who provide allerge immunotherapy to Medicare beneficiaries

RECOMMENDATIONS

Allergen immunotherapy services, while valuable, often are provided in an inappropriate manner and result in a significant number of improper Medicare payments. 

As allowances for allergen immunotherapy and related services have increased from $130 million in 2001 to approximately $171 million in 2003, so has Medicare’s vulnerability to related payment errors. 

Also, current national Medicare policy on immunotherapy is limited, and some national and local policies do not reflect current professionally recognized standards of health care.

Therefore, we recommend that CMS:

Instruct its carriers to educate physicians who provide allerge immunotherapy to Medicare beneficiaries about existing coding, documentation, and coverage requirements 

Develop national coverage criteria for allergen immunotherapy that are based on professionally recognized standards of health care

In addition to these recommendations, we have forwarded information on the medically unnecessary, miscoded, and undocumented services identified in our sample to CMS for appropriate action.

AGENCY COMMENTS

In its comments to our draft report, CMS stated that it is prepared to develop and disseminate educational materials and develop new coverage criteria for allergen immunotherapy services. 

CMS has identified two possibilities for developing national coverage criteria for allergen immunotherapy: adapting criteria directly from current professional society standards or opening a National Coverage Determination. 

CMS states that either option would require up to 12 months to fully implement,and that educating physicians on existing coding, documentation, and coverage requirements depends on the course chosen for developing national coverage criteria. 

OFFICE OF INSPECTOR GENERAL RESPONSE

We appreciate CMS’s support for our recommendations to increase physician education and to develop national coverage criteria based on professionally recognized standards of health care. 

Since the CMS letter identifies various methods for implementing the recommendations, we request that CMS provide to us an action plan that clarifies the specific steps it intends to take to fully implement the recommendations. 

Professionally Recognized Standards of Care We compared the findings of our medical review with the professionally recognized standards of health care found in the 2003 version of “Allergen immunotherapy: a practice parameter” and “Practice Parameters for Allergy Diagnostic Testing.

” Although “Allergen immunotherapy” was updated in 2003, our contracted allergy specialists stated that the standards therein were considered “good practice” for many years prior, and are, therefore, applicable to services provided in 2001.

“Allergen immunotherapy” expresses the standards as a series of “summary statements,” each addressing a single topic related to immunotherapy. 

“Allergy Diagnostic Testing” consists primarily of similar one- or two-sentence guidelines. The particular summary statements and guidelines relevant to our analysis are quoted below. “Allergen immunotherapy: a practice parameter”

Summary Statement 9. Immunotherapy is effective for treatment of allergic rhinitis, allergic asthma, and stinging insect hypersensitivity. Therefore, immunotherapy merits considerations in patients with these disorders.

Summary Statement 10. Clinical studies to date do not support the use of allergen immunotherapy for food hypersensitivity, chronic urticaria, and/or angioedema. Therefore, allergen immunotherapy for patients with these conditions is not recommended.

Summary Statement 11. Clinical parameters, such as symptom scores and medication use, may be useful measures of the efficacy of immunotherapy in a clinical setting. Routine periodic skin testing or in vitro IgE antibody testing of patients receiving immunotherapy is not recommended.

Summary Statement 14. Patients taking β-adrenergic blocking agents may be at increased risk when receiving immunotherapy, because [beta]-receptor blockade can make treatment of anaphylaxis more difficult. Therefore, [beta]-adrenergic blocking agents are relative contraindications for immunotherapy.

Summary Statement 15. Medical conditions that reduce the patient’s ability to survive a systemic reaction are relative contraindications for allergen immunotherapy. Examples include severe asthma uncontrolled by pharmacotherapy and significant cardiovascular disease.

Summary Statement 16. Allergen immunotherapy should be administered in a setting where procedures that can reduce the risk of anaphylaxis are in place and where the prompt recognition and treatment of anaphylaxis are assured.

Summary Statement 17. Allergen immunotherapy should be considered for patients who have demonstrable evidence of specific IgE antibodies to clinically relevant allergens. 

The decision to begin allergen immunotherapy depends on the degree to which symptoms can be reduced by avoidance and medication, the amount and type of medication required to control symptoms, and the adverse effects of medications. Patients who wish to avoid or reduce the long-term use of medications are good candidates for immunotherapy.

Summary Statement 18. Patients with severe, poorly controlled asthma are at higher risk for systemic reactions to immunotherapy injections.

Summary Statement 21. The components of a clinically relevant vaccine (and, therefore, a vaccine that is most likely to be effective) should be selected on the basis of a careful history of relevant symptoms, knowledge of possible environmental exposures, and correlation with positive tests for specific IgE antibodies.

Summary Statement 22. The immunotherapy vaccine should contain only clinically relevant allergens.

Summary Statement 23. Immediate-type skin testing has been the primary diagnostic tool in clinical studies of allergen immunotherapy. Therefore, in most patients, skin testing should be used to determine whether the patient has specific IgE antibodies. Appropriately interpreted and well performed [sic] in vitro tests for specific IgE antibodies may also be used.

Summary Statement 24. Immunotherapy is effective for pollen, fungi (molds), animal dander, dust mite, cockroach, and Hymenoptera sensitivity. Therefore, immunotherapy should be considered as part of the management program in patients who have symptoms related to exposure to these allergens and in whom the presence of specific IgE antibodies has been established.

Summary Statement 25. In the mixing of an allergen vaccine, the following factors must be considered: (1) the cross-reactivity of the allergens, (2) the optimal dose of each constituent, and (3) enzymatic degradation of the allergens.

Summary Statement 26. The selection of allergens for immunotherapy should be based in part on the cross-reactivity of clinically relevant allergens. Many related pollen contain allergens that are cross-reactive. 

When pollen allergens are substantially cross-reactive, selection of a single pollen within the cross-reactive genus or subfamily may suffice. When pollen allergens are not substantially cross-reactive, testing for and treatment with multiple locally prevalent pollen [sic] may be necessary.

Summary Statement 27. The efficacy of immunotherapy depends on achieving an optimal therapeutic dose of each of the clinically relevant constituents in the vaccine.

Summary Statement 28. Separation of aqueous extracts (vaccines) with high proteolytic enzyme activities (e.g., fungi, dust mites, cockroach, and insect venoms) from other extracts (vaccines) is recommended.

Summary Statement 43. When the patient has reached a maintenance dose, the interval between injections can often be progressively increased as tolerated to 4 to 6 weeks.

Summary Statement 44. Clinical improvement usually is observed within 1 year after the patient reaches a maintenance dose.

Summary Statement 45. Patients should be evaluated at least every 6 to 12 months while they receive immunotherapy.

Summary Statement 46. A decision to continue or stop immunotherapy should be made after 3 to 5 years.

Summary Statement 47. The vaccine contents, informed consent for immunotherapy, and administration of vaccines should be carefully documented.

Summary Statement 48. The preferred location for the administration of allergen immunotherapy is the office of the physician who prepared the patient’s vaccine.

Summary Statement 49. Generally, patients at high risk of systemic reaction should receive immunotherapy in the office of the physician who prepared the patient’s vaccine. 

Summary Statement 50. Regardless of location, allergen immunotherapy should be administered under the supervision of an appropriately trained physician and personnel.

Summary Statement 51. Immunotherapy injections should not be administered at home because of the risk of inadequate recognition and treatment of systemic reactions. 

Summary Statement 55. In older adults, medications and co-morbid medical conditions may increase the risk from immunotherapy. Therefore, special consideration must be given to the benefits and risks of immunotherapy in older adults. “Practice Parameters for Allergy Diagnostic Testing”

• To properly interpret allergy skin tests that detect immediate hypersensitivity, both positive (histamine) and negative (diluent) controls need to be performed.

• The appropriate clinical indications for retesting may include changing symptoms, new exposures, 3 to 5 years of venom immunotherapy or evaluation of newly discovered, purified, or standardized allergens.

• Avoidance measures and extract formulations for immunotherapy should be based on the skin tests coupled with adequate clinical correlation, i.e., integrating with the history and physical findings obtained by face-to-face contact with the patient.

• A prick/puncture skin test wheal response of at least 3 mm (with equivalent erythema) > than the diluent control done at the same time is required as proof of the presence of allergen specific IgE.

• The larger the prick/puncture skin test reaction, the more likely it is to be of clinical significance. However, the presence of a positive prick/puncture skin test per se does not establish whether clinical sensitivity currently is present.

• As a general rule, the starting test dose of intracutaneous extract solutions in patients with a preceding negative prick/puncture test should range between 100 and 1,000 fold dilutions of the prick/puncture test solution.

• Any reaction larger than the negative control may indicate the presence of specific IgE antibody. However, given the lower specificity of intracutaneous testing, small positive reactions may not be clinically relevant.

• The evaluation of inhalant allergy may require up to 70 prick/puncture tests followed by up to 40 intracutaneous tests, which are ordinarily performed when prick/puncture tests are negative. 

Under special circumstances and in certain geographic areas, a greater number of prick/puncture and/or intracutaneous tests may be appropriate. However, in many parts of the country and probably in most cases, fewer tests are required.

• The number of prick/puncture tests performed for suspected food hypersensitivity may vary from less than 20 to as many as 80 tests, depending on the clinical situation.

•for such agents as newsprint, formaldehyde, tobacco smoke, smog, cotton, sugar, and human dander, there is insufficient evidence to justify their use as allergen test reagents.