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Dec. 5 — The Centers for Medicare & Medicaid Services said Dec. 3 it will delay for six months a requirement that providers be enrolled in Medicare with approved status or have a valid opt-out affidavit on file for their prescriptions to be covered under Part D.
In a memorandum to Medicare Advantage and Part D drug plans, the agency said that, although its final regulation stated that the effective date for the requirement would be June 1, 2015, it will delay enforcement until Dec. 1, 2015.
In the final rule (RIN 0938-AR37, CMS–4159–F) released May 19, the CMS said it will require physicians and eligible professionals who write prescriptions for covered Part D drugs be enrolled in Medicare or have a valid record of opting out of Medicare. The rule was published May 23 (79 Fed. Reg. 29,844).
“This requirement will help CMS ensure that Part D drugs are only prescribed by qualified individuals,” the agency said in May.
The rule also required plans to establish a comprehensive outreach and education plan to ensure that prescribers and enrollees were aware of the new requirement.
However, during the CMS's Medicare Advantage & Prescription Drug Plan conference in September, several Medicare plan industry representatives expressed concern that enrollees would be harmed if they were turned away at the drugstore prescription counter.
“It might be really hard to explain to a member” the technicalities of why their prescription is denied, Wendy Krasner, a vice president of regulatory affairs at the Pharmaceutical Care Management Association, which represents pharmacy benefit managers, said at the conference.
“We should be getting a lot of complaints on the plan side if people are showing up at pharmacy counters not being able to fill scripts,” one attendee said.
Another attendee asked, “What do we do if our members are on a life-saving drug and it comes back denied?”
Amy K. Larrick, acting director of the CMS's Medicare Drug Benefit and C & D Data Group, said at the time that the agency was still working out some of the issues surrounding the new requirement.
In the notice of delay, the CMS said that prescribers of Part D drugs must, nonetheless, submit their Medicare enrollment applications or opt-out affidavits to their Medicare Administrative Contractors by June 1, 2015. This would ensure that MACs have sufficient time to process the applications or opt-out affidavits and avoid having their patients' prescription drug claims denied by their Part D plans beginning Dec. 1, 2015, the memo said.
The CMS said it plans to generate every two weeks files of prescribers enrolled or in opt-out status under its Provider Enrollment, Chain and Ownership System (PECOS).
The enrollment file will include the provider's National Provider Identifier and other identification information.
The Dec. 3 memo offered “a test file since the Part D prescriber enrollment requirement is not yet applicable.”
Despite the change in enforcement date, one health-care attorney who asked not to be named told Bloomberg BNA in an e-mail Dec. 5 that the requirement “is really cumbersome, problematic” for beneficiaries, plans and the wide range of prescribers, including dentists.
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