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Create hospitalist-patient partnerships for safety and quality
Hospitalists can help enlist patients in the movement toward improved patient safety, and they can begin simply by sharing their notes.
OpenNotes offers a new platform to do that, according to a BMJ Quality & Safety article, “A patient feedback reporting tool for OpenNotes: implications for patient-clinician safety and quality partnerships.”1
In their study, the researchers invited 6,225 patients to read clinicians’ notes and, through a patient portal, provide feedback. Forty-four percent of patients read the notes; nearly all (96%) respondents reported understanding the notes; 1 in 12 submitted feedback.
“Patients can [and did] find documentation errors in their notes and were willing to report them without any apparent negative effect on the patient-clinician relationship,” Dr. Bell says. “The majority of patients also wanted to share positive feedback with their providers. Sharing notes can also facilitate information transfer across care settings.”
Investigators also reported on feedback from patients that hearing the notes helped them to remember next steps.
“Reading discharge summaries and visit notes from follow-up visits after a hospitalization may prove particularly important,” Dr. Bell says. “Providing patients with access to their notes may help them to adhere to the care plan, better remember recommended follow up tests or visits, and potentially stem preventable readmissions.”
What hospitalists can do now, Dr. Bell adds, is:
- Share their notes with patients and families (by printing the discharge summaries if they are not available on the portal and/or sharing notes from post-discharge follow-up visits).
- Emphasize for patients and families the important role they play as safety partners.
- Ask patients who receive care in other healthcare centers if they have OpenNotes, which can help hospitalists obtain medical records quickly and efficiently.
- Encourage patients to sign up for the patient portal and ask for their notes, for ambulatory visits to begin with and for in-patient notes when they become available.
Suzanne Bopp is a freelance medical writer in New York City.
Reference
1. Bell SK, Gerard M, Fossa A, et al. A patient feedback reporting tool for OpenNotes: implications for patient-clinician safety and quality partnerships [published online ahead of print, Dec. 13, 2016]. BMJ Qual Saf. doi: 10.1136/bmjqs-2016-006020.
Hospitalists can help enlist patients in the movement toward improved patient safety, and they can begin simply by sharing their notes.
OpenNotes offers a new platform to do that, according to a BMJ Quality & Safety article, “A patient feedback reporting tool for OpenNotes: implications for patient-clinician safety and quality partnerships.”1
In their study, the researchers invited 6,225 patients to read clinicians’ notes and, through a patient portal, provide feedback. Forty-four percent of patients read the notes; nearly all (96%) respondents reported understanding the notes; 1 in 12 submitted feedback.
“Patients can [and did] find documentation errors in their notes and were willing to report them without any apparent negative effect on the patient-clinician relationship,” Dr. Bell says. “The majority of patients also wanted to share positive feedback with their providers. Sharing notes can also facilitate information transfer across care settings.”
Investigators also reported on feedback from patients that hearing the notes helped them to remember next steps.
“Reading discharge summaries and visit notes from follow-up visits after a hospitalization may prove particularly important,” Dr. Bell says. “Providing patients with access to their notes may help them to adhere to the care plan, better remember recommended follow up tests or visits, and potentially stem preventable readmissions.”
What hospitalists can do now, Dr. Bell adds, is:
- Share their notes with patients and families (by printing the discharge summaries if they are not available on the portal and/or sharing notes from post-discharge follow-up visits).
- Emphasize for patients and families the important role they play as safety partners.
- Ask patients who receive care in other healthcare centers if they have OpenNotes, which can help hospitalists obtain medical records quickly and efficiently.
- Encourage patients to sign up for the patient portal and ask for their notes, for ambulatory visits to begin with and for in-patient notes when they become available.
Suzanne Bopp is a freelance medical writer in New York City.
Reference
1. Bell SK, Gerard M, Fossa A, et al. A patient feedback reporting tool for OpenNotes: implications for patient-clinician safety and quality partnerships [published online ahead of print, Dec. 13, 2016]. BMJ Qual Saf. doi: 10.1136/bmjqs-2016-006020.
Hospitalists can help enlist patients in the movement toward improved patient safety, and they can begin simply by sharing their notes.
OpenNotes offers a new platform to do that, according to a BMJ Quality & Safety article, “A patient feedback reporting tool for OpenNotes: implications for patient-clinician safety and quality partnerships.”1
In their study, the researchers invited 6,225 patients to read clinicians’ notes and, through a patient portal, provide feedback. Forty-four percent of patients read the notes; nearly all (96%) respondents reported understanding the notes; 1 in 12 submitted feedback.
“Patients can [and did] find documentation errors in their notes and were willing to report them without any apparent negative effect on the patient-clinician relationship,” Dr. Bell says. “The majority of patients also wanted to share positive feedback with their providers. Sharing notes can also facilitate information transfer across care settings.”
Investigators also reported on feedback from patients that hearing the notes helped them to remember next steps.
“Reading discharge summaries and visit notes from follow-up visits after a hospitalization may prove particularly important,” Dr. Bell says. “Providing patients with access to their notes may help them to adhere to the care plan, better remember recommended follow up tests or visits, and potentially stem preventable readmissions.”
What hospitalists can do now, Dr. Bell adds, is:
- Share their notes with patients and families (by printing the discharge summaries if they are not available on the portal and/or sharing notes from post-discharge follow-up visits).
- Emphasize for patients and families the important role they play as safety partners.
- Ask patients who receive care in other healthcare centers if they have OpenNotes, which can help hospitalists obtain medical records quickly and efficiently.
- Encourage patients to sign up for the patient portal and ask for their notes, for ambulatory visits to begin with and for in-patient notes when they become available.
Suzanne Bopp is a freelance medical writer in New York City.
Reference
1. Bell SK, Gerard M, Fossa A, et al. A patient feedback reporting tool for OpenNotes: implications for patient-clinician safety and quality partnerships [published online ahead of print, Dec. 13, 2016]. BMJ Qual Saf. doi: 10.1136/bmjqs-2016-006020.
GOP health plan clears first hurdle; opposition lines up
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat on the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process. The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House. “House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
AGA is closely monitoring the process to ensure that patients are still able to receive coverage for preventive screenings without cost-sharing, such as colorectal cancer screenings, and they continue to advocate that this section remain. They are concerned that patients will not have access to specialty care. A repeal will result in millions of patients being uninsured and millions of dollars in uncompensated care to providers like gastroenterologists. AGA will continue to monitor the legislative process and voice its concerns. Learn more about how you can get involved through the AGA Political Action Committee.
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat on the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process. The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House. “House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
AGA is closely monitoring the process to ensure that patients are still able to receive coverage for preventive screenings without cost-sharing, such as colorectal cancer screenings, and they continue to advocate that this section remain. They are concerned that patients will not have access to specialty care. A repeal will result in millions of patients being uninsured and millions of dollars in uncompensated care to providers like gastroenterologists. AGA will continue to monitor the legislative process and voice its concerns. Learn more about how you can get involved through the AGA Political Action Committee.
The Republican plan to replace the Affordable Care Act cleared the first legislative hurdle when two house committees passed language that would repeal revenue provisions of the Affordable Care Act and lay the foundation for replacing the health care reform law.
The House Ways and Means Committee–approved legislation would eliminate the individual mandate in favor of allowing insurance companies to penalize individuals by up to 30% of premiums for lapses in coverage and would repeal taxes on high-cost health plans (Cadillac tax), over-the-counter and prescription medications, health savings accounts, tanning, investment, and on health insurers.
The language passed with a party-line vote March 9 with 23 Republicans voting for and 16 Democrats voting against after nearly 18 hours of debate and amendments.
The House Energy and Commerce Committee, after 27 hours of debate that started March 8, also passed its language along party lines with 31 Republicans voting for and 23 Democrats voting against. Their bill would end Medicaid expansion and reset the program’s funding to a per capita allotment based on population indicators, along with block grants, to provide states more flexibility to better manage its population.
In both committees, Democrats introduced a wide range of amendments, including guarantees there would be no impact from the reduction of Medicaid expansion and on funding to support coverage for mental health, women, children, seniors, and veterans, all of which were voted down. Ways and Means members also offered an amendment to require President Trump to release his income tax filings.
Rep. Frank Pallone (D-N.J.), lead Democrat on the Energy and Commerce Committee, voiced his colleagues’ objections to the bill and the process. The bill “would rip health care away from millions of Americans, raise costs for working families and seniors, and lead to the rationing of care for 76 million Americans who receive Medicaid.
The pace of action in the House even drew criticism from some in the GOP. Sen. Tom Cotton (R-Ark.) took to Twitter with a stern warning to the House. “House health-care bill can’t pass w/o major changes,” Sen. Cotton tweeted. “To my friends in House: pause, start over. Get it right, don’t get it fast.”
He followed up with two more tweets: “GOP shouldn’t act like Dems did in O’care. No excuse to release bill Mon night, start voting Wed. With no budget estimate!” He added: “What matters in long run is better, more affordable health care for Americans, NOT house leaders’ arbitrary legislative calendar.”
Four Republican senators – Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Cory Gardner (Colo.), and Lisa Murkowski (Alaska) – also expressed concerns regarding how Medicaid will be changed under the repeal/replace effort and vowed not to support any plan “that does not include stability for Medicaid expansion populations or flexibility for states.”
Republicans hold a slim 52-seat majority in the Senate and need only 50 votes to pass any legislation that uses the budget reconciliation process. If those four senators voted with Democrats, who are expected to vote as a party against the repeal effort, the current House Republican legislation would not clear the Senate.
Physicians’ groups also have voiced their opposition. American Medical Association President Andrew Gurman, MD, said in a statement that it is “not legislation we can support. The replacement bill, as written, would reverse the coverage gains of the ACA, causing many Americans to lose the health coverage they have come to depend on.” He added that the proposed changes to Medicaid “would limit states’ ability to respond to changes in service demands and threaten coverage for people with low incomes.”
Likewise, a joint statement issued by the American Academy of Family Physicians, American Academy of Pediatricians, American College of Physicians, American Congress of Obstetricians and Gynecologists and the American Osteopathic Association, expressed concern that the proposal “will likely result in less access to coverage and higher costs for millions of patients.”
AGA is closely monitoring the process to ensure that patients are still able to receive coverage for preventive screenings without cost-sharing, such as colorectal cancer screenings, and they continue to advocate that this section remain. They are concerned that patients will not have access to specialty care. A repeal will result in millions of patients being uninsured and millions of dollars in uncompensated care to providers like gastroenterologists. AGA will continue to monitor the legislative process and voice its concerns. Learn more about how you can get involved through the AGA Political Action Committee.
How you can help avoid catastrophic cuts to dermatology
It seems like only yesterday we were celebrating the elimination of the Medicare sustainable growth rate and the continuation of “global periods.” Now we are facing the elimination of the global payment periods again, and if we don’t bill the proper CPT code (99024) for our follow-up visits, during an upcoming survey period, it will indeed be a challenge for the specialty.
You may not know it, but there is payment for follow-up visits – global periods – built into codes dermatologists frequently use. As you can see, a large part of our specialty is vulnerable, from destruction of actinics and warts, to malignant and benign excisions, to destructions, to reconstructive surgery. This is real money, about a billion (yes, with a “b”) paid to dermatologists every year in Medicare alone. 
These embedded visits vary from one (actinic destruction) to five (full thickness graft of the nose) and make up a major part of your reimbursement. As part of MACRA (Medicare Access and CHIP Reauthorization Act), the CMS was directed to investigate the validity of these embedded visits.1
The CMS has decided to complete this data gathering by how often the CPT code 99024 is billed.
I am not worried that we don’t provide these visits. I know we do, but I am terribly worried that we won’t correctly report these visits and won’t get credit for them.
The problem is that 99024 pays nothing, it is simply a notation to indicate that the patient was seen in follow up. Since it pays nothing, and since billing anything has an inherent expense, and since 30% of dermatologists are still on paper claims, most dermatologists have never used this code and may not start. In addition, groups of under 10 physicians are not required to report, but can, and you must! Seventy percent of our members are in groups of under 10. That means there will be no data collected on most of these codes, which are almost all performed by dermatologists, the great majority of the time.
Let me say it clearly here: If you do not start filing 99024 every time you see a patient in follow-up (and perhaps for telephone follow-ups), the amount you are paid to perform the original procedure will be cut by 30%-75%. Since the CMS will erroneously think you are not seeing these follow-up patients, they will pull these embedded payments out of the codes. You will have to start billing patients (think additional copays and deductibles) for every suture removal and wound check visit.
Data on 99024 will be collected in only nine states (Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island). It will start July 1 and no one knows how long it will continue.
So, start preparing. You will not be penalized for adding this nonpaying code to every follow-up when you do not bill an evaluation and management code. I note that one electronic medical record vendor (Modernizing Medicine) has already started populating its bills with 99024. Good for them! You must report follow-up visits no matter the size of your practice. Report early and report often. Your future depends on it.
Common procedures on which the CMS is collecting postoperative visit data
10040 Acne surgery
10060 Drainage of skin abscess
10061 Drainage of skin abscess
10120 Remove foreign body
10140 Drainage of hematoma/fluid
10160 Puncture drainage of lesion
10180 Complex drainage wound
11200 Removal of skin tags <w/15
11400 Exc tr-ext b9+marg 0.5 cm<
11401 Exc tr-ext b9+marg 0.6-1 cm
11402 Exc tr-ext b9+marg 1.1-2 cm
11403 Exc tr-ext b9+marg 2.1-3cm/<
11404 Exc tr-ext b9+marg 3.1-4 cm
11406 Exc tr-ext b9+marg >4.0 cm
11420 Exc h-f-nk-sp b9+marg 0.5/<
11421 Exc h-f-nk-sp b9+marg 0.6-1
11422 Exc h-f-nk-sp b9+marg 1.1-2
11423 Exc h-f-nk-sp b9+marg 2.1-3
11440 Exc face-mm b9+marg 0.5 cm/<
11441 Exc face-mm b9+marg 0.6-1 cm
11442 Exc face-mm b9+marg 1.1-2 cm
11443 Exc face-mm b9+marg 2.1-3 cm
11601 Exc tr-ext mal+marg 0.6-1 cm
11602 Exc tr-ext mal+marg 1.1-2 cm
11603 Exc tr-ext mal+marg 2.1-3 cm
11604 Exc tr-ext mal+marg 3.1-4 cm
11606 Exc tr-ext mal+marg >4 cm
11621 Exc s/n/h/f/g mal+mrg 0.6-1
11622 Exc s/n/h/f/g mal+mrg 1.1-2
11623 Exc s/n/h/f/g mal+mrg 2.1-3
11640 Exc f/e/e/n/l mal+mrg 0.5cm<
11641 Exc f/e/e/n/l mal+mrg 0.6-1
11642 Exc f/e/e/n/l mal+mrg 1.1-2
11643 Exc f/e/e/n/l mal+mrg 2.1-3
11644 Exc f/e/e/n/l mal+mrg 3.1-4
11646 Exc f/e/e/n/l mal+mrg >4 cm
11750 Removal of nail bed
11765 Excision of nail fold toe
12031 Intmd rpr s/a/t/ext 2.5 cm/<
12032 Intmd rpr s/a/t/ext 2.6-7.5
12034 Intmd rpr s/tr/ext 7.6-12.5
12041 Intmd rpr n-hf/genit 2.5cm/<
12042 Intmd rpr n-hf/genit2.6-7.5
12051 Intmd rpr face/mm 2.5 cm/<
12052 Intmd rpr face/mm 2.6-5.0 cm
13101 Cmplx rpr trunk 2.6-7.5 cm
13121 Cmplx rpr s/a/l 2.6-7.5 cm
13131 Cmplx rpr f/c/c/m/n/ax/g/h/f
13132 Cmplx rpr f/c/c/m/n/ax/g/h/f
13151 Cmplx rpr e/n/e/l 1.1-2.5 cm
13152 Cmplx rpr e/n/e/l 2.6-7.5 cm
13160 Late closure of wound
14020 Tis trnfr s/a/l 10 sq cm/<
14021 Tis trnfr s/a/l 10.1-30 sqcm
14040 Tis trnfr f/c/c/m/n/a/g/h/f
14041 Tis trnfr f/c/c/m/n/a/g/h/f
14060 Tis trnfr e/n/e/l 10 sq cm/<
14061 Tis trnfr e/n/e/l10.1-30sqcm
14301 Tis trnfr any 30.1-60 sq cm
15100 Skin splt grft trnk/arm/leg
15120 Skn splt a-grft fac/nck/hf/g
15240 Skin full grft face/genit/hf
15260 Skin full graft een & lips
15732 Muscle-skin graft head/neck
15734 Muscle-skin graft trunk
15823 Revision of upper eyelid
17000 Destruct premalg lesion
17004 Destroy premal lesions 15/>
17110 Destruct b9 lesion 1-14
17111 Destruct lesion 15 or more
17260 Destruction of skin lesions
17261 Destruction of skin lesions
17262 Destruction of skin lesions
17263 Destruction of skin lesions
17270 Destruction of skin lesions
17271 Destruction of skin lesions
17272 Destruction of skin lesions
17273 Destruction of skin lesions
17280 Destruction of skin lesions
17281 Destruction of skin lesions
17282 Destruction of skin lesions
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].
References
1. Medicare Access and CHIP Reauthorization Act of 2015, HR 2, 114th Cong, 1st Sess (2015).
It seems like only yesterday we were celebrating the elimination of the Medicare sustainable growth rate and the continuation of “global periods.” Now we are facing the elimination of the global payment periods again, and if we don’t bill the proper CPT code (99024) for our follow-up visits, during an upcoming survey period, it will indeed be a challenge for the specialty.
You may not know it, but there is payment for follow-up visits – global periods – built into codes dermatologists frequently use. As you can see, a large part of our specialty is vulnerable, from destruction of actinics and warts, to malignant and benign excisions, to destructions, to reconstructive surgery. This is real money, about a billion (yes, with a “b”) paid to dermatologists every year in Medicare alone.
These embedded visits vary from one (actinic destruction) to five (full thickness graft of the nose) and make up a major part of your reimbursement. As part of MACRA (Medicare Access and CHIP Reauthorization Act), the CMS was directed to investigate the validity of these embedded visits.1
The CMS has decided to complete this data gathering by how often the CPT code 99024 is billed.
I am not worried that we don’t provide these visits. I know we do, but I am terribly worried that we won’t correctly report these visits and won’t get credit for them.
The problem is that 99024 pays nothing, it is simply a notation to indicate that the patient was seen in follow up. Since it pays nothing, and since billing anything has an inherent expense, and since 30% of dermatologists are still on paper claims, most dermatologists have never used this code and may not start. In addition, groups of under 10 physicians are not required to report, but can, and you must! Seventy percent of our members are in groups of under 10. That means there will be no data collected on most of these codes, which are almost all performed by dermatologists, the great majority of the time.
Let me say it clearly here: If you do not start filing 99024 every time you see a patient in follow-up (and perhaps for telephone follow-ups), the amount you are paid to perform the original procedure will be cut by 30%-75%. Since the CMS will erroneously think you are not seeing these follow-up patients, they will pull these embedded payments out of the codes. You will have to start billing patients (think additional copays and deductibles) for every suture removal and wound check visit.
Data on 99024 will be collected in only nine states (Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island). It will start July 1 and no one knows how long it will continue.
So, start preparing. You will not be penalized for adding this nonpaying code to every follow-up when you do not bill an evaluation and management code. I note that one electronic medical record vendor (Modernizing Medicine) has already started populating its bills with 99024. Good for them! You must report follow-up visits no matter the size of your practice. Report early and report often. Your future depends on it.
Common procedures on which the CMS is collecting postoperative visit data
10040 Acne surgery
10060 Drainage of skin abscess
10061 Drainage of skin abscess
10120 Remove foreign body
10140 Drainage of hematoma/fluid
10160 Puncture drainage of lesion
10180 Complex drainage wound
11200 Removal of skin tags <w/15
11400 Exc tr-ext b9+marg 0.5 cm<
11401 Exc tr-ext b9+marg 0.6-1 cm
11402 Exc tr-ext b9+marg 1.1-2 cm
11403 Exc tr-ext b9+marg 2.1-3cm/<
11404 Exc tr-ext b9+marg 3.1-4 cm
11406 Exc tr-ext b9+marg >4.0 cm
11420 Exc h-f-nk-sp b9+marg 0.5/<
11421 Exc h-f-nk-sp b9+marg 0.6-1
11422 Exc h-f-nk-sp b9+marg 1.1-2
11423 Exc h-f-nk-sp b9+marg 2.1-3
11440 Exc face-mm b9+marg 0.5 cm/<
11441 Exc face-mm b9+marg 0.6-1 cm
11442 Exc face-mm b9+marg 1.1-2 cm
11443 Exc face-mm b9+marg 2.1-3 cm
11601 Exc tr-ext mal+marg 0.6-1 cm
11602 Exc tr-ext mal+marg 1.1-2 cm
11603 Exc tr-ext mal+marg 2.1-3 cm
11604 Exc tr-ext mal+marg 3.1-4 cm
11606 Exc tr-ext mal+marg >4 cm
11621 Exc s/n/h/f/g mal+mrg 0.6-1
11622 Exc s/n/h/f/g mal+mrg 1.1-2
11623 Exc s/n/h/f/g mal+mrg 2.1-3
11640 Exc f/e/e/n/l mal+mrg 0.5cm<
11641 Exc f/e/e/n/l mal+mrg 0.6-1
11642 Exc f/e/e/n/l mal+mrg 1.1-2
11643 Exc f/e/e/n/l mal+mrg 2.1-3
11644 Exc f/e/e/n/l mal+mrg 3.1-4
11646 Exc f/e/e/n/l mal+mrg >4 cm
11750 Removal of nail bed
11765 Excision of nail fold toe
12031 Intmd rpr s/a/t/ext 2.5 cm/<
12032 Intmd rpr s/a/t/ext 2.6-7.5
12034 Intmd rpr s/tr/ext 7.6-12.5
12041 Intmd rpr n-hf/genit 2.5cm/<
12042 Intmd rpr n-hf/genit2.6-7.5
12051 Intmd rpr face/mm 2.5 cm/<
12052 Intmd rpr face/mm 2.6-5.0 cm
13101 Cmplx rpr trunk 2.6-7.5 cm
13121 Cmplx rpr s/a/l 2.6-7.5 cm
13131 Cmplx rpr f/c/c/m/n/ax/g/h/f
13132 Cmplx rpr f/c/c/m/n/ax/g/h/f
13151 Cmplx rpr e/n/e/l 1.1-2.5 cm
13152 Cmplx rpr e/n/e/l 2.6-7.5 cm
13160 Late closure of wound
14020 Tis trnfr s/a/l 10 sq cm/<
14021 Tis trnfr s/a/l 10.1-30 sqcm
14040 Tis trnfr f/c/c/m/n/a/g/h/f
14041 Tis trnfr f/c/c/m/n/a/g/h/f
14060 Tis trnfr e/n/e/l 10 sq cm/<
14061 Tis trnfr e/n/e/l10.1-30sqcm
14301 Tis trnfr any 30.1-60 sq cm
15100 Skin splt grft trnk/arm/leg
15120 Skn splt a-grft fac/nck/hf/g
15240 Skin full grft face/genit/hf
15260 Skin full graft een & lips
15732 Muscle-skin graft head/neck
15734 Muscle-skin graft trunk
15823 Revision of upper eyelid
17000 Destruct premalg lesion
17004 Destroy premal lesions 15/>
17110 Destruct b9 lesion 1-14
17111 Destruct lesion 15 or more
17260 Destruction of skin lesions
17261 Destruction of skin lesions
17262 Destruction of skin lesions
17263 Destruction of skin lesions
17270 Destruction of skin lesions
17271 Destruction of skin lesions
17272 Destruction of skin lesions
17273 Destruction of skin lesions
17280 Destruction of skin lesions
17281 Destruction of skin lesions
17282 Destruction of skin lesions
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].
References
1. Medicare Access and CHIP Reauthorization Act of 2015, HR 2, 114th Cong, 1st Sess (2015).
It seems like only yesterday we were celebrating the elimination of the Medicare sustainable growth rate and the continuation of “global periods.” Now we are facing the elimination of the global payment periods again, and if we don’t bill the proper CPT code (99024) for our follow-up visits, during an upcoming survey period, it will indeed be a challenge for the specialty.
You may not know it, but there is payment for follow-up visits – global periods – built into codes dermatologists frequently use. As you can see, a large part of our specialty is vulnerable, from destruction of actinics and warts, to malignant and benign excisions, to destructions, to reconstructive surgery. This is real money, about a billion (yes, with a “b”) paid to dermatologists every year in Medicare alone.
These embedded visits vary from one (actinic destruction) to five (full thickness graft of the nose) and make up a major part of your reimbursement. As part of MACRA (Medicare Access and CHIP Reauthorization Act), the CMS was directed to investigate the validity of these embedded visits.1
The CMS has decided to complete this data gathering by how often the CPT code 99024 is billed.
I am not worried that we don’t provide these visits. I know we do, but I am terribly worried that we won’t correctly report these visits and won’t get credit for them.
The problem is that 99024 pays nothing, it is simply a notation to indicate that the patient was seen in follow up. Since it pays nothing, and since billing anything has an inherent expense, and since 30% of dermatologists are still on paper claims, most dermatologists have never used this code and may not start. In addition, groups of under 10 physicians are not required to report, but can, and you must! Seventy percent of our members are in groups of under 10. That means there will be no data collected on most of these codes, which are almost all performed by dermatologists, the great majority of the time.
Let me say it clearly here: If you do not start filing 99024 every time you see a patient in follow-up (and perhaps for telephone follow-ups), the amount you are paid to perform the original procedure will be cut by 30%-75%. Since the CMS will erroneously think you are not seeing these follow-up patients, they will pull these embedded payments out of the codes. You will have to start billing patients (think additional copays and deductibles) for every suture removal and wound check visit.
Data on 99024 will be collected in only nine states (Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island). It will start July 1 and no one knows how long it will continue.
So, start preparing. You will not be penalized for adding this nonpaying code to every follow-up when you do not bill an evaluation and management code. I note that one electronic medical record vendor (Modernizing Medicine) has already started populating its bills with 99024. Good for them! You must report follow-up visits no matter the size of your practice. Report early and report often. Your future depends on it.
Common procedures on which the CMS is collecting postoperative visit data
10040 Acne surgery
10060 Drainage of skin abscess
10061 Drainage of skin abscess
10120 Remove foreign body
10140 Drainage of hematoma/fluid
10160 Puncture drainage of lesion
10180 Complex drainage wound
11200 Removal of skin tags <w/15
11400 Exc tr-ext b9+marg 0.5 cm<
11401 Exc tr-ext b9+marg 0.6-1 cm
11402 Exc tr-ext b9+marg 1.1-2 cm
11403 Exc tr-ext b9+marg 2.1-3cm/<
11404 Exc tr-ext b9+marg 3.1-4 cm
11406 Exc tr-ext b9+marg >4.0 cm
11420 Exc h-f-nk-sp b9+marg 0.5/<
11421 Exc h-f-nk-sp b9+marg 0.6-1
11422 Exc h-f-nk-sp b9+marg 1.1-2
11423 Exc h-f-nk-sp b9+marg 2.1-3
11440 Exc face-mm b9+marg 0.5 cm/<
11441 Exc face-mm b9+marg 0.6-1 cm
11442 Exc face-mm b9+marg 1.1-2 cm
11443 Exc face-mm b9+marg 2.1-3 cm
11601 Exc tr-ext mal+marg 0.6-1 cm
11602 Exc tr-ext mal+marg 1.1-2 cm
11603 Exc tr-ext mal+marg 2.1-3 cm
11604 Exc tr-ext mal+marg 3.1-4 cm
11606 Exc tr-ext mal+marg >4 cm
11621 Exc s/n/h/f/g mal+mrg 0.6-1
11622 Exc s/n/h/f/g mal+mrg 1.1-2
11623 Exc s/n/h/f/g mal+mrg 2.1-3
11640 Exc f/e/e/n/l mal+mrg 0.5cm<
11641 Exc f/e/e/n/l mal+mrg 0.6-1
11642 Exc f/e/e/n/l mal+mrg 1.1-2
11643 Exc f/e/e/n/l mal+mrg 2.1-3
11644 Exc f/e/e/n/l mal+mrg 3.1-4
11646 Exc f/e/e/n/l mal+mrg >4 cm
11750 Removal of nail bed
11765 Excision of nail fold toe
12031 Intmd rpr s/a/t/ext 2.5 cm/<
12032 Intmd rpr s/a/t/ext 2.6-7.5
12034 Intmd rpr s/tr/ext 7.6-12.5
12041 Intmd rpr n-hf/genit 2.5cm/<
12042 Intmd rpr n-hf/genit2.6-7.5
12051 Intmd rpr face/mm 2.5 cm/<
12052 Intmd rpr face/mm 2.6-5.0 cm
13101 Cmplx rpr trunk 2.6-7.5 cm
13121 Cmplx rpr s/a/l 2.6-7.5 cm
13131 Cmplx rpr f/c/c/m/n/ax/g/h/f
13132 Cmplx rpr f/c/c/m/n/ax/g/h/f
13151 Cmplx rpr e/n/e/l 1.1-2.5 cm
13152 Cmplx rpr e/n/e/l 2.6-7.5 cm
13160 Late closure of wound
14020 Tis trnfr s/a/l 10 sq cm/<
14021 Tis trnfr s/a/l 10.1-30 sqcm
14040 Tis trnfr f/c/c/m/n/a/g/h/f
14041 Tis trnfr f/c/c/m/n/a/g/h/f
14060 Tis trnfr e/n/e/l 10 sq cm/<
14061 Tis trnfr e/n/e/l10.1-30sqcm
14301 Tis trnfr any 30.1-60 sq cm
15100 Skin splt grft trnk/arm/leg
15120 Skn splt a-grft fac/nck/hf/g
15240 Skin full grft face/genit/hf
15260 Skin full graft een & lips
15732 Muscle-skin graft head/neck
15734 Muscle-skin graft trunk
15823 Revision of upper eyelid
17000 Destruct premalg lesion
17004 Destroy premal lesions 15/>
17110 Destruct b9 lesion 1-14
17111 Destruct lesion 15 or more
17260 Destruction of skin lesions
17261 Destruction of skin lesions
17262 Destruction of skin lesions
17263 Destruction of skin lesions
17270 Destruction of skin lesions
17271 Destruction of skin lesions
17272 Destruction of skin lesions
17273 Destruction of skin lesions
17280 Destruction of skin lesions
17281 Destruction of skin lesions
17282 Destruction of skin lesions
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].
References
1. Medicare Access and CHIP Reauthorization Act of 2015, HR 2, 114th Cong, 1st Sess (2015).
People often think functional neurological symptoms are feigned
Clinicians, other caregivers, and even patients often think that functional neurological symptoms and movement disorders are feigned or somewhat amenable to the patient’s control, according to two separate survey studies published online in the Journal of Neurology, Neurosurgery & Psychiatry.
In the first study, Sandra M. A. van der Salm, MD, and her associates reported their assessments of clinicians’ and patients’ views about “free will” pertaining to three movement disorders: functional (“psychogenic”) movement disorders, myoclonus, and tics. They administered survey questionnaires to 39 expert clinicians, 28 patients with functional movement disorders, 15 patients with myoclonus, 17 patients with tics, and 22 healthy control subjects.
Clinicians differed markedly from patients in their perceptions of patient control over movements and symptoms. The majority rated “raising one’s hand to vote” as completely voluntary, functional movement disorders as largely involuntary, tics as slightly more involuntary than voluntary, and myoclonus as completely involuntary. In contrast, most patients (other than some who said they were sometimes able to suppress tics) felt their movements and symptoms were well beyond their control, reported Dr. van der Salm of the department of neurology and clinical neurophysiology, Academic Medical Center, Amsterdam, and her associates (J Neurol Neurosurg Psychiatry. 2017 March 11. doi: 10.1136/jnnp-2016-315152).
“For clinicians, it may be helpful to realize that doctors and patients may have different views of voluntariness in movement disorders, in particular regarding tics and functional movement disorders. Keeping this gap in mind during consultation could prevent misunderstandings that might jeopardize the doctor-patient relationship,” the investigators wrote.
“Our results suggest that patients with functional movement disorders probably require different cognitive behavioral techniques than those used for tics, because patients with functional movement disorders experience less behavioral control” of their symptoms, they wrote.
In the second study, Richard A. A. Kanaan, MD, and Juen Mei Ding, MD, both in the department of psychiatry at the University of Melbourne, reported the results of their survey of 172 “people waiting in a general hospital outpatient department,” including patients, family members, and caregivers.
The questionnaire presented a hypothetical scenario to the respondent in which he or she had “leg weakness” for which all tests had come back negative. A doctor presented seven possible terms for the symptoms and then asked respondents whether such patients would be imagining their symptoms, faking their symptoms, mentally ill, or having a medical condition. The seven diagnoses were functional weakness, psychogenic weakness, medically unexplained weakness, somatic symptom disorder, dissociative disorder, conversion disorder, and stroke.
A total of 26% of the respondents said that at least one of the diagnoses connoted feigning, “confirming that suspicions of feigning in functional neurological symptoms remain a problem among patients and the public,” wrote Dr. Kanaan and Dr. Ding (J Neurol Neurosurg Psychiatry. 2017 March 9. doi: 10.1136/jnnp-2016-315224).
There was a strong correlation between the respondents’ opinions of “faking” and their level of education. Study participants with only a primary-school education were the most likely to think symptoms were feigned (32 of 94), while those with a tertiary education were very unlikely to think so (9 of 73), the investigators said.
It was encouraging that this correlation disappeared after a “simple remedy” was applied: briefly explaining the meaning of each diagnosis. Thus, “the problem appears to be largely one of public ignorance, rather than some inherent stigmatization of mental health,” Dr. Kanaan and Dr. Ding wrote.
Dr. van der Salm’s study was funded by the Academic Medical Center graduate school. No funding source was cited for the study by Dr. Kanaan and Dr. Ding. Both research groups reported having no relevant financial disclosures.
These two studies make interesting and worthwhile observations. They do make it clear that both the public and many physicians consider that many functional movement disorder patients have some voluntariness and hence are faking it. This is a stigma. A number of us have been trying to educate at least the physicians that almost all these patients do have involuntary movements. It is a problem for doctor-patient relationships and for patients to accept their diagnosis. We still have work to do!
Mark Hallett, MD, is chief of the National Institute of Neurological Disorders and Stroke’s Medical Neurology Branch and chief of its Human Motor Control Section. He is now president of the International Federation of Clinical Neurophysiology. He has been president of the Movement Disorder Society and vice president of the American Academy of Neurology.
These two studies make interesting and worthwhile observations. They do make it clear that both the public and many physicians consider that many functional movement disorder patients have some voluntariness and hence are faking it. This is a stigma. A number of us have been trying to educate at least the physicians that almost all these patients do have involuntary movements. It is a problem for doctor-patient relationships and for patients to accept their diagnosis. We still have work to do!
Mark Hallett, MD, is chief of the National Institute of Neurological Disorders and Stroke’s Medical Neurology Branch and chief of its Human Motor Control Section. He is now president of the International Federation of Clinical Neurophysiology. He has been president of the Movement Disorder Society and vice president of the American Academy of Neurology.
These two studies make interesting and worthwhile observations. They do make it clear that both the public and many physicians consider that many functional movement disorder patients have some voluntariness and hence are faking it. This is a stigma. A number of us have been trying to educate at least the physicians that almost all these patients do have involuntary movements. It is a problem for doctor-patient relationships and for patients to accept their diagnosis. We still have work to do!
Mark Hallett, MD, is chief of the National Institute of Neurological Disorders and Stroke’s Medical Neurology Branch and chief of its Human Motor Control Section. He is now president of the International Federation of Clinical Neurophysiology. He has been president of the Movement Disorder Society and vice president of the American Academy of Neurology.
Clinicians, other caregivers, and even patients often think that functional neurological symptoms and movement disorders are feigned or somewhat amenable to the patient’s control, according to two separate survey studies published online in the Journal of Neurology, Neurosurgery & Psychiatry.
In the first study, Sandra M. A. van der Salm, MD, and her associates reported their assessments of clinicians’ and patients’ views about “free will” pertaining to three movement disorders: functional (“psychogenic”) movement disorders, myoclonus, and tics. They administered survey questionnaires to 39 expert clinicians, 28 patients with functional movement disorders, 15 patients with myoclonus, 17 patients with tics, and 22 healthy control subjects.
Clinicians differed markedly from patients in their perceptions of patient control over movements and symptoms. The majority rated “raising one’s hand to vote” as completely voluntary, functional movement disorders as largely involuntary, tics as slightly more involuntary than voluntary, and myoclonus as completely involuntary. In contrast, most patients (other than some who said they were sometimes able to suppress tics) felt their movements and symptoms were well beyond their control, reported Dr. van der Salm of the department of neurology and clinical neurophysiology, Academic Medical Center, Amsterdam, and her associates (J Neurol Neurosurg Psychiatry. 2017 March 11. doi: 10.1136/jnnp-2016-315152).
“For clinicians, it may be helpful to realize that doctors and patients may have different views of voluntariness in movement disorders, in particular regarding tics and functional movement disorders. Keeping this gap in mind during consultation could prevent misunderstandings that might jeopardize the doctor-patient relationship,” the investigators wrote.
“Our results suggest that patients with functional movement disorders probably require different cognitive behavioral techniques than those used for tics, because patients with functional movement disorders experience less behavioral control” of their symptoms, they wrote.
In the second study, Richard A. A. Kanaan, MD, and Juen Mei Ding, MD, both in the department of psychiatry at the University of Melbourne, reported the results of their survey of 172 “people waiting in a general hospital outpatient department,” including patients, family members, and caregivers.
The questionnaire presented a hypothetical scenario to the respondent in which he or she had “leg weakness” for which all tests had come back negative. A doctor presented seven possible terms for the symptoms and then asked respondents whether such patients would be imagining their symptoms, faking their symptoms, mentally ill, or having a medical condition. The seven diagnoses were functional weakness, psychogenic weakness, medically unexplained weakness, somatic symptom disorder, dissociative disorder, conversion disorder, and stroke.
A total of 26% of the respondents said that at least one of the diagnoses connoted feigning, “confirming that suspicions of feigning in functional neurological symptoms remain a problem among patients and the public,” wrote Dr. Kanaan and Dr. Ding (J Neurol Neurosurg Psychiatry. 2017 March 9. doi: 10.1136/jnnp-2016-315224).
There was a strong correlation between the respondents’ opinions of “faking” and their level of education. Study participants with only a primary-school education were the most likely to think symptoms were feigned (32 of 94), while those with a tertiary education were very unlikely to think so (9 of 73), the investigators said.
It was encouraging that this correlation disappeared after a “simple remedy” was applied: briefly explaining the meaning of each diagnosis. Thus, “the problem appears to be largely one of public ignorance, rather than some inherent stigmatization of mental health,” Dr. Kanaan and Dr. Ding wrote.
Dr. van der Salm’s study was funded by the Academic Medical Center graduate school. No funding source was cited for the study by Dr. Kanaan and Dr. Ding. Both research groups reported having no relevant financial disclosures.
Clinicians, other caregivers, and even patients often think that functional neurological symptoms and movement disorders are feigned or somewhat amenable to the patient’s control, according to two separate survey studies published online in the Journal of Neurology, Neurosurgery & Psychiatry.
In the first study, Sandra M. A. van der Salm, MD, and her associates reported their assessments of clinicians’ and patients’ views about “free will” pertaining to three movement disorders: functional (“psychogenic”) movement disorders, myoclonus, and tics. They administered survey questionnaires to 39 expert clinicians, 28 patients with functional movement disorders, 15 patients with myoclonus, 17 patients with tics, and 22 healthy control subjects.
Clinicians differed markedly from patients in their perceptions of patient control over movements and symptoms. The majority rated “raising one’s hand to vote” as completely voluntary, functional movement disorders as largely involuntary, tics as slightly more involuntary than voluntary, and myoclonus as completely involuntary. In contrast, most patients (other than some who said they were sometimes able to suppress tics) felt their movements and symptoms were well beyond their control, reported Dr. van der Salm of the department of neurology and clinical neurophysiology, Academic Medical Center, Amsterdam, and her associates (J Neurol Neurosurg Psychiatry. 2017 March 11. doi: 10.1136/jnnp-2016-315152).
“For clinicians, it may be helpful to realize that doctors and patients may have different views of voluntariness in movement disorders, in particular regarding tics and functional movement disorders. Keeping this gap in mind during consultation could prevent misunderstandings that might jeopardize the doctor-patient relationship,” the investigators wrote.
“Our results suggest that patients with functional movement disorders probably require different cognitive behavioral techniques than those used for tics, because patients with functional movement disorders experience less behavioral control” of their symptoms, they wrote.
In the second study, Richard A. A. Kanaan, MD, and Juen Mei Ding, MD, both in the department of psychiatry at the University of Melbourne, reported the results of their survey of 172 “people waiting in a general hospital outpatient department,” including patients, family members, and caregivers.
The questionnaire presented a hypothetical scenario to the respondent in which he or she had “leg weakness” for which all tests had come back negative. A doctor presented seven possible terms for the symptoms and then asked respondents whether such patients would be imagining their symptoms, faking their symptoms, mentally ill, or having a medical condition. The seven diagnoses were functional weakness, psychogenic weakness, medically unexplained weakness, somatic symptom disorder, dissociative disorder, conversion disorder, and stroke.
A total of 26% of the respondents said that at least one of the diagnoses connoted feigning, “confirming that suspicions of feigning in functional neurological symptoms remain a problem among patients and the public,” wrote Dr. Kanaan and Dr. Ding (J Neurol Neurosurg Psychiatry. 2017 March 9. doi: 10.1136/jnnp-2016-315224).
There was a strong correlation between the respondents’ opinions of “faking” and their level of education. Study participants with only a primary-school education were the most likely to think symptoms were feigned (32 of 94), while those with a tertiary education were very unlikely to think so (9 of 73), the investigators said.
It was encouraging that this correlation disappeared after a “simple remedy” was applied: briefly explaining the meaning of each diagnosis. Thus, “the problem appears to be largely one of public ignorance, rather than some inherent stigmatization of mental health,” Dr. Kanaan and Dr. Ding wrote.
Dr. van der Salm’s study was funded by the Academic Medical Center graduate school. No funding source was cited for the study by Dr. Kanaan and Dr. Ding. Both research groups reported having no relevant financial disclosures.
FROM JOURNAL OF NEUROLOGY, NEUROSURGERY & PSYCHIATRY
Key clinical point:
Major finding: Most clinicians rated “raising one’s hand to vote” as completely voluntary, functional movement disorders as largely voluntary, tics as slightly more involuntary than voluntary, and myoclonus as completely involuntary.
Data source: Two separate survey questionnaires involving 172 respondents and 121 respondents, respectively.
Disclosures: Dr. van der Salm’s study was funded by the Academic Medical Center graduate school. No funding source was cited for the study by Dr. Kanaan and Dr. Ding. Both research groups reported having no relevant financial disclosures.
A Rare Case of Spontaneous Fusion of the Knee
Take-Home Points
- Post-infectious or post-inflammatory pathological knee arthrodesis is one of the most challenging complications in orthopedics.
- It can result in significant patient distress with some struggling to maintain any range of motion for functionality.
- TKA for the correction of knee ankylosis is an option, but not without significant morbidity and failure rates.
Spontaneous knee fusion is an unusual and rarely reported phenomenon. Progressive stiffness is commonly experienced by patients with arthritis. However, most patients maintain some range of knee motion, which may be enhanced with medical treatment, rehabilitation with physiotherapy, and ambulation devices. To our knowledge, this article is the first report of a case of spontaneous and progressive bony fusion of a knee joint without a prior diagnosis of inflammatory or septic arthritis or surgical arthrodesis. The patient provided written informed consent for print and electronic publication of this case report.
Case Report
In 2015, a 51-year-old woman presented to the orthopedics department with a 13-year history of complete loss of left knee flexion. She denied a history of trauma to or surgical intervention for the knee and denied a medical history of inflammatory or septic arthritis.
On initial referral to the department, in 2002, the patient, age 38 years at the time, had a 1-year history of progressive left knee stiffness and reduced range of motion (ROM). At the time, she recalled injuring the knee during an aerobics class 2 months prior. A physiotherapy trial (ROM actively and passively assessed 10°-90°) failed. All movement was painful, and 2 crutches were needed for ambulation. The patient was treated nonoperatively with analgesia and was advised to return to physiotherapy. Plain radiographs showed a small effusion but no bony abnormalities or fractures (Figures 1A, 1B). 
Four months after the initial referral, the patient returned to the outpatient department with persistent knee pain and ROM of 5° to 20°. A repeat radiograph showed extensive left knee joint destruction, cortical irregularity, and narrowing of the joint space (Figures 3A, 3B). 
At the latest presentation (2015), the patient had a painless fixed extension deformity of the left knee joint and poor quality of life and wanted surgical intervention. 
Discussion
We have reported a rare case of spontaneous knee fusion in a middle-aged patient with no significant predisposing factors and no clear diagnosis. Serologic results were normal and not significant, but imaging was highly suggestive of an inflammatory process and provided a probable diagnosis of an underlying inflammatory condition and/or infection.
In the literature, there are no other reports of similar cases of spontaneous knee joint fusion, though there are some rare cases of the phenomenon in other joints. In 2005, Budoff and Lichtman1 reported a case of spontaneous wrist fusion in an 18-year-old patient with a background of Kienböck disease, which may have predisposed the patient to an underlying synovitis progressing to autofusion of the joint. In 2014, Lui2 described the case of a 64-year-old woman with spontaneous subtalar fusion complicating a subtalar arthroereisis. Although an extensive literature review on the topic is difficult owing to the rarity of the condition, these few cases, unlike our case, appear to describe a predisposing factor or inciting event.
The reversibility of knee arthrodesis remains an issue in our patient’s case and in other cases, and total knee arthroplasty (TKA) may be the most obvious operative intervention. Cameron and Hu3 reported 17 cases of knee fusion take-down with conversion to TKA, and Kim and colleagues4 reported 16 TKAs performed after spontaneous osseous ankylosis and 14 performed after formal knee fusion take-down. Although functional improvements were found in both studies, complication rates were relatively high, at least 53%. Other authors have used TKAs in cases of knee ankylosis after infectious or inflammatory arthritis, but results were suboptimal and unpredictable, and complication rates were 27% and 53.3%.5,6In this difficult scenario, our middle-aged patient’s fixed extension deformity of the knee, likely the result of an idiopathic process, led to severe debilitation and poor quality of life. To perform a TKA in a 51-year-old patient is far from ideal. The reversibility of formally fused and spontaneously fused knees is still in question, and, though there are reports of relatively satisfactory results, most operative options are fraught with complications.
Am J Orthop. 2017;46(2):E83-E85. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Budoff JE, Lichtman DM. Spontaneous wrist fusion: an unusual complication of Kienböck’s disease. J Hand Surg Am. 2005;30(1):59-64.
2. Lui TH. Spontaneous subtalar fusion: an irreversible complication of subtalar arthroereisis. J Foot Ankle Surg. 2014;53(5):652-656.
3. Cameron HU, Hu C. Results of total knee arthroplasty following takedown of formal knee fusion. J Arthroplasty. 1996;11(6):732-737.
4. Kim YH, Kim JS, Cho SH. Total knee arthroplasty after spontaneous osseous ankylosis and takedown of formal knee fusion. J Arthroplasty. 2000;15(4):453-460.
5. Rajgopal A, Ahuja N, Dolai B. Total knee arthroplasty in stiff and ankylosed knees. J Arthroplasty. 2005;20(5):585-590.
6. Kim YH, Cho SH, Kim JS. Total knee arthroplasty in bony ankylosis in gross flexion. J Bone Joint Surg Br. 1999;81(2):296-300.
Take-Home Points
- Post-infectious or post-inflammatory pathological knee arthrodesis is one of the most challenging complications in orthopedics.
- It can result in significant patient distress with some struggling to maintain any range of motion for functionality.
- TKA for the correction of knee ankylosis is an option, but not without significant morbidity and failure rates.
Spontaneous knee fusion is an unusual and rarely reported phenomenon. Progressive stiffness is commonly experienced by patients with arthritis. However, most patients maintain some range of knee motion, which may be enhanced with medical treatment, rehabilitation with physiotherapy, and ambulation devices. To our knowledge, this article is the first report of a case of spontaneous and progressive bony fusion of a knee joint without a prior diagnosis of inflammatory or septic arthritis or surgical arthrodesis. The patient provided written informed consent for print and electronic publication of this case report.
Case Report
In 2015, a 51-year-old woman presented to the orthopedics department with a 13-year history of complete loss of left knee flexion. She denied a history of trauma to or surgical intervention for the knee and denied a medical history of inflammatory or septic arthritis.
On initial referral to the department, in 2002, the patient, age 38 years at the time, had a 1-year history of progressive left knee stiffness and reduced range of motion (ROM). At the time, she recalled injuring the knee during an aerobics class 2 months prior. A physiotherapy trial (ROM actively and passively assessed 10°-90°) failed. All movement was painful, and 2 crutches were needed for ambulation. The patient was treated nonoperatively with analgesia and was advised to return to physiotherapy. Plain radiographs showed a small effusion but no bony abnormalities or fractures (Figures 1A, 1B).
Four months after the initial referral, the patient returned to the outpatient department with persistent knee pain and ROM of 5° to 20°. A repeat radiograph showed extensive left knee joint destruction, cortical irregularity, and narrowing of the joint space (Figures 3A, 3B).
At the latest presentation (2015), the patient had a painless fixed extension deformity of the left knee joint and poor quality of life and wanted surgical intervention.
Discussion
We have reported a rare case of spontaneous knee fusion in a middle-aged patient with no significant predisposing factors and no clear diagnosis. Serologic results were normal and not significant, but imaging was highly suggestive of an inflammatory process and provided a probable diagnosis of an underlying inflammatory condition and/or infection.
In the literature, there are no other reports of similar cases of spontaneous knee joint fusion, though there are some rare cases of the phenomenon in other joints. In 2005, Budoff and Lichtman1 reported a case of spontaneous wrist fusion in an 18-year-old patient with a background of Kienböck disease, which may have predisposed the patient to an underlying synovitis progressing to autofusion of the joint. In 2014, Lui2 described the case of a 64-year-old woman with spontaneous subtalar fusion complicating a subtalar arthroereisis. Although an extensive literature review on the topic is difficult owing to the rarity of the condition, these few cases, unlike our case, appear to describe a predisposing factor or inciting event.
The reversibility of knee arthrodesis remains an issue in our patient’s case and in other cases, and total knee arthroplasty (TKA) may be the most obvious operative intervention. Cameron and Hu3 reported 17 cases of knee fusion take-down with conversion to TKA, and Kim and colleagues4 reported 16 TKAs performed after spontaneous osseous ankylosis and 14 performed after formal knee fusion take-down. Although functional improvements were found in both studies, complication rates were relatively high, at least 53%. Other authors have used TKAs in cases of knee ankylosis after infectious or inflammatory arthritis, but results were suboptimal and unpredictable, and complication rates were 27% and 53.3%.5,6In this difficult scenario, our middle-aged patient’s fixed extension deformity of the knee, likely the result of an idiopathic process, led to severe debilitation and poor quality of life. To perform a TKA in a 51-year-old patient is far from ideal. The reversibility of formally fused and spontaneously fused knees is still in question, and, though there are reports of relatively satisfactory results, most operative options are fraught with complications.
Am J Orthop. 2017;46(2):E83-E85. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
Take-Home Points
- Post-infectious or post-inflammatory pathological knee arthrodesis is one of the most challenging complications in orthopedics.
- It can result in significant patient distress with some struggling to maintain any range of motion for functionality.
- TKA for the correction of knee ankylosis is an option, but not without significant morbidity and failure rates.
Spontaneous knee fusion is an unusual and rarely reported phenomenon. Progressive stiffness is commonly experienced by patients with arthritis. However, most patients maintain some range of knee motion, which may be enhanced with medical treatment, rehabilitation with physiotherapy, and ambulation devices. To our knowledge, this article is the first report of a case of spontaneous and progressive bony fusion of a knee joint without a prior diagnosis of inflammatory or septic arthritis or surgical arthrodesis. The patient provided written informed consent for print and electronic publication of this case report.
Case Report
In 2015, a 51-year-old woman presented to the orthopedics department with a 13-year history of complete loss of left knee flexion. She denied a history of trauma to or surgical intervention for the knee and denied a medical history of inflammatory or septic arthritis.
On initial referral to the department, in 2002, the patient, age 38 years at the time, had a 1-year history of progressive left knee stiffness and reduced range of motion (ROM). At the time, she recalled injuring the knee during an aerobics class 2 months prior. A physiotherapy trial (ROM actively and passively assessed 10°-90°) failed. All movement was painful, and 2 crutches were needed for ambulation. The patient was treated nonoperatively with analgesia and was advised to return to physiotherapy. Plain radiographs showed a small effusion but no bony abnormalities or fractures (Figures 1A, 1B).
Four months after the initial referral, the patient returned to the outpatient department with persistent knee pain and ROM of 5° to 20°. A repeat radiograph showed extensive left knee joint destruction, cortical irregularity, and narrowing of the joint space (Figures 3A, 3B).
At the latest presentation (2015), the patient had a painless fixed extension deformity of the left knee joint and poor quality of life and wanted surgical intervention.
Discussion
We have reported a rare case of spontaneous knee fusion in a middle-aged patient with no significant predisposing factors and no clear diagnosis. Serologic results were normal and not significant, but imaging was highly suggestive of an inflammatory process and provided a probable diagnosis of an underlying inflammatory condition and/or infection.
In the literature, there are no other reports of similar cases of spontaneous knee joint fusion, though there are some rare cases of the phenomenon in other joints. In 2005, Budoff and Lichtman1 reported a case of spontaneous wrist fusion in an 18-year-old patient with a background of Kienböck disease, which may have predisposed the patient to an underlying synovitis progressing to autofusion of the joint. In 2014, Lui2 described the case of a 64-year-old woman with spontaneous subtalar fusion complicating a subtalar arthroereisis. Although an extensive literature review on the topic is difficult owing to the rarity of the condition, these few cases, unlike our case, appear to describe a predisposing factor or inciting event.
The reversibility of knee arthrodesis remains an issue in our patient’s case and in other cases, and total knee arthroplasty (TKA) may be the most obvious operative intervention. Cameron and Hu3 reported 17 cases of knee fusion take-down with conversion to TKA, and Kim and colleagues4 reported 16 TKAs performed after spontaneous osseous ankylosis and 14 performed after formal knee fusion take-down. Although functional improvements were found in both studies, complication rates were relatively high, at least 53%. Other authors have used TKAs in cases of knee ankylosis after infectious or inflammatory arthritis, but results were suboptimal and unpredictable, and complication rates were 27% and 53.3%.5,6In this difficult scenario, our middle-aged patient’s fixed extension deformity of the knee, likely the result of an idiopathic process, led to severe debilitation and poor quality of life. To perform a TKA in a 51-year-old patient is far from ideal. The reversibility of formally fused and spontaneously fused knees is still in question, and, though there are reports of relatively satisfactory results, most operative options are fraught with complications.
Am J Orthop. 2017;46(2):E83-E85. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Budoff JE, Lichtman DM. Spontaneous wrist fusion: an unusual complication of Kienböck’s disease. J Hand Surg Am. 2005;30(1):59-64.
2. Lui TH. Spontaneous subtalar fusion: an irreversible complication of subtalar arthroereisis. J Foot Ankle Surg. 2014;53(5):652-656.
3. Cameron HU, Hu C. Results of total knee arthroplasty following takedown of formal knee fusion. J Arthroplasty. 1996;11(6):732-737.
4. Kim YH, Kim JS, Cho SH. Total knee arthroplasty after spontaneous osseous ankylosis and takedown of formal knee fusion. J Arthroplasty. 2000;15(4):453-460.
5. Rajgopal A, Ahuja N, Dolai B. Total knee arthroplasty in stiff and ankylosed knees. J Arthroplasty. 2005;20(5):585-590.
6. Kim YH, Cho SH, Kim JS. Total knee arthroplasty in bony ankylosis in gross flexion. J Bone Joint Surg Br. 1999;81(2):296-300.
1. Budoff JE, Lichtman DM. Spontaneous wrist fusion: an unusual complication of Kienböck’s disease. J Hand Surg Am. 2005;30(1):59-64.
2. Lui TH. Spontaneous subtalar fusion: an irreversible complication of subtalar arthroereisis. J Foot Ankle Surg. 2014;53(5):652-656.
3. Cameron HU, Hu C. Results of total knee arthroplasty following takedown of formal knee fusion. J Arthroplasty. 1996;11(6):732-737.
4. Kim YH, Kim JS, Cho SH. Total knee arthroplasty after spontaneous osseous ankylosis and takedown of formal knee fusion. J Arthroplasty. 2000;15(4):453-460.
5. Rajgopal A, Ahuja N, Dolai B. Total knee arthroplasty in stiff and ankylosed knees. J Arthroplasty. 2005;20(5):585-590.
6. Kim YH, Cho SH, Kim JS. Total knee arthroplasty in bony ankylosis in gross flexion. J Bone Joint Surg Br. 1999;81(2):296-300.
Lasers for Latino skin – A balance of gentleness and strength
ORLANDO – With its unique tendency to develop postinflammatory hyperpigmentation (PIH), Latino skin needs a gentle touch from powerful lasers, according to Eduardo Weiss, MD.
“It’s often best to use a lower power, even though you trade off some efficacy for safety,” said Dr. Weiss, a dermatologist in Miami. “In general, it’s better to go with less aggressive treatment and more sessions, than to risk getting too aggressive and having a bad outcome.”
Dr. Weiss stressed that there are no “one size fits all” recommendations about laser treatment in typical Latino skin, because there’s no such thing as typical Latino skin. The group comprises all Fitzpatrick phototypes. But, in general, he said, the darker the skin, the greater the chance of an acute laser-induced burn, postinflammatory hyperpigmentation, and scarring.
Although general skin tone can provide a good first guess about the potential for hyperreaction to lasers, Dr. Weiss bolsters his judgments with a very simple – but effective – screen: palmar and digital crease pigmentation. First suggested by Hector G. Leal-Silva, MD, of the Institute of Dermatology and Cosmetic Surgery, Monterrey, Mexico, the screen divides patients into four groups, depending on the concentration of pigment present in palmar creases. A score of 0 means no pigment is visible, and the risk of PIH is negligible; a score of 3 means the creases are highly pigmented, and that the risk of PIH is very high.
But, with some adjustments in delivery – including using longer wavelengths and pulse duration, lower fluence and density, and smaller spot sizes – lasers can be used safely and effectively in these at-risk patients, Dr. Weiss said.
Safe treatment starts with pretreatment. It’s best to avoid laser procedures during the summer, when skin is at its darkest. Dr. Weiss also recommends a 6-week regimen aimed at lightening the area to be treated. This can include:
- Sun avoidance and the regular use of a high SPF sunscreen.
- Hydroquinone 4%-8%.
- A “Miami peel,” which is a modified Jessner’s peel with kojic acid and hydroquinone.
- Kligman’s formula of hydroquinone, tretinoin, and a corticosteroid.
- Heliocare, an oral extract of the Polypodium leucotomos fern.
About a month before the procedure, he performs a test spot with the intended laser and its planned settings, in the preauricular area. Any PIH will be obvious within 2-4 weeks. He also carefully screens patients or any photosensitizing condition, like lupus or herpes simplex, or a history of any photosensitizing drugs, such as tetracycline.
Dr. Weiss made specific suggestions for laser treatment of some common Latino skin issues:
Pigmented lesions
The high density of epidermal melanin in Fitzpatrick types IV-VI acts as a competitive chromophore against hemoglobin and oxyhemoglobin. This makes it quite challenging to treat vascular lesions such as port wine stains and telangiectasias, he said. The pulsed dye laser is a good choice, with wavelengths of 585-590 nm especially effective. “The longer 595-nm wavelength allows for a slightly deeper penetration,” Dr. Weiss said. “However, the absorption coefficient of oxyhemoglobin is three times higher at 585 nm than [at] 590 nm.”
Longer pulses are generally safer in dark-skinned patients, he noted. “It will be much less effective than the 585, but for darker-skinned patients, we must sacrifice a little efficacy for safety.”
For rosacea and telangiectasias, Dr. Weiss suggests a 515-nm intense pulsed light with pulse duration of 12-15/ms for these lesions, or pigmentation, he also uses 540 nm or 500-600 nm with pulse duration of 12-15/ms.
Melasma, a very common condition in dark-skinned Latinos, is also “one of the most difficult and frustrating conditions to manage,” he pointed out. He turns to a laser only when the case is resistant to more conservative treatment, which typically includes Kligman’s formula, sunscreen, light peels, and azelaic or kojic acid.
“Lasers are still controversial and, in my opinion, a last resort for melasma. I wouldn’t start unless everything else fails. I reserve them for the deep nonresponding melasmas.”
The Q-switched Nd:YAG is the most widely used for melasma. The fluence used is less than 5 J/cm2, with a 6-mm spot size and a frequency of 10 Hz. The number of treatment sessions varies from 5 to 10 at 1-week intervals, Dr. Weiss said. “Keep in mind that rebound hyperpigmentation could be due to the multiple subthreshold exposures that can stimulate melanogenesis in some areas.”
Skin rejuvenation
Ablative lasers – long the gold standard for skin rejuvenation in those with light skin – can be problematic for darker-skinned patients, Dr. Weiss said.
“These lasers, like the CO2 and Erbium:YAG, can cause several unwanted side effects in Latino skin.” These can include hyperpigmentation, which occurs in 50% of Fitzpatrick III or higher phototypes; erythema that can last for months; and delayed-onset hypopigmentation.
“I think better options for our darker-skinned patients are nonablative infrared, microneedling, and radiofrequency devices,” Dr. Weiss said. “There are, however, newer microablative resurfacing lasers. Fractional CO2, fractional Erbium, and the 2,790-nm yttrium scandium gallium garnet, offer a safer modality with which to treat skin types IV and above. Compared with the older-generation resurfacing lasers, the microablative lasers minimize the amount and duration of erythema and edema, which can last just 3-4 days.”
Dr. Weiss had no relevant financial disclosures.
ORLANDO – With its unique tendency to develop postinflammatory hyperpigmentation (PIH), Latino skin needs a gentle touch from powerful lasers, according to Eduardo Weiss, MD.
“It’s often best to use a lower power, even though you trade off some efficacy for safety,” said Dr. Weiss, a dermatologist in Miami. “In general, it’s better to go with less aggressive treatment and more sessions, than to risk getting too aggressive and having a bad outcome.”
Dr. Weiss stressed that there are no “one size fits all” recommendations about laser treatment in typical Latino skin, because there’s no such thing as typical Latino skin. The group comprises all Fitzpatrick phototypes. But, in general, he said, the darker the skin, the greater the chance of an acute laser-induced burn, postinflammatory hyperpigmentation, and scarring.
Although general skin tone can provide a good first guess about the potential for hyperreaction to lasers, Dr. Weiss bolsters his judgments with a very simple – but effective – screen: palmar and digital crease pigmentation. First suggested by Hector G. Leal-Silva, MD, of the Institute of Dermatology and Cosmetic Surgery, Monterrey, Mexico, the screen divides patients into four groups, depending on the concentration of pigment present in palmar creases. A score of 0 means no pigment is visible, and the risk of PIH is negligible; a score of 3 means the creases are highly pigmented, and that the risk of PIH is very high.
But, with some adjustments in delivery – including using longer wavelengths and pulse duration, lower fluence and density, and smaller spot sizes – lasers can be used safely and effectively in these at-risk patients, Dr. Weiss said.
Safe treatment starts with pretreatment. It’s best to avoid laser procedures during the summer, when skin is at its darkest. Dr. Weiss also recommends a 6-week regimen aimed at lightening the area to be treated. This can include:
- Sun avoidance and the regular use of a high SPF sunscreen.
- Hydroquinone 4%-8%.
- A “Miami peel,” which is a modified Jessner’s peel with kojic acid and hydroquinone.
- Kligman’s formula of hydroquinone, tretinoin, and a corticosteroid.
- Heliocare, an oral extract of the Polypodium leucotomos fern.
About a month before the procedure, he performs a test spot with the intended laser and its planned settings, in the preauricular area. Any PIH will be obvious within 2-4 weeks. He also carefully screens patients or any photosensitizing condition, like lupus or herpes simplex, or a history of any photosensitizing drugs, such as tetracycline.
Dr. Weiss made specific suggestions for laser treatment of some common Latino skin issues:
Pigmented lesions
The high density of epidermal melanin in Fitzpatrick types IV-VI acts as a competitive chromophore against hemoglobin and oxyhemoglobin. This makes it quite challenging to treat vascular lesions such as port wine stains and telangiectasias, he said. The pulsed dye laser is a good choice, with wavelengths of 585-590 nm especially effective. “The longer 595-nm wavelength allows for a slightly deeper penetration,” Dr. Weiss said. “However, the absorption coefficient of oxyhemoglobin is three times higher at 585 nm than [at] 590 nm.”
Longer pulses are generally safer in dark-skinned patients, he noted. “It will be much less effective than the 585, but for darker-skinned patients, we must sacrifice a little efficacy for safety.”
For rosacea and telangiectasias, Dr. Weiss suggests a 515-nm intense pulsed light with pulse duration of 12-15/ms for these lesions, or pigmentation, he also uses 540 nm or 500-600 nm with pulse duration of 12-15/ms.
Melasma, a very common condition in dark-skinned Latinos, is also “one of the most difficult and frustrating conditions to manage,” he pointed out. He turns to a laser only when the case is resistant to more conservative treatment, which typically includes Kligman’s formula, sunscreen, light peels, and azelaic or kojic acid.
“Lasers are still controversial and, in my opinion, a last resort for melasma. I wouldn’t start unless everything else fails. I reserve them for the deep nonresponding melasmas.”
The Q-switched Nd:YAG is the most widely used for melasma. The fluence used is less than 5 J/cm2, with a 6-mm spot size and a frequency of 10 Hz. The number of treatment sessions varies from 5 to 10 at 1-week intervals, Dr. Weiss said. “Keep in mind that rebound hyperpigmentation could be due to the multiple subthreshold exposures that can stimulate melanogenesis in some areas.”
Skin rejuvenation
Ablative lasers – long the gold standard for skin rejuvenation in those with light skin – can be problematic for darker-skinned patients, Dr. Weiss said.
“These lasers, like the CO2 and Erbium:YAG, can cause several unwanted side effects in Latino skin.” These can include hyperpigmentation, which occurs in 50% of Fitzpatrick III or higher phototypes; erythema that can last for months; and delayed-onset hypopigmentation.
“I think better options for our darker-skinned patients are nonablative infrared, microneedling, and radiofrequency devices,” Dr. Weiss said. “There are, however, newer microablative resurfacing lasers. Fractional CO2, fractional Erbium, and the 2,790-nm yttrium scandium gallium garnet, offer a safer modality with which to treat skin types IV and above. Compared with the older-generation resurfacing lasers, the microablative lasers minimize the amount and duration of erythema and edema, which can last just 3-4 days.”
Dr. Weiss had no relevant financial disclosures.
ORLANDO – With its unique tendency to develop postinflammatory hyperpigmentation (PIH), Latino skin needs a gentle touch from powerful lasers, according to Eduardo Weiss, MD.
“It’s often best to use a lower power, even though you trade off some efficacy for safety,” said Dr. Weiss, a dermatologist in Miami. “In general, it’s better to go with less aggressive treatment and more sessions, than to risk getting too aggressive and having a bad outcome.”
Dr. Weiss stressed that there are no “one size fits all” recommendations about laser treatment in typical Latino skin, because there’s no such thing as typical Latino skin. The group comprises all Fitzpatrick phototypes. But, in general, he said, the darker the skin, the greater the chance of an acute laser-induced burn, postinflammatory hyperpigmentation, and scarring.
Although general skin tone can provide a good first guess about the potential for hyperreaction to lasers, Dr. Weiss bolsters his judgments with a very simple – but effective – screen: palmar and digital crease pigmentation. First suggested by Hector G. Leal-Silva, MD, of the Institute of Dermatology and Cosmetic Surgery, Monterrey, Mexico, the screen divides patients into four groups, depending on the concentration of pigment present in palmar creases. A score of 0 means no pigment is visible, and the risk of PIH is negligible; a score of 3 means the creases are highly pigmented, and that the risk of PIH is very high.
But, with some adjustments in delivery – including using longer wavelengths and pulse duration, lower fluence and density, and smaller spot sizes – lasers can be used safely and effectively in these at-risk patients, Dr. Weiss said.
Safe treatment starts with pretreatment. It’s best to avoid laser procedures during the summer, when skin is at its darkest. Dr. Weiss also recommends a 6-week regimen aimed at lightening the area to be treated. This can include:
- Sun avoidance and the regular use of a high SPF sunscreen.
- Hydroquinone 4%-8%.
- A “Miami peel,” which is a modified Jessner’s peel with kojic acid and hydroquinone.
- Kligman’s formula of hydroquinone, tretinoin, and a corticosteroid.
- Heliocare, an oral extract of the Polypodium leucotomos fern.
About a month before the procedure, he performs a test spot with the intended laser and its planned settings, in the preauricular area. Any PIH will be obvious within 2-4 weeks. He also carefully screens patients or any photosensitizing condition, like lupus or herpes simplex, or a history of any photosensitizing drugs, such as tetracycline.
Dr. Weiss made specific suggestions for laser treatment of some common Latino skin issues:
Pigmented lesions
The high density of epidermal melanin in Fitzpatrick types IV-VI acts as a competitive chromophore against hemoglobin and oxyhemoglobin. This makes it quite challenging to treat vascular lesions such as port wine stains and telangiectasias, he said. The pulsed dye laser is a good choice, with wavelengths of 585-590 nm especially effective. “The longer 595-nm wavelength allows for a slightly deeper penetration,” Dr. Weiss said. “However, the absorption coefficient of oxyhemoglobin is three times higher at 585 nm than [at] 590 nm.”
Longer pulses are generally safer in dark-skinned patients, he noted. “It will be much less effective than the 585, but for darker-skinned patients, we must sacrifice a little efficacy for safety.”
For rosacea and telangiectasias, Dr. Weiss suggests a 515-nm intense pulsed light with pulse duration of 12-15/ms for these lesions, or pigmentation, he also uses 540 nm or 500-600 nm with pulse duration of 12-15/ms.
Melasma, a very common condition in dark-skinned Latinos, is also “one of the most difficult and frustrating conditions to manage,” he pointed out. He turns to a laser only when the case is resistant to more conservative treatment, which typically includes Kligman’s formula, sunscreen, light peels, and azelaic or kojic acid.
“Lasers are still controversial and, in my opinion, a last resort for melasma. I wouldn’t start unless everything else fails. I reserve them for the deep nonresponding melasmas.”
The Q-switched Nd:YAG is the most widely used for melasma. The fluence used is less than 5 J/cm2, with a 6-mm spot size and a frequency of 10 Hz. The number of treatment sessions varies from 5 to 10 at 1-week intervals, Dr. Weiss said. “Keep in mind that rebound hyperpigmentation could be due to the multiple subthreshold exposures that can stimulate melanogenesis in some areas.”
Skin rejuvenation
Ablative lasers – long the gold standard for skin rejuvenation in those with light skin – can be problematic for darker-skinned patients, Dr. Weiss said.
“These lasers, like the CO2 and Erbium:YAG, can cause several unwanted side effects in Latino skin.” These can include hyperpigmentation, which occurs in 50% of Fitzpatrick III or higher phototypes; erythema that can last for months; and delayed-onset hypopigmentation.
“I think better options for our darker-skinned patients are nonablative infrared, microneedling, and radiofrequency devices,” Dr. Weiss said. “There are, however, newer microablative resurfacing lasers. Fractional CO2, fractional Erbium, and the 2,790-nm yttrium scandium gallium garnet, offer a safer modality with which to treat skin types IV and above. Compared with the older-generation resurfacing lasers, the microablative lasers minimize the amount and duration of erythema and edema, which can last just 3-4 days.”
Dr. Weiss had no relevant financial disclosures.
EXPERT ANALYSIS FROM AAD 17
Loss of global periods could mean $1 billion loss for dermatologists
Failing to report on global period codes this year could lead to payment changes that would cost dermatologists a collective $1 billion.
Presently, surgical procedures and follow-up visits are paid by Medicare as a single bundled payment, with the expectation that the follow-ups will occur within a 10- or 90-day period. CMS tried to eliminate these global period codes in 2014, but Congress stepped in and, as part of passage of the MACRA reform law, required the agency to study the effects of such a shift.
Whether this test will demonstrate clearly just how much dermatologists rely on global periods to cover the services they render remains to be seen.
The required reporting is resource intensive and onerous, Murad Alam, MD, of Northwestern University, Chicago, said in an interview. “No one’s really going to report them.”
“I think its definitely not going to be successful in capturing the data needed to keep the global period,” he said, adding that dermatologists alone could lose more than $1 billion if global periods were eliminated.
CMS wants to understand when follow-up visits happen. It is asking providers in those nine states to submit CPT code 99024 for each follow-up visit related to a surgical procedure and will be looking for the follow-up visit code linked to procedures reported by 100 or more physicians, that have 10,000 or more occurrences, or that have allowed charges of more than $10 million annually. The extent to which the CPT code is reported could impact whether global periods are maintained.
“The way [the test] was developed was – I would hate to think by intent but certainly by design even if not intent – it’s going to necessarily result in significant underreporting, which will inevitably result in the conclusion that … the global periods will go away,” Dr. Alam said.
One possible solution would be to simply subtract the value of the follow-up visits from the global period payments and pay them separately, but Dr. Alam said that paying them separately would not necessarily provide equal levels of payment.
“If you subtract the value of the level two follow-up visits from that code, you don’t get where you need to be,” he said. “In some cases, you actually end up with negative values for codes.”
Plus, it would take a while to properly value the codes for the follow-up visits following a surgery, particularly for those following surgical procedures in dermatology, as they tend to be resource intensive, he said.
And that does not factor into the equation the additional administrative burden of filing claims for each individual follow-up visit.
The loss of global-period billing could be huge for dermatologists, and it could cause more economic disruption than the other MACRA-based reforms, according Clifford W. Lober, MD.
“If we were to lose our global periods, it would impact us far more than [the Merit-based Incentive Payment System] will,” said Dr. Lober, a dermatologist in Kissimmee, Fla. “The worst case under MIPS will be a 9% reduction in payments several years from now. We stand to lose significantly more than 9%, particularly from highly surgical practices, if we were to lose our global periods.”
Eliminating global-period billing also could mean higher out-of-pocket costs for patients, Dr. Lober said. “If patients have pay a [copayment] when they return for surgical follow-up visits, they simply may elect not to show up.”
Failing to report on global period codes this year could lead to payment changes that would cost dermatologists a collective $1 billion.
Presently, surgical procedures and follow-up visits are paid by Medicare as a single bundled payment, with the expectation that the follow-ups will occur within a 10- or 90-day period. CMS tried to eliminate these global period codes in 2014, but Congress stepped in and, as part of passage of the MACRA reform law, required the agency to study the effects of such a shift.
Whether this test will demonstrate clearly just how much dermatologists rely on global periods to cover the services they render remains to be seen.
The required reporting is resource intensive and onerous, Murad Alam, MD, of Northwestern University, Chicago, said in an interview. “No one’s really going to report them.”
“I think its definitely not going to be successful in capturing the data needed to keep the global period,” he said, adding that dermatologists alone could lose more than $1 billion if global periods were eliminated.
CMS wants to understand when follow-up visits happen. It is asking providers in those nine states to submit CPT code 99024 for each follow-up visit related to a surgical procedure and will be looking for the follow-up visit code linked to procedures reported by 100 or more physicians, that have 10,000 or more occurrences, or that have allowed charges of more than $10 million annually. The extent to which the CPT code is reported could impact whether global periods are maintained.
“The way [the test] was developed was – I would hate to think by intent but certainly by design even if not intent – it’s going to necessarily result in significant underreporting, which will inevitably result in the conclusion that … the global periods will go away,” Dr. Alam said.
One possible solution would be to simply subtract the value of the follow-up visits from the global period payments and pay them separately, but Dr. Alam said that paying them separately would not necessarily provide equal levels of payment.
“If you subtract the value of the level two follow-up visits from that code, you don’t get where you need to be,” he said. “In some cases, you actually end up with negative values for codes.”
Plus, it would take a while to properly value the codes for the follow-up visits following a surgery, particularly for those following surgical procedures in dermatology, as they tend to be resource intensive, he said.
And that does not factor into the equation the additional administrative burden of filing claims for each individual follow-up visit.
The loss of global-period billing could be huge for dermatologists, and it could cause more economic disruption than the other MACRA-based reforms, according Clifford W. Lober, MD.
“If we were to lose our global periods, it would impact us far more than [the Merit-based Incentive Payment System] will,” said Dr. Lober, a dermatologist in Kissimmee, Fla. “The worst case under MIPS will be a 9% reduction in payments several years from now. We stand to lose significantly more than 9%, particularly from highly surgical practices, if we were to lose our global periods.”
Eliminating global-period billing also could mean higher out-of-pocket costs for patients, Dr. Lober said. “If patients have pay a [copayment] when they return for surgical follow-up visits, they simply may elect not to show up.”
Failing to report on global period codes this year could lead to payment changes that would cost dermatologists a collective $1 billion.
Presently, surgical procedures and follow-up visits are paid by Medicare as a single bundled payment, with the expectation that the follow-ups will occur within a 10- or 90-day period. CMS tried to eliminate these global period codes in 2014, but Congress stepped in and, as part of passage of the MACRA reform law, required the agency to study the effects of such a shift.
Whether this test will demonstrate clearly just how much dermatologists rely on global periods to cover the services they render remains to be seen.
The required reporting is resource intensive and onerous, Murad Alam, MD, of Northwestern University, Chicago, said in an interview. “No one’s really going to report them.”
“I think its definitely not going to be successful in capturing the data needed to keep the global period,” he said, adding that dermatologists alone could lose more than $1 billion if global periods were eliminated.
CMS wants to understand when follow-up visits happen. It is asking providers in those nine states to submit CPT code 99024 for each follow-up visit related to a surgical procedure and will be looking for the follow-up visit code linked to procedures reported by 100 or more physicians, that have 10,000 or more occurrences, or that have allowed charges of more than $10 million annually. The extent to which the CPT code is reported could impact whether global periods are maintained.
“The way [the test] was developed was – I would hate to think by intent but certainly by design even if not intent – it’s going to necessarily result in significant underreporting, which will inevitably result in the conclusion that … the global periods will go away,” Dr. Alam said.
One possible solution would be to simply subtract the value of the follow-up visits from the global period payments and pay them separately, but Dr. Alam said that paying them separately would not necessarily provide equal levels of payment.
“If you subtract the value of the level two follow-up visits from that code, you don’t get where you need to be,” he said. “In some cases, you actually end up with negative values for codes.”
Plus, it would take a while to properly value the codes for the follow-up visits following a surgery, particularly for those following surgical procedures in dermatology, as they tend to be resource intensive, he said.
And that does not factor into the equation the additional administrative burden of filing claims for each individual follow-up visit.
The loss of global-period billing could be huge for dermatologists, and it could cause more economic disruption than the other MACRA-based reforms, according Clifford W. Lober, MD.
“If we were to lose our global periods, it would impact us far more than [the Merit-based Incentive Payment System] will,” said Dr. Lober, a dermatologist in Kissimmee, Fla. “The worst case under MIPS will be a 9% reduction in payments several years from now. We stand to lose significantly more than 9%, particularly from highly surgical practices, if we were to lose our global periods.”
Eliminating global-period billing also could mean higher out-of-pocket costs for patients, Dr. Lober said. “If patients have pay a [copayment] when they return for surgical follow-up visits, they simply may elect not to show up.”
The Impact of Obesity on Simvastatin for Lowering LDL-C Among Veterans
More than one-third of Americans and > 20% of veterans have obesity with a body mass index (BMI) ≥ 30 kg/m2.1,2 It is well documented that patients with obesity have altered lipid metabolism, drug distribution, and drug clearance.3-5 As many as 8.2 million Americans may receive statin (3-hydroxymethylglutaryl coenzyme A reductase inhibitors) prescriptions if the American College of Cardiology/American Heart Association 2013 Cholesterol Guidelines are followed; therefore, it is important to examine how the efficacy of these drugs is altered in patients with obesity.6
Multiple studies have examined the benefits of statin therapy through lowering low-density lipoprotein cholesterol (LDL-C); however, few have examined the impact of obesity on statin efficacy. For example, only 18% of subjects in the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial were classified as having obesity, and subjects in the Scandinavian Simvastatin Survival Study (4S) trial had a mean BMI of only 26 kg/m2.7,8 Though statins decreased mortality in both of these studies, it is unknown whether the lipid-lowering effects were the same for participants with and without obesity. The Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS) demonstrated a decrease in major cardiovascular events and all-cause mortality with atorvastatin 10 mg daily therapy in a sample where more than one-third of subjects had obesity.9 However, the mean baseline BMI of subjects in both study groups was only 28 kg/m2, and outcomes for those with and without obesity were not compared.9
Studies that have examined statin efficacy in those with and without obesity include the Heart Protection Study (HPS), a post hoc analysis of the West of Scotland Coronary Prevention Study (WOSCOPS), and a meta-analysis by Blassetto and colleagues. The HPS examined the event rate of vascular events with simvastatin 40 mg daily in patients with diabetes mellitus (DM).10 Though these subgroups were compared in HPS, no statistical difference was demonstrated between these groups for the rate of vascular events among those with and without DM.10 However, the obesity subgroup’s event rate ratios were consistently higher than were those for the nonobese group.10
A post hoc analysis of WOSCOPS examined obesity as a factor for change in LDL-C with pravastatin 40 mg therapy.11 Though the authors found that no significant difference was present between those with and those without obesity, the data supporting this claim were not disclosed, which makes drawing clinical conclusions from this analysis difficult.11 A meta-analysis by Blassetto and colleagues examined the association between rosuvastatin’s efficacy in lowering LDL-C among the subgroups of hypertension, atherosclerosis, type 2 DM, and obesity.12 Though these subgroups were not compared statistically, the obesity subgroup had the lowest mean percent change in lowering LDL-C. Moreover, patients without obesity were not examined as a subgroup.12
With the expected increase in statin therapy and a significant portion of the U.S. population having obesity, it is necessary to determine if obesity alters the efficacy of statins. This study was conducted to determine the effect of obesity on the percent change in LDL-C with statin therapy within a veteran population.
Methods
This study was a retrospective review examining follow-up data from January 1, 2009 to July 1, 2014 from the VA Midsouth Healthcare Network. This network services more than 350,000 patients each year in Tennessee, Kentucky, and West Virgin
Patients were excluded if they had received treatment for hyperlipidemia (niacin, colestyramine, colestipol, colesevelam, other statins, gemfibrozil, fenofibrate, omega-3 ethyl esters, ezetimibe) during the 6 weeks prior to the initial fill date of the statin prescription. Patients whose simvastatin therapy did not span the follow-up period from the time of filling to the follow-up lipid panel were excluded, as were those who had not filled a simvastatin prescription within 30 days of their baseline lipid panel. Also excluded were patients who were newly established at the VA, pregnant, or receiving concomitant antihyperlipidemia agents, dialysis, or interacting medications (tacrolimus, cyclosporine, atazanavir, darunavir, nelfinavir, saquinavir, ritonavir, indinavir, lopinavir, tipranavir, fosamprenavir, fluconazole, voriconazole, itraconazole, voriconazole, posaconazole, amiodarone, or colchicine). Patients with a BMI < 18 kg/m2, hepatic failure as measured by an aspartate transaminase/alanine transaminase (AST/ALT) ratio > 3 times the upper limit of normal, hepatitis, a history of alcoholism, any change in statin dose prior to follow-up cholesterol values, or no follow-up LDL-C values also were excluded.
The baseline data collected included age, sex, weight, height, BMI, hemoglobin A1c, LDL-C, ALT/AST, and serum creatinine (SCr). All other laboratory results were required to be within 270 days of the time the lipid panel was obtained. The index date was set as the date the initial prescription was filled between February 1, 2009 and April 1, 2014. Follow-up levels for LDL-C were obtained 40 to 95 days after the index date. Direct LDL-C values were preferred unless only calculated values were available. Calculated LDL-C values were determined by using the Friedewald equation. An audit of 150 patient charts was conducted to ensure the integrity of data pulled from the database.
The percent changes in LDL-C were calculated for those with and without obesity for both simvastatin 20 mg daily and simvastatin 40 mg daily. The primary outcome was the percent change in LDL-C from baseline. All laboratory values were compared using independent 2-tailed t tests with α set to .05. To have an 80% chance of detecting a 5% difference in percent change in LDL-C between the experimental and control groups, 129 patients were required. To determine whether an association was present, a correlation between BMI and percent change in LDL-C was conducted. All statistics were conducted using SAS software (Cary, North Carolina).
Results
From January 2009 through July 2014, 35,216 patients were initially screened. The majority of patients did not have a baseline LDL-C value and were excluded. A total of 1,183 patients with simvastatin 20 mg daily (BMI < 30 = 661; BMI ≥ 30 = 1,122) and 478 patients with simvastatin 40 mg daily (BMI < 30 = 259; BMI ≥ 30 = 219) met the inclusion criteria.
Baseline characteristics were similar between groups except for a slightly higher age in both groups without obesity (Table). Hepatic and renal serum markers indicated a baseline of adequate organ function for drug clearance for all groups. The mean baseline BMI of those without obesity was about 26 kg/m2, which is considered overweight. Baseline LDL-C values were clinically similar for those with and without obesity, though statistically different (145 mg/dL for the nonobese group and 141 mg/dL for the obese group, P < .05). The percent change in LDL-C was not statistically significant for those with and without obesity for simvastatin 20 mg daily (P = .293) or simvastatin 40 mg daily (P = .2773) (Figure). No correlation was found between the continuous percent change in LDL-C and continuous BMI for either simvastatin dosage (r2 = 0.0016 and 0.0028, respectively).
Discussion
In this retrospective chart review, it was determined that obesity did not affect the percent change in LDL-C from baseline with statin therapy. The HPS found similar results as a secondary endpoint, although that study was underpowered.10 In this study, all groups met power, and there was still no difference between those with and without obesity.
Nicholls and colleagues examined REVERSAL study data to determine whether BMI greater than the median BMI impacted inflammatory markers or lipid levels with atorvastatin 80 mg daily or pravastatin 40 mg daily. The REVERSAL study authors found no difference in percent change LDL-C between those above the median BMI compared with those below the median BMI for patients on pravastatin therapy. However, the authors did find a difference in percent change LDL-C with atorvastatin therapy.13 No difference in percent change LDL-C was present with simvastatin therapy in this study. As simvastatin is more lipophilic than is atorvastatin, lipophilicity remains an area for further study for statin therapy in patients with obesity.
The surrogate marker of percent change in LDL-C was used for the primary outcome in this study. The ACC/AHA 2013 guidelines and the National Lipid Association 2014 guidelines recommend an alternative goal of 30% to 50% change in LDL-C from baseline.14,15 Using this clinically relevant marker compensated for differences in baseline LDL-C and limited the effect of these differences on the primary outcome of this study.
Limitations
This study did not include patients who were underweight (BMI < 18 kg/m2), as these patients have previously demonstrated decreased outcomes with statin therapy.16 However, this limits these data to only those patients that have a BMI of at least 18 kg/m2. Limitations of this study also included the inability to consider adherence and lifestyle changes. These limitations were unavoidable due to the nature of a retrospective chart review.
Conclusion
The prevalence of obesity is increasing, and it is a disease that alters pharmacokinetics and lipid metabolism. Though this study did not find a difference between the LDL-C-lowering efficacy of simvastatin in those with and without obesity, continued study of the effect of obesity on the efficacy of medications is vital.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the James H. Qullen VAMC in Mountain Home, Tennessee.
1. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
2. Shen Y, Sambamoorthi U, Rajan M, Miller D, Banerjea R, Pogach L. Obesity and expenditures among elderly Veterans Health Administration users with diabetes. Popul Health Manag. 2009;12(5):255-264.
3. Chan DC, Watts GF, Wang J, Hegele RA, van Bockxmeer FM, Barrett PH. Variation in Niemann-Pick C1-like 1 gene as a determinant of apolipoprotein B-100 kinetics and response to statin therapy in centrally obese men. Clin Endocrinol (Oxf). 2008;69(1):45-51.
4. Cheymol G. Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000;39(3):215-231.
5. Hanley MJ, Abernethy DR, Greenblatt DJ. Effect of obesity on the pharmacokinetics of drugs in humans. Clin Pharmacokinet. 2010;49(2):71-87
6. Pencina MJ, Navar-Boggan AM, D’Agostino RB Sr, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370(15):1422-1431.
7. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998;339(19):1349-1357.
8. Pedersen TR, Kjekshus J, Berg K, et al; Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994. Atheroscler Suppl. 2004;5(3):81-87.
9. Colhoun HM, Betteridge DJ, Durrington PN, et al; CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364(9435):685-696.
10. Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003;361(9374):2005-2016.
11. Streja L, Packard CJ, Shepherd J, Cobbe S, Ford I; WOSCOPS Group. Factors affecting low-density lipoprotein and high-density lipoprotein cholesterol response to pravastatin in the West Of Scotland Coronary Prevention Study (WOSCOPS). Am J Cardiol. 2002;90(7):731-736.
12. Blasetto JW, Stein EA, Brown WV, Chitra R, Raza A. Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups. Am J Cardiol. 2003;91(5A):3C-10C; discussion 10C.
13. Nicholls SJ. Tuzcu EM, Sipahi I, et al. Effect of obesity on lipid-lowering, anti-inflammatory, and antiatherosclerotic benefits of atorvastatin or pravastatin in patients with coronary artery disease (from the REVERSAL Study). Am J Cardiol. 2006;97(11):1553-1557.
14. Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk on adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25, pt B):2889-2934.
15. Jacobson T, Ito M, Maki K, et al. National Lipid Association recommendation for patient-centered management of dyslipidemia: part 1-full report. J Clin Lipidol. 2015;9(2):129-169.
16. Nylén ES, Faselis C, Kheirbek R, Myers J, Panagiotakos D, Kokkinos P. Statins modulate the mortality risk associated with obesity and cardiorespiratory fitness in diabetics. J Clin Endocrinol Metab. 2013;98(8):33940-3401.
More than one-third of Americans and > 20% of veterans have obesity with a body mass index (BMI) ≥ 30 kg/m2.1,2 It is well documented that patients with obesity have altered lipid metabolism, drug distribution, and drug clearance.3-5 As many as 8.2 million Americans may receive statin (3-hydroxymethylglutaryl coenzyme A reductase inhibitors) prescriptions if the American College of Cardiology/American Heart Association 2013 Cholesterol Guidelines are followed; therefore, it is important to examine how the efficacy of these drugs is altered in patients with obesity.6
Multiple studies have examined the benefits of statin therapy through lowering low-density lipoprotein cholesterol (LDL-C); however, few have examined the impact of obesity on statin efficacy. For example, only 18% of subjects in the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial were classified as having obesity, and subjects in the Scandinavian Simvastatin Survival Study (4S) trial had a mean BMI of only 26 kg/m2.7,8 Though statins decreased mortality in both of these studies, it is unknown whether the lipid-lowering effects were the same for participants with and without obesity. The Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS) demonstrated a decrease in major cardiovascular events and all-cause mortality with atorvastatin 10 mg daily therapy in a sample where more than one-third of subjects had obesity.9 However, the mean baseline BMI of subjects in both study groups was only 28 kg/m2, and outcomes for those with and without obesity were not compared.9
Studies that have examined statin efficacy in those with and without obesity include the Heart Protection Study (HPS), a post hoc analysis of the West of Scotland Coronary Prevention Study (WOSCOPS), and a meta-analysis by Blassetto and colleagues. The HPS examined the event rate of vascular events with simvastatin 40 mg daily in patients with diabetes mellitus (DM).10 Though these subgroups were compared in HPS, no statistical difference was demonstrated between these groups for the rate of vascular events among those with and without DM.10 However, the obesity subgroup’s event rate ratios were consistently higher than were those for the nonobese group.10
A post hoc analysis of WOSCOPS examined obesity as a factor for change in LDL-C with pravastatin 40 mg therapy.11 Though the authors found that no significant difference was present between those with and those without obesity, the data supporting this claim were not disclosed, which makes drawing clinical conclusions from this analysis difficult.11 A meta-analysis by Blassetto and colleagues examined the association between rosuvastatin’s efficacy in lowering LDL-C among the subgroups of hypertension, atherosclerosis, type 2 DM, and obesity.12 Though these subgroups were not compared statistically, the obesity subgroup had the lowest mean percent change in lowering LDL-C. Moreover, patients without obesity were not examined as a subgroup.12
With the expected increase in statin therapy and a significant portion of the U.S. population having obesity, it is necessary to determine if obesity alters the efficacy of statins. This study was conducted to determine the effect of obesity on the percent change in LDL-C with statin therapy within a veteran population.
Methods
This study was a retrospective review examining follow-up data from January 1, 2009 to July 1, 2014 from the VA Midsouth Healthcare Network. This network services more than 350,000 patients each year in Tennessee, Kentucky, and West Virgin
Patients were excluded if they had received treatment for hyperlipidemia (niacin, colestyramine, colestipol, colesevelam, other statins, gemfibrozil, fenofibrate, omega-3 ethyl esters, ezetimibe) during the 6 weeks prior to the initial fill date of the statin prescription. Patients whose simvastatin therapy did not span the follow-up period from the time of filling to the follow-up lipid panel were excluded, as were those who had not filled a simvastatin prescription within 30 days of their baseline lipid panel. Also excluded were patients who were newly established at the VA, pregnant, or receiving concomitant antihyperlipidemia agents, dialysis, or interacting medications (tacrolimus, cyclosporine, atazanavir, darunavir, nelfinavir, saquinavir, ritonavir, indinavir, lopinavir, tipranavir, fosamprenavir, fluconazole, voriconazole, itraconazole, voriconazole, posaconazole, amiodarone, or colchicine). Patients with a BMI < 18 kg/m2, hepatic failure as measured by an aspartate transaminase/alanine transaminase (AST/ALT) ratio > 3 times the upper limit of normal, hepatitis, a history of alcoholism, any change in statin dose prior to follow-up cholesterol values, or no follow-up LDL-C values also were excluded.
The baseline data collected included age, sex, weight, height, BMI, hemoglobin A1c, LDL-C, ALT/AST, and serum creatinine (SCr). All other laboratory results were required to be within 270 days of the time the lipid panel was obtained. The index date was set as the date the initial prescription was filled between February 1, 2009 and April 1, 2014. Follow-up levels for LDL-C were obtained 40 to 95 days after the index date. Direct LDL-C values were preferred unless only calculated values were available. Calculated LDL-C values were determined by using the Friedewald equation. An audit of 150 patient charts was conducted to ensure the integrity of data pulled from the database.
The percent changes in LDL-C were calculated for those with and without obesity for both simvastatin 20 mg daily and simvastatin 40 mg daily. The primary outcome was the percent change in LDL-C from baseline. All laboratory values were compared using independent 2-tailed t tests with α set to .05. To have an 80% chance of detecting a 5% difference in percent change in LDL-C between the experimental and control groups, 129 patients were required. To determine whether an association was present, a correlation between BMI and percent change in LDL-C was conducted. All statistics were conducted using SAS software (Cary, North Carolina).
Results
From January 2009 through July 2014, 35,216 patients were initially screened. The majority of patients did not have a baseline LDL-C value and were excluded. A total of 1,183 patients with simvastatin 20 mg daily (BMI < 30 = 661; BMI ≥ 30 = 1,122) and 478 patients with simvastatin 40 mg daily (BMI < 30 = 259; BMI ≥ 30 = 219) met the inclusion criteria.
Baseline characteristics were similar between groups except for a slightly higher age in both groups without obesity (Table). Hepatic and renal serum markers indicated a baseline of adequate organ function for drug clearance for all groups. The mean baseline BMI of those without obesity was about 26 kg/m2, which is considered overweight. Baseline LDL-C values were clinically similar for those with and without obesity, though statistically different (145 mg/dL for the nonobese group and 141 mg/dL for the obese group, P < .05). The percent change in LDL-C was not statistically significant for those with and without obesity for simvastatin 20 mg daily (P = .293) or simvastatin 40 mg daily (P = .2773) (Figure). No correlation was found between the continuous percent change in LDL-C and continuous BMI for either simvastatin dosage (r2 = 0.0016 and 0.0028, respectively).
Discussion
In this retrospective chart review, it was determined that obesity did not affect the percent change in LDL-C from baseline with statin therapy. The HPS found similar results as a secondary endpoint, although that study was underpowered.10 In this study, all groups met power, and there was still no difference between those with and without obesity.
Nicholls and colleagues examined REVERSAL study data to determine whether BMI greater than the median BMI impacted inflammatory markers or lipid levels with atorvastatin 80 mg daily or pravastatin 40 mg daily. The REVERSAL study authors found no difference in percent change LDL-C between those above the median BMI compared with those below the median BMI for patients on pravastatin therapy. However, the authors did find a difference in percent change LDL-C with atorvastatin therapy.13 No difference in percent change LDL-C was present with simvastatin therapy in this study. As simvastatin is more lipophilic than is atorvastatin, lipophilicity remains an area for further study for statin therapy in patients with obesity.
The surrogate marker of percent change in LDL-C was used for the primary outcome in this study. The ACC/AHA 2013 guidelines and the National Lipid Association 2014 guidelines recommend an alternative goal of 30% to 50% change in LDL-C from baseline.14,15 Using this clinically relevant marker compensated for differences in baseline LDL-C and limited the effect of these differences on the primary outcome of this study.
Limitations
This study did not include patients who were underweight (BMI < 18 kg/m2), as these patients have previously demonstrated decreased outcomes with statin therapy.16 However, this limits these data to only those patients that have a BMI of at least 18 kg/m2. Limitations of this study also included the inability to consider adherence and lifestyle changes. These limitations were unavoidable due to the nature of a retrospective chart review.
Conclusion
The prevalence of obesity is increasing, and it is a disease that alters pharmacokinetics and lipid metabolism. Though this study did not find a difference between the LDL-C-lowering efficacy of simvastatin in those with and without obesity, continued study of the effect of obesity on the efficacy of medications is vital.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the James H. Qullen VAMC in Mountain Home, Tennessee.
More than one-third of Americans and > 20% of veterans have obesity with a body mass index (BMI) ≥ 30 kg/m2.1,2 It is well documented that patients with obesity have altered lipid metabolism, drug distribution, and drug clearance.3-5 As many as 8.2 million Americans may receive statin (3-hydroxymethylglutaryl coenzyme A reductase inhibitors) prescriptions if the American College of Cardiology/American Heart Association 2013 Cholesterol Guidelines are followed; therefore, it is important to examine how the efficacy of these drugs is altered in patients with obesity.6
Multiple studies have examined the benefits of statin therapy through lowering low-density lipoprotein cholesterol (LDL-C); however, few have examined the impact of obesity on statin efficacy. For example, only 18% of subjects in the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial were classified as having obesity, and subjects in the Scandinavian Simvastatin Survival Study (4S) trial had a mean BMI of only 26 kg/m2.7,8 Though statins decreased mortality in both of these studies, it is unknown whether the lipid-lowering effects were the same for participants with and without obesity. The Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS) demonstrated a decrease in major cardiovascular events and all-cause mortality with atorvastatin 10 mg daily therapy in a sample where more than one-third of subjects had obesity.9 However, the mean baseline BMI of subjects in both study groups was only 28 kg/m2, and outcomes for those with and without obesity were not compared.9
Studies that have examined statin efficacy in those with and without obesity include the Heart Protection Study (HPS), a post hoc analysis of the West of Scotland Coronary Prevention Study (WOSCOPS), and a meta-analysis by Blassetto and colleagues. The HPS examined the event rate of vascular events with simvastatin 40 mg daily in patients with diabetes mellitus (DM).10 Though these subgroups were compared in HPS, no statistical difference was demonstrated between these groups for the rate of vascular events among those with and without DM.10 However, the obesity subgroup’s event rate ratios were consistently higher than were those for the nonobese group.10
A post hoc analysis of WOSCOPS examined obesity as a factor for change in LDL-C with pravastatin 40 mg therapy.11 Though the authors found that no significant difference was present between those with and those without obesity, the data supporting this claim were not disclosed, which makes drawing clinical conclusions from this analysis difficult.11 A meta-analysis by Blassetto and colleagues examined the association between rosuvastatin’s efficacy in lowering LDL-C among the subgroups of hypertension, atherosclerosis, type 2 DM, and obesity.12 Though these subgroups were not compared statistically, the obesity subgroup had the lowest mean percent change in lowering LDL-C. Moreover, patients without obesity were not examined as a subgroup.12
With the expected increase in statin therapy and a significant portion of the U.S. population having obesity, it is necessary to determine if obesity alters the efficacy of statins. This study was conducted to determine the effect of obesity on the percent change in LDL-C with statin therapy within a veteran population.
Methods
This study was a retrospective review examining follow-up data from January 1, 2009 to July 1, 2014 from the VA Midsouth Healthcare Network. This network services more than 350,000 patients each year in Tennessee, Kentucky, and West Virgin
Patients were excluded if they had received treatment for hyperlipidemia (niacin, colestyramine, colestipol, colesevelam, other statins, gemfibrozil, fenofibrate, omega-3 ethyl esters, ezetimibe) during the 6 weeks prior to the initial fill date of the statin prescription. Patients whose simvastatin therapy did not span the follow-up period from the time of filling to the follow-up lipid panel were excluded, as were those who had not filled a simvastatin prescription within 30 days of their baseline lipid panel. Also excluded were patients who were newly established at the VA, pregnant, or receiving concomitant antihyperlipidemia agents, dialysis, or interacting medications (tacrolimus, cyclosporine, atazanavir, darunavir, nelfinavir, saquinavir, ritonavir, indinavir, lopinavir, tipranavir, fosamprenavir, fluconazole, voriconazole, itraconazole, voriconazole, posaconazole, amiodarone, or colchicine). Patients with a BMI < 18 kg/m2, hepatic failure as measured by an aspartate transaminase/alanine transaminase (AST/ALT) ratio > 3 times the upper limit of normal, hepatitis, a history of alcoholism, any change in statin dose prior to follow-up cholesterol values, or no follow-up LDL-C values also were excluded.
The baseline data collected included age, sex, weight, height, BMI, hemoglobin A1c, LDL-C, ALT/AST, and serum creatinine (SCr). All other laboratory results were required to be within 270 days of the time the lipid panel was obtained. The index date was set as the date the initial prescription was filled between February 1, 2009 and April 1, 2014. Follow-up levels for LDL-C were obtained 40 to 95 days after the index date. Direct LDL-C values were preferred unless only calculated values were available. Calculated LDL-C values were determined by using the Friedewald equation. An audit of 150 patient charts was conducted to ensure the integrity of data pulled from the database.
The percent changes in LDL-C were calculated for those with and without obesity for both simvastatin 20 mg daily and simvastatin 40 mg daily. The primary outcome was the percent change in LDL-C from baseline. All laboratory values were compared using independent 2-tailed t tests with α set to .05. To have an 80% chance of detecting a 5% difference in percent change in LDL-C between the experimental and control groups, 129 patients were required. To determine whether an association was present, a correlation between BMI and percent change in LDL-C was conducted. All statistics were conducted using SAS software (Cary, North Carolina).
Results
From January 2009 through July 2014, 35,216 patients were initially screened. The majority of patients did not have a baseline LDL-C value and were excluded. A total of 1,183 patients with simvastatin 20 mg daily (BMI < 30 = 661; BMI ≥ 30 = 1,122) and 478 patients with simvastatin 40 mg daily (BMI < 30 = 259; BMI ≥ 30 = 219) met the inclusion criteria.
Baseline characteristics were similar between groups except for a slightly higher age in both groups without obesity (Table). Hepatic and renal serum markers indicated a baseline of adequate organ function for drug clearance for all groups. The mean baseline BMI of those without obesity was about 26 kg/m2, which is considered overweight. Baseline LDL-C values were clinically similar for those with and without obesity, though statistically different (145 mg/dL for the nonobese group and 141 mg/dL for the obese group, P < .05). The percent change in LDL-C was not statistically significant for those with and without obesity for simvastatin 20 mg daily (P = .293) or simvastatin 40 mg daily (P = .2773) (Figure). No correlation was found between the continuous percent change in LDL-C and continuous BMI for either simvastatin dosage (r2 = 0.0016 and 0.0028, respectively).
Discussion
In this retrospective chart review, it was determined that obesity did not affect the percent change in LDL-C from baseline with statin therapy. The HPS found similar results as a secondary endpoint, although that study was underpowered.10 In this study, all groups met power, and there was still no difference between those with and without obesity.
Nicholls and colleagues examined REVERSAL study data to determine whether BMI greater than the median BMI impacted inflammatory markers or lipid levels with atorvastatin 80 mg daily or pravastatin 40 mg daily. The REVERSAL study authors found no difference in percent change LDL-C between those above the median BMI compared with those below the median BMI for patients on pravastatin therapy. However, the authors did find a difference in percent change LDL-C with atorvastatin therapy.13 No difference in percent change LDL-C was present with simvastatin therapy in this study. As simvastatin is more lipophilic than is atorvastatin, lipophilicity remains an area for further study for statin therapy in patients with obesity.
The surrogate marker of percent change in LDL-C was used for the primary outcome in this study. The ACC/AHA 2013 guidelines and the National Lipid Association 2014 guidelines recommend an alternative goal of 30% to 50% change in LDL-C from baseline.14,15 Using this clinically relevant marker compensated for differences in baseline LDL-C and limited the effect of these differences on the primary outcome of this study.
Limitations
This study did not include patients who were underweight (BMI < 18 kg/m2), as these patients have previously demonstrated decreased outcomes with statin therapy.16 However, this limits these data to only those patients that have a BMI of at least 18 kg/m2. Limitations of this study also included the inability to consider adherence and lifestyle changes. These limitations were unavoidable due to the nature of a retrospective chart review.
Conclusion
The prevalence of obesity is increasing, and it is a disease that alters pharmacokinetics and lipid metabolism. Though this study did not find a difference between the LDL-C-lowering efficacy of simvastatin in those with and without obesity, continued study of the effect of obesity on the efficacy of medications is vital.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the James H. Qullen VAMC in Mountain Home, Tennessee.
1. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
2. Shen Y, Sambamoorthi U, Rajan M, Miller D, Banerjea R, Pogach L. Obesity and expenditures among elderly Veterans Health Administration users with diabetes. Popul Health Manag. 2009;12(5):255-264.
3. Chan DC, Watts GF, Wang J, Hegele RA, van Bockxmeer FM, Barrett PH. Variation in Niemann-Pick C1-like 1 gene as a determinant of apolipoprotein B-100 kinetics and response to statin therapy in centrally obese men. Clin Endocrinol (Oxf). 2008;69(1):45-51.
4. Cheymol G. Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000;39(3):215-231.
5. Hanley MJ, Abernethy DR, Greenblatt DJ. Effect of obesity on the pharmacokinetics of drugs in humans. Clin Pharmacokinet. 2010;49(2):71-87
6. Pencina MJ, Navar-Boggan AM, D’Agostino RB Sr, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370(15):1422-1431.
7. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998;339(19):1349-1357.
8. Pedersen TR, Kjekshus J, Berg K, et al; Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994. Atheroscler Suppl. 2004;5(3):81-87.
9. Colhoun HM, Betteridge DJ, Durrington PN, et al; CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364(9435):685-696.
10. Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003;361(9374):2005-2016.
11. Streja L, Packard CJ, Shepherd J, Cobbe S, Ford I; WOSCOPS Group. Factors affecting low-density lipoprotein and high-density lipoprotein cholesterol response to pravastatin in the West Of Scotland Coronary Prevention Study (WOSCOPS). Am J Cardiol. 2002;90(7):731-736.
12. Blasetto JW, Stein EA, Brown WV, Chitra R, Raza A. Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups. Am J Cardiol. 2003;91(5A):3C-10C; discussion 10C.
13. Nicholls SJ. Tuzcu EM, Sipahi I, et al. Effect of obesity on lipid-lowering, anti-inflammatory, and antiatherosclerotic benefits of atorvastatin or pravastatin in patients with coronary artery disease (from the REVERSAL Study). Am J Cardiol. 2006;97(11):1553-1557.
14. Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk on adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25, pt B):2889-2934.
15. Jacobson T, Ito M, Maki K, et al. National Lipid Association recommendation for patient-centered management of dyslipidemia: part 1-full report. J Clin Lipidol. 2015;9(2):129-169.
16. Nylén ES, Faselis C, Kheirbek R, Myers J, Panagiotakos D, Kokkinos P. Statins modulate the mortality risk associated with obesity and cardiorespiratory fitness in diabetics. J Clin Endocrinol Metab. 2013;98(8):33940-3401.
1. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
2. Shen Y, Sambamoorthi U, Rajan M, Miller D, Banerjea R, Pogach L. Obesity and expenditures among elderly Veterans Health Administration users with diabetes. Popul Health Manag. 2009;12(5):255-264.
3. Chan DC, Watts GF, Wang J, Hegele RA, van Bockxmeer FM, Barrett PH. Variation in Niemann-Pick C1-like 1 gene as a determinant of apolipoprotein B-100 kinetics and response to statin therapy in centrally obese men. Clin Endocrinol (Oxf). 2008;69(1):45-51.
4. Cheymol G. Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000;39(3):215-231.
5. Hanley MJ, Abernethy DR, Greenblatt DJ. Effect of obesity on the pharmacokinetics of drugs in humans. Clin Pharmacokinet. 2010;49(2):71-87
6. Pencina MJ, Navar-Boggan AM, D’Agostino RB Sr, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370(15):1422-1431.
7. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998;339(19):1349-1357.
8. Pedersen TR, Kjekshus J, Berg K, et al; Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994. Atheroscler Suppl. 2004;5(3):81-87.
9. Colhoun HM, Betteridge DJ, Durrington PN, et al; CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364(9435):685-696.
10. Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003;361(9374):2005-2016.
11. Streja L, Packard CJ, Shepherd J, Cobbe S, Ford I; WOSCOPS Group. Factors affecting low-density lipoprotein and high-density lipoprotein cholesterol response to pravastatin in the West Of Scotland Coronary Prevention Study (WOSCOPS). Am J Cardiol. 2002;90(7):731-736.
12. Blasetto JW, Stein EA, Brown WV, Chitra R, Raza A. Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups. Am J Cardiol. 2003;91(5A):3C-10C; discussion 10C.
13. Nicholls SJ. Tuzcu EM, Sipahi I, et al. Effect of obesity on lipid-lowering, anti-inflammatory, and antiatherosclerotic benefits of atorvastatin or pravastatin in patients with coronary artery disease (from the REVERSAL Study). Am J Cardiol. 2006;97(11):1553-1557.
14. Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk on adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25, pt B):2889-2934.
15. Jacobson T, Ito M, Maki K, et al. National Lipid Association recommendation for patient-centered management of dyslipidemia: part 1-full report. J Clin Lipidol. 2015;9(2):129-169.
16. Nylén ES, Faselis C, Kheirbek R, Myers J, Panagiotakos D, Kokkinos P. Statins modulate the mortality risk associated with obesity and cardiorespiratory fitness in diabetics. J Clin Endocrinol Metab. 2013;98(8):33940-3401.
CMS delays start of cardiac pay bundles
The Centers for Medicare & Medicaid Services is delaying the start of three cardiac payment bundles finalized at the end of 2016.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model.
The payment bundles were schedule to go into effect on July 1, 2017, but an interim final rule published March 21 in the Federal Register delayed the start of the bundles for 3 months. The agency also is seeking comment on potentially delaying implementation of the bundles to Jan. 1, 2018.
The bundled payment models would place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Hospitals in 98 randomly selected metropolitan statistical areas would be placed in this model and monitored for 5 years to test whether the models lead to improved outcomes and lower costs.
For the cardiac rehabilitation model, CMS would be testing whether an incentive payment would increase the use of cardiac rehabilitation services during a care period that runs parallel with the AMI and CABG payment bundles.
Physician participation in the bundles would have been voluntary, but those participating would have been eligible for bonus payments under the Quality Payment Program as the bundles were considered advanced Alternative Payment Models.
The final rule also delays changes to the comprehensive joint replacement bundle.
CMS had announced the final rule implementing the payment bundles on Dec. 20, 2016, but it was not published in the Federal Register until Jan. 3, 2017. The March 21 interim final rule delaying the start of the bundles cites the Trump administration’s memorandum to federal agencies freezing in-process regulations to allow for review.
The Centers for Medicare & Medicaid Services is delaying the start of three cardiac payment bundles finalized at the end of 2016.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model.
The payment bundles were schedule to go into effect on July 1, 2017, but an interim final rule published March 21 in the Federal Register delayed the start of the bundles for 3 months. The agency also is seeking comment on potentially delaying implementation of the bundles to Jan. 1, 2018.
The bundled payment models would place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Hospitals in 98 randomly selected metropolitan statistical areas would be placed in this model and monitored for 5 years to test whether the models lead to improved outcomes and lower costs.
For the cardiac rehabilitation model, CMS would be testing whether an incentive payment would increase the use of cardiac rehabilitation services during a care period that runs parallel with the AMI and CABG payment bundles.
Physician participation in the bundles would have been voluntary, but those participating would have been eligible for bonus payments under the Quality Payment Program as the bundles were considered advanced Alternative Payment Models.
The final rule also delays changes to the comprehensive joint replacement bundle.
CMS had announced the final rule implementing the payment bundles on Dec. 20, 2016, but it was not published in the Federal Register until Jan. 3, 2017. The March 21 interim final rule delaying the start of the bundles cites the Trump administration’s memorandum to federal agencies freezing in-process regulations to allow for review.
The Centers for Medicare & Medicaid Services is delaying the start of three cardiac payment bundles finalized at the end of 2016.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model.
The payment bundles were schedule to go into effect on July 1, 2017, but an interim final rule published March 21 in the Federal Register delayed the start of the bundles for 3 months. The agency also is seeking comment on potentially delaying implementation of the bundles to Jan. 1, 2018.
The bundled payment models would place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Hospitals in 98 randomly selected metropolitan statistical areas would be placed in this model and monitored for 5 years to test whether the models lead to improved outcomes and lower costs.
For the cardiac rehabilitation model, CMS would be testing whether an incentive payment would increase the use of cardiac rehabilitation services during a care period that runs parallel with the AMI and CABG payment bundles.
Physician participation in the bundles would have been voluntary, but those participating would have been eligible for bonus payments under the Quality Payment Program as the bundles were considered advanced Alternative Payment Models.
The final rule also delays changes to the comprehensive joint replacement bundle.
CMS had announced the final rule implementing the payment bundles on Dec. 20, 2016, but it was not published in the Federal Register until Jan. 3, 2017. The March 21 interim final rule delaying the start of the bundles cites the Trump administration’s memorandum to federal agencies freezing in-process regulations to allow for review.
Artificial Pancreas Moves Closer to Real-Life Option
Roughly 25% of veterans have diabetes mellitus (DM) as opposed to 9% of the general public. A small percentage of veterans have type 1 DM, which according to research, can be caused by both physical and mental trauma that affects the pancreas.
“Managing type 1 diabetes currently requires a constant juggling act between checking bloodglucose levels frequently and delivering just the right amount of insulin while taking into account meals, physical activity, and other aspects of daily life, where a missed or wrong delivery could lead to potential complications,” said Dr. Andrew Bremer, of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). But that may change soon as we draw near to a functional “artificial pancreas,” a fully automated system that will sense rising glucose levels and adjust insulin automatically.
The FDA approved a hybrid model of an artificial pancreas in 2016, which still required users to adjust insulin intake. Now, 4 separate projects are designed to be the “potential last steps” toward requesting regulatory approval for permanent use of a fully automated system, according to NIDDK. The research studies beginning this year will look at safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. The participants will live at home and monitor themselves with remote monitoring by study staff.
“Nearly 100 years since the discovery of insulin,” said NIDDK Director Dr. Griffin P. Rodgers, “a successful artificial pancreas would mark another huge step toward better health for people with type 1 diabetes.”
Roughly 25% of veterans have diabetes mellitus (DM) as opposed to 9% of the general public. A small percentage of veterans have type 1 DM, which according to research, can be caused by both physical and mental trauma that affects the pancreas.
“Managing type 1 diabetes currently requires a constant juggling act between checking bloodglucose levels frequently and delivering just the right amount of insulin while taking into account meals, physical activity, and other aspects of daily life, where a missed or wrong delivery could lead to potential complications,” said Dr. Andrew Bremer, of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). But that may change soon as we draw near to a functional “artificial pancreas,” a fully automated system that will sense rising glucose levels and adjust insulin automatically.
The FDA approved a hybrid model of an artificial pancreas in 2016, which still required users to adjust insulin intake. Now, 4 separate projects are designed to be the “potential last steps” toward requesting regulatory approval for permanent use of a fully automated system, according to NIDDK. The research studies beginning this year will look at safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. The participants will live at home and monitor themselves with remote monitoring by study staff.
“Nearly 100 years since the discovery of insulin,” said NIDDK Director Dr. Griffin P. Rodgers, “a successful artificial pancreas would mark another huge step toward better health for people with type 1 diabetes.”
Roughly 25% of veterans have diabetes mellitus (DM) as opposed to 9% of the general public. A small percentage of veterans have type 1 DM, which according to research, can be caused by both physical and mental trauma that affects the pancreas.
“Managing type 1 diabetes currently requires a constant juggling act between checking bloodglucose levels frequently and delivering just the right amount of insulin while taking into account meals, physical activity, and other aspects of daily life, where a missed or wrong delivery could lead to potential complications,” said Dr. Andrew Bremer, of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). But that may change soon as we draw near to a functional “artificial pancreas,” a fully automated system that will sense rising glucose levels and adjust insulin automatically.
The FDA approved a hybrid model of an artificial pancreas in 2016, which still required users to adjust insulin intake. Now, 4 separate projects are designed to be the “potential last steps” toward requesting regulatory approval for permanent use of a fully automated system, according to NIDDK. The research studies beginning this year will look at safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. The participants will live at home and monitor themselves with remote monitoring by study staff.
“Nearly 100 years since the discovery of insulin,” said NIDDK Director Dr. Griffin P. Rodgers, “a successful artificial pancreas would mark another huge step toward better health for people with type 1 diabetes.”