New Myocardial Perfusion Imaging Approval Process for Blue Cross Blue Shield of North Carolina
Jamie Jollis, MD, FACC
Blue Cross Blue Shield of North Carolina (BCBSNC) will introduce a new approval process for outpatient myocardial perfusion imaging (MPI) through American Imaging Management (AIM). Based upon the American College of Cardiology Appropriateness Guidelines, the new system will now consider myocardial perfusion imaging (MPI) according to “pre-test probability of coronary disease.” For symptomatic patients, the guideline panel rated appropriateness according to age, gender, and chest pain symptoms (typical, atypical, non cardiac, and none). For patients without symptoms, the panel was asked to consider appropriateness according to coronary disease risk using the NHLBI Framingham coronary heart disease risk score as a reference.
Under the direction of Thomas P. Power, MD, a cardiologist in Pennsylvania employed by AIM, a computer-based review process has been developed to take into consideration pre-test probability of disease. Health care providers will be asked to enter information regarding demographics, symptoms, and coronary disease risk. AIM has chosen to use the European Systematic Coronary Risk Evaluation (SCORE) methodology. Based upon patients from12 European countries, the European SCORE determines risk of 10 year cardiovascular death according to age, gender, smoking status, cholesterol level, and systolic blood pressure. This model was developed by the European Society of Cardiology, as the Framingham model tended to overestimate coronary disease prevalence in European populations, and non-fatal cardiac events were difficult to identify in European data compared to the NHLBI Framingham study.
Blue Cross Blue Shield of North Carolina convened the Diagnostic Imaging Advisory Group composed of physicians and administrators throughout the state including primary care physicians, radiologists, oncologists, and three cardiologists. In reviewing the new AIM process, the group was generally very supportive of an approach that incorporates the American College of Cardiology Appropriateness Guidelines. The main concerns had to do with implementation of the new process. First, we were concerned that the AIM program will require the entry of specific cholesterol and blood pressure values, information that has the potential to incur significant administrative overhead for practices lacking electronic access to these values. Similar to clinical practice and approaches to risk assessment established by national organizations, we requested that the AIM process be simplified by allowing for the entry of categorical variables (yes / no - hypertension, hypercholesterolemia). A second related concern involves the implicit assumption on the part of the AIM process that cholesterol or hypertension treatment negates any prior contribution to coronary disease risk of these chronic conditions. We requested that treatment for hypertension or hyperlipidemia be identified as coronary disease risk markers, similar to their application in clinical practice. A third concern involves the use of the European SCORE methodology or any coronary disease risk model in isolation of other important and clinically relevant risk factors as outlined in the American Heart Association / American College of Cardiology Scientific Statement regarding the Assessment of Cardiovascular Risk by Use of Multiple Risk Factor Assessment Equations. This model does not account for major risk factors that are typically incorporated in clinical practice including family history and diabetes. Dr. Power has indicated that diabetes does enter into the AIM considerations.
Brandon Hunter, the Program Manager for Blue Cross Blue Shield of North Carolina has provided additional information below. We encourage ACC members to review the process and provide feedback, particularly concerning efficiency, whether or not the entry of specific cholesterol or blood pressure values represents a significant burden, and whether the process leads to denials in patients who warrant myocardial perfusion imaging. In future meetings, the Diagnostic Imaging Advisory Group will further review the AIM MPI process including feedback from colleagues and denied cases. We may consider suggesting the Personal Heart Early Assessment Risk Tool [HEART] score from the NHLBI Atherosclerosis Risk In Communities (ARIC) Study, a model developed and validated on United States patients that takes into account family history and diabetes. This HEART score can be calculated from simple, patient self-reported data, and has been shown to perform better than the European SCORE, particularly in U.S. women.
Blue Cross Blue Shield Update
Blue Cross Blue Shield of North Carolina would like to inform its participating providers of upcoming changes to the clinical scripts used when ordering certain cardiac imaging procedures through American Imaging Management (AIM).
On August 18, 2008, AIM will be introducing a revised clinical script for Myocardial Perfusion Imaging ("MPI"). The changes to this clinical script are consistent with the revisions that were made to AIM's Clinical Guidelines for MPI. The guideline changes were implemented earlier this year in order to bring AIM's Clinical Guidelines into alignment with appropriateness criteria issued by the American College of Cardiology ("ACC") and other recently published literature. To access AIM's clinical guidelines Click here
Consistent with the ACC's efforts to introduce risk calculation as part of appropriateness determination, AIM will introduce Pre-Exam Questions ("PEQ") for MPI requests. The PEQs for MPI are similar to the PEQs that were introduced for other cardiac imaging modalities on June 16. While answering the PEQs is not a requirement for submitting a request, providing this data may result in a more expedient review process by allowing AIM to introduce risk calculation at the initial stage of the review process.
The MPI script has undergone significant usability testing with over 40 cardiology providers across five states. These providers submitted their MPI order requests using the new script. AIM conducted follow-up interviews with these groups and reviewed every order submitted during the testing process. Through this process, the new clinical script will offer users a more streamlined form for information submission and users may experience fewer requests transferred for additional clinical review.
BCBSNC will be adding a guide to the new changes, including a data collection form and screen shot examples of the AIM Portal, to its Blue e-online provider application prior to August 11, 2008. If you have specific questions about the changes after that date, please contact your local Network Management representative.
An Update on RACE
Reperfusion of Acute Myocardial Infarction in Carolina Emergency Departments (RACE)
Jamie Jollis, MD, FACC
With support of members and councilors across the state, the Reperfusion in Acute Myocardial Infarction in Carolina Emergency Departments (RACE) project has developed into the leading state wide system in the United States. This quality improvement project of the North Carolina Chapter of the American College of Cardiology has the objective of providing timely coronary reperfusion for all eligible ST segment elevation myocardial infarction patients. To date, five regions spanning the state have been organized (Greenville, Durham-Chapel Hill-Greensboro, Winston Salem, Charlotte, and Asheville). Within each region, integrated STEMI treatment plans have been implemented by teams of physicians, nurses, technicians, administrators, and public officials at 65 hospitals and 400 emergency medical service agencies. Similar to the trauma system, the emergency medical service, emergency departments, critical care transport, and cardiac catheterization laboratories work in a concerted and urgent fashion to rapidly diagnose and most effectively open occluded coronary arteries. The success of RACE has been based on the efforts and contributions of hundreds of health care professionals. At the state level, cardiology leadership has included Yele Aluko, Bob Applegate, Joe Babb, Dave Bohle, Bruce Brodie, Paul Colavita, Chris Granger, Bill Hathaway, Jamie Jollis, Bill Maddox, Scott Valeri, and Hadley Wilson. The results of the RACE project were published in the Journal of the American Medical Association in November 2007, demonstrating substantial improvements in all treatment times across the state. The RACE project was named one of the top 10 advances in heart disease by the American Heart Association, and the North Carolina model is being adopted by other state Chapters.
Building on this success, our Chapter will expand the RACE project in a number of areas. Two additional regions and the remaining 40 hospitals and associated emergency medical systems will be added to the system with the goal of having a uniform coordinated response to ST elevation myocardial infarction throughout the state. To support these efforts in the most impoverished regions in the state (tier 1 and tier 2 counties and critical access hospitals), the Kate B. Reynolds Foundation has provided a 2 year $400,000 grant. For hospitals and emergency medical services already participating in RACE, we will attempt to further improve our rate and speed of coronary reperfusion, with a particular focus on the emergency medical service aspect of STEMI care. North Carolina has over 800 emergency medical service agencies, many of which are challenged in covering large rural regions and obtaining the necessary equipment and training to diagnose ST elevation myocardial infarction. The RACE project provides an important opportunity for cardiologists to provide training and support to the emergency medical technicians and emergency department personnel on the front lines of cardiac care.
NC/ SC Chapters ACC 15th Annual Joint Meeting
September 26-28, 2008 at Wild Dunes Resort, SC
|  | Wild Dunes Resort
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Wild Dunes Resort is an exclusive, yet family friendly, beach resort just north of Charleston, SC on the Isle of Palms. Beautiful beaches, tennis, world class golf, spas and more are available at the resort. Mount Pleasant Towne Centre is an upscale shopping experience in classic southern style just a few minutes down the road. And, historic downtown Charleston is less than a half hour away.
Room Rate is $229.00 for either a room at the four-diamond Boardwalk Inn or a 2 bedroom/2 bath luxury villa. Taxes, Services and Amenity Fee are not included in this rate.
Toll-free reservations line is 800-845-8880. Cutoff date is September 3, 2008. Use the code 3FY9BF or refer to the SC/NC Chapter ACC Annual Meeting when calling in. The office is open from 7am to 11pm Monday through Thursday, then from 7am to 10pm on Friday, and 8am to 8pm on Saturday and Sunday.
Golf tee times have been reserved for Saturday, Sept. 27.
Saturday dinner will be an oyster roast and Low Country boil at the oceanfront Grand Pavilion. A childrens program will be available.
Register Online Now!
View the Agenda
Sudden Cardiac Death in North Carolina
Paul Colavita, MD, FACC
As Immediate Past President of the North Carolina Chapter of the American College of Cardiology, I am writing to share with you my concerns about the prevalence of sudden cardiac death (SCD) in the state of North Carolina.
You may have heard about a new statewide initiative called “32” that is getting off the ground. The initiative’s name refers to the sobering fact that every day in North Carolina, there are “32” deaths from sudden cardiac arrest. This translates into 980 North Carolinians a month and 11,765 a year (1). In the United States, sudden cardiac death is the leading cause of death, with an estimated 300,000 deaths each year.
I’m sure you agree that these are alarming numbers for our state. They are even more alarming when we consider that SCD is largely preventable. I feel strongly that the issue is not that North Carolina simply has more patients at risk (our prevalence is above the national average), but that there is more that we can do as far as screening patients and recommending appropriate therapy.
As my professional colleagues, I would like to enlist your help in increasing awareness of the seriousness of SCD in our state — and in promoting solutions to help reduce deaths. In particular, I feel that implantable cardioverter defibrillator (ICD) therapy is a life-saving technology that the North Carolina cardiology community has not embraced to its full potential.
Device therapy is a recognized standard of care for appropriately selected patients. In my electrophysiology practice, I have seen numerous patients who have benefited from an ICD — and survived an episode of sudden cardiac arrest.
In this letter, I’d like to summarize some background information about ICD therapy. My hope is that you will take this opportunity to become acquainted with ICD therapy. Help us improve quality of care by implementing screening guidelines and ensuring that at-risk patients are appropriately evaluated.
Some facts about SCD and ICD therapy:
- Recent scientific research shows that a reduced EF (usually less than 35%) is the single most important risk factor for sudden cardiac death.
- Only one person in 20 usually survives an episode of sudden cardiac arrest. The other 19 die before reaching the hospital (2).
- In contrast, with an ICD, 19 out of 20 people will survive. ICD’s have been shown to effectively terminate the vast majority of lethal arrhythmias(3).
- According to the Heart Rhythm Society, ICDs are 99 percent effective in stopping life-threatening arrhythmias and are the most successful therapy to treat ventricular fibrillation, the major cause of sudden cardiac arrest (4).
- However, only 35 percent of patients who could be helped by an ICD have one. ICDs continuously monitor the heart rhythm, automatically function as pacemakers for heart rates that are too slow, and deliver life-saving shocks if a dangerously fast heart rhythm is detected.
- Between 70 and 89 percent of sudden cardiac deaths occur in men, and the annual incidence is three to four times higher in men than in women. However, this disparity decreases with advancing age.
- People who’ve had a heart attack have a sudden death rate that’s four to six times that of the general population (2).
Notable Research Studies on the Efficacy of ICD Therapy
Several research studies have shown the benefits of an ICD for appropriately evaluated patients:
- The Multicenter Automatic Defibrillator Implantation Trial (MADIT II) showed that ICDs provide a significant survival benefit for patients with prior MI and EF ≤ 30 %.
The results included a 31% relative reduction in all-cause mortality over average 20-month follow-up and 5.6% absolute reduction in all-cause mortality over average 20-month follow-up. Indication: Every patient with prior MI and low EF should be considered for ICD therapy (5).
MADIT II showed that mortality risk in contemporary post-MI patients with EF ≤ 30% tends to increase as a function of time from last MI. Even up to 15 years following MI, the survival benefit from the ICD remains substantial. Aggressive use of prophylactic ICDs in the late phase of MI associated with an EF ≤ 30% appears warranted (6).
- The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) concluded that in NYHA class II or III patients with EF ≤ 35% on optimal medical therapy, ICD therapy significantly decreased the relative risk of death by 23% (vs. placebo). Amiodarone had no beneficial effect on survival (vs. placebo), despite the use of appropriate dosage and reasonable compliance rates. Indication: Every NYHA class II/III patient with low EF should be considered for ICD therapy (7).
ACC/AHA Guidelines
In short, the American Heart Association and the American College of Cardiology’s latest guidelines give the highest recommendation that implantable defibrillators can help those who have heart failure or have suffered a heart attack survive an episode of sudden cardiac arrest. Here is a brief overview of the various clinical guidelines:
- ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: In May 2008, the American College of Cardiology (ACC), American Heart Association (AHA) and the Heart Rhythm Society (HRS) jointly released updated cardiac device-based therapy guidelines. The ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities are the first guidelines that combine indications for all cardiac implantable electronic devices.
In announcing the guidelines, leaders stressed that these guidelines are unique in that they emphasize not just taking care of rhythm problems or heart failure, but global cardiovascular needs of patients. The term “optimized medical therapy” used throughout the guidelines refers to treatment beyond devices, such as drug therapies, that may reduce the need for devices.
The guidelines also recommend a thorough risk assessment and quality of life discussion with patients and their families and provide a clear discussion of who should not get devices. According to HRS, the three major changes to the new 2008 guidelines are:
- The elevation of primary prevention of sudden cardiac arrest in patients with an ischemic cardiomyopathy from a level IIa to a level I
- The clarification of the ejection fraction for implantation at 35 percent, and
- The focus on optimized medical therapy for patients
- ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Developed in Collaboration with the Heart Rhythm Society and the European Heart Rhythm Association. This document updates and combines the previously published recommendations into one source approved by the major cardiology organizations in the United States and Europe. The streamlined document assists in locating recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias.
- The ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: The risk of sudden cardiac death is an underlying problem for many heart failure patients. Heart failure patients are six to nine times more likely to die of sudden cardiac death (2). These guidelines address device therapy recommendations for heart failure patients.
- The Centers for Medicare and Medicaid Services (CMS) guidelines: In 2005, CMS announced its expanded ICD coverage decision for primary prevention ICD therapy. Immediately, coverage for primary prevention was expanded to include many people who had not first had a heart attack, arrhythmias or proven risk of arrhythmias.
Implantable Cardioverter Defibrillator Indications at a Glance
ICDs are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
- Prior MI and EF ≤ 30%
- Ischemic or non-ischemic dilated cardiomyopathy, EF ≤ 35%, NYHA class II or III
- Prior MI and EF ≤ 35% and documented, non-sustained VT and inducible VT at EP testing
- Recurrent, poorly tolerated, sustained VT
- Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to VT
Cardiac Resynchronization Therapy Defibrillator (CRT-D) Indications at a Glance
A CRT device is used to treat dyssynchrony of the heart’s ventricles. A CRT-D also provides ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
- Moderate to severe heart failure (NYHA class III or IV)
- LVEF ≤ 35%
- QRS width ≥ 120 ms
- Remains symptomatic despite stable, optimal heart failure drug therapy
Cost-effectiveness and Reliability Issues
- From a cost perspective, studies show that in appropriately selected patients, ICDs compare favorably, in terms of cost-effectiveness, with other therapeutic interventions. (8)
- Reports in recent years have put the spotlight on device therapy and reliability issues. The U.S. Food and Drug Administration most recent advisories were prompted by data indicating that some ICD models have a design flaw that can potentially cause them to malfunction.
In ICDs, device malfunction may prevent generation of the electrical pulse necessary to correct a ventricular arrhythmia. This may be caused by an electrical malfunction of the lead wire or its insulation. Other, nonlife-threatening pulse generator malfunctions can occur and may require that the device be replaced. These types of malfunctions are very rare, occurring in only about 2 percent of cases.
- Although a device malfunction may mean the ICD does not provide life-saving therapy as designed, there is no record of the device itself causing death for any patients.
- Most device malfunctions are not harmful to the patient. Device problems often are related to the software and can be fixed by reprogramming. Although sometimes the device does need to be removed and replaced, in the vast majority of patients, this is not the best answer, as the risks associated with device removal can be greater than the risks of device malfunction.
- According to an HRS industry analysis, defibrillators experience no confirmed malfunctions in greater than 99 percent of cases. (9). The industry’s leading manufacturers actively report information about device reliability and malfunctions with physicians, regulatory bodies and the public.
Patient Education
- Many physicians have expressed concern about the time required to adequately explain device therapy and possible risks to patients. There are many resources available to assist in the discussion of device therapy with patients. With the right resources and the information provided in this overview, the initial discussion preceding a referral to an EP can be accomplished in about a 10 to 15-minute conversation.
- The most critical message is that implanted cardiac devices help tens of thousands of people enjoy full, active lives and are the most effective technology for stopping life-threatening arrhythmias. The statistics about sudden cardiac arrest survival rates that I’ve included on page 2 of this overview are also powerful testaments to the success of this technology.
- Device manufacturers and organizations such as the Sudden Cardiac Arrest Association, the Heart Rhythm Society and the American Heart Association offer a variety of helpful resources for patients.
- In addition, the Cleveland Clinic has authored an article for patients titled, “Implantable Heart Rhythm Devices: Safe, Effective Treatment” that provides a good overview of device therapy and also addresses reliability issues. View the PDF
I hope the information provided here has provided you with some additional insights about the value of ICDs in treating sudden cardiac arrest. Thank you in advance for your commitment to ensuring the highest quality care for our family members, neighbors, colleagues and friends in North Carolina who are at risk for death from such an episode. If I can be of a resource to you in any way, please do not hesitate to contact me.
Best regards,
Paul Colavita, MD, FACC
President, Carolinas Heart & Vascular Institute
Immediate Past President, North Carolina Chapter, American College of Cardiology
Paul Colavita
References:
1. CDC Morbidity and Mortality - February 15, 2002
2. American Heart Association statistics
3. Himmrich E, et al. Is ICD programming for double intraoperative defibrillation threshold energy safe and effective during long-time follow-up? Results of a prospective randomized multicenter study (Low-Energy ENDOTAK Trial – LEFT). Z Kardiol. 1999 ;88 :103–12. (German language edition).
4.Heart Rhythm SocietyAccessed June 6, 2008.
5. Moss AJ, Zareba W, Hall WJ, et al for the Multicenter Automatic Defibrillator Implantation Trial II Investigators. N Engl J Med. 2002;346 :877 –883 .
6. Wilber D, Zareba W, Jackson Hall W, et al. Time dependence of mortality risk and defibrillator benefit after myocardial infarction. Circulation. 2004;109:1082–1084.
7. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352 :225 –237 .
8. Sanders GD, Hlatky MA, Owens DK. Cost-effectiveness of implantable cardioverter defibrillators. N Engl J Med. 2005 Oct 6;353(14):1471-80.
9. Average estimated malfunction rate as reported in the Draft Recommendations Report by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines, April 26, 2006.
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1500 Sunday Drive, Suite 102
Raleigh, NC 27607
Telephone: 919-861-5581
Fax: 919-787-4916
www.nccacc.org
Officers
President
Oscar Jenkins, Jr., MD, FACC
Immediate Past President
Paul Colavita, MD, FACC
Secretary/ Treasurer
David Bohle, MD, FACC
Councilors
Christopher Barber, MD, FACC
Eric Carlson, MD, FACC
Donald Glower, MD, FACC
Todd Hansen, MD, FACC
WIlliam Hathaway, MD, FACC
Lee Jobe, MD, FACC
Jamie Jollis, MD, FACC
Henry Patel, MD, FACC
John Powers, MD, FACC
Joseph Rogers, MD, FACC
Robert Rothbart, MD, FACC
Ashley Stroud, MD, FACC
Thomas Trahey, MD, FACC
Ken Wallmeyer, MD, FACC
Hadley Wilson, MD, FACC
Leigh Younce, MD, FACC
CCA Liaison
Darren T. Absher, MSN, FNP, APRN-BC
FIT Liaison
Jon Piccini
Chapter Executive
Beth Denny
The American College of Cardiology’s (ACC) 2008 Legislative Conference will take place September 14-16 at the Fairmont Hotel in Washington, D.C. We hope you will take advantage of this opportunity to help educate Congress about the important work the ACC is doing in the areas of Medicare reform, healthy system reform and research and prevention.
With your participation, this year’s conference will be better than ever. We hope to see you in September!
Click here to register
For more information on ACC's Advocacy efforts, email Advocacy or call 1-800-435-9203.
Cardiac Care Associates – Important Part of ACC
The ACC's newest membership category, Cardiac Care Associates, is now accepting applications. Registered nurses, physician assistants, clinical nurse specialists, and nurse practitioners can download an ACC membership application. Questions? Call 800.253.4636, ext. 697. Cardiac Care Community
CardioSmart is a patient education site of the American College of Cardiology. Our mission is to engage, inform, and empower patients to better prepare them for participation in their own care. We are committed to providing visitors to our site with accurate, un-biased information in an advertising-free environment. We hope you enjoy visiting our site and find it a useful extension of your relationship with your cardiologist.
ACC Distinguished Awards
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