Michigan Ass'n of Independent Clinical Laboratories v. Shalala

52 F.3d 1340, 1994 WL 794826
CourtCourt of Appeals for the Sixth Circuit
DecidedDecember 19, 1994
DocketNo. 92-2554
StatusPublished
Cited by9 cases

This text of 52 F.3d 1340 (Michigan Ass'n of Independent Clinical Laboratories v. Shalala) is published on Counsel Stack Legal Research, covering Court of Appeals for the Sixth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Michigan Ass'n of Independent Clinical Laboratories v. Shalala, 52 F.3d 1340, 1994 WL 794826 (6th Cir. 1994).

Opinion

BATCHELDER, Circuit Judge.

This suit was filed on May 8, 1990, by plaintiffs-appellants, the Michigan Association of Independent Clinical Laboratories (“MAIL”) and four of its member laboratories, against defendants-appellees, the Secretary of Health and Human Services (the “Secretary”) and the Blue Cross/Blue Shield of Michigan (“BCBS”). In its complaint, MAIL alleged that defendants violated several provisions of the Medicare Act (the “Act”). Specifically, MAIL alleged that the defendants violated provisions of Part B of the Act, 42 U.S.C.A. §§ 1395j-1395w-4 (West 1992 & Supp.1995), by changing the level of reimbursement for six particular lab tests.

On October 29, 1992, the district court heard oral arguments on defendants’ motion to dismiss and plaintiffs’ motion for summary judgment. At the conclusion of argument, the district court dismissed, the plaintiffs’ case for lack of subject matter jurisdiction, concluding that this was an “amount determination” case and that the plaintiffs failed to exhaust their administrative remedies. On October 30, 1992, the district court entered its final judgment dismissing the action for lack of subject matter jurisdiction due to failure to exhaust administrative remedies. For the reasons that follow, we affirm.

I.

This case arises under Title XVIII of the Social Security Act. 42 U.S.C.A. §§ 1395-1395ccc (West 1992 & Supp.1995). Title XVIII establishes programs to provide medical benefits for the aged and disabled. Title XVIII is divided into two main sections: Part A (42 U.S.C.A. §§ 1395c-1395i-4) and Part B (42 U.S.C.A. §§ 1395j-1395w-4), that are known collectively as “Medicare.” This action is primarily concerned with the provisions of Part B.

Medicare -Part B is analogous to a private medical insurance program, subsidized in large part by the federal government. Part B is a voluntary program of supplementary medical insurance covering, in general, physician services, durable medical equipment, and certain other medical and health services, such as outpatient hospital services and laboratory tests — the dispute in this ease.

Congress authorized the Secretary to contract with private insurance “carriers” — such as BCBS of Michigan — to administer the payment of qualifying claims. 42 U.S.C.A § 1395u (West Supp.1995). The Part B carrier determines whether a claimed service or item is medically necessary and is otherwise covered under Part B, and establishes the reimbursement that may be paid using federal funds. In performing these functions, the carrier is required to use the coverage and reimbursement criteria prescribed by the statute and the Secretary.

The plaintiffs’ complaint in this case focuses on the reclassification of six tests by BCBS from “reasonable charge” reimbursement rates1 to “automated panel” reimburse[1343]*1343ment rates.2 The Health Care Financing Administration (“HCFA”), the operating component of the Department of Health and Human Services, addressed the subject of laboratory testing in its Part B Medicare Carrier’s Manual (the “Manual”), issued pursuant to the Secretary’s authority to issue interpretive guidelines for the Medicare program. The Manual explained that many tests “can be and are frequently done as groups and combinations on automated multichannel equipment.” However, carriers may “receive claims for laboratory services in which the physician or laboratory has separately billed for tests that are commonly available as part of an automated battery test.” To address this problem, the Manual instructed that when the sum of the reasonable charge for the separately billed tests exceeded the prevailing charge for the automated battery, the “lesser amount should be determined to be the reasonable charge.”3

In 1978, the Manual identified twenty tests which were, and are, considered to be commonly performed as part of an automated battery. The Manual also suggested that consultations by the carrier with representatives from the medical profession and independent laboratory associations “should be helpful” and “may be able to identify those laboratory tests in the areas that are most commonly performed on automated equipment.” However, the Manual authorized the carriers to determine ultimately which tests to include in light of circumstances prevailing in the carrier’s service area.

Acting in conformance with the Manual, BCBS sought input from local laboratories, including MAIL, regarding the use of automated testing equipment. In its response, MAIL indicated that it did not oppose the institution of a system of reimbursement based on automated panel rates; however, MAIL indicated that its members felt that the twenty tests in the Manual should be narrowed to fourteen tests which “can be done on automated equipment that is readily and generally available throughout the state.”

BCBS responded by letter on March 8, 1979, informing MAIL that they would initially administer the new program in accordance with MAIL’S suggestions, i.e., only the fourteen tests identified by MAIL as being done on automated equipment that is readily available would be reimbursed at automated panel rates. . However, BCBS expressly noted that “further evaluation of the number of commonly available automated tests in Michigan” would eventually be necessary.

There is some indication in the record that BCBS was concerned that the list of automated tests was underinelusive; however, BCBS did not directly address this issue until 1985, when a PATROL4 initiative addressing automated testing was issued. The PATROL initiative informed carriers that three additional tests should be treated as part of an automated panel.5 The Initiative continued:

To effect savings in program payments, all carriers are being asked to review their list of tests priced as part of a panel to ensure the above tests are included. If they are not on your list of panel tests, we would like you to add the above three tests to your list of automated panel tests as [1344]*1344soon as possible, but no later than April 1, 1985....
We would also like to review and possibly update the current MCM listing of panel tests. Please identify (narrative and code) any other tests not currently listed in the MCM that you have added to your list of panel tests, along with the date of the accretions.

BCBS thereafter informed HCFA that it would treat tests for triglycerides, CPK, and GGTP as commonly performed on automated equipment. In addition, BCBS informed HCFA that it had decided to add a variety of other tests to its list of automated panel tests, including tests for three electrolytes— sodium, potassium, and chloride.

Upon learning of the reclassification of these tests, MAIL strongly protested through a series of letters aimed first at BCBS and then at HCFA. At no time did hearings before an Administrative Law Judge' (ALJ) or other administrative proceedings take place. Not obtaining the desired result through the general letter writing campaign, MAIL filed suit in federal court.

II.

Before proceeding on to the merits of this appeal, it is necessary to explain the background against which plaintiffs’ Part B claims arise.

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Cite This Page — Counsel Stack

Bluebook (online)
52 F.3d 1340, 1994 WL 794826, Counsel Stack Legal Research, https://law.counselstack.com/opinion/michigan-assn-of-independent-clinical-laboratories-v-shalala-ca6-1994.