Word from Washington: January 2024

On January 16, the U.S. Department of Health and Human Services withdrew its appeal in the litigation over HHS’s copay accumulator adjuster regulation. Patient groups including HFA applauded this latest development in the lawsuit. 

As a reminder, patient groups led by the HIV + Hepatitis Policy Institute had filed suit against HHS, challenging its 2021 rule allowing health plans to implement copay accumulator adjusters. A federal district court ruled against HHS and in favor of the plaintiffs last September. The court vacated HHS’s 2021 rule and instructed the agency to reconsider its interpretation of the term “cost-sharing,” as used in federal statutes and regulations. In response, HHS asked the court to clarify its ruling and simultaneously filed a notice of appeal of the lower court ruling.  

In December 2023, the court provided the asked-for clarification, confirming that the September court order (overruling the 2021 regulation) leaves HHS’s 2020 rule in effect. The 2020 rule, as generally understood, requires insurers and PBMs to count copay assistance dollars toward patient out-of-pocket costs. However, in its clarifying order, the trial court declined to interpret the 2020 rule or to weigh in on whether HHS is now obligated to enforce the 2020 rule (HHS had previously advised the court that HHS does not plan to begin enforcing limits on health plan use of copay accumulator adjusters). 

As the legal wrangling continues, HFA and allied patient groups have reiterated their call for HHS to enforce its 2020 policies protecting patients who rely on copay assistance. HFA and allied groups also remain committed to advocating for legislative protections (federal and state) against harmful insurer copay diversion practices.   

Quick Hits: 

• President Biden signed another stopgap spending bill (“continuing resolution”) on Friday, January 19, funding federal agencies until early March.  The six-week spending measure maintains current federal funding levels and avoids yet another shutdown deadline.  
• With the start of the new year on January 1, many people may find themselves navigating a new health plan – or simply starting from scratch with newly reset health insurance deductibles. HFA together with NBDF presented a recorded webinar (“New Year, new health plan”) that offers guidance on actions you can take if you find that your 2024 health plan excludes coverage for medications that you need.  
• HFA, with NBDF and the Hemophilia Alliance, submitted comments on HHS’s 2025 Notice of Benefit and Payment Parameters (the annual rule governing aspects of health insurer operations for the coming year). The bleeding disorders groups applauded HHS for taking action to close the essential health benefit “loophole” that plans exploit to implement copay maximizers but called again for HHS to take action to protect patients against other copay diversion tactics (like copay accumulator adjusters).  
• The U.S. Centers for Medicare and Medicaid Services (CMS) finalized a rule streamlining and standardizing prior authorization processes for certain payers. Beginning primarily in 2026, Medicare Advantage plans and state Medicaid and Children’s Health Insurance Program (CHIP) programs will be required to issue prior authorization decisions within 72 hours for urgent requests and seven calendar days for standard requests for medical items and services. The rule also requires all impacted payers to include a specific reason for denying a prior authorization request. 
• CMS reported that more than 20 million Americans signed up for 2024 individual market health insurance coverage through HealthCare.gov and the state marketplaces since the beginning of the open enrollment period on November 1, 2023. This record-breaking figure represents an increase of 5 million over last year’s (then record high) enrollment. Enrollment gains are attributed to enhanced subsidies, which make premiums more affordable, and to new enrollments by people who have lost Medicaid coverage during the “unwinding” of COVID-era eligibility protections.  
• On January 5, the U.S. Food and Drug Administration for the first time approved a state’s application to import certain prescription drugs from Canada. This development will have little significance for people with bleeding disorders. Florida still has to clear many hurdles before it can move forward with drug importation; Canada opposes the scheme; and injectable/infusible products such as bleeding disorders drugs are ineligible for importation in any event.