Take Action: New CMS Proposed Rule Targeting Manufacturers, Patient Assistance Programs, ACOs, Payers and ACA Exchange Stakeholders

The Centers for Medicare and Medicaid Services (CMS) has issued a new proposed rule targeting Accountable Care Organizations (ACOs), payers and Affordable Care Act (ACA) exchange stakeholders. The proposed rule, titled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020“, reflects a priority of the Administration around the Patient Protection and Affordable Care Act (PPACA) of reducing fiscal and regulatory burdens across various areas within the law. This proposed rule has several components that affect different stakeholders.

Manufacturers and Patient Assistance Program Stakeholders:

Copay accumulators are being implemented by insurance companies and Pharmacy Benefit Managers (PBMs), harming patient access. With this payor program, the value of copay assistance cards/coupons issued by manufacturers do not count towards out-of-pocket costs that are applied toward deductibles. The result has caused a cost shift onto consumers and away from employers and payers.

In this proposed rule, the Administration defends the use of copay accumulators stating:

“The availability of a coupon may cause physicians and beneficiaries to choose an expensive brand-name drug when a less expensive and equally effective generic or other alternative is available. When consumers are relieved of copayment obligations, manufacturers are relieved of a market constraint on drug prices which can distort the market and the true costs of drugs. Such coupons can add significant long-term costs to the health care system that may outweigh the short-term benefits of allowing the coupons, and counter-balance issuers’ efforts to point enrollees to more cost-effective drugs.”

“We propose, for plan years beginning on or after January 1, 2020, notwithstanding any other provision of the annual limitation on cost sharing regulation, that amounts paid toward cost sharing using any form Start Printed Page 291of direct support offered by drug manufacturers to insured patients to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have a generic equivalent are not required to be counted toward the annual limitation on cost sharing. Not counting such amounts toward the annual limitation on cost sharing would promote: (1) Prudent prescribing and purchasing choices by physicians and patients based on the true costs of drugs and (2) price competition in the pharmaceutical market.”

Participating in this proposed rule is crucial for manufacturer and patient assistance programs to maintain patient access and stop unnecessary risk shifting from occurring in consumer spending.  We can help advocate your concerns.

ACOs, Payers and ACA Exchange Stakeholders:

Specifically, the proposed rule would set forth parameters and provisions related to the risk adjustment and risk adjustment data validation programs, cost sharing parameters, and user fees for Federally-facilitated Exchanges and State-based exchanges on the Federal Platform.

The proposal outlines changes that would allow greater flexibility related to the duties and training requirements for the Navigator program and proposes changes that would provide greater flexibility for direct enrollment entities, while strengthening program integrity oversight. Lastly, the proposal discusses policies that are intended to reduce the costs of prescription drugs. This includes proposed changes to Exchange standards related to eligibility and enrollment, exemptions, and other related topics.

The Administration has been making several changes to the ACA via regulation, as earlier Executive Orders described how regulatory changes would be used to make drastic reductions to the ACA. If you have an interest in the ACA or a direct one based off of an interest in the Exchanges, it is advised that you participate in this rule to ensure that your interests are represented. Not doing so will subject your organization to whatever policies may or may not arise from this rulemaking, potentially placing your organization and your priorities at a disadvantage.

Frier Levitt Government Affairs (FLGA) helps stakeholders comment on proposed regulations. FLGA understands the nuances around industry and has strategies that can help successfully communicate stakeholders’ positions to CMS.

The deadline to comment is February 19, 2019, so it is important that you contact Frier Levitt Government Affairs today to make sure your voice is heard.