CMS has issued a proposed rule to update the Medicare Advantage (MA) program and Part D prescription drug benefit rules for contract year 2019. The proposed rule would, among many other things:

  • Implement a Comprehensive Addiction and Recovery Act (CARA) provision that allows Part D plan sponsors to establish drug management programs that limit at-risk beneficiaries’ access to coverage of opioids to selected prescribers and/or network pharmacies (subject to various limitations);
  • Eliminate the “meaningful difference” requirement that limits the variety of plans an MA organization can offer in the same county;
  • Modify Part C and Part D Star Ratings rules;
  • Clarify the any willing pharmacy standard, including the definitions of mail-order and retail pharmacies;
  • Provide for a one month Part D drug transition supply in both the long term care and outpatient settings;
  • Update the electronic prescribing standards used by Part D drug plans;
  • Authorize CMS to change the data and methodology used to establish maximum out-of-pocket limits;
  • Modify Part D tiering exception policy;
  • Expedite generic substitutions in certain situations;
  • Encourage the use of follow-on biological products for certain beneficiaries;
  • Revise requirements related to the review of marketing materials;
  • Modify appeals policies;
  • Eliminate the prescriber and provider enrollment requirement and establish a “preclusion list” for program integrity risk screening; and
  • Streamline various reporting requirements.

CMS also solicits comments on how it 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 — and do so without increasing government costs and without reducing manufacturer payments under the coverage gap discount program. In addition, CMS requests comments on how it could update requirements governing the determination of negotiated prices to ensure that the reported price at the point of sale includes all pharmacy price concessions. CMS discusses in detail the options it is considering, and requests public input on a variety of operational and policy considerations.

CMS will accept comments on the proposed rule until January 16, 2018.