Health Law Informer

On January 10, 2013, President Obama signed into law H.R. 1845, which includes the Strengthening Medicare and Repaying Taxpayers Act of 2011 (SMART Act).[1] The SMART Act,  amends several portions of the Medicare Secondary Payer (MSP) Act that apply to non-group health plans, including liability (including self-insurance) and no-fault insurance and workers’ compensation plans (together, NGHPs).  Although the SMART Act makes significant substantive and procedural amendments to the MSP Act, many practical issues will continue to bedevil parties who are trying to settle a personal injury claim. Continue reading…

Since the implementation of the privacy and security regulations of the Health Insurance Portability and Accountability Act (“HIPAA”) in 2003 and 2005 respectively, business associates (“BAs”) – those entities that perform services for or on behalf of covered entities – had been a weak link in the overall protection of protected health information (“PHI”).   BAs were not directly subject to HIPAA, but were only indirectly subject to its requirements through the business associate agreements – which were generally boilerplate – that covered entities were required to maintain as a condition of sharing PHI.  Thus, under the original regulatory structure, the only risk for a BA was for a breach of contract. Continue reading…

As its title makes clear, the August 2012 report “Questionable Billing by Community Mental Health Centers” (the Report) by the U.S. Department of Health and Human Services Office of Inspector General (OIG) demonstrates its significant concern with fraud, waste, and abuse in Medicare payments for mental health services.  The OIG’s key findings include that in 2010, about 50% of community mental health centers (CMHCs) exhibited unusually high billing for at least one of nine so-called “questionable billing characteristics” in seeking reimbursement for partial hospitalization program (PHP) services; about 33% exhibited at least two of these characteristics.  Continue reading…

President Obama recently signed a bipartisan bill that authorizes Food and Drug Administration (“FDA” or “Agency”) user fees for five more years and establishes new user fees for the FDA’s review of generic drugs and biosimilar products.[1]  The bill reauthorizes the Prescription Drug User Fee Act (“PDUFA” or the “Act”), a law originally passed by Congress in 1992.  PDUFA permits the FDA to collect user fees from drug manufacturers to fund, among other FDA endeavors, new drug and medical device approval.  The most recent reauthorization of the bipartisan bill, which increases the amount of money drug and device manufacturers must pay the FDA to review a new drug or device application, has gained the support of both Congress and the pharmaceutical industry.

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In a heavily anticipated landmark ruling, the Supreme Court has upheld the constitutionality of the so-called “individual mandate” of the Affordable Care Act – i.e., the requirement that those not insured privately, through their employer or through a governmental program, must either purchase minimum essential health insurance coverage or pay a “penalty” for failing to do so.  The majority opinion was authored by Chief Justice Roberts and joined in part by Justices Breyer, Ginsburg, Kagan and Sotomayor. Continue reading…