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

Countdown has begun; do you have your NPI? Don’t risk disruption to your cash flow – Get your NPI now! National Provider Identifiers (NPIs) will be required on claims sent on or after May 23, 2007. Every healthcare provider needs to get an NPI! Learn more about NPI and how to apply by visiting www.cms.hhs.gov/NationalProvIdentStand/ on the CMS website.

This page also contains a section for Medicare Fee-For-Service (FFS) providers with helpful information on the Medicare NPI implementation.  A Countdown Clock is now available on this page to remind health care providers of the number of days left before the compliance date; bookmark this page as new information and resources will continue to be posted.

For more information on private industry NPI outreach, visit the Workgroup for Electronic Data Interchange (WEDI) NPI Outreach Initiative website at http://www.wedi.org/npioi/index.shtml on the web.

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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 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.
• 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.

Medicare Part A

Review of Application

The hospital/institution MUST furnish their fiscal intermediary with the following information prior to submission of a claim for payment:

• A copy of the FDA approval letter provided to the sponsor or manufacturer of the HDE
• The FDA HDE number
• The name of the device (both trade, common or usual, and classification name)
• The indications for use of the device;
• Action taken to conform to any applicable FDA special controls
• A narrative description of the device sufficient to make a payment determination
• A statement indicating how the device is similar to and/or different from other comparable products
• The provider’s protocol for obtaining informed consent from patients receiving the device

This information should be sent to:

Highmark Medicare Services
Mandy Garber, MD, MPH, MSc
Attention: IDE/HDE Applications
Fifth Avenue Place
120 Fifth Avenue, Suite P5101
Pittsburgh, PA 15222

Please allow four (4) weeks for review and processing of the HDE application.  Incomplete applications will not be reviewed until the missing information has been received by Highmark Medicare Services.

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.
• The HDE number should be placed on the 837i electronic claims format in 2300 Investigational Device Exemption Number REF Segment, data element REF02 (REF01=LX).
• The revenue code is 0624
• ICD-9 code V70.7 should be listed as a secondary diagnosis code.
• Condition code 30
• Providers may bill other charges on the HDE claim.

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.

Highmark Medicare Services
Mandy Garber, MD, MPH, MSc
Attention: IDE/HDE Applications
Fifth Avenue Place
120 Fifth Avenue · Suite P5101
Pittsburgh, PA 15222

Assistance

If you have any questions regarding this bulletin, please contact the appropriate Customer Contact Center at:

Maryland Providers: 1-866-488-0545
Pennsylvania Providers: 1-800-560-6170

References

• http://www.fda.gov/cdrh/ode/guidance/1381.html

• http://www.fda.gov/cdrh/pmapage.html

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm

• http://www.kansasmedicare.com/news_flash/2003/Bnews_covHumanDevices.pdf

• http://www.cms.hhs.gov/mcd/viewarticle.asp?article_id=7636&article_version=2&show=al