Corporate Compliance

Note from the Instructor: Investigational Device Exemption Studies

Medicare Insider, March 10, 2015

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This week’s note from the instructor is written by Debbie Mackaman, RHIA, CPCO, CCDS regulatory specialist for HCPro.  
 
In a recent issue of the Medicare Insider, Kimberly Anderwood Hoy Baker, JD, regulatory specialist for HCPro, wrote about the implementation of Condition Code 53 (initial placement of a medical device provided as part of a clinical trial or free sample) for hospital outpatient claims when certain criteria have been met. Since then, we have received several questions about investigational devices so I thought I would take this time to generally review the CMS policy on Investigational Device Exemption (IDE) studies.
 
Medicare may cover certain FDA-approved investigational devices and related routine care items and services when the investigational device meets certain coverage criteria as posted on the CMS Coverage website. Once approved, the devices are placed in Category A or Category B which have specific billing requirements.
 
Category A Device

The “absolute risk” of this type of device has not been established and the FDA is unsure whether the device can be safe and effective based on its intended use. Medicare covers only routine care items and services furnished in this type of study, if CMS has determined that the Medicare coverage criteria are met.
 
Routine care items are items and services that are otherwise generally available to Medicare beneficiaries. This means that a benefit category exists, it is not statutorily excluded, and there is not a national non-coverage decision.
 
Under a Category A IDE study protocol, a hospital may only submit a claim for the routine care items and services. The device cannot be reported on the claim since the device itself is not eligible for payment under the Medicare program. Payment for the related routine care items may not exceed what Medicare would have paid for comparable items that are usually approved for standard of care.
 
Category B Device

The “incremental risk” of this type of device is known and it has been determined to be safe and effective. Medicare covers the device and routine care items and services furnished in this type of study if CMS has determined that the Medicare coverage criteria are met.
 
Providers must notify their MAC before submitting claims for Category B IDE services. Once the MAC notifies the provider that all required information for the IDE has been accepted, the provider may bill for the services. Payment for Category B IDE study devices and routine care items may not exceed what Medicare would have paid for comparable devices and routine care items generally approved by Medicare.
 
General Billing Guidance
 
When billing for Category A IDE routine items or Category B IDE device and related routine items, specific information must be included on the claim. Here is a brief summary.
 
For all hospital claims:
  • Condition Code 30 (“non-research services provided to patients enrolled in a Qualified Clinical Trial”). Until further clarification is received, presumably both conditions codes 30 and 53 may be reported on the same outpatient claim when both criteria are met.
  • Value Code D4 (clinical trial number assigned by NLM/NIH). The number reported with the value code amount is equal to the mandatory 8-digit clinical trial number as specified on the Medicare Coverage webpage or on clinicaltrials.gov.
  • Charges are reported in the covered column when all applicable coverage criteria are met.
  • ICD-9 code V70.7 (“examination of participant in clinical trial”) must be reported on the claim; when applicable, ICD-10 diagnosis code Z00.6 should be reported.
 
For hospital inpatient claims:
  • Routine care costs incurred during an approved Category A or B IDE study may be billed on the claim when those items are considered to be otherwise generally available to Medicare beneficiaries.
  • When the hospital incurred a cost for the Category B device, report the IDE number under revenue code 0624 (FDA investigational device) with charges in the covered column.
  • When the hospital receives the Category B device without charge, the device should not be billed on the inpatient claim.
 
For hospital outpatient claims:
  • For Category B IDE studies, report the IDE number under revenue code 0624.
  • Report the Category B device HCPCS code under revenue code 0624, if one exists.
  • Report Modifier -Q0 (“investigational clinical service provided in a clinical research study that is an approved clinical research study”) to identify all lines containing an investigational item/service.
  • Routine care costs incurred during an approved Category A or B IDE study must be reported with Modifier -Q1 (“routine clinical service provided in a clinical research study that is an approved clinical research study”) to identify all lines containing routine services medically necessary for routine patient care or treatment of complications arising from a Medicare beneficiary’s participation in a Medicare-covered clinical trial.
  • Bill the Category B device and Category A or B routine care items as covered charges.
 
Billing for IDE services is very complicated and the guidance can be very confusing. More detailed information can be found in the Medicare Benefit Policy Manual, Chapter 14 and the Medicare Claims Processing Manual, Chapter 32.



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