Articles Posted in Health Law

Brookdale employed Prather to review Medicare claims before their submission for payment. Many of these claims were missing required certifications from physicians attesting to the need for the medical services provided. Certifications must “be obtained at the time the plan of care is established or as soon thereafter as possible.” 42 C.F.R. 424.22(a)(2).Prather filed a complaint under the False Claims Act, 31 U.S.C. 3729, alleging an implied false certification theory. The district court dismissed her complaint. The Sixth Circuit reversed in part, holding that Prather had pleaded two claims with the required particularity and that the claims submitted were false. On remand, the district court dismissed Prather's Third Amended Complaint in light of the Supreme Court’s 2016 clarification of the materiality element of an FCA claim. The Sixth Circuit reversed. Prather sufficiently alleged the required materiality element; the timing requirement in section 424.22(a)(2) is an express condition of payment and Prather alleges that the government paid the claims submitted by the defendants without knowledge of the non-compliance, making those payments irrelevant to the question of materiality. Section 424.22(a)(2) is a mechanism of fraud prevention, which the government has consistently emphasized in guidance regarding physician certifications and Prather adequately alleged “reckless disregard” of compliance and whether this requirement was material. View "Prather v. Brookdale Senior Living Community" on Justia Law

Abramge is a Brazilian nonprofit professional association of private health insurance providers, many of whom were impacted by a bribery and kickback scandal in the medical device market that broke in the Brazilian media in 2015. Abramge alleged that Stryker, a Michigan corporation, masterminded an “illicit scheme, which was planned and run from Michigan, designed to increase its market share by making improper payments and paying bribes and kickbacks to Brazilian doctors to induce the use of Stryker products” and “made improper payments and paid kickbacks to Brazilian doctors with the intent of influencing those doctors to use Stryker devices and products in patients even if those devices ... did not best meet the patients’ medical needs.” The scheme allegedly increased the cost of devices and the number of devices implanted and surgeries performed; health insurance providers paid for those increases. Abramge claims that Stryker’s actions injured not only its insurer members but also the entire Brazilian public health system and patients throughout the country. Abramge filed suit in the Western District of Michigan, claiming fraud, civil conspiracy, tortious interference with contractual relationships, and unjust enrichment. The district court dismissed, citing forum non conveniens. The Sixth Circuit reversed and remanded. Stryker did not carry its burden of proving that Brazil is an available and adequate alternative forum in which the case may be heard. View "Associacao Brasileira de Medicina v. Stryker Corp." on Justia Law

Raymond, a veteran of the U.S. Air Force, was born in 1947 and was a long-term resident of Middlesboro, Kentucky. He worked in the coal-mining industry for over 20 years and developed severe respiratory issues. Raymond, a non-smoker, sought benefits under the Black Lung Benefits Act, 30 U.S.C. 901, but died while his claim was pending. Raymond’s claim was consolidated with a claim for survivor’s benefits submitted by his widow, Joanna. The ALJ awarded benefits to Joanna, on both Raymond’s behalf, and as his surviving spouse. The Benefits Review Board affirmed. Zurich, the insurer of Straight Creek Coal, sought review. The Sixth Circuit denied Zurich’s petition, upholding the ALJ’s conclusions that Zurich failed to rebut the presumption of timeliness, that Raymond had worked for at least 15 years in qualifying employment, and that Raymond had a total respiratory disability. Raymond worked only in surface mines or coal-preparation plants during his career; the ALJ properly relied on 20 C.F.R. 718.305(b)(2) and determined whether Raymond’s mining employment was “substantially similar” to underground mining. View "Zurich American Insurance Group v. Duncan" on Justia Law

Michael, a licensed pharmacist at Chapmanville's Aracoma Pharmacy, separately co-owns another West Virginia pharmacy and one in Pennsylvania. The government suspected that Michael used the pharmacies to distribute on-demand prescription drugs, worth more than $4 million, over the Internet. A grand jury returned a multi-count indictment. Count 7 charged Michael with fraudulently submitting a claim for payment to Humana for dispensing medication that was never dispensed (18 U.S.C. 1347). Count 8 charged him with committing aggravated identity theft by using the “identifying information” of a doctor and a patient “in relation to the [health care fraud] offense” (18 U.S.C. 1028A(a)(1), (c)(11)). Michael had submitted a claim to Humana indicating that A.S. (doctor) had prescribed Lovaza for P.R., including the doctor’s National Provider Identifier and the patient’s name and birth date. A.S. was not P.R.’s doctor and did not issue the prescription. Section 1028A requires a person to “assume the identity” of someone else; the district court held that the statute covered only “impersonation,” and dismissed Count 8. The Sixth Circuit reversed. To “use” a means of identification is to “convert to one’s service” or “employ” the means of identification. Michael used A.S. and P.R.’s identifying information to fashion a fraudulent submission, making the misuse of these means of identification “during and in relation to” healthcare fraud. View "United States v. Michael" on Justia Law

Michael, a licensed pharmacist at Chapmanville's Aracoma Pharmacy, separately co-owns another West Virginia pharmacy and one in Pennsylvania. The government suspected that Michael used the pharmacies to distribute on-demand prescription drugs, worth more than $4 million, over the Internet. A grand jury returned a multi-count indictment. Count 7 charged Michael with fraudulently submitting a claim for payment to Humana for dispensing medication that was never dispensed (18 U.S.C. 1347). Count 8 charged him with committing aggravated identity theft by using the “identifying information” of a doctor and a patient “in relation to the [health care fraud] offense” (18 U.S.C. 1028A(a)(1), (c)(11)). Michael had submitted a claim to Humana indicating that A.S. (doctor) had prescribed Lovaza for P.R., including the doctor’s National Provider Identifier and the patient’s name and birth date. A.S. was not P.R.’s doctor and did not issue the prescription. Section 1028A requires a person to “assume the identity” of someone else; the district court held that the statute covered only “impersonation,” and dismissed Count 8. The Sixth Circuit reversed. To “use” a means of identification is to “convert to one’s service” or “employ” the means of identification. Michael used A.S. and P.R.’s identifying information to fashion a fraudulent submission, making the misuse of these means of identification “during and in relation to” healthcare fraud. View "United States v. Michael" on Justia Law

Community, the nation’s largest for-profit hospital system, obtained about 30 percent of its revenue from Medicare reimbursement. Instead of using one of the systems commonly in use for determining whether Medicare patients need in-patient care, Community used its own system, Blue Book, which directed doctors to provide inpatient services for many conditions that other hospitals would treat as outpatient cases. Community paid higher bonuses to doctors who admitted more inpatients and fired doctors who did not meet quotas. Community’s internal audits found that its hospitals were improperly classifying many patients; its Medicare consultant told management that the Blue Book put the company at risk of a fraud suit. Community attempted a hostile takeover of a competitor, Tenet. Tenet publicly disclosed to the SEC, expert analyses and other information suggesting that Community’s profits depended largely on Medicare fraud. Community issued press releases, denying Tenet’s allegations, but ultimately corroborated many of Tenet’s claims. Community’s shareholders sued Community and its CFO and CEO, alleging that the disclosure caused a decline in stock prices. The district court rejected the claim. The Sixth Circuit reversed. The Tenet complaint at least plausibly presents an exception to the general rule that a disclosure in the form of a complaint would be regarded, by the market, as comprising mere allegations rather than truth. The plaintiffs plausibly alleged that the value of Community’s shares fell because of revelations about practices that Community had previously concealed. View "Norfolk County Retirement System v. Community Health Systems, Inc." on Justia Law

Michigan mandates that school-age children be vaccinated before entering the public school system but offers exemptions for certain medical and nonmedical reasons. To get an exemption, a parent must visit a local health department. A devout Catholic, Nikolao, sought a religious waiver for her children. At the mandatory meeting, Wayne County nurses tried to disabuse Nikolao of the notion that her faith prohibited vaccination. The Religious Waiver Note contained a quote falsely attributed to Pope Benedict XVI stating that parents who chose not to vaccinate their children “would be in more proximate cooperation with evil" because of the life-saving nature of vaccines. Nikolao received the waiver. On the compliance form, the nurses wrote that Nikolao objected because she wanted her “child to have natural immunity.” Nikolao wanted the form to report her religious objection . She sued, 42 U.S.C. 1983, alleging violations of the First Amendment. The district court dismissed. The Sixth Circuit affirmed in part and vacated in part. The state is merely voicing its own opinion on religious objections to prevent the outbreak of communicable diseases. This does not constitute excessive entanglement for an Establishment Clause challenge. Nikolao has not presented any facts to suggest that the state has coerced her religious practices and did not suffer an injury-in-fact under the Free Exercise Clause; she did not have standing to pursue that claim. View "Nikolao v. Lyon" on Justia Law

Abilify is approved to treat schizophrenia, Bipolar Disorder, major depressive disorder and irritability associated with autism. There are no disapproved treatments for elderly patients, but the FDA has included a warning since 2007 that Abilify is associated with increased mortality in elderly patients with dementia-related psychosis. Relators, former BMS employees, alleged in a qui tam suit that BMS and Otsuka engaged in a scheme to encourage providers to prescribe Abilify for unapproved (off-label) uses and improperly induced providers to prescribe Abilify in violation of the Anti-Kickback Statute. Nearly identical allegations were leveled against the companies years earlier. In 2007-2008, the companies each entered into an Agreement as part of a settlement of qui tam actions concerning improper promotion of Abilify. Relators allege that, despite those agreements, the companies continued to promote Abilify off-label and offer kickbacks, causing claims for reimbursement for the drug to be submitted to the government, in violation of the False Claims Act (FCA), 31 U.S.C. 3729. The district court dismissed in part. The Sixth Circuit affirmed; the complaint did not satisfy Rule 9(b)’s requirement that relators adequately allege the entire chain to fairly show defendants caused false claims to be filed. As sales representatives, relators did not have personal knowledge of provider’s billing practices.The alleged plan was to increase Abilify prescriptions through improper promotion, which does not amount to conspiracy to violate the FCA. View "Ibanez v. Bristol-Myers Squibb Co." on Justia Law

Federal Medicaid funds are not available for state medical expenditures made on behalf of “any individual who is an inmate of a public institution (except as a patient in a medical institution),” 42 U.S.C. 1396d(a)(29)(A). "Inmate of a public institution" means a person who is living in a public institution. However, an individual living in a public institution is not an “inmate of a public institution” if he resides in the public institution “for a temporary period pending other arrangements appropriate to his needs.” Ohio submitted a proposed plan amendment aimed at exploiting this distinction: it sought to classify pretrial detainees under age 19 as noninmates, living in a public institution for only “a temporary period pending other arrangements appropriate to [their] needs,” for whom the state could claim Medicaid reimbursement. The Centers for Medicare and Medicaid Services rejected the amendment, finding that the inmate exclusion recognizes “no difference” between adults and juveniles, or convicted detainees and those awaiting trial. The Sixth Circuit denied a petition for review, agreeing that the involuntary nature of the stay is the determinative factor. The exception does not apply when the individual is involuntarily residing in a public institution awaiting adjudication of a criminal matter. View "Ohio Department of Medicaid v. Price" on Justia Law

Harold Persaud, M.D., a cardiologist in private practice, was charged with one count of health-care fraud, 18 U.S.C. 1347, 14 counts of making false statements relating to health-care matters, 18 U.S.C. 1035, and one count of money laundering, 18 U.S.C. 1957. The grand jury also returned a forfeiture finding, requiring Persaud to forfeit all property linked to the charges, including $343,634.671 seized from bank accounts associated with Persaud and his wife. At trial, the government presented 34 witnesses, including 11 physicians, eight patients, and four nurses. The defense relied on five witnesses, including an expert cardiologist, two referring physicians, and a coding expert. The jury convicted Persaud on all charges, except for one false-statement count. The jury concluded that the $343,634.67 seized from the Persauds’ bank accounts was forfeitable; the $250,188.42 seized from Persaud’s wife’s account was related to his money-laundering conviction; and Persaud’s scheme generated gross proceeds of $2,100,000. The district court sentenced Persaud to 20 years of imprisonment, a $1,500 special assessment, and restitution of $5,486,857.03, which consists of money damages to be paid to Persaud’s patients, their private insurers, and the government. The Sixth Circuit affirmed. The jury was entitled to accept the view of the government’s experts over those of Persaud’s experts. View "United States v. Persaud" on Justia Law