Health Care Watch: August 19, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 13 – August 19. 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 August 14, Speaker Kevin McCarthy (R-CA) said that a continuing resolution (CR) will be necessary at the end of September to allow more time for the chamber to pass its spending bills and reconcile them with the Senate versions. Some Freedom Caucus members have balked at this idea if it is not coupled with “conservative wins” from Democrats. Senate Majority Leader Chuck Schumer (D-NY) stated that he is supportive of a CR through early December. A short-term government shutdown is certainly possible.
On August 16, Energy & Commerce Committee Ranking Member Frank Pallone (D-NJ) announced that he is launching an inquiry into Medicaid managed care plans over their use of prior authorization. Ranking Member Pallone pointed to a Department of Health & Human Services (HHS) Office of Inspector General (OIG) report from last month that found the plans denied 1 in 8 treatment requests. Ranking Member Pallone stated that he will be contacting each of these health insurance companies directly for additional information and questions regarding their prior authorization practices.
Senate
On August 11, Sens. Martin Heinrich (D-NM), Jon Tester (D-MT), and Patty Murray (D-WA) sent a letter to the Food & Drug Administration (FDA) asking the agency to go beyond its April proposal, which would require that patients be given return mail envelopes and safe-disposal education when prescribed opioids in outpatient settings.
REGULATORY UPDATE
On August 14, HHS’ Office of the National Coordinator for Health Information Technology (ONC) announced two awards totaling $2 million under the Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) funding opportunity. The awards were given to projects examining the use of advanced fast health care interoperability resources (FHIR®) capabilities and projects identifying data quality improvements for United States Core Data for Interoperability (USCDI) data elements.
On August 14, FDA granted accelerated approval to Pfizer’s Elrexfio (elranatamab), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
On August 14, HHS announced that its planned and current uses of artificial intelligence (AI) have risen to 163 across its subagencies as of fiscal year 2023, up from 50 in the previous year. HHS states that it will continue to use AI and prepare an inventory of non-classified and non-sensitive current and planned AI use cases under Executive Order 13960, Promoting the Use of Trustworthy Artificial Intelligence in the Federal Government.
On August 15, FDA approved HEPZATO KIT containing melphalan as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
On August 16, CMS announced that registration is open for the next webinar of The National Action to Advance Patient Safety Summer Webinar Series on August 22 on “Engaging Boards and Executive Leadership in Safety.” The webinar will discuss the importance of board and executive leadership engagement in creating and sustaining a culture of safety. Registration can be found here.
On August 18, HHS Secretary Xavier Becerra traveled to Gandhinagar, India to participate in the G20 Health Ministers’ meeting and bilateral meetings. While at the meeting, Secretary Becerra highlighted that the United States supports all three priorities of the G20 Health Track under India's Presidency: improving global coordination on health emergencies prevention, preparedness, and response; improving the global availability of and access to affordable medical countermeasures; and supporting the use of digital health systems in low- and middle-income countries to improve healthcare service delivery.
WHITE HOUSE
On August 16, the Biden Administration released a statement on the one-year anniversary of the Inflation Reduction Act (IRA). The statement highlights the main provisions included in the IRA and highlights CMS implementation milestones including actions related to the drug inflation rebate programs, out-of-pocket drug costs, and expansion of eligibility for Medicare subsidies.
On August 16, the Biden Administration released a statement in strong opposition to the ruling from the Fifth Circuit Court of Appeals in the case Alliance for Hippocratic Medicine v. FDA. The Administration has stated that the Department of Justice (DOJ) will be seeking Supreme Court review of the Fifth Circuit’s decision.
On August 17, the White House’s Office of Science and Technology Policy (OSTP) and the Office of Management and Budget (OMB) sent a memo to the heads of executive agencies and departments asking them to prioritize certain public health priorities related to cancer, antibiotics and infectious diseases in funding requests. The memo lists broad guidance for research and development activities that agencies might propose, including funding activities to assist the cancer moonshot initiative, addressing antibiotic resistance as well as identifying and eliminating infectious outbreaks, and preventing exposure to harmful chemicals, including lead and per- and polyfluoroalkyl substances.
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
Minimum Staffing Standards for Long-Term Care Facilities (CMS-3442); Proposed Rule; 5/30/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule; 6/28/23
Mandatory Medicaid and Children's Health Insurance Plan (CHIP) Core Set Reporting (CMS-2440); Final Rule; 7/28/23
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
FDA
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
Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Certain Legally Marketed Medical Products: Questions and Answers (CDER, 2023-155); Notice; 7/13/23
Medical Devices; Laboratory Developed Tests; Proposed Rule; 7/26/23
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies; Guidance for Industry; Availability; Notice; 8/1/23
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies, Rev; Notice; 8/1/23
REPORTS
Office of Inspector General (OIG)
On August 14, OIG released a report examining inappropriate Medicaid claims made by Texas. OIG found that Texas followed applicable Federal and State requirements related to claiming Federal Medicaid reimbursement for $126.8 million ($96 million Federal share) in private Medicaid Management Information System (MMIS) contractor costs. However, Texas incorrectly claimed $2.5 million. For those costs, Texas inappropriately received $1.8 million in Federal funds. Texas did not have adequate policies and procedures in place to ensure that MMIS private contractor costs were tracked to the correct Advanced Planning Document (APDs). OIG recommends that Texas refund the $1.8 million Federal share to the Federal Government and strengthen or establish policies and procedures to track its private MMIS contractor costs to APDs and ensure that sufficient details are provided on contractors' employees timesheets, costs are allocated to Medicaid based on an approved methodology in the Public Assistance Cost Allocation Plan (CAP), the Federal match is claimed at the approved rate, and it does not claim costs when it is reimbursed for those costs by other agencies.
Government Accountability Office (GAO)
On August 16, GAO released a report examining HHS reserve funding for emergencies. HHS has used a fund designated for infectious disease emergencies and threats like COVID-19 and Ebola. HHS uses a variety of funding options to help address a public health emergency or threat. GAO found that HHS officials described challenges funding immediate needs during selected public health emergencies. HHS officials said that the Infectious Diseases Rapid Response Reserve Fund has helped to address some of these challenges, specifically for CDC. Officials said that having readily available, flexible, and consistently replenished funding has helped CDC respond quickly to emerging infectious disease threats before they worsen. However, HHS officials said they continue to face challenges addressing immediate needs, for example noting that the fund is available only for infectious diseases and not for other public health threats.
OTHER POLICY NEWS
On August 14, the Journal of the American Medical Association (JAMA) released a report finding that states that have adopted the use of telepharmacies to provide pharmaceutical care for patients have reduced populations living in pharmacy deserts. The report states that the results suggest that states looking to expand pharmacy access may benefit from adopting less restrictive telepharmacy policies.
On August 16, the 5th U.S. Circuit Court of Appeals ruled to restrict access to the abortion pill mifepristone but not remove it from the market entirely in the case Alliance for Hippocratic Medicine v. FDA. The decision effectively blocks mail-order prescriptions of the pill. However, access will remain unchanged for now, as the Supreme Court issued an emergency order this Spring to preserve the status quo while the case goes through the appeals process.
On August 17, two of the drugmakers challenging the IRA’s Medicare drug price negotiation policy filed motions for summary judgment to block the program from being implemented. In the pair of filings in a U.S. district court in New Jersey, Bristol Myers Squibb and Janssen argue that the IRA takes away their private property — in the form of at least two branded drugs, Eliquis and Xarelto — for public use without providing just compensation. Late last week, the Biden administration filed a motion to dismiss a similar lawsuit filed by the U.S. Chamber of Commerce seeking to block the negotiation program.