Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (Public Law 115-271)

The Policy

Synopsis

The SUPPORT for Patients and Communities Act (PL 115-271) represents the most significant legislative action to date addressing the ongoing opioid crisis in the United States. To this end, the law amends several previous pieces of legislation surrounding welfare programs, law enforcement, licit and illicit drug use, and public health, among other measures. The laws affected include:

The additions to these acts are broken down into eight different titles within the bill; each are addressed below excluding Title IV, which deals with offsetting budgetary changes:

  • Title I – Medicaid Provisions to Address the Opioid Crisis
    • Incarcerated juveniles who are eligible for Medicaid assistance will have their eligibility suspended during incarceration with the potential for reinstatement after they are released; previously, their eligibility was terminated following their release;
    • Former foster youth will be able to keep their Medicaid coverage until the age of 26;
    • States must have safety provisions in place to monitor opioid refills and concurrent opioid prescriptions;
    • The Department of Health and Human Services (HHS) will be required to issue best practices and guidance regarding infants with neonatal abstinence syndrome and states will provide improved care for infants and mothers in the form of prenatal services and residential pediatric recovery centers;
    • Increased flexibility for patients attempting to access non-opioid treatment options;
    • Enhanced opioid addiction treatment programs including initiatives to provide housing, telehealth, and food assistance to Medicaid recipients with opioid use disorder; and
    • Providers and managed care entities between states will have enhanced abilities to share data regarding opioid prescription data.
  • Title II – Medicare Provisions to Address the Opioid Crisis
    • Statutes regarding telehealth service restrictions will be relaxed to increase accessibility to treatment regardless of geographic location;
    • Screening for opioid use among seniors during Medicare wellness visits will become more stringent and seniors will be referred to treatment as deemed appropriate;
    • Beneficiaries identified as being at-risk of abusing prescriptions will be mandated to join a drug management program; and
    • Credible allegations of fraud against pharmacies will result in a suspension of Medicare payments.
  • Title III – FDA and Controlled Substance Provisions
    • The Food and Drug Administration (FDA) will issue updated guidance on how non-opioid pain treatments plans could be expedited;
    • The FDA will develop new, evidence-based guidance on when opioid analgesic prescriptions should be used versus when alternatives should be implemented;
    • The FDA will be given new authority to issue orders requiring manufacturers, importers, distributors, and pharmacists to cease distribution of controlled substances if it determines that there is reasonable probability the controlled substance could have serious adverse health consequences;
    • Labeling requirements for post-market changes will be tightened and the FDA will have increased authority to modify adverse drug reaction labels;
    • Clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists will be given permanent authority to prescribe medication-assisted treatment to up to 100 patients at a time;
    • Qualified employees of hospice-care centers will be authorized to dispose of controlled substances following patient death so that fewer prescriptions are diverted for illicit use;
    • The Attorney General will be granted authority to issue special waivers for healthcare providers to facilitate prescription of controlled substances via telemedicine when in-person consultations are not possible;
    • The Drug Enforcement Administration (DEA) will be required to consider diversion, abuse, overdose deaths, and public health impacts when setting its annual opioid quota, and will also be required to issue reports explaining why they set their quota where they do; and
    • The DEA will be required to design a database for the collection of all suspicious orders reported by registrants and share this data with the states.
  • Title V – Other Medicaid Provisions
  • Title VI – Other Medicare Provisions
    • HHS must conduct a study reporting on the adequacy of access to abuse-deterrent opioid formulations and the effectiveness of abuse-deterrent opioid formulations in preventing opioid misuse or abuse;
    • The annual Medicare & You handbook for Medicare beneficiaries must include references to educational resources regarding opioid use, descriptions of alternatives, and suggestions that beneficiaries consult their physicians before using opioids;
    • $75 million will be made available from the Supplementary Medical Insurance Trust Fund for providing outreach and education to outlier prescribers of opioids to reduce the amount of opioid prescriptions filled;
    • HHS will annually notify prescribers when they have been identified as outlier prescribers of opioids relative to others in their specialty and geographic area;
    • HHS must review payments made via the Outpatient Prospective Payment System to ensure there are no financial incentives to prescribe opioids instead of non-opioid alternatives; and
    • Open payment, or ‘sunshine’ programs, will be expanded so that more professionals will be required to report instances where drug and device manufacturers compensate them in any way.
  • Title VII – Public Health Provisions
    • HHS, in coordination with the Surgeon General, will submit a report to Congress on the effects of rising synthetic opioid use among adolescents and young adults;
    • First responders will receive grants to facilitate additional training on how to deliver drugs or devices to reverse opioid overdose such as naloxone;
    • Grants will be issued to state and local agencies to improve detection of synthetic opioids such as fentanyl;
    • HHS must develop indices describing how to measure success in curtailing the opioid crisis;
    • The National Institutes of Health (NIH) will be granted the authority to fund studies to find new, non-addictive drugs for pain management;
    • HHS must develop best practices for prominently displaying substance use disorder treatment information in electronic health records and educate providers, patients, and families about permitted disclosures of patient records;
    • HHS must develop strategies for protecting and educating pregnant women and mothers about pre-natal opioid use and pain-management strategies;
    • Substance Abuse and Mental Health Services Administration (SAMSHA) will receive allocated funds to establish comprehensive opioid recovery centers;
    • The Department of Education, in coordination with SAMSHA, will be authorized to issue grants to increase student access to trauma support services related to substance use;
    • The Centers for Disease Control and Prevention (CDC) will be authorized to expand its programs to prevent the spread of infectious diseases associated with illicit drug use (e.g. viral hepatitis, HIV, infective endocarditis);
    • Funds will be provided for the Building Communities of Recovery program to support long-term peer-based recovery programs; and
    • HHS will establish a program to support the reentry of patients with substance use disorder into the workforce.
  • Title VIII – Miscellaneous
    • A new one dollar fee will be applied on Inbound Express Mail Service items to support U.S. Customs and Border Protection (CBP) and the U.S. Postal Service (USPS) in their effort to curtail importation of illicit opioids;
    • The CBP and the USPS will collaborate with other Federal agencies to develop technologies to improve the detection of synthetic opioids entering the United States by mail; and
    • The Department of Labor will disburse grants to states via the Workforce Innovation and Opportunity Act to provide job training and treatment services to communities significantly impacted by opioid abuse.

Context

Tracing the etiology of crises such as the opioid epidemic is no simple matter. However, according to the National Institute on Drug Abuse (NIDA), the crisis can be partially traced back to a change in opioid prescription patterns that began in the late 1990s. “[P]harmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive.” Between 1992 and 2012, the number of opioids prescribed per year jumped from 112 million to an unprecedented 282 million.

According to the CDC, this over-prescription of opioid pain medication precipitated two related public health crises. First, in 2010, deaths due to heroin began to rise, which the President’s Commission on the Opioid Crisis attributes to a combination of prescription opioid crackdowns and an influx of cheap, pure, black-market heroin. Notably, the report presented by this Commission asserts that 80% of heroin users report having first misused prescription opioids before transitioning to heroin.

In addition, there has been an even sharper rise in deaths associated with synthetic opioids (e.g. fentanyl and carfentanil) from 2013 to 2018. These related compounds are particularly dangerous because they are many times more potent than other prescription opioids (e.g. hydrocodone) or heroin, increasing the risk of accidental overdoses. In 2010, NIDA reported that 3,007 deaths arose from synthetic opioids. By 2017, the number had risen to 29,406; this represents an increase of 978%.

The combination of over-prescribing opioids, abundant illegal heroin, and an unprecedented uptick in fentanyl and carfentanil in the US have collectively made 2017 the worst year on record for opioid overdoses: there were 49,068 opioid-related deaths, a nearly 500% increase from 1999. Furthermore, these data indicate that the rise in deaths has been ubiquitous across geographic, demographic, and socio-economic backgrounds. This wide range of affected groups crosses party lines; both Democrats and Republicans have previously paid lip-service to the idea that something needed to be done, and the SUPPORT Act passed overwhelmingly, with the Senate voting 98-1 and the House voting 393-8.

The Science

Science Synopsis

NIDA defines opioids as any chemical which interacts with the central nervous systems’ opioid receptors. The body’s opioid system is partially responsible for regulating pain, reward, and addictive behaviors. The body naturally contains many endogenous (internally produced) opioids. Exogenous (produced outside the body) opioids are derived from the poppy plant. Morphine, the prototypical opioid, occurs naturally in the plant and was first isolated in the early 19th century (though opium, a solution of morphine and related compounds taken directly from the poppy plant, has been used for far longer.)

In addition to relieving pain, opioids have been shown to have several other effects that contribute to their addictive nature. Most notably, they can induce a powerful euphoria that can quickly lead to reliance and a desire to continue consuming the drugs.

Two factors affect the addictive potential of different opioids: binding affinity (how strongly the substance activates the body’s endogenous opioid system) and route of administration (how the drug is consumed). Some opioids with a lower binding affinity, such as codeine, do not result in addiction as often as other, more potent derivatives such as heroin. Additionally, different routes of administration can make opioids more or less addictive. Generally, drugs consumed orally (by mouth) have the lowest risk of addiction, while those consumed intravenously (by injection) or via inhalation have the highest addiction potential.

Once opioid use is initiated, the combination of pain relief, euphoria, and reward can lead to continued use in some individuals. Tolerance to the drugs can quickly develop, leading users to consume higher doses to receive the same amount of reward. Opioid tolerance occurs quickly and is partially responsible for the current crisis: though most users begin their use with prescription opioids like oxycodone or hydrocodone (which are both consumed orally), rapid tolerance to their effects can lead to a transition to more powerful opioids such as heroin or morphine (which can be inhaled or injected). Finally, as noted in the Context section, there has been a recent uptick in the use of synthetic (not derived directly from poppy plants) opioids such as fentanyl and carfentanil.  These substances have binding affinities far exceeding heroin or morphine; the DEA has estimated that fentanyl is 80 to 100 times as powerful as heroin. The massive difference in binding affinity and efficacy makes fentanyl and carfentanil far more potent as potential drugs of abuse.

The rapid buildup of tolerance and the shift to more powerful opioids can lead to overdose. Overdoses can occur either purposefully when the user is attempting to reach a previous high, or accidentally when their drugs are ‘cut’ or ‘laced’ with more powerful opioids, leading to a miscalculation in the dosage. Overdoses are characterized by a low heart rate, depressed breathing, pinhole pupils, and unconsciousness, and can be fatal. However, if medical assistance is on-hand or reached quickly, the overdose can be reversed by drugs that are antagonists (act in the opposite manner) of opioids, therefore blocking the opioid system in the body and blunting the effects of the drug. The most prominent of these antagonists is naloxone, an opioid antagonist delivered nasally that can rapidly bring users who have overdosed back to stable condition.

When a chronic user attempts to cease using opioids, symptoms of withdrawal emerge; once the body becomes reliant on these substances, reducing opioid use will induce symptoms that are the opposite of the opioid’s initial effects. The U.S. National Library of Medicine describes opioid withdrawal symptoms as including agitation, anxiety, insomnia, pain, sweating, nausea, and cravings. To abate some of these symptoms (and prevent relapse), medical providers will sometimes prescribe less powerful opioids such as methadone either as acute relief from detox or as a long-term maintenance plan.  

Scientific Assumptions

  • Opioids are addictive substances that can lead to reliance and substance use disorder: A broad body of literature from fields including animal studies, psychopharmacology, and history thoroughly supports this claim.
  • Deaths associated with opioid overdose have increased dramatically: Epidemiological studies from a variety of sources agree that the US has experienced a precipitous increase in overdose deaths over the past two decades.
  • Aggressive overprescribing of opioids by the pharmaceutical industry is to blame for the crisis: Tracing the etiology of epidemics is difficult. While most researchers agree that the onus is at least partially on these companies, there is debate as to how big a role they played.
  • Synthetic opioids such as fentanyl are more prevalent now than they were in the past, and are responsible for the uptick in overdoses: Disaggregating the presence of drugs like fentanyl and their increased usage has been a challenge. However, whether fentanyl is now more readily available or is simply being used more, there is a consensus that there has been a many-fold increase in deaths associated with synthetic opioids.
  • Opioid abuse can be managed with less powerful opioids such as methadone: Most researchers agree that opioid use can be ‘managed’ with less powerful opioids, but some believe this is only a ‘lesser of two evils’ scenario and that fighting opioids with other opioids is not a real solution to the problem.
  • Educational outreach, workforce facilitation, and non-opioid alternatives decrease rates of opioid abuse: There is very little consensus on what the best way forward is to reduce the scale of the opioid epidemic. The unprecedented nature of the problem (and unprecedented nature of the response) means that there is little literature to consult when considering how to curtail the crisis; the bill has adopted a ‘shotgun’ approach to solutions by implementing a myriad of pilot programs and mandating they be closely analyzed and reported on.

The Debate

Scientific Controversies / Uncertainties

While there is broad agreement, both politically and scientifically, that opioids have a high potential for abuse and can lead to substance use disorder or death, there is little consensus on what the best path forward is. As such, many controversies remain. Two particularly contentious points center around how to mitigate the risk of overdose and other externalities faced by those with opioid use disorder, and whether better alternatives exist for treating those who truly need medication for chronic pain.

For those who are already using prescription opioids, several strategies have been put forth to encourage cessation. Some researchers believe we should immediately begin curtailing opioid prescriptions; others believe that pulling patients off opioids too quickly will only lead them to transition to consuming illicit substances such as heroin, and that the best path forward involves a combination of in-patient treatment and opioid replacement therapy. For those already dependent on opioids, some public health advocates are pushing for needle exchange programs and even supervised injection sites, providing an environment where health professionals can monitor drug use. Emerging evidence suggests that these sites are effective, and the largest study to date arguing against supervised injection sites has now been retracted.  

A second debate asks whether there are better alternatives to opioids. Many researchers now claim that we should not be prescribing opioids at all for certain conditions; others wish to move the status quo more slowly and emphasize the potential upside of these drugs, even in the midst of the epidemic. One path forward lies in the potential for marijuana to replace opioids as an analgesic; new evidence claims that states with legal marijuana show decreases in opioid prescription and abuse, though some are skeptical of their equivalency.

Endorsements & Opposition

  • Sen. Rob Portman (R-OH), statement, October 24, 2018: “This bill is a major victory for Ohio and for the country because it will strengthen the federal government’s response to the opioid crisis. Importantly, this bill will increase access to long-term treatment and recovery while also helping stop the flow of deadly synthetic drugs like fentanyl from being shipped into the United States through our own Postal Service.”
  • Senator Elizabeth Warren (D-MA), press release, September 18, 2018:  "The opioid epidemic demands an all-hands-on-deck response. I've repeatedly called on Congress to make the kind of commitment that will give communities the resources they need to win this. While the legislation that passed yesterday could do more to stem the tide of this deadly epidemic, I supported it because it makes some common-sense changes that will help us in this fight. I was especially pleased that several bipartisan provisions I worked on with my colleagues were included in this bill and I look forward to seeing it signed into law."
  • Representative Greg Walden (R-OR-2), press release, October 24, 2018:  “This bipartisan legislation brings critical support to the communities most desperately in need, provides new tools and resources for those on the ground in this fight, and helps stop the flow of deadly drugs across our borders. Rarely can we say that legislation will save lives, but there is no doubt that this bill will do just that. While there is much more work to be done, today is an important step forward to help stem the tide and get communities in Oregon on the road to recovery.”
  • Patrick Kennedy, former Democratic congressman, statement, October 3, 2018:  “I hope Congress doesn’t think they can put this behind them because they passed these bills. It takes an urgency like we had during HIV-AIDS. That will call to mind what it takes to address a crisis, it takes political will.”  
  • Dr. Leana Wen, incumbent president of Planned Parenthood, statement, October 24, 2018: “[The SUPPORT Act] is simply tinkering around the edges [of the opioid crisis].”

Potential Impacts

  • Keith Humphreys, drug policy expert at Stanford University, statement, October 24, 2018: “There are many ‘small sanities’ in the Senate and House opioid bills that will make a positive difference. But the response is far from what America undertook for, say, the HIV/AIDS epidemic… This reflects a fundamental disagreement between the parties over whether the government should appropriate the large sums a massive response would require. Lacking that, Congress did the next best thing — which is to find agreement on as many second-tier issues as they could.”
  • American Dental Association, statement, October 23, 2018: “The ‘SUPPORT for Patients and Communities Act’ will help improve the quality and interoperability of prescription drug monitoring programs in individual states, intensify federal research for alternative non-addictive therapies, and fund specialty specific continuing education opportunities, among other provisions… It contains many provisions that are good for both patients and providers, including additional funding for continuing education for health professionals and state prescription drug monitoring programs. The ADA strongly believes that improved prescription drug monitoring programs will help doctors prescribe more safely and effectively.”
  • Sarah Wakeman, addiction medicine doctor and medical director at the Massachusetts General Hospital Substance Use Disorder Initiative, statement, October 24, 2018:  “We hear a lot of talk about how addiction is a medical condition that needs to be addressed similarly to other chronic illnesses, yet the existing treatment system is largely separate from the medical mainstream and offers interventions that bear little resemblance to how we care for people with other health conditions. To actually stem the tide of overdose deaths, we need funding and innovation that is on par with our response to HIV/AIDS.”
  • Chicago Tribune Editorial Board, opinion piece, September 11, 2018: “The package is heartening and frustrating: heartening because it offers some positive steps, and frustrating because it doesn’t do more…What it doesn’t do is approve money on a large scale… Still, credit is due to lawmakers for moving in the right direction.
  • Daniel Raymond, Harm Reduction Coalition, interview, September 12, 2018: “This is an election year bill to show they are doing something. That’s not always a bad thing, but I do think to some degree it's a political document. When you drill down into it, it’s not that there aren’t good ideas, but it doesn’t reach the level of, this is what our nation needs right now."