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HTMLInvestor Concerns In Light Of New CMS Long-Term Care Rule
Kyle T. Molidor, Michael A. Witt; Duane Morris LLP;
Legal Alert/Article
January 17, 2017, previously published on December 8, 2016
Medicare and Medicaid requirements for participation of long-term care facilities (LTCs) were first published in 1989 and have not been comprehensively reviewed and updated since 1991. Over the past quarter century, significant changes in LTC care and assessment practices have emerged. These...

 

HTMLPennsylvania Announces Medical Marijuana Program Application Release Date and Timeline for Submission of Applications
Kenneth C. Foltz; Leech Tishman;
Legal Alert/Article
January 12, 2017, previously published on December 21, 2016
Pennsylvania Secretary of Health Dr. Karen Murphy announced today that applications for medical marijuana grower/processors and dispensaries will be available January 17, 2017.

 

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...

 

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...

 

HTMLPresident Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine
Joanne S. Hawana, Sarah Beth S. Kuyers; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 15, 2016
On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises. Our...

 

HTMLThe Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger
Lauren Marie Moldawer, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 16, 2016
The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.

 

HTMLProposed Changes to the Regulated Health Professions Act Furthering Patient Protection and Accountability
Patrick Hawkins, Henry Ngan; Borden Ladner Gervais LLP;
Legal Alert/Article
January 6, 2017, previously published on December 15, 2016
On December 8, 2016, Bill 87: Protecting Patients Act, 2016 was tabled for first reading at Queens Park. Bill 87 proposes numerous amendments to the Regulated Health Professions Act, 1991 (RHPA) in particular, to the Health Professions Procedural Code (Schedule 2 to the RHPA). These amendments aim...

 

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...

 

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...

 

HTMLIn the Wake of the Election, What’s Next for State Drug Pricing Initiatives?
Carrie A. Roll; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 8, 2016
A Trump victory was not the only surprise on election night. California’s drug pricing initiative, which would have required state agencies to negotiate drug prices at least as low as those paid by the U.S. Department of Veterans Affairs, was defeated by a wide margin (46% to 54%). This...

 


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