Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Strasburger & Price, L.L.P.
There is something inherently troubling when a prescription drug manufacturer argues in favor of parallel claims under state law.
Pepper Hamilton LLP
California hospitals are subject to a significantly increased risk of being fined when state authorities find deficiencies in their compliance.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Vermont's senate passed a GMO labeling bill that goes into effect without any "stinkin' other states."
Ostrow Reisin Berk & Abrams
Claim denials are a huge financial drain on physician practices.
Sheppard Mullin Richter & Hampton
We are pleased to share an article written by Dennis Eder and Hank Osowski, titled "Provider Sponsored Health Plans," available here.
Jones Day
FDA is streamlining the reporting process for medical device removals and corrections, according to a recent article in "Regulatory Focus".
Jones Day
FDA Commissioner Margaret Hamburg discussed the need for greater engagement with drug companies to develop new treatments for patients.
Jones Day
The level of attention garnered by the approval of Zohydro ER, and the efforts to overturn that approval, is perhaps unprecedented.
McGuireWoods LLP
Tendyne has announced it has secured $25 million in series C financing.
Waller Lansden Dortch & Davis
Government investigations, particularly those alleging violations of the False Claims Act, are an unfortunate fact of life in the healthcare industry.
Fox Rothschild LLP
What happens when the Food and Drug Administration (FDA) grants an accelerated approval for a prescription drug and postmarketing clinical trials reveal information that would require alterations to the drug’s labeling?
Reed Smith
On April 11, 2014, President Obama formally nominated Sylvia Mathews Burwell to replace Kathleen Sebelius as Secretary of Health and Human Services (HHS).
Reed Smith
CMS is hosting a provider call on May 19, 2014 regarding the Clinical Laboratory Improvement Amendments Individualized Quality Control Plan.
Jones Day
Celltrion Healthcare became the second company developing a biosimilar to file a declaratory judgment action before filing a licensure application.
Jones Day
On April 11, 2014, Kathleen Sebelius resigned from her post as Secretary of Health and Human Services (HHS).
Jones Day
On April 3, FDA published the much-anticipated report proposing a regulatory framework for health information technology.
Reed Smith
The HHS Office of Inspector General recommended that CMS limit Medicare hospital outpatient prospective payment system payments for some procedures.
Strasburger & Price, L.L.P.
On April 15, 2014, in Zogenix v Deval Patrick 1:14-cv-11698-RWZ, the U.S. District Court in Massachusetts ruled that the Commonwealth overstepped its power to regulate the practice of pharmacy and medicine by, effectively reversing the Food and Drug Administration's approval of the opioid analgesic Zohydro ER
Reed Smith
CMS is hosting Special Open Door Forum calls to solicit feedback on data elements for a new "Suggested Electronic Clinical Template for Home Health."
Fox Rothschild LLP
If you have ever bought or sold a business, or you have experience with the process, you are aware of the due diligence efforts and multiple agreements required to close the deal.
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McDermott Will & Emery
Recently issued final regulations on the employer reporting requirements under the Affordable Care Act clarify and streamline the process for reporting information relating to the provision of minimum essential coverage and health insurance coverage offered under employer-sponsored plans.
Jones Day
The Affordable Care Act ("ACA") infuses new complexities into collective bargaining negotiations over health insurance benefits.
Littler Mendelson
Despite the many Affordable Care Act implementation delays, rules governing the healthcare law’s various provisions have not stopped coming.
Proskauer Rose LLP
On October 31, 2013, the Internal Revenue Service (IRS) released Notice 2013-71 (Notice), which modifies the "use or lose" rule for health flexible spending accounts (health FSAs) to allow a $500 annual carryover of unused contributions, provided that cafeteria the plan offering the health FSA does not incorporate the "grace period" rule.
Although HIPAA does not create a private cause of action, a recent Indiana Superior Court jury verdict demonstrates that HIPAA still could play an important role in private causes of action in state court based on negligence and professional liability as it relates to confidentiality.
Waller Lansden Dortch & Davis
The United States Department of Justice recently filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities, alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill.
Littler Mendelson
On January 10, 2014, the Internal Revenue Service released final regulations governing the employer shared responsibility provisions of the Affordable Care Act.
Littler Mendelson
For several years, nurses’ unions have lobbied, with varying success, for legislation implementing nurse-patient ratios.
Holland & Knight
On April 7, 2014, the Centers for Medicare and Medicaid Services (CMS) released its Medicare Part C and Part D Final Call Letter. - See more at:
Reed Smith
The CMS has released its 2015 rate announcement and final call letter for Medicare Advantage and Part D prescription drug plans.
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