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buprenorphine

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Separate Notice of Proposed Rulemaking Would Completely Eliminate In-Person Evaluation for Prescribed Medications

The Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Drug Enforcement Agency (DEA) this month released three new prescribing-related telehealth rules.

The Final Rule On the Expansion of Buprenorphine Treatment Via Telemedicine Encounter authorizes DEA-registered practitioners to prescribe Schedule III-V controlled substances, including buprenorphine, for opioid use disorder, through an audio-only encounter for an initial six-month supply (split among multiple prescriptions over six calendar months). Although the rule has been published in the Federal Register and is set to take effect February 18, 2025, President Trump issued a regulatory freeze pending review that requires executive departments and agencies to consider postponing the rule’s effective date for 60 days to review “any questions of fact, law, and policy that the rules may raise.”

Under this final rule, practitioners must first review the patient’s prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. SAMHSA advises practitioners to check with their state medical boards about what specific telemedicine practices are currently authorized for prescribing controlled medications after this six-month period. RCPA has reached out to the Pennsylvania Department of State to determine whether there are telemedicine pathways in place to enable prescribing beyond the initial six-month period without an in-person examination.

This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. This final rule does not apply to practitioners who have already evaluated their patient in person.

Separate Proposed Rule Would Completely Eliminate In-Person Evaluation for Prescribed Medications

However, a separate proposed rule on Special Registrations for Telemedicine and Limited State Telemedicine Registrations would establish special registrations that will permit a patient to receive prescribed medications through telemedicine visits without ever having an in-person medical evaluation from a medical provider. According to the DEA, the special registration is available to medical providers who treat patients for whom they will prescribe Schedule III-V controlled substances. An Advanced Telemedicine Prescribing Registration is available for Schedule II medications when the medical practitioner is board certified in one of the following specialties: psychiatrists; hospice care physicians; physicians rendering treatment at long term care facilities; and pediatricians for the prescribing of medications identified as the most addictive and prone to diversion to the illegal drug market. This regulation allows specialized medical providers to issue telemedicine prescriptions for Schedule II-V medications.

DEA is seeking public comment by March 18, 2025, on additional medical specialists that should be authorized to issue Schedule II medications. Public comments will also be requested on additional patient protections for the prescribing of Schedule II medications by telemedicine, including whether the special registrant should be physically located in the same state as the patient being prescribed Schedule II medications; whether to limit Schedule II medications by telemedicine to medical practitioners whose practice is limited to less than 50 percent of prescriptions by telemedicine; and the appropriate duration needed for the rules’ provisions to be enacted.

For the first time, online platforms that facilitate connections between patients and medical providers that result in the prescription of medications will be required to register with DEA. This is critical, as DEA has found some unscrupulous medical providers on online platforms have used flexible telemedicine rules to put profit ahead of the well-being of patients.

The special registration rule will also require the establishment of a national PDMP to help the health industry protect against abuse and the diversion of controlled substances into the illegal drug market. A national PDMP will provide pharmacists and medical practitioners with visibility of a patient’s prescribed medication history.

Additionally, a Final Rule on Continuity of Care Via Telemedicine for Veterans Affairs (VA) patients was issued, allowing practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation. VA practitioners are permitted to prescribe controlled substances to VA patients if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions.

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As RCPA previously communicated, the Drug Enforcement Administration (DEA), jointly with the U.S. Department of Health and Human Services (HHS), has extended the temporary COVID-19 telemedicine flexibilities through December 31, 2025. These flexibilities enable prescribing of controlled medications via telemedicine. As such, the Pennsylvania Department of Drug and Alcohol Programs’ (DDAP) suspension of 28 Pa. Code § 715.9(a)(4), which allows an initial evaluation for a person who will be treated by an opioid treatment program (OTP) with buprenorphine to be completed via telehealth, is also extended.

DDAP’s complete Information Bulletin 03-2024 is available here.

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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.

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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.

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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.

Read the full announcement.

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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.

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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.

Read the full announcement.

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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:

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