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In Virginia, Medicaid must cover hormonal contraceptives and prevents certain utilization controls. In Kentucky, the cost of insulin is capped at $30 for a 30-day supply and requires it to be in a plan’s lowest tier Utah passed a similar law.
#Amcp dossier software
In Utah, a new law requires a pharmacy software system that receives electronic prescriptions for a controlled substance to allow an unfilled prescription to be transferred to a different pharmacy.Ī number of states passed laws regarding cost-sharing, tier restrictions, formulary requirements, and other utilization management tools. On the state level, there are 5 priorities for the organization, said Adam Colburn, JD, manager, Policy and Government Relations, including meaningful transparency on drug pricing and patient cost-sharing the development of metrics to shift pharmaceutical payments to value-based care data sharing and interoperability of electronic health records advocating for the group’s position on formulary requirements, tier restrictions, and coverage mandates and supporting the use of managed care tools.Īlthough dozens of bills regarding these issues have been filed around the country, in most of their priority areas, few bills have actually become laws.
The act that reauthorizes PDUFA could be one way to get PIE through Congress, she said AMCP is also considering a stand-alone bill.ĪMCP is also monitoring which health care provisions could become permanent, or not, in the American Rescue Plan, such as those related to telehealth, COVID-19 strategies around testing, treatment, and immunization, and the use of utilization management tools. Currently, payers do not begin their evaluations until after a drug is approved. This would speed patient access to therapies, said Mathieu.
#Amcp dossier trial
The idea is to have 2 steps, now separate in the current process, happen simultaneously, she said: As a developer submits its product to the FDA for review, payers and health plans could begin an evaluation of clinical trial and economic information at the same time in order to calculate demand and budgetary impacts. PDUFA is reauthorized by Congress every 5 years, and fees generated by industry fund about 70% of the FDA’s drug review budget.ĪMCP has been advocating for the idea of a PIE for several years, and to that end, will begin work with a new government affairs firm this spring to outline a plan for approaching Congress, Mathieu said. Mathieu said that industry representatives will begin talks with Congress later this year, with recommendations due by January 3, 2022. Notably, PDUFA VI expires September 2022. Mathieu, MA, director, Government Relations, kicked off the virtual session by reviewing various items of interest from a managed care pharmacy perspective at the federal level, including COVID-19 relief, drug pricing, supply chain issues, and the Biden administration’s “Build Back Better” plan. The Academy of Managed Care Pharmacy's (AMCP) number one federal legislative priority for 2021 is the enactment of a preapproval information exchange (PIE), either through a stand-alone bill or in a new Prescription Drug User Fee Act (PDUFA), according to the organization.īesides federal legislation to watch, AMCP’s government and regulatory affairs professionals reviewed regulatory issues as well as trends in state capitols, including bills that would affect various aspects of utilization management, during a session at AMCP 2021.
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