LCD Reference Article Response To Comments Article

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

A58535

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Source Article ID
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Article ID
A58535
Original ICD-9 Article ID
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Article Title
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF)
Article Type
Response to Comments
Original Effective Date
01/10/2021
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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 11/26/2020, and the final determination will become effective on 01/10/2020.

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.

Noridian has included codes for coverage of this treatment for fractures due to certain malignancies in its billing and coding article.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Updated On Effective Dates Status
11/18/2020 01/10/2021 - N/A Currently in Effect You are here

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