Health Care Watch: November 25, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 20 – November 25. 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
Last week, Energy & Commerce Health Subcommittee Ranking Member Anna Eshoo (D-CA) and Subcommittee members Bill Johnson (R-OH) and Tony Cardenas (D-CA) announced they would not seek re-election and will retire from Congress. Rep. Johnson may retire before the end of the Second Session to become President of Youngstown State University.
The House returns on November 28.
Senate
On November 21, Health, Education, Labor & Pensions (HELP) Chairman Bernie Sanders (I-VT) sent letters inviting the top executives of Merck, Johnson & Johnson and Bristol Myers Squibb to testify at a January 25 hearing entitled Why Does the United States Pay, By Far, The Highest Prices in the World for Prescription Drugs? The letters were signed by every Democratic member of the committee.
The Senate will reconvene on November 27.
REGULATORY UPDATE
On November 21, the Department of Health & Human Services (HHS) announced that approximately 4.6 million people selected an Affordable Care Act (ACA) Health Insurance Marketplace plan since the 2024 Marketplace Open Enrollment Period (OEP) opened on November 1. HHS noted that total plan selections include 920,000 people (20% of total) who are new to the Marketplaces for 2024, and 3.7 million people (80% of total) who have active 2023 coverage and returned to their respective Marketplaces to renew their coverage or select a new plan for 2024. The Centers for Medicare & Medicaid Services (CMS) snapshot of enrollment can be found here.
On November 21, CMS announced an Ambulance Open Door Forum. The forum will provide an overview of the changes finalized in the CY 2024 Physician Fee Schedule final rule on the Medicare Ground Ambulance Data Collection System. CMS will also announce the CY 2024 Ambulance Inflation Factor and Productivity Adjustment. The forum will take place on November 30 from 2:00 to 3:00 PM ET. Registration and more information can be found here.
On November 21, the Food & Drug Administration (FDA) released the Direct-to-Consumer Prescription Drug Advertisements final rule. The rule would require radio and TV ads selling prescription drugs to provide information on side effects and contraindications in a clear, conspicuous, and neutral manner. Although the rule is effective on May 20, 2024, the compliance date of the rule is November 20, 2024.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
ASPR
Health Resources Priority and Allocations System (HRPAS); Final Rule; 11/17/23
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
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
Federal Independent Dispute Resolution Process Fees (CMS-9890); Final Rule; 11/14/23
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
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
IHS
Calendar Year 2024 Reimbursement Rates Notice; Notice; 11/10/23
REPORTS
Office of Inspector General (OIG)
On November 21, OIG released a report examining California's Substance Use Prevention, Treatment, and Recovery Services Block Grant (SABG) program expenditures for Los Angeles County. OIG found that some of California's SABG expenditures for LA County, including expenditures for transitional housing providers, did not comply with Federal and State requirements. Specifically, OIG found that LA County submitted for reimbursement approximately $1.7 million in expenditures for transitional housing services that had been previously reimbursed. OIG recommends that California: 1) recover from LA County $1.7 million for transitional housing expenditures and establish a process to review whether counties, including LA County, were reimbursed for expenditures that had been previously reimbursed; and 2) instruct LA County to develop a cost allocation plan for its well-being centers, determine the portion of $1.8 million that should not have been allocated to the SABG, and recover any overpayment.
On November 22, OIG released a report examining Medicare Administrative Contractor (MAC) information security programs evaluations for fiscal year 2022. OIG found that a total of 92 gaps at the 7 MACs in FY 2022, which was 3% less than the number of gaps for the same 7 MACs in FY 2021. The number of high- and moderate-risk gaps increased by 24% from FY 2021. OIG found that deficiencies remained in six of the nine Federal Information Security Modernization Act of 2014 control areas that were tested. OIG stated that the results warrant CMS continuing its oversight visits to ensure that the MACs remediate all gaps to improve the MACs' IT security, especially those with increased gaps from the previous year. OIG made no recommendations.
UPCOMING HEARINGS
House
Energy & Commerce Committee
Health Subcommittee
November 29; 11:30 AM; 2322 Rayburn
Understanding How AI is Changing Health Care
Oversight & Investigations Subcommittee
November 30; 11:00 AM; 2322 Rayburn
Unmasking Challenges CDC Faces in Rebuilding Public Trust Amid Respiratory Illness Season
Witnesses: Mandy Cohen, Director, Centers for Disease Control and Prevention
Ways & Means Committee
TBD
Markup of drug and device legislation and hearing on the status of CMMI
Senate
HELP Committee
Week of December 4 or 11
SUPPORT Act reauthorization markup
December 15, TBD
Hearing on diabetes
TBD
Hearings on not-for-profit hospitals and the pharmaceutical industry
January 25; 10:00 AM
Why Does the United States Pay, By Far, The Highest Prices In The World For Prescription Drugs?