Biden Administration signals support for copay accumulator programs, sparking criticism from patient organizations
Patient advocates expressed frustration with the Biden Administration’s late November decision to appeal a recent district court ruling that struck down a 2021 provision that allows health insurers to use so-called co-pay accumulator programs (prohibiting drug manufacturer coupons/assistance to count toward a patient’s deductible or out-of-pocket maximum under the Affordable Care Act). “We can’t comprehend why the Biden administration, which has championed access and affordability of prescription drugs for the American people, would appeal this decision,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, one of the plaintiffs in the original lawsuit that challenged the use of co-pay accumulator programs. “By siding against patients who depend on prescription drugs and with insurers, they are allowing insurers to ‘double bill’ and extract more money from patients and drug manufacturers by implementing copay accumulators.” Other patient advocates said they’d challenge the Administration’s position in court: “We will vigorously defend the Court’s decision and oppose the government’s desire to disregard the Court’s ruling,” said George Huntley, CEO of additional plaintiffs the Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition. “The federal government does not have a choice to decide for itself if it will or will not enforce a federal Court ruling. We are confident the Court will side with patients, which will dramatically help reduce their costs of prescription drugs,” he said. At issue is the 2021 Notice of Benefit Payment and Parameters which allowed insurers to use co-pay accumulators. According to the All Copays Count coalition, a group of 80+ organizations that seek to change public policy to prohibit or restrict the use of co-pay accumulator programs, insurer use of such mechanisms harms patients by exposing vulnerable patients to large, unexpected costs; interrupts necessary treatment; and undermines patient protections contained in the ACA.
New #2 at the Food & Drug Administration; Chief Science Officer elevated to replace Dr. Janet Woodcock
FDA chief scientist Dr. Namandjé Bumpus was named as principal deputy commissioner last week. She will replace Dr. Janet Woodcock when she steps down early next year. Bumpus assumes the number two position at the FDA – second only to Commissioner Robert Califf, who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency. “As principal deputy commissioner, Namandjé will work closely with FDA leadership to develop, advance, and implement key public health initiatives, as well as to oversee the agency’s day-to-day functions,” said Califf in an email to staff. Prior to joining the FDA, Bumpus worked at Johns Hopkins University School of Medicine as head of the department of pharmacology and molecular sciences and previously served as the university’s associate dean for basic research. She holds degrees in biology and pharmacology and completed a post-doctoral fellowship in molecular and experimental medicine at the Scripps Research Institute and is also president of the American Society for Pharmacology and Experimental Therapeutics (ASPET). Since joining the FDA, Bumpus has already made her mark, leading the agency’s first overhaul of the regulatory framework for cosmetics since the 1930s and overseeing a fractious exchange between the FDA and Intarcia Therapeutics over the rejection of the company’s drug-eluting stent product ITCA 650. Woodcock, who led the FDA as acting commissioner during the COVID-19 pandemic and was replaced on a permanent basis by Robert Califf in February 2022, confirmed earlier this month that she would be retiring from the agency. Woodcock has worked at the agency since 1986 and served as director of the Center for Drug Evaluation and Research (CDER) for more than a decade on two occasions: initially, between 1994 and 2004, and then from 2007 to 2020, when she was asked to be the therapeutics lead for Operation Warp Speed, the federal response to COVID-19. Woodcock was once considered for the FDA commissioner role, but some members of Congress expressed concern that she was “too close to the biopharmaceutical industry”. Throughout her career, Dr. Bumpus—a Philadelphia native—has broken through several glass ceilings as a woman of color in science. To learn more about Dr. Bumpus’ journey, the FDA produced this informative video.
ACA enrollment hits new highs, while Trump raises repeal as a 2024 campaign issue
As we approach the end of the annual open enrollment period, the Centers for Medicare & Medicaid Services (CMS), announced that 4.6 million Americans have already selected a health plan via the Affordable Care Act marketplace—a significant increase over last year. CMS said about 80% of enrollments are renewals, while 20% are new enrollees. While more Americans now rely on the health care coverage passed by Congress and signed into law by former President Barack Obama in 2010, the ACA remains a political issue. Former President Donald Trump, who is seeking the 2024 Republican party nomination and currently leads in the polls, remains an ACA opponent, calling on Republicans to “never give up” trying to repeal the ACA. He later clarified his position on the social media platform X saying, ““I don’t want to terminate Obamacare, I want to REPLACE IT with MUCH BETTER HEALTHCARE. Obamacare Sucks!!!” Other Republicans have been less openly hostile to the ACA and Trump’s recent comments were not met with affirmations from key Republicans on Capitol Hill. Open enrollment runs through December 15 for 2024 coverage beginning January 1. For more information, visit www.healthcare.gov.
They’ve had enough: Key health care voices in both parties announce they won’t seek re-election in 2024
The ongoing political drama in Washington, D.C. is claiming more victims, as key health policy voices on both sides of the aisle have announced they will not seek re-election in 2024. Some specifically reference the “dysfunction” in Congress, while others are less specific about their rationale. Among key health care policymakers announcing their decision to step down after this term: Rep. Anna Eshoo (D-CA), who serves in a prominent role on the House Energy & Commerce (E&C) Committee, will retire after 32 years in Congress. Eshoo, who represents Silicon Valley, has been a relatively moderate voice on prescription drug and medical device policy during her tenure. She’s joined by two other Democratic E&C members, Rep. John Sarbanes (D-MD) and Rep. Tony Cardenas (D-CA). Republicans are also losing two prominent health leaders and co-chairs of the GOP Doctors Caucus. Rep. Brad Wenstrup (R-OH) announced he will retire after 10 years in Congress, and Rep. Michael Burgess (R-TX) is retiring after 20. As physicians, both Wenstrup and Burgess often led health care policy initiatives, with Wenstrup championing several patient-friendly bills during his tenure, including the Safe Step Act, which seeks to rein in health insurers’ ability to implement step therapy protocols. The federal bill builds of a variety of step therapy reforms passed at the state level in the last decade. Rep. Debbie Lesko (R-AZ), another House E&C Committee member, said she won’t seek re-re-election. While observers expect members of the same political party to win re-election to these now open seats, there is worry that the recent announcements further reduce the number of members of Congress willing to work across the aisle to advance bipartisan health care policy, a reputation enjoyed especially by Reps. Eshoo and Wenstrup.
Health Policy Snippets:
- North Carolina became the 40th state to expand its Medicaid program as of December 1. It’s estimated that the move (an agreement between the state’s Republican legislature and Democratic governor) will expand the state Medicaid rolls by about 600,000 individuals. The Kaiser Family Foundation has an updated map outlining where things stand nationally on Medicaid expansion.
- The FDA announced in late November it was launching an investigation related to the risk of secondary cancers in those who have received certain chimeric antigen receptor T-cell or CAR-T therapies. In announcing the review, the agency stated that the overall benefit of approved products still outweigh the risks. The FDA’s investigation applies to all approved CAR-Ts, which currently totals six. Dozens of companies have products in clinical trials that hope to improve on certain aspects of the CAR-T process.
