The Honorable Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1751-P
P.O. Box 8013
Baltimore, MD 21244-1850

RE: CMS-1751-P; CY 2022 Payment and Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies

Dear Administrator Brooks-LaSure,

CEO Action for Racial Equity (CEOARE) is pleased to submit our response to the CY 2022 Physician Fee Schedule and the Quality Payment Program Proposed Provisions. We commend you for recognizing the value of telehealth as a modality to improve disparities and health outcomes for patient populations, as well as your broader efforts to diagnose and address problems related to health equity.

CEO Action for Racial Equity is a Fellowship of over 100 companies that mobilizes a community of business leaders with diverse expertise across multiple industries and geographies to advance public policy in four key areas — healthcare, education, economic empowerment and public safety. Our mission is to identify, develop, and promote scalable and sustainable public policies and corporate engagement strategies that address systemic racism, social injustice, and improve societal well-being.

As representatives of the corporate community, we believe CMS’ work to advance equity across the healthcare ecosystem—specifically, equitable expansion of telehealth access—is critical and it is one of our policy priorities. We offer our support and collaboration on efforts related to health equity, notably, CMS’ work to extend telehealth services, expand modalities appropriate for telehealth visits, define appropriate sites for telehealth, and reorient data to confirm that racial equity concerns are properly represented.

Our comments are grounded in a principles-based approach which has relevance across several topics within the proposed rules. These are highlighted below:

We endorse the elimination of inequitable restrictions and barriers to coverage for comprehensive telehealth services;
We promote equitable telehealth via audio-only, video, and asynchronous modalities, prioritizing clinical appropriateness and patient informed consent;
We promote and amplify research that demonstrates the impact of telehealth expansion on Black patients; and
We support data collection to measure effectiveness/utilization/outcomes of telehealth for the Black community that include social determinants of health metrics.

Comments on the Proposed Physician Fee Schedule

II.D. Telehealth and Other Services Involving Communications Technology, and Interim Final Rule With Comment Period for Coding and Payment of Virtual Check-In Services—Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

PROPOSAL – Retaining Category 3 codes for Telehealth: Proposal to retain all services added to the Medicare telehealth services list on temporary (Category 3) basis until the end of CY 2023

RESPONSE: CEOARE is supportive of retaining all the services added to the Medicare telehealth services list on a temporary (Category 3) basis until the end of CY 2023 as it allows for time to collect and evaluate these services for their effectiveness in improving patient outcomes and can contribute to claims-based, evidence-informed decision making, and coverage decisions. We further urge CMS to permanently maintain the Category 3 framework after the end of CY 2023. In doing so, CMS would provide a permanent pathway for telehealth services the agency believes require additional evidence. Furthermore, a permanent Category 3 framework would create an additional way for CMS to proactively collect data measures on utilization specific to providers, geographies, and medical specialties. In doing so, CMS could begin to actively contrast that information between the broader population and geographically known areas of vulnerable and underserved Black communities. CMS could further leverage any available insights pertaining to social determinants of health metrics. This would achieve various agency goals – to develop the evidence needed for adding services to the telehealth services list on a permanent basis and analyzing the usage of telehealth by the Black community.

D. IMPLEMENTATION OF PROVISIONS OF THE CONSOLIDATED APPROPRIATIONS ACT, 2021 (CAA)

RESPONSE – General policy position on CAA, 2021: CEOARE supports the language in the CAA of 2021 removing Medicare restrictions on mental health services delivered virtually, but we are concerned that the inclusion of any in-person requirement for telehealth services may present a significant barrier to access within vulnerable and underserved communities. Such in-person requirements may result in harmful unintended consequences, which would disproportionately impact individuals who are already facing barriers to adequate mental health care, such as limited access to nearby mental health providers. CMS should endeavor to facilitate better access to mental health services for Medicare beneficiaries. While we see value in in-person care when feasible, we believe that equitable access to care should be prioritized, and thus do not support any policy that limits access without evidence demonstrating the need for such a requirement. We urge CMS to remove the proposed additional in-person six-month requirement as a condition of receiving virtual mental health services under the Medicare program.

While we appreciate CMS’ limited authority with regard to the specific requirements under the current law, we ask CMS not to impose additional barriers to care beyond what has been legally defined. This is especially important in mental health, as the in-person requirement every six months does not apply to telemental health services delivered in qualified rural areas, or when a patient is being treated for substance use disorders or a co-occurring mental health disorder. Thus, requirements are being applied to a subset of tele-mental health service beneficiaries and may inadvertently create inequities in access within the Medicare population. We urge CMS to consider the implications this requirement may have during an extraordinary public health emergency (PHE). Requiring an in-person visit every six months at this stage of the COVID-19 pandemic may put patients at risk based on the virulence of the Delta variant and the respective state of our public health response.

SEEKING COMMENT – In-person requirement of provider: “We are also seeking comment on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service.”

RESPONSE: CEOARE supports limiting any undue burden on patients and providers, specifically when it comes to access and continuity of care. While we fundamentally do not support an in-person requirement for care (as stated above), within the confines of the current law we support the option to have the required in-person service be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service, as well as consideration for including the referring provider. This will allow underserved communities more options for access and will help support more equitable delivery of services. Additionally, this consideration accommodates modern provider care delivery models – where patients are served by the first available professional in a practice.

PROPOSAL – In-person requirement intervals for audio-only: “We are proposing to require that an in-person, non-telehealth service must be furnished by the physician or practitioner at least once within 6 months before each telehealth service furnished for the diagnosis, evaluation, or treatment of mental health disorders by the same practitioner, other than for treatment of a diagnosed SUD or co-occurring mental health disorder, and that the distinction between the telehealth and non-telehealth services must be documented in the patient’s medical record…We believe that a 6-month interval strikes an appropriate balance between these competing considerations, but are seeking comment on whether a different interval, whether shorter, such as 3-4 months or longer, such as 12 months, may be appropriate to balance program integrity and patient safety concerns with increased access to care. Therefore, we are also seeking comment on whether it would be appropriate to establish a different interval for these telehealth services, for the diagnosis, evaluation, or treatment of mental health disorders, other than for treatment of diagnosed SUD or co-occurring mental health disorder, when furnished as permitted through audio-only communications technology.”

RESPONSE: Beneficiaries who are receiving audio-only telehealth services are often less likely to have the resources and mobility needed for the additional burden of an in-person visit. CEOARE recommends CMS explore other guardrails rather than an in-person requirement as it may inadvertently impact under-resourced beneficiaries and create an inequitable barrier to needed care. Additionally, we ask that CMS not impose additional barriers to care beyond what has been legally defined. If CMS deems it absolutely necessary to impose an in-person requirement, we encourage a longer interval, like 12 months, to limit the burden as much as possible.

PROPOSAL – Home as an originating site: “Given the addition of the home of the individual as a permissible originating site for telehealth services for purposes of diagnosis, evaluation, or treatment of a mental health disorder, we are proposing to revise our regulation at § 410.78(b)(3) to add a new paragraph (xiv) to identify the home of a beneficiary as an originating site for telehealth services for the diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished on or after the first day after the end of the PHE as defined § 400.200 of our regulations;”

RESPONSE: CEOARE supports the incorporation of the home as an originating site beyond the PHE time frame. However, we request further clarification on how “home” is being defined and ask that the definition is flexible and broad to confirm that certain populations (e.g., unhoused, those not comfortable/safe with conducting a mental health visit at their primary residence, etc.) are not inadvertently disenfranchised by this definition. Additionally, results from a recent survey conducted by SSRS on behalf of the Bipartisan Policy Center, which included a subset of Medicare patients, found that 26% of respondents reported access to a private location to complete a doctor appointment was a challenge.

E. PAYMENT FOR MEDICARE TELEHEALTH SERVICES FURNISHED USING AUDIO-ONLY COMMUNICATION TECHNOLOGY

PROPOSAL – Redefining telecommunications to include audio-only: “Therefore, we are proposing to amend our regulation at § 410.78(a)(3) to define interactive telecommunications system to include audio-only communications technology when used for telehealth services for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients when the originating site is the patient’s home.”

RESPONSE: CEOARE supports CMS’ decision to define “interactive telecommunications system” to include the audio-only modality to be used for the diagnosis, evaluation, or treatment of mental health disorders for established patients when the originating site is the patient’s “home” (as discussed supra – “home” to be as broadly defined as possible). This enables continued access to necessary care for patients with unreliable/limited or no broadband connectivity. CEOARE also suggests that CMS allows new patients to utilize audio-only telehealth services for mental health disorders if deemed clinically appropriate by the mental health care provider so that patients can access care when and where they need it during an acute mental health crisis. Additionally, we encourage CMS to create a framework for evaluating other disorders/disease states beyond mental health disorders for clinical appropriateness for audio-only telehealth services.

PROPOSAL – Documentation for clinical appropriateness of audio-only: “We are seeking comment on these proposals, as well as what, if any, additional documentation should be required in the patient’s medical record to support the clinical appropriateness of providing audio-only telehealth services for mental health in the event of an audit or claims denial. Additional required documentation could include information about the patient’s level of risk and any other guardrails that are appropriate to demonstrate clinical appropriateness, and minimize program integrity and patient safety concerns.”

RESPONSE: While continuation of audio-only telehealth services will help enable continued access to necessary care for many patients, we urge CMS to implement appropriate guardrails. While the potential risk of inappropriate and/or disparate use of audio-only technology by vulnerable patients exists, guardrails should not be unduly burdensome to providers by way of documentation. CEOARE encourages mental healthcare providers offering audio-only telehealth services to provide two-way audio-video services when possible. We believe that these providers should offer both audio-video and audio-only telehealth services to patients. For patients choosing audio-only services, CEOARE suggests that the documentation associated with the visit include confirmation that the patient was offered and declined audio-video services and an attestation of the clinical appropriateness of audio-only from healthcare providers. Any additional required documentation should align with the additional mental health parity requirements requiring claims approvals/denials as outlined in the CAA 2021.

B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)—Telecommunications Technology

1. REVISING THE DEFINITION OF AN RHC AND FQHC MENTAL HEALTH VISIT
A. PAYMENT RULES FOR RHC AND FQHC VISITS AND FOR MEDICARE TELEHEALTH SERVICES

PROPOSAL – Redefining “visit” for RHCs and FQHCs to include audio-only telecommunications: “We believe beneficiaries receiving mental health services from RHC and FQHC practitioners should have the same access to mental health care delivered via telecommunications technology as beneficiaries receiving services from practitioners paid under the PFS….To ensure that beneficiaries can access services furnished by RHCs and FQHCs in a manner similar to mental health services under the PFS after the PHE, we believe it is appropriate to consider modifying our regulatory definition of a mental health visit to provide for remote access to RHC and FQHC services…we are proposing to allow RHCs and FQHCs to furnish mental health visits using audio-only interactions in cases where beneficiaries are not capable of, or do not consent to, the use of devices that permit a two-way, audio/video interaction.”

SEEKING COMMENT – In-person requirement for telehealth visit through RHCs and FQHCs: “We are seeking comment on whether we should consider a similar requirement (6 month in person visit) for mental health services furnished by RHCs and FQHCs via telecommunications technology, or whether this requirement may be especially burdensome for beneficiaries receiving treatment at RHCs and FQHCs, particularly in rural areas.”

RESPONSE: CEOARE supports CMS’ decision to modify the definition of a mental health visit for remote access to RHC and FQHC services. However, we do not support undue burden for access to care that goes beyond what is required by law, and therefore do not support the addition of an in-person requirement for mental health services furnished by RHCs and FQHCs via telecommunications technology. This would be especially burdensome for beneficiaries receiving treatment in these facilities as they are often more rural and/or under-resourced and therefore would not support equitable delivery of services.

E. PROPOSAL TO ESTABLISH VALUES FOR REMOTE RETINAL IMAGING (CPT CODE 92229), COMMENT SOLICITATION FOR FRACTIONAL FLOW RESERVE DERIVED FROM COMPUTED TOMOGRAPHY (CPT CODE 0503T), AND COMMENT SOLICITATION FOR CODES INVOLVING INNOVATIVE TECHNOLOGY

SEEKING COMMENT – Guardrails for Artificial Intelligence (AI) bias: Additionally, taking into consideration that a software algorithm and/or AI may introduce bias into clinical decision making that could influence outcomes for racial and ethnic minorities and people who are socioeconomically disadvantaged, are there guardrails, such as removing the source of bias in a software algorithm and/or AI, that Medicare should require as part of considering payment amounts for services enabled by software algorithm and/or AI?

RESPONSE: CEOARE supports CMS’ consideration of guardrails to help remove Artificial Intelligence (AI) bias and software algorithms that may impact racial and ethnic minorities and people who are socioeconomically disadvantaged. We encourage CMS to seek out technological ethicists and AI technologists as well as other subject matter experts, including those who engage with patients, to better inform the Agency on the more effective use of guardrails for frameworks it will consider for implementation. There are two specific frameworks that we are aware of and support that may help inform CMS’ considerations in this area. The recently published “A Proposal for Identifying and Managing Bias in Artificial Intelligence” by the National Institute of Standards and Technology (NIST) details a three-stage approach to managing bias: pre-design, design and development, and deployment. CEOARE supports the identification and mitigation of biases in all three stages. Additionally, we recommend that CMS consider the Center for Applied AI at Chicago Booth framework to mitigate bias.

Comments on the Quality Payment Program proposed revisions and embedded RFIs

D. CLOSING THE HEALTH EQUITY GAP IN CMS CLINICIAN QUALITY PROGRAMS—REQUEST FOR INFORMATION (RFI)

“We are seeking public comment on two potential future expansions of the CMS Disparity Methods, including: (1) Future potential stratification of quality measure results by race and ethnicity…
We are interested in learning more about, and soliciting comments about, the potential benefits and challenges associated with measuring hospital equity using an imputation algorithm to enhance existing administrative data quality for race and ethnicity until self-reported information is sufficiently available.
and (2) improving demographic data collection.
We are interested in learning about, and are soliciting comments on, current data collection practices by hospitals to capture demographic data elements (such as race, ethnicity, sex, sexual orientation and gender identity (SOGI), language preference, tribal membership, and disability status). Further, we are interested in potential challenges facing clinicians with collecting a minimum set of demographic data elements in alignment with national data collection standards (such as the standards finalized by the Affordable Care Act [192]) and standards for interoperable exchange (such as the United States Core Data for Interoperability incorporated into certified health IT products as part of the 2015 Edition of health IT certification criteria [193]). We seek comments on other efforts we can take within the MIPS program to further bridge the equity gap.”

General comments
As you are aware, racial and ethnic inequities as well as their resulting health disparities have persisted over many decades despite national efforts to eliminate them. However, scientific research on the value and methods to eliminate health disparities is evolving rapidly, as shown by the January 2019 supplement issue of the American Journal of Public Health. As national healthcare priorities continue to focus on quality and move towards precision medicine, inequities in healthcare access and service delivery only hinder these efforts. These inequities result in significant annual costs: $35 billion in excess health care expenditures, $10 billion in illness-related lost productivity, and nearly $200 billion in premature deaths. It is in the interests of all stakeholders, including federal and state governments, health industry organizations, consumers, health systems and individual healthcare providers to target disparities and implement effective interventions to eliminate them. Fortunately, effective interventions have been developed and we know that disparities are not inevitable, as demonstrated by the elimination of racial and ethnic disparities in some child vaccination rates. Enhancing the quality of race and ethnicity data to more closely reflect self-identification is critical as populations and communities are complex. Tackling health disparities must have a targeted approach to address the needs of all affected communities.

Importance of Data Reporting
Data collection, reporting, and analysis are critical themes in the RFI. Data collection, specifically detailed demographic data collection on race and ethnicity, as well as disparity variables such as preferred language, tribal identity, disability status, sexual orientation, gender identity, socioeconomic status, social, psychological and behavioral health factors, are the foundation for identifying and addressing health disparities. It is therefore critical that the CMS Quality Payment Programs leverage this opportunity to collect meaningful patient data, especially with regard to the aforementioned disparity variables. Although robust demographic data collection is often cited as a critical component for reducing health disparities,,, opportunities to improve data collection through policy have been missed., We believe robust demographic and disparity data collection through the CMS Quality Payment Programs is critical to laying the foundation for advanced use of demographic data to target existing health disparities for elimination. The incorporation of standardized data stratification across most of these disparity variables is supported by Certified EHR Technology (CEHRT) currently facilitating stratification, reducing burden on hospitals and enhancing transparency.

Comments on Specific Portions of the Request for Information
Stratification of quality measure results by race and ethnicity
CEOARE supports CMS’ position that self-reported race and ethnicity data are the gold standard, and we encourage CMS to prioritize resources to facilitate this standard over an imputation algorithm. Effective collection of self-reported demographic data on race and ethnicity are foundational in addressing health disparities. This activity is critical to disparity identification and targeted health interventions and is not being effectively performed to the extent it is needed to support health disparity analysis. For example, Craddock Lee et al. demonstrated that high quality race and ethnicity data is attainable, however in some health care settings, especially where data collection is not prioritized, quality is poor with many “unknown” or blank fields. There is a need to incentivize high-quality data collection on race and ethnicity at the hospital level. Performance on this activity could be demonstrated by the percentage of complete records. Additionally, consideration should be given to a standardized demographic data collection protocol to assess whether the information collected is self-reported or filled in by staff. A standardized protocol would introduce incentive for more robust data collection and provide additional opportunities for standardization and data improvement.
Regarding specific recommendations for additional data elements in order to measure disadvantage and discrimination, we support the inclusion of disparity variables such as preferred language, tribal identity, disability status, sexual orientation, gender identity, socioeconomic status, social, psychological and behavioral health status. Robust demographic data collection is regarded as a critical component to addressing health disparities, and we support broad versus narrow consideration of data elements to augment this opportunity to enhance data collection. Douglas et al. has highlighted missed policy opportunities specific to demographic data collection as it relates to advancing health equity, and we encourage CMS to leverage this occasion in the rulemaking process to advance the foundational disparity variables needed to close the gap in health equity. In addition to expanding data elements, we also encourage CMS to consider the mechanisms for accountability to incentivize the collection of the determined data elements.

Demographic data collection process improvements
CEOARE supports CMS’ goal to improve the collection of demographic data with a minimum set of data elements and suggest the following: race, ethnicity, preferred language, tribal identity, disability status, sexual orientation, gender identity, socioeconomic status, social, psychological and behavioral health factors. We recommend continued collaboration and efforts to improve data collection, visibility, and specific measurements on how underserved and marginalized groups are captured in healthcare data. Additionally, we support efforts across CMS and other Federal agencies to move towards the more granular “Race Ethnicity – CDC” code system as well as standardization of data collection to enable higher quality data for targeted interventions. As other Federal healthcare agencies begin to explore how, for example, to best achieve data transparency in areas such as AI and racial bias – we encourage CMS to actively participate in those efforts to enable standardization of common data elements and heuristics.

(D) HEALTH EQUITY MEASURES IN MVPS—REQUEST FOR INFORMATION (RFI)
“Should health equity measures be developed in a manner to be broadly applicable to the various specialties and subspecialties that participate in MIPS?”
“Is there value in the development of more specialty specific health equity measures?”
“Considering MIPS and MVPs includes several specialties and subspecialties, what factors should be considered when developing a health equity measure?”
“Should we include a health equity measure in the foundational layer of all MVPs, as a required measure, in the future? If not, why not?”

General comments on Health Equity Measures in MVPS
CEOARE is encouraged by CMS’ initiative in expanding their impact to make a difference in health disparities through the MVPS. The incorporation of health equity measures into various specialties and subspecialties broadly can be beneficial to creating the incentive for affecting inequities in care. Though, we do believe it is important to have targeted approaches (as opposed to universal approaches) as they are imperative to advancing health equity and support the consideration of specialty specific health equity measures particularly within disease states that disproportionately impact the Black population. Critical to the implementation of health equity measures in MVPS is the use of this data to identify and address health disparities through stratification by race and ethnicity, mandatory reporting, and targeted interventions within specialties. Continued focus on universal health records supports the collection of demographic data. CEOARE encourages CMS to build on the momentum generated by the implementation of the interoperability final rule to increase the reliability of reported data.

The CMS Quality Payment Programs have the potential to advance health equity. It is critical that robust race and ethnicity data as well as disparity variables are collected as they are the first step to identifying inequities and are necessary to implement targeted interventions to address those disparities. Health inequities have persisted for far too long and it is time to aggressively implement policies that will improve outcomes for all and eliminate the gap in health equity.

Conclusion
CEOARE applauds CMS’ goal to close the health equity gap through its quality programs and appreciates the opportunity to comment on the proposed changes to the Physician Fee Schedule Proposed Rule. If you have any questions, please do not hesitate to contact Roz Brooks via email at roslyn.g.brooks@ceoactionracialequity.com.

Sincerely,

CEO Action for Racial Equity