Transmittal 88 Date: JULY 25, 2008

Transcription

1 anual ystem Pub edicare National overage Determinations Department of ealth & uman ervices (DD) enters for edicare & edicaid ervices () Transmittal 88 Date: JULY 25, 2008 hange equest 6154 UBJT: icrovolt T-Wave lternans (TW). UY O NG: The enters for edicare and edicaid ervices () was asked to reconsider the national coverage determination (ND) on microvolt t-wave alternans (TW) diagnostic testing to extend coverage to the modified moving average () method. ollowing its review, determines that the method of determining TW is not reasonable and necessary. Therefore, the current policy remains in place that provides for coverage of TW testing for the evaluation of patients at risk for sudden cardiac death only when the spectral analysis method is used. ection 20.30, is an ND. NDs are binding on all carriers, fiscal intermediaries, quality improvement organizations, qualified independent contractors, the edicare appeals council, and administrative law judges (LJs) (see 42 section (a) (4) (2005)). n ND that expands coverage is also binding on a edicare advantage organization. n addition, an LJ may not review an ND. (ee section 1869(f) (1) () (i).) NW / VD TL TV DT: Y 12, 2008 PLNTTON DT: ugust 25, 2008 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 /N/D PT / TON / UBTON / TTL 1/20.30/icrovolt T-Wave lternans (TW). UNDNG: TON : or iscal ntermediaries and arriers: No additional funding will be provided by ; contractor activities are to be carried out within their operating budgets. TON B: or edicare dministrative ontractors (s): The edicare administrative contractor 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

2 regarding continued performance requirements. V. TTNT: Business equirements anual nstruction *Unless otherwise specified, the effective date is the date of service.

3 ttachment - Business equirements Pub Transmittal: 88 Date: July 25, 2008 hange equest: 6154 UBJT: icrovolt T-Wave lternans (TW) ffective Date: ay 12, 2008 mplementation Date: ugust 25, GNL NOTON. Background: The enters for edicare and edicaid ervices () was asked to reconsider the national coverage determination (ND) on microvolt t-wave alternans (TW) diagnostic testing to extend coverage to the modified moving average () method. currently covers TW when it is performed using the spectral analysis method for the evaluation of patients at risk for sudden cardiac death (D) from ventricular arrhythmias, and patients who may be candidates for edicare coverage of the placement of an implantable cardiac defibrillator (D). B. Policy: ollowing its review, determines that the method of determining TW is not reasonable and necessary for patients at risk for D. Therefore, the current policy remains in place that provides for coverage of TW testing for the evaluation of patients at risk for sudden cardiac death only when the spectral analysis method is used.. BUN QUNT TBL Number equirement esponsibility (place an X in each applicable column) ffective ay 12, 2008, contractors shall be aware that reaffirms its current ND; section 20.30, of Pub , of the ND anual, and will continue to cover TW only when it is performed using the spectral analysis method for the evaluation of patients at risk for D.. POVD DUTON TBL / B X D X X hared-ystem aintainers V Number equirement esponsibility (place an X in each applicable column) / B D hared-ystem aintainers V None. V. UPPOTNG NOTON ection : or any recommendations and supporting information associated with listed requirements, use the box below: / / G / DO hange equest orm: Last updated 08 November 2007 Page 1 W W OT OT

4 Use "hould" to denote a recommendation. X-ef equirement Number ecommendations or other supporting information: N/ ection B: or all other recommendations and supporting information, use this space: N/ V. ONTT Pre-mplementation ontact(s): tuart aplan, coverage, , stuart.caplan@cms.hhs.gov, Pat Brocato-imons, coverage, , patricia.brocatosimons@cms.hhs.gov. Post-mplementation ontact(s): ppropriate regional office V. UNDNG ection : or iscal ntermediaries (s) and arriers: No additional funding will be provided by ; contractor activities are to be carried out within their operating budgets. ection B: or edicare dministrative ontractors (s): The edicare administrative contractor 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. / / G / DO hange equest orm: Last updated 08 November 2007 Page 2

5 icrovolt T-Wave lternans (TW) (ev. 88; ssued: ; ffective Date: ; mplementation Date: ). General icrovolt T-wave lternans (TW) testing is a non-invasive diagnostic test that detects minute electrical activity in a portion of the electrocardiogram (KG) know as the T-wave. TW testing has a role in the risk stratification of patients who may be at risk for sudden cardiac death (D) from ventricular arrhythmias. Within patient groups that may be considered candidates for implantable cardioverter defibrillator (D) therapy, a negative TW test may be useful in identifying low-risk patients who are unlikely to benefit from, and who may experience worse outcomes from, D placement. The test is performed by placing highly sensitive electrodes on a patient s chest prior to a period of controlled exercise. These electrodes detect tiny beat-to-beat changes, on the order of one-millionth of volt, in the KG T-wave. pectral analysis is used to calculate these minute voltage changes. pectral analysis is a sensitive mathematical method of measuring and comparing time and the KG signals. oftware then analyzes these microvolt changes and produces a report to be interpreted by a physician. B. Nationally overed ndications icrovolt T-wave lternans diagnostic testing is covered for the evaluation of patients at risk for D, only when the spectral analysis method is used.. Nationally Non-overed ndications icrovolt T-wave lternans diagnostic testing is non-covered for the evaluation of patients at risk for D if measurement is not performed employing the spectral analysis method. D. Other N/ (This ND last reviewed ay 2008.)