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From Health Law Daily, May 4, 2015

CMS extends enrollment requirements for Medicare Part D prescribers

By Harold M. Bishop, J.D.

To prevent unintended interruptions in coverage and potential harm to beneficiaries, CMS has issued an advance release of an Interim final rule with comment period (IFC) requiring that pharmacy claims and beneficiary requests for reimbursement for Medicare Part D prescriptions (written by prescribers other than physicians and eligible professionals who are permitted by state or other applicable law to prescribe medications) not be rejected at the point-of-sale by the Part D plan if all other requirements have been met. This IFC changes to January 1, 2016, the effective date of a Final rule published on May 23, 2014, that required prescribers of Part D drugs to enroll in or have a valid opt-out affidavit on file for their prescriptions to be covered under Part D. The May 23, 2014 Final rule had required compliance by June 1, 2015.

Under the IFC, Part D plans must also: (1) allow a provisional three-month supply of the prescription when written by a prescriber who is eligible to enroll but who is not enrolled in or opted out of Medicare; and (2) provide individualized written notice to the beneficiary that the supply is being provided on a provisional basis. The three-month provisional supply is intended to give the prescriber time to enroll as a Medicare provider or the beneficiary time to find a new Medicare-enrolled prescriber.

Background. Section 6405(c) of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) gave the Secretary of HHS the authority to require that pharmacy claims and beneficiary reimbursement requests for covered Part D drugs prescribed by a physician or eligible professional are not payable unless the prescribing physician or eligible professional is enrolled as a Medicare provider. This ACA provision was designed as a program integrity and quality assurance protection for Medicare beneficiaries.

In accordance with section 6405(c) of the ACA, CMS issued the May 23, 2014 Final rule (79 FR 29843) in order to confirm that Part D drugs are prescribed only by physicians and eligible professionals who are qualified to do so under state law and under the requirements of the Medicare program.

Avoiding potential harm to beneficiaries. Since the publication of the May 23, 2014 Final rule, CMS has discovered that certain pharmacists and other provider types who do not meet the statutory definitions of “physician” or “eligible professional” to enroll in Medicare are permitted to prescribe under state laws. Without this IFC action by CMS, valid prescriptions from these providers would be denied because the prescriber is neither enrolled in nor opted-out of Medicare.

CMS also has determined that Part D sponsors must cover a provisional supply and provide beneficiaries with individualized written notice before denying a Part D claim or beneficiary request for reimbursement on the basis of a prescriber’s Medicare enrollment status. This requirement is designed to reduce potential interruptions to beneficiaries’ access to needed medications.

Waiver of proposed rulemaking. CMS believes it has good cause to make the changes in this IFC without the normal notice-and-comment rulemaking. Without immediate IFC action, CMS claims it would be forced to either enforce the May 23, 2014 Final rule as written, which could cause beneficiary harm by disrupting access, or further delay enforcement, which also could cause beneficiary harm by continuing to permit unqualified individuals to prescribe Part D drugs. In addition, it was necessary for CMS to implement the provisions of the IFC prior to the Medicare Part D bid deadline for the 2016 contract year, which is June 1, 2015.

Official publication. The official version of this IRC will be published in the Federal Register on May 6, 2015, with the regulations effective June 1, 2015. Comments will be accepted for 60 business days after May 6, 2015. CMS encourages prescribers to submit their Medicare enrollment applications as soon as possible.

MainStory: TopStory DrugNews ReimbursementNews HealthCareReformNews CMSNews CoPNews CoverageNews DrugBiologicNews GenericDrugNews PartDNews PrescriptionDrugNews

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