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Unnecessary Regulatory Burden: Appropriate Use Criteria for Advanced Diagnostic Imaging

ann 2Ann R. Stroink, MD, CPE, FAANS
Chair, AANS/CNS Washington Committee
System Medical Director, Neurosciences Quality and Educational Program Development
Senior Neurosurgeon CINHS

Bloomington, IL


scanOrdering X-rays or other diagnostic imaging used to be purposeful and easy. Physicians, whether primary care or specialists, would see the patient, take a history and perform a careful physical and neurological exam to arrive at a preliminary diagnosis. This medical information (suspected diagnosis and pertinent clinical features) would be conveyed to the radiologist via a requisition form so that he or she could focus on critical clinical details while reading the requested images. Now that is what I call quality — patient-centered, efficient, timely and effective care. All of that changed, however, when the government began the heavy-handed regulation of the practice of medicine.

By the mid-90s physicians were directed to use International Classification of Diseases (ICD) diagnostic codes to replace the “old fashioned” requisition forms. The rationale: diagnostic codes were created and relied upon to show medical necessity, which is the crux of reimbursement. From that time forward, radiologists who rendered the imaging tests were blinded to the actual clinical diagnosis needed to perform a high quality focused read; instead, they were given diagnostic codes selected from a long list of options.

Now on the horizon is a new layer of regulations that will add to the complexity of ordering imaging tests: the Protecting Access to Medicare Act of 2014, or PAMA. PAMA establishes an appropriate use criteria (AUC) program for advanced diagnostic imaging services provided to Medicare beneficiaries. Under the program, every health care professional who orders an advanced diagnostic imaging test (e.g., MRI, CT, nuclear medicine, fluoroscopy and PET scans) must consult AUC using a clinical decision support mechanism (CDSM). A “qualified” CDSM is defined as an “interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient’s specific clinical condition.” The AUC program also sets up a complex exchange of communication of AUC consultation information between the ordering professional to the furnishing professional. Physicians ordering imaging must use AUC clinical decision support software certified by the Centers for Medicaid & Medicare Services (CMS), and the furnishing professionals must report the following information on Medicare claims:

  • Which qualified CDSM was consulted by the ordering professional;
  • Whether the service ordered would adhere to specified applicable AUC, would not adhere to specified applicable AUC, or whether specified applicable AUC was not applicable to the service ordered; and
  • The NPI of the ordering professional (if different from the furnishing professional).

Some industries and physician-led entities have joined the bandwagon in developing the new AUC software programs for use in this program. The American College of Radiology (ACR) has developed one such AUC tool, as have others. And while multiple medical specialties, including neurosurgery, work with the ACR to create relevant AUC, the additional regulatory burden and costs (including licensing and software fees, which are estimated to be $75,000 in a recent study conducted by the Association for Medical Imaging Management) associated with this program are substantial.

If this regulation is fully integrated into the practice of medicine, the consequences will be time-consuming documentation processes that impose substantial costs on physician practices already suffering from rising overhead. The number of physicians affected by this program is extensive, crossing the multiple disciplines of specialty and primary care. The workload alone will be time-consuming. For example, a specialty physician may see a number of patients who require advanced imaging to establish a diagnosis and/or follow up evaluation. The imaging needs are determined at the time the doctor sees the patient. During that time with the patient, the doctor will then consult a CDSM, which will be housed on a separate website that has met CMS requirements for certification. After reviewing a number of codes, one is selected to match as close as possible the reason for ordering the exam, and a decision support number (DSN) is then generated and recorded so that the order can be placed.

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This gives pause to ask: will this enhance quality or is this an agenda to reduce costs by a complicated scheme that serves as an additional barrier to ordering tests and takes away from face to face time with a patient? The fact is, we will have more regulation and burden that adds time and costs to physician practices and may delay necessary diagnostic tests for patients. In reality, will our radiologists of the future ever be advised of the real clinical reason for ordering a test, or will they only be concerned with receiving the DSN so they can perform and get paid for the test?

Several efforts have been initiated to stop and/or delay the implementation of these mandatory AUC programs. The AANS and CNS are leading a coalition of specialty societies seeking legislative efforts to scrap the AUC program, citing various reasons to do so:

  • The AUC program was enactedbefore Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which already includes a robust Medicare Quality Payment Program (QPP) that shares the same goals of the PAMA program. It is, therefore, unnecessary to have a complicated side-car program that is not integrated with the QPP, is administratively burdensome and is not linked with quality.
  • Concerns that the AUC program is more costly to administer than the potential savings it could generate.
  • The law is financially advantageous to the developers of the CDSMs, which house and sellthe AUC tools at the expense of clinicians who order advanced diagnostic imaging tests.

Organized neurosurgery remains vigilant in articulating its concerns about the AUC program with governmental agencies. Earlier this year, the U.S. Department of Health & Human Services (HHS) launched a physician regulatory relief initiative inviting some physician organizations to speak with then Secretary Tom Price, MD, and CMS administrator Seema Verma. The AANS and CNS were invited to participate, and we focused our discussions on the redundancy and burdens for physicians associated with the AUC program. At the subsequent HHS Cut the Red Tape Summit, we again raised neurosurgery’s objections to the AUC program.

red tape AUC 2Additionally, Congressional committees are actively seeking avenues for reducing regulation through the “Medicare Red Tape Relief Project,” which was announced earlier this year byHealth Subcommittee Chairman Pat Tiberi (R-Ohio). This project is tasked to provide relief from burdensome regulations and mandates that drive up costs, limits innovation and undermines timely care for Medicare beneficiaries. House Ways and Means Committee Chairman Kevin Brady (R-Texas) expressed strong support for this project and soughtfrom a variety of health care providers and medical organizations, including neurosurgery. To date, the AANS and CNS have submitted three comments to the Medicare Red Tape Relief Project based on our top priorities:, Medicare Global Surgery Data Collection and Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) improvements. We also joined the Alliance of Specialty Medicine in submitting comments on additional topics of concern.

Here’s the bottom line: Serious concerns about redundant regulations have arisen with the AUC advanced diagnostic imaging program need to be addressed. Although delays have been implemented, the AUC program is still scheduled to begin in January 2020. As physicians, we need to actively work with Congress and CMS to explore the use of more standardized, less burdensome mechanisms for reporting data and stop costly, unnecessary over-regulation that fails to deliver on quality. To do less will be a serious disservice to our patients.

Editor’s Note: We encourage everyone to join the conversation online by using the hashtag #RegRelief.

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