This article gives guidance for billing, coding, and other guidelines in relation to local coverage policy Intravenous Immune Globulin L35891.
General Guidelines for Claims submitted to Part A or Part B MAC:
Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare. For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim. A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.
Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines
An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.
Effective from April 1, 2010, non-covered services should be billed with modifier –GA, -GX, -GY, or –GZ, as appropriate.
The –GA modifier (“Waiver of Liability Statement Issued as Required by Payer Policy”) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e), or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts responsibility for payment. The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.
Modifier GX (“Notice of Liability Issued, Voluntary Under Payer Policy”) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, will automatically be denied services.
The –GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. If the service is statutorily non-covered, or without a benefit category, submit the appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny.
Documentation Requirements
The patient’s medical record should include but is not limited to:
- The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit,
- Relevant medical history
- Results of pertinent tests/procedures
- Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed.)
Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate intravenous immune globulin therapy and the continued need thereof. Required documentation of medical necessity includes but is not limited to:
- History and physical; supporting physician rationale (current within the last 12 months)
- Physicians orders not more than 30 days old to date of service specifying dose, frequency, administration route and duration office/progress note(s); that clearly document the necessity for both initiation and continuation of IVIG
- ICD-10-CM diagnosis codes supporting medical necessity must be submitted with each claim. Claims submitted without such evidence will be denied as not medically necessary.
- Documentation supporting the diagnosis
- A copy of applicable lab and procedure test results
- An accurate weight in kilograms should be documented prior to each infusion since the dosage is based mg/kg/dosage; and
- Prior failed conventional therapies or documentation that conventional therapy is contraindicated
- Medication administration records
- Each order (which must not be more than 30 days old) should be accompanied by documentation in the record as to the response to the prior infusions in order for ongoing therapy to be considered medically reasonable and necessary.
In addition, medical record documentation maintained by the treating physician for claims billed with a diagnosis of CVID must include the following: the initial presenting IgG levels and evidence that the patient has been vaccinated with Pneumovax and has had pre-and post-vaccine pneumococcal antibody titers performed to demonstrate the lack of ability to produce an antibody response to protein or carbohydrate antigens.
Documentation must include dual diagnoses listed for the underlying condition that demonstrates the medical necessity for intravenous immune globulin therapy.
Documentation must include a statement regarding lack of response to protein antigen.
For patients with HIV disease and ITP the medical record must specifically reflect that the patient has a platelet count of less than 30,000 and is actively bleeding. This must be supported by applicable lab results.
When IVIG is indicated in immunodeficient individuals (as defined above), with recurrent or chronic bacterial sinusitis, the medical record must document findings diagnostic of, or highly suggestive of, recurrent or chronic bacterial sinus infection. Such findings may include, but are not limited to, fever, unilateral purulent nasal discharge and unilateral facial pain." Absence of these findings will not preclude the use of IVIG, however, documentation will be considered insufficient to justify medical necessity when antibiotic therapy is prescribed routinely during the first few days of symptoms in the absence of these findings, or in the instance where antibiotic therapy is prescribed by phone without the benefit of an examination by a physician (or non-physician practitioner). IVIG is never indicated and therefore not reasonable and necessary for the treatment of simple rhinosinusitis, even in immunodeficient individuals and even if recurrent. The administration of antibiotics in and of itself will not be considered evidence of bacterial rhinosinustis. The medical record must substantiate the use of prolonged and/or recurrent antibiotic therapy in the treatment of these infections. Radiographic documentation of mucosal thickening of the paranasal sinuses, in and of itself, is not specific to bacterial sinusitis and as a sole finding will not be consideration sufficient documentation to support the use of IVIG.
For stiff-man syndrome documentation must support that the patient is under the care of a physician who is competent in the diagnosis of the syndrome. The current defined criteria for the diagnosis must be met.. Patient would have demonstrated failed conservative treatment (such as benzodiazapines). The record must show the patients response to therapy after initial treatment (0 and 1 month). Documentation must support objective response for continued coverage each month or at longer intervals.
All documentation must support the criteria for coverage as set forth in the "Indications and Limitations of Coverage and/or Medical Necessity" section of this policy.
Utilization Guidelines
Where no dosage guidelines are provided in this LCD and that realizing dosage may vary based on a patient’s individual situation, the dosage must be in keeping with the recommended dosage in current literature and the standard of practice. Initial and/or maintenance doses of IVIG may be administered as a single infusion or may be divided and administered over several days. Any time there is a departure from the standard dosing(either dose or frequency of administration), the rationale for this must be documented in the medical record.
For stiff man syndrome initial coverage is limited to up to 2g of immune globulin per kilogram of body weight per month.
