Woodfill v. Secretary of Health and Human Service et al
Memorandum and Order granting 48 Federal Defendant's Motion to Withdraw its Motion to Dismiss 34 is granted; granting 35 Defendant Humana's Motion to Dismiss and request to be removed from case. Federal Defendant shall have 30 days from receipt of this Order to file its Answer and Administrative Record of ALJ's decision in underlying Medicare appeal. Plaintiff shall file its Brief on the Merits within 45 days of the date of this Order; Defendant shall file its Brief on the Merits within 45 days after service of Plaintiff's Brief; Plaintiff's reply shall be filed within 14 days after service of defendant's brief. Magistrate Judge Vernelis K. Armstrong on 10/12/12. (A,P)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF OHIO
Mary K. Woodfill,
Kathleen Sebelius, Secretary,
Health and Human Services, et al.,
Case No. 3:11 CV 2236
Plaintiff Mary K. Woodfill (“Plaintiff”) seeks judicial review, pursuant to 42 U.S.C. § 405(g),
of Defendant Secretary’s (“Federal Defendant” or “Secretary”) decision to deny her Medicare
coverage for a Medtronic Synchromed infusion pump (“Medtronic pump”) (Docket No. 1, p. 2 of 8).
Pending is Federal Defendant’s Motion to Dismiss, filed June 26, 2012 (Docket No. 34), Defendant
Humana Inc.’s Motion to Dismiss, filed June 26, 2012 (Docket No. 35), Federal Defendant’s Motion
to Withdraw its Motion to Dismiss, filed September 28, 2012 (Docket No. 48) and Defendant
Humana’s Supplement to its Motion to Dismiss, filed October 3, 2012 (Docket No. 49). For the
reasons that follow, the Magistrate grants the motions.
II. PROCEDURAL BACKGROUND
Plaintiff seeks judicial review of the Secretary’s decision to deny her Medicare coverage for a
Medtronic pump, which is an implantable device designed to administer morphine (Docket No. 1, p. 2
of 8). Plaintiff’s physician requested prior authorization for Plaintiff’s use of the Medtronic pump from
Defendant Humana, the Medicare Advantage organization responsible for administering Plaintiff’s
Medicare benefits (Docket No. 1, pp. 3-4 of 8). Defendant Humana denied Medicare coverage for the
device and, after an administrative hearing, an Administrative Law Judge (“ALJ”) affirmed the denial
(Docket No. 1, p. 4 of 8). The Medicare Appeals Council (“MAC”) adopted the ALJ’s decision and its
decision became the final ruling of the Secretary (Docket No. 1, p. 6 of 8).
Both the ALJ and the MAC based their decisions on the terms of National Coverage
Determination (“NCD”) 280.14, which states that implantation of an infusion pump is contraindicated
in patients with other programmable devices (Docket No. 1, pp. 4-5 of 8). Because Plaintiff already
had an implanted spinal cord stimulator, she did not qualify for Medicare coverage of the Medtronic
pump, pursuant to NCD 280.14 (Docket No. 1, p. 3 of 8).
On October 19, 2011, Plaintiff filed a complaint in this Court challenging the MAC decision
(Docket No. 1). The complaint alleges that the Secretary erred in denying Plaintiff coverage for the
Medtronic pump because, contrary to the terms of the NCD, there is no crosstalk between Plaintiff’s
existing implanted spinal cord stimulator and the Medtronic pump (Docket No. 1, pp. 3-4 of 8).
On May 9, 2012, Plaintiff filed a Statement of Intention Relative to Alternative Appeal Route
(Docket No. 32). In that statement, Plaintiff indicated she intended to “file an alternate appeal under
Chapter 42 of the Federal Code of the United States” for review of the validity of the NCD (Docket
No. 32). On June 26, 2012, Federal Defendant filed a Motion to Dismiss the Complaint or
Alternatively to Stay the Proceedings (Docket No. 34). On that same date, Defendant Humana filed its
Motion to Dismiss (Docket No. 35). These Motions were filed based on representation by the Plaintiff
that she wished to pursue an administrative challenge of NCD 280.14 (Docket Nos. 32, 34, and 35).
According to both Defendant’s, since Plaintiff’s Complaint appeared to challenge the validity of the
NCD, this Court should refer the matter back to the agency, under the doctrine of primary jurisdiction,
as an issue involving the agency’s expertise (Docket No. 34, pp. 3-5 of 7; No. 35, p. 3 of 5). On July
10, 2012, Plaintiff filed a Notice of Decision Not to Pursue Alternate Appeal (Docket No. 37). On
August 6, 2012, Plaintiff filed a Supplemental Response to Defendants’ Motions to Dismiss and
requested a briefing schedule and hearing on the pending Motion (Docket No. 42).
On September 26, 2012, this Court conducted a hearing on the Motions to Dismiss. At that
hearing, Plaintiff, through counsel, represented to the Court that she did not wish to challenge the
validity of the NCD or pursue the administrative review process. On the contrary, Plaintiff alleged that
her Complaint challenged only the application of the NCD, not its validity. In response to this
argument, Federal Defendant filed a Motion to Withdraw its Motion to Dismiss on September 28, 2012
(Docket No. 48). On October 3, 2012, Defendant Humana filed a Supplement to its Motion to Dismiss
citing new federal case law1 which holds that the Secretary is the only proper defendant to an action of
this nature (Docket No. 49).
In Logan v. Sebelius (2012 U.S. Dist. LEXIS 136031 (Aug. 6, 2012)), plaintiff Logan was
diagnosed with severe mandibular atrophy with pre-existing partial destruction of the bone. 2012 U.S.
Dist. LEXIS 136031, *2. He was insured through a Medicare Advantage policy administered by Mid
Rogue Independent Physician Association (“MidRogue”). Id. MidRogue initially informed Logan that her
advantage plan would cover her surgery and hospitalization; however, MidRogue later denied coverage.
Id. Following an administrative hearing, the ALJ ruled MidRogue was required to pay for the plaintiff’s
procedure. Id. The MAC later reversed the ALJ’s decision. Id. On judicial review, the Court held that,
pursuant to the plain language of 42 C.F.R. § 405.1136(d)(1), only the Secretary, in his or her official
capacity, is the proper defendant in any action seeking judicial review of the MAC’s decision. Id. at *8.
In Madsen v. Kaiser Foundation Health Plan, Inc. (2009 U.S. Dist. LEXIS 46122 (June 2,
2009)), plaintiff Madsen requested Defendant Kaiser’s authorization and coverage for vascular surgery
and a left total hip arthroplasty at the Mayo Clinic. 2009 U.S. Dist. LEXIS 46122 at *1-2. Kaiser denied
coverage of both procedures. Id. at *2. This denial was upheld by an ALJ and the MAC. Id. Kaiser filed a
motion to dismiss on the grounds that it was not a proper defendant to the action. Id. at *6. Upon judicial
review, the Court held that since plaintiff Madsen was seeking review of the decision of the MAC, Kaiser
was in fact not a proper defendant. Id. at *9. Kaiser’s motion was therefore granted. Id.
In light of Plaintiff’s clarification that she is challenging the application rather than the validity
of NCD 280.14, this Court agrees with Federal Defendant that there is no longer a need to refer this
matter to the agency under the doctrine of primary jurisdiction, as argued in Federal Defendant’s
Motion to Dismiss. Furthermore, in light of recent case law and pursuant to the plain language of 42
C.F.R. § 405.1136(d)(1),2 this Court agrees with Defendant Humana that it is not a proper or necessary
party to this case and should be permitted to withdraw.
For the foregoing reasons, Federal Defendant’s Motion to Withdraw its Motion to Dismiss is
granted. Likewise, Defendant Humana’s Motion to Dismiss and request to be removed from the case
are granted. Federal Defendant shall have thirty (30) days from receipt of this Order to file its Answer
and the Administrative Record of the ALJ’s decision in the underlying Medicare appeal.
Additionally, in the interest of the orderly and efficient disposition of this action and to afford
the parties an opportunity to affirmatively present their factual and legal arguments, the following
schedule shall prevail:
Plaintiff’s BRIEF shall be filed within forty-five (45) days after the date of this order.
Such brief shall be captioned “Plaintiff’s Brief on the Merits,” and at the conclusion thereof
shall state the relief requested, e.g. reversal of the Commissioner’s final determination and
entry of final judgment in Plaintiff’s favor. Plaintiff’s brief shall also include a separate list
of “Legal Issues” and a list of “Facts in Dispute” with appropriate citations to the transcript
by page number.
Defendant’s BRIEF shall be filed within forty-five (45) days after service of Plaintiff’s
brief. Such brief shall be captioned “Defendant’s Brief on the Merits” and shall address the
specific legal issues and facts in dispute cited by Plaintiff. Defendant’s brief shall contain
appropriate citations to the transcript by page number for all factual averments.
Under 42 C.F.R. § 405.1136(d)(1), “in any civil action described in paragraph (a) of this
section, the Secretary of HHS, in his or her official capacity, is the proper defendant.”
If Plaintiff chooses to file a REPLY, such reply brief shall be filed within fourteen (14)
days after service of Defendant’s brief.
All briefs shall cite concisely the relevant statutory and case law supportive of the party’s
position and shall comply with Local Rule 7.1(g).
REQUEST FOR EXTENSION OF FILING DEADLINES WILL BE GRANTED
ONLY UPON A SHOWING OF IMPERATIVE CAUSE.
/s/Vernelis K. Armstrong
United States Magistrate Judge
Date: October 12, 2012
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