Hays v. Sebelius

589 F.3d 1279, 2009 U.S. App. LEXIS 28157, 2009 WL 4912383
CourtCourt of Appeals for the D.C. Circuit
DecidedDecember 22, 2009
Docket08-5508
StatusPublished
Cited by13 cases

This text of 589 F.3d 1279 (Hays v. Sebelius) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hays v. Sebelius, 589 F.3d 1279, 2009 U.S. App. LEXIS 28157, 2009 WL 4912383 (D.C. Cir. 2009).

Opinions

Opinion for the Court filed by Circuit Judge TATEL.

Concurring opinion filed by Senior Circuit Judge RANDOLPH.

TATEL, Circuit Judge:

Appellee, a Medicare Part B beneficiary, challenges a decision by a regional Medicare contractor to reimburse for a particular drug only up to the price of its least costly alternative. The district court held that the Medicare Act unambiguously forecloses that determination and requires instead that Medicare pay for covered items or services at a statutorily prescribed rate. Agreeing with the district court, we affirm.

[1280]*1280I.

Medicare Part B is a public health insurance program that provides the disabled and elderly with outpatient items and services, including durable medical equipment and certain prescription medications. The threshold for Medicare Part B coverage appears in 42 U.S.C. § 1395y(a)(l)(A), which states that “no payment may be made ... for any expenses incurred for items or services 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[.]”

The Secretary of Health and Human Services administers the Medicare Act and may delegate certain functions to contractors, including the development of local coverage determinations. 42 U.S.C. § 1395kk-l(a)(4). The Medicare Act defines local coverage determinations as decisions “whether or not a particular item or service is covered” in the contractor’s geographic area “in accordance with section 1395y(a)(l)(A).” 42 U.S.C. § 1395ff(f)(2)(B). The Secretary has instructed contractors that when determining whether a treatment is “reasonable and necessary” under section 1395y(a)(l)(A), they may apply the so-called least costly alternative policy. Ctrs. for Medicare and Medicaid Servs., Medicare Program Integrity Manual § 13.4.A (Rev.71, Apr. 9, 2004). Under that policy, Medicare provides reimbursement for treatments only up to the price of their “reasonably feasible and medically appropriate” least costly alternatives. Ctrs. for Medicare and Medicaid Servs., Medicare Benefit Policy Manual § 110.1.C.3 (Rev.93, July 25, 2008). Application of the policy is discretionary with regard to prescription drugs — the subject of this case — but mandatory with regard to durable medical equipment. See Medicare Program Integrity Manual § 13.4.A.

This case arose when Medicare contractors applied the least costly alternative policy to DuoNeb, an inhalation drug used to treat Chronic Obstructive Pulmonary Disease. DuoNeb provides a combination of albuterol sulfate and ipratropium bromide in one dose and can be slightly more expensive than separate doses of the two component drugs. Appellee llene Hays is a Medicare Part B beneficiary suffering from Chronic Obstructive Pulmonary Disease who has used DuoNeb for approximately four years. During that time, Medicare, pursuant to a statutory formula, provided reimbursement for DuoNeb at 106% of the drug’s average sales price. 42 U.S.C. §§ 1395w-3a(b)(l), 1395u(o)(l)(G)(ii).

In 2008, four Medicare contractors announced that the medical necessity of administering the two drugs in a combined dose, as compared to separate doses, had not been established. See NHIC (Region A), LCD for Nebulizers, L11499 (Apr. 10, 2008). Thus, pursuant to the least costly alternative policy, payment for the combination drug “[would] be based on the allowance for the least costly medically appropriate alternative,” the two component drugs as administered separately. Id. Hays challenged this decision in the United States District Court for the District of Columbia pursuant to a provision of the statute that allows beneficiaries to proceed without exhausting administrative remedies where “there are no material issues of fact in dispute, and the only issue of law is ... that a regulation, determination, or ruling by the Secretary is invalid.” 42 U.S.C. § 1395ff(f)(3). Hays argued that section 1395y(a)’s “reasonable and necessary” standard modifies “items and services.” Accordingly, she contended, the Secretary may determine only whether [1281]*1281DuoNeb is reasonable and necessary; if it is, Medicare must reimburse based on the 106% statutory formula. See 42 U.S.C. § 1395w-3a. The district court agreed with Hays and granted her motion for summary judgment. Hays v. Leavitt, 583 F.Supp.2d 62, 69, 72 (D.D.C.2008). The Secretary appeals, and our review is de novo. See, e.g., Transitional Hosps. Corp. of La., Inc. v. Shalala, 222 F.3d 1019, 1023 (D.C.Cir.2000) (reviewing de novo district court’s grant of summary judgment to plaintiffs challenging validity of Medicare regulations).

II.

The Secretary argues that section 1395y(a) is ambiguous and that we should defer to her reasonable interpretation of the statute. See Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Several features of the Medicare statute, however, convince us that it unambiguously forecloses the Secretary’s interpretation.

In relevant part, section 1395y provides: (a) Items or services specifically excluded. Notwithstanding any other provision of this subchapter, no payment may be made ... for any expenses incurred for items or services—
(1)(A) which, except for items and services described in a succeeding subpara-graph or additional preventive services ..., are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member[.]

The dispute in this case centers on whether “reasonable and necessary” modifies “expenses” (as the Secretary argues), or “items and services” (as Hays contends). If the Secretary is correct, then Medicare may, as it has here, partially cover an item or service, declining to reimburse expenses associated with the marginal difference in price between a prescribed item or service and its least costly and medically appropriate alternative. If Hays and the district court are correct, then the Secretary may make only a binary coverage decision, namely to reimburse at the full statutory rate or not at all.

We agree with Hays and the district court. As they point out, only a dependent clause separates “reasonable and necessary” from the phrase “items or services.” See § 1395y(a)(1) (“for any expenses incurred for items or services — which, ..., are not reasonable and necessary ... ”). “Expenses,” by contrast, appears earlier in the sentence. “Ordinarily, qualifying phrases are to be applied to the words or phrase immediately preceding and are not to be construed as extending to others more remote.” United States v. Pritchett,

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
589 F.3d 1279, 2009 U.S. App. LEXIS 28157, 2009 WL 4912383, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hays-v-sebelius-cadc-2009.