What We're Reading: Medicaid Work Requirements; Orphan Drug Designations; OUD Drug Gets Approved

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Michigan’s plan to require Medicaid beneficiaries to show workforce engagement was approved by the Trump administration, while attorneys continue to challenge Arkansas’ own Medicaid work requirements; a new report from the Government Accountability Office has highlighted serious deficiencies with how the FDA administers the Orphan Drug Act; the FDA has granted tentative approval to a weekly and monthly treatment for moderate-to-severe opioid use disorder (OUD), but cannot grant final approval until another treatment’s exclusivity period ends.

More on States’ Medicaid Work Requirements

Michigan’s plan to require Medicaid beneficiaries to show workforce engagement was approved by the Trump administration. Able-bodied adults will have to show an average of 80 hours a month of engagement, which includes work, school, job training, community service, or substance abuse treatment, in order to keep their coverage, reported the Associated Press. The work requirements begin in 2020 and the waiver extends the program’s expansion through 2023. Meanwhile in Arkansas, attorneys continue to challenge the state’s Medicaid work requirements. The Associated Press also reported that the attorneys are citing the 17,000 people who lost coverage as evidence the requirements are a benefits cut, which is not allowed under federal law.

Trouble With Orphan Drug Designations

A new report from the Government Accountability Office (GAO) has highlighted serious deficiencies with how the FDA administers the Orphan Drug Act. According to The Center for Biosimilars^®, a sister site of The American Journal of Managed Care^®, the report found that the FDA does not consistently ensure all required information is appropriately recorded and used in the regulatory decision-making process. GAO found that from 2008 to 2017, hematology and oncology drugs accounted for more than half of all orphan drug approvals.

Opioid Use Disorder Drug Gains Tentative Approval

The FDA has granted tentative approval to Braeburn’s Brixadi, a weekly and monthly treatment for moderate-to-severe opioid use disorder. Philadelphia Business Journal reported that the FDA cannot grant final approval until exclusivity for Indivior’s Sublocade expires in late 2020. Until that exclusivity ends, which could be challenged, Brixadi is not eligible for marketing in the United States. The same product was approved in November by the European Commission and the Australian Therapeutic Goods Administration to be marketed outside of the United States as Buvidal.