MEDiCAL | LEGAL Can Your Medical opinion Subject You to Criminal or Civil Liability? by Emily Park, JD Recent Federal Cases Involving Medical Opinions and False Claims hen providing health care services that are reimbursed by federal health care programs (i.e., Medicare and Medicaid), or other third party payers, providers must comply with a number of health care fraud and abuse laws, including the False Claims Act and a number of criminal statutes, including a statute specifically addressing healthcare fraud. The False Claims Act (FCA) imposes civil liability on those who present, or cause to be presented, a false or fraudulent claim for payment to the federal government. 1 While the FCA imposes civil liability, there are separate criminal statutes that can be used by the government to prosecute false claims and healthcare fraud. 2 Beginning in the early part of this decade, both the government and qui tam relators began scrutinizing hospices, which has created a unique body of law concerning the intersection of subjective clinical judgments and the objective falsity required in civil and criminal false claim cases. 3 Coverage for hospice services was added to the Medicare program in 1985. For patients covered by Medicare to be eligible for the hospice benefit, the patient must elect to forego all curative treatment for the terminal illness and must obtain a certification from two physicians that he or she has a prognosis of a life expectancy of six months or less if the illness runs its normal course. 4 Only allopathic and osteopathic physicians can certify or re-certify that a patient has a life expectancy of six months or less. 5 Section §1814(a)(7) of the Social Security Act specifies that certification of terminal illness for the hospice benefit shall be based on the clinical judgment of the hospice medical Emily Park, JD, an associate attorney in the Jefferson City office of Husch Blackwell wrote this article. she represents a full spectrum of health care providers on regulatory and other issues. the information contained in this article should not be construed as legal advice or a legal opinion on any specific facts or circumstances. the contents are intended for general information purposes only, and readers are encouraged to consult their own attorney concerning their specific situation and specific legal questions. Contact: Emily.Park@huschblackwell.com W director or physician member of the hospice interdisciplinary group and the patient’s attending physician, if he or she has one, regarding the normal course of the patient’s illness. In 1990, the federal government added the phrase “if the illness runs its normal course” to the definition of terminal illness based on a report by the federal Government Accountability Office. 6 This report concluded that physicians were reluctant to certify patients for hospice because they were required to state in their certification that the patient had a life expectancy of six months or less. 7 The GAO Report concluded that, “[t]he statement seemed to require certainty of prognosis, whereas the establishment of long-term prognoses always involves some uncertainty.” 8 CMS made the change to its regulation to prevent physicians from being discouraged to make the necessary certifications of terminal prognosis. 9 CMS later stated that the addition of this phrase was recognition of “the fact that making medical prognostications of life expectancy is not always exact.” 10 Thereafter, the number of persons electing the hospice benefit increased (as intended). 11 As with most dramatic utilization and spending increases, hospice services became a target for greater scrutiny, and the government began reviewing these services to determine if coverage requirements were being met. The United States Department of Health and Human Services Office of Inspector General (OIG) issued a report in 2009 detailing its investigation of hospice services for beneficiaries in skilled nursing facilities, which revealed additional issues that led to subsequent reviews by the OIG, Centers for Medicare & Medicaid Services (CMS), and CMS’s audit contractors. 12 Qui tam relators took note of the government investigations, leading to several actions brought against hospices under the FCA. In 2008, a qui tam suit was filed against hospice AseraCare, Inc., by three former employees. The government intervened and ultimately filed a complaint in federal court alleging that AseraCare falsely certified patients as eligible for hospice services. 13 The case proceeded to a jury, and the government’s evidence included testimony from only one expert witness who testified that the medical records for the patients did not support a medical prognosis of a life expectancy of six months or less. 14 As a part of its 442 | 116:6 | November/December 2019 | Missouri Medicine