their concerns about such a strategy. Government funding expires on November 17.
During the week of November 13, the House is scheduled to consider H.R. 5894 – the Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2024.
Senate
On November 6, Finance Committeeman Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released the Chairman’s Mark of the Better Mental Health Care, Lower-Cost Drugs And Extenders Act which would expand mental health care and substance use disorder services under Medicaid and Medicare, reform pharmacy benefit manager (PBM) practices, extend Medicaid and Medicare expiring provisions, and increase Medicare payments to physicians by 1.25%. On November 8, committee members unanimously voted to advance the bill.
On November 7, the Senate voted 62-36 to confirm the nomination of Dr. Monica Bertagnolli as director of the National Institutes of Health (NIH).
On November 7, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) sent a letter to Ambassador Pamela Hamamoto as negotiations on new rules for addressing pandemics are underway at the World Health Organization (WHO). The letter urges Ambassador Hamamoto to push for the inclusion of strong reasonable pricing, technology sharing, and access standards in the international agreement.
On November 8, HELP Committee Ranking Member Bill Cassidy (R-LA) released a statement bringing attention to the over 300 substance-abuse prevention and treatment, mental health and other policy organizations that have called on the HELP Committee to take up and reauthorize the SUPPORT Act. The SUPPORT Act funds programs that bolster prevention, treatment, and recovery services for Americans with substance use disorders. The SUPPORT Act expired on September 30, 2023.
On November 9, Finance Committee Chairman Wyden and Ranking Member Crapo sent letters requesting information from U.S. Customs and Border Protection (CBP), the Department of Homeland Security (DHS), and the Department of Health & Human Services (HHS) on how the departments are employing the use of artificial intelligence (AI) and what steps they are taking to ensure the technology is used appropriately. The letters urge the agencies to place important guardrails around the use of AI technology, to avoid unintended consequences such as bias in models and algorithms.
On November 9, Sen. Joe Manchin (D-WV) announced that he would not seek re-election. This presents Senate Republicans with their best pick-up opportunity in November. Popular Governor Jim Justice has already announced his intentions to run, as has Rep. Alex Mooney.
REGULATORY UPDATE
On November 6, CMS issued the contract year 2025 Medicare Advantage and Part D proposed rule. The proposed rule would promote access to behavioral health care providers, promote equity in coverage, improve utilization of supplemental benefits, and reform payments to third-party agents and brokers. A fact sheet detailing the rule can be found here. Comments are due January on 5, 2024.
On November 6, HHS, through the Health Resources and Services Administration (HRSA), announced the top 10% of health centers receiving a Gold Health Center Quality Leader badge for their achievements in improving health outcomes and providing high-quality care for patients in rural and underserved communities. A full list of badges and awardees is available here.
On November 6, CMS announced that it will host a webinar to share hospice-related updates around the Calendar Year (CY) 2024 Medicare Home Health Prospective Payment System final rule published on November 1. The webinar will take place on November 14 from 1:00 PM to 2:00 PM ET. Registration can be found here.
On November 7, the Federal Trade Commission (FTC) sent letters to 10 companies disputing the accuracy or relevancy of their patent listings for products like asthma inhalers and EpiPens. FTC is examining these companies’ patents listed in FDA’s Orange book. The companies could face legal action for improper Orange Book listings.
On November 8, FDA approved Eli Lilly’s Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition for use, in addition to a reduced calorie diet and increased physical activity. Tirzepatide, the active ingredient in Zepbound, is already approved under the trade name Mounjaro to be used along with diet and exercise to help improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
On November 8, CMS announced that it will begin displaying the “Birthing-Friendly” designation icon on CMS’ Care Compare online tool. CMS created the new designation to identify hospitals and health systems that participate in a statewide or national perinatal quality improvement collaborative program and that implement evidence-based care to improve maternal health.
On November 9, FDA cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326); Final Rule; 7/31/23
CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act (CMS-2447); Interim Final Rule; 8/16/23
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Proposed Rule; 9/18/23
Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities (CMS-6084); Final Rule; 9/19/23
Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057); Final Rule; 10/25/23
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Final Rule; 9/7/23
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability (CDER, 2023-357); Notice; 10/23/23
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability (CDER, 2023-356): Notice; 10/23/23
Menu Labeling: Supplemental Guidance for Industry (Edition 2); Draft Guidance for Industry; Notice; 10/31/23
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability; Notice; 11/8/23
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability; Notice; 11/9/23
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Final Rule’ 10/19/23
SAMHSA
Medications for the Treatment of Opioid Use Disorder; Final Rule; 10/24/23
REPORTS
Congressional Budget Office (CBO)
On November 6, CBO released a cost estimate of the of the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act and Certain Provisions of the Modernizing and Ensuring PBM Accountability (MEPA) Act.
Office of Inspector General (OIG)
On November 6, OIG released a report examining Medicare Part B payment amounts for two drugs that included noncovered self-administered versions in 2022. OIG found that CMS correctly removed noncovered self-administered versions of Orencia and Cimzia when calculating 2022 payment amounts, as required by law. Additionally, OIG found that payment amounts for both Fasenra and Xolair included noncovered self-administered versions in 2022, however, including the self-administered versions did not substantially affect per-injection payment amounts.
On November 7, OIG released a report examining CMS’ ability to leverage Medicare claims data to identify unreported incidents of potential abuse or neglect. OIG identified 30,258 Medicare claims for services provided from January 1, 2019, through December 31, 2020, that contained diagnosis codes indicating the treatment of injuries potentially caused by abuse or neglect of Medicare enrollees. Of the 100 Medicare claims sampled, 93 had medical records that contained evidence of potential abuse or neglect. OIG also determined that of these 93 claims, 14 were allegedly perpetrated by health care workers, 17 were related to incidents that occurred in medical facilities, and 18 were related to incidents that were not reported to law enforcement. On the basis of the sample results, OIG estimated that 27,522 of the 30,258 Medicare claims identified from 2019 and 2020 were supported by medical records that contained evidence of potential abuse or neglect. OIG made four recommendations including recommending that CMS conduct data analyses to identify trends and high-risk areas in Medicare claims containing diagnosis codes indicating potential abuse or neglect.
Government Accountability Office (GAO)
On November 7, GAO released a report examining building and maintaining infrastructure beyond the COVID-19 pandemic. GAO found that the COVID-19 pandemic demonstrated the need for strong public health infrastructure—including a skilled workforce and physical infrastructure—to prepare for and respond to threats. GAO noted that the Centers for Disease Control and Prevention (CDC) annually supports such infrastructure in states, localities, and territories through 2 programs. While these jurisdictions received billions of dollars in supplemental funding to respond to the pandemic, GAO found that state officials and others involved in preparedness said the temporary nature of supplemental funds meant that infrastructure changes are mostly temporary. GAO stated that this could affect the nation's response to future threats.
UPCOMING HEARINGS
House
Ways & Means Committee
TBD
Markup of drug and device legislation and hearing on the status of CMMI
Energy & Commerce Committee
Week of November 13
Markup of legislation including policies to reform the Part D program and PBMs, updating CMS’ national and local coverage decision policies, and low-cost, non-controversial bills.
Senate
Finance Committee
Health Subcommittee
November 14; 2:30 PM; 215 Dirksen
Ensuring Medicare Beneficiary Access: A Path to Telehealth Permanency
Witnesses: Nicki Perisho, Principal Investigator & Program Director, Northwest Regional Telehealth Resource Center; Eric Wallace, MD, Professor Of Medicine, UAB EMedicine, Medical Director, Co-Director of Home Dialysis, Director of Rare Genetic Kidney Disease Clinic, Division of Nephrology, Department of Medicine, University of Alabama at Birmingham; Chad Ellimoottil, MD, Associate Professor, Medical Director of Virtual Care, University of Michigan; Ateev Mehrotra, MD, Professor Of Health Care Policy, Department Of Health Care Policy, Harvard Medical School.
HELP Committee
December 15, TBD
Hearing on diabetes
TBD
Hearings on not-for-profit hospitals and the pharmaceutical industry