Is the Secretary statutorily authorized to deny benefit coverage for an entire group of benefits (here, enteral nutrition) which the Medicare Act recognizes as being within a benefit category?

QUESTIONS PRESENTED The questions presented are: (1) Is the Secretary statutorily authorized, or entitled to deference, to deny benefit coverage for an entire group of benefits (here, enteral nutrition) which the Medicare Act recognizes as being within a benefit category and (2) Is the Secretary statutorily authorized to exclude an entire class of Medicare beneficiaries from coverage for a benefit (here, enteral nutrition) by imposing a coverage requirement for that benefit (here, a feeding tube) that is relevant to the treatment of only one internal organ (here, a gastrointestinal tract dysfunction which requires a feeding tube to deliver enteral nutrition) and excludes coverage for that same medically necessary benefit for the treatment of a different internal organ (here, a liver dysfunction which is treated with an orally ingested enteral nutrition) based upon a Medicare Contractor’s non-evidence-based Policy Article when: (i) The Act covers all internal organ dysfunctions, excluding only dental, Gi) 42 U.S.C. §1395x(s)(8) provides benefit coverage for “prosthetic devices (other than dental) which replace all or part of an internal body organ,” Gi) 42 U.S.C. §1395m(h)(4)(B) identifies enteral nutrition as a covered prosthetic device within 42 U.S.C. §1395x(s)(8), (iv) 42 U.S.C. §1395u(s)(2)(D) identifies “Parenteral and enteral nutrients, ii QUESTIONS PRESENTED — Continued equipment and supplies” as items for which “the Secretary may implement a statewide or other area wide fee schedule” under §1395u(s)(1)(A), (v) 42 U.S.C. §1895y(1)(6) only authorizes the Secretary to determine whether “a particular item or service” is covered, (vi) National Coverage Determination (“NCD”) 180.2 stated that “Coverage of nutritional therapy as a Part B benefit is provided under the prosthetic device benefit provision which requires that the patient must have a permanently inoperative internal body organ or function thereof,” (vii) NCD 180.2 incorporated by reference Chapter 15, §120 of the Medicare Benefits Policy Manual which states “Examples of prosthetic devices include artificial limbs, and parenteral and enteral (PEN) nutrition,” (viii) The Medicare Contractor’s Policy Article that the Secretary relied upon to deny coverage stated that “Enteral nutrition is covered under the Prosthetic Device Benefit (Social Security Act 1861(s)(8)),” (ix) The Secretary confirmed that “Enteral nutrition is covered under the Prosthetic Device benefit (Social Security Act §1861(s)(8))”” when he retired his iii QUESTIONS PRESENTED Continued Medicare contractor’s Policy Article (which was the basis for his coverage denial) during these proceedings, (x) The use of a feeding tube is not medically necessary to treat the Beneficiary’s genetic defect affecting her liver and is, therefore, excluded from coverage under 42 U.S.C. §1395y(a)(1)(A), (xi) The Medicare Program standards at 68 Fed. Reg. 55634 provide that “Medicare payment is contingent upon a determination that a service meets a benefit category, is not specifically excluded from coverage, and the item or service is reasonable and necessary,” and both the services of the physician and medical necessity of the enteral nutrition she prescribed are undisputed, and (xii) The Secretary committed “not to discriminate against any person on the basis of .. . disability. ...” or does 42 U.S.C. §1395y(1)(6) only authorize the Secretary to determine whether “a particular item or service” is covered? The Petitioner’s answers to these questions are summarized in her Statement of Jurisprudential Significance, infra.