On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that announces and solicits public comments on proposed policy changes for Medicare payments under the Physician Fee Schedule (PFS), and other Medicare Part B issues, effective on or after January 1, 2024.
The calendar year (CY) 2024 PFS proposed rule is one of several proposed rules that reflect a broader Administration-wide strategy to create a more equitable health care system that results in better access to care, quality, affordability, and innovation.
Background on the Physician Fee Schedule
Since 1992, Medicare payment has been made under the PFS for the services of physicians and other billing professionals. Physicians’ services paid under the PFS are furnished in a variety of settings, including physician offices, hospitals, ambulatory surgical centers (ASCs), skilled nursing facilities and other post-acute care settings, hospices, outpatient dialysis facilities,
clinical laboratories, and beneficiaries’ homes. Payment is also made to several types of suppliers for technical services, most often in settings for which no institutional payment is made.
For most services furnished in a physician’s office, Medicare makes payment to physicians and other professionals at a single rate based on the full range of resources involved in furnishing the service. In contrast, PFS rates paid to physicians and other billing practitioners in facility settings, such as a hospital outpatient department (HOPD) or an ASC, reflect only the portion of the resources typically incurred by the practitioner in the course of furnishing the service.
For many diagnostic tests and a limited number of other services under the PFS, separate payment may be made for the professional and technical components of services. The technical component is frequently billed by suppliers, like independent diagnostic testing facilities and radiation treatment centers, while the professional component is billed by the physician or practitioner.
Payments are based on the relative resources typically used to furnish the service. Relative value units (RVUs) are applied to each service for work, practice expense, and malpractice expense. These RVUs become payment rates through the application of a conversion factor. Geographic adjusters (geographic practice cost indexes) are also applied to the total RVUs to account for variation in costs by geographic area. Payment rates are calculated to include an overall payment update specified by statute.
CY 2024 PFS Ratesetting and Conversion Factor
By factors specified in law, overall payment rates under the PFS are proposed to be reduced by 1.25% in CY 2024 compared to CY 2023. CMS is also proposing significant increases in payment for primary care and other kinds of direct patient care.
The proposed CY 2024 PFS conversion factor is $32.75, a decrease of $1.14 (or 3.34%) from the current CY 2023 conversion factor of $33.89.
Caregiver Training Services
For CY 2024, CMS is proposing to make payment when practitioners train and involve caregivers to support patients with certain diseases or illnesses (e.g., dementia) in carrying out a treatment plan. We are proposing to pay for these services when furnished by a physician or a non-physician practitioner (nurse practitioners, clinical nurse specialists, certified nurse-midwives, physician assistants, and clinical psychologists) or therapist (physical therapist, occupational therapist, or speech language pathologist) under an individualized treatment plan or therapy plan of care. This proposed action is consistent with the recent Biden-Harris Administration Executive Order on Increasing Access to High Quality Care and Supporting Caregivers, and if finalized, would help support care for persons with Medicare, by better training caregivers.
Services Addressing Health-Related Social Needs (Community Health Integration Services, Social Determinants of Health Risk Assessment, and Principal Illness Navigation Services)
For CY 2024, CMS is proposing coding and payment changes to better account for resources involved in furnishing patient-centered care involving a multidisciplinary team of clinical staff and other auxiliary personnel. These proposed services are aligned with the HHS Social Determinants of Health Action Plan and also help implement the Biden-Harris Cancer Moonshot goal of every American with cancer having access to covered patient navigation services. Specifically, we are proposing to pay separately for Community Health Integration, Social Determinants of Health (SDOH) Risk Assessment, and Principal Illness Navigation services to account for resources when clinicians involve community health workers, care navigators, and peer support specialists in furnishing medically necessary care. While these care support staff have been able to serve as auxiliary personnel to perform covered services incident to the services of a Medicare-enrolled billing physician or practitioner, the services described by the proposed codes are the first that are specifically designed to describe services involving community health workers, care navigators, and peer support specialists.
Community Health Integration (CHI) and Principal Illness Navigation (PIN) services involve a person-centered assessment to better understand the patient’s life story, care coordination, contextualizing health education, building patient self-advocacy skills, health system navigation, facilitating behavioral change, providing social and emotional support, and facilitating access to community-based social services to address unmet social determinations of health (SDOH) needs. Community Health Integration services are to address unmet SDOH needs that affect the diagnosis and treatment of the patient’s medical problems. Principal Illness Navigation services are to help people with Medicare who are diagnosed with high-risk conditions (for example, mental health conditions, substance use disorder, and cancer) identify and connect with appropriate clinical and support resources. CMS is further clarifying that the community health workers, care navigators, peer support specialists, and other such auxiliary personnel may be employed by Community-Based Organizations (CBOs) as long as there is the requisite supervision by the billing practitioner for these services, similar to other care management services.
In addition to better recognizing costs associated with patient-centered care, access to these services could contribute to equity, inclusion, and access to care for the Medicare population and improve the outcomes for the patient (particularly in RHCs, FQHCs, underserved, and low-income populations, where there is a disparity in access to quality care). We are also proposing coding and payment for SDOH risk assessments to recognize when practitioners spend time and resources assessing SDOH that may be impacting their ability to treat the patient. Additionally, we are proposing to add the SDOH risk assessment to the annual wellness visit as an optional, additional element with an additional payment. Separately, we are also proposing codes and payment for SDOH risk assessments furnished on the same day as an evaluation and management visit.
Evaluation and Management (E/M) Visits
Beginning January 1, 2024, CMS is proposing to implement a separate add-on payment for healthcare common procedure coding system (HCPCS) code G2211. This add-on code will better recognize the resource costs associated with evaluation and management visits for primary care and longitudinal care of complex patients. Generally, it will be applicable for outpatient office visits as an additional payment, recognizing the inherent costs clinicians may incur when longitudinally treating a patient’s single, serious, or complex chronic condition. If finalized, we expect that establishing payment for this add-on code would have redistributive impacts for all other CY 2024 payments, which, comparatively are less than what we initially estimated for this policy in CY 2021, under the Medicare Physician Fee Schedule, due to statutory budget neutrality requirements.
CMS originally finalized this policy in the CY 2021 Medicare Physician Fee Schedule final rule. However, Congress suspended the use of the add-on code by prohibiting CMS from making additional payment under the PFS for these inherently complex E/M visits before January 1, 2024. Since this policy would improve the accuracy of payment for primary and longitudinal care, CMS is proposing to implement the policy this year.
We are proposing refinements to the policy, however, after considering information from interested parties who shared feedback in earlier rulemaking about our utilization assumptions and the estimated redistributive impact of the code on PFS payments. These changes have reduced the redistributive impacts of this policy. Specifically, we are proposing that the add-on code would not be billed with a modifier that denotes an office and outpatient evaluation and management visit that is itself unbundled from another service (e.g., a procedure where complexity is already recognized in the valuation). Second, we have refined our utilization estimates for HCPCS code G2211 in response to public feedback. These refinements collectively reduce the redistributive impact to the CY 2024 CF by nearly one third of the estimated impact described in the CY 2021 Medicare Physician Fee Schedule final rule.
Split (or Shared) Evaluation and Management (E/M) visits
Split (or shared) E/M visits refer to visits provided in part by physicians and in part by other practitioners in hospitals and other institutional settings. For CY 2024, we are proposing to delay the implementation of our definition of the “substantive portion” as more than half of the total time through at least December 31, 2024. Instead, we are proposing to maintain the current definition of substantive portion for CY 2024 that allows for use of either one of the three key components (history, exam, or MDM) or more than half of the total time spent to determine who bills the visit.
Telehealth Services under the PFS
For CY 2024, we are proposing to add health and well-being coaching services to the Medicare Telehealth Services List on a temporary basis for CY 2024, and Social Determinants of Health Risk Assessments on a permanent basis.
We are also proposing a refined process to analyze requests received for addition of services to the Medicare Telehealth Services List, including a determination on whether the requested services should be added permanently or provisionally.
We are proposing to implement several telehealth-related provisions of the Consolidated Appropriations Act, 2023 (CAA, 2023), including the temporary expansion of the scope of telehealth originating sites for services furnished via telehealth to include any site in the United States where the beneficiary is located at the time of the telehealth service, including an individual’s home; the expansion of the definition of telehealth practitioners to include qualified occupational therapists, qualified physical therapists, qualified speech-language pathologists, and qualified audiologists; the continued the continued payment for telehealth services furnished by RHCs and FQHCs using the methodology established for those telehealth services during the PHE; delaying the requirement for an in-person visit with the physician or practitioner within six months prior to initiating mental health telehealth services, and again at subsequent intervals as the Secretary determines appropriate, as well as similar requirements for RHCs and FQHCs; and the continued coverage and payment of telehealth services included on the Medicare Telehealth Services List (as of March 15, 2020) until December 31, 2024.
We are proposing that, beginning in CY 2024, telehealth services furnished to people in their homes be paid at the non-facility PFS rate to protect access to mental health and other telehealth services by aligning with telehealth-related flexibilities that were extended via the CAA, 2023.
We are proposing to continue to define direct supervision to permit the presence and immediate availability of the supervising practitioner through real-time audio and video interactive telecommunications through December 31, 2024. We believe that extending this definition of direct supervision through December 31, 2024, would align the timeframe of this policy with many of the previously discussed PHE-related telehealth policies that were extended under provisions of the CAA, 2023. We are soliciting comment on whether we should consider extending the definition of direct supervision to permit virtual presence beyond December 31, 2024. Specifically, we are interested in input from interested parties on potential patient safety or quality concerns when direct supervision occurs virtually.
Collectively, these proposed policies, if finalized, would continue many of the flexibilities that practitioners have had during the PHE to furnish telehealth services until the end of 2024, as per statutory requirements. Telehealth services, both audiovisual and audio-only, have enabled individuals in rural and underserved areas to have improved access to care.
Telehealth Services Furnished in Teaching Settings
In the CY 2021 PFS final rule, CMS established a policy that, after the end of the PHE for COVID-19, teaching physicians must have a physical presence to bill for their services involving residents, including Medicare telehealth services. CMS finalized an exception for residency training sites located outside of a metropolitan statistical area (MSA), in which case the teaching physician could be present through audio/video real-time communications technology.
To be consistent with the telehealth policies that were extended under the CAA, 2023, we are proposing to allow teaching physicians to use audio/video real-time communications technology when the resident furnishes Medicare telehealth services in all residency training locations through the end of CY 2024. This virtual presence would meet the requirement that the teaching physician be present for the key portion of the service. We are seeking comment on other clinical treatment situations where it may be appropriate to allow the virtual presence of the teaching physician, and could consider finalizing these in the CY 2024 PFS final rule.
Payment for Outpatient Therapy Services, Diabetes Self-Management Training (DSMT), and Medical Nutrition Therapy (MNT) when Furnished by Institutional Staff to Beneficiaries in Their Homes Through Communication Technology
As discussed in Frequently Asked Questions on CMS waivers, flexibilities, and the end of the COVID-19 public health emergency (PHE), institutional providers are able to continue to bill for services on the telehealth list furnished remotely the same way that they could during the PHE through the end of CY 2023. CMS is proposing to continue to allow institutional providers to bill for outpatient therapy, DSMT, and MNT services until the end of CY 2024. CMS is also seeking comment about the effectiveness of these services when furnished remotely, compared to in-person.
Behavioral Health Services
For CY 2024, we are implementing Section 4121 of the CAA, 2023, which provides for Medicare Part B coverage and payment under the Medicare Physician Fee Schedule for the services of marriage and family therapists (MFTs) and mental health counselors (MHCs) when billed by these professionals. Additionally, we are proposing to allow addiction counselors that meet all of the applicable requirements to be an MHC to enroll in Medicare as MHCs. We are proposing to allow MFTs and MHCs to enroll in Medicare after the CY 2024 Physician Fee Schedule final rule is published, and they would be able to bill Medicare for services starting January 1, 2024, consistent with statute. We are also making corresponding changes to Behavioral Health Integration codes to allow MFTs and MHCs to provide integrated behavioral health care as part of primary care settings.
We are also implementing Section 4123 of the CAA, 2023, which requires the Secretary to establish new HCPCS codes under the PFS for psychotherapy for crisis services that are furnished in an applicable site of service (any place of service at which the non-facility rate for psychotherapy for crisis services applies, other than the office setting, including the home or a mobile unit) furnished on or after January 1, 2024. Section 4123 of the CAA, 2023 specifies that the payment amount for these psychotherapy for crisis services shall be equal to 150% of the fee schedule amount for non-facility sites of service for each year for the services identified (as of January 1, 2022) by HCPCS codes 90839 (Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy for crisis; each additional 30 minutes — List separately in addition to code for primary service), and any succeeding codes.
Additionally, we are proposing to allow the Health Behavior Assessment and Intervention (HBAI) services described by CPT codes 96156, 96158, 96159, 96164, 96165, 96167, and 96168, and any successor codes, to be billed by clinical social workers, MFTs, and MHCs, in addition to clinical psychologists. Health Behavior Assessment and Intervention codes are used to identify the psychological, behavioral, emotional, cognitive, and social factors included in the treatment of physical health problems. Proposing to allow a wider range of practitioner types to furnish these services would allow for better integration of physical and behavioral health care, particularly given that there are so many behavioral health ramifications of physical health illness.
We are also proposing an increase in the valuation for timed behavioral health services under the PFS. Specifically, we are proposing to apply an adjustment to the work RVUs for psychotherapy codes payable under the PFS, which we are proposing to implement over a four-year transition. This proposal, if finalized, would begin to address potential distortions that may have occurred in valuing time-based behavioral health services in the past.
The CAA, 2023 also established that the hospice interdisciplinary group is required to include at least one social worker, MFT, or MHC. Therefore, CMS is proposing to modify the requirements for the hospice Conditions of Participation (CoPs) to allow social workers, MHCs or MFTs to serve as members of the interdisciplinary group (IDG). Additionally, we are also proposing to add and revise definitions for these professionals, who are already eligible to provide services at RHCs and FQHCs.
We are also seeking comment on ways we can continue to expand access to behavioral health services and requesting information on digital therapies, including digital cognitive behavioral therapy.
Opioid Treatment Programs (OTPs)
CMS is proposing to extend current flexibilities for periodic assessments that are furnished via audio-only telecommunications through the end of CY 2024. We would allow OTPs to bill Medicare under the Part B OTP benefit for furnishing periodic assessments via audio-only telecommunications when video is not available to the beneficiary, to the extent that use of audio-only communications technology is permitted under the applicable SAMHSA and DEA requirements at the time the service is furnished and all other applicable requirements are met. We believe extending these flexibilities by an additional year (through CY 2024) may promote continued beneficiary access for these services by minimizing potential disruptions to services due to the end of the COVID-19 PHE. This extension would also better align telehealth flexibilities for OTPs with telehealth flexibilities authorized for certain other settings under the CAA, 2023.
Supervision Policy for Physical and Occupational Therapists in Private Practice
Since 2005, CMS has required PTs and OTs in private practices (PTPPs and OTPPs, respectively) direct supervision of their therapy assistants. CMS is proposing a regulatory change to allow for general supervision of their therapy assistants by PTPPs and OTPPs for remote therapeutic monitoring (RTM) services. This will align with the RTM general supervision policy that we finalized in our CY 2023 rulemaking.
CMS is also soliciting comments on whether to revise the current direct supervision regulatory policy for PTPPs and OTPPs of their therapy assistants to the general supervision policy for all services, not just for RTM services. We are particularly interested in receiving comments, including any available supporting data, on the potential effects of implementing such a policy, including but not limited to patient quality of care, patient safety, and changes in utilization.
Diabetes Self-Management Training (DSMT) Services Furnished by Registered Dietitians (RDs) and Nutrition Professionals
CMS is proposing to amend the regulatory provision at § 410.72(d), that we established during CY 2022 PFS rulemaking, to clarify that an RD or nutrition professional must personally perform MNT services, but the enrolled RD or nutrition professional, when acting as the DSMT certified provider, may bill for, or on behalf of, the entire DSMT entity, regardless of which professional personally delivers each aspect of the services. This proposal, if finalized, would build on recent policy changes designed to improve access to DSMT services.
Telehealth Proposals for DSMT Services
Currently, our manual instruction for DSMT payment in the Medicare Claims Processing Manual, Pub. 100-04, chapter 12, section 190.3.6, requires one hour of the 10-hour DSMT benefit’s initial training and one hour of the two-hour follow-up annual training to be furnished in-person to allow for effective injection training when injection training is applicable for insulin-dependent beneficiaries. However, with the expansion of the use of telehealth during the PHE for COVID-19, we believe that there have been significant changes in clinical standards, guidelines, and best practices regarding services furnished using interactive telecommunications technology, including for injection training for insulin-dependent patients. Because we do not want our policies to prevent injection training via telehealth when clinically appropriate, CMS is proposing to revise our policy by eliminating the regulatory prohibition on providing the full service via telehealth. This should better promote access to DSMT services, which are underutilized services that have been shown to improve care for individuals with diabetes.
Dental and Oral Health Services
In general, the statute precludes payment under Medicare Parts A or B for any expenses incurred for coverage, items, and services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth. Medicare has paid for dental services in some clinical circumstances when dental services are inextricably linked to the clinical success of specific covered medical services. In last year’s PFS final rule, we codified that Medicare payment under Parts A and B could be made when dental services are furnished in either the inpatient or outpatient setting under particular kinds of circumstances.
Specifically, in CY 2023, CMS finalized: 1) our proposal to clarify and codify certain aspects of previous Medicare FFS payment policies for dental services, 2) payment for dental services that are inextricably linked to other covered medical services, such as dental exams and necessary treatments prior to organ transplants, cardiac valve replacements, and valvuloplasty procedures, 3) a process to review and consider public submissions for potentially analogous clinical scenarios under which Medicare payment could be made for dental services, and 4) Medicare payment, beginning in CY 2024, for dental exams and necessary treatments prior to the treatment for head and neck cancers.
For CY 2024, we are proposing to codify the previously finalized payment policy for dental services prior to, or during, head and neck cancer treatments, whether primary or metastatic. Additionally, we are proposing to permit payment for certain dental services inextricably linked to other covered services used to treat cancer — chemotherapy services, Chimeric Antigen Receptor T- (CAR-T) Cell therapy, and the use of high-dose bone modifying agents (antiresorptive therapy). These proposals, if finalized, would improve the success of these cancer-related treatments and increase access to certain dental care in these circumstances. We are also seeking comment on additional circumstances where evidence supports dental services being integral to the clinical success of covered medical services.
Skin Substitutes
CMS is soliciting comments, for consideration for future rulemaking, on the best manner to incorporate skin substitutes as a supply within the PFS rate setting methodology.
Provisions from the Inflation Reduction Act Relating to Drugs and Biologicals Payable Under Medicare Part B
The Inflation Reduction Act (Pub. L. 117-169, August 16, 2022) contains several provisions that affect payment limits or beneficiary out-of-pocket costs for certain drugs payable under Part B. In this proposed rule we address the following:
- Section 11402 amends the payment limit for new biosimilars furnished on or after July 1, 2024 during the initial period when ASP data is not available. We are proposing to codify this provision in regulation.
- Section 11403 makes changes to the payment limit for certain biosimilars with an ASP that is not more than the ASP of the reference biological for a period of five years. We implemented section 11403 of the IRA under program instruction, as permitted under section 1847A(c)(5)(C) of the Act. We are now proposing conforming changes to regulatory text to reflect these provisions.
- Section 11101 requires that beneficiary coinsurance for a Part B rebatable drug is to be based on the inflation-adjusted payment amount if the Medicare payment amount for a calendar quarter exceeds the inflation-adjusted payment amount, beginning on April 1, 2023. We issued initial guidance implementing this provision, as permitted under section 1847A(c)(5)(C) of the Act, on February 9, 2023. We are proposing conforming changes to regulatory text.
- Section 11407 provides that for insulin furnished through an item of DME on or after July 1, 2023, the deductible is waived and coinsurance is limited to $35 for a month’s supply of insulin furnished through a covered item of DME. We have implemented this provision under program instruction for 2023, as permitted under section 11407(c) of the IRA. We are now proposing to codify this provision in a manner that is consistent with the program instruction for 2023.
Drugs and Biologicals which are Not Usually Self-Administered by the Patient, and Complex Drug Administration Coding
CMS is soliciting comments regarding our policies on the exclusion of coverage for certain drugs under Part B that are usually self-administered by the patient. In addition, we are seeking comment on coding and payment policies for complex non-chemotherapeutic drugs, in an effort to promote coding and payment consistency and patient access to infusion services.
Requiring Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs to Provide Refunds with Respect to Discarded Amounts
In the CY 2023 PFS final rule, we adopted many policies to implement section 90004 of the Infrastructure Act. Among them, we finalized: a definition of “refundable single-dose container or single-use package drug,” which also specifies certain exclusions; reporting requirements for use of the JW modifier to report discarded amounts of drugs from single-dose containers and the
use of the JZ modifier for such drugs with no discarded amounts; an increased applicable percentage of 35% for a category of drugs with unique circumstances; and a dispute resolution process.
In this proposed rule, we are proposing additional policies to implement this provision, including: timelines for the initial and subsequent discarded drug refund reports to manufacturers, the method of calculating refunds for discarded amounts from lagged claims data, the method of calculating refunds when there are multiple manufacturers for a refundable drug, increased applicable percentages for certain drugs with unique circumstances, and an application process by which manufacturers may request an increased applicable percentage for a drug with unique circumstances. We also propose modification to the JW and JZ modifier policy for drugs payable under Part B from single-dose containers that are furnished by a supplier who does not administer the drug.
Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
In this proposed rule, we are proposing conforming regulatory text changes to implement Sections 4113 and 4121 of the CAA, 2023, specifically, extending payment for telehealth services furnished in RHCs and FQHCs through December 31, 2024, and delaying the in-person requirements under Medicare for mental health visits furnished by RHCs and FQHCs, and including marriage and family therapists (MFTs) and mental health counselors (MHCs) as eligible for payment.
In addition, we are proposing to allow addiction counselors that meet all of the requirements of MHCs to enroll with Medicare as MHCs. Therefore, we are proposing that the definitions established for MFTs and MHCs under the PFS would also apply for RHCs and FQHCs. Accordingly, addiction counselors that meet all of the requirements of MHCs would be allowed to enroll with Medicare as MHCs.
We also note that Section 4124 of Division FF of the CAA, 2023 established Medicare coverage and payment for intensive outpatient program (IOP) services furnished by an RHC or FQHC. Implementation proposals will be described in the CY 2024 Outpatient Prospective Payment System rule.
We are also proposing to change the required level of supervision for behavioral health services furnished “incident to” a physician or NPP’s services in RHCs and FQHCs to allow general supervision, rather than direct supervision, consistent with the policies finalized under the PFS during last year’s rulemaking for other settings.
We are proposing to include remote physiologic monitoring and remote therapeutic monitoring in the general care management HCPCS code G0511 when these services are furnished by RHCs and FQHCs.
In addition, we are proposing to include Community Health Integration (CHI) and Principal Illness Navigation (PIN) services in the general care management HCPCS code G0511 when these services are provided by RHCs and FQHCs. RHCs and FQHCs that furnish CHI and PIN services would be able to bill these services using HCPCS code G0511, either alone or with other payable services on an RHC or FQHC claim, for dates of service on or after January 1, 2024.
We are also proposing a change in the methodology to calculate the payment rate for HCPCS code G0511 that takes into account how frequently the various services are utilized.
Finally, we are clarifying that for beneficiary consent for Chronic Care Management and virtual communications services, that the sequencing and mode of consent can take various forms and direct supervision is not needed.
Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-In of Payment Reductions
In accordance with section 4114 of the CAA, 2023, we are proposing to make certain conforming changes to the data reporting and payment requirements for clinical diagnostic laboratory tests (CDLTs). Specifically, we are proposing to update the regulatory definition of both the “data collection period” and “data reporting period,” specifying that for the data reporting period of January 1, 2024 through March 31, 2024, the data collection period is January 1, 2019 through June 30, 2019. We are also proposing revisions to indicate that initially, data reporting begins January 1, 2017 and is required every three years beginning January 2024. In addition, we are proposing to make conforming changes to our requirements for the phase-in of payment reductions to reflect the amendments in section 4114(a) of the CAA, 2023. Specifically, we are proposing to revise the regulations to indicate that for CY 2023, payment for an applicable CDLTs may not be reduced compared to the payment amount established for that test in CY 2022, and for CYs 2024 through 2026, payment may not be reduced by more than 15% as compared to the payment amount established for that test for the preceding year.
Ambulance Fee Schedule: Ambulance Extenders Provisions
Section 4103 of the CAA, 2023 extended three existing add-on payments to the ambulance base and mileage rates under the Ambulance Fee Schedule through December 31, 2024. Accordingly, CMS is revising our regulations at 42 CFR §414.610(c)(1)(ii) and 414.610(c)(5)(ii) in this proposed rule to align with existing law.
Medicare Ground Ambulance Data Collection System (GADCS)
Section 50203(b) of the Bipartisan Budget Act (BBA) of 2018 required CMS to finalize regulations for a ground ambulance data collection system by December 31, 2019. This legislation also required CMS to identify the providers and suppliers required to submit information each year through 2024 and no less than once every three years after 2024. The GADCS is required to collect cost, revenue, utilization, and other information with respect to providers and suppliers of ground ambulance services in order to evaluate the extent to which reported costs relate to payment rates. The GADCS portal went live on January 1, 2023 and, for the first time, CMS will collect this information and provide the data to MedPAC for its report to Congress. CMS identified opportunities to improve the GADCS instrument through stakeholder engagement. CMS is proposing the following changes to the instrument: Adding the ability to address partial year responses from ground ambulance organizations, introducing a minor edit to improve the reporting consistency of hospital-based ambulance organizations, and four technical corrections to typos.
Medicare Part B Payment for Preventive Vaccine Administration Services
In June 2021, CMS announced an additional payment for in-home COVID-19 vaccine administration, which was established on a preliminary basis during the PHE. Based on data that show that this payment has helped improve healthcare access to vaccines for underserved Medicare populations, CMS is proposing to maintain this additional payment for the administration of a COVID-19 vaccine in the home. CMS is also proposing to extend this in-home additional payment to the administration of the other three preventive vaccines included in the Part B preventive vaccine benefit — the pneumococcal, influenza, and hepatitis B vaccines — when provided in the home.
Under this proposal, effective January 1, 2024, the payment amount for administration of all four vaccines would be identical, that is, Medicare Part B will pay the same additional payment amount to providers and suppliers that administer a pneumococcal, influenza, hepatitis B, or COVID-19 vaccine in the home. This additional payment amount will be annually updated using the percentage increase in the Medicare Economic Index and adjusted to reflect geographic cost variations. CMS is proposing to limit the additional payment to one payment per home visit, even if multiple vaccines are administered during the same home visit. Every vaccine dose that is furnished during a home visit will still receive its own unique vaccine administration payment.
Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging Program
CMS is proposing to pause efforts to implement the Appropriate Use Criteria (AUC) program for reevaluation and to rescind the current AUC program regulations at 42 CFR 414.94. CMS will continue efforts to identify a workable implementation approach and will propose to adopt any such approach through subsequent rulemaking.
Request for Information (RFI) on the Histopathology, Cytology, and Clinical Cytogenetics Regulations under the Clinical Laboratory Improvement Amendments (CLIA) of 1988
CMS is soliciting comments in the following areas of CLIA: Histopathology, Cytology, and Clinical cytogenetics. The requirements have not been updated since 1992. This input is necessary to inform CMS as we address new innovative technology and current practices in the laboratory related to anatomic pathology and Clinical cytogenetics.
The Medicare Diabetes Prevention Plan (MDPP)
CMS is proposing to extend the MDPP Expanded Model’s Public Health Emergency Flexibilities for four years, which would allow all MDPP suppliers to continue to offer MDPP services virtually using distance learning delivery through December 31, 2027, if they maintain
an in-person Centers for Disease Control and Prevention organization code. CMS also proposes to simplify MDPP’s current performance-based payment structure by allowing fee-for-service payments for beneficiary attendance.
Medicare and Medicaid Provider and Supplier Enrollment
CMS is proposing several regulatory provisions regarding Medicare and Medicaid provider enrollment. These include, but are not limited to, the following:
- Creation of a new Medicare provider enrollment status labeled a “stay of enrollment,” which CMS believes will ease the burden on providers and suppliers while strengthening Medicare program integrity.
- Requiring all Medicare provider and supplier types to report additions, deletions, or changes in their practice locations within 30 days.
- Establishing several new and revised Medicare denial and revocation authorities.
- Clarifying the length of time for which a Medicaid provider will remain in the Medicaid termination database.
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