Health Care

Earlier this month, we discussed a memorandum issued by Deputy Attorney General Sally Quillian Yates of the U.S. Department of Justice (DOJ). This memorandum, referred to as the "Yates Memo," reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct.

A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule.

Next week, my colleague Karen Lovitch will be co-presenting a discussion on Hot Topics in Laboratory Compliance at the American Health Lawyers Association’s Fraud and Compliance Forum in Baltimore, Maryland.

Today the EU threw a huge wrench into one of the ways that personal data goes back and forth between EU countries and the U.S., as reported in Mintz Levin’s Privacy and Security Matters Blog.

On Thursday Mintz Levin attorney Daria Niewenhous will be moderating an American Health Lawyers Association webinar entitled “Behavioral Health and ACOs—Challenges and Opportunities.” 

Mintz Levin’s Health Care Enforcement Defense Group recently published another installment of its Health Care Qui Tam Update.  The September Update surveys 39 health-related False Claims Act (“FCA”) qui tam cases that were recently unsealed, discusses the trends in those cases, and spotlights three of them.

Today, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and Research (CDER), regarding the agency’s implementation of the new approval pathway for biosimilar products created under the BPCIA.

The Centers for Medicare & Medicaid Services ("CMS") recently announced that, beginning January 1, 2017, Medicare Advantage plans in Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania and Tennessee will be permitted to offer what are known as "value-based insurance design" ("VBID") plans.

Last week, we discussed the memorandum released by the Department of Justice emphasizing the Government’s commitment to holding individuals accountable when dealing with corporate wrongdoing.

Exellus BlueCross BlueShield has announced that the personal information of at least 10 million members has been compromised in a “very sophisticated” cyberattack that occurred on December 23, 2013 and was discovered by the plan on August 5, 2015.

The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate misconduct.

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common Rule,” originally promulgated in 1991. 

In June, an antitrust suit brought by plaintiff ambulatory surgery centers (“ASCs”) against a health system, health insurers, and a trade association survived a motion to dismiss. Last week, the ASCs’ case cleared the hump of summary judgment and will now proceed to trial. 

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products.

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security.  Here are four items to add to your fall to-do list, no #2 pencils required.

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to produce information to justify the sales price for their drugs.

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York.

Earlier this week Mintz Levin’s Privacy & Security Matters blog posted some useful “bytes” to consider for the latest installment of the “Privacy Monday” series.

Earlier this month, my colleague Andy Shin at ML Strategies co-authored an article in the American Journal of Managed Care for a special issue of Evidence–Based Oncology, focusing on personalized medicine.

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency).