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|Supreme Court Decides Validity of Implied False Certification Theory in Universal Health Services v. Escobar|
J. Andrew (Andy) Jackson, Laura F. Laemmle-Weidenfeld, Brian J. Murray, Kenton James Skarin, Stephen G. (Steve) Sozio; Jones Day;
June 26, 2016, previously published on June 2016On June 16, 2016, the U.S. Supreme Court decided Universal Health Services v. United States ex rel. Escobar, a widely anticipated decision with implications for health care provider and government contractor liability under the False Claims Act ("FCA"). The case addressed whether the...
|Important Amendments to the Personal Health Information Protection Act, 2004 Now in Force|
Roberto Ghignone; Borden Ladner Gervais LLP;
June 23, 2016, previously published on June 10, 2016At the start of June 2016, a number of significant amendments to the Personal Health Information Act, 2004 ("PHIPA") were proclaimed in force. The most significant changes relate to the duties and responsibilities of health information custodians with respect to notification in the event...
|Cyberattacks--Health Care is Vulnerable|
John F. Queenan; Iseman, Cunningham, Riester
& Hyde LLP;
June 21, 2016, previously published on May 17, 2016Health care is a prime target for cybersecurity incidents.
|MSHA Issues New Workplace Exam Proposed Rule|
William K. Doran, Gwendolyn K. Nightengale; Ogletree, Deakins, Nash, Smoak & Stewart, P.C.;
June 20, 2016, previously published on June 7, 2016The Mine Safety and Health Administration (MSHA) announced today that it was issuing a notice of proposed rulemaking that will amend the Workplace Examination regulation at 30 C.F.R. § 56.18002 (Surface) and § 57.18002 (Underground). The amended regulation, “Examinations of Working...
|FTC Granted 2-Week Reprieve in Effort to Block Pennsylvania Hospital Merger|
Farrah Short; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 17, 2016, previously published on May 13, 2016The Federal Trade Commission (“FTC”) and the state of Pennsylvania have two weeks to persuade the Court of Appeals for the Third Circuit that the pending merger of Penn State Hershey Medical Center (“Hershey”) and Pinnacle Health System (“Pinnacle”) is...
|Alternative Payment Models (APMs) Under MACRA Proposed Rule|
Jordan T. Cohen, Thomas S. Crane, Sarah Beth S. Kuyers, Lauren M. Moldawer; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 17, 2016, previously published on May 6, 2016Continuing our blog series on CMS’s massive proposed rule for the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), we dedicate this post to examining the Advance Payment Model (APM) provisions of the proposed rule. As our colleagues discussed on May 3rd, the...
|OIG Issues Favorable GPO Advisory Opinion|
Ryan J. Cuthbertson; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 17, 2016, previously published on May 16, 2016The OIG recently issued a favorable advisory opinion permitting a health system (the “Health System”) to become the sole owner of a Group Purchasing Organization (“GPO”), some of whose members were also owned by the Health System (the “Proposed Arrangement”).
|FDA Releases Draft Guidance for 3D Printed Medical Devices|
Jordan T. Cohen, Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 17, 2016, previously published on May 17, 2016On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations for Additive Manufactured Devices,” was informed by a public...
|Phase 2 HIPAA Audits Coming to You: Check Your Spam Filter!|
Dianne J. Bourque, Jordan T. Cohen, Cynthia J. Larose, Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 17, 2016, previously published on March 23, 2016The HHS Office for Civil Rights (“OCR”) officially launched the long-awaited (and dreaded) Phase 2 of the HIPAA Audits Program on March 21st. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails (check your spam filter!) from OCR...
|CMS Releases Proposed Rule for MACRA Implementation - Overview and Merit-Based Incentive Payment Systems (MIPS)|
Jordan T. Cohen, Thomas S. Crane; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 17, 2016, previously published on May 3, 2016On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would put in place key parts of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA impacts a number of laws and government initiatives that have been implemented over the past...