March 27, 2023

What is DEA Proposing

The DEA has proposed a change to the telemedicine prescribing rules established during the COVID-19 pandemic. This proposed change will create new barriers to treatment for those in the RLS community who have been treated via telemedicine over the past 3 years. If this change goes into effect, patients will no longer be able to receive a prescription for alpha-2-delta ligands (gabapentin, gabapentin enacarbil, pregabalin), benzodiazepines or opioids after an initial 30-day telemedicine prescription without an in-person appointment or qualified telemedicine referral (referral following an in-person doctor visit).

The RLS Foundation has certified 10 Quality Care Centers in the US where expert care is available. Telemedicine has enabled patients who live in areas where access to healthcare is limited or nonexistent to access care with a certified RLS provider.

How You Can Comment

Go to https://www.regulations.gov/commenton/DEA-2023-0029-0001 and click on the Comment box. Be succinct and tell how this prescription restriction will affect you and your quality of life. Include Docket No. DEA-407, limit your comment to 5000 characters and deadline is 11:59PM ET on March 31.

Following is the response from the RLS Foundation on behalf of the RLS community. It is imperative that each individual in the RLS community raise their voice and submit their own comment.

Requested Change in Proposed Rules

The RLS Foundation requests that the DEA change its proposed rules to exempt alpha-2-delta ligands (gabapentin, gabapentin enacarbil, pregabalin) and low-total-daily doses of opioids and comparably relax proposed rules with respect to all Schedule II-V drugs (including opioids) to permit RLS patients access to these critical treatments. Alternatively, we request a blanket exemption from the rules for patients diagnosed with RLS (ICD-10 code: G25.81). Either change can be accomplished under Exception 7 (21 C.F.R. §1300.04(i)(1)-(7)).

About Restless Legs Syndrome

RLS is a serious neurological disease affecting an estimated 12 million Americans. Patients may experience an overwhelming, agitating, and uncontrollable urge to move their legs. With symptoms peaking at night, sleep can be disrupted, exacerbating other chronic conditions and increasing the risk of depression and suicide. RLS is not chronic pain; it has a distinctly different underlying neuropathology, best managed by neurologists and/or sleep specialists.

RLS Treatment

There is a shortage of providers with the expertise to diagnose or treat RLS patients. Primary care providers are frequently unaware of the disease or current best practices, leading to long delays in diagnosis and inappropriate treatments. There are only 10 centers in the U.S. certified to provide comprehensive care; only 15% of the population is close to one of them. Thus, 85% of Americans often look to telemedicine for expert management. Diagnosis and management of RLS is based solely upon symptoms that can be evaluated as effectively through telemedicine as in person.

Existing Restrictions Already Impose Challenges to RLS Patients

Clinical experience of experts treating severe RLS with opioids has not shown drug misuse, dependence, or addiction. Results from a 2023 National RLS Opioid Registry documents that most RLS patients prescribed opioids take them in low-total-daily-doses, and generally do not exhibit dose escalation, tolerance, dependence, or opioid use disorder. Despite these facts, RLS specialists may have difficulty prescribing opioids because of institutional restrictions. Some physicians now refuse to renew long-standing opioid prescriptions. Some pharmacies reject legitimate prescriptions. Some insurers deny coverage of alpha-2-delta ligands and opioids for RLS.

Proposed Changes Create New Barriers to Treatment

Updated consensus treatment guidelines recommend iron therapy and alpha-2-delta ligands (Schedule V) as first-line treatments for RLS. Low-total-daily dose opioids -- buprenorphine (Schedule III) and methadone (Schedule II) -- are now recommended for the treatment of moderate-to-severe RLS refractory to other approaches.

Under the DEA’s proposed changes, telemedicine providers would be restricted to an initial 30-day prescription of Schedule II-V medications for RLS and is unable to provide future controlled medications without conducting an in-person exam or a qualified telemedicine referral. All telemedicine prescriptions would be required to have the notation “telemedicine prescription.” Taken together, these rules create significant barriers to accessing legitimate pharmacological treatment.

Effect of the Proposed Rules

The proposed rule changes will have a significant negative impact on RLS patients and their medical practitioners. With the difficulty that patients suffering from RLS already experience in finding a knowledgeable local doctor, any new barriers to telemedicine management would be devastating since many RLS patients are treated with controlled substances. The problem would be dramatic for those on low-total-daily-dose opioids who would face the sudden loss of the most potent treatment for refractory RLS.

Summary

RLS can be a devastating neurologic disorder, treated safely and effectively by telemedicine providers, who are often prescribing controlled substances. The DEA should consider relaxing the devastating effect that this will have on the RLS community and ease restrictions on the telemedicine prescribing of controlled substances with exemptions for medications and RLS patients as recommended above.