Health Care

Viewpoints

Filter by:

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.
Read more

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.
Read more

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.
Read more

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.
Read more

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”).
Read more

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.
Read more

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.
Read more

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.
Read more

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.
Read more

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.
Read more

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.
Read more

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. 
Read more

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.
Read more

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.
Read more

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.
Read more

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.
Read more

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. 
Read more

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”).
Read more

What the Administration Actually Can Do on Drug Pricing

February 12, 2016 | Blog

The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration, most of their proposals require Congressional authority that have virtually no chance of passing this year.
Read more

The Final 60-Day Rule Is Finally Here!

February 11, 2016 | Blog | By Karen Lovitch

The Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day rule"). 
Read more

Subscribe

Sign up to receive email updates from Mintz.
Subscribe Now
Health Law Diagnosed Podcast Blog Button

Health Law Diagnosed: A Mintz Podcast

Telehealth Promo Button

Telehealth Updates

covid-19-compliance

Value-Based Care

Viewpoint Editors

Explore Other Viewpoints:

I'm Looking For...