Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Transmittal 1905 Date: February 5, 2010

Transcription

1 anual ystem Pub edicare laims Processing Department of ealth & uman ervices (D) enters for edicare & edicaid ervices () Transmittal 1905 Date: ebruary 5, 2010 hange equest 6800 UBJT: New Waived Tests. UY O NG: This instruction informs contractors of new waived tests approved by the ood and Drug dministration under linical Laboratory mprovement mendments of ince these tests are marketed immediately after approval, the enters for edicare and edicaid ervices must notify its contractors of the new tests so that the contractors can accurately process claims. This ecurring Update Notification (UN) can be found in hapter 16, ection New / evised aterial ffective Date: pril 1, 2010 mplementation Date: pril 5, 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. 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 N/ hapter / ection / ubsection / Title. UNDNG: TON : or iscal ntermediaries and arriers: No additional funding will be provided by ; ontractor activities are to be carried out within their operating budgets. TON 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 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. V. TTNT: ecurring Update Notification *Unless otherwise specified, the effective date is the date of service.

2 ttachment ecurring Update Notification Pub Transmittal: 1905 Date: ebruary 5, 2010 hange equest: 6800 UBJT: New Waived Tests ffective Date: pril 1, 2010 mplementation Date: pril 5, GNL NOTON. Background: The linical Laboratory mprovement mendments of 1988 (L) regulations require a facility to be appropriately certified for each test performed. To ensure that edicare & edicaid only pay for laboratory tests categorized as waived complexity under L in facilities with a L certificate of waiver, laboratory claims are currently edited at the L certificate level. Listed below are the latest tests approved by the ood and Drug dministration as waived tests under L. The urrent Procedural Terminology (PT) codes for the following new tests must have the modifier QW to be recognized as a waived test. owever, the tests mentioned on the first page of the attached list (i.e., PT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test. PT ode ffective Date Description 80101QW, G0430QW July 1, 2009 for 80101QW, January 1, 2010 for G0430QW nverness edical nnovations ignify Drug creen 82274QW, G0328QW eptember 9, 2009 Germaine Laboratories imtep mmunological ecal Occult Blood Test (iobt) 81003QW, 82044QW, 82570QW eptember 14, 2009 iemens linitek 50 Urine hemistry nalyzer 87880QW eptember 15, 2009 L waived inc apid trep Test 82044QW October 26, 2009 Genzyme Diagnostics OO mmunodip Urinary lbumin Test We have been informed by Bayer ealthcare that the following tests are no longer manufactured or distributed: Bayer ulitstick Pro 7G eagent trips, Bayer ulitstick Pro 10L eagent trips, Bayer ulitstick Pro 11 eagent trips, Bayer linitek 50 Urine hemistry nalyzer, Bayer linitek tatus Urine hemistry nalyzer, Bayer linitek 50 Urine hemistry nalyzer - for microalbumin, creatinine, Bayer Diagnostics/ icroalbustix eagent trip, and Bayer linitek 50 Urine hemistry nalyzer - for G, urine. ence, these tests were removed from the attachment.

3 Based on a concern received from the laboratory industry on correct coding, the PT code assigned to the following test systems has been changed from 83518QW to 82044QW with an effective date of pril 1, 2010: Beckman oulter ON icroalb, Boehringer annheim hemstrip icral, Diagnostic hemicals mmunodip Urinary lbumin Test, Diagnostic hemicals mmunodip Urinary lbumin creen (Urine Dipstick), and oche Diagnostics hemstrip icral (urine dipstick). or 2010, the ealthcare ommon Procedure oding ystem (P) included the following new codes: G0430 Drug screen, qualitative; multiple drug classes other than chromatographic method, each procedure, and G0431 Drug screen, qualitative; single drug class method (e.g., immunoassay, enzyme assay), each drug class. Therefore, the P code G0430QW was added to the following test systems since they are qualitative drug screening tests for multiple drug classes using a non-chromatographic method: bbott Diagnostics ignify Drug creen Test, ccu-tat Drugs of buse ome Test for arijuana (T) and ocaine (O), ccu-tat Drugs of buse ome Test for arijuana, ocaine, mphetamine, ethamphetamines, Opiates and Phencyclidine, accutest ulti-drug, ulti-line creen Test Device, con One tep ulti-drug, ulti-line creen Test Device (Professional Use), D L Waived arijuana (T) and ocaine Test, D L Waived ultiple Drug Test ard, dvantage Diagnostics dvantage arijuana (T) and ocaine ome Drug Test, dvantage Diagnostics orporation D ultiple Drug Test ard, latex cientific Peace of ind ultiple Drugs of buse Test, lfa cientific Designs, nc. nstant View ulti-drug of buse Urine Test, lfa cientific Designs, nc. nstant View ulti-drug of buse Urine up Test, medica Biotech medica Drug creen Test up, merican Bio edica apid TO, ventir Biotech LL ome heck ultiple Drug Test up, ventir Biotech LL ome heck ultiple Drug up Test {Professional version}, Biotechnostix apid esponse ulti-drug, ulti-line creen Test ard with ntegrated up, Biotechnostix apid esponse One tep ulti-drug, ulti-line creen Test Device, Branan edical orporation astect Drug creen Dipstick Test, Branan edical orporation, astox ultiple Drug Dipcard, Branan edical orporation, QuickTox Drug creen Dipcard, Branan edical orporation Toxup Drug creen up, BTN nc. Know ulti-drug One tep creen Test Panel (Urine), BTN nc. apid esponse ulti-drug One tep creen Test Panel (Urine), Drug Detection Devices Ltd. ulti-drug ulti-line creeners Dip Drug Test With the ntegrated creeners utoplit KO Test up, irst heck Diagnostics irst heck ulti Drug up, irst heck Diagnostics irst heck 12 Drug Test,

4 orefront Diagnostics T/O Test Kit, iassette ulti-drug, ulti-line creen Test Device, nnovacon ntegrated -Z plit Key up {Professional Use}, nnovacon ulti-lin Drug creen Test Device, Jant Pharmacal ccutest ultidrug 11 Drug creen Test Device, 1 tep Detect ssociates DT Drug Test up ntegrated -Z plit Key up, Phamatech t ome Drug Test (odel 9150T), Quest Diagnostics ncorporated, xpress esults ntegrated ulti-drug creen up {professional use}, edicreen ulti-drug, ulti-line creen Test Device, edwood Toxicology Laboratory editest 6 assette substance abuse screening device {Professional Use}, yntron Bioresearch Quikscreen ultiple Drug up Test {Professional version}, Twin pirit, nc. Drugmart up, Wolfe Drug Testing ealityheck ntegrated pecimen up, Worldwide edical orporation, irst heck ome Drug Test (T-O), and Worldwide edical orporation, irst heck ome Drug Test Panel 4 (T-O-OP-T). n addition, the P code G0431QW was added to the following test systems since they are qualitative drug screening tests using a single drug class method: ccu-tat Drugs of buse ome Test for arijuana (T), D L Waived arijuana (T) Test, DyanGen Nicheck Test trips, irst heck Diagnostics LL, irst heck ome Drug Test arijuana, ossman ssociates, nc. Nicheck Test trips, Phamatech t ome Drug Test (odel 9068), Phamatech t ome Drug Test (odel 9073), Phamatech t ome Drug Test (odel 9073T), Phamatech t ome Drug Test (odel 9078), Phamatech t ome Drug Test (odel 9078T), Phamatech t ome Drug Test (odel 9083), Phamatech t ome Drug Test (odel 9133), Phamatech Quickcreen One tep ocaine creening Test, Phamatech Quickcreen One tep ethamphetamine Test, Phamatech Quickcreen One tep Opiate creening Test, Phamatech Quickcreen One tep PP creening Test, and Worldwide edical orporation, irst heck ome Drug Test (T). This UN can be found in hapter 16, B. Policy: The L regulations require a facility to be appropriately certified for each test performed. To ensure that edicare and edicaid only pay for laboratory tests categorized as waived complexity under L in facilities with a L certificate of waiver, laboratory claims are currently edited at the L certificate level.

5 . BUN QUNT TBL Number equirement esponsibility (place an in each applicable column) / B D hared- ystem aintainers The edicare contractor shall include the new tests listed above in L-covered code files with the QW modifier. V W OT The edicare contractor shall permit the use of codes G0430QW and G0431QW for claims submitted by facilities with a valid, current L certificate of waiver with dates of service on or after January 1, ontractors shall not search their files to either retract payment or retroactively pay claims; however, contractors should adjust claims if they are brought to their attention ontractors shall not use the explanatory information under the Use column in the attachment as the reason for rejecting a claim.. POVD DUTON TBL Number equirement esponsibility (place an in each applicable column) / B D hared- ystem aintainers 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. V W OT

6 Number equirement esponsibility (place an in each applicable column) / B D hared- ystem aintainers V W OT V. UPPOTNG NOTON ection : or any recommendations and supporting information associated with listed requirements, use the box below: N/ Use "hould" to denote a recommendation. -ef equirement Number ecommendations or other supporting information: ection B: or all other recommendations and supporting information, use this space: N/ V. ONTT Pre-mplementation ontact(s): Kathy Todd (410) Post-mplementation ontact(s): Kathy Todd (410) 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 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 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 TT GNTD WVD TTU UND L