Tissue Policy Group (TPG) Update
AATB to Meet with the FDA Regarding the 36-month Discretionary Period
Subsequent to the AATB TPG in-person meeting in October, the AATB and the AATB TPG requested a meeting with the FDA to further discuss the 36-month discretionary period. The FDA promptly responded to that request, and the joint meeting occurred April 3, 2019. In addition to the in-person meeting with the FDA, the AATB TPG hosted a series of Hill visits and a luncheon briefing on April 4, 2019.
AATB Responds to the New Tissue Registration Process
On November 9, 2018, the Food and Drug Administration (FDA or Agency) formally transitioned the tissue registration process from Form 3356 to the Electronic Human Cell and Tissue Establishment Registration (eHCTERS). Upon further reviewing the process (especially as it related to the listing of "other" tissue products), the AATB and AATB TPG sent a letter to the FDA requesting that the agency reinstate the ability of establishments to list "other" HCT/Ps as part of the tissue listing process by modifying eHCTERS to accept "other" HCT/P types. Further, due to the likely lag time to implement the change, we urged FDA to grant publicly announced enforcement discretion for "other" HCT/P types until 60 days after implementation. An alternative would be to allow submission of hard copy Form 3356 for "other" HCT/P types until eHCTERS can be modified. The FDA has acknowledged receipt of the letter, but has not yet formally responded. The AATB expects that this was a topic of discussion at the recent FDA meeting on April 3, 2019.
AATB Supports the Biological Implant Tracking and Veteran Safety Act
For the past several years, the AATB and the AATB TPG have been working with Congress to sign into law the "Biological Implant Tracking and Veteran Safety Act" – legislation to enhance the ability to "track and trace" within facilities serving veterans. This critical legislation contains two key items – (1) requirement for tissue procured by the facilities only be sourced from tissue processors accredited by the AATB or similar national accreditation organization; and (2) clarification that procured human tissue can be labeled with any of the three systems already identified by the FDA, namely GS1, Health Industry Business Communications Council (HIBCC), and ICCBBA. On January 15, 2019, Rep. Roe (R-TN) introduced H.R. 547, the "Biological Implant Tracking and Veteran Safety Act of 2019." The AATB TPG sent a letter of support for this legislation. While the legislation may not become law, the letter of support ensured an ongoing relationship with this key office.
TPG Provides Key Information re: CMS Requirements
Given some confusion among hospitals regarding the implementation of key CMS requirements, Hart Health Strategies prepared a memo which explained the various regulatory concepts related to tissue tracking. Specifically, the memo provided an overview of key regulatory concepts -- the FDA's tissue regulations which require the use of a distinct identification code (DIC), the FDA's final Unique Device Identifier (UDI) rule which required the DIC to be captured, the Office of the National Coordinator for Health Information Technology (ONC) final 2015 certification rule which required the DIC to be parsed, to the CMS rule which required hospitals to implement the 2015 certification criteria or receive penalties.