Highmark Medicare Advantage Medical Policy in West Virginia
Section: CMS National Guidelines
Number: N-30
Topic: Investigational Device Exemption (IDE) Clinical Trials (See Reference Section)
Effective Date: July 21, 2008
Issued Date: July 21, 2008

General Policy

Investigational Device Exemption (IDE)
The FDA assigns a special identifier number that corresponds to each device granted an investigational device exemption (IDE). Under the Food, Drug, and Cosmetic Act, devices are categorized into three classes. Class I devices are the least regulated. These are devices that the FDA has determined need to be subject only to general controls, such as good manufacturing practice regulations. Class II devices are those which, in addition to general controls, require special controls such as performance standards or post-market surveillance, to assure safety and effectiveness. Class III devices are those which cannot be classified into class I or class II because insufficient information exists to determine that either special or general controls would provide reasonable assurance of safety and effectiveness. Class III devices require pre-market approval.

NOTE:
In many situations, the cost of covering certain benefits related to clinical trials is not included in payment rates a Medicare Advantage organization receives from Centers for Medicare and Medicaid Services (CMS). In these instances, the provider of service is responsible for directly billing the appropriate Medicare intermediary or carrier. In order to determine coverage for routine costs or other services, or to obtain additional guidance concerning participation in a specific clinical trial, please refer to the Medicare Advantage Medical Policy governing the procedure or service. For additional information on clinical trials, please see www.hhs.gov/clinicaltrialpolicies.

For purposes of assisting CMS in determining Medicare coverage, the FDA will place all approved IDEs in one of two categories.

  1. Category A Devices (experimental/investigational);
  2. Category B Devices (non-experimental/investigational).

IDE Category A Device (experimental/investigational)
An IDE Category A device is an innovative medical device believed to be in Class III for which “absolute risk” of the device type has not been established (i.e., initial questions of safety and effectiveness have not been resolved and the FDA is unsure whether the device type can be safe and effective.)

IDE Category B Device (non-experimental/investigational)
An IDE Category B device is a non-experimental/investigational device believed to be in Class I or II or devices believed to be in Class III where the incremental risk is the primary risk in question (i.e., underlying questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA approval or clearance for that device type.

Indications and Limitations of Coverage

Category A devices are not covered because they do not satisfy the statutory requirement that Medicare pay for devices determined to be reasonable and necessary.

Category B devices may be covered if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met.

IDE Category A Devices

Section 731(b) of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 authorizes Medicare to cover the routine costs of clinical trials involving IDE Category A devices effective for routine costs incurred on or after January 1, 2005. This extension of coverage refers to the routine services performed for such clinical trials. The Category A device itself remains non-covered.

For a trial to qualify for payment of routine costs, it must meet certain criteria established by the Secretary of the Department of Health and Human Services to ensure that the trial conforms to appropriate scientific and ethical standards.

In addition, the MMA established additional criteria for trials initiated before January 1, 2010, to ensure that the devices involved in these trials be intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. As guidance in evaluating the immediately life-threatening requirement, the following definition should be used:  “a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.”

Prior to the MMA, the Centers for Medicare & Medicaid Services (CMS) limited coverage of clinical trials to:

IDE Category B Devices

Effective November 1, 1995, Medicare coverage was expanded to include certain devices with an FDA-approved IDE Category B status for Medicare members participating in FDA-approved clinical trials. CMS may cover Category B devices if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met.

Payment for a Category B IDE device may not exceed the amount that would have been paid for a comparable approved device. 

Coverage of Category B IDE devices is predicated, in part, upon their status with the FDA. In the event a sponsor (e.g., manufacturer) loses its Category B status or violates relevant IDE requirements necessitating FDA's withdrawal of the IDE approval, all payment for the device should cease. Billing for an IDE means that the provider attests that the study was approved at the time the service was rendered.

NOTE:
See Medicare Advantage Medical Policy Bulletin N-27 for information on routine costs in a clinical trial.

Reasons for Noncoverage

The IDE Category A device itself remains non-covered. CMS does not cover Category A devices under Medicare because they do not satisfy the statutory requirement that Medicare pay for devices determined to be reasonable and necessary. A network provider can bill the member for the denied device. The extension of coverage effective on and after January 1, 2005, only pertains to the routine costs in a clinical trial that involves an IDE Category A device, and only when such device is used in the trial for the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition.

Documentation Requirements

Providers participating in the clinical trial are responsible for furnishing all necessary information concerning the device, the clinical trial, and the participating Medicare Advantage members deemed necessary for a coverage determination and claims processing.

The IDE number of the Category A or Category B device must be reported on the claim.

Procedure Codes

Coding Guidelines

Modifier Q0 (FDA investigational device exemption) – Providers must bill the Category B IDE on a line with a Q0 modifier.

Modifier Q1 (item or service provided as routine care in a Medicare qualifying clinical trial) – Providers must bill the Category A IDE on a line with a Q1 modifier.

Publications

References

Federal Register, Vol. 60, No. 181, Tuesday, September 19, 1995, 42 CFR Parts 405 and 411

Medicare Benefit Policy Manual, Chapter 14, Medical Devices

Federal Register, Vol. 68, No. 187, Friday, September 26, 2003

CMS Manual System, Pub. 100-20 One-Time Notification, Transmittal 131, Change Request 3548

Medicare Claims Processing Manual Chapter 32, Section 68

www.cms.gov
www.medicare.gov

Attachments

Procedure Code Attachments

Diagnosis Codes

Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Medicare Advantage plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Medicare Advantage retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Medicare Advantage. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.