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By Matt Skoufalos

At the conclusion of one of the most protracted, contentious and tumultuous election seasons in recent memory, Americans selected a new president and several new federal legislators. As they prepare to begin the business of governing the nation, the eyes of the country are upon them; watching just as closely as anyone else to see where their priorities will fall are all corners of the medical imaging industry.

Among the most intensely avowed – if least able to be substantiated – positions of the Trump administration has been deregulation, “and it’ll be interesting to see if that’ll continue under the new administration,” said Greg Morrison, M.A., R.T.(R), CNMT, deputy CEO of the American Society of Radiologic Technologists (ASRT).

However, one of the most significant priorities from ASRT for the last several years has been seeking legislative efforts to help establish licensing and certification around the operation of medical imaging equipment, particularly modalities that rely on ionizing radiation. This issue has taken on greater significance in recent years, as non-imaging providers, from physicians’ assistants and nurse practitioners (NP)to physical therapists, have begun seeking access to order, perform and interpret diagnostic imaging studies. Without sufficient education and training, Morrison fears that those providers could make mistakes that could have lasting implications for patients.

“At the state level, and even at the federal level, CMS has opened regulations in this time of COVID to provide access to [imaging studies to] mid-level providers, particularly to the NP and physician’s assistants,” he said.

“Certain lab work and therapies outside of medical imaging they’re perfectly educated in, and competent to be involved in those areas. But when it comes to medical imaging, I do not believe that they have enough education to perform radiology studies, let alone radiation therapy studies, or interpret those or be involved in that process without additional education,” Morrison said.

In the absence of a federal statute in place that could certify the competency of an imaging professional in all 50 U.S. states – or the legislative willpower to deliver one – ASRT has refocused its efforts on developing responses to various initiatives at the state government level. (The Consumer Assurance of Radiologic Excellence, or CARE, bill was introduced eight times in the U.S. House of Representatives between 2000 and 2013, and six times in the U.S. Senate; it never cleared both houses at the same time, and by 2014, ASRT had shifted its attention to individual state legislation.) Among the biggest concerns at the society is the notion that state lawmakers working with various trade organizations could access imaging studies and therapies without appropriate understanding of how those modalities work and how to interpret their results.

“When it comes to radiology, we need a clearer understanding of what [these providers] mean when they say ‘diagnostic tests and therapies,’ ” Morrison said. “They are not sufficiently trained in radiology. PTs want to order imaging studies, but the language we see in state bills is vague enough that it may be understood as PTs also wanting to perform and interpret them, too. Saying ‘imaging studies,’ the language may be open enough to order CT or MR that in most instances would not be applicable to physical therapy.

“We have worked to assist the physical therapy lobbyists with some language with the hope that they’ll limit ordering to plain film radiography,” he said. “I think the PTs are seeking to just be able to order studies, but it comes down to what their bill language looks like, because it may allow them to do much more. Once something is in legislation or regulation, it’s much harder to go back and change it.”

Only 11 U.S. states don’t require their own licensing or certification from a nationally recognized certification body for imaging technologists to work in the field. Some don’t require licenses to work in radiation therapy and nuclear medicine, and only four states (New Hampshire, New Mexico, North Dakota and Oregon) require sonographers to be licensed in order to work with ultrasound equipment. In the coming years, ASRT is working to introduce or re-introduce bills around the areas of medical imaging expertise in various states across the country, including Alabama, Alaska, California, Georgia, Michigan, Missouri and Pennsylvania.

“I think the case for ensuring that the public has access to individuals who are appropriately educated, clinically competent, certified and licensed enhances patient care and ensures that appropriate radiation exposure processes are taking place is, in our mind, a very important issue,” Morrison said.

“Radiation has been deemed a carcinogen, so it’s important that the people who operate the equipment have a complete understanding of what goes on behind the scenes and what happens when you engage the imaging or therapy unit,” he said. “And it’s an understanding of what can happen as radiation is cumulative over a person’s lifetime.”

ASRT, like every imaging specialty group, is also paying close attention to the evolution of rules changes to federal reimbursement fee schedules amid the constraints of Congressional budget neutrality rules. The tug of war over resources – namely, the expansion of evaluation and management monies at the expense of specialty physician practice areas, including radiology – has become more high-stakes, particularly as almost every aspect of health care is working to rebound from the impact of the novel coronavirus (COVID-19) pandemic. In the medical imaging space, that’s meant shuttered operations for a quarter of 2020, widespread layoffs and furloughs, and the perception that imaging staffers aren’t frontline workers at risk of contracting infectious diseases.

“We’re fighting that battle everywhere we can to ensure that technologists in this profession, and the profession of medical imaging and radiation therapy as a whole, are being recognized as frontline workers,” Morrison said. “Every patient with suspected COVID gets a chest X-ray; they may get a CT scan.”

“We continue to be actively involved in the return-to-care movement, getting people back in for screening exams with the understanding that they need to be done in a COVID-safe environment,” he said. “Exams should not be put off. Increases in the number of undiagnosed cancers that will have occurred because of this nearly 10 months of folks not being seen will ripple; those folks will now require more care when it could have been prevented, which will only drive up costs.”

Among the most frustrating aspects of advocacy work “is the slow-moving or even stagnant nature of these things, with nothing really getting done,” Morrison said.

“It just feels like Washington is doing very little because there’s always something that seems to take the focus off our issues,” he said. “It’s one of those areas where medical imaging doesn’t need to feel like the Lone Ranger, either. Everybody, no matter what your profession is, is in the same boat.”

In addition to the change in leadership of the U.S. presidency, Kit Crancer, vice president of public policy at Center for Diagnostic Imaging (CDI) of Minneapolis, Minnesota, said he’s waiting to see how the legislative priorities of the new Congress unfold in a house of government that likely will have to reach across the aisle to get its business done.

“What Biden is going to be able to achieve on the health care front, he’s either going to need to achieve with bipartisan support, or through the rule-making process, or through executive order,” Crancer said. “I think that’s going to limit a little bit of what he can achieve as far as his agenda goes.”

In such an environment, Crancer is skeptical of sweeping health care reforms being enacted (“I think it takes a public option off the table,” he said), but more modest reforms – like rolling back the Trump administration’s promotion of short-term health plans, or perhaps trying to eliminate the work requirements that some states have put into Medicare expansion waivers – might make headlines. Even with a Democratic vice president breaking potential vote ties in the U.S. Senate, committee processes are likely to be divided affairs.

“It’s a little bit tougher to move things, and that probably moderates Biden’s agenda,” Crancer said. “But within this latest [COVID] stimulus bill, the thing that I was encouraged by is that you did see [Nancy] Pelosi and [Mitch] McConnell and [Kevin] McCarthy and [Chuck] Schumer work together; a cobbling-together of a bigger package than what anyone thought possible before the election. I was impressed to see that there was this bipartisan understanding that we needed to do something for the American people.”

Crancer also said he anticipates the possibility that McConnell’s relationship with Joe Biden could become another point upon which to build consensus, potentially clearing a path for more bipartisan bridge-building.

“These are two individuals who’ve referred to each other as friends over the past couple years,” Crancer said. “I think you’re going to see a warmer relationship between the two of them than Mitch and Trump ever enjoyed.”

Of course, for any of those priorities to come to the fore will require broad efforts to quell the spread and impact of the pandemic, which “is difficult for folks to see beyond,” particularly amid a lack of uniform federal response under Trump, Crancer said. As state governments have had to more directly manage a lot of their pandemic efforts for testing, sourcing personal protective equipment (PPE), and distributing vaccines, they are likely to remain the governments on which health care practitioners focus their attention until the pandemic – and the regulatory efforts that accompany it – is under control.

Indeed, he foresees “a lot more activity at the state level than congressionally” during the next election cycle because only Minnesota has a divided state legislature; in every other state in the nation, a single party controls both of its legislative bodies, which means national policies are more likely to be shaped at a state-by-state level as lobbyists seek to work with governments that are friendly to their priorities there.

“If you don’t see a plurality in congress, oftentimes you’ve got downhill sledding if you’re a special interest group, which makes it a heck of a lot easier to get things done at the state level,” Crancer said.

Alternatively, he said, operating in multiple states “is incredibly difficult” for health care entities, particularly during the pandemic, which has given rise to “layers and layers of bureaucracy.”

“We receive orders from different counties, cities, states, on a daily basis, as they’re trying to find ways to appropriately deal with the pandemic,” Crancer said.

If the Biden administration can move the national pandemic response past the slate of action items at the federal government level, there are several other critical issues that could be next up on the agenda. Crancer said in December 2020 that he’s curious to see if Congress will extend the moratorium on the sequestration cuts beyond the three months included in the recent stimulus bill; likewise, he’s also hopeful that legislators will offer up “a significant focus” on telemedicine and health care information security.

“A lot of Americans received their first telehealth visit over the past eight months; I think that’s probably with us to stay,” Crancer said. “And I hope that we see a lot more focus on security from the next administration because there are some vulnerabilities in our system that have been exposed as of late.”

“I hope that we get some more focus on it, and try and empower consumers to take control of their health information, too,” he said. “I think it’s a lot easier for consumers to understand the value of it, and demand that their information be protected from foreign government assets if they actually have access to it themselves.”

As valuable as such initiatives can be to the American people, Kavita Patel, nonresident fellow in economic studies at the USC-Brookings Schaeffer Initiative for Health Policy in Washington, D.C., said the questions about whether they’re taken up by policymakers hinge entirely upon who’s going to advocate for them.

Concerns about health care information security and surprise medical billing are easy enough to grasp; more detailed and nuanced issues like ASRT’s certification concerns, or negotiations over CMS reimbursement rates and budget neutrality are more complex and challenging to distill into action.

“I think the only way these nuanced issues get the consideration of lawmakers is when it’s easy to communicate,” Patel said. “The fact that these are complex issues makes it harder. You get buried in something broader, like E&M, or you end up being unable to effectively communicate what you’re doing.”

“I think people tend to get too much in the weeds because they’re content experts, and then they don’t really know how to communicate this to people who are dealing with domestic policies,” she said. “The most precious commodity on the Hill is time, and anything you can to do position your issue helps.”

If those issues are difficult ones for which to drive consensus, given their obscurity, then pushing for additional support of nuclear medicine is an even taller task, said Richard Wahl, MD, president-elect of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and director of the Mallinckrodt Institute of Radiology at Washington University School of Medicine in St. Louis, Missouri.

Approval of new radiopharmaceuticals by the U.S. Food and Drug Administration doesn’t automatically equate to CMS reimbursement for the procedures that use them. Moreover, some “pass-through” reimbursement approvals are temporary, lasting for only a couple of years; when the pass-through period ends, Medicare reimbursement rates can drop precipitously, which effectively limits patient access to them. And there’s little relief when it comes to insurers, which often erect their own barriers to reimbursement of the vital drugs.

“This is a big problem,” Wahl said. “These strange rules, which are related to available funds, mean that when the pass-through period ends, reimbursement rates drop over a cliff. It really limits patient access to what are life-changing, therapy-changing innovations.”

“This is an important opportunity for us to work on with the incoming administration,” he added. “Medicare is already paying for some of these procedures, but the private sector is not. Many private insurers have onerous processes that can delay or deny access to radiopharmaceuticals. It can be incredibly frustrating when dealing with insurers to be told that FDA-approved medicines are experimental – it’s a huge waste of physician time.”

Amid other potential federal policy shifts, Wahl said SNMMI will be waiting to see whether the new legislature and presidential administration will devote resources to the continued support and investment required to advance nuclear medicine, from research to job training and staffing of imaging facilities across the country to sourcing of the isotopes behind the radiopharmaceuticals themselves.

“Molybdenum-99 is an important ingredient, and maintaining an adequate supply is quite a challenge,” Wahl said. “If you run out of it, you can’t do nuclear medicine. Some of the new radioisotopes, like actinium-225, are in limited supply as well. Diagnostic and therapeutic isotopes will require continued government investment.”

Regardless of who’s in power, Wahl believes that “legislators – whether Democrat, Republican, socialist, independent or libertarian – want people to have health care and don’t want to see it limited by poor patient access to technology.”

“Continued investment in the science that drives radiology is important and offers great opportunities,” he said, “but we need to continue to invest in the medical imaging infrastructure as well to continue with the work.”

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