In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week (“Awareness Week”). As described in the Proclamation, the goal of Awareness Week is to “raise awareness about the prescription opioid and heroin epidemic and to consider concrete follow up activities.”
The SUPPORT Act: A Timeline
In the spirit of Awareness Week, Congress took uncharacteristically swift action to complete the legislative process needed to send the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act” (the “SUPPORT Act”) to President Trump’s desk for signature.
On June 22, 2018, the House of Representatives passed, with rare bipartisan support, its version of the SUPPORT Act. Immediately thereafter, the House version of the SUPPORT Act was sent to the Senate for the Senate’s consideration and approval.
On September 17, 2018, the Senate passed its version of the SUPPORT Act. The Senate version of the SUPPORT Act went back to the House for consideration.
On September 25, 2018, House and Senate negotiators agreed on a final legislative package to address the opioid crisis.
On September 28, 2018, the House voted 393-8 to pass the negotiated SUPPORT Act.
On October 3, 2018, the Senate voted 98-1 to pass the negotiated SUPPORT Act as passed by the House on September 28, 2018.
Now passed by both the House and the Senate, the SUPPORT Act is currently headed for signature by President Trump. The President has announced his intention to sign the SUPPORT Act quickly.
The SUPPORT Act: Sum and Substance
According to a September 7, 2018 Press Release from the U.S. Senate Committee on Health, Education, Labor & Pensions, the opioid legislation is intended to: (1) reduce use and supply; (2) encourage recovery; (3) support caregivers and families; and (4) drive innovation and long-term solutions. Although there are some concerns about urgency and funding, the version of the SUPPORT Act headed to the President’s desk includes provisions that aim to stop the entry of illegal drugs, provide for better drug monitoring communication between states, establish comprehensive opioid recovery centers, expand access to substance use disorder health professionals and medication-assisted treatment (“MAT”), improve plans of care and support for families and in schools and educational programs, progress research and development of strategies and technologies, and more. The SUPPORT Act will mean substantive changes to the Medicare and Medicaid programs, expanding services and aid for their vulnerable patient populations.
SUPPORT for Telemedicine
Also included in the SUPPORT Act are several provisions to support and expand telemedicine programs aimed at combatting opioid and heroin addiction. For example, states will receive guidance on options for providing telehealth services to address substance use disorders under Medicaid. Medicare coverage will be expanded for telehealth services furnished for treatment of substance use disorders and co-occurring mental health disorders, eliminating geographic restrictions on patient locations. Further, the Attorney General and the Secretary of the Department of Health and Human Services (“HHS”) will be required by the SUPPORT Act to issue final regulations for special registration for health care providers to prescribe controlled substances via telemedicine in legitimate emergency situations, such as lack of access to an in-person specialist. The SUPPORT Act will also permit utilization of the Project Extension for Community Health Outcomes (“ECHO”) model in comprehensive opioid recovery centers, enabling care coordination and services delivery through technology. A number of reports, evaluations, and assessments on the effectiveness of telemedicine services and technologies in substance use disorder treatment are also required.
In addition to the changes forthcoming under the SUPPORT Act, HHS and the Drug Enforcement Agency (“DEA”) also want health care providers to know that telemedicine is not only an acceptable, but an encouraged, means of treating opioid use disorder (“OUD”) under existing regulations and guidance.
In an HHS blog post entitled, “Secretary Price Announces HHS Strategy for Fighting Opioid Crisis” dated September 18, 2018, HHS emphasized that it, with the DEA, has developed materials “to help clarify how clinicians can use telemedicine as a tool to expand buprenorphine-based MAT for opioid use disorder treatment under current DEA regulations.” Such materials, like a September 2018 statement issued by HHS entitled, “Telemedicine and Prescribing Buprenorphine for the Treatment of Opioid Use Disorder,” make clear that the DEA and HHS have eased their restrictions to enable the use of telemedicine to curb the opioid crisis. Buprenorphine is a common medication used in MAT, described by the Substance Abuse and Mental Health Services Administration (“SAMHSA”) as helping lower the potential for misuse, diminish the effects of physical dependency to opioids, and increase safety in cases of overdose.
Generally, buprenorphine may only be prescribed for the treatment of OUD in federally regulated opioid treatment programs. To prescribe buprenorphine for this purpose outside of such a setting, practitioners must have a waiver under the Drug Addiction Treatment Act of 2000 (“DATA 2000”). Now, in accordance with a statement released by the DEA on May 15, 2018, titled “Use of Telemedicine While Providing Medication Assisted Treatment (MAT),” HHS and the DEA have made it clear that providers with DATA 2000 waivers may prescribe buprenorphine for the treatment of OUD via “an appropriately safeguarded interactive telecommunications system,” as long as a DEA-registered practitioner is present (whether in-person or via electronic communication) at the consultation (the “Telemedicine OUD Treatment Policy”). This exemption from the in-person medical evaluation requirement is particularly relevant for rural areas, which have been especially impacted by the opioid crisis and which frequently endure health care provider shortages.
The Telemedicine OUD Treatment Policy is in keeping with HHS’s “5-Point Strategy to Combat the Opioid Crisis,” launched in 2017. According to the “comprehensive strategy,” HHS has identified five specific tactics for the fight against OUD:
- Improving access to treatment and recovery services;
- Promoting use of overdose-reversing drugs;
- Strengthening our understanding of the epidemic through better public health surveillance;
- Providing support for cutting edge research on pain and addiction; and
- Advancing better practices for pain management.
Certainly, the Telemedicine OUD Treatment Policy speaks directly to HHS’s first strategic imperative – to increase access to treatment and recovery services – by expanding the availability and utility of telemedicine services.
The Sheppard Mullin Healthcare Law Blog has covered similar recent developments in telemedicine and telehealth, such as changes to the Texas Medical Board telemedicine regulations, exceptions to the Haight Act, and pending actions in the realm of online prescribing.