CMS Proposes Physician and Nonphysician Practices and Clinics Enroll as IDTFs

CMS has proposed new rules that would require any physician or nonphysician practitioner  * ("NPP") organization currently enrolled in Medicare Part B as a physician office, group practice or clinic to also enroll in Medicare as an Independent Diagnostic Testing Facility ("IDTF") if that organization provides diagnostic testing services other than diagnostic mammography, clinical laboratory tests or pathology tests.

In its July 7, 2008 publication of the Proposed 2009 Physician Fee Schedule rule, CMS proposes  revising the rules regarding diagnostic services billed under Medicare Part B. These proposed rules would:

1. apply the IDTF certification standards (found in 42 CFR § 410.33) to physician and  NPP offices, clinics, and group practices; 
2. require that diagnostic tests provided by mobile services be billed by that mobile  service regardless of where the test was performed; and
3. limit the amount of time an IDTF can submit claims after its billing number has been revoked.

As these are proposed rules, entities and individuals that may be affected by these rules are encouraged to submit comments to CMS for consideration before these rules are issued in their final form. Comments must be received by CMS no later than August 29, 2008.

1. Applicability of IDTF Certification to Physician Clinics and Groups.
CMS has provided substantial diagnostic testing quality of care safeguards for Medicare beneficiaries over the last two years through the addition of a number of IDTF certification requirements. CMS is now proposing that those certification standards should apply to diagnostic services performed by any physician or NPP entity that is currently enrolled in the Medicare program as a sole proprietorship or as an organizational entity such as a clinic or group practice.

Under the proposed rules, each physician or NPP organization furnishing diagnostic testing services (except diagnostic mammography services) must enroll as an IDTF for each practice location furnishing those services and would be required to meet most IDTF certification requirements, including, but not limited to:

• Having appropriately credentialed technical staff on duty to perform tests;
• Identifying a Supervising Physician with proficiency in the performance and interpretation of each type of diagnostic procedure furnished in the office;
• Limiting Supervising Physicians to supervising no more than three (3) locations; and
• Permitting unannounced and on-site inspections to confirm compliance with these standards.

However, physician and NPP organizations would be exempt from those IDTF certification standards that CMS believes are adequately met in the typical physician clinic and group practice. The standards that would not apply to physician or NPP organizations include:

• Maintaining comprehensive liability coverage of at least $300,000 per location;
• Establishing a formal clinical complaint process; and
• Posting the IDTF standards at the testing location.

In addition, physician and NPP organizations would be exempt from the certification standard that prohibits fixed-base IDTFs from sharing a practice location with another Medicare-enrolled individual or organization. However, a fixed-base IDTF enrolled by a physician or NPP organization could not: (1) lease or sublease its operations or its practice location to another Medicare-enrolled individual or organization; or (2) share diagnostic testing equipment used in the initial diagnostic test with another Medicare-enrolled individual or organization. These last two restrictions may very well bring about an end to arrangements whereby one practice leases access to equipment to another practice (e.g., "excess capacity leases," "tabletop arrangements," etc.), even when Medicare patients are not involved.

Under the proposed rules, physicians or NPP organizations that fail to enroll as an IDTF or to meet the applicable IDTF certification standards may be subject to claims denial for diagnostic testing services and the organizations could have their billing privileges revoked.
This rule would be effective September 30, 2009 for suppliers already enrolled in the Medicare program and January 1, 2009 for newly enrolling suppliers.

Solicitation of Comments.   CMS is also soliciting comments from the public on these proposed rules and a number of issues regarding these proposed rules, including:

• Should physicians or NPPs be permitted to conduct diagnostic tests without benefit of qualified nonphysician personnel and if so, under what circumstances? 
• Should the IDTF requirements be applied to all diagnostic testing services furnished in physicians' offices? For example, should the rule apply to diagnostic testing services such as electrocardiograms or other diagnostic testing services frequently furnished by primary care physicians?
• Should the rule's applicability to imaging services be limited to advanced, more costly diagnostic testing procedures such as MRI, CT, and PET?

2. Billing of Diagnostic Tests Performed by a Mobile Service.
CMS is also proposing a new enforcement standard for diagnostic tests performed by a mobile service. This proposed section 410.33(g)(16) would require that an entity furnishing mobile diagnostic testing services must be enrolled in the Medicare program and bill Medicare directly for these services. This  rule would be effective on the effective date of the final rule.

3. Billing After IDTF Billing Number Revocation.
Finally, CMS proposed to shorten the amount of time allowed for an entity to bill for diagnostic testing services after its IDTF billing number has been revoked. Currently, entities are allowed to continue billing for services furnished prior to the revocation date for up to 27 months after revocation. The proposed rule would require that all claims for services be submitted within 30 calendar days of the effective date of revocation.

If you have any questions about the possible application of the proposed rule to your business, or wish to discuss submitting comments on the proposed rule, please feel free to contact this article's authors, Jay Hardcastle or Scott Richardson or any member of the Health Care Team.

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* Nonphyiscian practitioners can include audiologists, clinical psychologists, and other practitioners licensed or certified to perform diagnostic tests reimbursable under Medicare Part B.