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FTC Submits Public Comments to States Considering Regulations of Cooperative Agreements Between Hospitals
October 19, 2015 | Blog | By Dionne Lomax
The Federal Trade Commission (FTC) recently submitted comments to Virginia and Tennessee regarding proposed laws in each state relating to Cooperative Agreements between hospitals and the granting of Certificates of Public Advantage (COPA). This continues the FTC’s active monitoring of state regulations potentially affecting competition in the health care market.
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FTC Provides Guidance Regarding Antitrust Compliance for State Regulatory Boards
October 19, 2015 | Blog | By Dionne Lomax
In North Carolina State Board of Dental Examiners v. FTC, 135 S. Ct. 1101 (2015), the U.S. Supreme Court held that the North Carolina Board of Dental Examiners (“Board”), a state agency, was not exempt from federal antitrust laws when it prohibited non-dentists from providing teeth whitening services in competition with the state’s licensed dentists.
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California Becomes Latest State to Pass Biosimilar Substitution Law
October 16, 2015 | Blog | By Joanne Hawana
On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product.The California legislature had attempted to pass a similar law in 2013, but the bill was vetoed by the governor.
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OCR Launches Platform for Developer HIPAA Questions
October 16, 2015 | Blog | By Ryan Cuthbertson
The HHS Office for Civil Rights (OCR) has released a new platform to provide mobile health developers (and any other interested stakeholders) a sounding board to ask questions, voice concerns, and “spitball” ideas about HIPAA and its interplay in the Health IT space.
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FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public
October 12, 2015 | Blog | By Joanne Hawana
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and their impact on pharmacies and dispensers.
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The Proposed 340B Guidance: Who is the Biggest Loser?
October 8, 2015 | Blog | By Lauren Moldawer
We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program.
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Arkansas Medical Board Proposes to Relax State Telemedicine Laws
October 6, 2015 | Blog | By Carrie Roll
Last month, the Arkansas State Medical Board’s Telemedicine Advisory Committee indicated that it was in the process of drafting a rule that would allow establishment of a physician-patient relationship through the use of real-time audiovisual communication rather than an in-person visit.
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Employment Matters: The Affordable Care Act’s Reporting Requirements for Carriers and Employers
October 5, 2015 | Blog | By Carrie Roll
On September 29, 2015, our colleague, Alden Bianchi, posted the latest installment of the Affordable Care Act’s Reporting Requirements for Carriers and Employers on Mintz Levin’s Employment Matters blog.
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Just in Time for the Phase II Audits: OIG Criticizes OCR’s Enforcement Efforts
October 1, 2015 | Blog | By Dianne Bourque
As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of the Office for Civil Rights' (OCR) HIPAA enforcement performance, effectively giving OCR "something to prove."
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“Two-Midnight” Rule Needs Tweaking, Says Federal Judge
September 28, 2015 | Blog
A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule.
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CMS Publishes Long-Awaited PAMA Proposed Rule
September 28, 2015 | Blog | By Karen Lovitch
Late on Friday afternoon the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule (MCLFS) made by the Protecting Access to Medicare Act of 2014 (PAMA).
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DOJ Clarifies Position on Individual Accountability in Corporate Investigations
September 28, 2015 | Blog
Earlier this month, we discussed a memorandum issued by Deputy Attorney General Sally Quillian Yates of the U.S. Department of Justice (DOJ). This memorandum, referred to as the "Yates Memo," reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct.
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Hot Topics in Laboratory Compliance at AHLA’s Fraud and Compliance Forum
September 24, 2015 | Blog | By Bridgette Keller
Next week, my colleague Karen Lovitch will be co-presenting a discussion on Hot Topics in Laboratory Compliance at the American Health Lawyers Association’s Fraud and Compliance Forum in Baltimore, Maryland.
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Trouble Brewing for International Data Transfers Under U.S.-EU Safe Harbor
September 23, 2015 | Blog | By Dianne Bourque
Today the EU threw a huge wrench into one of the ways that personal data goes back and forth between EU countries and the U.S., as reported in Mintz Levin’s Privacy and Security Matters Blog.
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Upcoming AHLA Webinar - Behavioral Health and ACOs
September 22, 2015 | Blog
On Thursday Mintz Levin attorney Daria Niewenhous will be moderating an American Health Lawyers Association webinar entitled “Behavioral Health and ACOs—Challenges and Opportunities.”
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September Health Care Qui Tam Update
September 21, 2015 | Blog | By Brian Dunphy
Mintz Levin’s Health Care Enforcement Defense Group recently published another installment of its Health Care Qui Tam Update. The September Update surveys 39 health-related False Claims Act (“FCA”) qui tam cases that were recently unsealed, discusses the trends in those cases, and spotlights three of them.
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Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock
September 17, 2015 | Blog | By Joanne Hawana
Today, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and Research (CDER), regarding the agency’s implementation of the new approval pathway for biosimilar products created under the BPCIA.
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Medicare to Permit Value-Based Insurance Design in Medicare Advantage Plans
September 16, 2015 | Blog
The Centers for Medicare & Medicaid Services ("CMS") recently announced that, beginning January 1, 2017, Medicare Advantage plans in Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania and Tennessee will be permitted to offer what are known as "value-based insurance design" ("VBID") plans.
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Executives Should Take a Closer Look at Insurance Coverage after New DOJ Policies
September 16, 2015 | Blog
Last week, we discussed the memorandum released by the Department of Justice emphasizing the Government’s commitment to holding individuals accountable when dealing with corporate wrongdoing.
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DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability
September 11, 2015 | Blog | By Eoin Beirne, Bridget Rohde
The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct.
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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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