CMS Proposes Revisions to Physician Fee Schedule Payment Policies and Medicare Part B for CY 2023 
  • The proposed rule would decrease the conversion factor by $1.53 from the CY 2022 rate.
  • If finalized, certain telehealth flexibilities implemented during the COVID-19 PHE would be extended.
  • CMS proposed to postpone the EPCS compliance date by one year and provide exceptions to the electronic prescribing requirement. 
Yesterday, the Centers for Medicare and Medicaid Services (CMS) proposed its calendar year (CY) 2023 updates to the Medicare Physician Fee Schedule (PFS) (proposed rule; fact sheet on Shared Savings Program proposals; fact sheet on Quality Payment Program proposals; press release). This annual proposed rule would revise payment policies under the Medicare physician fee schedule and make other policy changes to payments under Medicare Part D — to be applied to services furnished beginning January 1, 2023, if finalized. Additionally, this rule proposes updates to the Quality Payment Program (QPP) in an effort to increase clinician participation through the Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) and encourage participation in Advanced Alternative Payment Models (APMs), among others.  

  • Background. Since 1992, CMS has used the PFS to update reimbursement for physician and supplier services within the Medicare program annually, and payments are based on the relative resources typically used to furnish the service. 

This major proposed rule proposes to update the CY 2023 PFS conversion factor to $33.08, a decrease of $1.53 from the CY 2022 PFS conversion factor of $34.61. Additionally, the proposed rule would extend certain Medicare telehealth flexibilities adopted during the public health emergency (PHE) for 151 days after its expiration. Notably, if finalized, this proposed rule would expand access to substance use disorder (SUD) treatment by allowing Medicare to cover opioid use disorder (OUD) services furnished by opioid treatment programs (OTP) and by utilizing telehealth services and mobile components to reach underserved areas. In light of the Biden administration and Congress’ focus on mental health care over the course of the past year, CMS is proposing to expand access to mental health services by allowing Medicare to directly reimburse certain practitioners including, but not limited to, marriage and family therapists, licensed professional counselors, certified peer recovery specialists, and addiction counselors.  

CMS is proposing to make several updates and changes to reverse recent downward growth in the Medicare Shared Savings Program and encourage more participation in accountable care organizations (ACO). This proposed rule would allow for advanced payments for certain low-volume ACOs, provide smaller ACOs more time to shift to downside risk, and update its benchmark methodology to reduce biased regional expenditure calculations to advance health equity in the program. The proposed rule also includes a few notable policy changes related to payment for services provided by rural health clinics (RHC) and Federally Qualified Health Centers (FQHC). 

  • What’s next? This proposed rule is expected to be published in the Federal Register on July 29, 2022. Public comments on the proposal are due to CMS no later than September 5, 2022.  

Key policies changes outlined in the proposed Medicare PFS include: 

Conversion Factor — The proposed CY 2023 PFS conversion factor is $33.08, a decrease of $1.53 from the CY 2022 PFS conversion factor of $34.61. The CY 2023 proposed conversion factor is a result of: (1) the statutorily required budget neutrality adjustment; and (2) the expiration of a three percent increase in physician payments in 2022, implemented by the Protecting Medicare and American Farmers from Sequester Cuts Act

Telehealth Services — In this proposed rule, CMS is proposing to implement provisions of section 1834(m) of the Social Security Act — including the amendments made by the Consolidated Appropriations Act (CAA), 2021 — and provisions of the CAA, 2022 that extend certain Medicare telehealth flexibilities adopted during the PHE for 151 days after the end of the PHE.  

SUPPORT ACT

  • Electronic Prescribing for Controlled Substances for a Covered Part D Drug under a PDP/MA-PDP — CMS is proposing to extend sending letters to prescribers who are non-compliant with EPCS requirements from CY 2023 to CY 2024. Notably, this compliance date was also pushed back a year in the CY 2022 final rule until CY 2023. Regarding the determination of prescriber exceptions (to the SUPPORT Act regulation requiring that prescribers electronically prescribe at least 70 percent of their Schedule II through V drugs in Part D), CMS is proposing to utilize more current Prescription Drug Evident (PDE) data (e.g. evaluating CY 2023 prescriber practices based on CY 2023 data) to evaluate the number of Part D controlled substance average. This policy would take effect January 1, 2023, if finalized. CMS is also proposing to change its methodology for establishing when a provider qualifies for an emergency or disaster exception. Specifically, the agency is proposing to base its determination on PECOS (Provider Enrollment, Chain, and Ownership System) — instead of the NCPDP Pharmacy Database, which CMS currently employs — and those without a PECOS address would be evaluated using the National Plan and Provider Enumeration System (NPPES).  

  • Request for Comment — CMS is seeking input on its analysis that its proposed policy changes would not have an impact on the cost or time associated with prescriber compliance but that there will be a year delay in compliance and enforcement. Additionally, the agency is seeking comment on possible penalties for non-compliant prescribers, as CMS intends to increase penalties starting in CY 2025.  

  • Medicare Coverage for OUD Treatment Services Furnished by OTPs — CMS is proposing several provisions aimed at expanding access to SUD treatment, with a focus on medication-assisted treatment (MAT) programs.  

  • Pricing for Methadone — The proposed rule includes a provision that, if finalized, would revise the current methodology for CY 2023 and subsequent years for: (1) pricing the drug component of the methadone weekly bundle; and (2) the add-on code for take-home supplies of methadone as part of the Medicare Part B benefit category for OUD treatment services furnished by OTPs. Under the current methodology, payment rates are based on available average sales price (ASP) data at the time of ratesetting for the applicable calendar year. However, in the proposed rule, CMS explains that it does not believe that the current ASP data — which reflects voluntarily reported data from a small subset of methadone manufacturers — can provide an appropriate reflection of the changes in methadone costs for OTP and therefore cannot be used as an update pricing factor. For CY 2023 and subsequent years, CMS is proposing to revise the payment amount for the drug component and take-home add-on based on the payment amount for methadone in CY 2021 ($37.38) and update it annually to account for inflation based on the Producer Price Index (PPI) for Pharmaceuticals for Human Use. Since the payment amount for methadone was frozen for CY 2022, CMS is proposing to account for inflation for CY2022 and CY2023 for the CY2023 payment and set the payment rate for methadone for CY2023 at $39.29, which the agency predicts will increase Medicare spending by about 2.5 million in CY 2023. For subsequent years, CMS will adjust the payment rate using the PPI for Pharmaceuticals for Human Use. 

  • Payment Rate for Individual Therapy in the Bundle — After receiving feedback that the current rate for individual therapy provided as part of the non-drug component weekly bundle payment for episodes of care was not sufficient due to the needs of the patient population receiving OTP services, CMS is proposing to modify the payment rate based on a crosswalk of billing codes for a 45-minute psychotherapy session with a patient rather than the current crosswalk to the billing code for a 30-minute session. CMS is proposing this change because the agency believes a 45-minute psychotherapy session more closely correlates with the 50-minute weekly individual therapy session OUD patients receive at the beginning of their treatment. 

  • Mobile Components Operated by OTPs — CMS is proposing to clarify that the geographic location adjustment for OTP services furnished at a mobile unit will be treated as if the service was provided at a brick-and-mortar OTPs.  

  • Utilizing Telehealth to Initiate Treatment — In lieu of the flexibilities provided under the SUPPORT Act and Consolidation Appropriations Act, 2021, regarding the permissibility of Medicare payments for telehealth services under certain conditions, CMS is proposing to allow OTPs to bill for intake services furnished via two-way audio-video communications technology when provided for the initiation of treatment with buprenorphine. Additionally, CMS is proposing to permit the billing of using audio-only communication technology to initiate treatment for buprenorphine as an intake activity when the beneficiary does not have access to audio-video technology. Notably, billing for such activities will only be allowed to the extent that the use of such technology is permissible under regulations by the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA).  

Reimbursement for “Incident to” Physicians’ Services for Behavioral Health Providers — Under current regulations, there is no separate Medicare benefit category for services provided by licensed professional counselors (LPCs) and licensed marriage and family therapists (LMFTs). Therefore, Medicare payment for such services can only be made indirectly when an LPC or LMFT performs services as auxiliary personnel incident to, the services, and under direct supervision, of the billing physician or other practitioner. Under this proposed rule, CMS is proposing to permit LPCs or LMFTs to perform behavioral health services under general supervision of a physician or non-physician practitioner (NPP) when such services are provided incident to the services of a physician or NPP. Notably, the physician supervising the services is not required to be the same physician who is treating the patient more broadly. Furthermore, these practitioners can provide services without a doctor or nurse practitioner physically onsite, making it easier for rural and underserved communities to access services. 

Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs — The Infrastructure Investment and Jobs (IIJ) Act required manufacturers to provide CMS with a refund for certain discarded amounts of a refundable single-dose container or single-use package drug. CMS is proposing, as required by the IIJ Act, to implement provisions surrounding: (1) the definition of drugs subject to refunds and exclusions; (2) how discarded amounts of drugs are determined; (3) the frequency of notification by CMS to manufacturers of refunds; (4) the required frequency of payments to CMS; (5) refund calculation methodology; (6) enforcement mechanisms; and (7) a process for dispute resolutions. CMS, in the proposed rule, notes that it welcomes public comment on the specifics of the aforementioned proposals.  

ESRD Payments — The proposed rule notes that current guidance describing specimen drawings for ESRD patients is no longer applicable and would be removed from the manual. This payment is made through the ESRD bundled payment to the ESRD facility. 

Medicare Shared Savings Program Requirements — In the accompanying fact sheet, CMS notes that several of the proposals put forth in yesterday’s proposed rule seek to reverse recent trends as well as advance equity within the Shared Saving Program. The rule proposes the following changes: 

  • Health Equity Adjustment — CMS is proposing to institute a health equity adjustment for up to a 10 bonus point bump to ACO MIPS scores based on high-quality performance and servicing a high portion of dually eligible beneficiaries. Specifically, ACOs would benefit from these additional bonus points if the organization scores in the top or middle third of performance for each quality measure. CMS notes that, if finalized, the proposal would not run the risk of negatively impacting an ACO’s MIPS quality performance score.  

  •  SNF 3-day Rule Waiver Application — Under the proposed rule, the requirement that ACOs, when applying for the Skilled Nursing Facility (SNF) 3-day rule waiver, submit certain narratives — including a communication plan, care management plan, and beneficiary evaluation and admission plan — would be removed. Instead, CMS is proposing the implementation of a new requirement that ACOs submit an attestation that the ACO has established such narratives and is ready and willing to submit said narratives if requested by the agency. If finalized, this proposal would be effective for performance years beginning on January 1, 2024, and each subsequent year.  

  • Sliding Scale Approach for Shared Savings and Scaled Losses, Extending the Incentive for Reporting eCQMs/MIPS CQMS — The agency is proposing to calculate ACO eligibility for the Shared Savings Program based on quality performance to allow for scaling of Shared Savings benefits and avoid “all-or-nothing” determinations. The policy would apply to ACOs below the 30th percentile standard required to participate in Shared Savings but meet minimum quality reporting requirements. If finalized, this proposal would go into effect January 1, 2023. Also, the agency is proposing to extend incentives for eCQMs and MIPS CQMs through 2024 for the sake of allowing ACOs to determine their performance before full reporting requirements go into effect for the 2025 performance year.  

  • Advanced Shared Savings Payments — Under the proposed rule, CMS would provide advanced shared savings payments, referred to as advanced investment payments (AIP), to low revenue ACOs which meet the following criteria: (1) a first-time member in the Program; (2) “inexperienced” with performance-based risk Medicare ACO initiatives; and (3) serve an underserved population(s). The agency explains that AIP payments would increase as dually eligible beneficiaries, or beneficiaries who reside in areas with a high area deprivation index, are assigned to an ACO. If finalized, ACOs would receive a one-time fixed payment of $250,000 as well as quarterly payments for the first two years of the 5-year agreement period. Funds would be subject to certain limitations and would be required to be utilized for health care provider staffing and infrastructure, as well as to “address the social needs” of those with Medicare. CMS is proposing that the initial application cycle for AIPs begin on January 1, 2024.  

  • ACO Benchmarking Methodologies and Performance-Based Risk Updates — CMS is proposing to change certain aspects of its benchmarking methodologies aimed at improving participation amongst providers who treat a high percentage of beneficiaries with substantial clinical risk factors and dually eligible beneficiaries. Additionally, the agency is seeking comment on methods to calculate ACO historical benchmarks that are separate from FFS Medicaid.  

  • Adjusting ACO Benchmarks to Account for Prior Savings — In an effort to account for regional adjustments, CMS is proposing to consider a “prior savings” adjustment to ACO renewal benchmarks and ACOs entering agreements. If finalized, this policy would begin on January 1, 2024.  

  • Reducing the Impact of the Negative Regional Adjustment — CMS is proposing to institute policy changes to limit the impact of negative regional adjustments on ACO historical benchmarks and incentivize program participation among ACOs serving high-cost beneficiaries. Additionally, CMS is proposing to reduce the cap on negative regional adjustments from negative 5 percent to negative 1.5 percent of national per capita expenditures for Parts A and B services under the original Medicare FFS program in BY3 for assignable beneficiaries.  

  • Calculating County FFS Expenditures to Reflect Differences in Prospective Assignment and Preliminary Prospective Assignment with Retrospective Reconciliation — Since ACOs and other stakeholders have expressed concerns that CMS’ approach to determining FFS expenditures results in relatively lower benchmarks for ACOs, particularly ones with high market penetration in their regional service area, the agency is proposing a package of three proposals: (1) incorporating a prospective, external factor in the growth rates used in updating the benchmark; (2) adjusting rebased benchmarks to account for an ACO’s prior savings; and (3) reducing the impact of negative regional adjustments on ACO benchmarks. CMS is also seeking comment on a package of alternative options that the agency considered but decided again: (1) removing an ACO’s assigned beneficiaries from the assignable beneficiary population used in regional expenditure calculations; and (2) expanding the definition of the ACO’s regional service area to use a larger geographic area to determine regional FFS expenditures.  

  • Updates to ACO Beneficiary Assignment Methodology — Under the proposed rule, the definition of “primary care services used for purposes of beneficiary assignment” would be altered to cover new service codes, including those for prolonged services and chronic pain management. Additionally, the agency is proposing to modify the way in which it identifies facilities to account for variances in the CMS Certification Numbers (CCN)-based enrollment during the performance year. If finalized, these proposals would be effective for performance years beginning on January 1, 2023, and beyond.  

  • Risk Adjustment Methodology and Coding Initiatives — In the proposed rule, CMS noted concerns about the existing three percent cap on positive risk score growth, as well as the absence of a cap or floor on negative adjustments to account for risk score decreases. CMS recognized concerns that this existing policy is driving inequity and may disadvantage ACOs that serve more vulnerable populations or beneficiaries with complex medical needs. In response, CMS is proposing to adjust the benchmark for beneficiary characteristics and other factors to modify the existing three percent cap. CMS is also seeking comment on two potential alternatives to this proposal: (1) applying the three percent cap in aggregate across the four Medicare enrollment types without first accounting for changes in demographic risk scores for the ACO’s beneficiary population; and (2) allowing the cap on an ACO’s risk score growth to increase by a percentage of the difference between the current three percent cap and risk score growth in the ACO’s regional service area. 

  • Shared Savings Criteria for Low Revenue ACOs — If finalized, the proposed rule would expand the eligibility criteria to qualify for shared savings to enable certain low revenue ACOs participating in the BASIC track to share in savings even if the ACO does not meet the MSR as required in the Affordable Care Act (ACA). Instead, ACOs that meet the quality performance standard and otherwise maintain eligibility to participate in the Shared Savings Program would qualify for a shared savings payment if the ACO: (1) has average per capita Medicare Parts A and B FFS expenditures below the updated benchmark; (2) is a low revenue ACO at the time of financial reconciliation for the relevant performance year; and (3) has at least 5,000 assigned beneficiaries at the time of financial reconciliation.  

  • Adjustments for the Impact of the PHE for COVID-19 on ACOs’ Expenditures — According to analysis in the proposed rule, CMS believes that the current blended national-regional trend and update factors will be sufficient to address and mitigate the impact of the start of the COVID-19 PHE on benchmark year expenditures. As such, CMS is proposing to utilize a three-way blend of the ACPT/national-regional growth rates to update benchmarks. The agency hopes that this would further mitigate the potential adverse effects of the PHE on historical benchmarks while also protecting against unanticipated variation in performance year expenditures and utilization resulting from a future PHE. CMS is seeking comment on its analysis regarding the impact of the PHE on Shared Savings Program ACOs’ expenditures. 

  • MIPS Quality Performance Category Score Corrections — CMS proposes to clarify that the Shared Savings Program will reopen an ACO’s initial determination to correct errors in the MIPS quality performance category score identified through the targeted review process. Specifically, CMS would clarify that it would reopen the initial determination of an ACO’s financial performance for “good cause” to correct errors in the determination of: (1) whether an ACO is eligible for shared savings; (2) the amount of shared savings due to the ACO; or (3) the amount of shared losses owed to the ACO due to the miscalculation of MIPS quality performance category scores. 

  • Use of Unweighted MIPS Quality Performance Category Scores — CMS is proposing to clarify that the agency uses submission-level, unweighted MIPS quality scores to determine performance category scores for specified purposes. Additionally, CMS is proposing to clarify that it can utilize this unweighted distribution to determine if the ACO’s MIPS quality performance meets the Shared Savings Program quality metrics from performance year 2021 as well as subsequent performance years. 

  • Social Determinants of Health Measure, New CAHPS for the MIPS Survey Questions RFIs — The proposed rule includes an RFI on the use of two SDOH eCQM/MIPS CQM outcome-oriented measures for ACOs as well as the inclusion of Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey questions specific to discrimination and price transparency. The eCQM/MIPS CQM measures would assess providers on the percentage of individuals screened for social needs, and they are identical to the measures proposed as part of the Inpatient Prospective Payment System (IPPS) Proposed Rule for Hospital Inpatient Quality Reporting (IQR). 

  • Data Sharing — CMS is proposing to allow ACOs that act as organized health care agreements (OHCA) to request certain reports and claims data. Under the proposal, ACOs would have the option to structure their organization as an OHCA as a means to reduce eCQMs/MIPS CQM reporting requirements. If finalized, this rule would take effect for the January 1, 2023, performance year and beyond.  

Medicare Provider and Supplier Enrollment Changes — Under authority granted to CMS by the ACA, section. 424.518 outlines levels of screening by which CMS and its MACs review initial applications, revalidation applications, and applications to add a practice location, in which the categories and requirements are based on level of risk of fraud, waste, and abuse posed by a certain provider or supplier. CMS is proposing to add to section 424.518 language to require the reporting of any new owner via a change of information or other enrollment transaction. This proposal would also clarify that the provider and suppliers are subject to high-risk screening if they are submitting a change of ownership application or an application to report a new owner. Additionally, in order to clarify the extent of such adjustments to the screening levels, CMS is proposing to add language specifying that any adjustment made will apply to all other enrolled and prospective providers and suppliers with the same legal business name or tax identification number as the originally screened provider or supplier which triggered a screening level increase. Lastly, due to several cases of abuse and fraud in SNFs, CMS is proposing to move all SNFs from the "limited” level of categorical screening to the highest screening level.  

Updates and RFIs on QPP Incentives — In this proposed rule, CMS is continuing to move the QPP forward to focus on measurement efforts, refine how clinicians would be able to participate in a more meaningful way through the MIPS MVPs, and encourage participation in APMs.  

  • MIPS in the QPP — This proposed rule will continue CMS’ work to develop new MVPs and refine the subgroup participation option. CMS is also proposing changes in traditional MIPS to provide clinicians continuity and consistency while they gain familiarity with MVPs. As such, CMS is proposing to remove duplicative and topped out measures, as well as those with limited adoption, in order to continue streamlining and strengthening quality measure and improvement activities inventories. 

  • APMs in the QPP — To reduce burden and facilitate participation in APMs, CMS is proposing to permanently establish the eight percent minimum Generally Applicable Nominal Risk standard for Advanced APMs, which is currently set to expire in 2024. In a previously finalized rule, CMS set a limit of 50 for the number of clinicians in an organization that participates in Advanced APM through a Medical Home Model, using the Medical Home Model nominal financial risk criteria. In this proposed rule, CMS is proposing to apply the 50 eligible clinician limit to the APM Entity participating in the Medical Home Model based on the TIN/NPIs on the APM Entity’s participation list. Additionally, CMS is proposing conforming changes to the Other Payer Advanced APM policies in these areas. 

  • CMS is soliciting feedback through several Requests for Information (RFI):

  • Payment Gap for QPs, Enhanced Conversion Factor Updates — CMS is requesting information about whether the end of the five percent lump sum APM Incentive Payment awarded to QPs beginning in the 2025 payment year for the associated 2023 QP Performance Period would cause providers participating in the Advanced APM from dropping participation.

  • MIPS Quality Performance Category Health Equity — This proposed rule also requests information on aspects of the development and implementation of health equity measures for the quality performance category as CMS seeks to enhance and increase the number of measures in future years that address and/or incorporate factors pertaining to health equity 

  • QCDRs/QRs/Health IT Vendors Supporting all Measures in MVPs — CMS is seeking feedback on whether third-party intermediaries should have the flexibility to choose which measures they will support within the MVP. 

  • CME Organizations Submitting Improvement Activities for MVPs — CMS is requesting public feedback on whether to allow Continual Medical Education (CMS) Organizations to directly submit improvement activities for MVPs, which would, subsequently, require creating a new type of third-party intermediary. In addition, this RFI seeks feedback on the value of the implementation of policies to approve CME Organizations or accreditation entities as third-party intermediaries — including whether accreditation entities serving as third-party intermediaries could reduce clinician reporting burden.   

  • TEFCA Adjustment, FHIR in the QPP — This RFI is requesting input on opportunities to incentivize participation in the Trusted Exchange Framework and Common Agreement (TEFCA) through programs that incentivize high quality care, or through program features in value-based payment models that encourage certain activities that can improve care delivery. Additionally, as CMS continues to build upon the FHIR RFI included in the CY 2022 PFS rule —which aimed to continue stakeholder engagement on the topic of moving to digital quality measurement—this rule proposes to engage with stakeholders on the topics of data standardization and approaches to transition FHIR eCQM reporting, as initial steps in the transition to digital quality measurement.  

Conditions of Payment for DMEPOS Suppliers — CMS is proposing several changes to OIG definitions and authorities. Specifically, CMS is proposing to include managing organizations —as well as officers and directors of providers and suppliers — under CMS’s jurisdiction to deny or revoke providers’ or suppliers’ enrollment if the entity is furnishing services that are being paid for by a federal health care program. The agency also proposes to expand its authority to deny or revoke enrollment if a provider has a felony conviction (within the last 10 years) to include managing organizations, officers, and directors. For the sake of consistency, CMS is also proposing to add managing organizations, officers, and directors to the existing policy that program revocations and denials can be reversed if the provider or supplier terminates its contract and submits proof within 30 days of doing so. The agency is also proposing to clarify that CMS can bar participation from DMEPOS programs if the supplier or provider is barred from other state or federal health programs, if all appeals are exhausted or if the window for filing an appeal has expired. Additionally, CMS is proposing to add new provisions to its risk designation categories, including a change of ownership application, clarification of the scope of adverse actions conducted by a provider or supplier, and automatically categorizing initially enrolling SNFs into the high-level risk category. Regarding DMEPOS supply standards, CMS is proposing to add a new condition of payment requiring all suppliers to be in compliance with conditions of payment, which notably include that the supplier must comply with all state and federal licensure requirements.  

Furnishment of Certain Diagnostic Tests Without a Physician Order by Audiologists — Although some stakeholders have argued that removing the treating physician or practitioner order requirement for audiology hearing and balance assessment services would increase access, CMS decided against proposing such a measure, citing patient safety concerns as reasoning. Instead, CMS opted for a more narrowly tailored proposal that would remove the order requirement under certain circumstances for certain audiology services furnished personally by an audiologist for non-acute hearing conditions. By providing a narrow exception for non-acute hearing conditions, CMS hopes to increase access while ensuring that beneficiaries are still evaluated clinically for any serious medical conditions.  

RHCs and FQHCs — The proposed rule includes a few policy changes related to payment for services provided by RHCs and FQHCs. 

  • Chronic Pain Management (CPM) Services — CMS believes that the non-face-to-face time required for RHCs and FQHCs to coordinate care on CPM for their rural and/or low-income patients is not captured in the RHC All-Inclusive Rate (AIR) or the FQHC prospective payment system (PPS) payment. As such, CMS is proposing to allow separate payment for CPM services in RHCs and FQHCs to reflect the additional time and resources necessary. To be consistent with the new services that are being proposed for practitioners billing under the PFS, CMS is proposing to include CPM services in the general care management HCPCS code G0511 when they are provided by RHCs and FQHCs. In future rulemaking, CMS is considering other approaches for calculating the rate of HCPCS code G0511 as the number of services grows annually.  

  • Behavioral Health Integration (BHI) Services — The proposed rule would clarify that clinical psychologists (CP) and Clinical Social Workers (CSW) are practitioners that can provide services — for which they will be reimbursed — in RHCs and FQHCs as long as they work as a part of a patient’s primary care team. Further, the proposal would allow CPs and CSWs to bill HCPCS code G0511 when providing the services described in code GBHI1 in an RHC or FQHC. Additionally, CMS is seeking stakeholder feedback on whether Medicare should cover intensive management in community settings as well as on how the agency can best ensure beneficiary access to behavioral health services, including any potential adjustments to the PFS ratesetting methodology, for example, any adjustments to systematically address the impact on behavioral health services paid under the PFS.  

  • Cost Reports — Finally, the proposed rule includes a discussion of the implementation of ACA section 1833(f)(3) and clarification regarding the use of short-period cost reports versus 12-consecutive month cost reports to establish the payment limit for specific provider-based RHCs. CMS believes that this discussion and proposed clarification is necessary to accurately reflect the costs of providing RHC services and will establish a more accurate base from which the payment limits will be upgraded going forward.  

Medicare Part B Payment for Preventive Vaccine Administration Services — In the CY 2022 PFS final rule, CMS decoupled payment for vaccine administration services from the PFS crosswalk and finalized flat payment rates for influenza, pneumococcal, HBV, and COVID-19 vaccines. However, CMS inadvertently neglected to address a geographic adjustment policy for these payment rates. Resultantly, CMS is proposing to adjust payments by the Geographic Adjustment Factor (GAF) for each fee schedule area in order to reflect each area’s cost of administering vaccines. CMS is also considering applying geographic practice cost indices (GPCI) to adjust for geographic variation in the direct costs of providing services and the indirect costs of maintaining a clinical practice. Finally, CMS proposes to account for any changes in cost by updating the flat payment amounts based on the annual increase to the Medicare Economic Index (MEI). 

Payment for Monoclonal Antibodies for Treatment or Prevention of COVID-19 — CMS is proposing to continue to pay for COVID-19 monoclonal antibody products used for the treatment (or post-exposure) of COVID-19 under the Part B vaccine benefit through the end of the calendar year in which the emergency use authorization (EUA) declaration for drugs and biological products ends. CMS notes that the agency intends to maintain the payment rate for administering a COVID-19 monoclonal antibody product used for treatment of COVID-19 in a healthcare setting described in the CMS COVID-19 Monoclonal Toolkit. Effective January 1 of the year following the year in which the EUA declaration ends, CMS is proposing that it will pay physicians and other suppliers of COVID-19 monoclonal antibody products using rates similar to what they are paid for administering other complex biological products. In the rule, CMS is also clarifying the agency’s policy that coverage and payment under the Part B vaccine benefit for monoclonal antibody products includes those used for pre-exposure prophylaxis for prevention of COVID-19.  

Non-Face-to-Face Services/ RTM Services — CMS elected to postpone developing a generic remote therapeutic monitoring (RTM) device code and is instead seeking comments related to existing RTM devices that meet the “reasonable and necessary” definition, including: (1) types of data collected; (2) how the data solves specific health conditions; (3) associated costs; (4) length of episode of care; and (5) number of potential beneficiaries.  

Evaluation/Management (E/M) Visits — CMS is proposing to adopt the revised CPT E/M Guidelines for Other E/M visits with the exception of prolonged services. These revised guidelines were developed jointly with the American Medical Association (AMA). Additionally, the proposed rule would adopt the general (Current Procedural Terminology) framework for Other E/M visits, such that practitioner time or medical decision-making (MDM) would be used to select the E/M visit level. This includes the listing of qualifying activities by the physician or NPP that count toward the time spent when time is used required to select the visit level. However, because CMS has interpreted this rule for O/O E/M visits — when time is used to select visit level — CMS is not proposing to adopt the general CPT rule that allows a billable unit of time to be considered as having been attained when the midpoint is passed. Additionally, CMS does not interpret the CPT E/M Guidelines as adopting this general CPT rule.