Preparation of Immunotherapy

Undocumented. We did not receive substantiating documentation for 433 of the 1,434 services in our sample (29 percent). Despite repeatedattempts, physicians did not provide any medical records for 29 of the services in our sample. 

The physicians who rendered another 404 of the services sent records that did not substantiate that any service was performed on the date claimed. Based on these findings, we estimate that Medicare allowed approximately $45 million in 2001 for undocumented allergen immunotherapy and related services. 

Although some cases of missing documentation may be attributable to billing errors (e.g., putting the wrong date on the claim form), others may represent services not rendered. In any case, claims for services that lack sufficient documentation to show that care was provided do not meet the requirements of section 1833(e) of the Act.

Services billed with codes describing the preparation of immunotherapy extracts were undocumented most frequently. Although the Joint Task Force stresses the importance of documenting the contents of allergen extracts, 62 percent of these services lacked any substantiating documentation. 

In the absence of national guidance, some carriers have adopted policies that diverge from professionally recognized standards of health care 

As stated in the background, Medicare has little national coverage policy addressing allergen immunotherapy. In the absence of national guidance, many carriers have instituted LMRPs that address allergy-related issues. Some local, and even national, policies contradict the Joint Task Force standards. 

For example, section 110.11 of the National Coverage Decisions Manual prohibits a particular, nontraditional, kind of immunotherapy for food allergies, but does not restrict the use of traditional immunotherapy for this purpose. 

The Joint Task Force standards, on the other hand, state that current scientific evidence does not support the use of any allergen immunotherapy modality in managing food allergies.

Another example concerns patients who self-administer their allergy shots. Although the Joint Task Force standards clearly and strongly state that immunotherapy should not be given at home because of the risk of adverse reactions, no national Medicare policy addresses the issue. 

Most LMRPs are consistent with the Joint Task Force and indicate that shots should be provided in a setting appropriate for managing potential adverse reactions. 

However, one local policy states, “it is expected that when the patient is stable on chronic therapy, [allergen immunotherapy] injections may be self-administered.”

The care provided to approximately 70 percent of Medicare beneficiaries who received allergen immunotherapy in 2001 was inconsistent with professionally recognized standards of health care

In addition to examining the medical necessity and documentation of individual allergy services, our reviewers also assessed each beneficiary’s entire course of immunotherapy. 

Since national Medicare coverage rules for allergen immunotherapy are very limited, we compared beneficiaries’ treatment to the Joint Task Force standards for allergy testing and allergen immunotherapy. 

Overall, 30 percent of beneficiaries received care that met all Joint Task Force standards examined, 26 percent received care that did not meet standards related to one of the areas listed below, and 44 percent received care that did not meet standards related to two or more of these areas:

• clinical indications for immunotherapy (20 percent),

• contraindications (13 percent),

• duration of immunotherapy (22 percent),

• allergy diagnostic testing (15 percent),

• preparation and provision of injections (22 percent), and

• follow-up care (44 percent).

Approximately 20 percent of beneficiaries who received allergen immunotherapy services in 2001 had no clinical need for treatment “Allergen immunotherapy should be considered for patients who have demonstrable evidence of [reactivity] to clinically relevant allergens,” but the medical records for one in five beneficiaries lacked evidence that allergen immunotherapy was medically necessary. 

According to the patient histories that were available (9 percent of beneficiaries did not have a history in their record), 3 percent of beneficiaries on allergy shots had medical problems for which immunotherapy is not appropriate treatment. 

For example, several patients received allergy shots for chronic hives or angioedema (a type of swelling), although no clinical studies support treating these conditions with immunotherapy according to the Joint Task Force standards. 

Whether or not immunotherapy was appropriate for their complaints, 17 percent of Medicare immunotherapy patients did not show sufficient reactivity on their allergy tests to warrant treatment. The medical records for four of these beneficiaries contained no indication that they had ever received an allergy test.

Thirteen percent of beneficiaries received immunotherapy despite contraindications that should have precluded it Approximately 13 percent of beneficiaries on immunotherapy had conditions for which our reviewers believed the attendant risk outweighed the potential benefit of allergy shots. 

The most common contraindications included taking beta-blockers and having compromised lung function. Other contraindications included a recent heart attack or arrhythmia, bypass surgery, chronic heart failure, prostate cancer, and previous stroke. Nearly 28 percent of the beneficiaries who received medically unnecessary immunotherapy also had contraindications.

Approximately 22 percent of Medicare immunotherapy patients continued treatment well beyond clinical norms without justification

The Joint Task Force standards state that if a patient has not experienced clinical improvement after 1 year of maintenance-dose immunotherapy, the physician should pursue other treatment options. 

Although approximately 9 percent of beneficiaries experienced no clinical benefit after several years of immunotherapy, they continued to receive shots on a regular basis. For example, one beneficiary remained on immunotherapy for 39 years, but still had significant allergy symptoms and needed numerous medications. 

The practice parameter also states that the physician and patient should reevaluate the need for continued immunotherapy every 3 to 5 years. Seventeen percent of Medicare immunotherapy patients received shots for longer periods, with no indication in the medical record that the physician had ever considered discontinuing immunotherapy. 

At least 10 percent of Medicare beneficiaries had been  on allergy shots for 20 years or more without a reevaluation. In one extreme case, a beneficiary received continuous immunotherapy for 47 years; the treating physician did not try new medications that had been developed during the 47 years, which may have eliminated the need for the shots. 

Also, the physician never attempted a trial cessation of immunotherapy, which our reviewers believed should have occurred in such a prolonged course of treatment.

Fifteen percent of beneficiaries on immunotherapy received inappropriate allergy tests

Based on “Practice Parameters for Allergy Diagnostic Testing,” approximately 6 percent of Medicare beneficiaries on immunotherapy received allergy tests to allergens to which they reported no exposure or for which allergen immunotherapy was not indicated. Some physicians administered skin tests for substances, such as bacteria or smog, for which skin testing is of unproven diagnostic value. 

Others tested beneficiaries with allergens to which they had little or no history of exposure. A few other beneficiaries received tests for multiple crossreactive allergens when a test for a single representative member of the allergen group would have sufficed.

Approximately 2 percent were tested to an excessive number of potential allergens, especially foods. “This is a record for me: 141 prick skin tests and 91 intradermal tests,” wrote one reviewer.

For the results of skin tests to be meaningful, they must be performed with appropriate controls and the test reagents must be provided at the correct strength.

Physicians used incorrect procedures, however, to test about 1 of every 10 Medicare beneficiaries on immunotherapy in 2001. The most common error was performing skin tests with no negative or positive controls, rendering accurate interpretation impossible. 

Physicians used reagents that were too strong for other tests, resulting in a high probability of false positive results. Physicians tested approximately 6 percent of beneficiaries using serial endpoint titration, a technique used primarily by otolaryngologists. 

Our reviewers stated that the physicians for 27 percent of these patients performed the technique or interpreted the results incorrectly. 

Twenty-two percent of beneficiaries received allergy shots that were prepared improperly, provided too frequently, or delivered in an inappropriate setting

Approximately 8 percent of all Medicare immunotherapy patients received an allergen extract that was not prepared according to Joint Task Force standards. More than half of these extracts combined incompatible allergens or contained an excessive number of allergens, both of which can reduce treatment efficacy. 

Others contained allergens to which the beneficiary had tested negative or that had no correlation to the beneficiary’s allergy history. Some beneficiaries (2 percent overall) received extracts containing allergens, such as foods and poison ivy, for which immunotherapy is not indicated.

Patients on a maintenance schedule should generally receive injections at 2- to 4-week intervals, but allergy shots were provided too frequently to approximately 11 percent of Medicare beneficiaries. 

Providers for these beneficiaries generally did not increase the amount of time between shots after a maintenance dosage was reached, which should normally be attempted, according to Joint Task Force standards. 

For example, one beneficiary received weekly shots for 28 years, without any indication that the physician ever tried longer intervals between shots.

At least 7 percent of beneficiaries received their allergy shots at home despite Joint Task Force standards that state “immunotherapy injections should not be administered at home because of the risk of inadequate recognition and treatment of systemic reactions.”

These beneficiaries administered their own shots or were treated by family members. According to the progress notes in her medical record, one beneficiary received shots “on the rode [sic]” in her mobile home. 

An additional 3 percent of beneficiaries received shots away from their allergy specialists’ offices, but in locations that were not identified in their medical records. 

Some Medicare immunotherapy patients did not receive adequate follow-up care

The Joint Task Force standards advise physicians to evaluate their immunotherapy patients every 6 to 12 months, but 24 percent of beneficiaries on allergy shots did not have regular follow-up visits with their allergy specialists. 

For example, one medical record showed that the patient had not seen her allergy specialist in more than 10 years. Another beneficiary, on immunotherapy for approximately 20 years, had no documented follow-up visits to his allergist.

Even when conducted, followup was inappropriate for 27 percent of beneficiaries. For example, approximately 7 percent of patients had routine periodic skin tests without clinical justification—one beneficiary was inappropriately retested every time she had an exacerbation of her symptoms and another had skin tests at least nine times during a 6-year period. 

Other providers made no note of the beneficiary’s response to immunotherapy or did not respond appropriately to changes in the beneficiary’s symptoms or the results of reevaluations.