The method includes receiving, with a computer system after a claim requesting at least partial insurance coverage of a cost associated with the prescription drug has been submitted to an insurance benefits manager, a notification that prior authorization has been required. Before the request for ...
Before any clinical trials can start, Form FDA-1571 must be completed and submitted to the FDA.1 Indeed, US Federal law requires that a drug be the subject of an approved marketing application such as an IND before ...
In a recent op-ed, ophthalmologist and Executive Vice President of the California Academy of Eye Physicians and Surgeons, Dr. Craig H. Kliger points out that Aetna now requires prior-authorization for all cataract surgeries. He is astounded. And rightfully so. According to Aetna, prior-authorizat...
Developing an effective clinical supply chain strategy requires careful planning and coordination to ensure that the product is available when and where it is needed while meeting regulatory requirements and standards for quality and safety. R...
Under a prior pre-emergency use authorization, Emergent had been delivering millions of doses of the vaccine to the U.S. national stockpile. Cyfendus aims to be a next-generation, adjuvanted upgrade to its predecessor BioThrax, also developed by Emergent, which has been in use s...
See the listing for each drug or the Prior Authorization section for more information. Over-the-counter medications The PDL covers select over-the-counter (OTC) products. You are encouraged to prescribe OTC medications when clinically appropriate. Generic substitution The PDL requires generic ...
While the Draft Regulation requires that an MAH shall have the capability of compensation for liability, it does not explicitly impose that requirement on the local agent. Given that the local agent should fulfill the MAH’s obligations, it is important that the MAH selects its local agent ...
Using Medicare data, researchers examined trends in Part D plans excluding compounds from coverage or applying one of two utilization restrictions: "prior authorization," which requires plan members to get approval before filing a prescription; or "step therapy," which requires plan members to try ...
The advantage of tools such as prior authorization is that they might be more responsive to individual patients' needs than more blunt instruments such as beneficiary cost sharing or closed formularies, which are imposed uniformly on all beneficiaries, regardless of clinical need. The disadvantage is...
3 of 4 Medication Quetiapine XR (Seroquel XR) Teriparatide (Forteo) Vismodegib (Erivedge) Status Notes PA Seroquel XR now requires prior authorization: reserved for patients with significant documented compliance concerns. The immediate-release tablets are available as low-cost generics and are ...