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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.

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:

  • Prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs.
  • Establishes and expands programs to support increased detection and monitoring of fentanyl and other synthetic opioids, including a new grant program for public health laboratories and a pilot program for point-of-use drug testing.
  • Increases the maximum number of patients that healthcare practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver).
  • Requires certain Medicaid quality health measures to include behavioral health measures.
  • The CMS must report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in a prescription drug plan under Medicare or Medicare Advantage.
  • The CMS must develop an action plan to provide recommendations on changes to the Medicare and Medicaid programs to enhance the treatment and prevention of opioid addiction, as well as coverage and payment of medication-assisted treatment.
  • In support for seniors, the bill requires electronic prescription programs to be able to securely transmit prior authorization requests for covered drugs under Medicare.
  • HHS must establish a public information dashboard that coordinates programs related to opioid-abuse reduction, allows data sharing between different programs and regions of the country, and recommends alternatives to controlled substances for pain management.
  • HHS must develop best practices for healthcare providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records.
  • Requires SAMHSA to designate Regional Centers of Excellence in Substance Use Disorder Education. Such centers must improve pain-management and substance-use disorder education through the distribution of evidence-based curricula for health care professional schools.
  • Requires SAMHSA to award grants to establish or operate at least 10 comprehensive opioid recovery centers across the country. Such centers must conduct outreach and provide specified treatment and recovery services, including approved drug treatments (e.g., methadone), counseling, residential rehabilitation, and job-placement assistance.
  • The FDA may require certain packaging and disposal technologies, controls, or measures to mitigate the risk of abuse or misuse of a drug or a class of drugs.
  • HHS must provide resources to early childhood care and education providers and other professionals working with young children on ways to recognize and respond to children who may be affected by a family member's or other adult's substance abuse.
  • For pharmacists, the bill calls on HHS to develop training programs and materials on the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or indicative of abuse or diversion.

Lastly, of note, neither the legislation, nor the President's comments about the bill addressed specifically individuals suffering from intractable chronic pain. At most, one provision calls for technical expert panels to recommend "pain management strategies." Most of the language focuses on finding non-addictive controlled substance alternatives and abuse-deterrent methods to counter opioid usage, without a plan for the patients suffering in between.   

 

 

Last updated on: October 26, 2018
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