On August 25, 2022, CMS released a final rule to delay the current start date of the Radiation Oncology Model (RO Model) from January 1, 2023 to a date to be determined through future rulemaking. The proposal for this rule, released on April 6, came just a few months after Congress delayed the start of CMS’s mandatory RO Model from January 2022 to January 2023 by enacting the Protecting Medicare and American Farmers from Sequester Cuts Act on December 10, 2021.

Despite CMS’s continued belief in the value of the RO Model, the agency is delaying it indefinitely for two primary reasons. First, to mitigate the substantial operational resources required for CMS and RO Model participants to continue to prepare for the model amidst multiple delays and uncertainty about the timing of the model. Second, because CMS doesn’t think that key stakeholders will support the RO Model unless specific changes are made, such as lowering the discounts to 3% or lower, which would require trade-offs in the model design.

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Keep reading for more detail on the most recent changes as well as answers to the most frequently asked questions we’ve received about the model based on revisions made in CMS’s CY 2022 OPPS/ASC final rule.

Read through the entire page or jump to the most relevant section below:

• What revisions did CMS make to the RO Model in its August 2022 final rule?
• What revisions did CMS make to the RO Model in the CY 2022 OPPS/ASC final rule?
• What are CMS's goals with this model?
• When will this model start?
• Will my organization have to participate?
• Who's excluded from the model?
• How will CMS set the prices for an episode of care?
• Will this model include total costs of care during the 90-day episode?
• How will participants get paid?
• What is the aggregate quality score (AQS)?
• What clinical data elements will participants be required to submit?
• How would CMS calculate the AQS?
• How would the AQS impact payment?
• Would this model count as an advanced APM?
• What does this mean for practices enrolled in the OCM or other CMS payment programs?
• Will Medicare Advantage patients be enrolled?
• Is CMS really including proton beam therapy?
• Which radiation therapy modalities are excluded from the model?
• What were the major milestones in implementing the RO Model?

What revisions did CMS make to the RO Model in its August 2022 rule?

On August 25, 2022, CMS released a final rule that delays the current start date of the RO Model from January 1, 2023 to a date to be determined through future rulemaking. CMS stated that it continues to believe that the RO Model would address long-standing concerns related to radiation therapy delivery and payment, provide payment stability, and promote high-quality care for Medicare beneficiaries. However, the agency cited two primary reasons for the delay:

1. The operational, financial, and administrative investment and resources required for both CMS and RO Model participants to continue to prepare for the model amidst multiple delays and uncertainty about the timing of the model is substantial. Delaying the model indefinitely gives both parties the ability to pause their efforts to prepare for implementation.
2. CMS doesn't think that certain key stakeholders will support the RO Model unless specific changes are made, such as reducing the discounts to 3% or lower. Delaying the model indefinitely gives CMS the time to consider these potential changes and the trade-offs (e.g., expanding the geographic scope of the model) that would have to be made in the model design to incorporate them and get broader stakeholder buy-in.
3. In light of the delay, CMS has restricted access to the RO Portals, including making the RO Connect platform “read only,” limiting users from saving additional information in the RO Administrative Portal, and removing access to the RO Model Secure Data Portal.

What revisions did CMS make to the RO Model in the CY 2022 OPPS/ASC final rule?

CMS finalized the majority of the revisions proposed in the CY 2022 OPPS/ASC proposed rule as proposed, including that the RO Model will still start on January 1, 2022. However, the start date was pushed back to Jan. 1, 2023 with the passage of the Protecting Medicare and American Farmers from Sequester Cuts Act in December 2021. Notably, CMS’s proposals to adopt an extreme and uncontrollable circumstances (EUC) policy for the RO Model and to create tracks for participants were finalized with modifications.

Key RO Model proposed revisions finalized with modifications:

1. CMS will adopt an extreme and uncontrollable circumstances (EUC) policy that allows it to adjust model performance periods, reporting requirements, and/or payment methodology when necessary. Unless the Secretary terminates his renewal of the COVID-19 PHE prior to January 1, 2022, CMS intends to make the following modifications to the finalized revisions for performance year 1 for all RO Model participants (keep an eye on CMS’s RO Model website for more details):
   • The requirement that participants collect and submit quality measures and clinical data elements will be optional in PY1 (2022).
   • The 2% quality withhold will not be applied to professional episode payments in PY1 (2022) since quality reporting will be optional.
   • The requirement that participants actively engage with an AHRQ-listed patient safety organization (PSO) will be optional in PY1 (2022).
   • The requirement that participants conduct Peer Review (audit and feedback) on treatment plans will be optional in PY1 (2022).
   • CMS does NOT intend to amend the model performance period under the EUC policy.
2. There will be three tracks for RO Model participants related to Quality Payment Program (QPP) status:
   • Track One will be for professional and dual participants who comply with all RO requirements, including CEHRT; CMS expects this track to qualify as both an Advanced APM and MIPS APM.
   • Track Two will be for professional and dual participants who comply with all RO requirements except for CEHRT; CMS expects this track to qualify as a MIPS APM only.
   • Track Three will be for all other RO participants and will not qualify as a MIPS APM or Advanced APM.

Key RO Model proposed revisions finalized as proposed (although some of these will be affected if the EUC policy is invoked):

3. The model performance period will begin January 1, 2022 and end December, 31, 2026, with no new RO episodes beginning after October 3, 2026 to allow all episodes to end by December 31, 2026. Each performance year (PY) will be a full calendar year.
4. Participants in the Community Transformation track of the Community Health Access and Rural Transformation (CHART) Model or the Pennsylvania Rural Health Model (PARHM) will be excluded from participation. HOPDs that are eligible for but not participating in PARHM will not be excluded from the RO Model.
5. The "low volume opt-out" criteria were updated to include any physician group practice, freestanding radiation therapy center, or HOPD that furnishes fewer than 20 episodes in all of the selected CBSAs in the calendar year that is two years prior to the start of the PY.
6. The baseline period used to calculate the national base rates, historical experience adjustments, and case mix adjustments will be the three calendar year period beginning on January 1 before the start of each performance period; for PY1, the baseline period will be January 1, 2017 through December 31, 2019.
7. Case mix and historical experience adjustments will be calculated based on participants’ current TIN or CCN as well as their "legacy TIN(s)" or "CCN(s)."
8. Liver cancer will be removed from the model along with a slight revision to the cancer inclusion criteria to improve clarity and consistency.
9. Brachytherapy will be removed from the list of included modalities.
10. The discount factor will be lowered from 3.75% to 3.5% for the professional component and from 4.75% to 4.5% for the technical component.
11. Quality measure requirements and the 2% quality withhold for the professional component will begin in PY1 (instead of being delayed to PY2); RO Model participants' first annual submission of quality measures data will be in March 2023 to submit PY1 data. Finalized, but will be affected if the EUC policy is invoked.
12. Three quality measures (Plan of Care for Pain, Screening for Depression and Follow-Up Plan, and Advance Care Plan) will be pay-for-performance for PY1-5 (instead of PY2-5); the fourth quality measure (Treatment Summary Communication—Radiation Oncology) will be pay-for-reporting for PY1-2 (instead of PY2-3) and pay-for-performance for PY3-5 (instead of PY4-5). Finalized, but will be affected if the EUC policy is invoked.
13. CAHPS Cancer Care Survey for Radiation will be administered as early as April 2022 (instead of October 2021).
14. Data collection period for clinical data elements will begin in PY1 (instead of PY2), with the first submission of clinical data elements for Jan. 1, 2022 through June 30, 2022 due in July 2022. Finalized, but will be affected if the EUC policy is invoked.
15. CMS expects the RO Model to meet the criteria to be both an Advanced APM and a MIPS APM starting in PY1. However, whether individual participants qualify for these APMs will depend on their RO Model track. Finalized, but may be affected if the EUC policy is invoked.
16. Beginning in PY1, the individual practitioner list will be used to identify the relevant eligible clinicians for purposes of making Quality APM Participant (QP) determinations and for certain aspects of MIPS under the QPP. Participants will have until the last QP determination snapshot date to review and certify their individual practitioner lists. Technical participants will be provided an individual practitioner list in addition to professional and dual participants.
17. Participants must certify their use of CEHRT at the start of PY1 (instead of PY2) and each subsequent PY to be included in Track One of the RO Model.
18. CMS will remove the 2% sequestration amount and instead will apply sequestration "in accordance with applicable law."
19. In cases where a beneficiary switches from Medicare fee-for-service to Medicare Advantage during an episode before treatment is complete, their episode will be considered incomplete and CMS will pay the traditional Medicare rate.

What are CMS's goals with this model?

First off, cost control. Medicare Part B spending on radiation therapy increased 216% from 2000 to 2010. Second, CMS doesn't shy away from using "site neutrality" in its reasoning for this model. Interestingly, however, in its analysis of FY 2017 claims, CMS found that Medicare paid 11% more for radiation therapy episodes delivered in freestanding settings compared with hospital outpatient departments (HOPDs), even though Medicare payments are lower per-unit in freestanding settings. The findings indicate that these settings tend to use more expensive therapies, such as intensity-modulated radiation therapy (IMRT), and less hypofractionation (in which radiation therapy is given in higher doses over a shorter period of time) compared with HOPDs.

In addition to unequal payments, there is also inconsistent coding under the Physician Fee Schedule (PFS) and Outpatient Prospective Payment System (OPPS) for radiation services. Lastly, CMS calls out the need to align payments to quality and value, which isn't surprising. In particular, CMS emphasized the lack of uptake in hypofractionation despite growing evidence supporting its use.

When will this model start?

On April 6, 2022, CMS released a proposed rule that proposes to delay the current start date of the RO Model from January 1, 2023 to a date to be determined through future rulemaking. We expect to hear if this proposal will be finalized sometime this summer since CMS is accepting public comments through June 7th, 2022.

The RO Model was originally set to begin on Jan. 1, 2022 and continue for five years through Dec. 31, 2026 in accordance with the Consolidated Appropriations Act, 2021. However, the start date was pushed back to Jan. 1, 2023 with the passage of the Protecting Medicare and American Farmers from Sequester Cuts Act in December 2021.

Will my organization have to participate?

Participation in the RO Model is mandatory for all radiation therapy providers and suppliers within randomly selected Core-Based Statistical Areas (CBSAs) (listed here). The model is intended to include 30% of eligible radiation oncology episodes in the U.S.

Note: If CMS’s April 2022 proposal to delay the RO Model indefinitely is finalized, it’s possible that the geographic scope of the model will be expanded to include more than 30% of CBSAs to accommodate changes to the model discounts requested by key stakeholders. If the proposed rule is not finalized and CMS proceeds with a start date of January 1, 2023, the agency does not plan to change the CBSAs selected to participate before that start date.

Given the model mechanics (explained in more detail below), there will be three types of participants:

1. Professional participants: Physician groups billing under PFS that furnish just the professional component (physician-dependent services) at a freestanding center or HOPD;
2. Technical participants: HOPD or freestanding centers that furnish only the technical component (equipment, overhead, etc.) of radiation therapy; and
3. Dual participants: When the physicians performing radiation also own the location where it is delivered, meaning they furnish both the technical and professional components.

This structure means that one qualifying episode could be delivered by one dual participant or by one professional and one technical participant. 

Who's excluded from the model?

The model will exclude providers in Maryland, Vermont, U.S. territories, ambulatory surgical centers, critical access hospitals, PARHM, the Community Transformation track of the CHART Model, and PPS-exempt cancer hospitals. HOPDs that are eligible for but not participating in PARHM are not excluded from the RO Model.

Additionally, physician group practices, freestanding radiation therapy centers, or HOPDs that would otherwise be required to participate in the RO Model will be allowed to opt out of the RO Model on an annual basis if they furnish fewer than 20 episodes across all selected CBSAs in the calendar year that is two years prior to the start of the PY. CMS will consider episodes associated with participants’ current and legacy TINs or CCNs to determine eligibility; a legacy TIN or CCN is defined as a TIN or CCN that has previously been used to bill Medicare for included radiation therapy services.

How will CMS set the prices for an episode of care?

Here's a summary of the eight steps that CMS will use in its pricing methodology:

1. Create national base rates for the professional and technical components for each cancer type. Since 15 cancers are included (liver cancer was removed in CMS's CY OPPS/ASC 2022 final rule), CMS will create 30 base rates using historical average cost for an episode of care based on fee-for-service claims from 2017 to 2019.

   Here are the national base rates by cancer type CMS shared in the  CY 2022 OPPS/ASC final rule (in 2019 dollars):

   
2. Apply a trend factor to the base rates to reflect current trends in payment and treatment pattern changes.
3. Apply geographic adjustments.
4. Adjust the base rates for each participant's historical experience and case mix history. Each participant will receive one professional component and/or one technical component case mix adjustment. This adjustment will be based on a set of characteristics strongly correlated to costs, such as tumor site, age, sex, major procedures, chemotherapy, and death. (Note on this last point: This means that if a beneficiary dies or is enrolled in hospice during the episode, providers will still receive full payment whether or not treatment is completed.) Historical experience adjustment will be based on Winsorized payment amounts, then weighted with an efficiency factor that reflects if a provider has historically been more or less costly than the national base rates. Both historical experience and case mix will be calculated based on each participant’s current TIN or CCN and legacy TIN(s) or CCN(s).
5. Apply a discount factor. The discount is the set percentage by which CMS will reduce an episode payment amount after the trend, geographic, and historic adjustments. The discount will be 3.5% for the professional component and 4.5% for the technical component.
6. Apply an incorrect payment withhold, as well as a quality withhold and/or patient experience withhold.
   • Starting in PY1, the incorrect payment withhold reserves money for reconciling duplicate or incomplete episodes—it will be 1% of the total episode payment for the professional and technical components. There will be an annual reconciliation process to determine if participants receive back the full 1%, a portion of it, or owe money to CMS.
   • Starting in PY2, the quality withhold will hold back 2% of payment that participants can earn back based on their performance on and reporting of quality measures (aggregate quality score explained in more detail below). This applies only to the professional component. Note: If the EUC policy is invoked, the quality withhold will not be applied to RO Model professional episode payments in PY1.
   • Starting in PY3, a 1% patient experience withhold will kick in for the technical component and will be based on scores from the Cancer CAHPS for Radiation Therapy.
7. Apply beneficiary coinsurance. Beneficiaries will still have 20% coinsurance, but they will have fewer and higher payments because of the nature of the bundle. CMS encourages providers to help set up payment plans for these patients, especially those without secondary insurance. CMS also notes that beneficiary coinsurance for the participant-specific technical payment amount cannot exceed the inpatient deductible limit under OPPS.
8. Apply a sequestration adjustment in accordance with applicable law.

Will this model include total costs of care during the 90-day episode?

No. This makes this model different than the Oncology Care Model (OCM), in which providers are held accountable for total costs of care. In the Radiation Oncology Model, only specified radiation therapy services provided during the 90-day episode would be included.

How will participants get paid?

There will be two installments for all participants, one at the beginning and another at the end of an episode. To do this, CMS will issue new model-specific HCPCS codes and modifiers to signal the start and end points. Participants can submit an end of episode (EOE) claim requesting the second installment of the episode payment at the completion of the planned course of treatment (but no earlier than 28 days after the initial treatment planning service was furnished), instead of waiting until the end of the 90-day episode period as proposed (although the duration of the episode remains 90 days).

That said, participants will still need to submit encounter data (no-pay) claims for all radiation services included in the bundle. Even though they will not be separately reimbursed for this, it is critical for CMS to monitor utilization under the model.

What is the aggregate quality score (AQS)?

Starting in PY1, the AQS will be used to calculate the quality reconciliation payment for professional and dual participants. The AQS is based on the five pay-for-reporting and pay-for-performance quality measures in the table below and submission of clinical data elements.

CMS will administer the CAHPS Cancer Care Survey for Radiation starting no earlier than the fourth month of the model performance period. By PY3, patient experience scores will be added to the AQS for dual and professional participants. For technical participants, patient experience scores will be added in as well and applied to the 1% patient experience withhold outlined above.

For the clinical data elements component, professional and dual participants will be required to submit clinical data biannually describing cancer stage, disease characteristics, treatment intent, and specific treatment plan information for RO Model beneficiaries with five types of cancer: prostate, breast, lung, bone metastases, and brain metastases. More details about clinical data elements can be found in CMS's new RO Model Quality Measure and Clinical Data Element Collection and Submission Guide and other resources can be found in the "Technical Documents" section of CMS's RO Model webpage. Data collection will start in PY1 and will be shared with EHR vendors and specialty societies to help build reporting standards into current platforms.

Note: If the EUC policy is invoked, the quality withhold will not be applied to RO Model professional episode payments in PY1.

What clinical data elements will participants be required to submit?

The clinical data elements that professional and dual participants will be required to submit are included in the table below:

For RO beneficiaries with multiple primary cancers, participants must report the clinical data elements for the cancer type they bill for the episode.

Note: If the EUC policy is invoked, the quality withhold will not be applied to RO Model professional episode payments in PY1.

How would CMS calculate the AQS?

The equation for the AQS is: AQS = quality measures (0-50 points based on weighted measure scores and reporting) + clinical data (50 points when data is submitted for at least 95% of applicable beneficiaries)

For the pay-for-performance measures, participants' performance will be compared with MIPS benchmarks. For the pay-for-reporting measures, the plan is to gather those benchmarks and then shift them to pay-for-performance. All quality measures will be weighted equally, awarded up to 10 points, and then recalibrated to a denominator of 50 points.

How would the AQS impact payment?

AQS would be taken as a percentage against the 2% quality withhold amount. So, if a participant receives an AQS of 88.3, the participant will receive 1.77% of the reconciliation payment amount. If a total episode payment after all of the discounts and adjustments was $2,465.68, the quality reconciliation payment would be $43.64 ($2,465.68 x 0.0177).

Note: If the EUC policy is invoked, the requirement that participants collect and submit quality measures and clinical data elements will be optional in PY1. Because of this, the 2% quality withhold will not be applied to RO Model professional episode payments in PY1.

Would this model count as an advanced alternative payment model?

CMS expects the RO Model to qualify as an Advanced APM and a MIPS APM under the Quality Payment Program (QPP), because the model:

• Requires participants to annually certify their intent to use Certified Electronic Health Record Technology (CEHRT)
• Includes quality measure performance as a factor when determining payments
• Requires participants to bear more than a nominal amount of financial risk

However, whether individual participants are considered to be participating in either of these APMs depends on which of the three RO Model tracks they are assigned to based on their compliance with RO Model requirements:

1. Track One is for professional and dual participants who comply with all RO requirements, including CEHRT; CMS expects this track to qualify as both an Advanced APM and a MIPS APM.
2. Track Two is for professional and dual participants who comply with all RO requirements except for CEHRT; CMS expects this track to qualify as a MIPS APM only.
3. Track Three is for all other RO participants, including professional and dual participants who don’t meet one or more RO Model requirements (besides CEHRT) and all technical participants; CMS does not expect this track to qualify as a MIPS APM or Advanced APM (although it does expect participants in this track to be considered as participating in an APM).

CMS will make Qualifying APM Participant (QP) determinations for eligible clinicians on the RO Model Participation List for Track One; those who don’t meet the thresholds to become QPs can report to MIPS using reporting options applicable to MIPS APM participants. Beginning in PY1, the individual practitioner list will be used to identify the relevant eligible clinicians for purposes of making QP determinations (and for certain aspects of MIPS) under the Quality Payment Program. Participants will have until the last QP determination snapshot date to review and certify their individual practitioner lists.

CMS will not make QP determinations for eligible clinicians on the RO Model Participation List for Tracks Two and Three. And eligible clinicians on the RO Model Participation List for Track Three will not have unique MIPS reporting options available to participants in a MIPS APM (though they will receive MIPS Improvement Activity scoring credit for participation in an APM).

What does this mean for practices enrolled in the OCM or other CMS payment programs?

Practices in selected CBSAs that are also enrolled in OCM will still be required to participate. While the radiation oncology episode is limited to just radiation-related services, OCM looks at total costs of care so changes in radiation oncology costs could impact an OCM participant's performance. To account for this, CMS finalized the following provisions for addressing overlap between the OCM and the RO Model provisions in two potential scenarios:

• Entire radiation oncology model episode (90 days) occurs within a six-month OCM episode: The associated radiation payments would be included in the OCM episode. But to account for the radiation oncology model impact, the radiation oncology model's discount and withhold amounts (explained above) will be added to the total cost of the OCM episode during the reconciliation process. This is meant to avoid double counting of savings and double payments of the withhold amounts between the two models.
• Radiation oncology model overlaps partially with an OCM episode: The radiation oncology services and payments would be attributed to the OCM on a prorated basis based on the days of overlap.

CMS also stated that it intends to continue reviewing overlap with OCM and that CMMI will notify OCM participants of any further impact or information.

When it comes to other payment programs, CMS will waive specific payment adjustments that depend on whether care is delivered in a freestanding or HOPD setting. For example, it will waive the MIPS payment adjustment factor for the technical component of RO Model payments (not the professional component) and the Outpatient Quality Reporting Program payment adjustment for all radiation services included in the bundle. This will ensure that payment comparisons across HOPDs, freestanding centers, and physician group practices are not impacted due to performance in those specific programs. For the APM incentive program, CMS will waive the inclusion of technical fees and only include professional fees.

Will Medicare Advantage patients be enrolled?

Nope, just patients in Medicare fee-for-service. Patients must receive radiation services in a five-digit zip code linked to a selected CBSA, have a qualifying ICD-10 diagnosis code, and be enrolled in Medicare Part B. Patients in clinical trials for which CMS pays routine costs will also be enrolled in the model. If a beneficiary switches from Medicare fee-for-service to Medicare Advantage during an episode before treatment is complete, their episode will be considered incomplete and CMS will pay the traditional Medicare rate.

Is CMS really including proton bem therapy?

Yes, CMS finalized including proton specifically because of the debate around its value. CMS cited ICER's report finding that proton offers superior net health benefit for ocular tumors, incremental net health benefit for adult brain and spinal tumors and pediatric tumors, and comparable net health benefit for prostate, lung, and liver cancers. One of the main goals of this model is to incentivize providers to choose the highest-value modality, and including proton in the model is critical to accomplish that.

Of note, proton will be excluded if patients are enrolled in a federally funded, multi-organizational, randomized control clinical trial.

In addition to proton therapy, the following radiation modalities will also be included in the RO Model: 3-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), stereotactic radiosurgery (SRS), stereotactic body radiotherapy (SBRT), and image-guided radiation therapy (IGRT).

Which radiation therapy modalities are excluded from the model?

CMS excluded intraoperative radiotherapy (IORT) from the model in the 2021 OPPS/ASC final rule because the evidence base for IORT is limited only to certain cancer types and because it is primarily delivered in HOPDs during surgery, meaning it is not site neutral. However, CMS did solicit comments on how it might include IORT in future years in the CY 2022 OPPS/ASC proposed rule, and will consider these in future rulemaking.

In the CY 2022 OPPS/ASC final rule, CMS also excluded brachytherapy from the model to ensure that providers wouldn't be incentivized to forego brachytherapy in situations when a combination of both brachytherapy and EBRT is clinically indicated.

What were the major milestones in implementing the RO Model?

• July 2019: CMS first published its proposal for the Radiation Oncology Model.
• September 2020: CMS finalized the model with the intended start date of January 1, 2021.
• December 2020: CMS announced in the CY 2021 OPPS/ASC final rule its intent to delay the model start date to July 1, 2021 in response to feedback from stakeholders and the ongoing Covid-19 pandemic.
• December 2020: Congress enacted the Consolidated Appropriations Act,2021, which prohibited implementation of the RO Model prior to January 1, 2022.
• July 2021: CMS proposed additional modifications to the model design in the CY 2022 OPPS/ASC proposed rule, which proposed starting the model on January 1, 2022.
• November 2021: CMS finalized the majority of its proposals as proposed in the CY 2022 OPPS/ASC final rule, including the January 1, 2022 start date. But notably, CMS finalized its proposals to adopt an extreme and uncontrollable circumstances (EUC) policy for the RO Model and to create tracks for participants with modifications.
• December 2021: Congress delayed the start of the model to January 2023 by enacting the Protecting Medicare and American Farmers from Sequester Cuts Act.
• April 2022: CMS released a proposed rule that proposes to delay the current start date of the RO Model from January 1, 2023 to a date to be determined through future rulemaking.
• August 2022: CMS finalized the delay of the RO Model from January 1, 2023 to a date to be determined through future rulemaking.

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