LCD Reference Article Response To Comments Article

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

A58445

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A58445
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)
Article Type
Response to Comments
Original Effective Date
12/01/2020
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 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 © 2023 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.

CMS National Coverage Policy

N/A

Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.
We would like to thank those who suggested changes to the draft of the Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) LCD.
The official notice period for the final LCD begins on 10/15/2020, and the final determination will become effective on 12/01/2020.

Response To Comments

Number Comment Response
1

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.”

 

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.

2

One commenter requested removal of the “within 30 day” advanced imaging requirement.

We agree that this should be removed now that the timeframe has been expanded to subacute.

3

Some commenters requested coverage of chronic fractures, arguing coverage should be based on evidence of acuity on imaging (e.g., edema on MRI), regardless of timeframe.

We disagree. 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.

4

One commenter requested clarification that continuum of care activities should occur as follow-up after vertebral augmentation.

The current policy recommends all patients be referred for evaluation for BMD and osteoporosis education; timing of the evaluation will remain at the discretion of the treating provider.

5

Several commenters objected to a lifetime limit of three vertebral fractures.

Although this comment was out of scope of what was open for comment (i.e., the addition of subacute osteoporotic VCF to inclusion criteria and the clarification of multidisciplinary referral and education requirements), we felt it important to correct an apparent misunderstanding. 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.

6

One commenter requested a fifth option be added to indication 1.b.ii.2: “, “for any patient with a weakened or fractured vertebral body, unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level.”

Another out of scope comment that may involve a misunderstanding. This indication already requires “optimal non-surgical management,” which would presumably preclude “unacceptable side effects.”

7

One commenter requested inclusion of coverage of osteopenia, noting that some studies included patients with dual-energy x-ray absorptiometry (DXA) T-scores between -1 to -2.5.

Although a T-score of -1 to -2.5, in isolation, represents osteopenia, the addition of a fragility fracture is, by definition, osteoporosis.

8

Some commenters requested that cancer be addressed, either in coverage, coding, or both.

As noted in the LCD and the Billing and Coding article: “Provisions in this article and the LCD 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 article/LCD.”

N/A

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
N/A
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
10/08/2020 12/01/2020 - N/A Currently in Effect You are here

Keywords

N/A