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OTP

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.

The Center for Medicare and Medicaid Services (CMS) has released the Physician Fee Schedule CY 2025 Final Rule. You can view CMS’ press release, fact sheet, and final rule page in the Federal Register for more information. There were critical areas addressed in this year’s Physician Fee Schedule (PFS), including:

  • The extension of some telehealth flexibilities permitted under CMS’ authority absent Congressional action;
  • Updated payment for social determinants of health risk assessments as a part of Opioid Use Disorder intake activities furnished at Opioid Treatment Programs (OTP);
  • The establishment of a new add-on code to account for coordinated care, referral services, and peer supports at OTPs;
  • Payment for safety planning intervention and post-discharge follow-up;
  • The establishment of six G codes that mirror current interprofessional consultation Common Procedural Terminology codes used by practitioners who are eligible to bill E/M visits; and
  • Recognition of responses to CMS’ request for information on Certified Community Behavioral Health Clinics.

For the OPPS Final Rule, please see links to CMS’ press release, fact sheet, and final rule page in the Federal Register. Some highlights from this final rule include:

  • The maintenance of the Partial Hospitalization Program and Intensive Outpatient Program rate structures;
  • Narrowing the definition of “custody” in Medicare’s payment exclusion rule to mitigate barriers to Medicare access by individuals who have recently been released from incarceration or are on parole, probation, or home detention; and
  • Changes to Medicaid regulation, allowing states implementing the Medicaid clinic services benefit to cover clinic services outside the “four walls” of behavioral health clinics.

If you have any further questions regarding these final rulings or the application of the “four walls” impacts on Pennsylvania, please contact RCPA COO and Mental Health Director Jim Sharp.

On behalf of its opioid treatment program (OTP) provider members, RCPA submitted comments to the Independent Regulatory Review Commission (IRRC) in support of a final-omitted regulation that would allow an initial physical examination required for prescribing, administering, and dispensing controlled substances through an OTP to be conducted via telehealth under certain circumstances under Pa. 49 Code § 16.92.

This final-omitted regulation would enable the Pennsylvania Department of Drug and Alcohol Programs (DDAP) to grant a statewide exception to 28 Pa. Code § 715.9(a)(4), which today requires Pennsylvania OTPs (called narcotic treatment programs in DDAP regulations) to conduct a face-to-face determination of whether an individual is currently physiologically dependent on an opioid.

IRRC will consider the final-omitted regulation at a public meeting on December 5.

In its comments, RCPA wrote:

“Enabling OTPs to conduct the initial examination required as part of induction into methadone or buprenorphine treatment through telehealth significantly improves and expedites patient access to the gold standard treatment for OUD without sacrificing quality or safety. In a treatment environment where finding qualified physicians, physician assistants and certified registered nurse practitioners is challenging, telehealth bridges a significant gap. Physicians would no longer need to be physically on site at the OTP where treatment is to take place to examine a patient as part of the induction process. Rather, from anywhere in the commonwealth, a physician can examine more patients, who can then begin treatment with medication faster at a facility near their home. In fact, with this final-omitted regulation, OTPs will have the ability to accommodate same-day or walk-in admissions instead of scheduling intake appointments days later.”

The final-omitted regulation, submitted by the Department of State, Bureau of Professional and Occupational Affairs, State Board of Medicine, along with comments in support from the Department of Drug and Alcohol Programs and RCPA, can be viewed on the IRRC website.

Last Thursday (October 3, 2024), the Pennsylvania Department of State’s Board of Medicine submitted to the Independent Regulatory Review Commission (IRRC) a final-omitted regulation that would allow an initial physical examination required for prescribing, administering, and dispensing controlled substances to be conducted via telehealth under certain circumstances under 49 Pa. Code § 16.92. A final-omitted regulation does not require a public comment period and is in essence an expedited process for proposing a regulation change. IRRC will hold a public meeting on November 21 to approve or disapprove the regulation.

This final-omitted regulation would enable the Pennsylvania Department of Drug and Alcohol Programs (DDAP) to grant a statewide exception to 28 Pa. Code § 715.9(a)(4), which today requires Pennsylvania OTPs (called narcotic treatment programs in DDAP regulations) to conduct a face-to-face determination of whether an individual is currently physiologically dependent on an opioid.

In its Regulatory Analysis Form, the Department of State’s Board of Medicine wrote:

“This final-omitted rulemaking amends the Board’s regulations at § 16.92 by allowing the initial physical examination required for prescribing, administering, and dispensing controlled substances to be conducted by means of telehealth for those patients being admitted into an Opioid Treatment Program (OTP) for treatment of opioid use disorder with either buprenorphine or methadone, provided that the health care provider determines that an adequate evaluation of the patient can be accomplished via telehealth and a full in-person physical examination is completed within 14 days after admission to the OTP. This standard is the same physical examination standard utilized as a result of the Bureau of Professional and Occupational Affairs regulatory waiver issued during the COVID-19 epidemic, which proved to be safe and effective during and after the COVID-19 epidemic. This final-omitted regulation also conforms the Board’s regulations to the Federal opioid use disorder treatment standards as the Board does not wish to unnecessarily maintain a more stringent standard than required by Federal law for OTPs given the continued opioid crisis in this Commonwealth.”

In February 2024, the U.S. Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule amending the federal regulations for the certification of OTPs in 42 CFR Part 8. The changes to the federal rules were used temporarily to improve access to treatment during the COVID-19 federal public health emergency. SAMHSA has now made those changes permanent, and DDAP intends to implement the updated federal rules and reduce barriers to treatment, as described in its latest Licensing Alert 07-2024. This final-omitted regulation is part of the commonwealth’s process for aligning with the final rule on 42 CFR Part 8.

Photo by Markus Winkler on Unsplash

The Department of Drug and Alcohol Programs (DDAP) has issued Licensing Alert 02-2024, effective immediately, to inform opioid treatment programs (OTP) about the recent final rule issued by the Substance Abuse and Mental Health Services Administration (SAMHSA) on February 2, 2024, concerning medications for the treatment of opioid use disorder (OUD). RCPA issued an alert to its members on February 1 announcing the final rule.

This rule modifies and updates regulations pertaining to OTP accreditation, certification, and standards for the treatment of OUD. The most crucial aspects of SAMHSA’s final rule include the permanent adoption of COVID-19 era flexibilities, allowing patients to receive more take-home doses of methadone, which is proven to enhance treatment retention and reduce illicit opioid use. The update also permits the initiation of methadone and buprenorphine treatment via telehealth through OTPs and removes stringent admission criteria, thereby improving access to care for individuals in need.

DDAP is currently reviewing the final rule, set to take effect on April 2, 2024, with a compliance deadline of October 2, 2024, and plans to issue a follow-up Licensing Alert soon. For further information, contact the Bureau of Program Licensure.

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.