Loma Linda University Medical Center v. Leavitt

District Court, District of Columbia·Decided March 17, 2009·No. Civil Action No. 2006-1927·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

LOMA LINDA UNIVERSITY KIDNEY CENTER,

Plaintiff, Civil Action No. 06-1926 Consolidated with 06-1927 v. TFH/DAR

CHARLES E. JOHNSON, Acting Secretary, United States Department of Health and Human Services,

Defendant.

LOMA LINDA UNIVERSITY MEDICAL CENTER,

Plaintiff,

v.

CHARLES E. JOHNSON, Acting Secretary, United States Department of Health and Human Services,

Defendant.

REPORT AND RECOMMENDATION1 Plaintiffs, Loma Linda University Kidney Center (“LLKC”) and Loma Linda University Medical Center (“LLMC”), collectively “Loma Linda,” are certified Medicare providers of

1 The Court has substituted the Acting Secretary as Defendant in place of his predecessor, Michael O.

Leavitt, who had been a party to this suit in his official capacity only. See Fed.R.Civ.P. 25(d)(1).

Loma Linda v. Johnson 2 service which render hemodialysis services to individuals with end stage renal disease (“ESRD”).2 In this action, Plaintiffs challenge the final decision rendered by the Secretary of the United States Department of Health and Human Services (“Secretary”) denying Plaintiffs’ requests for an exception to the method for determining the prospective Medicare payment rate for dialysis treatments. Defendant maintains that his decision was proper pursuant to the terms of the applicable statutes and regulations. Pending for consideration by the undersigned United States Magistrate Judge are Plaintiffs’ Motion for Summary Judgment (Document No. 19), and Defendant’s Motion for Summary Judgment (Document No. 22).

Upon consideration of the motions; the memorandum in support thereof and in opposition thereto; the administrative record, and the entire record herein, the undersigned recommends that Plaintiffs’ motion for summary judgment be granted in part, and that Defendant’s motion for summary judgment be denied.

I. BACKGROUND (A) Statutory and Regulatory Framework This action arises under Title XVIII of the Social Security Act, more commonly known as the Medicare Act, a statutory scheme by which Congress established a federally funded health insurance program for the elderly and disabled. See 42 U.S.C. §§ 1395 et seq. At issue in this action are provisions which govern the cost reimbursements to providers of service (“Providers”) rendering outpatient dialysis treatment to qualified individuals for end stage renal disease

2 The court (Hogan, J.) consolidated for all purposes Loma Linda University Kidney Center v. Michael O.

Leavitt (Civil No. 06-1926), and Loma Linda University Medical Center v. Michael O. Leavitt (Civil No. 06-1927). See April 20, 2007 Order (Document No. 12) at 1.

Loma Linda v. Johnson 3 (“ESRD”). See 42 U.S.C. § 1395rr(b)(7). Reimbursement is administered by the Centers for Medicare and Medicaid Services (“CMS”), formerly the Health Care Financing Administration (“HCFA”),3 under the direction of the Secretary of the United States Department of Health and Human Services (“Secretary”). 42 C.F.R. § 413.170(a) (2000).4 Medicare reimbursement payments are determined by

a method (or methods) for determining prospectively the amounts of payments to be made for dialysis services furnished by providers of services[.] . . . Such method (or methods) shall provide for the prospective determination of a rate (or rates) for each mode of care based on a single composite weighted formula (which takes into account the mix of patients who receive dialysis services at a facility . . . and the relative costs of providing such services in such setting) for hospital-based facilities . . . or based on such other method or combination of methods . . . which the Secretary determines, after detailed analysis, will more effectively encourage the more efficient delivery of dialysis services[.]

42 U.S.C. § 1395rr(b)(7).5 Providers are authorized by statute to obtain “exceptions to such methods as may be warranted by unusual circumstances[.]” Id.; see also 42 C.F.R. § 413.180 (2000).

The Secretary has promulgated regulations enumerating the circumstances warranting an exception to the “method (or methods)” used for “the prospective determination of a rate (or

3

Any references to HCFA in cited regulations or the administrative record refers to the entity now known as CM S.

4

The court cites, where appropriate, the 2000 version of the Regulations that were in effect at the time Plaintiffs filed their requests for payment rate exception.

5

The reimbursement payments of the cost for services rendered by providers of service are made through private entities, known as fiscal intermediaries. See U.S.C. § 1395h; see also 42 C.F.R. § 413.180 (2000).

Loma Linda v. Johnson 4 rates)” which determine the amounts of payment to be made for dialysis services.6 Id.; see also 42 C.F.R. §§ 413.182, 413.180 (2000). Providers seeking such a “payment rate exception” must submit to CMS materials specified in the implementing regulations, and at the request of CMS, which are necessary for CMS to “adjudicate each type of exception.” Id. § 413.180(f). In pertinent part, Providers must request a payment rate exception “within 180 days of . . . the effective date that CMS opens the exceptions process[.]” Id. § 413.180(d)(2). The statute provides that “[e]ach application for such an exception shall be deemed to be approved unless the Secretary disapproves it by not later than 60 working days after the date the application is filed.” 42 U.S.C. § 1395rr(b)(7); see also 42 C.F.R § 413.180(h) (2000) (“An exception request is deemed approved unless it is disapproved within 60 working days after it is filed with its intermediary.”).7 In the event that CMS determines that a provider has failed to meet its burden of demonstrating that a payment rate exception is warranted by “convincing objective evidence,” the provider may seek administrative review of CMS’ decision. 42 C.F.R. § 413.182(b); see also §§ 413.180, 413.194(b) (2000). “The [Provider Reimbursement Review Board (“Board”)] has the authority to review the action taken by HCFA on the facility’s requests. However, the [Board’s] decision is subject to review by the Administrator[.]” Id. § 413.194(b)(2); see also 42 C.F.R. § 405.1875 (2000). “A decision of the Board shall be final unless the Secretary, on its

6 The Secretary’s implementing regulations authorize “an exception to the prospective payment rate based on atypical service intensity” to a facility that “demonstrates that a substantial proportion of the facility’s outpatient maintenance dialysis treatments involve atypically intense dialysis services, special dialysis procedures, or supplies that are medically necessary to meet special medical needs of the facility’s patients.” Id. § 413.184(a)(1) (2000).

7 70 Fed. Reg. 70116, 70331 (November 21, 2005) (redesignated this subsection, in full text, effective January 1, 2006, to 42 C.F.R. § 413.180(g)).

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