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LCD Reference Article Response To Comments Article

Response to Comments: Allergy Testing (L36402)

A54842

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Article ID
A54842
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Article Title
Response to Comments: Allergy Testing (L36402)
Article Type
Response to Comments
Original Effective Date
03/18/2016
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Allergy Testing (L36402). Thank you for the reviewing this draft policy and the comments.

Response To Comments

Number Comment Response
1 Request to increase limit of 50 patch tests for a year since it seemed a bit low. The standard North American series has 55 in it. We have increased the number of patch tests for a year to 55.
2 Request to remove the restriction for in vitro allergy testing. This person stated this testing allowed provider to better control patient’s triggers and reduce additional and unnecessary referrals and medications. It was also stated that there is so much modern literature showing equivalence or near equivalence performance of current IgE testing methods that the extraordinarily narrow populations eligible for testing (e.g. mentally ill persons or persons with generalized ichthyosis) no longer represents a rational position. Another expressed that the referral to a specialist for initial allergy testing is not only medically unnecessary it would increase the number of patients in allergist’s office which would result in delaying the diagnosis and treatment for patients. Overall, skin testing is quick, safe, and cost-effective. It remains the test of choice in most clinical situations where immediate hypersensitivity reactions are suspected. Patch Testing is the gold standard method of identifying the cause of allergic contact dermatitis. In vitro testing for inhalant allergens (pollens, molds, dust mites, animal danders), foods, insect stings, and other allergens such as drugs or latex, when direct skin testing is impossible due to extensive dermatitis, marked dermatographism, or in children younger than four years of age is allowed in the policy. It is covered when skin testing is not possible or would be unreliable; or medically reasonable and necessary as determined by the physician. When in-vitro testing is ordered or performed, the medical record must clearly document the indication and why it is medically necessary to be used instead of skin testing. It is not covered when done in addition to a skin test for the same antigen, except in the case of suspected latex sensitivity, hymenoptera, or nut/peanut sensitivity where both the skin test and the in-vitro test may be performed. Indications for in vitro testing are based on research and national guidelines. We will remove the statement, “In-vitro testing is not as sensitive as skin testing” from the policy.
3 Writer requested that in vitro IgE testing and skin prick allergy testing be given parity. It was stated that modern versions of serologic IgE testing are accurate in vitro techniques for determining whether a patient's serum contains IgE antibodies against specific allergens of clinical importance, and is considered to be equivalent with skin prick testing as a confirmatory test for food and inhalant sensitizations. Studies showed that the medical history with an assessment was the most valuable tool. Following this history taking, based on clinical judgment it could be determine whether to test with skin testing, in vitro testing, or both. All allergy testing must be medically reasonable and necessary to be covered by Medicare.
4 The proposed LCD specifies that, for in vitro IgE testing, 12 allergens/panel, but no more than 2 panels/beneficiary over a 12 month period will be covered. There is no clinical rationale for why the unit limits for in vitro IgE testing should differ from skin prick testing according to the writer. The writer agreed that it is rarely necessary to test for more than 50 allergens, and that fewer than 30 allergens are sufficient. We recommend that the unit limits for skin prick testing and in vitro specific should be at parity, and limited to 30 allergens/beneficiary over a 12-month period. We will change the statement to, “In vitro IgE testing will be limited to 30 allergens / beneficiary over a 12 month period.”
5 Adjunctive Testing The proposed LCD suggests that it is reasonable and medically necessary to perform skin testing in addition to in vitro IgE testing for the same antigen without any allergen specificity restrictions, if in vitro sIgE testing is inconclusive. However, the proposed LCD does not consider it reasonable or medically necessary to perform in vitro IgE testing for the same antigen, if skin testing is inconclusive, except in cases of suspected latex, hymenoptera, and peanut/nut sensitivities. The clinical rationale for this double standard is unclear. Hamilton, 2010 notes that: “Improved screening of patients for allergic disease can be achieved when epicutaneous skin test and serologic measurements of IgE antibody are used together.” We request that the final LCD allow for adjunctive testing for either skin prick testing or in vitro testing if an inconclusive result is observed, excluding instances where skin testing cannot be performed due to contraindications. Skin testing is to be done first and if it is inclusive, the in vitro IgE would be appropriate. No changes to the LCD.
6 Skin testing is performed almost exclusively by allergy specialists, and with rare exceptions, unavailable in primary care settings. Asthma alone impacts over 25 million people in the US. With allergy testing indicated by the NIH Asthma Guidelines for at least persistent asthmatics, and fewer than 4000 allergy specialist FTEs (full-time equivalents) in the US,1 it is logistically impossible for the entire population of patients suffering from asthma and other allergic diseases, requiring allergy testing, to be referred to allergy specialists for skin testing. This policy will lead to many unnecessary referrals, and more importantly unnecessary delays in treatment of many individuals. Delays in care will likely lead to increases in both downstream and overall costs for CMS and the patient. Providing access to in vitro sIgE tests under the same medical necessity criteria and diagnosis codes as skin testing, will help reduce health disparities by enabling primary care providers to deliver the standard of care as indicated by the NIH guidelines in managing patients with asthma and other allergic diseases – especially those from underserved populations. We agree that the NIH Asthma Guidelines suggest allergy testing for asthmatics. As stated in the LCD, Allergy Immunotherapy (L36408), “The physician prescribing immunotherapy should be trained and experienced in prescribing and administering immunotherapy. For those providers without formal training moving into an allergy type practice, ongoing yearly training specifically for allergy testing and treatment should be evident in CMEs. If any Medicare entity requests documentation of training, formal training or ongoing CME updates, this information must be made available. The CMS Publication 100-02 Medicare Benefit Policy Manual, Chapter 15, Section 50.4.4.1 states that Antigens need to be prepared by a physician who is a doctor of medicine or osteopathy who has examined the patient and has determined a plan of treatment and a dosage regimen. Antigens must be administered in accordance with the plan of treatment and by a doctor of medicine or osteopathy or by a properly instructed person (who could be the patient) under the supervision of the doctor.
7 One comment was received stating the LCD text represents a position that might have been held in the 1960s or 1970s. For example, the LCD carefully covers “RAST” or radioimmunassay tests, which are a defunct technology. Modern IgE testing (e.g. ImmunoCAP) are comparably sensitive and specific to skin testing, and entirely avoid an entire class of problems with human skin test performance that has been well-described in the clinical allergy literature. Simple tests such as skin prick testing (SPT) and serum food-specific IgE testing are the most commonly used diagnostic tests to evaluate for IgE-mediated food reactions. The policy lists Radioallergosorbent test (RAST), fluoroallergosorbent test (FAST), and multiple antigen simultaneous test (MAST) under limitations and states that, “these tests are not appropriate in most general allergy testing. Instead, individual IgE tests should be performed against a specific antigen.”
8 Writer proposed changes to the WPS LCD for the entire IN VITRO TESTING. Changes were not made as no peer-reviewed scientific medical evidence was provided to support the changes.
9 Several physicians agree that in many cases the most commonly administered initial screening patch test series(e.g. T.R.U.E), now consisting of 36 allergens, is unable to capture all clinically relevant data. The North American Contact Dermatitis Group Patch Test Results: 2011-2012 utilized a 70 patch test series in a standardized testing protocol. It was revealed that up to one-third of positive reactions discovered by the set of 70 allergens would have been missed by the more limited screening patch test series that is referred to in this LCD. Another study determined that the screening patch test series commonly used in the United States fully evaluates only 25 to 30% of patients with acute contact dermatitis. (Annals of Allergy, Asthma, and Immunology, 100 IgE(3):Supplement 3. March 2008) The LCD now states, “These allergens are part of a useful, but limited series of 36 allergens. While this series of 36allergens represents some of the most common contact allergies, there are a significant number of patients who suffer intractable contact dermatitis for which the 36allergens are inadequate to diagnose their problem. A supplemental series of allergens in this case can enhance accurate diagnosis, patient education, and treatment. This supplemental series is particularly critical in the diagnosis of occupationally induced dermatitis. If another supplemental series of allergens are clinical indicated for an accurate diagnosis, the documentation must support the medically reasonable and necessary use of the additional allergens.”
10 Several individuals stated, with the covered procedure sentence listing covered exposures could we add another sentence, stating, “Patch tests may also be used and may be helpful when a distribution and persistence of a dermatitis suggests a possible contact allergy, but the exact etiology of the dermatitis is not known. “ The statement was added as requested.
11 The focus on measuring the wheal and flare of a skin prick test, as discussed on page 9, could confuse the staff charged with evaluating documentation for patch tests. We suggest that a separate paragraph devoted to patch testing be added. Specifically, we advise that the paragraph include the following: The medical record should include the time after application that patch tests are read and a reading for each patch test applied, expressed as: - (Negative), IR (Irritant reaction), +/- (Equivocal or Slight), + or 1+ (Weak positive), ++ or 2+ (Strong positive), and +++ or 3+ (Extremely reactive) We added the following under documentation requirements: There should be a permanent record of the allergy test and its interpretation including the test methodology and measurement (in mm) of reaction size of both wheal and erythema response or a standardized grading system in vivo testing.
12 One comment was received that the draft LCD is straightforward and a clearly conceptualized document. Thank you for reviewing the draft LCD and the positive feedback.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36402 - Allergy Testing
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