Personalized Healthcare: Identifying the Gaps
Minka Schofield, MD Member, Diversity Committee, AAO-HNS Assistant Professor Department of Otolaryngology—Head and Neck Surgery The Ohio State University Medical Center Healthcare costs continue to rise, representing one of the key concerns of America. In 2005, about 16 percent ($2 trillion) of the gross domestic product (GDP) constituted healthcare expenses. This is expected to increase to about 20 percent ($4 trillion) by 2015. Despite the steady increase in healthcare spending, the quality of care based on outcomes of chronic health conditions and the life expectancy of the U.S. population remains lower compared to other developed countries. Furthermore, standard drug treatments are less than 60 percent effective in treating common chronic diseases. This trend has led to the concept of personalized healthcare to help lower the costs of healthcare delivery while improving patient health outcomes and quality of life. Leroy Hood, MD, PhD, a physician-scientist with a key role in the Human Genome Project, initiated the concept of P4 medicine: predictive, personalized, preventive, and participatory. This concept focuses on health and wellness of patients by predicting the risk of disease through the incorporation of genetics, behavioral and environmental factors, and preventing disease development via a more proactive model of healthcare delivery. Through personalized medicine, the goal is to treat patients with targeted and presumably more effective therapy and to move from a physician-directed practice of medicine to a participatory model that actively involves patients in their health management. Like any new concept, there are challenges or gaps that must be overcome to allow for change and “hard-wiring” of new ideals and practices into the healthcare community. Some of these gaps include accessibility of care, costs of development, negative physician and patient perspectives, regulation barriers set by governing bodies, private industry profit-driven focuses, and reimbursement limitations. Approximately 28 percent of U.S citizens have difficulty accessing medical care. Eliminating this problem has been one of the premises for President Barack Obama’s healthcare plan. This will remain a challenge even in the era of personalized medicine unless measures are taken to provide affordable healthcare services to U.S. citizens. Cost has always represented a barrier in healthcare delivery and advancement. Drug development has proven to be a costly process, often requiring billions of dollars and several years before new medications are available for use. This same resource utilization has been demonstrated in other areas of study including genomics, bioinformatics, systems biology, and nanotechnology. Research funding is also required to validate these new technologies through clinical trials. Other costs include those to promote patient and physician education and the coordination of patient data through health information technology systems such as the electronic medical record. The dedication of research dollars from both government and private industry are essential to help fund and validate targeted medical therapies and provide resources and reasonable incentives to physicians for personalized healthcare promotion. In order to develop these new technologies, research on human subjects is required. This brings to surface the ethical principles that must be maintained through this research, particularly when studying the genetic code to predict disease. Naturally, the fear of exploitation, loss of privacy, and discrimination are real barriers for patients when accepting genetic testing. Regulatory guidelines are needed to protect the patient from misuse of genetic data. In addition, the “contract” between science and society needs to be reframed to promote trust among patients. Meslin and Cho propose a “recipe for reciprocity” calling for scientists to provide society with: • a clear articulation of goals and visions of what constitutes benefit; • a commitment to achieving these goals over the pursuit of individual interests; • greater transparency; and • involvement of the public in the scientific process. • In return, society would provide: • trust in the process and goals of science; • a greater willingness to volunteer and participate in research trials; • sustained reliable funding; and • support for greater academic freedom, free from manipulation by political goals and ideology.4 Adopting the concept of personalized medicine also requires a modification of physician perspectives. For many practicing physicians, this represents a new concept and would require a shift in practice style. The education of physicians on the importance of P4 medicine and providing reimbursement incentives are key to effecting this change. Physician organizations, such as AAO-HNS and the AMA, must be actively involved in the institution of personalized healthcare by establishing new standards of care through evidence-based medicine and lobbying for improved reimbursement for physician time and effort required to establish the diagnosis. There are at least 75 university-based centers or institutes in the U.S. that focus on personalized medicine, genomics, and/or systems biology. The Ohio State University Medical Center has partnered with the non-profit Institute of Systems Biology, co-founded by Dr. Hood, to form the first organization of its kind, the P4 Medicine Institute. Finally, a change is needed in the current model of practicing medicine in the U.S., which is largely controlled by the Centers for Medicare and Medicaid Services (CMS). Physicians are in essence rewarded for procedures performed, hence the CPT code, and under-compensated for time and effort needed to obtain the correct diagnosis. CMS’s focus on the CPT code limits the use of new technology and procedures by failing to correlate CPT codes for services provided. This results in failure to reimburse for testing or procedures performed or inadequate reimbursement. As new technologies arise, it is essential that new codes are devised to encourage the process of personalized medicine. Furthermore, health promotion programs driven by insurance companies along with other patient incentives are essential to encourage patient participation in their healthcare. The era of personalized healthcare represents the beginning of efforts to reduce healthcare costs and improve health outcomes by preventing disease development and providing targeted medical therapies. Recognition of the patient, physician, and economic challenges and revision of the current model for practicing medicine are essential to the widespread institution of personalized medicine. References: 1. National Coalition of Healthcare website: http://nchc.org. 2. Aspinall MG, Hamermesh RG. Realizing the promise of personalized medicine. Harv Bus Rev 2007; 85: 108-117. 3. Hood L, SH Friend. Predictive, personalized, preventive, participatory (P4) cancer medicine Nat Rev Clin Oncol 2011; 8: 184-187. 4. Meslin EM, Cho MK. Research ethics in the era of personalized medicine: updating science’s contract with society. Public Health Genomics 2010; 13: 378-384. 5. Hwang J, Christensen C. Disruptive innovation in healthcare delivery: a framework for business-model innovation. Health Affairs 2007; 27: 1329-1335.
Minka Schofield, MD
Member, Diversity Committee, AAO-HNS
Assistant Professor
Department of Otolaryngology—Head and Neck Surgery
The Ohio State University Medical Center
Healthcare costs continue to rise, representing one of the key concerns of America. In 2005, about 16 percent ($2 trillion) of the gross domestic product (GDP) constituted healthcare expenses. This is expected to increase to about 20 percent ($4 trillion) by 2015.
Despite the steady increase in healthcare spending, the quality of care based on outcomes of chronic health conditions and the life expectancy of the U.S. population remains lower compared to other developed countries. Furthermore, standard drug treatments are less than 60 percent effective in treating common chronic diseases. This trend has led to the concept of personalized healthcare to help lower the costs of healthcare delivery while improving patient health outcomes and quality of life.
Leroy Hood, MD, PhD, a physician-scientist with a key role in the Human Genome Project, initiated the concept of P4 medicine: predictive, personalized, preventive, and participatory. This concept focuses on health and wellness of patients by predicting the risk of disease through the incorporation of genetics, behavioral and environmental factors, and preventing disease development via a more proactive model of healthcare delivery. Through personalized medicine, the goal is to treat patients with targeted and presumably more effective therapy and to move from a physician-directed practice of medicine to a participatory model that actively involves patients in their health management.
Like any new concept, there are challenges or gaps that must be overcome to allow for change and “hard-wiring” of new ideals and practices into the healthcare community. Some of these gaps include accessibility of care, costs of development, negative physician and patient perspectives, regulation barriers set by governing bodies, private industry profit-driven focuses, and reimbursement limitations.
Approximately 28 percent of U.S citizens have difficulty accessing medical care. Eliminating this problem has been one of the premises for President Barack Obama’s healthcare plan. This will remain a challenge even in the era of personalized medicine unless measures are taken to provide affordable healthcare services to U.S. citizens.
Cost has always represented a barrier in healthcare delivery and advancement. Drug development has proven to be a costly process, often requiring billions of dollars and several years before new medications are available for use. This same resource utilization has been demonstrated in other areas of study including genomics, bioinformatics, systems biology, and nanotechnology. Research funding is also required to validate these new technologies through clinical trials. Other costs include those to promote patient and physician education and the coordination of patient data through health information technology systems such as the electronic medical record. The dedication of research dollars from both government and private industry are essential to help fund and validate targeted medical therapies and provide resources and reasonable incentives to physicians for personalized healthcare promotion.
In order to develop these new technologies, research on human subjects is required. This brings to surface the ethical principles that must be maintained through this research, particularly when studying the genetic code to predict disease. Naturally, the fear of exploitation, loss of privacy, and discrimination are real barriers for patients when accepting genetic testing. Regulatory guidelines are needed to protect the patient from misuse of genetic data. In addition, the “contract” between science and society needs to be reframed to promote trust among patients. Meslin and Cho propose a “recipe for reciprocity” calling for scientists to provide society with:
• | a clear articulation of goals and visions of what constitutes benefit; |
• | a commitment to achieving these goals over the pursuit of individual interests; |
• | greater transparency; and |
• | involvement of the public in the scientific process. |
• | In return, society would provide: |
• | trust in the process and goals of science; |
• | a greater willingness to volunteer and participate in research trials; |
• | sustained reliable funding; and |
• | support for greater academic freedom, free from manipulation by political goals and ideology.4 |
Adopting the concept of personalized medicine also requires a modification of physician perspectives. For many practicing physicians, this represents a new concept and would require a shift in practice style. The education of physicians on the importance of P4 medicine and providing reimbursement incentives are key to effecting this change. Physician organizations, such as AAO-HNS and the AMA, must be actively involved in the institution of personalized healthcare by establishing new standards of care through evidence-based medicine and lobbying for improved reimbursement for physician time and effort required to establish the diagnosis.
There are at least 75 university-based centers or institutes in the U.S. that focus on personalized medicine, genomics, and/or systems biology. The Ohio State University Medical Center has partnered with the non-profit Institute of Systems Biology, co-founded by Dr. Hood, to form the first organization of its kind, the P4 Medicine Institute.
Finally, a change is needed in the current model of practicing medicine in the U.S., which is largely controlled by the Centers for Medicare and Medicaid Services (CMS). Physicians are in essence rewarded for procedures performed, hence the CPT code, and under-compensated for time and effort needed to obtain the correct diagnosis. CMS’s focus on the CPT code limits the use of new technology and procedures by failing to correlate CPT codes for services provided. This results in failure to reimburse for testing or procedures performed or inadequate reimbursement. As new technologies arise, it is essential that new codes are devised to encourage the process of personalized medicine. Furthermore, health promotion programs driven by insurance companies along with other patient incentives are essential to encourage patient participation in their healthcare.
The era of personalized healthcare represents the beginning of efforts to reduce healthcare costs and improve health outcomes by preventing disease development and providing targeted medical therapies. Recognition of the patient, physician, and economic challenges and revision of the current model for practicing medicine are essential to the widespread institution of personalized medicine.
References:
1. | National Coalition of Healthcare website: http://nchc.org. |
2. | Aspinall MG, Hamermesh RG. Realizing the promise of personalized medicine. Harv Bus Rev 2007; 85: 108-117. |
3. | Hood L, SH Friend. Predictive, personalized, preventive, participatory (P4) cancer medicine Nat Rev Clin Oncol 2011; 8: 184-187. |
4. | Meslin EM, Cho MK. Research ethics in the era of personalized medicine: updating science’s contract with society. Public Health Genomics 2010; 13: 378-384. |
5. | Hwang J, Christensen C. Disruptive innovation in healthcare delivery: a framework for business-model innovation. Health Affairs 2007; 27: 1329-1335. |