LCD L35490: Category III Codes

The American Medical Association (AMA) develops temporary Current Procedural Terminology (CPT) Category III codes to track the utilization of emerging technologies, services, and procedures. The CATEGORY III CPT Code description does not establish a service or procedure as safe, effective or applicable to the clinical practice of medicine.

Indications and Limitations:

Section 1862(a)(1)(A) of the Social Security Act (SSA) is the statutory basis for denying payment for types of care, items, services, and procedures, not excluded by any other statutory clause while meeting all technical requirements for coverage, that are determined to be any of the following:

• Not generally accepted by the medical community as safe and effective in the setting and for the condition for which it is used;

• Not proven safe and effective based on peer review or scientific literature;

• Experimental;

• Not medically necessary for a particular patient;

• Furnished at a level, duration, or frequency that is not medically appropriate;

• Not furnished in accordance with accepted standards of medical practice; or

• Not furnished in a setting appropriate to the patient’s medical needs and condition.

Items and services must be established as safe and effective to be considered medically necessary. That is, the items and services must be:

• Consistent with the symptoms of diagnosis of illness or injury under treatment; and

• Necessary for, and consistent with, generally accepted professional medical standards of care (e.g., not experimental) and ;

• Not furnished primarily for the convenience of the patient, the provider or supplier; and

• Furnished at the most appropriate level of care that can be provided safely and effectively to the patient.

Medical devices that are not approved for marketing by the Food and Drug Administration (FDA) are considered investigational and are not considered reasonable and necessary under SSA 1862(a)(1)(A). Medicare payment, therefore, may not be made for procedures performed using devices that have not been approved for marketing by the FDA unless performed within the context of a clinical trial qualifying under the National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) or in approved FDA Investigational Device Exemption (IDE) trial.

A/B MACs (B) continue to determine if a service is reasonable and necessary to treat illness or injury. If a service is not reasonable and necessary to treat illness or injury for any reason (including lack of safety and efficacy because it is an experimental procedure, etc.), A/B MACs (B) consider the service noncovered notwithstanding the presence of a payment amount for the service in the Medicare fee schedule.

FDA designation/determination of a device as 510(k) means that the device has been approved for marketing by the FDA because it is similar to something already on the market that was "grandfathered in" by the FDA and therefore these devices are eligible for coverage.

In addition, items, services, or devices may also be not covered under SSA 1862(a)(1)(D), (E), or (O).

0525T-0532T

0525T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; complete system (electrode and implantable monitor)

0526T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; electrode only

0527T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; implantable monitor only