Alert for Congress Members:
Another Proposed HHS Change Limits Access to HIV Medications

The Trump Administration recently issued its annual Notice of Benefits and Payment Parameters (NBPP), which outlines changes that the Department of Health and Human Services (DHHS) plans to apply to the Affordable Care Act (ACA) marketplaces and insurance rules in the next plan year. The new proposed guidance would make it harder for people with HIV in some states to access the HIV medications they need.

The new rule proposed for 2021 features numerous changes related to:

  • Payment Parameters and Provisions related to risk adjustment;
  • Cost-sharing parameters and cost-sharing reductions;
  • User fees for the federally facilitated marketplace and state-based marketplaces using the federal platform; and
  • Risk adjustment and data validation programs, among other proposals.

One notable NBPP change now being proposed affects how drug manufacturer coupons accrue towards the annual limitation on cost sharing, endorsing PBM and insurance programs known as “Co-Pay Accumulators.” Specifically, the Trump Administration proposes to revise §156.130(h) to state that: “to the extent consistent with applicable state law, amounts paid towards reducing the cost sharing incurred by an enrollee using any form of direct support offered by drug manufacturers for specific prescription drugs may be, but are not required to be, counted toward the annual limitation on cost sharing.” This proposed revision simply means that patients’ out of pocket prescription drug costs, in some states and plans, will NOT include expenditures covered by pharmaceutical manufacturer coupon assistance programs.

People with HIV and those using PrEP to avoid acquiring HIV often rely on the co-pay coupons they receive from pharmaceutical manufacturers to help them afford their prescriptions. On average, these manufacturers offer up to $7,500 per year in coupons that then help the customers using those coupons cover copayments, deductibles, and co-insurance required by their health plans.

The Trump Administration’s proposed rule change will force some patients with HIV or those who are on PrEP for prevention to cover the out-of-pocket medication costs on their own, thus increasing their likelihood of potentially falling off treatment. Once again, the Trump Administration is undermining its own Ending the Epidemic Plans, this time under the guise of cost sharing and financially incentivizing pharmacy benefit managers and insurance companies to make access more restrictive.

The American Academy of HIV Medicine opposes this proposed revision and the exclusion of co-pay coupons from insurance deductibles. People with HIV already face extremely high costs of medical care. While we are aware of, and often advocate around, high prescription drug costs, drug manufacturers’ support in the form of co-pay coupons means that doctors and patients can select the optimal treatment regimen, tailored to each individual and often mobilizing the latest science and research.

Allowing patients to apply the value of these coupons to their deductibles ensures that patients can afford their care. It also ensures that their health insurance plans cover routine monitoring and blood work without customers having to shell out money to meet often high out-of-pocket individual deductibles. Finally, it means that people with HIV do not have to expend personal money on deductibles if they have co-existing conditions, need preventive vaccinations, or are in treatment for opportunistic infections. In short, allowing patients to apply co-pay coupons towards individual deductibles helps keep them in care and healthy.

The Academy encourages patients and doctors to submit public comments on how this revision will impact patients’ health. Comments on the proposed NBPP must be submitted no later than 5:00 pm Eastern Time on March 2, and may be submitted electronically through http://www.regulations.gov or via mail using the address: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-9916-P, P.O. Box 8016, Baltimore, MD 21244-8016. In commenting, please refer to file code CMS-9916-P.