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Registration for the 2016 Mintz/ML Strategies Pharmacy Industry Summit is Open! (May 10, 2016)

April 12, 2016 | Blog | By Theresa Carnegie

The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement, and program integrity.
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LSU Hospital Operator May Proceed with Antitrust Suit Against Competing Health System

April 11, 2016 | Blog | By Dionne Lomax

The antitrust suit against Willis Knighton Medical Center will continue following the denial of its motion to dismiss.  BRFHH Shreveport v. Willis Knighton Med. Ctr., case number 5:15-cv-02057 (W.D. La. Mar. 31, 2016). The case was filed last July by BRFF Shreveport, a competing healthcare provider, and Vantage Health Plan, a health insurer.
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Talking about The Challenge of Quality in Health Care Policy Development

April 11, 2016 | Blog

Last week, I spoke at the National Quality Forum Annual Conference in Washington, D.C. about the role of health care quality in policymaking on the Hill. The challenge of policy making on the Hill is that many people know that quality is important. Policymakers know they need to be talking about health care quality.  Unfortunately, too often quality is just a buzz word. 
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Recent Updates to State Breach Notification Laws - Tennessee

April 8, 2016 | Blog

My colleagues in the Privacy and Security Group recently updated the Mintz Matrix, a summary of U.S. state data breach notification laws. While we often discuss HIPAA on Health Law and Policy Matters, health care organizations must be aware of separate state notification requirements and other privacy and security laws that may apply in the event of a data breach.
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FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

April 4, 2016 | Blog | By Joanne Hawana, Lauren Moldawer

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of biosimilar products that are approved via the abbreviated licensure pathway created in 2010 by the BPCIA.
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Biosimilar Developments Continue at a Rapid Pace

April 1, 2016 | Blog | By Joanne Hawana

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and efficacy history of an existing biological product for FDA approval by demonstrating that the biosimilar is “highly similar” to the reference product. 
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Judge Sides with AseraCare, Grants Summary Judgment in $200 Million FCA Case

April 1, 2016 | Blog | By Laurence Freedman, Samantha Kingsbury

Much like the rest of the health care world, we have been following the AseraCare case since May of last year when the Alabama federal district court granted AseraCare’s motion to bifurcate its False Claims Act (FCA) trial into Phase I that would address “falsity” and Phase II that would address “knowledge” and other FCA elements.
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Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?

March 31, 2016 | Blog | By Bridgette Keller, Karen Lovitch

As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most significant changes to the Medicare Part B payment structure for laboratories since implementation of the Medicare Clinical Laboratory Fee Schedule (MCLFS) in 1984.
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CMS Seeks Input on Medicare's Value-Based Insurance Design Model

March 29, 2016 | Blog

Last week, CMS asked Medicare Advantage Organizations for feedback on the Medicare Advantage Value-Based Insurance Design model test that will begin on January 1, 2017.
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Ready or Not, It’s Time For Phase 2 HIPAA Audits

March 22, 2016 | Blog | By Dianne Bourque

On March 21st, the HHS Office for Civil Rights (“OCR”) officially launched Phase 2 of the HIPAA Audit Program. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails from OCR that will begin the audit process.
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Drug Company Payments and Prescribing Patterns Linked, Massachusetts Is An Outlier

March 18, 2016 | Blog

As reported in yesterday's Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of brand-name drugs.
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Don’t Neglect Your Business Associate Agreements!

March 17, 2016 | Blog | By Dianne Bourque

As we have repeatedly emphasized on this blog, HIPAA Covered Entities must ensure that they have compliant business associate agreements (“BAAs”) in place with all of their business associates and must ensure that they have performed a comprehensive risk assessment.
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Mobile Health Apps Continue to Make Headlines

March 16, 2016 | Blog | By Joanne Hawana

Recently published studies are illustrating the types of issues that mobile health application, or "app," developers will continue to face as the industry matures alongside an evolving regulatory and enforcement landscape.
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Tackling Drug Prices: CMS and PhRMA Propose Steps to Promote Value-Based Purchasing

March 15, 2016 | Blog | By Theresa Carnegie, Lauren Moldawer

Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices.
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Mintz’s Employment Matters Blog Covers Supreme Court Ruling in ERISA Case

March 14, 2016 | Blog | By Samantha Kingsbury

On Monday, Alden Bianchi, Practice Group Leader of Mintz’s Employee Benefits & Executive Compensation practice, posted a detailed analysis of the Supreme Court’s recent decision Gobeille v. Liberty Mutual Insurance Company on Mintz’s Employment Matters blog.
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Oh No, Not Again…Chalk Up Yet Another Health Data Breach

March 14, 2016 | Blog | By Ryan Cuthbertson

21st Century Oncology Holdings, a company that operates a chain of 181 cancer treatment centers in the US and Latin America, announced on Friday March 4 that it was latest victim of a cyber-attack affecting 2.2 million individuals. When did the attack occur? Months ago.
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Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

March 11, 2016 | Blog | By Joseph Lipchitz, Joanne Hawana

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to treat Amarin’s proposed truthful and non-misleading off-label marketing about its drug, Vascepa (icosapent ethyl), as violative of the Food, Drug, and Cosmetic Act (“FDCA”).
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U.S. Department of Defense Expands Telemedicine Access for Military Members

March 8, 2016 | Blog | By Ellen Janos, Carrie Roll

Last month, Jonathan Woodson, M.D., the Assistant Secretary of Defense for Health Affairs for the U.S. Department of Defense, issued a memorandum that effectively changes the Military Health System (“MHS”) policy on telemedicine.
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Recent HIPAA Updates from OCR

March 7, 2016 | Blog

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has been busy lately, issuing three news releases on the HIPAA Privacy and Security Rules.
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Acquittals in Vascular Solutions Case Deal Setback to DOJ

March 2, 2016 | Blog | By Bridget Rohde, Laurence Freedman

On February 26, 2016, a federal jury in Texas returned not guilty verdicts with respect to charges brought against Vascular Solutions Inc. (“VSI”) and its CEO by the U.S. Department of Justice (“DOJ”), dealing a decisive blow in a case brought before the Yates Memo was issued but touted even then as an effort to enforce corporate and individual accountability.
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