TO: Administrative File
FROM: Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Joseph Chin, MD, MS
Acting Deputy Director, Coverage and Analysis Group
JoAnna Baldwin, MS
Senior Technical Advisor, Coverage and Analysis Group
SUBJECT: Final Decision Memorandum for the Expedited Removal of National Coverage Determinations (NCDs)
DATE: December 18, 2014
I. Decision
Effective 12/18/14 the Centers for Medicare & Medicaid Services removes the following NCDs from the NCD Manual (100-03):
- 50.6 - Tinnitus masking
- 160.4 - Stereotactic Cingulotomy as a Means of Psychosurgery
- 160.6 - Carotid Sinus Nerve Stimulator
- 160.9 - Electroencephalographic (EEG) Monitoring During Open-Heart Surgery
- 190.4 - Electron Microscope
- 220.7 - Xenon Scan
- 220.8 - Nuclear Radiology Procedure
CMS retains the following NCDs:
- 20.17 - Noninvasive Tests of Carotid Function
- 140.5 - Laser Procedures
- 160.17 - L-DOPA
II. Background
In an August 7, 2013 Federal Register notice (78 FR 48164), we established an expedited process for removing NCDs under certain circumstances. The notice is also available on our website at http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf. The process involves periodic review of NCDs
that have not been reviewed in 10 years in order to evaluate the continued need for those policies to remain active on a national scale. The NCDs selected for potential removal are posted to the CMS website for a 30-day public comment period. The final decision to keep or remove an NCD will be published in a decision memorandum. Removal of an NCD does not necessarily result in noncoverage. Rather, removal results in the local Medicare Administrative Contractor’s (MAC) ability to determine coverage of the specific items or services under section 1862(a)(1) of the Social Security Act (the Act). MACs determine coverage of items and services for beneficiaries in their respective geographic areas. We believe that local contractors are best positioned to use their discretion in these cases to better serve the needs of the Medicare program and its beneficiaries because we believe the future utilization for items and services will be limited.
CMS established this process because clinical science and technology evolve; therefore, that which was once state-of-the art may be replaced by more beneficial practices, technologies, or clinical paradigms. This expedited process serves to remove previously issued NCDs that no longer contain clinically pertinent and current information or that involve items or services that are used infrequently by beneficiaries. In some circumstances, removing an NCD may have the effect of striking national non-coverage, thus, permitting access to technologies beneficial for limited uses.
On November 27, 2013, CMS published the first list of NCDs proposed for removal consistent with the process described and circumstances of removal listed in the Federal Register notice (78 FR 48168). This list was posted on our website at http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=24
and was open for 30 days of public comment. The public comments received are available through the same website. This decision memorandum serves to communicate the agency’s final decision regarding the NCDs proposed for removal. Each full-text NCD is available in Appendix A.
III. Public Comments
The following is a summary of the public comments received during the comment period from November 27, 2013 to December 27, 2013 as well as a brief rationale for CMS’ decision to remove or retain the NCD.
CMS did not receive public comments on our proposals to remove the following NCDs: Stereotactic Cingulotomy as a Means of Psychosurgery (160.4); Carotid Sinus Nerve Stimulator (160.6); Electroencephalographic (EEG) Monitoring During Open-Heart Surgery (160.9); Electron Microscope (190.4); Xenon Scan (220.7); and Nuclear Radiology Procedure (220.8). CMS will remove these NCDs because they are each older than 10 years, contain outdated information, and we did not receive comments that opposed our proposal to remove the policies. The result of removing the NCDs will be local contractor discretion regarding coverage of these items and services.
Tinnitus masking (50.6)
We received one comment from the American Academy of Audiology which supported removal of this NCD. The commenter stated that current evidence indicates tinnitus maskers are not experimental.
This NCD will be removed.
Noninvasive Tests of Carotid Function (20.17)
One comment from the American College of Cardiology (ACC) requested CMS to reconsider the removal of this NCD. The ACC requested that if the NCD is removed, that CMS should specifically state that coverage for duplex scans of extracranial arteries will continue under NCD Ultrasound Diagnostic Procedures (220.5). Under this expedited removal process, we do not have the ability to modify, change language, or provide clarifications to other NCDs.
Due to the society’s concerns regarding the interpretation of the NCD and that particular interpretations could lead to the potential removal of coverage of carotid duplex studies, CMS will retain the NCD.
Laser Procedures (140.5)
We received three comments about this NCD: one from Trimedyne, Inc., one from the American Academy of Dermatology (AADA), and one from an individual commenter.
Trimedyne, Inc., a manufacturer of lasers and disposable fiber optic delivery services for use in surgical applications, supported CMS’ effort to expedite the coverage process; however they commented that removal of this NCD would have serious negative consequences for beneficiary access. They also stated concerns that removing the NCD may result in limited and inconsistent access for beneficiaries, increased Medicare costs, and pose a significant burden for
local contractors.
The American Academy of Dermatology Association (AADA) commented that removal of this NCD would adversely impact Medicare beneficiaries because there are few local coverage determinations (LCDs) that address laser procedures and that the NCD ensures patients receive laser procedures only by physicians with training in surgical management of the disease or condition being treated. They also argued an NCD is the most appropriate guide currently in use and requested CMS to reconsider the decision to remove this NCD.
An individual commenter questioned whether all laser procedures would be removed.
In response to these comments, we clarify that the result of any NCD policy removal would be local contractor discretion. However, upon reconsideration, CMS will retain the NCD out of the commenters concerns regarding patient access and lack of existing policies related to provider requirements. This NCD will be retained.
L-DOPA (160.17)
We received one comment from the Parkinson’s Action Network (PAN) to retain this NCD. PAN commented that removal of this NCD would further limit the accessibility to services for individuals with Parkinson’s, and that they support access to clinically-proven effective treatments, like L-DOPA, for Americans living with Parkinson’s disease.
Given the concerns raised by the commenter, this NCD will be retained.
IV. Conclusion
Based on CMS review of the NCDs discussed above, the public comments, and consistent with the procedures described in the August 7, 2013, Federal Register Notice. CMS will remove the seven NCDs identified above. We will also retain three NCDs for the reasons stated in section III. In the future, the NCDs that are being retained may be candidates for reconsideration under either the full or expedited reconsideration process described in the August 7, 2013, Federal Register Notice.
