Instructions for Both Part A and Part B Providers

July 03, 2006 (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 of this bulletin may be downloaded from our website.

Background

November 1, 1995:  Medicare coverage was expanded to allow coverage for certain medical devices that are being studied as part of a Food and Drug Administration (FDA) approved clinical trial but have not yet been approved for marketing.  Under this policy, the Centers of Medicare and Medicaid Services (CMS) and the FDA have established a more precise mechanism for classifying devices that may be undergoing clinical trials and determining if these devices are eligible for Medicare coverage.  These documents are available at the U.S. Food and Drug Administration web site. 

Investigational Device Exemptions—Classes and Categories

The U.S. Food and Drug Administration recognizes three regulatory classes of medical devices—Class I, Class II, and Class III.

• Class I devices are things that have minimal potential for harm and subject only to general controls. 
• Class II devices are subject to general controls and special controls because general controls by themselves are not sufficient to assure safety and effectiveness.
• Class III devices are those for which insufficient information exists to establish the safety and effectiveness of the device through the general and specific control process.  Theses devices are those that sustain or support life, are implanted into patients, or present a risk of illness or injury. 

CMS has subdivided IDEs into two groups—Category A and Category B. 

• Category A devices are considered experimental and are NOT covered by Medicare under the IDE request process.  They are novel and represent first-of-their-kind technologies.  Their safety and effectiveness has NOT been established by the FDA; they are Class III devices. 

Medicare covers ONLY the routine costs of clinical trials that involve a Category A IDE devices that are incurred on or after January 1, 2005; the cost of the device itself still remains non-covered.   In addition the Medicare Prescription Drug, Improvement, and Modernization ACT (MMA) §731 (b) established criteria for trials initiated before January 1, 2010 to ensure that those devices involved in the clinical trials are intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition.  A life-threatening disease or condition is defined as, “A state 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.” 

If the associated services in a clinical trial in which a Category IDE A is used meet the requirements for a qualified clinical trial, then the associated services of that trial may be covered.

• Category B devices are newer generations of proven devices (Class I, Class II or Class III) for which the questions of safety and effectiveness have been proven.  The device can only be considered for use if it is part of a FDA and Institutional Review Board (IRB) approved study.  Medicare covers Category B devices under the IDE request process if they are considered reasonable and necessary AND if all other applicable Medicare coverage requirements are met.  A request for approval of a Category B must be submitted to the contractor for review and determination of coverage eligibility (see requirements for that submission below).  After the review by the contractor, it may be found that the Category B IDE does not meet all of the requirements and therefore will not be covered.

Submission Information Required

Category A IDE Device

The use of this device can only be considered if it is part of a qualified Clinical Trial and meets all of the requirements of a qualified clinical trial.  Providers are required to notify their contractor that a Category A IDE device is a part of the qualified clinical trial before routine costs of that clinical trial can be billed.  After the contractor receives information about the clinical trial, the contractor will then determine if the Category A IDE that is used in the trial is used to diagnose, monitor, or treat any immediately life-threatening disease or condition.  If the contractor determines that the device does meet these requirements then the provider may begin billing the routine costs of the clinical trial. 

Category B IDE

The provider who is participating in the study of the IDE Category B device must submit the following information about the device, the study, the participating Medicare beneficiaries and the site where the study will be conducted prior to its use:

• A copy of the most recent FDA-approved letter sent to the sponsor or manufacturer of the device.  The IDE number must be included in the letter.
• Verification of Institutional Review Board approval
• Name of the device (both trade, common or usual, and classification name)
• Any action taken to conform to any applicable IDE special controls
• A narrative description of the device that tells how the device is similar or different form other comparable devices
• Indication if the device will be billed in an outpatient or inpatient setting
• A brief summary of the study design or a copy of the actual study protocol
• The provider’s protocol for obtaining informed consents from the beneficiaries that are participating in the trial.
• The provider’s NPI number.

All of the above information should be submitted to:

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

Review of the IDE Category B Application

After the contractor receives the submission, the request will be reviewed.   When reviewing this request the contractor is bound by the statute, regulation, and CMS issuances (including national coverage decisions) that apply for all FDA-approved devices.  In addition to these absolute requirements the Medicare contractor will also consider the following in their decision:

• the use of the devise in the context of the FDA and IRB approved clinical trial,
• the approved patient protocols for the trial,
• the medical necessity of the device for a specific patient,
• the medical appropriateness of the amount, duration, and frequency of use or application of the service, and
• if the device is furnished in a setting that meets the patient’s medical needs and condition.

It should be noted that if a device or item is statutorily excluded from Medicare coverage through regulation of CMS instruction, the device is not eligible for consideration of coverage. 

Billing and Coding Requirements

Category A IDE

Providers can submit claims for the routine costs of a clinical trial that utilized a Category A IDE by utilizing following the Clinical Trial billing instructions as found [hyperlink to clinical Trial document].

While the Category A IDE device itself is not billable or reimbursable, providers must identify that a Category A IDE was used.  The requirements for claim submission depend upon who is submitting the claim—Institution or Practitioner/Supplier.

Institutional

• Category A IDE number on a 0624 Revenue code line
• Charges for the device must be place in the “Non-covered” charges filed
• Q0 modifier is used
• The IDE number itself is placed on Form CMS-1450
  • Field locator is 43
  • Segment 2300, REF02 (REF01=LX)

 Practitioner/Supplier

• Category A IDE number
• Q modifier
  • QV—effective for dates of service on or before December 31, 2007
  • Q0—effective for dates of service on or after January 1, 2008
• The IDE number itself is placed Form CMS-1500
  • Item is 23
  • Segment 2300, REF02 (REF01=LX)

 Category B IDE

Providers may submit claims for a Category B device once they have received approval from the Contractor that the Category B device meets all of the requirements.  When billing for Category B IDEs, providers shall bill for the device and all related procedures.  The Category B IDE and the routine costs associated with its use are eligible for payment under Medicare.  (Reimbursement for the device may not exceed the Medicare-approved amount for a comparable device that has been already FDA-approved.)

Claim submission requirements for this device depend upon who is submitting the claim—Institution or Practitioner/Supplier. 

Institutional

• Category B IDE number on 0624 revenue code line
• If the institution purchases the device, then the charges are in the covered charges field
• If the institution receives the device free of charge, the IDE charges are billed as non-covered.

• The IDE number itself is placed on Form CMS-1450
  • Field locator is 43
  • Segment 2300, REF02 (REF01=LX)

 Practitioner/Supplier

• Category B IDE number
• Q modifier
  • QA—effective for dates of service on or before December 31, 200
  • Q0—effective for dates of service on or after January 1, 2008
• The IDE number itself is placed Form CMS-1500
  • Item is 23
  • Segment 2300, REF02 (REF01=LX)

FDA Withdrawal of IDE Approval

Potential Medicare coverage of Category B IDE devices is predicated, in part, upon their status with the FDA.  In the event a sponsor loses its Category B status, or violates relevant IDE requirements necessitating FDA’s withdrawal of IDE approval, all payment for the device will cease.

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 IDE 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 IDE approvals.

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

Appeals Process for IDE Categorization Decisions

The FDA issues an IDE number that corresponds to each device granted an Investigational Device Exemption.  Through an interagency agreement, CMS and the FDA have developed a process to categorize all FDA-approved IDEs for Medicare coverage and payment purposes.  This categorization process differentiates between novel, first-of-a-kind devices for which absolute risk of the device type has not been established (Category A), and those devices which are of a device type for which the underlying questions of safety and effectiveness have been resolved (Category B).

A sponsor (manufacturer) who does not agree with the FDA decision that categorizes its device as Category A may submit a written request asking the FDA to re-evaluate its categorization decision.  The sponsor may send a written request to the FDA at any time asking for re-evaluation of its original categorization decision.  Additional evidence and information should be submitted to support a re-categorization.  The FDA will notify both CMS and the sponsor of its re-evaluation decision.

If the FDA does not reverse its original decision on the categorization of the device, the sponsor may seek a review by CMS Central Office.  The sponsor must forward its request in writing, including all materials submitted with their re-evaluation request to the FDA.  CMS’s evaluation of a sponsor’s request for re-categorization will only include the information submitted to the FDA.  Information not submitted to the FDA for its consideration will not be reviewed by CMS.

Review requests must be addressed to:

Centers for Medicare & Medicaid Services
IDE Categorization Review Committee
Office of Clinical Standards and Quality Coverage and Analysis Group
7500 Security Boulevard
Room S3-25-25
Baltimore, MD 21244-1850

CMS will review this information to determine whether to change the categorization of the device.  CMS will issue a written decision notifying the sponsor and the FDA of its decision.  To the extent that CMS relies on confidential commercial or trade secret information in its review, the Agency will maintain confidentiality of the information in accordance with Federal law.  No reviews of a categorization decision, other than those described above are available to a sponsor.

Assistance

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