Comment for CMS 4207 CMay 20, 2024 Centers for Medicare & Medicaid Services RE: CMS-4207-NC; Medicare Program; Request for Information on Medicare Advantage Data Dear Administrator Brooks-LaSure, The American College of Physician Advisors (ACPA) is pleased to offer comments and information surrounding the Medicare Advantage program and data collection. American College of Physician Advisors represents more than 1173 members, spanning fifty states. Physician advisors are healthcare professionals, often licensed physicians, who integrate utilization management, patient safety, care delays, medically appropriate treatment, clinical documentation improvement and care coordination and transitions, they frequently interface directly with health plans including Medicare Advantage organizations and plans. With this boots-on-the-ground insight into Medicare Advantage plan processes and how those processes interface with the actual delivery of healthcare treatment, physician advisors as an industry are uniquely positioned to offer insight to CMS on MA plans’ impact to patient care. We appreciate and commend the Centers for Medicare and Medicaid Services (CMS) in its ongoing efforts to align the MA program with CMS Strategic Pillars. ACPA supports those pillars of advancing health equity; expanding access to healthcare services; driving innovation to promote value-based; patient-centered care; and safeguarding the Medicare program against fraud, waste, and abuse. ACPA echoes the public commentary to prior CMS RFIs surrounding the Medicare Advantage program that focus on issues related to prior authorization or other utilization management tools that restrict access to medically necessary care and coverage and payment that is no more restrictive than Traditional Medicare; MA plan and organization data collection and submission to CMS; and program transparency surrounding MA plan data. We commend CMS on its efforts to clarify expectations of Medicare Advantage plans through the 2024 Medicare Advantage plan Final Rule, 4201-F, and CMS’s willingness to receive provider feedback on MA plans’ interpretations and resistance to follow those explicit rules and further urge MA plans to honor CMS’s intent through your February 6, 2024 memo to Medicare Advantage Organizations and plans that explain CMS policy surrounding the 2024 Final Rule. Utilization Management And Prior AuthorizationUtilization Management And Review ActivitiesUtilization review and management consist of processes to monitor the use of, or evaluate the clinical necessity, appropriateness, efficacy, or efficiency of, health care services, procedures, or settings and are prevalent in Medicare Advantage plans. CMS places guardrails and restrictions on MA plans’ use of utilization review, including the composition of MA plans’ utilization review committees and the policy and procedure development within such committees. See generally 42 C.F.R. § 422.137. Individual state laws and regulations also frequently dictate similar guardrails and restrictions for health plans’ utilization review activities. For example, CMS requires an MA plan’s utilization management committee be led by the plan’s medical director who has a current, unrestricted license in any U.S. state. An individual state, such as Missouri for example, may further require the medical director be licensed in the state. See for example 20. C.S.R. 400-10.010. CMS has developed policy in other contexts which help align both federal and state law. For example, CMS allows non-physician practitioners like advanced practice registered nurses to supervise certain services, so long as such supervision is consistent with the practitioner’s scope of practice under applicable state law. We urge CMS to develop similar policy with respect to utilization management and review activities, which requires MA plans’ utilization review committees, policies, and practices to follow not only CMS federal regulation but require they also be in compliance with applicable state law. ACPA believes clarifying the relationship between state and federal rules for utilization review activities helps establish a utilization review scope of practice, so to speak. Access to MA Plan Utilization Management ActivitiesACPA members, who often interface with MA plans at the point of access to care in the hospital setting and/or during care transitions, frequently report a lack of access to and transparency in MA plan utilization management policies and the identification of individual(s) responsible for the development, approval, and review of such policies. We believe full transparency in how MA plans conduct utilization management is critical to ensure compliance with MA plan requirements, but also to reduce delays in access to care. MA plans frequently cite to non-interference provisions of federal rules which suggest CMS cannot interfere with private contracts, and/or label their policies confidential or proprietary and refuse to provide them to the healthcare organizations delivering care under arrangement on the MA plans’ behalf. ACPA members report numerous instances of large, national MA plans recharacterizing their utilization management or other coverage policies as “reimbursement policies”, “payment policies”, “protocols, but not policies” to suggest they fall outside the scope and purview of federal regulatory requirements. We encourage CMS to require MA plans to submit the plan’s utilization management policies, including evidence of annual review, to CMS. We encourage CMS to either make such submissions publicly accessible or require MA plans to make such information publicly accessible. We urge CMS to continue its outreach to MA plans to emphasize the functionality of a policy, protocol, or document as utilization management or coverage criteria is the determining factor that dictates the applicable requirements – rather than to the name to which an MA plan ascribes to such requirements. Prior AuthorizationACPA appreciates CMS’s clarifications in 4201-F surrounding when and how prior authorizations are permitted to be used by MA plans. We commend CMS in its ongoing efforts to reduce the administrative burden associated with prior authorizations and improve the technical process for submission and responses to prior authorizations so patient care is not delayed or otherwise adversely impacted. ACPA believes there may be additional opportunities to assess the utility and appropriateness surrounding the use of prior authorization and other utilization review activities. Medicare Advantage plans are increasingly offering value-based care contract opportunities to their network of participating providers and facilities. Often, a component of such programs assesses the utilization or cost of care in comparison to outcomes. We urge CMS to consider developing policies that allow MA plans and the providers delivering healthcare to MA plan members on the MA plan’s behalf to use such programs successfully and streamlining administrative burden for both parties. For example, we urge CMS to consider policy that prohibits the use of prior authorization or similar utilization review activities for any services covered by a value-based program arrangement where a component of the program is cost or utilization of care. Such policy would strongly incentivize MA plans to continue developing value-based care programs that include cost or utilization – a factor ACPA believes is critical to assess with overall outcomes to determine a provider or health system’s value. Including cost and utilization in such programs further supports the MA plans’ objective to manage their members’ care effectively and, in a cost-efficient manner. Simultaneously, such policy strongly incentivizes providers to consider and to participate in such value-based programs because of the potential to eliminate the significant administrative burden and delays to care access the utilization review imposes. Instead, the burden to manage cost and quality will fall where ACPA believes it is most appropriate – in the hands of the actual providers and facilities delivering care. If their utilization is high, they will be forced to outperform in quality in order to achieve value-based care incentives. Prior Authorization UseDistinguishing coordinated care plans from PFFS plans, identification on member ID cardsWe appreciate CMS clarifying that coordinated care MA plans can only use prior authorization to confirm the presence or absence of diagnoses or other medical criteria that ensure an item or service is medically necessary consistent with enhanced coverage criteria regulations. Stakeholders within hospitals and other health care facilities, including their health care professional counterparts, have difficulty understanding and distinguishing the distinction between a coordinated care plan and private fee-for-service (PFFS) plans, the latter of which are not permitted to use prior authorization policies or “prior notification” policies that reduce cost sharing for enrollees based on whether the enrollee or provider notifies the PFFS plan in advance that services will be furnished. See 42. C.F.R. § 422.138(a). We encourage CMS to require MA plans to identify the type of health plan (e.g. coordinated care, PFFS) clearly on member identification cards so internal stakeholders within provider facilities or professional organizations can readily discern the regulatory requirements and restrictions applicable to the member’s plan. Similarly, ACPA encourages CMS to require all MA plans to identify their CMS contract number on member ID cards, providing another mechanism by with the provider or facility may identify the type of benefit plans and the rules surrounding their coverage and payment while simultaneously enabling providers and facilities to readily communicate the specific plan at issue when sharing complaints or concerns about MA plan behavior. Prior Authorization DenialsACPA members consistently share stories of outrageous utilization management restrictions of MA plans, including the denial of prior authorization for needed medical care. We commend CMS for its interest in collection prior authorization data from MA plans. We encourage CMS to require MA plans to submit the lists of items and services for which the MA plan requires prior authorization, and the volume of prior authorization requests the MA plan received for each, within the preceding 12 months. We recommend CMS collect data from MA plans surrounding prior authorizations received that includes:
CMS expresses an interest in using these data points to compare MA plans with commercial or traditional health plan data. We believe these data points may help CMS coordinate with state departments of insurance in their own data collection of prior authorization or other utilization management tools, to discern whether MA plans deny authorization for care disproportionate to commercial or Traditional Medicare populations. Prior Authorization AppealsACPA members express significant concerns with the prior authorization appeal procedures under MA plans, and in particular MA plan medical directors’ familiarity with Medicare Advantage program requirements. For example, physician advisor members were recently1 polled on whether “Medicare Advantage plans follow the two-midnight benchmark on inpatient status requests”, to which more than 74% of respondents answered “No”. Physician advisors are often the individuals on the phone with MA plan medical directors with direct knowledge of MA plan’ medical directors understanding and application of such rules. ACPA members, who are often the direct line of communication between hospitals and MA plans during the prior authorization process, consistently report the following:
Use of and Reliance on Algorithms in Utilization ManagementACPA recognizes the growing use of artificial intelligence in healthcare creates both opportunities and challenges. We support its ethical, responsible use. As such, we believe artificial intelligence may have utility in expediting the approval of care under utilization management and review activities. We commend CMS for its clarification and directives to MA plans that such tools should not be used to deny coverage and payment. We encourage CMS to engage in focused conversations with MA plans to gain a deeper understanding of MA plans’ use of algorithms and artificial intelligence to ensure their use is compliant with the requirements at 42 C.F.R. § 422.101. Coverage And PaymentClinical ValidationACPA members and the hospital organizations they work for frequently report growing challenges with MA plans’ practices to deny coverage and payment in circumstances Traditional Medicare would cover and pay for care. One such area of concern is a practice called clinical validation auditing. CMS introduced the concept of a clinical validation audit in 2011 with the Recovery Audit Contractor (RAC) Statement of Work, seemingly to distinguish an audit focused on whether or not a patient truly possesses a diagnosis that was documented by a healthcare professional, from the process though which RAC auditors validated a diagnostic related group (DRG) by applying ICD-10-CM Official Guidelines for Coding and Reporting.2 “Clinical validation is a separate process, which involves a clinical review of the case to see whether or not the patient truly possesses the conditions that were documented. Clinical validation is beyond the scope of DRG (coding) validation, and the skills of a certified coder. This type of review can only be performed by a clinician or may be performed by a clinician with approved coding credentials.” By contrast, “DRG Validation is the process of reviewing physician documentation and determining whether the correct codes, and sequencing were applied to the billing of the claim. This type of review shall be performed by a certified coder. For DRG Validations, certified coders shall ensure they are not looking beyond what is documented by the physician, and are not making determinations that are not consistent with the guidance in Coding Clinic.” Through either the list of RAC Approved Issues or, more recently, explicitly in the RAC Statement of Work, RAC auditors have been prohibited from engaging in clinical validation audits. ACPA believes physicians or other licensed, qualified healthcare professionals with a direct provider-patient relationship and the legal responsibility and accountability for making medical diagnoses are in the best position to formally diagnose patients, rather than health plans. Our members report clinical validation is disproportionately prevalent among MA plans in comparison to their commercial counterparts, even underneath the umbrella of the same major health plan’s brand name. We are increasingly concerned with the growing administrative burden of these audits, the appropriateness of these audits, the criteria beings used, MA plans’ categorization of clinical validation denials as contractual write-offs in a manner that obfuscates CMS’s visibility into the extent of their use and impact as well as the true scope of MA plan denials of coverage and payment, and the potential opportunity for MA plans to secure payment from CMS for diagnoses that increase members’ apparent complexity through HCC reporting, while simultaneously declining to cover and pay hospitals for the resources expended to evaluate, diagnose and treat those same conditions. ACPA urges CMS address use of clinical validation among MA plans by:
EnforcementComplaint and Concern SubmissionWe believe it is critical to have a centralized and systematic process for intaking provider complaints on MA plan behavior, categorizing complaints, and making them available to the public. We believe this information would be valuable to consumers as they assess whether to enroll in the Medicare Advantage program and if so, with which plan; to providers consider which Medicare Advantage plans may be good partners for engaging in efforts to deploy population health programs that promote value in care delivery to MA members; to CMS in assessing providers’ real experiences and examples with MA plan processes; and even to MA plans themselves as a potential competitive edge that encourages compliant practices that could help promote their plan as an administratively less burdensome MA plan choice for both members and providers. Audit and AccountabilityACPA commends CMS and the Office of Inspector General for their work to ensure MA plans are held accountable to their statutory and regulatory expectations, and more importantly that their processes are protecting their members – our patients – ensuring appropriate care is delivered timely. We encourage CMS and OIG to continue their efforts to audit and holding financially and publicly accountable MA plans that are not contributing to the Medicare system as intended. For example, similar to audits of Hospital’s chargemasters under CMS price transparency rules and initiatives, MA plans can easily be audited for the public accessibility of coverage criteria they have identified as part of their utilization management programs to CMS. The American College of Physician Advisors sincerely appreciates CMS’s commitment to receiving provider stakeholder feedback on the Medicare Advantage program. Sincerely, 
Clarissa Barnes, MD |