Advocacy Update Feb. 10, 2026
IN THIS ISSUE / Feb. 10, 2026
FDA finally confirms iPLEDGE changes reducing patient and prescriber burdens
Dermatology and allergy groups demand FDA preserve patch testing access
Five Medicare contractors will require additional training for superficial radiation therapy
Regulatory Advocacy
FDA finally confirms iPLEDGE changes reducing patient and prescriber burdens
Following relentless sustained advocacy by AADA, the FDA finally approved significant modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program. These changes will reduce administrative burdens for both prescribers and patients while maintaining patient safety,
The modifications include giving prescribers the option to allow patients to complete pregnancy tests outside of a medical setting (e.g. at-home pregnancy tests) during and after treatment, removing the waiting period requirement for repeat pregnancy tests for patients who missed their first 7-day prescription window, and removing the requirement for monthly documentation of counseling for patients who cannot get pregnant.
The changes will go into effect in 180 days, around mid-August of 2026. Until then, FDA will exercise enforcement discretion regarding pregnancy testing requirements, allowing prescribers to use pregnancy tests that are not performed in CLIA-certified laboratories, and permit patients to complete and report home pregnancy tests during and after isotretinoin treatment, if procedures are established to ensure accurate documentation of at-home pregnancy test results.
For more details, check out the Breaking News Alert.
Regulatory Advocacy
Dermatology and allergy groups demand FDA preserve patch testing access
The AADA demanded that the FDA preserve patient access to high-quality patch testing haptens (PDF). The demand was made in collaboration with the American Contact Dermatitis Society, American Academy of Allergy, Asthma and Immunology, and the American College of Allergy, Asthma, and Immunology. The AADA is concerned that the agency’s regulatory approach restricts access to essential patch testing haptens. The group requested a meeting to discuss comprehensive approaches to preserving patient access to high-quality patch testing haptens.
Regulatory Advocacy
Five Medicare contractors will require additional training for superficial radiation therapy
Five Medicare contractors finalized coverage determinations for superficial radiation therapy (SRT) for the treatment of nonmelanoma skin cancers. The Medicare Administrative Contractors (MACs) issued policies effective March 1, 2026 that recognize dermatologists as qualified physicians to perform SRT, but will require training through an accredited residency and/or fellowship program. This includes qualified dermatology programs with didactic and clinical experience in radiation treatment.
The Local Coverage Determinations (LCDs) do not prohibit dermatologists from performing SRT, but they do require training and expertise. These can be acquired through an accredited residency or fellowship program in an applicable specialty or subspecialty, which includes a qualified dermatology program with didactic and clinical experience in radiation treatment.
The AADA’s Dermatologic Contractor Advisory Committee (DermCAC) provided comments on the LCDs before they were finalized, noting that the Academy supports consideration of SRT as a secondary option for the treatment of basal cell carcinoma and squamous cell carcinoma, for use in special circumstances, such as when surgical intervention is contraindicated or refused and after the benefits and risks of treatment alternatives have been discussed with the patient.
In addition, the group also pushed back on the residency/fellowship requirement language, emphasizing SRT training for dermatologists may occur through other educational pathways outside of residency and fellowship. However, the MACs finalized the training requirement as is. The comments were drafted based on input from the DermCAC and were reviewed and approved by DermCAC members in the affected regions prior to submission.
The finalized LCDs were issued by National Government Services, Noridian Healthcare Solutions, Palmetto GBA, CGS Administrators, and WPS Government Services. The DermCAC is currently assessing next steps.
Regulatory Advocacy
AADA urged FDA to advance sunscreen innovation
On Feb. 2, the AADA asked the FDA to increase access to nonprescription drugs, including sunscreens. Coming in response to a request for information, the letter urged the agency to continue modernization efforts through streamlined regulatory review pathways (PDF) to support access to safe and effective UV filters.
AADA News
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