Final Standards for Allergen Extract Compounding under USP Chapter 797 The long-awaited new USP Chapter 797 standards on sterile compounding were released June 1 and take effect Dec. 1. Read the final approved USP letter here. Have questions? Attend the AAOA…
Revisions to USP Chapter 797 Open for Comment
Since the United States Pharmacopeia (USP) released a proposed update to Chapter 797 in 2015, AAOA has been working with other concerned organizations including the American Academy of Allergy, Asthma & Immunology, the American College of Allergy, Asthma, and Immunology, and the American Medical Association, to ensure that the chapter does not limit members’ ability to compound allergen immunotherapy extracts in their offices, limiting patient access.
The initial proposal treated all sterile compounds, including allergen extracts, as equally and inherently dangerous. In response, AAOA, as well as AAAAI and ACAAI, submitted comments to USP about the negative impact finalizing this proposal would have on patient access and the cost of this therapy. The Academy also participated in multiple roundtables with the USP and Food and Drug Administration (FDA) to prevent the initial proposal from being finalized.
This summer USP released a significantly revised Chapter 797. AAOA’s advocacy was a success. In this revision, the compounding of allergen extracts was restored as a separate section of the chapter, and the proposed revisions are aligned with current FDA guidance. The chapter articulates requirements for personnel training and evaluation, hygiene and garbing, and updated documentation requirements. There are specific requirements for the compounding surface and surrounding area. Notably, the controversial requirement that a hood be in place for compounding allergen extracts has been removed.
USP is accepting comments on the proposed Chapter 797 until November 30. The final chapter is expected to be released June 1, 2019 and to take effect on December 1, 2019. AAOA encourages members to comment in support of these revisions.
CMS Considering Changes to E/M Documentation and Payment
In the proposed CY 2019 Physician Fee Schedule (PFS), the Centers for Medicare and Medicaid Services (CMS) included a proposal to change how evaluation and management (E/M) services are documented and billed. The agency’s goal is to reduce the administrative burden of the documentation requirements on physicians.
Rather than requiring physicians to use the 1995/1997 guidelines, they would only be required to document a level 2 visit for new and established patients using either time, medical decision making, or the current guidelines under the proposal. CMS also proposed creating single payment levels for level 2-5 office visits for new and established patients to address the auditing concerns raised by the documentation proposal. They also proposed creating a primary care and complexity add-on code, the latter can be billed for allergy services, to address potential decreases in payment. Other payment proposals included a prolonged E/M service for an additional 30 minutes of time spent with the patient and applying a multiple procedure payment adjuster when certain procedures are billed with E/M visits.
One of the unintended consequences of this proposal was a proposed decrease in practice expense (PE) for certain allergy services. CMS created a new PE category for the single payment level E/M services, and this adversely impacted the indirect PE for allergy and other specialties. This change is of great concern to AAOA.
The physician community united in opposition to this proposal and urged CMS to implement certain documentation changes that could be implemented separately from the E/M payment changes and work with stakeholders to develop an alternative payment proposal. The American Medical Association has convened a joint CPT-RUC workgroup to develop an alternative coding proposal in response.
CMS is expected to release the final PFS rule on or around November 1 and only then will we know what policy will be finalized. It is unlikely that the agency will implement the policy as proposed, but it is hard to know how significantly it will be changed. AAOA will update members once a final policy is released and inform you how it will impact your practice.