Specific to allergy testing and treatment services (CPT codes 95004 and 95165), please see below:
CPT code 95004 is defined as “Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report by a physician, specify number of tests.” (2013, AMA CPT Professional Edition, p. 529) A physician may delegate, with appropriate supervision, the performance of certain procedures and/or components of procedures for efficient use of physician, staff and patient time. Although a physician may delegate certain physical tasks of allergy testing, the definition of 95004 requires the physician to personally review the allergy test results — either by inspecting the test site(s) on the patient or analyzing a detailed report of the objective test findings. Then, using this personal test result review and taking the patient’s full medical history (including known allergies and occurrence of allergy- related conditions such as rhinitis and sinusitis) into account, the physician decides if the patient is an appropriate candidate for immunotherapy. This personal review and determination should be documented in the patient’s medical record to fully satisfy the “report” requirements of this code.
CPT Code 95165 is defined as “Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses).” (2013, AMA CPT Professional Edition, p. 531) A physician may delegate, with appropriate supervision, the performance of certain procedures and/or components of procedures for efficient use of physician, staff and patient time. A physician may delegate the tasks of physical antigen/serum mixing, patient instruction for serum injection, and providing serum vials to the patient. However, after determining a patient is an appropriate candidate for immunotherapy (as described above) the physician must personally select the allergens for immunotherapy, determine the specific concentrations and dilutions, and order the specific shot schedule. The physicians must also personally monitor the patient’s progress throughout the course of immunotherapy and not merely delegate that responsibility to ancillary (third party vendor) personnel.
In addition, BCBSTX limits payment for allergy serum to the amount actually provided to the patient on a given date of service but no more than 60 units per two (2) months. This policy does not apply to rapid desensitization.
CPT Code 95165
Medicare allowed approximately $98 million in charges for allergen immunotherapy codes in 2000. Nearly half of these charges, $47 million, were for CPT code 95165, professional services for the provision of antigens for allergen immunotherapy; single or multiple antigens, per dose. This code describes the preparation of antigen serums for use in immunotherapy, but not their injection. General allergists submitted about two-thirds of the claims for CPT code 95165, and ENT allergists account for about 20 percent. Most of the remainder come from internists, general practitioners, family doctors, and various group practices. Although per unit allowed charges are fairly constant across different specialties, ENT allergists bill more units (and receive greater reimbursement) per claim than other specialties
The interpretation of CPT code 95165 has been controversial. The code is unlike others in that it includes the concept of a ‘dose,’ which is not defined in the CPT manual. Traditionally, providers and payers defined a dose as the amount of antigen given in a single injection. In May 1998, CMS updated the carrier manual to define a dose as “the total amount of antigen to be administered to a patient during one treatment session, whether mixed or in separate vials.” Private payers, however, did not adopt this change; as a result, they paid 590 percent more per unit of CPT code 95165 than Medicare in 1999.2 After this change was instituted, the Relative Value Scale Update Committee recommended that CMS return to the traditional definition for the 1999 fee schedule update. At the time, though, CMS did not feel a revision was appropriate because the Committee failed to comment on the direct practice expense inputs to the code. In November 2000, after receiving many comments from specialty organizations, CMS revised the inputs for CPT code 95165. In this revision, effective January 1, 2001, CMS defines a dose, for billing and practice expense calculations, as “a one cc aliquot [part] from a single multidose vial.”3 All practice expense inputs for CPT code 95165 are based on this definition, although no allocation is made for resources and work used to create treatment or dilution boards.
Allergy Immunotherapy
For services rendered on or after January 1, 1995, all antigen/allergy immunotherapy services are paid for under the Medicare physician fee schedule. Prior to that date, only the antigen injection services, i.e., only codes 95115 and 95117, were paid for under the fee schedule. Codes representing antigens and their preparation and single codes representing both the antigens and their injection were paid for under the Medicare reasonable charge system. A legislative change brought all of these services under the fee schedule at the beginning of 1995 and the following policies are effective as of January 1, 1995:
1. CPT codes 95120 through 95134 are not valid for Medicare. Codes 95120 through 95134 represent complete services, i.e., services that include both the injection service as well as the antigen and its preparation.
2. Separate coding for injection only codes (i.e., codes 95115 and 95117) and/or the codes representing antigens and their preparation (i.e., codes 95144 through 95170) must be used If both services are provided both codes are billed. This includes allergists who provide both services through the use of treatment boards.
3. If a physician bills both an injection code plus either codes 95165 or 95144, A/B MACs (B) pay the appropriate injection code (i.e., code 95115 or code 95117) plus the code 95165 rate. When a provider bills for codes 95115 or 95117 plus code 95144, A/B MACs (B) change 95144 to 95165 and pay accordingly. Code 95144 (single dose vials of antigen) should be billed only if the physicianproviding the antigen is providing it to be injected by some other entity. Single dose vials, which should be used only as a means of insuring proper dosage amounts for injections, are more costly than multiple dose vials (i.e., code 95165) and therefore their payment rate is higher. Allergists who prepare antigens are assumed to be able to administer proper doses from the less costly multiple dose vials. Thus, regardless of whether they use or bill for single or multiple dose vials at the same time that they are billing for an injection service, they are paid at the multiple dose vial rate.
4. The fee schedule amounts for the antigen codes (95144 through 95170) are for a single dose. When billing those codes, physicians are to specify the number of doses provided. When making payment, A/B MACs (B) multiply the fee schedule amount by the number of doses specified in the units field.
5. If a patient’s doses are adjusted, e.g., because of patient reaction, and the antigen provided is actually more or fewer doses than originally anticipated, the physician is to make no change in the number of doses for which he or she bills. The number of doses anticipated at the time of the antigen preparation is the number of doses to be billed. This is consistent with the notes on page 30 of the Spring 1994 issue of the American Medical Association’s CPT Assistant. Those notes indicate that the antigen codes mean that the physician is to identify the number of doses “prospectively planned to be provided.” The physician is to “identify the number of doses scheduled when the vial is provided.” This means that in cases where the patient actually gets more doses than originally anticipated (because dose amounts were decreased during treatment) and in cases where the patient gets fewer doses (because dose amounts were increased), no change is to be made in the billing. In the first case, A/B MACs (B) are not to pay more because the number of doses provided in the original vial(s) increased. In the second case, A/B MACs (B) are not to seek recoupment (if A/B MACs (B) have already made payment) because the number of doses is less than originally planned. This is the case for both venom and nonvenom antigen codes.
6. Venom Doses and Catch-Up Billing – Venom doses are prepared in separate vials and not mixed together – except in the case of the three vespid mix (white and yellow hornets and yellow jackets). A dose of code 95146 (the two-venom code) means getting some of two venoms. Similarly, a dose of code 95147 means getting some of three venoms; a dose of code 95148 means getting some of four venoms; and a dose of 95149 means getting some of five venoms. Some amount of each of the venoms must be provided. Questions arise when the administration of these venoms does not remain synchronized because of dosage adjustments due to patient reaction. For example, a physician prepares ten doses of code 95148 (the four venom code) in two vials – one containing 10 doses of three vespid mix and another containing 10 doses of wasp venom. Because of dose adjustment, the three vespid mix doses last longer, i.e., they last for 15 doses. Consequently, questions arise regarding the amount of “replacement” wasp venom antigen that should be prepared and how it should be billed. Medicare pricing amounts have savings built into the use of the higher venom codes. Therefore, if a patient is in two venom, three venom, four venom or five venom therapy, the A/B MAC (B) objective is to pay at the highest venom level possible.
This means that, to the greatest extent possible, code 95146 is to be billed for a patient in two venom therapy, code 95147 is to be billed for a patient in three venom therapy, code 95148 is to be billed for a patient in four venom therapy, and code 95149 is to be billed for a patient in five venom therapy. Thus, physicians are to be instructed that the venom antigen preparation, after dose adjustment, must be done in a manner that, as soon as possible, synchronizes the preparation back to the highest venom code possible. In the above example, the physician should prepare and bill for only 5 doses of “replacement” wasp venom – billing five doses of code 95145 (the one venom code). This will permit the physician to get back to preparing the four venoms at one time and therefore billing the doses of the “cheaper” four venom code. Use of a code below the venom treatment number for the particular patient should occur only for the purpose of “catching up.” Code 95165 Doses. – Code 95165 represents preparation of vials of non-venom antigens. As in the case of venoms, some non-venom antigens cannot be mixed together, i.e., they must be prepared in separate vials. An example of this is mold and pollen. Therefore, some patients will be injected at
one time from one vial – containing in one mixture all of the appropriate antigens – while other patients will be injected at one time from more than one vial. In establishing the practice expense component for mixing a multidose vial of antigens, we observed that the most common practice was to prepare a 10 cc vial; we also observed that the most common use was to remove aliquots with a volume of 1 cc. Our PE computations were based on those facts. Therefore, a physician’s removing 10 1cc aliquot doses captures the entire PE component for the service.
This does not mean that the physician must remove 1 cc aliquot doses from a multidose vial. It means that the practice expenses payable for the preparation of a 10cc vial remain the same irrespective of the size or number of aliquots removed from the vial. Therefore, a physician may not bill this vial preparation code for more than 10 doses per vial; paying more than 10 doses per multidose vial would significantly overpay the practice expense component attributable to this service. (NOTE: this code does not include the injection of antigen(s); injection of antigen(s) is separately billable.) When a multidose vial contains less than 10cc, physicians should bill Medicare for the number of 1 cc aliquots that may be removed from the vial. That is, a physician may bill Medicare up to a maximum of 10 doses per multidose vial, but should bill Medicare for fewer than 10 doses per vial when there is less than 10cc in the vial.
If it is medically necessary, physicians may bill Medicare for preparation of more than one multidose vial.
EXAMPLES:
(1) If a 10cc multidose vial is filled to 6cc with antigen, the physician may bill Medicare for 6 doses since six 1cc aliquots may be removed from the vial.
(2) If a 5cc multidose vial is filled completely, the physician may bill Medicare for 5 doses for this vial.
(3) If a physician removes ½ cc aliquots from a 10cc multidose vial for a total of 20 doses from one vial, he/she may only bill Medicare for 10 doses. Billing for more than 10 doses would mean that Medicare is overpaying for the practice expense of making the vial.
(4) If a physician prepares two 10cc multidose vials, he/she may bill Medicare for 20 doses. However, he/she may remove aliquots of any amount from those vials. For example, the physician may remove ½ aliquots from one vial, and 1cc aliquots from the other vial, but may bill no more than a total of 20 doses.
(5) If a physician prepares a 20cc multidose vial, he/she may bill Medicare for 20 doses, since the practice expense is calculated based on the physician’s removing 1cc aliquots from a vial. If a physician removes 2cc aliquots from this vial, thus getting only 10 doses, he/she may nonetheless bill Medicare for 20 doses because the PE for 20 doses reflects the actual practice expense of preparing the vial.
(6) If a physician prepares a 5cc multidose vial, he may bill Medicare for 5 doses, based on the way that the practice expense component is calculated. However, if the physician removes ten ½ cc aliquots from the vial, he/she may still bill only 5 doses because the practice expense of preparing the vial is the same, without regard to the number of additional doses that are removed from the vial.
Medicare Regulations and Coding Guidelines for Allergen Immunotherapy
1. Codes 95115-95117 describes the professional service for the injection of the antigen but does not include the supply of the antigen.
2. Codes 95120-95134 describes complete service codes representing the combined preparation and supply of antigen for allergy immunotherapy in addition to the allergy injection provided. Medicare does not use these codes for payment purposes.
3. Codes 95144-95170 are for the preparation and provision of a single dose of antigen (see below for multiple dose vials code 95165). The reimbursement amounts for the antigen codes are for a single dose. The provider should specify the number of doses provided in the units field.
z Code 95144 describes the allergist’s preparation of single-dose vial(s) of antigens to be administered by another physician. A single-dose vial contains one dose of antigen that is administered in one injection.2 The vials are intended for use only when there is concern about accuracy of measurement doses from a multi-dose vial by a nonallergist office.The number of single-dose vials prepared and provided should be specified when reporting this code.
Example: Use of Code 95144
An individual’s allergist prepares two single-dose vials of allergenic extract for a patient who plans to travel to another city within the state during the time the injections are due. The patient receives the two allergy injections from the single-dose vial from a primary care physician.
Allergy injection codes and E/M codes should not be filed for the same day unless the E/M is separately identifiable. If the E/M is separately identifiable, append modifier -25 to the office visit. Code 96372 does not include injections for allergen immunotherapy. For allergen immunotherapy injections, use 95115-95117).
If a patient’s doses are adjusted, due to a reaction, and the antigen provided is actually more or less doses than originally anticipated, no changes should be made in the number of doses to be billed. Report the number of doses actually anticipated at the time of the antigen preparation for both venom and non-venom antigen codes. Regardless of whether a provider uses or files for a single dose vial (95144) or multiple dose vials ( 95165) and are billing for the administration of the injection at the same time (95115 or 95117) they will be reimbursed at the multiple dose vial rate of CPT code 95165.
Medicare considers a reasonable supply of antigens to be not more than a 12-month supply of antigens that has been prepared for a particular patient at any one time. The purpose of the reasonable supply limitation is to assure that the antigens retain their potency and effectiveness over the period in which they are to be administered to the patient.
The following CPT codes are covered for all product lines for the administration of the antigen(s): 95115 95117
The following CPT codes are covered for all product lines for the preparation and supply of the antigen: 95144 95145 95146
Based on our analysis, we found that data used by CMS to calculate practice expense inputs for CPT code 95165 are not accurate. The CMS estimates that in a typical practice, physicians provide immunotherapy from 10 cc multidose vials in shots of 1 cc each. We found that the median vial size is 4.9 cc and the median injection volume is 0.47 cc. In addition, while the current calculations assume 5 antigens are in each vial of immunotherapy, we found that a typical vial contains approximately 8 antigens. Lastly, while the new definition of a dose incorporates 2.2 minutes of clinical staff time, our research indicates that each dose requires 3.0 to 4.5 minutes to prepare. Practice expense calculations for CPT code 95165 do not factor in the dilution boards the typical provider creates, but the allocation per unit for this expense would probably be minimal.
CPT Code 95165
General allergists submitted about two-thirds of the claims for CPT code 95165, and ENT allergists account for about 20 percent. Most of the remainder come from internists, general practitioners, family doctors, and various group practices. The interpretation of CPT code 95165 has been controversial. The code is unlike others in that it includes the concept of a ‘dose,’ which is not defined in the CPT manual. Traditionally, providers and payers defined a dose as the amount of antigen given in a single injection. In May 1998, CMS updated the carrier manual to define a dose as “the total amount of antigen to be administered to a patient during one treatment session, whether mixed or in separate vials.” Private payers, however, did not adopt this change; as a result, they paid 590 percent more per unit of CPT code 95165 than Medicare in 1999.2 After this change was instituted, the Relative Value Scale Update Committee recommended that CMS return to the traditional definition for the 1999 fee schedule update. At the time, though, CMS did not feel a revision was appropriate because the Committee failed to comment on the direct practice expense inputs to the code. In November 2000, after receiving many comments from specialty organizations, CMS revised the inputs for CPT code 95165.
We used a stratified random sample to select physicians to whom we sent the survey. From 2001 National Claims History (NCH) data, we defined our universe as physicians appearing on claims for CPT code 95165 allowed in an office setting. These physicians were divided into three strata: allergists and immunologists in the first stratum, otolaryngologists in the second, and general practitioners, family doctors, internists, and group practices and clinics in the third. Together, these three strata accounted for 95 percent of the claims submitted for CPT code 95165 in 2001.
In addition, we spoke to several representatives of national allergy associations and consulted with practicing physicians. Several local allergists allowed us to observe the preparation of antigens and helped us develop our survey instrument. Lastly, we reviewed laws, regulations, policy letters, and other materials related to CPT code 95165.
We primarily used a national survey of a random sample of practitioners of allergen immunotherapy to develop the findings of this report. In addition to the survey, we interviewed staff and evaluated guidance documents from Medicare carriers. Lastly, we reviewed policy and regulations concerning CPT code 95165 and spoke with allergen immunotherapy providers. Based on our analysis, we found that current practice expense calculations do not accurately reflect typical practices among immunotherapy providers. Also, while most providers are aware of the new definition of a dose for CPT code 95165, most say it does not correspond with the way they provide allergen immunotherapy.
Most of the guidance issued by carriers reiterated the CMS guidance almost verbatim. We found most of the written notices to be clear and easy to understand, although four notices failed to adequately highlight information regarding CPT code 95165. We found that one notice was particularly confusing because it combined information for CPT code 95165 with information for CPT code 95115. On the other hand, one carrier offered several clinical examples in its bulletin to help clarify the new rule
The CMS commented on the working draft of this report and concurred with our findings. They indicated, however, that CMS will take no action at this time to address CPT code 95165. The CMS believes that using a 10 cc vial and 1 cc aliquots as the basis for practice expense calculations are not significantly different from using a 5 cc vial and 0.5 cc aliquots. Also, according to CMS, allocating the time and resources spent creating a dilution board to each individual dose would result in a minuscule, if any, change in payment. The clinical staff time required per dose, as stated in the report, requires more study before it could be used as a basis for changing reimbursement. The amount of antigen in a vial, however, is a practice expense issue that CMS has indicated they may address in the future.