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
Central Illinois Neuro Health Science
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.

For more information: http://nationaldecisionsupport.com/

For more information: http://nationaldecisionsupport.com/

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 by House Ways and Means Health 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 sought input from 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 Appropriate Use Criteria (AUC) for imagingMedicare 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. 

Posted in Access to Care, Congress, Guest Post, Health, Healthcare Costs, MACRA, Medicare, Regulatory Relief | Tagged , , , , , , , , , , , , , , , , , , , |

King Arthur or Don Quixote: What Kind of Knight are EHR Systems?

debGuest Post from Deborah L. Benzil, MD, FACS, FAANS
Chair, AANS/CNS Communications and Public Relations Committee
Vice Chair, Neurosurgery
Cleveland Clinic Foundation
Cleveland, OH

Electronic Health Records (EHRs) danced into the medical arena like a knight in shining armor.  Promised were the magical stuff of legends, like King Arthur and Excalibur including:

  • Legibility;
  • Speed;
  • Cost containment;
  • Improvement in quality outcomes;
  • Patient education; and
  • Patient empowerment.

ehr 3After its introduction and voluntary adoption by a small portion of the medical community, a $20 billion provision of a stimulus package in 2009 was designed to encourage use. The American Recovery and Reinvestment Act (Pub.L. 111-5) included the Health Information Technology for Economic and Clinical Health (HITECH) Act and with it, incentives from the Centers for Medicare & Medicaid Services (CMS) known as “meaningful use” or MU. It was, however, a bait-and-switch operation. Physicians were promised that the financial incentives would help offset the costs of acquiring electronic health records (EHR) and the regulatory burdens of the MU program were downplayed. Instead, the financial incentives came nowhere close to offsetting the real costs associated with implementing EHR systems, and MU has proven to be one of the most burdensome and frustrating federal government programs.

Thus, the reality of MU and EHR implementation has been more like the mad Don Quixote, tilting at hallucinatory windmills! Basic problems include:

  • Acquisition of EHR systems was expensive and time-consuming;
  • The better software systems were particularly costly and difficult to modify (and necessary modifications could not be shared across institutions);
  • Smaller practices often chose very basic systems that performed poorly;
  • Many practices opted out, accepting the penalties;
  • Physicians were rarely consulted in design of the systems resulting in administratively clumsy systems, ill-equipped for clinical and patient use; and
  • Health care settings were not designed to incorporate EHR use in a way conducive to enhance the patient-physician relationship.

Beyond these general issues, was yet another regulatory requirement to include patient education within the EHR system. Again, the purported goal of enhancing patient education was laudable, but the required implementation faltered badly. It was a predictable scenario because, once again, practicing physicians were not adequately involved in establishing the program requirements and components. What we got was EHR vendors creating milquetoast write-ups on limited topics sold at additional costs. Some examples:

  • Back pain material consisting of three paragraphs saying this is a common problem, not usually serious and call your doctor for any concerns;
  • No material on brain tumors; and
  • No content on routine post up for common spine surgeries.

This information is not regularly updated and is not held to any standard in form or substance. To make these educational documents available to patients, a physician must execute a series of 10-15 additional clicks on the computer to find and produce this mediocre material  (time the physician spends facing the computer rather than interacting with the patient). No “credit” is given to thoughtful, personalized patient information many doctors created for their practices or for the provision of information about excellent, unbiased website sources such as disease-specific groups (such as the Muscular Dystrophy Association, American Brain Tumor Foundation, or the Parkinson’s Foundation).

The educational elements of EHR were particularly onerous for surgeons and the surgical specialties. For one, we often see patients multiple times before and after surgery for a single problem (herniated disc, ruptured appendix, torn rotator cuff, etc.). As each of these visits counts separately, to avoid financial penalties, a physician has limited choices:

  • Provide the same material for each visit (how would you feel as a patient if your surgeon did this?);
  • Risk not meeting the requirement by only providing the information at the appropriate visit;
  • Supply unrelated information; or
  • Smudge things by clicking all the keys but then not giving it to the patient.

None of these options seems appropriate.

Recently, I was skimming through my Brown Medicine Magazine and was encouraged by some of the work being done that has real potential for lifting current EHRs much closer to King Arthur status. Elizabeth Toll, MD, a dedicated physician educator, refused to accept the miserable status quo of the EHR. Her efforts led to a multi-disciplinary conference, “The Patient, the Practitioner, and the Computer. Holding on to the Core of Our Healing Professional in a Time of Technological Change.” The work of this group recognized and acknowledged the potential benefits of these systems, especially for increased patient access to information and educational benefit but also the undisputed downsides. Notably, these include physician burnout and cost. Around 50 percent of a physicians’ time may be spent between the EHR and other desk work; an average emergency room visit is estimated at over 4,000 clicks! Because physicians are not involved in EHR design, decision-making and implementation, physician workflow is not the driver of the systems (the Israeli system was called out as a singular exception).

In related efforts, the Brown Center for Biomedical Informatics is devoted to finding functional and viable means to mine and coordinate real data, including extraction from commercial EHRs (currently a monumental challenge and gaping inadequacy of these systems) with the goal of improving quality and value across medical care.  The founding director, Indra “Neil” Sarkar, PhD, MLIS, astutely noted, “One thing that is essential in informatics is to avoid getting in the way of a doctor being a doctor.”

Many regulations have an origin of knightly purpose, as did the educational requirement heaped onto other meaningful use criteria of EHRs. The challenge is to ensure the resulting red tape does not lead to madness, to deterioration in the core of our healing profession, or to counter-purpose. In Don Quixote, Cervantes perceptively states,

“When life itself seems lunatic, who knows where madness lies? Perhaps to be too practical is madness. To surrender dreams — this may be madness. Too much sanity may be madness — and maddest of all: to see life as it is, and not as it should be!

“For neither good nor evil can last for ever; and so it follows that as evil has lasted a long time, good must now be close at hand.

“Too much sanity may be madness and the maddest of all, to see life as it is and not as it should be.”

The time has come to cut through many of the EHR mandates, to engage willing physicians in design and implementation, and to harness real technological power to create systems that deliver on the magical Excalibur promise.

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

Posted in Access to Care, Guest Post, Health Reform, Healthcare Costs, HIT, Regulatory Relief | Tagged , , , , , , , , , , , , |

Cost Post – Impact of Insurance Precertification on Neurosurgery Practice and Health Care Delivery

PAPre-authorization, prior authorization or precertification is a tool insurance companies use to limit the amount of services they provide for their customers. In essence, it’s a simple way to reduce costs by delaying or not approving planned, non-emergency (elective) surgery for patients who need it. The inefficiency and lack of transparency associated with prior authorization cost physician practices time and money. Furthermore, the lengthy complex processes can also have negative consequences for patient outcomes when treatment is delayed. Today’s post originally appeared in The Federalist. In the article, Richard Menger, MD, MPA, a neurosurgery resident, discusses prior authorization and highlights a study from the Journal of Neurosurgery which shows the impact of insurance precertification on neurosurgery practice and health care delivery. To read the full post, click here.

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

Posted in Access to Care, Cross Post, Health, Healthcare Costs, Regulatory Relief | Tagged , , , , , , , , , , , , , , , |