Medicare Part B Carrier - Idaho

CPT codes, descriptions and other data only are copyright 2008 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association.© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

• Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
• Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental.
• Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

• CMS Publication 100-2, Medicare Benefit Policy Manual, Chapter 14, Section 10 refers to the coverage of medical devices and the Food and Drug Administration (FDA) definition of a medical device.
• CMS Publication 100-4, Medicare Claims Processing Manual, Chapter 23, Section 30A refers to physician services paid under the Medicare Physicians Fee Schedule and notes that the presence of a payment amount in the MPFS and the Medicare physician fee schedule database (MPFSDB) does not imply that CMS has determined that the service may be covered by Medicare.
• CMS Publication 100-8, Medicare Program Integrity Manual, Chapter 13, Sections 5.1 defines reasonable and necessary provisions in LCDs, and 7.1 refers to evidence supporting LCDs.

1. Abstract:

   The American Medical Association (AMA) develops Current Procedural Terminology (CPT) Category III codes to allow for data collection concerning the use of "emerging technology, services, and procedures." ¹ The creation of a CPT Category III code by the AMA "neither implies nor endorses clinical efficacy, safety or the applicability to clinical practice." ²

   Because of the specific purpose these Category III codes serve, CIGNA Government Services will consider the item, service, or procedure represented by these codes to be not medically necessary, unless we have published an LCD or coverage article specifically extending coverage to a particular Category III code.

   ¹ Current Procedural Terminology (CPT®), Professional Edition, American Medical Association (2006), p. 429
   ² Ibid, p. 429

2. 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 the illness or injury under treatment;
   • Necessary for, and consistent with, generally accepted professional medical standards of care (e.g., not experimental);
   • Not furnished primarily for the convenience of the patient or of 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 or for those not included in an approved FDA Investigational Device Exemption (IDE) trial.

   * In addition, items, services, or devices may also be not covered under 1862 (a)(1)(D) or (E) or 42CFR15(O).

3. Other Comments:

   Limitation of liability and refund requirements apply when denials are based on medical necessity. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be considered medically necessary by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes. In these instances it is recommended, although not required, that the provider notify the beneficiary in writing with a Notice of Exclusion of Medicare Benefits (NEMB).

   Notice to beneficiaries related to discharge and coverage notification as described in CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 2, Sections 80-80.2, applies.

Not applicable

1. Current Procedural Terminology (CPT®), American Medical Association (2006)

Carrier Advisory Committee Meeting Date(s): 06/12/2008

This coverage determination does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this determination was developed in consultation with representatives from Advisory Committee members and/or from various state and local provider organizations.