Local Coverage Article Response to Comments

Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)


Expand All | Collapse All

Contractor Information

Article Information

General Information

Article ID
Article Title
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)
Article Type
Response to Comments
Original Effective Date
Retirement Date
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained 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. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Article Guidance

Article Text

The comment period for the Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) DL38737 Local Coverage Determination (LCD) began on 9/3/20 and ended on 11/7/20. The notice period for L38737 begins on 10/14/21 and will become effective on 11/28/21.

The comments below were received from the provider community.

Response To Comments


Multiple commentors requested that the references to Pedicle Periosteal Infiltration be removed stating that this treatment does not reflect current medical practice in the management of VCF patients and is not recommended by published specialty society guidelines. Given the lack of specialty society support for this treatment and the limited evidence available for its use.

This asterisked suggestion (not requirement) to “consider including pedicle periosteal infiltration” was included, not to treat pedicle fracture, but rather vertebral compression fracture; per VERTOS IV: “A future therapeutic pain strategy could be a combined regimen of periosteal infiltration during natural healing. Additional cementation seems indicated only in a selected subgroup of patients with insufficient pain relief after this early phase” ( Francesco CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomized sham controlled clinical trial. BMJ. 2018;361:k1551.).


Multiple commentors requested that the exclusion of greater than 3 fractures in VCF patients be removed. Multiple references were provided including the guidelines of several societies and retrospective studies. The studies provided appear to address a total number of procedures not the total of procedures done in a specific treatment session.

Regarding the three-fracture limit, the three-fracture limit was meant as a per procedure limit (not lifetime). This was clarified and the contraindication moved from the absolute to the relative group to provide more provider discretion in rare cases. The per procedure limit is consistent with most of the studied population.

  1. Clark, Firanescu, Beall DP, Chambers MR, Thomas S, et al. Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial. Neurosurgery. 2018.
  2. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-1024.
  3. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.

Several commented on the exclusion of treatment of fractures greater than 12 weeks old.

First, the definition of acuity used in studies generally involves both time and radiologic appearance. Second, there is a paucity of evidence showing a benefit beyond the subacute timeframe. Certainly, there are no blinded RCTs demonstrating a benefit in chronic VCF. If new literature to support this indication emerges, it can be submitted for reconsideration.


Several commenters requested the level restriction (T5-L5), be expanded to T1-L5, noting that: “Although osteoporotic fractures infrequently occur at levels T1-T4, the presentation occurs in the population with the most severe osteoporosis”. Others requested that the range be expanded to include the sacrum.

Expansion to include T1-T4 will be added. As stated in comments, the use in this region is infrequent, so frequent use may trigger focused medical review. Sacroplasty is not within the scope of this LCD and will be covered in a future LCD.


Several commented on the Timing of Continuum of Care Activities, suggesting that they be accomplished after the procedure.

The timing of the continuum of care was left vague to provide flexibility in the timing of these procedures. It is presumed that they will be accomplished after the procedure in the majority of cases.


One commented on the language in the coverage guidance. They stated: “As this proposed LCD only addresses PVA being performed for osteoporotic VCFs, please consider using similar language as the Noridian LCD to enhance clarity for providers:”

“Provisions in this LCD and related coding article only address Vertebral Augmentation for Osteoporotic Vertebral Compression Fracture (VCF). Coverage will remain available for medically necessary procedures for other conditions not included in this LCD.”

This paragraph is appropriate and will be added.

Associated Documents

Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
10/07/2021 10/14/2021 - N/A Currently in Effect You are here