Opinion ID: 1446262
Heading Depth: 2
Heading Rank: 1

Heading: Whether the certificate of medical necessity is conclusive proof of medical necessity

Text: The first question before us is one of statutory construction: whether the Medicare Act requires the Secretary to base his decision that an item of durable medical equipment is or is not medically reasonable and necessary solely on the contents of a certificate of medical necessity, or whether the Secretary may request additional documentation from a supplier of durable medical equipment. The two-step approach of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), governs our inquiry. We first ask whether the Medicare Act speaks directly to the question presented. If the intent of Congress is clear, that is the end of the matter, and this court must give effect to Congress's expressed intent. Id. at 842-43, 104 S.Ct. 2778. If, on the other hand, the Medicare Act is silent or ambiguous with respect to the question presented, then this court asks whether the[Secretary's] answer is based on a permissible construction of the statute. Id. at 843, 104 S.Ct. 2778. We begin with the statute's plain language. See Botosan v. Paul McNally Realty, 216 F.3d 827, 831 (9th Cir.2000). The provisions on which Maximum Comfort (and the district court) relied state: (2) Certificates of medical necessity (A) Limitation on information provided by suppliers on certificates of medical necessity (i) In general [A] supplier of medical equipment and supplies may distribute to physicians . . . a certificate of medical necessity for commercial purposes which contains no more than the following information completed by the supplier: (I) An identification of the supplier and the beneficiary to whom such medical equipment and supplies are furnished. (II) A description of such medical equipment and supplies. (III) Any product code identifying such medical equipment and supplies. (IV) Any other administrative information (other than information relating to the beneficiary's medical condition) identified by the Secretary. . . . (B) Definition For purposes of this paragraph, the term certificate of medical necessity means a form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. 42 U.S.C, § 1395m(j)(2)(A) & (B). Maximum Comfort draws from these provisions a command that the Secretary must accept the certificate of medical necessity as conclusive for purposes of reimbursing the equipment supplier. For reasons that parallel the reasoning of the Fourth Circuit in MacKenzie, 506 F.3d 341, 348-49, and the Eleventh Circuit in Gulfcoast, 468 F.3d at 1351-52, we reject this interpretation of § 1395m(j)(2). The language of the statute contains no such command or limitation. The first provision, § 1395m(j)(2)(A)(I), states that a supplier of medical equipment and supplies may distribute to physicians, or to individuals entitled to benefits under this part, a certificate of medical necessity. . . . (emphasis added). This subsection permits (but does not require) the supplier to distribute certificates to physicians or patients. It also limits the information suppliers may furnish in the certificate of medical necessity, but does not purport to explain the effect to be given a completed certificate or suggest that a completed certificate is sufficient and conclusive proof of medical necessity. See MacKenzie, 506 F.3d 341, 348. The second subsection, § 1395m(j)(2)(B), provides that [f]or purposes of this paragraph, the term `certificate of medical necessity' means a form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary . . . (emphasis added). The most logical reading of this sentence is that it is intended only to define the certificate of medical necessity for the purposes of applying the restrictions outlined in § 1395m(j)(2)(A). [5] The subsection does not state that the certificate of medical necessity is the sole vehicle for claims reimbursement, nor does it state that a completed certificate establishes, by itself, a right to reimbursement. See MacKenzie, 506 F.3d 341, 348; Gulfcoast, 468 F.3d at 1351. We reject, therefore, Maximum Comfort's view that § 1395m(j)(2) precludes the Secretary from requiring additional evidence, beyond the certificate, to establish medical necessity for equipment supplied. Not only do the plain words of § 1395m(j)(2) fail to impose any such restraint upon the Secretary, but reading such a limitation on the Secretary's powers into that provision would be inconsistent with § 1395y(a), which states: Notwithstanding any Other provision of this subchapter, no payment may be made under Part A' or `Part B of this subchapter for any expenses incurred for items or services (1)(A) which . . . are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. . . . (emphasis added). By the terms of this provision, § 1395m(j)(2) as an other provision of this subchapter cannot limit the Secretary's duty imposed by § 1395y(a) to ensure that no payment is made for items that are not medically necessary. We conclude, therefore, that the Secretary's interpretation of the relevant provisions of the Medicare Act is correct, and that the Secretary may require, as a condition of reimbursement to an equipment supplier, information in addition to that provided by the certificate of medical necessity. If there could be any doubt about the meaning of § 1395m(j)(2) in light of § 1395y(a), however, the provision would at worst be silent or ambiguous with regard to the Secretary's power to require additional information. In that case, for reasons that should be apparent from our discussion of the statutory provisions in issue, the interpretation of the Secretary is certainly reasonable and entitled to deference under Chevron, 467 U.S. at 842-43, 104 S.Ct. 2778. See MacKenzie, 506 F.3d 341, 349; Gulfcoast, 468 F.3d at 1352-53.