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Atlantic Urological Associates, P.A. v. Leavitt

March 31, 2008

ATLANTIC UROLOGICAL ASSOCIATES, P.A., ET AL., PLAINTIFF,
v.
MICHAEL O. LEAVITT, SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEFENDANT.



The opinion of the court was delivered by: Rosemary M. Collyer United States District Judge

MEMORANDUM OPINION

Plaintiffs brought this suit against Michael Leavitt, in his official capacity, as Secretary of the Department of Health and Human Services ("the Secretary" or "HHS") challenging the HHS's Final Order, 73 Fed. Reg. 404 (Jan. 3, 2008), which relates to Medicare billing of laboratory testing services. The Final Order delays for one year the application of the November 2007 Anti-Markup Rule*fn1 to services other than anatomic pathology diagnostic testing service. 73 Fed. Reg. 404 (Jan. 3, 2008). Plaintiffs include: (1) three urology physician group practices (the "Physician Groups")*fn2 that own and operate pathology laboratories; (2) Dr. Sam Michaels, a self- employed pathologist who performs testing services for other physician groups; (3) Uropath, LLC, a limited liability company that manages various pathology laboratories; and (4) Uropath's Director of Clinical Operations, Rebecca Page. Plaintiffs seek to enjoin and invalidate the Final Order.

Plaintiffs move for a preliminary injunction; HHS opposes and also moves to dismiss for lack of jurisdiction. In order to permit time for briefing and oral argument on the complex issues involved, the parties consented to an Interim Order, entered February 8, 2008. The Interim Order set a briefing schedule (with briefing completed on March 19, 2008) and a hearing on March 28, 2008. The Interim Order further provided that Secretary would not apply the Anti-Markup Rule, as amended by the Final Rule, until April 1, 2008, as follows:

[The Secretary] will not apply the final anti-markup rule, 72 Fed. Reg. 66,222 (Nov. 27, 2007), as amended by 73 Fed. Reg. 404 (Jan. 3, 2008), to claims submitted between February 1 and April 1, 2008, seeking Medicare reimbursement for anatomic pathology diagnostic testing services that are furnished in a centralized building that does not qualify as the "same building" under the physician self-referral exception at 42 C.F.R. § 411.355(b). Such claims shall remain subject to all other Medicare requirements. In the event the Court subsequently affirms the anti-markup rule as applied to anatomic pathology diagnostic testing services, the Secretary shall not recoup any Medicare payments made for any such claims submitted from February 1 to April 1, 2008, based on failure to comply with the provision governing payment for such services furnished in a centralized building that does not qualify as the "same building" under the physician self-referral exception.

Interim Order filed Feb. 8, 2008 [Dkt. #12] (emphasis added).

At the March 28, 2008, oral argument, the Court told the parties that it needed more than a weekend to decide the issues presented and invited the Secretary to extend the Interim Order. On March 31, 2008 at 12:10, the Secretary filed a Proposal to Extend Interim Agreement, indicating that it would extend the agreement not to apply the Anti-Markup Rule by thirty days, from April 1 to May 2, 2008. Critically, however, the Secretary indicated that "it reserves the right to recoup any Medicare payments in excess of the amounts that would be permissible under the anti-markup rule for any such claims submitted between April 2 to May 2, 2008." Def.'s Proposal to Extend Interim Agreement [Dkt. #23] at 1. In other words, the Secretary would have the Final Rule take effect. Because the Secretary insists on retaining the right to recoupment, the Court finds that, for the purpose of delaying a ruling on the Plaintiffs' motion for preliminary injunction, the Secretary has not sufficiently waived its right to implement the Anti-Markup Rule. Accordingly, as explained below, the Court will grant Plaintiffs' motion for a preliminary injunction.

I. FACTS

The Final Order challenged here delays for one year the application of the AntiMarkup Rule*fn3 to services other than anatomic pathology diagnostic testing service. 73 Fed. Reg. 404 (Jan. 3, 2008). Medicare Part B provides supplementary insurance coverage for physician and outpatient services, including diagnostic laboratory tests. 42 U.S.C. 1395x(s)(3). CMS published a notice of proposed rulemaking on July 12, 2007. 72 Fed. Reg. 38,122. This notice included an anti- markup rule regarding Medicare Part B payments for diagnostic testing services purchased from an outside provider or provided in a "centralized building." CMS was concerned that diagnostic testing services provided in a "centralized building" were overutilized and thus resulted in high costs to the Medicare program. See 72 Fed. Reg. 38,179. After receiving and reviewing numerous comments, on November 27, 2007, CMS published the final Anti-Markup Rule. The Anti-Markup Rule limited payment for anatomic pathology diagnostic testing services performed at a "site other than the office of the billing physician or other supplier"*fn4 to the lesser of: (1) the performing supplier's net charge to the billing physician or other supplier; (2) the billing physician or other supplier's actual charge; or (3) the fee schedule amount for the test that would be allowed if the performing supplier billed directly. 73 Fed. Reg. at 405; 42 C.F.R. § 4.14.50(a)(1).

Shortly thereafter, CMS received "informal" comments and published another rule, the Final Rule at issue here. The Final Rule delayed until January 1, 2009, the applicability of the Anti- Markup Rule except as to (1) the technical component of a diagnostic test,*fn5 and (2) anatomic pathology diagnostic testing services furnished in a "centralized building." CMS indicated, "[b]ecause anatomic pathology diagnostic testing arrangements precipitated our proposal for revision of the anti-markup provisions and remain our core concern, we are not delaying the date of applicability with respect to anatomic pathology diagnostic testing services." 73 Fed. Reg. at 405. At this juncture, the Secretary has submitted no administrative record reflecting the making of the January 2008 Final Rule. There is nothing in the record before the Court describing the nature or content of the "informal" comments that led to the Final Rule.

II. ANALYSIS

A. Motion to Dismiss for Lack of Jurisdiction

Federal courts are courts of limited jurisdiction and the law presumes that "a cause lies outside this limited jurisdiction." Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). Because subject matter jurisdiction is an Article III as well as a statutory requirement, "no action of the parties can confer subject[]matter jurisdiction upon a federal court." Akinseye v. District of Columbia, 339 F.3d 970, 971 (D.C. Cir. 2003). On a motion to dismiss for lack of subject-matter jurisdiction pursuant to Rule 12(b)(1), the plaintiff bears the burden of establishing that the court has subject matter jurisdiction. Evans v. B.F. Perkins Co., 166 F.3d 642, 647 (4th Cir. 1999); see also McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178, 182-83 (1936).

Here, the Secretary seeks dismissal. The Secretary argues that Uropath lacks standing to bring this suit. See Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). Moreover, the Secretary argues that Shalala v. Illinois Council on Long Term Care, 529 U.S. 449, 120 S.Ct. 1084 (1999) applies. See Illinois Council, 120 S.Ct. at 1093-94 (42 U.S.C. § 405(h) (incorporated into the Medicare Act by 42 U.S.C. § 3595ii) precludes review under 28 U.S.C. § 1331; claims under the Medicare Act must be channeled through HHS's administrative process before they can be heard in federal court). Plaintiffs counter that the exception to this rule, set forth in Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667 (1986), applies. Michigan Academy permits federal question jurisdiction where the application of section 405(h) would not lead to channeling of review through the agency but would result in no review at all. Id. at 681 n.12.

The Court has not decided the jurisdictional issues, but it need not do so prior to entering a preliminary injunction. See Belbacha v. Bush, No. 07-5258 (D.C. Cir. Mar. 14, 2008) (under the All Writs Act, the district court retains authority ...


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