New Rule for Part D Prescribers: Enroll or Opt-Out

Last year, CMS issued a final rule which requires prescribers of Part D drugs to be either enrolled with Medicare or have submitted an opt-out affidavit to their Medicare Administrative Contractor (MAC) in order for a prescription to be eligible for coverage under the Part D program.  See 42 CFR § 423.120(c)(5) and (6).  

While the rule is slated to go in effect on June 1, 2015, CMS announced that it will delay enforcement of the requirements in 42 CFR § 423.120(c)(6) until December 1, 2015.  Despite these additional six months, CMS advises prescribers to submit either the opt-out affidavit or the enrollment application by June 1, 2015 or earlier to give Medicare contractors enough time to process the enrollment or opt-out elections without interrupting claims processing.

The opt-out affidavit must be submitted to each MAC that may have jurisdiction over claims.  Currently CMS does not have standard opt-out affidavits but many MACs have their own forms.  Providers can also submit their opt-out decision in writing to the MAC provided it contains specific information such as, for example, legal name, NPI, TIN or SSN, among others.  A prescriber may opt-out of Medicare at the beginning of any calendar quarter, provided that the affidavit is submitted to the prescriber’s Medicare contractor at least 30 days before the beginning of the selected calendar quarter.

CMS will also be providing an enrollment file that identifies physician and eligible professionals who are enrolled in Medicare in an approved or opt out status in an effort to prepare for the December 1, 2015 enforcement date. A test file can be currently located at

For more information on this requirement, enrollment, revalidation, or if you have other health law questions, please contact our office.