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HIPAA Lessons from the Warner Chilcott Settlement

November 4, 2015 | Blog | By Ellen Janos

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations involving the promotion of the company’s drugs.
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FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

November 4, 2015 | Blog | By Joanne Hawana

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary names for biosimilars as compared to their reference biologics would signal clinically meaningful differences to already-confused physicians.
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MA Health Policy Updates - Moves to Strengthen HPC and Expand Telemedicine

November 2, 2015 | Blog

In a recent Alert, the Mintz Levin Health Law Practice and ML Strategies provided a comprehensive look at recent developments in Massachusetts health policy. In addition to a detailed report on recent Health Policy Commission (HPC) activities, the Alert highlights pending legislation that will affect the health industry.
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Data-Harvesting Zombie Hackers, Blood-Thirsty Auditors, and Other Reasons to be Scared on Halloween

October 30, 2015 | Blog | By Dianne Bourque

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying around unencrypted laptops or skipping out on HIPAA training.
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Skeletons in the Closet? Beware of Potential Enforcement Actions

October 29, 2015 | Blog | By Brian Dunphy, Karen Lovitch

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement Defense Group, have discussed a wide variety of state and federal health care fraud investigations and qui tam cases filed by relators under the False Claims Act (FCA).
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Yates Memo Discussed at Pharmaceutical Compliance Congress

October 28, 2015 | Blog

As readers of Health Law and Policy Matters know, we have covered recent developments in the Department of Justice's (DOJ's) commitment to prosecuting individuals involved in corporate misconduct.
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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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