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HTMLOIG Proposed Rule Would Amend Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules; CMS Launches Open Payments Database
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 25, 2014, previously published on October 17, 2014
On October 3, 2014, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) published a proposed rule that would amend the safe harbors to the anti-kickback statute (“AKS”) and the civil monetary penalty (“CMP”) rules under the...

 

HTML$840 Million in Grants Available Through New HHS Transformation Initiative
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 21, 2014, previously published on November 11, 2014
On Thursday, October 23, 2014, the U.S. Department of Health and Human Services (“HHS”) announced it would make available up to $840 million in grants over the next four years through the Transforming Clinical Practice Initiative (“TCPI”), an Affordable Care Act grant...

 

HTMLFDA Issues Draft Guidance on Stem Cell Same Surgery Exception
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 21, 2014, previously published on November 11, 2014
On October 23, 2014, the FDA’s Center for Biologics Evaluation and Research issued draft guidance for tissue establishments and healthcare professionals who implant stem cells and other cellular or tissue-based products into human patients. The FDA regulates human cells, tissues or cellular...

 

HTMLOIG Issues Favorable Advisory Opinion for Medigap “Preferred Hospital” Network Arrangement
Hilary B. Dudley, Tamara A. Klein, Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
November 20, 2014, previously published on November 11, 2014
On Monday, October 21, 2014, the Office of the Inspector General of the U.S. Department of Health and Human Services (“OIG”) issued a favorable advisory opinion regarding the use of a “preferred hospital” network as part of the Medicare Supplemental Health Insurance...

 

HTMLFinal Meaningful Use Regulations Published
Courtney Scrubbs, David S. Szabo, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
September 19, 2014, previously published on September 2014
On September 4, 2014, the U.S. Department of Health and Human Services, the Centers for Medicare & Medicaid Services (CMS), and the Office of the National Coordinator for Health Information Technology (ONC) published in the Federal Register a final rule on meaningful use. Significantly, the...

 

HTMLMassachusetts Finalizes Risk-Bearing Provider Organization Regulations
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
August 25, 2014, previously published on August 2014
On August 15, 2014, the Massachusetts Division of Insurance (the “Division”) released the final regulations implementing Chapter 176T of the Massachusetts General Laws (“Chapter 176T”).

 

HTMLFinal Meaningful Use Regulations under Review by OMB
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
August 25, 2014, previously published on August 2014
On August 8, 2014, the White House Office of Management and Budget (OMB) received the final rule addressing the meaningful use stage timeline, the definition of certified electronic health record technology (CEHRT), and the requirements for the reporting of clinical quality measures for 2014. The...

 

HTMLMassachusetts Bans Physician Self Referral to Clinical Labs; Healthfirst Case May Help Clarify 60-Day Rule
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 31, 2014, previously published on July 2014
Massachusetts physicians can no longer refer Medicaid and private pay patients to clinical laboratories in which they or a family member have a direct or indirect ownership interest. The provision was included in the commonwealth’s 2015 budget bill. Governor Deval Patrick signed the budget on...

 

HTMLCMS Proposes Changes to the Home Health Face-to-Face Encounter Requirement
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 21, 2014, previously published on July 2014
On July 7, 2014, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule updating the Home Health Prospective Payment System (“HH PPS”) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the...

 

HTMLFDA Issues Draft Guidance for Medical Device Data Systems
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 1, 2014, previously published on June 2014
On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance to inform manufacturers, distributors, and other entities that FDA does not intend to enforce compliance with the agency’s 2011 regulations governing medical device data systems (MDDS) subject to 21 CFR...

 


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