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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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Mintz BNA Article Discusses Medicare Overpayment Rule’s Implications for Compliance and Enforcement
March 1, 2016 | Blog | By Brian Dunphy
Expanding on our recent discussion of CMS’s long-awaited Final Rule governing the return of Medicare Part A and Part B overpayments (“Overpayment Rule"), my colleague Larry Freedman and I published an article in BNA’s Medicare Report entitled The Medicare Overpayment Rule: Implications for Compliance and Health Care Enforcement.
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CMS Releases 2017 Advance Notice and Draft Call Letter
February 29, 2016 | Blog | By Bridgette Keller, Lauren Moldawer
Last week, the Centers for Medicare & Medicaid Services (CMS) released its 2017 Advance Rate Notice and draft Call Letter (“2017 Draft Call Letter”) for the Medicare Advantage (“MA”) and Part D programs. With the final 2017 Call Letter to be released April 4, 2015, CMS is providing interested stakeholders until this Friday, March 4th to provide comments.
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Opioids, FDA and Medicare Advantage Spending on the List for Congress
February 24, 2016 | Blog
As Congress is back to Washington for its next work period, ML Strategies has published an Advisory outlining health care issues on the radar for the upcoming weeks. Highlights include: legislative initiatives on opioid abuse, mental health access, chronic care and a group of innovation bills; the FDA Commissioner nomination; and Medicare Advantage (MA) lobbying efforts.
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Groundbreaking Multi-Payer Alignment on Core Measures for Quality-Based Payments
February 23, 2016 | Blog | By Bridgette Keller
For too long, health industry stakeholders have bandied about massive amounts of information that could not be used in a comparative sense.
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Provider Confusion and Interoperability Concerns Prompt OCR and ONC to Release Guidance on PHI Sharing
February 22, 2016 | Blog
Last Friday, the U.S. Department of Health and Human Services Office of the National Coordinator for Health IT (“ONC”) and the Office for Civil Rights (“OCR”) released two fact sheets regarding permitted uses and disclosures of protected health information (“PHI”) among health care providers and other entities covered by HIPAA.
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Hollywood Presbyterian Concedes to Hacker’s Demands in Ransomware Attack
February 19, 2016 | Blog
In a chain of events that should be a wake-up call to any entity using and storing critical health information, Hollywood Presbyterian Medical Center (“HPMC”) has announced that it paid hackers $17,000 to end a malware attack on the hospital’s computer systems.
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FTC Again Urges Consideration of Competitive Impact on State Regulation of APRNs
February 17, 2016 | Blog | By Dionne Lomax
The Federal Trade Commission (FTC) submitted written comments last week on the likely competitive impact of a legislative proposal in West Virginia to modify the supervision requirements imposed on Advanced Practice Registered Nurses (APRNs) for certain activities.
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Amidst the Raucous Debate in D.C., States Quietly Take Action on Rising Prescription Drug Prices
February 16, 2016 | Blog | By Carrie Roll, Theresa Carnegie
Rising drug prices and attempts to contain drug costs continue to take center stage at the federal level – particularly in the ramp-up to the 2016 presidential election. In January 2015, a bill was introduced that would repeal the government non-interference clause and allow the Centers for Medicare & Medicaid Services (CMS) to directly negotiate Medicare Part D drug prices with manufacturers.
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CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note
February 16, 2016 | Blog | By Lauren Moldawer
Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies.
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The Final 60-Day Rule: the Good, the Bad, and the Ugly
February 12, 2016 | Blog | By Brian Dunphy, Laurence Freedman
As we announced yesterday, the Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited Final Rule governing the return of Medicare Part A and Part B overpayments within 60 days (the “Final Rule”).
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