Miller Health Law Group on New Developments for CT, MRI and PET Providers

Providers of advanced diagnostic imaging services, such as magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET), need to be aware of two important developments. One is the disclosure notice to comply with the Stark Law; the other is the deadline to become accredited in order to be able to continue to bill Medicare for these services

The Stark Law

Section 6003 of the Patient Protection and Affordable Care Act (“PPACA”) has amended the “in-office ancillary services” (IOAS) exception to the Stark Law (42 U.S.C. Section1395nn). Briefly, assuming its requirements are met, the IOAS exception permits physicians who have a financial relationship with their own medical group to make referrals to the group for the furnishing of “designated health services” (DHS) paid for by Medicare, such as CT, MRI and PET, and permits the group to bill for the DHS.

Section 6003 of PPACA adds two new requirements in order to qualify for the IOAS exception with respect to CT, MRI and PET scan services provided to Medicare patients: (1) the referring physician must inform the patient, in writing, at the time of the referral that the patient may obtain these services from someone else, and (2) provide the patient with a written list of suppliers who furnish the service in the area in which the patient resides. “Suppliers” are defined to include other medical groups and independent diagnostic testing facilities, but not hospitals.

By its terms, Section 6003 of PPACA applies to services furnished after January 1, 2010. Given that PPACA was not signed by President Obama until March 23, 2010, this creates a legal impossibility with respect to services rendered before March 23, 2010. Some commentators have also questioned whether the Section 6003 disclosure requirements are currently in effect at all. The Centers for Medicare and Medicaid Services (CMS) has now resolved this ambiguity in its proposed 2011 Medicare Physician Fee Schedule (MPFS). The proposed 2011 MPFS provides that the new disclosure requirements will not go into effect until the effective date of CMS’ final regulations implementing Section 6003, which it proposes will be January 1, 2011.

The proposed 2011 MPFS further provides that the disclosure notice to the patient should include a list of at least ten other suppliers located within a twenty-five mile radius of the physician’s office location. If there are fewer than 10 suppliers within a 25 mile radius, then all such suppliers are to be listed. Further, the proposed 2011 MPFS provides that the list must include each supplier’s name, address, telephone number, and distance from the physician’s office location. Finally, under the proposed 2011 MPFS, a record of the patient’s signature on the disclosure notice must be maintained in the patient’s medical record.

Medical groups and other interested parties have until August 24, 2010, to submit their comments on the proposed 2011 MPFS.

Mandatory Accreditation of Providers of Advanced Diagnostic Testing Services

Pursuant to the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), physicians, medical groups and independent diagnostic testing facilities (IDTF) which bill the Medicare program for the technical component of advanced diagnostic testing services (including CT, MRI and nuclear medicine such as PET) will need to become accredited by January 1, 2012, in order to continue to provide and bill Medicare for these services. Accreditation must be by one of three national accreditation organizations approved by CMS. The three approved accreditation organizations and their telephone numbers are the American College of Radiology-(800)770-0145; the Intersocietal Accreditation Commission-(800)838-2110; and The Joint Commission Ambulatory Care Accreditation Program-(630)792-5286.

Providers and suppliers who have billed Medicare in the past six months for these services should expect to receive an instructional letter from their Medicare Carrier in the next six months advising them of their need to become accredited by January 1, 2012. CMS urges affected providers and suppliers to act as soon as possible to take the necessary action to become accredited by the deadline because CMS expects that the accreditation process may take as much as nine months to complete.

If you have any questions regarding the matters discussed in this edition of our Health Law Bulletin, please contact your regular Miller Health Law Group attorney.

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