CMS published an interim final rule (with a comment period) on May 5, implementing several changes to the Medicare and Medicaid programs mandated by the Patient Protection and Affordable Care Act (PPACA). In the interim final rule, CMS exercised its discretion in expanding the requirements of the legislation in ways significant to imaging centers and radiology practices across the country. Notably, the rule places new burdens on providers to maintain written orders for imaging services and to indicate the legal name and national provider identifier (NPI) of the ordering physician or practitioner on the claim.The interim final rule represents one of the first efforts by CMS to issue rules implementing the requirements of the PPACA. In this effort, CMS addressed three separate issues. First, the new rule requires both the furnishing and ordering provider or supplier of Medicare Part B services to maintain documentation of the (apparently written) order or referral for seven years. Second, it requires providers and suppliers to include their NPIs on all Medicare enrollment applications, as well as on all claims submitted to the Medicare and Medicaid programs. Third, the rule requires physicians and other eligible professionals who order services for Medicare beneficiaries to be enrolled in the Medicare program or to maintain a valid opt-out record. The PPACA requires physicians who prescribe durable medical equipment (DME) or home health services to enroll in the Medicare program. It also gave CMS the authority to extend this requirement, by regulation, to other services, which CMS did by applying the requirement to imaging and other Part B services. The final rule requires physicians and eligible professionals who order (or refer patients for) any Part B items and services, excluding Part B drugs, to maintain an approved Medicare enrollment record or a valid opt-out record. Further, claims submitted for Part B items or services must contain the legal name and NPI of the physician or eligible professional who ordered, or referred the patient for, the item or service. If the item or service is ordered (or the patient is referred for it) by a resident or intern, the claim must indicate the teaching physician’s legal name and NPI as those of the ordering or referring supplier. According to CMS, Medicare administrative contractors will be instructed to reject claims from providers and suppliers for Part B items and services (excluding Part B drugs) if the legal name and NPI are not reported in the claim or if the ordering/referring physician or eligible professional does not have an approved enrollment record or valid opt-out. In the preamble to the final rule, CMS indicates that it reserves the right to apply these enrollment and ordering requirements to Part B drugs within the next year.Documentation RequirementsThe PPACA authorizes CMS to revoke, for up to one year, the Medicare enrollment of any provider or supplier who fails to maintain (and to provide access to) written orders or requests for payment for DME, certification for home health services, or referrals for other items and services, effective January 1, 2010. A requirement to maintain and to provide access to such documentation also is added to the general Medicare provider enrollment requirements of the Social Security Act. Moreover, the PPACA extends the OIG's authority to exclude individuals or entities from the Medicare program if they order, refer for, or certify the need for health-care services, but fail to provide adequate documentation to verify payment. The final rule implements these documentation requirements by requiring providers and suppliers who furnish DME, prosthetics, orthotics, and supplies (DMEPOS); home health services; and laboratory, imaging, or specialist services to maintain ordering and referring documentation for seven years from the date of service, including the NPIs received from physicians or eligible nonphysician practitioners. In addition, the final rule requires providers and suppliers who order DMEPOS; home health services; and laboratory, imaging, or specialist services to maintain ordering and referring documentation for seven years from the date of order, referral, or certification. The documentation of the order or referral must be supplied to CMS or the Medicare contractor upon request. It is unclear whether the final rule’s documentation requirements apply only to the technical-component provider/supplier of an imaging service. In many instances, the entity performing the technical component and the professional component is the same. It is frequently the case, however, that the professional services are performed by a radiologist or radiology group contracting with a hospital, imaging center, or physician’s office. The order is always placed with the technical-component provider/supplier; the interpreting physician does not have documentation of the order. Unfortunately, the final rule does not state whether the interpreting radiologist may rely upon the technical-component provider’s documentation of the written order. For the past year, Medicare Comprehensive Error Rate Testing (CERT) auditors have been demanding, of interpreting physicians, copies of orders for the imaging studies that they have interpreted and for which they have submitted claims to Medicare. Until now, apparently, there was no regulatory justification for these CERT audit requests. Until CMS provides greater clarity on this issue, radiologists providing professional services at an imaging site not owned by their practice might need to take steps to ensure that they have unrestricted access to documentation of the order or referral for the required seven-year period.  Submission of NPIsThe final rule requires all providers and suppliers who qualify for NPIs to include their NPIs on all applications to enroll in the Medicare program and on all Medicare and Medicaid claims for payment, including both paper and electronic claims. In addition, NPIs must be furnished to the state agency in connection with every Medicaid provider agreement. The PPACA requires the DHHS secretary to issue a regulation mandating that all Medicare, Medicaid, and Children’s Health Insurance Program providers and suppliers include their NPIs on enrollment applications. CMS issued the final rule to implement this statutory requirement. This aspect of the final rule does not depart from the current practice of most providers and suppliers. While the final rule creates the first federal regulation mandating submission of the NPI on the enrollment application and claim, the instructions for the Form CMS 855 Medicare Enrollment Application already requested disclosure of the NPI. The Medicare program has required fee-for-service providers and suppliers to use their NPIs on claims since May 23, 2008. Review Policies and ProceduresAlthough much of the interim final rule was required by various sections of the PPACA, CMS is exercising significant discretion in expanding the ordering and documentation requirements to imaging services. Members of a consortium of imaging organizations that includes the ACR®, the RBMA, the Association for Quality Imaging, the Healthcare Billing and Management Association, and AHRA: The Association for Medical Imaging Management are jointly filing comments on the interim final rule. Substantive changes in the rule could be made by CMS as a result of such comments. Until the rule is modified, however, imaging centers and radiology groups should review their document-maintenance policies and claims-processing procedures and make any necessary changes. The rule is effective on July 6, 2010, and comments to the rule will be accepted through the effective date. Thomas Greeson, JD, Esq is an attorney at Reed Smith LLP and is a member of the firm’s Life Sciences Health Industry Group. He is a partner resident in the firm’s Falls Church, Virginia, office; tgreeson@reedsmith.com. Paul Pitts, JD, Esq is an attorney at the firm and is a member of its Life Sciences Health Industry Group. He is an associate in its San Francisco, California, office; ppitts@reedsmith.com.