Articles Posted in Health 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participants the amount indicated by the statutory formula but riders in the FY 2015 and 2016 appropriations bills repealed or suspended the obligation to make payments out in an aggregate amount exceeding payments in.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

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Eilise was born in 1996 and had problems with gross motor skills and language development. After therapy, Eilise showed dramatic improvement. In 2001, Eilise received three vaccinations, including her second dose of the measles, mumps, and rubella vaccine. Five days later, Eilise’s brother witnessed her arching her back, thrusting her head back, rolling her eyes, and jerking. He did not know what was happening. Her parents, who did not witness the seizure, noted that Eilise was feverish and lethargic. Eilise had a grand mal seizure at school. She was taken to a hospital. She had another seizure there. Eilise’s MRI results were generally normal, but her EEG results were “consistent with a clinical diagnosis of epilepsy.” She continued to suffer seizures until she started a ketogenic diet. Her parents filed suit under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. 300aa, alleging that Eilise suffered from autism as a result of her vaccinations; they later amended to allege, instead, that Eilise suffered from a “seizure disorder and encephalopathy.” The Claims Court affirmed denial of her petition. The Federal Circuit vacated: in certain cases, a petitioner can prove a logical sequence of cause and effect between a vaccination and the injury with a physician’s opinion where the petitioner has proved that the vaccination can cause the injury and that the vaccination and injury have a close temporal proximity. View "Moriarty v. Sec'y of Health & Human Servs." on Justia Law

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Systemic juvenile idiopathic arthritis (SJIA), an autoinflammatory disease, has symptoms including arthritis, fever, rash, and muscle and joint pain, caused by dysfunctional production of proteins, which cells release almost immediately after contact with an antigen. Gardasil, a vaccine against HPV administered in three doses, contains virus-like particles created from an HPV protein, and an adjuvant to generate a robust immune response. Vanessia, born in 1995, was healthy until 2008. After receiving two doses of Gardasil, she experienced an all-over rash. Days later, she had joint pain and high fever. The hospital discharged her with a presumptive diagnosis of SJIA. Vanessia’s family history included SJIA. Her rheumatologist communicated these findings to the doctor who administered Vanessia’s third dose of Gardasil on August 19. Vanessia experienced a SJIA flare on August 25. Vanessia’s Vaccine Act injury claim was rejected. Injuries that do not appear on the Vaccine Injury Table, 42 C.F.R. 100.3, require proof of a medical theory causally connecting the vaccination to the injury; a logical sequence of cause and effect; and proximate temporal relationship between the vaccine and injury. The Claims Court and Federal Circuit affirmed, finding that the claim did not meet the burden of demonstrating proximate temporal relationship. View "Koehn v. Sec'y of Health & Human Servs." on Justia Law

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Gilbert served in the Navy. His reported medical history upon entry into service revealed no psychiatric defects. After leaving service, Gilbert was diagnosed with major depression and required treatment for psychiatric illness and alcohol dependence. Gilbert acknowledged that he experienced depressive episodes and suicidal ideation throughout his life, that he has been abusing drugs and alcohol since he was a teenager, and that he continued to abuse alcohol while in the Navy. Gilbert sought compensation for psychiatric disability and other conditions with the VA. Multiple psychiatric examinations produced conflicting opinions. The VA denied service connection; the Board affirmed. The statutory “[p]resumption of sound condition” was applicable because no psychiatric condition was noted upon entry into service, 38 U.S.C. 1111; to rebut the presumption, the government had to provide clear and unmistakable evidence demonstrating that the disease existed before enrollment and was not aggravated by service. Based on Gilbert’s acknowledged history, the Board concluded that the government proved that his psychiatric illness pre-existed enrollment, but that the government failed to establish that Gilbert’s “pre-existing depression was not aggravated by active service,” and did not rebut the presumption of soundness. The Board nevertheless denied service connection, concluding that Gilbert failed to prove that his post-service psychiatric conditions “were correlated to [his] military experiences.” The Veterans Court and Federal Circuit affirmed. View "Gilbert v. Shinseki" on Justia Law