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, CMS issued a final rule simplifying the Medicare Savings Program in Medicaid and the Senate HELP Committee held a markup of legislative proposals to boost primary care access and address health workforce shortages. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On September 15, 2023, the Department of Health and Human Services (HHS) issued guidance entitled, Basic Health Program, Federal Funding Methodology for Program Year 2024. This Informational Bulletin specifies the final values for the factors needed to calculate the Federal Basic Health Program (BHP) payment rates for 2024, using the methodology published in the 2023 BHP final rule. In addition, this guidance reminds states operating a BHP for 2024 of the need to make two decisions: (1) whether to develop a retrospective population health factor (PHF) adjustment methodology; and (2) whether to use the 2023 or 2024 qualified health plan (QHP) premiums as the basis for calculating the 2024 BHP federal payments.
- On September 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Streamlining Medicaid; Medicare Savings Program Eligibility Determination and Enrollment. This final rule simplifies processes for eligible individuals to enroll and retain eligibility in the Medicare Savings Programs (MSPs). This final rule better aligns enrollment into the MSPs with requirements and processes for other public programs. Finally, this final rule reduces the complexity of applications and reenrollment for eligible individuals.
- On September 18, 2023, FDA issued a request for comments on Information Technology Strategy. The Food and Drug Administration (FDA) is announcing the availability of an information technology (IT) strategic plan, the “FDA Information Technology Strategy”, and a request for comment on this IT Strategy. As part of our User Fee Program commitments and Omnibus Bill requirements, FDA will develop and publish an FDA Data and Technology Strategic Plan by September 29, 2023. This plan will define and shape the future course of FDA’s data and technology capabilities, building on the existing FDA Modernization Framework. The plan will also integrate FDA and strategies. Electronic or written comments on the Strategy are due by October 30, 2023.
- On September 18, 2023, FDA issued draft guidance entitled, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act. This guidance provides answers to common questions from prospective applicants and 17 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 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 for submission in an application under 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, 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).
- On September 19, 2023, FDA issued draft guidance entitled, Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. This guidance (the Confirmatory Evidence guidance) complements the draft guidance for industry Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (December 2019) (the 2019 Effectiveness draft guidance) and the guidance for 21 industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (May 1998) (the 1998 Effectiveness guidance). This guidance provides recommendations for sponsors to consider when planning a drug development program.
- On September 19, 2023, FDA issued draft guidance entitled, Regulatory Considerations for Prescription Drug Use Related Software. The guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) as the lead center. This guidance expands on and was developed in response to comments submitted in response to the Federal Register notice entitled, Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.
- On September 20, 2023, the Health Resources and Services Administration (HRSA) issued a notice of supplemental funding entitled, Supplemental Funding Opportunity: Fiscal Year 2023. This notice is intended to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is proposing to provide one-year supplemental funding in fiscal year (FY) 2023 to three Hawaii grant programs to support Maui residents in the aftermath of the Maui wildfires. The Hawaii State Department of Health, the recipient for Certified Community Behavioral Health Clinics Planning, Development, and Implementation (CCBHC-PDI), Grants for Expansion and Sustainability of the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances Program (CMHI), and Community Mental Health Services Block Grant (MHBG) will be offered a total of $2,765,556 in supplemental funding since they are the only recipient providing or able to provide services to Maui residents.
- On September 21, 2023, FDA issued draft guidance entitled, Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies. Disasters and public health emergencies (PHEs) have the potential to cause major disruptions in the conduct of clinical trials for medical products. Such events can include (but are not limited to) hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks. FDA is issuing this guidance to provide general considerations to assist sponsors, institutional review boards (IRBs), and clinical investigators in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during disasters and PHEs that may lead to major disruption of clinical trial conduct and operations. The appendix to this guidance further explains these general considerations in a question-and-answer format.
- On September 21, 2023, FDA issued a request for information entitled, In-Home Disposal Systems for Opioid Analgesics. FDA is reopening the comment period for the notice entitled, In-Home Disposal Systems for Opioid Analgesics; Request for Information , which was published in the Federal Register on April 4, 2023. FDA is reopening the comment period to allow interested persons additional time to develop and submit comments.
- On September 21, 2023, CMS issued proposed rules entitled, Federal Independent Dispute Resolution Process Administrative Fee and Certified IDR Entity Fee Ranges. This document sets forth proposed rules related to the fees established by the No Surprises Act for the federal independent dispute resolution (IDR) process, as established by the Consolidated Appropriations Act, 2021. These proposed rules would amend existing regulations to provide that the administrative fee amount charged by the Department of the Treasury, the Department of Labor, and HHS (the Departments) to participate in the federal IDR process, and the ranges for certified IDR entity fees for single and batched determinations will be set by the Departments through notice and comment rulemaking. These proposed rules would also set forth the methodology used to calculate the administrative fee and the considerations used to develop the certified IDR entity fee ranges. In addition, these proposed rules propose the amount of the administrative fee for disputes initiated on or after the later of the effective date of these rules or January 1, 2024. Finally, these proposed rules propose the certified IDR entity fee ranges for disputes initiated on or after the later of the effective date of these rules or January 1, 2024.
- On September 22, 2023, FDA issued draft guidance entitled, Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications. The purpose of this guidance is to provide information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications).
- On September 22, 2023, FDA issued draft guidance entitled, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter referred to as products) regulated by CDER and CBER.
- October 4, 2023: NIH announced that the National Cancer Institute Council of Research Advocates will hold a meeting to discuss National Cancer Institute updates.
- 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 an online meeting.
- 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.
II. Hearings and Markups
U.S. House of Representatives
- On September 19, 2023, the House Committee on Oversight and Accountability held a hearing entitled, The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered. Witnesses present included JC Scott, President and CEO, Pharmaceutical Care Management Association (PCMA); Lori Reilly, COO, PhRMA; Craig Burton, Executive Director, BioSimilars Council Senior Vice President, Association for Accessible Medicines (AAM); Hugh Chancy, RPh President, National Community Pharmacists Association (NCPA); and Rena Conti, Associate Professor, Markets, Public Policy, and Law Boston University.
- On September 19, 2023, the House Ways and Means Committee held a hearing entitled, Reduced Care for Patient: Fallout From Flawed Implementation of Surprise Medical Billing Protections. Witnesses present included Dr. Seth Bleier, MD, Vice President of Finance, Wake Emergency Physicians Professional Association; Mr. James Bobeck, President, Federal Hearings & Appeals Services, Inc.; Ms. Diane Spicer, Supervising Attorney, Community Health Advocates, Community Services Society; Ms. Jeanette Thornton, Executive Vice President of Policy and Strategy, America’s Health Insurance Plans; and Mr. Jim Budzinski, Executive Vice President & Chief Financial Officer, WellStar Health System.
- On September 19, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology. Legislation considered during this hearing included: H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023; H.R. 2408, the Access to Innovative Treatments Act of 2023; H.R. 133, the Mandating Exclusive Review of Individual Treatments (MERIT) Act; H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 1199, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023; H.R. 3842, the Expanding Access to Diabetes Self-Management Training Act of 2023; H.R. 1458, the Access to Prescription Digital Therapeutics Act of 2023; H.R. 2880, the Protecting Patients Against PBM Abuses Act; H.R. 5074, the Kidney PATIENT Act of 2023; H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program.; H.R. 5372, To amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars; H.R. 5376, the Share the Savings with Seniors Act; H.R. 5371, the Choices for Increased Mobility Act of 2023; H.R. 5394, the Expanding Remote Monitoring Access Act; H.R. 5386, the Cutting Copays Act; H.R. 5393, the Transparency and Fairness for Pharmacies Act; H.R. 5389, the National Coverage Determination Transparency Act; H.R. 5395, the Coverage Parity for Medicare Patients Act of 2023; H.R. 5396, the Coverage Determination Clarity Act of 2023; H.R. 5392, the Timely Access to Coverage Decisions Act of 2023; H.R. 5397, the Joe Fiandra Access to Home Infusion Act of 2023; H.R. 5385, the Medicare PBM Accountability Act; H.R. 5388, the Supporting Innovation for Seniors Act; and H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. Witnesses present included: Dr. Dora Hughes, MD, MPH, Acting Director, Center for Clinical Standards and Quality, Acting Chief Medical Officer, U.S. Centers for Medicare and Medicaid Services; and Mr. John Dicken, Director, Health Care, Public Health and Private Markets, U.S. Government Accountability Office.
- On September 20, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, At What Cost: Oversight of How the IRA's Price Setting Scheme Means Fewer Cures for Patients. Witnesses present included Mr. John Czwartacki, Founder Survivors for Solutions; Dr. Steve Potts, Ph.D., MBA Chair, Drug Development Council International Cancer Advocacy Network; Mr. John Crowley, Executive Chairman Amicus Therapeutics, Inc.; and Dr. Aaron S. Kesselheim, M.D., J.D., M.P.H. Professor of Medicine at Harvard Medical School, Director, Program on Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital.
- On September 19, 2023, the Senate Finance Committee Subcommittee on Health Care held a hearing entitled, Aging in Place: The Vital Role of Home Health in Access to Care. Witnesses present included Carrie Edwards, RN BSN MHA LSSGB, Director, Home Care Services, Mary Lanning Healthcare; Judith Stein, JD, Executive Director/Attorney, Center for Medicare Advocacy; Tracy M. Mroz, Ph.D., OTR/L, FAOTA, Associate Professor, University of Washington; William A. Dombi, JD, President, National Association of Home Care & Hospice; and David C. Grabowski, Ph.D., Professor, Harvard Medical School.
- On September 21, 2023 the Senate Committee on Health, Education, Labor, and Pensions (HELP) held an markup entitled, S. 1573, S. 2415, S. 1624, S._, Bipartisan Primary Care and Health Workforce Act. Legislation considered during the markup included: S. 1573, the PREEMIE Reauthorization Act of 2023; S. 2415, Preventing Maternal Deaths Reauthorization Act of 2023; S. 1624, Gabriella Miller Kids First Research Act 2.0; and S. 2840, the Bipartisan Primary Care and Health Workforce Act.
III. Reports, Studies & Analyses
- On September 19, 2023, the U.S. Government Accountability Office (GAO) released a report entitled, Medicare Part D:CMS Should Monitor Effects of Rebates on Drug Coverage and Spending. The report covered testimony from John E. Dicken, Director, Health Care before the House Energy and Commerce Committee Subcommittee on Health. The testimony discussed the key role of Medicare Part D drug coverage in giving beneficiaries access to innovative drug treatments. GAO found that while rebates that drugmakers give private insurance plans in exchange for preferred placement over competitors on formularies may lower plan premiums, they do not reduce beneficiaries’ payments for the drugs.
- On September 19, 2023, the Kaiser Family Foundation (KFF) issued a brief entitled, Pandemic-Era Changes to Medicaid Home- and Community-Based Services (HCBS): A Closer Look at Family Caregiver Policies. Drawing from KFF’s 50-state survey of state Medicaid HCBS officials conducted between May and August of 2023, this issue brief describes how states used the PHE authorities to strengthen their HCBS programs; changes as the PHE ends; and the role of family caregivers in providing HCBS.
- On September 22, 2023, GAO released a report entitled, Medicaid Program Integrity: Opportunities Exist for CMS to Strengthen Use of State Auditor Findings and Collaboration. This report describes state auditors’ Medicaid findings and the challenges they face auditing Medicaid. It also examines CMS’s use of state auditors’ findings and collaboration with auditors. From FYs 2019 through 2021, state auditors identified an average of over 300 Medicaid audit findings a year, including overpayments for services provided to beneficiaries and payments to providers not enrolled in Medicaid. CMS monitors states’ progress toward resolving these findings. GAO found nearly 60 percent of Medicaid single audit findings were repeated from the prior year, indicating incomplete or ineffective corrective actions.
IV. Other Health Policy News
- On September 18, 2023, the U.S. House of Representatives was set to vote on the Lower Cost, More Transparency Act, but the proposal was pulled from the calendar Monday afternoon. It is unclear when the bill will be scheduled again for a vote.
- On September 19, 2023, House leadership canceled a procedural vote on a proposed continuing resolution (CR). The legislation, entitled the Continuing Appropriations and Border Security Enhancement Act, 2024, was intended to avert a government shutdown by extending government funding until October 31, 2023. The CR also included an eight percent cut to all discretionary spending outside of the Department of Defense and the Department of Veterans Affairs. Currently, it appears unlikely that negotiations in Congress will lead to the passage of appropriations legislation by the October 1, 2023 deadline. It is more likely that Congress will pass a CR to continue to fund the government until a deal is reached or Democrats and Republicans may fail to reach an agreement, resulting in a government shutdown. The Continuing Appropriations and Border Security Enhancement Act, 2024 is available here. A Congressional Research Service Report entitled Shutdown of the Federal Government: Causes, Processes, and Effects is available here.
- On September 20, 2023, the Biden-Harris Administration announced awards of $600 million dollars to bolster U.S. manufacturing of COVID-19 tests and announced the re-opening of COVIDTests.gov. These manufacturing investments will improve preparedness for COVID-19 and secure approximately 200 million over-the-counter COVID-19 tests for federal government use. On September 25, households will be able to order four free tests through COVIDTests.gov. These tests will detect the currently circulating COVID-19 variants and are intended for use through the end of 2023. A press release with more information is available here.
- On September 20, 2023, HHS, through the Agency for Healthcare Research and Quality (AHRQ), announced grant awards totaling $45 million dollars to expand access to care for people with long covid. Nine grants of $1 million each for up to five years will be awarded to support existing multidisciplinary Long COVID clinics across the country to expand access to comprehensive, coordinated, and person-centered care for people with Long COVID, particularly underserved, rural, vulnerable, and minority populations that are disproportionately impacted by the effects of Long COVID. The press release is available here.
- On September 21, 2023, CMS required states to pause disenrollments and reinstate Medicaid and the Children’s Health Insurance Program (CHIP) coverage to individuals impacted by technical issues that were inappropriately disenrolling them from the programs. Following reports of system-wide issues among 30 states, CMS required a pause on disenrollments for all impacted individuals, unless states could ensure all eligible people would not be improperly disenrolled. Nearly 500,000 children and individuals will regain their Medicaid and CHIP coverage and be protected from improper disenrollments moving forward. A press release with more information is available here.
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