LCD Reference Article Response To Comments Article

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

A58462

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Source Article ID
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Article ID
A58462
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF)
Article Type
Response to Comments
Original Effective Date
03/11/2021
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Article Text

This is a revision of the previous policy on vertebral augmentation. Several changes were made from the most recent version including expansion to subacute (6-12 weeks) fractures, addition of continuum of care and removal of multi-disciplinary team consensus requirement. Proposed policy was taken to open meeting on June 23, 2020 with comment period from May 28, 2020 to July 12, 2020. Notice period for the updated policy will begin March 11, 2021 and become active on April 25, 2021.

Response To Comments

Number Comment Response
1

Comments were received from the Society of Interventional Radiology carrier advocacy workgroup with five key changes recommended:
1. They state older fractures that still have edema should be included and recommends the timeframe should be removed and replaced with evidence of edema on advanced imaging or the presence of a cleft or non-union fracture.
2. States the current policy excludes T1-T4 and recommends inclusion of T1-T4. They state, “Although osteoporotic fractures infrequently occur at levels T1-T4, the presentation occurs in the population with the most severe osteoporosis.”
3. Recommends removal of “absolute contraindication” for greater than three vertebral fractures and allow three to five levels per treatment.
4. Recommends adding a fourth inclusion to include 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.
5. Cancer must be included.

1. The policy was expanded to include subacute fractures (6-12 weeks). We disagree with expansion beyond 12 weeks based on inconsistent literature without clear evidence to support beyond 12 weeks or to support effectiveness in chronic time frame. If new literature to support this indication emerges it can be submitted for reconsideration.
2. 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.
3. There is a lack of data to support use over three levels. Several major trials had more than three fractures as part of the exclusion criteria including VERTOSIV. The EVOLE trial states 1-3 fractures. However, we understand there can be rare exceptions and the “absolute” contraindication will be changed to “relative”.
4. Literature to support this indication may be submitted on reconsideration.
5. Malignant fractures have been added to the policy and associated Billing and Coding article. The guidance for coverage is based on literature, societal guidance and stakeholder input. The policy title is changed to include non-osteoporosis related fractures. 

2

Comments from Stryker request the following:
1. Remove reference to pedicle periosteal infiltration.
2. Clarify timing for continuum of care activities.
3. Request expansion to >3 fractures.
4. Request cancer diagnosis be added.
5. Request for additional ICD-10 codes.

1. Based on comments this reference will be removed.
2. The current policy recommends all patients be referred for evaluation for BMD and osteoporosis education and timing of the evaluation will remain at the discretion of the treating provider.
3. See Response #1 above
4. See Response #1 above
5. See #1 Response above.

3

Presentation and comments from Dr. James Webb, principle investigator in the EVOLVE trial, include:
1. Recommendation to remove any cautionary recommendations including number of levels treated, treatment of chronic fractures and treatment of high thoracic level
2. Add cancer codes
3. Remove <30 day imaging requirement
4. Recommends removing STIR or SPECT positive image requirements and remove >25% height loss requirement
5. Remove restriction on 3 levels
6. Remove restriction on treating levels above T5

1. See Response #1 above
2. See Response #1 above
3. The <30 day limit has been removed.
4. The policy allows MRI, STIR or SPECT at provider discretion and allows the provider to select the image modality that they choose. The criteria require two of four possible findings to support the procedure and >25% height loss is one of the four. We will leave that so providers can determine what criteria meets eligibility for their patients.
5. See Response #1 above
6. See Response #1 above

4

Dr. Zohere Ghogawala on behalf of North American Spine Society (NASS) submitted the NASS Coverage Guidelines for common spine treatment and procedures and support for changes made to the LCD.

 

 

Thank you for developing and submitting the NASS Coverage Guidelines and your support of the changes in the LCD

5

Dr. Neil Shonnard, founder of US VCF Registry, presented and shared the following comments:
1. Remove limitations of fractures based on spinal column level.
2. Recommends inclusion of painful chronic fractures.
3. Remove exclusion of more than 3 fractures.
4. Remove recommendation for periosteal infiltration.
5. Add cancer codes.

1-5. See Response #1 above

6

Presentation and comments by Dr. Douglas Beall, representing the Society of Interventional Radiology as the Chairmen of the Service Line for Pain Management recommends the following changes:
1. Remove periosteal infiltration of the pedicle.
2. Remove restriction of more than 3 levels.
3. Add cancer codes.
4. Recommends active contraindications as follows: Active infection at surgical site and untreated blood borne infection.

1-3. See Response #1 above
5. The absolute contraindications include active systemic infection and will add active surgical site infection.

7

Presentation and comments by Dr. Jason Levy representing the Society of Interventional Radiology recommends the following:
1. Removal of restrictions on older fractures, cancer fractures, fractures T1-T4 and 3 more fractures.

See Response #1 above

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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
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