Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Transmittal 2827 Date: November

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anual ystem Pub 100-04 edicare laims Processing Department of ealth & uman ervices (D) enters for edicare & edicaid ervices () Transmittal 2827 Date: November 29 2013 hange equest 8537 UBJT: Transcatheter aortic valve replacement (TV) - mplementation of Permanent PT ode. UY O NG: This change request () is an update to 8168, transmittal 2628 dated January 7, 2013, that implemented replacement codes for TV claims with dates of service on and after January 1, 2013. pecifically, we are retiring the remaining temporary PT code 0318T with permanent PT code 33366 effective January 1, 2013. TV DT: January 1, 2014 PLNTTON DT: January 6, 2014 Disclaimer 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 NTUTON: (N/ if manual is not updated) =VD, N=NW, D=DLTD-Only One Per ow. /N/D PT / TON / UBTON / TTL 32/290.1.1/oding equirements for TV ervices urnished on or fter January 1, 2013 32/290.2/laims Processing equirements for TV ervices on Professional laims 32/290.3/laims Processing equirements for TV ervices on npatient ospital laims. UNDNG: or iscal ntermediaries (s), egional ome ealth ntermediaries (s) and/or arriers: No additional funding will be provided by ; ontractors activities are to be carried out with their operating budgets. 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 statement of Work. The contractor is not obliged 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 e-mail, and request formal directions regarding continued performance requirements.

V. TTNT: Business equirements anual nstruction *Unless otherwise specified, the effective date is the date of service.

ttachment - Business equirements Pub. 100-04 Transmittal: 2827 Date: November 29, 2013 hange equest: 8537 UBJT: Transcatheter aortic valve replacement (TV) - mplementation of Permanent PT ode TV DT: January 1, 2014 PLNTTON DT: January 6, 2014. GNL NOTON. Background: Transcatheter aortic valve replacement (TV - also known as TV or transcatheter aortic valve implantation) is a new technology for use in treating aortic stenosis. bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. The procedure is performed in a cardiac catheterization lab or a hybrid operating room/cardiac catheterization lab with advanced quality imaging and with the ability to safely accommodate complicated cases that may require conversion to an open surgical procedure. The interventional cardiologist and cardiac surgeon jointly participate in the intra-operative technical aspects of TV. On ay 1, 2012, the enters for edicare & edicaid ervices () issued a National overage Determination (ND) covering TV under overage with vidence Development (D). The policy is available at http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ndd=355. B. Policy: Prior transmittals have been issued related to claims processing for TV. efer to 7897, transmittal 2552, issued eptember 24, 2012, 8168, transmittal 2628, issued January 7, 2013, and 8255, transmittal 2737, issued July 11, 2013, for complete, historical information. This change request () is an update to 8168, transmittal dated January 7, 2013, that implemented replacement codes for TV claims with dates of service on and after January 1, 2013. pecifically, we are retiring the remaining temporary PT code 0318T - Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; transapical approach (e.g., left thoracotomy) with permanent PT code 33366 - Transcathether aortic valve replacement (TV/TV) with prosthetic valve; transapical exposure (e.g., left thoracotomy).. BUN QUNT TBL "hall" denotes a mandatory requirement, and "should" denotes an optional requirement. Number equirement esponsibility /B 8537.1 ffective for TV claims with dates of service on and after January 1, 2014, contractors shall recognize permanent PT code 33366 in place of retired, temporary PT code 0318T. B X D hared- ystem aintainers X V W Other This coding change appears in the January 2014 edicare Physician ee chedule Database and ntegrated Outpatient ode ditor updates.

Number equirement esponsibility /B D B hared- ystem aintainers V W Other. POVD DUTON TBL Number equirement esponsibility 8537.2 LN rticle: provider education article related to this instruction will be available at http://www.cms.gov/outreach-and- ducation/edicare-learning-network- LN/LNattersrticles/ shortly after the 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 Web sites and include information about it in a listserv message within one week of the availability of the provider education 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 X X D Other V. UPPOTNG NOTON ection : ecommendations and supporting information associated with listed requirements: N/ "hould" denotes a recommendation. X-ef equirement Number ecommendations or other supporting information: ection B: ll other recommendations and supporting information: N/ V. ONTT

Pre-mplementation ontact(s): Patricia Brocato-imons, 410-786-0261 or patricia.brocatosimons@cms.hhs.gov (overage), Lori shby, 410-786-6322 or lori.ashby@cms.hhs.gov (overage), Wanda Belle, 410-786-7491 or wanda.belle@cms.hhs.gov (overage). Post-mplementation ontact(s): ontact your ontracting Officer's epresentative (O) or ontractor anager, as applicable. V. UNDNG ection : or iscal ntermediaries (s), egional ome ealth ntermediaries (s), and/or arriers: No additional funding will be provided by ; ontractors activities are to be carried out with their operating budgets. ection B: or edicare dministrative ontractors (s): The edicare dministrative ontractor is hereby advised that this constitutes technical direction as defined in your contract. do not construe this as a change to the tatement of Work. 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 e-mail, and request formal directions regarding continued performance requirements.

290.1.1 - oding equirements for TV ervices urnished on or fter January 1, 2013 (ev.2827. ssued: 11-29-13, ffective: 01-01-14, mplementation: 01-06-14) Beginning January 1, 2013, the following are the applicable urrent Procedural Terminology (PT) codes for TV: 33361 Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; percutaneous femoral artery approach 33362 Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; open femoral approach 33363 Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; open axillary artery approach 33364 Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; open iliac artery approach 33365 Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy) 0381T Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; transapical approach (e.g., left thoracotomy) Beginning January 1, 2014, temporary PT code 0318T above is retired. TV claims with dates of service on and after January 1, 2014 shall instead use permanent PT code: 33366 Transcatheter aortic valve replacement (TV/TV) with prosthetic valve; transapical exposure (e.g., left thoracotomy) 290.2 - laims Processing equirements for TV ervices on Professional laims (ev.2827. ssued: 11-29-13, ffective: 01-01-14, mplementation: 01-06-14) Place of ervice (PO) Professional laims ffective for claims with dates of service on and after ay 1, 2012, place of service (PO) code 21 shall be used for TV services. ll other PO codes shall be denied. The following messages shall be used when edicare contractors deny TV claims for PO: laim djustment eason ode () 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. NOT: efer to the 835 ealthcare Policy dentification egment (loop 2110 ervice Payment nformation ), if present. emittance advice remark code () N428: Not covered when performed in this place of service. edicare ummary Notice (N) 21.25: This service was denied because edicare only covers this service in certain settings. panish Version: l servicio fue denegado porque edicare solamente lo cubre en ciertas situaciones." Professional laims odifier -62 or TV claims processed on or after July 1, 2013, contractors shall pay claim lines with 0256T, 0257T, 0258T, 0259T, 33361, 33362, 33363, 33364, 33365 & 0318T only when billed with modifier -62. laim lines billed without modifier -62 shall be returned as unprocessable. Beginning January 1, 2014, temporary PT code 0318T above is retired. TV claims with dates of service on and after January 1, 2014 shall instead use permanent PT code 33366.

The following messages shall be used when edicare contractors return TV claims billed without modifier -62 as unprocessable: 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: efer to the 835 ealthcare Policy dentification egment (loop 2110 ervice Payment nformation ), if present. N29: issing documentation/orders/notes/summary/report/chart. 130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Professional laims odifier -Q0 or claims processed on or after July 1, 2013, contractors shall pay TV claim lines for 0256T, 0257T, 0258T, 0259T, 33361, 33362, 33363, 33364, 33365 & 0318T when billed with modifier -Q0. laim lines billed without modifier -Q0 shall be returned as unprocessable. Beginning January 1, 2014, temporary PT code 0318T above is retired. TV claims with dates of service on and after January 1, 2014 shall instead use permanent PT code 33366. The following messages shall be used when edicare contractors return TV claims billed without modifier -Q0 as unprocessable: 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: efer to the 835 ealthcare Policy dentification egment (loop 2110 ervice Payment nformation ), if present. N29: issing documentation/orders/notes/summary/report/chart. 130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. or claims processed on or after July 1, 2013, contractors shall pay TV claim lines for 0256T, 0257T, 0258T, 0259T, 33361, 33362, 33363, 33364, 33365 & 0318T when billed with diagnosis code V70.7 (D- 10=Z00.6). laim lines billed without diagnosis code V70.7 (D-10=Z00.6) shall be returned as unprocessable. Beginning January 1, 2014, temporary PT code 0318T above is retired. TV claims with dates of service on and after January 1, 2014 shall instead use permanent PT code 33366. The following messages shall be used when edicare contractors return TV claims billed without diagnosis code V70.7 (D-10=Z00.6) as unprocessable: 16: laim/service lacks information which is needed for adjudication. t least one emark ode must be provided (may be comprised of either the NPDP eject eason ode, or emittance dvice emark ode that is not an LT). 76: issing/incomplete/invalid diagnosis or condition 130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information.

Professional laims 8-digit linicaltrials.gov dentifier Number or claims processed on or after July 1, 2013, contractors shall pay TV claim lines for 0256T, 0257T, 0258T, 0259T, 33361, 33362, 33363, 33364, 33365 & 0318T when billed with the numeric, 8-digit clinicaltrials.gov identifier number preceded by the two alpha characters T when placed in ield 19 of paper orm -1500, or when entered without the T prefix in the electronic 837P in Loop 230002(01=P4). laim lines billed without an 8-digit clinicaltrials.gov identifier number shall be returned as unprocessable. Beginning January 1, 2014, temporary PT code 0318T above is retired. TV claims with dates of service on and after January 1, 2014 shall instead use permanent PT code 33366. The following messages shall be used when edicare contractors return TV claims billed without an 8- digit clinicaltrials.gov identifier number as unprocessable: 16: laim/service lacks information which is needed for adjudication. t least one emark ode must be provided (may be comprised of either NPDP eject eason ode, or emittance dvice emark ode that is not an LT). 50: issing/incomplete/invalid nvestigational Device xemption number for D-approved clinical trial services. 130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. NOT: linicaltrials.gov identifier numbers for TV are listed on our website: (http://www.cms.gov/edicare/overage/overage-with-vidence-development/transcatheter-ortic- Valve-eplacement-TV-.html) 290.3 - laims Processing equirements for TV ervices on npatient ospital laims (ev.2827. ssued: 11-29-13, ffective: 01-01-14, mplementation: 01-06-14) npatient hospitals shall bill for TV on an 11X TOB effective for discharges on or after ay 1, 2012. efer to ection 69 of this chapter for further guidance on billing under D. npatient hospital discharges for TV shall be covered when billed with: V70.7 and ondition ode 30. n 8-digit clinicaltrials.gov identifier number listed on the website (effective July 1, 2013) npatient hospital discharges for TV shall be rejected when billed without: V70.7 and ondition ode 30. n 8-digit clinicaltrials.gov identifier number listed on the website (effective July 1, 2013) laims billed by hospitals not participating in the trial/registry shall be rejected with the following messages: : 50 -These are non-covered services because this is not deemed a medical necessity by the payer. N386 - This decision was based on a National overage Determination (ND). n ND provides a coverage determination as to whether a particular item or service is covered. copy of this policy is available at http://www.cms.hhs.gov/mcd/search.asp. f you do not have web access, you may contact the contractor to request a copy of the ND.

Group ode ontractual Obligation (O) N 16.77 This service/item was not covered because it was not provided as part of a qualifying trial/study. (ste servicio/artículo no fue cubierto porque no estaba incluido como parte de un ensayo clínico/estudio calificado.)