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30 Jul 2015 2nd Circuit Upholds Connecticut State Dental Commission “Economic Protectionism”

On July 17, 2015, the United States Court of Appeals for the 2nd Circuit affirmed a district court decision that the Connecticut State Dental Commission did not violate the Equal Protection and Due Process Clauses of the federal Constitution when it promulgated a regulation that only licensed dentists may use a light emitting diode (LED) procedure for teeth whitening.   The plaintiff in Sensational Smiles v. Mullen, 2015 WL 4385295, was a non-dentist owned company that provided the LED teeth whitening procedure. It argued that…

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14 Jul 2015 HIPAA SETTLEMENT – IMPROPER STORAGE OF EPHI

On July 10, 2015, the Office for Civil Rights (OCR) announced a HIPAA settlement with St. Elizabeth’s Medical Center (SEMC), a tertiary care hospital in Brighton, Massachusetts. SEMC has agreed to pay $218,400 and adopt a robust corrective action plan.   The settlement is the result of two alleged violations. First, SEMC workforce members filed a complaint of a HIPAA violation with the OCR in late 2012, alleging that workforce members used an internet-based document sharing application to store documents that contained the electronic protected…

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01 Jul 2015 Antitrust Enforcement for Market Allocation by Michigan Hospitals

On June 25, 2015, the United States Department of Justice (DOJ) and the Michigan Attorney General (Michigan AG) sued four Michigan hospital systems for entering into agreements with a competitor to unlawfully allocate territories for the marketing of competing healthcare services and to limit competition between them. The Michigan hospital systems include Hillsdale Community Health Center (Hillsdale), W.A. Foote Memorial Hospital, d/b/a Allegiance Health (Allegiance), Community Health Center of Branch County (Branch), and ProMedica Health System, Inc. (ProMedica).   An agreement among competitors to allocate…

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25 Jun 2015 King v. Burwell Decision

Observers noted prior to the 6-3 decision in King v. Burwell today, which upheld federal subsidies for all, that the case would hinge on just four words – “established by the state.” It turns out, the case hinged on one word – “such.” Although the plain language of section 36B of the Affordable Care Act (ACA) provided that subsidies flowed to residents buying an insurance policy on an “exchange established by the state,” of which there are currently only 16,  the chief justice and five…

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18 Jun 2015 NEW DEPUTY DIRECTOR AT OCR

The Department of Health and Human Services (HHS), Office for Civil Rights (OCR) just announced that Deven McGraw will be the Deputy Director of Health Information Privacy, effective June 29, 2015.  In her new position, Ms. McGraw will lead OCR’s HIPAA policy, enforcement and outreach efforts and OCR’s efforts on Presidential and Departmental priorities on health privacy and security. Ms. McGraw is an attorney and in 2009 was appointed by former HHS Secretary Kathleen Sebelius to the federal Health IT Policy Committee. Stacy CookStacy L….

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12 Jun 2015 PA COURT DISMISSES CLASS ACTION BREACH CASE

A state court in Pennsylvania recently dismissed a class action data breach lawsuit. The members of the class consisted of 62,000 employees and former employees of the University of Pittsburgh Medical Center (UMPC) who had been notified that their names, birth dates, addresses, social security numbers, tax information, salaries and bank account information were stolen from UPMC’s computer system.   The plaintiffs argued that UPMC had a duty to use reasonable care to protect their information and that UPMC breached this duty. The court declined…

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10 Jun 2015 Latest OIG Fraud Alert Signals Heightened Focus on Physician Compensation Arrangements

The Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert June 9, cautioning physicians entering compensation arrangements to scrutinize those arrangements for compliance with fraud and abuse laws.  The alert specifically highlights anti-kickback statute liability that may be triggered where “even one purpose of the arrangement is to compensate a physician for his or her past or future referrals of Federal healthcare program business.”   The alert follows a slew of recent settlements between OIG and individual physicians involving…

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02 Jun 2015 CMS Releases Physician-Level Payment Data Totaling More Than $90 Billion in Medicare Reimbursements for 2013

On June 1, the Centers for Medicare & Medicaid Services (CMS) released its second annual installment of Medicare reimbursement data for physicians and other practitioners. The data set contains records for more than 950,000 practitioners who received a collective $90 billion in Medicare payments during 2013 calendar year. The physician data consists of information on the number and type of healthcare services furnished by practitioners under Medicare Part B’s fee-for-service (FFS) program.  Consumers, providers and other stakeholders can review the data by individual provider (using…

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11 May 2015 Amarin Pharma Preemptively Sues FDA over First Amendment Rights

On Thursday, May 7, Amarin Pharma took the unprecedented step of proactively suing the U.S. Food and Drug Administration (FDA) over the agency’s alleged infringement of the company’s First Amendment Rights.  The case arises from Amarin’s desire to market its product, Vascepa, for uses broader than what the FDA has previously approved. While other companies have raised their First Amendment rights as a defense to enforcement actions brought by the FDA and the Department of Justice (DOJ), none so far has taken the step of…

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05 May 2015 Office of the Inspector General Issues Report Finding Medicaid Rebates Exceeded Medicare Part D Rebates by a Significant Margin

In April 2015, the Office of the Inspector General (OIG) of the U.S. Department of Health & Human Services issued a report analyzing and comparing drug rebates collected by State Medicaid programs and Medicare Part D plan sponsors. Requested by a Member of Congress, the analysis concluded that there were substantial differences in the rebate amounts collected under Medicaid and Medicare Part D.  It was the second such report; the OIG conducted a similar analysis in 2011.   OIG analyzed total Part D and Medicaid…

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