Article Detail - JA DME

Original Effective Date: 09/01/2000
Revision Effective Date: 11/01/2013

On June 7, 2000, the President of the United States issued an executive memorandum directing the Health Care Financing Administration (HCFA) to "explicitly authorize [Medicare] payment for routine patient care costs…and costs due to medical complications associated with participation in clinical trials." In keeping with the President's directive, this National Coverage Decision (NCD) serves to define the routine costs of clinical trials and identify the clinical trials for which payment for such routine costs should be made for eligible services furnished on or after September 19, 2000.

HCFA has developed a National Coverage Determination (NCD) which can be accessed and downloaded from the HCFA webpage at www.hcfa.gov/quality/8d.htm. This NCD states that Medicare covers: 1) the routine costs of qualifying clinical trials as well as, 2) reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. This instruction addresses routine costs of qualifying clinical trials including complications resulting from qualifying clinical trials. All other Medicare rules apply.

Clinical Trial Services That Qualify for Coverage

Clinical trial services covered by Medicare must meet both the following requirements:

1. Qualifying Trial. In order to be covered, the service must be part of a trial that meets all of the following criteria in order to be considered a qualifying trial:

a. Evaluates a Medicare Benefit. The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
b. Has a Therapeutic Intent. The trial must have a therapeutic intent (i.e., is not designed exclusively to test toxicity or disease pathophysiology).
c. Enrolls Diagnosed Beneficiaries. Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.
d. Has Desirable Characteristics. The desirable characteristics are listed in the NCD.
e. Deemed Trials. Some trials are considered automatically deemed as having desirable characteristics. They include (Effective September 19, 2000):

• Trials funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), HCFA, Department of Defense (DOD), and Department of Veterans Affairs (VA);
• Trials supported by centers or cooperative groups that are funded by the NIH, DC, AHRQ, HCFA, DOD and VA;
• Trials conducted under an investigational new drug application (IND) reviewed by the Food and Drugs Administration (FDA); and
• Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) are deemed until the qualifying criteria are developed and the certification process is in place. At time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.

Until the Medicare clinical trials registry is established, the sponsors of both IND trials and IND-exempt trials must identify themselves by e-mail to clinicaltrials@hcfa.gov for administration, payment and program integrity purposes.

• Self-Certified Trials - In the future, a multi-agency Federal panel (see NCD for further details) will develop qualifying criteria that will indicate a strong probability that a trial exhibits the desirable characteristics as stated in the NCD. No trials are covered based upon self-certification at this time.

2. Routine Costs. Routine costs of a clinical trial include all items and services that are provided in either the experimental or the control arms of a trial except those listed below as not covered. Services provided to Medicare beneficiaries in both the experimental group and the control group are eligible for coverage provided that all other criteria in this instruction are met.

Routine costs do NOT include (and are therefore are not covered):

• The investigational item or service, itself;
• Items and services:

For which there is no Medicare benefit category; or:

• Which are statutorily excluded; or
• That fall under a national noncoverage policy;
• Items and services furnished solely to satisfy data collection and analysis needs 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);
• Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial; and
• Items and services provided solely to determine trial eligibility.

Routine costs DO include (and are therefore covered):

• Items or services that are typically provided absent a clinical trial (e.g., medically necessary conventional care);
• Items and services required for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent);
• Items and services required for the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
• Items and services that are medically necessary for the diagnosis or treatment of complications arising from the provision of an investigational item or service.

This national coverage policy is based upon the authority found in §1862(a)(1)(E) of the Social Security Act (Act). It is binding on all Medicare carriers, intermediaries, Peer Review Organizations, Health Maintenance Organizations, Competitive Medical Plans, Health Care Prepayment Plans, and Medicare+Choice organizations (§1852 (a)(1)(A) of the Act)."

Effective for dates of service on or after September 19, 2000, when submitting claims for services or items that meet the requirements as outlined in the final National Coverage Decision you must identify these services with the "QV" procedure code modifier. "QV" - "Item or service provided as routine care in an approved clinical trial"

The modifier is line item specific and must be used to identify items and services that constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiary's participation in a Medicare covered clinical trial. Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the clinical management of the patient are not covered and may not be billed using the QV modifier. Items and services that are not covered by Medicare by virtue of a statutory exclusion or lack of a benefit category also may not be billed using the QV modifier. Finally, items and services customarily provided by the research sponsor free of charge for any enrollee in the trial may not be billed.

In addition to the QV modifier, providers must also report diagnosis code V70.5 (Health Examination of Defined Subpopulations) as a secondary diagnosis for patients participating in Medicare covered clinical trials.

The QV modifier and V70.5 diagnosis code will serve as your attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including complications associated with qualifying trial participation.)

Submit separate line items for clinical trial services when billing other covered services not directly related to a Medicare qualifying clinical trial on the same claim.

When submitting claims with the QV procedure code modifier and V70.5 diagnosis code, the billing provider must include in the beneficiary's medical record the following information: trial name, sponsor, and sponsor-assigned protocol number. This information should not be submitted with the claim but must be provided if requested for medical review. A copy of the signed informed consent document must also be made readily available if requested for medical review.

Payment for these qualifying clinical trial services furnished on or after September 19, 2000, will be made based on the payment methodology applicable for the service that was furnished (e.g., physician fee schedule, lab fee schedule, DME fee schedule, reasonable charge). All applicable deductible and coinsurance rules apply to these services with one exception. Managed care enrollees will not be responsible for the Part A and Part B deductibles for covered clinical trial services billed as fee for service.

If you have a claim for a Medicare qualifying clinical trial service that has been denied for a date of service on or after September 19, 2000, the action you take to get the claim paid will depend on whether the service was initially submitted with the QV modifier and ICD-9 code.

Initial Claim Did Not Include the QV Modifier and ICD-9 Code V70.5 --If clinical trial routine care services on a claim are denied and were not identified as clinical trial services (i.e., the clinical trial modifier and ICD-9 code was not included), resubmit the services on a new claim with the QV modifier and ICD-9 code V70.5 for the care or medical complications arising from a Medicare qualifying clinical trial.

Denied Service Included the QV Modifier and ICD-9 Code --If a service Medicare covers is billed with the QV modifier and ICD-9 code and initially denied (e.g., for medical necessity or utilization) contact us at 866.502.9056 if you are a Tennessee provider, 866.502.9051 if you are an Idaho provider, or 866.238.9651 if you are a North Carolina provider, and request an adjustment to the claim. If appropriate, we will adjust and pay the claim."

Payment Of Clinical Trial Services For Managed Care Enrollees -- Until Medicare capitation rates are adjusted to account for clinical trials, payment for clinical trial services furnished to beneficiaries enrolled in Medicare managed care plans will be made on a fee for service basis by the Medicare contractors that process fee for service claims. Providers will need to submit fee for service bills for Medicare covered clinical trial services furnished to managed care enrollees. The payment amounts will be based on the applicable Medicare fee schedules for such services. In addition, the Part A and Part B deductibles are assumed to be met for covered clinical trial services billed as fee for service for managed care enrollees.