CMS final rule shows DIR fees are on the radar

Agency will also consider greater pharmacist involvement in MTM and promote immunization

Pharmacists and patients can expect changes both major and modest in 2019 Medicare Advantage–Prescription Drug (MA–PD) and Part D plans. In its final call letter, released in April 2018, CMS announced it will continue to prioritize opioid controls, consider greater pharmacist involvement in enhanced medication therapy management (MTM), and promote immunization. A final rule, however, promises larger policy shifts that could have a big impact on pharmacies.

The annual call letter sets forth requirements for what sponsors’ plan bids must include. MA–PD and Part D plan sponsors—the private insurers who sell plans to Medicare beneficiaries—then use the CMS final call letter to craft their bids for the upcoming year.

For 2019, the opioid hard and soft edits CMS encouraged but did not require for 2018 plans will become compulsory.

CMS expects all Part D plans to implement a hard safety edit for initial opioid prescription fills for acute pain to no more than a 7-day supply. Part D plans must create channels for pharmacists to communicate any exemptions. The plans must set a formulary-level safety edit when a beneficiary’s medications exceed 90 morphine milligram equivalents (MME) per day.

Hard edits will be triggered at 200 MME or more. Soft edits will be triggered at 90 MME and for duplicative opioid therapy and/or concurrent use of benzodiazepines.

CMS cited comments it received from APhA and other pharmacy groups encouraging further pharmacist involvement in enhanced MTM and will consider these suggestions when assessing potential model enhancements in the future.

CMS includes language encouraging Part D plans to offer vaccines in a $0 vaccine tier or to place vaccines on a formulary tier with low cost-sharing.

A final rule—the first in 3 years—will have a more significant impact on plans, pharmacies, and patients.

In its draft rule, CMS included a request for information (RFI), calling for responses to the idea of including rebates and pharmacy price concessions—known as direct and indirect remuneration, or DIR fees—at the point of sale (POS). This is something the pharmacy community has long sought.

The final rule states that the potential application of rebates at POS, including a requirement for savings to be passed from Part D plans and PBMs onto beneficiaries, will be proposed through a separate notice and comment rulemaking in the future.

Another major issue for pharmacies is the use of “any willing pharmacy” (AWP) provisions. There’s already a requirement for all Part D plans to include in their standard or preferred networks any pharmacy that meets the standard terms of contracts. In the proposed rule, CMS noted that some PBMs were using practices to get around that—such as excluding pharmacies they deem to have nontraditional lines of business and therefore are not “similarly situated.”

The final rule clarifies that statutorily required AWP provisions apply to all pharmacies, regardless of their functional lines of pharmacy business. The rule also revises the definition of retail pharmacy to allow patients to continue getting their prescription drugs from the same pharmacy, prohibits plans and PBMs from requiring onerous pharmacy accreditation and credentialing requirements, and mandates the timeline for giving Part D standard terms and conditions information to pharmacies.

For the full article, please visit for the May 2018 issue of Pharmacy Today.