The Society for Cardiovascular Angiography and Interventions
Medicare Fee Schedule Reveals Big Changes for Interventional Cardiology
nterventional cardiologists will need to begin using a new family of bundled diagnostic cardiac catheterization codes in 2011. The values for new codes were revealed Nov. 2, 2010, when the Centers for Medicare and Medicaid Services (CMS) released the 2011 Medicare Physician Fee Schedule final rule, showing the agency had assigned physician work values for these codes at 10 percent below the recommendations developed through the AMA RUC process, whose purpose is to develop relative value recommendations for all new and revised codes for consideration by CMS. Had CMS accepted the recommendations of the RUC for these new codes, the value of their physician work components would have remained fairly stable, with CMS estimating only a 1 percent reduction in the physician work value associated with the RUC-recommended values for these services.
“This is an unexpected and significant departure for CMS, which has historically accepted upwards of 97 percent of the RUC’s recommended values,” said Cliff Kavinsky, M.D., Ph.D., FSCAI, who is SCAI’s representative to the RUC. “We are disappointed that CMS seems to be looking for economies where there just aren’t any. In fact, great care was taken in valuing the old component codes back in the early 1990s to ensure there wasn’t any overlap between the values of the various components. We successfully made this point to the RUC Panel, and their recommended values for these services reflected this understanding.” Ironically, the new diagnostic cardiac catheterization codes fared better than many other cardiology and cardiovascular services bundled in recent years. For example, the values for the new bundled lower extremity revascularization codes represent a 27 percent reduction in their physician work values.
(continued on page 2)
Early Career SCAI Announces New Leadership Development Program for Promising Early-Career Members
CAI has launched the Emerging Leader Mentorship (ELM) Program, a new initiative whose goal is to create the most comprehensive leadership pipeline for Interventional Cardiology by providing young interventional cardiologists with an unprecedented opportunity to get the help they need to become the field’s next generation of leaders. “Interventional cardiology is only about 30 years old, so many of our current leaders were there at the inception and are ready to pass on the torch,” says Srihari S. Naidu, M.D., FSCAI, who chairs the initiative. According to Dr. Naidu, “while those pioneers faced multiple challenges, today’s landscape has new hurdles for emerging leaders that just did not exist back then, making the institution of a comprehensive program imperative to our field’s continued success.” The highly competitive leadership development program targets interventional cardiologists who are 3–10 years out of training and motivated to excel both regionally and nationally in the arenas of clinical care, scholarship, education, and/or political advocacy.
Every two years, the program will select 10 cardiologists with the greatest leadership potential. Open to both adult and pediatric interventional cardiologists, the program will select participants solely on merit and potential. “We don’t care where people were born, where they trained, or where they work,” says Dr. Naidu. “It’s not going to be an old boys’ club.”
How the Program Works Early-career interventional cardiologists are facing new challenges that previous generations did not, says Dr. Naidu. These include increased clinical demands in the face of declining reimbursement; fewer resources for professional growth and scholarship, regardless of whether they work in academic, hybrid-academic, or private practice environments; the field’s growing sub-specialization that fragments the interventional voice; and far more stringent “relationship with industry” policies that limit that partnership as a path to success. As a result, many promising young leaders abandon the quest. (continued on page 6)
Medicare Fee Schedule (cont’d from pg 1) Practice Expense Data and SGR Take a Toll In addition to the new codes, the fee schedule demonstrates the continued negative impact of poor quality cardiology practice expense data, which began being phased in last year and will continue through 2013. Based on those data, CMS implemented cuts specific to cardiology services of approximately 2 percent for 2011, and a total 5 percent reduction between now and 2013. Those data also negatively impacted the practice expense values for the new catheterization codes. SCAI and ACC representatives to the RUC’s direct practice expense refinement process achieved substantial across-theboard gains for approved direct practice expense inputs, including non-physician clinical staff time, supplies, and equipment, for the new cardiac catheterization codes. Unfortunately, these increases were virtually negated due to the influence of the poor cardiology practice expense data on CMS’s indirect practice expense calculation for these new codes. Making matters worse are the ramifications of the sustainable growth rate, which manifested in the 2011 fee schedule conversion factor that will drop all physician services by an additional 1.9 percent on Jan. 1, 2011. This comes on top of the 23 percent reduction slated to go into effect Dec. 1, 2010, unless Congress intervenes with legislation. Table 1 provides details regarding the physician work RVUs assigned by CMS to the new family of diagnostic cardiac catheterization codes and the anticipated 2011 national average payment rates for these procedures under the Medicare system should the SGR issue reduce the 2011 conversion factor to $25.52, as is set to occur with comparison in reimbursement rates based on the current 2010 (June 1–Nov 30) conversion factor of $36.87. “SCAI will be working with the House of Medicine and the lame-duck Congress to advocate in opposition to the reductions,” said Joseph D. Babb, M.D., FSCAI, who serves as SCAI’s representative to the AMA House of Delegates. “We will soon be calling on members to take action and ask that everyone be on stand-by.” Understanding the New Codes SCAI is urging all members to get educated on how to use the newly created bundled codes for diagnostic catheterization. “These codes are very different from the previous component codes used to report these services,” explained Dr. Kavinsky. “It is imperative that our billing offices be prepared Cliff Kavinsky, M.D., to use the new codes when reporting Ph.D., FSCAI these services, starting Jan. 1, 2011.”
To help members prepare to implement the new coding, SCAI and ACC will host a special webinar on Wednesday, Dec. 1, from 3:30 p.m. to 5:00 p.m. (ET). Watch your email and www.SCAI.org for information on how to log on. It may also help billing staff to understand how the new bundled codes came to be: They were created in response to a directive from the AMA RUC and the CPT Editorial Panel requiring code pairs reported together more than 95 percent of the time under the Medicare claims system to be bundled into a single code. And CMS is indicating that physicians should expect more of the same. In the final rule, CMS asserts: “We expect this bundling of component services to continue over the next several years as the AMA RUC further recognizes the work efficiencies for services commonly furnished together. Stakeholders should expect that increased bundling of services into fewer codes will
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Larry S. Dean, M.D., FSCAI, President Christopher J. White, M.D., FSCAI, President-Elect Steven R. Bailey, M.D., FSCAI, Immediate Past President J. Jeffrey Marshall, M.D., FSCAI, Vice President Carl L. Tommaso, M.D., FSCAI, Treasurer Theodore Bass, M.D., FSCAI, Secretary Morton Kern, M.D., FSCAI, Editor-in-Chief _______________________________________________________________ Trustees Alexander Abizaid, M.D., FSCAI Lee N. Benson, M.D., FSCAI Jeffrey Cavendish, M.D., FSCAI Tyrone J. Collins, M.D., FSCAI Anthony Farah, M.D., FSCAI Runlin Gao, M.D., FSCAI James A. Goldstein, M.D., FSCAI James Hermiller, M.D, FSCAI Thomas Jones, M.D., FSCAI Upendra Kaul, M.D., FSCAI Clifford Kavinsky, M.D., Ph.D., FSCAI Ahmed Magdy, M.D., FSCAI Roxana Mehran, M.D., FSCAI Issam D. Moussa, M.D., FSCAI Kimberly A. Skelding, M.D., FSCAI Corrado Tamburino, M.D., FSCAI Zoltan G. Turi, M.D., FSCAI Trustees for Life Frank J. Hildner, M.D., FSCAI William C. Sheldon, M.D., FSCAI
Staff Norm Linsky Executive Director Kerry O’Boyle Curtis Senior Director for Education, Meetings, & Communications Wayne Powell Senior Director for Advocacy & Guidelines Rick Henegar Director of Meetings Kathy Boyd David Communications Director Terie King CPA, Director of Finance & Accounting Bea Reyes Director of Operations touch three Design and Production Imaging Zone Printing
Table 1. 2011 Medicare Physician Fee Schedule Values
Physician Work RVUs
2011 Transitional Non-facility TOTAL RVUs
2011 Transitional Facility TOTAL RVUs
BUNDLED CATH CODES
2011 National Avg Rate No SGR Fix
2011 National Avg Rate No SGR Fix
2011 National Avg Rate if Frozen at 2010 Rate*
2011 National Avg Rate if Frozen at 2010 Rate*
Right heart cath
Left hrt cath w/ventriclgrphy
R&l hrt cath w/ventriclgrphy
Coronary artery angio s&i
Coronary art/grft angio s&i
R hrt coronary artery angio
R hrt art/grft angio
L hrt artery/ventricle angio
L hrt art/grft angio
R&l hrt art/ventricle angio
R&l hrt art/ventricle angio
ADD ON PROCEDURES 93462
L hrt cath trnsptl puncture
Drug admin & hemodynamic meas
Exercise w/hemodynamic meas
INJECT/IMAGING CODES 93563
Inject congenital card cath
Inject hrt congntl art/grft
Inject l ventr/atrial angio
Inject r ventr/atrial angio
Inject suprvlv aortography
Inject pulm art hrt cath
result in reduced PFS [Physician Fee Schedule] payment for a comprehensive service by explicitly considering the efficiencies in work and/or PE that may occur when component services are furnished together.” SCAI worked with the ACC to craft the new family of codes for reporting non-congenital diagnostic cardiac catheterization procedures and created new codes bundling diagnostic injection procedures with their related imaging supervision and interpretation component. SCAI and ACC took great care in crafting the new codes to protect the continued flexibility for reporting diagnostic cardiac catheterization for congenital anomalies. In 2011, the existing codes and coding conventions for reporting these services remain intact; however, the congenital diagnostic cardiac catheterization codes will
now be reported in conjunction with the applicable new bundled inject/imaging codes. For non-congenital diagnostic cardiac catheterization, the new codes now “bundle” in the common components of these services that were previously able to be reported separately. This new family of codes includes 11 new diagnostic cardiac catheter codes, 3 “add-on” procedural codes, and 6 new inject-imaging codes. Table 2, shown on page 4, details how the various aspects of these procedures have now been bundled to create individual new diagnostic cardiac catheterization codes. SCAI invites members to duplicate the table and share it with their billing staff. Among the new codes are three new add-on codes created to report circumstances when cardiac catheterization is performed by transeptal/transapical
(continued on page 4)
Medicare Fee Schedule (cont’d from pg 3) Table 2. Diagnostic Cardiac Catheterization Codes – Services Bundled NEW DX CATH CODES
Catheter Placement(s) Included
Coronary Artery Placement
Right heart catheterization including measurement(s) of oxygen saturation and cardiac output, when performed (Do not report 93541 in conjunction with 93453, 93456, 93457, 93460, 93461)
Left heart catheterization including intraprocedural injection(s) for left ventriculography, imaging supervision and interpretation, when performed (Do not report 93452 in conjunction with 93453, 93458-93461)
Combined right and left heart catheterization including intraprocedural injection(s) for left ventriculography, imaging supervision and interpretation, when performed (Do not report 93XX3 in conjunction with 93453, 93452, 93456-9346)
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with catheter placement(s) in bypass graft(s) (internal mammary, free arterial venous grafts) including intraprocedural injection(s) for bypass graft angiography
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with right heart catheterization
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) including intraprocedural injection(s) for bypass graft angiography and right heart catheterization
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with left heart catheterization including intraprocedural injection(s) for left ventriculography when performed, catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) with bypass graft angiography
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed, catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) with bypass graft angiography
Imaging Bundled LT Venous Arterial Bypass Ventricular/ Coronary Angio Atrial Conduits Grafts 93563
(93510 or 93511 or 93514 or 93524) with (93543 and 93555)
(93526 or 93527 or 93528 or 93529) with (93543 and 93555)
CPT only ©2010 American Medical Association. All rights reserved.
Common coding combinations previously typically reported
93508 with (93545 and 93556)
93508 with (93545 and 93556) with (93539 and/or 93540)
(93501 and 93508), with (93545 and 93556)
(93501 and 93508), with (93545,and 93556), and with (93539 and/or 93540)
(93510 or 93511 or 93514 or 93524), with (93543 and 93555), and with (93545 and 93556)
(93510 or 93511 or 93514 or 93524), with (93543 and 93555), and with (93545 with 93556), and with (93539 and/or 93540)
(93526 or 93527 or 93528 or 93529), with (93543 and 93555), and with (93545 and 93556)
(93526 or 93527 or 93528 or 93529), with (93543 and 93555), and with (93545 and 93556), and with (93539 and/or 93540)
puncture and for the unique circumstances when a pharmacologic agent is administered or a physiologic exercise study is performed for the specific purposes of assessing the patient’s hemodynamic response: +93462
Left heart catheterization by transeptal puncture through intact septum or by transapical puncture (List separately in addition to code for primary procedure)
Pharmacologic agent administration (e.g., inhaled nitric oxide, intravenous infusion of nitroprusside, dobutamine, milrinone, or other agent), including assessing hemodynamic measurements before, during, after, and repeat pharmacologic agent administration, when performed (List separately in addition to code for primary procedure) (Use 93463 in conjunction with 93541-93453, 93456-93461, 93530-93533) (Report 93463 only once per catheter procedure)
Physiologic exercise study (e.g. bicycle or arm ergometry) including assessing hemodynamic measurements before and after (List separately in addition to code for primary procedure) (Use 93464 in conjunction with 93541-93453, 93456-93461, 93530-93533) (Report 93464 only once per catheter procedure)
The new non-congenital diagnostic cardiac catheterization codes include injection(s)/imaging typically performed during these procedures. However, when injection(s)/imaging is not typical, such as during right ventricular or right atrial angiography, supravalvular ascending aortography, or pulmonary angiography, these services are separately reportable. Additionally, when ad hoc catheter-based coronary therapeutic intervention(s) is performed in the same encounter as diagnostic cardiac catheterization, the service remains separately reportable. When catheter-based diagnostic and/or therapeutic peripheral vascular intervention is performed in the same encounter as diagnostic cardiac catheterization, the service also remains separately reportable. Table 3 lists these codes.
Looking Forward: Participation in RUC Surveys Is Crucial SCAI and ACC have and will continue to commit substantial resources both in terms of physicianvolunteer and staff time to the ongoing effort to protect the valuation of interventional cardiology services. The 2011 fee schedule, with its undervalued bundled codes for diagnostic cardiac catheterization, underscores the impact of the poor response rate to the first round of RUC surveys on these new codes. “There’s a lesson in this,” said Dr. Babb. “And it’s that when a RUC survey is sent out, we need to have the highest possible rate of member participation.” In this case, continued Dr. Babb, it was only after the RUC granted a reprieve and allowed a second Joseph D. Babb, M.D., FSCAI
Table 3. New Dx Cardiac Cath Inject-Imaging Codes
Common coding combinations previously typically reported
Injection procedure during cardiac catheterization including image supervision, interpretation and report; for selective coronary angiography during congenital heart catheterization (List separately in addition to code for primary procedure)
93545 and 93556
Injection procedure during cardiac catheterization including image supervision, interpretation and report for selective opacification of aortocoronary venous or arterial bypass graft(s) (e.g., aortocoronary saphenous vein, free radial artery, or free mammary artery graft) to one or more coronary arteries and in situ arterial conduits (e.g., internal mammary), whether native or used for bypass to one or more coronary arteries during congenital heart catheterization, when performed (List separately in addition to code for primary procedure)
93540 and 93556 with 93539
Injection procedure during cardiac catheterization including image supervision, interpretation and report for selective left ventricular or left atrial angiography (List separately in addition to code for primary procedure)
93543 and 93555
Injection procedure during cardiac catheterization including image supervision, interpretation and report for selective right ventricular or right atrial angiography (List separately in addition to code for primary procedure)
93542 and 93555
Injection procedure during cardiac catheterization including image supervision, interpretation and report for supravalvular aortography (List separately in addition to code for primary procedure)
93544 and 93556
Injection procedure during cardiac catheterization including image supervision, interpretation and report for pulmonary angiography (List separately in addition to code for primary procedure)
93541 and 93556
survey that finally resulted in achieving the requisite minimum survey numbers that the RUC developed recommendations that would have more fairly valued the diagnostic cardiac catheterization services. “It’s unfortunate that CMS rejected the RUC’s counsel and failed to accept those valuations,” said Dr. Babb, “but at least we know the RUC will heed our survey data if it is robust enough.” There is more to come: CMS has instructed the RUC to put these new codes through the RUC valuation process again. “The agency’s goal is to further erode the valuation of these services, so it is imperative that we present overwhelming data to support the continued protection of the values for these services,” said Dr. Kavinsky. “The take-home message for members is to do everything you can to support SCAI’s efforts on our behalf. Essentially that means committing to participate in all future RUC surveys.” To volunteer for future surveys, email Dawn Hopkins at firstname.lastname@example.org. n
Early Career Leadership Development Program (cont’d from pg 1) The ELM program will differ from traditional mentoring efforts, which often struggle because the mentors are overly busy and the mentees aren’t really sure what kind of help they need. The ELM program is more a leadership program than a mentorship one, Dr. Naidu emphasizes. “It’s a way to find and develop a generation of interventional cardiology leaders who can rise above the obstacles to achieve success.” he says. In addition to individualized mentoring, participants will receive group training tied to the annual meetings in the kinds of skills and topics cardiology’s leaders need to know — team building, political advocacy, healthcare reform, public speaking, and time management, for example. Each ELM graduating class will be successful as individuals but also as a team, says Dr. Naidu. Once they’re chosen, the first class of ELM participants will meet next May at a one-day symposium held during SCAI’s Annual Scientific Sessions. There they’ll join leaders from the profession to begin their training. At the next annual meeting, they’ll receive more advanced training on such topics as acquiring patents, serving on advisory boards, and working with industry. They’ll also learn more advanced advocacy techniques, to enhance their ability to contribute and lead, both locally and nationally. At the third annual meeting, in 2013, participants who have achieved their goals will graduate from the program and start working on a five-year “plan of action” they’ve developed during their two-year stint as ELM Emerging Leaders. In between these annual meetings, participants will come together — at ACC and TCT annual meetings, for example — for additional training. The program will also select a mentor for each participant based on his or her individual goals. “Say someone from the West Coast wants to become a leader in structural heart disease,” says Dr. Naidu. “We’ll pair him or her with someone (preferably within driving distance) who’s very engaged in that area and can offer high-level mentorship.” Together mentor and mentee will craft individualized career development plans. These plans might cover such topics as balancing career development and clinical care, developing regional and national connections, increasing research productivity, cultivating appropriate relationships with industry, and enhancing clinical or procedural expertise. Over the two years, mentees and mentors will conduct monthly meetings — either in-person or by phone — to see their individualized career plan through, discuss any obstacles the mentee is encountering in real-time, and develop a plan to overcome them. At the end of the first year, they will submit a report on what they’ve accomplished and their goals for the following year, both of which will be reviewed with the mentee at the annual meeting. Contingent on funding, mentees will receive a modest scholarship each year, to be used in accordance with their individualized career plan.
The program will screen would-be mentors just as carefully. Mentors, who should be at least 10 years beyond their fellowship, will have a proven track record of helping younger colleagues. They should be geographically close to their assigned mentees but not in the same hospital. And they should share their mentees’ aspirations, albeit at a later stage in their career. A third part of the program is active participation in professional society committees and scientific meetings, to develop each Emerging Leader’s network, foster a sense of teamwork and collegiality, develop presentation and oratory skills, and allow opportunities to present topics related to their developing niche as invited faculty. “We feel very strongly that each society or organization excels in a unique aspect of interventional cardiology, be it political advocacy, collegiality and professionalism, or innovation, and as such Emerging Leaders need to be active at all levels,” says Dr. Naidu. Over time, opportunities and partnerships between the ELM Program and other societies and conferences may develop as well.
How to Apply Applicants will be asked via the SCAI website to submit a curriculum vitae; a two-page statement about their short-, intermediate- and long-term goals; two writing samples; and two letters of recommendation attesting to their potential as leaders in clinical care, education, scholarship, or advocacy. The ELM Program Steering Committee will then meet, discuss the applicants, and winnow them down to roughly 10 outstanding individuals. “This is about identifying and nurturing the people who will be ambassadors for our profession,” says Dr. Naidu. “We want people who we’ll be proud of, but who will also do the work and be committed to the field over the long term.” Recognizing the importance of multi-organizational commitment to developing the next generation of interventionalist leaders, both ACC and the Cardiovascular Research Foundation have agreed to cosponsor SCAI-ELM and have each designated a representative to serve on the steering committee. In addition to Dr. Naidu (chair), the ELM Program Steering Committee includes William O’Neill, M.D., FSCAI (cochair), Mark Turco, M.D., FSCAI (senior advisor), John Hirshfeld, M.D., FSCAI, Morton Kern, M.D., FSCAI, Matthew Price, M.D., FSCAI, Robert Sommer, M.D. (CRF representative), Jonathan Tobis, M.D., FSCAI, and George Vetrovec, M.D., FSCAI (ACC representative). “A large amount of what this program provides is what I could have used myself over the past few years,” says Dr. Naidu. “Now I’m trying to help others.” The deadline for applications is Dec. 15. For more information about SCAI’s ELM program, contact Dr. Naidu at email@example.com or visit www.SCAI.org/ELM. n
Advocacy & Guidelines
SCAI Leads Multi-Society Effort to Establish Standards for Live Case Demonstrations
ive case demonstrations have been used for medical education since the earliest days of interventional cardiology. But with their growing popularity at large medical meetings has come increasing concerns about whether such broadcasts jeopardize patient safety and how much education physicians are actually getting from live case demonstrations. To address those concerns, SCAI and five other cardiology organizations have issued a statement laying out for the first time a Code of Conduct practitioners, institutions, and meeting planners should follow when broadcasting cardiovascular cases. The “Statement on the Use of Live Case Demonstrations Gregory J. Dehmer, at Cardiology Meetings: Assessments of M.D., FSCAI the Past and Standards for the Future” was published in Catheterization and Cardiovascular Interventions, Journal of the American College of Cardiology (JACC), and HeartRhythm Journal in September. Almost two years in development, the statement is the result of collaboration among SCAI, the American College of Cardiology, Heart Rhythm Society, European Society of Cardiology, Sociedad Latinoamericana de
In May, Dr. James B. Hermiller, SCAI annual meeting co-chair, moderated one of several live cases transmitted to San Diego from hospitals throughout North America.
Cardiologia Intervencionista, and the Asian-Pacific Society of Interventional Cardiology. The organizations also consulted with the Accreditation Council for Continuing Medical Education and the patient support group Mended Hearts.
Education or Entertainment? “Live cases had their beginning about a year after Dr. Andreas Gruentzig performed the first coronary intervention,” says Gregory J. Dehmer, M.D., FSCAI, a past president of SCAI and chair of the writing committee. “Dr. Gruentzig was so swamped with requests for learning this new procedure he couldn’t possibly handle them individually.” To respond to this demand, he began offering live case demonstrations as a way to educate the first wave of interventional cardiologists so they could understand and perform the break-through techniques he was pioneering. But live case demonstrations have changed dramatically since then, says Dr. Dehmer. Satellite technology now allows live cases to be transmitted around the world. “You can even find live case demonstrations posted on YouTube,” notes Dr. Dehmer. (continued on page 8)
Live Case Demonstrations (cont’d from pg 7) However, critics have suggested that live cases are now more entertainment or a marketing vehicle than education. They speculate patients could suffer undue risk because operators are distracted or eager to put on a good show for their audience. Unfortunately, says Dr. Dehmer, little formal research has been done to confirm that physicians actually learn something from live case demonstrations. These concerns, plus those of the Food and Drug Administration (FDA) about allegations of promotion of unapproved medical devices, prompted SCAI and its co-authoring societies to craft the consensus statement.
A Code of Conduct The resulting document is not a guideline, Dr. Dehmer emphasizes, but a code of conduct. “What we emphasize in the document is that the number-one purpose of live case demonstrations is medical education,” he says. “It’s not to make the operators look good or to get them more business. It’s for medical education.” Key elements of the code of conduct include: • Patient safety. Patient safety must be the highest priority, and the fact that a procedure is being performed as a live demonstration must not pose additional risks to the patient. To help ensure that, live case demonstrations should involve two operators— one focused on the patient and the procedure and another who interacts with the moderator. Because of unique issues in pediatric patients, the document notes that live case demonstrations of high-risk procedures in children are rarely justified. • Patient privacy. Operators performing live case demonstrations must ensure that patients aren’t identified. Confidentiality, while an absolute necessity in all instances, is even more crucial in pediatric cases, the document adds, because children and teens can be especially sensitive to embarrassment. • Informed consent. The document recommends a twopart consent process. First, the patient’s own physician should obtain consent for the medical procedure as they normally would for any procedure. As a way of avoiding feelings of obligation or pressure, someone else should obtain consent for the live case demonstration and explain that the demonstration is for educational purposes and not for the patient’s own direct benefit. • Conﬂict of interest. Physicians and host institutions should not use live case demonstrations as marketing opportunities, the document emphasizes. For example, operators should only mention specific products if their use is clinically relevant. The
document also urges the use of neutral oversight committees that can review potential conflicts of interest. This is especially important given the high cost of live cases and the prevalence of industry support for them. The document also calls for the creation of a registry for live case demonstration outcomes. A companion document by FDA staff, “Interventional Cardiology Live Case Demonstrations: Regulatory Considerations,” lays out the special procedures that must be followed when live case demonstrations performed in the United States use unapproved devices. “There’s a formal process that an investigator or sponsor has to go through to notify the FDA,” says lead author Andrew Farb, M.D., of FDA’s Office of Device Evaluation. “They have to explain why the live case is felt to be of benefit to the ongoing clinical trial and how it’s not posing any undue safety risk to the patient.” And while the FDA doesn’t review the use of alreadyapproved devices in live case demonstrations, adds Dr. Farb, it does take “an active interest” in making sure that such devices are used appropriately and safely. “We’re sensitive to off-label uses of approved devices,” he says. Live case demonstrations shouldn’t promote offlabel use, he explains, and the use of a device beyond its labeled indication should be identified for the audience.
A Meeting Planner’s Perspective “The new code of conduct will serve as a guidepost for people to make sure they do the right thing,” says SCAI President-Elect and Annual Scientific Sessions Program Chair Christopher J. White, M.D., FSCAI. Fortunately, he says, most meeting planners in interventional cardiology Christopher J. White, are already practicing what the M.D., FSCAI document recommends. He points to a 2009 study published in JACC: Cardiovascular Interventions that compared complications of carotid stenting performed during live cases to major trials of carotid stenting and found no difference. And that’s good news, he says, given what a valuable educational tool live case demonstrations are. “We’re proceduralists; we’re doing mechanical things with our hands,” he says. “For us to learn, we can’t read about it. We have to see it.” To read the joint statement and the FDA’s companion piece, visit www.SCAI.org/Publications/Guidelines.aspx n
Education Update SCAI’s Know What Counts Educational Program Educates Atlanta Patients About Adherence
Former U.S. Congressman Nathan Deal spoke at SCAI’s Know What Counts public awareness program in Atlanta, GA.
SCAI Vice President and Director of the Know What Counts program held in Atlanta, Dr. Jeff Marshall fielded questions from an audience composed mostly of patients interested in improving their heart health.
n September SCAI’s Know What Counts regional education program brought together more than 100 heart disease patients and their caregivers, physicians, nurses, cardiac rehabilitation specialists, and local business leaders in Atlanta for an educational event designed to highlight the importance of adherence to lifestyle changes and prescribed medical regimens. The free public event is the latest in SCAI’s series of programs aimed at raising awareness of heart disease, highlighting the role interventional cardiologists play in the care of cardiac patients, and promoting better patient outcomes through direct-to-patient education. “Our main message was that patients and families should understand that there’s a continuum of care,” said SCAI Vice President J. Jeffrey Marshall, M.D., FSCAI, cardiac catheterization lab director at the Northeast Georgia Heart Center and director of the program. “It doesn’t end when someone fixes the acute problem; you need to take your meds, exercise, eat right, go to cardiac rehabilitation, and so on. We want to help our patients be more informed so they make better decisions and don’t wind up back in the hospital with stent thrombosis or other complications.” Recognizing that behavior modification and adherence to medical regimens is a challenge for healthcare providers across medicine, SCAI welcomed as program cosponsors the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), Association of Black Cardiologists (ABC), The Mended Hearts Inc., Preventive Cardiovascular Nurses Association (PCNA), and WomenHeart: The National Coalition for Women with Heart Disease. “We were really honored to share the stage with each of these groups,” said Dr. Marshall. “We’re all working
toward the same goal—to provide the best possible care for heart disease patients. It makes sense to amplify one another’s messages.”
Educating Patients and Providers The program kicked off and ended with patients sharing their experiences. Heart attack survivor Ann Fuller Bendall, support network coordinator of WomenHeart of Memphis, admitted that she repeatedly ignored the warning signs of her heart attack and waited too long to get the help she needed. “I was a prime example of what not to do,” she stressed. For a few weeks prior to her heart attack, Mrs. Bendall had felt unusually tired. “I decided it was allergies, but it was actually an early warning sign of my heart problem,” she said. When the heart attack finally occurred, she dismissed her shoulder pain as the result of a too-heavy purse and her nausea as gastric reflux. When she still felt terrible despite a normal ECG, she concluded that she had a virus. Another 50 hours passed before her blood work revealed that she had actually had a moderate heart attack, and she began to receive the treatment she needed. Mrs. Bendall was successfully treated in the cath lab and now makes every effort to live a heart-healthy lifestyle and help others do the same. That is Steve Stanko’s goal, too. The president of the southern Nevada region chapter of Mended Hearts, Mr. Stanko has visited countless heart disease patients as part of the organizations visitors’ program. He described for the audience in Atlanta how he has not only survived five heart attacks, two bypass surgeries, angioplasty, and even cardiac death, but has in fact thrived, despite his cardiovascular disease.
The patient’s perspective is invaluable, said Dr. Marshall. Complementary Program Attracts Healthcare Providers “What’s better than hearing the story of someone who’s already In addition to interactive public forums for the been through what you’re facing? entire healthcare team, including patients and As physicians, most of us have their caregivers, SCAI’s Know What Counts treated thousands of patients, but programs also include regional programs where physicians, nurses, and other providers can earn not many of us have been patients continuing medical education credits. In Atlanta, ourselves. Our patients will learn approximately 100 attendees participated in a a lot if we create forums for them three-hour program on secondary prevention, to learn from one another.” dual-antiplatelet therapy, and cardiac rehabilitation. D r. M a r s h a l l a n d S C A I SCAI was represented by Program Director J. Jeffrey Marshall, M.D., as well as H. Vernon Secretary Ted A. Bass, M.D., Anderson, M.D, FSCAI, who discussed “The FSCAI, were joined by colleagues Future of Antiplatelet Therapy.” The program also from the nursing and cardiac Dr. Skip Anderson featured speakers from AACVPR, ABC, and PCNA. rehabilitation specialties. PCNA Board member and Clinical Having an Impact Associate Pr o f e s s o r a t t h e SCAI hosts Know What Counts programs in different University of North Florida’s School of Nursing, Barbara Johnston Fletcher, R.N., stressed the importance of taking cities throughout the year, and Dr. Marshall is eager to antiplatelet medications and demonstrated simple tools see the series grow even further. “This program is a way to get the message out about what cardiovascular physicians, to help with adherence. And AACVPR President-Elect Bonnie Sanderson, nurses, and other providers are doing for patients,” he said Feedback from attendees in Atlanta was “tremendously Ph.D., R.N., associate professor at the Auburn School of Nursing in Alabama, explained the benefits of cardiac positive,” said Dr. Marshall. “I really think we had an impact.” As proof, he pointed to an email SCAI received the rehabilitation. “It really gets to the root cause of the disease,” she explained, adding that scientific evidence day after the program from a woman who had attended has confirmed that cardiac rehab can improve patients’ with her husband: “This year my husband at the age of 56 health, quality of life, and recovery, and protect them had a heart attack and was life-flighted to the hospital,” she wrote. “This conference was much needed.... Next against future heart problems and even death. Dr. Bass, medical director of the Cardiovascular week at his cardiologist appointment, he plans on asking Center at the University of Florida College of Medicine his doctor about doing cardiac rehabilitation.” Another patient attendee wrote: “This made me aware in Jacksonville, offered attendees “heart-smart” strategies for defeating heart disease. He addressed the challenges of why patients should take medications … and what patients face with diet, exercise, and smoking, as well can occur if those meds are not taken. … This program as common questions on topics such as the potential should be mandatory for all patients who have had a stent benefits of dark chocolate and red wine for heart placement! Tape it and give it out on CDs to patients!” To view materials from the Know What Counts cardiovascular health. Dr. Marshall told participants how to practice good programs in Atlanta, visit www.Seconds-Count.org. “stent defense” and countered the common reasons cited If you are interested in hosting a Know What Counts when patients stop taking their medicines as prescribed. program in your area, contact Kathy Boyd David at “Often a patient will say ‘I felt better after I got a stent, so firstname.lastname@example.org. n I figured I didn’t need the medication,’” said Dr. Marshall. “But the placing of a stent does not cure the lifelong SCAI Thanks … process of atherosclerosis.” If you can’t afford the medications you need, Dr. Marshall told the audience, ask your physician about free SCAI has undertaken the Know What Counts clinics and prescription assistance programs. public educational initiative with its own resources as well as commercial support. The programs in A surprise addition to the program came when Atlanta were supported in part by Abbott Vascular, former U.S. Representative Nathan Deal (R-GA), Medtronic CardioVascular, and Daiichi-Sankyo Lilly. now a gubernatorial candidate, arrived to discuss with The Society gratefully acknowledges this support attendees the projected impact of healthcare reform on while taking sole responsibility for all content depatients in Georgia. veloped and disseminated through the effort.
SCAI Announces Regional Radial Programs for 2011
survey conducted earlier this year found SCAI members are seeking opportunities for training in transradial percutaneous coronary interventions. In response, SCAI has scheduled a series of training programs to be held throughout the United States in 2011. The programs were developed by the Society’s Transradial Working Group to fill what many consider a significant void in the formal training of interventional cardiologists. The first program was held in Boston in November 2010. The program was sold out, and there is a waiting list for the second program, to be held in Philadelphia in January 2011. “I have been primarily a radial operator since I started practice, and the increasing data in the area has just solidified my decision to utilize radial access,” says Kimberly A. Skelding, M.D., FSCAI, chair of SCAI’s Transradial Working Group and director of Cardiovascular Research at the Geisinger Kimberly A. Skelding, Health System in Danville, PA. “Many M.D., FSCAI interventionalists do not receive formal radial instruction. It was important to identify the obstacles interventionalists were experiencing in adopting radial procedures and develop a plan for addressing those obstacles to expand the field.” On the path to developing such a plan, Dr. Skelding teamed up with Samir Pancholy, M.D., FSCAI, who co-chairs the Transradial Working Group with Dr. Skelding and is associate professor of Medicine and program director of Cardiology Fellowship at the Wright Center for GME and The Samir Pancholy, M.D., Commonwealth Medical College in FSCAI Scranton, PA. The survey they conducted provided insights into SCAI members’ knowledge, experience, and interest in transradial PCI. “The results were not surprising,” says Dr. Pancholy. “The majority of respondents cited lack of training as the primary obstacle to providing radial-access procedures.” The main obstacles to performing radial procedures were unavailability of training, fear of artery occlusion, and concerns about guide placement or obtaining access. With this and other information in hand, Drs. Skelding and Pancholy assembled SCAI’s Transradial Working Group, whose charge is to educate and train interventionalists in the transradial technique, promote the collection of data, publish results on transradial procedures, and promote the technique as safe and effective. Already the group has developed a model program suitable for interventionalists at every level of experience.
Transradial Interventional Program The Transradial Interventional Program features didactic lectures, case-based presentations, facultyguided simulation, and panel discussion. Topics include: • Historical / Global perspective of TRI • Why Transradial, why change? • Do we need a mega-trial to prove TRA/I to the US • Patient selection and Cath lab set up • Radial artery access, cocktail, equipment, techniques • Catheters for TRA/I • Anatomic variations and their solutions • Right heart catheterization • Special subsets: Bypass grafts, LIMA, STEMI, Bariatrics • Anticoagulation for PCI via radial, strategies and logic • Hemostasis after TRA/I • Radial complications and their management • Transradial non-cardiac procedures • How to set-up a TRA/I program at your lab • Simulator session with pre-defined curriculum • Angiogram review and interactive discussion Faculty: Olivier Bertrand, M.D. Ron Caputo, M.D., FSCAI John Coppola, M.D., FSCAI Kirk Garratt, M.D., FSCAI Ian Gilchrist, M.D., FSCAI David Kandzari, M.D., Ph.D., FSCAI Morton J. Kern, M.D., FSCAI Mitchell Krukoff, M.D. Tak Kwan, M.D., FSCAI Tift Mann, M.D. Tejas Patel, M.D. Jeffrey J. Popma, M.D., FSCAI Christopher Pyne, M.D., FSCAI Sunil Rao, M.D., FSCAI Pinak (Binny ) Shah, M.D., FSCAI Jenniffer Tremmel, M.D., FSCAI Christopher J. White, M.D., FSCAI
“The series is designed to provide training for the radial beginner, as well as the advanced radial interventionalist,” says Dr. Pancholy. For more information about transradial training or to register for one of the programs, visit www.SCAI.org/ Education/TRIP.aspx. n
In the Trenches
Interventional Cardiologist Leads the Way for Emerging Leaders
hat is the future of interventional cardiology? Anyone can speculate, but in many respects the future is already here in the form of an increasing number of early-career interventionalists active in SCAI and eager to help other emerging leaders find their way. One of these leaders is Srihari S. Naidu, M.D., FSCAI, FACC, FAHA, director of the Cardiac Catheterization Laboratory, Interventional Cardiology Fellowship Program and Hypertrophic Cardiomyopathy Center at Winthrop University Hospital on Long Island. “I’ve always felt it important to be a national advocate or leader,” says Dr. Naidu. “I want to look back at my career when I retire and feel that I’ve made as much of a contribution to the field as I could.” He adds, “There’s a general sense that people in leadership roles should be credible, have something tangible to offer, and energize the field while making significant contributions at a high level. So for me, coming out of fellowship, it was very important to find ways of distinguishing myself as a true contributor to the field as a whole.” Less than a decade out of training, Dr. Naidu is already an accomplished clinician, researcher, and educator. A recognized expert on alcohol septal ablation for hypertrophic obstructive cardiomyopathy (HCM) and the official SCAI representative to the 2011 ACC/AHA Guidelines on the Diagnosis and Management of HCM, he has published over 70 original articles, book chapters, and abstracts dealing with angioplasty outcomes, new technology, and innovative procedural modifications; and he regularly lectures throughout the United States and Europe.
One Path to Emerging Leadership While others picked one area of focus, Dr. Naidu took a different approach. Inspired by the giants of academic medicine who came before him, he dreamed of becoming a triple threat with accomplishments in academic research, clinical care, and teaching. As a fellow at the University of Pennsylvania, he was fortunate to have outstanding mentors in each of those areas. “That’s where my aspirations started to grow,” he says. “I melded all my mentors together into the kind of person I had constructed as a goal for myself.” He credits John Hirshfeld, M.D., FSCAI, who was involved in multiple guideline-writing committees at SCAI and ACC, for modeling what interventionalists can and should do as national leaders. “He is so passionate
An emerging leader himself, Dr. Naidu (right) has developed a program to help other earlycareer interventional cardiologists acquire the skills needed to lead the profession. He is shown here with colleague Rami Khouzam, M.D., FSCAI.
about education, that as somebody who trains under him, you’re touched by the fact that he really, really cares,” says Dr. Naidu. The director of the university’s cath lab, Howard Herrmann, M.D., FSCAI, inspired Dr. Naidu’s clinical ambitions. “He is one of the most technically gifted physicians in interventional cardiology I’ve worked with, especially with structural heart disease and advanced techniques,” says Dr. Naidu. “His guidance taught me to be creative in the cath lab, always looking to new technology and procedures.” The third key mentor in Dr. Naidu’s quest to become a triple threat was Robert Wilensky, M.D., FSCAI, the director of University of Pennsylvania’s interventional research. “Dr. Wilensky showed me how to write better manuscripts and achieve the academic productivity necessary to ascend the academic ladder.” “Matching myself with these people has put me on the path to success,” says Dr. Naidu. “Once on that path, I pushed myself onto the national scene, supported by the mentors I already had and others I found along the way—even some from within industry.”
Leadership Pipeline Despite the help of mentors, Dr. Naidu and other (continued on page 14)
Emerging Leaders (cont’d from pg 13) early-career interventionalists he has met on the national scene agree that success does not come easily. Most learned by trial and error mixed with a little bit of luck. “It shouldn’t be that tough or that random,” says Dr. Naidu. “We need to keep the pipeline of leaders going and actively support and even tailor their development.” To address this need, Dr. Naidu is spearheading a SCAI effort called Emerging Leader Mentorship (ELM). “Imagine having the best of the best in interventional cardiology help you find your ideal mentor,” he says of the program that pairs highly selected emerging leaders, based on their goals and aspirations, with nationally renowned mentors who have succeeded on that same path. “If you select emerging leaders solely on merit and potential, then match mentors and mentees perfectly and give them all the resources they need, and finally hold them accountable for results, then you can almost guarantee their success,” says Dr. Naidu. And that’s the plan! For more information on ELM
and how to apply, check out the feature story on page 1 of this newsletter.
The Future Begins Today Dr. Naidu is also using his success as an emerging leader to build partnerships with his noninvasive colleagues in cardiology. “I’m very passionate about cardiology as a team sport, so I want to be actively involved in keeping us all together,” he says. “I feel there’s an obligation for me and other people who have the capacity to become national leaders,” says Dr. Naidu. “We need credible leaders who can work with similar leaders in the ACC and AHA to figure out a way for interventional cardiology to reintegrate as a credible partner in patient care with the other members of our field.” Dr. Naidu’s commitment to this goal keeps him very active in ACC and AHA as well as SCAI and TCT. “All of these societies and organizations are important to our field, perhaps in different ways, so making sure we all work together going forward will be vital to our success.” n
Coding Q&A Low Osmolar Contrast and Reimbursement
Is there additional reimbursement when low osmolar contrast is used in the performance of a procedure?
While Medicare continues to make separate payment for contrast imaging agents for the physician office and freestanding non-facility centers with their payment based on the average sales price plus 6 percent, starting in 2008 CMS elected to “package” all contrast media under the Hospital Outpatient Prospective Payment System (HOPPS). CMS based this decision on the belief that packaging the costs of supportive items and services into the payment for the independent procedure or service with which they are associated encourages hospital “efficiencies and enables hospitals to manage their resources with maximum flexibility.” CMS does instruct hospitals to continue to report charges for drugs, biologicals, and radiopharmaceuticals, regardless of whether the items are paid separately or packaged, employing the correct HCPCS codes for the items used. As HOPPS is a prospective payment system, the accurate reporting of these services should result in greater accuracy in future payments associated with the primary service into which the cost of the contrast agent has been bundled.
For diagnostic imaging procedures using contrast media, the appropriate HCPCS code should be reported for the product along with the appropriate CPT code(s) for the procedure(s). The contrast media code should be selected based on the iodine concentration. The number of units reported should be consistent with the quantity of contrast given to complete the procedure, as in the following: Q9965 LOCM 100-199mg/ml iodine, 1 ml Q9966 LOCM 200-299mg/ml iodine, 1 ml Q9967 LOCM 300-399mg/ml iodine, 1 ml n Please note: SCAI is committed to making every reasonable effort to provide accurate information regarding the use of CPT®, and the rules and regulations set forth by CMS for the Medicare program. However, this information is subject to change by CMS and does not dictate coverage and reimbursement policy as determined by local Medicare contractors or any other payor. SCAI assumes no liability, legal, ﬁnancial, or otherwise, for physicians or other entities who utilize this information in a manner inconsistent with the policies of any payors or Medicare carriers with which the physician or other entity has a contractual obligation. CPT codes and their descriptors are copyright 2009 by the American Medical Association.