United States District Court, M.D. North Carolina
RECOMMENDATION OF UNITED STATES MAGISTRATE
WEBSTER UNITED STATES MAGISTRATE JUDGE.
Janel Case brought this action to obtain review of a final
decision of the Medicare Appeals Council (“MAC”)
rejecting Plaintiff's contention that her use of the drug
Myfortic should be covered under Medicare Part D (“the
Plan”), the Medicare prescription drug benefit of the
Medicare program, 42 U.S.C. § 1395w-101 et seq.
The Court has before it the certified administrative record
and cross-motions for judgment.
FACTUAL AND PROCEDURAL BACKGROUND
received a lung transplant in 2005, which was covered by a
commercial health insurance plan. (AR 004, 0160.) The
transplant was necessary as a result of pulmonary fibrosis
related to treatment of Hodgkin's lymphoma.
(Id.) Post-transplant, Plaintiff experienced
“late acute cellular rejection requiring high levels of
immunosuppression drugs to maintain allograft
function.” (Id. at 004.) Since 2013, she has
taken the immunosuppressant drug Myfortic. (Id. at
0153, 0221.) After enrolling in the Plan, effective January
2017 (see id. at 0143, 0219), Plaintiff sought
Medicare Part D payment for the Myfortic. Although initially
approving coverage of Myfortic (id. at 0222), after
conducting an audit, the Plan denied coverage because
“the drug was not being prescribed for a medically
accepted indication as defined by Medicare law.”
(Id. at. 0004, 0225.) Plaintiff then initiated an
administrative appeal through the appropriate appellate
recourse available to dissatisfied Medicare Part D enrollees.
(Id. at 0004, 0168-0169.) “On further appeal,
the Independent Review entity (IRE) denied coverage on the
same grounds: that there are no citations in the Medicare
approved compendia that support the use of Myfortic for the
diagnosed condition.” (Id. at 0004
citing 0169.) “The IRE also noted that it
could not consider making an exception based on medical
necessity because Myfortic, as prescribed, does not meet the
definition of a Medicare Part D drug.” (Id. at
0004 citing 0169.)
element of the appellate process, Plaintiff received a
hearing by an Administrative Law Judge (“ALJ”).
(Id. at 0715-0734.) On May 19, 2017, the ALJ issued
a decision, which was unfavorable to Plaintiff. (Id.
at 0023-0029.) The ALJ determined that Myfortic does not meet
the definition of a covered Part D drug because it is not
prescribed for a medically accepted indication and is not
supported by the Medicare approved compendia. (Id.
at 0028.) The ALJ noted that the medically accepted
indication for Myfortic is for prophylaxis of organ rejection
in adult patients receiving kidney transplants, which is not
applicable to Plaintiff. (Id. at 0027, 0032.) In
closing, the ALJ recognized the gravity of Plaintiff's
circumstances but concluded that she had no authority to find
that the drug is a Medicare Part D drug for purposes of the
Plan's coverage. (Id. at 0029.)
then appealed to the MAC. (Id. at ¶ 0010.) On
June 13, 2017, the MAC issued a decision, which was
unfavorable to Plaintiff. (Id. at 0001-0008.) The
MAC “concur[red] with the ALJ that the Plan is not
required to cover Myfortic for [Plaintiff] because it is not
being prescribed for a medically accepted indication.”
(Id. at 0006.) This decision represented the final
agency decision of the Secretary of the Department of Health
and Human Services. Having exhausted her administrative
remedies, Plaintiff filed the instant civil suit for judicial
review of the final agency decision.
STANDARD FOR REVIEW
brought the instant action pursuant to 42 U.S.C. §
1395w-104(h)(1), which incorporates the rights of appeal and
judicial review provision of 42 U.S.C. § 1395w-22(g)(5).
Also, this action was brought pursuant to 42 U.S.C. §
405(g), the basic judicial review provision of the Social
Security Act. Under 42 U.S.C. § 405(g), a
court's “review of the Secretary's final
decision . . . is to be based solely on the administrative
record, and the Secretary's findings of fact, if
supported by substantial evidence, shall be
conclusive.” See MacKenzie Med. Supply, Inc. v.
Leavitt, 506 F.3d 341, 346 (4th Cir. 2007). Substantial
evidence has been defined by the Court of Appeals for the
Fourth Circuit as
evidence which a reasoning mind would accept as sufficient to
support a particular conclusion. It consists of more than a
mere scintilla of evidence but may be somewhat less than a
preponderance. If there is evidence to justify a refusal to
direct a verdict were the case before a jury, then there is
Laws v. Celebrezze, 368 F.2d 640, 642 (4th Cir.
1966) (citation omitted). Judicial review does not permit
this Court to weigh the evidence or to make credibility
assessments, because it is the Secretary's ultimate
responsibility to make findings of fact and resolve conflicts
in the evidence. Rudman v. Leavitt, 578 F.Supp.2d
812, 814-15 (D. Md. 2008) (citing Hays v. Sullivan,
907 F.2d 1453, 1456 (4th Cir. 1990)). In addition to
reviewing for substantial evidence, the Court also looks to
ascertain whether the Secretary applied the correct legal
standards. Bryan v. Sec'y of HHS, 758 F.Supp.
1092, 1096 (E.D. N.C. 1990) (citations omitted).
parties' dispute in this action arises out of whether
Myfortic is covered under the Plan such that Plaintiff's
Medicare insurance would be responsible for the costs. As
previously noted, the MAC “concur[red] with the ALJ
that the Plan is not required to cover Myfortic for
[Plaintiff] because it is not being prescribed for a
medically accepted indication.” (AR 0006.) The central
issue here surrounds the meaning and scope of the statutory
definition of a covered Part D drug. A covered Part D drug is
defined by statute at 42 U.S.C. § 1395w-102(e)(1):
as provided in this subsection, for purposes of this part,
the term “covered part D drug” means--
(A) a drug that may be dispensed only upon a
prescription and that is described in subparagraph (A)(i),
(A)(ii), or (A)(iii) of section 1396r-8(k)(2) of this title;
(B) a biological product described in
clauses (i) through (iii) of subparagraph (B) of such section
or insulin described in subparagraph (C) of such section and
medical supplies associated with the injection of insulin ...