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:
Senators Bernie Sanders (I-VT) and Roger Marshall (R-KS) released a new draft health bill, the “Bipartisan Primary Care and Health Workforce Act,” and CMS announced Medicare beneficiary copays for 34 prescription drugs may be lower between October and December 2023.
I. Regulations, Notices & Guidance
- On September 11, 2023, the Food and Drug Administration (FDA) issued guidance entitled, Over-the-Counter Monograph Drug User Fee Program--OTC Monograph Order Requests Fee Rates for Fiscal Year 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMOR). This notice publishes the OMOR fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024.
- On September 12, 2023, FDA issued a notice entitled, Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn from Sale for Reasons of Safety or Effectiveness. FDA determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. Thus, the agency will not accept or approve abbreviated new drug applications (ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg.
- On September 14, 2023, the FDA issued a notice of establishment of a public docket entitled, Quality Management Maturity Program for Drug Manufacturing Establishments. FDA announced the establishment of a docket to solicit comments that will assist the agency in developing a Quality Management Maturity (QMM) program for establishments manufacturing human drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER).
- On September 14, 2023, FDA issued final guidance entitled, Breakthrough Devices Program. The document describes policies that FDA intends to use to implement a section of the FD&C Act. This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018, and describes how the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities. Consistent with the agency’s obligations under the SUPPORT for Patients and Communities Act (SUPPORT Act), the Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction.
- On September 14, 2023, FDA issued draft guidance entitled, Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals. The document provides recommendations on informed consent forms (ICF) used for studies that enroll client-owned companion animals.
- On September 15, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice of charter renewal entitled, Board of Scientific Counselors, National Institute for Occupational Safety and Health. CDC announced the renewal of the charter of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH).
- On September 15, 2023, FDA issued a notice entitled, Labeling for Biosimilar and Interchangeable Biosimilar Products. This draft guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products. The recommendations for biosimilar and interchangeable biosimilar product labeling in this draft guidance pertain only to the prescribing information, except for certain recommendations pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use). This draft guidance provides an overview of FDA’s recommendations for labeling for biosimilar and interchangeable biosimilar products. When finalized, this draft guidance will revise and replace the guidance for industry entitled “Labeling for Biosimilar Products.”
- On September 15, 2023, FDA issued draft guidance entitled, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989. This guidance is intended for applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products under section 506B of the FD&C Act and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70. FDA explains in the guidance that this document is intended for applicants that are required by statute or regulation, or that have agreed in writing, to conduct postmarketing studies or clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements (PMRs) or postmarketing commitments (PMCs).
- On September 15, 2023, FDA issued draft guidance entitled, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program. FDA issued this guidance to describe its policy regarding FDA’s participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices. The VIP builds on the framework piloted through FDA’s 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot.
- On September 15, 2023, FDA issued draft guidance entitled, Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations. This draft guidance document provides recommendations regarding clinical study design for devices with indications for use associated with weight loss, include discussion on how FDA considers the benefit-risk analysis to support such indications, and provide recommendations for the nonclinical testing to support premarket submissions for these medical devices.
- On September 15, 2023, FDA issued draft guidance entitled, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act. This draft guidance provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
- On September 15, 2023, FDA issued draft guidance entitled, Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations. This draft guidance document provides recommendations regarding clinical study design for devices with indications for use associated with weight loss, includes discussion on how FDA considers the benefit-risk analysis to support such indications, and provides recommendations for the nonclinical testing to support premarket submissions for these medical devices.
- On September 18, 2023, FDA issued draft guidance entitled, Labeling for Biosimilar and Interchangeable Biosimilar Products. This guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products or submission in an application under section 351(k) of the Public Health Service Act (PHS Act). The recommendations for biosimilar and interchangeable biosimilar product labeling in this guidance pertain only to the Prescribing Information, except for certain recommendations in section V of the draft guidance, FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar Products, pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use).
- October 13, 2023: NIH announced that the National Advisory Eye Council will hold a public in-person meeting. The meeting will discuss the National Eye Institute (NEI) Director’s report, various NEI programs, and concept clearances.
- October 16, 2023: NIH announced that the Interagency Pain Research Coordinating Committee will hold a public virtual meeting. The meeting will provide updates to the Helping to End Addiction Long-term and Federal Pain Research Strategy research progress, as well as committee business items and the Committee members’ updates.
- October 19, 2023: NIH announced that the Literature Selection Technical Review Committee will hold a in person meeting to discuss the National Library of Medicine Director’s report.
- October 24, 2023: NIH announced that the National Heart, Lung, and Blood Advisory Council will hold a hybrid meeting to discuss program policies and issues.
- November 16, 2023: Agency for Healthcare Research and Quality (AHRQ) announced a meeting of the National Advisory Council for Healthcare Research and Quality to discuss AHRQ’s conduct of its mission.
II. Hearings and Markups
U.S. House of Representatives
- On September 14, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Legislative Proposals to Prevent and Respond to Generic Drug Shortages. Legislation considered during this hearing included: H.R. ___, Stop Drug Shortages Act; H.R. 3008, Drug Shortage Prevention Act of 2023; H.R. 3810, Drug Origin Transparency Act of 2023; H.R. 3793, Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. Witnessed present included: Michael Ganio, Pharm.D., M.S., BCSCP, FASHP, Senior Director, Pharmacy Practice and Quality, American Society of Health System Pharmacists (ASHP); Todd Ebert, R.Ph., President and CEO, Healthcare Supply Chain Association (HSCA); Chester “Chip” Davis, Jr., JD, President and Chief Executive Officer, Healthcare Distribution Alliance (HDA); Melissa Barber, Postdoctoral fellow at the Yale School of Medicine, Yale Law School, and Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT); Allan Coukell, BScPharm, Senior Vice President, Public Policy, Civica; and David Gaugh, R.Ph., Interim President and CEO, Association for Accessible Medicines (AAM).
- On September 14, 2023, the House Committee on Oversight and Accountability, Select Subcommittee on the Coronavirus Pandemic hearing entitled, Oh Doctor, Where Art Thou? Pandemic Erosion of the Doctor-Patient Relationship. Witnesses present included: Jeffrey Singer, M.D., Surgeon, Senior Fellow, Cato Institute, Department of Health Policy Studies; Azadeh Khatibi, M.D., M.S., M.P.H, Physician, Medical Ethics and Freedom Advocate; Jerry Williams, M.D., Founder, Urgent Care 24/7; and Andi Shane, M.D., M.P.H, M S.C, Chief, Division of Infectious Diseases, Department of Pediatrics, Emory University School of Medicine.
- On September 14, 2023, the House Committee on Oversight and Accountability, Subcommittee on Health Care and Financial Services hearing entitled, The Inflation Reduction Act: A Year in Review. Witnesses present included Preston Brashers, PhD, Senior Policy Analyst, Tax Policy, Grover M. Hermann Center for the Federal Budget, The Heritage Foundation; and Joel White, President, Council for Affordable Health Coverage.
III. Reports, Studies & Analyses
- On September 11, 2023, the Congressional Research Service (CRS) released a report entitled Naloxone for Opioid Overdose: Considerations for Congress. Naloxone is a medication that can reverse an opioid overdose, and CRS noted that Congress may have an interest in increasing the accessibility of the drug. CRS emphasized the following areas of naloxone policy that Congress could consider: the distribution of naloxone; the cost; federal funding; education, training, and accessibility; and Good Samaritan laws and liability protections.
- On September 11, 2023, the Kaiser Family Foundation (KFF) released a brief entitled, How Many Physicians Have Opted Out of the Medicare Program? The brief explains that Medicare physician payments are on average lower than payments from private insurers, potentially leading physicians to opt out of Medicare, potentially leading to a shortage of physicians willing to treat people with Medicare. The brief found that one percent of all non-pediatric physicians have opted out of Medicare in 2023. Among all the medical specialties, psychiatrists account for the largest share of physicians who opted out of Medicare.
- On September 12 2023, the HHS Office of Inspector General (OIG) released a report entitled, Medicare Improperly Paid Acute-Care Hospitals for Inpatient Claims Subject to the Post-Acute-Care Transfer Policy Over a 4-Year Period, but CMS's System Edits Were Effective in Reducing Improper Payments by the End of the Period. OIG sought to investigate improper claims pursuant to Medicare’s post-acute-care transfer policy (transfer policy). According to OIG, some hospitals transferred patients to certain post-acute care settings, such as skilled nursing facilities (SNFs), but claimed the higher reimbursements associated with discharges to home. OIG found that during the study period, Medicare improperly paid $41.4 million to acute-care hospitals for inpatient claims subject to the transfer policy.
- On September 14, 2023, the Congressional Budget Office (CBO) released a report entitled, Estimated Direct Spending and Revenue Effects of H.R. 5378, the Lower Costs, More Transparency Act. CBO and the staff of the Joint Committee on Taxation estimated that enacting sections 101, 102, 103, 104, 105, 107, 108, 109, 110, and 401 of H.R. 5378 would have no effect on direct spending or revenues. Further, the report found that the PBM transparency requirements in section 402 would not have incremental effects on direct spending and revenues and are estimated to have no cost. CBO estimates that if section 402 was enacted by itself, the deficit would be $1.3 billion smaller over the 2023-2033 period.
IV. Other Health Policy News
- On September 11, 2023, Senators Bill Cassidy (R-LA), Roger Marshall (R-KS), Mike Braun (R-IN), Ted Budd (R-NC) urged the Food and Drug Administration (FDA) to provide more on its intent to reorganize the Human Foods Program. Under the reorganization, all of the FDA’s Human Foods Program divisions will be combined into one organization led by a Deputy Commissioner for Human Foods. The Senators noted that FDA has had recent shortcomings with respect to its oversight of foods, including the infant formula crisis. Thus, the Senators emphasized the importance of this reorganization and demanded more information to assess whether it would foster an improved culture with the Human Foods Program. The letter can be found here.
- On September 12, 2023, an updated draft of the Lower Costs, More Transparency Act was released and could move to the House floor for a vote the week of September 18, 2023. The legislation is focused on health care price transparency including increased oversight of pharmacy benefit managers (PBMs), site-neutral reimbursement policies, and extending certain funding that is due to expire on September 30, 2023, for Community Health Centers, the National Health Service Corps, and the Teaching Health Centers Graduate Medical Education Program. This legislation would also delay the start of Medicaid Disproportionate Share Hospital (DSH) payment cuts scheduled to take effect on October 1, 2023, for two years. The updated draft of the bill can be found here. More information on the vote can be found here.
- On September 13, 2023, CMS announced the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Under the Inflation Reduction Act, drug companies must pay a rebate to CMS if it raises prices for certain drugs faster than the rate of inflation. More information can be found here, the list of 34 prescription drugs can be found here, and a fact sheet can be found here.
- On September 13, 2023, Senators Mark Warner (D-VA), John Thune (R-SD), Catherine Cortez Masto (D-NV), Shelley Moore Capito (R-WV), Dan Sullivan (R-AK), and Sheldon Whitehouse (D-RI) wrote a joint letter to the Drug Enforcement Agency (DEA) Administrator Anne Milgram on their concerns about the agency’s new proposals to walk back flexibilities in prescribing controlled substances via telemedicine established during the COVID-19 public health emergency. The Senators wrote that DEA’s proposals are insufficient to meet the country’s health care needs, and said they are concerned about the rule’s requirement that an individual needs to obtain a in person appointment within 30 days of starting a new controlled substance medication. The letter can be found here.
- On September 14, 2023, the Senate HELP Committee released a healthcare workforce bill entitled the Bipartisan Primary Care and Health Workforce Act. The bill would reauthorize numerous healthcare workforce programs, such as the Teaching Health Center Graduate Medical Education (THCGME) program, the Community Health Center Fund, and the National Health Service Corps. The bill would also implement site neutral payments for beneficiaries with private health plans for certain in-person evaluation and management services. The bill is co-sponsored by Senator Bernie Sanders (I-VT), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Senator Rodger Marshall, Ranking Member of the Subcommittee on Primary Health and Retirement Security of the HELP Committee. The Senate HELP Committee will hold a markup on this bill on September 21, 2023. Of note, Ranking Member Bill Cassidy (R-LA) announced he opposes the bill. More information can be found here, the bill text can be found here, and a summary of the bill can be found here.
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