               NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
                          File Name: 14a0162n.06

                                      Case No. 13-3729
                                                                                    FILED
                         UNITED STATES COURT OF APPEALS                        Feb 27, 2014
                              FOR THE SIXTH CIRCUIT                        DEBORAH S. HUNT, Clerk



MARY K. WOODFILL,                                 )
                                                  )
       Plaintiff-Appellant,                       )
                                                  )      ON APPEAL FROM THE UNITED
v.                                                )      STATES DISTRICT COURT FOR
                                                  )      THE NORTHERN DISTRICT OF
SECRETARY OF HEALTH AND HUMAN                     )      OHIO
SERVICES,                                         )
                                                  )
       Defendant-Appellee.                        )
                                                  )


       BEFORE: DAUGHTREY, SUTTON and DONALD, Circuit Judges.


       SUTTON, Circuit Judge. Mary Woodfill sought Medicare coverage for an implantable

infusion pump. Because Medicare prohibits coverage for this kind of device in this setting, the

Secretary of Health and Human Services denied coverage.         The district court upheld that

determination, and we affirm.

       Woodfill has “severe spinal degenerative disease,” and has lived with “chronic low back

pain . . . for over twenty years.” R.54 at 5. She currently uses “high dosages of multiple pain

medications” to manage the pain. Id. On top of that, her doctors implanted a spinal cord

stimulator in the mid-1990s, which provided some relief.       Id.   To provide further relief,

Woodfill’s doctors recommended an implantable infusion pump, which would deliver pain
Case No. 13-3729
Woodfill v. Sec’y of Health and Human Servs.
medication directly to the spinal cord and thus offered the prospect of additional relief. R.54 at

13.

       Woodfill’s health insurance provider, Humana, denied the request to cover the costs of

the pump and the procedure for inserting it. R.55 at 166–67, 189. Woodfill appealed the

decision—first to Humana for reconsideration, then to an outside reviewer and then to the

Department of Health and Human Services. R.55 at 159–60. An administrative law judge,

Catherine Fuller, upheld the denial of benefits. R.54 at 26–28. The Medicare Appeals Council

adopted the administrative law judge’s decision. R.54 at 4–8. And, as permitted by Congress,

Woodfill filed this action challenging that decision. See 42 U.S.C. § 405(g); R.1. The district

court upheld the agency’s determination, holding that substantial evidence supports it.

       Woodfill receives Medicare benefits through the Medicare Advantage Program (also

known as Medicare Part C). The program allows individuals to receive health benefits from

private health insurance companies that contract with the federal government to provide them.

42 U.S.C. § 1395w-21. The individual receives any benefits that traditional Medicare programs

cover along with any other benefits she opts to pay for or the private company opts to provide.

42 U.S.C. § 1395w-22.

       Medicare covers “reasonable and necessary” services, and the Secretary may issue

national coverage determinations that describe the services satisfying these requirements. 42

U.S.C. §§ 1395y(a), 1395ff(f)(1)(B). The process works as follows: After receiving a request

for a determination or deciding to issue a determination on her own, the Secretary may issue a

proposed determination, solicit public comment and, if appropriate, issue a final determination.

See Notice, Revised Process for Making National Coverage Determinations, 78 Fed. Reg.

48,164-01 (Aug. 7, 2013). When handling requests for coverage, insurers like Humana as well



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Woodfill v. Sec’y of Health and Human Servs.
as all agency actors in the administrative appeals process must adhere to those determinations.

42 C.F.R. § 405.1060(a).

       The Secretary has issued a national coverage determination with respect to infusion

pumps. It permits Medicare coverage for an “implantable infusion pump” when, among other

things, it is “used to administer opioid drugs . . . for treatment of severe chronic intractable pain.”

National Coverage Determination Manual Ch. 1 Pt. 4, 142, 280.14(B)(2)(c). An individual must

show that she expects to live at least three months, that she “would not respond adequately to

noninvasive methods of pain control,” and that she responded well to a temporary trial that

approximates the effects of the pump. Id. The determination adds, however, that the pump “is

contraindicated”—which is to say, not recommended—for patients with “other implanted

programmable devices since crosstalk between the devices may inadvertently change the

prescription.” Id. at 142–43, 280.14(B)(2)(e). “Crosstalk” means unprompted communications

between devices, such as a signal from a spinal cord stimulator that changes the pain medication

dosage setting on an implantable infusion pump.

       In view of the “is contraindicated” limitation, the Secretary has categorically excluded

implantable pumps from coverage if a patient already has one implanted electronic device.

Woodfill has not challenged that interpretation. Before the district court and before this court,

Woodfill has argued only that the rationale behind the bar—the risk of crosstalk—does not apply

to her case. R.62. We will proceed under the Secretary’s reading of the determination, as

Woodfill has offered no other.

       In view of the Secretary’s unchallenged interpretation of the regulation, she permissibly

denied coverage for Woodfill’s pump.           Medicare covers implantable infusion pumps to

administer pain medication except when an otherwise eligible patient already has another



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Woodfill v. Sec’y of Health and Human Servs.
implanted electronic device. Woodfill already has another implanted electronic device: the

spinal cord stimulator. Medicare thus does not cover her pump.

       Woodfill’s main argument—that the requested pump does not present any risk of

crosstalk—speaks to the wisdom of the determination’s categorical bar, not to its existence.

Woodfill argues that many patients like her need two implanted electronic devices to control pain

and physicians often recommend two devices. See, e.g., R.54 at 10. And she points to the

administrative law judge’s finding that the pump she wants “was engineered not to crosstalk with

other devices,” limiting the risk of “crosstalk between the spinal cord stimulator and the

proposed implantable pump.” R.54 at 40. These facts may well suggest that the determination’s

categorical bar deserves further consideration. But this action is not the route for reconsidering

the bar. Instead, Woodfill may wish to file a complaint with the Department of Health and

Human Services. 42 U.S.C. § 1395ff(f)(1)(A). For present purposes, the Secretary did not abuse

her discretion in applying the categorical bar here.

       For these reasons, we affirm.




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