New Regulations Threaten Patient Access to Allergy Shots

Patient Access to Allergy ShotsThe AAAAI is spreading the word that newly proposed regulations from the United States Pharmacopeia (USP) could dramatically limit patient access to allergen immunotherapy (allergy shots). These proposed regulations were the subject of a public comment period, which is now closed.

Thank you to everyone who submitted comments to USP during this public comment period and to all who shared the AAAAI’s petition to save patient access to allergy shots. The response from AAAAI members and their patients was extraordinary.

Keep reading for more information about how these changes may affect you, if they are finalized.

What are allergy shots and who is proposing these new regulations?
Allergy shots, also known as allergen immunotherapy, are an important treatment for allergic diseases that has substantially improved patient care, reduced emergency room visits, decreased medication costs and decreased hospitalization.

As mentioned above, the new regulations are being introduced by the United States Pharmacopeia (USP). There is no data in the peer-reviewed medical literature that allergy shots have ever caused infections in patients, but this is the concern driving USP to propose these new guidelines.

If these new regulations go into effect, how will it impact patients?
The more extensive procedures for mixing under the new regulations would make it highly unlikely that allergists would be able to continue to mix allergen extracts for their patients in the office setting.

Non-healthcare system employed physicians will have very limited options to secure allergy immunotherapy prescriptions for their patients. There are only two facilities that have been identified as resources for this service in the United States. Having to use outside facilities may limit the timelines of allergy shot treatment, among other consequences. Also Medicare currently does not cover allergen immunotherapy manufactured by a third party vendor. Thus, Medicare recipients, and potentially commercially insured patients, would no longer have allergen immunotherapy as a covered service. USP’s proposed requirements would directly transfer the cost of a previously covered benefit to the beneficiary.  

"The AAAAI recognizes and supports the USP's goal to assure patient safety, but disagrees that allergy immunotherapy compounding as currently practiced places patients at risk for infectious complications. There have been no reported adverse infectious complications from an allergy immunotherapy injection in the 100 plus years of use. What is at risk is patient access to a proven effective treatment that can alleviate allergy symptoms, halt progression of allergic disease, improve patients' quality of life and in the case of insect allergy prevent fatal allergic reactions while potentially saving millions of dollars in health care resources,” said AAAAI President Robert F. Lemanske, Jr., MD, FAAAAI.

How did the AAAAI respond to these changes?
The AAAAI collaborated with the American College of Allergy, Asthma & Immunology and its Advocacy Council; the American Rhinologic Society; the American Association of Otolaryngic Allergy; the American Academy of Otolaryngology-Head and Neck Surgery; and the Allergy and Asthma Network to develop comments to send to USP.

You can read our letter here.

Click here updates on the situation.

This article has been reviewed by Thanai Pongdee, MD, FAAAAI

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