Mondaq USA: Food, Drugs, Healthcare, Life Sciences
In today's world, there are a few things most people can agree on: Sean Connery was the best James Bond, ice cream is the perfect dessert for any season – and patent applications are expensive!
Fox Rothschild LLP
Loren D. Danzis, Jeffrey H. Nicholas and Elizabeth D. Sigety were featured in the Pennsylvania Business Daily article, "Blumberg Institute Hosts ‘Entrepreneur Spotlight' for Business, Biotech Leaders."
Reinhart Boerner Van Deuren S.C.
HHS touts the proposed rule as one that will result in a reduction of unnecessary hospital readmissions and infections, increase the quality of care, and strengthen safety measures for residents.
Thompson Coburn LLP
Today, July 24, 2015, the FDA announced that on Monday, July 27, 2015, the FDA is opening up a comment period on a supplemental proposed rule related to added sugars.
Duane Morris LLP
For the fifth time since 2013, the Centers for Medicare and Medicaid Services has extended its Medicare, Medicaid and CHIP enrollment moratoria for home health agencies and ambulance providers in certain geographic areas.
Jones Day
Health care providers, government contractors, and others defending investigations and lawsuits under the False Claims Act ("FCA") face many difficult strategic considerations.
Reed Smith
On July 8, 2015, the Centers for Medicare & Medicaid Services ("CMS") released proposed regulations "to reduce burden and to facilitate compliance" under the physician self-referral law known as the Stark Law. See 80 Fed. Reg. 41686, 41910 (July 15, 2015).
McDermott Will & Emery
This article is part of a series that takes an in-depth look at several proposals that would affect managed care organizations, health care providers and other industry stakeholders participating in, and contracting with participants of, state Medicaid and CHIP managed care programs.
Dentons (US)
With the recent announcement of Sarepta's filing for approval of its drug, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD), it has become clear that the role of patient advocates and patient-centered outcomes has had a significant favorable impact both upon the FDA and the development of products for rare diseases.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Today the Safe and Accurate Food Labeling Act of 2015 passed the House, in a vote of 275 to 150.
Thompson Coburn LLP
Cybersecurity is a hot topic at both the state and federal level. Specifically, Illinois is in the process of amending its Personal Information Protection Act ("PIPA").
McGuireWoods LLP
On June 14, 2015, Texas Governor Greg Abbott signed into law Senate Bill No. 519, which imposes new registration requirements on dental support organizations ("DSOs").
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On July 21, 2015, the Federal Circuit issued a divided decision in Amgen Inc. v. Sandoz Inc., interpreting two provisions of the Biologics Price Competition and Innovation Act.
Thompson Coburn LLP
In 1996, California voters passed Proposition 215 and California became the first state to legalize medical marijuana.
Thompson Coburn LLP
Illinois' "Compassionate Use of Medical Cannabis Pilot Program Act" creates an entire regime of laws, regulations and procedures by which individuals and companies are building medical cannabis growing facilities and dispensaries.
Sheppard Mullin Richter & Hampton
On July 14th, 2015, the Centers for Medicare and Medicaid's latest proposed rule introduced a new alternative payment model.
Fox Rothschild LLP
Although it may be debatable whether privacy is dead or still on life support, physicians have had to live with a system that allows hospitals, insurers, medical boards and others to discover some of their darkest secrets for a quarter century.
McDermott Will & Emery
On June 29, 2015, President Barack Obama signed the Trade Preferences Extension Act (the Act) into law.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
On July 21, 2015, UCLA became a defendant in a class action lawsuit after plaintiff Michael Allen filed the action in California federal court.
Wilson Elser Moskowitz Edelman & Dicker LLP
Numerous federal acts govern the introduction of products, including biotechnology products, into the environment.
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Morgan Lewis
Major changes to Stark law are ahead, including new exceptions for timeshare arrangements and employment of NPPs.
Frommer Lawrence & Haug LLP
Less than three years after implementation of the Inter Partes Review process, the life science industry is already calling upon Congress for significant reform.
Patterson Belknap Webb & Tyler LLP
The Biologics Price Competition and Innovation Act of 2009 was passed as part of health reform signed into law by President Barack Obama in March 2010.
Bradley Arant Boult Cummings LLP
Changes in the health care marketplace and uncertainties regarding the implementation and future of the Affordable Care Act have placed tremendous strain on not-for profit hospitals and health systems.
Supreme Court Decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission Prompts Legal Challenges to State Professional Boards.
On Monday, June 15, 2015, the Colorado Supreme Court confirmed what actions employers may take against employees in Colorado who use medical marijuana during off-duty time.
Anderson Kill
With the legalization for medical use in 21 states, and for adult use in Colorado, Washington, Alaska and the District of Columbia (and Oregon, effective July 1, 2015), the cannabis industry is said to be the fastest growing industry in the United States.
While the new law codifies payment for chronic care management under the Medicare physician fee schedule, effective immediately, it leaves many of the details largely to CMS’s discretion.
The Texas Legislature in Senate Bill 760 removed barriers to Medicaid recipients receiving healthcare services and required improved access for services through managed care plans.
Reed Smith
Most notably, MACRA permanently repeals the statutory Sustainable Growth Rate (SGR) formula, achieving a goal that has eluded Congress for years.
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