anual ystem Pub 100-04 edicare laims Processing Department of ealth & uman ervices (D) enters for edicare & edicaid ervices () Transmittal 1418 Date: JNUY 18, 2008 hange equest 5805 UBJT: New P odifiers when Billing for Patient are in linical esearch tudies. UY O NG: is discontinuing the Q, Q, and QV P modifiers and creating Q0 and Q1 to identify investigational and routine clinical services provided in a clinical research study approved by edicare. These two new modifiers will be included in the 2008 nnual P Update. The is to be implemented no later than pril 7, 2008. New / evised aterial ffective Date: January 1, 2008 mplementation Date: No Later Than pril 7, 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-Only One Per ow. /N/D hapter / ection / ubsection / Title 1/80.3.2.1.3/arrier pecific equirements for ertain pecialties/ervices 32/68.3/Billing equirements for Providers Billing outine osts of linical Trials nvolving a ategory D 32/68.4/Billing equirements for Providers Billing outine osts of linical Trials nvolving a ategory B D 32/69.6/Billing equirements for linical Trials 32/69.7/eserved for uture Use
. 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 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 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: 1418 Date: January 18, 2008 hange equest: 5805 UBJT: New P odifiers when Billing for Patient are in linical esearch tudies ffective Date: January 1, 2008 mplementation Date: No Later Than pril 7, 2008. GNL NOTON. Background: The current, 2007 nnual P Update contains the following three modifiers to bill for patient care when beneficiaries are enrolled in clinical research studies (formerly referred to as clinical trials): Q - D nvestigational Device xemption. Q - tem or ervice Provided in a edicare pecified tudy. QV - tem or ervice Provided as outine are in a edicare Qualifying linical Trial. t has come to our attention that these modifiers are not being used as intended as the long descriptors are vague and overlapping. s a result, the enters for edicare and edicaid ervices () is revising its modifier coding policy. B. Policy: is discontinuing the Q, Q, and QV modifiers as of December 31, 2007, and creating the following two new modifiers that will be used solely to differentiate between routine and investigational clinical services. These new modifiers will be included in the 2008 nnual P Update and are effective for dates of service on and after January 1, 2008: Q0 - nvestigational clinical service provided in a clinical research study that is in an approved clinical research study. o nvestigational clinical services are defined as those items and services that are being investigated as an objective within the study. nvestigational clinical services may include items or services that are approved, unapproved, or otherwise covered (or not covered) under edicare. Q1 - outine clinical service provided in a clinical research study that is in an approved clinical research study. o outine clinical services are defined as those items and services that are covered for edicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and, do not meet the definition of investigational clinical services. outine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent); clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers); and items or services required for the prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function). ontractors are to update their edits as follows: The Q0 modifier replaces Q and Q.
The Q1 modifier replaces QV. ll claims submitted for patient care in clinical research studies must use the two new modifiers for routine and investigational clinical services. This includes studies that are certified under the edicare linical esearch Policy, nvestigational Device xemption (D) trials, and studies required under a coverage with evidence development (D) national coverage determination (ND). ffective for dates of service on and after January 1, 2008, claims submitted with the discontinued modifiers will be processed as return-to-provider/return as unprocessable.. BUN QUNT TBL Use hall" to denote a mandatory requirement Number equirement esponsibility (place an X in each applicable column) 5805.1 ffective for dates of service on or after January 1, 2008, contractors accept the two new modifiers Q0 and Q1 used for clinical research studies. / B D hared-ystem aintainers V W OT X X X X X X X X OB N NOT: The two new modifiers will be part of the 2008 nnual P Update. 5805.2 ffective for dates of service on or after January 1, 2008, contractors shall create new edits, and/or modify existing edits, per the following P update: The Q0 modifier replaces the Q and Q modifiers The Q1 modifier replaces the QV modifier 5805.3 ontractors shall educate via a LN article that if a ategory or B investigational device is used in the clinical trial, they should continue to place the D number in item 23 of the -1500 or electronic equivalent and place modifier Q0 on the claim. 5805.3.1 ontractors shall NOT return claims billed with modifier Q0 that do not contain an D number in item 23 of the -1500 form or the electronic equivalent. 5805.4 The standard system maintainer shall develop hard coded D controlled edits for D number validation when the modifier Q0 and the D # for either a ategory or B device appears on the claim. 5805.4.1 The standard system maintainer shall validate an exact match on the D # if Q0 is present on an D claim. 5805.4.2 The standard system maintainer shall validate that the date of service (DO) on the claim service line X X X X X X X X X X X X X X X X X X X
Number equirement esponsibility (place an X in each applicable column) containing the Q0 falls within the DO on the D file. 5805.4.3 ontractors shall return the claim as unprocessable if the claim with a Q0 modifier and D # does not meet the criteria in B 4, 4.1, 4.2. (Use eason ode 16 along with emark code 50.) 5805.5 ontractors shall not search files for claims already processed but should adjust claims brought to their attention. / B D X X X X X X hared-ystem aintainers V W OT. POVD DUTON TBL Number equirement esponsibility (place an X in each applicable column) 5805.6 provider education article related to this instruction will be available at http://www.cms.hhs.gov/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 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. / B D X X X X X hared-ystem aintainers V W OT 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 equireme nt Number ecommendations or other supporting information:
X-ef equireme nt Number ecommendations or other supporting information: B. or all other recommendations and supporting information, use this space: V. ONTT Pre-mplementation ontact(s): National overage Determination: Leslye itterman, leslye.fitterman@cms.hhs.gov, 410-786-3669 nstitutional laims Processing: Joe Bryson, joseph.bryson@cms.hhs.gov, 410-786-2986 or Valeri itter, valeri.ritter@cms.hhs.gov, 410-786-8652 Physician laims Processing: Vera Dillard, vera.dillard@cms.hhs.gov, 410-786-6149 D laims Processing: Tracey emphill, tracey.hemphill@cms.hhs.gov, 410-786-7169 Post-mplementation ontact(s): ppropriate O V. UNDNG. No additional funding will be provided by ; contractor activities are to be carried out within their operating budgets. B. The 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 (OW). 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.