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CMS Issues Final Rule Affecting Patient Access and Prescription Drug Affordability

Posted: June 14, 2019

The Centers for Medicare and Medicaid (CMS) published its Medicare Advantage and Part D Drug Pricing Final Rulein May which seeks to increase drug pricing transparency, lower prescription drug costs, and improve patient medication adherence. CMS says the Rule focuses on strengthening negotiation leverage for Medicare Advantage (MA) and Part D plans, making more tools available to MA plans for negotiating prices with manufacturers for physician-administered medicines in Part C, and regulations for the use of utilization management protocols for the six protected classes.

CMS outlined set terms for accelerating the use of Real Time Benefit Tools (RTBT) in the Part D program in the Rule. Each Part D plan will be required by 2021 to adopt one or more RTBTs that have integrating capabilities with prescribers’ electronic health record (HER) systems or ePrescribing systems. CMS opted not to include in the Final Rule provisions which would have allowed Part D sponsors to exclude a protected class drug from a formulary when a manufacturer raises prices beyond inflation. Requirements for Part D plans to notify their members of drug price increases and offer information on any lower cost therapeutic prescription alternatives are also to be implemented by 2021. CMS asserts that Medicare beneficiaries will benefit from receiving information on how to reduce their out-of-pocket costs, resulting in more informed treatment decisions being made between patients and providers.

Additionally, CMS chose not to adopt the initial step therapy policy proposal in the Final Rule which would have allowed for MA plans to implement step therapy protocols for stable patients taking Part B drugs. Instead, step therapy protocols will only apply to new medication starts; and all exemption requests are required to be reviewed by plans’ pharmacy and therapeutics committees. Additionally, the timeframes for plans to respond to requests and appeals for Part B drugs will be shortened and mirror the current Part D rules.

More information on the Final Rule can be found on CMS’s website.