CMS Releases Final Rule on Medicare Advantage and Part D Drug Pricing Rule


By Madison Mason, Policy Associate, National Health Council

On May 16, 2019, The Centers for Medicare and Medicaid Services (CMS) finalized their Medicare Advantage and Part D Prescription Drug Price Rule. The final rule withdrew many harmful provisions that the NHC opposed and strengthened patient protections that we recommended. Additionally, CMS finalized many provisions that the NHC supported. The chart below outlines provisions of the proposed rule, the NHC’s Comments, and CMS’ responses in the final rule.

CMS Proposed Rule (November 2018)

NHC Reaction

CMS Finalized Rule (May 2019)

CMS proposed several exceptions to the requirements related to coverage and utilization of the six protected drug classes.

The NHC asked for withdrawal of this proposal because of the negative impact it would bestow upon patients, especially those with chronic and complex conditions.

CMS withdrew this proposal.

CMS proposed allowing step- therapy for Part B drugs in Medicare Advantage.

The NHC expressed concern with this proposal and outlined a set of patient safeguards to mitigate the policy’s harmful effects. Notably:

1. The NHC requested a longer lookback window to consider someone a “new start” for a therapy.

2.The NHC urged CMS to enhance their oversight to ensure plans are not discriminatory and operate within regulation.

1. CMS changed the 108-day lookback period to 365 days.

2.CMS will require all plans to submit their step-therapy protocols to be reviewed and will only be able to proceed if CMS deems them clinically appropriate.

CMS proposed requiring that prescription drug plans include drug pricing information in the explanation of benefits (EOB).

The NHC supported this proposal and agreed with CMS that the EOB enhancements would “spark dialogue between the Part D beneficiaries and their providers about lower-cost therapeutic alternatives that empower them to make more informed decisions when choosing a prescription.”

CMS finalized this proposal.

CMS proposed requiring Part D plan sponsors to implement an electronic real-time benefit tool (RTBT) that would enable prescribers and patients to make more informed choices at the point of prescribing.

The NHC supported this proposal because patients can make better choices about their health care when they have access to more information.

CMS finalized this proposal, which will go into effect in 2021.

CMS proposed to prohibit plans from implementing “gag clauses.”

The NHC supported this proposal because patients have a right to accurate information regarding their health care choices, and the associated costs.

CMS finalized this proposal.

CMS proposed to reduce cost sharing by re-defining “negotiated price” to consider pharmacy discounts.

The NHC supported this proposal and asked for them to go further by considering manufacturer discounts.

CMS decided to withdraw this rule, and it will not be finalized.

In a statement, NHC Chief Executive officer Marc Boutin, JD said, “This is a great win for the patient community. We thank CMS for listening to the concerns of patients and for not restricting access to needed medications. We are also pleased CMS finalized changes to increase drug pricing transparency for patients and providers. We look forward to advancing our work with Congress and the Administration to reduce drug costs for our nation’s seniors.”

Please read our comment letter, which offers far greater detail on each of the provisions made by the NHC on CMS’ proposed rule on Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-Of-Pocket Expenses.