Policy Progress for Patient Protections in 2024

By Mark Hobraczk, JD, MPA, HFA’s Director of Policy and Advocacy, and Mary Catherine Moffett, MSW, HFA’s Vice President of Policy and Advocacy

Hemophilia Federation of America is committed to pursuing a carefully constructed agenda of policy priorities that directly impact the bleeding disorders community. The Policy and Advocacy Team monitors state and federal legislative and regulatory language with a dedication to and focus on health equity, and here’s what is on their radar in 2024:

The top-tier priority in state legislatures and Congress has been monitoring and advocating for policies that ensure patient protections against harmful and discriminatory copay accumulator adjuster programs (CAAPs). While there has been great progress, there remains one necessary component to this work: the continued work of advocates who are directly impacted by harmful policies like these. 

CAAPs are a tactic used by health plans to contain their costs by denying a covered patient any benefit of a third-party copay assistance benefit toward accessing their specialty drugs. It works by redirecting that copay assistance away from meeting the patient’s out-of-pocket cost-share and directly to the health plan’s bottom line. Because copay assistance is a lifeline for many persons with bleeding disorders or other high-cost conditions, the impact of tactics like CAAPs can be devastating to patients. 

How do CAAPs Work? 

When an insurer applies a copay accumulator, the insurer collects double (or even more than double) the amount of a patient’s required cost-sharing: once from the copay assistance program and then, when the assistance dollars are depleted, the full amount of the cost-sharing (again) from the patient. On the patient’s side, all too often, the result is that the patient encounters an unexpected and unaffordable charge for their drug refill. The patient, if unable to pay, may be forced to abandon their prescription, discontinue therapy, and potentially end up in the emergency room for treatment of an acute (and avoidable) health issue. HFA has made it a priority to protect patient access to that assistance across the board – ensuring all copays count.

Who’s Impacted? 

Anyone who relies on a specialty drug who also has health insurance coverage. State laws can protect patients with individual, small group or state employee coverage, but large employer and self-funded coverage can only be regulated by the federal government (under a law called ERISA).

Progress in Patient Protections

It’s critical to highlight the progress made up to this point is a collective effort in which HFA is working diligently on, as a member of the All Copays Count Coalition and alongside other local and regional stakeholders. 

We saw progress in more than 10 states in 2024:

• Oregon: 20th state to enact patient protections from CAAPs
• Vermont: The governor is expected to sign a comparable ban into law as part of a PBM reform bill that cleared the legislature just this month (H.233). 
• CAAP bills advanced in several other states including California, Maryland, Massachusetts, Missouri, New Hampshire and Rhode Island. 
• New CAAP bill to be introduced next month in New Jersey.”    
• At least a dozen states including California, Florida, Maryland, Michigan, Missouri, North Dakota, Ohio, Pennsylvania, South Carolina, Utah and Wisconsin are expected to renew efforts to pass CAAP prohibitions in 2025.

We also saw health insurers start to attack existing CAAP laws. Fortunately, bills that would weaken these laws by inserting language allowing copay maximizers were defeated in Colorado, Oklahoma and Tennessee. 

On the Federal Level

We succeeded in getting the Department of Health and Human Services to close a “loophole” that insurers started using to pocket the entire amount of copay assistance available to consumers (instead of just their annual out-of-pocket maximum under the Affordable Care Act). Employer plans used this loophole to call the highest-cost specialty drugs “non-essential” in order to circumvent ACA rules on essential health benefits and cost-sharing. HHS eliminated this loophole for individual and small group plans starting in 2025 (and pledged to do so in future rulemaking for large employer/self-funded plans regulated solely by the federal government).   

The HELP Copays Act, a piece of Congressional legislation that would ban CAAPs in both federally and state-regulated plans continues to draw broad bipartisan support despite election-year inertia. HFA supports this legislation enthusiastically. 

We are also actively urging members of Congress to compel HHS to promptly rewrite its 2021 rule permitting CAAPs—HHS was directed last year by a federal court to do this and make it consistent with its 2020 rule banning CAAPs when no generic drug alternative exists (Nevada is the only state insurance department that agreed to enforce the 2020 rule.). Following this process closely is especially important for protecting members of the bleeding disorders community where generic alternatives are not a part of the scope of treatment (and this is the case for nearly all specialty drugs). Because HHS has given no indication whether its revised rule will ban CAAPs (or when it will be issued), state laws are still needed to protect consumers in individual and small group plans.  

Insights for 2025

Health plans have increasingly relied on CAAPs to divert a patient’s copay assistance to the plan’s own bottom line. Because this diversion has become so profitable, Avalere Health found that more than 83% of private health plan consumers currently face some form of them, including copay maximizers through alternative funding programs (which have become increasingly prevalent in employer-sponsored coverage). 

Although banning CAAPs remains a top policy priority, it is just part of HFA’s commitment to ensure timely access to affordable and quality care for all persons with bleeding disorders.  Since the start of 2024, HFA has successfully advocated for federal rules protecting patients from “junk” health plans, discriminatory health benefit designs, and blanket exclusions of persons with bleeding disorders from inpatient rehabilitation settings. At the state level, HFA strongly supports ongoing efforts to expand the number of states creating Rare Disease Advisory Councils (Mississippi became the 28th state this year), ensure Medicaid patients are not wrongly terminated during the COVID-19 “unwinding” and strengthen patient protections from step therapy, formulary exclusions for entire categories of bleeding disorder products, or other burdensome prior authorization/cost-containment tactics that are intended to create barriers to care.