News & Analysis as of

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

OIG Releases Report on Medicaid Fraud Control Units

The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2013 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCU)...more

FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers

Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of...more

FDA Updates Guidance Addressing Distribution of Scientific and Medical Publications on Unapproved New Uses

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The draft guidance,...more

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

China Introduces New Health Care Sector Anti-Corruption Regulations

China Introduces New Health Care Sector Anti-Corruption Regulations As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and Family Planning...more

The Healthcare Industry And Chief Compliance Officers

The healthcare industry has been an innovative leader in developing compliance tools and strategies. They have come by it honestly – prosecutors and HHS-OIG have been pounding on pharmaceutical companies, medical device...more

Drug and Device Manufacturers Beware: Comments Could Result in FDA Troubles

After appearing on CNBC television show Fast Money, the CEO of Aegerion Pharmaceuticals received a warning letter from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion. The agency...more

More Open Questions About Open Payments Under the Sunshine Act

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...more

Justice Department Announces $3.8 Billion In False Claims Act Recoveries In FY 2013

On December 20, 2013, the Justice Department announced a total of $3.8 billion dollars in settlements and judgments from civil cases involving the False Claims Act for Fiscal Year (FY) 2013. Total recoveries under the False...more

What Hath GSK Wrought? More Compliance Lessons From China

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical Affairs Law

On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more

Physician Groups Seek Sunshine Act Changes

Seventy-four state and federal physician organizations, including the American Medical Association, recently asked the Centers for Medicare & Medicaid Services (“CMS”) to exclude textbooks and peer-reviewed medical journal...more

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments and Unsealed Cases: September 2013

Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more

The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin [Video]

Attorney Karen Lovitch, Practice Leader of Mintz Levin's Health Law Practice, discusses the challenges facing pharmaceutical and medical device manufacturers in complying with the Sunshine Act....more

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

FTC Investigations of Pharma and Medical Device Transactions – Am I at Risk?

A recent article in the Antitrust Law Journal titled “A Survey of Evidence Leading to Second Requests at the FTC,” by Darren S. Tucker, an attorney advisor to a FTC Commissioner who reviewed non-public information on the...more

Ready or Not – Sunshine Act Data Collection Starts Today

Today pharmaceutical and medical device manufacturers and group purchasing organizations (“GPOs”) start to collect data on their financial arrangements with physicians and teaching hospitals to comply with the Physician...more

Client News Alert: Regarding Physician Payments Sunshine Act

On August 1, 2013 a new reporting obligation under the federal Physician Payments Sunshine Act (“Sunshine Act”) takes effect. The Sunshine Act was originally signed into law on March 23, 2010, as part of the Patient...more

Ten Required Steps To Ensure Effective Compliance Programs By Pharmaceutical And Medical Device Companies (Part III Of III)

In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more

Astros Swept Again – Is A China Sweep Coming Next?

What is a sweep? It is certainly a well-known and relevant term in the sporting world....more

Pharmaceutical And Medical Device Companies: Taking It On The Chin (Part II Of III)

As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring. ...more

Bad News For The Drug And Device Industries: Glaxo’s Systemic Breakdown In China (Part I Of III)

Mark Twain, one of my favorite authors, always said it best – “Do the right thing. It will gratify some people and astonish the rest.” - For drug and device companies, Mark Twain’s observation is becoming the industry...more

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