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FTC-DOJ Join Forces: Encourage Repeal/Retrenchment of Virginia CON Laws
October 27, 2015 | Blog | By Dionne Lomax
The Federal Trade Commission (“FTC”) and Department of Justice Antitrust Division (“DOJ”) (collectively, “agencies”) issued a joint statement to Virginia’s Certificate of Public Need (“COPN”) Work Group, which was recently charged with reviewing Virginia’s certificate of public need process and its impact on health care services in Virginia.
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Mintz's October Health Care Qui Tam Update
October 26, 2015 | Blog
Mintz's Health Care Enforcement Defense Group has published the latest edition of its Qui Tam Update. The October Qui Tam Update reviews 15 health-related False Claims Act cases that were recently unsealed.
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BNA Article Highlights Compliance Issues for Hospital Laboratories
October 22, 2015 | Blog
Hospital lawyers, whether in-house or outside counsel, have oversight over many facets of the hospital’s operations. One department they may not be focused on, but should be, is the hospital’s laboratory.
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ML Strategies: Medicare Cuts in the Crosshairs of a Budget Agreement?
October 21, 2015 | Blog | By Bridgette Keller
Congress returns this week, and ML Strategies has re-launched its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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Jury Sides with DOJ in First Phase of FCA Statistical Sampling Trial
October 21, 2015 | Blog | By Samantha Kingsbury
Last week, a jury in Alabama federal court sided with the Department of Justice (DOJ) and qui tam relators in the first part of a False Claims Act (FCA) case against AseraCare Inc., a provider of hospice and palliative care services, and found that claims submitted by AseraCare for 104 patients were objectively false.
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Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?
October 20, 2015 | Blog
Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule, it was an open question as to whether certain provisions in the Proposed Guidance would even be enforceable.
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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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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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