You Spoke, They Listened: DEA Extends Telemedicine Rules Through 2024

DEA Issues Extension of Telemedicine Controlled Substance Flexibilities to Dec. 31, 2024

Late last week, the Drug Enforcement Administration (DEA) issued a temporary rule extending the allowance for physicians and practitioners to prescribe controlled medications to new patients based on a relationship solely established through telemedicine (live video or telephone for buprenorphine) until Dec. 31, 2024.  The extension will give the DEA time to consider permanent changes to their rules around prescribing controlled substances moving forward. 

Prior to the COVID-19 public health emergency (PHE), a prior in person visit was required in most circumstances in order for physicians and practitioners to establish relationships with patients before the prescribing of controlled substances could occur.  During the COVID-19 PHE this was waived, and the allowance for prescribing controlled substances based on a telemedicine interaction was further extended in May 2023 until November 11, 2023 following the proposal of permanent regulations that received over 38,000 comments. In response to the overwhelming feedback, in September, the DEA conducted listening sessions to allow medical practitioners, patients, pharmacy professionals, industry members, law enforcement and other third parties to express their view.  CCHP provided a recap of the listening sessions in a previous newsletter.  Key concerns from stakeholders expressed during the listening sessions were related to in-person visit requirements, the 30-day prescribing limit in the initially proposed rules, and adding various reporting requirements, such as notating on prescriptions that they were prescribed via telemedicine. During the session Administrator Anne Milgram, indicated there would be an additional comment period forthcoming.  The temporary extension until December 31, 2024 of the COVID-19 PHE allowances for prescribing controlled substances will allow the DEA time to thoughtfully craft these rules in light of the vast public interest and commentary on the requirements.  The rule itself lists additional reasons the extension is being issued:

• “Prevent a reduction in access to care for patients who do not yet have an existing telemedicine relationship;
• For relationships established both during the COVID-19 PHE and those established shortly after, prevent backlogs with respect to in-person medical evaluations in the months shortly before and after the expiration of the telemedicine flexibilities;
• Address the urgent public health need for continued access to the initiation of buprenorphine as medication for opioid use disorder in the context of the continuing opioid public health crisis;
• Allow patients, practitioners, pharmacists, service providers, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine;
• Enable DEA and potentially HHS to thoroughly consider the presentations made at the Telemedicine Listening Sessions;
• Enable DEA, jointly with HHS, to conduct a thorough evaluation of regulatory alternatives in order to promulgate regulations that most effectively expand access to telemedicine encounters in a manner that is consistent with public health and safety, while also effectively mitigating against the risk of possible diversion; and
• Avoid incentivizing the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices by limiting the second extension of flexibilities to a short, time-limited period.”

To read more on the background, and DEA’s reasoning for the rule, see the full rule text.

HHS Rule on Discrimination on the Basis of Disability Addresses Requirements for Telehealth Applications

In September, the Department of Health and Human Services (HHS) introduced a proposed rule aimed at enhancing protections for individuals with disabilities, including access through telehealth devices such as mobile apps, kiosks and requirements for accessible medical equipment. The proposed rule is designed to ensure that people with disabilities have equal opportunities to participate in and benefit from healthcare programs. The COVID-19 pandemic underscored the importance of web-based information and services, especially for individuals with disabilities who were at a higher risk of COVID-19 exposure and severe illness. Nevertheless, there exists a digital divide due to inadequate accessibility, hindering equal access to programs and activities for people with disabilities.  Notably, this is not the first time that HHS has addressed this issue; last year, in collaboration with the Department of Justice, HHS issued guidance explaining how various federal laws mandate telehealth accessibility for people with disabilities and limited English proficiency.

As part of the proposal, HHS is proposing that recipients of federal funding make their mobile apps accessible, recognizing the growing role of mobile applications in providing services and reaching the public. These apps are distinct from websites and are essential for tasks like patient portal access, appointment scheduling, and communication with healthcare providers. HHS also acknowledges the use of kiosks and self-service machines in healthcare settings, highlighting that these devices may be inaccessible to individuals with disabilities. The lack of accessibility can result in delays, privacy concerns, and difficulties in accessing essential health and human services. To address these issues, the Department aims to establish technical standards for web and mobile app accessibility, ensuring consistent and predictable access for individuals with disabilities. Specifically, the proposed rule:

• Ensures that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities, judgments that an individual will be a burden on others, or beliefs that the life of an individual with a disability has less value than the life of a person without a disability;
• Clarifies obligations for web, mobile, and kiosk accessibility;
• Establishes enforceable standards for accessible medical equipment;
• Clarifies requirements in HHS-funded child welfare programs and activities;
• Prohibits the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when that method is used to limit access or to deny aids, benefits, and services;
• Clarifies obligations to provide services in the most integrated setting appropriate to the needs of individuals with disabilities.

For complete information on the rule and its requirements, see the rule text in its entirety.  Public comments can be submitted on the rule until November 13, 2023 through the federal register.

Indian Health Services “Four Walls” Grace Period Extension

In a recent Informational Bulletin, the Centers for Medicare & Medicaid Services (CMS) has extended the grace period for Indian Health Service (IHS) facilities, including those operated by Tribes and Tribal organizations, to claim Medicaid reimbursement for services provided outside of their facilities (or “four walls”). Originally set to expire on October 31, 2021, this grace period has been extended twice. First to February 11, 2024, and second by an additional twelve months until February 11, 2025.   The reason behind the additional extension involves complications arising as a result of the unwinding of COVID-19 policies, and transitioning back to regular Medicaid eligibility operations, which can be straining for state and Tribal resources, with anticipated challenges lasting into 2024. The extensions alleviate some of the strain and allow states and Tribes more time to evaluate the “Tribal FQHC option” (which allows tribal health care facilities to be redesignated as federally qualified health centers (FQHCs)) within Medicaid programs.  IHS-operated facilities will also benefit from this extension to facilitate compliance with the four walls requirement. For more information including contact information for questions, see the full bulletin.

CMS Online Resource Dedicated to Process for Requests for Telehealth Service Additions

The Centers for Medicaid and Medicare Services (CMS) has created a new section of their website dedicated to explaining the process to request additions to their list of eligible telehealth services for which Medicare reimburses.  It has been a long-standing criticism of CMS that the process is unclear and difficult to navigate.  The website section describes the main elements required in submission requests as the following:

• Name(s), address(es) and contact information of the requestor.
• The HCPCS code(s) that describes the service(s) proposed for addition or deletion to the list of Medicare telehealth services.
• A description of the type(s) of medical professional(s) providing the telehealth service at the distant site.
• A detailed discussion of the reasons the proposed service should be added to the definition of Medicare telehealth.
• An explanation as to why the requested service cannot be billed under the current scope of telehealth services, for example, the reason why the HCPCS codes currently on the list of Medicare telehealth services would not be appropriate for billing the service requested.
• Evidence that supports adding the service(s) to the list on either a category 1 or category 2 basis (see further description of these categories below).

There is also a section explaining CMS’ criteria for submitted requests, including that they must fall into one of two categories.

1. Category 1:  The proposed new addition code(s) are similar to professional consultations, office visits and office psychiatry services that are currently on the list.
2. Category 2:  The proposed new addition code(s) are not similar to existing codes on the telehealth list, but the requester is able to demonstrate clinical benefit to the patient that justifies their addition.  Examples of clinical benefits are listed on the webpage, and include reduced recovery time, reduced complication rates and ability to diagnose a medical condition in a patient population without access to appropriate in person services.

Although the website section does not mention it, there is currently also a Category 3 code list of services that have been approved temporarily for reimbursement when delivered via telehealth during the COVID-19 pandemic, but do not yet have enough evidence to justify a move on to the permanent list.  The CMS website section also provides logistical information regarding the submission of code requests, such as the deadline of submitting codes no later than February 10^th of each calendar year in order to be considered for the following year’s proposed physician fee schedule (PFS) rule, and provides submission instructions for both mail and electronic requests.  CMS has already released its proposals for the 2024 physician fee schedule (PFS) and while they did not decide to add any new codes on a Category 1 or 2 basis, they are proposing new codes on a Category 3 temporary basis.  CMS also proposed to change the code approval process to eliminate the category system and designate codes as either permanent, provisional or rejected.  See CCHP’s factsheet on the proposed 2024 PFS for more information.  Stay tuned to future CCHP updates regarding changes to the approval process and finalization of the 2024 PFS.

Latest Policy Developments in CCHP’s Telehealth Policy Finder and Policy Trends Map

Significant changes in the states included Michigan Medicaid revising their Medicaid Provider Manual to incorporate their post-COVID telemedicine policies that had been previously communicated through a bulletin issued in March 2023.  The bulletin describes that telemedicine must only be used when there is a clinical benefit to the beneficiary and lists examples of such cases.  It also allows for reimbursement of audio-only services for certain codes, which are listed in the bulletin.  Finally, the bulletin addresses place of service code requirements as well as modifiers, (among other requirements), which are detailed in the bulletin including considerations for specific programs and service sites. 

CCHP also found that Pennsylvania Medicaid issued a new bulletin clarifying their updated telehealth policy.  It specifies that they will recognize both place of service code (POS) 02 (telehealth delivered in a setting other than the patient’s home), and POS 10 (telehealth delivered to a patient’s home).  The bulletin also clarifies that Pennsylvania Medicaid will continue to reimburse for services delivered through audio-only telecommunications technology that are in compliance with state and federal requirements.  Services rendered via telehealth, the bulletin explains, are paid at the same rate as services rendered in person. 

In addition to the modifications of telehealth policy in Medicaid in both Pennsylvania and Michigan mentioned above, Missouri adopted three new interstate licensing compacts, including the Counseling Compact, the Interstate Medical Licensure Compat and the Social Work Compact. 

Given the nuanced and varied approaches states are taking with their telehealth policies, please reference CCHP’s telehealth Policy Finder to link to additional details and access each states’ policies in their entirety.  As mentioned previously, this completes CCHP’s fall revisions of our Policy Finder.  Keep an eye out later this month for our upcoming Fall Summary Report on the latest telehealth policy trends based on updates to our policy finder between late May and early September.  Note that the summary report will now transition to being released once per year in the Fall only (as opposed to Spring and Fall as we have historically done), with three separate rounds of updates being made to each jurisdiction in the Policy Finder per year.

Revised Medicare Enrollment Application, Includes Telehealth Practice Location Type

Last month the Centers for Medicare and Medicaid Services (CMS) announced a revised enrollment application that will be used starting November 1, 2023.  The new application expands practice location types to include telehealth with options to designate a practice location as a business office for telehealth use only or a home office for telehealth use only.  The instructions indicate that providers should complete practice location information for each location where providers render telehealth services, including all locations they would disclose on claim forms for reimbursement.  The form does require a physical address, and cannot use a Post Office (PO) box.  During the Public Health Emergency (PHE), CMS had allowed practitioners to render telehealth services from their home address without reporting the address on their Medicare enrollment while continuing to bill from their currently enrolled location.  That allowance is anticipated to end December 31, 2023, and has likely prompted the inclusion of the telehealth instructions and practice location type to the application.  Providers have raised concerns about the possibility of their addresses becoming publicly accessible on patient bills and other documents due to this change. Although there is a potential that CMS might offer a method for providers to protect their addresses, CCHP has not yet found specific instructions on if and how CMS will implement this safeguard.

Noridian (a Medicare Administrative Contractor) will be hosting a webinar on telehealth enrollment basics on October 25, 2023.  It is possible that they may provide more insight into the address issue during the webinar.  To view the webinar, be sure to register through Noridian’s form.  Additionally, keep an eye out for forthcoming updates from CCHP on this in future newsletters.  In the meantime, see the newly revised application to review all the changes CMS made.

American Telemedicine Association New Tools on Disparities and Inequities in Telehealth

The American Telemedicine Association (ATA)’s advisory group on using telehealth to eliminate disparities and inequities has recently released three new resources to help decipher how telehealth impacts disparities and inequities.  The tools include: 

• The Digital Infrastructure Disparities Score and Map – This tool employs a composite measure, developed to assess a community’s digital infrastructure, rated on a scale from 1 to 100.  Users can look up their specific region in the map to determine the percentage of households/population that has access to the internet, high speed internet subscriptions, smartphones, etc.  All the data gathered was used to determine the region’s digital infrastructure score.
• The Economic and Social Value-Added Calculator – The calculator serves the purpose of estimating the expenses associated with telehealth-based clinical or social interventions. This includes calculating the overall value generated by such interventions, benefiting payers, providers, government entities, and businesses. The calculator scrutinizes both the capital and operational costs linked to these interventions, encompassing technology platforms (telehealth solutions) and the financial resources required to establish robust, dependable, and continuous broadband connectivity within communities.
• Resource Summary – This tool is a PDF document downloadable from the ATA website that summarizes materials and resources released by the group up to the present date. It includes a newly developed roadmap aimed at addressing disparities in the delivery of healthcare information and services, with a dual focus on enhancing accessibility and improving outcomes.

To explore all of the ATA’s new resources developed by the Disparities Advisory Group, complete their online registration form and be taken to the content immediately.

Milbank North Carolina Telehealth Medicaid Issue Brief

The Milbank Memorial Fund recently published an issue brief examining the impact of Medicaid telehealth changes on equitable access to telehealth services in North Carolina.  The issue brief examines the impact of policies that expanded reimbursement for telehealth services that resulted from the COVID-19 pandemic.  Specifically, the North Carolina Department of Health and Human Services (DHHS) took action early in the COVID-19 pandemic to promote expanded delivery of Medicaid and Children’s Health Insurance Program (CHIP) services via telehealth by eliminating originating site limitations and distance requirements, enabling virtual patient communication services and interprofessional consultations, and expanding telehealth-eligible services and providers, among other allowances. Simultaneously, North Carolina dedicated substantial resources to enhance its telehealth infrastructure and support providers during the COVID-19 pandemic.  For example, the state’s governor’s office utilized federal grants to establish broadband infrastructure and assist residents in enrolling in the Affordable Connectivity Program, which provided eligible low-income households with reduced rates for high-speed internet access and access to computing devices such as laptops, tablets, and desktop computers.  DHHS also invested in expanded analytic capacity to measure and understand the impact of the telehealth flexibilities.

According to the issue brief (which examined Medicaid data between March 2020 and January 2022), there was a higher number of telehealth encounters in urban areas compared to rural areas, but the proportion of telehealth usage in relation to total claims did not significantly differ based on geography. However, telehealth utilization varied significantly based on the characteristics of members, with Black members consistently exhibiting the lowest rates of telehealth use. Disparities in the rates at which telehealth services were offered may have played a role in the variations in telehealth utilization by race and ethnicity. Findings revealed a notable difference, though not statistically significant, in telehealth offer rates between Black and White members (19.1% and 24.1%, respectively), as well as a statistically significant difference in offer rates between Hispanic and non-Hispanic members (14.6% and 22.5%, respectively).

North Carolina’s data reveals persistent disparities in telehealth usage based on race and ethnicity, even after significant policy changes and state investments in expanding telehealth access. Notably, rural telehealth utilization, when adjusted for volume, closely paralleled urban use during the COVID-19 pandemic, possibly attributed to the state’s substantial investments in broadband infrastructure. The authors of the issue brief conclude that achieving health equity may necessitate distinct strategies beyond simply enhancing telehealth access in rural areas, such as ensuring universal telehealth offerings by providers and implementing implicit bias training. For more information, including charts and graphs of the data, see the full report.

Open for Questions:  FQHC Billing Assistance Technical Assistance

If you are an FQHC with questions about telehealth, connect with your regional telehealth resource center (RTRC)!  There are 12 RTRCs that cover specific states and have some of the most knowledgeable telehealth experts in the country.  Find the RTRC that covers your state through the National Consortium of Telehealth Resource Centers’ website.

Additionally, CCHP has set up a technical assistance email box for FQHCs to ask their telehealth billing questions.  This service is only for FQHCs.  You can send in your FQHC billing questions to: [email protected] 

FEDERAL LEGISLATION

Expanding Remote Monitoring Access Act
HR 5394 (Rep. Balderson R-OH) – Requires the Health and Human Services (HHS) Secretary to submit a report to congress not later than one year after the date of enactment that includes a summary and analysis of previous experience with remote monitoring services being payable, recommendations for reimbursement models, analysis and justification for the appropriate place of service and estimated savings resulting from interventions. See bill for further details.  (Status: 9/12/23 – Introduced in House)

Expanded Telehealth Access Act
S 2880 (Sen. Daines R-MT) – Expands the practitioners eligible to be reimbursed for telehealth services under Medicare to include an audiologist, occupational therapist, occupational therapist assistant, physical therapist, physical therapist assistant, speech-language pathologist, a facility described in paragraph (8) or (9) of section 1833(a), and any additional provider of services or suppliers specified by the Secretary. (Status: 9/21/23 – Introduced in Senate)

Helping Ensure Access to Local TeleHealth (HEALTH) Act of 2023
HR 5611 (Rep. Thompson R-PA) – Redefines a ‘visit’ for purposes of reimbursement for FQHCs and RHCs to include any two-way, real-time interactive communication between an individual and the distant site FQHC or RHC, whether by audiovisual or audio-only communication.  It also specifies that a telehealth service furnished by a RHC or FQHC serving as a distant site shall be deemed to be furnished to such individual as an outpatient of such clinic or facility and costs associated the telehealth services shall be considered allowable costs for purposes of the prospective payment system.  It also provides an exception from the Medicare originating site rural requirement and site requirement for telehealth services furnished by FQHCs and RHCs. (Status: 9/20/23 – Introduced in House)

Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act of 2023
HR 5541 (Rep. Latta R-OH) – Specifies that a health care professional may practice within the scope of the individual’s license, certification, or authorization with respect to mental health services, through telehealth, in any emergency area during an emergency period, based on the licensure, certification, or authorization of such individual in any one State, the District of Columbia, or territory or possession of the United States.  This applies whether the health care professional has a prior treatment relationship with the patient, provided that, if the health care professional does not have a prior treatment relationship with the patient, a new relationship may be established only via a written acknowledgment or synchronous technology.  The bill also requires written notice be provided to the patient to include information about the provider’s credentials.  See text for details.  (Status: 9/18/23 – Introduced in House)

CALIFORNIA
AB 1369 – Under this bill, a person licensed as a physician and surgeon in another state, as specified, who does not possess a certificate issued by the board would be authorized to deliver health care via telehealth to a patient who, among other requirements, has a disease or condition that is immediately life-threatening.  (Status: 9/13/23 – Enrolled and presented to Governor)

MICHIGAN
HB 4131 – Modifies Michigan’s telehealth private payer law to require, among other elements, that coverage is provided for the cost of health care services through telemedicine on the same basis and to the same extent that coverage is provided for the same service through in-person treatment or consultation.  It also specifies that coverage must not be limited to third party telemedicine providers.  (Status: 9/14/23 – Referred to Committee on Policy)

MASSACHUSETTS
H 3585 – Requires insurers (including Medicaid managed care) provide coverage for telehealth services to include reimbursement for interpreter services for patients with limited English proficiency or those who are deaf or hard of hearing.  It also specifies that coverage may include utilization review to determine the appropriateness of telehealth as a means of delivering the health care service, provided that the determination is made in the same manner as if the service was delivered in person. (Status: 9/12/23 – Hearing held)

NEW HAMPSHIRE
HB 409 – Enacts the Social Worker Licensure Compact in New Hampshire, which allows social workers to provide services across state lines if their home state is a member state and they have completed the Compact application process.  (Status: 8/10/23 – Signed by Governor; Executive Session scheduled for 11/8/23)

TENNESSEE
HB 7066 – Establishes the Temporary Youth Mental Health Services Program.  Requires the department to reimburse providers who participate in the program for each mental health session with a youth, either in-person or via telehealth, up to a maximum of three (3) sessions per youth client. The department may reimburse a provider for additional sessions, subject to available funding. (Status: 8/23/23 – Laid on Table)

VERMONT
HB 222 – Specifies that Controlled Substances for use in treatment of opioid use disorder may be prescribed via telehealth in accordance with federal requirements. (Status: 9/1/23 – Approved by Governor in May.  Bill took effect Sept. 1, 2023)