Senate opioid bill passes, but industry leaders lament shortcomings

The Opioid Crisis Response Act of 2018 passed through the U.S. Senate by a 99-1 vote on Monday, but response from the addiction treatment industry was decidedly more mixed. Several organizations issued statements praising the Senate for passing the bill while still lamenting key elements that were not included.

The legislative package was crafted by five Senate committees from more than 70 proposals after seven hearings that included representatives from the U.S. Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, state legislators and industry leaders. It follows similar legislation that passed through the House in June. A final version that reconciles the two is expected to reach President Donald Trump’s desk for signing by early October.

What the Senate’s bill includes

The bill passed by the Senate on Monday includes the Synthetics Trafficking and Overdose Prevention (STOP) Act, introduced by Sen. Rob Portman (R-OH) in an attempt to crack down on fentanyl shipments into the U.S. by requiring the Postal Service to gather advance electronic data on packages entering the country similar to what is required of private carriers.

The Senate bill also gives the FDA the authority to create limited-amount packaging for opioids, such as three- or seven-day supplies, and to require opioid manufacturers to provide patients a safe and simple way to dispose of leftover drugs as part of the packaging.

The bill will also:

• Enable federal agencies to focus funds on areas hit hardest by the opioid crisis, and permit states and Native American tribes to direct funds to local treatment needs
• Require HHS to issue best practices for entities operating recovery housing facilities
• Require the Secretary of HHS to issue a report on the impact of laws regulating the lengthy, quantity or dosage of opioid prescriptions
• Expand a grant from the Comprehensive Addiction and Recovery Act for additional first responder training on administration of a drug or device to treat an opioid overdose

What’s not included

In statements issued by their respective agencies, several industry leaders expressed disappointment over certain elements not being included in the bill.

Linda Rosenberg, president and CEO of the National Council for Behavioral Health, criticized the legislative package for not providing “the one thing communities hit by the opioid crisis need most: funding,” specifically by not including the Excellence in Mental Health and Addiction Treatment Expansion Act, which would expand the current eight-state, two-year Certified Community Behavioral Health Clinics program.

National Council also supported lifting the Institutions for Mental Diseases exclusion, which the Senate did not include in its bill.

“To truly address the root causes of the opioid crisis, we need to invest in the full continuum of behavioral health services,” Rosenberg said. “We need a comprehensive solution. This package of bills does not achieve that.”

The Partnership to Amend 42 CFR Part 2, a coalition of healthcare organizations advocating for the alignment of 42 CFR Part 2 with HIPAA for the purposes of treatment, payment and healthcare operations, said in a statement that it was disappointed that, unlike the House bill passed in June,  enhanced privacy and confidentiality provisions for substance use disorder records, Part 2, were excluded from the Senate bill.

“Modernizing Part 2, federal regulations that govern confidentiality of drug and alcohol treatment and prevention records, is essential for providing safe, high-quality treatment and care coordination,” the partnership said in a statement. “Aligning Part 2 with HIPAA will bolster the effectiveness of other key provisions in the opioid package that promote coordinated care and expand access to treatment.”

As the legislation moves to the committee that will reconcile the House and Senate bills, the National Association of Addiction Treatment Providers also urged legislators to adopt the House’s language on amending 42 CFR Part 2 and to also remove the IMD exclusion for Medicaid patients.

“The House version will provide critical patient confidentiality while allowing for the use of electronic medical records,” NAATP said in its statement. “It would move substance use disorder treatment into the mainstream of primary medical care.”