United States Ex Rel. Kneepkins v. Gambro Healthcare, Inc.

115 F. Supp. 2d 35, 2000 U.S. Dist. LEXIS 10424, 2000 WL 1377366
CourtDistrict Court, D. Massachusetts
DecidedJuly 18, 2000
DocketCiv.A. 97-10400-GAO
StatusPublished
Cited by17 cases

This text of 115 F. Supp. 2d 35 (United States Ex Rel. Kneepkins v. Gambro Healthcare, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States Ex Rel. Kneepkins v. Gambro Healthcare, Inc., 115 F. Supp. 2d 35, 2000 U.S. Dist. LEXIS 10424, 2000 WL 1377366 (D. Mass. 2000).

Opinion

MEMORANDUM AND ORDER

O’TOOLE, District Judge.

The government’s complaint asserts that predecessor corporations of the three named defendants, Gambro Healthcare, Inc., Dialysis Holdings, Inc., and Transitional Hospitals Corporation, Inc., engineered a scheme to defraud Medicare by performing unnecessary and wasteful blood tests at a medical testing laboratory in Smyrna, Georgia. 1 Three of the seven counts arise under the False Claims Act, 31 U.S.C. §§ 3729(a)(1), (2), and (3);' the other four assert common law claims for fraud, payment by mistake of fact, unjust enrichment, and disgorgement of illegal profits.

Two motions to dismiss are pending, one filed by Gambro, and the other filed jointly by Dialysis Holdings and Transitional Hospitals.

1. The following is a brief summary of the complaint’s allegations. Without a kidney transplant, a person suffering from End-Stage Renal Disease (“ESRD”) requires kidney dialysis several times a week as well as regular testing and monitoring of her blood. Many elderly ESRD patients rely-on Medicare to cover the cost of regular dialysis and necessary blood tests.

Different types of ESRD blood tests are reimbursed by Medicare in different ways. For example, there are “routine tests” which are performed on an ESRD patient’s blood every time she undergoes dialysis. Reimbursement for these tests is rolled into the lump-sum “composite payment” that the Medicare beneficiary’s dialysis provider receives from Medicare for regular dialysis services. Hence, routine tests cannot be billed separately to Medicare. Other tests, classified in the Medicare system as “allowable tests” and “non-routine tests” and referred to hereafter as “nonroutine tests” for the sake of simplicity, are performed at less predictable intervals depending on the patient’s particular needs. These tests, unlike routine tests, *38 are billed to Medicare on a fee-for-service basis.

Certain blood tests may be performed simultaneously as a group, or “panel,” on a given blood sample. Lab equipment developed during the- 1980s allowed many routine and nonroutine tests to be performed together as a single panel. Thus, the marginal cost of performing additional nonroutine tests on a blood sample already slated for routine testing was greatly diminished. Questions arose as to whether a panel which included both routine and non-routine tests could, either wholly or in part, be billed to Medicare.

In 1987, Health and Human Services published, in its “Medicare Carriers Manual,” the so-called “50/50 Rule.” Under the rule, direct reimbursement for any given panel would depend on the panel’s ratio of routine to nonroutine tests. If half or more of the tests were routine, there would be no direct reimbursement; if less than half, the entire panel would be reimbursed. Furthermore, any request for reimbursement for nonroutine tests — which, per the 6%o Rule, could only be made for panels that were predominantly nonrou-tine — was required to have an “ICD-9 Code” assuring that the tests were medically necessary.

Around that time in 1987, Community Psychiatric Centers Laboratories, Inc. (“CPC Labs”), a wholly-owned subsidiary of a major dialysis services provider, Community Psychiatric Centers, Inc. (“CPC”), struck a five-year partnership agreement with Clinical Laboratory Services, Inc. (“Damon CLS”), a wholly-owned subsidiary of Damon Clinical Laboratories, Inc. (“Damon”). They agreed to create and run a clinical testing laboratory operating under the name Damon Clinical Laboratories in Smyrna, Georgia (the “Smyrna Lab”). Damon and CPC, through their subsidiaries, split the Smyrna Lab profits evenly. In exchange for the Smyrna Lab’s performance of routine tests for CPC for a below-cost fee of $1 per test, CPC agreed to refer its nonroutine tests also to the Smyrna Lab, which then separately billed Medicare for those tests on a fee-for-service basis.

Damon and CPC initially planned to perform a monthly panel for each dialysis patient called the “Chem 19,” consisting of roughly nineteen tests, seven of which were nonroutine and, prior to the announcement of the 50/50 Rule, would have been separately billable. The 50/50 Rule was announced while Damon and CPC were hammering out their agreement. It posed an immediate threat to the venture’s ability to turn a profit. Damon and CPC decided, therefore, to split the Chem 19 panel in two. One new panel would be composed solely of routine tests (the “Chem 12”), the other solely of nonroutine tests (the “Chem 7”). The panels would be performed on separate days, and would require separate blood samples drawn from each patient. All of the tests in the split panels could have been, but were not, performed as a single panel. Indeed, for a different dialysis provider serviced by the Smyrna Lab during the same period of time, all the relevant tests were performed in single Chem 19 panels.

According to the government, running separate Chem 7 and Chem 12 panels on different days required extra blood samples drawn for each patient. 2 To assuage doubts and secure the needed ICD-9 codes, doctors were assured that the additional blood draws and split-panel procedures were necessary. They were not told that all of the tests could have been accomplished in a single panel, or that CPC’s stake in the joint venture gave it an interest in maintaining the level of billable non-routine Medicare tests. Nor was the Smyrna Lab’s Medicare carrier informed, at that time or in later years, of the partnership agreement between Damon and CPC.

*39 In 1988, Damon and CPC agreed to add several nonroutine tests to the battery of otherwise predominantly routine weekly and monthly tests that the doctors typically ordered. (For convenience, this will be referred to as the “Added Test Plan.”) The added nonroutine tests were then separately billed to Medicare. Smyrna Lab technicians were told that these additional nonroutine tests were specifically ordered by CPC doctors and carried the imprimatur of CPC’s consulting board of medical experts. The doctors were given forms which identified the newly added tests as routine; doctors who expressed misgivings were also told that CPC’s board of experts had approved them. According to the complaint, none of these assurances was true. Non-CPC doctors who referred tests to the Smyrna Lab received different test-ordering forms which, accurately segregated routine tests from nonroutine.

In 1989, CPC spun off its dialysis division to Vivra, Inc. (“Vivra”). Thereafter, CPC played a diminished role in the joint venture, taking a share of the profits from the Smyrna Lab until 1991. Through its Community Dialysis Centers, Inc. (“Vivra CDC”) subsidiary, like CPC before it, Viv-ra agreed to refer most of its nonroutine tests to the Smyrna Lab in exchange for below-cost routine testing and a share of the Smyrna Lab’s profits. Vivra also continued to support the split-panel procedure and the encouragement of unnecessary weekly and monthly nonroutine tests. Vivra referred tests to the Smyrna Lab under the terms of the agreement until the partnership was terminated in 1996.

None of the named defendants was directly involved in these events.

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Bluebook (online)
115 F. Supp. 2d 35, 2000 U.S. Dist. LEXIS 10424, 2000 WL 1377366, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-kneepkins-v-gambro-healthcare-inc-mad-2000.