‘The pharmacist fix’: More information from CMS on interim final rule

Agency’s change came in response to pharmacy groups’ concerns

On May 6, CMS held a short information session with national pharmacy groups on the agency’s newly published interim final rule allowing Medicare Part D plans to continue covering pharmacy claims for prescriptions written by “other authorized prescribers,” such as pharmacists.

The change to prescriber enrollment policy followed a February 6 joint letter by eight pharmacy organizations. The new regulations appear to be a direct response to the associations’ efforts, which were spearheaded by APhA. The interim final rule updated the existing Part D final rule published on May 23, 2014. Such a regulatory change is rare, said Jillanne Schulte, JD, APhA Director of Regulatory Affairs.

CMS staff collectively refer to the change as “the pharmacist fix.” APhA, Schulte said, “looks forward to working more closely with CMS on outreach and education on this and other issues, which we hope will allow us to maintain and reinforce a strong working relationship with the agency.”

CMS previously was set to require physicians (including dentists) and other eligible professionals (e.g., nurse practitioners, physician assistants) who write prescriptions for Part D drugs or supplies to be enrolled in an approved status or to have a valid opt-out affidavit on file by a deadline in 2015. Pharmacists authorized to prescribe under state law, or “prescribing pharmacists,” do not fit into either category, and thus are unable to comply with the enrollment/opt-out requirements of the 2014 final rule.

That means without the change in the new interim final rule, Part D could not cover patients’ prescriptions from pharmacists. This change does not make pharmacists eligible to enroll in or opt out of Medicare, nor does the definition of “other authorized prescribers” apply to other CMS provisions.

As detailed in the interim final rule, an “other authorized prescriber” must have an active and valid NPI (national provider identifier number) that is contained in the pharmacy claim. CMS said that pharmacists should check the validity of their NPIs, including verifying their taxonomy is correct in the NPPES (National Plan & Provider Enumeration System).

The regulations also include a “provisional supply” option to maintain patient access to medications if the patient’s prescriber is not enrolled in Medicare. Under this provision, unenrolled prescribers can provide a 3-month medication supply to patients to allow the prescriber time to enroll in Medicare. The supply can be for more than one medication, but can’t be offered more than once.

CMS asked that pharmacists help educate patients and their prescribers about Medicare enrollment requirements as well as the “provisional supply” option. The agency indicated it will provide additional information and guidance on prescriber enrollment, provisional supply in general, and provisional supply when a patient’s prescriber will not enroll in Medicare and the patient must find a new Medicare-enrolled provider to keep receiving Medicare coverage for the drug.

Enforcement of the regulations has been shifted from December 1, 2015, to January 1, 2016.