How Many Units of 95165 Can You Bill, Really?
Three credible sources give three different answers, and only one is right.
The definition for billing units of allergy serum preparation for patients was recently challenged by a colleague of mine who works in the allergy space. Are there limitations on diluted antigens when counting units for CPT 95165 Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)? We were at odds, so I decided to do my homework.
According to the Final Rule
In doing so, I found the instructions in the 2001 Medicare Physician Fee Schedule (MPFS) final rule, published in the November 2000 Federal Register, only partially made it into the Centers for Medicare & Medicaid Services (CMS) Internet Only Manual (IOM).
The final rule states:
“Therefore Medicare should be billed for a maximum of ten doses per vial, even if more than ten doses are obtained from the vial. Furthermore, when a physician dilutes a multidose vial (for example, taking one cc aliquot from a multidose vial and mixing it with nine cc’s of diluent in a new multidose vial), Medicare should not be billed an additional amount for these diluted doses for CPT 95165.”
It goes on to say:
“In a diluted vial there are no associated allergen costs, since they have already been billed in preparation of the initial vial. Therefore, we expect a maximum of ten doses to be billed for each multidose vial.”
The section finishes with:
“We will revise this section of the carrier manual to define a dose as one cc aliquot from a single multidose vial. With this clarification physicians will be able to bill Medicare for each dose prepared in each multidose vial. We plan to issue new instructions to the carriers and update the carrier manual to ensure that appropriate payment is made as of January 1, 2001.”
As a result of this final rule for the 2001 MPFS, allergy serum preparation for Medicare Part B patients includes only 1 cc aliquot unit. Diluted doses are not separately billable because they are already billed when the maintenance vials are billed. But is that the final word?
According to the Internet-Only Manual
The IOM (section 15050) addresses only the limitation in counting 1 cc aliquot. It does not address that Medicare will not pay for diluted vials beyond the maintenance vials, as instructed in the 2001 MPFS final rule.
My colleague stated that since the limitations on diluted antigens when counting units for 95165 was not included in the IOM, that part of the rule was not implemented, and all diluted serum could be billed to Medicare.
Specialty Associations Follow the Final Rule
I referred to the American Academy of Allergy Asthma & Immunology’s (AAAAI) Practice Resource Guide, Chapter 6, and found their guidance to be consistent with the November 2000 Federal Register.
The AAAAI guideline states:
CMS defines the 95165 code as a 1-cc aliquot from a single multiple dose vial. Diluted doses are not billable according to the CMS definition. If you are mixing a “set” for a Medicare patient, you will charge only for the vial that is designated as the maintenance vial. If you “dilute down,” the diluted doses are not billable to Medicare. Medicare also requires you to provide the first dose prior to billing the number of anticipated doses (1-cc each) the patient will receive.”
There are various educational presentations available for download from AAAAI’s website that all refer to the Medicare definition for 95165 as “per cc of the concentrated solution.”
The American College of Allergy, Asthma & Immunology (ACAAI) published an article in March 2018 on 95165, as well. It acknowledges that there has been some confusion as to Medicare rules for allergy immunotherapy billing (CPT® 95165) even though there has been “no recent change in the past several years.” The ACAAI also acknowledges that the confusion is due to the IOM not being updated consistent with the final rule published in the November 2000 Federal Register.
According to the Code of Federal Regulations
I reached out to Robert Liles, Esq., of Liles Parker, PC. Liles is a leading healthcare attorney who defends providers nationwide in both audits and investigations.
As Liles reviewed with me, the rulemaking for Medicare goes through a three-step process:
- Preliminary Federal Register where comments are made relative to the rules being promulgated.
- Final Federal Register where the rules in the finalized after review of all the comments.
- Code of Federal Regulations (CFR) where the rules are put into place.
Per 42 CFR Sec. 410.68 Antigens: Scope and conditions, Medicare will not pay for more than 12 months of antigen at a time. Nothing is referenced in terms to the 1 cc aliquot limitation and nothing is referenced to the limitations on paying for dilution beyond what is needed for the maintenance dose.
From the CFR, guidance is created in the form of the IOM. The IOM does not contain regulations; it represents guidance as to how to implement the rules reflected in the rule-making process. However, providers are expected to follow the guidance when submitting claims.
So, we have three sources: the final rule, the CFR, and the IOM — each containing conflicting information as to how to bill 95165. One can understand why providers would be confused.
The Definitive Source for Billing 95165
When there is conflicting information such as this, Liles explained, the source with the most amount of detail on how the code(s) should be submitted is the definitive source for how Medicare expects claims to be submitted. Liles told me that not all the final rules from the Federal Register and CFR make it into the IOM, but the final and definitive voices are the Federal Register and CFR. The IOM is guidance and only memorializes the rulemaking as a resource; absence from the IOM does not mean the rule does not exist.
Practices should follow the 2001 MPFS final rule in the November 2000 Federal Register for how to bill Medicare Part B for the preparation of allergy serum. Providers are limited to 1 cc aliquots no matter what the dose size is to the patient, and may only bill for the quantity of maintenance dose that is prepared. Medicare does not pay for diluent beyond what is needed to create the maintenance dose.
Payers other than Medicare are to be billed for the number of doses of antigen and diluent expected to be administered from the multidose vial(s). For example, if a 10 cc vial is prepared and the patient is receiving a 0.5 cc dose, that vial would be billed 20 units. Also, unless the payer indicates otherwise in their reimbursement policies, non-Medicare payers pay for antigens and diluent for all doses that will be administered (within the limits of their reimbursement policies). Keep in mind that payers have limits to the number of units they will pay for at a single time. If more than that limit is made, the practice will not be paid for the amount in excess of the payer’s limits. And do not bill the excess units “next month” because that would be considered fraud if those excess units were prepared and provided last month, not this month.
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