Allergen Immunotherapy and Related Services

INTRODUCTION

OBJECTIVE

To determine (1) if allergen immunotherapy and related services met Medicare coverage and documentation requirements, and (2) if allergen immunotherapy provided to Medicare beneficiaries was of a quality that met professionally recognized standards of health care.

BACKGROUND

Allergies: What are they, and how are they diagnosed and treated? 

One in six Americans suffers from allergies—hypersensitive immune reactions to substances that are harmless to nonallergic people. Specific allergy triggers, or allergens, vary among sufferers, but commonly include animal dander, molds, pollens, and foods. Allergy symptoms range from mild respiratory irritation to anaphylaxis, a systemic and potentially fatal allergic reaction.

An allergist uses allergy tests, along with his or her knowledge of possible environmental exposures and the patient’s history, to diagnose allergies and determine the substances to which a patient is allergic.

Prick and intradermal skin tests are the most widely used diagnostic tests, although blood tests and skin endpoint titration are sometimes used, particularly by otolaryngic allergists. Skin tests must be administered with positive and negative controls to properly interpret the patient’s reactions.

Several treatment options for allergies exist. If less costly measures are ineffective, the physician may start the patient on a program of allergy shots. 

In this treatment, also called allergen immunotherapy, a physician administers gradually increasing amounts of an extract containing one or more allergens until the patient reaches a maintenance dose. The patient’s symptoms should generally improve within 1 year of shots at the maintenance dose. 

If not, the physician should explore other treatment options. Since many patients experience a prolonged asymptomatic period after several years of successful immunotherapy, the physician should reevaluate the beneficiary’s need for continued treatment after 3 to 5 years of maintenance shots.

Allergy shots are generally safe, but involve a small risk of triggering adverse events, including anaphylaxis, and should be given only in a clinical setting appropriate for managing such reactions. 

Providers must be especially careful with the elderly, because older adults are more likely to have health problems or use medications that increase  the risks associated with allergy shots. 

In particular, the use of betablockerscan make anaphylaxis more severe and difficult to treat should it occur. Severe, uncontrolled asthma and significant cardiovascular disease also reduce a patient’s chance of surviving a systemic reaction to allergy shots. 

Immunotherapy for patients with such conditions is appropriate only if the benefits of treatment clearly outweigh the increased risks, e.g., the patient has a life-threatening venom allergy.

Medicare coverage of and requirements for immunotherapy services According to the National Claims History Data File, Medicare allowed $130 million for allergen immunotherapy and related services provided to 202,359 beneficiaries in 2001. 

As shown in Figure 1, $49 million was allowed for preparing allergen extracts and $51 million for injections, which are treated as distinct services for Medicare reimbursement. 

In addition, Medicare allowed $12 million for allergy tests furnished to beneficiaries on allergy shots in 2001 and another $12 million for ancillary services, such as office visits, billed by the provider of an immunotherapy service.

Provisions of the Social Security Act (the Act) and related regulations govern Medicare reimbursement of allergy services. 

Section 1862(a)(1)(A) of the Act, implemented by 42 CFR § 411.15(k), limits Medicare coverage to services that are medically necessary. Section 1833(e) of the Act, as reflected in 42 CFR § 424.5(a)(6), requires that providers furnish sufficient information to determine the amount due. 

In addition, section 1156(a)(2) of the Act requires that providers ensure that all health care services they bill to Medicare, including allergy services, are of a quality that meets professionally recognized standards of health care. 

“Professionally recognized standards of health care” are defined by 42 CFR § 1001.as “ Statewide or national standards of care that professional peers of the individual or entity recognize as applying to those peers practicing or providing care within a State.” The only national rules specific to Medicare coverage of allergen immunotherapy appear in the National Coverage Determinations Manual. 

Section 110.9 of the manual precludes reimbursement for allergen immunotherapy delivered via antigen drops placed under the tongue. Sections 110.11 and 110.13 limit certain types of testing and treatment for food allergies. 

Other Medicare manual sections provide rules for proper billing of allergy services, but contain no additional restrictions on coverage. In the absence of national rules, many carriers have instituted Local Medical Review Policies (LMRP) that address allergy services.

The Joint Task Force on Practice Parameters develops standards for the diagnosis and treatment of allergies that embody generally accepted practices within the profession. 

The three societies that make up the Joint Task Force — the American Academy of Allergy, Asthma, and Immunology, the American College of Allergy, Asthma, and Immunology, and the Joint Council of Allergy, Asthma, and Immunology—represent an estimated 95 percent of the allergist/immunologists practicing in the United States, according to the chair of the Task Force. 

In 1995, the Task Force published “Practice Parameters for Allergy Diagnostic Testing,” which outlines the proper use of clinical and laboratory tests for allergies. “Allergen immunotherapy: a practice parameter,” which was published in 1996 and updated in 2003, provides standards for evaluating and treating allergic patients. 

The Joint Task Force standards specify medical necessity criteria for, contraindications to, and the appropriate duration of allergen immunotherapy. They also outline proper procedures for administering allergy tests, preparing and delivering injections, and providing follow-up care. 

Because, to our knowledge, there exist no competing local or State standards for allergen immunotherapy, we considered the Joint Task Force standards to be “professionally recognized standards of health care” under section 1156(a)(2) of the Act. Appendix A lists the specific standards that are related to the findings in this report.