by Ellen Riker & Johanna Gray, Artemis Policy Group, Hemophilia Alliance Advocacy Consultants

In October, the Alliance Newsletter included an article on the United States District Court for the District of Columbia ruling that insurers can no longer implement copay accumulator adjustor programs (CAAPs) for drugs that lack generic equivalents. CAAPs essentially disallow copay assistance from counting towards a person’s out-of-pocket maximum or deductible, increasing patients’ costs. We recognized the court ruling as a significant positive step forward, we stated that additional guidance from the Biden Administration was needed for implementation and enforcement of the policy.

Unfortunately, we have two signs that the Biden Administration may not be moving quickly towards implementing a favorable new policy. First, they filed a motion with the court seeking confirmation of their interpretation that they did not have to retroactively implement a ban on CAAPs before they do new rulemaking. They also filed a notice to appeal the initial decision, but it’s not clear whether they intend to really appeal the decision or if they are keeping their options open depending on what the Court says in response to their clarification motion. In any event, the Administration is yet to publish a new regulation and we are still unsure of what that rulemaking will say.

The Alliance along with a coalition of organizations that advocate against the practice of CAAPs reached out to Congress to weigh in. Forty-eight Members of Congress signed a letter to HHS asking that it drop its appeal of the decision that struck down the rule on accumulators. The letter, led by Reps Buddy Carter (R-GA) and Nanette Diaz Barragan (D-CA), reflects the bipartisan co-signers disappointment in the HHS decision and states, “We believe this decision is an important step in the right direction for patients who rely on manufacturer copay assistance to alleviate affordability and access challenges for their medicines.” There is also a Senate version of the letter, led by Senators Kaine and Marshall that will be finalized and sent next week.

The Alliance will continue its work to seek passage of the Help Ensure Lower Patient (HELP) Copays Act (H.R. 830/S. 1375). In addition to banning the practice of CAAPs, this legislation would address copay maximizers (or the “EHB Loophole”), another practice by insurers that results in patients paying more for their vital treatments by carving them out of the essential health benefits (EHB).

by Johanna Gray, Artemis Policy Group, Hemophilia Alliance Advocacy Consultant

On November 15, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters (NBPP) proposed rule for the 2025 plan year. The NBPP set rules and regulations for plans on the federally run Marketplaces and for other private insurance plans subject to the Affordable Care Act’s provisions.

The proposed rule includes a few provisions that, if finalized, would strengthen the rules and make them better for people with bleeding disorders:

First, there is a provision which clarifies that covered prescription drugs not included in a State’s essential health benefit (EHB) benchmark plan are still considered essential health benefits (EHBs) and therefore, they are subject to requirements including the annual limitation on cost sharing and the restriction on annual and lifetime dollar limits. While this does not address copay accumulator adjustor programs (CAAPs), it does clarify, in federal regulation, that any prescription drug covered by a plan must be considered an EHB and therefore, some copay maximizer programs would not be allowed. We are still waiting on additional guidance from HHS regarding the September ruling on CAAPs, but this provision is another positive step forward in the fight against deceptive insurance practices.

Second, there is a provision in the rule suggesting that HHS is going to change the way they define which drugs must be covered by plans – moving from a list that primarily focuses on drugs covered under Medicare Part D to one that is broader. The Alliance, along with the bleeding disorders patient organizations have encouraged HHS to make this change so that it is clearer what Medicare Part B drugs plans must cover, like clotting factor and other bleeding disorders treatments. The proposed rule refers to this new grouping as the USP DC. Separately, the Alliance worked with NBDF and HFA to advocate to the organization that creates the USP DC that they should separate bleeding disorders treatments into multiple categories and classes to ensure that plans aren’t able to cover, only one hemophilia B treatment and say that is sufficient for all people with bleeding disorders in their plans.

Both provisions are positive signs, though we know that more work is necessary. The Alliance will continue to work with the patient organizations to support these policies and make additional recommendations for HHS to ensure that people with bleeding disorders have access to care.