II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated) R=REVISED, N=NEW, D=DELETED

Transcription

1 anual ystem Pub edicare laims Processing Department of Health & Human ervices (DHH) enters for edicare & edicaid ervices () Transmittal 1888 Date: January 6, 2010 hange equest 6753 Transmittal 1879, dated December 18, 2009, is being rescinded and replaced by Transmittal The effective date was incorrect under ection on the transmittal page and in the manual text Table of ontents; the correct date is November 10, ll other material remains the same. UBJET: Positron Emission Tomography (PET) (DG) for ervical ancer. UY O HNGE: Effective for claims with dates of service on and after November 10, 2009, will end the coverage with evidence development requirements for DG PET for cervical cancer and will cover only one DG PET for cervical cancer for staging in beneficiaries with biopsy-proven tumors when the treating physician determines that the study is needed to determine the location and/or extent of the tumor for specific therapeutic purposes related to initial treatment strategy as outlined in Pub , ND anual, section NEW / EVED TEL EETVE DTE: NOVEBE 10, 2009 PLEENTTON DTE: JNUY 4, 2010 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. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.. HNGE N NUL NTUTON: (N/ if manual is not updated) =EVED, N=NEW, D=DELETED /N/D N HPTE / ETON / UBETON / TTLE 13/Table of ontents 13/60/60.13/Billing equirements for PET cans for pecific indications of ervical ancer Performed on or fter January 28, /60/60.15/Billing equirements for - pproved linical Trials and overage With Evidence Development laims for PET cans for Neurodegenerative Diseases, Previously pecified ancer ndications, and ll Other ancer ndications Not Previously pecified 13/60/60.16/Billing and overage hanges for PET cans Effective for ervices on and fter pril 3, /60/60.17/Billing and overage for PET cans for ervical

2 ancer Effective for ervices on or fter November 10, UNDNG: ETON : or iscal ntermediaries and arriers: No additional funding will be provided by ; contractor activities are to be carried out within their operating budgets. ETON B: 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 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 contracting 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 contracting officer, in writing or by , and request formal directions regarding continued performance requirements. V. TTHENT: Business equirements anual nstruction *Unless otherwise specified, the effective date is the date of service.

3 ttachment Business equirements Pub Transmittal: 1888 Date: January 6, 2010 hange equest: 6753 Transmittal 1879, dated December 18, 2009, is being rescinded and replaced by Transmittal The effective date was incorrect under ection on the transmittal page and in the manual text Table of ontents; the correct date is November 10, ll other material remains the same. UBJET: Positron Emission Tomography (PET) (DG) for ervical ancer EETVE DTE: NOVEBE 10, 2009 PLEENTTON DTE: JNUY 4, GENEL NOTON. Background: The enters for edicare & edicaid ervices () generated a request to reconsider section of the National overage Determinations (ND) anual to end the prospective data collection requirements (coverage with evidence development (ED)) for -18 flouro-d-glucose (DG) PET imaging for the initial anti-tumor treatment strategy for cervical cancer under certain circumstances. n the context of this document, the term DG PET includes DG PET/T. is revising Pub , ND anual, section 220.6, and Pub , laims Processing anual, chapter 13, section 60, to reflect this change. ee Pub , ND anual, section for specific coverage language, and Pub chapter 13, sections and The previously reviewed scientific literature and established coverage for DG PET for cervical cancer indications. summary of past oncologic DG PET cervical cancer indications is in the following table: Effective Date linical ondition/ndication overage January 28, 2005 January 28, 2005 Brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers ll other cancers and indications not previously specified overage with evidence development (ED) for all DG PET indications except limited cervical staging conditions overage with evidence development pril 3, 2009 olid Tumors and yeloma overage for most uses related to initial management, coverage with evidence development for most uses related to subsequent management. Non-coverage for uses related to initial management of prostate cancer. B. Policy: Effective for claims with dates of service on and after November 10, 2009, will end the ED requirements and will cover only one (1) DG PET for cervical cancer under the following circumstances: or staging in beneficiaries who have biopsy proven cervical cancer when the beneficiary s treating physician determines that the DG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to initial treatment strategy:

4 To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or To determine the optimal anatomic location for an invasive procedure; or To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor. NOTE: Exception: continues to non-cover DG PET for initial diagnosis of cervical cancer related to initial treatment strategy. NOTE: The -QO modifier is no longer necessary on claims meeting the above criteria.. BUNE EQUEENT TBLE Use hall" to denote a mandatory requirement Number equirement esponsibility (place an X in each applicable column) / B D E hared-ystem aintainers OTHE Effective for claims with dates of service on or after November 10, 2009, contractors shall accept DG PET oncologic claims billed to inform initial treatment strategy for staging in beneficiaries who have biopsy-proven cervical cancer when the beneficiary s treating physician determines that the DG PET study is needed to determine the location and/or extent of the tumor as specified in Pub , section Effective for claims with dates of service on or after November 10, 2009, contractors shall return as unprocessable/return to provider claims for DG PET for cervical cancer for initial treatment strategy billed without: PET or PET/T PT code (78608, 78811, 78812, 78813, 78814, 78815, O 78816), ND -P modifier, ND D-9 cervical cancer diagnosis code. Use the following messages: Wrong/Lack of modifier: laim djustment eason ode () 4 The procedure code is inconsistent with the modifier used or a required modifier is missing. emittance dvice emark ode () Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. ubmit a new claim with the complete/correct information. E X X X X X X H H V W

5 Number equirement esponsibility (place an X in each applicable column) / B D E hared-ystem aintainers OTHE 16 - lert: ee our Web site, mailings, or bulletins for more details concerning this policy/procedure/decision or DG PET oncologic cervical cancer claims for initial treatment strategy for dates of service November 10, 2009, through January 3, 2010, contractors shall not search their files. However, contractors shall adjust claims brought to their attention. E X X X H H V W. POVDE EDUTON TBLE Number equirement esponsibility (place an X in each applicable column) / B D E hared-ystem aintainers OTHE provider education article related to this instruction will be available at 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 site 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 your 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. E X X X H H V W V. UPPOTNG NOTON. or any recommendations and supporting information associated with listed requirements, use the box below: Use "hould" to denote a recommendation. X-ef equirement Number ecommendations or other supporting information:

6 B. or all other recommendations and supporting information, use this space: N/ V. ONTT Pre-mplementation ontact(s): tuart aplan, coverage, , Pat Brocato-imons, coverage, , Yvette ousar, practitioner claims processing, , Bill uiz, institutional claims processing, , ntoinette Johnson, institutional claims processing, , Post-mplementation ontact(s): Os V. UNDNG. or iscal ntermediaries (s), egional Home Health ntermediaries (HHs), and/or arriers: No additional funding will be provided by ; contractor activities are to be carried out within their operating budgets. B. 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 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 contracting 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 contracting officer, in writing or by e- mail, and request formal directions regarding continued performance requirements.

7 edicare laims Processing anual hapter 13 - adiology ervices and Other Diagnostic Procedures Table of ontents (ev. 1888, ) Billing equirements for - pproved linical Trials and overage With Evidence Development laims for PET cans for Neurodegenerative Diseases, Previously pecified ancer ndications, and ll Other ancer ndications Not Previously pecified Billing and overage hanges for PET cans Effective for ervices on or fter pril 3, Billing and overage for PET cans for ervical ancer Effective for ervices on or fter November 10, 2009

8 Billing equirements for PET cans for pecific ndications of ervical ancer for ervices Performed on or fter January 28, 2005 (ev. 1888; ssued: , Effective date: ; mplementation Date: ) ontractors shall accept claims for these services with the appropriate PT code listed in section efer to Pub , section , for complete coverage guidelines for this new PET oncology indication. The implementation date for these PT codes will be pril 18, lso see section 60.17, of this chapter for further claims processing instructions for cervical cancer indications Billing equirements for - pproved linical Trials and overage With Evidence Development laims for PET cans for Neurodegenerative Diseases, Previously pecified ancer ndications, and ll Other ancer ndications Not Previously pecified (ev. 1888; ssued: , Effective date: ; mplementation Date: ) - arriers and s Effective for services on or after January 28, 2005, contractors shall accept and pay for claims for PET scans for lung cancer, esophageal cancer, colorectal cancer, lymphoma, melanoma, head & neck cancer, breast cancer, thyroid cancer, soft tissue sarcoma, brain cancer, ovarian cancer, pancreatic cancer, small cell lung cancer, and testicular cancer, as well as for neurodegenerative diseases and all other cancer indications not previously mentioned in this chapter, if these scans were performed as part of a -approved clinical trial. (ee Pub , ND anual, sections and ) ontractors shall also be aware that PET scans for all cancers not previously specified at Pub , ND anual, section , remain nationally non-covered unless performed in conjunction with a -approved clinical trial. - arriers Only arriers shall pay claims for PET scans for beneficiaries participating in a -approved clinical trial submitted with an appropriate PT code from section , of this chapter and the -Q (tem or ervice Provided in a edicare pecified tudy) modifier. - s Only n order to pay claims for PET scans on behalf of beneficiaries participating in a -approved clinical trial, s require providers to submit claims with D-9 code V70.7 in the second diagnosis position on the (UB-04), or the electronic equivalent, with the appropriate principal diagnosis code and an appropriate PT code from section Effective for PET scan claims for dates of service on or after January 28, 2005, s shall accept claims with the -Q modifier on other than inpatient claims.

9 NOTE: Effective for services on or after January 1, 2008, -Q0 (investigational clinical service provided in a clinical research study that is in an approved clinical research study) replaces the -Q modifier Billing and overage hanges for PET cans Effective for ervices on or fter pril 3, 2009 (ev. 1888; ssued: , Effective date: ; mplementation Date: ). ummary of hanges Effective for services on or after pril 3, 2009, edicare will not cover the use of DG PET imaging to determine initial treatment strategy in patients with adenocarcinoma of the prostate. edicare will also not cover DG PET imaging for subsequent treatment strategy for tumor types other than breast, cervical, colorectal, esophagus, head and neck (non-n/thyroid), lymphoma, melanoma, myeloma, non-small cell lung, and ovarian, unless the DG PET is provided under the coverage with evidence development (ED) paradigm (billed with modifier - Q0, see section of this chapter). Last, edicare will cover DG PET imaging for initial treatment strategy for myeloma. or further information regarding the changes in coverage, refer to Pub , ND anual, section B. New odifiers for PET cans Effective for claims with dates of service on or after pril 3, 2009, the following modifiers have been created for use to inform for the initial treatment strategy of biopsy-proven or strongly suspected tumors or subsequent treatment strategy of cancerous tumors: P -Positron Emission Tomography (PET) or PET/omputed Tomography (T) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing. hort descriptor: PET tumor init tx strat P - Positron Emission Tomography (PET) or PET/omputed Tomography (T) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary's treatment physician determines that the PET study is needed to inform subsequent anti-tumor strategy. hort descriptor: P - PET tumor subsq tx strategy. Billing hanges for /B s, s and arriers

10 Effective for claims with dates of service on or after pril 3, 2009, contractors shall accept DG PET claims billed to inform initial treatment strategy with the following PT codes ND modifier P: 78608, 78811, 78812, 78813, 78814, 78815, Effective for claims with dates of service on or after pril 3, 2009, contractors shall accept DG PET claims with modifier P for the subsequent treatment strategy for solid tumors using a PT code above ND an D-9 cancer diagnosis code. ontractors shall also accept DG PET claims billed to inform initial treatment strategy or subsequent treatment strategy when performed under ED with one of the PET or PET/T PT codes above ND modifier -P O modifier -P ND an D-9 cancer diagnosis code ND modifier -Q0 (nvestigational clinical service provided in a clinical research study that is in an approved clinical research study). NOTE: or institutional claims continue to use diagnosis code V70.7 and condition code 30 on the claim. D. edicare ummary Notices, emittance dvice emark odes, and laim djustment eason odes Effective for dates of service on or after pril 3, 2009, contractors shall return as unprocessable/return to provider claims that do not include the -P modifier with one of the PET/PET/T PT codes listed in subsection. above when billing for the initial treatment strategy for solid tumors in accordance with Pub , ND anual, section n addition, contractors shall return as unprocessable/return to provider claims that do not include the -P modifier with one of the PT codes listed in subsection. above when billing for the subsequent treatment strategy for solid tumors in accordance with Pub , ND anual, section The following messages apply: -laim djustment eason ode 4 the procedure code is inconsistent with the modifier used or a required modifier is missing. -emittance dvice emark ode Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. ubmit a new claim with the complete/correct information. -emittance dvice emark ode 16 - lert: ee our Web site, mailings, or bulletins for more details concerning this policy/procedure/decision. lso, effective for claims with dates of service on or after pril 3, 2009, contractors shall return as unprocessable/return to provider DG PET claims billed to inform initial treatment strategy or subsequent treatment strategy when performed under ED without one of the

11 PET/PET/T PT codes listed in subsection. above ND modifier P O modifier P ND an D-9 cancer diagnosis code ND modifier Q0. The following messages apply to return as unprocessable claims: -laim djustment eason ode 4 the procedure code is inconsistent with the modifier used or a required modifier is missing. -emittance dvice emark ode Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. ubmit a new claim with the complete/correct information. -emittance dvice emark ode 16 - lert: ee our Web site, mailings, or bulletins for more details concerning this policy/procedure/decision. Effective pril 3, 2009, contractors shall deny claims with D-9 diagnosis code 185 for DG PET imaging for the initial treatment strategy of patients with adenocarcinoma of the prostate. ontractors shall also deny claims for DG PET imaging for subsequent treatment strategy for tumor types other than breast, cervical, colorectal, esophagus, head and neck (non- N/thyroid), lymphoma, melanoma, myeloma, non-small cell lung, and ovarian, unless the DG PET is provided under ED (submitted with the -Q0 modifier) and use the following messages: -edicare ummary Notice edicare does not support the need for this service or item -laim djustment eason ode 50 - These are non-covered services because this is not deemed a 'medical necessity' by the payer. - ontractors shall use Group ode O (ontractual Obligation) f an BN is provided with a G modifier indicating there is a signed BN on file, contractors shall use Group ode P (Patient esponsibility) and the liability falls to the beneficiary. f an BN is provided with a GZ modifier indicating no BN was provided, contractors shall use Group ode O (ontractual Obligation) and the liability falls to the provider Billing and overage hanges for PET cans for ervical ancer Effective for ervices on or fter November 10, 2009 (ev. 1888; ssued: , Effective date: ; mplementation Date: ). Billing hanges for /B s, s, and arriers Effective for claims with dates of service on or after November 10, 2009, contractors shall accept DG PET oncologic claims billed to inform initial treatment strategy; specifically for

12 staging in beneficiaries who have biopsy-proven cervical cancer when the beneficiary s treating physician determines the DG PET study is needed to determine the location and/or extent of the tumor as specified in Pub , section EXEPTON: continues to non-cover DG PET for initial diagnosis of cervical cancer related to initial treatment strategy. NOTE: Effective for claims with dates of service on and after November 10, 2009, the Q0 modifier is no longer necessary for DG PET for cervical cancer. B. edicare ummary Notices, emittance dvice emark odes, and laim djustment eason odes dditionally, contractors shall return as unprocessable /return to provider for DG PET for cervical cancer for initial treatment strategy billed without the following: one of the PET/PET/ T PT codes listed in above ND modifier P ND an D-9 cervical cancer diagnosis code. Use the following messages: - laim djustment eason ode 4 the procedure code is inconsistent with the modifier used or a required modifier is missing. - emittance dvice emark ode Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. ubmit a new claim with the complete/correct information. - emittance dvice emark ode 16 - lert: ee our Web site, mailings, or bulletins for more details concerning this policy/procedure/decision.