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As the medical community braces for implementation of the Protecting Access to Medicare Act (PAMA) by the Jan. 1, 2020 deadline, some wonder if it's even feasible or if another program delay is on the horizon.

The policy, aimed at reducing unnecessary testing, mandates that all advanced diagnostic imaging orders go through an algorithm that provides key confirmation codes required when Medicare is billed later on for the service.

Dubbed a "clinical decision support mechanism" (CDSM), this software processes each CT, MRI, nuclear medicine, and PET order before spitting out its verdict to the ordering professional: "appropriate," "maybe appropriate," or "rarely appropriate," according to a certain set of appropriate use criteria (AUC).

Essentially, the CDSM confirmation code provides proof that the ordering physician consulted AUC. Eventually, Medicare will not pay claims or advanced imaging without these codes.

The program has been delayed several times, and the 2020 deadline equates to a "soft launch," as improper imaging claims won't be rejected until the following year, with no firm deadline for additional penalties beyond that. Still, many physician organizations have raised concerns about the policy.

"To be clear, we are all for AUC. We want to apply the AUC but not in this fashion," cardiologist Rami Doukky, MD, MSc, of Cook County Health and Hospitals System in Chicago, who also sits on the board of directors of the American Society of Nuclear Cardiology (ASNC), said in an interview. "The way PAMA requires AUC to be implemented is very prescriptive, very limiting to physicians, with the potential for unintended consequences."

Doukky said he and the ASNC are asking that the Centers for Medicare and Medicaid Services (CMS) postpone PAMA implementation "until we come up with an alternative way to apply AUC and practice value-based imaging."

The ASNC is one of more than that have asked CMS to loosen the AUC program requirements.

An Uncertain Road Ahead

For now, CMS has identified eight (suspected coronary artery disease, suspected pulmonary embolism, headache, hip pain, low back pain, shoulder pain, lung cancer, and cervical or neck pain) that flag outlier physicians who order too many inappropriate tests.

These outliers may become subject to prior authorization if they demonstrate a pattern of non-compliant orders.

But what happens to individuals who do not correctly report their CDSM codes? How will clinicians be scored on their adherence to AUC? How are claims even processed?

Specific instructions for PAMA have not yet been released, and CMS hasn't decided when penalties that force the worst offenders to get prior approval will begin.

Only after the program has its concrete plans laid out can the "tremendous amount of provider education" take place, Doukky suggested.

Early PAMA adopters are currently in a voluntary reporting period that ends in December. Once January 2020 hits, the program officially starts with a , the American College of Radiology (ACR) explains on its website, during which physicians are not penalized for incorrect reporting.

The formal start date is Jan. 1, 2021; after that, Medicare will reject noncompliant claims.

"This program is, to my knowledge, unique in the history of health informatics in creating a nationwide regulatory requirement for implementation of something -- comprehensive imaging clinical decision support -- that no one has yet done successfully," complained radiologist John Mongan, MD, PhD, of the University of California San Francisco Medical Center.

Recently, a randomized trial of providers at Wisconsin's Aurora Health Care showed that their CDSM resulted in a in targeted imaging orders, but no change in total number of high- or low-cost scans.

"The literature contains examples of successes and failures of narrowly targeted imaging decision support, as well as failures of comprehensive imaging decision support -- notably, the Medicare Imaging Demonstration, but no examples of successful comprehensive imaging decision support," Mongan told 乌鸦传媒.

"This puts imaging providers in the position of either implementing systems that have been shown to be ineffective to meet a regulatory requirement, or doing R&D under a regulatory deadline to try to be among the first to achieve a challenging goal in health informatics," he continued.

Implementing CDSM -- whether through a separate program or embedded into the electronic health record (EHR) -- can certainly be a challenge for a safety net hospital like Doukky's institution.

"We have a lot of competing priorities and unfortunately we have to spend a lot of time, energy, and money to deploy a CDSM that doesn't work so well," he said.

Several Kinks to Iron Out

PAMA was signed into law in 2014 and its rollout was delayed several times.

Cindy Moran, executive vice president of government relations and health policy at the ACR, which has developed its own appropriate use criteria for imaging, said her group does not anticipate the deadline to be extended any longer.

"The AUC approach reduces low-value imaging and costs without delaying care or interfering in doctor-patient decision making," Moran said. "Thousands of facilities nationwide are already using AUC as an imaging management tool. The provider community, most of whom supported the AUC Mandate when passed, have had several years to prepare."

Notably, ACR is one medical society that has not asked to delay the policy.

Mongan of UCSF sees it differently: "I expect this will be a difficult transition. Although the go-live deadline has been pushed back several times, many institutions will struggle to have a compliant system in place by the regulatory deadline."

For example, transitioning to PAMA compliance will be particularly difficult in situations where the ordering professional is not part of the same integrated health system as the imaging center.

"In these circumstances, the ordering professional will have to use an ordering workflow or decision support that is outside of their usual EHR and/or arrange for transmission of the documentation of decision support consultation along with the order. In the absence of extensive work to electronically integrate systems across institutional boundaries, transmission of documentation of decision support consultation may involve manual transcription of lengthy code numbers," according to Mongan.

"This drives us back 20 years to faxing codes. It's very time-consuming," said Doukky. "And even if the test is performed in the same system, it requires serious hard-wiring of information technology."

Then there is the issue of the hospital choosing AUCs differing from those physicians currently recognize.

Doukky said that he had been consulting AUC provided by cardiovascular societies like the American College of Cardiology and the ASNC for over a decade -- when his hospital decided to implement CDSM utilizing AUC from a different organization.

"I'm already well-educated, well-aware of AUC, and now all of a sudden I'm using AUC that I'm not familiar with, and sometimes at odds with those developed by the cardiovascular societies," he said. "In an ideal world, you'd like physicians to use the AUC they are comfortable with."

He cited a study showing that different criteria may lead to different yields in testing. "You could use one set of AUC and the test would be appropriate; use another set and get an inappropriate test determination."

Things are different in the University of California system, where leaders are creating their own AUC under a Qualified Provider Led Entity certification from CMS.

"We are working from the principle of having the system be invisible as much as possible, interacting with the ordering professional only when the system has evidence-based, actionable advice to provide," according to Mongan.

Will Providers Rebel?

Nevertheless, Mongan maintained that interacting with decision support increases the click burden of ordering professionals, which has time, financial, and psychological costs and may contribute to burn-out.

And that means some may try to work around CDSM instead of using it.

"One behavior that has been reported is using the same false indication for all imaging orders of a particular type, because that indication is known to be rated as appropriate," Mongan noted. "This decreases quality of imaging diagnosis by removing the clinical context from the interpretation, and if audited by CMS may put the ordering professional and/or their institution at risk of fraud charges and large financial penalties."

Frustrated physicians trying to order a test that needs an AUC determination might also try to shortcut the system and refer the patient to a specialist just to avoid having to deal with the CDSM, Doukky suggested.

"In this scenario we will be driving cost up, not down," he said.

Redundant testing is another possibility, Doukky said, if physicians start with the wrong test order -- one that might not require AUC determination, just to avoid the hurdle -- only to end up ordering the right test later on.

Transitioning to PAMA will bring a lot of challenges, he summarized. "I suspect it's going to be an uphill battle."

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