Health Care Week in Review: Rep. McCarthy Ousted as Speaker of the House; CMS Announces Drug Manufacturer Participation in Medicare Price Negotiations

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, Rep. Kevin McCarthy (R-CA) was ousted as Speaker of the House and CMS announced all manufacturers of the selected drugs for the Medicare Part D Price Negotiation Program will participate. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On October 2, 2023, the Food and Drug Administration (FDA) issued the following guidance entitled, Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding”. This guidance provides recommendations to assist applicants in incorporating information into proposed human prescription drug labeling for injectable drug products when: (1) dosing for the drug product is based on weight or body surface area (BSA); (2) the drug product is available in a range of strengths in ready-to-use containers; and (3) the entire drug content of the ready-to-use container(s) is intended to be administered to a patient. For the purposes of this guidance, this practice is referred to as dose banding. This guidance applies to proposed labeling in a new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); a biologics license application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act); or a supplement to one of these approved applications.  
• On October 3, 2023, FDA issued the following guidance entitled, Electronic Submission Template for Medical Device 510(k) Submissions. This guidance document introduces submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA. This guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This guidance facilitates the implementation of FDA’s mandate under section 745A(b) of the FD&C Act, amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA) to provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.  
• On October 3, 2023, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce. AHRQ is seeking scientific information submissions from the public. Specifically, scientific information is being solicited to inform the review on Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.  
• On October 3, 2023, AHRQ issued a notice entitled, Patient Safety Organizations: Voluntary Relinquishment for The Envision Healthcare Center for Quality and Patient Safety. The Patient Safety and Quality Improvement final rule authorizes AHRQ, on behalf of the Secretary of the Department of Health and Human Services (HHS), to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO’s listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Envision Healthcare Center for Quality and Patient Safety PSO, PSO number P0197, of its status as a PSO, and has delisted the PSO accordingly.  
• On October 3, 2023, the Centers for Medicare & Medicaid (CMS) issued a notice entitled, Privacy Act; Matching Program. In accordance with the Privacy Act of 1974, as amended CMS is providing notice of the re-establishment of a matching program between CMS and State-Based Administering Entities (AEs) entitled, Determining Eligibility for Enrollment in Applicable State Health Subsidy Programs Under the Patient Protection and Affordable Care Act.  
• On October 3, 2023 FDA issued a notice entitled, ULTRAM (Tramadol Hydrochloride) Tablets, 50 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. FDA has determined that ULTRAM (tramadol hydrochloride) Tablets, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.  
• On October 3, 2023, FDA issued a notice entitled, Withdrawal of Approval of 11 Abbreviated New Drug Applications: Dr. Reddy's Laboratories, Inc. FDA is withdrawing approval of 11 ANDAs from Dr. Reddy’s Laboratories, Inc. The applicant notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.   On October 3, 2023, HHS issued a proposed rule entitled, National Institute on Minority Health and Health Disparities Research Endowment Programs. HHS, through the National Institutes of Health (NIH), is proposing to amend the regulation governing the National Institute on Minority Health and Health Disparities (NIMHD) Research Endowment Programs (REP) to update the heading of the regulation to reflect the new name of the program, the eligibility requirements for the program to indicate the new expanded eligibility for research endowment awards that is mandated by statute, the heading of one section of the regulation, and certain references to regulations and policies cited in the regulation that apply to program grant awards.  
• On October 3, 2023, the Indian Health Service (IHS) issued a notice entitled, Special Diabetes Programs for Indians. IHS is accepting applications for the Special Diabetes Program for Indians (SDPI – formerly Community-Directed SDPI). This program is authorized under the Snyder Act; the Transfer Act, and Section 330C of the Public Health Service Act (PHS Act), codified at 42 U.S.C. 254c-3.  
• On October 4, 2023, CMS issued an RFI entitled, Request for Information; Coverage of Over-the-Counter Preventive Services. This RFI addresses the application of the preventive services requirements under section 2713 of the PHS Act to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider. The Department of the Treasury, the Department of Labor (DOL), and HHS (the Departments) are issuing this CMS-9891-NC 2 RFI to (1) gather input from the public regarding the potential benefits and costs of requiring non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage to cover OTC preventive items and services without cost sharing and without a prescription by a health care provider; (2) seek comment on any potential challenges associated with providing such coverage; (3) understand whether and how providing such coverage would benefit consumers; and (4) assess any potential burden that plans and issuers would face if required to provide such coverage. Comments must be received by December 4, 2023.  
• On October 4, 2023, FDA issued guidance entitled, Stimulant Disorders: Developing Drugs for Treatment. The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. Specifically, this guidance addresses FDA’s current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications of treatment of moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder.  
• On October 4, 2023, FDA issued a notice entitled, Revocation of Eleven Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19. FDA announced the revocation of the Emergency Use Authorizations (EUAs) issued to Luminostics, Inc.; NeuMoDx Molecular, Inc.; LGC, Biosearch Technologies; LGC, Biosearch Technologies; Becton, Dickinson and Co.; Verily Life Sciences; Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard; Xtrava Health; Exact Sciences Laboratories; and dba SpectronRx. FDA revoked these Authorizations under the FD&C Act as requested by the authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted in the notice.  
• On October 5, 2023, HHS issued a proposed rule entitled, Public Health Service Policies on Research Misconduct. HHS, the Office of the Secretary, the Office of the Assistant Secretary for Health (OASH), and the Office of Research Integrity (ORI) propose to revise the Public Health Service (PHS) policies on research misconduct. The proposed revisions are based on the experience ORI and institutions have gained with the regulation since it was released in 2005. This NPRM seeks comment from individuals, institutional officials, organizations, institutions, research funding agencies, and other members of the public on the proposed revisions and how to improve the clarity of substantive and non-substantive.   On October 5, 2023, HHS issued a rule entitled, Annual Civil Monetary Penalties Inflation Adjustment. HHS updated its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts in its regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and adds references to new penalty authorities. 
• On October 6, 2023, the Drug Enforcement Agency (DEA) and HHS issued a temporary rule entitled, Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. On March 1, 2023 DEA, in concert with HHS, promulgated two notices of proposed rulemakings (NPRMs) soliciting comments on proposals to allow for prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. On May 10, 2023, DEA, jointly with HHS, issued a temporary rule extending certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID–19 Public Health Emergency (COVID–19 PHE). In this second temporary rule, as DEA and HHS continue to consider revisions to the proposed rules set forth in the March 1, 2023, NPRMs, DEA and HHS are further extending such exceptions to existing DEA regulations for new practitioner-patient relationships through December 31, 2024.  

Event Notices

• October 11, 2023: FDA announced that the Office of Women’s Health Office of Clinical Pharmacology will hold a public workshop entitled, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research. The purpose of the public workshop is to discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA regulated drugs and biologics used by menopausal women for non-menopause-related indications.  
• October 13, 2023: NIH announced that the National Advisory Eye Council will hold a public in-person meeting to discuss the National Eye Institute (NEI) Director’s report, various NEI programs, and concept clearances.  
• October 17 and 18, 2023: CDC announced that it will hold public information sessions entitled, World Trade Center Health Program; Notices of Funding Opportunities Public Information Sessions. These sessions will provide information on current research funding opportunities published by the World Trade Center (WTC) Health Program and will provide information to members of the public who may be interested in submitting applications for funding.  
• October 18, 2023: HHS announced that the Secretary’s Advisory Committee on Health Research Protections will hold a virtual meeting open to the public.  
• October 18, 2023: NIH announced a meeting of the Advisory Committee on Research on Women's Health. This is a virtual meeting open to the public.  
• October 25 and October 26, 2023: HHS announced a meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. This is a hybrid meeting that is open to the public.  
• October 25, October 26, and October 27, 2023: CDC announced it will hold a meeting of the Advisory Committee on Immunization Practices. This meeting is open to the public and time will be available for public comment.  
• October 26, 2023: NIH announced a meeting of the Office of AIDS Research Advisory Council that will focus on focus on HIV and health disparities, guest speakers and a discussion panel. This is a virtual meeting open to the public.  
• October 26, 2023: HHS announced a meeting of the President’s Council on Sports, Fitness, and Nutrition. This is a virtual meeting open to the public.  
• October 31, 2023: NIH announced a meeting of the National Advisory Child Health and Human Development Council Stillbirth Working Group. This is a virtual meeting that is open to the public.  
• October 31 and November 1, 2023: CMS announced a meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. The committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the DOL, HHS, and the Treasury, and relevant States, and the prevention of balance billing to consumers. This is a virtual meeting that is open to the public.  
• November 2 and 3, 2023: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting open to the public.  
• November 7, 2023: FDA announced a meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting that is open to the public.
• November 14, 2023: CDC announced a meeting of the Advisory Committee to the Director, CDC. This is a hybrid meeting that is open to the public. There will be an opportunity for public comment.  
• November 16, 2023: NIH announced that the Diabetes Mellitus Interagency Coordinating Committee will hold a public online meeting entitled, The Application of Digital Health Technology to Type 2 Diabetes Management: Current Status, Research Gaps, and Opportunities.  
• November 16, 2023: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting that will be open to the public and FDA is establishing a docket for public comment on this document.  
• November 17, 2023: NIH announced a meeting of the National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group. This is a virtual meeting that is open to the public.  
• November 29, 2023: NIH announced the National Cancer Institute will hold a meeting of their Frederick National Laboratory Advisory Committee. This meeting will be held virtually and is open to the public.  
• November 30, 2023: FDA announced it will hold a public workshop entitled, Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients with Renal Impairment. The workshop will discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.  
• December 4 and 5, 2023: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The meeting will be videocast and is open to the public.  
• December 6, 2023: the Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include reports from the ISUDCC Working Groups, and discussion of the ISUDCC’s recommendations to HHS on how the federal government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices. This is a virtual meeting that is open to the public.  
• December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting of the Sleep Disorders Advisory Board. This is a virtual public meeting that requires registration to attend.  
• December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting to update their Advisory Board and public stakeholders on research agendas across NIH for fiscal year (FY) 2024. This is a virtual public meeting that requires registration to attend.  
• December 12 and 13, 2023: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This is a virtual meeting open to the public.  
• December 13 and December 14, 2023: HHS announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).  
• January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.   

II. Reports, Studies & Analyses

• On September 29, 2023 the Office of Inspector General (OIG) released a report entitled, New Jersey Could Better Ensure That Nursing Homes Comply With Federal Requirements for Life Safety, Emergency Preparedness, and Infection Control. OIG found that New Jersey could better ensure that nursing homes participating in Medicare or Medicaid programs comply with federal requirements for life safety, emergency preparedness, and infection control if additional resources were available. OIG identified deficiencies related to life safety, emergency preparedness, or infection control at all 20 nursing homes that were audited during the investigation, totaling 363 deficiencies. OIG stated that the identified deficiencies occurred because of frequent management and staff turnover, which contributed to a failure to address federal requirements. In addition, OIG found that New Jersey had limited resources to conduct surveys of all nursing homes more frequently than CMS required.
• On October 2, 2023 OIG released a report entitled, Biosimilars Have Lowered Costs for Medicare Part B and Enrollees, but Opportunities for Substantial Spending Reductions Still Exist. OIG stated that biosimilars have led to lower costs in the Medicare Part B program for enrollees, remain more affordable, and could be more widely utilized. OIG estimated that increased use of biosimilars instead of reference products could have saved Medicare Part B and enrollees $179 million dollars, or four percent. This report identifies alternative payment policies that could have reduced spending by an estimated $419 million dollars, or nine percent, in 2021, even without an increase in the use of more affordable biosimilars.  
• On October 4, 2023, the RAND Corporation published a journal article entitled, National Travel Distance for Emergency Care. This article analyzed the distances a randomly collected sample of patients travelled between their home addresses and the hospital-based emergency department (ED) addresses to receive care. The authors conducted the study to understand how far patients are willing to travel for care, and if this metric is indicative of whether patient populations have adequate access to ED services. Analysis of the data shows that patients travel farther to avoid a low-performing hospital, and the authors provide evidence that discharged to the community (DTC) patients likely do exercise some choice among EDs, indicating market incentives for higher-quality care. The authors noted analysis of this issue will help policymakers better define access to ED care and assist in directing quality improvement efforts.    

III. Other Health Policy News

• On September 30, 2023, President Joe Biden signed into law a continuing resolution (CR) entitled, the Continuing Appropriations Act, 2024 and Other Extensions Act, which temporarily averts a government shutdown. The 71-page short term bill funds the government through November 17, 2023, giving the House and Senate additional time to pass the 12 appropriations bills that fund the federal government. The CR also includes short-term funding extensions for community health centers (CHCs), the Teaching Health Center Graduate Medical Education (THCGME) program, and the Special Diabetes Programs until November 17, 2023. Additionally, the legislation delays cuts to disproportionate share hospital (DSH) programs and includes disaster relief funding.  Of note, the CR does not address other health programs that expired on October 1, 2023. These include federal addiction programs created by the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), certain maternal health programs, and pandemic preparedness funding. The bill text is available here.
• On October 3, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the manufacturers of all the selected drugs for the Medicare Part D Price Negotiation Program (Negotiation Program) for 2026 have chosen to participate. The Inflation Reduction Act (IRA), signed into law in August 2022, granted CMS the ability to directly negotiate drug prices in Medicare on certain high expenditure, single source drugs without generic or biosimilar competition. In August 2023, CMS announced the ten drugs covered under Medicare Part D selected for the first cycle of negotiations. CMS has until February 1, 2024 to send an initial offer of what the agency considers a maximum fair price for the drug, followed by six months of negotiations with the drug manufacturers. On January 1, 2026, maximum fair prices negotiated between Medicare and drug manufacturers for the selected drugs will take effect. The fact sheet with more information is available here.  
• On October 3, 2023, House members voted to remove Representative Kevin McCarthy (R-CA-20) from his position as Speaker of the House in a historic 216-210 vote. The Motion to Vacate was brought to the House floor by Representative Matt Gaetz (R-FL-1). All House Democrats and eight Republicans voted in favor of removing Representative McCarthy. This marks the first time in history that the Speaker has been removed through a vote and came on the heels of Representative McCarthy’s decision to work with Democrats to pass a CR last week to avert a government shutdown. Representative Patrick Henry (R-NC-10) has been named “Speaker pro tempore,” the interim speaker, whose responsibilities include exercising authorities as are “necessary and appropriate” to elect a new Speaker. In the absence of a Speaker of the House, much Congressional business—such as voting on appropriations legislation—will be halted. This could have a significant impact on appropriations negotiations that are necessary to avoid a government shutdown once the CR expires on November 17, 2023. The House is in recess until next week, and it is expected they will hold the first vote to elect a new Speaker on October 11, 2023.  
• On October 3, 2023, Senate Committee on Finance Chair Ron Wyden (D-OR) and House Committee on Energy and Commerce Ranking Member Frank Pallone (D-NJ) announced an investigation into the prior authorization practices of several of the nation’s largest Medicaid Managed Care Organizations (MCOs). Specifically, Committee members are seeking to investigate the high rate of denials of prior authorizations by MCOs. The announcement references a recent report by the HHS OIG which found “that MCOs denied, on average, one out of every eight prior authorization requests for service – a denial rate of 12.5 percent, which is more than double the denial rate in Medicare Advantage”. The companies contacted as a part of the investigation include Aetna, Inc., AmeriHealth Caritas, CareSource, Centene Corporation, Elevance, Molina Healthcare Inc., and United Healthcare. The announcement is available here.
• On October 4, 2023, SAMHSA announced nearly $35 million in grant awards intended for comprehensive behavioral health care and HIV prevention care to historically underserved populations. The funds align with the Biden Administration’s commitment to address and remedy inequities in care through focusing on the mental health crisis and opioid epidemic. The grant awards facilitate ongoing efforts throughout the nation to expand treatment, recovery support, and harm reduction programs. The grant awards also advance the Biden Administration’s National Drug Control Strategy and support the goals of the National HIV Strategy. The press release with more information is available here.  
• On October 5, 2023, CMS announced it will release three new state reports on the Medicare-Medicaid Financial Alignment Initiative (FAI), a CMS partnership with states that tests payment models designed for Medicare-Medicaid enrollees to improve quality, reduce expenditures, and integrate primary, acute, behavioral health, and long-term services to create a more connected system. CMS is releasing the third evaluation report for Ohio, the preliminary third evaluation report for the New York Intellectual and Developmental Disabilities (IDD) demonstration, and an actuarial report for the Washington demonstration. More information on the Medicare-Medicaid FAI is available here.  

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