On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs.  Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date, provisional supplies, and “other authorized prescribers” (a newly defined term).  CMS initially proposed rules relating to these topics in January 2014. After issuance of these rules, many parties voiced their concerns that the proposed requirements would result in many beneficiaries losing access or having delayed access to their Part D drugs. The changes that CMS announced on May 6, 2015 appear positioned to address these concerns.

Under the interim final rules, prescribers (which include physicians and eligible professionals) now have until January 1, 2016 to enroll in Medicare or file an opt-out affidavit.  This is the second time that CMS has delayed the requirement; first from June 1, 2015 to December 1, 2015, and now to January 1, 2016.  By allowing prescribers more time to enroll or out-opt, CMS believes that fewer beneficiaries will be faced with the prospect of submitting a prescription to a pharmacy written by a prescriber who failed to meet the initial or second deadline.

The other two significant announcements in the internal final rules, those relating to other authorized prescribers and provisional supplies and beneficiary notices, may have a more significant impact on beneficiary access than CMS’s decision to delay the enroll/opt-out effective date.

As a result of the requirement that prescribers either enroll in Medicare or file an opt-out affidavit, certain prescribers faced loss of their ability to prescribe medications for Part D members.  Prescribers slated for ineligibility were prescribers recognized under certain states’ laws as having prescriptive authority, but not recognized under the Social Security Act (“Act”) as a physician or meeting the definition of an eligible professional.  Such prescribers are not eligible to enroll in Medicare and, under CMS’s rules, not eligible to file an opt-out affidavit.  To remedy this gap, CMS proposes to allow Part D plans to approve prescriptions written by “other authorized prescribers,” even though such prescribers have not enrolled in Medicare or opted-out, so long as their prescriptions meet all other Medicare Part D requirements.  An “other authorized prescriber” is defined as “a person other than a physician (as defined in section 1861(r) of the Act) or eligible professional (as defined in section 1848(k)(3)(B) of the Act) who is authorized under state or other applicable law to write prescriptions.”

Finally, once the enroll/opt-out requirement becomes effective, CMS will require that Part D plans provide a beneficiary who submits a prescription written by an ineligible prescriber a three-month provisional supply (benefit limits apply) of the prescribed drug and a notice explaining that the prescription is only being covered on a provisional basis. CMS believes that three months is an adequate time for a prescriber to either enroll or submit an opt-out affidavit or for the beneficiary to seek care from a different prescriber.  The provisional supply and notice requirement are both prescriber specific and drug specific so a beneficiary who files a prescriptions from an unenrolled prescriber in January for drug 1 and a prescription from the same prescriber in February for drug 2 will receive provisional supplies of both drugs and notices specific to both drugs.  CMS will issue additional guidance regarding how “drug” is defined, and many other intricacies that Part D plans and PBMs will need to attempt to operationalize.  This approach is very similar to CMS’s approach to transition supplies, a requirement that many Part D plans and PBMs have struggled to accurately operationalize over the years.  Part D plans and PBMs should cross their fingers and hope that CMS’s additional guidance will provide clear steps and is ideally written by an agency that understands the complexity of implementing provisional supplies and notice requirements and the inevitable challenges to come