TO: Administrative File
FROM: Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Joseph Chin, MD, MS
Deputy Director, Coverage and Analysis Group
Susan Miller, MD
Medical Officer, Division of Items and Devices, 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: September 30, 2015
Effective September 30, 2015 the Centers for Medicare & Medicaid Services removes the following NCDs from the NCD Manual (100-03):
210.4 - Smoking and Tobacco-Use Cessation Counseling
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 a section 1862(a)(1)(A) 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
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 March 18, 2015, CMS published a 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=30&mcdtypename=Expedited+Process+to+Remove+National+Coverage+Determinations&MCDIndexType=7&bc 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.
III. Public Comments
The following is a summary of the public comments received during the comment period from March 18, 2015 to April 17, 2015 as well as CMS’ decision.
Smoking and Tobacco-Use Cessation Counseling (210.4)
CMS did not receive any public comments on our proposal to remove Smoking and Tobacco-Use Cessation Counseling (210.4). CMS will remove this NCD because it is older than 10 years, a more recent policy has since been published, and we did not receive comments that opposed our proposal to remove the policy. The
more recent preventive service policy related to cessation services entitled Counseling to Prevent Tobacco Use (210.4.1) will remain effective and better serves the needs of Medicare beneficiaries because those services do not impose cost-sharing obligations.
Apheresis – therapeutic apheresis (110.14)
CMS received a total of 55 comments concerning 110.14, Therapeutic Apheresis. Among the public comments, were commenters that expressed the importance of apheresis to patients and showed general support for the service. This group of commenters did not address if the policy should be removed or retained.
Other commenters supported a formal reconsideration of the current NCD. There was variation within that group with some commenters suggesting the NCD should be expanded to be unrestrictive in the use of therapeutic apheresis while others suggested either a single indication for expansion or suggested the NCD should follow professional society practice guidelines. The final group of commenters agreed with removing the NCD with a subgroup stating that if CMS did not to remove the policy then it should be reconsidered.
In light of the inconsistent public comments, CMS will take additional time to consider potential next steps regarding this policy. Therefore, CMS will not move forward with expedited removal of the NCD.
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 only the NCD titled Smoking and Tobacco-Use Cessation Counseling (210.4).