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Employment Matters: The Affordable Care Act’s Reporting Requirements for Carriers and Employers

October 5, 2015 | Blog | By Carrie Roll

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.
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Just in Time for the Phase II Audits: OIG Criticizes OCR’s Enforcement Efforts

October 1, 2015 | Blog | By Dianne Bourque

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."
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“Two-Midnight” Rule Needs Tweaking, Says Federal Judge

September 28, 2015 | Blog

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.
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CMS Publishes Long-Awaited PAMA Proposed Rule

September 28, 2015 | Blog | By Karen Lovitch

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).
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DOJ Clarifies Position on Individual Accountability in Corporate Investigations

September 28, 2015 | Blog

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.
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Hot Topics in Laboratory Compliance at AHLA’s Fraud and Compliance Forum

September 24, 2015 | Blog | By Bridgette Keller

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.
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Trouble Brewing for International Data Transfers Under U.S.-EU Safe Harbor

September 23, 2015 | Blog | By Dianne Bourque

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.
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Upcoming AHLA Webinar - Behavioral Health and ACOs

September 22, 2015 | 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.” 
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September Health Care Qui Tam Update

September 21, 2015 | Blog | By Brian Dunphy

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.
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Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

September 17, 2015 | Blog | By Joanne Hawana

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.
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Medicare to Permit Value-Based Insurance Design in Medicare Advantage Plans

September 16, 2015 | Blog

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.
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Executives Should Take a Closer Look at Insurance Coverage after New DOJ Policies

September 16, 2015 | Blog

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.
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DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability

September 11, 2015 | Blog | By Eoin Beirne, Bridget Rohde

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.
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Exellus BlueCross BlueShield – Latest Victim of a “Sophisticated” Health Plan Cyberattack

September 11, 2015 | Blog | By Dianne Bourque

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.
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Drastic Changes Proposed for Clinical Research Rules

September 8, 2015 | Blog | By Dianne Bourque

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. 
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Kissing Camels Antitrust Suit Clears the Hump of Summary Judgment

September 3, 2015 | Blog | By Dionne Lomax

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. 
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FDA’s New Four-Letter Guidance on Biosimilars

August 31, 2015 | Blog | By Joanne Hawana

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.
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Back to School – HIPAA 101

August 27, 2015 | Blog

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.
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State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

August 26, 2015 | Blog

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.
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Off-Label Marketing and the False Claims Act

August 21, 2015 | Blog

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.
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