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AUA’s Deep Dive Summary of the Medicare Physician Fee Schedule (MPFS) for CY 2025
CY 2025 Medicare Physician Fee Schedule Proposed Rule Summary
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule (MPFS) proposed rule for CY 2025 (CMS-1807-P). This rule updates payment policies and payment rates for Part B services furnished under the MPFS, as well as makes changes to the Quality Payment Program (QPP). The rule in its entirety and the addenda, including Addendum B, which lists the proposed RVUs for each CPT® code can be found here. Comments are due September 9.
- CY 2025 MPFS Impacts on Urology Codes Compared with CY 2024 Rates (Facility and Non-Facility Rates)
- CY 2025 MPFS Impacts on Evaluation & Management Codes Compared with CY 2024 Rates (Facility and Non-Facility Rates)
In this proposed rule, CMS discusses several significant policy changes, including creating a new code to address the global surgical package policy, requiring use of modifiers for 90-day global surgeries, redefining telehealth services to include audio-only services, and declining to accept and pay for the new 16 of the 17 telemedicine E/M codes. The following summarizes the major policies in the proposal. Note that the page numbers listed in this document refer to the display copy of the proposed rule. Additionally, revised and new CPT codes do not have final code numbers assigned. The complete code numbers will be provided when the final rule is released in early November.
Appendix A lists the new codes with RUC recommended values and CMS proposed values for services performed by urologists.
Regulatory Impact Analysis
Highlight: Conversion factor set for a decrease yet again for CY 2025.
Conversion Factor for 2025
The conversion factor for 2025 is set to decrease by approximately 2.80% from $33.2875 to $32.3562. The cut is primarily driven by the expiration of the conversion factor increase that Congress passed in March.
Specialty Level Impact of the Proposed Changes – p. 1,561
The impact of the proposed rule’s policies on group practices and individual physicians varies based on practice type and the mix of patients and services provided to those patients. Table 128 of the rule, (Appendix A of this summary) estimates the specialty level impacts of the policies included in the proposed rule and includes impacts of rate-setting changes and changes to RVUs within the budget neutral system. Table 1 below highlights estimated specialty level impacts and includes some of the specialties with the greatest impact, both positive and negative for comparison. Note that the impact table values do not reflect the decrease in the conversion factor for 2025.
Table 1: CY 2025 Estimated Impact Total Allowed Charges by Specialty
Specialty |
Medicare Allowed Charges (millions) |
Work RVU Impact |
PE RVU Impact |
MP RVU Impact |
Overall Impact |
Clinical Social Worker |
$794 |
3% |
1% |
0% |
4% |
Clinical Psychologist |
$680 |
3% |
1% |
0% |
3% |
Internal Medicine |
$8,771 |
0% |
0% |
0% |
1% |
Dermatology |
$3,717 |
0% |
0% |
0% |
0% |
Nephrology |
$1,571 |
0% |
0% |
0% |
0% |
Obstetrics/Gynecology |
$531 |
0% |
0% |
0% |
-1% |
Urology |
$1,532 |
0% |
0% |
0% |
-1% |
Interventional Radiology |
$418 |
0% |
-2% |
0% |
-2% |
Determination of Practice Expense RVUs – p. 31
Highlight: No change in the MEI methodology while CMS waits for updated practice expense data from the AMA.
Citing the continued collection of data from the American Medical Association’s Physician Practice Information Survey (PPIS), CMS has again delayed implementation of the rebased MEI data. The agency does not wish to duplicate efforts, and “will continue to monitor data available related to physician services’ inputs” while the AMA PPIS survey is completed.
Supply Pack Pricing Update – p. 41
During the 2024 rule making cycle, the AMA RUC submitted comments that certain components and associated individual items within the supply pack practice expense inputs were potentially misvalued. However, due to the possible large redistributive effects of implementing the pricing updates, the agency chose to revisit the issue in future rules. Now, CMS proposes to implement the supply pack pricing updates for 2025, as recommended by the AMA RUC.
There are two supply pack practice inputs that affect the practice of urology. Table 2 below shows the price currently, and the proposed price for 2025. The changes in the supply packs may have an impact on overall Medicare payments for the urology specialty.
Table 2: Supply Pack Updates
Supply |
Current Price |
Proposed Price 2025 |
Percent Change |
Pack, drapes, cystoscopy |
$17.33 |
$14.99 |
-14% |
Pack, urology cystoscopy visit |
$113.70 |
$37.63 |
-67% |
CY 2025 Clinical Labor Pricing Update Proposals – p. 49
Highlight: CMS is accepting comments on updated clinical labor types.
The agency did not receive new wage data or any other information for use in its calculation of clinical labor pricing. Therefore, the data finalized in 2024 will be used for the proposed clinical labor pricing in 2025. Table 5 of the proposed rule lists the clinical labor types and price per minute for 2025. The agency is accepting comments if stakeholders wish to recommend changes to any of the labor types and rates.
Development of Strategies for Updates to Practice Expense Data Collection and Methodology – p. 51
Highlight: CMS seeks comment on ways to improve practice expense inputs.
CMS continues to grapple with updating direct and indirect practice expense data inputs. In recent years, the agency has requested information from stakeholders that would provide the agency with alternatives and solutions to update these inputs. Through this work, the agency has determined that using the PPIS data, despite its limitations, is the best source for data at this point. However, CMS notes in this year’s proposed rule that they still have concerns about the use and validity of the new PPIS data. The agency believes that advertising and endorsements for the PPIS survey may have “injected bias in the validity and reliability of the information collected.”
To assist the agency with updating, revising, and implementing new PE data, CMS has contracted with the RAND Corporation to create and develop other methods for measuring PE and the related inputs for future implementation. As such, the agency seeks comment on how to “improve the stability and predictability of future updates.” Specific topics the agency has requested comments for include:
- Alternatives to using the PPIS data.
- Timing of recurring updates.
- Updates to supply and equipment costs including submission of third-party data sources.
- The use of a four-year phase-ins of new data.
- How do or should economies of scale (meaning a general principle that cost per unit of production decreases as the scale of production increases) factor into the PE methodology.
- Use of data, mechanisms, or approaches that “leverage meaning a general principle that cost per unit of production decreases as the scale of production increases.”
Payment for Medicare Telehealth Services under Section 1834(m) of the Act – p. 75
Highlight: CMS adds audio-only communication technology to the definition of a telehealth service.
Requests to Add Services to the Medicare Telehealth Services List for CY 2025
CMS plans to complete a comprehensive analysis in future rulemaking of all the services on the Medicare Telehealth Services List provisionally before determining which codes should be made permanent. The process and decision-making parameters that the agency uses to make determinations as to whether a code(s) may be placed on the telehealth service list is found on page 78 of the proposed rule.
Care Management – p. 87
CMS received a request to permanently add General Behavioral Health Integration (CPT code 99484) and Principal Care Management (CPT codes 99424-99427) to the Medicare Telehealth Services List. The agency does not consider these to be Medicare telehealth services and therefore is not proposing to add these services to the Medicare Telehealth Services List. As noted in the rule the agency states “We do not consider these services to be Medicare telehealth services because they are not inherently face-to-face services, and the patient need not be present for the services to be furnished in its entirety.”
Posterior Tibial Nerve Stimulation for Voiding Dysfunction – p. 88
The agency received a request to permanently add posterior tibial neurostimulation (CPT code 64566) to the Medicare Telehealth Services list. CPT code 64566 has never been on the telehealth list, nor does the service meet the agency’s criteria for addition to the list. The requestor described the services as “the continual or recurring treatments over a period of time consisting of the remote monitoring of device utilization and bladder diary for the generation of reports for review by the care provider.” CMS disagrees with this description of the service based on the elements of the procedure as described by the CPT code. Therefore, the agency states the services associated with the posterior tibial neurostimulation require an in-person interaction and are not eligible for placement on the telehealth list.
Frequency Limitations of Medicare Telehealth Subsequent Care Services in Inpatient and Nursing Facility Settings, and Critical Care Consultations – p.96
Prior to the COVID pandemic, there were frequency limitations (i.e., the number of times a provider may bill for a service during a given time frame) for services associated with subsequent inpatient visits (CPT codes 99231, 99232, and 99233), subsequent nursing facility visits (CPT codes 99307, 99308, 99309, and 99310), and critical care consultation services (HCPCS G codes, G0508 and G0509). However, during the pandemic, CMS lifted the frequency restrictions to allow greater access to care.
Now, the agency proposes to permanently remove frequency limitations for these services when provided via telehealth. The agency received many comments in last year’s rule supporting removal. CMS has stated that frequency limitation for these services is rarely met, and that removing the frequency limitations will have little impact on overall telehealth volume. The agency will accept comments on this proposal, and requests information on the importance of in-person care for patients with higher acuity, and if there are other considerations or changes the agency should consider given the way that practice patterns have changed since the pandemic.
Audio-only Communication Technology to Meet the Definition of “Telecommunications Systems” – p. 99
CMS proposes to revise the definition of an interactive telecommunications system to also include two-way, real-time audio-only communication technology for any telehealth service furnished to a beneficiary in their home if the distant site physician is technically capable of using an audio/video system, but the patient is not capable of, or does not consent to, the use of video technology. The agency notes that providers should continue to use their clinical judgment to decide if audio-only technology is sufficient to provide a telehealth service. However, the agency recognizes that lack of access to broadband may make video calls impractical, or that patients may prefer to engage with their provider in their homes using audio-only technology. For claims for audio-only services, providers must use CPT modifier 93 to verify that all conditions have been met.
Distant Site Requirements – p.101
CMS proposes to continue through CY 2025 to allow a distant site practitioner to use their currently enrolled practice location instead of their home address when providing telehealth services from their home. The agency will consider proposals to better protect the safety and privacy of providers.
Direct Supervision via Use of Two-way Audio/Video Communications Technology – p. 103
CMS proposes to continue to define direct supervision to permit the presence and immediate availability of the supervising practitioner through real-time audio and visual interactive telecommunications through December 31, 2025. The agency proposes to permanently adopt the definition of direct supervision permitting virtual presence for services that are considered lower risk, such as services that do not ordinarily require the presence of the billing practitioner, do not require as much direction by the billing practitioner as other services, and are not typically performed by the supervising practitioner.
Teaching Physician Billing for Services Involving Residents with Virtual Presence – p. 109
CMS proposes to continue the current policy through December 31, 2025, that allows teaching physicians to have a virtual presence when billing for services involving residents in teaching settings only when the service is furnished virtually (i.e., the patient, resident and teaching physician are all in separate locations). The teaching physician’s virtual presence requires real-time observation and excludes audio-only technology.
Telehealth Originating Site Facility Fee Payment Amount Update – p. 113
CMS proposes that for CY 2025, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) will be $31.04. This will be updated in the final rule based on historical data through the second quarter of 2024.
Valuation of Specific Codes
Intra-Abdominal Tumor Excision or Destruction (CPT codes 4X015, 4X016, 4X017, 4X018, and 4X019) – p. 140
The CPT Editorial Panel created five new codes to describe the removal of intra-abdominal tumors based on the sum of the maximum length of the tumor(s). The AUA participated in the RUC survey valuation process.
CMS proposes to accept the RUC recommended work values for 4X015, 4X016, and 4X017. However, for codes 4X018 and 4X019, CMS proposes lower work values than the RUC recommended values, proposing a work RVU of 40.00 for code 4X018 instead of the RUC recommended value of 45.00 and a work RVU of 50.00 for 4X019, instead of the RUC recommended value of 55.00. CMS’ reasoning for proposing lower values is because the RUC recommended work values that were in the 25th percentile for three of the codes in the family (4X015, 4X016, and 4X017), but instead chose to elevate the values to “inappropriately high levels” above the 25th percentile for codes 4X018 and 4X019. The agency accepted without modification the PE inputs for all the codes in the family.
Bladder Neck and Prostate Procedures (CPT codes 5XX05 and 5XX06) – p. 143
CMS proposes to accept the AMA RUC recommended values for new CPT codes that describe services associated with the use of a temporary device that remodels the bladder neck and prostate to alleviate symptoms of the lower urinary tract secondary to benign prostate hyperplasia. The RUC proposed a work value of 3.10 for CPT code 5XX05, and work value of 1.48 for CPT code 5XX06.
The agency did accept the RUC recommended PE inputs for both services but seeks clarification on the possible duplication of supply items as provided by the RUC. AUA will submit comments and work with the AMA RUC to resolve any discrepancies.
MRI-Monitored Transurethral Ultrasound Ablation of Prostate (CPT codes 5X006, 5X007, and 5X008) – p. 144
At the April 2023 CPT Editorial Panel meeting, the CPT Panel approved three new codes to describe services associated with MRI-monitored transurethral ultrasound ablation of the prostate. CMS proposes to accept the RUC recommended values for all three services, noted as follows: CPT code 5X006 work RVU of 4.05, 5X007 work RVU of 9.80, and CPT code 5X007 work RVU of 11.50. The agency will accept comments from interested parties if there is concern as to the experience of the survey respondents and the intra-service times captured in the survey. The agency will review additional data from commenters that may be considered in the valuation of the work and direct PE inputs for these services. The PE inputs have been accepted by CMS, without refinement. Table 3 provides the code descriptors and work RVUs for the codes of interest to AUA.
Table 3: RUC Recommended vs. CMS Recommended Work RVUs
CPT Code |
Descriptor |
RUC Recommended Work RVU |
CMS Proposed Work RVU |
4X015 |
Excision or destruction, open, intra-abdominal (ie, peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 5 cm or less |
22.00 |
22.00 |
4X016 |
Excision or destruction, open, intra-abdominal (ie, peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 5.1 to 10 cm |
28.65 |
28.65 |
4X017 |
Excision or destruction, open, intra-abdominal (ie, peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 10.1 to 20 cm |
34.00 |
34.00 |
4X018 |
Excision or destruction, open, intra-abdominal (ie, peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 20.1 to 30 cm |
45.00 |
40.00 |
4X019 |
Excision or destruction, open, intra-abdominal (ie, peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); greater than 30 cm |
55.00 |
50.00 |
5X006 |
Insertion of transurethral ablation transducers for delivery of thermal ultrasound for prostate tissue ablation, including suprapubic tube placement during the same session and placement of an endorectal cooling device, when performed |
4.05 |
4.05 |
5X007 |
Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation |
9.80 |
9.80 |
5X008 |
Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with insertion of transurethral ultrasound transducers for delivery of the thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed |
11.50 |
11.50 |
5XX05 |
Cystourethroscopy with insertion of temporary device for ischemic remodeling (ie, pressure necrosis) of bladder neck and prostate |
3.10 |
3.10 |
5XX06 |
Catheterization with removal of temporary device for ischemic remodeling (ie, pressure necrosis) of bladder neck and prostate |
1.48 |
1.48 |
Telemedicine Evaluation and Management (E/M) Services (CPT codes 9X075, 9X076, 9X077, 9X078, 9X079, 9X080, 9X081, 9X082, 9X083, 9X084, 9X085, 9X086, 9X087, 9X088, 9X089, 9X090, and 9X091) – p. 157
As a part of its work in a nearly complete overhaul of the E/M section of the CPT code book, the CPT Editorial Panel created, and the RUC subsequently valued 17 new codes to describe services for the provision of telemedicine E/M. The new codes for telemedicine E/M, notes the agency, mirror nearly exactly the codes for new and established office E/M services, and the RUC recommended RVUs also are nearly identical to the office visit E/M services.1 The agency also created a table for stakeholders to reinforce this point. Table 10, Comparison of Elements and Work RVU between Telemedicine E/M Codes (9X075 through 9X090) and Office/Outpatient E/M Codes (99202 through 99215), can be found on page 165.
Noting that there are already services on the Medicare telehealth services list (office/outpatient E/M code set) that describe E/M services when furnished via telemedicine and that the agency is required by section 1834(m)(2)(A) to “pay an equal amount for a service furnished using a “telecommunications system” as for a service furnished in person, the agency believes that there is not a programmatic need to recognize and provide payment for the newly established telemedicine E/M codes. The codes 9X075-9X090 will be assigned a procedure status indicator of “I” indicating that there is a more specific code that should be used in the Medicare program, in this instance the existing office E/M codes. Providers should continue to use the appropriate modifier and place service codes.
However, CMS did propose to value one of the 17 new codes. CMS proposes to accept the RUC recommended value, and make payment for CPT 9X091 (Brief communication technology-based service (eg, virtual check-in) by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related evaluation and management service provided within the previous 7 days nor leading to an evaluation and management service or procedure within the next 24 hours or soonest available appointment, 5-10 minutes of medical discussion). This code is almost identical to the code that CMS created to report these services. Therefore, CMS will delete HCPCS code G2012, and instead providers should use the new CPT code to report a virtual check-in. CMS proposes to accept the RUC recommended work value of 0.30, and the RUC recommended direct PE inputs
The agency does realize that the statutory extension of certain Medicare telehealth flexibilities—the waiver of the originating site requirement and geographic restrictions and coverage of audio-only services—will expire at the end of 2024 unless Congress takes additional action to maintain the flexibilities. Therefore, considering this, the agency seeks comment on mitigating the negative impact of the expiration of the flexibilities, and how the agency may be able, under its authority, to maintain access to care.
Request for Information for Services Addressing Health-Related Social Needs (Community Health Integration (G0019, G0022), Principal Illness Navigation (G0023, G0024), Principal Illness Navigation-Peer Support (G0140, G0146), and Social Determinants of Health Risk Assessment (G0136) – p. 213
Highlight: CMS seeks comment on ways to improve new codes used for reporting services like illness navigation and community health integration.
During last year’s rule making cycle, the agency proposed and finalized payment under the MPFS for services that address the health-related social needs of Medicare beneficiaries. These services included community health integration, principal illness navigation, principal illness navigation-peer support, and the provision of a social determinants of health risk assessment. The new services were created as part of the Biden administration’s plan to increase access to care in a fair and equitable manner. Now, the agency is requesting additional information on ways to improve these services, address any care gaps that may not be covered by the new codes, and possibly create additional codes within the scope of this policy. Other comments and information requested include:
- Are there any real or perceived barriers to furnishing the services?
- Are there other types of auxiliary personnel, other certifications or training requirements that should be allowed to provide these services?
- What types of auxiliary personnel are providing these services?
- How does the provision of community health integration services, and principal illness navigation services interact with community-based organizations (CBOs)? Have collaborative roles been developed between the billing practitioners and the CBOs?
- Seeking comment on the extent of practitioners contracting with CBOs to provide these services.
Evaluation and Management (E/M) Visits – p. 243
Highlight: CMS continues to update, revise and implement policies that support primary and non-procedural care provided to Medicare beneficiaries including expanded use of G2211.
Office/Outpatient (O/O) E/M Visit Complexity Add-on – p. 243
In the CY 2024 MPFS final rule, CMS finalized separate payment for the O/O visit complexity add-on code G2211 to reflect “the time, intensity, and PE resources involved when practitioners furnish the kinds of O/O E/M visits that enable them to build longitudinal relationships with all patients…and to address the majority of a patient’s health care needs with consistency and continuity over longer periods of time.” The final policy prohibited payment for the add-on code when the O/O E/M code is reported with modifier -25. In response to stakeholder concerns, CMS proposes to allow the add-on code to be billed when an O/O E/M code is reported on the same day as an annual wellness visit (AWV), vaccine administration service, or any Medicare Part B preventive service delivered in the office or outpatient setting.
Strategies for Improving Global Surgery Payment Accuracy – p. 337
Highlight: Refinement of the global surgical package remains on the agency’s radar, as this rule proposes to increase the use of transfer of care modifiers and creates a new code to capture post-operative care services when NOT provided by the practitioner who performed the surgery.
After years of studying the concept of the global surgical package and the associated payments, the agency proposes two changes that will provide for the collection of additional information on the resources involved in delivering global surgical services and the included follow-up visits. The research the agency has completed thus far on the global surgical packages is outlined on page 339 of the rule. Per the agency, studies have shown that the E/M services bundled into a global surgical package are not always provided, and therefore Medicare is overpaying for the service.2 The agency also states that the review of the global surgical package policy and proposed reforms align with other policy objectives to “pay more accurately for services to right-size the valuation of PFS services based on how practitioners currently furnish these services.” The agency also noted that payments to practitioners, and the relative values assigned to the global surgical packages are accurate and reflect “real-world objective and updateable information regarding the relative resources involved in furnishing these services.”
Therefore, CMS proposes to “broaden the applicability of the transfer of care modifiers” and require that practitioners use the existing modifiers for all 90-day global surgical procedures when a practitioner other than the one performing the procedure is expected to provide the pre- and post- operative portions of the service.
Transfer of care modifiers, created and implemented when the MPFS was developed more than thirty years ago, are used to indicate that the proceduralist, and one or more different practitioners, not in the same group practice as the proceduralist, will be providing distinct portions of the global package service. Current CMS policy requires the transfer of care modifiers must be appended to the global surgical procedure when this arrangement is entered into by the physicians and when a formal transfer of care is documented in the medical record in the form of a letter, annotation, or other means indicating this transfer of care has been agreed to by all involved practitioners. The agency recognizes that it may not be feasible or even typical for the same practitioner to provide all portions of the global surgical package. For example, there may be times when the surgeon believes that the primary care physician can safely and effectively provide the post-operative care. Or there may be instances when the patient finds it difficult to travel for a post-operative visit, and therefore a different practitioner, based locally would then provide the follow-up care.
The proposed policy to expand the use of global surgical package modifiers will require them to be reported with all “90-day global surgical packages in any case when a practitioner plans to furnish only a portion of a 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.”
The modifiers are 54 (surgical care only), 55 (post-operative management only), and 56 (preoperative management only). The agency anticipates the use of the modifiers will provide data on how certain components of the surgical package are provided, who is performing the services, and which specialties are billing for services with the 90-day global period. Finally, the use of the modifiers will prevent, it is hoped, the duplicative Medicare payment for post-operative care given that the payment will be adjusted based on the appended modifier.
The agency currently pays a portion of the care to the providers as appropriate when the modifiers are used, but now the agency is interested refining those payments, and making changes to the allocated proportions to reflect the care that is provided by each practitioner. CMS seeks comment how to best allocate the payment and wish to collect “data-driven method for assigning shares to portions of the global package payment to more appropriately reflect the resources involved in each portion.”
Additionally, CMS proposes a new HCPCS code, GPOC1 that is to be used when a practitioner provides post-operative care to a Medicare beneficiary when the practitioner did NOT perform the surgical procedure. The code was created by the agency to capture the resources provided to a surgical patient post-operatively, despite the absence of a formal transfer of care. The code may only be reported with an office E/M service for new or established patients. The new code is not billable when the physician who provided the surgical care, and the physician who is providing the follow-up care are in the same group practice or of the same specialty. Also, GPOC1 may only be billed once during the 90-day global period because the agency “believes the practitioner would only have additional resources costs for the first visit following the procedure.” The proposed work RVU is 0.16. The complete description of the new code may be found on page 353 of the display copy of the proposed rule.
CMS seeks comment on the global surgical package proposals, including comments on the appropriateness of the value for GPOC1, which may include comments on the typical time and intensity for a post-operative visit for a patient when the physician is not the physician who performed the surgical procedure.
Drugs and Biological Products Paid under Medicare Part B – p. 454
Requiring Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs to Provide Refunds with Respect to Discarded Amounts – p. 455
Recently, CMS finalized several policies to implement section 90004 of the Infrastructure Investment and Jobs Act, which requires manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or a single-use package drug for calendar quarters starting on January 1, 2023.
The agency proposes to revise how they determine the beginning of the 18-month exclusion period for certain drugs where the date of first sale as reported to CMS does not adequately approximate the first date of payment under Part B. In these cases, the first date where the drug is actually paid under Part B would be used to determine the start of the 18-month exclusion period.
CMS proposes to revise the definition of refundable single-dose container or single-use package drug to include injectable drugs with a labeled volume of 2 mL or less and that lack the package type terms and explicit discard statements in their product labeling, as well as to include drugs supplied in ampules.
Payment Limit Calculation when Manufacturers Report Negative or Zero Average Sales Price (ASP) Data
CMS proposes a methodology for calculating payment limits when manufacturers report negative or zero ASP data. The agency will consider that positive manufacturer’s ASP data is “available” while negative or zero ASP data is “not available” for CMS to calculate a payment limit. The agency sets out several proposed calculations that depend on the following factors:
- 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; or all NDCs for a billing and payment code have a negative or zero ASP; and
- Whether relevant applications to all NDCs for a billing and payment code have a marketing status of discontinued.
Appendix A: Specialty Level Impact Table
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