Weekly Spotlight
Of course, this week’s spotlight shone on President Biden and his remarks on the State of the Union (SOTU). Whether from the dais in the House chamber or through related actions, the President made it clear that health care access and cost will be critical themes for his administration this year and his campaign for a second term.
For example, the President started off the address by naming anti-abortion legislation as a threat to America’s freedoms and calling on Congress to protect fertility treatments while earlier in the week, the Centers for Medicare and Medicaid Services announced that cell and gene therapy (CGT) manufacturers participating in the CMS innovation center’s new model will need to directly pay for fertility preservation services at no cost to patients.
Many in the pharmaceutical space are also grappling with the President’s announcement that his administration will seek to more than double the size of the Medicare drug price negotiation program established under the Inflation Reduction Act (IRA). The current program applies to 10 named drugs but is slated to expand to 20 as the program evolves. The President asked Congress to expand that list to 50 drugs. He also asked lawmakers to expand the law’s $2,000 annual cap on out-of-pocket drug costs and penalties for drug price hikes to apply to patients with insurance through their employers, not just Medicare. At the same time, pharmaceutical companies looking to stop the drug price negotiations altogether finally had their challenge heard by U.S. District Court. Bristol Myers Squibb, Johnson & Johnson, Novartis, and Novo Nordisk combined their arguments to be considered in the same hearing this week on the impact of the IRA policies on innovation. According to reporting, Judge Zahid Quraishi was skeptical of the argument that drug companies would be forced to limit their investments in innovative treatments if their products were subject to price negotiations. He also appeared dubious of the companies’ position that the negotiation program amounted to an unconstitutional taking of their property, and unconvinced that the negotiations were not voluntary under the terms set forth in the IRA.
Earlier in the week, industry leaders convened at the White House to discuss the role of pharmacy benefit managers in escalating drug prices. Stat reports that Mark Cuban, co-founder of Cost Plus Drug Company, called “the big three” PBMs “everything that is wrong with this industry.”
Other Regulatory News
Food and Drug Administration (FDA)
F.D.A. Delays Action on Closely Watched Alzheimer’s Drug
The New York Times reports FDA will delay action on Eli Lilly’s Alzheimer’s drug, donanemab and will instead require donanemab to undergo the scrutiny of a panel of independent experts.
#Drug, #Patient
Upcoming Oncologic Drugs Advisory Committee Meetings
The FDA Oncologic Drugs Advisory Committee announced two upcoming meetings
- supplemental biologics license application (sBLA) 125746.74 for CARVYKTI (ciltacabtagene autoleucel), suspension for intravenous infusion, submitted by Janssen Biotech, Inc., a general discussion focused on the overall survival data in the Study MMY3002 (CARTITUDE-4) and the risk and benefit of ciltacabtagene autoleucel in the intended population, and discuss sBLA 125736.218 for ABECMA (idecabtagene vicleucel), suspension for intravenous infusion, submitted by Celgene Corp.
- new drug application 217779 for imetelstat for injection, submitted by Geron Corporation for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents.
#Drug, #Patient
FDA Publishes Guidance on Informed Consent
To improve the informed consent process, the U.S. Food and Drug Administration and the Office for Human Research Protections have published a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.” Comments are due by April 30, 2024. More information.
#Patient, #Provider
Department of Health and Human Services
Eyes Turn to Braidwood as Preventive Services Get Another Day in Court
The Biden administration is set to urge a U.S. appeals court to preserve a federal mandate that requires health insurers to cover preventive care services including HIV-prevention medication and cancer screenings at no extra cost to patients. The preventive care mandate, which covers a wide range of services chosen by the United State Preventive Serives Task Force, is part of the 2010 Affordable Care Act. The arguments scheduled before a three-judge panel of the 5th U.S. Circuit Court of Appeals stem from a lawsuit brought by a group of businesses, including Christian wellness center operator Braidwood Management, objecting to a requirement they provide coverage for HIV PrEP medicines.
#All
Hill Happenings
Sens Brown and Warren Pursue MA Reforms
Senators Sherrod Brown (D-OH) and Elizabeth Warren (D-MA) called on the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to improve oversight and accountability in Medicare Advantage (MA), which could save taxpayers hundreds of billions of dollars, and use those savings to make long-needed improvements in traditional Medicare. Their press release if available, here.
#All
Cassidy Tries Procedural Maneuver to Block Biden Guidance on Generic Drugs
The Biden administration issued a draft framework allowing the government bring in generic drugmakers to make medicines even before their patents expire. However, d that this publication should be characterized as a “rule” by the Congressional Review Act (CRA), and is therefore subject to appropriate notice and comment. He has asked the Government Accountability Office to Review the notice.
#Drug
Notable Notes
Kaiser Family Foundation Shares “What to Know About How Medicare Pays Physicians”
KFF primer on the physician fee schedule.
#All
FTC, DOJ, and HHS Launch Cross-Government Inquiry on Private Equity in Health Care
Three federal agencies are probing private equity’s control over health care, issuing a request for information Tuesday to get public input that could inform future regulation. The RFI “seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care and affordable health care for patients and taxpayers.”
Meanwhile, Holy Cross Hospital in Florida and St. Joseph’s Hospital Health Center in New York, which are owned by Trinity Health, filed lawsuits last week against North American Partners in Anesthesia, an anesthesiology staffing firm owned by private equity firms. They allege NAPA is using its monopoly power in local markets to charge hospitals exorbitant fees to use its anesthesia providers, and is enforcing noncompetes that prevent the hospitals from directly employing those providers.
#All
Change Healthcare Outage Continues to Rock Stakeholders
The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT. UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline.
The Centers for Medicaid & Medicare Services also announced flexibilities intended to help providers continue to serve patients in the wake of the cyberattack on Change Healthcare. They include expedited claims processing; guidance for Medicare Advantage and Part D programs to remove or relax prior authorization, utilization management and filing requirements; and exceptions, waivers or extensions available through Medicare Administrative Contractors in addition to paper claim submissions. CMS also encouraged Medicaid and Children’s Health Insurance Program agencies to offer the same flexibilities during the Change Healthcare system outages. However, the American Hospital Association says these concessions are not enough.
#Hospital, #Provider, #Payer, #Patient
Missing data is making it difficult for the pharmaceutical industry to help LGBTQ+ people
Lack of health data on LGBTQ+ people has real-world consequences. See also, this report from the National Academies.
#Patient
