FDA Issues Draft Guidance on Regulatory Oversight of Lab Tests – On September 30th, the Food and Drug Administration (FDA) released draft guidance concerning the proposed oversight framework for regulating laboratory developed tests. To view the draft guidance, click here. King & Spalding will distribute a more detailed description of the draft guidance in an upcoming client alert.

MACs Begin Sending Fingerprint Requests – Medicare Administrative Contractors (MACs) have begun sending fingerprint request letters pursuant to CMS’s recently implemented fingerprint-based background requirements. These letters, which will be sent to the correspondence and special payment addresses on file with Medicare, will list all owners who are required to be fingerprinted. If identified individuals are not fingerprinted within 30 days from the date of the letter, the provider or supplier may face denial of its Medicare enrollment application or revocation of Medicare billing privileges. More information is available here.