SAMHSA Final Rule Makes Permanent OTP Take-Home Flexibilities, Enables Methadone Induction Via Telehealth
buprenorphine
RCPA Submits Comments to DEA on Tele-Prescribing
DEA Accepting Public Comment on Proposal Limiting Tele-Prescribing of Buprenorphine Without In-Person Visit
The Drug Enforcement Agency (DEA) is proposing to roll back flexibilities implemented during the public health emergency (PHE) in tele-prescribing buprenorphine. The proposed new regulation would mandate an initial in-person visit with a prescriber in order for a patient to receive more than a 30-day buprenorphine prescription. Since 2020, those with opioid use disorder have been able to receive prescriptions for buprenorphine, including the initial prescription, following a tele-appointment.
Patients who began buprenorphine treatment during the PHE under the expanded flexibilities would have a 180-day grace period but would then need to see a prescriber in person before continuing treatment under the DEA’s proposed rule.
The proposed rule and instructions for providing comments are available online. The public comment period closes March 31, 2023.
Congress Eliminates X-Waiver Requirement to Prescribe Buprenorphine to Treat OUD
With the passage and signing into law of a federal omnibus appropriations bill last week, the requirement that healthcare providers possess a Drug Enforcement Administration (DEA) X-waiver to prescribe buprenorphine to treat opioid use disorder (OUD) has been eliminated. The move is intended to expand access to addiction treatment.
Named for the “x” that accompanies a narcotics prescribing license, DEA X-waivers have been required to prescribe buprenorphine, a Schedule III drug, as treatment for OUD. Applying for an X-waiver required providers to undergo additional training. The X‑waiver requirement had also limited the number of patients providers can treat. It was largely seen as a barrier preventing many practitioners from treating addiction.
Read the White House’s statement on elimination of the X-waiver.
SAMHSA Proposes Update to Federal Rules to Expand Access to OUD Treatment Through Opioid Treatment Programs
The Substance Abuse and Mental Health Services Administration (SAMHSA) is proposing to expand access to treatment for opioid use disorder (OUD) by making permanent medication flexibilities put in place during the COVID pandemic, including an increase in number of take-home doses of methadone and the use of telehealth in initiating buprenorphine at opioid treatment programs (OTPs).
In its Notice of Proposed Rulemaking to update 42 CFR Part 8, SAMHSA is proposing to improve access to OUD treatment through OTPs. The proposed changes reflect the widespread desire by many stakeholders for SAMHSA to provide greater autonomy to OTP practitioners, positively support recovery, and continue flexibilities that were extended at the start of the nation’s COVID-19 public health emergency. For example, in March and April 2020, SAMHSA published flexibilities for the provision of take-home doses of methadone and for the use of telehealth in initiating buprenorphine in OTPs. Patients deemed stable by physicians have been able to take home up to 28 days’ worth of methadone doses; other patients — again, so determined by their physicians — received up to a 14-day supply. A recent study showed that patients who received increased take-home doses after federal flexibilities were enacted during COVID-19 saw positive impacts on their recovery, including being more likely to remain in treatment and less likely to use illicit opioids.
Medicare Physician Fee Schedule Final Rule for CY 2023 Released
The Centers for Medicare and Medicaid Services (CMS) published the calendar year (CY) 2023 Medicare Physician Fee Schedule (MPFS) in the Federal Register for November 18, 2022. Some of the key provisions contained in the final rule include (and are effective on January 1, 2023):
Medicare Telehealth Services
- Addition of new HCPCS codes to the list of Medicare telehealth services on a Category 1 basis.
- Implementation of the 151-day extensions of Medicare telehealth flexibilities, including allowing telehealth services to be provided in any geographic area and in any originating site setting.
- Permission for physical therapists, occupational therapists, speech-language pathologists, and audiologists to provide telehealth services.
- Listing of codes added to the telehealth services list are here.
Evaluation & Management (E&M) Visits
- For CY 2023, CMS finalized changes for “Other E/M” visits that parallel the changes that were made in recent years for office/outpatient E/M visit coding and payment. Other E/M visits include hospital inpatient, hospital observation, emergency department, nursing facility, home services, residence services, and cognitive impairment assessment visits.
Behavioral Health
- Proposal finalized to create a new HCPCS code (G0323) describing General Behavioral Health Integration performed by clinical psychologists or clinical social workers to account for monthly care integration where the mental health services provided are serving as the focal point of care integration.
Chronic Pain Management
- Finalized a CY 2023 proposal to create two new G codes (G3002 and G3003) performed by physicians and other qualified health professionals describing monthly CPM for payment starting January 1, 2023.
Opioid Treatment Programs (OTPs)
- CMS finalized the proposal to allow the OTP intake add-on code provided via 2-way, interactive, audio-video technology when billing for the initiation of treatment with buprenorphine using audio-video technology to start treatment with buprenorphine as authorized by the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) at the time the service is provided.
- CMS also finalized the proposal to permit the use of 2-way, interactive, audio-only technology to start treatment with buprenorphine in cases where audio-video technology isn’t available to the patient and all other applicable requirements are met.
SAMHSA Extends OTP Exemption for In-Person Physical Exam for Buprenorphine Treatment
The Substance Abuse and Mental Health Services Administration (SAMHSA) announced today it is extending its opioid treatment program (OTP) exemption for an in-person physical evaluation for buprenorphine treatment for a period of one year from the end of the COVID-19 Public Health Emergency (PHE). The extension goes into effect upon the expiration of the COVID-19 PHE.
PA Department of State Extends Waiver Allowing Tele-Induction of Buprenorphine
The Pennsylvania Department of State (DOS) has reversed course and extended its waiver allowing for an initial prescription of buprenorphine without an in-person physical exam. DOS had announced previously that the waiver would expire on June 30, 2022; however, DOS’s waiver will now continue until the last day of the federal public health emergency declaration, unless the exemptions are ended sooner by the Substance Abuse and Mental Health Services Administration (SAMHSA) or the US Drug Enforcement Administration (DEA).
On Sept. 4, 2020, DOS issued a waiver suspending the State Board of Medicine’s regulation at 49 Pa. Code § 16.92(b)(1), which requires an initial physical examination of a patient prior to prescribing buprenorphine for the treatment of opioid use disorder. This waiver was sought specifically to complement the Department of Drug and Alcohol Programs’ (DDAP) suspension of 28 Pa. Code § 715.9(a)(4) and “relates to Federal exemptions granted under the Federal public health emergency (PHE) declaration,” specifically the exemptions granted by the federal Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Drug Enforcement Agency (DEA).
Therefore, in accordance with section 2102-F(a.3) of the Pennsylvania Administrative Code of 1929 (amended by Act 14 of 2022), the Department of State’s waiver will continue until the last day of the federal public health emergency declaration, unless the exemptions are ended sooner by SAMHSA or the DEA. This waiver will not expire on June 30, 2022. More information about the federal public health emergency can be found here.
It is important to note that, to be considered within the acceptable and prevailing standard of care, the physician/prescriber must be following the applicable SAMHSA/DEA guidelines.
Pennsylvania has not received notification that the PHE will be terminated on July 15. The commonwealth expects the PHE to be extended again. If this occurs, this waiver and others tied to or related to the PHE will be extended until mid-October 2022.
Additional information:
DDAP Waivers Extended With Signing of Act 14
With Senate Bill 1019 passed into law as Act 14, the Department of Drug and Alcohol’s (DDAP) regulatory suspensions are also extended. These regulatory suspensions are “related to federal exemptions granted under the federal public health emergency declaration” until “the last day federal exemptions granted under the federal public health emergency declaration are authorized.” In addition to three DDAP regulatory suspensions, one additional regulation from the Department of State, also relevant to the field, is included in the chart below and also remains suspended.
| Statute/Regulation | Statute/Regulation Purpose |
Waiver Benefit/Explanation |
|
28 Pa. Code § 715.16(e) |
Prohibits narcotic treatment programs (NTPs — methadone clinics) from permitting a patient to receive more than a 2-week take-home supply of medication | In response to COVID-19, SAMHSA is allowing up to 28 days of take-home medications for patients on stable dosages, if the physician deems appropriate. |
| 28 Pa. Code § 715.9(a)(4) | Requires NTPs to make a face-to-face determination before admission to treatment, for those clients who will receive buprenorphine treatment. | In response to COVID-19, SAMHSA is allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth. |
| 28 Pa. Code § 715.6(d) | Requires NTPs to have narcotic treatment physician services onsite. | In response to COVID-19, SAMHSA is allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth. |
| 49 Pa. Code § 16.92(b)(1)
(Department of State) |
Before a patient can be prescribed any controlled substance in Pennsylvania, a person licensed to practice medicine and surgery in the commonwealth, or otherwise licensed or regulated by the State Board of Medicine, must take an initial medical history and conduct an initial physical examination, unless emergency circumstances justify otherwise. |
In response to COVID-19, the Department of State suspended the initial medical history and physical examination requirement specifically for the treatment of opioid-use disorder with buprenorphine. |
In November 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that the methadone take-home flexibilities will be extended for one year after the eventual expiration of the federal COVID-19 Public Health Emergency. DDAP has submitted its written concurrence with this exemption. SAMHSA has also indicated that they are currently considering mechanisms to make this flexibility permanent. Narcotic treatment programs do not need to do anything additional at this time to continue taking advantage of this flexibility.
Similarly, the U.S. Drug Enforcement Administration (DEA) also announced last week that they are currently working to make their teleprescribing regulations permanent. DDAP will continue to provide additional information and guidance as it becomes available.
If you have any further questions, please contact the Bureau of Program Licensure at (717) 783-8675 or via email.