Drugs & Biologicals Decision Tree
This set of questions will assist with review of documentation requirements:
1. Is an order or intent to order for the drug by the approved specialty present?
2. If order or intent to order is present, does it contain a valid signature?
Yes No
3. Is a purchase order present with name of drug and information regarding vials?
Yes No
4. Are ALL the following present in the documentation for the Drug Administration?
- Patients weight if applicable for drug dosage
- Name of the drug
- Date of Service
- Signed inform consent specific to the drug being administered
- Drug was administered to the correct beneficiary
- Does documentation state the amount of the drug administered per the order
- Does the documentation support the route of drug administered
- Does documentation contain the location the drug was administered
- Does the documentation contain the amount of the drug wasted and signed by person wasting and claim billed with JW modifier for wasted amount if applicable
Yes No
5. Does all documentation meet signature requirements and include the name, signature and credentials of the person performing the service?
Yes No
6. Which Drug and Service Code are being administered and billed?
Abatacept/Orencia J0129
Aflibercept/Eylea J0178
Pegloticase/Krystexxa J2507
7. Is the provider specialty 66 Rheumatology or 07 Dermatology?
8. Does the documentation support an approved diagnosis of Adult Rheumatoid Arthritis, Adult Psoriatic Arthritis, or Juvenile Idiopathic Arthritis?
Yes No
9. Does the documentation support a 3-month trial of oral agent or IV agent that failed, or other indication?
Yes No
Progress note or medical record should support 3-month trial of oral agent, IV agent that failed, or other indication based on medical standard of care
10. Does the dosage and administration meet FDA approved guidelines?
Yes No
11. Is one of the follow stated as medically necessary reason not to give SQ, such as:
- Age related (17 years and younger IV only)
- Patient/PCG mentally or medically impaired to self-inject (crippled hands), to learn self-injections (dementia), no available caregivers
- Patient may have condition flare and requires IV does(s) to obtain remission
- Patient may have skin condition more susceptible for infection
- Physician documentation specifying rationale
Yes No
Documentation must indicate if after initial intravenous (IV) dose, subcutaneous (SQ) is appropriate for future doses or contain a stated medically necessary reason not to give SQ
7. Is the provider specialty 18 Ophthalmology or (KY) 41 Optometrist?
8. Does the documentation support or of the following diagnoses are present?
- Neovascular (Wet) Aged-related Macular Degeneration (AMD)
- Macular Edema following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
Yes No
9. Does the dosage and administration meet FDA approved guidelines of each 2mg injection?
Yes No
10. Is the frequency every 28 days(supported by documentation of last dose administered) or documentation to support a change in frequency?
Yes No
7. Does the adult patient have chronic gout refractory to conventional therapy proven by having ALL the following present in the documentation?
- Baseline serum uric acid of at least 8mg/dl
- Has symptomatic gout with at least 3 gout flares in the previous 18 months, at least 1 gout tophi (sodium urate monohydrate, or uric acid, builds up around your joints) or gouty arthritis
- Patient is currently on NSAIDS or Colchicine or both within last 30 days OR Documented intolerance, FDA labeled contraindication or hypersensitivity to both
- Insufficient response uric acid levels > 6mg/dl after at least 3 months of therapy with both allopurinol and febuxostat at maximum tolerated doses unless medically contraindicated. If the patient has well documented medical contraindications, monotherapy will be considered as sufficient.
Progress note or medical record should support conventional therapy proven by all listed based on medical standard of care.
8. Does the dosage and administration meet FDA approved guidelines of 8 mg intravenous (IV) infusion every 2 weeks?
Yes No
Join Electronic Mailing List
Print
Bookmark
Email
Facebook
YouTube
LinkedIn
CGS Medicare Mobile App