Opioids

FDA’s psychopharmacologic drugs and drug safety advisory committees, in a joint meeting on Thursday (Nov. 1). voted against approval of a proposed new opioid combination drug indicated to treat major depressive disorder.

CMS told states they do not need to defray the costs of new benefits that may be included in a revised essential health benefit (EHB) benchmark plan unless the coverage has been legislatively mandated, and encouraged states to implement revisions that would better address the opioid epidemic.

Two California men have pleaded guilty to conspiring to defraud Affordable Care Act plans in at least 12 states by enrolling people in coverage and transporting them to expensive drug treatment facilities in California that paid referral and other fees, the Department of Justice announced.

FDA will ask two of its advisory committees to weigh in on expanding the availability of naloxone for use in the community during a two-day meeting Dec. 17 and 18, the agency announced Tuesday (Oct. 23).

HHS Secretary Alex Azar touted the agency's Regulatory Sprint to Coordinated Care on Wednesday (Oct. 17), including upcoming work on 42 CFR Part 2 privacy requirements, and the administration’s fall unified agenda indicates the Substance Abuse and Mental Health Services Administration intends to publish a proposed rule on the privacy requirements next year.

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

Deputy Attorney General Rod Rosenstein praised the recently-passed opioid bill and said the Department of Justice is beefing up criminal prosecutions and civil penalties against over-prescribers of opioids and illegal distributors of synthetic opioids.

The Senate cleared a massive bicameral package of opioid legislation on Wednesday (Oct. 3) by a vote of 98-1, with Sen. Mike Lee (R-UT) as the sole “no” vote, and Sen. Ted Cruz (R-TX) not voting.

A partial repeal of the Medicaid IMD exclusion in the final opioid bill agreed to by the House and Senate conference negotiators will cost the federal government just over $1 billion over 10 years, the Congressional Budget Office said Thursday (Sept. 27).