(a) Basis. This subpart implements the test of the Radiation Oncology (RO) Model under section 1115A(b) of the Act. Except as specifically noted in this subpart, the regulations under this subpart do not affect the applicability of other regulations affecting providers and suppliers under Medicare FFS, including the applicability of regulations regarding payment, coverage, and program integrity.

(b) Scope. This subpart sets forth the following:

(1) RO Model participation.

(2) Episodes being tested under the RO Model.

(3) Methodology for pricing.

(4) Billing and payment under the RO Model.

(5) Data reporting requirements.

(6) Medicare program waivers.

(7) Payment reconciliation and review processes.

(c) RO participants are subject to the general provisions for Innovation Center models specified in subpart A of this part 512 and in subpart K of part 403 of this chapter.

For purposes of this subpart, the following definitions apply:

Aggregate quality score (AQS) means the numeric score calculated for each RO participant based on its performance on, and reporting of, quality measures and clinical data. The AQS is used to determine an RO participant's quality reconciliation payment amount.

APM means Alternative Payment Model.

ASC means Ambulatory Surgery Center.

Baseline period means the three calendar year period that begins on January 1 no fewer than five years but no more than six years prior to the start of the model performance period during which episodes must initiate in order to be used in the calculation of the national base rates, each RO participant's historical experience adjustment for the PC or TC or both for the model performance period, and the RO participant's case mix adjustment for the PC or TC or both for PY1. The baseline period is January 1, 2017 through December 31, 2019, unless the RO Model is prohibited by law from starting in calendar year (CY) 2022, in which case the baseline period will be delayed based on the new model performance period (for example, if the model performance period starts any time in CY 2023, then the baseline period would be CY 2018 through CY 2020).

Blend means the weight given to an RO participant's historical experience adjustment relative to the geographically-adjusted trended national base rate in the calculation of its participant-specific episode payment amounts.

CAH means Critical Access Hospital.

CEHRT means Certified Electronic Health Record Technology.

Clean period means the 28-day period after an RO episode has ended, during which time an RO participant must bill for medically necessary RT services furnished to the RO beneficiary in accordance with Medicare FFS billing rules.

Core-Based Statistical Area (CBSA) means a statistical geographic area, based on the definition as identified by the Office of Management and Budget, with a population of at least 10,000, which consists of a county or counties anchored by at least one core (urbanized area or urban cluster), plus adjacent counties having a high degree of social and economic integration with the core (as measured through commuting ties with the counties containing the core).

Discount factor means the percentage by which CMS reduces payment of the professional component and technical component.

(1) The reduction of payment occurs after the trend factor, the geographic adjustment, and the RO Model-specific adjustments have been applied, but before beneficiary cost-sharing and standard CMS adjustments, including sequestration, have been applied.

(2) The discount factor does not vary by cancer type.

(3) The discount factor for the professional component is 3.5 percent; the discount factor for the technical component is 4.5 percent.

Dual participant means an RO participant that furnishes both the professional component and technical component of RT services of an RO episode through a freestanding radiation therapy center, identified by a single TIN.

Duplicate RT service means any included RT service that is furnished to an RO beneficiary by an RT provider or RT supplier that is not excluded from participation in the RO Model at § 512.210(b), and that did not initiate the PC or TC of the RO beneficiary's RO episode. Such services are furnished in addition to the RT services furnished by the RO participant that initiated the PC or TC and continues to furnish care to the RO beneficiary during the RO episode.

Episode means the 90-day period of RT services that begins on the date of service that an RT provider or RT supplier that is not an RO participant furnishes an initial treatment planning service to a beneficiary, provided that an RT provider or RT supplier furnishes a technical component RT service to the beneficiary within 28 days of such initial treatment planning service. Additional criteria for constructing episodes to be included in determining the national base rates are set forth in § 512.250.

EOE stands for “end of episode” and means the end of an RO episode.

EUC stands for “extreme and uncontrollable circumstance” and means a circumstance that is beyond the control of one or more RO participants, adversely impacts such RO participants' ability to deliver care in accordance with the RO Model's requirements, and affects an entire region or locale.

HCPCS means Healthcare Common Procedure Coding System.

HOPD means hospital outpatient department.

Included cancer types means the cancer types determined by the criteria set forth in § 512.230, which are included in the RO Model test.

Included RT services means the RT services identified at § 512.235, which are included in the RO Model test.

Incomplete episode means an RO episode that is deemed not to have occurred because:

(1) A Technical participant or a Dual participant does not furnish a technical component to an RO beneficiary within 28 days following a Professional participant or the Dual participant furnishing an initial treatment planning service to that RO beneficiary;

(2) An RO beneficiary ceases to have traditional FFS Medicare as his or her primary payer at any time after the initial treatment planning service is furnished and before the date of service on a claim with an RO Model-specific HCPCS code and an EOE modifier; or

(3) An RO beneficiary switches RT provider or RT supplier before all included RT services in the RO episode have been furnished.

Individual practitioner means a Medicare-enrolled physician (identified by an NPI) who furnishes RT services to Medicare FFS beneficiaries, and has reassigned his or her billing rights to the TIN of an RO participant.

Individual practitioner list means a list of individual practitioners who furnish RT services under the TIN of a Dual participant or a Professional participant, which is annually compiled by CMS and which the RO participant must review, revise, and certify in accordance with § 512.217. The individual practitioner list is used for the RO Model as a Participation List as defined in § 414.1305 of this chapter.

Initial reconciliation means the first reconciliation of a PY that occurs as early as August following the applicable PY.

Legacy CCN means a CMS certification number (CCN) that an RO participant that is a hospital outpatient department (HOPD) or its predecessor(s) previously used to bill Medicare for included RT services but no longer uses to bill Medicare for included RT services.

Legacy TIN means a taxpayer identification number (TIN) that an RO participant that is a PGP, or a freestanding radiation therapy center, or its predecessor(s) previously used to bill Medicare for included RT services but no longer uses to bill Medicare for included RT services.

MIPS means Merit based Incentive Payment System.

Model performance period means the 5 performance years (PYs) during which RO episodes initiate and terminate. CMS will establish the start and end dates of the model performance period for the RO Model through future rulemaking.

National base rate means the total payment amount for the relevant component of an RO episode, before application of the trend factor, discount factor, adjustments, and applicable withholds, for each of the included cancer types.

NPI means National Provider Identifier.

OPPS means outpatient prospective payment system.

Participant-specific professional episode payment means a payment which is calculated by CMS as set forth in § 512.255 and which is paid by CMS to a Professional participant or Dual participant as set forth in § 512.265, for the provision of the professional component to an RO beneficiary during an RO episode.

Participant-specific technical episode payment means a payment which is calculated by CMS as set forth in § 512.255 and which is paid by CMS to a Technical participant or Dual participant in accordance with § 512.265, for the provision of the technical component to an RO beneficiary during an RO episode.

PGP means physician group practice.

PPS means prospective payment system.

Professional component (PC) means the included RT services that may only be furnished by a physician.

Professional participant means an RO participant that is a Medicare-enrolled PGP identified by a single TIN that furnishes only the PC of an RO episode.

PSO means patient safety organization.

PY stands for performance year and means each 12-month period beginning on January 1 and ending on December 31 during the model performance period, unless the model performance period begins on a date other than January 1, in which case, the first performance year (PY1) begins on that date and ends on December 31 of the same year.

QP means Qualifying APM Participants.

Reconciliation payment means a payment made by CMS to an RO participant, as determined in accordance with § 512.285.

Repayment amount means the amount owed by an RO participant to CMS, as determined in accordance with § 512.285.

Reconciliation report means the annual report issued by CMS to an RO participant for each PY, which specifies the RO participant's reconciliation payment amount or repayment amount.

RO beneficiary means a Medicare beneficiary who meets all of the beneficiary inclusion criteria at § 512.215(a) and whose RO episode meets all the criteria defined at § 512.245.

RO episode means the 90-day period that, as set forth in § 512.245, begins on the date of service that a Professional participant or a Dual participant furnishes an initial treatment planning service to an RO beneficiary in a freestanding radiation therapy center or an HOPD, provided that a Technical participant or the same Dual participant furnishes a technical component RT service to the RO beneficiary within 28 days of such RT treatment planning service.

RO participant means a Medicare-enrolled PGP, freestanding radiation therapy center, or HOPD that participates in the RO Model in accordance with § 512.210. An RO participant may be a Dual participant, Professional participant, or Technical participant.

RT provider means a Medicare-enrolled HOPD that furnishes RT services.

RT services are the treatment planning, technical preparation, special services (such as simulation), treatment delivery, and treatment management services associated with cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors.

RT supplier means a Medicare-enrolled PGP or freestanding radiation therapy center that furnishes RT services.

SOE stands for “start of episode” and means the start of an RO episode.

Stop-loss limit means the set percentage at which loss is limited under the Model used to calculate the stop-loss reconciliation amount.

Stop-loss reconciliation amount means the amount set forth in § 512.285(f) owed by CMS for the loss incurred under the Model to RO participants that have fewer than 60 episodes during the baseline period and were furnishing included RT services before the start of the model performance period in the CBSAs selected for participation.

Technical component (TC) means the included RT services that are not furnished by a physician, including the provision of equipment, supplies, personnel, and administrative costs related to RT services.

Technical participant means an 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 TC of an RO episode.

TIN means Taxpayer Identification Number.

Track One means a track for Professional participants and Dual participants that meet all RO Model requirements as specified in § 512.220, including use of CEHRT.

Track Two means a track for Professional participants and Dual participants that meet all RO Model requirements as specified in § 512.220, except for use of CEHRT.

Track Three means a track for Professional participants and Dual participants who do not meet one or more of the RO Model requirements set forth at § 512.220(a); and for all Technical participants.

Trend factor means an adjustment applied to the national base rates that updates those rates to reflect current trends in the OPPS and PFS rates for RT services.

True-up reconciliation means the process to calculate additional reconciliation payments or repayment amounts for incomplete episodes and duplicate RT services that are identified after the initial reconciliation and after a 12-month claims run-out for all RO episodes initiated in the applicable PY.

(a) RO participants. Unless otherwise specified in paragraph (b) or (c) of this section, any Medicare-enrolled PGP, freestanding radiation therapy center, or HOPD that furnishes included RT services in a 5-digit ZIP Code linked to a CBSA selected for participation to an RO beneficiary for an RO episode that begins and ends during the model performance period must participate in the RO Model.

(b) Participant exclusions. A PGP, freestanding radiation therapy center, or HOPD is excluded from participation in the RO Model if it:

(1) Furnishes RT services only in Maryland;

(2) Furnishes RT services only in Vermont;

(3) Furnishes RT services only in U.S. Territories;

(4) Is classified as an ambulatory surgery center (ASC), critical access hospital (CAH), or Prospective Payment System (PPS)-exempt cancer hospital; or

(5) Participates in the Pennsylvania Rural Health Model; or

(6) Participates in the Community Transformation Track of the Community Health Access and Rural Transformation (CHART) Model as a participating hospital.

(c) Low volume opt-out. A PGP, freestanding radiation therapy center, or HOPD that would otherwise be required to participate in the RO Model may choose to opt-out of the RO Model as follows:

(1) If the PGP, freestanding radiation therapy center, or HOPD furnished fewer than 20 episodes in the calendar year that is two years prior to the start of PY1 across all CBSAs selected for participation, it may opt out of the RO Model for PY1.

(2) If the PGP, freestanding radiation therapy center, or HOPD furnished fewer than 20 episodes in the calendar year that is two years prior to the start of PY2 across all CBSAs selected for participation, it may opt out of the RO Model for PY2.

(3) If the PGP, freestanding radiation therapy center, or HOPD furnished fewer than 20 RO episodes in PY1 across all CBSAs selected for participation, and PY1 begins on January 1, it may choose to opt out of the RO Model for PY3. In the event that PY1 begins on a date other than January 1, the PGP, freestanding radiation therapy center, or HOPD may opt-out of the RO Model for PY3 if the total number of furnished episodes of the calendar year in which PY1 began and RO episodes in PY1 is fewer than 20 across all CBSAs selected for participation.

(4) If the PGP, freestanding radiation therapy center, or HOPD furnished fewer than 20 RO episodes in PY2 across all CBSAs selected for participation, it may opt out of the RO Model for PY4.

(5) If the PGP, freestanding radiation therapy center, or HOPD furnished fewer than 20 RO episodes in PY3 across all CBSAs selected for participation, it may opt out of the RO Model for PY5.

(6) At least 30 days prior to the start of each PY, CMS provides notice to RO participants eligible for the low volume opt-out for the upcoming PY of such eligibility. The RO participant must attest that it intends to opt out of the RO Model prior to the start of the upcoming PY.

(7) An entity is not eligible for the low-volume opt out if its current TIN or CCN, or its legacy TIN or legacy CCN, or both were used to bill Medicare for 20 or more episodes or RO episodes, as applicable, of RT services in the two years prior to the applicable PY across all CBSAs selected for participation.

(d) Selected CBSAs. CMS randomly selects CBSAs to identify RT providers and RT suppliers to participate in the RO Model through a stratified sample design, allowing for participant and comparison groups to contain approximately 30 percent of all episodes in eligible geographic areas (CBSAs).

(e) Notice of change in TIN or CCN. An RO participant must furnish written notice to CMS in a form and manner specified by CMS at least 90 days before the effective date of any change in TIN or CCN that is used to bill Medicare.

(a) Beneficiary inclusion criteria. An individual is an RO beneficiary if:

(1) The individual receives included RT services from an RO participant that billed the SOE modifier for the PC or TC of an RO episode during the Model performance period for an included cancer type; and

(2) At the time that the initial treatment planning service of an RO episode is furnished by an RO participant, the individual:

(i) Is eligible for Medicare Part A and enrolled in Medicare Part B;

(ii) Has traditional FFS Medicare as his or her primary payer (for example, is not enrolled in a PACE plan, Medicare Advantage or another managed care plan, or United Mine Workers insurance); and

(iii) Is not in a Medicare hospice benefit period.

(b) Any individual enrolled in a clinical trial for RT services for which Medicare pays routine costs is an RO beneficiary if the individual satisfies all of the beneficiary inclusion criteria in paragraph (a) of this section.

(a) General. Upon the start of each PY, CMS creates and provides to each RO participant that is a PGP or a freestanding radiation therapy center an individual practitioner list identifying by NPI each individual practitioner associated with the RO participant. For RO participants that begin participation in the RO Model after the start of a PY, but at least 30 days prior to the last QP determination date as specified at § 414.1325 of this chapter, CMS creates and provides an individual practitioner list to that RO participant.

(b) Review of individual practitioner list. Up until the last QP determination date as specified at § 414.1325 of this chapter, the RO participant must review the individual practitioner list, correct any inaccuracies in accordance with paragraph (d) of this section, and certify the list (as corrected, if applicable) in a form and manner specified by CMS and in accordance with paragraph (c) of this section. The RO participant may correct any inaccuracies in its individual practitioner list until the last QP determination date as specified at § 414.1325 of this chapter. Any Dual participant, Professional participant, or Technical participant that is a freestanding radiation therapy center and joins the RO Model after the start of a PY must review and certify its individual practitioner list by the last QP determination date as specified at § 414.1325 of this chapter.

(c) List certification. (1) Up until the last QP determination date as specified at § 414.1325 of this chapter, an individual with the authority to legally bind the RO participant must certify the accuracy, completeness, and truthfulness of the individual practitioner list to the best of his or her knowledge, information, and belief.

(2) All Medicare-enrolled individual practitioners that have reassigned their right to receive Medicare payment for provision of RT services to the TIN of the RO participant must be included on the RO participant's individual practitioner list and each individual practitioner must agree to comply with the requirements of the RO Model before the RO participant certifies the individual practitioner list.

(3) If the RO participant does not certify the individual practitioner list in PY2 through PY5:

(i) Eligible clinicians in the RO Model will not be considered participants in a MIPS APM for purposes of MIPS reporting and scoring rules;

(ii) Eligible clinicians in the RO Model will not have Qualifying APM Participant (“QP”) determinations made based on their participation in the RO Model; and

(d) Changes to the individual practitioner list—(1) Additions. (i) An RO participant must notify CMS of an addition to its individual practitioner list when an eligible clinician reassigns his or her rights to receive payment from Medicare to the RO participant. The notice must be submitted in the form and manner specified by CMS up until the last QP determination date as specified at § 414.1325 of this chapter.

(ii) If the RO participant timely submits notice to CMS, then the addition of an individual practitioner to the RO participant's individual practitioner list is effective on the date specified in the notice furnished to CMS, but no earlier than 30 days before the date of the notice. If the RO participant fails to submit timely notice to CMS, then the addition of an individual practitioner to the individual practitioner list is effective on the date of the notice.

(2) Removals. (i) An RO participant must notify CMS when an individual on the RO participant's individual practitioner list ceases to be an individual practitioner up until the last QP determination date as specified at § 414.1325 of this chapter. The notice must be submitted in the form and manner specified by CMS.

(ii) The removal of an individual practitioner from the RO participant's individual practitioner list is effective on the date specified in the notice furnished to CMS. If the RO participant fails to submit a timely notice of the removal, then the removal is effective on the date that the individual ceases to be an individual practitioner.

(e) Update to Medicare enrollment information. The RO participant must ensure that all changes to enrollment information for an RO participant and its individual practitioners, including changes to reassignment of the right to receive Medicare payment, are reported to CMS consistent with § 424.516 of this chapter.

(a) RO participant-specific requirements. (1) An RO participant must satisfy the requirements of this section to be included in Track One under the RO Model in a particular PY. An RO participant that meets all of these RO Model requirements in a particular PY, excluding use of CEHRT, will be in Track Two for such PY. An RO participant that does not meet one or more of the RO Model requirements in paragraph (a) of this section in a particular PY will be in Track Three for such PY.

(2) Each Professional participant and Dual participant must ensure its individual practitioners:

(i) Starting in PY1, discuss goals of care with each RO beneficiary before initiating treatment and communicate to the RO beneficiary whether the treatment intent is curative or palliative;

(ii) Starting in PY1, adhere to nationally recognized, evidence-based clinical treatment guidelines when appropriate in treating RO beneficiaries or, alternatively, document in the medical record the extent of and rationale for any departure from these guidelines;

(iii) Starting in PY1, assess each RO beneficiary's tumor, node, and metastasis cancer stage for the CMS-specified cancer diagnoses;

(iv) Starting in PY1, assess the RO beneficiary's performance status as a quantitative measure determined by the physician;

(v) Starting in PY1, send a treatment summary to each RO beneficiary's referring physician within 3 months of the end of treatment to coordinate care;

(vi) Starting in PY1, discuss with each RO beneficiary prior to treatment delivery his or her inclusion in, and cost-sharing responsibilities under, the RO Model; and

(vii) Starting in PY1, perform and document Peer Review (audit and feedback on treatment plans) before 25 percent of the total prescribed dose has been delivered and within 2 weeks of the start of treatment for:

(A) 50 percent of new patients in PY1,

(B) 55 percent of new patients in PY2,

(C) 60 percent of new patients in PY3,

(D) 65 percent of new patients in PY4,

(E) 70 percent of new patients in PY5.

(3) Starting in PY1, at such times and in the form and manner specified by CMS, each Technical participant and Dual participant must annually attest to whether it actively participates with a AHRQ-listed patient safety organization (PSO). Examples include maintaining a contractual or similar relationship with a PSO for the receipt and review of patient safety work product.

(b) CEHRT. (1) RO participants must use CEHRT, and ensure that their individual practitioners use CEHRT, in a manner sufficient to meet the applicable requirements of the Advanced APM criteria as specified at § 414.1415(a)(1)(i) of this chapter.

(2) Within 30 days of the start of PY1 and each subsequent PY, the RO participant must certify its use of CEHRT throughout such PY in a manner sufficient to meet the requirements set forth in § 414.1415(a)(1)(i) of this chapter.

(3) An RO participant that joins the RO Model at any time during an ongoing PY must certify their use of CEHRT by the last QP determination date as specified at § 414.1325 of this chapter.

(a) General. Starting in PY1, each Professional participant and Dual participant must notify each RO beneficiary to whom it furnishes included RT services—

(1) That the RO participant is participating in the RO Model;

(2) That the RO beneficiary has the opportunity to decline claims data sharing for care coordination and quality improvement purposes. If an RO beneficiary declines claims data sharing for care coordination and quality improvement purposes, then the RO participant must inform CMS within 30 days of receiving notification from the RO beneficiary that the beneficiary is declining to have his or her claims data shared in that manner; and,

(3) Of the RO beneficiary's cost-sharing responsibilities.

(b) Form and manner of notification. Notification of the information specified in paragraph (a) of this section must be carried out by an RO participant by providing each RO beneficiary with a CMS-developed standardized written notice during the RO beneficiary's initial treatment planning session. The RO participants must furnish the notice to the RO beneficiary in the form and manner specified by CMS.

(c) Applicability of general Innovation Center provisions. The beneficiary notifications under this section are not descriptive model materials and activities under § 512.120(c). The requirement described in § 512.120(c)(2) does not apply to the standardized written notice described in paragraph (b) of this section.

(a) Included cancer types. CMS includes in the RO Model cancer types that satisfy the following criteria:

(1) The cancer type is commonly treated with radiation per nationally recognized, evidence-based clinical treatment guidelines;

(2) The cancer type has one or more associated current ICD-10 codes that have demonstrated pricing stability; and

(3) The Secretary has not determined that the cancer type is not suitable for inclusion in the RO Model.

(b) Removing cancer types. CMS removes cancer types in the RO Model if it determines:

(1) That there is a ≥10 percent error in established national base rates; or

(2) The cancer type does not meet the criteria set forth in paragraph (a) of this section.

(c) ICD-10 codes for included cancer types. CMS displays on the RO Model website no later than 30 days prior to each PY the ICD-10 diagnosis codes associated with each included cancer type.

(a) Only the following RT services furnished using an included modality identified at § 512.240 for an included cancer type are included RT services that are paid for by CMS under § 512.265:

(1) Treatment planning;

(2) Technical preparation and special services;

(3) Treatment delivery; and,

(4) Treatment management.

(b) All other RT services furnished by an RO participant during the Model performance period are subject to Medicare FFS payment rules.

The modalities included in the RO Model are 3-dimensional conformal RT (3DCRT), intensity-modulated RT (IMRT), stereotactic radiosurgery (SRS), stereotactic body RT (SBRT), proton beam therapy (PBT), and image-guided radiation therapy (IGRT).

(a) General. Any RO episode that begins on or after the first day of the model performance period and ends on or before the last day of the model performance period is included in the model performance period.

(b) Death or election of hospice benefit. An RO episode is included in, and paid for under, the RO Model if the RO beneficiary dies after the TC of an RO episode has been initiated, or if the RO beneficiary elects the Medicare hospice benefit after the initial treatment planning service, provided that the TC is initiated within 28 days following the initial treatment planning service. Each RO participant will receive both installments of the episode payment under such circumstances, regardless of whether the RO beneficiary dies or elects the Medicare hospice benefit before the relevant course of RT treatment has ended.

(c) Clean periods. An RO episode must not be initiated for the same RO beneficiary during a clean period.

CMS determines a national base rate for the PC and TC for each included cancer type.

(a) National base rates are the historical average cost for an episode of care for each of the included cancer types prior to the Model performance period.

(b) National base rates are determined in the following manner:

(1) CMS excludes from episode pricing and RO episode pricing any claim containing an RT service furnished:

(i) In Maryland, Vermont, or any of the U.S. Territories;

(ii) In the inpatient setting;

(iii) By an entity classified as an ASC, CAH, or PPS-exempt cancer hospital; or

(iv) By an HOPD participating in the Pennsylvania Rural Health Model at the time the RT service was furnished.

(2) CMS excludes the following episodes from the determination of the national base rates:

(i) Episodes that are not linked to a CBSA selected for participation in the RO Model;

(ii) Episodes that are not attributed to an RT provider or RT supplier;

(iii) Episodes that are not assigned an included cancer type; or

(iv) Episodes for which the total allowed amount for RT services listed on claims used to calculate an episode's payment amount is not greater than $0.

(3) CMS calculates the episode amount CMS paid on average to RT providers and RT suppliers for the PC and TC for each of the included cancer types in the HOPD setting, creating the RO Model's national base rates.

(a) Thirty days before the start of each PY, CMS provides each RO participant its case mix and historical experience adjustments for both the PC and TC as calculated in paragraphs (c)(3) and (4) of this section. If an RO participant is not eligible to receive a historical experience adjustment or case mix adjustment as described under paragraph (c)(7) of this section, then CMS provides a zero value for those adjustments.

(b) Any episode used to calculate the participant-specific professional episode payment amounts and the participant-specific technical episode payment amounts for an RO participant is subject to the exclusions described in § 512.250(b)(1) and (2).

(c) CMS calculates the participant-specific professional episode payment amounts and participant-specific technical episode payment amounts for each included cancer type using the following:

(1) Trend factors. For every PY, CMS adjusts the national base rates for the PC and TC of each cancer type by calculating a separate trend factor for the PC and TC of each included cancer type.

(2) Geographic adjustment. CMS adjusts the trended national base rates prior to applying each RO participant's case mix and historical experience, and prior to applying the discounts and withholds, for local cost and wage indices based on where RT services are furnished, as described by existing geographic adjustment processes in the OPPS and PFS.

(3) Case mix adjustment. CMS establishes and applies a case mix adjustment to the national base rate after the trend factor and geographic adjustment have applied. The case mix adjustment reflects episode or RO episode characteristics that may be beyond the control of RO participants such as cancer type, age, sex, presence of a major procedure, death during the episode, and presence of chemotherapy.

(4) Historical experience adjustment. CMS establishes and applies a historical experience adjustment to the national base rate after the trend factor, geographic adjustment, and case mix adjustment have been applied. The historical experience adjustments reflect each RO participant's actual historical experience.

(5) Blend. CMS blends each RO participant's historical experience adjustment and the geographically-adjusted trended national base rate. The blend for RO participants with a professional historical experience adjustment or technical historical experience adjustment with a value equal to or less than zero is 90/10, meaning the calculation of the participant-specific episode payment amount is weighted according to 90 percent of the RO participant's historical experience adjustment and 10 percent of the geographically-adjusted trended national base for PY1 through PY5. The blend for RO participants with a professional historical experience adjustment or technical historical experience adjustment of more than zero is 90/10 in PY1, 85/15 in PY2, 80/20 in PY3, 75/25 in PY4, and 70/30 in PY5.

(6) Changes in business structure. (i) RO participants must notify CMS in writing of a merger, acquisition, or other new clinical or business relationship, at least 90 days before the date of the change as described in § 424.516.

(ii) CMS updates case mix and historical experience adjustments according to the relevant treatment history that applies as a result of a merger, acquisition, or other new clinical or business relationship in the RO participant's case mix and historical experience adjustment calculations from the effective date of the change.

(7) Adjustments for RO participants with fewer than 60 episodes during the baseline period. (i) RO participants that have fewer than 60 episodes in the baseline period do not receive a historical experience adjustment during the model performance period.

(ii) RO participants that have fewer than 60 episodes in the baseline period do not receive a case mix adjustment for PY1.

(iii) RO participants that have fewer than 60 episodes in the baseline period that continue to have fewer than 60 episodes in the rolling 3-year period used to determine the case mix adjustment for each PY and that have never received a case mix adjustment do not receive a case mix adjustment for that PY.

(iv) RO participants that have fewer than 60 episodes in the baseline period and were furnishing included RT services in the CBSAs selected for participation before the start of the model performance period are eligible to receive a stop-loss reconciliation amount, if applicable, as described in § 512.285(f).

(8) Discount factor. CMS reduces each episode payment by the discount factor after applying the trend factor, geographic adjustment, and case mix and historical experience adjustments to the national base rate.

(9) Incorrect payment withhold. To account for duplicate RT services and incomplete episodes:

(i) CMS withholds from each RO participant 1 percent from each episode payment, after applying the trend factor, geographic adjustment, case mix and historical experience adjustments, and discount to the national base rate.

(ii) CMS determines during the annual reconciliation process set forth at § 512.285 whether an RO participant is eligible to receive a portion or all of the withheld amount or whether any payment is owed to CMS.

(10) Quality withhold. In accordance with § 414.1415(b)(1) of this chapter, CMS withholds 2 percent from each professional episode payment after applying the trend factor, geographic adjustment, case mix and historical experience adjustments, and discount factor to the national base rate. RO participants may earn back this withhold, in part or in full, based on their AQS.

(11) Patient experience withhold. Starting in PY3,

(i) CMS withholds 1 percent from each technical episode payment after applying the trend factor, geographic adjustment, case mix and historical experience adjustments, and discount factor to the national base rate.

(ii) RO participants may earn back their patient-experience withhold, in part or in full, based on their results from the CAHPS® Cancer Care Radiation Therapy survey.

(12) Coinsurance. RO participants may collect beneficiary coinsurance payments for services furnished under the RO Model in multiple installments under a payment plan.

(i) The availability of payment plans may not be used as a marketing tool to influence beneficiary choice of health care provider.

(ii) RO participants offering a payment plan may inform the RO beneficiary of the availability of the payment plan prior to or during the initial treatment planning session and as necessary thereafter.

(iii) The beneficiary coinsurance payment equals 20 percent of the episode payment amount to be paid to the RO participant(s) prior to the application of sequestration for the billed RO Model-specific HCPCS code with a SOE modifier and for the billed RO Model-specific HCPCS code with an EOE modifier for the PC and TC, except as provided in paragraph (c)(12)(iv) and(v) of this section.

(iv) In the case of incomplete episodes, the beneficiary coinsurance payment equals 20 percent of the FFS amounts that would have been paid in the absence of the RO Model for the services furnished by the RO participant that initiated the PC and the RO participant that initiated the TC (if applicable).

(v) In the case of duplicate RT services, the beneficiary coinsurance payment equals 20 percent of the episode payment amount to be paid to the RO participant(s) per § 512.255(c)(12)(iii) and 20 percent of the FFS amount to the RT provider and/or RT supplier furnishing one or more duplicate RT services.

(13) Sequestration. In accordance with applicable law, CMS deducts a percentage from each episode payment after applying the trend factor, geographic adjustment, case mix and historical experience adjustments, discount, withholds, and coinsurance to the national base rate.

(14) Modifications to the participant-specific adjustments for changes in TINs or CCNs. (i) CMS calculates the RO participant's case mix adjustments in accordance with paragraph (c)(3) of this section based on all episodes and RO episodes, as applicable, attributed to the RO participant's legacy TIN(s) or legacy CCN(s), and current TIN or CCN, during the 3-year period that determines the case mix adjustment for each PY.

(ii) CMS calculates the RO participant's historical experience adjustments in accordance with paragraph (c)(4) of this section based on all episodes attributed to the RO participant's legacy TIN(s) or legacy CCN(s), and current TIN or CCN, during the baseline period.

(a) Reassignment of billing rights. Each Professional participant and Dual participant must ensure that its individual practitioners reassign their billing rights to the TIN of the Professional participant or Dual participant.

(b) Billing under the RO Model. (1) Professional participants and Dual participants must bill an RO Model-specific HCPCS code and a SOE modifier to indicate that the treatment planning service has been furnished and that an RO episode has been initiated.

(2) Dual participants and Technical participants must bill an RO Model-specific HCPCS code and SOE modifier to indicate that a treatment delivery service was furnished.

(3) RO participants must bill the same RO Model-specific HCPCS code that initiated the RO episode and an EOE modifier to indicate that the RO episode has ended.

(4) RO participants may submit a claim with an EOE modifier only after the RT course of treatment has ended, except that such claim must not be submitted earlier than 28 days after the date of the initial treatment planning service.

(c) Billing for RT services performed during a clean period. RO participants must bill for any medically necessary RT services furnished to an RO beneficiary during a clean period in accordance with existing FFS billing processes in the OPPS and PFS.

(d) Submission of no-pay claims. RO participants must submit no-pay claims for any medically necessary included RT services furnished to an RO beneficiary during an RO episode pursuant to existing FFS billing processes in the OPPS and PFS.

(a) Payment for episodes. CMS pays an RO participant for all included RT services furnished to an RO beneficiary during a completed RO episode as follows:

(1) CMS pays a Professional participant a participant-specific professional episode payment for the professional component furnished to an RO beneficiary during an RO episode.

(2) CMS pays a Technical participant a participant-specific technical episode payment for the technical component furnished to an RO beneficiary during an RO episode.

(3) CMS pays a Dual participant a participant-specific professional episode payment and a participant-specific technical episode payment for the professional component and technical component furnished to an RO beneficiary during an RO episode.

(b) Payment installments. CMS makes each of the payments described in paragraph (a) of this section in two equal installments, as follows:

(1) CMS pays one-half of a participant-specific professional episode payment to a Professional participant or Dual participant or one-half of the participant-specific technical episode payment to a Technical participant or Dual participant after the RO participant bills an RO Model-specific HCPCS code with a SOE modifier.

(2) CMS pays the remaining half of a participant-specific professional episode payment to a Professional participant or Dual participant or one-half of the participant-specific technical episode payment to a Technical participant or Dual participant after the RO participant bills an RO Model-specific HCPCS code with an EOE modifier.

(c) Duplicate RT services. Duplicate RT services are reimbursed at the FFS amount, whether or not the RT provider or RT supplier that furnished such services is an RO participant.

(a) CMS does not make separate Medicare FFS payments to RO participants for any included RT services that are furnished to an RO beneficiary during an RO episode.

(b) An RO participant may receive Medicare FFS payment for items and services furnished to an RO beneficiary during an RO episode, provided that any such other item or service is not an included RT service.

(a) Data privacy compliance. The RO participant must—

(1) Comply with all applicable laws pertaining to any patient-identifiable data requested from CMS under the terms of the Innovation Center model, including any patient-identifiable derivative data, as well as the terms of any attestation or agreement entered into by the RO participant with CMS as a condition of receiving that data. Such laws may include, without limitation, the privacy and security rules promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as modified, and the Health Information Technology for Economic and Clinical Health Act (HITECH).

(2) Contractually bind all downstream recipients of CMS data to the same terms and conditions to which the RO participant was itself bound in its agreements with CMS as a condition of the downstream recipient's receipt of the data from the RO participant.

(b) RO participant public release of patient de-identified information. The RO participant must include the disclaimer codified at § 512.120(c)(2) on the first page of any publicly-released document, the contents of which materially and substantially references or is materially and substantially based upon the RO participant's participation in the RO Model, including but not limited to press releases, journal articles, research articles, descriptive articles, external reports, and statistical/analytical materials.

(c) Reporting quality measures and clinical data elements. In addition to reporting described in other provisions in this part, Professional participants and Dual participants must report selected quality measures on all patients and clinical data elements describing cancer stage, disease characteristics, treatment intent, and specific treatment plan information on beneficiaries treated for specified cancer types, in the form, manner, and at a time specified by CMS.

(d) Technical participants and reporting of quality measures and clinical data elements. Technical participants that are freestanding radiation therapy centers and also begin furnishing the professional component during the model performance period must:

(1) Notify CMS no later than 30 days after the technical participant begins furnishing the professional component, in a form and manner specified by CMS; and

(2) Report quality measures and clinical data elements by the next submission period, as described in paragraph (c) of this section.

(a) General. The Secretary may waive certain requirements of title XVIII of the Act as necessary solely for purposes of testing of the RO Model. Such waivers apply only to the participants in the RO Model.

(b) Hospital Outpatient Quality Reporting (OQR) Program. CMS waives the application of the Hospital OQR Program 2.0 percentage point reduction under section 1833(t)(17) of the Act for only those Ambulatory Payment Classifications (APCs) that include only RO Model-specific HCPCS codes during the Model performance period.

(c) Merit-based Incentive Payment System (MIPS). CMS waives the requirement under section 1848(q)(6)(E) of the Act and § 414.1405(e) of this chapter to apply the MIPS payment adjustment factor, and, as applicable, the additional MIPS payment adjustment factor (collectively referred to as the MIPS payment adjustment factors) to the TC of RO Model payments to the extent that the MIPS payment adjustment factors would otherwise apply to the TC of RO Model payments.

(d) APM Incentive Payment. CMS waives the requirements of § 414.1450(b) of this chapter such that technical component payment amounts under the RO Model shall not be considered in calculation of the aggregate payment amount for covered professional services as defined in section 1848(k)(3)(A) of the Act for the APM Incentive Payment made under § 414.1450(b)(1) of this chapter.

(e) PFS Relativity Adjuster. CMS waives the requirement to apply the PFS Relativity Adjuster to RO Model-specific APCs for RO participants that are non-excepted off-campus provider-based departments (PBDs) identified by section 603 of the Bipartisan Budget Act of 2015 (Pub. L. 114-74), which amended section 1833(t)(1)(B)(v) and added paragraph (t)(21) to the Social Security Act.

(f) General payment waivers. CMS waives the following sections of the Act solely for the purposes of testing the RO Model:

(1) 1833(t)(1)(A).

(2) 1833(t)(16)(D).

(3) 1848(a)(1).

(4) [Reserved].

(5) 1869 claims appeals procedures.

(a) General. CMS conducts an initial reconciliation and a true-up reconciliation for each RO participant for each PY in accordance with this section.

(b) Annual reconciliation calculations. (1) To determine the reconciliation payment or the repayment amount based on RO episodes initiated in a PY, CMS performs the following steps:

(i) CMS calculates an RO participant's incorrect episode payment reconciliation amount as described in paragraph (c) of this section.

(ii) CMS calculates the RO participant's quality reconciliation amount as described in paragraph (d) of this section, if applicable.

(iii) CMS calculates the RO participant's patient experience reconciliation amount, as described in paragraph (e) of this section, if applicable.

(iv) CMS calculates the stop-loss reconciliation amount, as described in paragraph (f) of this section, if applicable.

(v) CMS adds, as applicable, the incorrect episode payment reconciliation amount, any quality reconciliation payment amount, any patient experience reconciliation amount, and any stop-loss reconciliation payment amount. The sum of these amounts results in a reconciliation payment or repayment amount.

(2) CMS calculations use claims data available at the time of reconciliation.

(c) Incorrect episode payment reconciliation amount. CMS calculates the incorrect episode payment reconciliation amount as follows:

(1) Total incorrect payment withhold amount. CMS calculates the total incorrect payment withhold amount by adding the incorrect payment withhold amount for each episode initiated in the PY.

(2) Total duplicate RT services amount. CMS calculates the total duplicate RT services amount by adding all FFS amounts for duplicate RT services furnished during each episode initiated in the PY. The duplicate RT services amount is capped for each episode and will not be more than the participant-specific professional episode payment amount or participant-specific technical episode payment amount received by the RO participant for an RO episode, even if the duplicate RT services amount exceeds the participant-specific professional episode payment amount or the participant-specific technical episode payment amount.

(3) Total incomplete episode amount. For incomplete episodes initiated in the PY, CMS determines the total incomplete episode amount by calculating the difference between the following amounts:

(i) The sum of all FFS amounts that would have been paid to the RO participant in the absence of the RO Model for any included RT services furnished during such incomplete episodes, as determined by no-pay claims. CMS owes this sum to the RO participant for such incomplete episodes.

(ii) The sum of the participant-specific episode payment amounts paid to the RO participant for such incomplete episodes initiated in the PY.

(4) Total incorrect episode payment amount. CMS calculates the total incorrect episode payment amount as follows:

(i) If the sum described in paragraph (c)(3)(i) of this section is more than the sum described in paragraph (c)(3)(ii) of this section, the difference is subtracted from the total duplicate RT services amount described in paragraph (c)(2) of this section and the resulting amount is the total incorrect episode payment amount.

(ii) If the sum described in paragraph (c)(3)(i) of this section is less than the sum described in paragraph (c)(3)(ii) of this section, the difference is added to the total duplicate RT services amount described in paragraph (c)(2) of this section and the resulting amount is the total incorrect episode payment amount.

(5) Incorrect episode payment reconciliation amount. If the total incorrect episode payment amount represents money owed by the RO participant to CMS, CMS subtracts the total incorrect episode payment amount from the total incorrect payment withhold amount. In the case that the total incorrect episode payment amount represents money owed by CMS to the RO participant, CMS adds the total incorrect episode payment amount to the total incorrect payment withhold amount. The resulting amount is the RO participant's incorrect episode payment reconciliation amount.

(d) Quality reconciliation payment amount. For Professional participants and Dual participants, CMS determines the quality reconciliation payment amount for each PY by multiplying the participant's AQS (as a percentage) by the total quality withhold amount for all RO episodes initiated during the PY.

(e) Patient experience reconciliation amount. For PY3 and subsequent PYs, CMS determines the patient experience reconciliation amount for RO participants by multiplying the participant's AQS (as a percentage) by the total patient experience withhold amount for all RO episodes initiated during the PY.

(f) Stop-loss reconciliation amount. CMS determines the stop-loss reconciliation amount for RO participants that have fewer than 60 episodes during the baseline period and were furnishing included RT services before the start of the model performance period in the CBSAs selected for participation by—

(1) Using no-pay claims, CMS calculates the total FFS amount by summing the FFS amounts that would have been paid to the RO participant in the absence of the RO Model for all included RT services furnished during the RO episodes initiated in the PY; and

(2) CMS calculates the sum of all participant-specific professional episode payments and participant-specific technical episode payments paid to the RO participant for the RO episodes initiated in the PY.

(3) If the total FFS amount exceeds the sum of the participant-specific episode payment amounts for the PY by more than 20 percent then CMS owes the RO participant the amount that exceeds 20 percent, either increasing the amount of the RO participant's reconciliation payment or reducing the amount of the RO's participant's reconciliation repayment.

(g) True-up reconciliation. CMS conducts a true-up reconciliation in the same manner described in paragraph (b) of this section (except that the quality reconciliation payment amount and the patient experience reconciliation amount are not calculated) to determine any additional reconciliation payment or repayment amount that are identified using 12-months of claims run-out.

(h) Reconciliation report. CMS issues each RO participant a reconciliation report for each PY. Each reconciliation report contains the following:

(1) The RO participant's reconciliation payment or repayment amount, if any, for the relevant PY.

(2) Any additional reconciliation payment or repayment amount owed for a previous PY as a result of the true-up reconciliation.

(3) The net reconciliation payment or repayment amount owed.

(i) Payment of amounts owed. (1) CMS issues a reconciliation payment to the RO participant in the amount specified in the reconciliation report 30 days after the reconciliation report is deemed final.

(2) The RO participant must pay a repayment amount to CMS in the amount specified in the reconciliation report by a deadline specified by CMS. If the RO participant fails to timely pay the full repayment amount, CMS recoups the repayment amount from any payments otherwise owed by CMS to the RO participant, including Medicare payments for items and services unrelated to the RO Model.

(3) No coinsurance is owed by an RO beneficiary with respect to any repayment amount or reconciliation payment.

(a) Timely error notice. Subject to the limitations on review in § 512.170, an RO participant that identifies and wishes to contest a suspected error in the calculation of its reconciliation payment or repayment amount or AQS must provide written notice of the suspected calculation error to CMS within 45 days of the date of the reconciliation report. Such timely error notice must be in a form and manner specified by CMS. RO participants are not permitted to contest the RO Model pricing methodology or AQS methodology.

(1) Unless a timely error notice is received by CMS within 45 days of the date of issuance of a reconciliation report, the reconciliation payment or repayment amount determination specified in that reconciliation report is deemed binding and not subject to further review.

(2) If CMS receives a timely error notice, then CMS responds in writing within 30 days either to confirm that there was an error in the calculation or to verify that the calculation is correct. CMS may extend the deadline for its response upon written notice to the RO participant.

(3) Only the RO participant may use the timely error notice process described in this paragraph and the reconsideration review process described in paragraph (b) of this section.

(b) Reconsideration review—(1) Reconsideration request by an RO participant. (i) If the RO participant is dissatisfied with CMS' response to the timely error notice, then the RO participant may request a reconsideration review as specified in paragraph (b)(2) of this section.

(ii) If CMS does not receive a request for reconsideration from the RO participant within 10 days of the issue date of CMS' response to the RO participant's timely error notice, then CMS' response to the timely error notice is deemed binding and not subject to further review.

(2) Submission of a reconsideration request—(i) Information needed in the reconsideration request. The reconsideration review request must—

(A) Provide a detailed explanation of the basis for the dispute; and

(B) Include supporting documentation for the RO participant's assertion that CMS or its representatives did not accurately calculate the reconciliation payment or repayment amount or AQS in accordance with the terms of this subpart.

(3) Form, manner, and deadline for submission of the reconsideration request. The information specified in paragraph (b)(2)(i) of this section must be submitted—

(i) In a form and manner specified by CMS; and

(ii) Within 10 days of the date of the CMS response described in paragraph (a)(2) of this section.

(4) Designation of and notification from a CMS-designated reconsideration official.

(i) Designation of reconsideration official. CMS designates a reconsideration official who—

(A) Is authorized to receive such requests; and

(B) Was not involved in the responding to the RO participant's timely error notice.

(ii) Notification to the RO participant. The CMS-designated reconsideration official makes reasonable efforts to notify the RO participant and CMS in writing within 15 days of receiving the RO participant's reconsideration review request of the following:

(A) The issue(s) in dispute;

(B) The briefing schedule; and

(C) The review procedures.

(5) Resolution review. The CMS reconsideration official makes all reasonable efforts to complete the on-the-record resolution review and issue a written determination no later than 60 days after the submission of the final position paper in accordance with the reconsideration official's briefing schedule.

Participant-specific professional episode payments and Participant-specific technical episode payments made under the RO Model are not adjusted to reflect payments made under models being tested under 1115A of the Act or the Medicare Shared Savings Program under section 1899 of the Act.

(a) General. If CMS determines that there is an EUC pursuant to paragraph (b) of this section, CMS may grant RO participants exceptions to the RO Model requirements under paragraph (c) of this section and revise the RO Model's pricing methodology under paragraphs (e) and (f) of this section.

(b) Determination factors. CMS determines whether there is an EUC based on the following factors:

(1) Whether the RO participants are furnishing services within a geographic area considered to be within an “emergency area” during an “emergency period” as defined in section 1135(g) of the Social Security Act;

(2) Whether the geographic area within a county, parish, U.S. territory, or tribal government designated under the Stafford Act served as a condition precedent for the Secretary's exercise of the 1135 waiver authority, or the National Emergencies Act; or

(3) Whether a state of emergency has been declared in the geographic area.

(c) Modified requirements. CMS may grant RO Participants exceptions to the following RO Model requirements:

(1) Reporting requirements. CMS may delay or exempt RO participants from one or more of the RO Model's quality measure or clinical data element reporting requirements if an EUC impacts the RO participants' ability to comply with quality measure or clinical data element reporting requirements.

(2) Other requirements. CMS may issue a notice on the RO Model website that may waive compliance with or modify the following RO Model requirements:

(i) The requirement set forth at § 512.220(a)(2)(vii) that RO participants provide Peer Review (audit and feedback on treatment plans).

(ii) The requirement set forth at § 512.220(a)(3) that RO participants actively engage with an AHRQ-listed patient safety organization (PSO).

(d) Model performance period. If CMS determines that the EUC affects the United States and if CMS determines that the EUC would impact RO participants' ability to implement the requirements of the RO Model prior to the start of the model performance period, CMS may amend the model performance period.

(e) Trend factor. If CMS determines that the EUC affects the entire United States, and if CMS determines that as a result of the EUC, the trend factor (specific to the PC, TC, or both for an included cancer type) for the upcoming PY has increased or decreased by more than 10 percent compared to the corresponding trend factor of the previous CY when FFS payment rates are held constant with the previous CY, CMS may modify the trend factor calculation for the PC, TC, or both the PC and TC of an included cancer type in a manner that ensures the trend factor is consistent with the average utilization from the previous CY.

(f) Quality withhold. In response to a national, regional, or local event, CMS may adjust the quality withhold by choosing to repay the quality withhold during the next reconciliation and award all possible points in the subsequent AQS calculation amount or to not apply the quality withhold to RO Model payments during the EUC if CMS removes the quality measure and clinical data element reporting requirements pursuant to paragraph (c)(1) of this section.