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DEA Proposed Rule on Telemedicine Suboxone

In February 2023, the United States Drug Enforcement Administration proposed new rules about prescribing controlled substances — including buprenorphine — via telemedicine.[1]

Per the proposed rules, people using buprenorphine-based products like Suboxone could get a 30-day supply of their medication via a telemedicine appointment. But to refill that prescription, they’d need an in-person exam from a clinician. That clinician could then refer the patient back to telemedicine, permanently. 

Officials claim the new rules could help doctors provide better care while curbing substance misuse concerns. But doctors and other experts worry the proposed regulations are far too restrictive, ensuring that even more people are denied access to lifesaving care. 

If the proposed rules go into law without changes, they will decrease access to treatment for opioid use disorder and  increase the risks of overdose death. Tens of thousands more may experience other harm because they can’t get the care they need to treat opioid use disorder (OUD).

Why the Rules Around Telemedicine Suboxone Are Changing

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires an in-person exam by a qualified medical practitioner before controlled substances can be prescribed.[2] 

During the government’s declared COVID-19 emergency, doctors could prescribe controlled substances via telehealth appointments without the need for an in-person exam.[3] Relaxing this restriction has been helpful for many people with OUD. This includes people in rural areas that have few or no buprenorphine providers nearby.[4] The COVID-era policies have also benefited people with childcare needs or people who have disabilities, for whom travel is difficult. 

With easier access to medications like buprenorphine (an FDA-approved medication proven to help people with OUD avoid opioid misuse), patients began having better outcomes: rates of opioid-related emergency visits and opioid overdoses declined. It’s clear that better access to addiction medications via telemedicine saves lives.

But the U.S. Department of Health and Human Services has declared that the emergency will end on May 11,  2023.[5] Telemedicine treatment programs that added thousands of patients during the pandemic need a new set of rules in order to operate, once the PHE ends. 

Under the Biden administration omnibus bill the DEA was supposed to come up with a special registration process that would allow telemedicine companies to operate once the PHE ends. However, DEA defied congress and instead came up with this in-person requirement, which is not support by any medical evidence.

The DEA’s Proposed Rule & Suboxone

Per the proposed rules, doctors can provide most controlled substances via telemedicine only after an in-person visit. However, buprenorphine (the active ingredient in Suboxone) is treated slightly differently. If the rules go into effect, these three aspects of your care could change. 

1. How You Conduct Telemedicine Visits

In some states, doctors can’t use audio-only methods for their telehealth check-ins. During the pandemic, these rules were waived, allowing people with a weak or missing internet connection to get the care they needed. 

Per the proposed rules, people in these states would need video and audio connections for their telemedicine appointments, and no exceptions are allowed.[6]

2. How Your Doctor Checks Your Eligibility

Prior to this new proposed rule, there were no hard and fast rules or standards around medication monitoring and randomized drug screening in telemedicine. This rule is trying to correct this by adding an in-person requirement

Per the new rules, prescribers would have to check a Prescription Drug Monitoring Program (PDMP) before authorizing buprenorphine products.[7] These checks make delivering the medication slightly more time-consuming and complex. They could also prompt some doctors to deny refills to people due to misuse concerns. 

3. How You Get Refills 

If the new guidelines go into effect, there are four paths to medication for opioid use disorder (MOUD). These are the options:

  • Choose in-person treatment, where all your care is provided in person.
  • Start with in-person treatment and transition to telemedicine care.
  • Begin with telemedicine treatment. Have a one-time, in-person, follow-up appointment. Then, get a referral from your in-person visit back to telemedicine for the remainder of your care.
  • If you are already in telemedicine treatment, you must have an in-person, follow-up appointment within six months. After that one-time appointment, you can transition back to telemedicine for the rest of your care.[8]  

If unchanged, these new rules would require patients to see a medical professional in-person at some point during your recovery journey. No telemedicine-only option would exist. 

This makes it much harder for patients to access the medication they need to stay in recovery. This change will put vulnerable people at risk.

Downsides for People Using Suboxone 

The proposed rules could be catastrophic for the tens of thousands of people who rely on telemedicine to give them quick, convenient access to OUD care. 

Known downsides include the following:

  • Higher cost of care: An in-person medical appointment often requires a high copayment for people with insurance, and the appointment could simply be too costly for those without insurance coverage. Also, since buprenorphine (Suboxone) reduces rates of opioid overdose, including emergency room visits and fatal overdoses, it greatly lowers the cost of care for those with opioid use disorder. If the medication helps a patient avoid relapse and overdose, the savings on medical care and hospitalizations are substantial.
  • Lack of a realistic timeframe: Some communities have 60-day (or longer) wait times for routine appointments. Getting a refill in a month is nearly impossible in these places. 
  • No proven benefits: While authorities claim that an in-person appointment keeps people safer, that’s not documented in studies. 
  • No evidence of widespread misuse: Controlling buprenorphine so tightly contributes to OUD treatment stigma. All of the medical evidence shows that people rarely misuse Suboxone or buprenorphine and when they do, they are typically using them to recover from opioids and are only misusing buprenorphine because they cannot get access to it legally. 
  • Higher risk of overdose: People with access to just 30 days of Suboxone may return to opioid misuse. In fact, studies show that the vast majority of people who take buprenorphine for only 28 to 30 days relapse.[7] Overdose is more likely to occur during a relapse if the person has stopped using for a period of time and then abruptly returns to using their prior dose. This is because people can lose tolerance to drugs if they stop using for a period of time. Staying on buprenorphine for longer than 30 days (i.e., several months or more) have much higher success rates in staying drug-free.
  • Shorter treatment timelines: Patients who receive telemedicine addiction treatment stay in treatment significantly longer than those who receive in-person care.[8]
  • Fewer success stories: Suboxone is a life-changing medication for people with OUD. Limiting access means denying people the science-based therapies they need. 

Several national organizations, including the American Telemedicine Association, American Hospital Association, American Medical Association, American Hospital Association, and American Psychiatric Association, believe the proposed rules are far too restrictive.[9,10, 17,18,19] These groups continue to lobby officials to change the rules rather than enacting them. 

Restrictions to care also disproportionately affect people from racial and ethnic minority groups that are most likely to suffer from regulatory barriers to treatment.[11] Obstacles to care are stigmatizing, and removing those barriers improves treatment rates among the medically underserved.[12] The easing of telehealth restrictions in the past two years has improved care for people that have historically struggled to get help. These gains could be undone if telehealth-based care becomes more restricted again.

Telehealth treatment for opioid use disorder is well supported by the evidence. It works, and it saves lives. There is no need for in-person care to get an opioid use disorder diagnosis or a prescription for Suboxone. If these propositions are made permanent, many lives will be potentially destroyed and lost.   

Benefits for People Using Suboxone

The DEA has said that they feel the proposed rules come with some benefits for people using Suboxone.[5] For example, they say an in-person exam could help doctors catch health problems that may be exacerbated by buprenorphine. They also suggest an in-person visit could help doctors identify people who aren’t complying with their treatment protocols. 

But people who are treated via telemedicine for OUD thrive. Researchers have looked at how patient outcomes changed once policies around telehealth become easier to access during COVID. The evidence shows that telehealth works. One large study found that when people were prescribed buprenorphine for a longer period of time without having to see a doctor in person, they had fewer interruptions in therapy.[13] Another study of nearly 200,000 people found that telehealth care with buprenorphine reduced fatal overdose risk.[14] 

Concerns about buprenorphine misuse due to expanded access to telehealth-based care seem unwarranted. The largest studies to date have found that patients receiving buprenorphine by telehealth do just as well as those receiving in-person treatment on a range of outcomes, such as overdoses and infections due to IV drug use.[15] In many cases, they were doing even better. Telehealth patients from medically underserved communities were more likely to stay in treatment than patients seen in-person.[16] People who just couldn’t get the medication before could finally get the help they needed via telemedicine. 

What You Can Do Right Now

The DEA stopped accepting comments on the proposed rules on March 31. 

But, you can still let your voice be heard. Visit this website to learn more and share news and updates on social media.  More news comes out every day in opposition to this rule and officials read these stories. 

Make your voice heard, so common sense regulations on medications for opioid use disorder can remain accessible for everyone who needs them.

DEA Proposed Rule on Telemedicine Suboxone FAQs 

When are these new rules on telemedicine Suboxone going into effect?

These are proposed plans that haven’t been formally accepted. They may never go into effect as they are written now. Hopefully they won’t, so people who need life-saving medication can still get the help they need. 

Are there exceptions in the rules for people who started Suboxone treatment via telemedicine?

No. The same rules apply to everyone. 

What can I do about this new potential law?

Share news and updates on social media, and tell officials why you think it’s a bad idea. Your words could make a big difference. Make your voice heard in an effort to save lives.


References


1. DEA Announces Proposed Rules for Permanent Telemedicine Flexibilities. United States Drug Enforcement Administration. https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities. February 2023. Accessed March 2023. 

2. Proposed Rule: Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation. Federal Register. https://www.federalregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had. March 2023. Accessed March 2023. 

3. Policy Changes During COVID-19. Health Resources and Services Administration. https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency. Accessed March 2023.

4. Access to treatment for opioid dependence in rural America: challenges and future directions. https://jamanetwork.com/journals/jamapsychiatry/article-abstract/1819581. April 2014. Accessed April 2023. 

5. Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap. U.S. Department of Health and Human Services. https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html. February 2023. Accessed March 2023.

6. Proposed Rule: Expansion of Induction of Buprenorphine via Telemedicine Encounter. Federal Register. https://www.federalregister.gov/documents/2023/03/01/2023-04217/expansion-of-induction-of-buprenorphine-via-telemedicine-encounter. March 2023. Accessed March 2023.

7. Buprenorphine Tapering Schedule and Illicit Opioid Use. Addiction. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3150159/. August 2011. Accessed March 2023.

8. Collaborative, Patient-Centred Care Model That Provides Tech-Enabled Treatment of Opioid Use Disorder Via Telehealth. BMJ Interventions. https://innovations.bmj.com/content/8/2/117.full. April 2022. Accessed March 2023.

9. ATA and ATA Action Call DEA’s Proposed Rule on Controlled Substances Overly Restrictive, Fear Consequences in Patient Care. American Telemedicine Association. https://www.americantelemed.org/press-releases/ata-and-ata-action-call-deas-proposed-rule-on-controlled-substances-overly-restrictive-fear-consequences-in-patient-care/. February 2023. Accessed March 2023. 

10. AHA Comment Letter to DEA on Telemedicine Prescribing of Controlled Substances Proposed Rule. https://www.aha.org/lettercomment/2023-03-29-aha-comment-letter-dea-telemedicine-prescribing-controlled-substances-proposed-rule. March 2023. Accessed April 2023. 

11. Permanent Methadone Treatment Reform Needed to Combat the Opioid Crisis and Structural Racism. Journal of Addiction Medicine. https://pubmed.ncbi.nlm.nih.gov/33758114/ March 2022. Accessed April 2023.

12. Breaking Down Barriers: Young Adult Interest and Use of Telehealth for Behavioral Health Services. Rhode Island Medical Journal. https://pubmed.ncbi.nlm.nih.gov/35081185/ February 2022. Accessed April 2023.

13. Association Between Increased Dispensing of Opioid Agonist Therapy Take-Home Doses and Opioid Overdose and Treatment Interruption and Discontinuation. JAMA. https://pubmed.ncbi.nlm.nih.gov/35230394/. March 2022. Accessed April 2023.

14. Association of Receipt of Opioid Use Disorder–Related Telehealth Services and Medications for Opioid Use Disorder With Fatal Drug Overdoses Among Medicare Beneficiaries Before and During the COVID-19 Pandemic. JAMA Psychiatry. https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2802946. March 2023. Accessed April 2023.

15. Telemedicine Use and Quality of Opioid Use Disorder Treatment in the US During the COVID-19 Pandemic. JAMA Network Open. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800718. January 2023. Accessed April 2023.

16. Telehealth to improve continuity for patients receiving buprenorphine treatment for opioid use disorder. Annals of Family Medicine. https://www.annfammed.org/content/20/Supplement_1/2936.abstract. April 2022. Accessed April 2023.

17. Docket No. DEA-948, Expansion of Induction of Buprenorphine via Telemedicine Encounter. AMA. https://searchltf.ama-assn.org/letter/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2Flfrd.zip%2F2023-3-31-Letter-to-Milgram-re-DEA-Comments-on-Buprenorphine-v4.pdf. March 2023. Accessed April 2023.

18. Proposed Rule for Expansion of Induction of Buprenorphine via Telemedicine

Encounter. American Hospital Association. https://www.aha.org/system/files/media/file/2023/03/aha-comment-letter-to-dea-on-buprenorphine-telemedicine-prescribing-proposed-rule-3-29-23.pdf. March 2023. Accessed April 2023.

19.  Expansion of Induction of Buprenorphine via Telemedicine Encounter (Docket No. DEA-948). American Psychiatric Association. https://www.psychiatry.org/getattachment/4428f9f0-8fdf-4976-a9b8-e266b2cd5d4d/APA-Letter-to-DEA-Buprenorphine-Telemedicine-Docket-No-DEA-948-03312023.pdf. March 2023. Accessed April 2023. 


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