Health Care Watch: August 12, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 6 – August 12. 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 8, Oversight and Accountability Committee Chairman James Comer (R-KY) sent a letter to the Federal Trade Commission (FTC) expressing concerns regarding consolidation in the vision insurance market and requests a staff-level briefing on the FTC’s work to ensure the consolidation does not negatively impact consumers.
On August 9, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chairman Morgan Griffith (R-VA) sent a letter to Department of Health & Human Services (HHS) Secretary Xavier Becerra requesting the documents he signed appointing Dr. Jeanne Marrazzo to a five-year term to serve as Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).
On August 10, Energy & Commerce Committee Chair Rodgers, Health Subcommittee Chairman Guthrie, and Oversight & Investigations Subcommittee Chairman Griffith sent a letter to the Substance Abuse and Mental Health Services Administration (SAMHSA) requesting a full accounting of how the agency spent more than $8 billion that it allocated in response to the COVID-19 pandemic. The letter is a continuation of the Committee’s investigation into the COVID supplemental funds received by SAMHSA and awarded to states. Previous responses from SAMHSA did not detail how much of these funds have been spent and how these expenditures were used.
Senate
On August 7, Sens. Elizabeth Warren (D-MA), Chuck Grassley (R-IA), Raphael Warnock (D-GA), and Bill Cassidy (R-LA) sent a letter to the Treasury Inspector General for Tax Administration (TIGTA) and the Internal Revenue Service (IRS) requesting an evaluation of nonprofit hospitals’ compliance with their tax-exempt requirements and a full examination of existing oversight authorities, following reports that some nonprofit hospitals are taking advantage of their tax-exempt status in ways that restrict care or drive up costs for patients. The lawmakers are requesting a response within 60 days.
On August 8, Intelligence Committee Chairman Mark Warner (D-VA) sent a letter to Alphabet Inc. CEO Sundar Pichai expressing concerns regarding reports that Google began providing Med-PaLM 2 artificial intelligence (AI) to hospitals to test early this year. The letter suggests that Google released its generative AI to hospitals for testing too quickly. Chairman Warner stated that premature deployment of an unproven technology could lead to the erosion of trust in medical professionals and institutions, the exacerbation of existing racial disparities in health outcomes, and an increased risk of diagnostic and care-delivery errors.
On August 10, Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent a letter to HHS Secretary Xavier Becerra asking that the agency properly implement the bipartisan No Surprises Act – legislation that protects American patients from surprise medical bills and out-of-network costs. Senator Cassidy stated that “HHS has continued to ignore and deviate from statutory instructions explicitly included in the legislation, creating confusion and uncertainty for patients, health care providers, and other stakeholders.”
REGULATORY UPDATE
On August 4, the Food & Drug Administration (FDA) approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. Treatment for PPD was previously only available as an IV injection given by a health care provider in certain health care facilities. Zurzuvae is manufactured by Sage Therapeutics and Biogen.
On August 6, HHS Secretary Becerra hosted a High-Level Meeting on Health and the Economy (HLMHE) at the Asia-Pacific Economic Cooperation (APEC) Senior Officials' and Ministerial Meetings (SOM 3) in Seattle, Washington. The HLMHE focused on three priorities: strengthening primary health care (PHC) and its linkages to pandemic prevention, preparedness, and response (PPR); innovation in digital health; and strengthening gender and health equity in the economy.
On August 7, the Equal Employment Opportunity Commission issued a proposed rule outlining the agency’s enforcement plans for the Pregnant Workers Fairness Act. The policy further defines the reasonable accommodations required for pregnant employees including accommodations based on their ability to stand for long periods or lift heavy objects, as well as receiving time off for health care appointments, including therapy for postpartum depression or IVF treatments. A fact sheet detailing the rule can be found here. Comments are due by October 10, 2023.
On August 9, HHS, through the Health Resources and Services Administration (HRSA), awarded $30 million to 151 HRSA-funded health centers to improve developmental outcomes among children ages 0-5 through increased screenings and follow-up services.
On August 9, Centers for Disease Control and Prevention (CDC) director Mandy Cohen announced that José Romero, who has led the National Center for Immunization and Respiratory Diseases (NCIRD) for the past 14 months, will be leaving the agency at the end of the month. Demetre Daskalakis, who has spent the past year as deputy director of the White House’s national mpox response team, will take on the role in an acting capacity.
On August 9, the Centers for Medicare & Medicaid Services (CMS) sent letters to all state Medicaid agencies reviewing their call center wait times and abandonment rates, procedural terminations and processing times for income verification checks during May. The letters encourage states to make a number of adjustments to streamline their redeterminations, including hiring additional call center staff, switching from manual to automatic renewal processes and expanding their non-English language services and materials.
On August 10, HRSA announced awards of more than $100 million to train more nurses and grow the nursing workforce. These investments aim to address the increasing demand for registered nurses, nurse practitioners, certified nurse midwives, and nurse faculty. The awards focus on key priorities such as helping licensed practical nurses to become registered nurses ($8.7 million), training nurses who will deliver primary care, mental health care, and maternal health care ($34.8 million), addressing the bottlenecks in nurse training by supporting more nurse faculty ($30 million), and implementing a nurse faculty loan program ($26.5 million).
On August 11, CMS released an FAQ document on surprise billing Independent Dispute Resolution (IDR) on administrative fees. The document clarifies the amount that each disputing party must pay to engage in the Federal IDR process as a result of the opinion and order from the United States District Court for the Eastern District of Texas in Texas Medical Association v. United States Department of Health and Human Services.
WHITE HOUSE
On August 9, the Biden Administration, through HHS’ Office of Climate Change and Health Equity (OCCHE), launched an online information portal called the Heat-Related Illness EMS Activation Surveillance Dashboard (“EMS HeatTracker”), which maps emergency medical services responses to heat-related illness across the country.
On August 10, the White House asked Congress for an additional $350 million for its overdose epidemic response. Funding would be used for grants to States, Territories and Tribal Nations, through the State Opioid Response (SOR) grant program, providing funding for prevention, treatment, case management, support and recovery services. Of this amount, $50 million would be transferred to the Indian Health Service for prevention, treatment, recovery support services, and harm reduction interventions.
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
Independent Dispute Resolution Operations (CMS-9897); Proposed Rule; 8/3/23
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 9, OIG released a data brief addressed to CMS that identifies the potential amount of drug rebates associated with separate Children’s Health Insurance Programs (separate CHIPs) under the Medicaid Drug Rebate Program (MDRP). The objective of the brief is to identify the total drug rebates that States could have collected under their separate CHIPs if States had been required to obtain those rebates through the MDRP. OIG found that if the MDRP were to cover drug expenditures paid for by separate CHIPs, the States could (based on 2020 calculations) have collected an estimated $641.2 million in drug rebates annually, including drug rebates totaling $125.5 million for the States and $515.7 million for the Federal Government.
OTHER POLICY NEWS
On August 7, the Red Cross announced that it will assess potential blood donors based on individual risk factors. Under this new screening process, all donors answer the same eligibility questions regardless of gender or sexual orientation and will be assessed for blood donation based on individual risk factors, not on sexual orientation.
On August 8, in second-quarter earnings, Novavax announced that it had begun the process of submitting its updated XBB.1.5 COVID-19 shot to FDA for authorization ahead of a fall rollout. The company also said it had begun the process of applying for full approval from FDA to approve its original COVID-19 vaccine.
On August 8, Novo Nordisk announced that its obesity drug, Wegovy, cut the risk of major heart complications by 20% in a recent trial. The 17,500-patient trial is the first to show that an obesity medication leads to long-term cardiovascular benefits.
On August 8, the Journal of the American Medical Association (JAMA) released a research letter that found that in 2022, 65% of FDA’s 37 drug approvals were based on a single trial compared with 20% in 2016. Additionally, the report finds that only 11% of approved drugs in 2022 had three or more clinical studies compared with 55% in 2016.