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Cutaneous SCC in a Renal Transplant Patient Derived From Donor Kidney Tumor Cells: Should Donor Transplant Organs Undergo Genetic Profiling for Cancer-Associated Mutations?
Squamous cell carcinoma (SCC) on sun-exposed sites following prolonged immunosuppression is one of the main long-term complications of allogeneic transplantations. In an article published in the Journal of Clinical Investigation (2013;123:3797-3801), the investigators demonstrated that the SCC tumor cells from a renal transplant patient had the donor genotype and harbored a TP53 (tumor-suppressing p53) mutation in codon 175; in addition, the same TP53 mutation had previously been documented 7 years earlier in p53+ cells in the renal tubules from a kidney graft biopsy. The observations in this patient provide evidence that the kidney donor can contribute to subsequent SCCs in renal transplant recipients.
What’s the issue?
Donor contribution to the malignant epithelium of cutaneous cancer in organ transplant recipients has several important implications. First, this observation provides additional insight into the initiation and progression of tumor carcinogenesis. Second, because there is longer survival of patients following renal transplant and therefore a prolonged duration of immunosuppression in these individuals, the development of long-term complications such as SCC of sun-exposed skin may be greater. Third, should genetic profiling of kidneys from potential donors to screen for cancer-associated mutations be performed? And fourth, is this phenomenon restricted only to patients receiving kidneys or might it be a possible complication in the recipients of other organs such as hearts, lungs, or even faces?
Squamous cell carcinoma (SCC) on sun-exposed sites following prolonged immunosuppression is one of the main long-term complications of allogeneic transplantations. In an article published in the Journal of Clinical Investigation (2013;123:3797-3801), the investigators demonstrated that the SCC tumor cells from a renal transplant patient had the donor genotype and harbored a TP53 (tumor-suppressing p53) mutation in codon 175; in addition, the same TP53 mutation had previously been documented 7 years earlier in p53+ cells in the renal tubules from a kidney graft biopsy. The observations in this patient provide evidence that the kidney donor can contribute to subsequent SCCs in renal transplant recipients.
What’s the issue?
Donor contribution to the malignant epithelium of cutaneous cancer in organ transplant recipients has several important implications. First, this observation provides additional insight into the initiation and progression of tumor carcinogenesis. Second, because there is longer survival of patients following renal transplant and therefore a prolonged duration of immunosuppression in these individuals, the development of long-term complications such as SCC of sun-exposed skin may be greater. Third, should genetic profiling of kidneys from potential donors to screen for cancer-associated mutations be performed? And fourth, is this phenomenon restricted only to patients receiving kidneys or might it be a possible complication in the recipients of other organs such as hearts, lungs, or even faces?
Squamous cell carcinoma (SCC) on sun-exposed sites following prolonged immunosuppression is one of the main long-term complications of allogeneic transplantations. In an article published in the Journal of Clinical Investigation (2013;123:3797-3801), the investigators demonstrated that the SCC tumor cells from a renal transplant patient had the donor genotype and harbored a TP53 (tumor-suppressing p53) mutation in codon 175; in addition, the same TP53 mutation had previously been documented 7 years earlier in p53+ cells in the renal tubules from a kidney graft biopsy. The observations in this patient provide evidence that the kidney donor can contribute to subsequent SCCs in renal transplant recipients.
What’s the issue?
Donor contribution to the malignant epithelium of cutaneous cancer in organ transplant recipients has several important implications. First, this observation provides additional insight into the initiation and progression of tumor carcinogenesis. Second, because there is longer survival of patients following renal transplant and therefore a prolonged duration of immunosuppression in these individuals, the development of long-term complications such as SCC of sun-exposed skin may be greater. Third, should genetic profiling of kidneys from potential donors to screen for cancer-associated mutations be performed? And fourth, is this phenomenon restricted only to patients receiving kidneys or might it be a possible complication in the recipients of other organs such as hearts, lungs, or even faces?
Battle of the Sexes: “Brotox”
In the October 2013 issue of Dermatologic Surgery (2013;39:1434-1443), Keaney and Alster reviewed the use of botulinum toxin in men. Although botulinum toxin injection was the most common cosmetic procedure performed in 2011 in both sexes, men represented only 6% of participants. The authors reviewed the sexual differences in the anatomy of treatment areas. As described, men were noted to have more prominent supraorbital ridges, which contributed to a flatter eyebrow contour that was positioned lower along the orbital rim compared to women. Also the medial supraorbital ridge blended into the glabellar complex on men, giving a greater forward projection. Additionally, forehead height and width were greater in men and there was a greater backward slope compared to women. The female forehead had a greater contour and the female orbit was proportionally larger in relation to skull size. With regard to facial musculature, men were thought to have greater skeletal muscle mass. Men were reported to have greater upward vertical movement for facial expressions, which was thought to contribute to the differences in rhytide severity and distribution.
The authors also reviewed 2 published studies that accounted for sex in study design or subgroup analysis. In a study performed by Brandt et al (Dermatol Surg. 2009;35:1893-1901) of abobotulinumtoxinA for the treatment of glabellar lines, 158 participants (23 men [15%]) were randomized (2:1 ratio) to receive a single 50-U injection of abobotulinumtoxinA or placebo. This study found that women in the abobotulinumtoxinA group were more likely to respond than men, and therefore Brandt et al concluded that treatment of the male glabella required an abobotulinumtoxinA dose of more than 50 U.
What’s the issue?
The number of men seeking botulinum toxin injections has been increasing and therefore it is important to understand the inherent anatomic differences. There have been numerous clinical articles and trials using botulinum toxin but not all include men. It is important to consider the differences in muscle mass and anatomic differences when injecting botulinum toxin in men. Although clinical trials and studies provide guidelines on dosing, it is important to assess each patient individually according to muscle strength and mass. The standardized doses used in clinical trials may not be appropriate for all patients, especially men, because this patient population is not equally represented in these trials. Some male patients may state that botulinum toxin did not work, which may be due to inherent underdosing for the muscle size or strength. It is important to understand and appreciate these anatomic and structural differences in men when utilizing botulinum toxin. With a growing proportion of men seeking cosmetic treatments, are you equipped to assess the nuances?
In the October 2013 issue of Dermatologic Surgery (2013;39:1434-1443), Keaney and Alster reviewed the use of botulinum toxin in men. Although botulinum toxin injection was the most common cosmetic procedure performed in 2011 in both sexes, men represented only 6% of participants. The authors reviewed the sexual differences in the anatomy of treatment areas. As described, men were noted to have more prominent supraorbital ridges, which contributed to a flatter eyebrow contour that was positioned lower along the orbital rim compared to women. Also the medial supraorbital ridge blended into the glabellar complex on men, giving a greater forward projection. Additionally, forehead height and width were greater in men and there was a greater backward slope compared to women. The female forehead had a greater contour and the female orbit was proportionally larger in relation to skull size. With regard to facial musculature, men were thought to have greater skeletal muscle mass. Men were reported to have greater upward vertical movement for facial expressions, which was thought to contribute to the differences in rhytide severity and distribution.
The authors also reviewed 2 published studies that accounted for sex in study design or subgroup analysis. In a study performed by Brandt et al (Dermatol Surg. 2009;35:1893-1901) of abobotulinumtoxinA for the treatment of glabellar lines, 158 participants (23 men [15%]) were randomized (2:1 ratio) to receive a single 50-U injection of abobotulinumtoxinA or placebo. This study found that women in the abobotulinumtoxinA group were more likely to respond than men, and therefore Brandt et al concluded that treatment of the male glabella required an abobotulinumtoxinA dose of more than 50 U.
What’s the issue?
The number of men seeking botulinum toxin injections has been increasing and therefore it is important to understand the inherent anatomic differences. There have been numerous clinical articles and trials using botulinum toxin but not all include men. It is important to consider the differences in muscle mass and anatomic differences when injecting botulinum toxin in men. Although clinical trials and studies provide guidelines on dosing, it is important to assess each patient individually according to muscle strength and mass. The standardized doses used in clinical trials may not be appropriate for all patients, especially men, because this patient population is not equally represented in these trials. Some male patients may state that botulinum toxin did not work, which may be due to inherent underdosing for the muscle size or strength. It is important to understand and appreciate these anatomic and structural differences in men when utilizing botulinum toxin. With a growing proportion of men seeking cosmetic treatments, are you equipped to assess the nuances?
In the October 2013 issue of Dermatologic Surgery (2013;39:1434-1443), Keaney and Alster reviewed the use of botulinum toxin in men. Although botulinum toxin injection was the most common cosmetic procedure performed in 2011 in both sexes, men represented only 6% of participants. The authors reviewed the sexual differences in the anatomy of treatment areas. As described, men were noted to have more prominent supraorbital ridges, which contributed to a flatter eyebrow contour that was positioned lower along the orbital rim compared to women. Also the medial supraorbital ridge blended into the glabellar complex on men, giving a greater forward projection. Additionally, forehead height and width were greater in men and there was a greater backward slope compared to women. The female forehead had a greater contour and the female orbit was proportionally larger in relation to skull size. With regard to facial musculature, men were thought to have greater skeletal muscle mass. Men were reported to have greater upward vertical movement for facial expressions, which was thought to contribute to the differences in rhytide severity and distribution.
The authors also reviewed 2 published studies that accounted for sex in study design or subgroup analysis. In a study performed by Brandt et al (Dermatol Surg. 2009;35:1893-1901) of abobotulinumtoxinA for the treatment of glabellar lines, 158 participants (23 men [15%]) were randomized (2:1 ratio) to receive a single 50-U injection of abobotulinumtoxinA or placebo. This study found that women in the abobotulinumtoxinA group were more likely to respond than men, and therefore Brandt et al concluded that treatment of the male glabella required an abobotulinumtoxinA dose of more than 50 U.
What’s the issue?
The number of men seeking botulinum toxin injections has been increasing and therefore it is important to understand the inherent anatomic differences. There have been numerous clinical articles and trials using botulinum toxin but not all include men. It is important to consider the differences in muscle mass and anatomic differences when injecting botulinum toxin in men. Although clinical trials and studies provide guidelines on dosing, it is important to assess each patient individually according to muscle strength and mass. The standardized doses used in clinical trials may not be appropriate for all patients, especially men, because this patient population is not equally represented in these trials. Some male patients may state that botulinum toxin did not work, which may be due to inherent underdosing for the muscle size or strength. It is important to understand and appreciate these anatomic and structural differences in men when utilizing botulinum toxin. With a growing proportion of men seeking cosmetic treatments, are you equipped to assess the nuances?
Open Notes, Open Risk?
The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.
What’s the issue?
From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?
The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.
What’s the issue?
From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?
The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.
What’s the issue?
From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?
Shared Medical Appointments: A New Practice Model for Dermatologists?
In a recent article published online in Time magazine, “The New Group Medical Checkup,” the potential benefits of shared medical appointments are discussed. The author mentions that “[a]mong those who try shared visits, about 85% don’t go back to individual exams for everything from diabetes to weight loss and skin-related issues.”
A shared medical appointment is a group visit for the patient. For example, patients sign in and have their vital signs taken. If the visit includes a one-on-one examination by the physician, the nonphysician office personnel answers questions for the other patients. Discussion of the patients’ problems and treatments is then conducted in a group setting; additional time (eg, 90 minutes) is allocated to the visit so that the patients can learn from each other’s medical problems and have ample opportunity to ask questions.
Group visits are already being conducted by family medicine practices. It also is anticipated that additional specialties may incorporate shared medical appointments because group visits shall provide an efficient means for lowering costs when major provisions of the Patient Protection and Affordable Care Act are implemented next year.
Group visits can provide advantages for both the physician and the patient. The shared medical appointment enables the physician to streamline the delivery of care without having to repeat the same recommendations to each patient separately. The group visit encourages patients to inquire about their disease and to learn more about their condition by being able to share the experience with other patients.
What’s the issue?
The practice of medicine (and dermatology) continues to evolve, from sole practitioners to group practices to multispecialty groups to corporate-owned and -managed institutions. Some of the established means for interaction between the physician and the patient occur in a setting that is either private, hospital based, or concierge. However, social and financial influences are promoting another practice model: shared medical appointments. Is this approach to medical management appropriate for dermatology? If group visits are considered to be an appropriate approach to dermatology patient care, should dermatologists embrace this new concept and incorporate it into their practices?
In a recent article published online in Time magazine, “The New Group Medical Checkup,” the potential benefits of shared medical appointments are discussed. The author mentions that “[a]mong those who try shared visits, about 85% don’t go back to individual exams for everything from diabetes to weight loss and skin-related issues.”
A shared medical appointment is a group visit for the patient. For example, patients sign in and have their vital signs taken. If the visit includes a one-on-one examination by the physician, the nonphysician office personnel answers questions for the other patients. Discussion of the patients’ problems and treatments is then conducted in a group setting; additional time (eg, 90 minutes) is allocated to the visit so that the patients can learn from each other’s medical problems and have ample opportunity to ask questions.
Group visits are already being conducted by family medicine practices. It also is anticipated that additional specialties may incorporate shared medical appointments because group visits shall provide an efficient means for lowering costs when major provisions of the Patient Protection and Affordable Care Act are implemented next year.
Group visits can provide advantages for both the physician and the patient. The shared medical appointment enables the physician to streamline the delivery of care without having to repeat the same recommendations to each patient separately. The group visit encourages patients to inquire about their disease and to learn more about their condition by being able to share the experience with other patients.
What’s the issue?
The practice of medicine (and dermatology) continues to evolve, from sole practitioners to group practices to multispecialty groups to corporate-owned and -managed institutions. Some of the established means for interaction between the physician and the patient occur in a setting that is either private, hospital based, or concierge. However, social and financial influences are promoting another practice model: shared medical appointments. Is this approach to medical management appropriate for dermatology? If group visits are considered to be an appropriate approach to dermatology patient care, should dermatologists embrace this new concept and incorporate it into their practices?
In a recent article published online in Time magazine, “The New Group Medical Checkup,” the potential benefits of shared medical appointments are discussed. The author mentions that “[a]mong those who try shared visits, about 85% don’t go back to individual exams for everything from diabetes to weight loss and skin-related issues.”
A shared medical appointment is a group visit for the patient. For example, patients sign in and have their vital signs taken. If the visit includes a one-on-one examination by the physician, the nonphysician office personnel answers questions for the other patients. Discussion of the patients’ problems and treatments is then conducted in a group setting; additional time (eg, 90 minutes) is allocated to the visit so that the patients can learn from each other’s medical problems and have ample opportunity to ask questions.
Group visits are already being conducted by family medicine practices. It also is anticipated that additional specialties may incorporate shared medical appointments because group visits shall provide an efficient means for lowering costs when major provisions of the Patient Protection and Affordable Care Act are implemented next year.
Group visits can provide advantages for both the physician and the patient. The shared medical appointment enables the physician to streamline the delivery of care without having to repeat the same recommendations to each patient separately. The group visit encourages patients to inquire about their disease and to learn more about their condition by being able to share the experience with other patients.
What’s the issue?
The practice of medicine (and dermatology) continues to evolve, from sole practitioners to group practices to multispecialty groups to corporate-owned and -managed institutions. Some of the established means for interaction between the physician and the patient occur in a setting that is either private, hospital based, or concierge. However, social and financial influences are promoting another practice model: shared medical appointments. Is this approach to medical management appropriate for dermatology? If group visits are considered to be an appropriate approach to dermatology patient care, should dermatologists embrace this new concept and incorporate it into their practices?
Looking Forward: Juvéderm Voluma for Midface Volume
Callan et al (Clin Cosmet Investig Dermatol. 2013;6:81-89) reported on the efficacy and safety profile of Juvéderm Voluma (Allergan, Inc) for midface volume deficiency in 103 participants over 24 months. Study participants received treatment with the hyaluronic acid filler to the malar area in 1 or 2 sessions over a 4-week period. An additional treatment was administered at week 78 of the study. At least a 1-point improvement on the midface volume deficit scale (MFVDS) and on the global aesthetic improvement scale (GAIS) was defined as clinically meaningful improvement. Of the 103 participants enrolled, 84% had moderate or significant volume deficiency at baseline. At week 8, 96% were reported to be responders on the MFVDS and 98% deemed themselves responders on the GAIS.
Seventy-two participants completed 24 months of treatment; 45 of these participants did not receive supplementary filler at week 78. Forty-three of the 45 (95.6%) participants were deemed responders on the MFVDS. At end of the study (n=72), 66 participants were either satisfied or very satisfied with the product, with 70 participants indicating that they would recommend the product to others. Adverse events included bruising, swelling, pain/tenderness, erythema, eyelid edema, and vasovagal syncope. Injection-site bruising and swelling were the most commonly reported adverse events. There was a single case of swelling in the left tear trough area, which occurred approximately 17 weeks after the week 4 treatment with the study product and 2 months after bilateral administration of Juvéderm Ultra (Allergan, Inc) to the tear troughs (done outside the study), which was speculated to have led to bilateral hardening of the Juvéderm Voluma implant. Oral prednisolone 5 mg daily was administered over 5 days and Hyalase (sanofi-aventis Australia)(100–150 U) was injected 3 times over a 3-week period. The swelling completely resolved approximately 1 month after the third Hyalase session.
What’s the issue?
Juvéderm Voluma currently is not available in the United States. It differs from other hyaluronic acid fillers in that it has a lower cohesivity but higher gel hardness that results in a more viscous solution. These properties are purported to be more suited for deeper injection in the skin at the deep dermal/subcutaneous level and submuscular/supraperiosteal level, which would allow for higher lift of tissue and volume restoration, while still being injected via a small-diameter needle. Although this filler has been used outside the United States, it will be interesting to see the adaptation and adoption in the US filler market. Is it the future of fillers or another one to add to the toolbox?
Callan et al (Clin Cosmet Investig Dermatol. 2013;6:81-89) reported on the efficacy and safety profile of Juvéderm Voluma (Allergan, Inc) for midface volume deficiency in 103 participants over 24 months. Study participants received treatment with the hyaluronic acid filler to the malar area in 1 or 2 sessions over a 4-week period. An additional treatment was administered at week 78 of the study. At least a 1-point improvement on the midface volume deficit scale (MFVDS) and on the global aesthetic improvement scale (GAIS) was defined as clinically meaningful improvement. Of the 103 participants enrolled, 84% had moderate or significant volume deficiency at baseline. At week 8, 96% were reported to be responders on the MFVDS and 98% deemed themselves responders on the GAIS.
Seventy-two participants completed 24 months of treatment; 45 of these participants did not receive supplementary filler at week 78. Forty-three of the 45 (95.6%) participants were deemed responders on the MFVDS. At end of the study (n=72), 66 participants were either satisfied or very satisfied with the product, with 70 participants indicating that they would recommend the product to others. Adverse events included bruising, swelling, pain/tenderness, erythema, eyelid edema, and vasovagal syncope. Injection-site bruising and swelling were the most commonly reported adverse events. There was a single case of swelling in the left tear trough area, which occurred approximately 17 weeks after the week 4 treatment with the study product and 2 months after bilateral administration of Juvéderm Ultra (Allergan, Inc) to the tear troughs (done outside the study), which was speculated to have led to bilateral hardening of the Juvéderm Voluma implant. Oral prednisolone 5 mg daily was administered over 5 days and Hyalase (sanofi-aventis Australia)(100–150 U) was injected 3 times over a 3-week period. The swelling completely resolved approximately 1 month after the third Hyalase session.
What’s the issue?
Juvéderm Voluma currently is not available in the United States. It differs from other hyaluronic acid fillers in that it has a lower cohesivity but higher gel hardness that results in a more viscous solution. These properties are purported to be more suited for deeper injection in the skin at the deep dermal/subcutaneous level and submuscular/supraperiosteal level, which would allow for higher lift of tissue and volume restoration, while still being injected via a small-diameter needle. Although this filler has been used outside the United States, it will be interesting to see the adaptation and adoption in the US filler market. Is it the future of fillers or another one to add to the toolbox?
Callan et al (Clin Cosmet Investig Dermatol. 2013;6:81-89) reported on the efficacy and safety profile of Juvéderm Voluma (Allergan, Inc) for midface volume deficiency in 103 participants over 24 months. Study participants received treatment with the hyaluronic acid filler to the malar area in 1 or 2 sessions over a 4-week period. An additional treatment was administered at week 78 of the study. At least a 1-point improvement on the midface volume deficit scale (MFVDS) and on the global aesthetic improvement scale (GAIS) was defined as clinically meaningful improvement. Of the 103 participants enrolled, 84% had moderate or significant volume deficiency at baseline. At week 8, 96% were reported to be responders on the MFVDS and 98% deemed themselves responders on the GAIS.
Seventy-two participants completed 24 months of treatment; 45 of these participants did not receive supplementary filler at week 78. Forty-three of the 45 (95.6%) participants were deemed responders on the MFVDS. At end of the study (n=72), 66 participants were either satisfied or very satisfied with the product, with 70 participants indicating that they would recommend the product to others. Adverse events included bruising, swelling, pain/tenderness, erythema, eyelid edema, and vasovagal syncope. Injection-site bruising and swelling were the most commonly reported adverse events. There was a single case of swelling in the left tear trough area, which occurred approximately 17 weeks after the week 4 treatment with the study product and 2 months after bilateral administration of Juvéderm Ultra (Allergan, Inc) to the tear troughs (done outside the study), which was speculated to have led to bilateral hardening of the Juvéderm Voluma implant. Oral prednisolone 5 mg daily was administered over 5 days and Hyalase (sanofi-aventis Australia)(100–150 U) was injected 3 times over a 3-week period. The swelling completely resolved approximately 1 month after the third Hyalase session.
What’s the issue?
Juvéderm Voluma currently is not available in the United States. It differs from other hyaluronic acid fillers in that it has a lower cohesivity but higher gel hardness that results in a more viscous solution. These properties are purported to be more suited for deeper injection in the skin at the deep dermal/subcutaneous level and submuscular/supraperiosteal level, which would allow for higher lift of tissue and volume restoration, while still being injected via a small-diameter needle. Although this filler has been used outside the United States, it will be interesting to see the adaptation and adoption in the US filler market. Is it the future of fillers or another one to add to the toolbox?
Melanoma Regression: A Quandary of Progression, Progress, and Prognosis
The British Journal of Dermatology recently described prognostic data regarding 1693 consecutive melanoma patients (American Joint Committee on Cancer stage I to II). Based on disease-free and overall survival and sentinel lymph node biopsy (SLNB) characteristics, the study found that the majority of regional lymph node metastases were in patients who did not undergo SLNB and that histologic regression was considered protective. The authors concluded that regression should not be an indication for SLNB in thin melanomas; in fact, it may be a favorable prognostic factor.
What’s the issue?
The art of medicine and its gray areas are respected and in full effect for melanoma, as clinicians always have to take into account the patient’s clinical history, comorbidities, and a fair amount of “gut instinct” in addition to the pathology specimen characteristics when deciding on surgical margins, imaging/laboratory tests, and particularly SLNB. How do you approach cases with regression? Although not an official upstaging factor anymore and now with evidence presented in the above study, how much do we worry and account for the mysterious route a particular melanoma took clinically and molecularly before the patient presented to us?
The British Journal of Dermatology recently described prognostic data regarding 1693 consecutive melanoma patients (American Joint Committee on Cancer stage I to II). Based on disease-free and overall survival and sentinel lymph node biopsy (SLNB) characteristics, the study found that the majority of regional lymph node metastases were in patients who did not undergo SLNB and that histologic regression was considered protective. The authors concluded that regression should not be an indication for SLNB in thin melanomas; in fact, it may be a favorable prognostic factor.
What’s the issue?
The art of medicine and its gray areas are respected and in full effect for melanoma, as clinicians always have to take into account the patient’s clinical history, comorbidities, and a fair amount of “gut instinct” in addition to the pathology specimen characteristics when deciding on surgical margins, imaging/laboratory tests, and particularly SLNB. How do you approach cases with regression? Although not an official upstaging factor anymore and now with evidence presented in the above study, how much do we worry and account for the mysterious route a particular melanoma took clinically and molecularly before the patient presented to us?
The British Journal of Dermatology recently described prognostic data regarding 1693 consecutive melanoma patients (American Joint Committee on Cancer stage I to II). Based on disease-free and overall survival and sentinel lymph node biopsy (SLNB) characteristics, the study found that the majority of regional lymph node metastases were in patients who did not undergo SLNB and that histologic regression was considered protective. The authors concluded that regression should not be an indication for SLNB in thin melanomas; in fact, it may be a favorable prognostic factor.
What’s the issue?
The art of medicine and its gray areas are respected and in full effect for melanoma, as clinicians always have to take into account the patient’s clinical history, comorbidities, and a fair amount of “gut instinct” in addition to the pathology specimen characteristics when deciding on surgical margins, imaging/laboratory tests, and particularly SLNB. How do you approach cases with regression? Although not an official upstaging factor anymore and now with evidence presented in the above study, how much do we worry and account for the mysterious route a particular melanoma took clinically and molecularly before the patient presented to us?
Antibiotic Use: Yet Another Threat?
The issue of increasing antibiotic resistance has become a serious global threat. The World Health Organization proclaimed that World Health Day 2011 would be dedicated to a comprehensive consolidated strategy to prevent regression to a preantibiotic era when infections were the single leading causes of death. At the 2013 G8 summit, the health ministers of the 8 wealthiest nations in the world proclaimed that antibiotic resistance is the single biggest threat to health security facing the 21st century. In addition to the problem of resistance, the use of antibiotics can lead to long-lasting alterations in the gut flora, making posttraumatic septicemia due to enteric organisms difficult to manage. Antibiotic use also has been associated with the development of inflammatory bowel disease in a number of well-done studies. Acute antibiotic side effects have included dyschromia, photosensitivity, potential hepatic and/or renal dysfunction, gastrointestinal tract distress, and various cutaneous events ranging from morbilliform eruptions to hives and even toxic epidermal necrolysis. All of the foregoing begs for more rational, appropriate, and circumspect use of antibiotic medications by all health care providers.
If the preceding commentary didn’t catch your attention, perhaps the findings from a recent article published online in the British Journal of Dermatology will. In this thoughtful and comprehensive review, a meta-analysis was performed on 20 large-scale observational studies involving individuals aged 0 to 25 years, which assessed the impact of antibiotic exposure in utero or within the first year of life on the subsequent risk for developing eczema. Both cross-sectional and longitudinal studies demonstrated a consistently increased risk (odds ratio, 1.4) of developing atopic eczema associated with postnatal antibiotic exposure. In fact, this association was so reliable that a dose-response association could be determined, suggesting a 7% increased risk for eczema for each additional oral or parenteral antibiotic course received during the first year of life. Why this effect happens remains uncertain, but the association is clear.
What’s the issue?
Think about your use of antibiotics! Do you use open-ended and prolonged courses for acne, rosacea, hidradenitis suppurativa, dissecting cellulitis of the scalp, and other conditions in adults? Are you contributing to the ever-expanding pool of antibiotic-resistant microbes carried by the adult population? When you do utilize antibiotics, do you always verify the presence of infection by culture? Do you always obtain sensitivities on bacterial isolates? Do you explicitly admonish antibiotic recipients or their parents/guardians to finish the antibiotic course and not save or share? This recent article now makes concerns about antibiotic use early in life highly relevant. Do you treat impetigo, for example, with one of the several approved topical agents or still routinely administer oral antibiotics? How would you manage neonatal acne or furunculosis in a young child? This paper from the British Journal of Dermatology supplies us with yet another good reason to evaluate and refine our own prescribing habits when it comes to antibiotics.
The issue of increasing antibiotic resistance has become a serious global threat. The World Health Organization proclaimed that World Health Day 2011 would be dedicated to a comprehensive consolidated strategy to prevent regression to a preantibiotic era when infections were the single leading causes of death. At the 2013 G8 summit, the health ministers of the 8 wealthiest nations in the world proclaimed that antibiotic resistance is the single biggest threat to health security facing the 21st century. In addition to the problem of resistance, the use of antibiotics can lead to long-lasting alterations in the gut flora, making posttraumatic septicemia due to enteric organisms difficult to manage. Antibiotic use also has been associated with the development of inflammatory bowel disease in a number of well-done studies. Acute antibiotic side effects have included dyschromia, photosensitivity, potential hepatic and/or renal dysfunction, gastrointestinal tract distress, and various cutaneous events ranging from morbilliform eruptions to hives and even toxic epidermal necrolysis. All of the foregoing begs for more rational, appropriate, and circumspect use of antibiotic medications by all health care providers.
If the preceding commentary didn’t catch your attention, perhaps the findings from a recent article published online in the British Journal of Dermatology will. In this thoughtful and comprehensive review, a meta-analysis was performed on 20 large-scale observational studies involving individuals aged 0 to 25 years, which assessed the impact of antibiotic exposure in utero or within the first year of life on the subsequent risk for developing eczema. Both cross-sectional and longitudinal studies demonstrated a consistently increased risk (odds ratio, 1.4) of developing atopic eczema associated with postnatal antibiotic exposure. In fact, this association was so reliable that a dose-response association could be determined, suggesting a 7% increased risk for eczema for each additional oral or parenteral antibiotic course received during the first year of life. Why this effect happens remains uncertain, but the association is clear.
What’s the issue?
Think about your use of antibiotics! Do you use open-ended and prolonged courses for acne, rosacea, hidradenitis suppurativa, dissecting cellulitis of the scalp, and other conditions in adults? Are you contributing to the ever-expanding pool of antibiotic-resistant microbes carried by the adult population? When you do utilize antibiotics, do you always verify the presence of infection by culture? Do you always obtain sensitivities on bacterial isolates? Do you explicitly admonish antibiotic recipients or their parents/guardians to finish the antibiotic course and not save or share? This recent article now makes concerns about antibiotic use early in life highly relevant. Do you treat impetigo, for example, with one of the several approved topical agents or still routinely administer oral antibiotics? How would you manage neonatal acne or furunculosis in a young child? This paper from the British Journal of Dermatology supplies us with yet another good reason to evaluate and refine our own prescribing habits when it comes to antibiotics.
The issue of increasing antibiotic resistance has become a serious global threat. The World Health Organization proclaimed that World Health Day 2011 would be dedicated to a comprehensive consolidated strategy to prevent regression to a preantibiotic era when infections were the single leading causes of death. At the 2013 G8 summit, the health ministers of the 8 wealthiest nations in the world proclaimed that antibiotic resistance is the single biggest threat to health security facing the 21st century. In addition to the problem of resistance, the use of antibiotics can lead to long-lasting alterations in the gut flora, making posttraumatic septicemia due to enteric organisms difficult to manage. Antibiotic use also has been associated with the development of inflammatory bowel disease in a number of well-done studies. Acute antibiotic side effects have included dyschromia, photosensitivity, potential hepatic and/or renal dysfunction, gastrointestinal tract distress, and various cutaneous events ranging from morbilliform eruptions to hives and even toxic epidermal necrolysis. All of the foregoing begs for more rational, appropriate, and circumspect use of antibiotic medications by all health care providers.
If the preceding commentary didn’t catch your attention, perhaps the findings from a recent article published online in the British Journal of Dermatology will. In this thoughtful and comprehensive review, a meta-analysis was performed on 20 large-scale observational studies involving individuals aged 0 to 25 years, which assessed the impact of antibiotic exposure in utero or within the first year of life on the subsequent risk for developing eczema. Both cross-sectional and longitudinal studies demonstrated a consistently increased risk (odds ratio, 1.4) of developing atopic eczema associated with postnatal antibiotic exposure. In fact, this association was so reliable that a dose-response association could be determined, suggesting a 7% increased risk for eczema for each additional oral or parenteral antibiotic course received during the first year of life. Why this effect happens remains uncertain, but the association is clear.
What’s the issue?
Think about your use of antibiotics! Do you use open-ended and prolonged courses for acne, rosacea, hidradenitis suppurativa, dissecting cellulitis of the scalp, and other conditions in adults? Are you contributing to the ever-expanding pool of antibiotic-resistant microbes carried by the adult population? When you do utilize antibiotics, do you always verify the presence of infection by culture? Do you always obtain sensitivities on bacterial isolates? Do you explicitly admonish antibiotic recipients or their parents/guardians to finish the antibiotic course and not save or share? This recent article now makes concerns about antibiotic use early in life highly relevant. Do you treat impetigo, for example, with one of the several approved topical agents or still routinely administer oral antibiotics? How would you manage neonatal acne or furunculosis in a young child? This paper from the British Journal of Dermatology supplies us with yet another good reason to evaluate and refine our own prescribing habits when it comes to antibiotics.
Distribution based on contribution: The merit-based ACO shared savings distribution model
Our nation is in the midst of an inexorable shift in health care delivery from "pay for volume" to "pay for value." It is well documented that our current largely fee-for-service system is unsustainable and a dramatic incentive shift must occur. Every provider needs to be committed to providing the highest quality at the lowest cost. This is the fundamental goal of the pay-for-value system.
If quality and patient satisfaction criteria are met and providers working together in an accountable care organization or similar entity create savings for a defined patient population, then the ACO usually gets a portion of the savings, commonly 50%. Unlike capitated arrangements, shared savings arrangements can avoid or limit downside financial risk and therefore can serve as stepping-stones toward fuller accountability and incentives. They are quite appropriate for start-up and smaller ACOs.
The ACO gets the savings, if there are any. But what the ACO does with them is crucial to the success and sustainability of the organization. "ACOs must offer a realistic and achievable opportunity for providers to share in the savings created from delivering higher-value care. The incentive system must reward providers for delivering efficient care as opposed to the current volume-driven system" (The ACO Toolkit; the Dartmouth Institute, p. 9, Jan. 2011).
If providers or hospital stakeholders feel that their efforts to drive value are not being fairly recognized, they will no longer participate meaningfully, the goals of value-based medicine will be thwarted, and savings will not occur in the long-run. Before signing a participation contract, physicians should scrutinize how each ACO plans to distribute the savings it receives.
The Centers for Medicare and Medicaid Services administers the Medicare Shared Savings Program (MSSP). The fact that CMS’s regulations concerning MSSP are not prescriptive about a given savings distribution formula gives ACOs flexibility in this area. But the regulations are specific about the ultimate purpose of distributions: "As part of its application, an ACO must describe the following: (1) how it plans to use shared savings payments, including the criteria it plans to employ for distributing shared savings among its ACO participants and ACO providers/suppliers, ... and (3) how the proposed plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures" (42 CFR 425.204(d), 76 Fed. Reg. 6798 [Nov. 2, 2011]).
Fatal flaw?
Some ACOs, however, have lost sight of the fact that failure to have a fair shared savings distribution formula (linking relative distributions to relative contributions) will be fatal to its sustainability. Some view them as "profits" to go to the owners or shareholders. Some simply lock in a fixed allocation similar to fee-for-service payment ratios, without regard to who generated the savings. Some employers of physicians have contracted to compensate only on a work production basis with zero performance incentive payments at all. Other ACOs are putting off the issue because it is sensitive culturally. As health care moves more and more to value-based compensation, the distribution of savings must be viewed primarily as the providers’ professional remuneration and not corporate "profit." Payments for administrative services and debt service must, of course, come out of the savings distribution to "keep the pump primed," but they should be carefully managed. The bulk must be distributed in proportion to contribution toward quality and cost-effective care.
One physician stated, "No physician is going to join an ACO when someone else is telling them what they are worth unless they know that the savings distribution formula is impeccably fair." To those putting off design of a fair merit-based compensation system until there is more physician buy-in, we respectfully submit that you cannot get buy-in without one.
A need for honed metrics
Yes, this concept is pretty basic when you think about it. But though it may be easy to understand, it can be complex to implement, especially when multiple specialists and facilities are involved in an ACO’s care coordination. One not only needs to determine the relative potential and actual value contribution for each provider, but also the clinically valid metrics by which to measure them. Under fee for service, metrics for success were usually transactional and objective (in other words, volume of procedure times rate). An ACO’s success metrics may be neither. Success may come from things not happening (that is, fewer ED visits, avoidable admissions, and reduced readmissions). At the same time, the distribution model needs to be clear, practical, and capable of being understood by all.
But there can be a replicable framework for any ACO to use to create a fair and sustainable shared savings distribution model. There are necessary subjective judgments – at this time, many metrics are imprecise or nonexistent – and the sophistication of the distribution process must parallel the sophistication of the ACO’s infrastructure. But, if the right people are involved and apply the ACO’s guiding principles on savings allocation, participants will be appropriately incentivized. The precision of distribution application will grow over time. Don’t let the perfect be the enemy of the good.
The six guiding principles for shared savings distribution
Though application will vary widely because of differing circumstances and types of initiatives, chances for success will increase if every activity can be judged by whether it is consistent with a set of guiding principles viewed as fair by the ACO members. You may want to consider a savings distribution formula with the following principles:
• Eyes on the prize: Triple Aim. It offers incentives for the delivery of high-quality and cost-effective care to achieve the Triple Aim – better care for individuals, better health for populations, and lower per capita costs.
• Broad provider input. It is the result of input from a diverse spectrum of knowledgeable providers who understand what drives patient population value.
• Fairness. It is fair to all in that it links relative distribution to relative contribution to the organization’s total savings and quality performance, and adheres to measurable clinically valid metrics.
• Transparency. It is clear, transparent, practical to implement and replicable.
• Constant evolution. It adapts and improves as the capabilities and experience as the ACO grows.
• Maximized incentive to drive value by all participants. After prudently meeting overhead costs, it allows gradual transition as well as commercially reasonable return on capital investment or debt service. It makes the most of ongoing incentive programs for all to deliver value by distributing as much of the savings surplus as possible to those who generate them.
Weighting: How to assign relative percentage among providers
As mentioned, it is important that design of a fair distribution formula be the product of collaboration among informed and committed clinicians who understand patient population management. Like virtually all organization compensation formulas, the determination of relative contributions of the different providers in a given ACO, or care initiative within the ACO, will involve a certain amount of inherent subjectivity but will be guided by weighted criteria applied in good faith.
• Step 1: Break down each initiative into its value-adding elements and assign provider responsibility for each. The ACO will have a number of different care management initiatives. Some, like outpatient diabetes management, may be completely the responsibility of one provider specialty, (that is, primary care). Others may involve coordination across multiple settings for patients with multiple conditions involving multiple specialties. Each initiative was chosen for a reason – to drive value. In setting relative potential distribution percentages, envision the perfect implementation of each initiative. Next, look at what tasks or best practices are needed to drive success, and then who is assigned responsibility for each.
• Step 2: Assign relative percentages to each specialty relative to its potential to realize savings. For a pure primary care prevention initiative, they would get 100% in all categories. For multispecialty initiatives, the percentage is tied to the proportion of those savings predicted to flow from that provider class.
N.B.: Historically, cost centers are not necessarily the cost savers. A mature ACO will be able to allocate savings to each initiative and the relative savings distribution within each. But for a start-up ACO, because it is so apparently logical and fits the traditional fee-for-service mindset, it is tempting to look at claims differences in the various service categories, such as inpatient, outpatient, primary care, specialists, drugs, and ancillaries, and attribute savings to the provider historically billing for same (that is, hospitals get "credit" for reduced hospital costs). However, a successful wellness, prevention, or lifestyle counseling program in a medical home may be the reason those patients never go to the hospital. The radiologist embedded in the medical home diagnostic team may have helped make an informed image analysis confirming a negative result and avoided those admissions. But, do use those service categories to set cost targets.
• Step 3: Individual attribution. We now know every provider group’s potential savings, but how do we determine the actual distribution based on actual results? Select metrics that are accurately associated with the desired individual and collective conduct of that provider class. They should cover both quality and efficiency. In the value-based reimbursement world, even if the performance is superb, if it is not measured appropriately, it will not be rewarded.
Once the proper metrics are selected, each provider’s performance is measured.
Keep it simple and open
Pick a few of the very best quality and efficiency metrics and have them and the data collection process thoroughly vetted by the providers. Following the guiding principles, the distribution model will be a success if: (1) everyone understands that this is the best practical approach, (2) the process has been open, and (3) everyone is acting in good faith to have as fair a shared savings distribution process as the current sophistication level of the ACO’s infrastructure allows. It cannot be viewed as coming from a "black box." For a young ACO, it will be crude, at best, in the beginning.
Conclusion
Even at this dawning of the movement to value-based reimbursement in health care, a framework for a fair merit-based shared savings distribution is available to all ACOs. As ACOs gain actual performance data, their health information technology capabilities improve, and refined quality and efficiency metrics emerge, the process will evolve from an open and good-faith application of the guiding principles with limited tools, to more and more refined determinations of the sources of the ACO’s quality and savings results. The path will get easier over time, but the destination is always clear – distribution in proportion to contribution.
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author (bbobbitt@smithlaw.com or 919-821-6612).
Our nation is in the midst of an inexorable shift in health care delivery from "pay for volume" to "pay for value." It is well documented that our current largely fee-for-service system is unsustainable and a dramatic incentive shift must occur. Every provider needs to be committed to providing the highest quality at the lowest cost. This is the fundamental goal of the pay-for-value system.
If quality and patient satisfaction criteria are met and providers working together in an accountable care organization or similar entity create savings for a defined patient population, then the ACO usually gets a portion of the savings, commonly 50%. Unlike capitated arrangements, shared savings arrangements can avoid or limit downside financial risk and therefore can serve as stepping-stones toward fuller accountability and incentives. They are quite appropriate for start-up and smaller ACOs.
The ACO gets the savings, if there are any. But what the ACO does with them is crucial to the success and sustainability of the organization. "ACOs must offer a realistic and achievable opportunity for providers to share in the savings created from delivering higher-value care. The incentive system must reward providers for delivering efficient care as opposed to the current volume-driven system" (The ACO Toolkit; the Dartmouth Institute, p. 9, Jan. 2011).
If providers or hospital stakeholders feel that their efforts to drive value are not being fairly recognized, they will no longer participate meaningfully, the goals of value-based medicine will be thwarted, and savings will not occur in the long-run. Before signing a participation contract, physicians should scrutinize how each ACO plans to distribute the savings it receives.
The Centers for Medicare and Medicaid Services administers the Medicare Shared Savings Program (MSSP). The fact that CMS’s regulations concerning MSSP are not prescriptive about a given savings distribution formula gives ACOs flexibility in this area. But the regulations are specific about the ultimate purpose of distributions: "As part of its application, an ACO must describe the following: (1) how it plans to use shared savings payments, including the criteria it plans to employ for distributing shared savings among its ACO participants and ACO providers/suppliers, ... and (3) how the proposed plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures" (42 CFR 425.204(d), 76 Fed. Reg. 6798 [Nov. 2, 2011]).
Fatal flaw?
Some ACOs, however, have lost sight of the fact that failure to have a fair shared savings distribution formula (linking relative distributions to relative contributions) will be fatal to its sustainability. Some view them as "profits" to go to the owners or shareholders. Some simply lock in a fixed allocation similar to fee-for-service payment ratios, without regard to who generated the savings. Some employers of physicians have contracted to compensate only on a work production basis with zero performance incentive payments at all. Other ACOs are putting off the issue because it is sensitive culturally. As health care moves more and more to value-based compensation, the distribution of savings must be viewed primarily as the providers’ professional remuneration and not corporate "profit." Payments for administrative services and debt service must, of course, come out of the savings distribution to "keep the pump primed," but they should be carefully managed. The bulk must be distributed in proportion to contribution toward quality and cost-effective care.
One physician stated, "No physician is going to join an ACO when someone else is telling them what they are worth unless they know that the savings distribution formula is impeccably fair." To those putting off design of a fair merit-based compensation system until there is more physician buy-in, we respectfully submit that you cannot get buy-in without one.
A need for honed metrics
Yes, this concept is pretty basic when you think about it. But though it may be easy to understand, it can be complex to implement, especially when multiple specialists and facilities are involved in an ACO’s care coordination. One not only needs to determine the relative potential and actual value contribution for each provider, but also the clinically valid metrics by which to measure them. Under fee for service, metrics for success were usually transactional and objective (in other words, volume of procedure times rate). An ACO’s success metrics may be neither. Success may come from things not happening (that is, fewer ED visits, avoidable admissions, and reduced readmissions). At the same time, the distribution model needs to be clear, practical, and capable of being understood by all.
But there can be a replicable framework for any ACO to use to create a fair and sustainable shared savings distribution model. There are necessary subjective judgments – at this time, many metrics are imprecise or nonexistent – and the sophistication of the distribution process must parallel the sophistication of the ACO’s infrastructure. But, if the right people are involved and apply the ACO’s guiding principles on savings allocation, participants will be appropriately incentivized. The precision of distribution application will grow over time. Don’t let the perfect be the enemy of the good.
The six guiding principles for shared savings distribution
Though application will vary widely because of differing circumstances and types of initiatives, chances for success will increase if every activity can be judged by whether it is consistent with a set of guiding principles viewed as fair by the ACO members. You may want to consider a savings distribution formula with the following principles:
• Eyes on the prize: Triple Aim. It offers incentives for the delivery of high-quality and cost-effective care to achieve the Triple Aim – better care for individuals, better health for populations, and lower per capita costs.
• Broad provider input. It is the result of input from a diverse spectrum of knowledgeable providers who understand what drives patient population value.
• Fairness. It is fair to all in that it links relative distribution to relative contribution to the organization’s total savings and quality performance, and adheres to measurable clinically valid metrics.
• Transparency. It is clear, transparent, practical to implement and replicable.
• Constant evolution. It adapts and improves as the capabilities and experience as the ACO grows.
• Maximized incentive to drive value by all participants. After prudently meeting overhead costs, it allows gradual transition as well as commercially reasonable return on capital investment or debt service. It makes the most of ongoing incentive programs for all to deliver value by distributing as much of the savings surplus as possible to those who generate them.
Weighting: How to assign relative percentage among providers
As mentioned, it is important that design of a fair distribution formula be the product of collaboration among informed and committed clinicians who understand patient population management. Like virtually all organization compensation formulas, the determination of relative contributions of the different providers in a given ACO, or care initiative within the ACO, will involve a certain amount of inherent subjectivity but will be guided by weighted criteria applied in good faith.
• Step 1: Break down each initiative into its value-adding elements and assign provider responsibility for each. The ACO will have a number of different care management initiatives. Some, like outpatient diabetes management, may be completely the responsibility of one provider specialty, (that is, primary care). Others may involve coordination across multiple settings for patients with multiple conditions involving multiple specialties. Each initiative was chosen for a reason – to drive value. In setting relative potential distribution percentages, envision the perfect implementation of each initiative. Next, look at what tasks or best practices are needed to drive success, and then who is assigned responsibility for each.
• Step 2: Assign relative percentages to each specialty relative to its potential to realize savings. For a pure primary care prevention initiative, they would get 100% in all categories. For multispecialty initiatives, the percentage is tied to the proportion of those savings predicted to flow from that provider class.
N.B.: Historically, cost centers are not necessarily the cost savers. A mature ACO will be able to allocate savings to each initiative and the relative savings distribution within each. But for a start-up ACO, because it is so apparently logical and fits the traditional fee-for-service mindset, it is tempting to look at claims differences in the various service categories, such as inpatient, outpatient, primary care, specialists, drugs, and ancillaries, and attribute savings to the provider historically billing for same (that is, hospitals get "credit" for reduced hospital costs). However, a successful wellness, prevention, or lifestyle counseling program in a medical home may be the reason those patients never go to the hospital. The radiologist embedded in the medical home diagnostic team may have helped make an informed image analysis confirming a negative result and avoided those admissions. But, do use those service categories to set cost targets.
• Step 3: Individual attribution. We now know every provider group’s potential savings, but how do we determine the actual distribution based on actual results? Select metrics that are accurately associated with the desired individual and collective conduct of that provider class. They should cover both quality and efficiency. In the value-based reimbursement world, even if the performance is superb, if it is not measured appropriately, it will not be rewarded.
Once the proper metrics are selected, each provider’s performance is measured.
Keep it simple and open
Pick a few of the very best quality and efficiency metrics and have them and the data collection process thoroughly vetted by the providers. Following the guiding principles, the distribution model will be a success if: (1) everyone understands that this is the best practical approach, (2) the process has been open, and (3) everyone is acting in good faith to have as fair a shared savings distribution process as the current sophistication level of the ACO’s infrastructure allows. It cannot be viewed as coming from a "black box." For a young ACO, it will be crude, at best, in the beginning.
Conclusion
Even at this dawning of the movement to value-based reimbursement in health care, a framework for a fair merit-based shared savings distribution is available to all ACOs. As ACOs gain actual performance data, their health information technology capabilities improve, and refined quality and efficiency metrics emerge, the process will evolve from an open and good-faith application of the guiding principles with limited tools, to more and more refined determinations of the sources of the ACO’s quality and savings results. The path will get easier over time, but the destination is always clear – distribution in proportion to contribution.
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author (bbobbitt@smithlaw.com or 919-821-6612).
Our nation is in the midst of an inexorable shift in health care delivery from "pay for volume" to "pay for value." It is well documented that our current largely fee-for-service system is unsustainable and a dramatic incentive shift must occur. Every provider needs to be committed to providing the highest quality at the lowest cost. This is the fundamental goal of the pay-for-value system.
If quality and patient satisfaction criteria are met and providers working together in an accountable care organization or similar entity create savings for a defined patient population, then the ACO usually gets a portion of the savings, commonly 50%. Unlike capitated arrangements, shared savings arrangements can avoid or limit downside financial risk and therefore can serve as stepping-stones toward fuller accountability and incentives. They are quite appropriate for start-up and smaller ACOs.
The ACO gets the savings, if there are any. But what the ACO does with them is crucial to the success and sustainability of the organization. "ACOs must offer a realistic and achievable opportunity for providers to share in the savings created from delivering higher-value care. The incentive system must reward providers for delivering efficient care as opposed to the current volume-driven system" (The ACO Toolkit; the Dartmouth Institute, p. 9, Jan. 2011).
If providers or hospital stakeholders feel that their efforts to drive value are not being fairly recognized, they will no longer participate meaningfully, the goals of value-based medicine will be thwarted, and savings will not occur in the long-run. Before signing a participation contract, physicians should scrutinize how each ACO plans to distribute the savings it receives.
The Centers for Medicare and Medicaid Services administers the Medicare Shared Savings Program (MSSP). The fact that CMS’s regulations concerning MSSP are not prescriptive about a given savings distribution formula gives ACOs flexibility in this area. But the regulations are specific about the ultimate purpose of distributions: "As part of its application, an ACO must describe the following: (1) how it plans to use shared savings payments, including the criteria it plans to employ for distributing shared savings among its ACO participants and ACO providers/suppliers, ... and (3) how the proposed plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures" (42 CFR 425.204(d), 76 Fed. Reg. 6798 [Nov. 2, 2011]).
Fatal flaw?
Some ACOs, however, have lost sight of the fact that failure to have a fair shared savings distribution formula (linking relative distributions to relative contributions) will be fatal to its sustainability. Some view them as "profits" to go to the owners or shareholders. Some simply lock in a fixed allocation similar to fee-for-service payment ratios, without regard to who generated the savings. Some employers of physicians have contracted to compensate only on a work production basis with zero performance incentive payments at all. Other ACOs are putting off the issue because it is sensitive culturally. As health care moves more and more to value-based compensation, the distribution of savings must be viewed primarily as the providers’ professional remuneration and not corporate "profit." Payments for administrative services and debt service must, of course, come out of the savings distribution to "keep the pump primed," but they should be carefully managed. The bulk must be distributed in proportion to contribution toward quality and cost-effective care.
One physician stated, "No physician is going to join an ACO when someone else is telling them what they are worth unless they know that the savings distribution formula is impeccably fair." To those putting off design of a fair merit-based compensation system until there is more physician buy-in, we respectfully submit that you cannot get buy-in without one.
A need for honed metrics
Yes, this concept is pretty basic when you think about it. But though it may be easy to understand, it can be complex to implement, especially when multiple specialists and facilities are involved in an ACO’s care coordination. One not only needs to determine the relative potential and actual value contribution for each provider, but also the clinically valid metrics by which to measure them. Under fee for service, metrics for success were usually transactional and objective (in other words, volume of procedure times rate). An ACO’s success metrics may be neither. Success may come from things not happening (that is, fewer ED visits, avoidable admissions, and reduced readmissions). At the same time, the distribution model needs to be clear, practical, and capable of being understood by all.
But there can be a replicable framework for any ACO to use to create a fair and sustainable shared savings distribution model. There are necessary subjective judgments – at this time, many metrics are imprecise or nonexistent – and the sophistication of the distribution process must parallel the sophistication of the ACO’s infrastructure. But, if the right people are involved and apply the ACO’s guiding principles on savings allocation, participants will be appropriately incentivized. The precision of distribution application will grow over time. Don’t let the perfect be the enemy of the good.
The six guiding principles for shared savings distribution
Though application will vary widely because of differing circumstances and types of initiatives, chances for success will increase if every activity can be judged by whether it is consistent with a set of guiding principles viewed as fair by the ACO members. You may want to consider a savings distribution formula with the following principles:
• Eyes on the prize: Triple Aim. It offers incentives for the delivery of high-quality and cost-effective care to achieve the Triple Aim – better care for individuals, better health for populations, and lower per capita costs.
• Broad provider input. It is the result of input from a diverse spectrum of knowledgeable providers who understand what drives patient population value.
• Fairness. It is fair to all in that it links relative distribution to relative contribution to the organization’s total savings and quality performance, and adheres to measurable clinically valid metrics.
• Transparency. It is clear, transparent, practical to implement and replicable.
• Constant evolution. It adapts and improves as the capabilities and experience as the ACO grows.
• Maximized incentive to drive value by all participants. After prudently meeting overhead costs, it allows gradual transition as well as commercially reasonable return on capital investment or debt service. It makes the most of ongoing incentive programs for all to deliver value by distributing as much of the savings surplus as possible to those who generate them.
Weighting: How to assign relative percentage among providers
As mentioned, it is important that design of a fair distribution formula be the product of collaboration among informed and committed clinicians who understand patient population management. Like virtually all organization compensation formulas, the determination of relative contributions of the different providers in a given ACO, or care initiative within the ACO, will involve a certain amount of inherent subjectivity but will be guided by weighted criteria applied in good faith.
• Step 1: Break down each initiative into its value-adding elements and assign provider responsibility for each. The ACO will have a number of different care management initiatives. Some, like outpatient diabetes management, may be completely the responsibility of one provider specialty, (that is, primary care). Others may involve coordination across multiple settings for patients with multiple conditions involving multiple specialties. Each initiative was chosen for a reason – to drive value. In setting relative potential distribution percentages, envision the perfect implementation of each initiative. Next, look at what tasks or best practices are needed to drive success, and then who is assigned responsibility for each.
• Step 2: Assign relative percentages to each specialty relative to its potential to realize savings. For a pure primary care prevention initiative, they would get 100% in all categories. For multispecialty initiatives, the percentage is tied to the proportion of those savings predicted to flow from that provider class.
N.B.: Historically, cost centers are not necessarily the cost savers. A mature ACO will be able to allocate savings to each initiative and the relative savings distribution within each. But for a start-up ACO, because it is so apparently logical and fits the traditional fee-for-service mindset, it is tempting to look at claims differences in the various service categories, such as inpatient, outpatient, primary care, specialists, drugs, and ancillaries, and attribute savings to the provider historically billing for same (that is, hospitals get "credit" for reduced hospital costs). However, a successful wellness, prevention, or lifestyle counseling program in a medical home may be the reason those patients never go to the hospital. The radiologist embedded in the medical home diagnostic team may have helped make an informed image analysis confirming a negative result and avoided those admissions. But, do use those service categories to set cost targets.
• Step 3: Individual attribution. We now know every provider group’s potential savings, but how do we determine the actual distribution based on actual results? Select metrics that are accurately associated with the desired individual and collective conduct of that provider class. They should cover both quality and efficiency. In the value-based reimbursement world, even if the performance is superb, if it is not measured appropriately, it will not be rewarded.
Once the proper metrics are selected, each provider’s performance is measured.
Keep it simple and open
Pick a few of the very best quality and efficiency metrics and have them and the data collection process thoroughly vetted by the providers. Following the guiding principles, the distribution model will be a success if: (1) everyone understands that this is the best practical approach, (2) the process has been open, and (3) everyone is acting in good faith to have as fair a shared savings distribution process as the current sophistication level of the ACO’s infrastructure allows. It cannot be viewed as coming from a "black box." For a young ACO, it will be crude, at best, in the beginning.
Conclusion
Even at this dawning of the movement to value-based reimbursement in health care, a framework for a fair merit-based shared savings distribution is available to all ACOs. As ACOs gain actual performance data, their health information technology capabilities improve, and refined quality and efficiency metrics emerge, the process will evolve from an open and good-faith application of the guiding principles with limited tools, to more and more refined determinations of the sources of the ACO’s quality and savings results. The path will get easier over time, but the destination is always clear – distribution in proportion to contribution.
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author (bbobbitt@smithlaw.com or 919-821-6612).
Telomeres and Telomerase: Can a Topical Telomerase Activator Reverse Cutaneous Aging?
In an article published online in Maclean’s magazine on May 14, 2013, postulated hypotheses regarding the potential cellular pathophysiology of longevity are summarized. Telomeres, telomerase, and telomerase activators each—individually or in concert—may have a critical role in this process.
Telomeres, the tiny bits of DNA that cap the ends of chromosomes, shorten each time a cell divides and also as people age. Telomeres function to prevent chromosomes from unraveling and fusing with each other, yet when they become too short, the cell dies. Shorter telomeres have been observed in patients with chronic stress, such as mothers of children with chronic illnesses and spouses who care for parents with Alzheimer disease; domestic abuse victims; and individuals with untreated depression. Several systemic conditions also are associated with shorter telomeres, including cancer, cardiovascular disease, dementia, diabetes mellitus, and osteoporosis. However, individuals who are older than 100 years have remarkably long telomeres. Hence, telomere length may be a more accurate indicator of a person’s physiologic age than one’s date of birth.
Telomerase, an antiaging enzyme, rebuilds telomeres and protects them from wearing down. Lifestyle changes, such as diet (with increased omega-3 fatty acids found in fish oils), exercise (approximately 30 minutes 4 or 5 times a week), and meditation, can potentially slow down the shortening of telomeres, increase telomerase activity, or both. Experiments performed on genetically engineered mice with a controllable telomerase gene show that when the enzyme is turned off, it becomes prematurely old, mentally impaired, and infertile. However, even after the mice reach this state of severe degeneration, the changes reverse when the gene is turned on again; the mice eventually resemble young active adults, with a healthy sheen restored to their hair coat, improved cognition, and restored fertility.
Telomerase activators, products that can stimulate telomerase, are the next logical progression in this quest to remain young. Indeed, at least one agent is commercially available (and sold as a nutritional supplement); however, the US Food and Drug Administration has not approved the oral agent.
What’s the issue?
The skin is the largest organ of the body. It is reasonable to speculate that the aging of one’s skin may be related to overall senescence. Therefore, the cellular longevity of a person’s keratinocytes also might be related to the length of their telomeres. Increasing the telomerase activity of these keratinocytes should favorably influence the length of the telomeres. To the best of my knowledge, a topical telomerase activator remains to be developed. However, it is very intriguing to consider the potential possibilities of a new topical cutaneous antiaging agent. Will the next antiaging agent for the skin be a topical telomerase activator?
In an article published online in Maclean’s magazine on May 14, 2013, postulated hypotheses regarding the potential cellular pathophysiology of longevity are summarized. Telomeres, telomerase, and telomerase activators each—individually or in concert—may have a critical role in this process.
Telomeres, the tiny bits of DNA that cap the ends of chromosomes, shorten each time a cell divides and also as people age. Telomeres function to prevent chromosomes from unraveling and fusing with each other, yet when they become too short, the cell dies. Shorter telomeres have been observed in patients with chronic stress, such as mothers of children with chronic illnesses and spouses who care for parents with Alzheimer disease; domestic abuse victims; and individuals with untreated depression. Several systemic conditions also are associated with shorter telomeres, including cancer, cardiovascular disease, dementia, diabetes mellitus, and osteoporosis. However, individuals who are older than 100 years have remarkably long telomeres. Hence, telomere length may be a more accurate indicator of a person’s physiologic age than one’s date of birth.
Telomerase, an antiaging enzyme, rebuilds telomeres and protects them from wearing down. Lifestyle changes, such as diet (with increased omega-3 fatty acids found in fish oils), exercise (approximately 30 minutes 4 or 5 times a week), and meditation, can potentially slow down the shortening of telomeres, increase telomerase activity, or both. Experiments performed on genetically engineered mice with a controllable telomerase gene show that when the enzyme is turned off, it becomes prematurely old, mentally impaired, and infertile. However, even after the mice reach this state of severe degeneration, the changes reverse when the gene is turned on again; the mice eventually resemble young active adults, with a healthy sheen restored to their hair coat, improved cognition, and restored fertility.
Telomerase activators, products that can stimulate telomerase, are the next logical progression in this quest to remain young. Indeed, at least one agent is commercially available (and sold as a nutritional supplement); however, the US Food and Drug Administration has not approved the oral agent.
What’s the issue?
The skin is the largest organ of the body. It is reasonable to speculate that the aging of one’s skin may be related to overall senescence. Therefore, the cellular longevity of a person’s keratinocytes also might be related to the length of their telomeres. Increasing the telomerase activity of these keratinocytes should favorably influence the length of the telomeres. To the best of my knowledge, a topical telomerase activator remains to be developed. However, it is very intriguing to consider the potential possibilities of a new topical cutaneous antiaging agent. Will the next antiaging agent for the skin be a topical telomerase activator?
In an article published online in Maclean’s magazine on May 14, 2013, postulated hypotheses regarding the potential cellular pathophysiology of longevity are summarized. Telomeres, telomerase, and telomerase activators each—individually or in concert—may have a critical role in this process.
Telomeres, the tiny bits of DNA that cap the ends of chromosomes, shorten each time a cell divides and also as people age. Telomeres function to prevent chromosomes from unraveling and fusing with each other, yet when they become too short, the cell dies. Shorter telomeres have been observed in patients with chronic stress, such as mothers of children with chronic illnesses and spouses who care for parents with Alzheimer disease; domestic abuse victims; and individuals with untreated depression. Several systemic conditions also are associated with shorter telomeres, including cancer, cardiovascular disease, dementia, diabetes mellitus, and osteoporosis. However, individuals who are older than 100 years have remarkably long telomeres. Hence, telomere length may be a more accurate indicator of a person’s physiologic age than one’s date of birth.
Telomerase, an antiaging enzyme, rebuilds telomeres and protects them from wearing down. Lifestyle changes, such as diet (with increased omega-3 fatty acids found in fish oils), exercise (approximately 30 minutes 4 or 5 times a week), and meditation, can potentially slow down the shortening of telomeres, increase telomerase activity, or both. Experiments performed on genetically engineered mice with a controllable telomerase gene show that when the enzyme is turned off, it becomes prematurely old, mentally impaired, and infertile. However, even after the mice reach this state of severe degeneration, the changes reverse when the gene is turned on again; the mice eventually resemble young active adults, with a healthy sheen restored to their hair coat, improved cognition, and restored fertility.
Telomerase activators, products that can stimulate telomerase, are the next logical progression in this quest to remain young. Indeed, at least one agent is commercially available (and sold as a nutritional supplement); however, the US Food and Drug Administration has not approved the oral agent.
What’s the issue?
The skin is the largest organ of the body. It is reasonable to speculate that the aging of one’s skin may be related to overall senescence. Therefore, the cellular longevity of a person’s keratinocytes also might be related to the length of their telomeres. Increasing the telomerase activity of these keratinocytes should favorably influence the length of the telomeres. To the best of my knowledge, a topical telomerase activator remains to be developed. However, it is very intriguing to consider the potential possibilities of a new topical cutaneous antiaging agent. Will the next antiaging agent for the skin be a topical telomerase activator?
Fraxel for Actinic Keratosis: A New Therapeutic Option
Weiss and colleagues (J Am Acad Dermatol. 2013;68:98-102) conducted a 6-month safety, tolerance, and efficacy trial of nonablative 1927-nm fractional resurfacing of facial actinic keratosis (AK) with the Fraxel Dual (Solta Medical) laser. Twenty-four patients (5 male; 19 female) underwent up to 4 facial treatments with the 1927-nm laser with a 6-month follow-up period. The average patient age was 60 years, and Fitzpatrick skin types I and II were most common. Skin biopsy was performed in 7 patients prior to the initial procedure and at the 6-month follow-up.
Overall, there was an 86.6% reduction in absolute number of AK lesions at the 6-month follow-up visit. Cosmetic improvement was assessed on a 4-point scale. At the end of the 6-month study, the patients graded their improvement as 3.04 and investigators graded the improvement as 3.54. All 7 patient biopsies confirmed AK prior to treatment. At 6-month follow-up, 6 specimens (85.7%) showed histologic evidence of AK clearance.
What’s the issue?
The fractionated 1927-nm nonablative thulium laser is approved by the US Food and Drug Administration for the treatment of AK. Fraxel works by creating thermal zones, and the thermal damage targets AK lesions in the superficial skin. Actinic keratosis, the second most common condition treated by dermatologists, has many therapeutic options, including cryosurgery, photodynamic therapy, and multiple topical agents.
According to this study, 1927-nm fractional resurfacing appears to be a promising option for facial AK treatment. The added cosmetic benefit is a huge plus for many patients. More studies with long-term follow-up are needed.
How do you use Fraxel Dual to treat AK?
Weiss and colleagues (J Am Acad Dermatol. 2013;68:98-102) conducted a 6-month safety, tolerance, and efficacy trial of nonablative 1927-nm fractional resurfacing of facial actinic keratosis (AK) with the Fraxel Dual (Solta Medical) laser. Twenty-four patients (5 male; 19 female) underwent up to 4 facial treatments with the 1927-nm laser with a 6-month follow-up period. The average patient age was 60 years, and Fitzpatrick skin types I and II were most common. Skin biopsy was performed in 7 patients prior to the initial procedure and at the 6-month follow-up.
Overall, there was an 86.6% reduction in absolute number of AK lesions at the 6-month follow-up visit. Cosmetic improvement was assessed on a 4-point scale. At the end of the 6-month study, the patients graded their improvement as 3.04 and investigators graded the improvement as 3.54. All 7 patient biopsies confirmed AK prior to treatment. At 6-month follow-up, 6 specimens (85.7%) showed histologic evidence of AK clearance.
What’s the issue?
The fractionated 1927-nm nonablative thulium laser is approved by the US Food and Drug Administration for the treatment of AK. Fraxel works by creating thermal zones, and the thermal damage targets AK lesions in the superficial skin. Actinic keratosis, the second most common condition treated by dermatologists, has many therapeutic options, including cryosurgery, photodynamic therapy, and multiple topical agents.
According to this study, 1927-nm fractional resurfacing appears to be a promising option for facial AK treatment. The added cosmetic benefit is a huge plus for many patients. More studies with long-term follow-up are needed.
How do you use Fraxel Dual to treat AK?
Weiss and colleagues (J Am Acad Dermatol. 2013;68:98-102) conducted a 6-month safety, tolerance, and efficacy trial of nonablative 1927-nm fractional resurfacing of facial actinic keratosis (AK) with the Fraxel Dual (Solta Medical) laser. Twenty-four patients (5 male; 19 female) underwent up to 4 facial treatments with the 1927-nm laser with a 6-month follow-up period. The average patient age was 60 years, and Fitzpatrick skin types I and II were most common. Skin biopsy was performed in 7 patients prior to the initial procedure and at the 6-month follow-up.
Overall, there was an 86.6% reduction in absolute number of AK lesions at the 6-month follow-up visit. Cosmetic improvement was assessed on a 4-point scale. At the end of the 6-month study, the patients graded their improvement as 3.04 and investigators graded the improvement as 3.54. All 7 patient biopsies confirmed AK prior to treatment. At 6-month follow-up, 6 specimens (85.7%) showed histologic evidence of AK clearance.
What’s the issue?
The fractionated 1927-nm nonablative thulium laser is approved by the US Food and Drug Administration for the treatment of AK. Fraxel works by creating thermal zones, and the thermal damage targets AK lesions in the superficial skin. Actinic keratosis, the second most common condition treated by dermatologists, has many therapeutic options, including cryosurgery, photodynamic therapy, and multiple topical agents.
According to this study, 1927-nm fractional resurfacing appears to be a promising option for facial AK treatment. The added cosmetic benefit is a huge plus for many patients. More studies with long-term follow-up are needed.
How do you use Fraxel Dual to treat AK?
