Definition

As defined in the Federal Food, Drug, and Cosmetic Act, a Humanitarian Use Device (HUD) is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year.

Background

On June 26, 1996, the FDA issued a final rule to carry out provisions of the Safe Medical Devices Act of 1990 regarding humanitarian use devices (HUDs). This regulation provides for the submission of an humanitarian device exemption (HDE) application, which is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.

An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for the FDA to determine the following:

The device does not pose an unreasonable or significant risk of illness or injury;
The probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment; and
No comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

An approved HDE authorizes marketing of the HUD. However, an HUD may only be used after IRB approval has been obtained for the use of the device for the FDA approved indication. A HUD may only be used in facilities that have an Institutional Review Board (IRB) and after the IRB has approved the use of the device to treat or diagnose the specific disease.

Coverage of HDEs

The Centers for Medicare and Medicaid Services (CMS) and the FDA have established a mechanism for classifying devices undergoing clinical trials that make it possible for certain devices to be eligible for Medicare coverage. Medicare covers HDEs if they are considered reasonable and necessary, and if all other applicable Medicare coverage requirements are fulfilled.

Physician Requirements

IMPORTANT! Physicians may not bill Medicare for these services prior to receiving Medicare Part A approval. Please submit approval requests to:

Office of the Contractor Medical Director
Highmark Medicare Services
1800 Center Street, 1A306
Camp Hill, PA 17089-0089
Attention: HDE Applications

Please allow 45 calendar days from date of receipt for review and processing of the HDE application.

Billing & Coding Guidelines

Each FDA-approved HUD is assigned an identification code by the FDA, which enables Medicare contractors to establish special claims processing procedures.

The HDE code will be seven positions in length, and may or may not include an alphabetic value in the first position.
Physicians who bill electronically must place the HDE number on the 2300 Investigational Device Exemption Number REF Segment, data element REF02 (REF01=LX) of the 837p.
List the CPT code(s) that appropriately describes the service(s) performed; when a NOC code is used, then a description of the services and the device must be entered on line 19.
ICD-9 code V70.7 should be listed as a secondary diagnosis code.

FDA Withdrawal of HDE approval

If the FDA makes the determination that more than 4,000 individuals in the U.S. are affected or manifest a certain disease or condition per year, the agency would need to decide if the HDE should be withdrawn. In making this decision, FDA would consider factors such as the number of patients with the disease/condition, the feasibility of conducting a pivotal clinical trial to demonstrate safety and effectiveness, and the public health need for the device.

If the HDE is withdrawn, the provider must notify Highmark Medicare Services within 30 days, at the address provided below so that all coverage and payment ceases as of the date of the violation, and/or FDA action. Billing for an HDE means that the provider attests that the device was approved at the time the service(s) was rendered. The CMS master file will be updated to reflect withdrawals of FDA HDE approvals.

Office of the Contractor Medical Director
Highmark Medicare Services
1800 Center Street, 1A306
Camp Hill, PA 17089-0089
Attention: HDE Applications

Assistance

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

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