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HTMLSenate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?
Jordan T. Cohen, Bethany Hills; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 9, 2016
On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5. Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of...

 

HTMLMaking the Sausage: Medicaid Block Grants in the 115th Congress
Eli Greenspan, Bridgette Keller, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on November 28, 2016
Republicans have been talking about remodeling the Medicaid program through block grants or per capita caps for years. Both block grants and per capita caps are designed to limit federal spending by providing a state with a set amount of federal money to fund its Medicaid program. With the sweeping...

 

HTMLThe Future of the Medicare Part B Payment Demo under a Republican-held Congress
Theresa C. Carnegie, Eli Greenspan, Lauren Marie Moldawer, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on November 29, 2016
There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016. As we await the release of the final rule, the fate of this demonstration will be in the hands of a Republican-held Congress and...

 

HTMLFrance Unveils its Information System Security Plan in the Health Care Sector
Olivier Haas, Daniel J. (Dan) McLoon, Hatziri Minaudier, Mauricio F. Paez, Cristiana Spontoni; Jones Day;
Legal Alert/Article
January 6, 2017, previously published on December 2016
On October 14, 2016, France's Ministry of Social Affairs and Health issued an instruction notice (document in French) providing for the implementation of the "information systems security plan" for the health care sector. The plan is intended to ensure a harmonized minimum baseline level...

 

HTMLInformed Consent for Surgery: Does a Surgeon’s Experience Level Matter?
John Hoelzer; Heyl, Royster, Voelker & Allen Professional Corporation;
Legal Alert/Article
January 6, 2017, previously published on Fourth Quarter 2016
If a surgeon fails to tell his patient about the material risks of a procedure, thereby causing the patient to consent to treatment that the patient otherwise would not have consented to, then the surgeon could be accused of malpractice in the event that the patient is injured. In such a situation,...

 

HTMLOCR Warns of Phishing Campaign Disguised as Official OCR Communication
Jordan T. Cohen; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on November 29, 2016
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS letterhead under the signature of OCR’s Director Jocelyn Samuels and is...

 

HTMLOCR Provides Additional Clarification on Phishing Scam
Jordan T. Cohen; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 2, 2016
As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR’s Phase 2 audit program. The email, which was disguised as an official...

 

HTMLFederal Judge Blocks Rule That Would Ban Arbitration in Nursing Home Disputes
Amee Lakhani; Heyl, Royster, Voelker & Allen Professional Corporation;
Legal Alert/Article
January 6, 2017, previously published on Fourth Quarter 2016
A federal district court recently issued a preliminary injunction barring enforcement of a rule prohibiting the use of pre-dispute arbitration agreements with patients in long-term care facilities that participate in Medicare and Medicaid programs.

 

HTMLForty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking
Ellyn Leslie Sternfield, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 7, 2016
Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still approximately 45 days remaining in the current administration. A perusal of the...

 

HTMLAt Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors
Rachel Irving Pitts, Carrie A. Roll, Ellyn Leslie Sternfield; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 12, 2016
More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment...

 


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