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.
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.
Since the last Jones Day Update, FDA determined that JADELLE (levonorgestrel) Implant, 75mg was not withdrawn for reasons of safety or effectiveness.
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.
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).
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.
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.
According to Center for Drug Evaluation and Research reports, FDA has approved 27 new drugs so far this year.
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.
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.