This bulletin has been retired. Please visit our  Clinical Trials webpage for detailed information regarding clinical trials.

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On June 7, 2000, the President of the United States issued an executive memorandum directing the Centers for Medicare & Medicaid Services (CMS) to explicitly authorize [Medicare] payment for routine patient care and costs due to medical complications associated with participation in clinical trials. CMS has developed a National Coverage Determination (NCD), which defines the routine costs of clinical trials and identifies the clinical trials for which payment for such routine costs should be made. This NCD is available at. http://www.cms.hhs.gov/ClinicalTrialPolicies/

Effective for items and services furnished on or after September 19, 2000, Medicare covers: (i) the routine costs of qualifying clinical trials, and (ii) reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.

Qualifying for Medicare Coverage of Clinical Trials

(I) Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements:

• 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, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery).
• The trial must have therapeutic intent; it cannot be designed exclusively to test toxicity or disease pathophysiology.
• The trial 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.

(II) The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials also should have the following desirable characteristics:

• The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes;
• The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use;
• The trial does not unjustifiably duplicate existing studies;
• The trial design is appropriate to answer the research question being asked in the trial;
• The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
• The trial is in compliance with Federal regulations relating to the protection of human subjects; and
• All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

(III) Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because the multi-agency federal panel has deemed that they have the above-listed seven desirable characteristics of clinical trials. Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:

• Trials funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), CMS, Department of Defense (DOD), and the Department of Veterans Affairs (VA);
• Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA;
• Trials conducted under an investigational new drug (IND) application reviewed by the FDA; and
• Drug trials that are exempt from having an IND under 21 CFR 312.2(b) (1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that 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@cms.hhs.gov for administration, payment and program integrity purposes.

(IV) 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.

Routine Costs of Clinical Trials

Routine costs of a clinical trial include: (i) all items and services that are otherwise generally available to Medicare beneficiaries and (ii) services that are provided in either the experimental or the control arm.

Routine costs DO include (and are therefore 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 noncovered 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; and
• Items and services that may be covered according to local coverage determinations.

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

• The investigational item or service, itself;
• Items and services for which there is no benefit category;
• Items and services, which are statutorily excluded;
• Items and services for which there is a national non-coverage decision;
• 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);
• 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.

For non-covered items and services, including items and services for which Medicare payment is statutorily prohibited; Medicare only covers the treatment of complications arising from the delivery of the noncovered item or service and unrelated reasonable and necessary care.

If the item or service is not covered by virtue of a national non-coverage policy in the Coverage Issues Manual and is the focus of a qualifying clinical trial, the routine costs of the clinical trial (as defined above) will be covered by Medicare but the non-covered item or service itself will not be covered.

Billing & Coding Guidelines Medicare Part A (Form 1450)

Effective for claims with dates of service on or after September 19, 2000 that meet the requirements as outlined in the final National Coverage Decision for Medicare qualifying clinical trial services:

General Information:

• Applicable deductibles and coinsurance rules apply to clinical trial items and services.
• In the case of fee for service claims for managed care enrollees, the beneficiary will not be responsible for the Part A deductible; managed care enrollees are liable for the coinsurance amounts applicable to clinical trial services paid under Medicare fee for service rules.
• In the case of bundled payments, (e.g., DRG payments) which include non-covered investigational items and services, Medicare will adjust the amount paid such that the non-covered service would not be included as part of the bundled payment. Hospitals under the Maryland waiver will be reimbursed at 94% of covered charges, less deductible and coinsurance.
• For managed care enrollees, services not defined as routine costs should be billed separately and directly to the Medicare Advantage organization. When an inpatient stay contains both clinical trial services and other services related to co-morbid conditions, do not separate services; send the entire claim to Medicare Part A and do not bill the Medicare Advantage organization.
• Payments for Medicare Advantage enrollees will be made on a fee-for-service basis using original Medicare payment amounts. Indirect medical education (IME) payments will be included in these amounts therefore; Medicare Advantage enrollee providers should not submit IME-only bills.

Billing & Coding:

• Bill on a CMS-1450 or electronic equivalent.
• All institutional provider bill types (inpatient and outpatient) are applicable.
• When utilizing the UB-92 flat file use record type 40 to report bill type. Record type (Field No. 1), sequence number (Field No. 2), patient control number (Field No. 3), and type of bill (Field No. 4) are required.
• When utilizing the Medicare A 837 Health Care Claim version 3051 implementations 3A.01 and 1A.C1, report the applicable bill type in 2-130-CLM01, CLM05-01, and CLM05-03.
• Report condition code 30- Qualifying Clinical Trials
• Code the principal ICD-9-CM diagnosis code that best describes the service(s) rendered.
• Report V70.7 (Examination of participant in clinical trial) as secondary diagnosis code. 
• Attach “QV” modifier to the procedure codes for items and services that are routine costs of clinical trials in the outpatient setting.
• When utilizing the UB-92 flat file use record type 70, Other Diagnoses Code (Field No. 6-12) to report the ICD-9 code.
• When utilizing the hard copy UB-92 (Form CMS-1450) report the applicable bill type in Form Locator (FL) 4 "Type of Bill."
• When utilizing the hard copy UB-92 report the ICD-9 code in Form Locators (FLs) 69-75 (Other Diagnoses Codes).
• When utilizing the Medicare A 837 Health Care Claim version 3051 implementations 3A.01 and 1A.C1, report the ICD-9 in 2-225.A-HI04-02 through HI10-02.
• When utilizing the Health Care Claim: Institutional 837 version 4010, report the ICD-9 in OTHER DIAGNOSIS INFORMATION HI02.

Billing for the National Cancer Institute (NCI) sponsored clinical trials for Colorectal cancer:

• The off-label use of Oxaliplatin, Irinotecan, Cetuximab, and Bevacizumab are covered in these trials
• Use revenue code 0250 for inpatient claims and revenue code 636 for outpatient claims
• Include the QR modifier when billing outpatient services under revenue code 636
• When using the QR modifier, include HCPCS code of J9035, J9055, J9026, J9263, J8520, J8521, J9190, or J9201, as appropriate for the drug being billed
• Include the QR modifier when billing for non-routine costs associated with these clinical trials.

Medical Records Documentation Requirements:

When submitting claims with the V70.7 diagnosis code and medical records are requested, the following information should also be included:

1. The clinical trial name
2. Sponsor assigned protocol number
3. Signed informed consent document
4. If this is a trial conducted under Investigational New Drug (IND) application, provide the IND number.
5. A copy of the clinical trial protocols, if not already on file to the Highmark Medicare Services Medical Review Department.
6. Physician orders and the patient’s diagnosis
7. Diagnostic testing reports and operating reports for surgical procedures
8. Physician progress notes, consultations and/or plan of treatment(s)
9. Detailed listing of all medications administered, including dosage and route of administration
10. Itemized bill

This information should not be submitted with the claim but must be provided if requested for medical review.

Appeals for Submitted Claims

Claims denied for a date of service on or after September 19, 2000 may be resubmitted if the following scenarios apply:

Initial Claim Did Not Include the Clinical Trial Diagnosis Code V70.7

Submit an adjustment bill with the clinical trial ICD-9 V70.7 diagnosis code. If the claim or any line item on the claim is denied, notify Highmark Medicare Services that a billing error was made and that the denied service(s) on the claim was related to a Medicare covered clinical trial. If all other Medicare rules are satisfied, payment will be made.

Denied Claim Was Submitted With the Clinical Trial Diagnosis Code as the Third or Subsequent Diagnosis

Notify Highmark Medicare Services that a billing error was made and that the denied service(s) on the claim was related to a Medicare covered clinical trial service. If all other Medicare rules are satisfied, payment will be made.

Notice

If a trial's principal investigator misrepresented that the trial met the necessary qualifying criteria in order to gain Medicare coverage of routine costs, Medicare coverage of the routine costs would be denied under §1862(a)(1)(E) of the Act. In the case of such a denial, the Medicare beneficiaries enrolled in the trial would not be held liable (i.e., would be held harmless from collection) for the costs consistent with the provisions of §§1879, 1842(l), or 1834(j) (4) of the Act, as applicable. Where appropriate, the billing providers would be held liable for the costs and fraud investigations of the billing providers and the trial's principal investigator may be pursued.