Radiology Lobby: Advocacy for High Stakes on Capitol Hill
Not every lobbying effort on the part of the imaging industry is a success. When the DRA was passed, for example, radiology took a hit; reimbursements were pared, and the industry emerged feeling that its rapid growth had left it with a target on its back.
Cindy Moran, who now directs what she calls “a totally full-service deep advocacy program” for the ACR® default.aspx, recalls, “The pressure was extraordinary to cut, and because diagnostic imaging was vulnerable, we were reduced significantly.”
Moran says that the passage of the DRA, which came at 3 am on a Friday near Christmas, taught a lesson to the ACR and to the diagnostic-imaging industry in general: prepare better and lobby harder. “At 3 am, the ability to stop that bill was next to zero, so you spend a lot of time trying to understand and react,” she says.
Moran, who is the ACR’s assistant executive director for government relations and economic policy, says that the ACR now employs seven in-house lobbyists. It also employs about two dozen analysts who look at the economic and policy impacts of ongoing and proposed legislation and regulations, Moran adds.
The ACR also hires outside consultants. She says, “Let’s say that there’s a parliamentary maneuver on the floor of the House that could affect whether a bill we support is brought up or killed. We would call on outside consultants who have expertise in House rules, so we could learn from them what to expect.”
Moran says that consultants might also be hired because they have relationships with key legislators. “Because the Congressional world is so broad and so deep in expertise, you can’t go to the Hill and be unable to have an in-depth discussion of what the policies are. The back-slapping days are no more. There is so much oversight and scrutiny that you need all the help you can get,” she says.
If the radiology industry has learned to keep its ear to the ground, it has also learned that strength lies in numbers. Following the DRA setback, Moran says, the ACR helped found the Access to Medical Imaging Coalition (AMIC), an organization of subspecialty societies, imaging-equipment manufacturers, and patient-advocacy groups that focuses on image quality and the appropriate utilization of imaging exams.
“Creating such a broadly represented coalition has helped us tremendously,” Moran says. “When there were efforts to put mandatory preauthorization into legislation, with the coalition, we were able to kill that.” She adds, “At times, in Washington, DC, there can be an effort to seek the less bad. We try to mitigate the losses, and that’s what happens, year after year, with the DRA.”Manufacturer InvolvementThe radiology lobby isn’t composed solely of professional societies and coalitions; manufacturers of imaging equipment also get involved. GE Healthcare (Waukesha, Wisconsin), which manufactures imaging devices and scanners of all kinds, as well as providing a broad range of health products and services, has its own lobbying arm that works with the ACR and other industry groups. GE is a member of AMIC and another important industry coalition, the Medical Imaging Technology Alliance (MITA), which is composed of makers of imaging equipment and related software.
Orrin Marcella is manager of government relations for GE Healthcare. He works in Washington, DC, but mentions that GE Healthcare also has staff dedicated to advocacy on the state level. The driving forces behind GE’s lobbying, Marcella says, are often the needs of its customers. GE watches reimbursement policies closely and will speak with national and state lawmakers on issues involving the imaging providers that make up its customer base. “From our perspective, we want to see our customers do well and provide optimal care,” Marcella says. “If an imaging provider goes out of business, that’s not good for patients, for the providers themselves—or ultimately, for GE, because there’s no more business there.”
One controversial area that GE prefers not to get involved in, Marcella says, is imaging-exam self-referral by nonradiologist physicians who have their own scanners. “We have customers in all the various specialties, so we try to stay out of those areas,” he notes.
That doesn’t mean that GE takes no stand on appropriate utilization of imaging exams, Marcella adds. In fact, he says, the company is a strong advocate for—and lobbies for—greater use of appropriateness standards in imaging. “We would like to see more informed decisions being made when it comes to imaging policy,” he says, noting that GE advocates the development and use of decision-support tools to guide referrers in ordering appropriate imaging exams.
“Inappropriate imaging is not good use of the technology, and it brings scrutiny that leads to reimbursement cuts. We have no interest in runaway volumes, even if we would sell more equipment. It’s not sustainable,” he says.Natural AlliesThrough its various lobbying arms, GE reaches out to all legislators on both the federal and state levels, but it often focuses special effort on what Marcella calls its natural allies: legislators who represent the districts where GE has manufacturing sites, especially in Southeastern Wisconsin.
“When there are issues like the medical-device tax proposed under health reform, those are the folks we go to,” Marcella says. “That’s where our employees live and work. Why would a member of a Congress in a district with zero medical-device employees care about a medical-device tax on the manufacturer?”
Marcella says that GE Healthcare is also lobbying for increased transparency on the US Preventive Services Task Force (USPSTF), which promotes disease prevention by issuing recommendations on various screening procedures and tests.
“The USPSTF has been given the authority, by the health-reform law, to determine which preventive services will be covered (with no cost to patients) under a qualified health plan, so this group has tremendous power now,” Marcella says. GE is lobbying to get specialists, including radiologists, included as panelists on the USPSTF, so that the recommendations that the task force makes will reflect that broader expertise. Currently, the USPSTF is composed solely of primary-care physicians, Marcella says.
One screening test not yet recommended by the USPSTF (or approved for national coverage by Medicare) that GE is lobbying for is CT colonography screening for colon cancer. “We’re hopeful that in the near future, Medicare will issue a positive national-coverage decision. We’re working with a number of organizations toward that end,” Marcella says.
GE Healthcare—along with the ACR and other imaging-industry groups—is also carrying the message that imaging’s growth spurt has now leveled off, after it brought advanced imaging so much cost-reduction scrutiny. “There are robust data to show that imaging volume has slowed significantly, to the point where the rest of medicine is growing faster than advanced imaging,” Marcella says.MITA and Device ClearanceMITA is a division of NEMA, which has members including GE Healthcare and other imaging-device makers. MITA takes the lead in lobbying on behalf of NEMA members that are imaging-equipment manufacturers. David Fisher is vice president of NEMA and executive director of MITA. He is also a registered lobbyist, and in that role, he works for MITA.
Fisher says that MITA covers the whole gamut of legislation and regulation affecting diagnostic-imaging or radiation-therapy devices. A major concern for MITA now, Fisher says, is convincing the FDA to streamline its approval process, so that new devices can come to market quickly.
Recently, the FDA, in response to criticism in the wake of several high-profile radiation-dose overexposures at hospitals, said that it would curtail the use of third-party analysts in its device-approval process. For MITA, however, the idea of slowing down that approval process by cutting third-party reviewers puts device manufacturers at competitive risk.
“The FDA has to clear the product, and the length of time it takes to get that product cleared is critical to the recovery of investment,” Fisher says. “There is no evidence that third-party reviews led to more recalls.”
With new imaging products continuously in development, manufacturers typically have only 18 to 24 months to recoup investment on a given device, Fisher says. “If you spend a year getting it cleared, you’ve lost half that time. Research does not stop based on the FDA clearing a product. A product that goes to market has competitors soon after, which forces new research. Your product has a relatively short life cycle,” he says.
Fisher says that MITA is also advising and lobbying on radiation-overexposure prevention and radiation safety. “We support the idea of recording each exposure dose, as well as the reporting of medical errors with our products,” he says.
In August, California passed legislation to monitor and control radiation exposure from imaging exams. Fisher says that MITA worked with the bill’s sponsors prior to its introduction to make sure that legislators understood how the imaging equipment functioned. “We helped them make sure the bill would do what they aimed for it to do,” he says.RadPAC and Self-advocacyLobbying is a larger effort than just sending industry experts to buttonhole legislators with the latest data. It involves grassroots efforts as well—and add to those the wheel-greasing of political contributions.
The ACR, Moran says, has a political action committee, RadPAC, that always ranks in the top three among physician-group PACS. Last year, Moran says, RadPAC put more than $2 million into the campaign coffers of sympathetic and/or influential legislators.
Moran adds that the ACR also takes legislators on tours of imaging facilities so that lawmakers have the opportunity to see, firsthand, why advanced imaging is such an important health-care tool. These facility visits can also couple as fundraising events, Moran says, either in Washington or at imaging facilities in legislators’ home districts. “We did about 50 of those last year—and the benefits have been pretty palpable,” she says.
Moran notes that one disadvantage that radiologists face with politicians is that radiologists—since they typically have no patient contact—have no ready-made patient base that they can activate to help advocate their causes. This is not entirely true in the case of mammography, she adds, where patient coalitions have been organized. “Patient groups and disease groups can help, and they make the song a lot stronger,” Moran says.
Lacking advocacy from patients, radiology must turn to radiologists themselves to become politically active. Moran says, “We have a very sophisticated grassroots effort to mobilize radiologists to become their own advocates.”Accreditation ExpansionThe key legislative and regulatory issues requiring advocacy are the same for the ACR as for other imaging-industry groups—reimbursement, quality standards, and patient safety—but the ACR adds its own spin. The college would like to see the accreditation standards for modalities and technologists that are now set to become mandatory for imaging centers in 2012 extended to hospitals and therapeutic centers as well, Moran says. It is also calling on CMS to limit the accrediting bodies to “those with a long history and expertise in radiology and diagnostic-imaging services,” Moran adds.
In other words, the ACR questions whether CMS should include the Joint Commission on its approved list of accrediting bodies because the Joint Commission uses different methods to accredit imaging facilities than those that the ACR and the Intersocietal Accreditation Commission (IAC) use. While the ACR and IAC require submission of actual imaging exams to achieve accreditation, the Joint Commission relies on site visits to fulfill that purpose.
“We’re not pointedly trying to get rid of the Joint Commission,” Moran says. “We want to make sure that the guidance from CMS for accreditation is more specific. We want to make sure the value of the image and the radiation dose are being judged.”
Moran says that recent incidents of radiation overexposure have given the radiology lobby leverage to seek tightened accreditation standards industrywide. “Radiation dosage is clearly linked to accreditation and to training standards for technologists,” she says. “We think these standards will be expanded to the hospital setting.”Health Care, ReformedMuch of what will be lobbied for by radiology in the future depends on deep changes taking shape in the wake of health reform, Moran says. Bundled care and accountable-care organizations will clearly be part of health-care delivery in the future. Along with these will come the integration of multispecialty practices and a “huge push to consolidate services,” she adds. “Congress,” she says, “will put more resources into primary care and take them away from specialty medicine.”
How will radiology fare under such a scenario? If primary-care physicians are the gatekeepers for imaging services, then more emphasis will have to be placed on decision-support tools and appropriate utilization of imaging tests so that referring physicians know what tests they are ordering, Moran says. The ACR is deeply involved in a demonstration project for CMS that looks at just this, she adds.
Whatever the future, Moran says, lobbyists and analysts at the ACR are preparing models to see how proposals will work in terms of treatment and reimbursement. “My responsibility is to make sure we’re involved in the design of these payment models and that we proactively come up with our own models,” she says. “None of the proposals will work without diagnostic imaging—you can’t have a party without the radiologists there.”George Wiley is a contributing writer for ImagingBiz.com.
Cindy Moran, who now directs what she calls “a totally full-service deep advocacy program” for the ACR® default.aspx, recalls, “The pressure was extraordinary to cut, and because diagnostic imaging was vulnerable, we were reduced significantly.”
Moran says that the passage of the DRA, which came at 3 am on a Friday near Christmas, taught a lesson to the ACR and to the diagnostic-imaging industry in general: prepare better and lobby harder. “At 3 am, the ability to stop that bill was next to zero, so you spend a lot of time trying to understand and react,” she says.
Moran, who is the ACR’s assistant executive director for government relations and economic policy, says that the ACR now employs seven in-house lobbyists. It also employs about two dozen analysts who look at the economic and policy impacts of ongoing and proposed legislation and regulations, Moran adds.
The ACR also hires outside consultants. She says, “Let’s say that there’s a parliamentary maneuver on the floor of the House that could affect whether a bill we support is brought up or killed. We would call on outside consultants who have expertise in House rules, so we could learn from them what to expect.”
Moran says that consultants might also be hired because they have relationships with key legislators. “Because the Congressional world is so broad and so deep in expertise, you can’t go to the Hill and be unable to have an in-depth discussion of what the policies are. The back-slapping days are no more. There is so much oversight and scrutiny that you need all the help you can get,” she says.
If the radiology industry has learned to keep its ear to the ground, it has also learned that strength lies in numbers. Following the DRA setback, Moran says, the ACR helped found the Access to Medical Imaging Coalition (AMIC), an organization of subspecialty societies, imaging-equipment manufacturers, and patient-advocacy groups that focuses on image quality and the appropriate utilization of imaging exams.
“Creating such a broadly represented coalition has helped us tremendously,” Moran says. “When there were efforts to put mandatory preauthorization into legislation, with the coalition, we were able to kill that.” She adds, “At times, in Washington, DC, there can be an effort to seek the less bad. We try to mitigate the losses, and that’s what happens, year after year, with the DRA.”Manufacturer InvolvementThe radiology lobby isn’t composed solely of professional societies and coalitions; manufacturers of imaging equipment also get involved. GE Healthcare (Waukesha, Wisconsin), which manufactures imaging devices and scanners of all kinds, as well as providing a broad range of health products and services, has its own lobbying arm that works with the ACR and other industry groups. GE is a member of AMIC and another important industry coalition, the Medical Imaging Technology Alliance (MITA), which is composed of makers of imaging equipment and related software.
Orrin Marcella is manager of government relations for GE Healthcare. He works in Washington, DC, but mentions that GE Healthcare also has staff dedicated to advocacy on the state level. The driving forces behind GE’s lobbying, Marcella says, are often the needs of its customers. GE watches reimbursement policies closely and will speak with national and state lawmakers on issues involving the imaging providers that make up its customer base. “From our perspective, we want to see our customers do well and provide optimal care,” Marcella says. “If an imaging provider goes out of business, that’s not good for patients, for the providers themselves—or ultimately, for GE, because there’s no more business there.”
One controversial area that GE prefers not to get involved in, Marcella says, is imaging-exam self-referral by nonradiologist physicians who have their own scanners. “We have customers in all the various specialties, so we try to stay out of those areas,” he notes.
That doesn’t mean that GE takes no stand on appropriate utilization of imaging exams, Marcella adds. In fact, he says, the company is a strong advocate for—and lobbies for—greater use of appropriateness standards in imaging. “We would like to see more informed decisions being made when it comes to imaging policy,” he says, noting that GE advocates the development and use of decision-support tools to guide referrers in ordering appropriate imaging exams.
“Inappropriate imaging is not good use of the technology, and it brings scrutiny that leads to reimbursement cuts. We have no interest in runaway volumes, even if we would sell more equipment. It’s not sustainable,” he says.Natural AlliesThrough its various lobbying arms, GE reaches out to all legislators on both the federal and state levels, but it often focuses special effort on what Marcella calls its natural allies: legislators who represent the districts where GE has manufacturing sites, especially in Southeastern Wisconsin.
“When there are issues like the medical-device tax proposed under health reform, those are the folks we go to,” Marcella says. “That’s where our employees live and work. Why would a member of a Congress in a district with zero medical-device employees care about a medical-device tax on the manufacturer?”
Marcella says that GE Healthcare is also lobbying for increased transparency on the US Preventive Services Task Force (USPSTF), which promotes disease prevention by issuing recommendations on various screening procedures and tests.
“The USPSTF has been given the authority, by the health-reform law, to determine which preventive services will be covered (with no cost to patients) under a qualified health plan, so this group has tremendous power now,” Marcella says. GE is lobbying to get specialists, including radiologists, included as panelists on the USPSTF, so that the recommendations that the task force makes will reflect that broader expertise. Currently, the USPSTF is composed solely of primary-care physicians, Marcella says.
One screening test not yet recommended by the USPSTF (or approved for national coverage by Medicare) that GE is lobbying for is CT colonography screening for colon cancer. “We’re hopeful that in the near future, Medicare will issue a positive national-coverage decision. We’re working with a number of organizations toward that end,” Marcella says.
GE Healthcare—along with the ACR and other imaging-industry groups—is also carrying the message that imaging’s growth spurt has now leveled off, after it brought advanced imaging so much cost-reduction scrutiny. “There are robust data to show that imaging volume has slowed significantly, to the point where the rest of medicine is growing faster than advanced imaging,” Marcella says.MITA and Device ClearanceMITA is a division of NEMA, which has members including GE Healthcare and other imaging-device makers. MITA takes the lead in lobbying on behalf of NEMA members that are imaging-equipment manufacturers. David Fisher is vice president of NEMA and executive director of MITA. He is also a registered lobbyist, and in that role, he works for MITA.
Fisher says that MITA covers the whole gamut of legislation and regulation affecting diagnostic-imaging or radiation-therapy devices. A major concern for MITA now, Fisher says, is convincing the FDA to streamline its approval process, so that new devices can come to market quickly.
Recently, the FDA, in response to criticism in the wake of several high-profile radiation-dose overexposures at hospitals, said that it would curtail the use of third-party analysts in its device-approval process. For MITA, however, the idea of slowing down that approval process by cutting third-party reviewers puts device manufacturers at competitive risk.
“The FDA has to clear the product, and the length of time it takes to get that product cleared is critical to the recovery of investment,” Fisher says. “There is no evidence that third-party reviews led to more recalls.”
With new imaging products continuously in development, manufacturers typically have only 18 to 24 months to recoup investment on a given device, Fisher says. “If you spend a year getting it cleared, you’ve lost half that time. Research does not stop based on the FDA clearing a product. A product that goes to market has competitors soon after, which forces new research. Your product has a relatively short life cycle,” he says.
Fisher says that MITA is also advising and lobbying on radiation-overexposure prevention and radiation safety. “We support the idea of recording each exposure dose, as well as the reporting of medical errors with our products,” he says.
In August, California passed legislation to monitor and control radiation exposure from imaging exams. Fisher says that MITA worked with the bill’s sponsors prior to its introduction to make sure that legislators understood how the imaging equipment functioned. “We helped them make sure the bill would do what they aimed for it to do,” he says.RadPAC and Self-advocacyLobbying is a larger effort than just sending industry experts to buttonhole legislators with the latest data. It involves grassroots efforts as well—and add to those the wheel-greasing of political contributions.
The ACR, Moran says, has a political action committee, RadPAC, that always ranks in the top three among physician-group PACS. Last year, Moran says, RadPAC put more than $2 million into the campaign coffers of sympathetic and/or influential legislators.
Moran adds that the ACR also takes legislators on tours of imaging facilities so that lawmakers have the opportunity to see, firsthand, why advanced imaging is such an important health-care tool. These facility visits can also couple as fundraising events, Moran says, either in Washington or at imaging facilities in legislators’ home districts. “We did about 50 of those last year—and the benefits have been pretty palpable,” she says.
Moran notes that one disadvantage that radiologists face with politicians is that radiologists—since they typically have no patient contact—have no ready-made patient base that they can activate to help advocate their causes. This is not entirely true in the case of mammography, she adds, where patient coalitions have been organized. “Patient groups and disease groups can help, and they make the song a lot stronger,” Moran says.
Lacking advocacy from patients, radiology must turn to radiologists themselves to become politically active. Moran says, “We have a very sophisticated grassroots effort to mobilize radiologists to become their own advocates.”Accreditation ExpansionThe key legislative and regulatory issues requiring advocacy are the same for the ACR as for other imaging-industry groups—reimbursement, quality standards, and patient safety—but the ACR adds its own spin. The college would like to see the accreditation standards for modalities and technologists that are now set to become mandatory for imaging centers in 2012 extended to hospitals and therapeutic centers as well, Moran says. It is also calling on CMS to limit the accrediting bodies to “those with a long history and expertise in radiology and diagnostic-imaging services,” Moran adds.
In other words, the ACR questions whether CMS should include the Joint Commission on its approved list of accrediting bodies because the Joint Commission uses different methods to accredit imaging facilities than those that the ACR and the Intersocietal Accreditation Commission (IAC) use. While the ACR and IAC require submission of actual imaging exams to achieve accreditation, the Joint Commission relies on site visits to fulfill that purpose.
“We’re not pointedly trying to get rid of the Joint Commission,” Moran says. “We want to make sure that the guidance from CMS for accreditation is more specific. We want to make sure the value of the image and the radiation dose are being judged.”
Moran says that recent incidents of radiation overexposure have given the radiology lobby leverage to seek tightened accreditation standards industrywide. “Radiation dosage is clearly linked to accreditation and to training standards for technologists,” she says. “We think these standards will be expanded to the hospital setting.”Health Care, ReformedMuch of what will be lobbied for by radiology in the future depends on deep changes taking shape in the wake of health reform, Moran says. Bundled care and accountable-care organizations will clearly be part of health-care delivery in the future. Along with these will come the integration of multispecialty practices and a “huge push to consolidate services,” she adds. “Congress,” she says, “will put more resources into primary care and take them away from specialty medicine.”
How will radiology fare under such a scenario? If primary-care physicians are the gatekeepers for imaging services, then more emphasis will have to be placed on decision-support tools and appropriate utilization of imaging tests so that referring physicians know what tests they are ordering, Moran says. The ACR is deeply involved in a demonstration project for CMS that looks at just this, she adds.
Whatever the future, Moran says, lobbyists and analysts at the ACR are preparing models to see how proposals will work in terms of treatment and reimbursement. “My responsibility is to make sure we’re involved in the design of these payment models and that we proactively come up with our own models,” she says. “None of the proposals will work without diagnostic imaging—you can’t have a party without the radiologists there.”George Wiley is a contributing writer for ImagingBiz.com.