The text of both of the discussions of the Independent Diagnostic Testing Facility (IDTF) regulations and of the specific regulations themselves are posted below in full. The fundamental changes from the earlier proposals are as follows:

1.      IDTF must maintain comprehensive general professional liability insurance in the amount of $300,000 per location.

2.      There will no longer be retroactive enrollment. The enrollment date will be the later of the completion of the application or the date the IDTF actually begins services, and enrollments will be processed through an online application.

3.      The IDTF will be required to provide updated information regarding any changes contained in the enrollment application regarding ownership, location, general supervision or adverse legal actions within 30 days of occurrence.

4.      The IDTF must have a documented complaint process. 

5.      The physician responsible for general supervision will not be ultimately responsible for the operations of the IDTF. The regulations will clarify that these responsibilities remain the responsibilities of the owners/shareholders.

6.      A physician may be responsible for only three IDTF sites, whether they be fixed or mobile. The responsibility clarification will not change the existing requirements for direct or personal supervision of tests.

7.      The sharing of facilities at fixed sites will be prohibited.

The specific requirements regarding these changes are listed in the proposed regulations and discussed in the comments below.

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