Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Transmittal 196 Date: April 27, 2018

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1 anual ystem Pub emonstrations epartment of ealth & uman ervices () enters for edicare & edicaid ervices () Transmittal 196 ate: pril 27, 2018 hange Request UBJT: omprehensive R are () odel Telehealth - mplementation. URY O NG: The omprehensive R are () odel is designed to identify, test, and evaluate new ways to improve care for edicare beneficiaries with nd-tage Renal isease (R). T T: October 1, 2018 *Unless otherwise specified, the effective date is the date of service. PLNTTON T: October 1, 2018 isclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. ny other material was previously published and remains unchanged. owever, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.. NG N NUL NTRUTON: (N/ if manual is not updated) R=R, N=N, =LT-Only One Per Row. R/N/ N/ PTR / TON / UBTON / TTL N/. UNNG: or edicare dministrative ontractors (s): The edicare dministrative ontractor is hereby advised that this constitutes technical direction as defined in your contract. does not construe this as a change to the tatement of ork. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the ontracting Officer. f the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the ontracting Officer, in writing or by , and request formal directions regarding continued performance requirements.. TTNT: emonstrations

2 ttachment - emonstrations Pub Transmittal: 196 ate: pril 27, 2018 hange Request: UBJT: omprehensive R are () odel Telehealth - mplementation T T: October 1, 2018 *Unless otherwise specified, the effective date is the date of service. PLNTTON T: October 1, GNRL NORTON. Background: The omprehensive R are () odel is designed to identify, test, and evaluate new ways to improve care for edicare beneficiaries with nd-tage Renal isease (R). Through the odel, will partner with health care providers and suppliers to test the effectiveness of a new payment and service delivery model in providing beneficiaries with person-centered, high-quality care. The odel builds on ccountable are Organization (O) experience from the Pioneer O odel, Next Generation O odel, and the edicare hared avings Program to test ccountable are Organizations for R beneficiaries. ore than 600,000 mericans have R and require life sustaining dialysis treatments several times per week. any beneficiaries with R suffer from poorer health outcomes, often the result of underlying disease complications and multiple co-morbidities. These can lead to high rates of hospital admission and readmissions, as well as a mortality rate that is higher than that of the general edicare population. ccording to the United tates Renal ata ystem, in 2014, R beneficiaries comprised less than 1% of the edicare population, but accounted for an estimated 7.2% of total edicare ee-or-ervice () spending, totaling over $32.8 billion. Because of their complex health needs, beneficiaries often require visits to multiple providers and follow multiple care plans, all of which can be challenging for beneficiaries if care is not coordinated. The odel seeks to create incentives to enhance care coordination and to create a person-centered, coordinated, care experience, and to ultimately improve health outcomes for this population. n the odel, dialysis clinics, nephrologists and other providers join together to create an R eamless are Organization (O) to coordinate care for aligned beneficiaries. Os are accountable for clinical quality outcomes and financial outcomes measured by edicare Part and B spending, including all spending on dialysis services for their aligned R beneficiaries. This model encourages dialysis providers to think beyond their traditional roles in care delivery and supports them as they provide patientcentered care that will address beneficiaries health needs, both in and outside of the dialysis clinic. The odel includes separate financial arrangements for larger and smaller dialysis organizations. Large ialysis Organizations (LOs), which have 200 or more dialysis facilities, will be eligible to receive shared savings payments. These LOs will also be liable for shared losses, and will have higher overall levels of risk compared with their smaller counterparts. Non-Large ialysis Organizations (Non-LOs) include chains with fewer than 200 dialysis facilities, independent dialysis facilities, and hospital-based dialysis facilities. Non-LOs will have the option of participating in a one-sided track where they will be able to receive shared savings payments, but will not be liable for payment of shared losses, or participating in a track with higher risk and the potential for shared losses. The one-sided track is offered in recognition of non-los more limited resources. The odel began October 1, 2015 and will run until ecember 31, The odel released a solicitation in 2016 to add more Os for Performance Year two (2) of the odel to start January 1, 2017.

3 The odel has no current plans for another round of solicitation. The odel LO payment track and Non-LO two-sided payment track are considered lternative Payment odels (Ps) for the purpose of the Quality Payment Program. B. Policy: ection 1115 of the ocial ecurity ct (the ct) (added by section 3021 of the ffordable are ct) (42 U a) authorizes the enter for edicare and edicaid nnovation () to test innovative health care payment and service delivery models that have the potential to lower edicare, edicaid, and the hild ealth nsurance Program (P) spending while maintaining or improving the quality of beneficiaries care. The odel will implement design elements with implications for the system for its third performance year. The odel also offers increased monitoring to account for different financial incentives and the provision of enhanced benefits. The model s quality requirements are similar to hared avings Program (P) and Next Generation O odel, modified as needed to take into account unique aspects of dialysis care, in keeping with the agencies initiatives to unify and streamline quality measurement and requirements. 1) Telehealth aiver n order to emphasize high-value services and support the ability of Os to manage the care of beneficiaries, plans to design policies, as well as, use the authority under section 1115 of the ocial ecurity ct (section 3021 of the ffordable are ct) to conditionally waive certain edicare payment requirements as part of the odel. The will make available to qualified Os a waiver of the originating site requirement for services provided via telehealth. This benefit enhancement will allow beneficiaries to receive qualified telehealth services in nonrural locations and locations that are not specified by statute, such as homes and dialysis facilities. The waiver will apply only to eligible aligned beneficiaries receiving services from O providers. n aligned beneficiary will be eligible to receive telehealth services through this waiver if the services are otherwise qualified with respect to (1) the service provided, as designated by urrent Procedural Terminology (PT) or ealthcare ommon Procedure oding ystem (P) codes and (2) the remote site. ontractors shall apply claims processing edit logic, audit, medical review, P, and fraud and abuse activities, appeals and overpayment processes for claims in the same manner as normal claims. Notwithstanding these waivers, all telehealth services must be furnished in accordance with all other edicare coverage and payment criteria, and no additional reimbursement will be made to cover set-up costs, technology purchases, training and education, or other related costs. n particular, the services allowed through telehealth are limited to those described under section 1834(m)(4)() of the ocial ecurity ct and subsequent additional services specified through regulation with the exception that claims will not be allowed for the following telehealth services rendered to aligned beneficiaries: ollow-up inpatient telehealth consultations furnished to beneficiaries in hospitals or killed Nursing acilities (Ns). P codes G0406 G0408. ubsequent hospital care services, with the limitation of 1 telehealth visit every 3 days. PT codes ubsequent nursing facility care services, with the limitation of 1 telehealth visit every 30 days. PT codes Telehealth consultations, emergency department or initial inpatient. P codes G0425-G0427 Telehealth onsultation, ritical are, initial. P code G0508 Telehealth onsultation, ritical are, subsequent. P code G0509 Prolonged service in the inpatient or observation setting requiring unit/floor time beyond the usual service. PT codes BUN RQURNT TBL

4 "hall" denotes a mandatory requirement, and "should" denotes an optional requirement. Number Requirement Responsibility /B hared- ystem aintainers ffective October 1, 2018, contractors shall prepare their systems to process omprehensive R are () claims with dates of service October 1, 2018 and later. B ontractors shall consider claims with demo code 85 in the first O code field to be telehealth claims. GL s shall not consider demo code 85 if the other O code fields on the claim record are populated with other demo codes Providers submitting electronic 837 claims will have entered the O 85 in the R segment 2300 Loop emonstration Project dentifiers. Providers will include Qualifier P4. shall move the demo code 85 from the R segment 2300 Loop emonstration Project dentifiers to the demo code field. Providers submitting paper claims will have entered the O 85 in the treatment authorization field. shall move the demo code 85 from the treatment authorization field to the demo code field The O-O shall send the iscal ntermediary hared ystem ()/ulti-arrier ystem () the initial provider files for each R are Organization (O) that will bill under the waiver. The file will include a header and trailer record. shall include the following data elements/fields on the provider alignment file: 1. etail records consisting of: a. Record dentifier; b. O dentifier 2. Participating Tax dentification Number (TN) 3. Participating National Provider dentifier (NP) 4. Participating ertification Number (N) 5. ffective tart ate in the telehealth waiver 6. ffective nd ate in the telehealth waiver GL, s

5 /B hared- ystem aintainers 7. record type (benefit enhancement flag values identified by a single character). benefit enhancement flag value of 6 would identify a telehealth provider. B s shall be prepared to accept the above listed data elements in on the initial provider files for each O The T shall provide to O-O the provider and beneficiary data to create the test files by June 12, 2018., T, s To assist with the testing files creation, T shall provide a list of at minimum 15 beneficiaries (as indicated by N) and 15 providers (as indicated by TN and NP). Providers may be primary care providers, nephrologists, dialysis facilities and other diverse providers. These sample beneficiaries and providers will be provided in a single omma eparated alue () file using the layout of Ns, TNs, and NPs. The primary OT point of contact is Yani ellacheruvu (Yani.ellacheruvu@cms.hhs.gov) and the secondary OT point of contact is Tej Ghimire (Tej.Ghimire@cms.hhs.gov) The O-O shall provide the provider alignment and beneficiary alignment test and final files to T on or before the week of July 9, 2018., T, s The s shall provide to O-O the provider and beneficiary data to create the test files on or about the week of July 9, 2018., s To assist with the testing files creation, the s shall provide a list of at minimum 15 beneficiaries (as indicated by N) and 15 providers (as indicated by TN and NP). Providers may be primary care providers, nephrologists, dialysis facilities and other diverse providers. These sample beneficiaries and providers will be provided in a single excel file using the layout of Ns, TNs, and NPs. The O-O will provide a

6 /B hared- ystem aintainers template of this excel document. B These files will be sent with password protection by the s to an OT contact. This OT contact will unlock them and place them on harepoint. The primary OT point of contact is Yani ellacheruvu (Yani.ellacheruvu@cms.hhs.gov) and the secondary OT point of contact is Tej Ghimire (Tej.Ghimire@cms.hhs.gov). The O-O shall push the test files to the s on or about ugust 6, 2018 for T and eptember 10, 2018 for UT to transmit the test files. The s shall transmit the provider and beneficiary alignment test file responses via T., s, s shall push test files with aligned beneficiaries and providers to by June 15, s shall maintain an update-date in their internal file, which will reflect the date the updated files were loaded into the shared systems. The creation date will be reflected for records captured for the initial load of records. The field shall be viewable to the edicare dministrative ontractors (s) The T will be sent an updated provider file. The T can submit changes to the provider file on or before ugust 7, T T shall send the provider file to. shall send the provider file to. shall include a header record on the provider file to identify the O provider file and the reporting period. The file layout will be aligned with the file layout used by the Next Generation O odel for beneficiary enhancements. The provider file will be a national file shall receive and edit the provider files. shall push the provider files to.

7 /B hared- ystem aintainers The contractor shall process claims as telehealth claims when the provider is indicated as being a telehealth provider based on the benefit enhancement flag value of 6. B (O-O) shall send the initial beneficiary alignment files detailing beneficiaries aligned to participating Os. The file layout will be aligned with the file layout used by the Next Generation O odel in R9151 for beneficiary enhancements. The beneficiary file will be a national file., s Note: The beneficiary alignment file will be a national file accessible by all s shall provide the beneficiary file with the most current ealth nsurance laim Number (N) to / s shall be prepared to accept the above listed data elements in on the initial beneficiary files for each O (O-O) shall include the following data elements on the aligned beneficiary file: Unique Key: O (####) Bene N ff tart ate of lignment to O ff nd ate of lignment to O eleted Beneficiary = alue Beneficiary edical ata haring Preference ndicator The same data elements shall be included by on the beneficiary alignment file they share s shall maintain an update-date in their internal file, which will reflect the date the updated file was loaded into the shared system. The creation date will be reflected for records captured for the initial load of records. The field shall be viewable to the s The T will be sent an updated beneficiary file. T

8 /B hared- ystem aintainers The T can submit changes to the beneficiary file on or before ugust 7, B T shall apply the O BN file to the current OB uxiliary ile that carries the Update ate The (O-O) shall provide the provider and beneficiary alignment files to the irtual ata enter (s) when they become available., s NOT: BRs shall be applicable to all test files The (O-O) shall transmit the provider and beneficiary alignment files through lectronic ile Transfer (T) The (O-O) shall notify the contractors of the provider and beneficiary alignment file names and when they will become available., T, s s shall create response files to the O-O when they have received and validated the provider () and beneficiary alignment () files. These validation result files will indicate that the file was processed and contained no errors if no validation errors were encountered s shall produce a response file that indicates specific records and fields that did not pass the validation checks using defined error codes listed in the nterface ontrol ocument () if any errors are encountered. The shall use the following error codes listed below: ode escription/xplanation: 00 = uccess/the record was processed successfully. 10 = eader Record rror/the eader contains a Record but the last three characters are not PR or BN. 11 = eader Record ate rror/the eader Record date is missing or invalid.

9 /B hared- ystem aintainers 20 - etail Record rror - The data in the file does not conform to the file layout specified for the file transfer. The data format of the field or the data in the field does not conform to the list of valid values specified P O rror - The P O is missing or invalid TN rror - The TN is invalid N rror - The Provider N is missing or invalid on the Part file ffective tart ate rror - The ffective tart ate is missing or invalid ffective nd ate rror - The ffective nd ate is missing or invalid Beneficiary N rror - The Beneficiary N is missing or invalid. 30 = Trailer Record rror/the Trailer contains a Record but the last three characters are not PR or BN. 31 = Trailer Record ate rror/the Trailer Record date is missing or invalid. 32 =Trailer Record ount rror/ The Trailer Record ount in the Trailer does not equal the number of detail records sent by. 98 = eader Record issing/the eader record is missing or does not begin with R. 99 = Trailer Record issing/the Trailer record is missing or does not begin with TRL. B (O-O) shall provide the final provider and beneficiary alignment files from the mainframe on or about October 1, On or about October 1, 2018 the shall push the final files to the s and datacenters specific to their contractor workload(s)., s, s s shall produce response files via T acknowledging receipt of the provider ( shall produce the provider response files) and beneficiary ( shall produce the beneficiary response files) final files The s shall transmit the provider and beneficiary alignment final file responses via T., s

10 /B hared- ystem aintainers (O-O) shall send updated aligned beneficiary files and provider files as often as monthly. B, s shall not send aligned beneficiary or provider files if there are no updates, s s shall process the updated provider and aligned beneficiary files as full replacement files shall generate an nformational Unsolicited Response (UR) for claims with demo code 85 and benefit enhancement flag of '6' when there is a change to the beneficiary alignment file. pecifically, an UR will be generated for claims with service dates greater than 90 ays after the effective end date of a beneficiary. shall carry the new benefit enhancement flag of '6' representing Telehealth should process an UR as an adjustment if it is received. The adjustment will remove demo code 85 and the benefit enhancement flag of 6 and reprocess the claim as a non-demo service should process an UR as an adjustment if it is received. The adjustment will remove the benefit enhancement flag of 6 and reprocess the claim as a non-demo service s shall update the provider record of O aligned providers according to the update in BR s shall update the system with aligned beneficiary data according to the update in BR s shall consider the beneficiary dropped when the ffective and nd dates are the same s shall consider a beneficiary aligned if the from

11 /B hared- ystem aintainers date on the date of service on the claim is on or after the effective start date and on or before 90 days after the effective end date. B s shall identify telehealth claims at the header level (claim level) by the claim identifier of demo code s shall populate the demo code 85 in the demo code field when the provider has submitted it. s shall process claims and append benefit enhancement indicator of '6' as Telehealth claims under certain conditions. shall process institutional claims and append benefit enhancement indicator of 6 as Telehealth claims when the claim includes: n aligned provider with a telehealth indicator of '6'; n aligned beneficiary; t least one claim detail line for the rendering providers that includes one of the PT or P codes in ; emo code 85 in the header; and No other demo codes in the header besides demo code 85 (since claims with other demo codes will not be paid as telehealth claims in accordance with BR ) shall populate the benefit enhancement indicator of '6' at the claim header level. f a claim has a demo code of 85 and finds that the claim also goes to another demonstration, then shall remove the demo code of 85.

12 /B hared- ystem aintainers shall process professional claims and append benefit enhancement indicator of 6 as Telehealth claims when the claim includes: B n aligned provider with a telehealth indicator of '6'; n aligned beneficiary; t least one claim detail line for the rendering Part B providers that includes one of the PT or P codes in ; emo code 85 in the header; and No other demo codes in the header besides demo code 85 (since claims with other demo codes will not be paid as telehealth claims in accordance with BR ) shall populate the benefit enhancement indicator of '6' at the claim line level. s shall send the, demo code and the benefit enhancement flag to on the transmit file using the fields currently used for NGO claims s shall ensure the claim identifier (demo code 85) at the header level will flow to downstream systems including but not limited to: National laims istory (N), ntegrated ata Repository (R), and hronic ondition arehouse (). P, R, N ontractors shall process telehealth claims with Place of ervice (PO) = 02 (Telehealth) when the provider is an O provider and the beneficiary is aligned to the same O for the ate of ervice (O) on the claims and when the claim contains the demo code 85 and one of the following PT or P codes: 90785

13 /B hared- ystem aintainers B

14 /B hared- ystem aintainers G0108 G0109 G0270 G0396 G0397 G0420 G0421 G0438 G0439 G0442 G0443 G0444 G0445 G0446 G0447 G0459 G0506 G9481 G9482 G9483 G9484 G9485 G9486 G9487 G9488 G9489 B ontractors shall not process as telehealth claims that contain the following codes. laims that contain these codes can be processed following existing claims processing logic: P codes G0406 G0408.

15 /B hared- ystem aintainers PT codes PT codes P codes G0425-G0427 P code G0508 P code G0509 PT codes B ontractors shall process telehealth claims when the provider is an O provider and the beneficiary is aligned to the same O for the ate of ervice (O) on the claims and when the claim is on a Type of Bill 12, 13, 22, 23, 71, 72, 76, 77, and 85 and contains the demo code 85 and one of the following PT or P codes:

16 /B hared- ystem aintainers G0108 G0109 G0270 G0396 G0397 G0420 G0421 G0438 G0439 G0442 G0443 G0444 G0445 G0446 G0447 G0459 G0506 B

17 /B hared- ystem aintainers G9481 G9482 G9483 G9484 G9485 G9486 G9487 G9488 G9489 B ontractors shall not process as telehealth claims that contain the following codes. laims that contain these codes can be processed following existing claims processing logic: P codes G0406 G0408. PT codes PT codes P codes G0425-G0427 P code G0508 P code G0509 PT codes ontractors shall process and flag Telehealth originating site claims with benefit enhancement indicator 6 when this benefit enhancement is elected by the provider for the ate of ervice (O) on the claim, when the beneficiary is aligned for the submitted claim, and the following P code: Q ontractors shall process Telehealth claims for bill types 12, 13, 22, 23, 71, 72, 76, 77, and 85, with revenue code 078 when this benefit enhancement is elected by the provider for the O on the claims and when the claim contains the following P code: Q ontractors shall retain the demo code 85 on the

18 /B hared- ystem aintainers telehealth claims even when the claim denied or rejected. B The contractor shall treat patients the same as edicare patients for cost reporting purposes ontractors shall return the professional claim if the provider appends demo code 85 and: provider is not on participant provider list with a telehealth record type; or ate of service from date is prior to the provider s telehealth effective date; or ate of service from date is after the provider s telehealth termination date; or The date of service from date was prior to the beneficiary s effective date; or The date of service from date was more than 90 days after the beneficiary s termination date; or The beneficiary was not aligned to the same O with which the provider was participating (as identified by O ), non-telehealth services are billed on the same claim. n these cases, none of the services on the claim should be processed f the contractor identifies that the claim does not meet the terms of the demonstration based on , edicare contractors shall return the claim as unprocessable and shall assign: R 16 (laim/service lacks information or has submission/billing error(s) which is needed for adjudication.) & RR N763 (The demonstration code is not appropriate for this claim; resubmit without a demonstration code.) Group ode: O (contractual obligation). This does not require N information because the beneficiary does not need to take any action.

19 /B hared- ystem aintainers B ontractors shall return institutional claim to the provider, if the provider appends demo code 85 and: the provider is not on participant provider list with a telehealth record type; or ate of service from date is prior to the provider s telehealth effective date; or ate of service from date is after the provider s telehealth termination date; or The date of service from date was prior to the beneficiary s effective date; or The date of service from date was more than 90 days after the beneficiary s termination date; or The beneficiary was not aligned to the same O with which the provider was participating (as identified by O ); or the Type of Bill is not 12, 13, 22, 23, 71, 72, 76, 77, or 85; or, non-telehealth services are billed on the same claim f the contractor identifies that the claim does not meet ther terms of the demonstration based on , edicare contractors shall return the claim to the provider (RTP). This does not require a Group ode because there is no R (and there cannot be one without the other). This does not require N information because the beneficiary does not need to take any action ontractors shall process telehealth claims when demo code 85 is appended to the claim if all of the following conditions are met: the Type of Bill is 12, 13, 22, 23, 71, 72, 76, 77, or 85 (Part only requirement); and The P or PT codes are included in BR or ; and the ate of ervice (O) on the claim falls on or within the provider s active dates with the O (i.e., is on or after the effective date

20 /B hared- ystem aintainers and on or before the termination date of the provider); and The O on the claim occurred when the beneficiary is active with the O (i.e., on or after the effective date and on or before 90 days after the exclusion date of the beneficiary); and the beneficiary and provider are associated with the same O (as identified by O ). B ontractors shall generate the N essage on claim details identified as related to the new Telehealth enhancement. The N message can be applied at the claim level. The N message number is This is a new message. nglish You received this telehealth service from your R eamless are Organization (O) provider. You may have received this service because of your relationship with the O. sk your doctor to tell you more about your O. panish Recibió este servicio de telesalud de parte de su proveedor de Organización de uidado ontinuo para R (O en inglés). s posible que haya recibido este servicio debido a su relación con la O. Pregúntele a su médico a cerca de su O s shall send demo code 85 to the RT in the laim emonstration (dentification) Number data element in the laim Resolution ile ontractors shall use O information online screens to display Provider file data to include file update history ontractors shall use O information online screens to display Beneficiary file data to include file update history. RT

21 . PROR UTON TBL Number Requirement Responsibility LN rticle: provider education article related to this instruction will be available at Network-LN/LNattersrticles/ shortly after the R is released. You will receive notification of the article release via the established "LN atters" listserv. ontractors shall post this article, or a direct link to this article, on their eb sites and include information about it in a listserv message within 5 business days after receipt of the notification from announcing the availability of the article. n addition, the provider education article shall be included in the contractor's next regularly scheduled bulletin. ontractors are free to supplement LN atters articles with localized information that would benefit their provider community in billing and administering the edicare program correctly. /B B. UPPORTNG NORTON ection : Recommendations and supporting information associated with listed requirements: "hould" denotes a recommendation. -Ref Requirement Number Recommendations or other supporting information: N/ ection B: ll other recommendations and supporting information: N/. ONTT Pre-mplementation ontact(s): Zoe ruban, or zoe.hruban@cms.hhs.gov, aria lexander, or maria.alexander1@cms.hhs.gov Post-mplementation ontact(s): ontact your ontracting Officer's Representative (OR).. UNNG ection : or edicare dministrative ontractors (s): The edicare dministrative ontractor is hereby advised that this constitutes technical direction as defined in your contract. does not construe this as a change to the tatement of ork. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the ontracting Officer. f the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the ontracting Officer, in writing or by , and request formal directions regarding continued performance requirements.

22 TTNT: 0

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