Health Care

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.

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.

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.

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.

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”).

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.

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.

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.

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.

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.

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.

For too long, health industry stakeholders have bandied about massive amounts of information that could not be used in a comparative sense. 

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.

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.

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.

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.

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. 

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”).

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.

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").