Billing Update for Clinical Trial Services for Managed Care Beneficiaries

on Wednesday, 04 November 2009. All News Items

On October 15, 2009, CMS revised MLN Matters 6455  concerning the billing of clinical trial services to Managed Care beneficiaries to include the following note:

“NOTE: Providers who are not required to report HCPCS codes, or for revenue codes that do not require a HCPCS code, providers shall report a Not Otherwise Classified (NOC) code when reporting lines related to the clinical trial for a managed care beneficiary. By doing so, the provider is able to report the appropriate clinical trial HCPCS modifier (Q0 or Q1) for the NOC line.”

This applies to claims submitted to Medicare for services related to the clinical trial.  Per the original transmittal, outpatient clinical trial services for managed care beneficiaries will be rejected when there is at least one line on the claim that does not contain either a HCPCS modifier Q0 or Q1.

MMP, Inc. is unsure which Not Otherwise Classified HCPCS code or codes would be appropriate to use as directed by this article.  We have submitted a question to Cahaba GBA for further clarification and will pass on any information we receive.

Information Summary from Original Transmittal

Medicare pays for covered clinical trial services furnished to beneficiaries enrolled in managed care plans.  These services are paid in accordance with applicable fee for service rules except that beneficiaries are not responsible for Part A or Part B deductibles.
Transmittal 1723 (CR 6455) released May 1, 2009 provides additional clarification about billing and processing claims for outpatient clinical trial services to managed care enrollees.

Institutional providers, like hospitals, must not include services unrelated to the clinical trial on the same claim with the clinical trial services.  The provider must bill only the clinical trial services to Medicare.  Any covered outpatient services provided during the same day/stay that are unrelated to the clinical trial should be billed to the managed care plan.  Claim requirements for clinical trial billing for managed care enrollees are the same as regular Medicare FFS claims.

For additional information, please refer to the MLN Matters article or Transmittal 1723.
MLN Matters 6455
CMS Transmittal 1723

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