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CMMI Radiation Oncology Alternative Payment Model “RO Model” Proposed Rule Summary

July 11, 2019

On Wednesday, July 10, 2019, the Centers for Medicare and Medicaid Innovation Center issued a proposed rule establishing a Radiation Oncology Alternative Payment Model (RO Model), requiring participation from approximately 40% of radiation oncology practices. ASTRO issued a statement on the RO Model, noting that with modifications, the model as the potential to incentivize higher quality, more convenient radiation treatments for patients.

The “RO Model” is proposed to establish a 90-day episode of care for 17 disease sites that are prospectively paid using a site neutral payment methodology. As proposed, the RO Model meets Advanced Alternative Payment Model (APM) requirements by satisfying the Medicare Access and CHIP Reauthorization Act (MACRA) Advanced APM nominal risk requirement, inclusion of MIPS comparable measures and Certified Electronic Health Records Technology (CHERT) utilization requirements.

According to the proposed rule, the RO Model is designed to test whether prospective episode-based payments to physician group practices (PGPs), hospital outpatient departments (HOPDs), and freestanding radiation therapy centers for episodes of care would reduce Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. The Agency proposes launching the model either January 1, 2020 or April 1, 2020, and estimates savings of $250-260 million (or 3%) over the Model’s five-year implementation period. CMS asserts that the RO Model’s episode payment is designed to give radiation oncologists greater predictability in payment and greater opportunity to clinically manage episodes of care, rather than being driven by Fee-For-Service payment incentives.

Below is a comprehensive summary of the key elements included in the proposed RO Model. ASTRO will develop extensive comments on the proposed rule based detailed data analysis and stakeholder input. Comments are due by September 16, 2019.

Participation Requirements

CMS will identify randomly selected Core Based Statistical Areas (CBSAs) for participation in the model. Based on a sample size large enough to achieve 3% in Medicare savings, the RO Model is expected to include 40 percent of radiation oncology episodes in eligible geographic areas. While the proposed rule does not list specific CBSAs for participation in the model, the Agency does provide a simulation of the approach it will use to identify selected CBSAs. The CMS simulation identified 616 PGPs (325 of which are freestanding centers) and 541 HOPDs in the simulated selected CBSAs. These providers and suppliers delivered 39.7% of radiation episodes nationally, based on data from 2015-2017. The list of selected CBSAs will be published in the final rule.

ASTRO has long-supported voluntary participation in a radiation oncology APM, and we are very concerned about launching a model that requires mandatory participation from such a large number of radiation oncology practices at the outset. Given the significant change and rapid implementation of the model, forcing some unready practices to participate while at the same time prohibiting others that are well-prepared is problematic. ASTRO will urge CMS to reconsider pursuing a mandatory model, or at least consider requiring many fewer practices to participate. ASTRO is also concerned that practices won’t find out if they’re in the model until just weeks before it starts, so it’s possible that ASTRO will recommend that the model start no sooner than April 1, 2020 or even later.

If finalized as proposed, the RO Model starting January 2020, would include an estimated 364,000 episodes, 322,000 beneficiaries, and $5.4 billion in total episode spending of allowed charges over the five-year demonstration period. If finalized as proposed, with an April 2020 start date, the RO Model would include an estimated 346,000 episodes, 307,000 beneficiaries and $5.1 billion in total episode spending of allowed charges.

CMS is requiring participation of three distinct types of RO participants: “Professional participants,” “Technical participants” and “Dual participants”. Professional participants are Medicare-enrolled physician group practices, identified by a single Taxpayer Identification Number (TIN), that deliver only the professional component of radiation therapy services at either a freestanding radiation therapy center or a Hospital Outpatient Department. A “technical participant” is a RO participant that is a Medicare-enrolled HOPD or freestanding radiation therapy center, identified by a single CMS certification number (CCN) or TIN, which furnishes only the technical component of RT services. A “dual participant” is a RO participant that furnishes both the professional component and technical component of an episode of RT services through a freestanding radiation therapy center, identified by a single TIN.

Beneficiary Populations
CMS proposes to include all traditional Medicare beneficiaries who receive radiation therapy services for at least one identified cancer type in one of the selected CBSAs. The Agency also proposes to include any Medicare beneficiary participating in a clinical trial for radiation therapy services that are provided in either the experimental or control arms of a clinical trial.

Professional participants and Dual participants must notify Medicare beneficiaries that they are participating in the RO Model by providing written notice to each beneficiary during the initial treatment planning session. CMS plans to provide a notification template that can be personalized, which explains that the RO participant is participating in the RO Model and would include information regarding beneficiary cost-sharing responsibilities, and the beneficiary’s right to refuse having his or her data shared with CMS. In these circumstances, the RO participant will have 30 days to notify CMS in writing regarding the beneficiary’s decision to refuse to participate.

Model Exemptions
CMS is not proposing to establish a hardship exemption for RO participants under the RO Model, which is a concern to ASTRO. According to the proposed rule, the Agency believes that the pricing methodology, which is based on historical rates and recognizes practices’ efficiencies, does not represent a significant burden for practices and thus does not warrant any type of hardship exemption. The Agency welcomes input on this decision for future rulemaking.

Radiation oncology centers in Maryland, Vermont or in U.S. Territories are excluded from the model, as are Ambulatory Surgical Centers (ASC), Critical Access Hospitals, PPS-exempt Cancer hospitals and Pennsylvania Rural Health Model participants.

Cancer Types, Episode Length and Trigger

CMS is proposing a 90-day episode of care that is triggered when two criteria are met: 1) there is an initial treatment planning service (submission of treatment planning codes 77261-77263) furnished by a Professional participant or Dual participant, and 2) at least one radiation treatment delivery services is furnished by a technical participant or dual participant within the following 28 days. This is based on claims data indicating that 99 percent of Medicare beneficiaries complete their course of radiation within 90 days of their initial treatment planning service. In order to disincentivize the extension of a treatment course beyond the 90-day episode window, CMS is establishing a clean period in which no episodes can be triggered that would last 28 days after the close of the previous episode. During the “clean period,” should a patient require radiation therapy services, then they would be billed in accordance with Fee-For-Service (FFS) billing rules.

The proposed RO Model includes 17 disease sites as depicted in the table below:

TABLE 1: IDENTIFIED CANCER TYPES AND CORRESPONDING ICD-9 AND ICD-10 CODES

Cancer Type ICD-9 Codes ICD-10 Codes
Anal Cancer 154.2x, 154.3x C21.xx
Bladder Cancer 188.xx C67.xx
Bone Metastases 198.5x C79.5x
Brain Metastases 198.3x C79.3x
Breast Cancer 174.xx, 175.xx, 233.0x C50.xx, D05.xx
Cervical Cancer 180.xx C53.xx
CNS Tumors 191.xx, 192.0x, 192.1x, 192.2x, 192.3x, 192.8x, 192.9x C70.xx, C71.xx, C72.xx
Colorectal Cancer 153.xx, 154.0x, 154.1x, 154.8x C18.xx, C19.xx, C20.xx
Head and Neck Cancer 140.xx, 141.0x, 141.1x, 141.2x, 141.3x, 141.4x, 141.5x, 141.6x, 141.8x, 141.9x, 142.0x, 142.1x, 142.2x, 142.8x, 142.9x, 143.xx, 144.xx, 145.0x, 145.1x, 145.2x, 145.3x, 145.4x, 145.5x, 145.6x, 145.8x, 145.9x, 146.0x, 146.1x, 146.2x, 146.3x, 146.4x, 146.5x, 146.6x, 146.7x, 146.8x, 146.9x 147.xx, 148.0x, 148.1x, 148.2x, 148.3x, 148.8x, 148.9x, 149.xx, 160.0x, 160.1x, 160.2x, 160.3x, 160.4x, 160.5x, 160.8x, 160.9x, 161.xx, 195.0x C00.xx, C01.xx, C02.xx, C03.xx, C04.xx, C05.xx, C06.xx, C07.xx, C08.xx, C09.xx, C10.xx, C11.xx, C12.xx, C13.xx, C14.xx, C30.xx, C31.xx, C32.xx, C76.0x
Kidney Cancer 189.0x C64.xx
Liver Cancer 155.xx, 156.0x, 156.1x, 156.2x, 156.8x, 156.9x C22.xx, C23.xx, C24.xx
Lung Cancer 162.0x, 162.2x, 162.3x, 162.4x, 162.5x, 162.8x, 162.9x, 165.xx C33.xx, C34.xx, C39.xx, C45.xx
Lymphoma 202.80, 202.81, 202.82, 202.83, 202.84, 202.85, 202.86, 202.87, 202.88, 203.80, 203.82, 200.0x, 200.1x, 200.2x, 200.3x, 200.4x, 200.5x, 200.6x, 200.7x, 200.8x, 201.xx, 202.0x, 202.1x, 202.2x, 202.4x, 202.7x, 273.3x C33.xx, C34.xx, C39.xx, C45.xxC81.xx, C82.xx, C83.xx, C84.xx, C85.xx, C86.xx, C88.xx, C91.4x
Pancreatic Cancer 157.xx C25.xx
Prostate Cancer 185.xx C61.xx
Upper GI Cancer 150.xx, 151.xx, 152.xx C15.xx, C16.xx, C17.xx
Uterine Cancer 179.xx, 182.xx C54.xx, C55.xx

Included Services

CMS proposes that the model would include most radiation therapy services, including consultation; treatment planning; dose planning; radiation physics and dosimetry, treatment devices and special services; treatment delivery; and treatment management. The Agency proposed to exclude evaluation and management (E/M) services from the model; however, radiation oncologists can continue to bill these codes under Medicare Fee-For-Service. Additionally, CMS is proposing to exclude low volume services from the model, including certain brachytherapy surgical procedures, neutron beam therapy, hyperthermia treatment and radiopharmaceuticals.

The Agency considered excluding brachytherapy sources due to evidence that physicians sometimes contract with others to supply or administer brachytherapy sources or radioisotopes. CMS decided to include brachytherapy sources since hospitals are usually the purchasers of the radioactive elements that are generally furnished in HOPDs; however, any services delivered in an ASC would be excluded.

Included Modalities

CMS proposes to include all modalities of treatment, including external beam therapy: three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, stereotactic radiosurgery, stereotactic body radiotherapy and proton beam therapy; intraoperative radiotherapy; image guided radiation therapy; and brachytherapy.

CMS is considering excluding proton beam therapy from the included modalities in instances where a beneficiary is participating in a federally funded, multi-institutional, randomized control clinical trial for proton beam therapy so that further clinical evidence assessing its health benefit comparable to other modalities can be gathered.

Site Neutral Test

The RO Model proposal includes a “site neutral test” that would establish a common payment amount for services regardless of where they are furnished. The Agency believes this would offer RO participants more certainty regarding the pricing of radiation therapy services and remove incentives to promote the provision of radiation therapy services at one site over another. Since the HHS Secretary does not have the authority to adjust payments outside of the established MPFS and HOPPS payment methodologies, this test would only be applicable to RO Model participants.

Episode Payment Construct

CMS is proposing that each episode would have corresponding professional component and technical component payment amounts. These amounts represent the totals of calculated payment amounts for the professional and technical services of the radiation treatment furnished over the 90-day episode of care. The Agency proposes to calculate the payment amounts for the professional component (PC) and technical component (TC) of each episode as the product of: 1) the OPPS or PFS national payment rates for each radiation therapy service included in the RO Model multiplied by 2) the volume of each professional and technical radiation therapy service included on a paid claim line during an episode of care.

Pricing Methodology

CMS proposes to define the term “participant-specific professional episode payment” as a payment made by CMS to a Professional participant or Dual participant for the provision of the professional component of radiation therapy services furnished to a beneficiary during an episode of care. The term “participant-specific technical episode payment” is defined as a payment made by CMS to a technical or dual participant for the provision of the technical component radiation therapy services to a beneficiary during an episode of care.

Additionally, the Agency proposes to provide RO participants with updated participant-specific professional episode payment and technical episode payment amounts for each cancer type 30 days prior to the start of each performance year.

The proposed payment methodology includes eight steps:

Step 1: National Base Rates
The first step involves the development of national base rates for the PC and TC of each of the included cancer types. CMS is proposing to define national base rates as the total payment amount for each episode before the application of a trend factor, discount factor, adjustments and applicable withholds for each cancer type. Episodes used to develop the national base rate include 1) episodes initiated between 2015-2017; 2) episodes attributed to a HOPD; and 3) during an episode, the majority of the technical services were provided in a HOPD. The Agency is proposing to use HOPD episodes, rather than freestanding and HOPD episodes, because it believes Outpatient Prospective Payment System (OPPS) payments have been more stable over time and have a stronger empirical foundation, because they are derived from hospital cost reports, than those under the Medicare Physician Fee Schedule (MPFS). ASTRO will do further analysis to determine the appropriateness of solely relying on the OPPS payments for the national base rates. The following table provides proposed national base rates by cancer type.

TABLE 3 – NATIONAL BASE RATES BY CANCER TYPE (in 2017 DOLLARS)

RO Model-Specific Placeholder Codes Professional or Technical Cancer Type Base Rate
MXXXX Professional Anal Cancer $2,968
MXXXX Technical Anal Cancer $16,006
MXXXX Professional Bladder Cancer $2,637
MXXXX Technical Bladder Cancer $12,556
MXXXX Professional Bone Metastases $1,372
MXXXX Technical Bone Metastases $5,568
MXXXX Professional Brain Metastases $1,566
MXXXX Technical Brain Metastases $9,217
MXXXX Professional Breast Cancer $2,074
MXXXX Technical Breast Cancer $9,740
MXXXX Professional Cervical Cancer $3,779
MXXXX Technical Cervical Cancer $16,955
MXXXX Professional CNS Tumor $2,463
MXXXX Technical CNS Tumor $14,193
MXXXX Professional Colorectal Cancer $2,369
MXXXX Technical Colorectal Cancer $11,589
MXXXX Professional Head and Neck Cancer $2,947
MXXXX Technical Head and Neck Cancer $16,708
MXXXX Professional Kidney Cancer $1,550
MXXXX Technical Kidney Cancer $7,656
MXXXX Professional Liver Cancer $1,515
MXXXX Technical Liver Cancer $14,650
MXXXX Professional Lung Cancer $2,155
MXXXX Technical Lung Cancer $11,451
MXXXX Professional Lymphoma $1,662
MXXXX Technical Lymphoma $7,444
MXXXX Professional Pancreatic Cancer $2,380
MXXXX Technical Pancreatic Cancer $13,070
MXXXX Professional Prostate Cancer $3,228
MXXXX Technical Prostate Cancer $19,852
MXXXX Professional Upper GI Cancer $2,500
MXXXX Technical Upper GI Cancer $12,619
MXXXX Professional Uterine Cancer $2,376
MXXXX Technical Uterine Cancer $11,221

Step 2: Application of a Trend Factor
The second step involves the application of a trend factor that would be updated and applied each year to both the PC and TC of each cancer type. The trend factor would account for trends in payment rates and volume for radiation therapy services outside of the RO Model that continue to be paid at PFS and OPPS rates. For both the PC and TC, the Agency is proposing to calculate the ratio of: a) volume-weighted FFS payment rates for radiation therapy services included in that component for each specific cancer type in the upcoming participation year (numerator) to b) volume-weighted FFS payment rates for RT services included in that component for each cancer type in the most recent base line year (denominator). Any new codes that are introduced are proposed to be cross-walked to volumes based on existing code sets.

Step 3: Case Mix, Historical Experience and Efficiency Adjustments
In the third step, the Agency proposes to adjust the national base rates to account for each RO participant’s case mix, historical experience, and efficiency.  The case mix adjustment accounts for care patterns and factors that are beyond the RO participant’s control, which tend to vary by practice, such as cancer type; age; sex; presence of major procedure; death during the first 30 days, second 30 days, or last 30 days of the episode; and presence of chemotherapy. There would be one PC and one TC case mix adjustment that measures the occurrence of the case mix variables among the beneficiary population by cancer type that each RO participant has treated historically compared to the occurrence of these variables in the national beneficiary profile over the same period of time (2015-2017). The Agency proposes to use a Winsorization process to cap episode payments attributed to the RO participant at the 99th and 1st percentiles. It then compares a RO participant’s predicted payments, which recognize case mix, to a RO participant’s expected payments, which do not consider case mix. The difference between a RO participant’s predicted payment and expected payment divided by the expected payment yields either the PC or TC case mix adjustment for that RO participant.

The historical experience adjustment is proposed to include episode data attributed to the RO participant during 2015-2017. A historical experience adjustment would be calculated for the PC and the TC based on attributed episodes. The methodology for the historical experience adjustment is similar to the Case Mix Adjustment methodology in that it uses a Winsorization process to cap episode payments, but it does not vary by cancer type. The historical experience adjustment for the PC and TC component would be the difference between: the sum of a) Winsorized payments for episodes attributed to the radiation oncology participant and b) the summed predicted payments from the case mix adjustment calculation, which would then be divided by c) the summed expected payments used in case mix adjustment calculations.

The historical experience adjustment is proposed to be further weighted by an efficiency factor that measures whether a RO participant’s episodes have historically been more or less costly than the national base rate. According to the proposed rule, if a RO participant’s Winsorized episode payments are equal to or less than the predicted payments used to determine case mix adjustments, then it would have historical experience adjustments with a value equal to or less than 0.0, making it an efficient practice. Conversely, if a RO participant’s episode payments are greater than the predicted payments used to determine the case mix adjustment, then it would be determined an inefficient practice. For RO participants with historical experience adjustments with a value greater than 0.0, the efficiency factor would decrease over time to reduce the impact of historical practice patterns on payment over the Model’s performance period. For RO participants, with a PC or TC historical experience adjustment with a value greater than 0.0, the efficiency factor would be 0.90 in performance year 1, 0.85 in performance year 2, 0.80 in performance year 3, 0.75 in performance year 4, and 0.70 in performance year 5. For RO participants with a PC or TC historical experience adjustment with a value equal to or less than 0.0, the efficiency factor would be fixed at 0.990 over the model’s performance period.

Below is a summary of the Adjustment Factor Calculations:

  • Case Mix Adjustment = (predicted payment – expected payment)/expected payment
  • Historical experience adjustment = Winsorized payments – predicted payments)/expected payments
  • Efficiency Factor:
    Winsorized episode payments > predicted payments = 0.90 (PY1), 0.85 (PY2), 0.80 (PY3), 0.75 (PY4), 0.70 (PY%)
  • Winsorized episode payments ≤ predicted payments = 0.90 (PY1-PY5)
  • Combined Adjustment = (Historical experience adjustment * Efficiency Factor) + Case Mix Adjustment + 1.0

Step 4: Discount Factor
The fourth step involves a discount factor. The Agency proposes a discount factor of 4 percent for the PC and 5 percent for the TC. CMS believes that the proposed discount factors strike a balance between creating savings for Medicare, while not creating substantial financial burden on radiation oncology participants. ASTRO is concerned about the amount of the discount factors, which when combined with other payment withholds (below), could create cash-flow challenges for practices, particularly relative to those not participating in the model.

Step 5: Withholds for Payment Issues and Quality Measures Performance
In the fifth step, CMS proposes to withhold a percentage of the total episode payments, which is the payment after the trend factor, adjustments and discount factor have been applied to the national base rates, to address payment issues and create quality measures incentives. The Agency proposes an incorrect payment withhold, and either a quality withhold, or a patient experience withhold, depending on the type of component (PC or TC) furnished during the episode.

The 2% incorrect payment withhold reserves money for purposes of reconciling duplicate radiation therapy services and incomplete episodes during the reconciliation process. A duplicate radiation therapy service is any service that is furnished to a single beneficiary by a radiation therapy provider or supplier that did not initiate the PC or the TC for that episode. An incomplete episode occurs when 1) a Technical participant or a Dual participant do not furnish a technical component to a beneficiary within 28 days following a Professional participant or Dual participant furnishing a treatment planning service, or 2) when traditional Medicare stops being the primary payer, or 3) a beneficiary stops meeting the beneficiary criteria. The annual reconciliation process would be used to determine whether a radiation oncology participant is eligible to receive back the full 2% withhold amount, a portion of it, or must repay funds to CMS.

The 2% quality withhold for the professional component allows the model to include quality measure results as a factor in determining payment to model participants. Professional and dual participants would be able to earn back up to the 2% withhold amount each year based on their aggregate quality score (AQS).

A separate 1% patient experience withhold would be applied, starting in 2022, to the technical component to account for patient experience in the model. Technical participants and dual participants would be able to earn back up to the full amount of the withhold based on their results from the patient-reported Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey for Radiation Therapy.

Step 6: Geographic Adjustments
In the sixth step, geographic adjustments would be made to payments for local cost and wage indices based on where the radiation therapy services are delivered, pursuant to existing geographic adjustment processes in the OPPS and MPFS. The OPPS automatically applies a wage index adjustment; however, the MPFS geographic adjustment is applied to three separate components, work, practice expense and malpractice. CMS is proposing to create a set of RO Model specific RVUs using the national (unadjusted) payment rates for each HCPCS code that is included in the RO Model.

Step 7: Coinsurance
In the seventh step, CMS proposes to calculate and apply beneficiary coinsurance. Currently, Medicare FFS beneficiaries are required to pay 20 percent of allowed charges for services delivered by HOPDs and physicians. This policy would remain the same under the RO Model. Beneficiaries would pay 20 percent of each of the bundled PC and TC payments for their cancer type. CMS is recommending that RO participants who see beneficiaries without secondary insurance, establish payment plans with multiple installments.

Step 8: Sequestration
Finally, the payment methodology includes a 2 percent adjustment for sequestration.

Proposed Professional and Technical Billing and Payment

As previously described, all episodes would be split into separate PC ad TC components. CMS is proposing to prospectively pay the full participant-specific professional and technical episode payments in two installments. The Agency believes that two installments reduce the amount of money that may need to be recouped due to incomplete episodes and reduces the likelihood that the limit on beneficiary liability for copayment for a procedure provided in a HOPD is met. Accordingly, CMS is proposing to pay for complete episodes in two installments: one tied to the beginning of the episode and other tied to the end of the episode. Payments for radiation therapy services will be made under existing Medicare payment systems using new RO Model specific HCPCS codes and modifiers indicating the start of an episode (SOE) and the end of an episode (EOE).

Radiation oncology participants would be required to submit encounter claims data that include all radiation therapy services identified on the RO Model bundled HCPCS list (table 2) as services are delivered. The encounter data will be used for evaluation and model monitoring, specifically trending the utilization of radiation therapy services.

In the event that a Medicare beneficiary changes their radiation oncology provider after the SOE claim has been paid, CMS will subtract the first episode payment paid to the RO participant from the FFS payments owed to the radiation oncology participant for services furnished to the beneficiary before the transition occurred and listed on the no-pay claims. This would occur during the reconciliation process. CMS proposes to make similar arrangements should a beneficiary dies, enters hospice, chooses to defer treatment, or if Medicare stops being the primary payer.

If traditional Medicare stops being an beneficiary’s primary payer after the TC of the episode has been initiated then, regardless of whether the beneficiary’s course of radiation therapy treatment was completed, the 90-day period is considered an incomplete episode and the RO participant may receive only the first installment of the episode payment. In the event that a beneficiary dies or enters hospice during an episode, then the RO participant may receive both installments of the episode payment regardless of whether the beneficiary’s course of radiation therapy has ended.

Other Model Parameters

Low Volume Practices
If a HOPD or Freestanding Radiation Therapy Center provides fewer than 60 attributed episodes during the 2015-2017 period, the radiation oncology participant’s participant-specific professional episode payment and technical episode payment amounts are proposed to equal the trended national base rates in the first performance year. This would continue in year 2 should the participant not achieve the 60-episode threshold, but a case mix adjustment would be applied to the national case rate.  In performance year 3, if the participant continues to have fewer than 60 episodes, then the Agency will reevaluate.

Merger, Acquisition, or Other New Clinical or Business Relationship
CMS is proposing that a new TIN or CCN that results from a merger, acquisition or other new clinical or business relationship that occurs prior to October 3, 2024, or any new TIN or CCN that begins to furnish radiation therapy services within a selected CBSA be compelled to participate in the RO Model. According to the Agency, this would prevent HOPDs and Freestanding Radiation Therapy Centers from engaging in these types of activities in order to avoid participating the model.

Quality

CMS proposes to adopt the following set of quality measures for the RO Model in order to assess the quality of care provided during episodes. The Agency believes these measures allow it to quantify the impact of the Model on quality of care, RT services and processes, outcomes, patient satisfaction, and organizational structures and systems.

  • Oncology: Medical and Radiation – Plan of Care for Pain – NQF41 #0383; CMS Quality ID #144
  • Preventative Care and Screening: Screening for Depression and Follow-Up Plan – NQF #0418; CMS Quality Data ID #134
  • Advanced Care Plan – NQF #0326; CMS Quality ID #047
  • Treatment Summary Communication – Radiation Oncology

The Agency proposes to begin requiring annual quality measures data submission by professional participants and dual participants by March 31, 2021, for episodes starting and ending in performance year 1. These measures would be used to determine a RO participant’s AQS, and subsequent quality reconciliation amount, as described above in the payment methodology withhold section.

CMS notes that Advanced APMs must include at least one outcomes measure. The Agency concedes that there is no appropriate outcomes measures currently for radiation oncology, thus the requirement does not apply. However, if a relevant outcome measures become available the Agency will consider it for future use.

CAHPS Cancer Care Survey
In addition to the quality measures described above, CMS also proposes to incorporate selected patient experience measures based on the CAHPS Cancer Care Survey. Survey data will be incorporated into the AQS for professional and dual participants beginning in performance year 3. For technical participants, results from these patient experience measures will be incorporated into the AQS starting in performance year 3 and applied to the patient experience withhold described in the payment methodology section above.

In future rulemaking, the Agency plans to propose a set of patient experience measures based on the CAHPS Cancer Care Survey, which would be included in the AQS as pay-for-performance measures beginning in performance year 3.

TABLE 7. RO PARTICIPANT QUALITY MEASURE, CLINICAL DATA, AND PATIENT EXPERIENCE SUBMISSION REQUIREMENTS

RO Participant Data Submission Requirements Level of Reporting Pay-for Reporting Pay-for-Performance
1. Oncology: Medical and Radiation - Plan of Care for Pain- NQF #0383; CMS Quality ID #144 Aggregate N/A PYs 1-5
2. Preventive Care and Screening: Screening for Depression and Follow-Up Plan- NQF #0418; CMS Quality ID #134 Aggregate N/A PYs 1-5
3. Advance Care Plan- NQF #0326; CMS Quality ID #047 Aggregate N/A PYs 1-5
4. Treatment Summary Communication – Radiation Oncology Aggregate PYs 1-2 PYs 3-5
5. CAHPS Cancer Care Survey N/A: Patient-Reported N/A PYs 3-5
Clinical Data Elements Beneficiary-Level PYs 1-5 N/A

Data Collection Process
CMS is proposing to require that Professional and Dual participants report aggregated quality measure data, instead of beneficiary-level quality measure data. Additionally, the Agency is proposing to require that data be reported for all applicable patients (not just Medicare beneficiaries) based on the numerator and denominator specifications for each measure. CMS believes that collecting data for all patients who meet the denominator specifications for each measure from a Professional participant or Dual participant, and not just Medicare beneficiaries, is appropriate because it is consistent with the applicable measure specifications, and any segmentation to solely the Medicare populations would be inconsistent with the measure and add a substantial reporting burden to RO participants.

Similar to the MIPS program, the RO Model will not score measures for a given Professional participant or Dual participant that does not have at least 20 applicable cases according to each measure’s specifications. If measures do not have at least 20 applicable cases for the participant, CMS would not require the measures to be reported.

Finally, CMS proposes to provide Professional participants and Dual participants with a mechanism to input quality measure data, including a secure portal for data submission. ASTRO will work with CMMI to ensure that RO participants can utilize the QOPI Qualified Clinical Data Registry as a mechanism for measures data submission. The QOPI system currently captures data each of the proposed quality measures.

Proposed Clinical Data Collection
In addition to collecting quality measures data, CMS is also proposing to collect clinical information on certain Medicare beneficiaries from Professional participants and Dual participants. On a pay-for-reporting basis, the Agency is proposing that Professional participants and Dual participants report basic clinical information, not available on claims or captured in quality measures, on Medicare beneficiaries treated for prostate, breast, lung, bone metastases and brain metastases. CMS proposes to use the data to support clinical monitoring and evaluation of the RO Model. The Agency will determine specific data elements and reporting standards prior to the start of the Model. Additionally, the proposed rule would require biannually reporting of clinical data in July and January for each performance year.

Proposed Calculation for the Aggregate Quality Score (AQS)
The proposed AQS is based on each Professional participant’s and Dual participant’s performance on the set of proposed evidence-based quality measures compared to those measures’ benchmarks; reporting of data for proposed pay-for-reporting measures; and reporting of clinical data elements. CMS is proposing to weight 50 percent of AQS on the successful reporting of required clinical data and the other 50 percent of the AQS on quality measure reporting, and, where applicable, performance on those measures.Quality measures would be scored as pay-for-performance or pay-for-reporting depending on whether established benchmarks exist. The measures proposed as pay-for-performance for performance year 1 are 1) Advance Care Plan; 2) Preventative Care and Screening: Screening for Depression and Follow-Up Plan; 3) Oncology: Medical and Radiation – Plan of Care for Pain. RO Model participants would receive up to ten points for their performance rates on each measure, similar to MIPS. In cases where Professional participants and Dual participants do not have sufficient cases for a given measure that measure would be excluded from the AQS denominator calculation and the denominator would be recalibrated to reach a denominator of 50 points to prevent participants from receiving any benefit or penalty for having an insufficient number of cases.

To calculate the AQS, CMS proposes to sum each Professional participant’s or Dual participant’s points awarded for clinical data reporting with its aggregated points awarded for quality measures to reach a value that would range between 0 and 100 points. The AQS would be calculated approximately eight months after the end of each performance year and applied to calculate the quality withhold payment amount for the relevant performance year.

Annual Reconciliation Process

CMS proposes to establish an annual reconciliation process that would occur in August following each performance year in order to allow time for claims run-out, data collection, reporting and calculating results that will be used to reconcile payments that are either due to the RO participant or payments owed to CMS that exceed the withhold policies.

To calculate the reconciliation payment, CMS proposes to sum all of the money the RO participant owes CMS due to incomplete episodes and duplicate services and subtract the amount from the incorrect payment withhold amount.

For Professional participants, CMS will add the incomplete episode amount to the quality reconciliation amount, which is determined by multiplying the participant’s AQS against the 2-percentage point maximum withhold amount.

For Technical participants, in performance years 1 and 2, the reconciliation amount would be equal to the incomplete episode reconciliation amount. There would be no further additions or subtractions. For Technical participants in performance years 3, 4 and 5, the incomplete episode reconciliation amount would be added to the patient experience reconciliation amount. Technical and Dual participants can potentially earn up to the full amount (1% of technical episode payment amounts) of the patient experience withhold for a given performance year based on results from the patient-reported CAHPS Cancer Care Radiation Therapy Survey.

For Dual participants, in performance years 3, 4 and 5, CMS will add the incorrect payment reconciliation amount to the quality reconciliation amount. As described above, the quality reconciliation amount is determined by multiplying the participant’s AQS against the total two-percentage point maximum withhold amount.

The geographic adjustment and the 2% sequestration adjustment will be applied to the incorrect payment withhold, quality withhold, and patient experience withholds during the reconciliation process.

Timely Error Notice and Reconsideration Request Process

CMS is proposing a timely error notice and reconsideration request period in which RO participants may dispute suspected errors in the calculation of their reconciliation payment amount or repayment amount. The dispute process is limited to the reconciliation process and will not be extended to RO Model pricing methodology or AQS methodology. The Agency is proposing a two-level process for RO participants to request reconsideration of reconciliation determinations. The first level is a timely error notice process and the second level is a reconsideration review process.  The timely error notice allows RO participants to notify CMS of reconciliation errors within 30 days from the date the RO reconciliation report is issued. CMS would then respond within 30 days to either confirm the calculation error or to verify that the calculation is correct. In the reconsideration review process, RO participants would be permitted to dispute CMS’ response to the RO participant’s identification of errors in the timely error notice, by requesting a reconsideration review. The reconsideration review must be submitted within 10 days of the issue date of CMS’ written response to the timely error notice. CMS proposes that a CMS reconsideration official will issue a

RO Model: Advanced APM and MIPS APM

CMS intends for the RO Model to qualify as an Advanced APM and to also meet the criteria to be a MIPS APM. The Agency proposes that the RO participant, specifically either a Professional participant or a Dual participant, would be the APM entity. CMS will issue an “individual practitioner list” for Professional participants and Dual participants to review, revise, certify and return to CMS so that the Agency may make Qualified Participant determinations for the Advanced APM incentive payment amount and to identify any MIPS eligible clinicians who would be scored for MIPS based on their participant in the RO Model as a MIPS APM.

The Agency projects that 82% of RO participants will receive the APM incentive payment for at least one performance period during the model performance period. As discussed in more detail in the section below on waivers, the APM incentive payment would apply only to the professional episode payment amounts and not the technical episode payment amounts.

In order to be an Advanced APM, the RO Model must meet the criteria specified in the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, which requires participants to use Certified Electronic Health Records Technology (CHERT). For performance periods beginning in 2019, to meet this requirement, an Advanced APM must require at least 75% of eligible clinicians in the APM entity to use CEHRT to document and communicate clinical care to their patients or other health care providers. RO Model Professional participants and Dual participants will be required to certify their intent to use CEHRT throughout the model year within 30 days of the start of the first performance year.

Additionally, in order to meet the Advanced APM requirements, participants must report on MIPS Comparable Measures. According to the Agency, the proposed measures 1) Oncology: Medical and Radiation – Plan of Care for Pain; 2) Preventative Care and Screening: Screening for Depression and Follow-Up Plan; and 3) Advanced Care Plan meet MACRA Advanced APM and MIPS APM requirements since they are already adopted in MIPS. Additionally, the other measures are considered evidence based, reliable and valid. As previously mentioned, the requirement for the inclusion of one outcomes measure has been waived as none exist.

Finally, Advanced APM entities must bear financial risk for monetary losses of more than a nominal amount. The RO Model meets the nominal risk requirement because there is no minimum (or maximum) financial stop loss for Model participants.

MACRA sets the standard for nominal risk at either “eight percent of the average estimated total Medicare Parts A and B revenues of participating APM entities” or “three percent of the expected expenditures for which the APM Entity is responsible for under the APM.” For the RO Model, CMS is proposing that the APM Entities would be at risk for all costs associated with RT services, and would therefore be at risk for 100% for all expenditures in excess of the expected amount of expenditures.

Medicare Program Waivers

CMS recognizes that it is necessary to waive certain requirements for the purposes of carrying out the RO Model. Key among the proposed waivers is a recommendation to waive the MACRA-required Technical Component Payments in the calculation of the APM incentive payment.

According to MACRA, Qualified Advanced APM Participants are eligible to receive 5 percent of his or her prior year estimated aggregate payments for covered professional services. CMS believes it is necessary to exclude payments for the technical RO Model-specific HCPCS codes from the estimated aggregate payment amounts for covered professional services used to calculate the APM incentive payment because those services are considered “technical” in nature and represent the cost of the equipment, supplies and personnel used to perform the procedure.

CMS asserts that if the waiver were not applied and technical RO Model-specific HCPCS codes are included in the calculation, then radiation oncologists delivering radiation therapy services in the freestanding setting would have technical radiation therapy services included in the calculation of the APM incentive payment, but radiation oncologists delivering radiation therapy services in hospital outpatient settings would not have those services included in the calculation of the APM incentive payment. The Agency believes this scenario would result in Dual participants changing their billing behavior by shifting their site of service from the hospital setting to the freestanding setting, thus jeopardizing the site neutral intent of the model. ASTRO will further examine the implications of CMS excluding the technical component services from the APM incentive payment.

CMS also proposes to waive existing claims appeals processes for RO Model participants to utilize the proposed timely error and reconsideration request process specific to the RO Model. The Agency notes that if RO Model participants have general Medicare claims issues they wish to appeal, the RO participants should continue to use the standard CMS claims appeals procedures.

Additionally, the agency is proposing to waive requirements associated with payment under the Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment System, including the application of the PFS relativity adjuster that is applied to non-excepted services delivered at off-campus provider-based departments; participation in the Hospital Quality Reporting Program; and the MIPS Payment Adjustment Factor, which may apply to payments made for services delivered by a MIPS eligible clinician and billed under the professional RO Model-specific HCPCS codes.

Monitoring

CMS proposes to monitor RO participants for compliance with Model requirements, including attempts to manipulate the system through patient recruitment and billing practices. The Agency proposes to focus on patient and provider/supplier characteristics, such as variations in size, profit status and episode utilization patterns, over time to detect changes that may suggest attempts at such manipulation.

As previously mentioned, CMS is proposing to require all participants to annually attest that they are using CHERT in a manner sufficient to meet the requirements of MACRA.  Additionally, the Agency is proposing that each Technical participant and Dual participant annually attest to active participation in a radiation oncology-specific AHRQ-listed patient safety organization (PSO).

In order to monitor for compliance, the Agency is also proposing that all Professional participants and Dual participants document in the medical record that the participant has:

  1. discussed goals of care with each Medicare beneficiary before initiating treatment and communicated to the beneficiary whether the treatment intent is curative or palliative;
  2. adheres to nationally recognized, evidence-based treatment guidelines when appropriate in treating Medicare beneficiaries or document in the Medical record the rationale for the departure from these guidelines;
  3. assesses the Medicare beneficiaries’ tumor, node, and metastasis (TNM) cancer stage for the CMS-specified cancer diagnosis;
  4. assesses the Medicare beneficiaries’ performance status as a quantitative measure determined by the physician;
  5. sends a treatment summary to each Medicare beneficiary’s referring physician within three months of the end of treatment to coordinate care;
  6. discusses with each Medicare beneficiary prior to treatment delivery his or her inclusion in and cost-sharing responsibilities; and
  7. performs and documents Peer Review for 50 percent of new patients in performance year 1, 55 percent of new patients in performance year 2, 60 percent of new patients in performance year 3, 65 percent of patients in performance year 4, and 70 percent of patients in performance year 5, preferably before starting treatment, but in all cases before 25 percent of the total prescribed dose has been delivered and within two weeks of starting treatment.

Performance Feedback

CMS proposes to utilize clinical data, quality measures reports, claims data and compliance monitoring to provide information to RO participants on their adherence to evidence-based practice guidelines, quality and patient experience measures, and other quality initiatives. The frequency and design of these reports will be determined in conjunction with the RO Model implementation and monitoring contractor.

Evaluation

CMS proposes to focus evaluation efforts on understanding how successful the RO Model is in achieving improved quality and reduced expenditures, as evidenced by changes in radiation therapy utilization patterns, costs for Medicare FFS beneficiaries, changes in utilization and costs with other services that may be affected as a result of the RO Model (such as ED services, imaging, prescription drugs, and inpatient hospital care), performance on clinical care process measures (such as adhering to evidence-based guidelines), patient experience of care and provider experience of care. The evaluation will use a multi-level approach, including analyses at the CBSA-level, participant-level and beneficiary-level.

Potential Overlap with other Models

CMS believes that the RO Model is compatible with other CMS models and programs. However, the Agency recognizes that there may be situations in which overlap may occur at the beneficiary level in which a beneficiary in the RO Model may be receiving care associated with another payment model, as well as at the provider and supplier level in which a physician or organization could be participating in multiple models. Below are current scenarios for potential overlap.

Accountable Care Organizations (ACO)
According to CMS, there would be potential for overlap between the RO Model and ACO initiatives but because the RO Model is an episode-based payment initiative, providers and suppliers participating in the RO Model would not be precluded from also participating in an ACO initiative. CMS believes that shared savings payments under an ACO initiative have the potential to overlap with discounts and withholds in the RO Model; however, the agency said it is difficult to determine the level of potential overlap. The Agency proposes to continue reviewing potential overlap in these situations and pursue any future changes through ACO initiative procedures.

Oncology Care Model (OCM)
Because the OCM and RO Model both involve care for patients with a cancer diagnosis who receive radiation therapy services, CMS anticipates that there will be Medicare beneficiaries who will be in both OCM and RO Model episodes. The OCM is a total cost of care model that encompasses a six-month episode of care. OCM episodes that include radiation therapy services receive a risk adjustment when calculating episode benchmarks, with the goal of mitigating incentives to shift these services outside the episode.

CMS proposes that for those instances in which radiation therapy services are provided before or after the OCM episode, then the radiation therapy services that are part of that RO Model episode would not be included in the OCM episode. If the entire RO-Model episode occurs completely within the six-month OCM episode, then the associated radiation oncology payments for radiation therapy services would be included in the OCM episode. CMS will add the RO Model’s discount and withhold amounts to the total cost of the OCM episode during the OCM’s reconciliation process to ensure there is no double counting of savings and no double payment of the withhold amounts. This provides both the medical oncologist and the radiation oncologist with the opportunity to collaboratively work within a value-based payment arrangement, while allowing them to independently manage the delivery of those services for which they are accountable.

In those cases in which the two models partially overlap, CMS proposes to allocate the RO Model payments for radiation therapy services and the RO Model discount and withhold amounts to the OCM episode on a prorated basis, based on the number of days of overlap.

Bundled Payments for Care Improvement (BPCI) Advanced
While there are no cancer episodes included in the design of BPCI Advanced, a Medicare beneficiary in a RO episode could be treated by a provider or suppler that is participating in BPCI Advanced. Since prospective episode payments made under the RO Model will not be affected by BPCI Advanced, BPCI Advanced will determine whether to account for RO Model overlap in its reconciliation calculations.

Conclusion and Next Steps

In general, ASTRO is pleased that a RO Model is moving forward, as the Society agrees with CMS that there is great promise for an alternative payment model to drive even higher quality care in radiation oncology. Since the passage of MACRA, ASTRO has urged CMS to create a Advanced APM for radiation oncology, and the release of the RO model is a significant step in that direction, despite some concerning aspects of the proposal.

ASTRO certainly recognized many of our model recommendations in the CMS RO Model, confirming that the agency carefully considered and built upon the model ASTRO proposed. Several components of the model will help address our longstanding concerns about payment stability, and we generally agree with the inclusion of meaningful quality measures and programs. ASTRO will work closely with the radiation community, CMS, congressional champions and others to find common ground on this new payment approach that supports access to the best possible care for radiation oncology patients.

As noted in a recent Red Journal editorial by ASTRO Immediate Past Chair Dr. Brian Kavanagh, MD, MPH, FASTRO, the new Medicare payment system ensures that practices not participating in APMs will have lower annual payment updates than those participating. Practices that avoid APMs will struggle, either financially through lower payment nor through additional burdens of quality reporting and prior authorization.

ASTRO has spent a significant amount of time and resources to provide input and guidance in the development of the CMMI proposal, and the organization will continue to devote resources to help members assess the APM launched by Medicare and understand how they will fare under the model. As the details of the CMMI model emerge, we urge ASTRO members to give us their perspectives on how the model could impact their practices and patient care. Then, the Society will need to channel this input into advocacy that improves the CMMI model into one that works well for all practices and supports high quality radiation oncology care.

Please send your thoughts on the model to ASTRO's Health Policy Team

Additional Resources

Additional information about the RO Model proposed rule can be found at the following links:

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