On this page, view the below information.
- Coverage
- UB-04 Billing
- Billing Scenarios
- Humanitarian Device Exemption
Coverage
Medicare may pay for items and services in clinical research studies under three policies:
- Clinical Trial Policy (CTP)
- A National Coverage Determination (NCD) that allows payment of routine items/services, and payment of the investigational item/service if it is normally covered outside of the trial and meets medical necessity requirements, in clinical trials that qualify for coverage. See the CMS Routine Costs in Clinical Trials (310.1) NCD for details.
- Coverage with Evidence Development (CED)
- Medicare may issue an NCD that requires participation in certain clinical trials, longitudinal studies, or registries for coverage of an item/service and routine and related items/services.
- See all CED studies on the CMS Coverage with Evidence Development webpage.
- Investigational Device Exemption (IDE) Policy
- Medicare may cover certain items/services in Food and Drug Administration (FDA)-approved IDE trials.
- Trials initially approved by FDA before January 1, 2015, the Medicare Administrative Contractors (MACs) review IDE studies to determine coverage.
- Trials approved by FDA after January 1, 2015, view listing on the CMS Approved IDE Studies webpage. MACs may require additional information to facilitate claims payment.
Clinical Trials, Prospective Studies, and Registries Coverage
| Coverage Elements | CTP | IDE | CED |
|---|---|---|---|
| CMS approval required | No. Must qualify under NCD 310.1 | Yes. Each specific study approved by FDA before 1/1/2015, requires MAC approval; studies approved by FDA after 1/1/2015 require CMS approval | Yes. Requires CMS approval for each specific study |
| Public notification | No. Provider determines qualification | Each study approved by FDA after 1/1/2015 appears on CMS IDE Website | Each study approved by CMS appears on CMS CED Website |
| Routine services (Q1) | Covered if otherwise coverable by Medicare in qualified study | Covered if study is approved by CMS and otherwise coverable by Medicare | Covered if study is approved by CMS and otherwise coverable by Medicare |
| Investigational item/ service (Q0) | Covered if otherwise covered by Medicare in qualified study | Covered if item/service is Category B, and approved by CMS | Covered if study is approved by CMS |
UB-04 Billing
Providers must ensure that their clinical trial claims contain the proper components when billing Medicare:
- Condition code 30
- Condition codes 49, 50, 53
- IDE billing only
- Hospitals must report one of the below condition codes when the value code "FD" is present on the claim:
- 49 Product Replacement within Product Lifecycle - Replacement of a product earlier than the anticipated lifecycle.
- 50 Product Replacement for Known Recall of a Product - Manufacturer or FDA has identified the product for recall and therefore replacement.
- 53 Initial placement of a medical device provided as part of a clinical trial or free sample - Code is for outpatient claims that have received a device credit upon initial medical device placement in a clinical trial or a free sample.
- ICD-10 diagnosis code Z00.6
- Primary or secondary positions
- Must be reported on all clinical trial claims
- Modifier Q0 (zero)
- Outpatient claims only
- Modifier Q1
- Outpatient claims only
- Append on all line items that are routine clinical services provided in a clinical research study that is an approved clinical research study
- Primary or secondary position
- Revenue code 0624
- IDE billing only
- IDE number should be entered into
- UB04 FL 43; or
- 837I and Loop 2300, REF02 (REF01=P4)
- Value code D4
- Enter eight-digit National Clinical Trial (NCT) number (numeric characters only) on electronic claims
- For NCT number, see the Clinical Trials website
- Value code FD
- IDE billing only
- Hospital furnishing the below must report amount of device credit in the amount portion for value code "FD" (Credit Received from the Manufacturer for a Medical Device):
- A free sample medical device; or
- Without cost an initial placement of a medical device as part of a clinical trial; or
- Without cost a new replacement device; or
- With a credit of 50 percent or more of the cost of a new replacement from a manufacturer, due to:
- Warranty
- Recall; or
- Field action
- Hospitals paid under Outpatient Prospective Payment System (OPPS) that implant a device furnished at no cost to the hospital shall report a charge of zero for device, or, if hospital's billing system requires that a charge be entered, hospital shall submit a token charge (e.g. $1.00) on the line with the device code.
Billing Scenarios
| Case Number | Scenario | Solution |
|---|---|---|
| 1 | Patient is admitted for sepsis, dehydration, or pain control because of the clinical trial. Do providers still bill with the NTC number? | No. Complications stemming from participation in a clinical trial do not need an NCT number. |
| 2 | Patient has a Medicare Advantage (MA) plan. Who should providers bill? | Medicare will reimburse qualifying clinical trial claims on behalf of MA members and will waive the Part A and Part B deductibles. MA plans are responsible for remaining original Medicare coinsurance minus the plan's normal member copays for the incurred types of service, with exception to CEDs listed in Change Request (CR) 10238; in those instances, the MA plan is responsible. |
| 3 | Patient has completed a clinical trial; however, they are being seen yearly for observation. Do providers still bill with the NCT number? | No. Once the patient has completed the clinical trial, there is no requirement to report the NCT number. |
| 4 | Provider doesn't know the NCT number. Can providers still bill with 999999999, per Medicare Learning Network (MLN) Matters Special Edition (SE) 1344? | Yes. However, actual NCT identifier numbers are required if they are known. If the study is an IDE study or a CED study, the NCT number is always required. |
Humanitarian Device Exemption
"Under section 520(m)(6)(A)(i) of the FD&C Act, an [Humanitarian Use Device] HUD is only eligible to be sold for profit after receiving an HDE approval if the device is intended for the treatment or diagnosis of a disease or condition that either:
- occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; OR
- occurs in adult patients and does not occur in pediatric patients or occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe." - U.S. Department of Health and Human Services, FDA
Humanitarian Device Exemption (HDE) is an approval process the FDA offers for HUDs that impact an "orphan" populous (fewer than 8,000 individuals in the United States, annually). HDE claims are not guaranteed payment, and many are denied. The 0624 revenue code should be used, along with applicable clinical trial coding, when the HDE has been reviewed and approved as a clinical trial meeting medical necessity.
Resources
- CMS Coverage with Evidence Development
- CMS CR 8401
- Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015 or Later
- CMS Internet Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 4, Section 61.3.5
- CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 69.6
- CMS Mandatory Reporting of National Clinical Trial (NCT) Identifier Numbers on Medicare Claims - Q&A
- CMS Medicare Coverage Related to Investigational Device Exemption (IDE) Studies
Last Updated Dec 09 , 2023
As a seasoned expert in Medicare coverage policies for clinical research studies, I can confidently navigate the intricate landscape of reimbursem*nt protocols and regulations. Let's delve into the concepts mentioned in the provided article:
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Clinical Trial Policy (CTP): Medicare may cover routine items/services and investigational items/services in clinical trials that meet specific criteria outlined in the National Coverage Determination (NCD) 310.1.
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Coverage with Evidence Development (CED): Medicare may issue an NCD requiring participation in certain clinical trials, longitudinal studies, or registries for coverage. These studies are listed on the CMS Coverage with Evidence Development webpage.
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Investigational Device Exemption (IDE) Policy: Medicare may cover certain items/services in FDA-approved IDE trials. Studies approved before January 1, 2015, require MAC approval, while those approved after require CMS approval.
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UB-04 Billing: Providers must ensure proper billing components, including condition codes, ICD-10 diagnosis codes, modifiers, revenue codes, and value codes, particularly for IDE billing.
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Billing Scenarios: Scenarios outline billing procedures for various situations, such as complications from clinical trial participation, patients with Medicare Advantage plans, and completion of clinical trials.
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Humanitarian Device Exemption (HDE): FDA offers HDE approval for devices intended for rare diseases affecting fewer than 8,000 individuals annually. HDE claims may utilize the 0624 revenue code and clinical trial coding for reimbursem*nt.
To fully comprehend and implement these concepts, familiarity with CMS resources such as the CMS Coverage with Evidence Development page, CMS Internet Only Manual, and Medicare Claims Processing Manual is crucial. Additionally, understanding FDA regulations regarding IDE studies and HDE approvals is essential for compliance and successful reimbursem*nt.
