Letters
An asymptomatic 60-year-old obese woman with a family history of premature cardiovascular disease presents for evaluation. The standard workup reveals borderline levels of triglycerides, high-density lipoprotein cholesterol, and fasting blood glucose. Her 10-year Framingham risk score is 1%. Understanding the limitations of the Framingham risk score,2 her physician does not simply admonish her to exercise and lose weight but instead looks deeper by performing imaging with carotid intima-media thickness (CIMT) and coronary artery calcification and examining blood and urine for apolipoprotein B, C-reactive protein, lipoproteinassociated phospholipase A2, and microalbumin. Age- and sex-matched CIMT and coronary artery calcification results categorize her in the worst 10% and 1%, respectively. Blood and urine biomarkers are also abnormal. Imaging proves the existence of premature vascular disease; biomarkers reveal the presence of active metabolic derangements. The physician has discovered invisible but real and threatening disease and consequently can more effectively address the patient. In the context of Fineberg’s 4 approaches to curative vs preventive medicine, this patient’s disease can now be cured rather than her hypothetical risk of developing disease simply prevented. Pathology (not simply risk) was identified; health can now be restored (not just reduced risk); her individual responsibility to follow prescribed therapeutic lifestyle changes and accept medications can be promoted, moving beyond population-based advice; and individualized clinical recommendations can be established, not just broad-brushed behavioral advice. This stratagem also solved 4 prevention difficulties cited by Fineberg: success is no longer invisible as biomarkers and CIMTs change with interventions3,4; there is no longer a lack of drama—demonstrating disease through personal images and blood work produces visceral and motivating responses; the emotionless world of statistics has been supplanted by the reality of self-danger; and the barrier inherent in delay of results has been breached because biomarkers can rapidly right themselves.5 Embracing interventional prevention adds a vital dimension to the construct of population-based prevention. The 2 systems are not mutually exclusive; they complement and support each other. Seth J. Baum, MD Author Affiliation: Department of Medicine, University of Miami Vol Miller School of Medicine, Miami, Florida. Corresponding Author: Seth J. Baum, MD, Preventive Cardiology Inc, 7900 Glades Rd, Ste 400, Boca Raton, FL 33434 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported being a consultant to Solstas and Diadexus. 1. Fineberg HV. The paradox of disease prevention: celebrated in principle, resisted in practice. JAMA. 2013;310(1):85-90. 2. Simprini LA, Taylor AJ. Cardiac CT in women: clinical application and considerations. J Cardiovasc Comput Tomogr. 2012;6(2):71-77. 3. Peters SA, Grobbee DE, Bots ML. Carotid intima–media thickness: a suitable alternative for cardiovascular risk as outcome? Eur J Cardiovasc Prev Rehabil. 2011;18(2):167-174.
2202
4. Nemet D, Oren S, Pantanowitz M, Eliakim A. Effects of a multidisciplinary childhood obesity treatment intervention on adipocytokines, inflammatory and growth mediators. Horm Res Paediatr. 2013;79(6):325-332. 5. Esposito K, Marfella R, Ciotola M, et al. Effect of a Mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA. 2004;292(12):1440-1446.
In Reply As Dr Baum notes, the opportunity to individualize preventive measures to meet the clinical circumstances of each patient may be an important strategy to make prevention more meaningful, tangible, and acceptable to a patient. One means to accomplish this goal is to identify the subset of general preventive care guidelines that offer the greatest benefit to a patient’s specific clinical circumstances.1 Baum describes another means that relies on biomarkers that can be targets for preventive measures, and changes in biomarker status give tangible evidence of an improving risk profile. As genomic and related research identifies more molecular targets for prevention, this type of precision medicine will be expected to expand and may help overcome some of the obstacles to prevention outlined in my article. Over time, precision medicine can exert a profound effect on the choice of treatment for disease, and this may be accompanied by an even greater effect on personalizing population-based strategies for prevention of disease. Harvey V. Fineberg, MD, PhD Author Affiliation: Institute of Medicine, Washington, DC. Corresponding Author: Harvey V. Fineberg, MD, PhD, Institute of Medicine, 500 Fifth St NW, Washington, DC 20001 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Taksler GB, Keshner M, Fagerlin A, Hajizadeh N, Braithwaite RS. Personalized estimates of benefit from preventive care guidelines: a proof of concept. Ann Intern Med. 2013;159(3):161-168.
Sharing of Medicare Claims Data To the Editor In their Viewpoint, Drs Toussaint and Berwick1 discussed the qualified entity (QE) program authorized by §10332 of the Affordable Care Act. I agree that the QE program is an important avenue for sharing information about quality and efficiency with both providers (eg, hospitals, skilled nursing facilities, physicians, and other practitioners) and the public. The Centers for Medicare & Medicaid Services (CMS) currently has 11 organizations participating in the QE program and anticipates additional organizations will be selected to participate in the future. However, I would like to clarify certain statements regarding reuse of CMS data provided to QEs. It is possible for QEs to qualify to receive CMS data for another purpose unrelated to the QE program. In these cases, the CMS generally does not ask the QE to pay for data that it already has or require it to reobtain that data from the CMS. Instead, the CMS would enter into a second data use agreement (DUA) with the organization to govern the use of the data for the non–QE-related purpose. Data use agreements are important because they establish rules that ensure CMS data are used appropriately and patient privacy
JAMA November 27, 2013 Volume 310, Number 20
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/25/2015
jama.com
Letters
is safeguarded. Qualified entities also must pay a nominal fee to cover the costs of processing the new use of the data and the new DUA. The CMS expects a QE to carefully manage the data and ensure that it is complying with applicable requirements. For those organizations unable to meet the requirements in the DUAs without obtaining another data set, the CMS can redeliver the data under the second DUA. The CMS is always willing to work with requestors of data to achieve the most efficient and flexible means of data access that are compliant with applicable laws. I hope that this clarification will assist existing QEs in pursuing use of CMS data for other statutorily approved purposes, as well as encourage other organizations to participate in the QE program. The CMS is committed to greater transparency and availability of its data resources and has taken significant steps in recent years to increase the amount and type of program data available, while protecting patient privacy. Niall Brennan, MPP Author Affiliation: Office of Information Products and Data Analytics, Centers for Medicare & Medicaid Services, Washington, DC. Corresponding Author: Niall Brennan, MPP, Centers for Medicare & Medicaid Services, 200 Independence Ave SW, Washington, DC 20201 (niall.brennan @cms.hhs.gov). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Toussaint JS, Berwick DM. The need for access to Medicare fee-for-service claims data. JAMA. 2013;310(1):29-30.
In Reply We applaud the ongoing efforts of the CMS to make Medicare data more available for transparency and improvement, and the clarifications that Mr Brennan offer are welcome. However, our nation would be better served if there were scores of QEs, rather than only a handful, using those data. The small number of QEs engaged to date does indicate that barriers to use of CMS data in real time remain high. We urge continual reduction of these barriers (with strict attention to protecting patient privacy), including the statutory
and regulatory changes that we recommended in our article. We do believe that allowing QEs to assess fees for use of data may prove essential to many in establishing sustainable business models. John Toussaint, MD Donald M. Berwick, MD Author Affiliations: ThedaCare Center for Healthcare Value, Appleton, Wisconsin (Toussaint); Institute for Healthcare Improvement, Cambridge, Massachusetts (Berwick). Corresponding Author: Donald M. Berwick, MD, Institute for Healthcare Improvement, 131 Lake Ave, Newton, MA 02459 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Toussaint reported having nonpaid, nonvoting membership on the Wisconsin Health Information Organization board. No other disclosures were reported.
Guidelines for Letters Letters discussing a recent JAMA article should be submitted within 4 weeks of the article's publication in print. Letters received after 4 weeks will rarely be considered. Letters should not exceed 400 words of text and 5 references and may have no more than 3 authors. Letters reporting original research should not exceed 600 words of text and 6 references and may have no more than 5 authors. They may include up to 2 tables or figures but online supplementary material is not allowed. All letters should include a word count. Letters must not duplicate other material published or submitted for publication. Letters not meeting these specifications are generally not considered. Letters being considered for publication ordinarily will be sent to the authors of the JAMA article, who will be given the opportunity to reply. Letters will be published at the discretion of the editors and are subject to abridgement and editing. Further instructions can be found at http://jama.com/public /InstructionsForAuthors.aspx. A signed statement for authorship criteria and responsibility, financial disclosure, copyright transfer, and acknowledgment and the ICMJE Form for Disclosure of Potential Conflicts of Interest are required before publication. Letters should be submitted via the JAMA online submission and review system at http: //manuscripts.jama.com. For technical assistance, please contact [email protected]. Section Editor: Jody W. Zylke, MD, Senior Editor.
jama.com
JAMA November 27, 2013 Volume 310, Number 20
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/25/2015
2203
An asymptomatic 60-year-old obese woman with a family history of premature cardiovascular disease presents for evaluation. The standard workup reveals borderline levels of triglycerides, high-density lipoprotein cholesterol, and fasting blood glucose. Her 10-year Framingham risk score is 1%. Understanding the limitations of the Framingham risk score,2 her physician does not simply admonish her to exercise and lose weight but instead looks deeper by performing imaging with carotid intima-media thickness (CIMT) and coronary artery calcification and examining blood and urine for apolipoprotein B, C-reactive protein, lipoproteinassociated phospholipase A2, and microalbumin. Age- and sex-matched CIMT and coronary artery calcification results categorize her in the worst 10% and 1%, respectively. Blood and urine biomarkers are also abnormal. Imaging proves the existence of premature vascular disease; biomarkers reveal the presence of active metabolic derangements. The physician has discovered invisible but real and threatening disease and consequently can more effectively address the patient. In the context of Fineberg’s 4 approaches to curative vs preventive medicine, this patient’s disease can now be cured rather than her hypothetical risk of developing disease simply prevented. Pathology (not simply risk) was identified; health can now be restored (not just reduced risk); her individual responsibility to follow prescribed therapeutic lifestyle changes and accept medications can be promoted, moving beyond population-based advice; and individualized clinical recommendations can be established, not just broad-brushed behavioral advice. This stratagem also solved 4 prevention difficulties cited by Fineberg: success is no longer invisible as biomarkers and CIMTs change with interventions3,4; there is no longer a lack of drama—demonstrating disease through personal images and blood work produces visceral and motivating responses; the emotionless world of statistics has been supplanted by the reality of self-danger; and the barrier inherent in delay of results has been breached because biomarkers can rapidly right themselves.5 Embracing interventional prevention adds a vital dimension to the construct of population-based prevention. The 2 systems are not mutually exclusive; they complement and support each other. Seth J. Baum, MD Author Affiliation: Department of Medicine, University of Miami Vol Miller School of Medicine, Miami, Florida. Corresponding Author: Seth J. Baum, MD, Preventive Cardiology Inc, 7900 Glades Rd, Ste 400, Boca Raton, FL 33434 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported being a consultant to Solstas and Diadexus. 1. Fineberg HV. The paradox of disease prevention: celebrated in principle, resisted in practice. JAMA. 2013;310(1):85-90. 2. Simprini LA, Taylor AJ. Cardiac CT in women: clinical application and considerations. J Cardiovasc Comput Tomogr. 2012;6(2):71-77. 3. Peters SA, Grobbee DE, Bots ML. Carotid intima–media thickness: a suitable alternative for cardiovascular risk as outcome? Eur J Cardiovasc Prev Rehabil. 2011;18(2):167-174.
2202
4. Nemet D, Oren S, Pantanowitz M, Eliakim A. Effects of a multidisciplinary childhood obesity treatment intervention on adipocytokines, inflammatory and growth mediators. Horm Res Paediatr. 2013;79(6):325-332. 5. Esposito K, Marfella R, Ciotola M, et al. Effect of a Mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA. 2004;292(12):1440-1446.
In Reply As Dr Baum notes, the opportunity to individualize preventive measures to meet the clinical circumstances of each patient may be an important strategy to make prevention more meaningful, tangible, and acceptable to a patient. One means to accomplish this goal is to identify the subset of general preventive care guidelines that offer the greatest benefit to a patient’s specific clinical circumstances.1 Baum describes another means that relies on biomarkers that can be targets for preventive measures, and changes in biomarker status give tangible evidence of an improving risk profile. As genomic and related research identifies more molecular targets for prevention, this type of precision medicine will be expected to expand and may help overcome some of the obstacles to prevention outlined in my article. Over time, precision medicine can exert a profound effect on the choice of treatment for disease, and this may be accompanied by an even greater effect on personalizing population-based strategies for prevention of disease. Harvey V. Fineberg, MD, PhD Author Affiliation: Institute of Medicine, Washington, DC. Corresponding Author: Harvey V. Fineberg, MD, PhD, Institute of Medicine, 500 Fifth St NW, Washington, DC 20001 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Taksler GB, Keshner M, Fagerlin A, Hajizadeh N, Braithwaite RS. Personalized estimates of benefit from preventive care guidelines: a proof of concept. Ann Intern Med. 2013;159(3):161-168.
Sharing of Medicare Claims Data To the Editor In their Viewpoint, Drs Toussaint and Berwick1 discussed the qualified entity (QE) program authorized by §10332 of the Affordable Care Act. I agree that the QE program is an important avenue for sharing information about quality and efficiency with both providers (eg, hospitals, skilled nursing facilities, physicians, and other practitioners) and the public. The Centers for Medicare & Medicaid Services (CMS) currently has 11 organizations participating in the QE program and anticipates additional organizations will be selected to participate in the future. However, I would like to clarify certain statements regarding reuse of CMS data provided to QEs. It is possible for QEs to qualify to receive CMS data for another purpose unrelated to the QE program. In these cases, the CMS generally does not ask the QE to pay for data that it already has or require it to reobtain that data from the CMS. Instead, the CMS would enter into a second data use agreement (DUA) with the organization to govern the use of the data for the non–QE-related purpose. Data use agreements are important because they establish rules that ensure CMS data are used appropriately and patient privacy
JAMA November 27, 2013 Volume 310, Number 20
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/25/2015
jama.com
Letters
is safeguarded. Qualified entities also must pay a nominal fee to cover the costs of processing the new use of the data and the new DUA. The CMS expects a QE to carefully manage the data and ensure that it is complying with applicable requirements. For those organizations unable to meet the requirements in the DUAs without obtaining another data set, the CMS can redeliver the data under the second DUA. The CMS is always willing to work with requestors of data to achieve the most efficient and flexible means of data access that are compliant with applicable laws. I hope that this clarification will assist existing QEs in pursuing use of CMS data for other statutorily approved purposes, as well as encourage other organizations to participate in the QE program. The CMS is committed to greater transparency and availability of its data resources and has taken significant steps in recent years to increase the amount and type of program data available, while protecting patient privacy. Niall Brennan, MPP Author Affiliation: Office of Information Products and Data Analytics, Centers for Medicare & Medicaid Services, Washington, DC. Corresponding Author: Niall Brennan, MPP, Centers for Medicare & Medicaid Services, 200 Independence Ave SW, Washington, DC 20201 (niall.brennan @cms.hhs.gov). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Toussaint JS, Berwick DM. The need for access to Medicare fee-for-service claims data. JAMA. 2013;310(1):29-30.
In Reply We applaud the ongoing efforts of the CMS to make Medicare data more available for transparency and improvement, and the clarifications that Mr Brennan offer are welcome. However, our nation would be better served if there were scores of QEs, rather than only a handful, using those data. The small number of QEs engaged to date does indicate that barriers to use of CMS data in real time remain high. We urge continual reduction of these barriers (with strict attention to protecting patient privacy), including the statutory
and regulatory changes that we recommended in our article. We do believe that allowing QEs to assess fees for use of data may prove essential to many in establishing sustainable business models. John Toussaint, MD Donald M. Berwick, MD Author Affiliations: ThedaCare Center for Healthcare Value, Appleton, Wisconsin (Toussaint); Institute for Healthcare Improvement, Cambridge, Massachusetts (Berwick). Corresponding Author: Donald M. Berwick, MD, Institute for Healthcare Improvement, 131 Lake Ave, Newton, MA 02459 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Toussaint reported having nonpaid, nonvoting membership on the Wisconsin Health Information Organization board. No other disclosures were reported.
Guidelines for Letters Letters discussing a recent JAMA article should be submitted within 4 weeks of the article's publication in print. Letters received after 4 weeks will rarely be considered. Letters should not exceed 400 words of text and 5 references and may have no more than 3 authors. Letters reporting original research should not exceed 600 words of text and 6 references and may have no more than 5 authors. They may include up to 2 tables or figures but online supplementary material is not allowed. All letters should include a word count. Letters must not duplicate other material published or submitted for publication. Letters not meeting these specifications are generally not considered. Letters being considered for publication ordinarily will be sent to the authors of the JAMA article, who will be given the opportunity to reply. Letters will be published at the discretion of the editors and are subject to abridgement and editing. Further instructions can be found at http://jama.com/public /InstructionsForAuthors.aspx. A signed statement for authorship criteria and responsibility, financial disclosure, copyright transfer, and acknowledgment and the ICMJE Form for Disclosure of Potential Conflicts of Interest are required before publication. Letters should be submitted via the JAMA online submission and review system at http: //manuscripts.jama.com. For technical assistance, please contact [email protected]. Section Editor: Jody W. Zylke, MD, Senior Editor.
jama.com
JAMA November 27, 2013 Volume 310, Number 20
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/25/2015
2203
