Health Care Watch: June 24, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 18 – June 24. 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 June 21, more than 230 House members and 61 Senators, led by Rep. Suzan DelBene (D-WA), sent a letter to Department of Health & Human Services Secretary (HHS) Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urging CMS to make changes to a proposed rule that would require health insurance companies to modernize the way they process requests from providers to authorize treatments. The letter calls on the agency to include provisions from Rep. DelBene’s Improving Seniors’ Timely Access to Care Act, which aims to speed up the prior authorization process for Medicare Advantage plans.
On June 21, the House passed multiple pieces of legislation including the CHOICE Arrangement Act, the Paperwork Burden Reduction Act, and the Employer Reporting Improvement Act. These bills aim to improve health care coverage options for workers and lower administrative burdens on small businesses.
On June 21, the House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing on competition and transparency in the healthcare market. The focus of the hearing was on rising healthcare costs as a result of pharmacy benefit manager (PBM) practices and hospital consolidation. During the hearing, there was bipartisan support for increasing transparency around PBMs and hospital charges, as well as a need to address hospital consolidation. A recap of the hearing can be found here.
On June 21, Energy & Commerce Health Subcommittee member Lisa Blunt Rochester (D-DE) announced her plans to run for Senate to fill the seat being vacated by the retiring Sen. Tom Carper (D).
Majority Leader Charles Schumer (D-NY) intends to bring legislation to implement a $35 monthly cap on insulin costs in commercial health plans and bipartisan PBM reforms and FDA policies the week of July 11.
The House is in recess until July 11.
Senate
On June 21, the Banking, Housing and Urban Affairs Committee unanimously approved the FEND Off Fentanyl Act. The legislation was introduced by Sen. Tim Scott (R-SC) and would allow the President to block and prohibit all U.S. transactions involving property and interests of foreign persons and organizations engaged in “significant trafficking” of illicit fentanyl, raw materials used to manufacture the synthetic opioid, and other related opioids.
On June 21, three former National Institutes of Health (NIH) directors — Harold Varmus, Elias Zerhouni and Francis Collins — sent a letter to Senate leadership urging them to rapidly confirm Monica Bertagnolli as the next NIH director. NIH has been without a director for a year and a half.
On June 22, the Appropriations Committee approved the Fiscal Year 2024 (FY24) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act. The measure was advanced unanimously and provides $26 billion in discretionary funding, including $3.55 billion for the Food & Drug Administration (FDA), a $20 million net increase to base funding.
On June 22, Finance Committee Ranking Member Mike Crapo (R-ID) introduced the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act. The legislation would ensure Medicare patients have coverage for innovative tests that can detect multiple types of cancer before symptoms develop.
The Senate is in recess until July 10.
REGULATORY UPDATE
On June 20, the U.S. Preventive Services Task Force recommended, for the first time, that all Americans ages 19 to 64 be screened for anxiety. The panel also continues to recommend that all adults get screened for depression, regardless of risk factors.
On June 20, FDA announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in-vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. The program will ask up to nine drugmakers to submit performance data on tests used to enroll patients in oncology-drug clinical trials.
On June 20, FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of oral medicines to treat pediatric type 2 diabetes.
On June 21, FDA published its annual report on the state of pharmaceutical quality. The report presents analyses surrounding pharmaceutical manufacturers and their products. Additionally, the report highlights several ongoing initiatives such as the New Inspection Protocol Project (NIPP), the Quality Management Maturity (QMM) program, and the CARES Act Drug Amount Reporting Program.
On June 21, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted, 9-5, that adults 65 and older should receive a single respiratory syncytial virus (RSV) vaccine from either Pfizer or GSK this fall. Additionally, 13 members, with one abstention, voted in favor of people 60 to 64 receiving the shot.
On June 21, HHS’ Substance Abuse and Mental Health Services Administration (SAMHSA) issued a new advisory linking long COVID-19 and mental health issues. SAMHSA found that people with long COVID-19 can experience depression, anxiety, brain fog, psychosis, obsessive-compulsive disorder, and post-traumatic stress disorder.
On June 22, CMS announced new details of the agency’s plan to cover new Alzheimer’s drugs. CMS has stated that Medicare will cover Alzheimer’s drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this information through a nationwide, CMS-facilitated portal. A fact sheet can be found here.
On June 22, CMS issued a proposed procedural notice outlining a new voluntary Medicare coverage pathway – called the Transitional Coverage for Emerging Technologies (TCET) pathway – for Breakthrough Devices. As a general overview, the new pathway would use national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain Breakthrough Devices. TCET would be voluntary (requiring manufacturers to apply (“self-nominate”) for participation) and would offer participating manufacturers an opportunity for increased pre-market engagement with CMS, and a pre-market evaluation of potential harms and benefits of technologies as well as the identification of evidence gaps. Such evidence gaps could be addressed through fit-for-purpose studies, where the study design, analysis plan, and study data are appropriate for the question the study aims to answer. Finally, TCET would help coordinate benefit category determinations, coding, and payment reviews. A fact sheet can be found here. Comments on the proposal are due by August 27.
On June 22, FDA approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with this therapy.
On June 23, FDA published its first draft guidance on clinical trials for psychedelic drugs, coming as research into use of psychedelics to treat conditions like depression and post-traumatic stress disorder becomes increasingly widespread.
On June 23, the Office of Management and Budget (OMB) concluded review of the CY 2024 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program proposed rule. The rule is expected to be out early next week.
WHITE HOUSE UPDATE
On June 20, the Biden Administration hosted a meeting with U.S. drug manufacturers who currently have FDA-approved opioid overdose reversal medication products. The purpose of the meeting was to discuss increasing access to and affordability to these medications.
On June 23, President Biden issued an Executive Order (EO) aimed at increasing access to contraception and family planning services. The EO directs the Secretaries of the Treasury, Labor, and HHS to consider new guidance to ensure that private health insurance under the Affordable Care Act covers all FDA-approved, -granted, or -cleared contraceptives without cost sharing. Additionally, the EO directs the Secretary of HHS to consider new actions that expand access to affordable family planning services and supplies across the Medicaid program.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061); Final Rule; 3/1/22
CY 2024 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare; Proposed Rule; 4/18/23
Short-Term Limited Duration Insurance; Update (CMS-9904); Proposed Rule; 4/20/23
CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1786); Proposed Rule; 4/20/23
CY 2024 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1780); Proposed Rule; 4/24/23
Minimum Staffing Standards for Long-Term Care Facilities (CMS-3442); Proposed Rule; 5/30/23
Request for Information; Episode-based Payment Model (CMS-5540-NC); Notice; 6/9/23
FDA
Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Notice; 5/19/23
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format; Final Rule; 5/19/23
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President's Emergency Plan for Acquir; Notice; 6/12/23
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under the President's Emergency Plan for Acquir; Notice; 6/12/23
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; 6/12/23
REPORTS
Government Accountability Office (GAO)
On June 21, GAO released a report examining CMS information surrounding nursing home choice and comparisons on its Care Compare tool. GAO found that the nursing home quality information CMS provides on Care Compare at least partially aligns with 11 of 15 characteristics of understandability and relevancy for an effective transparency tool. GAO also noted that CMS takes various approaches to assess the completeness and accuracy of the sources for the staffing data, inspections, and quality measure information it provides on Care Compare. GAO is making no new recommendations in this report.
On June 22, GAO released a report examining how Medicare payments and other factors affect behavioral health services. Officials from multiple critical access hospitals (CAH) and stakeholders said that factors outside of Medicare were substantial challenges to their ability to provide behavioral health services and patients’ access to these services. Hiring and recruitment of behavioral health professionals, such as psychiatrists and licensed clinical social workers, was cited as one of their biggest challenges due to nationwide workforce shortages. In addition, stakeholders indicated that shortages of inpatient psychiatric beds made it difficult to find inpatient treatment for patients. As a result, patients were sometimes stuck in an emergency department for several days waiting to be transferred to an open psychiatric bed elsewhere in their community or state.
OTHER POLICY NEWS
On June 21, the Pharmaceutical Research and Manufacturers of America (PhRMA), along with the National Infusion Center Association (NICA) and the Global Colon Cancer Association (GCCA), filed a lawsuit in the U.S. District Court for the Western District of Texas challenging the Medicare drug negotiation program of the Inflation Reduction Act (IRA) as unconstitutional and requesting that the court enjoin HHS from implementing the program. This marks the fourth lawsuit challenging the IRA’s Medicare negotiation program.