A new OIG report reviews Medicare Part B spending on drugs purchased by eligible health care providers through the 340B drug discount program.
The Obama Administration has released its latest regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity.
CMS is holding a town hall meeting on February 16, 2016 to discuss fiscal year (FY) 2017 applications for add-on payments for new medical services and technologies under the Medicare IPPS.
CMS has announced that the Advisory Panel on Hospital Outpatient Payment (HOP Panel) will hold its next meeting on March 14-15, 2016.
Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle...
Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants, November 18, 2015, Federal Register.
McDermott Will & Emery
The guidance contains specific recommendations on the use of the term GMO for genetically modified organism.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects could add a 30-day comment period extension to the things they were grateful for at this year's Thanksgiving dinner.
On November 18, 2015, the House Energy and Commerce Committee approved several public health policy bills.
President Obama has signed into law S 799, the Protecting Our Infants Act of 2015, which is intended to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome (NAS).
Hanson Bridgett LLP
On October 5, 2015, Governor Brown signed the controversial End of Life Option Act, making California the fourth state to enact legislation allowing terminally ill individuals to take life-ending drugs.
Cadwalader, Wickersham & Taft LLP
The ultimate fate of Executive Order 38, together with the promulgated regulations, still remains uncertain.
Day Pitney LLP
A new proposed bill in New Jersey would require healthcare providers to disclose to patients in advance whether their services are covered in-network by the patient's health insurance plan.
In the October 27, 2015, Federal Register, FDA issued a final order classifying an autosomal recessive carrier screening gene mutation detection system into class II (special controls).
In the November 2, 2015, Federal Register, FDA issued a final order classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls).
Wilson Elser Moskowitz Edelman & Dicker LLP
In Rojas v. Cigna Health and Life Ins. Co., 793 F.3d 253, 258 (2d Cir. 2015), the Second Circuit joined several other circuits in holding that "healthcare providers are not 'beneficiaries' of an ERISA...
In the November 17, 2015, Federal Register, FDA issued a reproposal of a proposed rule to classify IVD devices for Bacillus species (spp.) detection into class II (special controls)...
In the November 17, 2015, Federal Register, FDA issued a priority review voucher to the sponsor of a rare pediatric disease product application for Strensiq (asfotase alfa), manufactured by Alexion Pharmaceuticals, Inc.
In the November 18, 2015, Federal Register, FDA published a list of premarket approval applications ("PMAs") that have been approved between July 1, 2015, and September 30, 2015.