A bipartisan group of 50 Senators, led by Senator Brian Schatz (D-HI), introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021, which builds on prior iterations of the bill with learnings from the COVID-19 pandemic. The bill attempts to address the post-pandemic Medicare telehealth landscape. While the federal government provided sweeping enhanced access to telehealth services during the pandemic, many of those flexibilities are tied to the temporary public health emergency (PHE) declaration for COVID-19. Specific waivers that are foundational for expanded access require legislative action to continue post-pandemic. CONNECT for Health would permanently extend some of these flexibilities.
The bill adds to a dynamic landscape of telehealth legislation, including more than 23 bills that have been introduced this Congress. Many of the bills address specific conditions or sites of care in an attempt to provide greater stability after the PHE. CONNECT for Health would go further than some of these bills by permanently repealing Medicare’s geographic telehealth restrictions and making an individual’s home an originating site. However, the bill would not go as far as some other recently introduced telehealth legislation, including the Telehealth Modernization Act, also sponsored by Senator Schatz, which would fully repeal both the originating site and geographic restrictions, among other provisions.
At the same time, some stakeholders have stopped short of proposing permanent legislative action, instead calling for shorter extensions of the PHE flexibilities. For example, the Medicare Payment Advisory Commission (MedPAC) recently recommended that Congress extend the current flexibilities for one to two years. Some in Congress have also supported a shorter extension of flexibilities to allow additional study of telehealth’s impact on affordability, access and equity, even though many of the broader telehealth reform bills require extensive reporting and assessment on the value and quality of telehealth.
Stakeholders have called on Congress to create greater stability in the marketplace for telehealth services by providing some certainty for the post-pandemic landscape. We expect additional conversation throughout 2021 on the future of telehealth, with potential legislative action in the fall through the end of the calendar year.
Below is a summary of key provisions of the CONNECT for Health Act.
Removing Statutory Limitations
CONNECT for Health contains several provisions intended to permanently expand telehealth access after the PHE ends. These include provisions that would:
- Allow the US Secretary of Health and Human Services (HHS), upon determining that there would be no “adverse impact [to] quality of care,” to waive current statutory restrictions that prevent Medicare reimbursement for telehealth services beginning January 1, 2022 (including limitations based on type of originating site, geographic location of originating site, type of technology, kind of practitioner, type of service or any other restriction that the Secretary identifies), and allow the Secretary to implement parameters for delivering services, including payment, program integrity and beneficiary protections
- Eliminate the requirement that the originating site of the telehealth service be (i) located in a rural health professional shortage area, (ii) located in a county not included in a Metropolitan Statistical Area, or (iii) an entity that participates in a federal telemedicine demonstration
- Expand originating sites to include the home and allow the Secretary to establish requirements for other new permissible originating sites
- Permanently allow for the waiver of telehealth restrictions during PHEs.
These provisions would substantially reduce existing statutory barriers to telehealth services. However, because CONNECT for Health would defer a great deal of originating site and waiver flexibility to the Secretary, it does not go as far as many stakeholders had hoped to ensure predictable and reliable expansion of telehealth access and coverage.
Specific to the originating site provision, CONNECT for Health would establish the home as an originating site but would defer establishment of other originating sites to the administrative process. In contrast, the Telehealth Modernization Act includes full repeal of both originating site and geographic restrictions. Full repeal would provide greater certainty to stakeholders, rather than requiring a second, time-consuming and uncertain regulatory process to pursue an expanded list of permissible originating sites.
Prior to the pandemic, the Centers for Medicare and Medicaid Services (CMS) established a process for stakeholders to request that services be added to the Medicare Telehealth Services List. Stakeholders could make requests under two categories:
- Category 1 services are similar to the professional consultations, office visits and office psychiatry services already included on the list.
- Category 2 services are not similar to those services already on list. CMS reviews the requests for Category 2 services annually to see whether the corresponding code accurately describes the service when delivered via telehealth, and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient.
The application of this two-category system and relatively rigid criteria for inclusion has led to slow adoption of new services.
In the CY 2021 Medicare Physician Fee Schedule (MPFS) Final Rule, CMS finalized a third category for adding services to the Medicare Telehealth Services List on a temporary basis. CMS adopted a standard allowing the temporary addition of a Category 3 telehealth service for payment when it has a “reasonable potential likelihood of clinical benefit and improved access to care.” Services that met the Category 3 criteria were temporarily added to the list only through the end of the year in which the PHE ends.
CONNECT for Health would permanently codify the Category 3 pathway for adding services to the list on a temporary basis. As in the 2021 MPFS Final Rule, CONNECT for Health would allow the HHS Secretary to temporarily add services to the list when they have a “reasonable potential likelihood of clinical benefit and improved access to care.” However, unlike the 2021 MPFS Final Rule (which permitted these services to remain on the List only through the end of the calendar year in which the PHE ends), CONNECT for Health does not contain a sunset clause tied to the PHE. The CONNECT provision does not contain additional details regarding how a service that has been added temporarily to the list can become permanent in the future.
The CONNECT provision also does not describe what kind of evidence or information should be considered in determining whether the service meets the Category 3 “likelihood” standard. Accordingly, CMS may use the same factors that it uses to assess services for inclusion on the telehealth list, including improvement in patient outcomes, effective use of resources, effective safeguards for patient safety, and ability to support and expand the healthcare workforce.
CONNECT for Health would also require the HHS Secretary to conduct a review of the current process for adding telehealth services to the list so that the inclusion criteria prioritize “improved access to care through clinically appropriate telehealth services.” It would then require the HHS Secretary to make corresponding revisions and clarifications regarding what should be included in requests to add services. The provision does not establish a timeline for this review, require stakeholder input, or provide regulatory specificity regarding how temporarily covered services would be identified or how they could be made permanent.
Removing Barriers for Specific Provider and Service Types
CONNECT for Health also contains provisions that would remove restrictions for specific types of providers or services, including:
- Permanently allowing Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to furnish telehealth services as distant site providers and establishing reimbursement for such services
- Removing originating site restrictions for Indian Health Services and Native Hawaiian Health Care Systems
- Removing restrictions for emergency medical care services
- Allowing telehealth for recertification of a beneficiary for the hospice benefit.
These provisions create additional opportunities for expanded access to telehealth services across specific sites of care or service types, particularly for communities and populations with disparate access barriers In general, these provisions have been favorably received by the stakeholder community, particularly as they relate to stabilizing reimbursement for FQHCs and RHCs.
As telehealth utilization expands, Congress and federal agencies have a strong interest in protecting beneficiaries and the Medicare Trust Fund against fraud and abuse. CONNECT for Health includes two provisions intended to advance program integrity:
- Clarification that providing technology to a Medicare beneficiary for the purpose of furnishing services using technology is not considered “remuneration” under fraud and abuse laws
- Provision of $3 million for telehealth audits, investigations and oversight by the HHS Office of Inspector General.
Compared to previous conversations about guardrails and provisions included in other bills, the program integrity provisions in CONNECT are relatively light touches. We expect this to be an area of ongoing policy development on Capitol Hill and one that stakeholders should closely monitor.
Provider and Beneficiary Education
CONNECT for Health would require the Secretary to create training and educational resources for providers and beneficiaries on (at a minimum) payment, privacy and security and using telehealth to advance health equity, within six months of enactment. Such education and training would be required to account for demographic characteristics that influence interaction with technology. The Secretary would also be required to consider mandating such education and training for quality improvement organizations.
Data Development and Testing New Models
Many members of Congress and other stakeholders have expressed interest in better understanding the data around telehealth utilization, quality and impact on health outcomes. CONNECT for Health would seek to enhance available information about telehealth utilization by requiring HHS to conduct a quantitative and qualitative study on telehealth services, virtual check-ins, remote patient monitoring services and other services furnished through the use of technology as a result of telehealth flexibilities during COVID-19.
Examples of data collection include utilization rates by area, demographic or type of professional, technology (including audio-only) and service; quality measures, such as readmission rates and patient/provider satisfaction; health outcomes; and challenges and investments associated with implementing telehealth. The study would require interim and final reports and stakeholder input from MedPAC, the Medicaid and CHIP Payment and Access Commission, and nongovernmental stakeholders such as patient and provider organizations and telehealth experts. This type of study, informed by a wider array of stakeholders, would create an opportunity to shape the information that HHS reviews and would provide a more comprehensive picture of the telehealth landscape.
CONNECT for Health would also require an analysis of the telehealth waivers’ impact on CMS Innovation Center models. The Innovation Center has offered telehealth waivers as part of certain model design tests for years, including the Next Generation Accountable Care Organization model. These waivers have been underutilized by providers participating in those models, however. A study could help the agency better understand these low adoption rates and improve waiver design in the future.
Finally, CONNECT for Health includes specific language around Innovation Center models relating to telehealth. One provision would authorize a model allowing additional health professionals to furnish telehealth services, and a second provision would direct the HHS Secretary to test telehealth models for Medicare patients. While the Innovation Center can serve as a powerful vehicle to test and ultimately expand access to services, the use of telehealth has become so expansive during the pandemic that it is unclear whether demonstration projects would meet the need of stakeholders more broadly—particularly health professionals who have been able to provide telehealth services during the pandemic but might lose that ability once the PHE concludes. There may be specific disease states or new types of services where a demonstration would make sense, but demonstrations would need to be specifically assessed against the broader access landscape (i.e., taking into account whether originating site and geographic restrictions have been lifted).
The following provisions are not included in CONNECT for Health, but have been of high interest to the stakeholder community.
Repeal of Face-to-Face Visit Requirement for Telehealth Services for Mental Health and Substance Use Disorder Treatment
The Consolidated Appropriations Act (CAA) of 2021 included a provision that claimed to expand access to mental health services furnished through telehealth by removing the originating site and geographic restrictions. The provision in the CAA included a limitation that Medicare would only cover the telehealth mental service under these circumstances if the practitioner (1) has conducted an in-person consult with the patient in the prior six months and (2) subsequently continues to conduct in-person exams. Otherwise, the encounter must meet the originating site and geographic restrictions to qualify for reimbursement.
Stakeholders have broadly criticized this CAA provision as limiting access to telehealth services, and have called for removal of the face-to-face visit requirement. Many observers were disappointed that CONNECT for Health would not repeal this requirement.
In addition, following the end of the PHE, similar barriers will go back into place to prevent providers from prescribing controlled substances, including those used in medication-assisted treatment for opioid use disorder, without a face-to-face encounter. Opioid use disorder has been called a “hidden epidemic” as overdose rates continue to surge amidst COVID-19, and received specific attention in the president’s “skinny budget” released in April 2021. Proposed bills such as Senator Rob Portman’s (R-OH) Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act include provisions to address this issue.
Infrastructure for Telehealth Delivery
CONNECT for Health is limited to issues of coverage and access. While the bill is a valuable step forward, support for structural components, such as access to technology and affordable broadband, is a necessary corollary for widespread adoption and implementation of telehealth. Senator Amy Klobuchar’s (D-MN) and House Majority Whip James Clyburn (D-SC) introduced the Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act outlining a potential approach that would directly impact the Medicare beneficiary population. President Biden also signaled support for broadband expansion in the American Jobs Plan, and the American Rescue Plan includes additional incremental measures.
As telehealth adoption and infrastructure continues to grow, not all beneficiaries can afford or have access to the tools and services necessary for telehealth visits with a video component. Some providers have urged greater flexibility for audio-only visits as a result. One unique challenge relates to the Medicare Advantage program. During COVID-19, CMS has allowed Medicare Advantage plans to submit diagnosis codes from audio-video visits for payment purposes. Prior to the PHE, CMS had interpreted face-to-face visits to be in person, so the audio-video policy represents an expansion of the prior interpretation. However, the agency has continued to exclude diagnoses from audio-only visits for payment purposes. Some advocates believe this presents an unnecessary barrier for both patients and providers and that certain diagnoses should be included for Medicare Advantage risk adjustment for an audio-only telehealth consultation. This would help ensure appropriate coding and payment for patients that may have limited access to technology. This policy, in addition to payment parity for audio-only visits, is captured in the Ensuring Parity in Medicare Advantage for Audio-Only Telehealth Act of 2021, sponsored by Senators Catherine Cortez Masto (D-NV) and Tim Scott (R-SC).
Without the flexibilities offered by telehealth waivers under the PHE, in general, Medicare requires that providers be licensed in the state in which the patient is located. Medicaid licensure requirements vary by state. As a statutory limitation, legislation is necessary to repeal this restriction and allow providers to practice telemedicine across state lines. This would allow more providers to remotely reach patients who may live in a geography that has a limited capacity of primary or specialty providers.
Legislation, the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, has been introduced to allow this flexibility during the PHE and for six months after the PHE concludes..
The Biden Administration has indicated it will likely extend the PHE declaration through the end of 2021. Congressional action prior to the end of the PHE seems unlikely. Therefore, between now and the end of the year, stakeholders should continue to articulate their priorities, reinforce their points and build support for a viable, permanent Medicare telehealth landscape post-pandemic.
For more information, contact Aaron Badida, Meg Gilley, Kelsey Haag, Mara McDermott, Emma Chapman (McDermott Will & Emery LLP – Associate), Marshall Jackson (McDermott Will & Emery LLP – Partner), Lisa Mazur (McDermott Will & Emery LLP – Partner) or Dale Van Demark (McDermott Will & Emery LLP – Partner).