ACS Surgery News

Revision of the Health Insurance Portability and Accountability Act (HIPAA) rules has prompted numerous questions about business associates (BAs) and business associate agreements (BAAs). Apparently there is confusion about exactly which businesses qualify as BAs and how your BAAs should be modified to reflect the new provisions.

The criteria for identifying BAs are admittedly vague: The act defines them as nonemployees, performing “functions or activities” on behalf of the “covered entity” (your practice) that involve “creating, receiving, maintaining, or transmitting” personal health information (PHI).

Clearly, answering and billing services, independent transcriptionists, hardware and software companies, and any other vendors involved in creating or maintaining your medical records always qualify as BAs. Other businesses may or may not qualify, depending on whether they need direct access to PHI in order to provide their service. These include practice management consultants, attorneys, companies that store or microfilm medical records, and record-shredding services.

Specialty pharmacies are seldom mentioned in the BA discussion, but they probably should be. Pharmaceutical manufacturers are increasingly using them as intermediaries for their products – particularly the more expensive ones, such as biologics. Many of them ship products directly to patients, for which they require home addresses and other personal information, and in order to file payment paperwork and claim forms, they usually request diagnoses and associated medical information. By any reasonable interpretation of the new rules, this makes them BAs, and you should have BAAs in place before allowing them to fill your prescriptions.

To further complicate the situation, manufacturers and insurers routinely compile information about the real world uses of their products. To that end, they often ask specialty pharmacies to provide them with any patient data that they collect. Under the new rules, patients may restrict any PHI shared with third parties when patients pay for the drugs or services themselves. Your specialty pharmacy BAA should include a provision noting that the pharmacy is forbidden from disclosing any data to pharmaceutical companies or insurers from patients who self-pay and request confidentiality.

Mail carriers, package delivery people, cleaning services, copier repairmen, bank employees, and the like are not considered BAs. While they might conceivably come in contact with PHI on occasion, they don’t need it to do their job. You are required to use “reasonable diligence” in limiting the PHI that these folks may encounter, but you do not need to enter into written BA agreements with them.

Independent contractors who work within your practice – aestheticians and physical therapists, for example – are not considered BAs either, and do not need to sign a BA agreement. Just train them, as you do your employees.

Another source of confusion is the provision in the new rules that makes BAs directly responsible for their own HIPAA violations. While this might seem to eliminate the need for BAAs entirely, unfortunately that is not the case. In fact, even more responsibility has been placed on physicians for confidentiality breaches committed by their BAs. It is not enough to simply have a BAA in place; you are expected to use “reasonable diligence” in monitoring the work of your BAs. While BAs and their subcontractors are responsible for their own actions, the primary responsibility remains with you. Furthermore, you now must assume the worst-case scenario. Previously, when PHI was compromised, you would have to notify affected patients (and the government) only if there was a “significant risk of financial or reputational harm”; but now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice, as well as the contractor, to significant fines.

If you haven’t yet revised your Notice of Privacy Practices (NPP) to explain your relationships with BAs, and their status under the new rules, do it now. (You should have done it last September.) You need to explain the breach notification process too, as well as the new patient rights mentioned above. You must post your revised NPP in your office, and make copies available there, but you need not mail a copy to every patient.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

Revision of the Health Insurance Portability and Accountability Act (HIPAA) rules has prompted numerous questions about business associates (BAs) and business associate agreements (BAAs). Apparently there is confusion about exactly which businesses qualify as BAs and how your BAAs should be modified to reflect the new provisions.

The criteria for identifying BAs are admittedly vague: The act defines them as nonemployees, performing “functions or activities” on behalf of the “covered entity” (your practice) that involve “creating, receiving, maintaining, or transmitting” personal health information (PHI).

Clearly, answering and billing services, independent transcriptionists, hardware and software companies, and any other vendors involved in creating or maintaining your medical records always qualify as BAs. Other businesses may or may not qualify, depending on whether they need direct access to PHI in order to provide their service. These include practice management consultants, attorneys, companies that store or microfilm medical records, and record-shredding services.

Specialty pharmacies are seldom mentioned in the BA discussion, but they probably should be. Pharmaceutical manufacturers are increasingly using them as intermediaries for their products – particularly the more expensive ones, such as biologics. Many of them ship products directly to patients, for which they require home addresses and other personal information, and in order to file payment paperwork and claim forms, they usually request diagnoses and associated medical information. By any reasonable interpretation of the new rules, this makes them BAs, and you should have BAAs in place before allowing them to fill your prescriptions.

To further complicate the situation, manufacturers and insurers routinely compile information about the real world uses of their products. To that end, they often ask specialty pharmacies to provide them with any patient data that they collect. Under the new rules, patients may restrict any PHI shared with third parties when patients pay for the drugs or services themselves. Your specialty pharmacy BAA should include a provision noting that the pharmacy is forbidden from disclosing any data to pharmaceutical companies or insurers from patients who self-pay and request confidentiality.

Mail carriers, package delivery people, cleaning services, copier repairmen, bank employees, and the like are not considered BAs. While they might conceivably come in contact with PHI on occasion, they don’t need it to do their job. You are required to use “reasonable diligence” in limiting the PHI that these folks may encounter, but you do not need to enter into written BA agreements with them.

Independent contractors who work within your practice – aestheticians and physical therapists, for example – are not considered BAs either, and do not need to sign a BA agreement. Just train them, as you do your employees.

Another source of confusion is the provision in the new rules that makes BAs directly responsible for their own HIPAA violations. While this might seem to eliminate the need for BAAs entirely, unfortunately that is not the case. In fact, even more responsibility has been placed on physicians for confidentiality breaches committed by their BAs. It is not enough to simply have a BAA in place; you are expected to use “reasonable diligence” in monitoring the work of your BAs. While BAs and their subcontractors are responsible for their own actions, the primary responsibility remains with you. Furthermore, you now must assume the worst-case scenario. Previously, when PHI was compromised, you would have to notify affected patients (and the government) only if there was a “significant risk of financial or reputational harm”; but now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice, as well as the contractor, to significant fines.

If you haven’t yet revised your Notice of Privacy Practices (NPP) to explain your relationships with BAs, and their status under the new rules, do it now. (You should have done it last September.) You need to explain the breach notification process too, as well as the new patient rights mentioned above. You must post your revised NPP in your office, and make copies available there, but you need not mail a copy to every patient.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

Revision of the Health Insurance Portability and Accountability Act (HIPAA) rules has prompted numerous questions about business associates (BAs) and business associate agreements (BAAs). Apparently there is confusion about exactly which businesses qualify as BAs and how your BAAs should be modified to reflect the new provisions.

The criteria for identifying BAs are admittedly vague: The act defines them as nonemployees, performing “functions or activities” on behalf of the “covered entity” (your practice) that involve “creating, receiving, maintaining, or transmitting” personal health information (PHI).

Clearly, answering and billing services, independent transcriptionists, hardware and software companies, and any other vendors involved in creating or maintaining your medical records always qualify as BAs. Other businesses may or may not qualify, depending on whether they need direct access to PHI in order to provide their service. These include practice management consultants, attorneys, companies that store or microfilm medical records, and record-shredding services.

Specialty pharmacies are seldom mentioned in the BA discussion, but they probably should be. Pharmaceutical manufacturers are increasingly using them as intermediaries for their products – particularly the more expensive ones, such as biologics. Many of them ship products directly to patients, for which they require home addresses and other personal information, and in order to file payment paperwork and claim forms, they usually request diagnoses and associated medical information. By any reasonable interpretation of the new rules, this makes them BAs, and you should have BAAs in place before allowing them to fill your prescriptions.

To further complicate the situation, manufacturers and insurers routinely compile information about the real world uses of their products. To that end, they often ask specialty pharmacies to provide them with any patient data that they collect. Under the new rules, patients may restrict any PHI shared with third parties when patients pay for the drugs or services themselves. Your specialty pharmacy BAA should include a provision noting that the pharmacy is forbidden from disclosing any data to pharmaceutical companies or insurers from patients who self-pay and request confidentiality.

Mail carriers, package delivery people, cleaning services, copier repairmen, bank employees, and the like are not considered BAs. While they might conceivably come in contact with PHI on occasion, they don’t need it to do their job. You are required to use “reasonable diligence” in limiting the PHI that these folks may encounter, but you do not need to enter into written BA agreements with them.

Independent contractors who work within your practice – aestheticians and physical therapists, for example – are not considered BAs either, and do not need to sign a BA agreement. Just train them, as you do your employees.

Another source of confusion is the provision in the new rules that makes BAs directly responsible for their own HIPAA violations. While this might seem to eliminate the need for BAAs entirely, unfortunately that is not the case. In fact, even more responsibility has been placed on physicians for confidentiality breaches committed by their BAs. It is not enough to simply have a BAA in place; you are expected to use “reasonable diligence” in monitoring the work of your BAs. While BAs and their subcontractors are responsible for their own actions, the primary responsibility remains with you. Furthermore, you now must assume the worst-case scenario. Previously, when PHI was compromised, you would have to notify affected patients (and the government) only if there was a “significant risk of financial or reputational harm”; but now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice, as well as the contractor, to significant fines.

If you haven’t yet revised your Notice of Privacy Practices (NPP) to explain your relationships with BAs, and their status under the new rules, do it now. (You should have done it last September.) You need to explain the breach notification process too, as well as the new patient rights mentioned above. You must post your revised NPP in your office, and make copies available there, but you need not mail a copy to every patient.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

CHICAGO – Pancreaticoduodenal and gastroduodenal artery aneurysms should be repaired at diagnosis, according to Dr. Michael Corey, a vascular surgeon at Massachusetts General Hospital in Boston.

The reason is “they rupture at small sizes. Most other small splanchnic artery aneurysms” – below 25 mm – “do not grow or rupture over time and can safely undergo surveillance imaging every 3 years,” he said at a meeting hosted by the Society for Vascular Surgery.

The insights come from Dr. Corey’s review of 264 splanchnic artery aneurysms (SAAs) treated at Massachusetts General Hospital from 1994 to 2014 .

Pancreaticoduodenal (PDA) and gastroduodenal (GDA) artery aneurysms were the most likely to cause trouble. Almost all of the 36 in the study were associated with high-grade celiac axis stenosis, and 12 (33%) were symptomatic at presentation, including 7 (19%) that had ruptured at a mean size of 27.4 mm, range 15-48 mm.

Those 7 accounted for more than half of the 13 ruptures in the study. There were also five ruptures among 95 splenic artery aneurysms – the most common aneurysm type in the study – at a mean of 42 mm, and one among 34 hepatic artery aneurysms at 40 mm. Thirty-day morbidity after rupture repair was 54% and mortality 8%.

Pancreaticoduodenal (odds ratio, 14.41; 95% confidence interval, 3.5-59.9; P = .0002) and gastroduodenal artery aneurysms (OR, 6.95; 95% CI, 1.1-45.1; P = .042) were far more predictive of rupture than aneurysm size (OR, 1.04; 95% CI, 1.01-1.08; P = .0042). The strongest predictor was type 4 Ehlers-Danlos syndrome (OR, 34.09; 95% CI, 2.4-479.8; P = .0089). Calcification, meanwhile, did not predict rupture, growth, or thrombus burden.

Dr. Corey and his colleagues reviewed Massachusetts General’s experience with SAAs because “no strong consensus exists in the literature concerning the indications for treatment; 2 cm is currently the indication for surgical treatment of asymptomatic lesions,” he said.

Two centimeters might be too aggressive in some cases. Among 176 aneurysms put under surveillance for a mean of 36.1 months, the mean aneurysm size was 16.3 mm but ranged up to 40 mm. Even so, none of them ruptured. Just 12 aneurysms grew during surveillance, and only 8 eventually needed intervention. Perhaps most “small asymptomatic lesions do not affect longevity,” Dr. Corey said. The mean aneurysm size was 31.1 mm in the 88 patients repaired within 6 months of diagnosis. Splenic, pancreaticoduodenal, gastroduodenal, and hepatic aneurysms were the most likely to be repaired early, the majority by coil embolization and other endovascular techniques. Thirty-day morbidity for intact repair was 13% and mortality 3%.

Most of the splenic artery aneurysms were asymptomatic at presentation. In the half that were watched, just six grew.

Similarly, 78 celiac artery aneurysms – the second most common in the study – all presented without symptoms. Just 3 of the 60 under surveillance grew over a mean of 43.6 months. “These aneurysms rarely change,” Dr. Corey said.

Most of the 34 hepatic artery aneurysms and 17 superior mesenteric artery (SMA) aneurysms were asymptomatic. Between both groups, 20 aneurysms were put under surveillance; growth was noted in 1, an SMA lesion.

Although there was a shift from open to endovascular repair during the study period, there were no statistically significant differences in morbidity or mortality between the two approaches.

Dr. Corey has no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Pancreaticoduodenal and gastroduodenal artery aneurysms should be repaired at diagnosis, according to Dr. Michael Corey, a vascular surgeon at Massachusetts General Hospital in Boston.

The reason is “they rupture at small sizes. Most other small splanchnic artery aneurysms” – below 25 mm – “do not grow or rupture over time and can safely undergo surveillance imaging every 3 years,” he said at a meeting hosted by the Society for Vascular Surgery.

The insights come from Dr. Corey’s review of 264 splanchnic artery aneurysms (SAAs) treated at Massachusetts General Hospital from 1994 to 2014 .

Pancreaticoduodenal (PDA) and gastroduodenal (GDA) artery aneurysms were the most likely to cause trouble. Almost all of the 36 in the study were associated with high-grade celiac axis stenosis, and 12 (33%) were symptomatic at presentation, including 7 (19%) that had ruptured at a mean size of 27.4 mm, range 15-48 mm.

Those 7 accounted for more than half of the 13 ruptures in the study. There were also five ruptures among 95 splenic artery aneurysms – the most common aneurysm type in the study – at a mean of 42 mm, and one among 34 hepatic artery aneurysms at 40 mm. Thirty-day morbidity after rupture repair was 54% and mortality 8%.

Pancreaticoduodenal (odds ratio, 14.41; 95% confidence interval, 3.5-59.9; P = .0002) and gastroduodenal artery aneurysms (OR, 6.95; 95% CI, 1.1-45.1; P = .042) were far more predictive of rupture than aneurysm size (OR, 1.04; 95% CI, 1.01-1.08; P = .0042). The strongest predictor was type 4 Ehlers-Danlos syndrome (OR, 34.09; 95% CI, 2.4-479.8; P = .0089). Calcification, meanwhile, did not predict rupture, growth, or thrombus burden.

Dr. Corey and his colleagues reviewed Massachusetts General’s experience with SAAs because “no strong consensus exists in the literature concerning the indications for treatment; 2 cm is currently the indication for surgical treatment of asymptomatic lesions,” he said.

Two centimeters might be too aggressive in some cases. Among 176 aneurysms put under surveillance for a mean of 36.1 months, the mean aneurysm size was 16.3 mm but ranged up to 40 mm. Even so, none of them ruptured. Just 12 aneurysms grew during surveillance, and only 8 eventually needed intervention. Perhaps most “small asymptomatic lesions do not affect longevity,” Dr. Corey said. The mean aneurysm size was 31.1 mm in the 88 patients repaired within 6 months of diagnosis. Splenic, pancreaticoduodenal, gastroduodenal, and hepatic aneurysms were the most likely to be repaired early, the majority by coil embolization and other endovascular techniques. Thirty-day morbidity for intact repair was 13% and mortality 3%.

Most of the splenic artery aneurysms were asymptomatic at presentation. In the half that were watched, just six grew.

Similarly, 78 celiac artery aneurysms – the second most common in the study – all presented without symptoms. Just 3 of the 60 under surveillance grew over a mean of 43.6 months. “These aneurysms rarely change,” Dr. Corey said.

Most of the 34 hepatic artery aneurysms and 17 superior mesenteric artery (SMA) aneurysms were asymptomatic. Between both groups, 20 aneurysms were put under surveillance; growth was noted in 1, an SMA lesion.

Although there was a shift from open to endovascular repair during the study period, there were no statistically significant differences in morbidity or mortality between the two approaches.

Dr. Corey has no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Pancreaticoduodenal and gastroduodenal artery aneurysms should be repaired at diagnosis, according to Dr. Michael Corey, a vascular surgeon at Massachusetts General Hospital in Boston.

The reason is “they rupture at small sizes. Most other small splanchnic artery aneurysms” – below 25 mm – “do not grow or rupture over time and can safely undergo surveillance imaging every 3 years,” he said at a meeting hosted by the Society for Vascular Surgery.

The insights come from Dr. Corey’s review of 264 splanchnic artery aneurysms (SAAs) treated at Massachusetts General Hospital from 1994 to 2014 .

Pancreaticoduodenal (PDA) and gastroduodenal (GDA) artery aneurysms were the most likely to cause trouble. Almost all of the 36 in the study were associated with high-grade celiac axis stenosis, and 12 (33%) were symptomatic at presentation, including 7 (19%) that had ruptured at a mean size of 27.4 mm, range 15-48 mm.

Those 7 accounted for more than half of the 13 ruptures in the study. There were also five ruptures among 95 splenic artery aneurysms – the most common aneurysm type in the study – at a mean of 42 mm, and one among 34 hepatic artery aneurysms at 40 mm. Thirty-day morbidity after rupture repair was 54% and mortality 8%.

Pancreaticoduodenal (odds ratio, 14.41; 95% confidence interval, 3.5-59.9; P = .0002) and gastroduodenal artery aneurysms (OR, 6.95; 95% CI, 1.1-45.1; P = .042) were far more predictive of rupture than aneurysm size (OR, 1.04; 95% CI, 1.01-1.08; P = .0042). The strongest predictor was type 4 Ehlers-Danlos syndrome (OR, 34.09; 95% CI, 2.4-479.8; P = .0089). Calcification, meanwhile, did not predict rupture, growth, or thrombus burden.

Dr. Corey and his colleagues reviewed Massachusetts General’s experience with SAAs because “no strong consensus exists in the literature concerning the indications for treatment; 2 cm is currently the indication for surgical treatment of asymptomatic lesions,” he said.

Two centimeters might be too aggressive in some cases. Among 176 aneurysms put under surveillance for a mean of 36.1 months, the mean aneurysm size was 16.3 mm but ranged up to 40 mm. Even so, none of them ruptured. Just 12 aneurysms grew during surveillance, and only 8 eventually needed intervention. Perhaps most “small asymptomatic lesions do not affect longevity,” Dr. Corey said. The mean aneurysm size was 31.1 mm in the 88 patients repaired within 6 months of diagnosis. Splenic, pancreaticoduodenal, gastroduodenal, and hepatic aneurysms were the most likely to be repaired early, the majority by coil embolization and other endovascular techniques. Thirty-day morbidity for intact repair was 13% and mortality 3%.

Most of the splenic artery aneurysms were asymptomatic at presentation. In the half that were watched, just six grew.

Similarly, 78 celiac artery aneurysms – the second most common in the study – all presented without symptoms. Just 3 of the 60 under surveillance grew over a mean of 43.6 months. “These aneurysms rarely change,” Dr. Corey said.

Most of the 34 hepatic artery aneurysms and 17 superior mesenteric artery (SMA) aneurysms were asymptomatic. Between both groups, 20 aneurysms were put under surveillance; growth was noted in 1, an SMA lesion.

Although there was a shift from open to endovascular repair during the study period, there were no statistically significant differences in morbidity or mortality between the two approaches.

Dr. Corey has no disclosures.

aotto@frontlinemedcom.com

Transparency, until recently, was rarely associated with health care. Not anymore. For better and sometimes worse, there is a revolutionary movement toward transparency in all facets of health care: transparency of costs, outcomes, quality, service, and reputation. Full transparency now has come to medical records in the form of OpenNotes. This is a patient-centered initiative that allows patients full access to their chart including all their providers’ notes.

Patients always have had the right to see their record. Ordinarily though, they would be required to go to the medical records office, fill out paperwork, and request copies of their chart. They would have to supply a reason and often pay a fee. OpenNotes changes that. Open patient charts are free and easy to access, usually digitally. OpenNotes programs are still rare, and before we go any further, it’s important to examine what we’ve learned about them.

In 2010, Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle invited 105 primary care physicians to open their notes to nearly 14,000 patients. The results were overwhelmingly (and to me, surprisingly) positive: More than 85% of patients accessed their notes at least once. Nearly 100% of patients wanted the program to continue. Patients reported a better understanding of their medical issues, better medication adherence, increased adoption of healthy habits, and less anxiety about their health. I would have expected more confusion and anxiety among the patients.

What about the physicians? According to the initiative, whereas one in three patients thought they should have unfettered access to their physicians’ notes, only 1 in 10 physicians did. That’s understandable. The physicians in the pilot shared many of the same concerns you and I have, namely that OpenNotes would lead to an increased workload to explain esoteric notes to patients and to allay anxieties.

Yet, this extra workload didn’t occur. Only 3% of physicians reported spending more time answering patients’ questions, although one-fifth did report that they changed the language they used when writing notes, primarily to avoid offending patients. Every physician in the initiative said he or she would continue using OpenNotes. Surprised? So was I.

Even the usually conservative SERMO physician audience responded in an unexpected manner. According to a poll conducted this June, SERMO asked 2,300 physicians if patients should have access to their medical records (including physician notes). Forty-nine percent said “only on a case-by-case basis,” 34% said “yes, always,” and 17% said “no, never.”

So, are OpenNotes a success? Let’s take a closer look at some of the challenges. First, we physicians use language that will confuse patients at best and lead them to incorrect conclusions at worst. “Acne necrotica?” Not as bad as it sounds. Or consider, “differential diagnosis includes neuroendocrine tumor.” It doesn’t mean you have it, but some patients will believe they do. Will we have to dumb down our charts then to appease them? Won’t this degrade note quality, one of the primary objectives we are trying to avoid? It’s unclear.

The purpose of a patient note is to inform other providers and to remind ourselves of the critical information needed to care for a patient. It must be pithy and honest. It often reflects our inchoate thoughts as much as our diagnoses. It also must include the sundry requirements we know and love that are needed only to bill for the visit. These are not characteristics that make for a good patient read.

Indeed, the benefits of transparency are not limitless. In some instances, more transparency is worse. Imagine if all your emails and texts were transparent to everyone. Or if everything you’ve ever said about your mother-in-law was viewable by her. Clearly, bad transparency, bad transparency. Not sharing everything doesn’t mean we are dishonest or duplicitous. It means we are civil. It doesn’t mean we don’t care; it means we do care. We care about our friends and family. We care about our patients and the best way to make them well.

Unless we make it clear to patients that the notes they are viewing are not written for them, I’m worried simply opening charts could damage the doctor-patient relationship as much as it fosters it. Interestingly, there are companies trying to build a technical solution for this conundrum. Others are advocating for standardization of pathology and lab reports that are patient friendly. I’ll research these topics and let you know what I find out in a future column.

Perhaps I shouldn’t have been surprised by the positive results from the OpenNotes initiative. After all, for the last several years, I have given patients their actual pathology report for every biopsy I’ve done (which numbers in the many thousands). I have had fewer than five follow-up questions from patients that I can remember. Pretty much all were legitimate, as I recall, including a wrong site error in a report.

Today, more than 5 million patients have access to their providers’ notes on OpenNotes. That number will grow. Our biggest risk is to not be involved. “Just say no” didn’t work for Nancy Reagan; it won’t do our cause any good either.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Transparency, until recently, was rarely associated with health care. Not anymore. For better and sometimes worse, there is a revolutionary movement toward transparency in all facets of health care: transparency of costs, outcomes, quality, service, and reputation. Full transparency now has come to medical records in the form of OpenNotes. This is a patient-centered initiative that allows patients full access to their chart including all their providers’ notes.

Patients always have had the right to see their record. Ordinarily though, they would be required to go to the medical records office, fill out paperwork, and request copies of their chart. They would have to supply a reason and often pay a fee. OpenNotes changes that. Open patient charts are free and easy to access, usually digitally. OpenNotes programs are still rare, and before we go any further, it’s important to examine what we’ve learned about them.

In 2010, Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle invited 105 primary care physicians to open their notes to nearly 14,000 patients. The results were overwhelmingly (and to me, surprisingly) positive: More than 85% of patients accessed their notes at least once. Nearly 100% of patients wanted the program to continue. Patients reported a better understanding of their medical issues, better medication adherence, increased adoption of healthy habits, and less anxiety about their health. I would have expected more confusion and anxiety among the patients.

What about the physicians? According to the initiative, whereas one in three patients thought they should have unfettered access to their physicians’ notes, only 1 in 10 physicians did. That’s understandable. The physicians in the pilot shared many of the same concerns you and I have, namely that OpenNotes would lead to an increased workload to explain esoteric notes to patients and to allay anxieties.

Yet, this extra workload didn’t occur. Only 3% of physicians reported spending more time answering patients’ questions, although one-fifth did report that they changed the language they used when writing notes, primarily to avoid offending patients. Every physician in the initiative said he or she would continue using OpenNotes. Surprised? So was I.

Even the usually conservative SERMO physician audience responded in an unexpected manner. According to a poll conducted this June, SERMO asked 2,300 physicians if patients should have access to their medical records (including physician notes). Forty-nine percent said “only on a case-by-case basis,” 34% said “yes, always,” and 17% said “no, never.”

So, are OpenNotes a success? Let’s take a closer look at some of the challenges. First, we physicians use language that will confuse patients at best and lead them to incorrect conclusions at worst. “Acne necrotica?” Not as bad as it sounds. Or consider, “differential diagnosis includes neuroendocrine tumor.” It doesn’t mean you have it, but some patients will believe they do. Will we have to dumb down our charts then to appease them? Won’t this degrade note quality, one of the primary objectives we are trying to avoid? It’s unclear.

The purpose of a patient note is to inform other providers and to remind ourselves of the critical information needed to care for a patient. It must be pithy and honest. It often reflects our inchoate thoughts as much as our diagnoses. It also must include the sundry requirements we know and love that are needed only to bill for the visit. These are not characteristics that make for a good patient read.

Indeed, the benefits of transparency are not limitless. In some instances, more transparency is worse. Imagine if all your emails and texts were transparent to everyone. Or if everything you’ve ever said about your mother-in-law was viewable by her. Clearly, bad transparency, bad transparency. Not sharing everything doesn’t mean we are dishonest or duplicitous. It means we are civil. It doesn’t mean we don’t care; it means we do care. We care about our friends and family. We care about our patients and the best way to make them well.

Unless we make it clear to patients that the notes they are viewing are not written for them, I’m worried simply opening charts could damage the doctor-patient relationship as much as it fosters it. Interestingly, there are companies trying to build a technical solution for this conundrum. Others are advocating for standardization of pathology and lab reports that are patient friendly. I’ll research these topics and let you know what I find out in a future column.

Perhaps I shouldn’t have been surprised by the positive results from the OpenNotes initiative. After all, for the last several years, I have given patients their actual pathology report for every biopsy I’ve done (which numbers in the many thousands). I have had fewer than five follow-up questions from patients that I can remember. Pretty much all were legitimate, as I recall, including a wrong site error in a report.

Today, more than 5 million patients have access to their providers’ notes on OpenNotes. That number will grow. Our biggest risk is to not be involved. “Just say no” didn’t work for Nancy Reagan; it won’t do our cause any good either.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Transparency, until recently, was rarely associated with health care. Not anymore. For better and sometimes worse, there is a revolutionary movement toward transparency in all facets of health care: transparency of costs, outcomes, quality, service, and reputation. Full transparency now has come to medical records in the form of OpenNotes. This is a patient-centered initiative that allows patients full access to their chart including all their providers’ notes.

Patients always have had the right to see their record. Ordinarily though, they would be required to go to the medical records office, fill out paperwork, and request copies of their chart. They would have to supply a reason and often pay a fee. OpenNotes changes that. Open patient charts are free and easy to access, usually digitally. OpenNotes programs are still rare, and before we go any further, it’s important to examine what we’ve learned about them.

In 2010, Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle invited 105 primary care physicians to open their notes to nearly 14,000 patients. The results were overwhelmingly (and to me, surprisingly) positive: More than 85% of patients accessed their notes at least once. Nearly 100% of patients wanted the program to continue. Patients reported a better understanding of their medical issues, better medication adherence, increased adoption of healthy habits, and less anxiety about their health. I would have expected more confusion and anxiety among the patients.

What about the physicians? According to the initiative, whereas one in three patients thought they should have unfettered access to their physicians’ notes, only 1 in 10 physicians did. That’s understandable. The physicians in the pilot shared many of the same concerns you and I have, namely that OpenNotes would lead to an increased workload to explain esoteric notes to patients and to allay anxieties.

Yet, this extra workload didn’t occur. Only 3% of physicians reported spending more time answering patients’ questions, although one-fifth did report that they changed the language they used when writing notes, primarily to avoid offending patients. Every physician in the initiative said he or she would continue using OpenNotes. Surprised? So was I.

Even the usually conservative SERMO physician audience responded in an unexpected manner. According to a poll conducted this June, SERMO asked 2,300 physicians if patients should have access to their medical records (including physician notes). Forty-nine percent said “only on a case-by-case basis,” 34% said “yes, always,” and 17% said “no, never.”

So, are OpenNotes a success? Let’s take a closer look at some of the challenges. First, we physicians use language that will confuse patients at best and lead them to incorrect conclusions at worst. “Acne necrotica?” Not as bad as it sounds. Or consider, “differential diagnosis includes neuroendocrine tumor.” It doesn’t mean you have it, but some patients will believe they do. Will we have to dumb down our charts then to appease them? Won’t this degrade note quality, one of the primary objectives we are trying to avoid? It’s unclear.

The purpose of a patient note is to inform other providers and to remind ourselves of the critical information needed to care for a patient. It must be pithy and honest. It often reflects our inchoate thoughts as much as our diagnoses. It also must include the sundry requirements we know and love that are needed only to bill for the visit. These are not characteristics that make for a good patient read.

Indeed, the benefits of transparency are not limitless. In some instances, more transparency is worse. Imagine if all your emails and texts were transparent to everyone. Or if everything you’ve ever said about your mother-in-law was viewable by her. Clearly, bad transparency, bad transparency. Not sharing everything doesn’t mean we are dishonest or duplicitous. It means we are civil. It doesn’t mean we don’t care; it means we do care. We care about our friends and family. We care about our patients and the best way to make them well.

Unless we make it clear to patients that the notes they are viewing are not written for them, I’m worried simply opening charts could damage the doctor-patient relationship as much as it fosters it. Interestingly, there are companies trying to build a technical solution for this conundrum. Others are advocating for standardization of pathology and lab reports that are patient friendly. I’ll research these topics and let you know what I find out in a future column.

Perhaps I shouldn’t have been surprised by the positive results from the OpenNotes initiative. After all, for the last several years, I have given patients their actual pathology report for every biopsy I’ve done (which numbers in the many thousands). I have had fewer than five follow-up questions from patients that I can remember. Pretty much all were legitimate, as I recall, including a wrong site error in a report.

Today, more than 5 million patients have access to their providers’ notes on OpenNotes. That number will grow. Our biggest risk is to not be involved. “Just say no” didn’t work for Nancy Reagan; it won’t do our cause any good either.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

In the previous two editions of this column, I have written about the new Medicare Access and CHIP Reauthorization Act (MACRA) and the changes it will bring to Medicare physician payment beginning in January 2019 with the Merit-Based Incentive Payment System (MIPS). In June’s column, three of the four MIPS performance categories were outlined. Specifically, those include the Quality, Resource Use, and Electronic Health Record Meaningful Use components and encompass the Physician Quality Reporting System (PQRS), Value-Based Modifier (VBM), Physician Quality Reporting System (PQRS), and Electronic Health Record Meaningful Use (EHR-MU) programs with which Fellows are hopefully familiar. As promised, this month I will discuss the final performance category component, namely the Clinical Practice Improvement Activities (CPIA) as well as the Alternative Payment Models program (APMs). Lastly, I wish to bring to the attention of Fellows a new web-based resource developed by the ACS Division of Advocacy and Health Policy to assist them in avoiding current law Medicare penalties.

The CPIA are designed to assess and credit surgeons according to their effort toward improving their clinical practice OR their preparation toward participating in the APMs. The menu of specific, recognized activities will be established in collaboration with the Centers for Medicare & Medicaid Services and the providers to whom the activities will be applicable. Many of the specifics are yet to be determined and will be part of the rule-making process in coming years. However, the MACRA legislation specifies that the CPIA must be applicable to all specialties and be attainable for small practices and professionals in rural and underserved areas. To support the efforts of surgeons and other providers in small or rural practice, Congress set aside $20 million dollars for each year, 2016-2020, for technical assistance to support the efforts of practices with 15 or fewer professionals to improve MIPS performance or transition to APMs.

The new law takes concerted steps to incentivize and encourage the development of and participation in APMs. As with the CPIA outlined above, the details of APMs are not yet fully clear and will be established going forward. However, in general, these programs will base payment on quality measures, not volume or intensity, and will include an element of financial risk for providers. For those surgeons who receive a significant share of their revenue from an APM, an annual 5% bonus will be available for each of the years 2019-2024. To qualify for that bonus surgeons must receive 25% of their Medicare revenue from an APM in the years 2019 and 2020, with the requirement subsequently increasing to 50% in 2021 and ultimately to 75% beginning in 2023. Providers may qualify based on a combination of private APMs and Medicare APMs as well.

In recognition of the lack of APMs in many areas or applicability for many specialties, MACRA prioritizes development of models for small practices, models that are specialty specific, and model development in conjunction with private payers as well as Medicaid-based options, all with the ultimate goal of encouraging the development of new and innovative payment models. The legislative language in MACRA is broad enough that it may allow for creation of a model based on the ACS’ Clinical Affinity Group (CAG) concept whereby providers are grouped together based on the patients or conditions that they treat, not their specialty designation.

Surgeons who meet a threshold of payment received from a qualified APM will be exempted from participation in MIPS to include most EHR-MU requirements and also receive the 5% bonus as described above. Those who participate in an APM but fail to meet the threshold necessary to receive that bonus will receive credit for such in the CPIA portion of their MIPS composite score.

Finally, even though the permanent repeal of the SGR found in MACRA represents the successful culmination of long-standing, combined advocacy efforts of the American College of Surgeons (ACS) and other medical associations toward meaningful, future Medicare physician payment reform, Fellows should be well aware that the three current law Medicare quality programs, namely the PQRS, EHR-MU, and VBM and their corresponding requirements as well as their associated penalties remain in effect until January 2019.

Surgeons who do not successfully participate in the PQRS, EHR-MU, and VBM face significant penalties on future Medicare payments. Specifically, failure to meet the requirements imposed by these three programs in 2015 could result in total penalties of up to 9% in Medicare payments in 2017.

To assist Fellows in navigating the complexities of complying with current law quality program requirements and thus avoid Medicare penalties, the ACS Division of Advocacy and Health Policy has developed a new online interactive flowchart which can be found at [WEB ADDRESS]. Fellows may wish to refer to and bookmark this page as an ongoing reference in order to familiarize themselves with current law requirements, facilitate their individual compliance with same, and thus successfully avoid penalties. As always, Fellows with questions may contact the DAHP at 202-337-2701.

Until next month ….

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.

In the previous two editions of this column, I have written about the new Medicare Access and CHIP Reauthorization Act (MACRA) and the changes it will bring to Medicare physician payment beginning in January 2019 with the Merit-Based Incentive Payment System (MIPS). In June’s column, three of the four MIPS performance categories were outlined. Specifically, those include the Quality, Resource Use, and Electronic Health Record Meaningful Use components and encompass the Physician Quality Reporting System (PQRS), Value-Based Modifier (VBM), Physician Quality Reporting System (PQRS), and Electronic Health Record Meaningful Use (EHR-MU) programs with which Fellows are hopefully familiar. As promised, this month I will discuss the final performance category component, namely the Clinical Practice Improvement Activities (CPIA) as well as the Alternative Payment Models program (APMs). Lastly, I wish to bring to the attention of Fellows a new web-based resource developed by the ACS Division of Advocacy and Health Policy to assist them in avoiding current law Medicare penalties.

The CPIA are designed to assess and credit surgeons according to their effort toward improving their clinical practice OR their preparation toward participating in the APMs. The menu of specific, recognized activities will be established in collaboration with the Centers for Medicare & Medicaid Services and the providers to whom the activities will be applicable. Many of the specifics are yet to be determined and will be part of the rule-making process in coming years. However, the MACRA legislation specifies that the CPIA must be applicable to all specialties and be attainable for small practices and professionals in rural and underserved areas. To support the efforts of surgeons and other providers in small or rural practice, Congress set aside $20 million dollars for each year, 2016-2020, for technical assistance to support the efforts of practices with 15 or fewer professionals to improve MIPS performance or transition to APMs.

The new law takes concerted steps to incentivize and encourage the development of and participation in APMs. As with the CPIA outlined above, the details of APMs are not yet fully clear and will be established going forward. However, in general, these programs will base payment on quality measures, not volume or intensity, and will include an element of financial risk for providers. For those surgeons who receive a significant share of their revenue from an APM, an annual 5% bonus will be available for each of the years 2019-2024. To qualify for that bonus surgeons must receive 25% of their Medicare revenue from an APM in the years 2019 and 2020, with the requirement subsequently increasing to 50% in 2021 and ultimately to 75% beginning in 2023. Providers may qualify based on a combination of private APMs and Medicare APMs as well.

In recognition of the lack of APMs in many areas or applicability for many specialties, MACRA prioritizes development of models for small practices, models that are specialty specific, and model development in conjunction with private payers as well as Medicaid-based options, all with the ultimate goal of encouraging the development of new and innovative payment models. The legislative language in MACRA is broad enough that it may allow for creation of a model based on the ACS’ Clinical Affinity Group (CAG) concept whereby providers are grouped together based on the patients or conditions that they treat, not their specialty designation.

Surgeons who meet a threshold of payment received from a qualified APM will be exempted from participation in MIPS to include most EHR-MU requirements and also receive the 5% bonus as described above. Those who participate in an APM but fail to meet the threshold necessary to receive that bonus will receive credit for such in the CPIA portion of their MIPS composite score.

Finally, even though the permanent repeal of the SGR found in MACRA represents the successful culmination of long-standing, combined advocacy efforts of the American College of Surgeons (ACS) and other medical associations toward meaningful, future Medicare physician payment reform, Fellows should be well aware that the three current law Medicare quality programs, namely the PQRS, EHR-MU, and VBM and their corresponding requirements as well as their associated penalties remain in effect until January 2019.

Surgeons who do not successfully participate in the PQRS, EHR-MU, and VBM face significant penalties on future Medicare payments. Specifically, failure to meet the requirements imposed by these three programs in 2015 could result in total penalties of up to 9% in Medicare payments in 2017.

To assist Fellows in navigating the complexities of complying with current law quality program requirements and thus avoid Medicare penalties, the ACS Division of Advocacy and Health Policy has developed a new online interactive flowchart which can be found at [WEB ADDRESS]. Fellows may wish to refer to and bookmark this page as an ongoing reference in order to familiarize themselves with current law requirements, facilitate their individual compliance with same, and thus successfully avoid penalties. As always, Fellows with questions may contact the DAHP at 202-337-2701.

Until next month ….

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.

In the previous two editions of this column, I have written about the new Medicare Access and CHIP Reauthorization Act (MACRA) and the changes it will bring to Medicare physician payment beginning in January 2019 with the Merit-Based Incentive Payment System (MIPS). In June’s column, three of the four MIPS performance categories were outlined. Specifically, those include the Quality, Resource Use, and Electronic Health Record Meaningful Use components and encompass the Physician Quality Reporting System (PQRS), Value-Based Modifier (VBM), Physician Quality Reporting System (PQRS), and Electronic Health Record Meaningful Use (EHR-MU) programs with which Fellows are hopefully familiar. As promised, this month I will discuss the final performance category component, namely the Clinical Practice Improvement Activities (CPIA) as well as the Alternative Payment Models program (APMs). Lastly, I wish to bring to the attention of Fellows a new web-based resource developed by the ACS Division of Advocacy and Health Policy to assist them in avoiding current law Medicare penalties.

The CPIA are designed to assess and credit surgeons according to their effort toward improving their clinical practice OR their preparation toward participating in the APMs. The menu of specific, recognized activities will be established in collaboration with the Centers for Medicare & Medicaid Services and the providers to whom the activities will be applicable. Many of the specifics are yet to be determined and will be part of the rule-making process in coming years. However, the MACRA legislation specifies that the CPIA must be applicable to all specialties and be attainable for small practices and professionals in rural and underserved areas. To support the efforts of surgeons and other providers in small or rural practice, Congress set aside $20 million dollars for each year, 2016-2020, for technical assistance to support the efforts of practices with 15 or fewer professionals to improve MIPS performance or transition to APMs.

The new law takes concerted steps to incentivize and encourage the development of and participation in APMs. As with the CPIA outlined above, the details of APMs are not yet fully clear and will be established going forward. However, in general, these programs will base payment on quality measures, not volume or intensity, and will include an element of financial risk for providers. For those surgeons who receive a significant share of their revenue from an APM, an annual 5% bonus will be available for each of the years 2019-2024. To qualify for that bonus surgeons must receive 25% of their Medicare revenue from an APM in the years 2019 and 2020, with the requirement subsequently increasing to 50% in 2021 and ultimately to 75% beginning in 2023. Providers may qualify based on a combination of private APMs and Medicare APMs as well.

In recognition of the lack of APMs in many areas or applicability for many specialties, MACRA prioritizes development of models for small practices, models that are specialty specific, and model development in conjunction with private payers as well as Medicaid-based options, all with the ultimate goal of encouraging the development of new and innovative payment models. The legislative language in MACRA is broad enough that it may allow for creation of a model based on the ACS’ Clinical Affinity Group (CAG) concept whereby providers are grouped together based on the patients or conditions that they treat, not their specialty designation.

Surgeons who meet a threshold of payment received from a qualified APM will be exempted from participation in MIPS to include most EHR-MU requirements and also receive the 5% bonus as described above. Those who participate in an APM but fail to meet the threshold necessary to receive that bonus will receive credit for such in the CPIA portion of their MIPS composite score.

Finally, even though the permanent repeal of the SGR found in MACRA represents the successful culmination of long-standing, combined advocacy efforts of the American College of Surgeons (ACS) and other medical associations toward meaningful, future Medicare physician payment reform, Fellows should be well aware that the three current law Medicare quality programs, namely the PQRS, EHR-MU, and VBM and their corresponding requirements as well as their associated penalties remain in effect until January 2019.

Surgeons who do not successfully participate in the PQRS, EHR-MU, and VBM face significant penalties on future Medicare payments. Specifically, failure to meet the requirements imposed by these three programs in 2015 could result in total penalties of up to 9% in Medicare payments in 2017.

To assist Fellows in navigating the complexities of complying with current law quality program requirements and thus avoid Medicare penalties, the ACS Division of Advocacy and Health Policy has developed a new online interactive flowchart which can be found at [WEB ADDRESS]. Fellows may wish to refer to and bookmark this page as an ongoing reference in order to familiarize themselves with current law requirements, facilitate their individual compliance with same, and thus successfully avoid penalties. As always, Fellows with questions may contact the DAHP at 202-337-2701.

Until next month ….

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.