,,ii #aaith ,,congress #ast ,session ,s4 #ajca ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ac1 #bjbe,mr4 ,tillis 7for himself and ,mr4 ,peters7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend ,title ,,xviii of the ,social ,security ,act to create a ,radiation ,oncology ,case ,rate ,value ,based ,payment ,program exempt from budget neutrality adjustment requirements1 and to amend section #aabh;,a of title ,,xi of the ,social ,security ,act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services4 #a4 ,short title ,this ,act may be cited as the ,radiation ,oncology ,case ,rate ,value ,based ,program ,act of #bjbe or the ,,rocr ,value ,based ,program ,act4 #b4 ,findings 7a7 ,findings ,congress finds the following3 7#a7 ,radiation therapy is the careful use of various forms of radiation1 such as external beam radiation therapy1 to treat cancer and other diseases safely and effectively4 ,radiation oncologists develop radiation treatment plans and coordinate with highly specialized care teams to deliver radiation therapy4 ,nearly #fj percent of cancer patients will receive radiation therapy during their treatment4 7#b7 ,in #bjba1 the ,centers for ,medicare ,medicaid ,services reported approximately #d1bjj1jjj1jjj in total spending for radiation oncology services between the ,medicare physician fee schedule and hospital outpatient departments4 7#c7 ,the ,centers for ,medicare ,medicaid ,services has historically faced challenges in determining accurate pricing for services that involve costly capital equipment1 resulting in fluctuating payment rates under the ,medicare physician fee schedules for services involving external beam radiation therapy4 ,additionally1 the ,medicare physician fee schedule has inadequately recognized the professional expertise physicians and nonphysician professionals need to deliver radiation therapy4 7#d7 ,the current payment systems incentivize greater volumes of care while bundled payments incentivize patient centered1 efficient1 and high value care4 7#e7 ,in #bjag1 the ,centers for ,medicare ,medicaid ,services recognized that the ,medicare payment systems were not adequately addressing radiation oncology services1 and the ,center for ,medicare ,medicaid ,innovation released a congressionally requested report on the pursuit of an alternative payment model for radiation oncology 7referred to in this section as the ,radiation ,oncology ,model7 that addresses the issues in the ,medicare physician fee schedule and the ,medicare hospital outpatient prospective payment system payment methods4 7#f7 ,concerns regarding the proposed ,radiation ,oncology ,model included the significant payment reductions proposed in the model that would jeopardize access to high-quality radiation therapy services and the onerous reporting requirements for participating providers4 ,the ,radiation ,oncology ,model saw indefinite implementation delays4 7#g7 ,it is necessary1 therefore1 to create a payment program for radiation oncology services that appropriately recognizes the value of quality radiation oncology services through its financial incentives while containing costs and providing patient-centered care4 #c4 ,radiation oncology case rate value based payment program 7a7 ,in general ,title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 is amended by adding at the end the following3 #ahii;,c4 ,radiation oncology case rate value based payment program 7a7 ,establishment 7#a7 ,in general ,not later than #a year after the date of enactment of the ,,rocr ,value ,based ,program ,act1 the ,secretary shall promulgate regulations1 using the procedures described in paragraph 7#e71 establishing a ,radiation ,oncology ,case ,rate ,value ,based ,payment ,program 7referred to in this section as the ,,rocr ,program7 under which per episode payments are provided to radiation therapy providers or radiation therapy suppliers for covered treatment furnished to a covered individual during an episode of care 7as such terms are defined in subsection 7j77 in accordance with this section4 7#b7 ,maintaining payment rates during period prior to effective date of regulations ,the ,secretary shall not reduce the established payment rates for radiation therapy services under the physician fee schedule under section #ahdh or the hospital outpatient prospective payment system under section #ahcc7t7 during the time period beginning on the date of enactment of the ,,rocr ,value ,based ,program ,act and ending on the date that the regulations issued by the ,secretary pursuant to paragraph 7#a7 become effective4 7#c7 ,,rocr ,program goals ,the ,,rocr ,program shall seek to-- 7,a7 create stable1 unified payments for radiation therapy services under this title2 7,b7 reduce disparities in radiation therapy care for ,medicare beneficiaries by increasing access to radiation therapy services close to the homes of beneficiaries2 7,c7 enhance quality of radiation therapy care through practice accreditation and shorter courses of treatment1 when appropriate2 7,d7 leverage and encourage the utilization of state-of-the-art technology to improve care and outcomes2 and 7,e7 protect ,medicare resources by achieving reasonable spending reductions in ,medicare for radiation therapy services4 7#d7 ,payments ,under this section1 with respect to covered treatment furnished to covered individuals1 payments shall include-- 7,a7 per episode payments1 as described in subsection 7b71 to radiation therapy providers or radiation therapy suppliers of radiation therapy services which meet such requirements as the ,secretary shall establish by regulation2 and 7,b7 the health equity achievement in radiation therapy add-on payment described in subsection 7g74 7#e7 ,notice and comment rulemaking ,the ,secretary shall promulgate the regulations described in paragraph 7#a7 in accordance with section #eec of title #e1 ,united ,states ,code1 and issue an advanced notice of proposed rulemaking and notice of proposed rulemaking with a comment period of not less than #fj days for each4 7b7 ,per episode payments 7#a7 ,in general 7,a7 ,payments ,the ,secretary shall pay to a radiation therapy provider or radiation therapy supplier an amount equal to #hj percent of the per episode payment amount determined under paragraph #c 7referred to in this section as the per episode payment amount7 for each covered individual furnished covered treatment for an included cancer type to cover all professional and technical services furnished during such treatment by the radiation therapy provider or radiation therapy supplier during an episode of care 7as defined in subsection 7j774 7,b7 ,deductibles and coinsurance ,subject to subsection 7e71 the ,secretary shall pay the per episode payment amount 7subject to any deductible and coinsurance otherwise applicable under part ,b7 to the radiation therapy provider or radiation therapy supplier for an episode of care1 as described in subsection 7c74 7#b7 ,per episode payment requirements and timing 7,a7 ,in general ,subject to subparagraph 7,b71 for each episode of care furnished to a covered individual3 7i7 ,first-half of payment ,the ,secretary shall issue #a_/b of the payment amount under paragraph 7#a7 prospectively not later than #cj days after the day of the first delivery of covered treatment4 7ii7 ,second-half of payment ,the ,secretary shall issue1 with the exception of an episode of care for treatment of bone or brain metastases and subject to clause 7iii71 the remaining half of the payment amount under paragraph 7#a7 on the date that is the earlier of-- 7,i7 the day the course of covered treatment is scheduled to end2 or 7,,ii7 the #ijth day of the episode of care4 7iii7 ,second-half of payment for bone and brain metastases ,the ,secretary shall issue the remaining half of the payment amount under paragraph 7#a7 for an episode of care for treatment of bone or brain metastases on the date that is the earlier of-- 7,i7 the day the course of covered treatment is scheduled to end2 or 7,,ii7 the #cjth day of the episode of care4 7,b7 ,patient death ,if a covered individual dies during treatment1 both episode of care payments under subparagraphs 7,a7 and 7,b7 shall be paid to the radiation therapy provider or radiation therapy supplier not later than #cj days after the day of the final delivery of radiation therapy treatment to the covered individual4 7,c7 ,consistency of payment 7i7 ,in general ,the per episode payment amount shall not change depending on the site of service4 7ii7 ,site of service defined ,for the purposes of this subparagraph1 the term site of service means the hospital outpatient department or physician office in which radiation therapy treatment is furnished by the radiation therapy provider or radiation therapy supplier4 7#c7 ,determination of per episode payment amount 7,a7 ,in general ,the ,secretary shall determine a per episode payment amount for the professional component and technical component of treatment for each included cancer type4 7,b7 ,amount ,the ,secretary shall determine the per episode payment amount based on national base rates1 as described in subsection 7d77#a7 and as updated in subsection 7d77#b74 7,c7 ,adjustments ,the per episode payment amount shall be subject to-- 7i7 the adjustments as described in subsection 7d77#b7 and 7d77#c72 7ii7 a geographic adjustment1 as described in subsection 7d77#c77;,a72 7iii7 an inflation adjustment1 pursuant to which the ,secretary shall adjust the per episode payment amount by the percentage increase in the ,medicare ,economic ,index 7as described in section #ahdb for the professional component payments and the applicable percentage increase in the ,hospital ,inpatient ,market ,basket ,update 7as described in section #ahhf7;b77#c77;,b77i77 for the technical component payments during each #ab-month period1 and which varies for the professional and technical components of the service2 7iv7 a savings adjustment1 as described in subsection 7d77#c77;,b72 7v7 a health equity achievement in radiation therapy adjustment applicable only to the technical component payments1 as described in subsection 7g72 and 7vi7 a practice accreditation adjustment1 as described in subsection 7h71 that is only applicable to technical component payments4 7c7 ,treatment of incomplete episodes of care2 concurrent treatment 7#a7 ,incomplete episode of care ,in the case of an incomplete episode of care1 payment shall be made to the radiation therapy provider or radiation therapy supplier for services furnished under the physician fee schedule under section #ahdh or the hospital outpatient prospective payment system under section #ahcc7t71 as applicable4 7#b7 ,multiple episodes of care for the same covered individual ,a radiation therapy provider or radiation therapy supplier may initiate a new episode of care for the same beneficiary for the same course of therapy by providing another radiation therapy treatment planning service and billing under an applicable radiation therapy planning trigger code 7as defined in subsection 7j774 7#c7 ,concurrent treatments ,in the case where a treatment modality described in subsection 7j77#d77;,b77i77,i7 is furnished to a covered individual during an episode of care for an included cancer type1 payment may be made concurrently for the treatment modality under the applicable payment system under this title with per episode payment under this section for covered treatment during the episode of care4 7d7 ,national base rate 7#a7 ,determination of national base rates ,for purposes of the ,secretary determining the per episode payment amount under subsection 7b77#c71 the national base rates for the professional component and technical component of radiation therapy services for each included cancer type are based on the ,m-,code national base rates identified in table #ge 7including ,,hcpcs ,codes for radiation therapy services and supplies7 of the ,federal ,register on ,november #af1 #bjba1 #hf ,fed4 ,reg4 #fcdeh1 #fcibe4 7#b7 ,updates to the national base rates 7,a7 ,annual updates 7i7 ,in general ,subject to clause 7ii71 the ,secretary shall annually update the initial national base rates by-- 7,i7 in the case of the professional component of the covered treatment1 the percentage increase in the ,medicare ,economic ,index2 and 7,,ii7 in the case of the technical component of the covered treatment1 the applicable percentage increase described in section #ahhf7;b77#c77;,b77i74 7ii7 ,payment floor ,for each annual update1 the ,secretary shall not reduce the national base rates below the established rates from the prior year4 7,b7 ,periodic updates 7i7 ,in general ,the ,secretary shall1 through notice and comment rulemaking1 rebase or revise the national base rates in #e-year intervals1 beginning on the day that is #e years after the date the regulations issued pursuant to subsection 7a77#a7 become effective4 7ii7 ,rebasing limit ,the ,secretary shall not reduce the national base rates through the process of rebasing by more than #a percent every #e years4 7iii7 ,input from providers and suppliers ,in rebasing or revising the national base rates pursuant to clause 7i71 the ,secretary shall seek significant input from radiation therapy providers1 radiation therapy suppliers1 and other stakeholders to ensure that such rates are sufficient1 particularly for any new technology or service and any treatment modality described in clause 7i77,i7 of subsection 7j77#d77;,b7 that is determined to be a covered treatment by the ,secretary under clause 7ii7 of such subsection4 7,c7 ,rebase and revise defined ,in this subsection3 7i7 ,rebase ,the term rebase means to move the base year for the structure of costs of the national base rates4 7ii7 ,revise ,the term revise means types of changes to national base rates other than rebasing1 such as using different data sources1 cost categories1 or price proxies in the national base rates input4 7,d7 ,new technology or services 7i7 ,treatment under the national base rates 7,i7 ,exclusion during initial period ,the ,secretary shall not incorporate a radiation therapy service that is a new technology or service 7as defined in subsection 7j77 into the national base rates for an included cancer type prior to the date that is #ab years after such service is first identified as a new technology or service4 7,,ii7 ,incorporation after initial period ,after the date specified in subclause 7,i7 with respect to a radiation therapy service that is a new technology or service1 the ,secretary shall1 through stakeholder meetings1 requests for information1 and notice and comment rulemaking1 engage providers1 suppliers1 radiation therapy vendors1 patient groups1 and the public on possible incorporation of the new technology or service into the national base rates for included cancer types under paragraph 7#a74 7ii7 ,before incorporation into the national base rate ,until incorporated into the national base rates under clause 7i77,,ii71 any new technology or service shall be paid under the applicable payment system under this title4 7iii7 ,development and transitional payment period for adaptive radiation therapy planning 7,i7 ,development and valuation for adaptive radiation therapy planning ,not later than the date the regulations issued pursuant to subsection 7a77#a7 become effective and in consultation with the ,american ,medical ,association's ,current ,procedural ,terminology ,editorial ,panel and ,specialty ,society ,relative ,value ,scale ,update ,committee1 radiation oncology specialty societies1 and radiation oncology stakeholders1 the ,secretary shall develop and value codes for adaptive radiation therapy planning 7as defined in subsection 7j774 7,,ii7 ,transitional payment 7aa7 ,in general ,during the period beginning on the date the regulations issued pursuant to subsection 7a77#a7 become effective and ending on the date any adaptive radiation therapy planning code is developed and valued1 the ,secretary shall provide a separate payment under the applicable payment system1 in addition to the per episode payment amount1 for any medically necessary online and offline adaptive radiation therapy planning furnished to a covered individual after the initial treatment plan for a covered individual4 7bb7 ,modifier ,the ,secretary shall establish a modifier to identify claims for the transitional payment for adaptive radiation therapy planning for a covered individual4 7iv7 ,assessment of certain criteria ,prior to incorporating a new technology or service into the national base rates pursuant to clause 7i77,,ii71 the ,secretary shall consider market penetration and adoption1 costs relative to base rates1 clinical benefits of the new technology or service1 and the clear consensus of the stakeholder community4 7#c7 ,adjustments to national base rates 7,a7 ,geographic adjustment ,prior to applying the savings adjustment described in subparagraph 7,b71 the ,secretary shall adjust the national base rates for local cost and wage indices based on where the radiation therapy services are furnished-- 7i7 in the case of the professional component payment rates1 the geographic adjustment processes described in the ,medicare ,physician ,fee ,schedule ,geographic ,practice ,cost ,index2 and 7ii7 in the case of the technical component payment rates1 the geographic adjustment processes in the hospital outpatient prospective payment system under section #ahcc7t74 7,b7 ,savings adjustment 7i7 ,in general ,the ,secretary shall apply a savings adjustment under this subparagraph after the geographic adjustments have been applied under subparagraph 7,a74 7ii7 ,savings adjustment defined ,the term savings adjustment means the percentage by which the professional component and technical component payment rates are each reduced to achieve ,medicare savings4 7e7 ,availability of payment plans for payment of coinsurance ,following the application of the adjustments described in subsection 7d71 but before the application of any sequestration order issued under the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe 7#b ,u4,s4,c4 #ijj et seq471 radiation therapy providers and radiation therapy suppliers shall collect coinsurance for services furnished under the ,,rocr ,program subject to the following rules3 7#a7 ,in general ,radiation therapy providers and radiation therapy suppliers may collect coinsurance applicable under subsection 7b77#a7 for covered treatment furnished to a covered individual under the ,,rocr ,program in multiple installments under a payment plan4 7#b7 ,limitation on use as a marketing tool ,radiation therapy providers and radiation therapy suppliers may not use the availability of payment plans for such coinsurance as a marketing tool to influence the choice of health care provider by covered individuals4 7#c7 ,timing of provisions of information ,radiation therapy providers and radiation therapy suppliers offering a payment plan for such coinsurance may inform the covered individual of the availability of the payment plan prior to or during the initial treatment planning session and as necessary thereafter4 7#d7 ,beneficiary coinsurance payment ,the beneficiary coinsurance payment shall equal #bj percent of the payment amount to be paid to the radiation therapy provider or radiation therapy supplier prior to the application of any sequestration order issued under the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe 7#b ,u4,s4,c4 #ijj et seq47 for the billed ,,rocr ,program episode of care1 except as provided in paragraph 7#e74 7#e7 ,incomplete episode of care ,in the case of an incomplete episode of care1 the beneficiary coinsurance payment shall equal #bj percent of the amount that would have been paid in the absence of the ,,rocr ,program for the radiation therapy services furnished by the radiation therapy provider or radiation therapy supplier that initiated the professional component and1 if applicable1 the radiation therapy provider or radiation therapy supplier that initiated the technical component4 7f7 ,mandatory participation 7#a7 ,in general ,except as provided under paragraph 7#b7 or 7#c71 a radiation therapy provider or radiation therapy supplier that is participating in the program under this title and furnishes a covered treatment to a covered individual shall be required to participate in the ,,rocr ,program4 7#b7 ,concurrent participation in the ,,rocr ,program and other models ,a radiation therapy provider or radiation therapy supplier that is participating in a ,state-based ,center for ,medicare ,medicaid ,innovation model-- 7,a7 shall not be prohibited from also participating in the ,,rocr ,program2 and 7,b7 is not required to participate in the ,,rocr ,program4 7#c7 ,significant hardship exemption 7,a7 ,in general ,the ,secretary may1 on a case-by-case basis1 exempt a radiation therapy provider or radiation therapy supplier from the ,,rocr ,program if the ,secretary determines that application of the program would result in a significant hardship1 such as in the case of a natural disaster1 for such radiation therapy provider or radiation therapy supplier or for beneficiaries in the geographic area of the radiation therapy provider or radiation therapy supplier4 7,b7 ,procedure ,the ,secretary shall promulgate regulations1 using the procedures described in subsection 7a77#e71 regarding eligibility and the procedure for applying for a significant hardship exemption4 7g7 ,health equity achievement in radiation therapy add-,on payment 7#a7 ,in general ,pursuant to paragraph 7#b7 and subject to paragraph 7#g71 the ,secretary shall adjust the per episode payment amount in the amount of a health equity achievement in radiation therapy add-on payment to advance health equity and support covered individuals in accessing and completing their radiation therapy treatments for covered treatments of included cancer types through the provision of transportation services1 subject to the succeeding provisions of this subsection4 7#b7 ,eligibility 7,a7 ,in general ,the health equity achievement in radiation therapy add-on payment shall be made when the ,,icd-#aj diagnosis code ,z#ei4hb1 transportation insecurity is reported pursuant to subparagraph 7,b74 7,b7 ,determination of reporting code ,the radiation therapy provider or radiation therapy supplier shall follow the following procedures to determine if the ,,icd-#aj diagnosis code ,z#ei4hb1 transportation insecurity needs to be reported3 7i7 ,the radiation therapy provider or radiation therapy supplier shall ask the patient at the time of patient intake during the initial patient consultation if1 within the previous #b months1 a lack of reliable transportation has kept the patient from attending medical appointments1 meetings1 or work1 or from completing activities of daily living4 7ii7 ,if the patient answers yes to the question in clause 7i71 ,,icd-#aj diagnosis code ,z#ei4hb shall be reported4 7#c7 ,amount ,the health equity achievement in radiation therapy add-on payment shall be in the amount of-- 7,a7 for services furnished during the year following the date the regulations issued pursuant to subsection 7a77#a7 become effective1 #ejj per patient per episode of care2 and 7,b7 for services furnished in subsequent years1 the amount determined under this paragraph for the preceding year1 increased by #aj4 7#d7 ,payment recipient ,the health equity achievement in radiation therapy add-on payment shall be paid to the radiation therapy provider or radiation therapy supplier that provides the technical component of the radiation therapy services4 7#e7 ,not to be used in addition to or in lieu of other services ,the health equity achievement in radiation therapy add-on payment shall not be made in addition to or in lieu of any other ,state or ,federal program benefits that may be used for transportation services4 7#f7 ,documentation 7,a7 ,in general ,radiation therapy providers and radiation therapy suppliers who receive the health equity achievement in radiation therapy add-on payment shall maintain all documentation related to the spending of such payment on transportation services per covered individual for a period of #e years after the end of the episode of care of the applicable covered individual4 7,b7 ,availability to the ,secretary ,the documentation described in subparagraph 7,a7 shall be made available to the ,secretary upon request4 7#g7 ,no modification of coinsurance ,the ,secretary may not modify any coinsurance obligation when implementing the health equity achievement in radiation therapy add-on payment4 7h7 ,quality incentives in the ,,rocr ,value ,based ,payment ,program 7#a7 ,in general 7,a7 ,initial increase in payment ,with respect to covered treatment for an included cancer type furnished to a covered individual on or after the date the regulations issued pursuant to subsection 7a77#a7 become effective and before the date that is #b years after such date1 in the case of a radiation therapy provider or radiation therapy supplier that meets the requirements described in paragraph 7#b71 payments otherwise made to such radiation therapy provider or radiation therapy supplier under the ,,rocr ,program for the technical component of such services shall be increased by #a percent 7or #j4be percent in the case of such a provider or supplier that is a limited resource radiation therapy supplier or limited resource radiation therapy provider74 7,b7 ,reduction in payment 7i7 ,in general ,subject to clause 7ii71 with respect to covered treatment for an included cancer type furnished to a covered individual on or after the date that is #b years after the regulations issued pursuant to subsection 7a77#a7 become effective1 in the case of a radiation therapy provider or radiation therapy supplier that does not meet the requirements described in paragraph 7#b71 the per episode payment to such provider or supplier under the ,,rocr ,program shall be reduced by #b4e percent4 7ii7 ,exclusion of limited resource radiation therapy providers and limited resource radiation therapy suppliers ,this subparagraph shall not apply with respect to a limited resource radiation therapy provider or a limited resource radiation therapy supplier4 7,c7 ,definition of limited resource radiation therapy provider and limited resource radiation therapy supplier 7i7 ,in general ,in this subsection1 the terms limited resource radiation therapy provider and limited resource radiation therapy supplier mean1 with respect to a radiation therapy provider or radiation therapy supplier1 a provider or supplier that meets the criteria specified by the ,secretary that may include criteria relating to the volume and socioeconomic status of patients treated by the radiation therapy provider or radiation therapy supplier1 the geographic area or medically-underserved area served by the radiation therapy provider or radiation therapy supplier1 including rural areas1 or such other criteria as the ,secretary determines is appropriate1 through notice and comment rulemaking and in consultation with radiation therapy stakeholder organizations4 7ii7 ,cap on number of limited resource radiation therapy providers and limited resource radiation therapy suppliers ,in specifying the criteria for limited resource radiation therapy providers and limited resource radiation therapy suppliers under clause 7i71 the ,secretary shall ensure that the total number of such providers and suppliers does not exceed #aj percent of the total number of all radiation therapy providers and radiation therapy suppliers4 7#b7 ,accreditation ,requirements 7,a7 ,in general ,the requirements described in this subparagraph with respect to a radiation therapy provider or radiation therapy supplier 7other than such a provider or supplier that is a limited resource radiation therapy provider or limited resource radiation therapy supplier7 are that the supplier or provider must-- 7i7 maintain or be in the process of obtaining accreditation by the ,american ,college of ,radiology1 ,american ,college of ,radiation ,oncology1 or ,american ,society for ,radiation ,oncology 7referred to in this section as covered radiation oncology accreditation organizations72 7ii7 comply with certified electronic health record technology requirements as determined by the ,secretary with exceptions that are consistent with those of the ,merit-,based ,incentive ,payment ,system established under section #ahdh7q72 and 7iii7 submit to the ,secretary proof of the accreditation described in clause 7i7 in such form and manner as specified by the ,secretary4 7,b7 ,requirements for limited resource radiation therapy providers and limited resource radiation therapy suppliers ,a radiation therapy provider or radiation therapy supplier that is a limited resource radiation therapy provider or limited resource radiation therapy supplier may elect to satisfy the accreditation requirement under this paragraph by-- 7i7 meeting the requirements of subparagraph 7,a72 7ii7 using an external audit that encompasses similar criteria as a nationally recognized radiation oncology accreditation organization and submit the outcome of such external audit to the ,secretary2 or 7iii7 complying with certified electronic health record technology requirements as determined by the ,secretary with exceptions that are consistent with those of the ,merit-,based ,incentives ,payment ,system established under section #ahdh7q74 7,c7 ,new providers ,a new radiation therapy provider or new radiation supplier shall complete an initiation of accreditation or external audit not later than the date that is #a year after such provider or supplier begins furnishing covered treatment to covered individuals4 7,d7 ,radiation oncology accreditation organization quality standards ,each covered radiation oncology accreditation organization 7and any successor organization7 shall develop quality standards for radiation therapy providers and radiation therapy suppliers to ensure covered treatments are delivered using adequate and modern linear accelerator technology1 staffing1 and other components that protect patient safety and quality by-- 7i7 consulting with radiation therapy manufacturers and key stakeholders2 7ii7 soliciting public comment on proposed quality standards1 including from physicians1 medical physicists1 and other health professionals and experts2 7iii7 updating quality standards not later than every #e to #g years in partnership with stakeholders2 7iv7 ensuring quality standards for linear accelerator technology are adequate and on par with current technological advances and modern requirements for staffing and other procedures associated with the delivery of safe and effective radiation therapy2 7v7 collecting timely information from radiation therapy providers and radiation therapy suppliers for each linear accelerator owned or used on or after the effective date of the regulations issued pursuant to subsection 7a77#a72 and 7vi7 giving sufficient weight to compliance with quality standards among other accreditation standards in determining accreditation status for radiation therapy providers or radiation therapy suppliers4 7i7 ,reporting requirements 7#a7 ,report on the ,,rocr ,program ,not earlier than #g years after the date of the enactment of this section1 the ,comptroller ,general of the ,united ,states 7referred to in this subsection as the ,comptroller ,general7 shall1 after seeking out the perspectives of radiation oncology stakeholders1 submit to the appropriate committees of jurisdiction of the ,senate and the ,house of ,representatives a report that-- 7,a7 evaluates-- 7i7 the implementation of the ,,rocr ,program1 and the impact such ,program has had on ,federal healthcare spending2 7ii7 the impact the ,,rocr ,program has had on the ability of covered individuals to access covered treatment2 7iii7 whether any cancer types or radiation therapy services1 such as brachytherapy1 proton therapy1 or therapeutic radiopharmaceuticals1 should be added or removed from the ,,rocr ,program2 and 7iv7 the potential application of the ,,rocr ,program to benefits provided under part ,c of this title2 and 7,b7 includes any recommendations for administrative and legislative changes4 7#b7 ,report on access to radiation therapy in rural and underserved areas ,not later than #c years after the date of the enactment of this section1 the ,comptroller ,general shall submit a report to the appropriate committees of jurisdiction of the ,senate and the ,house of ,representatives that identifies the following3 7,a7 ,radiation therapy deserts4 7,b7 ,methods to increase access to new radiation therapy technologies in rural and underserved areas1 including technologies required for clinical treatment planning1 simulation1 dosimetry1 medical radiation physics1 radiation treatment devices1 radiation treatment delivery1 radiation treatment management1 and such other items as the ,comptroller ,general may determine are medically necessary4 7,c7 ,a program to provide assistance in the form of grants or loans to radiation therapy providers or radiation therapy suppliers for the purpose of ensuring access to the most current radiation therapy technology4 7#c7 ,determination and definition of radiation therapy deserts 7,a7 ,definition ,for purposes of this subsection1 the term radiation therapy desert means a region determined by the ,comptroller ,general under subparagraph 7,b7 with a mismatch between radiation therapy resources and oncologic need4 7,b7 ,determination ,in determining whether a region qualifies as a radiation therapy desert1 the ,comptroller ,general shall take into account the ratio or density of radiation therapy providers and radiation therapy suppliers practicing in a geographic area as compared to the population size in that geographic area4 7j7 ,definitions ,in this section3 7#a7 ,adaptive radiation therapy planning ,the term adaptive radiation therapy planning means any new technology or services identified1 as of the date that the regulations issued pursuant to subsection 7a77#a7 become effective1 by the following ,,hcpcs codes 7and as subsequently modified by the ,secretary7 performed after the initial treatment plan for a covered individual3 7,a7 #ggbie1 #c-;dimensional radiotherapy plan1 including dose-volume histograms4 7,b7 #ggcjj1 basic radiation dosimetry calculation1 central axis depth dose calculation1 ,,tdf1 ,,nsd1 gap calculation1 off axis factor1 tissue inhomogeneity factors1 calculation of non-ionizing radiation surface and depth dose1 as required during course of treatment1 only when prescribed by the treating physician4 7,c7 #ggcja1 intensity modulated radiotherapy plan1 including dose-volume histograms for target and critical structure partial tolerance specifications4 7,d7 #ggcch1 multi-leaf collimator 7,,mlc7 devices for intensity modulated radiation therapy 7,,imrt71 design and construction per ,,imrt plan4 7,e7 #ggccd1 ,treatment devices1 design and construction2 complex 7irregular blocks1 special shields1 compensators1 wedges1 molds or casts74 7,f7 #ggbic1 ,respiratory motion management simulation 7,list separately in addition to code for primary procedure74 7#b7 ,applicable radiation therapy planning trigger code ,the term applicable radiation therapy planning trigger code means services identified1 as of the date that the regulations issued pursuant to subsection 7a77#a7 become effective1 by the following ,,hcpcs codes 7and as subsequently modified by the ,secretary73 7,a7 #ggbfa1 therapeutic radiology treatment planning1 simple4 7,b7 #ggbfb1 therapeutic radiology treatment planning1 intermediate4 7,c7 #ggbfc1 therapeutic radiology treatment planning1 complex4 7#c7 ,covered individual ,the term covered individual means an individual who-- 7,a7 is enrolled for benefits under part ,b2 7,b7 is not enrolled in a ,medicare ,advantage plan under part ,c or a ,,pace program under section #ahid2 and 7,c7 is diagnosed with an included cancer type4 7#d7 ,covered treatment 7,a7 ,in general ,the term covered treatment means1 subject to subparagraph 7,b71 radiation therapy services furnished to a covered individual4 7,b7 ,exclusions 7i7 ,in general ,such term does not include-- 7,i7 subject to clause 7ii71 during the period beginning on the date on which the regulation issued pursuant to subsection 7a77#a7 become effective and ending on the date that is #ab years after such date1 brachytherapy1 proton beam radiation therapy services1 intraoperative radiotherapy1 superficial radiation therapy1 hyperthermia1 and therapeutic radiopharmaceuticals2 7,,ii7 inpatient radiation therapy services furnished in a subsection 7d7 hospital or ambulatory surgical center2 7,,iii7 radiation therapy services furnished in cancer hospitals that are exempt from the hospital outpatient prospective payment system under section #ahcc7t72 7,,iv7 physician services that are furnished or supervised by the physician or the physician practice furnishing radiation therapy or by another physician1 including any surgical procedures1 chemotherapy1 and other services2 7,v7 physician and technical services that are furnished using technology represented by ,healthcare ,common ,procedure ,coding ,system codes that are not included in the ,m-code national base rates identified in table #ge 7including in ,,hcpcs ,codes for radiation therapy services and supplies7 of the ,federal ,register on ,november #af1 #bjba1 #hf ,fed4 ,reg4 #fcdhe1 #fcibe2 or 7,,vi7 durable medical equipment 7as defined in section #ahfa7n774 7ii7 ,inclusion of certain treatment ,after the date that is #ab years after the date on which the regulation issued pursuant to subsection 7a77#a7 become effective1 the ,secretary may determine by regulation to include any of the treatment modalities described in clause 7i77,i7 as covered treatment4 ,before making such determination1 the ,secretary shall-- 7,i7 consider-- 7aa7 market penetration2 7bb7 the cost of such items or services relative to base rates2 7cc7 the clinical benefits of such items or services2 and 7dd7 the clear consensus of the stakeholder community2 and 7,,ii7 publish a notice of a proposed determination under subsection 7b77#c77;,b7 regarding the payment amount proposed to be established with respect to such item or service4 7#e7 ,episode of care ,the term episode of care means1 with respect to a covered individual1 the period-- 7,a7 beginning on the day radiation therapy planning for an included cancer type1 billed under an applicable radiation therapy planning trigger code1 is furnished to a covered individual if radiation therapy treatment is initiated not later than #cj days after the day such radiation therapy planning service is furnished2 and 7,b7 ends-- 7i7 for treatment of all included cancer types except bone and brain metastases treatment1 the day that is #ij days after the day the episode of care begins under clause 7i72 and 7ii7 for bone and brain metastases treatment1 the day that is #cj days after the day the episode of care begins under clause 7i74 7#f7 ,included cancer types ,the term included cancer type means any of the following types of cancer3 7,a7 ,anal4 7,b7 ,bladder4 7,c7 ,bone ,metastases4 7,d7 ,brain ,metastases4 7,e7 ,breast4 7,f7 ,cervical4 7,g7 ,central ,nervous ,system ,tumors4 7,h7 ,colorectal4 7,i7 ,head and ,neck4 7,j7 ,lung4 7,k7 ,lymphoma4 7,l7 ,pancreatic4 7,m7 ,prostate4 7,n7 ,upper ,gastrointestinal4 7,o7 ,uterine4 7#g7 ,healthcare ,common ,procedure ,coding ,system ,the term ,healthcare ,common ,procedure ,coding ,system means the standardized coding system used by ,medicare and other health insurance programs to ensure that claims are processed in an orderly and consistent manner4 7#h7 ,incomplete episode of care ,the term incomplete episode of care means1 with respect to a covered individual1 an episode of care that is not completed because-- 7,a7 the individual being treated ceases to be a covered individual1 including in the case where the individual loses benefits under this title1 at any time after the initial treatment planning service is furnished and before the episode of care for the covered treatment is complete2 or 7,b7 a covered individual switches radiation therapy provider or radiation therapy supplier before all included radiation therapy services in the episode of care for the covered treatment have been furnished4 7#i7 ,new technology or services ,the term new technology or services means any technology or services that1 after the date of enactment of this section1 receives a ,category #a ,current ,procedural ,terminology code or is established in the yearly update to the ,medicare physician fee schedule direct practice expense inputs or any successor repository of the direct practice expense input for the delivery of radiation therapy services4 7#aj7 ,professional component ,the term professional component means the included radiation therapy services that may only be furnished by a physician4 7#aa7 ,radiation therapy ,the term radiation therapy means the careful use of various forms of radiation1 such as external beam radiation therapy1 to treat cancer and other diseases safely and effectively4 7#ab7 ,radiation therapy provider ,the term radiation therapy provider means a hospital outpatient department enrolled under this title that furnishes radiation therapy services4 7#ac7 ,radiation therapy services ,the term radiation therapy services means the treatment planning1 technical preparation1 special services 7such as simulation71 treatment delivery1 and treatment management services associated with cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors4 7#ad7 ,radiation therapy supplier ,the term radiation therapy supplier means a physician group practice or freestanding radiation therapy center enrolled under this title that furnishes radiation therapy services4 7#ae7 ,technical component ,the term technical component means the included radiation therapy services that are not furnished by a physician1 including the provision of equipment1 supplies1 personnel1 and administrative costs related to radiation therapy services4 7#af7 ,transportation services ,the term transportation services means the provision of free or discounted transportation made available to covered individuals furnished covered treatment which are not air1 luxury1 or ambulance-level transportation1 but may include car services1 ride shares1 autonomous vehicles1 or public transportation4 4 7b7 ,exclusion of participating radiation therapy providers1 radiation therapy suppliers1 and physicians from the merit-,based incentive payment system ,section #ahdh7q77#a77;,c77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#a77;c77,,ii77 is amended-- 7#a7 in subclause 7,,ii71 by striking or at the end2 7#b7 in subclause 7,,iii71 by striking the period at the end and inserting 2 or2 and 7#c7 by adding at the end the following new subclause3 7,,iv7 is a radiation therapy provider or radiation therapy supplier 7as those terms are defined in subsection 7j7 of section#ahii;,c7 that is participating in the ,radiation ,oncology ,case ,rate ,value ,based ,payment ,program established under that section4 4 #d4 ,revision to civil monetary penalties regarding radiation oncology case rate patient transportation services ,section #aabh;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is amended-- 7#a7 in subsection 7i77#f7-- 7,a7 in subparagraph 7,i71 by striking or at the end2 7,b7 in subparagraph 7,j77iii71 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following new subparagraph3 7,k7 the provision of transportation services by an eligible entity1 as defined in subsection 7t71 if-- 7i7 the availability of the transportation services-- 7,i7 is set forth in a policy that the eligible entity1 as defined in subsection 7t71 applies uniformly and consistently2 and 7,,ii7 is not determined in a manner related to the past or anticipated volume or value of ,federal health care program business2 7ii7 the eligible entity does not publicly market or advertise the transportation services2 7iii7 the driver who provides the transportation services does not market health care items or services during the course of the transportation or at any time2 7iv7 the driver or individual arranging for the transportation services is not paid on a per-beneficiary-transported basis2 7v7 the eligible entity makes the transportation services available only to an individual who-- 7,i7 is an established patient1 as defined in subsection 7t71 of the eligible entity that is providing or facilitating free or discounted transportation2 7,,ii7 resides-- 7aa7 within a #ge-mile-radius of the radiation therapy provider or radiation therapy supplier to or from which the patient would be transported2 or 7bb7 in a rural area1 as defined in subsection 7t72 and 7,,iii7 is receiving radiation therapy services for the purpose of obtaining medically necessary items and services2 and 7vi7 the eligible entity that makes the transportation services available bears the costs of the transportation services and does not shift the burden of those costs onto any ,federal health care program1 other payers1 or individuals4 2 and 7#b7 by adding at the end the following new subsection3 7t7 ,for purposes of subsection 7i77#f77,k71 the following definitions apply3 7#a7 ,the term eligible entity means any individual or entity1 or any individual or entity acting on behalf of such individual or entity that does not supply health care items as the primary occupation of the individual or entity4 7#b7 ,the term established patient means an individual who-- 7,a7 has selected and scheduled an appointment with a radiation therapy provider or radiation therapy supplier2 or 7,b7 has attended an appointment with such provider or supplier4 7#c7 ,the terms radiation therapy provider1 radiation therapy services1 and radiation therapy supplier have the meaning given such terms in section #ahff;,g7j74 7#d7 ,the term rural area means an area that is not an urban area4 7#e7 ,the term transportation services-- 7,a7 means the provision of free or discounted transportation made available to ,federal health care program beneficiaries receiving radiation therapy services2 7,b7 includes car services1 ride shares1 and public transportation2 and 7,c7 does not include air1 luxury1 or ambulance-level transportation4 7#f7 ,the term urban area means-- 7,a7 a ,metropolitan ,statistical ,area or ,new ,england ,county ,metropolitan ,area1 as defined by the ,office of ,management and ,budget2 7,b7 ,litchfield ,county1 ,connecticut2 7,c7 ,york ,county1 ,maine2 7,d7 ,sagadahoc ,county1 ,maine2 7,e7 ,merrimack ,county1 ,new ,hampshire2 and 7,f7 ,newport ,county1 ,rhode ,island4 4 #e4 ,exemption of ,radiation ,oncology ,case ,rate ,value ,based ,payment ,program from budget neutrality adjustment requirements 7a7 ,payment of benefits ,section #ahcc7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 is amended by adding at the end the following new paragraph3 7#bc7 ,non budget neutral application of reduced expenditures resulting from the ,radiation ,oncology ,case ,rate ,value ,based ,payment ,program ,the ,secretary shall not take into account the reduced expenditures that result from the implementation of section #ahii;,c in making any budget neutrality adjustments under this subsection4 4 7b7 ,payment for physicians' services ,section #ahdh7;c77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;c77#b77;,b77 is amended-- 7#a7 in clause 7iv7-- 7,a7 in subclause 7,v71 by striking and at the end2 7,b7 in subclause 7,,vi71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new subclause3 7,,vii7 section #ahii;,c shall not be taken into account in applying clause 7ii77,,ii7 for a year following the enactment of section #ahii;,c4 2 and 7#b7 in clause 7v71 by adding at the end the following new subclause3 7,,xii7 ,reduced expenditures attributable to the ,radiation ,oncology ,case ,rate ,value ,based ,payment ,program ,effective for fee schedules established following the enactment of section #ahii;,c1 reduced expenditures attributable to the ,radiation ,oncology ,case ,rate ,value ,based ,payment ,program under section #ahii;,c4 4