HHS/DoJ WOULD ISSUE "ADVISORY OPINIONS" ON LEGALITY OF SUPPLIER-PROVIDER DEALS UNDER INSURANCE REFORM MEASURE; RISK-SHARING PROTECTION ALSO INCLUDED
This article was originally published in The Gray Sheet
Health care-suppliers and providers could receive federal "advisory opinions" on the legality of their business arrangements under an anti-fraud provision in the health insurance reform legislation (HR 3103) reported out of a House/Senate conference committee July 31. The bill was adopted by the House on Aug. 1, followed by the Senate on Aug. 2.
You may also be interested in...
As arguments rage over whether the UK regulator has rushed its assessment of the Pfizer/BioNTech vaccine, the European Medicines Agency explains why its conditional marketing authorization approach is taking a little longer.
The IVDR implementation schedule is problematic. European notified bodies say solutions must be grasped if public health is not to suffer.
Amid several new and updated draft guidance documents and the potential approach of the first approval, interchangeability continues to be a buzzword in US biosimilars. AbbVie has projected that two Humira (adalimumab) biosimilars will hold the designation when they launch in 2023.