| CMS Proposes 2025 Physician Fee Schedule, Strives to Preserve Telehealth Flexibilities Amid Statutory Constraints |
|
Last week the Centers for Medicare and Medicaid Services (CMS) released their proposed Calendar Year (CY) 2025 Physician Fee Schedule (PFS) outlining CMS’ proposals for telehealth in Medicare for 2025. The telehealth sections of the proposals are clouded by the looming end of COVID telehealth flexibilities that have been in place since the beginning days of the COVID-19 public health emergency (PHE) and are currently set to expire December 31, 2024. Among the flexibilities that will be expiring at the end of the year, include allowing non-mental health services to be provided to patients located in their homes and in urban (rather than only rural) areas, an allowance for an expanded list of practitioners to deliver services (such as occupational therapists, physical therapists and speech language pathologists), and the waiver of an initial in-person visit requirement before mental health services can be delivered via telehealth. These reimbursement requirements are explicitly outlined in statute and, absent legislative action by Congress, pre-COVID telehealth limitations will go back into effect for 2025. For a complete run down of Medicare policy, both permanent and temporary, see CCHP’s Policy 101 webpage.
Despite the statutory constraints described above, CMS does seem to be proactively trying to find ways within the proposed fee schedule to avoid an abrupt return to pre-COVID policies. The agency acknowledges that such a shift could disrupt access to services, particularly for underserved communities, and is taking steps (where possible) to prevent this outcome.
Some of their noteworthy proposals in the 2025 PFS specific to telehealth include:
- Allowing rural health clinics (RHCs) and federally qualified health centers (FQHCs) to continue to bill for non-behavioral health services using HCPCS code G2025 as they have been over the past four years, including services furnished using audio-only communications technology. They are proposing to calculate the payment amount based on the average amount for all PFS telehealth services on the telehealth list, weighted by volume.
- Revising the definition of interactive telecommunications system, on a permanent basis, to state that it “may also include two-way, real-time audio-only communication technology for any telehealth service furnished to a beneficiary in their home if the distant site physician or practitioner is technically capable of using an interactive telecommunications system as defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication, but the patient is not capable of, or does not consent to, the use of video technology.”
- Continuing to pause certain pre-pandemic frequency limitations on telehealth services including Subsequent Inpatient Visits, Subsequent Nursing Facility Visits, and Critical Care Consultation Services.
- Continuing to allow virtual presence to fulfill the requirements of direct supervision permanently for a subset of services while allowing it until Dec. 31, 2025 for all other services. Allowances for physicians to be virtually present for residents in a clinical setting would also extend until Dec. 31, 2025 under the proposal.
- Allowing periodic assessments to be furnished via audio-only telecommunications on a permanent basis in an opioid treatment program.
- Adding new codes to the Medicare list of eligible telehealth services for home international normalized ratio (INR) monitoring and caregiver training on a provisional basis, and individual counseling for pre-exposure prophylaxis (PrEP) by a physician or qualified healthcare professional (QHP) to prevent human immunodeficiency virus on a permanent basis. CMS is also proposing to remove one code (CPT 77427) for radiation treatment management.
In addition to the bullets above, CMS also details in their proposal how they considered the addition of 17 new telemedicine evaluation and management (E/M) codes added by the American Medical Association CPT Editorial Panel in February 2023. While a few changes were made based on the Editorial Panel’s modifications (such as replacing G2012 with 9X091 and eliminating telephone codes 99441, 99442 and 99443), in most cases CMS states that the code descriptors and requirements for billing with the new AMA codes generally mirror the existing office/outpatient E/M codes CMS already reimburses with the exception of the technological modality used to furnish the service. Therefore, CMS does not see a need at this time to recognize audio/video and audio-only telemedicine E/M codes for payment. However, CMS is interested in how the new telemedicine E/M codes could be used to help mitigate the expiration of COVID flexibilities discussed earlier, stating:
“We are seeking comment from interested parties on our understanding of the applicability of section 1834(m) of the Act to the new telemedicine E/M codes, and how we might potentially mitigate negative impact from the expiring telehealth flexibilities, preserve some access, and assess the magnitude of potential reductions in access and utilization.”
The above are merely highlights of the proposals, but the proposed 2025 PFS includes countless policy changes, including additional proposed changes for telehealth not covered in this write up. Stay tuned in the coming days for a new CCHP Factsheet on the proposed rule that will take a deeper dive into the issue areas noted above, plus more. In the meantime, reference the proposed 2025 PFS text itself for CMS’ proposals and their commentary on each item. CMS will be accepting comments on their proposals until 5:00 PM EST on September 9, 2024. |
|
Regulatory Crossroads: Past, Present and Potential Future - Telemedicine Controlled Substance Prescribing Amid Fraud Concerns |
|
 |
As the Drug Enforcement Agency (DEA) prepares to unveil new regulations for the telemedicine prescribing of controlled substances, many are eager to see how these changes may reshape the policy landscape for telemedicine delivery of care. With this in mind, the following provides a recap of how we arrived at this juncture and what may lie ahead on the policy horizon.
In 2008, the Ryan Haight Online Pharmacy Consumer Protection Act was enacted to regulate the dispensing of controlled substances via the internet, requiring a valid prescription issued after at least one in-person evaluation, in most cases. Telemedicine was only permissible under certain conditions, such as when patients are treated in hospitals or clinics or under direct practitioner supervision. Then, in 2018, the SUPPORT for Patients and Communities Act mandated the Attorney General (AG) to promulgate regulations within two years governing a telemedicine special registration that would allow for the prescribing of controlled substances via telehealth in limited circumstances, such as for prescribing drugs used in medication assisted therapy (MAT) to treat substance use disorder. |
|
|
The AG was previously required to promulgate such regulations related to the telemedicine special registration process under the Ryan Haight Act, but had no deadline as to when a final rule must be issued. Even with the passage of the mandate for the special registration, a rule pertaining to the special registration has yet to be issued.
The landscape for telemedicine shifted dramatically during the COVID-19 pandemic, prompting temporary flexibilities to facilitate an increase in remote patient care. This included allowances for telemedicine prescribing of controlled substances without prior in-person evaluations as long as the following requirements are met:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.
- The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.
- The practitioner is acting in accordance with applicable Federal and State law.
Additionally, in March 2020, the DEA had issued a letter to its registrants stating that a practitioner may conduct an initial evaluation via the use of a telephone for purposes of prescribing buprenorphine (commonly used in medication assisted treatment to treat substance use disorder).
In March 2023, in anticipation of the end of the COVID-19 emergency (May 11, 2023), the DEA and Department of Health and Human Services (HHS) released proposed regulations on how they permanently planned to regulate controlled substances. However, they received a massive amount of feedback on their proposal, which would have significantly limited controlled substance prescribing absent an in-person visit. Consequently, the DEA and HHS didn’t have enough time to revise their rule before the PHE ended on May 11, 2023, so a temporary rule was initially issued extending the COVID-19 PHE flexibilities until November 11, 2023, with a grace period until Nov. 11, 2024 for practitioner-patient relationships established via telemedicine during the COVID-19 PHE. In October 2023, the DEA then further delayed implementation of their in-person requirements until after Dec. 31, 2024 for all practitioner-patient telemedicine relationships (not just established relationships) to allow additional time to revise their rules, and potentially release the ‘telemedicine registration’ regulations required under the Ryan Haight Act, and in the SUPPORT for Patients and Communities Act.
Now, with the year-end expiration of current rules looming, anticipation mounts regarding the DEA's forthcoming decisions on the in-person requirement for prescribing controlled substances. In a recent mid-June development, reports surfaced that the DEA had submitted their proposed telemedicine prescribing rule to the Office of Management and Budget for review, and a Politico email [received by Politico subscribers only] indicates that the White House has set a fall deadline for finalizing the rules. Against a backdrop of heightened scrutiny driven by concerns over fraudulent practices, including recent indictments targeting telehealth company providers for overprescribing substances like Adderall, the outlook for a friendly policy environment for telemedicine prescribing appears uncertain. This was covered in detail, in CCHP’s Telehealth Tuesday newsletter titled ‘Fraud is Fraud (so don’t blame telehealth)’. Subsequent developments have revealed that the Department of Justice has filed nearly two hundred additional charges related to healthcare fraud. However, it's important to note that not all charges filed are related to telemedicine. For instance, one scheme allegedly targeted indigenous Americans involving sham sober homes where patients were allegedly provided drugs and alcohol. This highlights that fraud stems from individual actions rather than the modality in which care is provided. Nevertheless, the regulatory environment being shaped amidst these developments could be concerning for providers and patients who hope to be able to continue to utilize telemedicine to prescribe and receive medications without reverting to the limited allowances of pre-COVID times.
Links to the proposed and temporary rules that the DEA made last year are provided below:
Stay tuned to CCHP newsletters for future updates.
|
|
CMS Clarifies Rate for Place of Service Code 10 in Manual
In June the Centers for Medicare & Medicaid Services (CMS) issued a new transmittal announcing updates to the Medicare Claims Processing Manual. Effective January 1, 2024, and implemented by July 8, 2024, these changes primarily focus on billing and payment for telehealth services using Place of Service (POS) code 10. Notably, it reiterates a point that was made in the Final 2024 Physician Fee Schedule (PFS) that claims for covered telehealth services provided at the distant site with POS code 10, (when the patient is at home), are to be paid at the non-facility rate. Meanwhile, POS 02 (when the patient is at a location other than their home), is paid at the facility rate. CCHP highlighted this in the factsheet we released at the time of publication of the final 2024 PFS. Still, this became a source of confusion in the first half of the year when Medicare Administrative Contractors were reimbursing the lower facility rate for claims billed with POS 10, despite the 2024 PFS indicating they should be receiving the higher non-facility rate. At the time, Noridian, a Medicare Administrative Contractor (MAC) for several states, flagged the issue through an alert, and reassured providers that CMS was aware of the issue and was working to resolve it. CMS also notes in the transmittal that POS codes 02 and 10 must be paired with the appropriate modifier (93 for audio-only and 95 for audio/video).
The transmittal reflects necessary modifications to the corresponding sections of the Medicare Claims Processing Manual, and CMS has mandated that contractors apply these changes to claims with dates of service on or after January 1, 2024. To ensure smooth implementation and compliance, CMS states that it will disseminate national provider education content through the Medicare Learning Network (MLN). For more information on the changes and CMS’ explanation of the rate of reimbursement for POS 10, see the full transmittal document. |
|
Medicaid and CHIP Services Bulletin on Enhancing Mental Health and Substance Use Disorder Treatments through Health IT
In mid-June, the Center for Medicaid and CHIP Services (CMCS) released an information bulletin detailing how state Medicaid information technology (IT) expenditures can improve access and coordination of treatment for beneficiaries with mental health conditions and/or substance use disorders (SUDs). The bulletin also guides state Medicaid agencies on applying for enhanced federal matching rates for these expenditures.
The bulletin opens with a background section highlighting findings from various studies that demonstrate how the use of health IT can enhance care access and reduce costs for Medicaid enrollees. Various technologies play a crucial role in this integration. Patient-facing technologies like applications, web services, and text messaging can extend practice capabilities, while web-based platforms support specialist consultations, tele-mentoring, and provider education. Telehealth, in particular, has proven effective for virtual evaluations and therapy, significantly improving mental health and SUD treatment access. Additionally, electronic connections to health information exchanges (HIEs) have been shown to improve care coordination between physical health practitioners and mental health/SUD specialists. Effective integration models also feature provider-to-provider consultations by mental health and SUD specialists. With this in mind, the informational bulletin points out that CMCS previously updated its guidance and toolkit to assist states in adopting telehealth coverage policies for Medicaid and CHIP, highlighting telehealth's role in supporting treatment availability, provider access, integration, and crisis response. Furthermore, in January 2023, CMCS clarified that state Medicaid and CHIP programs can directly compensate specialists for interprofessional consultations, aligning with Medicare's policy.
The majority of the remainder of the CMCS bulletin is dedicated to providing specific examples of state IT spending that may qualify for enhanced federal Medicaid matching rates. These examples include technologies to make mental health and SUD screenings available in schools, data-sharing capabilities between hospitals and community-based mental health and SUD treatment providers, and the establishment of an eConsent management system. For additional examples and details on how to qualify for the federal matching rate, please refer to the full bulletin. |
|
An Update on Federal Legislation to Extend (or Make Permanent) COVID Medicare Telehealth Flexibilities
A planned markup at the end of June of an amended version of HR 7623, Telehealth Modernization Act of 2024 was cancelled due to a dispute over privacy legislation according to a Politico subscriber newsletter sent on June 27, which halted consideration of HR 7623. Passage of a bill that would allow for the extension of Medicare flexibilities would have a major impact on Medicare’s plans for telehealth reimbursement for 2025, as currently detailed in their proposed 2025 Physician Fee Schedule and highlighted as the lead story of this newsletter. CMS would likely adjust their final rules to align with any statutory changes in the new law.
CCHP has not been able to access the amended text, however according to text proposed in March 2024, HR 7623 would allow the home as an originating site for all services in Medicare, eliminate the geographic requirement, and allow the secretary to consult with stakeholders and expand the types of practitioners who may furnish telehealth services to include any health care professional eligible under the program. It also provides clarification that federally qualified health centers (FQHC) or rural health clinic (RHC) services furnished through telehealth to an outpatient individual would be payable under the prospective payment system (PPS) or other payment methodology established for FQHCs/RHCs. Costs would be considered allowable for purposes of PPS. The bill also would require Medicare provide coverage and payment for certain telehealth services that are furnished via an audio-only communication system. However, according to the Politico newsletter, the updated/amended version of the bill merely extends Medicare flexibilities for two years rather than making them permanent. To keep up to date on the movement of federal telehealth bills through the legislative process, view CCHP’s federal legislative tracker, and stay tuned for future updates in CCHP Telehealth Tuesday newsletters. |
|
Advancing Personalized Care with Remote Patient Monitoring and AI
Recently introduced federal legislation, HR 8816, highlights the growing importance of artificial intelligence (AI) in healthcare. If passed, this bill would require the Centers for Medicare & Medicaid Services (CMS) to develop guidance on Medicare payment for services involving AI, including clarifying how AI-related expenses can be reimbursed. This legislative attention underscores AI's growing role in advancing healthcare delivery and highlights the need to ensure financial support for healthcare providers adopting these technologies.
An article from earlier this year in HealthTech Magazine summarizes how remote patient monitoring (RPM) and AI are revolutionizing personalized healthcare. While RPM uses digital technologies to collect and transmit patient health data, AI enhances RPM by analyzing vast health data to identify patterns and predict health events, allowing for personalized treatment plans based on individual patient data. This combination leads to more precise and effective care, such as predicting potential health issues and suggesting proactive measures based on a patient’s vital signs, medication adherence, and lifestyle factors. The benefits of RPM and AI include enhanced chronic disease management, improved patient engagement, and cost savings. For example, continuous monitoring and AI analysis help detect early signs of deterioration in chronic disease patients, preventing severe complications. Patients become more involved in their health management through RPM devices, and AI-driven insights provide personalized feedback, encouraging adherence to treatment regimens and healthier lifestyle choices. Additionally, these technologies can reduce healthcare costs by minimizing the need for frequent in-person visits and hospitalizations through early intervention and preventive care.
The convergence of RPM and AI hints at a future of personalized, efficient, and effective care. The potential success of these technologies will depend on how policies develop and support their growth. AI has already captured the attention of the Biden Administration which issued an executive order last year that aimed to create standards and rules around the use of AI. Several federal agencies have looming July deadlines for deliverables required by the Executive Order (such as reports and best practice guidance) due in late July. Representatives from the Departments of Commerce, Homeland Security, and the U.S. Patent and Trademark Office, which face these July deadlines, have confirmed they are on schedule to meet the executive order's requirements.
For more information on RPM and AI, see this discussion featured in an article in HealthTech Magazine, and see the full text of the proposed federal bill, HR 8816. |
|
AMA CPT Editorial Panel Meeting Stalls Changes to Remote Patient Monitoring Codes
The American Medical Association's (AMA) Current Procedural Terminology (CPT) Editorial Panel recently held a significant meeting in May, where potential changes to the billing codes for remote patient monitoring (RPM) were on the agenda. These changes were highly anticipated by healthcare providers and stakeholders as they promised to streamline and enhance the reimbursement process for RPM services. However, the meeting concluded with the decision to suspend the proposed revisions (see the CPT Editorial Panel’s Summary of Actions), leaving the current billing framework unchanged. The specific proposed changes included:
- Addition of a new code covering 2 to 15 days of collected and transmitted data. (currently, CPT 99454 requires at least 16 days of data).
- Revision of CPT 99457 to include 11-20 minutes of RPM care management time (currently, the code requires at least 20 minutes of recorded care management time)
- Revision of CPT 99458 to cover each additional 10 minutes of interactive communication (currently, the code requires at least 20 minutes of interactive communication for billing)
The decision to halt the proposed revisions was influenced by several factors including fear that the proposals would add too much complexity to the already intricate billing system and feedback from various stakeholders around concerns about the practical implementation and potential unintended consequences of the changes. Although discussions are currently stalled, it doesn't mean they won't resume at future AMA Editorial Panel meetings. The next panel meeting, scheduled for September 19-21, 2024, provides an opportunity for the topic to be raised again. Stay tuned for further updates. |
|
FCC's Net Neutrality Rules Face Legal Challenges Ahead of July 22 Implementation
In April, the Federal Communications Commission (FCC) voted to finalize a proposal reinstating the 2015 open internet (net neutrality) rules, set to take effect on July 22, 2024. These net neutrality rules prohibit internet service providers (ISPs) from blocking or slowing down traffic to specific websites and engaging in paid prioritization of lawful content. The principle of net neutrality is contentious for sectors like telehealth, as it ensures that all medical services and applications receive equal internet access without interference. However, some argue that net neutrality could lead to network congestion if ISPs cannot prioritize healthcare-related traffic during peak usage times. Net neutrality was initially enforced under the Obama administration but was repealed in 2017 during the Trump administration. The repeal was justified by claims that the rules stifled innovation and investment. As a result of the upcoming reinstatement of the FCC net neutrality rules, major ISPs—including AT&T, Comcast, and Verizon—have mounted legal challenges, which the U.S. 6th Circuit Court of Appeals is scheduled to hear according to a Reuters article. These industry groups have requested the FCC to delay the order’s implementation to seek judicial review or a temporary court block. The Supreme Court's recent decision to overturn Chevron USA, Inc. v. Natural Resources Defense Council (which formerly gave federal agencies the ability to make decisions when the law is ambiguous about a matter as long as their interpretation of the law is reasonable), might also influence the legal landscape for net neutrality, potentially affecting how courts interpret the FCC's authority to enforce these rules. As the July 22 date approaches, the legal outcomes will be pivotal in shaping the future of internet regulation in the United States. For more information on the details surrounding the restoration of net neutrality, see the full text of the order on the FCC’s website. |
|
Latest Policy Developments in CCHP’s Telehealth Policy Finder and Policy Trends Map
CCHP’s Telehealth Policy Finder look-up tool and Policy Trend Maps were updated throughout the past month based on the latest information from our ongoing state telehealth policy tracking. The latest states to be updated include Alabama, Alaska, District of Columbia, California, Florida, Hawaii, Idaho, Kansas, Louisiana, Minnesota, Montana, New Mexico, New York, North Dakota, Ohio, Oklahoma, Utah, Vermont, Washington.
Over the past month, multiple states made changes to their telehealth policies in an array of policy areas, including their Medicaid programs, professional regulations, and cross-state licensing. Highlighted changes from this group of states include:
- ALABAMA: Amended a rule prohibiting physicians from utilizing any form of telemedicine when certifying or recommending, or recertifying or re-recommending, a patient for the use of medical cannabis, or when conducting any examination associated with medical cannabis.
- ALASKA: Alaska Medicaid released a new Frequently Asked Questions (FAQ) document for tribal federally qualified health centers (FQHCs) which clarifies that tribal FQHCs should defer to Alaska Medicaid’s current guidance on telehealth as well as their Telehealth Coverage FAQs document for information on telemedicine, telephonic and store and forward telehealth services. In response to the question around whether a tribal FQHC can provide services off-site after February 11, 2025, the Tribal FQHC FAQ directs providers to a regulation adopted in 2023 which allows the provision of services via telehealth.
- CALIFORNIA: The Department of Health Care Services (DHCS) in California issued a notice that specifies that clinically appropriate telehealth may be considered in determining compliance with network adequacy standards and for purposes of approving an alternative access standard (AAS) request, however behavioral health plans (BHPs) cannot require a member to access services via telehealth only. DHCS also issued a news alert retroactively allowing certain codes 99402-99403 (preventive medicine counseling and/or risk factor reduction intervention) to be reimbursed within the Local Educational Agency Billing Option Program under the state’s Medicaid program (Medi-Cal), including via telehealth when using the modifier 95. In addition, SB 233 was enacted to authorize Arizona physicians to treat Arizona patients in CA, specific to abortion care and registration with the applicable state board, but only through November 30, 2024.
- DISTRICT OF COLUMBIA: Passed B 25-0545 which includes a section on telehealth stating that health professionals may provide telehealth services consistent with the standard of care. It also specifies that that a practitioner-patient relationship can be established through telehealth, though additional requirements for specific health professions may apply including a need for an initial in-person physical exam. The new law also clarifies that a license from the District of Columbia is necessary unless the client or patient is temporarily present in the District or they are a resident and the services provided do not exceed 120 days or a longer period of time as determined by the mayor.
- FLORIDA: Passed House Bill 855 which requires that any advertisement for dental services provided through telehealth include the statement that “An in-person examination with a dentist licensed under chapter 466, Florida Statutes, is recommended before beginning telehealth treatment in order to prevent injury or harm.” The new law also lists the specific dental services this statement applies to (such as digital scanning, denture repair, etc.). Florida also joined the Interstate Medical Licensure Compact and the Audiology and Speech Language Pathology Interstate Compact.
- HAWAII: Hawaii Medicaid updated their Provider Manual’s chapter on Dental Services, specifying that clinics that qualify for FQHC Prospective Payment System (PPS) reimbursement may submit telehealth claims using PPS reimbursement, as long as both the patient and dentist were each physically located at separate eligible FQHC/RHC sites during the encounter and the diagnosis. Claims for patients that were located at “public health settings” not federally registered as a FQHC or RHC service site are not eligible for PPS reimbursement. Additional clarification was also provided for how radiographic services using asynchronous technology should be billed (see manual). A new statutory allowance was also found that allows the Board of Dentistry to issue a temporary license without an examination to a qualified resident nonresident who is under contract with the state, county or legally incorporated eleemosynary dispensary or infirmary, private school, or welfare center. The temporary license authorizes the practice of dentistry exclusively while engaged in the employment of one the entities previously mentioned or contracted by the department of health to conduct dental education and training.
- KANSAS: The KS Medical Assistance Program (KMAP) updated the General Benefits section of their provider manual in May to specify that services provided through telemedicine must be medically necessary and are subject to the terms and conditions of the individual’s health benefits plan. KMAP cannot require a covered individual to use telemedicine in lieu of receiving an in-person healthcare service or consultation from an in-network provider. It also adds that nothing in the Kansas Telemedicine Act authorizes the delivery of any abortion procedure via telemedicine.
- LOUISIANA: The Louisiana Department of Health and Hospitals updated their Behavioral Health Services Manual to indicate that group psychotherapy is only allowed via telehealth when utilized for Dialectical Behavioral Therapy (DBT) and must include synchronous, interactive, real-time electronic communication comprising of both audio and visual elements.
|
|
|