Local Coverage Determination (LCD): Noncovered Services (L33777)
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Contractor Information
CONTRACTOR NAME CONTRACT TYPE CONTRACT NUMBER JURISDICTION STATE(S)
First Coast Service Options, Inc. A and B MAC 09101 - MAC A J - N Florida
First Coast Service Options, Inc. A and B MAC 09102 - MAC B J - N Florida
First Coast Service Options, Inc. A and B MAC 09201 - MAC A J - N Puerto Rico Virgin Islands
First Coast Service Options, Inc. A and B MAC 09202 - MAC B J - N Puerto Rico
First Coast Service Options, Inc. A and B MAC 09302 - MAC B J - N Virgin Islands
LCD Information
Document Information
LCD ID Original Effective Date L33777 For services performed on or after 10/01/2015
LCD Title Revision Effective Date Noncovered Services For services performed on or after 01/01/2019
Proposed LCD in Comment Period Revision Ending Date N/A N/A
Source Proposed LCD Retirement Date DL33777 N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Notice Period Start Date Statement N/A CPT codes, descriptions and other data only are copyright 2018 American Medical Association. All Rights Notice Period End Date Reserved. Applicable FARS/HHSARS apply. N/A
Current Dental Terminology © 2018 American Dental Association. All rights reserved.
Copyright © 2018, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained
Created on 01/24/2019. Page 1 of 48 within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816 or Laryssa Marshall at (312) 893-6814. You may also contact us at [email protected].
CMS National Coverage Policy
References from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are listed throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.560[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 coverage guidelines from one or more of the following CMS sources:
CMS Manual System, Pub. 100-01, Medicare General Information, Eligibility, and Entitlement Manual CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Transmittal 61, CR 5294, dated November 24, 2006 CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Transmittal 67, CR 5530, dated April 6, 2007 CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Transmittal 93, CR 6185, dated August 29, 2008 CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Transmittal 95, CR 6185, dated September 10, 2008 CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Transmittal 117, CR 6775, dated March 9, 2010 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Transmittal 1258, CR 5614, dated May 29, 2007 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Transmittal 1482, CR 5980, dated March 21, 2008 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Transmittal 1528, CR 6087, dated May 30, 2008
Created on 01/24/2019. Page 2 of 48 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Transmittal 1930, CR 6775, dated March 9, 2010 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50 (Advance Beneficiary Notice of Noncoverage [ABN]) CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13 Change Request 5432, transmittals 64 and 1147, dated January 5, 2007 Change Request 6185, transmittals 95 and 1592, dated September 10, 2008 Change Request 6291, transmittals 1646 and 97, dated December 9, 2008 Change Request 6351, transmittal 1661, dated 01/02/2009 Change Request 6484, transmittal 1748, dated May 29, 2009 Change Request 6492, transmittal 1745, dated May 22, 2009 Change Request 7117, transmittal 2061, dated October 1, 2010 Change Request 7147, transmittal 2045, dated September 10, 2010 Change Request 7443, transmittal 2234, dated May 27, 2011 Change Request 7545, transmittal 2296, dated September 2, 2011 Change Request 7547, transmittal 2305, dated September 15, 2011 Change Request 7610, transmittal 141, dated January 26, 2012 Change Request 8228, transmittal 2664, March 1, 2013 Change Request 8237, transmittal 2662, March 1, 2013 Change Request 8249, transmittal 2693, dated May 2, 2013 Change Request 8317, transmittal 2704, May 17, 2013 Change Request 8338, transmittal 2718, June 7, 2013 Change Request 10236, transmittal 3864, September 15, 2017 Change Request 10117, transmittal 3815, July 28, 2017
Coverage Guidance
Coverage Indications, Limitations, and/or Medical Necessity
A given service or procedure may not be linked to a National Coverage Determination (NCD) or Local Coverage Determination (LCD). Assuming all other requirements of the program are met and absent specific coverage criteria outlined in an LCD or NCD, all procedures or services must meet the medically reasonable and necessary threshold for coverage as demonstrated by the performing provider or attending physician in the official medical record. The Noncovered Services LCD compiles services or procedures that have been addressed by the Medical Policy department as to the medically reasonable and necessary threshold for coverage. Certain services or procedures will not have specific level I or level II HCPCS coding. Such services or procedures would be coded as the appropriate unclassified code. Occasionally services or procedures will be identified by a specific level I (Category I or Category III CPT code) or level II HCPCS code. It is the expectation that physicians and allied providers code to specificity. Payment of a claim is not a coverage statement especially if payable codes were used to bypass the medical review of more specific Level I/Category I unlisted codes or Level I/Category III codes or level II HCPCS codes.
In determining if a service or procedure reaches the threshold for coverage, this contractor addresses the quality of the evidence per the program integrity manual in making its recommendation to non-cover a service, pending new information in the public domain. This recommendation is taken through the LCD development process (draft recommendation of noncoverage, 45-day comment period, CAC advisory meeting, open public meeting, finalization, and 45-day notice period). Any interested stakeholder can request a reconsideration of an LCD after the notice period. In the case of the Noncovered Services LCD the stakeholder will receive a list of the articles and related information in the public domain that were addressed by the Medical Policy department in making the noncoverage decision. If the stakeholder has new information based on the evaluation of the list, an LCD reconsideration can be initiated. It is the responsibility of the interested stakeholder to request the evidentiary list from the contractor and to submit the additional articles, data, and related information in support of their request for coverage. The request
Created on 01/24/2019. Page 3 of 48 must meet the LCD reconsideration requirements outlined on the web site.
It is not unusual that there will be a paucity of information for an emerging technology or service, and the Medial Policy department may noncover a service as noted in this LCD awaiting information in the public domain on safety and efficacy based on the quality of evidence. Also this contractor may be silent in terms of LCD in regard to a service or procedure (such a procedure or service is not listed in the Noncovered Services LCD or has been removed from the Noncovered Services LCD). A service or procedure not addressed in the Noncovered Services LCD is not a positive coverage statement. Claims for such services assuming all other requirements of the program are met would always need to meet the medically reasonable and necessary threshold for coverage in a prepayment or post payment audit of the official medical record.
To summarize, emerging technologies that are billed as either an unlisted procedure code or, when applicable, a Category III CPT or HCPCS code the procedures are addressed as:
• Not medically necessary and no coverage per this LCD; or • Medically necessary per certain criteria as indicated in the development and communication of a separate LCD; or • Have no positive coverage statement (in other words, no active LCD) and in which case these services as reported by the applicable unlisted procedure code or Category III CPT/HCPCs code would have to meet the regulatory requirements as documented in the medical record. Such services could be audited on pre-payment or post-payment review.
Section 1862(a)(1)(A) of the Social Security Act precludes program payment for services not deemed to be medically reasonable and necessary. This section of the Act underpins all Medicare regulations. Any document issued by the Centers for Medicare & Medicaid Services (CMS) or any of its contractors, which contains statements regarding criteria for coverage and payment of any service (e.g., office visits, procedures, diagnostic tests, etc.) has as an underlying assumption that the service must comply with the requirements of §1862(a)(1)(A). As a consequence, it is incumbent upon such providers to be sure the service they provide is medically necessary, even in the instance where the documentation that proves medical necessity is created and/or housed by an entity other than the performing provider.
In order to be covered and reimbursed, an item or service must meet several requirements. It must fall within a defined benefit category, it cannot be excluded from coverage, either by statute or policy, and it must be medically reasonable and necessary. In the absence of a NCD, discretion may be used to establish medical policy, currently known as LCDs. The purpose of this LCD is to create a working list of services and procedures that have been evaluated by the Medical Policy staff, and determined that the services listed below do not meet the reasonable and necessary criteria as defined in Section 1862 (a)(1)(A) of the Social Security Act. LCDs are based on the strongest evidence available. In order of preference, LCDs are based on:
Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:
• Scientific data or research studies published in peer-reviewed medical journals; • Consensus of expert medical opinion (i.e., recognized authorities in the field); or • Medical opinion derived from consultations with medical associations or other health care experts.
Acceptance by individual health care providers, or even a limited group of health care providers, does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general
Created on 01/24/2019. Page 4 of 48 acceptance by the medical community. The available published evidence must be considered and its quality shall be evaluated before a conclusion is reached.
A service or item is considered to be reasonable and necessary if it is:
• Safe and effective; • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: