The Next Wave: Compliance With Medicare IDTF Standards Requires Ongoing Diligence

To say that the health care regulatory environment has been active over the past two years would be an understatement. The focus of this article is Medicare: the primary payor for health care services in this country and, often, the standard by which other payors establish their payment rules. Revisions to Medicare regulations often foretell what can be expected from other payors. Changes to Medicare regulations in the past two years have been especially challenging for IDTFs. While basic rules for IDTFs were established by CMS in 2000, consistent enforcement of these rules did not begin in earnest until 2005. With the implementation of certain aspects of the DRA and the IDTF standards in 2007, IDTFs have experienced an almost exponential growth in regulatory pressures. In order to succeed, IDTF providers must actively seek to stay current in the ever-changing Medicare regulatory environment. In July 2008, CMS issued proposed changes to the IDTF standards1 (proposed rules) that, if finalized as presented, will change the business environment for all nonhospital-based outpatient imaging providers. Couple this with impending accreditation and physician/technologist qualification requirements under the Medicare Improvements for Patients and Providers Act² enacted in July 2008, and the stage is set for significant regulatory changes in the imaging industry. While other regulatory pressures exist at federal and state levels, Medicare may be the most significant regulatory force that diagnostic imaging faces in today’s health care environment. Regulatory Equality Evolution The evolution of regulatory equality has been slow. Prior to the July 2008 activity, there was no regulatory equality when comparing the three main providers of diagnostic imaging services; hospitals, physician practices, and IDTFs. The table demonstrates that prior to the recent changes, imaging IDTFs were often held to a higher standard relative to their regulatory obligations as Medicare providers. Column three demonstrates the impact of the proposed regulations. Medicare regulations are often created in response to issues that arise in our industry. These issues may relate to quality concerns, efforts to reduce costs, or past abuse of the system. Regardless of their genesis, laws, rules, and regulations are here to stay, and we are obligated to operate our businesses in a manner that seeks to comply with them. Assuming that the proposed changes to the IDTF standards are included in the final rules, physician practices performing imaging services in their offices, including radiology practices, will have to meet many of the standards that IDTFs have been meeting for the past several years. Because the rules are proposed, this article will deal only with those that are likely to be included in the final rule. Proposed Rule: All Nonhospital Imaging Providers Will Become IDTFs The first assumption is that any nonhospital provider of outpatient imaging services will be required to enroll the diagnostic testing portion of its practice as an IDTF. The IDTF portion of the physician practice will then have to comply with the IDTF standards found under 42 CFR §410.33 (with a few minor exceptions). The proposed exceptions for physician practices are noted below. The first step in doing the right thing is to understand the rules. IDTF and physician-practice leaders must take the time to become knowledgeable about the Medicare rules and regulations governing their facilities. The key regulations governing diagnostic imaging and IDTFs are found at 42 CFR §410.32 (“Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and other Diagnostic Tests, Conditions”); and at 42 CFR §410.33 (“Independent Diagnostic Testing Facility”). The IDTF standards are found at 42 CFR §410.33(g). CMS provides guidance on the IDTF regulations in its online manual system at http://www.cms.hhs.gov/Manuals/IOM/list.asp: publication 100-08, Medicare Program Integrity Manual: chapter 10, section 4.19 (Revised March 14, 2008); and publication 100-04, Medicare Claims Processing Manual: chapter 35 (new chapter, revised May 16, 2008). CMS has also developed a site-review checklist for its Medicare contractors. This form will assist you in preparation for a site visit. The form, CMS 10221, is available online at http://www.cms.hhs.gov/CMSForms/.
Table 1. Each Medicare carrier or Medicare administrative contractor (MAC) has the authority to specify requirements for technologists’ and supervising physicians’ qualifications. Not all carriers have published such requirements. Where the carrier/MAC has not been specific, the IDTF is left with the more nebulous requirement that the supervising physician(s) must show “evidence of proficiency in performance and interpretation of each type of diagnostic procedure performed by the IDTF.”4 For an imaging IDTF, this is generally interpreted by the carriers/MAC as meaning that supervising physicians must be radiologists for most CPT codes. Some carriers require board certification and some do not. It is important for IDTF leadership to become familiar with the requirements of its carrier/MAC. Nonphysician practitioners (advanced registered nurse practitioners, physician assistants, and clinical nurse specialists) cannot substitute for a physician in fulfilling the supervisory requirements.5 Services provided without meeting the physician-supervision requirements are not considered reasonable and necessary.6 Technologists’ qualification requirements also vary by carrier/MAC. Some require specialty certification in modalities such as CT, MRI, ultrasound, and bone densitometry. Each technologist performing Medicare scans must meet the specific state and carrier/MAC licensure and certification requirements for each scan when that scan is performed. The carrier/MAC is also directed to review payroll records to substantiate performance of procedures by qualified technologists.7 Demonstrating Compliance It takes planning to have a successful Medicare site visit and to show compliance with the IDTF standards. Some standards are simple and others are more complex. They may be divided into three groups; the direct standards, the operational standards, and the ongoing standards (see 42 CFR §410.33[g]). Under the direct standards, an IDTF must:

• maintain a physical facility (based on a US Postal Service address);
• have its testing equipment at the facility, and there must be a catalog of permanent and mobile equipment listing the name, model, and serial number of each piece of equipment;
• maintain a telephone number that is available in the telephone book or through directory assistance;
• post the IDTF standards for the public (this is not required for physician practices under the proposed rule); and
• clearly post its hours of operation (visible to the public) and be accessible to the Medicare carrier during the posted hours of operation for an unannounced site visit (this is not required for physician practices under the proposed rule).

The operational standards require initial work and understanding, but little ongoing effort once the policies are established. The IDTF must ensure that technical staff meet state and federal licensure and certification standards (including qualification standards defined by the Medicare carrier). The challenge is to recruit and retain certified technologists when other entities competing for scarce employee resources (physician practices and hospitals) may not require modality certification. Equipment must be calibrated and maintained in accordance with manufacturer’s specifications, and the IDTF must maintain records of such calibration and maintenance (and may be required to present records during the site visit). Medical records must be stored on-site or must be available within two days of a request by the Medicare carrier. The IDTF must disclose on its enrollment application any individual with ownership, financial, control, or legal interest in the facility at the time of enrollment (or within 30 days of a change in such interest). The IDTF must maintain liability insurance and must be able to produce documentation of the insurance during a site visit (additional insurance is not required for a physician practice under the proposed rule). You must provide the Medicare surveyor with the name and contact information for the agent and insurance carrier to permit verification of the IDTF’s liability insurance coverage at the time of the site visit. The ongoing standards require ongoing diligence. The IDTF must agree not to solicit patients directly. This includes direct-marketing efforts, such as telephone campaigns aimed at individual patients in order to influence their choice of provider. This does not include mass advertising (including billboards and television/radio advertisements). The IDTF must operate its business in compliance with all applicable laws and regulations. The Medicare enrollment application (855B), including the information on attachment 2, must be kept current in a timely manner. The Medicare carrier/MAC must be notified within 30 days of changes in ownership, physical location (address), or general supervising physician, as well as of adverse legal actions. Other changes, such as additions or deletions of technologists, interpreting physicians, equipment, test codes, and direct supervising physicians, are to be updated with the Medicare carrier/MAC within 90 days of the change. The IDTF must document and answer patient complaints about clinical services provided by the IDTF. A patient-complaint policy must be written and implemented (this is not required for physician practices under the proposed rule). The specific elements that must be documented are included in the published IDTF standards. With the exception of mobile IDTFs and IDTFs that are physically within a hospital facility, IDTFs are prohibited from sharing space, equipment, or operations with any other Medicare-enrolled individual or entity. An IDTF cannot sublease a portion of its physical address or time on its equipment to or from another Medicare provider. This includes a prohibition on an IDTF subleasing space in its facility to a Radiology Practice and leasing per-click or block time on the IDTF’s equipment to other physicians (where the leasing physician bills the services as in-office ancillary to his or her practice). These prohibitions became effective on January 1, 2008, with the exception of current space-sharing arrangements, which have until January 1, 2009 to be dissolved.8 Failure to meet the IDTF standards can result in denial of an enrollment application or an update to a current application, loss or delay of billing privileges, and, in some cases, revocation of the IDTF’s provider number.9 Being adequately prepared is the key to a successful Medicare site visit. The comment period on the proposed rule ended on August 29, 2008, and the final rule will be published before the end of the year. Many questions remain to be answered in the final rule. The answers promise to affect the imaging industry significantly. In addition, the next two years are likely to see significant change in the Medicare program as Congress continues its efforts to address deficit reduction, health care spending, and health care fraud and abuse. The diagnostic imaging industry needs to remain aware and active in educating Congress on the cost-effective, high-quality services that it provides.