Instructions for Both Part A and Part B Providers

July, 2007 (Original Date of Notice)

Revision Date: June 26, 2008

This bulletin should be shared with all health care practitioners and managerial members of the provider/supplier staff. Additional copies may be downloaded from our website at:

www.highmarkmedicareservices.com

Background

Notable dates:

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 associated with participation in clinical trials.”

September 19, 2000: CMS implemented its initial Clinical Trial Policy through the NCD process--NCD for Routine Costs on Clinical Trials (310.1)

July 10, 2006: CMS opened reconsideration of its NCD on clinical trials.

October 9, 2007: CMS implemented version number 2 of the NCD for Routine Costs in Clinical Trials (310.1).

April 7, 2008: CR 5805 implemented to change HCPCS Modifiers used when billing clinical trials and CR 5790 implemented that requires the voluntary submission of an 8-digit clinical trial number on claims.

As a result of the activities noted in the timeline above Medicare will cover the routine costs of qualifying clinical trials and the reasonable and necessary items and services to diagnose and treat complications arising from the participation in ALL clinical trials.

Clinical Trials

Patients may be enrolled in a variety of clinical trials. Medicare only will cover the routine costs of clinical trials when the clinical trial meets the following 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, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.
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.

NCD 310.1 also states that in addition to the above characteristics, clinical trials 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.”

Some clinical trials are considered automatically qualified as having the desirable characteristics. These include:

Trials funded by the NIH, CDC, AHRQ, CMS, DOD, and VA
Trials supported by centers of cooperative groups that are funded by the NIH, CDC, AHQR, DOD and VA.
Trials conducted under an investigational new drug application (IND) reviewed by the Food and Drug Administration (FDA).
Drug trials that are exempt from having an IND under 21 CFR 312.2(b) 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 retroactively to change the deemed status.

At times CMS may make the determination that through an individualized assessment of benefits, risk, and research potential there is significant medical benefit for a specific treatment but there is yet inadequate data to support that it is reasonable and medically necessary. In these instances CMS will provide for participation in a clinical trial through the NCD process.

The NCD 310.1 also stated that a multi-agency federal panel will be established to develop criteria for qualifying clinical trials. This panel has not yet been established, so no trials are covered based on this self-certification process.

Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries and services that are provided in either the experimental or the control arms of a clinical trial.

Routine costs DO include (and therefore are 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 non-covered 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.

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

The investigational item or service, itself unless otherwise covered outside of the clinical trial;
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); and
Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.

Submission of Routine Cost Requirements

Medicare covers routine costs of qualifying clinical trials. In addition reasonable and necessary items that are used to diagnose and treat complications arising from participation in clinical trials are also covered. Payment for these covered services is based on the payment methodology applicable for the service that was furnished. Applicable deductibles and coinsurance rules apply to clinical trial items and services.

If clinical trial and non-clinical trial services are submitted on the same claim, then separate line items must be used for each type of service. If a service requires a Certificate of Medical Necessity (CMN), this must also be submitted. Items and services provided free of charge by research sponsors may not be billed to be paid by Medicare, and providers are not required to submit the charge to Medicare. If it is necessary for a provider to show the items and services that are provided free of charge in order to receive payment for the covered routine costs (e.g. administration of a non-covered

chemotherapeutic agent), providers are instructed to submit such charges as non-covered at the time of entry, while also assuring that the beneficiary is not held liable. This instruction applies to all hospitals including hospitals located in Maryland under the jurisdiction of the Health Services Cost Review Commission (HSCRC).

Services furnished to Medicare beneficiaries who are control group volunteers who are participating in a qualified clinical trials may also be submitted for reimbursement. The claim submission requirements for these claims depend upon the source of the submission--Institutional Providers or Practitioners/Suppliers.

Institutional Providers

Condition code 30
HCPSC modifier used only for institutional outpatient claims
QV--For claims with date of service before January 1, 2008
Q1—For claims with date of service on or after January 1, 2008
Diagnosis code V70.7 (Examination of participant on clinical trial) is reported as the secondary diagnosis
Clinical trial number
- Use of this 8-digit number is voluntary at this time
- Used on claims received after April 1, 2008
- Claim locators that should be used to bill with this 8-digit number
  - CMS-1450—Form Locator 39-42
  - 837 PI-Loop 2300 HI—VALUE INFORMATION (segment qualifier BE), REF02, REF01-P4 (do not use ‘CT’ on the electronic form)

Practitioners/Suppliers

HCPCS modifier
- QV--For claims with date of service before January 1, 2008
- Q1—For claims with date of service on or after January 1, 2008
Diagnosis code V70.7 (Examination of participant on clinical trial) is reported as the primary diagnosis
Clinical trial number
- This 8-digit number is voluntary at this time
- Used on claims received after April 1, 2008
- Claim locators that should be used to bill with this 8-digit number
  - CMS-1500 paper form-place in Filed 19 (preceded by ‘CT’)
  - 837 P—Loop 2300, REF02, REF01-P4 (do not use ‘CT’ on the electronic form)

Medical Records Documentation Requirements

When submitting claims for a beneficiary who was or is participating in a clinical trial the following must be included:

Clinical trial name
Sponsor of the clinical trial
Sponsor-assigned protocol number

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

Appeals for Submitted Claims

Claims denied may be resubmitted if the following scenarios apply:

A. Initial Claim did NOT include the Clinical Trial Diagnosis Code V70.7

Submit an adjusted bill with the clinical trial ICD-9-CM 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.

B. Denied Claim was submitted with the Clinical Diagnosis Code as the Third or subsequent Diagnosis.

Notify Highmark Medicare Services that a billing error was made and that the deemed 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 trail 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 9a)(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 1843(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 trials’ principal investigator may be pursued.

CONTACT INFORMATION

If you have any questions regarding this information, please contact Highmark Medicare Services at 717-302-4102.

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