Several Medicare contractors have initiated prepayment audits of billings for immunotherapy billings and documentation has been requested to support the medial necessity of the claims. Under Medicare law, only items or services determined to be medically necessary are considered covered.  Since there is not sufficient information on the claims form itself to support medical necessity, Medicare contractors have the authority to periodically request documentation from a physician to support the claims submitted.

These reviews might be conducted because of specific concern with the utilization of services for a specific provider or might be conducted because it is a high volume code in which case all physicians billing that code might be targeted.

Based on feedback we have received from some AAOA members who have experienced these reviews, we wanted to alert you to two specific problem areas that have been found. The first relates the documentation in the medical record supporting medical necessity of the services provided and the second relates to deficiencies in the legibility of clinical notes and other supporting documentation.

Medical Necessity:  Medical necessity requires that services be reasonable, necessary and/or appropriate based on evidence-based clinical standards of care. According to CMS “to meet medical necessity the service/procedure should be medically necessary and must be performed in the correct setting….To prove medical necessity, accurate and detailed information must be provided to: 1) support the diagnosis; 2) justify the treatment/procedures; 3) document the course of care; 4) identify treatment/diagnostic test results; and 5) continuity of care among healthcare providers.”

The documentation in your medical record should be sufficient to address these points particularly for patients who are on long term immunotherapy.  Some allergists have experienced denials because their progress notes did not support the medical necessity for the treatment provided.  Please keep in mind that the individuals conducted the reviews for the contractor may not be individuals with deep knowledge of allergy immunotherapy.

Thus, documentation which might seem adequate to a busy practicing allergist is not supportive of medical necessity in the eyes of a reviewer.  We urge you to review your medical documentation and assure yourself that, if audited, the medical record and progress notes supports the medical necessity for the treatments provided.

Legibility: This might seem basic but another area you must consider if you wish to prevent claim denials in the case of an audit is legibility. Obviously this can be a particular problem with physicians who are still using paper records as opposed to EHR. Notes in the medical record which are too cryptic to be understood or are virtually illegible will not be considered adequate documentation. In addition, CMS requires that “medical records should be complete and legible and medical records should include legible identity of the provider and date of service.”

CMS has indicated that while a missing signature from documentation can be validated by looking to a signature log or attestation statement to determine the identity of the author, if a signature is missing from an order, a reviewer may treat the order as though it was never written. Personnel who compound allergen extracts as CSPs, must be aware of greater potential risk of microbial and foreign material contamination when allergen extracts are compounded in compliance with the foregoing criteria instead of the more rigorous standards in the USP chapter for CSP microbial contamination risk levels. Although contaminated allergen extracts as CSPs can pose health risks to patients when they are injected intradermally or subcutaneously, these risks are substantially greater if the extract is inadvertently injected intravenously.”

References

1. Lay PC, Bass R, Lin SY. Allergen vial mixing and immunotherapy:  risks of infection and vial contamination.  Otolaryngol Head Neck Surg. 2007 Aug;137(2):243-5

2. Lin SY, Lay PC, Hughes LF, Bass R. The safety of multi-dose vials in allergy immunotherapy.  Otolaryngol Head Neck Surg. 2008 Aug;139(2):195-7

3. Lay PC, Bass R, Hughes LF, Lin SY. Risks of allergy vial contamination: Comparison of mixing in-office versus under ventilation hood. Otolaryngol Head Neck Surg. 2008 Sep;139(3):364-6.

4. Gilbert KC, Sundareshan V, Bass RM, Lin SY.  Antibacterial Properties of Additives Used in Injection Immunotherapy. Int Forum Allergy Rhinol.  2011 Dec 7. doi: 10.1002/alr.20105. [Epub ahead of print].