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Last Modified: 7/10/2022 Location: FL, PR, USVI Business: Part A, Part B

Billing/coding of routine costs

Investigational device exemption (IDE) studies

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 CMS IOM Publication 100-04 Medicare Claims Processing Manual, Chapter 32 - Billing Requirements for Special Services, Section 69 which is also described in the clinical trials section below.
The Category A IDE device shall not be reported on institutional claims since Category A IDE devices are not eligible for payment under Medicare.
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 CMS IOM Publication 100-04 Medicare Claims Processing Manual, Chapter 32 - Billing Requirements for Special Services, Section 69 which is also described in the clinical trials section below.
The Category A IDE device shall not be reported on practitioner claims since Category A IDE devices are not eligible for payment under Medicare.
Institutional inpatient billing for items and services in Category B IDE studies
Routine care items and services:
Institutional providers shall submit claims for the routine care items and services in Category B 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 CMS IOM Publication 100-04 Medicare Claims Processing Manual, Chapter 32 - Billing Requirements for Special Services, Section 69 which is also described in the clinical trials section below.
Category B device:
On a 0624 revenue code line, institutional providers must bill the following:
Category B IDE number
Charges for the device billed covered charges field.
Hospital inpatient providers should not bill for the Category B IDE device if receiving the device free-of-charge.
Institutional outpatient billing for items and services in Category B IDE studies
Routine care items and services:
Institutional providers shall submit claims for the routine care items and services in Category B 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 CMS IOM Publication 100-04 Medicare Claims Processing Manual, Chapter 32 - Billing Requirements for Special Services, Section 69 which is also described in the clinical trials section below.
Category B device:
On a 0624 revenue code line, institutional providers must bill the following for Category B IDE devices for which they incur a cost:
Category B IDE device HCPCS code, if applicable
HCPCS modifier Q0 or Q1, as appropriate
Category B IDE number
Charges for the device billed as covered charges
Note: If the Category B IDE device is provided at no cost, outpatient prospective payment system (OPPS) providers must report a token charge in the covered charge field along with the applicable HCPCS modifier (i.e., modifier – FB) appended to the procedure code that reports the service to furnish the device, in instances when claims processing edits require that certain devices be billed with their associated procedures. For more information on billing ‘no cost items’ under the OPPS, refer to chapter 4, 20.6.9 and 61.3.1 of CMS IOM Publication 100-04 Medicare Claims Processing Manual.
Practitioner billing for items and services in Category B IDE studies
Routine care items and services:
Practitioners shall submit claims for routine care items and services in Category B 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 CMS IOM Publication 100-04 Medicare Claims Processing Manual, Chapter 32 - Billing Requirements for Special Services, Section 69 which is also described in the clinical trials section below.
Category B device:
HCPCS modifier Q0
Category B IDE number.
Mandatory reporting of clinical trial ("NCT") number
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 external link 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/Medicare/Medicare-General-Information/MedicareApprovedFacilitie/index.html external link.
Important: Claims submitted without a clinical trial number shall be returned as unprocessable.
Practitioner Category A and Category B IDE paper claim
CMS-1500 paper form, place the 8-digit clinical trial number in Field 19 (preceded by ‘CT’)
Practitioner Category A and Category B electronic claim
Electronic claim 837P, place the 8-digit clinical trial number in Loop 2300, REF02, REF01=P4 (do not use ‘CT’ prefix on the electronic claim)
In addition to the clinical trial number, paper and electronic claims for Category A IDE practitioners and Category B IDE institutional and practitioners shall include:
ICD-10 diagnosis code Z00.6 (in either the primary/secondary positions)
HCPCS modifier Q0 or Q1 as appropriate (outpatient claims only)
Reporting of IDE Number
Institutional and practitioner IDE claims must continue to report the associated IDE number on the claim form as well as the mandatory 8-digit clinical trial number.
Designated field locations to report the Category A IDE number on Category A IDE studies practitioner paper and electronic claims:
CMS - 1500 paper claim form - Field Locator (Item) 23
837I and 837P - Loop 2300, REF02 (REF01=LX)
Designated field locations to report the Category B IDE number on Category B IDE Studies on institutional and practitioner paper and electronic claims:
CMS-1450 claim form - Field Locator 43
CMS - 1500 claim form - Field Locator (Item) 23
837I and 837P - Loop 2300, REF02 (REF01=LX)
Designated field locations to report the Category B IDE number on clinical trials involving a Category B IDE on institutional and practitioner paper and electronic claims:
CMS-1450 claim form - Revenue Code Description field
CMS - 1500 claim form - Field Locator (Item) 23
837I and 837P - Loop 2300, REF02 (REF01=LX)
When more than one IDE applies, they must be split into separate claims.
Enter the IDE number for an investigational device issued in an FDA approved clinical trial. Post Market Approval number should also be placed here when applicable.
Contractors will validate the IDE number for the Category A or B device when modifier Q0 is submitted, as appropriate, on the claim along with the IDE number. Claims containing an invalid IDE number will be returned to the provider.

Clinical trials

Medicare covers routine costs of qualifying clinical trials. Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial except:
Routine costs do not include (and therefore are not covered):
The investigational item or service, itself unless otherwise covered outside of the clinical trial;
Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and
items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.
Routine costs do include (and therefore are covered):
Items or services that are typically provided absent a clinical trial (e.g., conventional care)
Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications;
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service – in particular, for the diagnosis or treatment of complications.
In addition, reasonable and necessary items that are used to diagnose and treat complications arising from participation in clinical trials are also covered. Applicable deductibles and coinsurance rules apply to clinical trial items and services.
General billing requirements
If clinical trial and non-clinical trial services are submitted on the same claim, then separate line items must be used for each type of service. Items and services provided free of charge by research sponsors may not be billed to Medicare.
Note: If it is necessary for a provider to show the items and services that are provided free of charge in order to receive payment for the covered routine costs (e.g., administration of a non-covered chemotherapeutic agent), providers are instructed to submit such charges as non-covered.
Services furnished to Medicare beneficiaries who are control group volunteers participating in a qualified clinical trial may also be submitted for reimbursement. The claim submission requirements for these claims depend upon the source of the submission--Institutional providers or practitioners/suppliers.
Mandatory reporting of clinical trial ("NCT") number
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 CED. This is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov external link 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 clinical trials/registry web site at: http://www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilitie/index.html external link.
Important: All claims submitted without an 8-digit clinical trial number shall be returned as unprocessable.
Institutional paper or direct data entry (DDE) claim
CMS-1450 (UB-40) claim form, place 8-digit clinical trial number in Field Locators 39-41 (use 'D4')
DDE claim, place 8-digit clinical trial number in the value amount of value code 'D4'
Institutional electronic claim
Electronic claim 837I, place the 8-digit clinical trial number in Loop 2300 REF02 (REF01=P4)
Practitioner paper claim
CMS-1500 form, place the 8-digit clinical trial number in Field 19 (preceded by ‘CT’)
Practitioner electronic claim
Electronic claim 837P, place the 8-digit clinical trial number in Loop 2300, REF02, REF01=P4 (do not use ‘CT’ prefix on the electronic claim)
In addition to the 8-digit clinical trial number, institutional and practitioner paper and electronic claims shall include:
Condition code 30
ICD-10 diagnosis code Z00.6 (in either the primary/secondary positions)
HCPCS modifier Q0 or Q1 as appropriate (outpatient claims only)
Modifier Definitions
Q0: Investigational clinical service provided in a clinical research study that is in an approved clinical research study.
Q1: Routine clinical service provided in a clinical research study that is in an approved clinical research study.
Inpatient clinical trial claims
Institutional providers billing clinical trial service(s) must report ICD-10 diagnosis code Z00.6, if applicable, in either the primary or secondary position and a condition code 30 regardless of whether all services are related to the clinical trial or not.
Note: HCPCS codes are not reported on inpatient claims. Therefore, the HCPCS modifier requirements (i.e., Q0/Q1) as outlined for outpatient clinical trials above, are not applicable to inpatient clinical trial claims.
Resources:
See CMS Internet-Only Manual (IOM) Publication 100-02, Medicare Benefit Policy Manual, Chapter 14 - Medical Devices external pdf file for complete Medicare coverage requirements for items and services in Category A and B IDE studies.
See CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Section 310.1 - Routine Costs in Clinical Trials external pdf file for coverage requirements for routine costs of qualifying clinical trial services.
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