Instructions for Both Part and Part B Providers

June 30, 2006  (Original Date of Notice)

Revision Date:  December 13, 2006

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.

Definition

A Post-Market Approval (PMA) Study is a clinical study or other investigation, usually conducted under a single protocol and included in the Pre-Market Approval order, to gather specific information to address precise study objectives about an approved medical device.

Post-Approval Extension Studies represent an extension of a post-market approval study.  For Medicare purposes, these studies use the PMA number assigned to the original FDA-approved post-market approval (PMA) study,

Background

On October 12, 2004, the Centers for Medicare and Medicaid Services (CMS) issued Change Request (CR) 3489, Transmittal 314 to provide contractors with instructions for processing claims for carotid artery stenting procedures performed in the Food and Drug Administration (FDA)-approved post-approval studies.  As the post-approval studies began to end, CMS received requests to extend coverage for the post-approval studies.  Extensions of post-approval studies are not subject to approval by the FDA; new Post-Mark Approval (PMA) numbers cannot be issued.

Coverage of Post-Market Approval Devices

CMS has determined that for Medicare purposes, the FDA must review all post approval extension studies.  Upon review of an extension study, the FDA issues an acknowledgement letter stating that the extension study is scientifically valid and will generate clinically relevant post-market data.  Upon receipt of this FDA letter, and review of the extension study protocol, CMS will issue a letter to the study sponsor indicating that the study under review will be covered by Medicare.  These studies will continue to use the PMA number assigned to the original FDA-approved post-approval study.

Review of Application

In order to receive Medicare coverage for patients participating in post-approval extension studies, providers shall follow the process for informing contractors of their participation as established in CR 3489, Transmittal 314.

Both Part A and Part B providers MUST furnish Highmark Medicare Services with the following information prior to submission of a claim for payment:

• A copy of the FDA acknowledgement letter provided by CMS.
• A copy of the CMS letter issued to the study sponsor, indicating that the study will be covered by Medicare.
• All other materials needed for review of FDA-approved post-approval studies.

This information should be sent to:

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

Attention: IDE /PMA Applications

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

Billing & Coding Guidelines

Each FDA-approved post-market approval (PMA) device is assigned an identification code by the FDA, which enables Medicare contractors to establish special claims processing procedures associated with each study.

General Claims Submission

The PMA device code will be seven positions in length, and may or may not include an alphabetic value in the first position.

NOTE:  Providers billing fiscal intermediaries must bill using the most current ICD-9-CM procedure codes.

Post-Market Approval Device Billing

• The revenue code is 0624.
• The PMA device must have a related HCPCS code for pricing purposes. The related PMA device number and HCPCS submitted on a claim will be edited against a Master File. The Master File is furnished by CMS.
• The PMA device number and the ICD-9 CM diagnosis codes should relate.
• The PMA device number should be placed on the 837i electronic claims format in 2300 Investigational Device Exemption Number REF Segment, data element REF02 (REF01=LX).
• Payment for a PMA device provided to a hospital patient is no different than payment for a FDA approved device.  Deductible and coinsurance apply.
• Payment for a PMA device in an inpatient setting is included in the DRG payment.
• Providers may bill other charges on the PMA device claim.

Assistance

If you have any questions regarding this bulletin, please contact Highmark Medicare Services at one of the following numbers:

            Medicare Part A Maryland                         1-866-488-0545
            Medicare Part A Pennsylvania                    1-800-560-6170
            Medicare Part B Pennsylvania                    1-866-488-0548

References

CR 3489, Transmittal 314:

http://www.cms.hhs.gov/transmittals/Downloads/R25NCD.pdf

CR5088, Transmittal 951:

http://www.cms.hhs.gov/transmittals/Downloads/R951CP.pdf