Renal Physn Assn v. HHS

489 F.3d 1267
CourtCourt of Appeals for the D.C. Circuit
DecidedJune 12, 2007
Docket06-5133
StatusPublished
Cited by2 cases

This text of 489 F.3d 1267 (Renal Physn Assn v. HHS) 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
Renal Physn Assn v. HHS, 489 F.3d 1267 (D.C. Cir. 2007).

Opinion

489 F.3d 1267

RENAL PHYSICIANS ASSOCIATION, Appellant
v.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Appellees.

No. 06-5133.

United States Court of Appeals, District of Columbia Circuit.

Argued March 8, 2007.

Decided June 12, 2007.

Appeal from the United States District Court for the District of Columbia (No. 05cv00067).

Robert S. Plotkin argued the cause for appellant. With him on the briefs was E. Duncan Getchell, Jr.

Jeffrey T. Green was on the brief for amici curiae American Medical Association et al. in support of appellant.

Stephanie R. Marcus, Attorney, U.S. Department of Justice, argued the cause for appellees. With her on the brief were Jeffrey S. Bucholtz, Acting Assistant Attorney General, Jeffrey A. Taylor, U.S. Attorney, and Thomas M. Bondy, Attorney.

Before: GINSBURG, Chief Judge, and GARLAND and BROWN, Circuit Judges.

Opinion for the Court filed by Circuit Judge BROWN.

BROWN, Circuit Judge:

The issue in this case is standing to challenge a regulatory safe harbor where the direct cause of injury is the independent action of a third party. The same issue was before this court in National Wrestling Coaches Ass'n v. Department of Education, 366 F.3d 930 (D.C.Cir.2004) (National Wrestling), though the factual context there was very different. Here, relying on National Wrestling, the district court dismissed the complaint for lack of standing. We affirm.

* Congress first enacted the "Stark Law" as part of the Omnibus Budget Reconciliation Act of 1989. See Pub.L. 101-239, § 6204, 103 Stat. 2106, 2236-43 (1989). The law, which added section 1877 to the Social Security Act, limited the ability of a physician to refer Medicare patients to clinical laboratories with which the physician had a "financial relationship." 42 U.S.C. § 1395nn(a)(1). In 1993, Congress extended the law to several other health services, id. § 1395nn(h)(6), and also included Medicaid patient referrals within the scope of the law, id. § 1396b(s). See Pub.L. 103-66, §§ 13562, 13624, 107 Stat. 312, 604, 636 (1993). Among other things, the law prohibits payment for services furnished pursuant to a prohibited referral, 42 U.S.C. §§ 1395nn(a)(1)(B), 1396b(s), imposing civil penalties in the case of a prohibited referral, id. § 1395nn(g). The Stark Law includes several exceptions, id. § 1395nn(b)-(e), and authorizes the Secretary of Health and Human Services to make additional exceptions by regulation, where the "financial relationship . . . does not pose a risk of program or patient abuse," id. § 1395nn(b)(4).

One of the exceptions to the referral prohibition is for "[p]ersonal service arrangements." Id. § 1395nn(e)(3). Essentially, this exception covers market-rate, pay-for-service arrangements. In other words, if the physician's only financial interest in the clinic is receipt of agreed-upon compensation at or below "fair market value" for "reasonable and necessary" services, then the physician may make referrals to the clinic without violating the law. Id. § 1395nn(e)(3)(A). The Stark Law, however, limits the extent to which the physician's compensation may be based on the volume or value of patient referrals. Id. at § 1395nn(e)(3)(B). The law defines "fair market value" as "the value in arm[']s length transactions, consistent with the general market value." Id. § 1395nn(h)(3) (emphasis added). Obviously, this definition of "fair market value" is critical to determining the scope of the Stark Law exception, and the definition hinges on the term "general market value."

The Centers for Medicare and Medicaid Services ("CMS")—formerly called the Health Care Financing Administration ("HCFA")—is the division within the United States Department of Health and Human Services that oversees regulatory implementation of the Stark Law. In 1998, in a notice of proposed rulemaking, HCFA proposed a set of regulations to clarify and implement the various provisions of the law, including defining "general market value" as "the compensation that would be included in a service agreement, as the result of bona fide bargaining between well-informed parties to the agreement . . . at the time of the service agreement." 63 Fed.Reg. 1659, 1721 (Jan. 9, 1998). Several comments on this proposed rule focused on how (i.e., with what sort of evidence) a party could establish it had met this standard. 66 Fed.Reg. 856, 944 (Jan. 4, 2001). HCFA responded in 2001 by stating its intent "to accept any method [of proof] that is commercially reasonable and provides us with evidence that the compensation is comparable to what is ordinarily paid for an item or service in the location at issue, by parties in arm's-length transactions who are not in a position to refer to one another." Id. At the same time, the HCFA issued a final rule defining "general market value" in accord with its proposed rule. See 66 Fed.Reg. at 856; 42 C.F.R. § 411.351 (2006).

The 2001 rulemaking did not address several subsections of the Stark Law, and HCFA stated it would address those subsections "shortly" in a "Phase II" rulemaking. 66 Fed.Reg. at 856. In addition, this Phase II rulemaking would address comments received in response to the 2001 rulemaking (i.e., "Phase I"). Id. Phase II was completed in 2004, when HCFA (by this time renamed "CMS") issued an interim final rule, which it planned to finalize within three years. 69 Fed.Reg. 16,054, 16,126 (Mar. 26, 2004). To a large extent, the new rulemaking duplicated portions of the 1998 proposed rulemaking, addressing Stark Law subsections Phase I had not covered. Id. at 16,125. However, because a new law (effective December 8, 2003) required the agency to finalize its proposed rules within three years, see 42 U.S.C. § 1395hh(a)(3)(B), a question arose about the continuing viability of the 1998 proposal. Although the agency was unsure the new law prohibited the Secretary from finalizing rules proposed more than three years before December 8, 2003, it took the cautious approach of publishing the new rule as an interim final rule with a comment period. See 69 Fed.Reg. at 16,125.

In short, CMS restarted the rulemaking process from scratch but waived publication of a notice of proposed rulemaking, finding the customary notice and comment period "impracticable, unnecessary, or contrary to the public interest" because the public had been afforded two prior opportunities to comment and could also comment on the interim final rule. See id. at 16,125 (quoting 5 U.S.C. § 553(b)).

As part of this interim final rule, CMS created a safe harbor provision within the existing regulatory definition of "fair market value." Id. at 16,092, 16,128. The agency emphasized the safe harbor was "entirely voluntary; [health service providers] may continue to establish fair market value through other methods." Id. at 16,092.

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Bluebook (online)
489 F.3d 1267, Counsel Stack Legal Research, https://law.counselstack.com/opinion/renal-physn-assn-v-hhs-cadc-2007.