On April 2, CMS published their final rule for contract year 2019 that revises regulations related to Medicare Advantage (MA) and the Prescription Drug Benefit Program (Part D). The primary focus of this rule is to implement provisions from the Comprehensive Addiction and Recovery Act (CARA) to help fight the opioid epidemic, implement provisions from the 21st Century Cures Act and ultimately, improve consumer experience.
CMS notes in its press release that this final rule will “save Medicare beneficiaries money on prescription drugs while offering additional plan choices” and “further the Trump Administration’s commitment to lowering drug prices.” CMS Administrator Seema Verma added, “The steps we are taking will drive more competition among plans and pharmacies to meet the needs of seniors and lower costs.”
CMS estimates annual savings of $295M for the Medicare program over the 5-year period of 2019 – 2023. The rule goes into effect 60 days after the date of publication in the Federal Register.
Highlights of Final Rule
- Codifies key features of MA and Part D Star Rating methodology to, in part, allow for MA and Part D plans to develop multi-year initiatives by informing them of measures in advance, thereby giving them additional lead time to plan
- Implements statutory provisions of CARA by establishing a framework for Part D plan sponsors to develop a drug management program for beneficiaries considered at risk for opioid misuse
- Drug management program includes provision for Part D plans to engage in case management for at-risk beneficiaries.
- Implements provisions of 21st Century Cures Act by establishing a new annual open enrollment period (OEP) for MA from January 1st to March 31st
- Modifies requirements related to delivery methods for mandatory disclosures in both the MA and Part D programs
- CMS will now allow MA plans to meet disclosure and delivery requirements for certain beneficiary documents by providing notice of electronic posting and making provisions to provide hard copy documents when requested to do so.
- Repeals provisions in current regulations that require prescribers of Part D drugs and providers of MA services to enroll in Medicare for the Part D drug or MA service to be covered
- This regulation asserts that Part D plan sponsors or their pharmacy benefit manager (PBM) are required to reject any pharmacy claims for Part D drugs and not cover MA services if the prescribing or furnishing party respectively, are listed on the preclusion list.
- Revises regulatory provisions pertaining to control of maximum out-of-pocket (MOOP) limits to account for future changes in methodology
- Revises existing policy concerning Part D tiering exceptions, eliminating the provision that allowed plans to exclude dedicated generic tier(s) from the tiering exceptions process
- Clarifies any willing pharmacy provisions and defines retail pharmacy in accordance with the proposed rule
- Enhances formulary flexibility by expediting the substitution of certain generics and other mid-year changes, allowing Part D sponsors to immediately substitute brand-name drugs with certain generics on the same or a lower cost-sharing tier if certain requirements are met
- Foreshadows changes to the CMS measurement process including the possible inclusion of more patient-reported outcomes under MA
- Removes the quality improvement project requirement for MA organizations to reduce duplication and enhance focus on the management of chronic conditions.