Articles Posted in Health Law

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A.M. received a human papillomavirus vaccine in 2007. Shortly thereafter, she developed autoimmune limbic encephalitis and an intractable seizure disorder, resulting in cognitive impairment. Her mother (McCulloch) sought compensation under the Vaccine Act, 42 U.S.C. 300aa. A special master awarded compensation for A.M.’s injury and accepted the parties' agreement on the amounts and mechanisms of compensation. Neither party sought review. Months later McCulloch sought an award of attorneys’ fees and costs under section 300aa15(e)(1). A special master awarded fees and costs and included amounts to cover the expenses, under Florida guardianship law, of maintaining the guardianship for A.M,-- a required condition for receiving the full payments under the merits judgment. The Claims Court upheld inclusion of those amounts, but cited section 300aa-15(a), the provision governing merits awards of compensation, instead of 300aa-15(e), the fees/costs provision on which the special master relied. The Federal Circuit affirmed while acknowledging that the Claims Court improperly reopened a final merits judgment by awarding money under section 300aa-15(a). Nonetheless, it was appropriate for the special master to award guardianship-maintenance expenses under that section because McCulloch incurred a continuing liability to pay such expenses as a condition of receiving, for her daughter, the compensation awarded on the merits in this proceeding. View "McCulloch v. Secretary of Health and Human Services" on Justia Law

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Procopio served aboard the U.S.S. Intrepid in 1964-1967. In July 1966, the Intrepid was deployed in the waters offshore the landmass of the Republic of Vietnam, including its territorial sea. Procopio sought entitlement to service connection for diabetes mellitus in 2006 and for prostate cancer in 2007 but was denied service connection for both in 2009. The Federal Circuit reversed, holding that the unambiguous language of the Agent Orange Act, 38 U.S.C. 1116, entitles Procopio to a presumption of service connection for his prostate cancer and diabetes mellitus. The term “in the Republic of Vietnam,” unambiguously includes the territorial sea under all available international law. Congress indicated those who served in the 12 nautical mile territorial sea of the “Republic of Vietnam” are entitled to section 1116’s presumption if they meet the section’s other requirements. View "Procopio v. Wilkie" on Justia Law

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In April 2009, E.O. visited a pediatrician for his six-month visit and received several vaccinations. That night, Mrs. Oliver found E.O. seizing in his bed and called 9-1-1. At the emergency room, E.O. presented with a fever, red eyes with discharge, and a runny nose. The next day, E.O.’s pediatrician diagnosed E.O. with “complex febrile seizure and conjunctivitis.” E.O. did not have any health issues or seizures for two months but had several seizures over the summer and began to experience prolonged seizures in March 2010. Each seizure resulted in an emergency room visit. A pediatric neurologist diagnosed E.O. with an SCN1A gene defect. E.O. exhibited developmental delay. A pediatric neurologist performed examinations, which demonstrated “intractable, symptomatic childhood absence and complex partial seizures of independent hemisphere origin secondary to SCN1A gene defect (borderline SMEI syndrome) and encephalopathy characterized by speech delay.” E.O.’s family sought compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-2–300aa-33, alleging that E.O. developed Dravet syndrome as a result of the vaccinations. The Claims Court and Federal Circuit affirmed the rejection of their claim. The government’s expert provided strong evidence that Dravet syndrome will develop in children with the SCN[1]A mutation, whether or not they receive vaccinations; the Olivers failed to establish that their theory has garnered widespread acceptance, as evidenced by an extensive discussion of articles with contradictory findings. View "Oliver v. Secretary of Health and Human Services" on Justia Law

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A three-year “risk corridors” program described in the Patient Protection and Affordable Care Act, 42 U.S.C. 18001, implemented by the Department of Health and Human Services (HHS), was intended to promote participation in insurance exchanges. Participating insurers, whose costs of providing coverage exceeded the premiums received (using a statutory formula) were to be paid a share of their excess costs while participating plans whose premiums exceeded their costs would pay in a share of their profits. The program “permit[ted] issuers to lower [premiums] by not adding a risk premium" for uncertainties in the 2014-2016 markets. The actual total "payments in"were less than requested "payments out" and Congress prohibited HHS from using its appropriations for the program. Prorated payments were issued. The insurer filed suit. The Federal Circuit affirmed summary judgment in favor of the government. The statute created an obligation of the government to pay exchange participants the amount indicated by the statutory formula but riders in the FY 2015 and 2016 appropriations bills repealed or suspended the obligation to make payments out in an aggregate amount exceeding payments in. Congress made the policy choice to cap payments. No statement or action by the government evinced an intention to form a contract; the risk corridors program was simply an incentive program. Because there was no contract, the insurer’s “takings” claim also failed. View "Land of Lincoln Mutual Health Insurance Co. v. United States" on Justia Law

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A three-year “risk corridors” program described in the Patient Protection and Affordable Care Act, 42 U.S.C. 18001, implemented by the Department of Health and Human Services (HHS), was intended to promote participation in insurance exchanges. Participating insurers, whose costs of providing coverage exceeded the premiums received (using a statutory formula) were to be paid a share of their excess costs while participating plans whose premiums exceeded their costs would pay in a share of their profits. The program “permit[ted] issuers to lower [premiums] by not adding a risk premium" for uncertainties in the 2014-2016 markets. The actual total "payments in"were less than requested "payments out" and Congress prohibited HHS from using its appropriations for the program. Prorated payments were issued. Moda filed suit. The Claims Court granted Moda partial summary judgment as to liability, stipulated to be $209,830,445.79. Dozens of other insurers filed actions, with mixed results. The Federal Circuit reversed. The statute created an obligation of the government to pay exchange participants the amount indicated by the statutory formula but riders in the FY 2015 and 2016 appropriations bills repealed or suspended the obligation to make payments out in an aggregate amount exceeding payments in. Congress made the policy choice to cap payments. No statement by the government evinced an intention to form a contract; the statute, its regulations, and HHS’s conduct simply created an incentive program. View "Moda Health Plan, Inc. v. United States" on Justia Law

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A three-year “risk corridors” program described in the Patient Protection and Affordable Care Act, 42 U.S.C. 18001, implemented by the Department of Health and Human Services (HHS), was intended to promote participation in insurance exchanges. Participating insurers, whose costs of providing coverage exceeded the premiums received (using a statutory formula) were to be paid a share of their excess costs while participating plans whose premiums exceeded their costs would pay in a share of their profits. The program “permit[ted] issuers to lower [premiums] by not adding a risk premium" for uncertainties in the 2014-2016 markets. The actual total "payments in"were less than requested "payments out" and Congress prohibited HHS from using its appropriations for the program. Prorated payments were issued. Moda filed suit. The Claims Court granted Moda partial summary judgment as to liability, stipulated to be $209,830,445.79. Dozens of other insurers filed actions, with mixed results. The Federal Circuit reversed. The statute created an obligation of the government to pay exchange participants the amount indicated by the statutory formula but riders in the FY 2015 and 2016 appropriations bills repealed or suspended the obligation to make payments out in an aggregate amount exceeding payments in. Congress made the policy choice to cap payments. No statement by the government evinced an intention to form a contract; the statute, its regulations, and HHS’s conduct simply created an incentive program. View "Moda Health Plan, Inc. v. United States" on Justia Law

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TRICARE provides current and former members of the military and their dependents' medical and dental care. Hospitals that provide TRICARE services are reimbursed under Department of Defense (DoD) guidelines. TRICARE previously did not require, DoD to use Medicare reimbursement rules. A 2001 amendment, 10 U.S.C. 1079(j)(2), required TRICARE to use those rules to the extent practicable. DoD regulations noted the complexities of the transition process and the lack of comparable cost report data and stated “it is not practicable” to “adopt Medicare OPPS for hospital outpatient services at this time.” A study, conducted after hospitals complained, determined that DoD underpaid for outpatient radiology but correctly reimbursed other outpatient services. TRICARE created a process for review of radiology payments. Each plaintiff-hospital requested a discretionary payment, which required them to release “all claims . . . known or unknown” related to TRICARE payments. Several refused to sign the release and did not receive any payments. Although it discovered calculation errors with respect to hospitals represented by counsel, TRICARE did not recalculate payments for any hospitals that did not contest their discretionary payment offer. The Claims Court dismissed the hospitals’ suit. The Federal Circuit reversed in part, finding that they may bring a claim for breach of contract but may not bring money-mandating claims under 10 U.S.C. 1079(j)(2) and 32 C.F.R. 199.7(h)(2) because the government’s interpretation of the statute was reasonable. View "Ingham Regional Medical Center v. United States" on Justia Law

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Goodman served in the U.S. Army, 1972-1992, with service in Southwest Asia during the Persian Gulf War. During his service and at his discharge, Goodman underwent medical examinations that returned negative for rheumatoid arthritis; he denied having pain in his joints or arthritis. In 2007, Goodman sought treatment at a VA medical center for hand stiffness and knee pain, which he said had begun during service. He sought VA benefits for rheumatoid arthritis. The Board sought an independent medical advisory opinion from the Veterans Health Administration, which was conducted by a VA medical center Director of Rheumatology in 2014 and concluded that “it is less likely than not” that Goodman’s rheumatoid arthritis can be characterized as a medically unexplained chronic multi-symptom illness (MUCMI) under 38 C.F.R. 3.317, and that it “is less likely than not that his rheumatoid arthritis is related to a specific exposure event experienced … during service. The Board concluded that Goodman was not entitled to a presumptive service connection for a MUCMI; the Federal Circuit affirmed. The VA adjudicator may consider evidence of medical expert opinions and all other facts of record to make the final determination of whether a claimant has proven, based on the claimant’s unique symptoms, the existence of a MUCMI. View "Goodman v. Shulkin" on Justia Law

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Prime Hospitals provide inpatient services under the Medicare program, submitting payment claims to private contractors, who make initial reimbursement determinations. Prime alleged that many short-stay claims were subject to post-payment review and denied. Prime appealed through the Medicare appeal process. Prime alleged short-stay claims audits were part of a larger initiative that substantially increased claim denials and that the Center for Medicare & Medicaid Services (CMS) was overwhelmed by the number of appeals. CMS began offering partial payment (68 percent) in exchange for dismissal of appeals. Prime alleged that it executed CMS's administrative settlement agreement so that CMS was contractually required to pay their 5,079 Medicare appeals ($23,205,245). CMS ultimately refused to allow the Prime to participate because it was aware of ongoing False Claims Act cases or investigations involving the facilities. Prime alleged that the settlement agreement did not authorize that exclusion. The district court denied a motion to dismiss Prime’s suit but transferred it to the Court of Federal Claims. The Federal Circuit affirmed in part. The breach of contract claim is fundamentally a suit to enforce a contract and does not arise under the Medicare Act, so the Claims Court has exclusive jurisdiction under the Tucker Act, 28 U.S.C. 1491. That court does not have jurisdiction, however, over Prime’s alternative claims seeking declaratory, injunctive, and mandamus relief from an alleged secret and illegal policy to prevent and delay Prime from exhausting administrative remedies. View "Alvarado Hospital, LLC v. Cochran" on Justia Law

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In 2003, following a physical examination, Contreras, 13 years old, received the Tetanus-Diphtheria and Hepatitis B vaccines. About 24 hours later, he was diagnosed with atypical Guillain-Barre Syndrome (GBS), a peripheral nervous system disease that causes descending paralysis. Three months later, Contreras was discharged from the hospital with a diagnosis of Transverse Myelitis (TM), an inflammatory disease of the spinal cord. His petition for compensation under the Vaccine Act, accompanied by an expert report indicating that he developed both conditions as a result of the vaccines, was denied, on the basis that the time interval between the administration of Contreras’s vaccines and the onset of TM was too short to establish causation. Contreras submitted the expert report of pediatric neurologist concerning his rapid adverse immunological response. In 2012, a Special Master concluded that Contreras failed to establish that the TM arose within a “medically appropriate” timeframe. Following a remand from the Claims Court, the government disclosed that the medical license of its expert (Sladsky) was suspended during the time that he had provided witness services in this case. The Special Master again denied compensation, stating that Sladky’s opinion “retain[ed] some value” and that Contreras did not suffer from GBS—a violation of the court’s instruction to refrain from diagnosing Contreras. The Claims Court again remanded, with instructions to address Sladky’s credibility in light of his misrepresentations and to issue an alternative ruling that disregards Sladky’s testimony. The Special Master denied compensation. The Claims Court denied review based on the time interval. The Federal Circuit vacated. The Special Master improperly diagnosed Contreras and failed to consider evidence relevant to his GBS. View "Contreras v. Secretary of Health & Human Services" on Justia Law