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 Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable 
and necessary. You can find this rule in the Centers for Medicare and Medicaid Services (CMS), Internet Only 
Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
 
Medicare may cover the use of a Food and Drug Administration (FDA)-approved drug or biological if it is safe 
and effective and otherwise reasonable and necessary for the patient. FDA approved drugs used for indications 
other than what is indicated on the official label may be covered if the use is determined to be medically 
accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted 
standards of medical practice. You can find this rule in the Centers for Medicare and Medicaid Services, 
Internet Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections 50.4.1 and 
50.4.2. 
 
The rules say that physicians should provide appropriate informed consent with respect to the off-label use of 
this drug and maintain it in the patient chart. 
 
Though the optimal frequency of vascular endothelial growth factor (VEGF) inhibitors is yet to be determined, 
the expectation is that the clinical assessment pre-treatment on date of service (DOS) (or close to it) should 
support decision making for treatment and subsequent follow-up treatment. Generally, a maximum of monthly 
intervals (4 weeks) should be assessed after the initial 3 months (12 weeks) of treatment for possible alternative 
frequency (such as 8 weeks to quarterly etcetera (etc.)) based on the clinical assessment. The treatment 
frequency should be consistent with the clinical assessment (symptoms, exam, testing when indicated (optical 
coherence tomography (OCT), fluorescein dye retinal angiography (FA), etc.) as documented in the medical 
record. Office based retina diagnostic tests are addressed in other polices. The diagnosis of age-related macular 
degeneration (AMD) or other retinal diseases may require FA, OCT, as well as other testing per standards of 
care. After establishment of a diagnosis and during treatment protocol for indicated VEGF Inhibitors OCT, 
Ultrasound, FA may be necessary to assess new symptoms and/or assess treatment progress for decisions on 
the subsequent frequency prescription. Documentation must support the need for testing and testing not used 
for decision making will be denied. Multiple testing modalities on a DOS may be subject to medical review and 
denial if testing exceeds the medical need. 
 
 
  Injections of drugs that are administered at an excessive frequency are not medically necessary. Frequency is 
considered excessive when services are performed more frequently than listed in the package insert or 
generally accepted by peers and the reason for additional services is not justified by documentation. Dose and 
frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When 
services are performed in excess of established parameters, they may be subject to review for medical 
necessity. 
 
The following are considered not reasonable and necessary and therefore may be denied: 
 
   1. It is not reasonable and necessary to inject more than one anti-VEGF medication (pegaptanib sodium, 
ranibizumab, bevacizumab, aflibercept) in the same eye during the same treatment session. 
    2. It is not expected to inject one anti-VEGF medication in one eye and another in the other eye. If different 
medications are injected into each eye during the same date of service, the rationale for this therapy must be 
documented in the medical record and the billing modifier (right eye (RT)/left eye (LT)) must be appended to 
the correct drug. 
    3. VEGF inhibitors addressed in this Local Coverage Determination (LCD) are contraindicated in patients 
with ocular or periocular infections and in patients with known hypersensitivity to the VEGF inhibitor or any of 
its inactive ingredients. 
    4. Frequency is considered excessive when services are performed more frequently than listed in the package 
insert or generally accepted by peers and the reason for additional services is not justified by documentation. 
Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). 
When services are performed in excess of established parameters, they may be subject to review for medical 
necessity. 
    5. Multi-dosing from a single eye use vial or syringe or single-dose syringe is not medically reasonable and 
necessary, and is not a covered service. 
 
You can find this information in the LCD: Vascular Endothelial Growth Factor Inhibitors for the Treatment of 
Ophthalmological Diseases (L36962). 
 
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.