Health Care

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and their impact on pharmacies and dispensers.

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program.

Last month, the Arkansas State Medical Board’s Telemedicine Advisory Committee indicated that it was in the process of drafting a rule that would allow establishment of a physician-patient relationship through the use of real-time audiovisual communication rather than an in-person visit.

On September 29, 2015, our colleague, Alden Bianchi, posted the latest installment of the Affordable Care Act’s Reporting Requirements for Carriers and Employers on Mintz Levin’s Employment Matters blog.

As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of the Office for Civil Rights' (OCR) HIPAA enforcement performance, effectively giving OCR "something to prove."

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.

Late on Friday afternoon the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule (MCLFS) made by the Protecting Access to Medicare Act of 2014 (PAMA).

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.

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.

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.

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 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.