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IDTF rules for physician offices nixed for 2009

Radiology Administrator's Compliance and Reimbursement Insider, January 1, 2009

Last summer, CMS wanted to require physicians with in-office diagnostic services to enroll in Medicare and meet the performance standards for IDTFs. As proposed, the annual changes to the Medicare Physician Fee Schedule (MPFS) required physician offices to:

  • Have a supervising physician with expertise in each type of diagnostic procedure performed in the office
  • Maintain equipment and inventory according to IDTF guidelines
  • Have credentialed technical staff members on-site

The proposal excluded mammography (there are already extensive accreditation requirements for breast imaging services under the Mammography Quality Standards Act of 1992) and certain physician organizations.

Nevertheless, it had seemed likely, at least during the summer months, that these additional standards would become CMS payment requirements. But enough outpouring of physician concern led CMS to back away from including the IDTF rule in its final rule, released in the Federal Register November 19. CMS deferred this requirement, a move that caused relief for some and worry for others. 

“How the final fee schedule will be perceived will likely depend on who you ask,” says Joshua M. Kaye, a partner at McDermott Will & Emery, LLP, in Miami, and chair of the firm’s Health Transaction Practice Group. 

Praise for IDTF rule delay

Trade organizations such as the Medical Imaging and Technology Alliance (MITA), an Arlington, VA–based trade association representing medical imaging companies, commends CMS’ decision. In an October 31 statement, MITA praised CMS for reconsidering, saying the rule “would have drastically limited patient access to diagnostic medical testing, including life-saving medical imaging technologies.”

MITA argued that IDTF requirements were overly stringent for physicians’ offices, and that inclusion of the changes in the final rule would, in effect, stop many phy-sicians from providing imaging services in their offices.

The Access to Medical Imaging Coalition (AMIC), an advocacy group based in Washington, DC, echoed MITA’s statement. “The more you try to regulate these physicians as IDTFs, the less likely it will be that the physician will be able to provide access and convenience to their patients, which will slow the dispersement of services,” says Tim Trysla, executive director of AMIC and an attorney at Alston & Bird in Washington, DC. “If physicians have to go through all of these hoops to treat the Medicare population, they’ll often limit their exposure to that group.”

The IDTF standard of participation is very detailed, says Eleanor Kerr, director of government affairs at the healthcare division of Siemens in Washington, DC, a MITA member. MITA argued that such a comprehensive standard should not be applied to a cardiologist or gynecologist who has limited imaging equipment and capability. “We think many physicians would have had to stop offering those services in their offices, and that would add extra stops for the patient,” Kerr says. “The motivation is the notion of making sure providers are adequately trained and using good equipment, of course, but there was no reason to take a sledgehammer approach to it.”

 CMS decided it doesn’t need to do anything on this issue, thanks to imaging accreditation requirements included in last summer’s passage of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), says Maureen Zilly, MITA’s director of government relations in Rosslyn, VA. (See “MIPPA maintains accreditation emphasis” on p. 4.) 

If CMS had included the IDTF requirements for physician offices in the MPFS, it would have been “duplicative and burdensome” for providers to comply with new Medicare regulations and the new MIPPA rules, says Zilly.

Trysla, a former senior policy advisor to the administrator at CMS, acknowledges that the agency’s motivations in proposing the changes—increasing quality and safety—are legitimate, but says the point is moot with MIPPA in the works. 

Disappointment varies

Physician practices that perform diagnostic imaging will probably be pleased with the rule since it’s consistent with prior rulemaking under the Stark Law, Kaye says. 

However, “from the IDTF perspective, the medical imaging perspective, I’d say that there is likely a mixed bag of frustrations,” Kaye says. “To some extent, the medical imaging companies out there could perceive that CMS is placing the focus at deterring fraud and abuse in the wrong place.”

The American College of Radiology (ACR) isn’t happy about the decision. In a written statement, ACR says it “believes that all providers in every practice setting should be required to meet all quality and performance standards that are required of IDTFs and accredited sites.”

Most of the comments CMS received regarding the MPFS came from physicians who complained about the rigor and burden of the proposed rules, says Thomas W. Greeson, Esq., a partner at Reed Smith, LLP, in Falls Church, VA. 

“It is disappointing that CMS veered in their direction instead of implementing the rules now,” Greeson says. “CMS worked hard to create an effective tool that might curtail increasing utilization of high-demand diagnostic imaging services, but in the end, they failed.”

In deferring the rule, CMS does not hold physician offices to the same standard as IDTFs, Greeson says. And that means some physicians without radiology experience could expose patients to unacceptable levels of ionizing radiation simply because they are not accredited according to a strict and uniform standard, he adds.

Physician practices have long been the subject of an increasingly complex web of CMS rules and regulations. These include the Stark Law and the anti-kickback statute, which restrict the ability to share space and equipment and have radiologists supervise the services performed. 

“Yet it’s the physician practices that are often the catalyst for the [type of] sharing arrangements that CMS is concerned with,” Kaye says.

Essentially, the MPFS final rule allows physicians to provide and profit from in-office ancillary services (e.g., diagnostic imaging exams) with little or no restructuring.

Understanding the rules

For now, most facilities that perform diagnostic imaging tests must enroll with Medicare as IDTFs. However, physician offices with diagnostic imaging equipment remain free of this Medicare requirement and can bill for the technical component of the diagnostic tests as long as the office:

  • Is a physician practice owned directly or indirectly by one or more physicians or a hospital
  • Is a facility that primarily bills for physician services and not for diagnostic tests 
  • Is a facility that furnishes diagnostic tests primarily to patients whose medical conditions are being treated or managed on an ongoing basis by one or more physicians in the practice
  • Performs and interprets diagnostic tests at the same location where the practice physicians treat patients

In the proposed rules set forth in July, CMS suggested that supervising physicians would have to be proficient in the performance and interpretation of the test billed to Medicare Part B. But Greeson says CMS created a loophole in revisions to its anti-markup rule. 

Because of the anti-markup loophole, physician offices with high-tech in-office diagnostic services will be able to appoint a nonradiologist to serve as the supervising physician for the office’s equipment, Greeson says. 

“So these practices can use anyone with a medical degree to supervise, even though that person may have no qualifications to supervise MR, CT, PET, or other such equipment,” he notes. Now, there is “no limit on how many sites any one physician can supervise. Under the IDTF rules, they would have been limited to supervising three at the most.”

Mobile rules remain

Although physician offices have avoided IDTF requirements for now, mobile diagnostic testing services have not.

The final rule requires all entities that provide mobile diagnostic testing services to bill Medicare directly for their diagnostic tests except when the tests are furnished to hospitals under arrangement. This requirement becomes effective January 1, 2009. 

CMS strongly implied in its commentary on the final 2009 rules that the direct billing requirement will prohibit physicians from billing for diagnostic tests performed using equipment and technicians leased from a mobile entity, noted legal firm Foley & Lardner, LLP, in its November Legal News Alert. 

Instead, the mobile entity will be required to enroll and bill Medicare directly.

Implications remain 

Although referring physicians who use MR, CT, or PET in their offices have dodged the IDTF/accreditation bullet for 2009, they still have to prepare for accreditation.

As Kaye notes, improvements in technology will allow physician offices to buy more complex equipment at lower prices. Physicians and their patients will con-tinue to see this as an important and convenient resource in the greater scope of patient care services. These improvements will likely result in more physician practices becoming interested in offering imaging and diagnostic services.  

“Taking all of that into account ... one would have to expect that more tests are going to be ordered,” Kaye says, adding that more tests ordered translates into more dollars paid out by the Medicare program, which should be reason enough for CMS to try to limit physicians’ ability to profit from these services.

MIPPA maintains accreditation emphasis

Physician practices performing imaging exams need not worry about Medicare’s Conditions of Participation for ITDFs yet. But they will need to comply with new accreditation mandates thanks to the July passage of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Beginning January 1, 2012, providers of advanced diagnostic imaging—MRI, CT, and PET—must be accredited by a designated organization to receive reimbursement for services, according to Section 135 of the law. 

This form of universal mandate for accreditation will be far less of a burden on providers than the proposed IDTF rule in the Medicare Physician Fee Schedule, says Tim Trysla, executive director of the Access to Medical Imaging Coalition and an attorney at Alston & Bird in Washington, DC.

“This will be a great first step [toward improving] quality of care and safety for patients,” Trysla says, adding that the accreditation required by MIPPA represents a seismic shift toward increasing quality while protecting patient access to imaging services. 

With three years to go before accreditation becomes mandatory, CMS has a lot of work to do. It still needs to go through its usual process of delineating the rules for accreditation and appointing accrediting bodies, says Eleanor Kerr, director of government affairs at the healthcare division of Siemens, a member of the Medical Imaging and Technology Alliance in Washington, DC.

CMS has not yet chosen the accrediting bodies but will likely do so by 2010. 

Although not set in stone, CMS could choose the American College of Radiology (ACR) of Reston, VA, or the Intersocietal Accreditation Commission (IAC) of Columbia, MD, since both organizations have extensive experience accrediting imaging entities. 

In a July statement, IAC applauded Congress for passing MIPPA and requiring providers to obtain accreditation to receive reimbursement for services. Although the requirements won’t take effect until 2012, the best time to think about accreditation is now, Kerr says. 

“To the extent that providers are able to prepare for accreditation, they definitely should,” she says, adding that many providers already apply for and obtain accreditation, and those who may not understand the process should at least begin to conduct some research.

Many physician practices that provide medical imaging services have already obtained accreditation to improve quality, says Trysla. “There is not the penetration [of accredited physician practices] we would like yet, but many are seeking it out,” he says. “It will be mandatory soon, but providers [should] be getting accredited now [even] without the stick of the federal government.” 

Note: RACRI subscribers can access a special report that includes common accreditation questions and answers from the ACR and IAC at www.hcpro.com/content/71716.pdf; scroll to p. 9.

To read an article in the October RACRI containing tips to prepare for accreditation, visit our archives at www.hcpro.com/content/220573.cfm.

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