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Reminder: Pharmaceutical Industry Enforcement Webinar - Wednesday, October 26
October 24, 2016 | Blog
Pharmaceutical industry enforcement has been one of the hottest topics in the news in the past month. Last week, Ellyn Sternfield and Rodney Whitlock were quoted by cnbc.com regarding the recent Mylan settlement.
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Updates on Privacy and Security in the EU
October 20, 2016 | Blog
If you missed the Mintz Levin Privacy and Security Practice Webinar last week, you can still get it! The current Privacy Webinar Series is focusing on the EU General Data Protection Regulation (GDPR), which will impact how US businesses handle and process personal data from the EU, including possible changes to business processes.
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Massachusetts Licensure of Clinics Proposed Regulations – Key Take-Aways
October 19, 2016 | Blog | By Ellen Janos, Daria Niewenhous
In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent regulatory review and overhaul, we address the proposed amendments to the clinic licensure regulations.
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HHS Publishes Guidance on HIPAA and Cloud Computing
October 19, 2016 | Blog | By Dianne Bourque
On October 7, 2016, the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance.
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CMS Releases MACRA Final Rule, Easing 2017 Reporting Requirements
October 18, 2016 | Blog
On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
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FDA Opens Comment Period for Harmonized SaMD Clinical Evaluation Guidance
October 17, 2016 | Blog | By Benjamin Zegarelli
On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the "SaMD Draft Guidance"). The draft guidance was prepared by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF), chaired by Bakul Patel, Associate Director for Digital Health at CDRH, and was endorsed by the IMDRF Management Committee in September 2016.
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Five Things to Know About the Mylan EpiPen "Settlement" - What It Is and What It Isn't
October 14, 2016 | Blog
Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate obligations for EpiPen.
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FTC Gets Creative to Help Failing Medical Practice
October 13, 2016 | Blog | By Bridgette Keller
Earlier this week my colleagues, Bruce Sokler and Farrah Short published an alert detailing the FTC's creative solution to permit a presumptively anticompetitive merger for a financially failing medical practice.
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Senate Bill Targets Part D DIR Fees
October 11, 2016 | Blog | By Tara E. Dwyer
Just last month the “Improving Transparency and Accuracy in Medicare Part D Spending Act” was introduced in the Senate to amend the Social Security Act. The bill seeks to prohibit Part D plans (and their contracted pharmacy benefit managers (PBMs)) from retroactively reducing payments to pharmacies for clean claims.
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CMS releases Final Rule Overhauling Long-Term Care Facility Requirements
October 10, 2016 | Blog | By Lauren Moldawer, Cassandra Paolillo
The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”).
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Join Us For A Webinar On October 26th Discussing Pharmacy Industry Enforcement
October 6, 2016 | Blog | By Brian Dunphy
Please join Mintz Levin for a webinar discussing health care fraud enforcement in the pharmacy and pharmaceutical industry on October 26, 2016 at 1 pm (ET). My colleagues Theresa Carnegie, Larry Freedman, and Ellyn Sternfield, members of Mintz Levin’s Health Law and Health Care Enforcement Defense practices, will discuss enforcement trends facing the industry.
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Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations
October 4, 2016 | Blog | By Daria Niewenhous
The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”).
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Did You Miss Our Webinar on FTC Enforcement and the Hershey Hospital Merger?
October 3, 2016 | Blog | By Samantha Kingsbury
On Friday, Robert Kidwell and Bruce Sokler, members of the Firm’s Antitrust and Federal Regulatory practice group, presented a webinar on the Third Circuit’s hotly anticipated decision on the FTC’s appeal of the District Court’s denial of its request for a preliminary injunction on the merger of Penn State Hershey Medical Center and Pinnacle Health System.
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Massachusetts Dialysis Unit Licensing Proposed Regulations - Key Take-Aways
September 29, 2016 | Blog | By Ryan Cuthbertson
As we've previously reported, the Massachusetts Department of Public Health (DPH) has recently proposed a number of amended regulations in connection with the regulatory review and overhaul mandated by Governor Baker’s Executive Order 562. Senior DPH staff presented these proposed regulations at a Public Health Council Meeting on September 14 (the “PHC Meeting”).
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FTC Enforcement and Hershey Hospital Merger - Webinar this Friday
September 28, 2016 | Blog
Join us this Friday at 1:30 pm EDT for a webinar with two of our Antitrust colleagues, Robert Kidwell and Bruce Sokler. They will discuss recent events in the Hershey Hospital merger and their impact on FTC's hospital merger enforcement program. Learn more about these recent updates from the comfort of your computer in our one-hour webinar.
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Billing Companies Beware – OIG Signals a Crack Down on Fraud and Abuse at All Levels
September 28, 2016 | Blog | By Carrie Roll
In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a medical billing company for preparing and submitting claims to Medicare for diagnostic tests that were never conducted.
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FDA Holding its First Public Meeting on Drug Product Identification Requirements in October
September 27, 2016 | Blog | By Joanne Hawana
Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in White Oak, Maryland.
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Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference
September 26, 2016 | Blog | By Benjamin Zegarelli
The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the global centers of life sciences regulations, including the United States, the European Union (both the unified government and the individual countries), Brazil, Mexico, China, Japan, and other regions.
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Massachusetts Hospital Licensing Regulations Proposed Amendments - Key Take-Aways
September 26, 2016 | Blog | By Daria Niewenhous
The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to enable the regulations to meet a number of goals, among them ensuring a high quality of care, industry standardization and strong consumer protection for hospital patients.
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Penalties For Health Care Law Violations Surge
September 21, 2016 | Blog | By Brian Dunphy
The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”).
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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