CMS Pub. 100-04, ch. 32, § 68.1

Category A IDE Studies

(Rev. 3105, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)

A. Institutional Inpatient and Outpatient Billing in Category A IDE Studies

Routine Care Items and Services

Institutional providers shall submit claims only for routine care items and services in Category A IDE device studies

approved by CMS (or its designated entity) and listed on the CMS Coverage Website, by billing according to the

clinical trial billing instructions found in §69.6 of this chapter, and as described below under subsection C (“General

Billing Requirements”). The Category A IDE device shall not be reported on institutional claims since Category A

IDE devices are not eligible for payment under Medicare.

B. Practitioner Billing in Category A IDE Studies

Routine Care Items and Services

Practitioners shall submit claims for the routine care items and services in Category A IDE studies approved by CMS

(or its designated entity) and listed on the CMS Coverage Website, by billing according to the clinical trial billing

instructions found in §69.6 of this chapter, and as described below under subsection C (“General Billing

Requirements”). The Category A IDE device shall not be reported on practitioner claims since Category A IDE

devices are not eligible for payment under Medicare.

C. General Billing Requirements

Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number

on claims for items/services provided in clinical trials/studies/registries, or under coverage with evidence development

(CED). This is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov Website when a

new study appears in the NLM Clinical Trials data base. This number is listed prominently on each specific study’s

page and is always preceded by the letters “NCT.” Contractors verify the validity of a trial/study/registry by

consulting CMS’s Coverage Website at: http://www.cms.gov/Center/Special-Topic/Medicare-Coverage-

Center.html?redirect=/center/coverage.asp. Providers report the 8-digit number on the following claims locators:

CMS-1500 paper form-place in Field 19 (preceded by ‘CT’); or

837 P—Loop 2300, REF02, REF01=P4 (do not use ‘CT’ on the electronic claim)

In addition to the clinical trial number, claims shall include:

ICD-9 diagnosis code V70.7/ICD-10 diagnosis code Z00.6 (in either the primary/secondary positions)

HCPCS modifier Q0 or Q1 as appropriate

Claims submitted without a clinical trial number shall be returned as unprocessable reporting the following messages:

CARC 16: “Claim/service lacks information which is needed for adjudication. At least one Remark Code must be

provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an

ALERT.)”

RARC MA50: “Missing/incomplete/invalid Investigational Device Exemption number for FDA-approved clinical

trial services.”

RARC MA130: “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.”

Group Code - Contractual Obligation (CO)

Effective for dates of service on or before December 31, 2007, practitioners must place a QV modifier (Item or

service provided as routine care in a Medicare qualifying clinical trial) on the line for the device along with the IDE

number.

Effective for dates of service on or after January 1, 2008, practitioners will no longer bill a QV modifier to identify the

device. Instead, practitioners will bill a Q0 (numeral 0 versus the letter O) modifier (Investigational clinical service

provided in a clinical research study that is in an approved clinical research study) along with the IDE number.

The following table shows the designated field locations to report the Category A IDE number on practitioner claims:

Data CMS-1500 837i and 837p

IDE # Item 23 Segment 2300,

REF02(REF01=LX)

Contractors will validate the IDE number for the Category A device when modifier Q0 is submitted on the claim

along with the IDE number. Claims containing an invalid IDE number will be returned to the provider using the

following messages:

RARC MA50: “Missing/incomplete/invalid Investigational Device Exemption Number for FDA approved clinical

trial services.”

CARC 16: “Claim/service lacks information which is needed for adjudication. At least one Remark Code must be

provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an

ALERT).”