Justia Government Contracts Opinion Summaries

Articles Posted in Health Law
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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

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Hartgrove, a psychiatric hospital, is enrolled with the Illinois Department of Healthcare and Family Services to receive Medicaid reimbursement. Hartgrove agreed to comply with all federal and state laws and “to be fully liable for the truth, accuracy and completeness of all claims submitted.” Upon receipt of Medicaid reimbursements, Hartgrove is required to certify that the services identified in the billing information were actually provided. On 13 occasions in 2011, adolescent patients suffering from acute mental illness were placed in a group therapy room, rather than patient rooms, sleeping on roll-out beds until patient rooms were available. Hartgrove submitted Medicaid claims for inpatient care for those patients. Bellevue, a Hartgrove nursing counselor until 2014, voluntarily provided the information on which his allegations are based to federal and state authorities, then filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729, and the Illinois False Claims Act. Both declined to intervene. The district court dismissed and denied Bellevue’s motion to reconsider in light of the Supreme Court’s 2016 “Universal Health” holding that an implied false certification theory is a viable basis for FCA liability. The Seventh Circuit affirmed. Bellevue’s allegations fall within the FCA's public‐disclosure bar; the information was available in audit reports and letters. View "Bellevue v. Universal Health Services of Hartgrove, Inc." on Justia Law

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Plaintiffs purchased Illinois nursing homes and obtained new state licenses and federal Medicare provider numbers. Most of the residents in the 10 homes qualify for Medicaid assistance. The Illinois Department of Healthcare and Family Services (IDHFS) administers Medicaid funds under 42 U.S.C. 1396-1396w-5, reimbursing nursing homes for Medicaid-eligible expenses on a per diem basis. The rate must be calculated annually based on the facility's costs. When ownership of a home changes, state law requires IDHFS to calculate a new rate based on the new owner’s report of costs during at least the first six months of operation. The Medicaid Act requires states to use a public process, with notice and an opportunity to comment, in determining payment rates. The owners allege that IDHFS failed to: recalculate their reimbursement rates; provide an adequate notice-and-comment process; and comply with the state plan, costing them $12 million in unreimbursed costs. The Seventh Circuit affirmed denial of a motion to dismiss. Section 1396a(a)(13)(A) confers a right that is presumably enforceable under 42 U.S.C. 1983; it benefits the owners and is not so amorphous that its enforcement would strain judicial competence. While the Eleventh Amendment may bar some of the requested relief, if it appears that owners have been underpaid, that does not deprive the court of jurisdiction over the case as a whole. View "BT Bourbonnais Care, LLC v. Norwood" on Justia Law

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Parrino worked as a pharmacist for NRS. He was responsible for preparing medications, mainly inhalers. After leaving NRS, Parrino was contacted by the FDA and FBI, which were investigating reports that NRS was filling prescription medications for Pulmicort, a steroid used for the treatment of asthma, with a sub-potent amount of the active ingredient. Parrino cooperated and pleaded guilty to introducing misbranded drugs into interstate commerce, 21 U.S.C. 331(a), 352(a), and 18 U.S.C. 2, a strict liability misdemeanor. Parrino was sentenced to one year of probation and ordered to pay $14,098.24 in restitution for Medicaid and Medicare payments. The Department of Health and Human Services notified Parrino that it was required to exclude him from participation in any capacity in the Medicare, Medicaid, and all federal healthcare programs for at least five years, under 42 U.S.C. 1320a-7(a). Rejecting Parrino’s argument that he lacked any mens rea to commit a crime and was convicted of a strict liability misdemeanor, an ALJ and the Appeals Board upheld HHS’s decision. The Sixth Circuit affirmed dismissal of Parrino’s suit, finding that HHS’s action affected no substantive due process right because “health care providers are not the intended beneficiaries of the federal health care programs” and that the decision to exclude Parrino was “not so shocking as to shake the foundations of this country.” View "Parrino v. Price" on Justia Law

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Critical Access Hospitals are reimbursed by Medicare for the reasonable and necessary costs of providing services to Medicare patients. The Medicaid program requires states to provide additional (DSH) payments to hospitals that serve a disproportionate share of low-income patients, 42 U.S.C. 1396a(a)(13)(A)(iv). In Kentucky, DSH payments are matched at 70% by the federal government. Kentucky’s contribution to DSH programs comes from payments from state university hospitals and Kentucky Provider Tax, a 2.5% tax on the revenue of various hospitals, including Appellants, The amount of DSH payments a hospital receives is unrelated to the amount of KP-Tax it paid. During the years at issue, DSH payments covered only 45% of Appellants' costs in providing indigent care. Appellants filed cost reports in 2009 and 2010 claiming their entire KP-Tax payment as a reasonable cost for Medicare reimbursement. Previously, they had received full reimbursement; for 2009 and 2010, however, the Medicare Administrative Contractor denied full reimbursement, offsetting the KP-Tax by the amount of DSH payments Appellants received. The Provider Reimbursement Review Board and Centers for Medicare and Medicaid Services upheld the decision. The Sixth Circuit affirmed, reasoning that the net economic impact of Appellants’ receipt of the DSH payment in relation to the cost of the KP-Tax assessment indicated that the DSH payments reduced Appellants’ expenses such that they constituted a refund. View "Breckinridge Health, Inc. v. Price" on Justia Law

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Plaintiff filed a qui tam suit under the False Claims Act (FCA), 31 U.S.C. 3729-3733, and the state equivalents, alleging that Manor Care was overbilling the government for medical services. Plaintiff also alleged a separate claim of retaliation, claiming that he was terminated after he notified his employer of the alleged overbilling. Christine A. Ribik had previously filed a qui tam suit under seal in the Eastern District of Virginia on behalf of the United States against Manor Care. The court dismissed the complaint under the FCA's first-to-file rule. The court concluded that plaintiff has not managed to avoid the first-to-file bar simply by alleging additional facts relating to how Manor Care overbilled, even though some of those specific allegations were not mentioned in Ribik's complaint. The court also concluded that plaintiff's alternative argument, that his complaint should not be dismissed because the district court consolidated them with Ribik's, failed under the plain language of the FCA. Therefore, the district court properly determined that it lacked subject matter jurisdiction over plaintiff's qui tam action under the FCA. The court concluded, however, that the first-to-file rule has no relation to a claim for retaliation. Finally, the court concluded that the district court did not support its decision with any discussion or authority to establish that any of the states apply the FCA first-to-file rule, or its equivalent, to that state's statute. Therefore, the court affirmed in part, but vacated and remanded that part of the judgment concerning plaintiff's retaliation and state fraud claims. View "US ex rel. Carson v. Manor Care, Inc." on Justia Law

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In 1973, two Kalamazoo, Michigan hospitals formed a consortium to manage their health education programs and to train interns and residents. In the 1980s, they joined Michigan State University to form the Michigan State University Kalamazoo Center for Medical Studies (KCMS). KCMS administered graduate medical programs for residency programs for the hospitals. The hospitals agreed to incur “joint and equal responsibility for providing [KCMS] with sufficient financing to carry out its programs as negotiated on a yearly basis.” KCMS also received patient-care revenue, support from Michigan State University, and funds from contracts and grants. The hospitals sought reimbursement on their Medicare cost reports (42 U.S.C. 1395ww(h)) during fiscal years 2000–2004 for costs incurred for residents’ training at KCMS’s nonhospital clinics. The Centers for Medicare and Medicaid Services found that the hospitals failed to show they incurred all or substantially all of the costs of their residency programs and that they failed to comply with a requirement of a written agreement detailing the financing of their offsite programs. The district court and D.C. Circuit affirmed the denials of reimbursement, rejecting an argument that the “written agreement” requirement was satisfied by a collection of documents executed over the years. None of the documents met the regulatory criteria. View "Borgess Medical Center v. Burwell" on Justia Law

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Brookdale Senior Living hired Prather to review documentation related to thousands of Brookdale residents who had received home-health services from Brookdale. Medicare claims regarding those patients were on hold and Brookdale faced possible recoupment of payments it had received if it did not review and submit final Medicare claims. Prather noticed that the required certifications stating that the doctor had decided that the patient needed home-health services, established a plan of care, and met with the patient, were signed long after care was provided. Prather repeatedly raised this issue, but was rebuffed. Brookdale, facing financial disaster, began paying doctors to complete the paperwork months after treatment was provided. Prather thought that Brookdale was not just asking treating physicians to complete forgotten paperwork, but had provided the services without physician involvement and then found doctors willing to validate the care after-the-fact. Prather's suit under the False Claims Act, 31 U.S.C. 3729, was dismissed. The Sixth Circuit reversed as to unlawful retention of payments. Completing certifications months after the fact was not “as soon as possible” after the plan was established, as required by regulations. Prather provided a detailed description of the alleged fraudulent scheme and her personal knowledge. Affirming dismissal of her false-records claim, the court concluded that Prather failed to plead with particularity the use of government forms to certify falsely that care had been provided under a doctor’s orders, or that unnecessary care had been provided. View "Prather v. Brookdale Senior Living Communities, Inc." on Justia Law

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Relator filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729-33, alleging that his former employer, AAKC, violated the FCA by submitting claims for Medicare reimbursement of anesthesia services at the “Medical Direction” rate. Relator alleged that, because AAKC anesthesiologists were not present in the operating room during patients’ “emergence” from anesthesia, and therefore AAKC did not comply with the Medicare conditions of payment for submitting such claims. The district court granted AAKC summary judgment. The court granted the United States leave to appear as amicus curiae supporting neither party. The court concluded that, because the agency had not clarified an obvious ambiguity in its Step Three regulation for decades, AAKC’s failure to obtain a legal opinion or prior CMS approval cannot support a finding of recklessness. The court also concluded that the district court did not abuse its discretion in refusing to consider a new theory first articulated in relator's summary judgment papers. Finally, the court rejected relator's claim that AAKC violated 42 C.F.R. 415.110(b). Accordingly, the court affirmed the judgment. View "Donegan v. Anesthesia Assoc." on Justia Law

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Relator brought a qui tam action (False Claims Act, 31 U.S.C. 3730(b)), alleging KHN (network of hospitals, physicians, and healthcare facilities) falsely certified its compliance with the Health Information Technology for Economic and Clinical Health Act (HITECH), 123 Stat. 226 (2009), to receive “meaningful use” incentive payments. HITECH was designed to encourage the adoption of sophisticated electronic health record technology and creates incentive payments for “meaningful use” of certified technology, 42 U.S.C. 1395. To receive incentive payments, providers must meet meaningful-use objectives and accompanying compliance measures. Stage 1 of Act implementation required a security risk analysis in accordance with 45 C.F.R. 164.308(a)(1); implementation of need security updates; and correction of identified security deficiencies. During Stage 2, providers are required to address[] the encryption/security of data stored in Certified EHR Technology in accordance with 45 C.F.R. 164.312(a)(2)(iv) and 164.306(d)(3). To receive incentive payments, providers must attest to meeting these standards. The Sixth Circuit affirmed dismissal, finding that Relator failed to plausibly allege that KHN’s attestation of HITECH compliance was false and failed to plead a specific claim for payment; and that Relator’s claims were precluded by a prior Ohio state judgment in a case involving similar claims filed by Relator against KHN. View "United States v. Kettering Health Network" on Justia Law