The pandemic has worsened an existing drug overdose crisis that claimed the lives of more than 81,000 people in the U.S. from May 2019-June 2020. As the Biden-Harris administration firms up and implements its proposed response¹ to the opioid epidemic, this brief provides evidence-based recommendations to consider.

We focus our recommendations on the evidence and our experience in three areas: reducing the demand for opioids through policies that increase access to prevention, treatment, and recovery services; reducing the harms from opioid use through strategies that reduce morbidity and mortality; and reducing the supply of opioids through opioid stewardship that limits prescribing by the medical community and promotes adequate pain management. We also address the accountability of the pharmaceutical industry in contributing to the crisis and recommend ways to target settlement funds for maximal impact on the communities most affected.

Recommendations

1. Increase the Availability of Prevention, Treatment, and Recovery Services.

The Biden administration should expand access to medications for opioid use disorder, which reduce overdose risk and promote higher rates of recovery when compared to abstinence-based treatment. Despite strong evidence of the effectiveness of these medications, most patients continue to receive treatment without medications in all outpatient and residential settings.² There are also longstanding gaps in access to medication treatment in correctional settings, and little connection to treatment upon release. The following strategies can increase access to prevention, treatment, and recovery services across all settings.

Eliminate the X-waiver. For 20 years, federal policy has required that health care providers receive a waiver and additional training (the X-waiver) to prescribe buprenorphine, which limits the number of patients that these providers can treat. The bipartisan Mainstreaming Addiction Treatment Act³ would eliminate the X-waiver and integrate opioid use disorder treatment into mainstream practice.

Make expansions to telehealth prescribing permanent. During the pandemic, the federal government expanded access to buprenorphine by allowing telehealth prescribing, which increased ease of access to treatment for many people living in rural areas or areas with a shortage of providers. Making this permanent would improve access to remote drug screening and prescribing and address access challenges⁴ in rural and underserved areas.

Relax federal regulations on methadone. Methadone can be dispensed only at highly regulated and monitored opioid treatment programs, where people must present daily for treatment until they are eligible for take-home doses. Onerous federal and state regulations result in crowded methadone clinics that may be too distant from some patients who might benefit (for example, in rural areas). Relaxing these regulations⁵ would allow methadone to be prescribed in primary care settings, putting it more on par with buprenorphine and addressing racial disparities in the use of these medications. Canada, for example, has authorized approved pharmacies to dispense methadone to patients without resulting problems with diversion.

Use payment and policy levers to increase the provision of effective medications in treatment programs. Nationally, the share of opioid treatment centers offering any medications for opioid use disorder increased from just 20% to 37% from 2007-2016.⁶ Payment and policy levers⁷ could accelerate the provision of evidence-based treatments. For example, Medicare and Medicaid reimbursement for inpatient or residential treatment of substance use disorders could be made contingent on the availability of these medications. In conjunction with the states, the federal government could make the availability of medication treatment a requirement a condition for licensure of treatment programs and facilities.

Strengthen access, reimbursement, and best practices for peer recovery specialists. This has become an increasingly vital strategy⁸ in caring for patients with opioid use disorder. Peers are essential in helping patients stay safe, obtain social services, and navigate treatment. However, peer services are not available in many areas, and effective approaches to incorporating peers in health care settings remain in development. Given variation in approaches to reimbursement for peer services across states, federal guidance is needed to standardize coverage as well as requirements for optimal use of peer services.

Increase support for treating opioid use disorder in primary care through collaborative care models. Primary care providers are more likely than many mental health providers to accept insurance, and may be more accessible to the nearly 120 million Americans who live in mental health care Professional Shortage Areas. Importantly, primary care providers can also offer a more coordinated approach to treatment, as OUD is often correlated with health conditions like chronic pain.⁹ Medicare payment policy and programs can bolster primary care capacity to treat these patients. For example, in 2017, Medicare introduced four new payment codes that made behavioral health directly and separately reimbursable to primary care providers for the first time,¹⁰ an approach that is now being used by health systems nationwide, including Penn Medicine.¹¹ In addition to new payment codes, the administration should support and evaluate innovative programs like the Value in Opioid Use Disorder Treatment Demonstration Program from the Centers for Medicare & Medicaid Services’ Innovation Center, which offers providers a monthly management fee and performance incentives to improve access, engagement, and retention in evidence-based treatments.¹²

2. Promote and Support Harm Reduction Strategies.

The Biden administration should increase support for harm reduction strategies, such as naloxone access, syringe services programs, fentanyl testing strip distribution, safe consumption spaces, and decriminalization. These strategies are evidence-based and reduce the risk of morbidity and mortality associated with substance use, including opioids and stimulants. In many cases, harm reduction organizations can connect people with vital medical and social services, and expand the reach of “low-barrier” treatment programs and providers that prioritize reduction of drug-related harms over abstinence.¹³

Increase funding to states for naloxone distribution. Universal naloxone access is vital to increase rates of overdose reversal in the community. It has been well-demonstrated that laypeople can safely and effectively reverse overdoses with naloxone and that greater community-level naloxone distribution is associated with fewer overdose deaths.¹⁴

Allow pharmacy dispensing and community distribution of naloxone without a prescription. Access laws currently in place in many states¹⁵ – for example, those allowing for third-party prescribing or for pharmacies to dispense naloxone to individuals without a prescription – can increase naloxone dispensing at community pharmacies.¹⁶ Access laws should be expanded to include options for mailing naloxone, which would address stigma and geographic barriers to pharmacies. Mail and community programs ensure naloxone gets in the hands of those most likely to witness and reverse overdoses.

Legalize fentanyl test strips and increase availability, including via mail-based services. Fentanyl test strips can reduce fatal overdoses¹⁴ by alerting individuals to substances that are contaminated with fentanyl.^12,13 In many parts of the country, opioids and non-opioids alike can be mixed with fentanyl,¹⁷ including pressed pills¹⁸ that are sold on the street as amphetamines or benzodiazepines. Despite their effectiveness, testing strips are illegal in many states, which interferes with distribution efforts even when the laws aren’t enforced.¹⁹ The Biden administration should endorse a nationwide effort to overturn state laws that consider fentanyl strips to be illegal drug paraphernalia, and support increasing the availability of fentanyl strips through community- and mail-based services.

Legalize and fund syringe exchange programs. The legality of syringe exchange programs varies across states and municipalities. Meanwhile, its criminalization hampers effective public health responses to the current opioid overdose crisis and other substance use disorders including limiting the transmission of HIV,²⁰ hepatitis C,²¹ and other infectious complications of injection.²² The Biden administration should support legalizing syringe exchange programs in all jurisdictions and direct funding for these programs, including services by mail to overcome geographic and stigma-related barriers to use.

Permit the operation of safe consumption spaces. Also known as overdose prevention sites or supervised injection facilities, safe consumption spaces are legal and operating in 11 countries²³ and promote health through HIV testing²⁴ and referral to other health services,²⁵ including opioid use disorder treatment. There are currently no sanctioned safe consumption spaces in the U.S., although research of one unsanctioned consumption space has found no instances of fatal overdoses since the site opened in 2014.²⁶ The U.S. Department of Justice and the U.S. Attorney General should clarify that these spaces do not fall under federal ‘crack house’ statutes, and halt all enforcement actions against safe injection sites.

3. Reduce Overprescribing of Opioids While Improving Access to Effective Pain Management.

In response to escalating deaths, opioid prescribing stewardship has evolved and improved, spearheaded by clinical guidelines issued by the CDC in 2016,²⁷ and a myriad of state and professional society guidelines. While education and awareness has decreased overprescribing, additional strategies can further reduce opioid prescribing. The Biden administration should support and widely disseminate, through all Department of Health and Human Services agencies, the following strategies to reduce overprescribing:

Limit and standardize new opioid initiation. Patients who are opioid-naïve should be kept naïve, with new opioid prescriptions limited to patients with acute severe pain. Multiple studies²⁸ have demonstrated the risk of long-term opioid use once opioids are initiated (even following minor procedures²⁹), a risk that increases when greater quantities of opioid are prescribed. Opioid prescriptions should be standardized using prescribing guidelines³⁰ and diagnosis-based order sets. Electronic health record defaults³¹ and policies limiting the number of pills³² dispensed should be used to decrease opioid exposure to the patient and also benefit communities by decreasing leftover pills that could be misused or diverted. These kinds of interventions, based on behavioral economic principles, should be integrated into health systems to optimize patient-centered choices of judicious and safe analgesic options.

Target providers and patients with tools to decrease opioid prescribing and promote shared decision-making. Giving providers feedback³³ about their prescribing compared to peers and to norms using dashboards and one-on-one education decreases the amounts of opioids prescribed and increases guideline-concordant prescribing. For patients, providing narratives about experiences with opioids can help inform shared decision-making.³⁴ These strategies must be applied uniformly and monitored so they do not widen racial and ethnic disparities in existing pain treatments. Further, they should ensure that opioids are not abruptly discontinued for chronic pain patients.

Improve access to and coverage of effective pain management. Adequate treatment for chronic pain is essential to reducing the use of street-bought substances and their associated risks. Further, it is critical to address existing racial disparities in pain management. However, insurers are often unwilling to pay for non-pharmacologic but effective pain-management approaches, such as acupuncture, physical therapy, and cognitive behavioral therapy, or make coverage approval an onerous and expensive process for providers.³⁵ We recommend that insurance coverage be improved for effective alternatives to chronic pain management, to make integrated and non- opioid approaches more widely and easily accessible, including increasing Medicare and Medicaid coverage for services provided by multidisciplinary pain clinics.³⁶

4. Ensure Effective Distribution of Funds from Pharmaceutical Settlements.

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