In an effort to support the Trump Administration’s American Patient First Blueprint, on April 18, 2019 the Centers for Medicare and Medicaid Services (CMS) announced in 2020, individual market, small and large group, and self-insured group health plans will be allowed to implement copay accumulator or maximizer programs for prescription brand name drugs that have an available and medically appropriate generic equivalent.2 Copay accumulator programs work by targeting select specialty drugs for which a manufacturer provides out-of-pocket assistance (ie, copay cards). When accumulator programs are implemented, the manufacturer’s payment does not count toward a patient’s deductible or out-of-pocket maximum.
Copay accumulator programs are controversial; it is notable that Virginia and West Virginia recently banned copay accumulators to insurance plans sold on the state-regulated individual market. However, CMS’s guidance may be viewed as a compromise since the allowance of accumulators applies to brand medications available as generics. CMS’s goals with the ruling is to continue to drive low-cost options to patients and cost savings to federal spending.
What does this mean to market access? While payers currently focus these programs on specialty agents the language in the ruling does not limit these programs from being implemented by payers in traditional disease states where more value could be realized based on the availability of generically equivalent agents. This new guidance may allow payers to test the waters and eventually leverage accumulator programs into traditional disease states in commercial plans. Therefore, it is important to remain vigilant and consider when and if payers will move these programs into nonspecialty therapeutic areas. Clinical and economic differentiation become more important to drive optimal access for branded medications in crowded therapeutic areas, because copay/patient assistance programs may not be sustainable and impact gross-to-net projections.
As payers consider conditions (ie, traditional and/or specialty), populations (ie, commercial and/or exchange), administrative burden, and the ability to generate meaningful savings through accumulator programs, market access strategies need to include models that demonstrate incremental value to access decision-makers.
- Department of Health & Human Services. Centers for Medicare and Medicaid Services. 2020 draft letter to issuers in the federally-facilitated exchanges. https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Final-2020-Letter-to-Issuers-in-the-Federally-facilitated-Exchanges.pdf. Accessed June 19, 2019.
- Department of Health & Human Services. Centers for Medicare and Medicaid Services. Fact sheet and frequently asked questions. https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/CMS-9926-F-Fact-Sheet.pdf. Accessed June 19, 2019.
- Federal Register. Patient and affordable care act; HHS notice of benefit and payment parameters for 2020. https://www.federalregister.gov/documents/2019/04/25/2019-08017/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2020. Accessed June 19, 2019.
- Modern Healthcare. CMS to allow copay accumulators, cut exchange user fees. https://www.modernhealthcare.com/insurance/cms-allow-copay-accumulators-cut-exchange-user-fees. Accessed June 19, 2019.