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).

The final opioid legislation unveiled by House and Senate negotiators late Tuesday (Sept. 25) includes two controversial provisions -- one expanding Medicaid payments for opioid-abuse treatment in large inpatient facilities and another allowing non-physician providers to prescribe a drug used to treat opioid addiction.

The final opioid legislation negotiated by House and Senate negotiators includes a number of FDA-focused provisions, including measures to expand the agency’s authorities in international mail facilities; allow the agency to impose certain packaging and disposal requirements for drugs that pose serious risks; and let FDA require labeling changes for drugs when new effectiveness information emerges.

The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker is upset the Senate tucked into its recently passed opioid bill a provision expanding the sunshine law to require that drug and medical device makers also publicly disclose payments made to nurse practitioners, physician assistants and midwives – not just doctors and hospitals – for promotional talks, consulting and other interactions.

HHS’ Biomedical Advanced Research and Development Authority (BARDA) has entered into a contract with Opiant Pharmaceuticals, a company that develops nasal sprays for substance use and eating disorders, to develop a fast-acting, long-lasting intranasal form of nalmefene to reverse overdose, HHS announced Thursday (Sept. 20).

Despite being omitted from the Senate’s recently approved opioid bill, some rollback of a federal prohibition on using Medicaid funds to pay for substance-abuse treatment in large inpatient facilities may still be included in the final version of opioid legislation slated to be released in coming days, Senate aides say.

The Senate will vote on a package of opioid legislation Monday (Sept. 17), according to a spokesperson from Sen. Mitch McConnell’s (R-KY) office and the Senate Democrats’ online schedule.

As stakeholders urge the Drug Enforcement Administration to rethink its proposed cuts to opioid production quotas, which they fear could cause increased drug shortages, one health policy expert argues the quotas are unlikely to have that much of an effect on the drug supply, especially as most of the highly publicized shortages are a result of manufacturing and facility issues.