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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...

 

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...

 

Adobe PDFHHS Releases Practical Guidance for Boards of Directors on Compliance Oversight
Caroline Gould Bergner, Steve Postal, James C. Pyles, Barbara Straub Williams; Powers Pyles Sutter & Verville, PC;
Legal Alert/Article
July 14, 2015, previously published on May 15, 2015
On April 20, 2015, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS OIG), in collaboration the Association of Healthcare Internal Auditors, the American Health Lawyers Association, and the Health Care Compliance Association, released compliance guidance for...

 

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.

 

HTMLFourth District Court of Appeal Declares Medical Malpractice Cap Unconstitutional
Conroy Simberg;
Legal Alert/Article
July 14, 2015, previously published on July 8, 2015
On July 1, 2015, the Fourth District Court of Appeal issued its opinion in North Broward Hospital District v. Kalitan, Case Nos. 4D11-4806, 4D11-4833 and 4D11-4834, finding the statutory cap on noneconomic damages unconstitutional in medical malpractice personal injury actions.

 

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...

 

Adobe PDFDraft 340B Legislation Could Be Included in 21st Century Cures
Joel M. Hamme, Jason B. Reddish, Peggy Tighe, Barbara Straub Williams; Powers Pyles Sutter & Verville, PC;
Legal Alert/Article
July 14, 2015, previously published on May 19, 2015
Late Friday, the House Energy and Commerce Committee staff circulated to a small number of organizations a “discussion draft” of 340B program legislation that could significantly alter the 340B program. There is a possibility that the discussion draft, which one committee staffer...

 

HTMLOIG Adds New Litigation Unit Focused on Fines and Exclusions
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
July 14, 2015, previously published on July 8, 2015
On June 30, 2015, the Department of Health and Human Services’ Office of Inspector General (OIG) announced that it would be staffing a new specialty litigation unit whose sole focus will be on levying civil monetary penalties (CMPs) and excluding individuals and entities from participation in...

 

HTMLHospital’s Board Meeting Minutes May Be Protected by Attorney-Client and Peer Review Privileges, But a Department of Health Investigation is Not Privileged
Daniel Dolente; Marshall Dennehey Warner Coleman & Goggin, P.C.;
Legal Alert/Article
July 14, 2015, previously published on July 6, 2015
Michael Yocabet received a kidney transplant from Christina Mecannic. Prior to the transplant, Yocabet did not have Hepatitis C. It was determined after the surgery that UPMC had transplanted a Hepatitis C-infected kidney from Mecannic. As a result of the transplant, the Department of Health (DOH)...

 

HTMLA Defendant’s Answer Does Not “Open the Door” to Privileged Communications
Daniel Dolente; Marshall Dennehey Warner Coleman & Goggin, P.C.;
Legal Alert/Article
July 13, 2015, previously published on July 6, 2015
The plaintiff averred in her complaint that an anesthesiologist who performed a pre-surgical evaluation of the decedent was impaired by alcohol at the time of his consult. The anesthesiologist specifically denied that he suffered from any condition that affected his ability to provide appropriate...

 


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