Articles Posted in Health Law

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Caremark is a pharmacy benefit manager. In 2006, Caremark employees identified approximately 4,500 Prescription Drug Events (PPDEs) under Medicare Part D that had been authorized for payment by Caremark, but not yet submitted to the Centers for Medicare and Medicaid Services (CMS), due to the lack of a compatible Prescriber ID. Caremark then used a dummy Prescriber ID for those PDEs and programmed that dummy Prescriber ID into its system. Thereafter, when any claim with a missing or incorrectly formatted Prescriber ID was processed, the system would default to the dummy, which allowed Caremark to submit for payment PDEs without trigging CMS error codes. Spay, a pharmacy auditor, discovered the use of “dummy” Prescriber IDs while auditing a Caremark client. That client dropped all issues identified in the audit, collected no recovery from Caremark, and did not pay Spay. Spay filed a qui tam lawsuit, asserting violations of the False Claims Act because the inaccurate PDEs were used to support reimbursement requests. The government declined to intervene. The court granted Caremark summary judgment, finding that Caremark had established sufficient government knowledge to preclude finding the required element of scienter, noting that several courts have adopted the government knowledge inference doctrine. The Third Circuit affirmed, declining to adopt that doctrine but stating that the misrepresentations were not material to the government’s decision to pay the underlying claims. View "Spay v. CVS Caremark Corp" on Justia Law

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Horizon Blue Cross Blue Shield provides health insurance products and services to approximately 3.7 million members. Two laptop computers, containing sensitive personal information about members, were stolen from Horizon. Four plaintiffs filed suit on behalf of themselves and other Horizon customers whose personal information was stored on those laptops, alleging willful and negligent violations of the Fair Credit Reporting Act (FCRA), 15 U.S.C. 1681, and numerous violations of state law. The district court dismissed the suit for lack of Article III standing. According to the court, none of the plaintiffs had claimed a cognizable injury because, although their personal information had been stolen, none of them had adequately alleged that the information was actually used to their detriment. The Third Circuit vacated. In light of the congressional decision to create a remedy for the unauthorized transfer of personal information, a violation of FCRA gives rise to an injury sufficient for Article III standing purposes. Even without evidence that the plaintiffs’ information was in fact used improperly, the alleged disclosure of their personal information created a de facto injury. View "In re: Horizon Healthcare Inc. Data Breach Litigation" on Justia Law

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Penn State Hershey Medical Center is a leading academic medical center, with 551 beds and more than 800 physicians. Hershey offers all levels of care, but specializes in more complex, specialized services, unavailable at most other hospitals. Hershey draws patients from a broad area. PinnacleHealth System has three hospital campuses, two in Harrisburg, and another in Mechanicsburg, focusing on cost-effective primary and secondary services, with only a limited range of more complex services. It employs fewer than 300 physicians and provides 646 beds. In 2014, Hershey and Pinnacle signed a letter of intent for a proposed merger. Their respective boards subsequently approved the merger; the Hospitals notified the Federal Trade Commission (FTC), and, in 2015, executed a “Strategic Affiliation Agreement.” The FTC opposed the merger and filed suit under the Clayton Act and the FTC Act. The district court denied a preliminary injunction pending the FTC’s adjudication on the merits, finding that the opponents of the merger did not properly define the relevant geographic market, a necessary prerequisite to determining whether a proposed combination is sufficiently likely to be anticompetitive as to warrant injunctive relief. The Third Circuit reversed after determining the government’s likelihood of success and weighing the equities, finding that a preliminary injunction would be in the public interest. The Hospitals did not rebut the government’s prima facie case that the merger is likely to be anticompetitive. View "Fed. Trade Comm'n v. Penn State Hershey Med. Ctr." on Justia Law

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Deborah is a New Jersey charity hospital. CGPA is a group of New Jersey cardiologists. Because no CGPA physician could perform advanced cardiac interventional procedures (ACI) procedures, in 1992, CGPA and Deborah began a relationship that resulted in the transfer of numerous ACI patients to Deborah. In 2005, the CGPA doctors entered into an exclusive agreement to provide Virtua Hospital with cardiovascular services. Referrals to Deborah dropped off significantly. In 2006, CGPA hired a doctor who had previously worked at Deborah and was capable of performing some ACIs. CGPA terminated its agreement with Deborah. In 2007, CGPA signed agreements with doctors who worked primarily at Penn Presbyterian Hospital. Virtua is not mentioned in those contracts, but Deborah alleges that Virtua was an unnamed participant in negotiations and that the goal was to drive Deborah out of business. Deborah sued, asserting that this arrangement constituted an illegal restraint on trade and resulted in harm to competition, in violation of the Sherman Act. The district court granted Virtua and CGPA summary judgment, holding that Deborah did not introduce sufficient evidence to show injury to competition in the designated market. The Third Circuit affirmed, noting that Deborah identified the “products” and i the market at issue. Virtua did not challenge Deborah’s market definitions in the district court. Having set the parameters for the dispute, Deborah failed to meet its self-imposed burden. View "Deborah Heart & Lung Center v. Virtua Health Inc" on Justia Law

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Morris worked as a coal miner for nearly 35 years, 19 years underground. Morris’s breathing difficulties caused him to leave work. In 2006, Dr. Cohen diagnosed him with pneumoconiosis (black lung disease). Eighty Four Mining’s physician also examined Morris, but determined that Morris’s breathing difficulties were caused by smoking and that there was no radiographic evidence of pneumoconiosis. In 2008, aPennsylvania Workers’ Compensation Judge denied benefits. Morris did not appeal. Morris’s breathing problems worsened; a doctor put him on oxygen nearly full-time. In 2011, Morris sought Black Lung Benefits Act (BLBA), 30 U.S.C. 901, benefits. He did not rely upon the 2006 report that had been discredited, but on a 2011 arterial blood gas study and pulmonary function testing that supported a finding of black lung disease. In 2013, an ALJ granted BLBA benefits, rejecting a timeliness challenge and reasoning that a denial of black lung benefits due to the repudiation of the claimant’s pneumoconiosis diagnosis renders that diagnosis a “misdiagnosis” and resets the three-year limitations period for subsequent claims. Morris sufficiently established the existence of pneumoconiosis through medical evidence obtained after 2010 and Eighty Four failed to adequately explain why Morris’s years of coal dust exposure were not a substantial cause of his impairment. The Benefits Review Board affirmed, citing judicial estoppel as precluding the timeliness argument. The Third Circuit denied a petition for review. View "Eighty Four Mining Co. v. Morris" on Justia Law

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Temporary civil commitment at New Jersey psychiatric hospitals is subject to regular review; patients have the right to counsel, to be present at the hearing, to present evidence, and to cross-examine witnesses. In a challenge to the state’s “Rennie process” for forcible medication, the Third Circuit held, in 1984, that civilly committed psychiatric patients “have a qualified constitutional right to refuse antipsychotic medication” in nonemergency situations and the process accommodated that right consistent with the Due Process Clause. A 2010 challenge alleged that the Rennie process violated the Constitution, the Americans With Disabilities Act, and the Rehabilitation Act, and demanded that the state “provide patients who refuse the non-emergency administration of psychotropic medication with meaningful due process protections—including legal counsel, notice and a hearing before a judicial decision-maker.” The state replaced the Rennie process with policies for forcible treatment in emergencies (AB 5:04A), which were not challenged, and nonemergent situations (AB 5:04B). The nonemergency policy permits longer-term forcible medication of a patient, involuntarily committed, who, as a result of a diagnosed mental illness, poses a substantial risk of serious harm to self, others, or property “within the reasonably foreseeable future” if psychotropic medication is not administered. Patients who satisfy the substantive requirements may be forcibly medicated only pursuant to procedures that stop short of prior judicial review. The Third Circuit affirmed that AB 5:04B is valid, except as to patients who have been not to require continued commitment but who remain in custody pending transfer. View "Disability Rights N.J., Inc. v. Comm'r N.J. Dep't of Human Servs." on Justia Law

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Hospitals that are disadvantaged by their geographic location may reclassify to a different wage index area for certain Medicare reimbursement purposes by applying for redesignation to the Medicare Geographic Classification Review Board. Section 401 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, enacted 10 years after the Board was established, creates a separate mechanism by which qualifying hospitals located in urban areas “shall [be] treat[ed] . . . [as] rural” for the same reimbursement purposes. To avoid possible strategic maneuvering by hospitals, the U.S. Department of Health and Human Services issued a regulation providing that hospitals with Section 401 status cannot receive additional reclassification by the Board on the basis of that status, 42 C.F.R. 412.230(a)(5)(iii) (Reclassification Rule). Geisinger, a hospital located in an urban area, received rural designation under Section 401 but was unable to obtain further reclassification by the Board pursuant to the Reclassification Rule. Geisinger sued. The district court upheld the regulation. The Third Circuit reversed, finding that Section 401 is unambiguous: HHS shall treat Section 401 hospitals as rural for Board reclassification purposes, 42 U.S.C. 1395ww(d)(8)(E)(i) View "Geisinger Cmty. Med. Ctr. v. Sec'y United States Dep't of Health & Human Servs." on Justia Law

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Hansler was hired by Lehigh Valley in 2011. In 2013, Hansler began experiencing shortness of breath, nausea, and vomiting, of unknown origins. Hansler’s physician completed a medical certification form “requesting intermittent leave at a frequency of 2 times weekly starting on March 1, 2013 and lasting for a probable duration of one month.” Hansler submitted the certification as part of a formal request for leave under the Family Medical Leave Act, 29 U.S.C. 2601. Hansler was unable to work on March 13, 14, 23, 24, and 25. Without seeking further information from either Hansler or her physician, Lehigh terminated Hansler on March 28, citing absenteeism, including the five days she took off in March. Lehigh informed her, for the first time, that her leave request had been denied because her “condition presently does not qualify as a serious health condition under the criteria set forth by the [Act].” After her dismissal, Hansler received a diagnosis of diabetes and high blood pressure. The district court dismissed her suit under the Act, on the basis that the medical certification supporting Hansler’s request for leave was “invalid.” The Third Circuit reversed, finding that Lehigh violated the Act in failing to afford Hansler a chance to cure any deficiencies in her medical certification. View "Hansler v. Lehigh Valley Hosp. Network" on Justia Law

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Kolodesh owned a home-health services company. He approached his employee, Pugman, about starting a home-based hospice care company. Pugman's agreed. Kolodesh funded the new company, Home Care Hospice. Pugman managed the operations. Kolodesh’s wife and Pugman were listed as owning equal shares; Kolodesh was intimately involved in forming and overseeing its management. In 2000 or 2001, Kolodesh, Pugman, and Pugman's wife began giving gifts and cash “kickbacks” to doctors in exchange for patient referrals. At Kolodesh’s suggestion, Pugman placed doctors or their employees on the Hospice payroll with sham job titles and issued paychecks in exchange for patient referrals. About 90% of the revenue generated by Hospice came from Medicare reimbursements. Kolodesh and Pugman had contractors submit fake invoices Hospice would pay; the contractor would give most of the money to Kolodesh and Pugman, keeping a portion. The participants were charged with conspiracy to defraud a health care benefit program, 18 U.S.C. 1349, 21 counts of health-care fraud, 18 U.S.C. 1347, two counts of mail fraud, 18 U.S.C. 1341, and 11 counts of money laundering, 18 U.S.C. 1957. Pugman testified for the government after having pled guilty. The Third Circuit affirmed Kolodesh's sentence of 176 months’ imprisonment and a restitution order of $16.2 million. View "United States v. Kolodesh" on Justia Law

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Babaria, a licensed radiologist and medical director and manager of Orange Community MRI, an authorized Medicare and Medicaid provider, pleaded guilty to one count of making illegal payments (kickbacks), 42 U.S.C. 1320a-7b(b)(2)(A). From 2008 through 2011, he paid physicians to refer patients to Orange for diagnostic testing and billed Medicare and Medicaid for testing that was tainted by the corrupt referrals. Orange received $2,014,600.85 in payments that were directly traceable to the kickback scheme. There was no evidence that Babaria falsified patient records, billed Medicare or Medicaid for testing that was not medically necessary, or otherwise compromised patient care. Babaria objected to the PreSentence Investigation Report, which recommended a two-level adjustment for abuse of a position of trust (USSG 3B1.3) and a four-level adjustment for aggravating role (USSG 3B1.1(a)), resulting in a recommended Guidelines range of 70-87 months’ imprisonment. Ultimately, the Guidelines range was 60 months, capped by the statutory maximum for Babaria’s count of conviction. He argued that the correct range was 37 to 46 months. The court applied both adjustments but granted a downward variance and sentenced Babaria to 46 months’ imprisonment, a fine of $25,000, and forfeiture of the $2,014,600.85. The Third Circuit affirmed the sentence. View "United States v. Babaria" on Justia Law