Health Care Watch: September 9, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 1 – September 7. 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 September 6, Speaker Mike Johnson (R-LA) released the House Republican’s proposed stopgap funding bill that would largely fund the government at current levels through March 28, 2024. The bill also includes a provision that would require proof of U.S. citizenship to vote in federal elections. Senate Majority Leader Chuck Schumer (D-NY) stated his opposition to the package, making it all but certain to stall in the Senate if it even passes the House. The House is scheduled to consider this legislation as early as September 10.
On September 9, the House will consider:
The House returns from its August recess on September 9.
Senate
On September 3, Finance Committee Chairman Ron Wyden (D-OR) sent a letter to the Centers for Medicare & Medicaid Services (CMS) and the Administration for Children and Families (ACF), asking that the Biden Administration provide updates on how federal agencies plan to safeguard and bolster access to behavioral health services for Medicaid-enrolled youths in residential treatment facilities (RTFs). Specifically, the letter asks that CMS and ACF issue joint guidance to states prioritizing community-based behavioral health and prevention services, clarify and streamline federal oversight requirements for RTFs, and boost engagement with youth in congregate care programs.
On September 4, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released astatement following the refusal of Steward Health Care’s CEO Dr. Ralph de la Torre’s to appear before the HELP Committee despite a bipartisan subpoena compelling his testimony. Dr. Ralph de la Torre asked the Committee to move the hearing until after Steward’s bankruptcy process was completed. Chairman Sanders stated that he will not accept the postponement.
The Senate returns from its August recess on September 9.
REGULATORY UPDATE
On August 30, the Food & Drug Administration (FDA) granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.
On September 3, the Supreme Court rejected Oklahoma's emergency appeal seeking to restore a $4.5 million grant for family planning services in an ongoing dispute over the state’s refusal to refer pregnant women to a nationwide hotline that provides information about abortion and other options. The emergency order came with no explanation for the majority’s decision, but noted that Justices Clarence Thomas, Samuel Alito, and Neil Gorsuch would have sided with the state.
On September 3, the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID)awarded grants for 10 projects to improve diagnostic tools for congenital and adult syphilis.
On September 3, CMS announced that it is publishing the Inpatient Rehabilitation Facility (IRF) Patient Assessment Instrument (IRF-PAI) Quarterly Q&As and the Long-Term Care Hospital (LTCH) Continuity Assessment Record and Evaluation (CARE) Data Set (LCDS) Quarterly Q&As in September of 2024.
On September 4, CMS issued a Request for Information to obtain feedback from industry and the public about the potential consolidation of four Medicare Administrative Contractor (MAC) jurisdictions into two jurisdictions, as well as to obtain input on extending MAC contracts to 10 years.
On September 5, the Drug Enforcement Agency (DEA) announced that it will allow increased production of the ADHD drug Vyvanse, adjusting the 2024 aggregate production quota in an attempt to help reduce a shortage of ADHD medication. DEA will allow a bump in production of about 24% following a request from FDA in July.
On September 6, CMS and the Wisconsin Physicians Service Insurance Corporation (WPS) announced that they will be notifying people whose protected health information or other personally identifiable information (PII) may have been compromised in connection with Medicare administrative services provided by WPS. WPS is a MAC that handles Medicare Part A/B claims and related services for CMS.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
HHS Notice of Benefit and Payment Parameters for 2026 (CMS-9888); Proposed Rule; 7/17/24
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/8/24
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Final Rule; 8/22/24
Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023 (CMS-1799); Final Rule; 8/23/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Stakeholders; Availability (2023-814); Notice; 7/25/24
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability; Notice; 7/25/24
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Notice; 8/26/24
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs; Notice; 9/3/24
OASH
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; 8/6/24; Proposed Rule
Public Health Service Policies on Research Misconduct; Final Rule; 8/7/24
OS
HHS Adoption of Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Interim Final Rule; 8/22/24
REPORTS
Office of Inspector General (OIG)
On September 3, OIG released a report examining Massachusetts opioid treatment program (OTP) services. OIG found that Massachusetts could improve its oversight of OTPs to ensure that they complied with certain Federal and State requirements. OIG also found that of the 100 OTP sampled services, only 74 complied with Federal and State requirements and of the remaining 26 OTP sampled services, 23 OTP services did not meet the treatment plan review requirements and 3 were not supported by the medical records. OIG recommends that Massachusetts follow up with OTP providers about the three services that were not supported by the medical records and continue its procedures to prevent OTP noncompliance with Federal and State requirements.
On September 5, OIG released a report examining provision of personal care services (PCS) for Medicaid enrollees in New Mexico. OIG found that New Mexico did not ensure that PCS were provided by qualified attendants in accordance with Federal and State requirements. OIG found that for 106 of the 300 sampled claims, the associated attendants met qualification requirements. However, for the remaining 194 claims, the associated attendants did not meet 1 or more requirements related to criminal background checks, abuse registry checks, TB testing, written competency tests, annual training, and CPR and first aid certifications. OIG made a series of recommendations to New Mexico, including that it workwith Medicaid managed care organizations to develop procedures to monitor PCS providers’ compliance with attendant qualification requirements and to educate providers about these requirements.
HEARINGS
House
Oversight and Accountability Committee
Select Subcommittee on the Coronavirus Pandemic
September 10; 2:00 PM; 2154 Rayburn
A Hearing with Former New York Governor Andrew Cuomo
Witness: Andrew Cuomo (D), Former Governor, State of New York
Energy & Commerce Committee
Health Subcommittee
September 10; 10:00 AM; 2123 Rayburn
Evaluating FDA Human Foods and Tobacco Programs
Witnesses: Jim Jones, Deputy Commissioner for Human Foods, FDA; Brian King, Director, Center for Tobacco Products, FDA
Oversight and Investigations Subcommittee
September 11; 10:30 AM; 2322 Rayburn
Exploring Implementation of the U.S. Organ Procurement and Transplantation Network Act
Ways & Means Committee
Health Subcommittee
September 18
Hearing on wellness initiatives
September TBD
Markup of health care legislation
Education and Workforce Committee
Subcommittee on Health, Employment, Labor, and Pensions
September 10; 10:15 AM; 2175 Rayburn
ERISA’s 50th Anniversary: The Value of Employer-Sponsored Health Benefits
Judiciary Committee
Administrative State, Regulatory Reform, and Antitrust Subcommittee
September 11; 2:00 PM; 2141 Rayburn
The Role of Pharmacy Benefit Managers
Senate
HELP Committee
September 12; TBD
Examining the Bankruptcy of Steward Health Care: How Management Decisions Have Impacted Patient Care
Testimony from Ralph De La Torre, CEO, Steward Health Care System
September 24; 10:00 AM; SD-562
Budget Committee
September 11; 10:00 AM; 608 Dirksen
Social Security Forever: Delivering Benefits and Protecting Retirement Security
Witnesses: The Honorable Martin O'Malley, Commissioner, Social Security Administration; Rebecca Vallas, Chief Executive Officer, National Academy of Social Insurance; Roger Boudreau, President Rhode Island AFT/Retirees Local #8037R; Additional witnesses to be announced.
Finance Committee
September 18
Hearing on the Inflation Reduction Act
ADDITIONAL POLICY NEWS
On September 3, Eli Lilly & Co. filed a complaint against FDA in an Indiana District Court, regarding FDA’s decision to designate its obesity medicine, retatrutide, as a drug instead of a biological product. In the complaint, Lilly stated that FDA’s determination that Lilly’s product is “neither a protein nor analogous to a protein and is therefore not a biological product” is arbitrary and capricious.
On September 4, Humana Chief Financial Officer Susan Diamond stated that the company plans to leave 13 Medicare Advantage markets and scale back plan offerings in other areas next year.
On September 5, the Medicare Payment Advisory Commission (MedPAC) held its September public meetings. Topics discussed included context for Medicare policy, cost sharing for outpatient services at critical access hospitals and Medicare’s measurement of rural provider quality.