Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules. The rules say 
percutaneous vertebroplasty and percutaneous vertebral augmentation (PVA or Kyphoplasty) procedures will 
be considered medically reasonable and necessary for the following indications: 
1. Painful, debilitating, osteoporotic vertebral collapse/compression fractures, defined as those that have 
not responded to non-surgical medical management (e.g. narcotic and/or non- narcotic medication, 
physical therapy modalities) with and without methods of immobility (e.g. rest, bracing). 
 Both PVP and PVA will be considered reasonable and necessary when ALL of the following 
criteria are met: 
o Acute (<6 wks) or subacute (6-12 wks)
18,28,42 
osteoporotic VCF (T1 L5), based on 
symptom onset, and documented by advanced imaging demonstrating bone marrow 
edema on MRI or bone-scan/SPECT/CT uptake 
1-3,8,26,43
 and 
o The beneficiary is symptomatic and is hospitalized with severe pain (Numeric Rating 
Scale [NRS] or Visual Analog Scale [VAS] pain score  8)
4-7
 or is non-hospitalized with 
moderate to severe pain (NRS or VAS 5) despite optimal non-surgical management 
(NSM)
8
 with one of the following: 
 Worsening Pain or 
 Stable to improved pain (but NRS or VAS 5) when 2 or more of the following 
are present: o Progression of vertebral body height loss 
o > 25% vertebral body height reduction 
o Kyphotic deformity 
o Severe impact of VCF on daily functioning (Roland Morris Disability 
Questionnaire [RDQ] >17) 
Limitations 
1. Exclusion criteria 
 Absolute contraindication 
o Current back pain is not primarily due to the identified acute or subacute VCF(s). 
o Osteomyelitis, discitis or active systemic infection 
o Pregnancy 
o Active surgical site infection 
 Relative contraindication 
o Greater than three vertebral fractures per procedure 
o Allergy to bone cement or opacification agents 
o Uncorrected coagulopathy 
o Spinal instability 
o Myelopathy from the fracture 
o Neurologic deficit 
o Neural impingement 
o Fracture retropulsion/canal compromise 
You can find this information in Medicares Local Coverage Determinate (LCD)  Percutaneous Vertebral 
Augmentation (PVA) for Vertebral Compression Fracture (VCF) (L35130).