Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Krokidas & Bluestein
The Centers for Medicare & Medicaid Services ("CMS") surprised many health care providers in enacting its final rule on consolidating medical staffs (the "Final Rule").
Pepper Hamilton LLP
The "Purple Book," will list all biological products, including any biosimilar and interchangeable biological products, licensed by the FDA.
Foley & Lardner
The Report indicates that payers are becoming more interested in the concept of personalized medicine as more targeted therapies enter the U.S. market.
Thompson Coburn LLP
The HIPAA Omnibus Rule, enacted last year, made a number of changes to the HIPAA privacy, security and breach notification rules.
Jones Day
A topical cream product manufacturer recalled a mole, wart, and skin tag remover for lack of FDA approval.
Sheppard Mullin Richter & Hampton
The New York Times noted big changes to estimated Medicare spending in the latest Congressional Budget Office report published last week.
The Department of Health & Human Services OIG issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy to pay local pharmacies a per-fill fee.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Why does the FCPA seem to attract government investigations into the practices of health care companies specifically, and what should my company be worried about?
Strasburger & Price, L.L.P.
In June 2014, the office manager at a hematology and oncology center pleaded guilty to purchasing and selling unapproved and improperly labeled chemotherapy drugs.
Jones Day
Since the last Jones Day Update, FDA determined that JADELLE (levonorgestrel) Implant, 75mg was not withdrawn for reasons of safety or effectiveness.
Jones Day
In the September 4, 2014, Federal Register, FDA announced its establishment of a public docket to discuss issues related to developing drugs for Duchenne Muscular Dystrophy.
Jones Day
In the September 3, 2014, Federal Register, FDA issued a final order classifying early growth response 1 ("EGR1") gene fluorescence in-situ hybridization ("FISH") test system for specimen characterization into class II (special controls).
Jones Day
In the August 27, 2014, Federal Register, FDA announced the fee rate for tropical disease priority review vouchers, in addition to the normal PDUFA fee, will be $2,562,000.
Arent Fox LLP
The United States Department of Justice filed an action against two nursing homes located in Watsonville, California for defrauding the Medicare and Medicaid programs.
Sheppard Mullin Richter & Hampton
As reported in the New York Times, Walmart has taken the plunge into the retail primary care healthcare delivery market.
McGuireWoods LLP
CMS issues final roll on ACA re-enrollment process. SHOP small business exchange early access will launch in five states. Pennsylvania "private option" Medicaid expansion waiver granted.
Jones Day
According to Center for Drug Evaluation and Research reports, FDA has approved 27 new drugs so far this year.
Jones Day
The Drug Enforcement Agency announced aggregate production quotas for Schedules I and II controlled substances and List I chemicals manufactured in 2015.
Ropes & Gray LLP
CMS and the ONC issued a final rule that adopts, without significant alteration, modifications to the EHR Incentive Programs described in the May 23, 2014 proposed rule.
Jones Day
The memo ordered all federally funded labs that handle animal or plant materials that are infectious agents or toxins to spend a month reviewing safety and security plans.
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Venable LLP
The Affordable Care Act (ACA) imposes new reporting requirements on employers and insurance companies offering health coverage.
Littler Mendelson
On January 10, 2014, the Internal Revenue Service released final regulations governing the employer shared responsibility provisions of the Affordable Care Act.
Ropes & Gray LLP
The Food and Drug Administration took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices.
Klein Moynihan Turco LLP
Amidst the publication of the Federal Drug Administration's ("FDA") draft e-cig regulations and New York City, Chicago and Los Angeles banning the indoor use of e-cigs, the World Health Organization ("WHO") chimed in this week voicing its approval of the United States' proposed treatment of e-cigs.
Reinhart Boerner Van Deuren S.C.
The government is taking aggressive action after years of warning nursing homes and hospices about requesting or providing illegal compensation.
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.
Littler Mendelson
On August 28, the IRS released draft instructions for completing health insurance reporting forms required under the Affordable Care Act.
Jones Day
The Affordable Care Act ("ACA") infuses new complexities into collective bargaining negotiations over health insurance benefits.
Littler Mendelson
For several years, nurses’ unions have lobbied, with varying success, for legislation implementing nurse-patient ratios.
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.
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