CMS has announced final Medicare Advantage (MA) and Part D plan policies and rates for 2019. The final 2019 rule, published on April 16, 2018, implements a Comprehensive Addiction and Recovery Act (CARA) provision that allows Part D plan sponsors to establish drug management programs. Under this policy, plan sponsors may limit at-risk beneficiaries’ access to coverage of “frequently abused drugs” (opioids and benzodiazepines) to selected prescribers and/or network pharmacies, and they may use of point-of-sale claim edits, subject to various conditions.

Other policies adopted in the final rule include the following:

  • CMS eliminates the “meaningful difference” requirement that limits the variety of plans an MA organization can offer in the same county.
  • CMS reinterprets MA uniformity requirements for “similarly situated individuals” to allow plans to reduce cost sharing for certain covered benefits, offer specific tailored supplemental benefits, and offer different deductibles for beneficiaries that meet specific medical criteria.
  • CMS modifies Part C and Part D Star Ratings rules.
  • The rule clarifies the any willing pharmacy standard, including the definition of retail pharmacy. Note that CMS is not adopting a definition of mail-order pharmacy, as it had proposed.
  • CMS provides for a one month Part D drug transition supply in both the long term care and outpatient settings.
  • The rule authorizes CMS to change the data and methodology used to establish maximum out-of-pocket limits, beginning no earlier than CY 2020.
  • The rule modifies the Part D tiering exception policy, including removing the generic tier exclusion.
  • The rule expedites certain generic substitutions and other midyear formulary changes.
  • CMS applies generic drug cost-sharing to biosimilar and interchangeable biological products for Part D Low Income Subsidy enrollees.
  • The rule updates the electronic prescribing standards used by Part D drug plans.
  • CMS rescinds current requirements that prescribers of Part D drugs and providers of MA items/services must enroll in Medicare in order for the Part D drug or MA item/service to be covered. Instead, CMS will establish a “preclusion list” for program integrity risk screening.
  • The rule streamlines various reporting requirements as part of the Administration’s “Patients over Paperwork” Initiative (e.g., by eliminating the requirement for plans to submit certain overlapping accounting information and by authorizing expanded use of electronic beneficiary notices).

CMS acknowledged receiving more than 1400 responses to its proposed rule’s solicitation of comments on how the agency could most effectively require Part D drug plan sponsors to pass through at the point of sale a share of the manufacturer rebates they receive. CMS did not summarize or substantively discuss these comments. CMS observes that “[a]ny new requirements regarding the application of rebates at the point of sale would be proposed through notice and comment rulemaking, in the future.”

In addition, earlier this month, CMS released the final 2019 Medicare Advantage and Part D Rate Announcement and Call Letter, which is expected to increase plan payments by 3.40% relative to 2018 levels, plus an additional adjustment for underlying coding trend that CMS expects to increase risk scores by 3.1% on average, according to a CMS fact sheet. CMS finalized its proposal to reinterpret the “primarily health related” supplemental benefit standard to allow MA plans to offer a broader range of benefits, including “daily maintenance” items (e.g., fall prevention devices). Under the final 2019 policy, CMS will consider a service or item to be primarily health related if it:  is used to diagnose, prevent, or treat an illness or injury; compensates for physical impairments; acts to ameliorate the functional/psychological impact of injuries or health conditions; or reduces avoidable emergency and healthcare utilization.