Posted: 25 Jun 2020 06:25 PM PDT
By Alan M. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui —
CMS Proposed MDRP regulation: In the Federal Register of Friday, June 19, CMS published a proposed rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance. The variety of topics covered in this rule include:
Federal District Court Decision on Base AMP Reset: On the same day that CMS published its proposed rule, the Federal District Court for the District of Columbia issued a decision upholding CMS’s rejection of a base AMP reset by a drug manufacturer. In Ipsen Biopharmaceuticals, Inc. v. Azar, Ipsen had obtained approval in 2007 for Somatuline Depot for the treatment of acromegaly. In 2014, FDA approved two supplemental NDAs (sNDAs), one for changes in manufacturing and the container closure system, and the other for a new indication for treatment of gastroenteropancreatic neuroendocrine tumors. Ipsen notified CMS that it intended to establish a new baseline AMP for the revised product, because the revisions were substantial and required two sNDA approvals. CMS responded that the new version must assume the same base AMP as the original version, because the dosage form and strengths of the drug remained the same and they were marketed under the same NDA. Ipsen ultimately filed suit against HHS, claiming that CMS’ decision was arbitrary and capricious and exceeded CMS’ statutory authority. The Court upheld CMS’s position. At least for drugs that are not subject to an alternative rebate for line extensions (because the original drug was not an oral dosage form drug), CMS’s bright line rule prevails: a manufacturer may establish a new baseline AMP for a drug only if the manufacturer obtains approval (i.e., an NDA or BLA) for a new dosage form or strength of the drug.
CMS Proposed MDRP regulation: In the Federal Register of Friday, June 19, CMS published a proposed rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance. The variety of topics covered in this rule include:
- Best price changes and other and other measures to encourage value based arrangements in Medicaid (and elsewhere)
- Additional regulations to implement the alternative rebate for line extensions, including an exceptionally broad definition of “new formulation” and a definition of “oral dosage form”
- Introduction of a new, problematic hurdle for claiming the best price exceptions for manufacturer coupon and other patient savings programs
- Clarification of the average manufacturer price (AMP) and best price treatment of rebates to Medicaid Managed Care plans that are not paid pursuant to a CMS-approved supplemental rebate program.
- Implementation of statutory amendments to exclude sales of authorized generics from the brand AMP, redefine single source and innovator source drugs to remove references to “original NDAs”; and redefine multiple source drugs to include OTC drugs that are covered outpatient drugs.
Federal District Court Decision on Base AMP Reset: On the same day that CMS published its proposed rule, the Federal District Court for the District of Columbia issued a decision upholding CMS’s rejection of a base AMP reset by a drug manufacturer. In Ipsen Biopharmaceuticals, Inc. v. Azar, Ipsen had obtained approval in 2007 for Somatuline Depot for the treatment of acromegaly. In 2014, FDA approved two supplemental NDAs (sNDAs), one for changes in manufacturing and the container closure system, and the other for a new indication for treatment of gastroenteropancreatic neuroendocrine tumors. Ipsen notified CMS that it intended to establish a new baseline AMP for the revised product, because the revisions were substantial and required two sNDA approvals. CMS responded that the new version must assume the same base AMP as the original version, because the dosage form and strengths of the drug remained the same and they were marketed under the same NDA. Ipsen ultimately filed suit against HHS, claiming that CMS’ decision was arbitrary and capricious and exceeded CMS’ statutory authority. The Court upheld CMS’s position. At least for drugs that are not subject to an alternative rebate for line extensions (because the original drug was not an oral dosage form drug), CMS’s bright line rule prevails: a manufacturer may establish a new baseline AMP for a drug only if the manufacturer obtains approval (i.e., an NDA or BLA) for a new dosage form or strength of the drug.
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