February 14, 2007—On January 26, the Centers for Medicare and Medicaid Services (CMS) issued a last-minute transmittal containing significant changes to the 14 new compliance standards independent diagnostic testing facilities must meet in order to bill Medicare. The revisions create far stricter limitations on IDTFs than originally called for in the proposed rule published in the Federal Register last summer or the Final Physician Fee Schedule for 2007.

One such change would require IDTFs to be fully operational, fully staffed, and fully compliant with all 14 regulations before being allowed to apply for Medicare billing, requiring immense capital output. Not lessening the financial onus placed on IDTFs is a rule prohibiting facilities from collecting Medicare payments retroactively to the time their application was received. An alteration to another standard prohibits IDTFs from sharing space and equipment with other Medicare suppliers; this change is presumably an attempt to block controversial leasing agreements.

“A lot of people are asking whether CMS may have gone a bridge too far by putting these in the Program Integrity Manual in stead of the regulations,” W. Kenneth Davis Jr, JD, attorney with Katten Muchin Rosenman LLP, Chicago, told ImagingBiz.com. “CMS may have gone farther than it has the authority to do. It may have effectively issued regulations without going through the federal rule-making process. Someone may challenge it.”

—Cat Vasko