United States ex rel. Mikes v. Straus, 274 F.3d 687 (2d Cir. 2001)
Issue
The issue in this case was whether physicians can be held liable for a violation of the False Claims Act (FCA) under a theory of “false implied certification.”
AMA interest
The AMA has consistently maintained that FCA liability should require a violation of definite and understandable laws.
Case summary
Patricia S. Mikes, MD, sued Mark J. Straus, MD, and two other physicians under the FCA qui tam (“whistleblower”) provisions. The defendants were partners in a medical group specializing in problems of oncology and hematology. Mikes was a former employee of the defendants, and she had been involuntarily terminated.
The defendants had submitted Medicare claims for spirometry tests, which measure breathing capacity. According to Mikes, these tests were performed improperly, because the measuring equipment was calibrated incorrectly and the technicians who performed the tests were insufficiently trained to do so. Mikes contended that the defendants’ protocol for calibrating the measuring equipment fell beneath the standards recommended by the American Thoracic Society (ATS).
The trial court held for the defendants. It found that, when they submitted their payment claims, the defendants had neither explicitly nor implicitly promised that the tests met any specific standard of care. The defendants had complied with the standards set forth by the equipment manufacturer, which were less rigorous than the ATS recommendations, and this was sufficient. The court rejected Mikes’s theory that, by submitting the claims, the defendants implied that they satisfied the customary standard of care. The court also noted that, although the case had proceeded for several years, Mikes was unable to identify any specific test results that were incorrect.
Mikes appealed. The United States Department of Justice, the American Association for Respiratory Care, and Taxpayers Against Fraud filed amicus curiae briefs on her behalf.
Litigation Center involvement
The Litigation Center, along with the Medical Society of the State of New York and several specialty medical societies, filed an amicus brief on behalf of the defendants. Amici’s counsel participated in oral argument.
United States ex rel. Swafford v. Borgess Medical Center,
2001 U.S. App. LEXIS 26669 (unpublished opinion) (6th Cir. 2001)
Issue
The issue in this case was whether physicians can be held liable for a violation of the False Claims Act (FCA) under a theory of “false implied certification.”
AMA interest
The AMA supports physicians’ right to exercise professional judgment in choosing the most appropriate billing code to use in identifying medical services they have rendered (or have caused to be rendered) and billed to Medicare.
Case summary
Plaintiff Swafford was a registered vascular technologist employed by defendant Borgess Medical Center’s vascular ultrasound department. Plaintiff analyzed the results, through videotape, of venous ultrasound studies ordered by defendant physicians for patients with suspected deep vein thrombosis. Plaintiff performed the ultrasound tests, examined the data for five risk factors identified by the physicians, and indicated on a worksheet the presence or absence of the risk factors. The physicians reviewed the worksheets and prepared a final report, setting forth findings and conclusions.
Plaintiff filed a qui tam (“whistleblower”) lawsuit, which the government declined to join. Plaintiff alleged that the defendant physicians billed Medicare for conducting venous ultrasound tests although, in fact, they did not provide those services. Plaintiff insisted that the doctors did not really interpret the test results, as the physicians represented to Medicare, but rather plagiarized the worksheets prepared by plaintiff and other technicians and submitted them as “interpretations.” Plaintiff further alleged that Borgess Medical Center was aware of these practices and conspired with the physicians.
The district court granted defendants summary judgment. It ruled that plaintiff failed to demonstrate that the claims submitted were, in fact, false. The Health Care Financing Administration (HCFA) Provider Guidelines do not include a billing code for venous ultrasound studies, so the physicians had to exercise their professional judgment in choosing the most appropriate billing code. The defendants had sufficient information to form a professional opinion regarding the test results. The court also found that the defendants’ readings of the test results were within the standard of care and therefore constituted a proper submission. Further, insufficient evidence existed to suggest that defendants possessed the requisite scienter (i.e., a mental state embracing intent to deceive or defraud) to render them liable under the FCA. The plaintiff appealed to the Sixth Circuit.
The Sixth Circuit affirmed. Swafford petitioned the Supreme Court for certiorari, but the Court denied that request.
AMA involvement
The Michigan State Medical Society and the AMA filed an amicus brief in the Sixth Circuit to support the defendants.
United States ex rel. Walker v. R & F Properties,
433 F.3d 1349 (11th Cir. 2005)
Issue
The issue in this case was whether the federal False Claims Act (FCA) was violated by physicians submitting claims to Medicare for services rendered by non-physicians when physicians were not on the premises.
AMA interest
Because the AMA has consistently maintained that FCA liability should require a violation of definite and understandable laws, the Litigation Center filed an amicus curiae brief to support the physicians in their defense of this appeal.
Case summary
In this qui tam (“whistleblower”) action under the FCA, Karyn Walker contended that the defendant physicians should be bound by the Medicare Carrier's Manual (MCM) rules for the billing of "incidental" services, even though those rules were not set forth in the Medicare Act or the Code of Federal Regulations.
R & F Properties of Lake County, Inc. is a medical corporation in Lake County, Florida, which provides family care. Most of its patients are covered by Medicare. R & F formerly employed Karyn Walker as a nurse practitioner. From time to time, R & F used its physician assistants/nurse practitioners, including Walker, to service its Medicare patients without a physician's being physically present on the premises. The physicians were, however, always available by telephone or pager. R & F’s billings to Medicare included charges for the services rendered by the physician assistants/nurse practitioners.
At the time covered by the lawsuit (prior to 2002), the relevant federal regulation stated:
"Medicare Part B pays for services and supplies incident to a physician's professional services … if the services or supplies are of the type that are commonly furnished in a physician's office or clinic, and are commonly … included in the physician's bill."
The Medicare regulations did not explicitly say whether a physician had to be physically present on the premises in order to qualify "incidental" services for payment. However, the MCM stated that services rendered by non-physicians could be deemed "incident to a physician's professional service" only if the physician were "present in the office suite and immediately available to provide assistance and direction throughout the time that the aide is performing services."
Walker filed a qui tam action, alleging that R & F had violated the FCA by billing for services of non-physicians while physicians had not been physically present. She claimed that R & F was bound by the MCM requirement that a physician be physically present on the premises when the services were rendered. The United States Department of Justice, although notified of the suit, declined to intervene.
The trial court entered summary judgment for R & F. It held that, during the relevant time period, "neither the Medicare statutes nor the regulations provided much guidance on the level of supervision required in order to bill … services … as 'incident to.'" R & F had complied with the federal law and regulations in existence at the time of the billings, and the MCM requirements did not carry the force of law. The court noted that its holding was consistent with Florida law, which encouraged physicians to delegate health care tasks to qualified assistants.
Walker appealed to the Eleventh Circuit, which reversed the trial court’s opinion. While the appellate court acknowledged that the Medicare regulations did not fully define the term “incident to” during at least the majority of the time at issue, it held that Walker should be allowed to introduce evidence as to how the industry and CMS defined that term.
Litigation Center involvement
The Litigation Center filed a brief amicus curiae in the Eleventh Circuit to support
R & F.
View the brief. (PDF, 2MB)
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