Council For Urological Interes v. Sylvia Mathews Burwell

790 F.3d 212, 416 U.S. App. D.C. 143, 2015 U.S. App. LEXIS 9867, 2015 WL 3634632
CourtCourt of Appeals for the D.C. Circuit
DecidedJune 12, 2015
Docket13-5235
StatusPublished
Cited by39 cases

This text of 790 F.3d 212 (Council For Urological Interes v. Sylvia Mathews Burwell) 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
Council For Urological Interes v. Sylvia Mathews Burwell, 790 F.3d 212, 416 U.S. App. D.C. 143, 2015 U.S. App. LEXIS 9867, 2015 WL 3634632 (D.C. Cir. 2015).

Opinions

Opinion for the Court on Parts I, II.A, III, IV, and V filed by Circuit Judge GRIFFITH.

Opinion for the Court on Part II.B filed by Circuit Judge HENDERSON.

Opinion dissenting from Part II.A filed by Circuit Judge HENDERSON.

Opinion dissenting from Part II.B filed by Circuit Judge GRIFFITH.

I

The Secretary of Health and Human Services issued regulations that effectively prohibit physicians who lease medical equipment to 'hospitals from referring their Medicare patients to these same hospitals for outpatient care involving that equipment. The regulations accomplish this through two separate provisions. The first prohibits physicians from charging hospitals for leased equipment on a peruse basis when the physicians also refer patients to the hospital for procedures using that equipment. The second interprets the relevant statute to apply to physician-groups that perform procedures rather than only the entities that bill Medicare. Challenging the regulations here is an association of physicians who partieipáte in leasing agreements with hospitals, under which they charge hospitals for equipment on a per-use basis and perform the procedures using the equipment. The association argues that the regulations exceed the Secretary’s statutory authority and violate both the Administrative Procedure Act and the Regulatory Flexibility Act. The district court granted the Secretary’s motion for summary judgment. Although one majority agrees with the district court that the statute is ambiguous as to the regulation of leases that charge on a per-use basis (Part II.A), a different majority concludes that the Secretary’s explanation for prohibiting these leases is unreasonable (Part II.B). The court unanimously concludes that the Secretary’s interpretation of the statute to apply to the physician-groups performing the procedures is reasonable (Part III), and that the Secretary complied with the Regulatory Flexibility Act (Part IV)- We therefore affirm in part, reverse in part, .and remand to the district court with instructions to remand the regulation relating to leases charging by use to the Secretary for further proceedings.

A

This case involves the interplay between complicated statutory provisions and regu[215]*215lations. Resolving the questions before us requires that we undertake a sometimes arduous journey through the tangled regime. We begin our slog with a look at the Medicare program.

Medicare provides federally funded health insurance to disabled persons and those aged 65 or older for various services, including the outpatient hospital procedures at issue here. 42 U.S.C. §§ 1395 et seq. In addition to paying the performing physician a fee that covers her services for the outpatient care, see generally 42 U.S.C. §§ 1395W-4, 1395x(s)(l); 42 C.F.R. §§ 410.20, 414.32, Medicare also pays the hospital a fee that covers charges for space, equipment, supplies, diagnostic testing, and the services of any non-physician personnel, 42 U.S.C. § 13951(t); 42 C.F.R. pt. 419. Typically a hospital will have an employee perform the outpatient procedures using its own equipment, but Medicare also permits hospitals to contract with third parties to provide such outpatient services. See 42 U.S.C. § 1395x(w)(l); 42 C.F.R. § 410.42(a). Under these agreements, the third party provides equipment and technicians for a procedure while the hospital provides space and support services, pays for the lease of the equipment, and bills Medicare.

The members' of the association challenging the regulations here have just this kind of relationship with hospitals. These arrangements are attractive to them because Medicare reimburses outpatient procedures that take pla.ce in hospitals at higher rates than if they were performed elsewhere.1 Compare 42 C.F.R. § 419.2(b) (listing eighteen categories of costs Medicare covers for outpatient hospital procedures), with 42 C.F.R. § 416.61(a) (listing eight categories of costs Medicare covers in ambulatory surgical centers).

This disparity creates a financial incentive for physicians to make referrals based more on maximizing their income than on maximizing the Medicare patient’s well-being. For example, suppose a physician has an ownership interest in a hospital laboratory that diagnoses various illnesses. The physician profits by sending his Medicare patient to that hospital to undergo the diagnostic tests. The patient, by contrast, has little financial incentive to limit the cost of the tests, as Medicare covers most of the costs. This imbalance in interests can lead to a physician ordering a battery of unnecessary tests. In fact, a 1991 study showed this very outcome where Florida physicians had ownership interests in diagnostic clinics. See Joint Ventures Among Health Care Providers in Florida: Hearing Before the H. Subcomm. on Health of the H. Comm, on Ways and Means, 102d Cong. (1991). To address this problem, Congress enacted the Stark Law (named for former Representative Pete Stark of California). See generally 42 U.S.C. [216]*216§ 1395nn; see also Medicare and Medicaid Programs; Physician’s Referrals to Health Care Entities With Which They Have Financial Relationships, 63 Fed.Reg. 1659, 1718 (proposed Jan. 9, 1998). The Stark Law places restrictions on both the referring physicians and the hospitals. It prohibits a physician who has a “financial relationship” with a hospital from referring Medicare patients to that hospital.2 It also bars hospitals from receiving Medicare payments based on these prohibited referrals. See 42 U.S.C. § 1395nn(a)(l)(A), (a)(1)(B), (h)(6)(K). For the Stark Law’s purposes, a physician has a “financial relationship” with a hospital if she owns or invests in it, or if she has a compensation agreement with the hospital covering services, equipment, and the like. Id. § 1395nn(a)(2)(A)-(B), (h)(1).

Despite the general prohibition on potentially self-interested referrals, the Stark Law permits referrals by physicians to entities in which they have a financial interest in certain limited circumstances. It does so by excluding some forms of compensation agreements and ownership interests from the definition of “financial relationship,” thus allowing both the relationships and the referrals. See 42 U.S.C. § 1395nn(b)-(e). The provision at issue here is the equipment rental exception, under which physicians may both lease equipment to a hospital and refer their Medicare patients to that hospital for procedures using the equipment so long as the leasing agreement meets certain conditions.

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Bluebook (online)
790 F.3d 212, 416 U.S. App. D.C. 143, 2015 U.S. App. LEXIS 9867, 2015 WL 3634632, Counsel Stack Legal Research, https://law.counselstack.com/opinion/council-for-urological-interes-v-sylvia-mathews-burwell-cadc-2015.