Medicare Allergen Preparation

Prior Office of Inspector General work

As part of “Medicare Allergen Preparation” (OEI-09-00-00530), published in 2002, we evaluated a probe sample of a small number of allergy services rendered to Medicare beneficiaries in 2000 and 2001. Seventeen of the twenty-seven services reviewed as part of this probe were inadequately documented or not medically necessary.

Beneficiaries of the 12 services determined to be medically unnecessary had allergy test results that did not demonstrate the need for immunotherapy, had contraindications, or were on allergy shots for extended periods without clinical justification.

METHODOLOGY

Our primary methodology involved medical review of a sample of allergy services randomly selected from the Medicare 2001 National Claims History Date File. Because our objective required us to address both beneficiary- and service-level issues, we used a two-stage cluster sample to select records for the medical review. 

As diagramed in Figure 2 on the next page, we first defined the beneficiary universe as all Medicare beneficiaries on allergen immunotherapy in 2001, i.e., for whom at least one allergen immunotherapy service was allowed.

From this universe of 202,359 beneficiaries, we selected 400 to create the beneficiary sample. Next, we defined the service universe as all Part B allergy and ancillary services allowed in 2001 for members of the beneficiary universe.

The service universe comprised 4,325,670 services, with $130,388,941 allowed. To obtain the service sample, we randomly selected four services billed for each sampled beneficiary. Since some beneficiaries had fewer than 4 services allowed in 2001, our sample contained 1,434 services. 

FIGURE 2 Graphical representation of the sample 

After selecting the cluster sample, we requested medical records from all providers who billed at least one allergy service in 2001 on behalf of the sampled beneficiaries. 

We requested that each provider send all records related to each beneficiary’s allergy treatment, including the patient’s history and the results of allergy tests. 

We made at least two follow-up requests to each provider who did not respond to our initial request, for a total of three contacts. Our overall response rate was 96 percent, because eight physicians did not respond to our repeated requests for records, and we chose not to contact eight others.

We contracted with allergist/immunologists and otolaryngic allergists to review the records using a protocol we developed in collaboration with the medical reviewers.The protocol had two parts. 

First, the reviewers determined if the beneficiary’s allergy care as a whole met Joint Task Force standards. Then, the reviewers determined if each individual service in the sample was medically necessary. 

If the physician reviewer found that the beneficiary was an appropriate candidate for immunotherapy, a Certified Professional Coder then determined if each service was documented adequately and billed according to the definitions in the 2001 CPT Manual. We did not share the results of our review with the Medicare carriers that paid for the services.

Along with the medical and coding reviews, we analyzed legislation, Medicare regulations, and Medicare and carrier LMRPs related to allergy services and compared them to the Joint Task Force standards. Because we reviewed only allergy and related services provided in 2001, our results cannot be extrapolated to other periods. 

Accordingly, we make no inferences to subsequent years. However, to our knowledge, the Centers for Medicare & Medicaid Services (CMS) has made no national policy changes that would impact the incidence of allergen immunotherapy payment errors since 2001.

This study was conducted in accordance with the “Quality Standards for Inspections” issued by the President’s Council on Integrity and Efficiency and the Executive Council on Integrity and Efficiency. 

Sixty-two percent of the allergen immunotherapy and related services allowed by Medicare in 2001 did not meet program requirements, resulting in $75 million in improper payments 

Medicare allowed approximately $130 million in 2001 for allergen immunotherapy and related services. According to our medical review, 31 percent of these services were not medically necessary (and, therefore, noncovered). 

An additional 7 percent were miscoded and 29 percent were undocumented. Six percent had multiple errors, yielding an overall error rate of 62 percent.13 Figure 3 groups the improperly paid services in our sample by the type of error and gives statistical projections of these errors to the population. 

Medically unnecessary. Medical reviewers determined that 31 percent of the allergen immunotherapy and related services Medicare allowed in 2001 were not medically necessary because immunotherapy was not indicated or the beneficiary had been on allergy shots for an excessive length of time. 

Immunotherapy services were more likely (34 percent) to be medically unnecessary than allergy tests (5 percent) or ancillary services (11 percent).

Medically unnecessary: Not indicated. There was no clinical basis for approximately 15 percent ($17 million) of the allergen immunotherapy and related services that Medicare beneficiaries received. 

Medical reviewers determined that the allergy test results for 74 percent of these cases (i.e., of the 15 percent that did not have a clinical basis) did not indicate that the beneficiaries had any allergies, and 3 percent were not supported by any allergy test. 

The rest were not medically necessary because patient histories did not demonstrate that allergy shots were likely to alleviate the beneficiaries’ complaints or had never been completed.

Medically unnecessary: Excessive duration. According to our reviewers, 24 percent ($24 million) of allergen immunotherapy and related services were provided to beneficiaries for whom allergy shots were indicated originally, but whose duration of treatment exceeded Joint Task Force standards. 

The reviewers found some of these services to be medically unnecessary because the beneficiaries had not experienced any clinical benefits after 1 year of maintenance treatment. 

Other services were deemed unnecessary because the beneficiaries had been on immunotherapy for extended periods of time without evidence that such an extended course of immunotherapy was needed. 

Miscoded. In 2001, Medicare allowed approximately $13 million for allergen immunotherapy and related services that were billed with a code that did not accurately reflect the service provided.

If these services had been coded properly, Medicare would have allowed only $9 million, yielding an overpayment of $4 million. The most common error was billing CPT code 95117 (two or more injections of an allergen extract) when the documentation showed only one shot was provided. 

Other problems included billing for a greater volume of extract than was actually prepared or billing preparation of a multi-dose extract vial as preparation of a more expensive, single-dose vial. In several instances, physicians coded nonallergy services—including two lupron injections, a vitamin B12 injection, and an echocardiogram—as allergy shots.