United States District Court, E.D. Virginia, Alexandria Division
M. HILTON UNITED STATES DISTRICT JUDGE.
MATTER comes before the Court on Plaintiff's and
Defendant's cross Motions for Summary Judgment.
Lisa Roeder, Executor of the Estate of William F. Roeder,
Jr., seeks Medicare Part D coverage for mycophenolate
mofetil, brand name CellCept. Mr. Roeder took CellCept prior
to his death to treat systemic sclerosis with interstitial
lung disease and pulmonary fibrosis. By decision of the
Medicare Appeals Council ("MAC"), the Secretary
determined that Plaintiff s Medicare Part D plan was neither
required nor permitted to cover his use of CellCept. Coverage
was denied because the Medicare statute, regulations, and
manual instructions do not recognize CellCept as a covered
Part D drug as used by Mr. Roeder. Mr. Roeder's
"off-label" use was not for a "medically
accepted indication." CellCept as prescribed to Mr.
Roeder is not a covered Part D drug.
acknowledges that Mr. Roeder's CellCept prescription was
neither written nor used for a "medically accepted
indication." Plaintiff argues that Medicare must
nonetheless cover the prescription because the drug is
approved for sale by the Food and Drug Administration
("FDA"), and because his prescribing physician
found it effective treatment for his condition.
Roeder was a Medicare beneficiary enrolled in Medicare Part D
as a member of AARP MedicareRx Preferred, a prescription drug
plan offered by United Healthcare Insurance Company
("United Healthcare"). His treating physician
diagnosed him with systemic sclerosis with interstitial lung
disease, and prescribed mycophenolate mofetil (the generic of
Roeder sought authorization from United Healthcare for the
CellCept prescription. On June 27, 2013, upon expedited
redetermination, the plan sponsor confirmed its initial
denial because the drug was "not supported by the FDA or
one of the Medicare approved references for treating
[plaintiff's] medical conditions."
sought reconsideration of this determination from Maximus, a
Medicare Part D IRE. Maximus affirmed United Healthcare's
coverage denial based on Mr. Roeder's prescribed use of
CellCept not qualifying as a "medically accepted
indication, " finding it thus "d[id] not meet the
definition of a Medicare Part D drug." For the same
reason, Maximus also found that Mr. Roeder was not entitled
to an "exceptions request based on medical
Roeder appealed the Maximus decision to an ALJ. After a
hearing in which Plaintiff's counsel and a United
Healthcare representative participated, the ALJ issued a
"Fully Favorable" decision to Plaintiff. The ALJ
noted that the Medicare statute and regulations require a
drug to be used for its FDA-approved use or a use supported
by citation in the compendia to be a covered Part D drug.
Nevertheless, because CellCept became the "standard of
care for the treatment of scleroderma lung disease, "
and based on the "evidence of 9 separate studies showing
that the drug has been used successfully for the
Beneficiary's condition, " he concluded that
"the treatment is covered due to the circumstances
presented in this case."
decided on its own motion to review the ALJ's decision
"because there [wa]s an error of law material to the
outcome of the claim." The MAC reversed the ALJ's
decision and held that Medicare did not cover plaintiff's
CellCept prescription because the plain language of the
statute, implementing regulations, and manual provision limit
the definition of "medically accepted indication"
to a use approved by the FDA or supported by one or more
citations in the compendia, and the prescription here was not
for a "medically accepted
indication." In so ruling, the MAC noted that "the
appropriate inquiry in this case was not whether [CellCept]
was medically reasonable and necessary for the treatment of
the enrollee's condition, but whether [CellCept] met the
definition of a Part D drug, i.e., whether it is prescribed
for a 'medically accepted indication.'" The MAC
also ruled that Mr. Roeder did not qualify for a formulary
exception because that process "may not be invoked to
cover a drug that is not otherwise within the definition of a
Part D drug.
the crux of Plaintiff's argument is that the Secretary
improperly interpreted the relevant statutory language to
deny his request for Part D coverage, this Court must apply
the framework set forth in Chevron U.S.A., Inc. v.
Natural Res. Def. Council, Inc. Under Chevron, the
Court must employ a two-step analysis:
First, applying the ordinary tools of statutory construction,
the court must determine whether Congress has directly spoken
to the precise question at issue.
If the intent of Congress is clear, that is the end of the
matter; for the court, as well as the agency, must give
effect to the unambiguously expressed intent of Congress. But
if the statute is silent of ambiguous with respect to the
specific issue, the question for the court is whether the
agency's answer is based on a permissible construction of
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 Mr. Roeder'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 FDA, 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.
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 Mr. Roeder'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 definitively resolves the question.
Third, Plaintiff's claim to a drug formulary exception