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|Here Comes the Sunshine Act|
Grace D. Mack; Wilentz, Goldman & Spitzer P.A.;
August 25, 2014, previously published on August 19, 2014The Centers for Medicare and Medicaid Services (CMS) released a guide for physicians to prepare for the Dispute Resolution period of the Physician Payments Sunshine Act. The CMS guide is available on the CMS Open Payments website http://go.cms.gov/openpayments. CMS announced "mid-July"...
|Final Meaningful Use Regulations under Review by OMB|
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
August 25, 2014, previously published on August 2014On August 8, 2014, the White House Office of Management and Budget (OMB) received the final rule addressing the meaningful use stage timeline, the definition of certified electronic health record technology (CEHRT), and the requirements for the reporting of clinical quality measures for 2014. The...
|Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed|
Jacqueline N. Acosta; Foley & Lardner LLP;
August 25, 2014, previously published on August 18, 2014In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for harmful off-label uses. United States ex rel. Paulos v. Stryker Corp. et...
|CMS Re-Opens Open Payments System|
Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
August 22, 2014, previously published on August 18, 2014As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the Sunshine Act report payments and transfers of value made to physicians and...
|One Step Closer to the Supreme Court: The Fate of Obamacare Premium Tax Credits in the Face of the Circuit Split|
Anna L. Sweigart; Spilman Thomas & Battle, PLLC;
August 22, 2014, previously published on August 13, 2014Last month, two federal courts of appeals issued opposing decisions on whether the Patient Protection and Affordable Care Act (the “ACA”) permitted subsidies, in the form of premium tax credits, to health coverage bought through insurance Exchanges operated by the federal government. As...
|Federal Court Rejects Relator’s Swapping Allegations in False Claims Act Case|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
August 22, 2014, previously published on August 15, 2014This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former employee, Kevin P. McDonough. McDonough accused Mobilex of...
|New Virginia Law Prohibits Physician Mark-Ups for Anatomic Pathology Services|
T. Braxton McKee, Laura Dickson Rixey; Kaufman & Canoles A Professional Corporation;
August 22, 2014, previously published on August 2014Effective as of July 1, 2014, Virginia licensed healthcare practitioners are prohibited from marking-up anatomic pathology services performed by independent pathologists. The law is codified as new Section 54.1-2962.01 of the Virginia Code.
|Acute Care Hospitals Settle FCA Lawsuits for $98 Million|
Brian P. Dunphy; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
August 22, 2014, previously published on August 18, 2014Community Health Systems, Inc. (CHS) and Community Health Systems Professional Services Corporation, together a national owner and operator of acute care hospitals, and 119 of their hospitals, agreed to pay $98 million to settle seven False Claims Act (FCA) lawsuits filed by qui tam relators around...
|OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program|
Theresa C. Carnegie, Carrie A. Roll; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
August 22, 2014, previously published on August 13, 2014The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other than the requestor, it potentially opens the door for...
|The Affordable Care Act—Countdown to Compliance for Employers, Week 19: Changes in Employment Status under the Look-Back Measurement Method|
Alden J. Bianchi; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
August 22, 2014, previously published on August 18, 2014An earlier post explained the two principle methods—the “monthly measurement method” and the “look-back measurement method”—available to applicable large employers to identify full-time employees for purposes of determining exposure for “assessable...