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Federal Opioid Legislation Passed

October 25, 2018
Time and implementation strategies will tell whether new mandates can solve the US opioid crisis.
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In scope-changing regulatory news, President Trump used the one-year anniversary of declaring a national opioid public health emergency to sign into law the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” or for short, the SUPPORT for Patients and Communities Act). Passed by large bipartisan majorities in both the House and Senate, the legislation and aims to reduce “access to and the supply of opioids” while also expanding “access to prevention, treatment, and recovery services.”

The bill includes provisions that: require electronic prescribing of controlled substances under Medicare; promote the development of new, less addictive pain management medications; and temporarily expand access to MAT treatment for those on Medicaid. See other noteworthy provisions below.

US Capitol Building (Source: 123RF)

How much of a dent will the new legislation make? Lynn Webster, MD, past president of the American Academy of Pain Medicine, told CNN that it, "has the potential to make a small difference, but its potential effectiveness will depend on how the legislation is implemented.”  He added that a major challenge will be the healthcare community’s"lack of understanding the root causes for drug abuse and the way we manage the disease."

The American Medical Association also chimed in, concerned about the bill’s federal mandate for physicians to electronically prescribe controlled substances by January 2021. The association did note, however, that the legislation requires the DEA to update its regulations regarding the way in which how prescribers authenticate prescriptions using biometrics. See the AMA’s list of “10 ways the bill could help.”

FDA Commissioner Scott Gottlieb’s take on the bill centered on gaining more enforcement capabilities. For instance, the agency will be able to:

  • “more efficiently stop illegal, illicit, unapproved, counterfeit and potentially dangerous drugs from entering the US;”
  • “issue a mandatory recall order for any controlled substance if there is a reasonable probability that the controlled substance would cause serious adverse health consequences or death" (previously, such recalls could only be done on voluntarily); 
  • “advance efforts to reduce exposure to opioids as a way to lower the rate of new addiction;” and thus, allow the agency to require certain packaging, “such as unit dose blister packs, for opioids and other drugs that pose a risk of abuse or overdose.”

As part of the announcement, the White House shared the establishment over the past year of partnerships with several companies, including health insurance leaders, such as Cigna and Blue Cross Blue Shield, and national pharmacy chains, such as CVS Health and Walgreens. These organizations are working to implement a variety of programs aimed at curbing the opioid crisis, such as adding drug disposal sites  (note: October 27 is National Prescription Take-Back Day), awareness campaigns, and medical training. Even Amazon has programmed Alexa to answer important questions about opioids and addiction. See the full list of involved companies and their proposed actions. 

In addition, the First Lady’s “Be Best” program was highlighted. One of its components focuses on supporting families and children affected by opioids and raising awareness of neonatal abstinence syndrome.

Other noteworthy provisions, directly from the bill:

Last updated on: October 26, 2018