Medicare Shared Savings Program (MSSP) Archives · mTelehealth

Calendar Year (CY) 2025 Medicare Physician Fee Schedule Final Rule

Dr. M Telehealth — Mon, 04 Nov 2024 16:34:57 +0000

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a rule finalizing changes for Medicare payments under the PFS and other Medicare Part B policies, effective on or after January 1, 2025.

The CY 2025 PFS final rule is one of several final rules that reflect a broader Administration-wide strategy to create a more equitable health care system that results in better accessibility, quality, affordability, empowerment, and innovation for all Medicare beneficiaries.

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 an office setting, Medicare makes payments to physicians and other practitioners 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 while 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, such as 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 indices) 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 2025 PFS Rate Setting and Conversion Factor

By factors specified in law, average payment rates under the PFS will be reduced by 2.93% in CY 2025, compared to the average amount these services were paid for most of CY 2024. The change to the PFS conversion factor incorporates the 0% overall update required by statute, the expiration of the temporary 2.93% increase in payment for CY 2024 required by statute, and a relatively small estimated 0.02% adjustment necessary to account for changes in work relative value units (RVUs) for some services. This amounts to an estimated CY 2025 PFS conversion factor of $32.35, a decrease of $0.94 (or 2.83%) from the current CY 2024 conversion factor of $33.29.

Caregiver Training Services (CTS)

For CY 2025, we are finalizing our proposal to establish new coding and payment for caregiver training for direct care services and supports. The topics of trainings can include, but would not be limited to, techniques to prevent decubitus ulcer formation, wound care, and infection control. We are also finalizing our proposal to establish new coding and payment for caregiver behavior management and modification training that can be furnished to the caregiver(s) of an individual patient. We are also finalizing a policy to allow these CTS to be furnished via telehealth.

Services Addressing Health-Related Social Needs (Community Health Integration Services, Social Determinants of Health Risk Assessment, and Principal Illness Navigation Services)

In the CY 2025 PFS proposed rule, we issued a broad request for information (RFI) on the newly implemented Community Health Integration (CHI) services, Principal Illness Navigation (PIN) services, and Social Determinants of Health (SDOH) Risk Assessment to engage interested parties on additional policy refinements for CMS to consider in future rulemaking. We requested information on other factors for us to consider, such as other types of auxiliary personnel (including clinical social workers) and other certification and training requirements that are not adequately captured in current coding and payment for these services, and how to improve utilization in rural areas. We also sought comment about how these codes are being furnished in conjunction with community-based organizations. We received many detailed comments in response to this RFI, which we summarize in the final rule and may consider for future rulemaking.

Office/Outpatient (O/O) Evaluation and Management (E/M) Visits

For CY 2025, we are finalizing our proposal to allow payment of the O/O E/M visit complexity add-on code, Healthcare Common Procedure Coding System (HCPCS) code G2211, when the O/O E/M base code — Current Procedural Terminology (CPT) codes 99202-99205, 99211-99215 — is reported by the same practitioner on the same day as an annual wellness visit (AWV), vaccine administration, or any Medicare Part B preventive service, including the Initial Preventive Physical Examination (IPPE), furnished in the office or outpatient setting.

Telehealth Services under the PFS

Absent Congressional action, beginning January 1, 2025, the statutory limitations that were in place for Medicare telehealth services prior to the COVID-19 PHE will retake effect for most telehealth services. These include geographic and location restrictions on where the services are provided, and limitations on the scope of practitioners who can provide Medicare telehealth services. However, the final rule reflects CMS’ goal to preserve some important, but limited, flexibilities in our authority, and expand the scope of and access to telehealth services where appropriate.

For CY 2025, we are finalizing our proposal to add several services to the Medicare Telehealth Services List, including caregiver training services on a provisional basis and PrEP counseling and safety planning interventions on a permanent basis. We are finalizing to continue the suspension of frequency limitations for subsequent inpatient visits, subsequent nursing facility visits, and critical care consultations for CY 2025.

We are finalizing that beginning January 1, 2025, an interactive telecommunications system may include two-way, real-time, audio-only communication technology for any Medicare telehealth service furnished to a beneficiary in their home, if the distant site physician or practitioner is technically capable of using an interactive telecommunications system, but the patient is not capable of, or does not consent to, the use of video technology.

We are finalizing that, through CY 2025, we will continue to permit distant site practitioners to use their currently enrolled practice locations instead of their home addresses when providing telehealth services from their home.

We are finalizing, for a certain subset of services that are required to be furnished under the direct supervision of a physician or other supervising practitioner, to permanently adopt a definition of direct supervision that allows the supervising physician or practitioner to provide such supervision via a virtual presence through real-time audio and visual interactive telecommunications. We are specifically finalizing to make permanent that the supervising physician or practitioner may provide such virtual direct supervision (1) for services furnished incident to a physician or other practitioner’s professional service, when provided by auxiliary personnel employed by the billing physician or supervising practitioner and working under his or her direct supervision, and for which the underlying HCPCS code has been assigned a PC/TC indicator of “5” and services described by CPT code 99211, and (2) for office or other outpatient visits for the evaluation and management of an established patient who may not require the presence of a physician or other qualified health care professional. For all other services furnished incident that require the direct supervision of the physician or other supervising practitioner, we are finalizing to continue to permit direct supervision be provided through real-time audio and visual interactive telecommunications technology only through December 31, 2025.

We are finalizing a policy to continue to allow teaching physicians to have a virtual presence for purposes of billing for services furnished involving residents in all teaching settings, but only in clinical instances when the service is furnished virtually (for example, a three-way telehealth visit, with the patient, resident, and teaching physician in separate locations) through December 31, 2025. This virtual presence will continue to meet the requirement that the teaching physician be present for the key portion of the service.

Advanced Primary Care Management Services (APCM)

A strong foundational primary care system is fundamental to improving health outcomes, lowering mortality, and reducing health disparities, which is why the Department of Health and Human Services has been taking action to strengthen primary care, including establishing coding and payment for advanced primary care management services in the CY 2025 PFS final rule.

For CY 2025, we are finalizing our proposal to establish coding and payment under the PFS for a new set of APCM services described by three new HCPCS G-codes (G0556, G0557, G0558). The finalized APCM services incorporate elements of several existing care management and communication technology-based services into a bundle of services that reflects the essential elements of the delivery of advanced primary care, including Principal Care Management, Transitional Care Management, and Chronic Care Management. However, unlike existing care management codes, there are no time-based thresholds included in the service elements, which is intended to reduce the administrative burden associated with current coding and billing. Instead, the new APCM codes are stratified into three levels based on an individual’s number of chronic conditions and status as a Qualified Medicare Beneficiary, reflecting the patient’s medical and social complexity.

Level 1 (G0556) is for persons with one chronic condition; Level 2 (G0557) is for persons with two or more chronic conditions; and Level 3 (G0558) is for persons with two or more chronic conditions and status as a Qualified Medicare Beneficiary.

This new finalized coding and payment makes use of lessons learned from the CMS Innovation Center’s testing of a series of advanced primary care models, such as Comprehensive Primary Care Plus (CPC+) and Primary Care First (PCF), to inform the service elements and practice-level capabilities of APCM services. The code requirements that we are finalizing include consent, initiating visit, 24/7 access and continuity of care, comprehensive care management, patient-centered comprehensive care plan, management of care transitions, care coordination, enhanced communication, population-level management, and performance measurement. In addition, we are finalizing that for MIPS eligible clinicians, the performance management service element can be satisfied by reporting the Value in Primary Care MIPS Value Pathway (MVP), as it was developed to include quality measures that reflect clinical actions that are indicative of high-quality primary care. Reporting for the MVP would begin in 2026 based on the 2025 performance year.

CMS received many comments recommending increased valuation of the codes, and CMS may revisit the valuation for all of these services in future rulemaking. After consideration of the comments, CMS is finalizing an increase in the valuation for the Level 1 code (HCPCS code G0556). Beginning January 1, 2025, physicians and non-physician practitioners (NPPs) who use an advanced primary care model of care delivery as described by the service elements of the APCM codes could bill for APCM services when they are the continuing focal point for all needed health care services and responsible for all the patient’s primary care services. This new finalized coding and payment better recognizes and describes advanced primary care services, encourages primary care practice transformation, helps ensure that patients have access to high quality primary care services, and simplifies billing and documentation requirements, as compared to existing care management and communication technology-based services codes. The finalized codes also represent a step towards paying for primary care services with hybrid payments (a mix of encounter and population-based payments) to support longitudinal relationships between primary care providers and beneficiaries, by paying for care in larger units of service, and also help drive accountable care. A practitioner who is participating in a Shared Savings Program ACO, a Realizing Equity, Access, and Community Health ACO (REACH ACO), a Primary Care First practice, or a Making Care Primary practice may satisfy requirements for these codes by virtue of meeting requirements under the Shared Savings Program or Innovation Center model.

We sought comment from interested parties through an Advanced Primary Care Hybrid Payment RFI on whether and how we should consider additional payment policies that recognize the delivery of advanced primary care services, and we will take these comments into consideration for future rulemaking.

Cardiovascular Risk Assessment and Management

The CMS Innovation Center tested the Million Hearts® Model, which coupled payments for cardiovascular risk assessment with cardiovascular care management, and was found to reduce the rate of death by lowering heart attacks and strokes among Medicare Fee-for-Service beneficiaries. In order to incorporate these lessons learned and increase access to these lifesaving interventions, beginning with CY 2025, we are finalizing coding and payment for an Atherosclerotic Cardiovascular Disease (ASCVD) risk assessment service and risk management services. The ASCVD risk assessment will be performed in conjunction with an E/M visit when a practitioner identifies a patient at risk for CVD who does not have a diagnosis of CVD. The standardized, evidence-based risk assessment tool used includes demographic data (e.g., age, sex), modifiable risk factors for CVD (e.g., blood pressure & cholesterol control, smoking status/history, alcohol and other drug use, physical activity and nutrition, obesity), possible risk enhancers (e.g., pre-eclampsia), and laboratory data (lipid panel), and the output must include a 10-year estimate of the patient’s ASCVD risk. We are also finalizing coding and payment for ASCVD risk management services that include service elements related to the ABCS of CVD risk reduction (aspirin, blood pressure management, cholesterol management, smoking cessation) for beneficiaries at intermediate, medium, or high risk in the next 10 years for CVD.

Behavioral Health Services

In this rule, CMS is finalizing several additional actions to help support access to behavioral health, in line with the CMS Behavioral Health Strategy.

Several studies have demonstrated that safety planning, when properly performed, can help prevent suicide. For CY 2025, we are finalizing separate coding and payment under the PFS describing safety planning interventions for patients in crisis, including those with suicidal ideation or at risk of suicide or overdose. Specifically, we are finalizing payment for a G-code that may be billed in 20-minute increments when safety planning interventions are personally performed by the billing practitioner in a variety of settings. Additionally, we are finalizing payment for a monthly billing code that requires specific protocols in furnishing post-discharge follow-up contacts that are performed in conjunction with a discharge from the emergency department for a crisis encounter, as a bundled service describing four calls in a month.

To further support access to psychotherapy, CMS worked with the U.S. Food & Drug Administration (FDA) and is also finalizing Medicare payment for digital mental health treatment devices, cleared under section 510(k) of the Federal Food, Drug and Cosmetic Act or granted de no novo authorization by FDA and classified under 21 CFR 882.580 furnished incident to professional behavioral health services, used in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care. CMS is finalizing three new HCPCS codes to describe these services and will monitor how digital mental health treatment devices are used as part of overall behavioral health care. We are also finalizing six G codes, to be billed by practitioners in specialties whose covered services are limited by statute to services for the diagnosis and treatment of mental illness (including clinical psychologists, clinical social workers, marriage and family therapists, and mental health counselors), that mirror current interprofessional consultation CPT codes used by practitioners who are eligible to bill E/M visits.

Lastly, we summarize comments received from the comment solicitation on coding and payment for Intensive Outpatient Program (IOP) services under the PFS, as well as Certified Community Behavioral Health Clinics (CCBHCs) and facilities that offer crisis stabilization services and non-emergent, urgent care. We will take these comments into consideration for future rulemaking.

Opioid Treatment Programs (OTPs)

CMS is finalizing several telecommunication technology flexibilities for opioid use disorder (OUD) treatment services furnished by OTPs, so long as all requirements are met, and the use of these technologies are permitted under the applicable Substance Abuse and Mental Health Services (SAMHSA) and the Drug Enforcement Administration (DEA) requirements at the time the services are furnished. First, CMS is making permanent the current flexibility for furnishing periodic assessments via audio-only telecommunications beginning January 1, 2025, so long as all other applicable requirements are met. Second, CMS is allowing the OTP intake add-on code to be furnished via two-way audio-video communications technology when billed for the initiation of treatment with methadone (using HCPCS code G2076) if the OTP determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform. We believe these telecommunication flexibilities will meaningfully promote access to care for populations that often face barriers to entering and participating in OUD treatment and allow OTPs and their patients to mutually agree on the best modality for receiving care.

CMS is also finalizing payment increases in response to recent regulatory reforms for OUD treatment finalized by SAMHSA at 42 CFR part 8. Specifically, CMS is updating payment for SDOH risk assessments as part of intake activities within OUD treatment services furnished by OTPs, if medically reasonable and necessary to adequately reflect additional effort for OTPs, to identify a patient’s unmet health-related social needs (HRSNs) or the need and interest for harm reduction interventions and recovery support services that are critical to the treatment of an OUD. After consideration of public comments, CMS is also updating payment for periodic assessments to include payment for SDOH risk assessments to reflect additional reassessments that OTPs may conduct throughout treatment, to monitor potential changes in a patient’s HRSNs or support services. We believe these updates will help OTPs address key issues, during initial and periodic assessments, that may increase the risk of a patient leaving OUD treatment prematurely or that pose barriers to treatment engagement.

In the proposed rule, CMS requested information to understand how OTPs currently coordinate care and make referrals to community-based organizations that address unmet HRSNs, provide harm reduction services, and/or offer recovery support services. After receiving detailed, supportive comments of these integral activities in OTP settings, CMS is finalizing new add-on codes to account for coordinated care and referral services, patient navigational services, and peer recovery support services. Establishing payment for these services can support OTPs in coordinating with community-based organizations to address various patient needs across the continuum of care, and directly provide or refer patients to navigational and/or peer recovery support services to assist patients in navigating multiple care settings and meeting MOUD treatment and recovery goals.

CMS is finalizing payment for new opioid agonist and antagonist medications approved by the FDA. First, CMS is finalizing a new add-on code for nalmefene hydrochloride nasal spray, indicated for the emergency treatment of known or suspected opioid overdose. CMS is also finalizing payment for a new injectable buprenorphine product via (1) a new weekly bundled payment code for the weekly formulation of the new injectable buprenorphine product, and (2) including payment for the monthly formulation of the new injectable buprenorphine product into the existing code for monthly injectable buprenorphine.

Lastly, CMS is clarifying a billing requirement that OTPs must append an OUD diagnosis code on claims for OUD treatment services, consistent with Medicare coverage and payment provisions under the Social Security Act.

Hospital Inpatient or Observation (I/O) Evaluation and Management (E/M) Add-On for Infectious Diseases

For CY 2025, we are finalizing a new HCPCS add-on code to describe the intensity and complexity inherent to hospital inpatient or observation care, associated with a confirmed or suspected infectious disease, performed by a practitioner with specialized training in infectious diseases. The new HCPCS add-on code describes service elements, including disease transmission risk assessment and mitigation, public health investigation, analysis, and testing, and complex antimicrobial therapy counseling and treatment.

Strategies for Improving Global Surgery Payment Accuracy

For CY 2025, we are finalizing a policy to broaden the applicability of the transfer of care modifier 54, for all 90-day global surgical packages (global packages), in any case when a practitioner expects to furnish only the surgical procedure portion of the global package, including but not limited to when there is a formal, documented transfer of care as under current policy or an informal, non-documented but expected, transfer of care.

This finalized policy will improve payment accuracy for these 90-day global package services and is expected to inform CMS about how global package services are typically furnished. For CY 2025, we are also finalizing a new add-on code, HCPCS code G0559, for post-operative care services furnished by a practitioner other than the one who performed the surgical procedure (or another practitioner in the same group practice). This add-on code will more appropriately reflect the time and resources involved in these post-operative follow-up visits by practitioners who were not involved in furnishing the surgical procedure.

Supervision Policy for Physical Therapists (PTs) and Occupational Therapists (OTs) in Private Practice

For CY 2025, we are finalizing a regulatory change to allow for general supervision of physical therapist assistants (PTAs) and occupational therapy assistants (OTAs) by PTs in private practice (PTPPs) and OTs in private practice (OTPPs) for all applicable physical and occupational therapy services. This finalized change will give PTPPs and OTPPs more flexibility in meeting the needs of beneficiaries and safeguard patient access to medically necessary therapy services, including those experiencing challenges accessing these services in rural and underserved areas, and it will align with general supervision of PTAs and OTAs by PTs and OTs who work in institutional providers.

Certification of Therapy Plans of Treatment with a Physician or NPP Order

For CY 2025, CMS is finalizing amendments to the certification regulations to lessen the administrative burden for therapists (PTs, OTs, and speech-language pathologists (SLPs)) and physician/NPPs. These changes will provide an exception to the physician/NPP signature requirement on the therapist-established treatment plan for purposes of the initial certification, in cases where a written order or referral from the patient’s physician/NPP is on file and the therapist has documented evidence that the treatment plan was transmitted to the physician/NPP within 30 days of the initial evaluation. CMS also solicited comment, as suggested by interested parties, as to the need for a regulation to address the amount of time during which the physician/NPP who signed the written order for therapy services could make changes to the therapist-established treatment plan by contacting the therapist directly, but CMS did not adopt such a timeline restriction. Instead, CMS clarified that, for the cases meeting the exception to the signature requirement policy, payment should be made available for any therapy services furnished prior to a physician/NPP-modified treatment plan if all payment requirements are met. The comment solicitation as to whether there should be a 90-day (or other) limit to the physician/NPP order extending from the order date to the first date of treatment/evaluation by the therapist did not result in a policy being adopted by CMS.

Dental and Oral Health Services

We are finalizing our proposal to amend our regulations, at § 411.15(i)(3), to add to the list of clinical scenarios under which FFS Medicare payment may be made for dental services inextricably linked to covered services, to include: (1) dental or oral examination in the inpatient or outpatient setting prior to, or contemporaneously with, Medicare-covered dialysis services for the treatment of end-stage renal disease and (2) medically necessary diagnostic and treatment services to eliminate an oral or dental infection prior to, or contemporaneously with, Medicare-covered dialysis services for the treatment of end-stage renal disease. Interested parties have suggested that we should focus on this patient population and have submitted clinical evidence describing the links between dental and oral health and dialysis for beneficiaries with end-stage renal disease through our established public submissions process.

CMS also solicited comment on the potential connection between dental services and covered services used in the treatment of diabetes, and covered services for individuals with autoimmune diseases receiving immunosuppressive therapies, as well as requesting any additional evidence regarding covered services for sickle cell disease and hemophilia. We received many comments, which we considered and continue to engage with interested parties in clarifying definitions. We remain committed to exploring the inextricable link between dental and medical services associated with these chronic conditions.

CMS is also finalizing two policies related to billing of dental services inextricably linked to covered services. Effective July 1, 2025, we will require the submission of the KX modifier on claims for dental services that clinicians believe to be inextricably linked to covered medical services. We believe that the required usage of the KX modifier will support claims processing and program integrity efforts and that the delay provides time for any testing and education needed for implementation.

CMS is also finalizing our proposal to require the submission of a diagnosis code on the 837D dental claims format beginning July 1, 2025. Both the statute and our regulations require the submission of a diagnosis code on claims for physician services. However, this requirement has not been specifically addressed in the context of the 837D dental claims format. Therefore, we are finalizing that a diagnosis code will be required on claims for dental services inextricably linked to covered medical services submitted via the 837D dental claims format.

Drugs and Biological Products Paid Under Medicare Part B

Requiring Manufacturers of Certain Single-dose Container or Single-use Package Drugs to Provide Refunds with Respect to Discarded Amounts

In rulemaking over the last few years, we finalized many policies to implement section 90004 of the Infrastructure Investment and Jobs Act, which established a refund for discarded amounts of certain single-dose container or single-use package drugs under Part B. We are finalizing clarifications to several policies implemented in the CY 2023 and CY 2024 PFS final rules, including: exclusions of drugs, for which payment has been made under Part B for fewer than 18 months, from the definition of refundable single-dose container or single-use package drug, and identifying single-dose containers. We are also finalizing a requirement that the JW modifier must be used if a billing supplier is not administering a drug, but there are amounts discarded during the preparation process before supplying the drug to the patient. Finally, we are finalizing that skin substitutes will not be included in the identification of refundable drugs for the calendar quarters in 2025.

Approach to Payment Limit Calculations when Negative or Zero Average Sales Price (ASP) Data Is Reported to CMS

CMS is finalizing an approach to how it will calculate payment limits when manufacturers report negative or zero ASP data to CMS. Generally, we are finalizing a policy that negative and zero ASP data is considered “not available” under section 1847A(c)(5)(B) of the Act and that positive ASP data is considered available. The finalized policies to determine a payment limit when ASP data is not available vary based on factors about the drug or biological, such as whether the drug is single source or multiple source; whether some, but not all National Drug Codes (NDCs) for a billing and payment code have a negative or zero ASP data, or all NDCs for a billing and payment code have a negative or zero ASP data; and whether relevant applications for all NDCs for a billing and payment code have a marketing status of discontinued.

Altogether, CMS is finalizing its policies for calculating the payment limit when a manufacturer reports negative or zero ASP data for a drug, with a modification relating to biosimilars, such that the finalized payment limit calculation will use the biosimilar’s own, most recently available, positive manufacturer’s ASP data.

Payment for Radiopharmaceuticals in the Physician Office Setting

In an effort to provide clarity on which methodologies are available to Medicare Administrative Contractors (MACs) for pricing of radiopharmaceuticals in the physician office setting, CMS is finalizing a clarification that, for radiopharmaceuticals furnished in a setting other than a hospital outpatient department, MACs shall determine payment limits for radiopharmaceuticals based on any methodology used to determine payment limits for radiopharmaceuticals in place on or prior to November 2003. Such methodology may include, but is not limited to, the use of invoice-based pricing.

Immunosuppressive Therapy

Because some people rely on compounded immunosuppressive drugs for maintenance therapy, we are finalizing revisions to regulations to include certain compounded formulations of FDA-approved drugs that have approved immunosuppressive indications in the immunosuppressive drug benefit, or for use in conjunction with immunosuppressive drugs, or that have been determined by a MAC to be reasonable and necessary to prevent or treat rejection of a transplanted organ or tissue. Specifically, we are finalizing inclusion of certain compounded formulations that are orally or enterally administered. In addition, we are finalizing two changes regarding supplies of immunosuppressive drugs to align with current standards of practice and reduce barriers to medication adherence: to allow payment of a supplying fee for a prescription of a supply of up to 90 days and to allow payment for refills of prescriptions for these immunosuppressive drugs.

Blood Clotting Factors

Blood clotting factor treatments are covered under Medicare Part B, whether the treatment is self-infused or provided in the physician office setting. Clotting factor furnishing fees are paid when self-infused products are furnished to beneficiaries. In contrast, when clotting factor is administered in health care settings, administration fees are paid, reflecting the resources involved in administering the product.

Additionally, gene therapies have recently been FDA-approved for the treatment of hemophilia. These gene therapies for hemophilia are not administered by the patient in his or her home, but rather are typically administered via a one-time, single dose intravenous infusion in a setting where personnel and equipment are immediately available to treat infusion-related reactions. These gene therapies treating hemophilia are not clotting factors themselves; rather, they are genetic treatments that enable the body to produce its own clotting factors. Because gene therapies are not themselves clotting factors, they are not eligible for the clotting factor furnishing fee. We note that they are eligible for the administration fee. We also clarify this policy in this final rule.

Accordingly, we are finalizing an update to regulatory text to clarify existing CMS policy that blood clotting factors must be self-administered and must not be therapies that enable the body to produce clotting factors and do not directly integrate into coagulation cascade to be considered clotting factors for which the furnishing fee applies.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

Care Coordination Services in RHCs and FQHCs

We are finalizing several changes related to reporting care coordination services in RHCs and FQHCs to better align payment to RHCs and FQHCs for these services with other entities furnishing similar care coordination. Specifically, we are finalizing with a modification to our proposal, a policy that, starting in 2025, RHCs and FQHCs will report the individual CPT and HCPCS codes that describe care coordination services instead of the single HCPCS code G0511. We are also allowing for a transition period of six-months, to at least until July 1, 2025, to enable those RHCs/FQHCs to be able to update their billing systems. We are also finalizing a policy that permits billing of the add-on codes associated with these services. This will improve payment accuracy for RHCs and FQHCs when furnishing these services and will allow beneficiaries to better understand which services (generally not furnished face-to-face) they are receiving. For 2025, we are also adopting the coding and policies regarding APCM services for RHC and FQHC payments. Under these finalized rules, payments to RHCs and FQHCs would be made at the national, non-facility, PFS amounts when the individual code is on an RHC or FQHC claim, either alone or with other payable services and payment rates. We would pay for these services in addition to the RHC All-Inclusive Rate (AIR) or FQHC prospective payment system (PPS). Payment rates would be updated annually based on the PFS amounts for these codes. RHCs and FQHCs, not eligible for MIPS, are not required to report the Value in Primary Care MVP to meet the performance measurement requirement.

We also sought comment on the payment policy for care coordination services, to gather feedback on how we can improve the transparency and predictability regarding which HCPCS codes are eligible for this policy, and we plan to evaluate the comments received for potential future rulemaking.

Telecommunication Services in RHCs and FQHCs

We are finalizing a policy clarification to continue to allow direct supervision via interactive audio and video telecommunications and to extend the definition of “immediate availability” as including real-time audio and visual interactive telecommunications (excluding audio-only) through December 31, 2025. We are also finalizing a policy to allow payment, on a temporary basis, for non-behavioral health visits furnished via telecommunication technology under the methodology that has been in place for these services during and after the COVID-19 PHE through December 31, 2024. Specifically, under our finalized policy, RHCs and FQHCs can continue to bill for RHC and FQHC services furnished using telecommunication technology by reporting HCPCS code G2025 on the claim, including services furnished using audio-only communications technology through December 31, 2025. For payment for non-behavioral health visits furnished via telecommunication technology in CY 2025, we will calculate the payment amount based on the average amount for all PFS telehealth services on the telehealth list, weighted by volume for those services reported under the PFS.

We are finalizing a continued policy to delay the in-person visit requirement for mental health services furnished via communication technology by RHCs and FQHCs to beneficiaries in their homes until January 1, 2026.

Intensive Outpatient Program Services (IOP) in RHCs and FQHCs

We are finalizing a new payment rate when four or more services per day in the RHC and FQHC setting, in addition to the current payment amount based on only three services. We are also aligning the four or more IOP services per day payment rate with the same payment rate for four or more IOP services in hospital outpatient departments, which will be updated annually.

Payment for Preventive Vaccine Costs in RHCs and FQHCs

We are allowing RHCs and FQHCs to bill and be paid for Part B preventive vaccines and their administration at the time of service. We are finalizing that payments for these claims will be made according to Part B preventive vaccine payment rates in other settings, to be annually reconciled with the facilities’ actual vaccine costs on their cost reports. Due to the operational systems changes needed to facilitate payment through claims, we are finalizing that RHCs and FQHCs begin billing for preventive vaccines and their administration at the time of service, effective for dates of service beginning on or after July 1, 2025. The intent of this policy is to improve the timeliness of payment for critical preventive vaccine administration in RHCs and FQHCs.

Clarification for Dental Services Furnished in RHCs and FQHCs

We are clarifying that when RHCs and FQHCs furnish dental services inextricably linked to other covered medical services we would consider those services to be RHC and FQHCs services and paid under the RHC AIR methodology and FQHC PPS, respectively. We are also aligning operational requirements, including the submission of the KX modifier effective July 1, 2025. Finally, we clarify that a dental service can be billed separately from a medical visit provided on the same day, provided the dental service is inextricably linked to other covered medical services.

RHC Productivity Standards

RHCs are currently subject to productivity standards that can impact the AIR, if the productivity standards are not met. Productivity standards were first established in 1978 and updated in 1982 to help determine the average cost per patient for Medicare payment in RHCs as a cost control mechanism. Section 130 of the CAA, 2021, restructured the payment limits for RHCs beginning April 1, 2021. We believe that the productivity standards are outdated and redundant with the CAA, 2021 provisions; therefore, we are finalizing to remove these standards effective for cost reporting periods beginning on or after January 1, 2025.

Rebasing and Revising of the FQHC Market Basket

Approximately every four years, CMS rebases and revises the FQHC market basket used to update FQHC PPS payments to reflect more recent data on FQHC cost structures. CMS last rebased and revised the FQHC market basket in the CY 2021 PFS rule, where CMS adopted a 2017-based FQHC market basket. For CY 2025, CMS is finalizing to rebase and revise the FQHC market basket to reflect a 2022 base year and include changes to the market basket cost weights and price proxies. We are also finalizing to continue to apply a productivity adjustment to the 2022-based FQHC market basket percentage increase.

The final CY 2025 FQHC market basket update is 3.4%. This reflects a 4.0% increase in the 2022-based FQHC market basket, reduced by a 0.6 percentage point productivity adjustment.

RHC Conditions for Certification

CMS is finalizing changes to the RHC Conditions for Certification to increase flexibility and decrease provider burden, while also improving access to services for patients. Specifically, CMS is finalizing the proposal to explicitly require that RHCs must provide primary care services rather than being “primarily engaged” in furnishing these services, as indicated in the subregultory guidance. The revised language more closely aligns with the intent of the statute while also preserving access to primary care services in communities served by RHCs.

Additionally, CMS is finalizing the removal of “hemoglobin and hematocrit (H&H)” and “examination of stool specimens for occult blood” from the list of laboratory services that RHCs must perform directly in the regulatory text. By finalizing the removal of these requirements, CMS anticipates facilities will see a decrease in the burden associated with purchasing and maintaining the laboratory equipment and having qualified staff needed to process these tests. Alleviating these burdens will allow RHCs to focus their resources on the other services they provide, thereby, improving overall efficiency and patient care. Lastly, CMS is also finalizing updates to the regulations text for laboratory tests in RHCs to reflect modern lab techniques.

Ambulance Fee Schedule Reimbursement for Prehospital Blood Transfusion (PHBT)

For CY 2025, we are finalizing our proposal to modify the definition of ALS2 at §414.605 by adding the administration of PHBT, which now includes low titer O+ and O- whole blood transfusion therapy (WBT), packed red blood cells (PRBCs), plasma, or a combination of PRBCs and plasma. A ground ambulance transport that provides one of these PHBTs would itself constitute an ALS2 level transport.

Medicare Part B Payment for Preventive Services

For CY 2025, we are addressing two issues related to coverage and payment of the hepatitis B vaccine and its administration under Part B. Hepatitis B is a vaccine-preventable, communicable disease of the liver. In this final rule, we are expanding coverage of hepatitis B vaccinations to include individuals who have not previously received a completed hepatitis B vaccination series or whose vaccination history is unknown. This policy expansion will help protect Medicare beneficiaries from acquiring hepatitis B infection and contribute to eliminating viral hepatitis as a viral health threat in the United States.

In this rule, we clarify that a physician’s order will no longer be required for the administration of a hepatitis B vaccine under Part B, which will facilitate roster billing by mass immunizers for hepatitis B vaccine administration. Additionally, we are finalizing a policy to set payment for hepatitis B vaccines and their administration at 100% of reasonable cost in RHCs and FQHCs, separate from payment under the FQHC PPS or the RHC All-Inclusive Rate (AIR) methodology, in order to streamline payment for all Part B vaccines in those settings.

We are also finalizing a fee schedule for Drugs Covered as Additional Preventive Services (DCAPS drugs), per section 1833(a)(1)(W)(ii) of the Act. CMS has not yet covered or paid for any drugs under the benefit category of additional preventive services. CMS is finalizing policies that specify how a payment limit will be determined for DCAPS drugs. That is, we will set a payment limit according to the ASP methodology set forth in section 1847A of the Act when ASP data is available and will use alternative payment mechanisms for calculating payment limits for DCAPS drugs if ASP data is not available. We are also finalizing that we will set payment limits for the supplying and administration of DCAPS drugs that are similar to those fees for drugs paid in accordance with the ASP methodology set forth in section 1847A of the Act. Finally, we will use this same fee schedule for DCAPS drugs and any administration and supplying fee when those services are provided in RHCs and FQHCs. In RHCs and FQHCs, DCAPS drugs and any administration and supplying fee will be paid at 100% of the Medicare payment amount and will be paid on a claim-by-claim basis.

On September 30, 2024, CMS released a national coverage determination(NCD) for Pre-Exposure Prophylaxis (PrEP) to Prevent Human Immunodeficiency Virus (HIV), which established coverage of HIV PrEP drugs under Part B as additional preventive services. PrEP for HIV drugs will therefore be paid under the DCAPS fee schedule effective January 1, 2025. More information can be found at https://www.cms.gov/medicare/coverage/prep.

Expand Colorectal Cancer Screening

We are finalizing an update and expansion of coverage of colorectal cancer (CRC) screening. We are removing coverage of barium enema as a method of screening because this service is rarely used in Medicare and is no longer recommended as an evidence-based screening method. We are also expanding coverage for CRC screening to include computed tomography colonography (CTC). Finally, we are adding Medicare covered blood-based biomarker CRC screening tests as part of the continuum of screening. Like stool-based CRC screening tests, which are already in the definition of a “complete CRC Screening,” a blood-based biomarker test with a positive result will lead to a follow-on screening colonoscopy (with no beneficiary cost-sharing). We are also revising the regulation text to clarify that CRC screening frequency limitations do not apply to the follow-on screening colonoscopy in the context of “complete CRC screening.” These actions will promote access and remove barriers for much needed cancer prevention and early detection within rural communities and communities of color that are especially impacted by the incidence of CRC.

Medicare Prescription Drug Inflation Rebate Program

The Inflation Reduction Act of 2022 (IRA) (Pub. L. 117–169, enacted August 16, 2022) established new requirements under which drug companies must pay inflation rebates if they raise their prices for certain Part B and Part D drugs faster than the rate of inflation. In this final rule, CMS is codifying policies established in the revised guidance for the Medicare Part B Drug Inflation Rebate Program and Medicare Part D Drug Inflation Rebate Program^[1] collectively referred to as the “Medicare Prescription Drug Inflation Rebate Program.” Additionally, CMS is finalizing policies that include, but are not limited to, the following:

Establishing the method and process for reconciliation of a rebate amount for Part B and Part D rebatable drugs, including the circumstances that may trigger such a reconciliation.
Establishing a civil money penalty process for when a manufacturer of a Part B rebatable drug or Part D rebatable drug fails to pay the rebate amount in full by the payment deadline for such drug, for such applicable calendar quarter or applicable period, respectively.
Clarifying rebate calculations for Part B and Part D rebatable drugs in specific circumstances, including exclusion of Part B units of single-dose container or single-use package drugs subject to discarded drug refunds.

CMS also stated in the final rule that it will explore establishing a Medicare Part D claims data repository to comply with the statutory obligation for removal of 340B units from Part D drug inflation rebate calculations, starting January 1, 2026. CMS plans to continue exploring the development of detailed policies and requirements related to any such repository for future rulemaking, related to this topic and the exclusion of 340B units, starting January 1, 2026.

Electronic Prescribing for Controlled Substances (EPCS) for a Covered Part D Drug Under a Prescription Drug Plan or a Medicare Advantage Prescription Drug Plan

We are finalizing our proposal to extend the date after which prescriptions written for a beneficiary in a long-term care (LTC) facility would be included in determining the CMS EPCS Program compliance, from January 1, 2025, to January 1, 2028, and that related non-compliance actions would commence on or after January 1, 2028. EPCS improves prescriber workflow, thus, it reduces prescriber burden and increases patient safety. We are aligning CMS EPCS Program compliance calculations to the date by which the new NCPDP SCRIPT standard version 2023011, which includes three-way communication functionality that improves communication between pharmacies and LTC facilities, is required for prescribers when electronically transmitting prescriptions and prescription-related information for covered Part D drugs for Part D eligible individuals.

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[1] Medicare Part B Drug Inflation Rebate Revised Guidance: https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-revised-guidance.pdf; Medicare Part D Drug Inflation Rebate Revised Guidance: https://www.cms.gov/files/document/medicare-part-d-inflation-rebate-program-revised-guidance.pdf collectively referred to as the “revised guidance.” These revised guidance documents, published December 14, 2023, implemented policies relating to the Medicare Prescription Drug Inflation Rebate Program for 2022, 2023, and 2024. CMS also published guidance on the use of the 340B modifier to report separately payable Part B drugs and biologicals acquired under the 340B program (Revised Part B Inflation Rebate Guidance: Use of the 340B Modifier, https://www.cms.gov/files/document/revised-part-b-inflation-rebate-340b-modifier-guidance.pdf.

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HHS Finalizes Physician Payment Rule Strengthening Person-Centered Care and Health Quality Measures

Dr. M Telehealth — Mon, 04 Nov 2024 16:32:10 +0000

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced it is finalizing new policies in the calendar year (CY) 2025 Medicare Physician Fee Schedule (PFS) final rule to strengthen primary care, expand access to preventive services, and further access to whole-person care for services such as behavioral health, oral health, and caregiver training. The final rule reflects the Biden-Harris Administration’s commitment to protecting and expanding Americans’ access to quality and affordable health care.

“The Medicare physician payment final rule continues our work to strengthen primary care while also supporting preventive care and promoting better access to behavioral health care. In addition, the final rule codifies and builds on guidance to continue our ability to use rebates from drug manufacturers to strengthen Medicare”, said HHS Secretary Xavier Becerra. “This is made possible by the Biden-Harris Administration’s historic prescription drug law, the Inflation Reduction Act. This rule ensures that everyone can get health care, regardless of the color of their skin, what language they speak, or where they were born. And, it encourages more participation in the Medicare Shared Savings Program by accountable care organizations serving people in rural and underserved communities – to the benefit of millions.”

“CMS remains committed to delivering affordable, high-quality care to all Americans while continually driving innovation to help better meet the individual needs of every person with Medicare,” said CMS Administrator Chiquita Brooks-LaSure. “This final Medicare physician payment rule increases access to preventive health services, improving health care providers’ ability to identify health problems early, when they are easier to treat, and takes additional steps to support caregivers.”

In accordance with update factors specified in law, finalized average payment rates under the PFS will be reduced by 2.93% in CY 2025 compared to the average payment rates for most of CY 2024. The change to the PFS conversion factor reflects the 0% update required by statute for CY 2025, the expiration of the 2.93% temporary increase in payment amounts for CY 2024 required by statute, and a small budget neutrality adjustment necessary to account for changes in valuation for particular services. This amounts to a finalized CY 2025 PFS conversion factor of $32.35, a decrease of $0.94 (or 2.83%) from the current CY 2024 conversion factor of $33.29.

Advancing High-Quality Primary and Accountable Care

Over the last few years, CMS has taken action to support person-centered approaches to health care, which starts with strengthening primary care as a foundation of our health care system. Building on previously finalized policies that recognize the importance, time, and effort required for a primary care team to develop long-lasting relationships with patients, CMS is finalizing new coding and payment policies for advanced primary care management services that advanced primary care teams may provide, such as 24/7 access to care and care plan development. The codes for these services are stratified based on patient medical and social complexity. Overall, these policies incorporate lessons learned over the last decade of Innovation Center value-based primary care models, and as such, these finalized codes also represent the beginnings of a new permanent pathway towards accountable care in the PFS.

“Whole-person care means moving towards a health care system that recognizes the impact of each unique aspect of a person on their wellbeing. From physical, behavioral, and oral health to social determinants of health and caregiving supports, whole-person care necessitates looking at how all of these aspects together impact someone’s care journey. It all starts with a foundation of primary care that can integrate these components together,” said Meena Seshamani, M.D. Ph.D., Deputy CMS Administrator and Director of CMS’ Center for Medicare. “With this final rule, we are also taking lessons learned from numerous CMS Innovation Center models to strengthen primary care teams and accountable care organizations, allowing them to better meet the unique needs of every person with Medicare.”

Additionally, evaluation results from the Innovation Center’s Million Hearts® model demonstrated that payment for cardiovascular risk assessment and cardiovascular care management led to fewer deaths related to cardiovascular disease and significant reductions in heart attacks and strokes. Informed by these results, CMS is finalizing new payment and coding policies for these services to better assess and manage heart health.

CMS is continuing steps to further strengthen the Medicare Shared Savings Program (Shared Savings Program), which is Medicare’s permanent Accountable Care Organization (ACO) program. For the first time, CMS will allow eligible ACOs with a history of success in the program to receive an advance on their earned shared savings. This will encourage ACO investment in staffing, health care infrastructure, and certain additional services for people with Medicare, such as dental, vision, hearing, healthy meals, and transportation. CMS is also adopting a health equity benchmark adjustment to further incentivize participation in the Shared Savings Program by ACOs that serve people with Medicare and Medicaid from rural and underserved communities.

Further, CMS is finalizing a methodology for adjustments to account for the impact of improper payments when reopening an ACO’s shared savings and shared losses calculations, and to mitigate the impact of significant, anomalous, and highly suspect (SAHS) billing activity in CY 2024 or subsequent calendar years on annual ACO financial reconciliation. This action complements the Medicare Shared Savings Program SAHS Billing Activity Final Rule issued on September 24, 2024, and will improve the accuracy, fairness, and integrity of Shared Savings Program financial calculations, while also recognizing ACOs as a partner in the identification of anomalous and highly suspect billing and improper payments.

Finally, the CMS Quality Payment Program’s Merit-based Incentive Payment System (MIPS) is a program that rewards Medicare practitioners for improving the quality of patient care and outcomes. In its commitment to continue increasing high-quality care for individuals with Medicare, CMS is finalizing the addition of six new MIPS Value Pathways that address: ophthalmology, dermatology, gastroenterology, pulmonology, urology, and surgical care.

Increasing Access to Behavioral Health, Oral Health, and Caregiver Training Services

CMS is finalizing several impactful additions in this year’s final rule to increase access to services that better meet the needs of the whole person, building on policies established in previous years.

To improve access to behavioral health, CMS is, for the first time, finalizing new coding and payment for U.S. Food & Drug Administration (FDA)-cleared digital mental health treatment devices, safety planning interventions that can help prevent suicides and overdoses, and services to better integrate behavioral health with primary care. This final rule is also improving access to crucial services in Opioid Treatment Programs, such as social determinants of health assessments, coordinated care and referral services, patient navigational services, and peer recovery support services.

In this year’s rule, CMS is finalizing that payment can be made for certain dental services associated with dialysis services for the treatment of end-stage renal disease, building on the clinical scenarios identified in previous years, including for persons undergoing chemotherapy, head and neck cancer treatment, and transplantation. CMS is also finalizing new payment for caregiver training services related to direct care services and supports, as well as new policies that will allow caregiver training services to be provided virtually, further supporting caregivers consistent with the Biden Administration Executive Order on Caregiving.

Removing Barriers to Covered Preventive Services: Hepatitis B Vaccinations, Colorectal Cancer Screening, and Pre-Exposure Prophylaxis (PrEP) to Prevent Human Immunodeficiency Virus (HIV)
Preventive health care is key to detecting health problems early, preventing certain diseases, and living longer, healthier lives. CMS is finalizing a coverage expansion of the hepatitis B vaccine for people with Medicare who have not received the hepatitis B vaccine or whose vaccination status is unknown, at no cost to the individual. This policy enables people with Medicare to get the hepatitis B vaccine from pharmacies and also allows pharmacies and mass immunizers to roster bill Medicare consistent with current billing for flu, pneumococcal, and COVID-19 vaccines.

CMS is also updating and expanding coverage of colorectal cancer screening to promote access and remove barriers for much needed cancer prevention and early detection, especially within rural communities and communities of color. Finally, CMS finalized payment under Part B as an additional preventive service for Pre-Exposure Prophylaxis (PrEP) to Prevent Human Immunodeficiency Virus (HIV), following the National Coverage Determination released in September. More information can be found at https://www.cms.gov/medicare/coverage/prep.

Preserving Telehealth Flexibilities

Under current law, the temporary extension of flexibilities related to payment for many telehealth services is scheduled to expire at the end of 2024. This final rule reflects CMS’ goal to preserve some important, but limited, flexibilities in our authority, and expand the scope of and access to telehealth services where appropriate. Through today’s final rule, CMS is continuing to permit certain practitioners to provide direct supervision via a virtual presence of auxiliary personnel, when required, virtually through immediate availability via real-time, audio-video technology. CMS is also finalizing temporary extensions to allow teaching physicians to be present virtually when they furnish telehealth services involving residents in teaching settings.

Absent Congressional action, beginning January 1, 2025, the statutory limitations that were in place for Medicare telehealth services prior to the COVID-19 PHE will retake effect for most telehealth services. These include geographic and location restrictions on where the services are provided, and limitations on the scope of practitioners who can provide Medicare telehealth services. After that date, people with Medicare generally will need to be located in a medical facility in a rural area to receive most Medicare telehealth services, with a notable exception for behavioral health telehealth services which can continue to be provided in the patient’s home.

Implementation of the Inflation Reduction Act
The Inflation Reduction Act, the Biden-Harris Administration’s prescription drug law, discourages runaway price increases by drug companies by requiring them to pay rebates to Medicare when they increase prices faster than the rate of inflation for certain drugs covered under Part B and Part D. In this year’s final rule, CMS is codifying and building on established guidance to continue implementation of the inflation rebates and the next phase of implementation.

For a fact sheet on the CY 2025 Physician Fee Schedule final rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2025-medicare-physician-fee-schedule-final-rule

For a fact sheet on final changes to the CY 2025 Quality Payment Program, please visit: https://qpp-cm-prod-content.s3.amazonaws.com/uploads/3057/2025-QPP-Policies-Final-Rule-Fact-Sheet.pdf

For a fact sheet on final changes to the Medicare Shared Savings Program in the CY 2025 PFS final rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2025-medicare-physician-fee-schedule-final-rule-cms-1807-f-medicare-shared-savings

For a fact sheet on the final changes to the Medicare Prescription Drug Inflation Rebate Program changes in the CY 2025 PFS final rule, please visit: https://www.cms.gov/inflation-reduction-act-and-medicare/inflation-rebates-medicare

To view the CY 2025 Physician Fee Schedule final rule, please visit: https://www.federalregister.gov/public-inspection/2024-25382/medicare-and-medicaid-programs-calendar-year-2025-payment-policies-under-the-physician-fee-schedule

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Calendar Year (CY) 2025 Home Health Prospective Payment System Final Rule Fact Sheet (CMS-1803-F)

Dr. M Telehealth — Mon, 04 Nov 2024 16:27:54 +0000

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) final rule, which updates Medicare payment policies and rates for Home Health Agencies (HHAs). This rule also updates the intravenous immune globulin (IVIG) items and services’ payment rate for CY 2025 for Durable Medical Equipment (DME) suppliers. As described further below, CMS estimates that Medicare payments to HHAs in CY 2025 would increase in the aggregate by 0.5%, or $85 million, compared to CY 2024.

This rule finalizes a permanent prospective adjustment of -1.975% (half of the calculated permanent adjustment of -3.95%) to the CY 2025 home health payment rate to account for the impact of implementing the Patient-Driven Groupings Model (PDGM). This adjustment, which is required by the Bipartisan Budget Act of 2018 and amended section 1895(b) of the Social Security Act, accounts for differences between assumed behavior changes and actual behavior changes on estimated aggregate expenditures due to the CY 2020 implementation of the PDGM and the change to a 30-day unit of payment. For CY 2023 and CY 2024, CMS previously applied a 3.925% reduction and a 2.890% reduction, respectively, which were half of the estimated required permanent adjustments.

In addition, CMS is finalizing a crosswalk for mapping responses on the current Outcome and Assessment Information Set-E (OASIS-E) to the prior OASIS-D responses for use in the methodology to analyze the difference between assumed and actual behavior changes on estimated aggregate expenditures; recalibrated PDGM case-mix weights; and updated low-utilization payment adjustment (LUPA) thresholds, functional impairment levels, and comorbidity adjustment subgroups. CMS is also finalizing and adopting the most recent Office of Management and Budget (OMB) Core-Based Statistical Area (CBSA) delineations for the home health wage index; an occupational therapy (OT) LUPA add-on factor and updated physical therapy (PT), speech-language pathology (SLP), and skilled nursing (SN) LUPA add-on factors; and an updated CY 2025 fixed-dollar loss ratio (FDL) for outlier payments. Additionally, this rule finalizes the rate update for the CY 2025 intravenous immune globulin (IVIG) items and services’ payment under the IVIG benefit. Furthermore, CMS is finalizing updates to the HHA Conditions of Participation (CoPs) to reduce avoidable care delays by helping ensure that referring entities and prospective patients can select the most appropriate HHA based on their care needs.

The actions CMS is taking in this final rule will help improve patient care and protect the Medicare program’s sustainability for future generations.

CY 2025 Payment and Policy Updates for Home Health Agencies

This rule finalizes routine, statutorily required updates to the home health payment rates for CY 2025. The CY 2025 updated rates include the final CY 2025 home health payment update of 2.7% ($445 million increase), which is offset by an estimated 1.8% decrease that reflects the permanent behavior adjustment ($295 million decrease) and an estimated 0.4% decrease that reflects the updated FDL ($65 million decrease). CMS estimates that Medicare payments to HHAs in CY 2025 would increase in the aggregate by 0.5%, or $85 million, compared to CY 2024, based on the finalized policies.

PDGM and Behavior Assumptions
On January 1, 2020, CMS implemented the home health PDGM and a 30-day unit of payment, as required by section 1895(b) of the Social Security Act, as amended by the Bipartisan Budget Act of 2018. The PDGM better aligns payments with patient care needs, especially for clinically complex individuals. The law requires CMS to make assumptions about behavior changes that could occur because of the 30-day unit of payment and the PDGM. CMS finalized three behavior assumptions in the CY 2019 HH PPS final rule: clinical group coding, comorbidity coding, and LUPA threshold. The law also requires CMS to annually determine the impact of differences between assumed behavior changes and actual behavior changes on estimated aggregate expenditures, beginning with 2020 and ending with 2026, and to make temporary and permanent increases or decreases, as needed, to the 30-day payment amount to offset such increases or decreases. Additionally, in the CY 2019 HH PPS final rule (83 FR 56455), CMS stated that we interpret actual behavior change to encompass both behavior changes that were previously outlined, as assumed by CMS when determining the budget-neutral 30-day payment amount for CY 2020, and other behavior changes not identified at the time the 30-day payment amount for CY 2020 was determined.

In the CY 2023 HH PPS final rule (87 FR 66790), CMS finalized a methodology for analyzing the impact of the differences between assumed and actual behavior changes on estimated aggregate expenditures and calculated levels of actual and estimated aggregate expenditures. Based on analyses of CYs 2020 and 2021 claims data, CMS determined a permanent adjustment was needed and finalized implementing half (-3.925%) of the permanent adjustment estimated at the time (7.85%).

In the CY 2024 HH PPS final rule (88 FR 77676), using CY 2022 claims and the finalized methodology, CMS determined that an additional permanent adjustment needed to be applied and finalized implementing half (-2.890%) of the permanent adjustment estimated at the time (5.779%). This estimated permanent adjustment necessary for CY 2024 included the remaining -3.925% (to account for CYs 2020 and 2021) that was not applied to the CY 2023 payment rate.

For the CY 2025 HH PPS final rule, using CY 2023 claims and the methodology finalized in the CY 2023 HH PPS final rule, CMS determined that Medicare is still paying more under the new system than it would have under the old system. We determined a total permanent behavior adjustment of -3.95% is needed to be applied to the 30-day base payment rate to account for overpayments in CY 2023, as well as the remaining adjustment of 2.890% that CMS delayed finalizing in CY 2024. However, in response to commenter concerns that this would impose too large a reduction in a single year, we are finalizing only half of the adjustment (1.975%) to the CY 2025 payment rate. This adjustment will continue to satisfy the statutory requirements at section 1895(b)(3)(D) of the Act to offset any increases or decreases resulting from the impact of differences between assumed behavior and actual behavior changes on estimated aggregate expenditures, reduce the need for any future large permanent behavior adjustments, and help slow the accrual of the temporary payment adjustment amount. The final permanent behavior adjustment is also anticipated to lessen any potential temporary adjustments in future years. While we did not propose to implement a temporary behavior adjustment in CY 2025, the final rule does provide the calculated temporary behavior adjustment dollar amount (approximately $971 million) based on analysis of CY 2023 claims. The law provides CMS the discretion to make any future permanent or temporary behavior adjustments in a time and manner determined appropriate through analysis of estimated aggregate expenditures through CY 2026.

Crosswalk for Mapping OASIS-D Data Elements to The Equivalent OASIS-E Data Elements
The Outcome and Assessment Information Set (OASIS)-D was the home health assessment instrument used under the prior 153-group system and the first three years (CYs 2020-2022) of the current PDGM. However, the Office of Management and Budget (OMB) approved an updated version of the OASIS instrument, OASIS-E, on November 30, 2022, effective January 1, 2023 (OMB-control number 0938-1279). To accurately determine payments under the 153-group system, we use the October 2019 3M Home Health Grouper (v8219) to assign a Health Insurance Prospective Payment System (HIPPS) code to each simulated 60-day episode of care. This older version of the Home Health Grouper requires responses from OASIS-D. Therefore, to continue with the methodology, CMS will need to impute responses for the three items from OASIS-D that have changed in the OASIS-E. Additionally, 13 items on the OASIS-E are no longer required to be asked at a follow-up visit. For these items, we can use the most recent Start of Care or Resumption of Care assessment (SOC/ROC) to determine a response, which would not require imputation. We are finalizing a crosswalk to address this issue by mapping the OASIS-E items back to the OASIS-D in this final rule.

Final OT LUPA Add-on Factor and LUPA Add-on Factor Updates
With sufficient recent claims data available, and to establish equitable compensation for all home health services, CMS proposed to establish a definitive occupational therapy (OT) specific LUPA add-on factor and discontinue the temporary use of the physical therapy (PT) LUPA add-on factor as a proxy. We are finalizing the establishment of the OT LUPA add-on factor with the same methodology used to establish the skilled nursing (SN), physical therapy (PT), and speech-language pathology (SLP) LUPA add-on factors, as described in the CY 2014 HH PPS final rule. The final OT LUPA add-on factor is 1.7238, to be used when that discipline is the first skilled visit in a LUPA episode that occurs as the only episode or an initial episode in a sequence of adjacent episodes.

Additionally, we are finalizing updates to the SN, PT, and SLP LUPA add-on factors to more accurately reflect current health care practices and costs, by using recent claims through CY 2023. The SN, PT, and SLP LUPA add-on factors are 1.7200, 1.6225, and 1.6696, respectively.

Recalibration of PDGM Case-Mix Weights
Each of the 432 payment groups under the PDGM has an associated case-mix weight and LUPA threshold. CMS’ policy is to annually recalibrate the case-mix weights and LUPA thresholds using the most complete utilization data available at the time of rulemaking. In this final rule, CMS is finalizing the recalibrated case-mix weights — including the functional levels and comorbidity adjustment subgroups — and LUPA thresholds using CY 2023 data to more accurately pay for the types of patients HHAs are serving.

Wage Index Update
This rule finalizes an update to the home health wage index and adopts the new labor market delineations from the July 21, 2023, OMB Bulletin No. 23-01 based on data collected from the 2020 Decennial Census. The July 21, 2023, OMB Bulletin No. 23-01 contains several significant changes. It is standard practice to adopt the latest OMB update when available, as using the most recent OMB statistical area delineations results in a more accurate and up-to-date payment system that reflects the reality of population shifts and labor market conditions. For example, there are new CBSAs, urban counties that have become rural, rural counties that have become urban, and existing CBSAs that have been split. We note that existing home health PPS regulations limit one-year wage index decreases to 5%, which will help mitigate the impact of CBSA changes on payment.

Home Health Conditions of Participation (CoPs) Updates

CMS is finalizing updates to the HHA CoPs to reduce avoidable care delays by helping ensure that referring entities and prospective patients can select the most appropriate HHA based on their care needs. CMS is finalizing a new standard that requires HHAs to develop, implement, and maintain, through an annual review, a patient acceptance-to-service policy that is applied consistently to each prospective patient referred for home health care. We are finalizing a requirement that the policy must address, at a minimum, the following criteria related to the HHA’s capacity to provide patient care: the anticipated needs of the referred prospective patient, the HHA’s caseload and case mix, the HHA’s staffing levels, and the skills and competencies of the HHA staff. This final rule does not prevent HHAs from maintaining their existing acceptance-to-service policies; rather, it is intended to complement them. Additionally, CMS is finalizing that HHAs must make available to the public accurate information regarding the services offered by the HHA and any service limitations related to types of specialty services, service duration, or service frequency. The HHA must review this information as frequently as the services are changed, but no less often than annually.

Home Health (HH) Quality Reporting Program (QRP) Updates

CMS is finalizing four new items as standardized patient assessment data elements in the social determinants of health (SDOH) category and modifying one item collected as a standardized patient assessment data element in the SDOH category, beginning with the CY 2027 HH QRP via the OASIS. The four assessment items are: one living situation item, two food items, and one utilities item. In addition, CMS is modifying the current transportation item beginning with the CY 2027 HH QRP via the OASIS instrument.

CMS is also changing all-payer data collection to begin with the start of care OASIS data collection timepoint instead of the discharge timepoint.

Expanded Home Health Value-Based Purchasing (HHVBP) Model

Request for Information (RFI) on Future Performance Measure Concepts for the Expanded HHVBP Model
This final rule summarizes comments received on a summary of responses to RFI that will build on input from the Expanded Home Health Value-Based Purchasing (HHVBP) Model’s Implementation and Monitoring technical expert panel (TEP), which met in November 2023. Discussions included potential future measure concepts that could fill measurement gaps in the expanded HHVBP Model. These include function measures complementing the existing cross-setting Discharge (DC) Function measure. These measures include care activities like bathing and dressing, which are important for home health patients and caregivers but are not included in the DC Function measures. Based on TEP feedback, CMS may also consider adding the existing Medicare Spending per Beneficiary measure in future rulemaking. Other potential areas for measure development activities discussed with the TEP include family caregiver status and claims-based falls with major injuries. We will share a summary of the comments with the TEP.

Health Equity Update
CMS is including an update on health equity, affirming our commitment to meaningfully advance health equity in the expanded HHVBP Model. As we move this important work forward, we will continue to take input from home health stakeholders and monitor the application of proposed health equity policies across CMS initiatives, such as proposed payment adjustments in the Hospital and SNF Value-Based Purchasing Programs. We have summarized the comments received and will share them with the TEP.

Long-Term Care (LTC) Facility Acute Respiratory Illness Data Reporting

CMS is finalizing a new data reporting standard to address a broader range of acute care respiratory illnesses. Beginning on January 1, 2025, LTC facilities are required to electronically report information about COVID-19, influenza, and respiratory syncytial virus (RSV) in a standardized format and frequency specified by the Secretary. This new standard replaces the current COVID-19 reporting standards for LTC facilities that sunset in December 2024. CMS is finalizing that the new data elements for which reporting will be required include facility census; resident vaccination status for COVID-19, influenza, and RSV; confirmed resident cases of COVID-19, influenza, and RSV (overall and by vaccination status); and hospitalized residents with confirmed cases of COVID-19, influenza, and RSV (overall and by vaccination status). CMS continues to believe that sustained data collection and reporting of respiratory illnesses outside of emergencies will help LTC facilities gain important insights related to their evolving infection control needs.

We are also finalizing that, in the event of a declared national public health emergency (PHE) for an acute respiratory illness, there may be additional categories or reporting required, such as: reporting data up to a daily frequency and additional or modified data elements relevant to the PHE — including but not limited to relevant confirmed infections, supply inventory shortages, staffing shortages, and relevant medical countermeasures and therapeutic inventories.

Medicare Provider Enrollment

CMS is adding providers and suppliers that are reactivating their Medicare billing privileges to the categories of new providers and suppliers subject to a provisional period of enhanced oversight (PPEO). CMS may impose a PPEO for 30 days to one year for new providers and suppliers. The goal of a PPEO is to reduce and prevent fraud, waste, and abuse. During a PPEO, CMS may, among other things, conduct prepayment medical review and cap payments. CMS can apply a PPEO to new providers or suppliers, which are defined as providers or suppliers that are: (1) newly enrolling; (2) undergoing a change of ownership under 42 CFR § 489.18; and/or (3) undergoing a 100% change of ownership via a change of information. This final rule adds reactivating providers and suppliers as another category of new providers and suppliers subject to a PPEO.

Resources

For additional information about the Home Health Prospective Payment System, visit: https://www.cms.gov/medicare/medicare-fee-for-service-payment/homehealthpps and https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.

For additional information about the Home Health Patient-Driven Groupings Model, visit https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.

For additional information about the expanded Home Health Value-Based Purchasing Model, visit: https://innovation.cms.gov/innovation-models/expanded-home-health-value-based-purchasing-model.

The final rule can be downloaded from the Federal Register at: https://public-inspection.federalregister.gov/2024-25441.pdf.

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CMS 2025 Physician Fee Schedule Proposed Rule: What PAs Need to Know

Dr. M Telehealth — Mon, 05 Aug 2024 15:37:08 +0000

AAPA Reimbursement Team
August 2, 2024

The Centers for Medicare and Medicaid Services (CMS), the federal agency that oversees the Medicare program, released the 2025 Physician Fee Schedule (PFS) proposed rule. The rule updates numerous Medicare coverage and payment policies that impact PAs, physicians, and other health professionals.

This year’s rule made no mention of any change to the Split (or Shared) Visit billing policies implemented in last year’s rule, suggesting the finalized policy from the 2024 fee schedule will remain in place. Some of the key provisions of the 2025 proposed rule are highlighted below. If finalized, all provisions would take effect on January 1, 2025, unless otherwise noted.

Telehealth

Due to statutory expirations, CMS is unable to further extend geographic or site of service telehealth flexibilities that were originally implemented in response to the COVID-19 public health emergency. Consequently, if Congress does not act, as of January 1, 2025, Medicare beneficiaries who wish to receive non-behavioral telehealth services will need to be in a rural area, as well as located in certain medical settings.

Despite this, CMS is extending various telehealth flexibilities within their purview. These include the suspension of frequency limitations for subsequent inpatient and skilled nursing facility visits, as well as critical care consultations provided by telehealth. CMS proposes a permanent authorization to use two-way, real-time, audio-only communication technology when a telehealth service is furnished to a beneficiary in their home (in those instances when the home is deemed a permissible originating site) and to provide direct supervision by electronic means for a subset of lower-risk services. CMS proposes to prolong the flexibility for a distant site practitioner to use a currently enrolled practice address, in lieu of their home address, when providing telehealth services from home and allow Federally Qualified Health Centers and Rural Health Clinics to meet direct supervision requirements virtually.

Advanced Primary Care Management

CMS is proposing to establish codes and make payment for Advanced Primary Care Management (APCM) services furnished by healthcare professionals who would take responsibility for all a beneficiary’s primary care and be the continuing focal point for all needed healthcare services in a calendar month. Participating health professionals would be required to provide certain benefits and meet certain capability requirements. APCM services would fall under one of three G-codes representing three different payment levels that would be based on the clinical complexity and income/resource level of the patient. Participating health professionals would also submit data to measure performance.

Global Surgical Code Modifiers

CMS is proposing to utilize three existing transfer of care modifiers (modifiers 54, 55, and 56) to identify when someone provides care for only one portion (pre-operative, procedure, or post-operative) of a 90-day global surgical service. CMS is also proposing that, for the 2025 calendar year, an add-on code may be used by those practitioners who provide follow-up outpatient/office E/M visits for post-op care during the global period, and who is not affiliated with the practitioner who performed the procedure. This add-on code would only be able to be billed once per 90-day global period.

Prepaid Shared Savings

CMS is proposing multiple changes to the Medicare Shared Savings Program. One such change is that, starting in January 2026, the agency would allow Accountable Care Organizations with a history of earning shared savings, to access advanced payments for shared savings to make investments, such as for staffing and infrastructure, and to provide additional direct services to beneficiaries. At least 50% of these prepaid shared savings would be required to be spent on direct patient services.

Continued Medicare Conversion Factor Cuts

The conversion factor is scheduled to be reduced by nearly 2.8%, from $33.29 to $32.36, for 2025. This payment reduction is primarily due to the expiration of the 2.93% payment increase provided by Congress for 2024, as well as a .05% positive budget neutrality adjustment. AAPA is working in coordination with medical societies and other health professional groups advocating for Congress to intervene and eliminate the projected payment cuts.

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CMS Finalizes Physician Fee Schedule, with ACO Changes Relevant to Nursing Homes

Dr. M. Rosen — Fri, 03 Nov 2023 15:29:14 +0000

The Centers for Medicare & Medicaid Services (CMS) aims to further advance its overall value-based care strategy with the finalized 2024 Medicare Physician Fee Schedule (PFS) – adding ways for medically complex, high-cost beneficiaries like those in nursing homes to participate in Medicare Shared Savings Programs (MSSPs).

Additionally, CMS therapy assistants can be more generally supervised for remote therapeutic monitoring services with changes in the PFS for 2024.

The agency also finalized its proposal to make payment when practitioners train caregivers to support patients with certain diseases, including dementia, when carrying out a treatment plan in 2024.

“Medicare will 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) as part of the patient’s individualized treatment plan or therapy plan of care,” CMS said.

The PFS was finalized late Thursday, with payment amounts reduced by 1.25% overall compared to 2023. CMS is also finalizing increases in payment for visits for many services, such as primary and longitudinal care. Overall, the finalized 2024 PFS conversion factor is $32.74, a decrease of $1.15, or 3.4%, from CY 2023.

The rule involves numerous updates to accountable care organizations (ACOs), including financial benchmarking methodology for ACOs starting in January 2024 and subsequent years. There will now be a cap to risk score growth in an ACO’s regional service area.

The same risk adjustment methodology will be applied to benchmark and performance years, eliminating overall negative regional adjustment. CMS hopes this will encourage ACO participation by providers caring for medically complex, high-cost beneficiaries.

“We are finalizing our proposal to modify the calculation of the regional component of the three-way blended benchmark update factor (weighted one-third [Accountable Care Prospective Trend], and two-thirds national-regional blend), for agreement periods beginning on January 1, 2024, and in subsequent years,” according to a statement from the agency.

Such broadened criteria and an attractive high needs population track may be a major draw for those in the skilled nursing space, leaders said in October.

CMS anticipates this change will improve accuracy of regional update factors, if an ACO operates in an area with high-risk growth. The move also maintains a disincentive against coding intensity for ACOs with high market share.

“We sought to reduce the impact of negative regional adjustments in several ways for agreement periods beginning on January 1, 2024, and subsequent years, to incentivize ACOs that serve high-cost beneficiaries to join or continue to participate in the Shared Savings Program,” the agency said in a statement. “ACOs that would have had an overall negative regional adjustment under the methodology adopted in the CY 2023 PFS final rule will benefit from this policy.”

Potential future developments to MSSP policies include incorporating a higher risk track than the ENHANCED track, modifying the amount of prior savings adjustment and potential refinements to the Accountable Care Prospective Trend.

While advocacy groups like the National Association of ACOs (NAACOS) appreciated the agency’s efforts to engage more high risk beneficiaries, there was disappointment that “several favorable policies only apply to new or renewing ACOs in 2024, leaving out existing ACOs,” NAACOS President and CEO Clif Gaus said in a statement.

The agency hopes these changes will increase MSSP participation by 10% to 20%.

ACO beneficiary assignment methodology added a third step as well to provide greater recognition of the role of nurse practitioners, physician assistants and clinical nurse specialists in delivering primary care services.

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CMS Releases CY 24 Medicare Physician Fee Schedule Proposed Rule

Dr. M. Rosen — Thu, 27 Jul 2023 18:33:05 +0000

The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1784-P) Proposed Rule, which includes proposals related to Medicare physician payment and the Quality Payment Program (QPP).
The Proposed Rule includes several health equity-focused coding and payment proposals for new services to help underserved communities and a number of new behavioral health provisions to expand access to care.
The Proposed Rule is open for a 60-day comment period that will close on Sept. 11, 2023. The Final Rule with comment is expected to be issued in early November 2023.

The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1784-P) Proposed Rule, which includes proposals related to Medicare physician payment and the Quality Payment Program (QPP).

The Proposed Rule, released on July 13, 2023, includes several health equity-focused coding and payment proposals for new services to help underserved communities. These include certain caregiver training programs, separate coding and payment for community health integration services, payment for principal illness navigation services, and coding and payment for social determinants of health risk assessments.

The Proposed Rule also includes payments for certain dental services before and during different cancer treatments, including chemotherapy. The agency also proposed several new behavioral health provisions to expand access to care. Marriage and family therapists and mental health counselors can enroll in Medicare and bill for their services for the first time.

For its Medicare Shared Savings Program (MSSP), CMS proposed new changes to promote whole-person care, including revisions to Accountable Care Organization (ACO) assignment methodology and financial benchmarking methodology.

In addition, the rule proposes delaying the implementation of a new policy under which the payment rate for split (or shared) evaluation and management visits would be based on the amount of time spent by the billing practitioner. The agency has also proposed the extension of several telehealth provisions, such as reimbursement at nonfacility rates for certain telehealth services in a patient’s home.

The Proposed Rule is open for a 60-day comment period that will close on Sept. 11, 2023. The Final Rule with comment is expected to be issued in early November 2023.

To learn more about the Medicare Physician Fee Schedule Proposed Rule, review the following resources

Key Proposals of Note

Notable proposals made by CMS in the rule include:

extending flexibilities to permit split/shared evaluation and management (E/M) visits to be billed based on one of three components (history, exam or medical decision-making) or time through at least 2024
amending the list of telehealth practitioners to recognize marriage and family therapists and mental health counselors as telehealth practitioners, effective Jan. 1, 2024
reimbursing telehealth services furnished to patients in their homes at the typically higher, nonfacility progression-free survival (PFS) rate
continuing to allow direct supervision by a supervising practitioner through real-time audio and video interaction telecommunications through 2024, including for Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs)
continuing coverage and payment of telehealth services included on the Medicare Telehealth Services List through 2024
causing implementation and rescinding the Appropriate Use Criteria program regulations
increasing the performance threshold from 75 points to 82 points for all three Merit-Based Incentive Payment System (MIPS) reporting options
adding five new MIPS Value Pathways related to women’s health, prevention and treatment of infectious disease, quality care in mental health/substance use disorder, quality care for ear, nose and throat, and rehabilitative support for musculoskeletal care

Conversion Factor

CMS proposes an MPFS conversion factor (CF) of $32.75 for CY 2024, a 3.34 percent decrease from the current CF of $33.89. This reduction is due to a 2.18 percent decrease to maintain budget neutrality, which is partially offset by a 1.25 percent increase from the Consolidated Appropriations Act of 2023 (CAA). The original CY 2023 CF was $33.06 but increased to $33.89 from the CAA. The 3.34 percent decrease represents the difference between the proposed $32.75 CF and CY 2023 $33.89 CF. Table 104 in the Proposed Rule shows the impact by specialty, which varies based on several factors. Notably, the table does not reflect a statutory fix that decreased this year. Thus, the actual impact on specialties would be approximately 1.25 percent lower than what is shown in Table 104. Specialties that are negatively impacted include anesthesiology, interventional radiology, radiology, vascular and thoracic surgery, physical/occupational therapy and audiology.

Determination of Practice Expense Relative Value Units (RVUs)

CMS did not receive new wage data or other information for use in clinical labor pricing prior to the CY 2024 Proposed Rule, and thus proposes that CY 2024 clinical labor pricing be based upon CY 2023 pricing. For the second year, CMS seeks public comment on strategies to update practice expense data collection and methodology.

Add-On Complexity Code

Starting Jan. 1, 2024, CMS proposes a separate add-on payment for healthcare common procedure coding system (HCPCS) code G2211. The add-on code is designed to capture resource costs associated with E/M visits for primary care and longitudinal care of complex patients. The add-on code will generally be available for outpatient office visits. CMS estimates that, if the add-on code is finalized, it will have redistributive effects for all other 2024 payments. CMS finalized this policy in 2021, but Congress suspended its use and prohibited CMS from implementing it before 2024. Hence, CMS proposes implementing the policy this year, but with refinements that would result in a less significant negative budget neutrality adjustment.

The agency states that the code will not be payable when an office visit is reported with modifier 25 or bundled with another service. Also, the code “would not be appropriately reported, such as when the care furnished during the [office] E/M visit is provided by a professional whose relationship with the patient is of a discrete, routine, or time-limited nature,” the agency states, offering examples including “treatment of a simple virus; for counseling related to seasonal allergies; initial onset gastroesophageal reflux disease; treatment for a fracture; and where comorbidities are either not present or not addressed.”

CMS proposes coding and payment changes to account for the resources involved in a multidisciplinary team of clinical staff and other auxiliary personnel furnishing services. To accurately identify and value this work, CMS proposes separate payments for:

Community Health Integration Services HCPCS Codes GXXX1 and GXXX2
Social Determinants of Health (SDOH) Risk Assessment HCPCS code GXXX5
Principal Illness Navigation (PIN) Services HCPCS codes GXXX3 and GXXX4

Community Health Integration services address unmet SDOH needs that affect a patient’s diagnosis and treatment. Principal Illness Navigation services assist Medicare beneficiaries diagnosed with high-risk conditions like cancer and substance use disorder by matching them with appropriate clinical resources. The Proposed Rule also clarifies that community health workers, care navigators, peer support specialists and other auxiliary personnel may be employed by community-based organizations (CBOs) so long as the requisite supervision and billing requirements are met.

CMS also proposes coding and payment for SDOH risk assessments to account for the time and resources practitioners spend on these assessments that may impact patient care. The Proposed Rule recommends making the SDOH assessment optional in a patient’s annual wellness visit.

Split/Shared Services E/M Visits

Under Medicare, a service can only be billed by one clinician, and if non-physician practitioners bill for a service, they only receive 85 percent of the total Medicare rate. The primary issue around split/shared services is deciding who provides the “substantive” portion of the service and can therefore bill for it. In the CY 2022 MPFS final rule, CMS created a policy that provided some flexibility for how that decision could be made. Specifically, the clinician who performed the history and physical exam, the clinician who performed the medical decision-making or the clinician who spent more than half of the total time spent with the patient could be selected as the clinician who provided the substantive portion of the split/shared service. In the future, however, CMS planned only to allow the third option (time) to be used to determine the substantive portion of a split/shared service. Last year, CMS delayed the transition to time-only until 2024.

CMS is again proposing to delay the implementation of changes to how split/shared E/M visits are billed. CMS intends to modify the definition of “substantive portion” to mean more than half of the total time of the visit, but those changes may now be delayed until at least Jan. 1, 2025. CMS plans to maintain current split billing rules, which means the billing provider needs to perform one of the three key components (history, exam or medical decision-making) or spend more than half of the total time performing the split visit.

Telehealth Extensions

The Proposed Rule implements all telehealth provisions extended through the end of 2024 by the Consolidated Appropriations Act of 2023. This includes:

lifting geographic restrictions and maintaining the expanded list of originating sites, including a patient’s home
expanding the list of distant site practitioners to include physical therapists (PTs), occupational therapists (OTs), speech language pathologists (SLPs) and audiologists. Marriage and family therapists (MFTs) and mental health counselors (MHCs) will be recognized as telehealth practitioners effective Jan. 1, 2024
extending telehealth to FQHCs and RHCs
delaying until Jan. 1, 2025, the required in-person visit for telehealth mental health services
extending audio-only telehealth

Revised Process for Adding Codes to the Telehealth Services List

CMS proposes to clarify and modify its process for making changes to the Medicare Telehealth List. In previous years services were added on a Category 1, Category 2 or Category 3 basis. Now that the COVID-19 public health emergency (PHE) is over, CMS proposes to clarify and modify its process for making changes to the Medicare Telehealth List. One goal is to distinguish services added to the telehealth list based on COVID-19 PHE-related authorities versus services added temporarily on a Category 3 basis, which do not rely on a PHE-related authority.

CMS will assign permanent or provisional status to any service that maps to the service elements of a permanent telehealth service or has evidence of clinical benefit when delivered via telehealth. Once provisional services have enough evidence of clinical benefit, they will be assigned permanent status. For CY 2024, CMS proposes that services currently added on a “temporary Category 2” or Category 3 basis will be assigned to the “provisional” category.

CMS also proposes temporarily adding health and well-being coaching services to the Medicare Telehealth List for CY 2024. Additionally, CMS proposes to permanently add a new code to the Medicare Telehealth List for the administration of standardized evidence-based SDOH Risk Assessments as long as the broader proposal for Medicare to pay for such risk assessments is finalized. More specifically, CMS is allowing a face-to-face encounter element of the SDOH risk assessment service to be performed via two-way interactive audio-video technology as a substitute for in-person interaction as long as the telehealth modality does not affect the accuracy or validity of the results gathered via a standardized screening tool. CMS also proposes that the practitioner furnish this service on the same date they furnish an E/M visit, as the SDOH assessment would be reasonable and necessary when used to inform the patient’s diagnosis and treatment plan established during the visit.

Telehealth Payment Rates

CMS proposes to allow a higher nonfacility payment rate for telehealth services performed for patients at their homes. These services would be billed under the place of service (POS) code 10. CMS proposes, however, to return to its pre-pandemic policy of paying the lower facility-based rate for all telehealth services where patients are not located in their home. CMS believes that the cost of providing telehealth services, as reflected in the practice expense RVUs, is more accurately reflected by the nonfacility rate. Clinicians would be required to use POS 02 for these telehealth services.

Direct Supervision

CMS proposes to continue defining direct supervision to allow the supervising practitioner to be present through real-time audio and video interactive telecommunications through Dec. 31, 2024. CMS seeks comment on whether it should consider extending its definition of direct supervision to allow virtual presence after Dec. 31, 2024.

Request for Information on Digital Therapies

CMS requests information on the opportunities and challenges related to coverage and payment policies for digital therapies, as well as claims processing of remote therapeutic monitoring (RTM) and remote physiologic monitoring (RPM). Specifically, CMS asks for real-life examples of digital therapeutics (DTx) in practice models, the industry’s standards for safety and privacy, and whether could be billed under existing remote therapeutic monitoring codes. CMS asks what aspects of DTx for behavioral health it should consider when evaluating whether to design a new Medicare benefit category.

Skin Substitutes

CMS is soliciting comments on how best to use sources of price information and various billing approaches as potential methods to establish appropriate payment for skin substitute products under the MPFS.

Mandated Manufacturer Refunds for Discarded Amounts of Refundable Drugs

CMS will provide annual reports to manufacturers with discard information. The initial refund report is proposed to be issued by Dec. 31, 2024. Manufacturers must pay refunds in 12-month intervals as specified by CMS. Payment deadlines will be determined in future rulemaking. Proposed changes in the refund calculation include using lagged claims data to revise refund amounts for updated quarters and apportioning refund responsibilities among multiple manufacturers based on sales volume. These changes align with the method used for inflation rebate obligations and would apply from CY 2023 onward.

The rule also proposes increasing the applicable percentage for drugs with unique circumstances. Two categories are proposed: drugs with low volume doses and rarely utilized orphan drugs. The Proposed Rule introduces an application process for manufacturers to request an increased applicable percentage for individual drugs with unique circumstances. Additionally, the proposal addresses the determination of discarded amounts and refund amounts, clarifies the use of the JW modifier for Medicare Advantage plans, makes technical changes to streamline the text, and requires the JZ modifier for drugs furnished but not administered by the billing supplier.

Medicare Shared Savings Program

CMS is proposing changes to the quality performance standard and reporting requirements under the Alternative Payment Model (APM) Performance Pathway (APP) within the QPP that “would continue to move ACOs toward digital measurement of quality and align with the QPP.”

CMS proposes updating the definition of primary care services used for beneficiary assignment to remain consistent with billing and coding guidelines. Additionally, CMS is proposing to make refinements to the benchmarking methodology for ACOs beginning on Jan. 1, 2024, and in subsequent years “to cap the risk score growth in an ACO’s regional service area when calculating regional trends used to update the historical benchmark at the time of financial reconciliation for symmetry with the cap on ACO risk score growth.” Lastly, CMS is proposing to refine policies for advanced investment payments (AIPs) and make updates to “other programmatic areas including the program’s eligibility requirements and make timely technical changes to the regulations for clarity and consistency.”

CMS seeks comments on potential future developments to MSSP policies, mainly related to the ENHANCED track, refining the “three-way blended benchmark update factor” and the prior savings adjustment, and promoting ACO and community-based organization collaboration.

Medicare Part B Payment for Preventive Vaccine Administration Services

CMS proposes to maintain the in-home additional payment for COVID-19 vaccine administration under the Part B preventive vaccine benefit. CMS also proposes to “extend the 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.” CMS proposes to “limit the additional payment to one payment per home visit,” even in cases of multiple vaccine administrations in one visit. CMS requests comment on this proposal and states that if this aspect is to be finalized, the in-home additional payment for the administration of pneumococcal, influenza and hepatitis B vaccines would be effective Jan. 1, 2024. Additionally, CMS states that the agency would apply a newly calculated Medicare Economic Index (MEI) percentage increase to update last year’s $36.85 CY 2023 in-home additional payment amount for Part B preventive vaccine administration. Lastly, CMS states that the agency will not be “proposing any payment regulations regarding monoclonal antibodies for PreP of COVID-19 at this time.”

Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging

CMS states that “having considered many rounds of input from interested parties, including internal and external experts, and diligent exploration of options, CMS believes that the real-time claims-based reporting requirement prescribed by section 1834(q)(4)(B) of the Act presents an insurmountable barrier for CMS to operationalize the AUC program fully.”

CMS believes that “due to the inability of the Medicare claims processing system to automate claims processing edits that ensure only claims subject to the AUC program requirements as prescribed in section 1834(q) of the Act will be processed as such, returned or denied accordingly, CMS believes the inherent risks in terms of data integrity and accuracy, beneficiary access, and potential beneficiary financial liability for advanced diagnostic imaging services render the AUC program impracticable and have led us to a proposal to pause efforts to implement the AUC program for reevaluation and rescind current regulations.” Specifically, CMS proposes to amend regulations to rescind the current regulations by removing the text of section 414.94 and reserving it for future use.

Updates to the Quality Payment Program

CMS reiterated the National Quality Strategy’s focus on initiatives prioritizing health equity, outcome-based healthcare, and quality. CMS seeks comments about how QPP can improve healthcare for Medicare beneficiaries, particularly through implementing learnings from CMS Innovation Center models. Additionally, CMS released a request for information (RFI) on potential approaches to publicly reporting performance on MIPS cost measures and is seeking comments on how to modify policies to foster clinicians’ continuous performance improvement.

For MIPS, CMS proposes:

updating 12 existing MIPS value pathways and adding five new ones: Women’s Health, Infectious Disease (Including HIV and Hepatitis C), Mental Health and Substance Use Disorder, Quality Care for Ear, Nose, and Throat, and Rehabilitative Support for Musculoskeletal Care.
establishing the performance threshold for CY 2024 to be the mean final score across MIPS clinicians in CYs 2017–2019, which is 82 points.
keeping performance category weights the same for performance year 2024/payment year 2026: 30 percent a piece for the quality performance cost performance categories, 15 percent for the improvement activities performance category and 25 percent for the promoting interoperability performance category.
- Quality: CMS proposes requiring the use of the Spanish CAHPS survey, increasing the data completeness threshold to 80 percent starting in the performance year 2027 (payment year 2029), and changing the existing MIPS quality measure set by adding nine measures, removing 15 measures, modifying 75 measures and updating specialty sets.
- Cost: CMS proposes adding episode-based cost measures for Depression, Emergency Medicine, Heart Failure, Low Back Pain, and Psychoses and Related Conditions and removing the episode-based cost measure for Simple Pneumonia with Hospitalization.
- Improvement Activities: CMS proposes adding five new improvement activities (four of which are related to advancing health equity), modifying one existing improvement activity and removing three previously adopted improvement activities.
- Promoting Interoperability: CMS proposes extending the performance period to from 90 to 180 days, making technical updates to existing measures and weighting the category at 0 percent for clinical social workers for performance year 2024.

Notably, CMS states most clinicians won’t be able to meet the proposed new MIPS performance threshold. Further, for those seeking to transition to an advanced APM to avoid a MIPS penalty, it should be noted that it remains unclear if Congress will extend the 3.5 percent bonus for another year. For background, in December 2022, Congress extended availability of the advanced APM incentive payment for one year, allowing eligible clinicians to receive a 3.5 percent (down from the 5 percent) incentive payment in the 2023 performance year/2025 payment year.

Medicare Ground Ambulance Data Collection System (GADCS)

The Bipartisan Budget Act (BBA) of 2018 required CMS to implement regulations for a ground ambulance data collection system by Dec. 31, 2019. The GADCS portal went live on Jan. 1, 2023, and CMS has identified opportunities to improve it with the assistance of stakeholders. CMS proposes the following changes to the GADCS instrument:

enabling partial year responses from ground ambulance organizations
improving reporting consistency of hospital-based ambulance organizations through minor edits
correcting four technical typos

Medicare Part A and B Payment for Dental Services

CMS proposes to codify previously finalized payment policies for dental services prior to or during head and neck cancer treatments, whether primary or metastatic. CMS also proposes to permit payment for certain dental services inextricably linked to other covered services used to treat cancer, including chemotherapy, chimeric antigen receptor (CAR) T-cell therapy and antiresorptive therapy. CMS does not anticipate a significant increase in overall spending and utilization under the MPFS for additional dental services performed prior to and during certain cancer treatments or drug therapies, given the historically low utilization of these therapies. CMS continues to seek comment on additional circumstances where evidence supports dental services as an integral part of the clinical success of covered medical services.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.

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CMS RELEASES CY 2024 PHYSICIAN FEE SCHEDULE PROPOSED RULE

Dr. M. Rosen — Mon, 17 Jul 2023 19:02:55 +0000

On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B [CMS-1784-P] Proposed Rule, which includes proposals related to Medicare physician payment and the Quality Payment Program (QPP). Physicians and other clinicians are once again facing large, proposed cuts of more than 3.36% for CY 2024. While Congress has provided temporary partial fixes to physician payment in the last several years, its latest fix in the Consolidated Appropriations Act, 2023 (CAA, 2023), enacted at the end of 2022, does not offset all the proposed cuts in this rule. In all, the budget neutrality constraints of the fee schedule continue to result in a negative proposed conversion factor (CF) update. Beyond the cut to the CF, CMS proposes significant policies related to telehealth services, updates to the Medicare Shared Savings Program (MSSP), initiatives promoting health equity and other changes to further develop physician quality initiatives.

READ OUR FULL ANALYSIS

KEY TAKEAWAYS FROM THE CY 2024 PFS PROPOSED RULE:

CF Reduction: Proposes a 2024 CF of $32.7476, representing a 3.36% reduction from the 2023 physician CF of $33.8872, and a 2024 anesthesia CF of $20.4370, representing a 3.26% reduction from the 2023 anesthesia CF of $21.1249
Add-on Code for Complexity: Would implement a new add-on code for complexity, G2211, that was previously finalized but delayed by Congress until 2024
Behavioral and Social Needs: Outlines policies to promote behavioral healthcare and services addressing health-related social needs
Telehealth: Proposes a new process for adding, removing or otherwise changing codes on the Medicare Telehealth Service list, and would create differential payment based on the place of service
Merit-Based Incentive Payment System (MIPS): Would raise the MIPS performance threshold to 82 points in 2024, from 75 points in both 2022 and 2023
Appropriate Use Criteria (AUC) Program: Would permanently sunset the AUC program
MSSP: Proposes changes to the MSSP, including to the financial benchmarking methodology, assignment methodology and more.

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CMS releases calendar year 2023 Medicare Physician Fee Schedule Changes: key takeaways for providers

Dr. M. Rosen — Wed, 16 Nov 2022 14:50:59 +0000

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule for the 2023 Calendar Year (CY 2023) Medicare Physician Fee Schedule (MPFS) (the Final Rule). The Final Rule, issued on November 1, includes updates and policy changes related to Medicare payments under the MPFS.

While the Final Rule is far-reaching in a number of areas, this alert focuses on key topics and takeaways for physicians and other clinicians regarding the following: (1) telehealth services; (2) chronic pain management and treatment; (3) opioid treatment programs; (4) DME enrollment matters; and (5) the Medicare Shared Savings Program (MSSP).

The Final Rule’s implementation brings both opportunity and limitations to certain service lines. Accordingly, physicians and other clinicians that provide services in these areas should review the summary of the changes described herein, and work to implement any necessary modifications to their internal practices to comply with the Final Rule.

Updates to telehealth

The CMS updates to telehealth in the Final Rule largely mirror the August 2022 Fact Sheet for physicians.

Notably, CMS implemented the telehealth provisions in the Consolidated Appropriations Act (CAA) 2022 to ensure a smooth transition to the end of the public health emergency (PHE). Specifically, CMS finalized that services that are currently temporarily available due to the PHE, which is set to end January 11, 2023, will continue to be available at least 151 days following the end of the PHE, in line with the CAA. CMS also finalized that through this time period, providers may continue to deliver telehealth services in any geographic area and originating site setting. Additionally, through this period, physicians and practitioners may continue to bill with modifier 95 along with the place of service code that corresponds to where the provider would have furnished the service, if the service had been delivered in-person.

However, 151 days after the PHE ends, unless there is further action by Congress, the telehealth flexibilities extended during the COVID-19 public health emergency will expire and physicians and other clinicians seeking to deliver telehealth services to Medicare beneficiaries and receive reimbursement under the MPFS will be required to comply with the restrictions set forth under Section 1834(m) of the Social Security Act. Accordingly, physicians and clinicians must assess the impact of the end of the PHE as it pertains to their service lines and their ability to comply with Medicare’s restrictions on telehealth, in addition to any state law limitations.

We continue to recommend that our clients have backup systems in place to transition away from providing these telehealth services to Medicare beneficiaries for those services that CMS will no longer permit. Additionally, all telehealth providers should continue to monitor developments from Congress, CMS and other Department of Health and Human Services regulators with respect to changes in coverage and enforcement priorities in the telehealth space. As described in our previous client alert, we expect that the government will ramp up its enforcement of fraud and abuse of telehealth services provided during and after the PHE.

For providers of mental health, we note that CMS finalized its proposal (in line with the CAA) that delays the in-person requirements for the provision of mental health services until day 152 after the PHE ends. Once such proposal is effective, CMS will require mental health providers to see patients in-person within six months prior to a patient’s initial telehealth service and once every twelve months thereafter. This will directly impact telehealth providers that operate fully remote platforms.

Further, when finalizing this proposal, CMS emphasized that audio-only telephone evaluation and management services are inherently non-face-to-face services, and outside of the circumstances of the PHE, these services will not serve as a substitute for in-person care furnished in a face-to-face encounter. Telehealth services delivered post-PHE and the applicable 151-day extension will likely require the use of two-way audio-visual modalities in order to coverage to be available.

Lastly, as discussed in more detail below, we note that Medicare will cover some telehealth-based treatment services delivered under Opioid Treatment Programs (OTPs).

Chronic pain management and treatment

The Final Rule finalized new HCPCS codes (G3002 and G3003) for chronic pain management (CPM) and provided sub-regulatory guidance related to the use of these codes. For clinicians that provide CPM services, it is important to note that CMS defined chronic pain as “persistent or recurrent pain lasting longer than three months.” The CPM codes require that a clinician see a patient in-person prior to billing G3002; however, CMS stated that a clinician may furnish any of the in-person components via telehealth, as clinically appropriate, after this initial visit in order to increase beneficiaries’ access to care.

Further, CMS noted that clinicians may bill CPM codes in conjunction with remote patient monitoring, remote physiologic monitoring, remote therapeutic monitoring, chronic care management, transitional care management, and behavioral health integration on the same day so long as the clinician meets all of the requirements to report each service and that the time spent for CPM does not represent the time spent for providing any other reported service.

For those clinicians that provide CPM services, we note that CMS provided additional sub-regulatory guidance and sample scenarios for how it envisions clinicians will use CPM.

Opioid treatment programs

CMS also finalized modifications to regulations and policies for Medicare coverage and payment as it relates to opioid use disorder (OUD) treatment services furnished by OTPs. These modifications include increases to methadone pricing, pricing changes related to individual therapy in the bundled rate, and two initiatives focused on increased flexibilities to allow OTPs to reach more beneficiaries: (i) the use of telecommunications when initiating treatment with buprenorphine; and (ii) the inclusion of mobile components of OTPs in determining Medicare payments.

CMS finalized two changes related to pricing. First, as it relates to methadone pricing, CMS finalized a proposal to use the Producer Price Index (PPI), utilizing the payment rate for CY 2021 and updating it via the PPI for CY 2023, resulting in a roughly $2.00 increase. Second, as it relates to individual therapy in the bundled rate, CMS, after analyzing two years of utilization data, finalized the payment for the non-drug component of the bundled payment, cross-walking the payment to CPT code 90834, describing 45 minutes of psychotherapy. This represents an increase, as CMS previously utilized CPT code 90932, describing 30 minutes of psychotherapy. In the Final Rule, CMS has clarified, in response to a comment, that the CPT code crosswalk is for valuation/pricing purposes and does not prohibit an OTP from billing for the bundled code even if the therapy session did not last 45 minutes. Further, CMS clarified that it is not limiting the clinicians who can provide these services in an OTP to those practitioners who can bill Medicare directly; rather any professional authorized by state law and their scope of practice to furnish this type of therapy or counseling may do so as part of the treatment included in the bundled payments to OTPs under Medicare.

CMS also finalized two proposals which enable OTPs to reach more beneficiaries. First, CMS finalized additional flexibilities to allow OTPs to furnish intake/initiation of treatment with buprenorphine via two-way audio-video communications technology (to the extent authorized by the Drug Enforcement Agency (DEA) and Substance Abuse and Mental Health Services Agency (SAMHSA) at the time the clinician furnishes the service). CMS also finalized its proposal to permit, during the PHE, the use of audio-only communication technology to initiate treatment with buprenorphine in cases where audio-video technology is not available to the beneficiary.

CMS will continue to evaluate whether these flexibilities will continue at the end of the PHE. Further, CMS finalized its proposal to consider services furnished via OTP mobile units when determining payments to OTPs under the Medicare OTP bundled payment codes and/or add-on codes, to the extent services are medically reasonable and necessary and furnished in accordance with SAMSHA and DEA guidance.

DMEPOS suppliers

CMS finalized its proposal to add another condition of payment for DMEPOS suppliers. Specifically, CMS now requires that in order to receive payment for a furnished DMEPOS item or service, the supplier must have been in compliance with all conditions of payment set forth under 42 C.F.R. § 424.57(b) as well as with the application certification standards set forth under 42 C.F.R. § 424.57(c)(1)(ii)(A) at the time the item or service was provided, including state licensure, where a state requires such licensure to furnish certain items or services.

Notably, this directly impacts DMEPOS suppliers that may experience a licensure lapse, as now a licensure lapse might trigger a repayment obligation given that the licensure requirement is now an explicit condition of payment. As a result, DMEPOS suppliers should carefully and regularly review state licensure requirements, renewal timeframes, and any relevant changes to state law that could potentially affect the ability of the supplier to maintain licensure.

Medicare Shared Savings Program

CMS finalized a number of changes for the Medicare Shared Savings Program (MSSP) with the aim of encouraging the continued growth of the MSSP and to address health inequities. CMS expressed particular concern with a trend in recent years showing that the growth in the number of Medicare beneficiaries assigned to accountable care organizations (ACOs) in the MSSP has plateaued. By way of example only, finalized changes include:

Smoothing the transition to performance-based risk. For agreement periods beginning on January 1, 2024 and thereafter, CMS will allow inexperienced ACOs to participate in one five-year agreement under a one-sided shared savings model. Overall, under these changes, CMS will allow these ACOs to be eligible for one-sided shared savings, with no downside risk, for a total of seven years.
Providing an option for advance investment payments. Beginning January 1, 2024, CMS will make available a new option to make advance investment payments to new ACOs that are identified as low revenue and inexperienced with performance-based risk Medicare ACO initiatives. Under this option, an ACO would receive a one-time payment of $250,000 and quarterly payments for the first two years of the five-year agreement. CMS will recoup these payments from the ACO’s shared savings (if any) or from the ACO if it terminates its participation during the agreement period. The payments must be used to improve the quality and efficiency of items and services furnished to Medicare beneficiaries, including through increased staffing, infrastructure and serving underserved beneficiaries.
Adjustments to benchmarks. Beginning January 1, 2024, CMS finalized a number of revisions with respect to its use of benchmarks for the MSSP with the goal of ensuring that benchmarks serve as a reasonable baseline and do not otherwise discourage entry into and continued participation in the MSSP, while pushing ACOs to continually beat their own performances.
Implementing slide scale for determining payments and adjusting for health equity. The Final Rule indicated that CMS is moving away from its “all-or-nothing” approach for when ACOs may be eligible for shared savings based on quality performance in favor of scaling shared savings rates for ACOs if the ACO falls below certain thresholds. CMS also finalized a health equity adjustment to reward ACOs for serving underserved population.
Reducing administrative burden for ACOs. To reduce the administrative burden on ACOs, CMS finalized four changes beginning January 1, 2023. First, while CMS will continue to regulate marketing materials, CMS will no longer require ACOs to submit marketing materials for prior approval. Second, CMS adjusted the timing for beneficiary notifications and requirements for signage. Third, in lieu of submitting narratives describing communication plans, care management plans, and beneficiary evaluation and admission plans for SNF 3-day rule waivers, ACOs will submit attestations that such plans have been established. Fourth, CMS updated data sharing regulations to make it easier for ACOs that are organized health care arrangements (a HIPAA-governed status) to obtain aggregate reports and beneficiary-identifiable claims data from CMS.
Updating ACO beneficiary assignment methodology. Beginning January 1, 2023, CMS updated how it defines primary care services for the purposes of beneficiary assignment. Additionally, CMS is modifying its approach for when facilities (e.g., federally qualified health centers) will be used for assigning beneficiaries to an ACO.

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Billing for Telehealth Encounters – An Introductory Guide On Fee-for-Service

Dr. M Telehealth — Tue, 16 Mar 2021 16:58:20 +0000

Billing for Telehealth Encounters – An Introductory Guide On Fee-for-Service – 2021-03-16 Download

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Medicare Shared Savings Program Saved a Record $1.19B in 2019

Dr. A. Connor — Tue, 15 Sep 2020 19:28:45 +0000

CMS also reported that ACOs in the Medicare Shared Savings Program saved more under new Pathway to Success tracks and if they assumed downside risk.

By Jacqueline LaPointe

September 15, 2020 – Medicare Shared Savings Program (MSSP) generated $1.19 billion in total net savings to Medicare in 2019, representing the third consecutive year for net program savings and the largest annual savings for the program to date, CMS Administrator Seema Verma recently reported.

In a Health Affairs blog post yesterday, Administrator Verma shared the results from the MSSP’s 2019 performance year. It was the first year accountable care organizations (ACOs) in the program could participate under new tracks through Pathways to Success.

In 2019, MSSP ACOs had the option of joining a new Pathways to Success track starting in July or continuing in one of the existing participation or “legacy” tracks. In total, 541 ACOs participated in the program during the performance year.

But ACOs in the Pathways to Success tracks performed better than their counterparts in legacy tracks, according to Verma.

ACOs under Pathways to Success options generated net per-beneficiary savings of $169 per beneficiary versus $106 per beneficiary for legacy track ACOs.

Even new entrants to the MSSP that joined through a Pathways to Success track saved (net per-beneficiary savings of $150) despite the long-standing record of first-time ACOs not achieving savings in their first performance year, Verma highlighted.

Rural ACOs, which have also had a rocky past with program savings, improved their performance under Pathways to Success, she reported.

Urban ACOs and rural ACOs participating in the new tracks generated $170 net per-beneficiary savings and $158 net per-beneficiary savings, respectively, while among all the MSSP ACOs in 2019, urban ACOs generated $125 net per-beneficiary savings and rural ACOs generated $64 net per-beneficiary savings.

Additionally, Verma reported that ACOs that took on downside financial risk under both participation options in 2019 saved more per beneficiary than those that remained in upside-only tracks ($152 per beneficiary compared to $107 per beneficiary).

Physician-led ACOs also continued to outperform their hospital-led counterparts as demonstrated by low-revenue ACOs producing net per-beneficiary savings of $201 per beneficiary compared to $80 per beneficiary among high-revenue ACOs.

Finally, nearly all ACOs in 2019 met the quality performance standard, Verma reported. About 92 percent of eligible ACOS also earned quality improvement reward points for the year.

The early results from the 2019 MSSP performance period show that Pathways to Success is living up to its moniker, according to Verma.

“When the redesign of the program was first announced, some stakeholders expressed concern that new ACOs might be reluctant to participate in these new participation options, given the changes in the financial benchmarks and the speed at which ACOs would need to take on downside risk. However, these early results suggest that greater financial accountability under the Pathways to Success policies has produced the stronger incentives for ACOs to deliver better coordinated and more efficient care for Medicare beneficiaries,” she wrote in the blog post.

The redesigned program also better supports rural ACOs and encourages more rural providers to implement value-based care, the post continued.

But the National Association of ACOs (NAACOS) – one of the stakeholders that has expressed concerns about the Pathways to Success redesign – is still worried about MSSP participation.

Only 5 percent of eligible ACOs elected to enter the redesigned program early, with the remaining ACOs choosing to stay in one of the legacy MSSP tracks, the industry group reported.

“Unfortunately, ‘Pathways to Success’ has already shown to diminish ACO participation,” Clif Gaus, ScD, president and CEO of NAACOS, said in a statement shortly following the results.

Gaus’ group urged Congress to consider new legislation that would improve the Medicare ACO program despite Verma’s report on MSSP performance in 2019.

The NAACOS-backed legislation titled the Value in Health Care Act was introduced this July to boost participation in the MSSP by increasing shared savings rates for ACOs in upside-only risk tracks to at least 50 percent for those in the Levels A and B of the Pathway to Success’ BASIC track and 55 percent for those in Levels C and D.

The bill would also extend the 5 percent incentive payment for participation in certain alternative payment models under MACRA and reduce thresholds for participation in the models.

Other groups like Premier Inc. also used the Verma’s blog post to push other legislation like the Rural ACO Improvement Act (2648) and Accountable Care in Rural America Act (H.R. 5212), which would remove an ACO’s attributed population from the regional benchmark calculation.

The Value in Health Care Act though could not come at a better time, Gaus emphasized.

“These results clearly show that ACOs are helping improve our health system at a time when it’s needed more than ever,” he stated. “When we emerge from the ongoing pandemic, we’ll need alternatives to fragmented fee-for-service and better cost-control strategies, which ACOs provide. There should be no debate that we need to foster the growth of more ACOs so their benefits are delivered to more seniors.”

COVID-19 has the potential to derail ACO progress, according to providers.

“As with everyone in the industry, we’re concerned about the impact of COVID-19 on our value-based care programs,” Shawn Morris, CEO of Privia Health, told RevCycleIntelligence. “Many patients postponed wellness visits and health screenings while following stay-at-home orders and maintaining social distancing – thus limiting a physician’s ability to address and capture their patient’s medical conditions. This can have a negative impact on the ACO’s ability to improve patient outcomes and achieve shared savings.”

Privia Health is maintaining its commitment to participating in the MSSP with its four ACOs though. In 2019, the ACOs earned shared savings of $57 million, Morris reported.

“Our providers use technology, team-based care, and unique wellness programs to keep people healthy, prevent disease, and improve care coordination both in and outside of the doctor’s office – including our virtual visits platform, chronic care management programs, remote patient monitoring and digital communications tools (patient app, texting, provider messaging, online scheduling, etc.),” Morris said.

“We appreciate the expanded telehealth for Medicare beneficiaries, and believe this played a crucial role in our provider’s ability to stay connected to patients throughout the year,” Morris continued. “Telehealth and virtual visits are now woven throughout our healthcare delivery system. This modern face-to-face doctor’s appointment – embraced by patients of all ages – must continue as a means to provide care both related, and unrelated, to global pandemics.”

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