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HTMLCMS Proposes Easing Two-Midnight Restrictions (But 2016 OPPS Rule Is Not All Good News)
David W. Grauer, Rebekah N. Plowman, Elizabeth E. Trende; Jones Day;
Legal Alert/Article
July 16, 2015, previously published on July 2015
On July 8, 2015, the Centers for Medicare and Medicaid Services ("CMS") issued the 2016 proposed rule for the Hospital Outpatient Prospective Payment System ("OPPS") and Ambulatory Surgery Center ("ASC") payment system ("Proposed Rule"). While the Proposed...

 

Adobe PDFCMS Talks Sense for Stark Compliance under Proposed 2016 Medicare Physician Fee Schedule
Laurel E. Baum, Jennifer R. Bolster, Raymond R. D'Agostino, Catherine A. Diviney, Meghan S. Gaffey; Hancock Estabrook, LLP;
Legal Alert/Article
July 16, 2015, previously published on July 2015
On July 8, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that could provide some much needed breathing room for inadvertent lapses in Stark law compliance. By way of background, the physician self-referral or “Stark” law governs...

 

HTMLDelivery System Reform 2.0: Scaling Alternative Payment Models is the New Normal
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
July 16, 2015, previously published on July 13, 2015
For some health care providers, a pair of recent announcements made by the Obama Administration to implement mandatory alternative payment models (APMs) for home health value-based purchasing and bundled payments for hip and knee episodes of care will come as a shock. For others who have...

 

HTMLNew CMS Proposed Rule: Comprehensive Care for Joint Replacement
Claire E. Castles, Catherine A. Ehrgott, Lisa Ge Shang Han, David T. Morris; Jones Day;
Legal Alert/Article
July 16, 2015, previously published on July 15, 2015
On July 9, 2015, the Centers for Medicare & Medicaid Services ("CMS") announced a proposed rule to test a new payment model, the Comprehensive Care for Joint Replacement ("CCJR"), for hip and knee replacements (also called lower extremity joint replacements or...

 

HTMLFCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing
Russell H. Fox, Stephen J. Wang; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
July 15, 2015, previously published on July 13, 2015
On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio equipment. Notably, the FCC clarified that some cost...

 

Adobe PDFFederal Court Upholds $237 Million Sanction Against Tuomey Healthcare
Laurel E. Baum, Jennifer R. Bolster, Raymond R. D'Agostino, Catherine A. Diviney, Meghan S. Gaffey; Hancock Estabrook, LLP;
Legal Alert/Article
July 15, 2015, previously published on July 8, 2015
On July 2, 2015, the Federal Court of Appeals for the Fourth Circuit affirmed a lower court’s decision that Tuomey Healthcare violated the Stark law and the Federal False Claims Act, paving the way for the government to enforce the $237 million in court-awarded damages and penalties against...

 

HTMLFinal Drug Shortage Reporting Rules Will Go Into Effect September 2015
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
July 15, 2015, previously published on July 9, 2015
Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological products to FDA. The final rule requires enhanced reporting to assist FDA in...

 

Adobe PDFHRSA Proposed Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties
Ronald S. Connelly, William H. von Oehsen; Powers Pyles Sutter & Verville, PC;
Legal Alert/Article
July 15, 2015, previously published on July 9, 2015
On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking related to 340B ceiling prices and the imposition of civil monetary penalties on manufacturers under the 340B Drug Pricing Program. The proposed rule would implement provisions of the...

 

HTMLNew Study Suggests Xarelto May Double Risk of Gastrointestinal Bleeding
Waters Kraus LLP;
White Paper
July 14, 2015, previously published on July 10, 2015
The British Medical Journal has recently published results from a new study indicating that Xarelto, as compared to the generic version of warfarin, may double the risk for gastrointestinal bleeding.

 

HTMLConsider Leaving Informed Consent Claims in Your Case to Bolster Your Defense
Daniel Dolente; Marshall Dennehey Warner Coleman & Goggin, P.C.;
Legal Alert/Article
July 14, 2015, previously published on July 6, 2015
The Pennsylvania Supreme Court ruled that, generally, a patient’s informed consent to the risks of treatment is irrelevant in a case sounding in only medical negligence. The Supreme Court, however, refused to adopt the Superior Court’s bright line ruling that all aspects of informed...

 


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