Update: BCBSA Balloon Sinus Ostial Dilation Reference Medical Policy
Since the beginning of 2011 members of the Physician Payment Policy (3P) workgroup and Academy staff have been in communication with staff from the Blue Cross Blue Shield Association (BCBSA) regarding its balloon sinus ostial dilation reference medical policy. (Catheter-based inflatable device is used as a synonymous term in the policy.) The Academy’s Rhinology and Paranasal Sinus Committee provided valuable input during the process. These communications included a letter from Academy Executive Vice President and CEO David R. Nielsen, MD, responding to the draft reference medical policy and a conference call with members from 3P and Academy staff on the final reference policy. In all of these communications, the Academy expressed disagreement with the classification of balloon sinus ostial dilation as “Investigational/ Not Medically Necessary” and provided evidence supporting the safety and effectiveness of the procedure. Despite these efforts, BCBSA decided to keep the “Investigational/ Not Medically Necessary” designation until future studies could meet the research criteria necessary for the policy to be changed. One study submitted by the Academy (Plaza G, et al. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. 2011;120(8):511-8) was acknowledged to be the type of literature needed to revise coverage determinations but was, unfortunately, deemed insufficiently powered by BCBSA to change its policy. Note that the BCBSA Reference Policies are available for use by each BCBS plan in making independent decisions about medical policy. Each plan may adopt the reference policy in whole or in part, may modify it, or may reject it. These reference policies are developed by BCBSA staff and then reviewed by a BCBSA Medical Policy Panel (MPP) comprised of senior medical plan directors. The Academy has been, and remains, ready to cooperate with appropriate industry and other groups to develop requested prospective studies that could evaluate the efficacy and safety of devices and raise the level of evidence. The BCBSA Medical Director stated that there was no reference policy on denying payment for an entire surgical session when one portion or element was considered “Investigational/ Not Medically Necessary.” The Academy will continue to work with BCBS plans, and any others with similar policies, to allow the balloon to be used as a tool to complement a procedure without the entire procedure being denied. The 3P workgroup strongly believes the use of a balloon as a tool in a standard approach to a sinus ostial dilation is acceptable. Members may use a template appeal letter to appeal the denial of an entire surgical session where a balloon is used for sinus ostial dilation as a component of that session. It is available at http://www.entnet.org/Practice/Appeal-Template-letters.cfm. If you receive this type of denial, forward information including an EOB/Explanation of Benefits (HIPAA information redacted), indicating whether the full session is being denied and in what setting the procedure is being denied to healthpolicy@entnet.org so we can continue to track these. Also let us know if your local BCBSA plan is covering and paying for balloon sinuplasty. Advocacy Efforts So Far January 1, 2011: CPT approved new CPT codes for balloon sinus ostial dilation (31295-31297). February 11, 2011: AAO-HNS received request from WellPoint to provide input on draft reference medical policy for balloon sinus ostial dilation. Sends to Rhinology and Paranasal Sinus Committee (RPS) for review and comments, then sends to Academy’s 3P workgroup for final review with final approval from the AAO-HNS Board. May 17, 2011: AAO-HNS sent comments to WellPoint, which forwards them to BCBSA for review. May 2011: BCBSA reviewed the draft medical policy for balloon sinus ostial dilation at its Medical Policy Panel meeting, AAO-HNS received reviewed comments. July 29, 2011: BCBSA reported that draft policy was final after May 2011 BCBSA medical policy panel review. August 25, 2011: Via “The News,” sends request for members to inform the Academy of problems with third-party payer coverage of balloon sinus ostial dilation and opposition to outright denial of payment for any, including classic endoscopic sinus surgery, when balloons are used during a surgical session. The Academy’s interpretation of extant literature led it to a different conclusion, and the Academy strongly opposed this action. September 21, 2011: AAO-HNS conducted conference call with BCBSA Technical Evaluation Committee Medical Chairman, 3P, and Academy staff. BCBSA indicated classification remains investigational/not medically necessary due to current insufficient evidence of comparative effectiveness. 3P provides the Plaza, et al., study. The Medical Chairman notes on September 24, 2011, in a written response that BCBSA determined that the study does not present a sufficient quality level and has serious limitations. September 30, 2011: AAO-HNS sent BCBSA a follow-up letter requesting what further study/information is required to eliminate “investigational” designation for balloon sinus ostial dilation going forward. October 6, 2011: Received response from BCBSA providing more information on types of trials needed to provide sufficient evidence for coverage, noting that for a treatment such as balloon sinus ostial dilation, they would expect high-quality clinical trials that compare this modality to alternatives, including a trial of sufficient size, analysis of the most clinically important outcome measures, and avoidance of major bias. The improvement in the outcome measure(s) should be both statistically and clinically significant.
Since the beginning of 2011 members of the Physician Payment Policy (3P) workgroup and Academy staff have been in communication with staff from the Blue Cross Blue Shield Association (BCBSA) regarding its balloon sinus ostial dilation reference medical policy. (Catheter-based inflatable device is used as a synonymous term in the policy.) The Academy’s Rhinology and Paranasal Sinus Committee provided valuable input during the process.
These communications included a letter from Academy Executive Vice President and CEO David R. Nielsen, MD, responding to the draft reference medical policy and a conference call with members from 3P and Academy staff on the final reference policy. In all of these communications, the Academy expressed disagreement with the classification of balloon sinus ostial dilation as “Investigational/ Not Medically Necessary” and provided evidence supporting the safety and effectiveness of the procedure.
Despite these efforts, BCBSA decided to keep the “Investigational/ Not Medically Necessary” designation until future studies could meet the research criteria necessary for the policy to be changed. One study submitted by the Academy (Plaza G, et al. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. 2011;120(8):511-8) was acknowledged to be the type of literature needed to revise coverage determinations but was, unfortunately, deemed insufficiently powered by BCBSA to change its policy.
Note that the BCBSA Reference Policies are available for use by each BCBS plan in making independent decisions about medical policy. Each plan may adopt the reference policy in whole or in part, may modify it, or may reject it. These reference policies are developed by BCBSA staff and then reviewed by a BCBSA Medical Policy Panel (MPP) comprised of senior medical plan directors.
The Academy has been, and remains, ready to cooperate with appropriate industry and other groups to develop requested prospective studies that could evaluate the efficacy and safety of devices and raise the level of evidence. The BCBSA Medical Director stated that there was no reference policy on denying payment for an entire surgical session when one portion or element was considered “Investigational/ Not Medically Necessary.” The Academy will continue to work with BCBS plans, and any others with similar policies, to allow the balloon to be used as a tool to complement a procedure without the entire procedure being denied.
The 3P workgroup strongly believes the use of a balloon as a tool in a standard approach to a sinus ostial dilation is acceptable. Members may use a template appeal letter to appeal the denial of an entire surgical session where a balloon is used for sinus ostial dilation as a component of that session. It is available at http://www.entnet.org/Practice/Appeal-Template-letters.cfm.
If you receive this type of denial, forward information including an EOB/Explanation of Benefits (HIPAA information redacted), indicating whether the full session is being denied and in what setting the procedure is being denied to healthpolicy@entnet.org so we can continue to track these. Also let us know if your local BCBSA plan is covering and paying for balloon sinuplasty.
Advocacy Efforts So Far
January 1, 2011: CPT approved new CPT codes for balloon sinus ostial dilation (31295-31297).
February 11, 2011: AAO-HNS received request from WellPoint to provide input on draft reference medical policy for balloon sinus ostial dilation. Sends to Rhinology and Paranasal Sinus Committee (RPS) for review and comments, then sends to Academy’s 3P workgroup for final review with final approval from the AAO-HNS Board.
May 17, 2011: AAO-HNS sent comments to WellPoint, which forwards them to BCBSA for review.
May 2011: BCBSA reviewed the draft medical policy for balloon sinus ostial dilation at its Medical Policy Panel meeting, AAO-HNS received reviewed comments.
July 29, 2011: BCBSA reported that draft policy was final after May 2011 BCBSA medical policy panel review.
August 25, 2011: Via “The News,” sends request for members to inform the Academy of problems with third-party payer coverage of balloon sinus ostial dilation and opposition to outright denial of payment for any, including classic endoscopic sinus surgery, when balloons are used during a surgical session. The Academy’s interpretation of extant literature led it to a different conclusion, and the Academy strongly opposed this action.
September 21, 2011: AAO-HNS conducted conference call with BCBSA Technical Evaluation Committee Medical Chairman, 3P, and Academy staff. BCBSA indicated classification remains investigational/not medically necessary due to current insufficient evidence of comparative effectiveness. 3P provides the Plaza, et al., study. The Medical Chairman notes on September 24, 2011, in a written response that BCBSA determined that the study does not present a sufficient quality level and has serious limitations.
September 30, 2011: AAO-HNS sent BCBSA a follow-up letter requesting what further study/information is required to eliminate “investigational” designation for balloon sinus ostial dilation going forward.
October 6, 2011: Received response from BCBSA providing more information on types of trials needed to provide sufficient evidence for coverage, noting that for a treatment such as balloon sinus ostial dilation, they would expect high-quality clinical trials that compare this modality to alternatives, including a trial of sufficient size, analysis of the most clinically important outcome measures, and avoidance of major bias. The improvement in the outcome measure(s) should be both statistically and clinically significant.