Please ensure Javascript is enabled for purposes of website accessibility

No Medicare Drug Coverage for ‘Off Label’ Use

Deborah Elkins//July 11, 2016

No Medicare Drug Coverage for ‘Off Label’ Use

Deborah Elkins//July 11, 2016//

Listen to this article

An Alexandria U.S. District Court upholds denial of Medicare Part D coverage for myco­phenolate mofetil, brand name CellCept, for off-label treatment of systemic sclerosis with interstitial lung disease and pulmonary fibrosis; although an ALJ found the drug should be covered based on evidence of nine separate studies showing successful use of the drug for this condition, the district court defers to the contrary decision on appeal to the Medicare Appeals Council.

Plaintiff is suing for coverage for the drug, which was used to treat her husband, who is now deceased. Because the crux of plaintiff’s argument is that the Secretary of Health & Human Services improperly interpreted the relevant statutory language to deny his re­quest for Part D coverage, this court must apply the framework set forth in Chevron USA Inc. v. Natural Res. Def. Council Inc. The issue is whether the definition of “cov­ered part D drug,” as set forth in Section 102(e), is limited to a “medically accepted indication” – either by the plain terms of the statute or, to the extent the court deems the statute ambiguous, by a permissible inter­pretation the Secretary expressed through adjudication of this case and regulation duly published through notice-and-comment rulemaking. Plaintiff acknowledges that decedent’s CellCept prescription was not made for a “medically accepted indication” within the meaning of that provision, as the prescription was neither for an “on label” use approved by the Food and Drug Adminis­tration, nor for a non-cancer “off label” use that is supported by citation in a qualifying drug compendia. Thus, the issues raised by this case are purely legal and of statutory construction.

Part D coverage limits

Summary judgment must be entered in favor of the Secretary for three reasons. First, the plain language of Section 102(e) (1) unambiguously limits Part D coverage to drugs prescribed for a “medically accepted indication,” which plaintiff admits is a con­dition that decedent’s CellCept prescription did not satisfy. Second, even if the court were to find the statute ambiguous on this ques­tion, the Secretary’s interpretation of the statute is entitled to substantial deference and definitely resolves the question. Third, plaintiff’s claim to a drug formulary excep­tion under 42 C.F.R. § 423.578 must fail: The same reasons that foreclose his interpreta­tion of the statute bar his construction of this regulatory exception.

The fact that Congress provided a detailed framework and different definitions for “medically accepted indication” depending on the nature of the drug use, underscores that this term is definitional and restrictive, and not (as plaintiff would have it) merely illustrative. As Nievod v. Sebelius, (N.D. Cal. Feb. 8, 2013), explained, to hold otherwise would read the “medically accepted indica­tion” requirement out of the statute.

The more expansive “Medicare Part B” definition of “medically accepted indication” that Congress extended in 2008 to Part D drugs prescribed as part of an anti-cancer chemotherapeutic regimen existed long before Congress enacted Part D. Had Con­gress wanted to more broadly define a cov­ered Part D drug to include uses supported by peer-reviewed literature, as well as uses supported by the compendia, it could have referenced the Medicare Part B definition of “medically accepted indication.” Instead, in creating Part D, Congress chose to define “medically accepted indication” as it did for Medicaid, which a decade earlier it had spe­cifically limited to off-label uses supported by compendia citations. Congress plainly knew how to draft a statute that would ex­pressly include a broader definition of “med­ically accepted indication,” but it chose not to do so for Part D.

The plain language of Section 102(e)(1) limits Part D coverage to drugs prescribed for a “medically accepted indication.” Plain­tiff admits decedent’s CellCept prescription did not satisfy that condition. Even if the statute were ambiguous, the Secretary’s in­terpretation of the statute is entitled to sub­stantial deference.

Summary judgment for defendant..

Roeder v. Burwell (Hilton) No. 1:15cv1194, June 21, 2016; USDC at Alexandria, Va.; Caitlin K. Lhommedieu for plaintiff; Antonia Konkoly, AUSA, for defendant. VLW 016-3-292, 13 pp.


VLW 016-3-292

Verdicts & Settlements

See All Verdicts & Settlements

Opinion Digests

See All Digests