Read Health Law updates, alerts, news, and legal analysis from leading lawyers and law firms:
Generic Drugs to Market - What's the Climate in 2014?
What's Next in Health Reform 2014
Health Care Antitrust & the Supreme Court – Interview with Bruce Sokler, Member, Mintz Levin
What Employers Need to Know about Obesity in the Workplace
Next Accreditation System – Interview with Andy Roth, Member, Mintz Levin
Affordable Care Act Delays - What it Really Means for Employers
Innovative Exit Strategies for Life Sciences Companies – Interview with Bill Whelan, Member, Mintz Levin
The Affordable Care Act & the Impact on the C-Suite – Interview with Alden Bianchi, Member, Mintz Levin
The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
The Affordable Care Act: The Structure of Health Plans – Interview with Alden Bianchi, Member, Mintz Levin
Financing Trends in Life Sciences – Interview with Bill Whelan, Member, Mintz Levin
Building Strong Client Relationships – Interview with Andy Urban, Vice Chairman, Mintz Levin
The Transformation of the VC Business Model – Interview with Bill Whelan, Member, Mintz Levin
What Is Driving Stepped Up Government Health Care Enforcement? – Interview with Hope Foster, Member, Mintz Levin
Collaborative Development Financings by Richard Hsu
PODCAST - Inside Law- Hot Topics in Health Care From the President of the American Health Lawyers Association
Clinton: SCOTUS Myriad Genetics Decision 'Terrific'
PODCAST - Inside Law - HIPAA Changes Overview by Emily Wey
Going on the Offense: Proactive Strategies to Reduce Uncertainty
Craft Beer Boom in Michigan
Following enactment of the Drug Quality and Security Act last month, FDA has quickly issued a new guidance for compounding pharmacies that choose to not register as "outsourcing facilities" and subject themselves to federal...more
On Wednesday, Nov. 27, 2013, President Obama signed the Drug Quality and Security Act (the "Act"). The Act is an attempt by Congress to bring some compounding pharmacies that use certain bulk products under more federal...more
In This Issue:
- Snapshot of the Agency: FDA-regulated products
- Recent Public Health Milestones
- Innovative Programs at FDA
..A. FDA has a number of programs intended to speed the availability of...more
Under the Health Insurance Privacy and Accountability Act of 1996 (“HIPAA”), health plans, health care clearinghouses, and most health care providers (collectively, “Covered Entities”) must protect the privacy and security of...more
On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more
A new OIG Advisory Opinion 13-15, the OIG has resurrected the issue of whether awarding exclusive contracts to hospital based providers involves remuneration in exchange for referrals, because it grants the opportunity for...more
..Increase in penalties for non-compliance
-On 12 March 2014 substantial amendments to the Privacy Act come into effect. The new laws are backed by a significant increase in penalties for...more
In a thoughtful amendment to Washington’s Anti-Rebate Statute, the Legislature has aligned the parameters of chapter 19.68 RCW with those of the federal Anti-Kickback Statute, granting greater protection for EHR donation...more
What is new in the world of follow-on biologics?
Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more
A federal district court in Illinois recently issued a pair of rulings in cases where insurers sought to recoup payments from practitioners. Pennsylvania Chiropractic Association v. Blue Cross Blue Shield Association, 2013...more
Welcome to our series, “The 12 Days of Privacy” as we look to “gifts” that may be received this season and some of the big issues ahead ….
Day One – - HIPAA 2014 – Where will the Audit Trail Lead?
The year 2013...more
Approximately 300 employers and other organizations, many of which are in Northern California, were named as co-defendants in an ERISA class action lawsuit filed on November 22, 2013, in the U.S. District Court for the...more
Health care providers are competing in a dynamic environment with a host of challenges and opportunities. With the population aging, reimbursement rates declining, and government regulatory efforts expanding, health care...more
First you have the problem and then you have the litigation. This more-or-less iron rule of American life will be honored once again in the aftermath of the “roll out” of Obamacare.
The design and operational failures...more
On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance...more
Drakeford v. Tuomey and U.S. vs. Bradford Regional Medical Center -
With the Affordable Care Act and market forces driving consolidation and creative transactions across the health care industry, health care...more
The Supreme Court announced last week that it will hear two cases in which for-profit businesses are challenging the Affordable Care Act’s (“ACA”) “contraceptive mandate” on freedom of religion grounds. The key issue before...more
I can think of only three reasons why you might want to know about the Business Court's decision in Sykes v. Health Network Solutions, 2013 NCBC 53:
- You are a chiropractor or you live with one.
- You are...more
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act. Title I of this law—entitled the Compounding Quality Act (the "CQA")—allows the federal Food and Drug Administration (FDA) to oversee...more
The New York Times recently reported that it found that the amount paid by a patient’s insurance plan for a routine colonoscopy varies significantly: between $740 and $8,500, depending upon the location, the particular...more
In Granger v. Christus Health Central Louisiana d/b/a Christus St. Francis Cabrini, the Louisiana Supreme Court ruled that medical staff bylaws are a contract between the hospital and a the medical staff member....more
The U.S. District Court for the Central District of California recently upheld coverage under a commercial general liability policy for a hospital data breach that compromised the confidential medical records of nearly 20,000...more
The pool of potential qui tam relators may have just shrunk a little, based on a recent decision by the 2nd Circuit Court of Appeals that has put the ability of in-house lawyers to become qui tam relators into serious...more
It is often said that advisory opinions are requested from the U.S. Office of Inspector General (OIG) when one wants a very safe deal blessed or when one wants to dissuade a competitor or counter-party from entering into or...more
In a series of new bills amending existing California privacy laws, the State of California increases the protections presently provided to its residents by broadening the requirements for reporting breach of personal data;...more