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Telehealth

On Friday, November 1, the Centers for Medicare & Medicaid Services (CMS) released an anticipated Final Rule titled “CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS 1809-FC),” which includes three new exceptions for the federal “four walls” rule. At present, the “four walls” rule prohibits Medicaid payment for clinic services when both the practitioner and individual receiving service are outside of the “four walls” of the clinic unless the services are being provided to unhoused individuals (such as through street medicine). The new exception for Indian Health Services and Tribal Facilities is required nationally. The exceptions for Behavioral Health Clinics and Rural clinics are optional. States who determine that their Behavioral Health Clinic and/or Rural Health Clinic populations served meet the four criteria established by CMS (see page 1323 of the final rule) must submit a Medicaid State Plan Amendment (SPA) and receive approval from CMS for these exceptions to be in place for their state.

The Office of Mental Health and Substance Abuse Services (OMHSAS) had been working toward a short-term state level solution to the four walls issue for both Outpatient Psychiatric Clinics and Drug and Alcohol Clinics. However, now that a long-term federal option has been made available, the team in OMHSAS will be pivoting to pursue this newly available federal exception for Behavioral Health Clinics. While OMHSAS is still in the process of developing a timeline for the new State Plan Amendment, their team will be working on this as a top priority, with the goal of having a SPA in place in early 2025.

It has been confirmed that OMHSAS will not be shifting their current enforcement policy around the four walls while they work through getting this waiver in place. RCPA will continue its collaboration with OMHSAS on the process as this move forwards. If you have any questions, please contact RCPA COO and Mental Health Policy Director Jim Sharp.

For additional information, please see the following:

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This week, the Drug Enforcement Agency (DEA) submitted a final rule regarding virtual prescribing of controlled substances to the White House’s Office of Management and Budget (OMB). Though the final rule is not yet publicly available, the OMB registry posting, titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,” suggests an extension is coming that will go beyond the current expiration date of December 31, 2024.

Without a new rule or extension of the current flexibility beyond December 31, virtual prescribing of controlled substances without a prior in-person evaluation would no longer be allowed.

DEA received more than 38,000 public comments following its proposed rule in February 2023 for telemedicine prescribing of controlled substances. Subsequently, the telehealth flexibilities were extended to the current December 31, 2024, expiration date.

RCPA will continue to monitor progress on the final rule and communicate the details of the final rule once it is made public.

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, 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.

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The Pennsylvania Department of Drug and Alcohol Programs (DDAP), through RCPA, is seeking input on its plan to license telehealth-only outpatient SUD treatment providers.

In an effort to regulate unlicensed, out-of-state telehealth providers marketing themselves as addiction treatment providers as well as expand access, DDAP plans to license telehealth-only outpatient SUD treatment providers. These DDAP-licensed telehealth-only providers may provide intake, evaluation, and referral, as well as outpatient, intensive outpatient, or partial hospitalization services via telehealth only, without a physical plant location in Pennsylvania, to individuals who are located in the Commonwealth as long as the provider complies with all applicable federal, state, and local laws.

DDAP will not require the provider to maintain a physical location in Pennsylvania. DDAP also will grant all telehealth-only providers an exception to §709.11(b) regarding the requirement to conduct an onsite inspection for the renewal of a license as part of licensure.

DDAP has also said licensure is no guarantee of payment. Providers that are considering applying for a telehealth-only license should consult their public and private insurance payers to confirm whether they will meet conditions for network enrollment and payment, as DDAP cannot guarantee a DDAP-licensed telehealth-only provider funding or a contract.

Some providers have raised concerns about:

  • The effectiveness and quality of tele-only treatment without an ability for in-person counseling and how it could harm patients;
  • The siphoning of commercial patients from community-based providers and how it would negatively affect their financial situation;
  • The long-term sustainability of community-based providers who understand their community as large national players enter Pennsylvania; and
  • Maximizing existing outpatient capacity in Pennsylvania.

Comments may be emailed directly to DDAP Deputy Secretary Kelly Primus. Or, by the close of business this Friday, Sept. 20, please submit to RCPA SUD Treatment Services Provider Policy Director Jason Snyder any comments about this plan. RCPA will then share the comments with DDAP. In addition to any concerns you may have about this new license category, please include in your comments any proposed solutions you have about preventing unlicensed telehealth-only outpatient organizations from providing SUD treatment counseling via telehealth in Pennsylvania.

Legislation for Telehealth Flexibilities Introduced:
HB 2560 To Address Psychiatry Time Requirements and “4 Walls”

RCPA is pleased to announce that yesterday, September 10, State Representative Tina Pickett (R-District 10) introduced House Bill 2560, which was referred to the House Health and Human Services Committee. The legislation is focused on addressing two critical telehealth considerations, including an update of the outpatient psychiatric outpatient time requirements and the Federal Medicaid payment standard known as the “4 Walls.” The latter would abrogate DHS 55 PaCode § 1153.52 Payment Conditions for Various Services and 55 PaCode § 5200.52 Treatment Planning. By addressing the “4 Walls” requirement, telehealth services by a practitioner can be delivered outside the physical outpatient clinics and will be categorized under licensed mobile mental health services.

On a parallel track, the Center for Medicare and Medicaid Services (CMS) has proposed a final rule exception that would eliminate the “4 Walls” requirements among several other actions. On September 9, 2024, RCPA submitted comments regarding the Medicaid Clinic Services 4 Walls Exceptions on behalf of our membership in support of the proposed exception to eliminate this Medicaid standard.

Additionally, the bill requires that providers who want to deliver telehealth services 100% must maintain a written agreement with a geographically proximate outpatient psychiatric clinic that operates a physical facility and provides in-person services at the outpatient psychiatric clinic within 40 miles or 60 minutes travel from the residence of the individual receiving services AND that the written agreement must include a provision that a referred individual must be seen by the geographically proximate outpatient psychiatric clinic within 10 days of the referral.

Finally, the bill addresses the required 50% psychiatric in-clinic time requirements of 55 Pa. Code Chapter 5200 for Psychiatric Outpatient Clinics. The proposed legislation outlines that required psychiatric time may be provided in person or by the use of telebehavioral health technology by psychiatrists, as specified by department regulations. Advanced practice professionals may also provide a portion of the psychiatric time, as specified by department regulations, either in person or by the use of telebehavioral health. Onsite supervision requirements can be performed by either a psychiatrist or an advanced practice professional. Lastly, the legislation permits DHS to issue waivers to fully remote providers so they can serve patients covered by private insurance.

The introduction of the bill represents a unified effort with OMHSAS, our partners in the Pennsylvania General Assembly, and stakeholders across the Commonwealth to enhance our system’s capacity to deliver services to those most in need. We ask that you join us in working with your legislators to pass this critical legislation.

RCPA will continue to update members as the legislation advances. If you have any questions, please contact RCPA COO and Mental Health Director Jim Sharp.

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The Office of Mental Health and Substance Abuse Services (OMHSAS) Deputy Secretary Jen Smith recently provided an update on the federal four walls rule. The Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule, or Notice of Public Rulemaking, that could create exceptions to the existing four walls requirement for IHS/Tribal clinics, behavioral health clinics, and clinics located in rural areas.

The official language posted to the federal register can be found on page 15 of the Federal Register, which is scheduled to be published on July 22, and is copied below.

“This proposed rule includes a proposal to create exceptions to the Medicaid clinic services benefit four walls requirement, to authorize Medicaid payment for services provided outside the four walls of the clinic for IHS/Tribal clinics, behavioral health clinics, and clinics located in rural areas. Our current regulation at 42 CFR § 440.90(b) includes an exception to the four walls requirement under the Medicaid clinic services benefit only for certain clinic services furnished to individuals who are unhoused. We believe these proposed exceptions would help maintain and improve access for the populations served by IHS/Tribal clinics, behavioral health clinics, and clinics located in rural areas.”

As a reminder, this is a proposed rule intended to announce and explain CMS’s plan to address the problem. As such, all proposed rules must be published in the Federal Register to notify the public and give them an opportunity to submit comments. The proposed rule and the public comments received on it form the basis of a final rule. More information on the final rulemaking process is available here. Interested parties should provide public comments on this proposed rule to the addresses listed in the federal register by September 9, 2024.

While CMS works through this process, OMHSAS, RCPA, and the PA General Assembly continue efforts to address this through the recently released HCO 3450 legislation that will address the psychiatric outpatient in-office requirements and the Medicaid “4 walls” standards. RCPA will work with our members and the National Council for Mental Wellbeing on developing public comments for submission regarding this proposed rule. If you have any questions, please contact RCPA COO and Mental Health Policy Director Jim Sharp.

Last week, House Bill 2300 was referred to the House Professional Licensure Committee. HB 2300: Legislative Package to Join the National Counseling Compact & Changes to Behavioral Specialists (Former HB 2852), allows Pennsylvania to join the Counseling Compact, enabling Licensed Professional Counselors (LPC) to practice across state lines without needing additional licenses. This change aims to improve access to mental health services by supporting telehealth, allowing LPCs to provide remote counseling. The compact also mandates standardized licensure requirements, including a 60 semester-hour master’s degree, a nationally recognized exam, and supervised postgraduate experience. RCPA is seeking member input as we develop our position on the legislation.

The Compact establishes a data system for sharing licensure and disciplinary information among member states, enhancing oversight and public safety. It mentions granting authority to member states to take actions against LPCs who violate regulations and creates the Counseling Compact Commission to oversee the implementation and administration. These changes ensure consistent standards for mental and behavioral health providers, increasing mobility and the availability of BH services.

As RCPA reviewed the details of this piece of legislation, one item of interest was that the bill entails the creation of a commission in Pennsylvania that will need to be funded. In the past, portions of commission operating costs have been realized by an increase in licensing fees. It is important to note that RCPA has not yet seen any fiscal package associated with the bill.

We ask that members review the bill and provide commentary as well as an organizational position of support, neutrality, or non-support. Please contact RCPA COO and Policy Director Jim Sharp with any feedback or questions.