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CMS asked to scrap definition
ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association are calling for regulators to withdraw their new definition of a “multiple source drug” under Medicaid. The definition is critical for pharmacies because it is used for federal upper limits (FULs) capping reimbursements for generic drugs.
Comments submitted to the Centers for Medicare and Medicaid Services (CMS) by NACDS president and chief executive officer Steve Anderson and Bruce Roberts, executive vice president and chief executive officer of NCPA, cite two legal concerns with the revised definition. The redefinition was not subject to the normal public notice and comment period prior to most rule changes, say Anderson and Roberts.
Secondly, the Social Security Act provides that a medication is not a multisource drug unless there are two or more equivalent products for it in each state, they say. CMS did not accept this standard, according to the comments.
“While we appreciate CMS’ efforts to redefine ‘multiple source drug,’ it is critical that the revisions meet all guidelines and compliance requirements,” say Anderson and Roberts. “Pharmacies are at risk of improper and inadequate Medicaid reimbursements due to the AMP [average manufacturer price] rule and the revised definition. As a result, those who will suffer the greatest burden will be the patients and the states.”
NACDS and NCPA filed suit in November to block the AMP rule, which would sharply cut Medicaid reimbursements for generic prescriptions. The two groups won a temporary victory in December when a federal district court enacted a preliminary injunction blocking the rule’s implementation. The injunction is saving pharmacies more than $5 million a day, according to Anderson.
CMS could have avoided problems by accepting comments on the proposed redefinition before issuing the final rule, Anderson and Roberts say. The fact that the court issued a preliminary injunction against the old rule did not entitle the agency to eliminate notice and comments on the redefinition, they add.
CMS lacks authority to assume that multisource drugs will be available nationwide, Anderson and Roberts maintain. Instead, the Social Security Act “establishes a specific and detailed process that CMS must follow to confirm that drug products are generally available to the public through retail pharmacies in each state.”
While pressing on with their court fight, NACDS and NCPA are urging Congress to work with community pharmacy to find alternative reimbursement models. They have asked federal legislators to pass the Fair Medicaid Drug Payment Act — authored by Sen. Max Baucus (D., Mont.) — and a companion measure introduced in the House by Rep. Frank Pallone Jr. (D., N.J.).
The preliminary injunction, emphasize Anderson and Roberts, is not a permanent solution. Original Text
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