Medicare Program; Contract Year 2019 Policy and Technical Changes Final Rule

Apr 23, 2018

DIR Fees

CMS decided to “kick the can down the road” on DIR fees at this time, but noted that the President’s Fiscal Year 2019 Budget included language that all price concessions should be at the point-of-sale.  CMS believes the statute provides them with discretion to require that Part D sponsors apply at least a portion of the manufacturer rebates and all pharmacy price concessions they receive to the price of a Part D drug at the point of sale. Any new requirements regarding the application of rebates at the point of sale will be proposed through notice and comment in future rulemaking.

LIS Patient Special Election Period

Specifically, the dual SEP is being amended so that it can be used once per calendar quarter during the first nine months of the year (that is, one election during each of the following time periods: January-March, April-June, July-September). During the last quarter of the year, a beneficiary can use the AEP to make an election that would be effective on January 1. By still allowing multiple changes throughout the year, dual and other LIS-eligible beneficiaries will maintain additional flexibilities not afforded to other Part D-eligible beneficiaries.

CARA Patient Lock-In Provisions

Get ready, Medicare Part D will be implementing patient pharmacist/physician lock-in for at-risk patients. At-risk beneficiaries are to be identified under guidelines developed by CMS with stakeholder input. CMS beginning standards: use of opioids (regardless of average daily MME) during the most recent 6 months with 7 or more opioid prescribers OR 7 or more opioid dispensing pharmacies. CMS is expanding the definition of frequently abused drugs to include opioids and benzodiazepines. CMS will also limit the use of the special enrollment period (SEP) for dually- or other low income subsidy (LIS)-eligible beneficiaries who are identified as at-risk or potentially at-risk for prescription drug abuse under such a drug management program.

Accreditation Requirements

CMS noted that community and regional pharmacies have complained about excessive barriers to entry, and alleged that they only underwent accreditation because they were forced to do so. Otherwise, they would have been cut out of approximately 75 to 80 percent of the market. While CMS supports the use of third party accreditation, they are concerned that Part D plan sponsors may require or do not recognize one accreditation certification versus another. CMS believes it is unrealistic to expect pharmacies to obtain multiple accreditation certifications.


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