• In The Trenches

    We’re Working to Smooth Coming Rx and Telehealth Changes

    April 5, 2023

    By Stephanie Quinn
    Senior vice president of advocacy, practice advancement and policy

    In what’s shaping up to be a consequential year for how clinicians prescribe controlled substances, we’re working to smooth the regulatory path for your practices and fighting to make sure that evolving policy — some of which reflects our advocacy — makes sense for you and your patients.

    Within days of the AAFP delivering recommendations on how best to implement the Medication Access and Training Expansion Act, we earned a victory when the DEA said physicians will be able to attest that they have fulfilled training required by the MATE Act without submitting detailed paperwork. In addition, both the DEA and the Substance Abuse and Mental Health Services Administration updated curricular recommendations to confirm that previous X-waiver and substance use disorder training hours will count toward the new requirements when completed with an accredited organization.

    Doctor

    The Academy has published a new member resource to guide you through this policy change, which takes effect June 27. We know that you will not need to attest to completing the training requirement until it’s time for you to renew your existing DEA license. Recent residency graduates will not need to complete any additional training. These are substantial wins in our work to enable family physicians to complete SUD-related training in a way that best fits their practices’ needs and reduces time away from patient care. More work remains, however — and it’s already well underway.

    We are aware that the updated guidance I’m talking about here does not list the AAFP as a qualifying accrediting organization, an issue we’re aggressively pushing to correct. For now, we know that some past AAFP education, X-waiver training and other SUD-related offerings will count toward (and, in many cases, satisfy) the updated training requirement. In a March 30 meeting the agencies convened with stakeholders, the Academy urged SAMHSA and the DEA to specify that safe prescribing and SUD training accredited by the AAFP is compliant with the new requirement. (Numerous AAFP CME offerings are already compliant because the accrediting organizations so far specified in the guidance have recognized our trainings.) And we reiterated our call for a grace period (through at least Dec. 31) to give physicians whose licenses expire soon after June 27 time to complete any necessary trainings.

    The Academy also just shared crucial feedback with the DEA on two proposed rules centered on telehealth prescribing of controlled substances after the end of the COVID-19 public health emergency. One addresses telehealth prescribing of schedule III-V non-narcotic medications to patients who haven’t had an in-person medical evaluation; the other provides a telehealth prescribing exception for buprenorphine, a schedule III narcotic, for the treatment of opioid use disorder. Both would be significant wins for the Academy’s advocacy, and we expressed support for the rules’ intent. However, we also pointed out elements that could disrupt patient care or add unnecessary administrative complexity. Our comments — informed by scientific evidence, existing AAFP policy and conversations with family physicians and partner organizations — further advance our advocacy on telehealth and opioid use disorder treatment, emphasizing timely, equitable access to continuous, patient-centered primary care.

    Specifically, we’re calling on the DEA to

    • remove overly burdensome documentation requirements and duplicative licensing requirements for prescribers;
    • allow telehealth prescribing of schedule III-V non-narcotic controlled medications for six months before an in-person exam is required, instead of the proposed 30-day limit;
    • remove in-person examination requirements for the prescribing of buprenorphine for detoxification and maintenance treatments;
    • impose no additional restrictions for telehealth prescribing of controlled medications for physicians who have performed an in-person exam and therefore have a relationship with the patient;
    • rescind the proposal to limit prescriptions to a seven-day supply if the prescriber cannot access a prescription drug monitoring program;
    • finalize the proposal to implement a 180-day grace period for prescribers to conduct a qualified in-person examination on patients with whom they established a relationship during the PHE;
    • focus efforts to prevent diversion primarily on law enforcement tactics instead of establishing specific standards of care through DEA rulemaking; and
    • implement a grace period for complying with recordkeeping requirements while EHR systems are updated.

    Let me get into a little detail about a couple of these points, starting with our recommendation against additional restrictions for telehealth prescribing of controlled medications for physicians who have performed an in-person exam.

    The word additional is key because the rule as written already delivers us a win: If the rule is finalized this way, most family physicians will be able to prescribe controlled substances by telehealth without restriction. We’ve long highlighted the importance of a continuous patient-physician relationship in providing high-quality telehealth, and we’re glad to see that recognized here. But we did recommend modifications for prescribers who have not seen the patient in person.

    First, we’re advocating against any in-person requirements for prescribing buprenorphine and to extend the timeframe for telehealth prescribing of other controlled substances beyond the proposed 30 days. The problem here is twofold. The 30-day timeframe is not evidence-based and takes into account neither the patient’s condition nor the prescriber’s opinion and treatment plan. And we’re worried that the short timeframe will place unnecessary strain on your practices as patients scramble to obtain an in-person evaluation before they need to refill a medication that’s working well for them.

    Our suggested solution is a two-parter. One, we recommended that the DEA allow physicians to provide prescriptions of non-narcotic schedule III-V medications via telehealth for six months before an in-person exam is required. We’ve heard from practicing family physicians that this timeframe is both safe and operationally feasible. Two, the process involving what the proposed rule calls “qualified referral pathways” must not be overly complicated. The rule as written would allow prescribers to rely on an in-person evaluation conducted by another practitioner in order to continue prescribing controlled medications via telehealth beyond 30 days. We see the good in this; such qualified referrals would be helpful for family physicians who, for example, want to refer a patient to specialized behavioral health care that’s not available locally. But the DEA’s proposed processes for obtaining and providing those referrals need to be simplified.

    Of the seven-day limit mentioned above, I’ll add that the AAFP wants family physicians to use their state PDMP before prescribing any pharmaceutical product that could be misused. But the success of such efforts depends on state reporting systems that are accessible, timely, interoperable and comprehensive. Broadly speaking, not every state is set up for that success, making the seven-day limit a burden to many of our members and potentially impeding their care plans. The DEA, we said, must work with states to improve the functionality, utility and interoperability of PDMPs and develop best practices for their use and implementation.

    I know that gets into the weeds a bit, but our big-picture message to policymakers remains very straightforward: Family physicians play a critical role in safe pain management and other prescribing practices, especially as the country continues to cope with a behavioral health care crisis. Permanent telehealth policies, if crafted in line with our guidance, could successfully strike the balance of ensuring patient safety, protecting the continuous relationship you have with your patients and allowing robust access to services via telehealth when they are accessible in person. 

    Following the substantial win for our advocacy that came with the X-waiver’s elimination, we’re confident that these rules, if finalized with care, will build on recent momentum. The PHE’s welcome flexibilities helped bring about a sharp increase in buprenorphine initiation in particular, and studies have confirmed that telehealth-only treatment of OUD using buprenorphine, including audio-only telehealth, increased treatment retention and reduced illicit opioid use compared with in-person treatment options. This was true across demographics and geographic locations. It’s also clear now that telehealth and audio-only buprenorphine treatment boosted patient satisfaction, lowered health care costs and improved access to treatment, and that buprenorphine prescribing is particularly well suited to virtual-only visits.

    While in-person care can provide valuable touchpoints for some patients with OUD and may be the preferred standard of care at some practices, the dire urgency of the OUD crisis demands multiple modalities of care.

    Nearly 160 million individuals live in a mental health professional shortage area. Many more are unable to see the mental health professionals in their area because their insurance doesn’t line up or the cost-sharing isn’t feasible. Some 99 million people live in a primary care health professional shortage area and would be unable or unlikely to receive medication for OUD without telehealth or audio-only visits. Thoughtful, patient-centered rulemaking would help connect more of these patients to needed care.

    Update on Braidwood v. Becerra

    On March 30, a federal judge in Texas ruled in Braidwood v. Becerra that the Patient Protection and Affordable Care Act’s preventive service coverage requirements were unconstitutional under the Administrative Procedure Act. This decision means that coverage without cost-sharing will no longer be required for any services listed under the U.S. Preventive Services Task Force’s A and B recommendation. These services include but are not limited to cervical cancer screenings, diabetes screenings, vision tests for preschool-aged children and drugs to prevent HIV. This decision does not affect the contraceptive coverage mandate or coverage recommendations made by the Health Resources and Services Administration or the CDC’s Advisory Committee on Immunization Practices, which include vaccine schedules and some women’s and children’s preventive services. While the ruling has immediate effect, we expect that individual and employer coverage will not be affected in the near term; the Biden administration is likely to seek an emergency stay to allow for the decision to be reviewed by other courts.

    The AAFP issued a statement last week and joined a Group of Six statement raising our concerns with this decision, including the impact on preventive health services for millions of Americans. Our staff is continuing its analysis and will follow up with additional information. 

    Your Turn

    I’m pleased to see how many members have committed to joining me in Washington, D.C., May 22-23 for the AAFP’s 2023 Family Medicine Advocacy Summit. There’s room for more of you, though, so please register today to fly in and meet with your elected officials. Ahead of your time advocating for your practice and your patients (while earning CME), you’ll learn more about the AAFP’s top legislative priorities and how to most effectively tell the story of your practice and your patients.

    Disclaimer

    The opinions and views expressed here are those of the authors and do not necessarily represent or reflect the opinions and views of the American Academy of Family Physicians. This blog is not intended to provide medical, financial, or legal advice. All comments are moderated and will be removed if they violate our Terms of Use.