The FP advised the patient that she had keratoconus, a condition in which the cornea bulges out in the middle (like a cone). Keratoconus, which can adversely affect the health of the eye, is one of several eye findings related to atopic dermatitis. Others include recurrent conjunctivitis, cataracts, and periorbital darkening.

The patient in this case was referred to her ophthalmologist for further evaluation and the FP advised her to avoid rubbing her eyes. In some severe cases, keratoconus treatment requires corneal transplantation.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Finklea L. Atopic dermatitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:584-590.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The FP advised the patient that she had keratoconus, a condition in which the cornea bulges out in the middle (like a cone). Keratoconus, which can adversely affect the health of the eye, is one of several eye findings related to atopic dermatitis. Others include recurrent conjunctivitis, cataracts, and periorbital darkening.

The patient in this case was referred to her ophthalmologist for further evaluation and the FP advised her to avoid rubbing her eyes. In some severe cases, keratoconus treatment requires corneal transplantation.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Finklea L. Atopic dermatitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:584-590.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The FP advised the patient that she had keratoconus, a condition in which the cornea bulges out in the middle (like a cone). Keratoconus, which can adversely affect the health of the eye, is one of several eye findings related to atopic dermatitis. Others include recurrent conjunctivitis, cataracts, and periorbital darkening.

The patient in this case was referred to her ophthalmologist for further evaluation and the FP advised her to avoid rubbing her eyes. In some severe cases, keratoconus treatment requires corneal transplantation.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Finklea L. Atopic dermatitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:584-590.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

Eating breakfast is sometimes promulgated as a component of an effective weight loss strategy. Correlational studies have suggested that breakfast consumption is associated with lower body weight. As the thinking goes, breakfast promotes morning satiety, thus suppressing caloric intake later in the day. Skipping breakfast, however, results in increased caloric intake later in the day.

But most people are breakfast eaters. Data exist suggesting that the adverse effects of skipping breakfast may occur only in habitual breakfast eaters. In other words, it may be harmful only if you suddenly change your habits.

So, what should we be telling our “breakfast-skippers” about breakfast and weight loss?

Gabrielle LeCheminant and her colleagues conducted a randomized trial of habitual breakfast skippers to evaluate the effects of eating breakfast versus not on energy, macronutrient consumption, and physical activity over 1 month (Appetite. 2017 May 1. doi: 10.1016/j.appet.2016.12.041).

Subjects were required to eat within 90 minutes of waking up and finish eating by 8:30 a.m. No eating or snack restrictions were imposed after breakfast. Subjects were 18-55 years of age, ate breakfast (at least 2 days/week), slept at least 6 hours per night, and woke up consistently before 8:00 am. Biometric and food diaries were completed.

Dr. Ebbert is a professor of medicine and general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

Eating breakfast is sometimes promulgated as a component of an effective weight loss strategy. Correlational studies have suggested that breakfast consumption is associated with lower body weight. As the thinking goes, breakfast promotes morning satiety, thus suppressing caloric intake later in the day. Skipping breakfast, however, results in increased caloric intake later in the day.

But most people are breakfast eaters. Data exist suggesting that the adverse effects of skipping breakfast may occur only in habitual breakfast eaters. In other words, it may be harmful only if you suddenly change your habits.

So, what should we be telling our “breakfast-skippers” about breakfast and weight loss?

Gabrielle LeCheminant and her colleagues conducted a randomized trial of habitual breakfast skippers to evaluate the effects of eating breakfast versus not on energy, macronutrient consumption, and physical activity over 1 month (Appetite. 2017 May 1. doi: 10.1016/j.appet.2016.12.041).

Subjects were required to eat within 90 minutes of waking up and finish eating by 8:30 a.m. No eating or snack restrictions were imposed after breakfast. Subjects were 18-55 years of age, ate breakfast (at least 2 days/week), slept at least 6 hours per night, and woke up consistently before 8:00 am. Biometric and food diaries were completed.

Dr. Ebbert is a professor of medicine and general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

Eating breakfast is sometimes promulgated as a component of an effective weight loss strategy. Correlational studies have suggested that breakfast consumption is associated with lower body weight. As the thinking goes, breakfast promotes morning satiety, thus suppressing caloric intake later in the day. Skipping breakfast, however, results in increased caloric intake later in the day.

But most people are breakfast eaters. Data exist suggesting that the adverse effects of skipping breakfast may occur only in habitual breakfast eaters. In other words, it may be harmful only if you suddenly change your habits.

So, what should we be telling our “breakfast-skippers” about breakfast and weight loss?

Gabrielle LeCheminant and her colleagues conducted a randomized trial of habitual breakfast skippers to evaluate the effects of eating breakfast versus not on energy, macronutrient consumption, and physical activity over 1 month (Appetite. 2017 May 1. doi: 10.1016/j.appet.2016.12.041).

Subjects were required to eat within 90 minutes of waking up and finish eating by 8:30 a.m. No eating or snack restrictions were imposed after breakfast. Subjects were 18-55 years of age, ate breakfast (at least 2 days/week), slept at least 6 hours per night, and woke up consistently before 8:00 am. Biometric and food diaries were completed.

Dr. Ebbert is a professor of medicine and general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

Oral baricitinib, when added to standard rheumatoid arthritis treatment, improved symptoms and slowed the progression of joint damage, compared with both placebo and adalimumab, according to a report published online Feb. 15 in the New England Journal of Medicine.

The JAK inhibitor’s beneficial effects were noted as early as the first week of treatment and persisted throughout 1 year of follow-up in an international manufacturer-sponsored phase III trial (RA-BEAM) involving 1,305 adults with moderate to severe active rheumatoid arthritis (RA). The study participants had not responded to methotrexate and had never been treated with biologics; the majority had previously received at least two conventional synthetic disease-modifying antirheumatic drugs (DMARDs), said Peter C. Taylor, MD, PhD, of the Nuffield Department of Orthopedics, Rheumatology, and Musculoskeletal Sciences and the Kennedy Institute of Rheumatology at the University of Oxford (England), and his associates.

Oral baricitinib, when added to standard rheumatoid arthritis treatment, improved symptoms and slowed the progression of joint damage, compared with both placebo and adalimumab, according to a report published online Feb. 15 in the New England Journal of Medicine.

The JAK inhibitor’s beneficial effects were noted as early as the first week of treatment and persisted throughout 1 year of follow-up in an international manufacturer-sponsored phase III trial (RA-BEAM) involving 1,305 adults with moderate to severe active rheumatoid arthritis (RA). The study participants had not responded to methotrexate and had never been treated with biologics; the majority had previously received at least two conventional synthetic disease-modifying antirheumatic drugs (DMARDs), said Peter C. Taylor, MD, PhD, of the Nuffield Department of Orthopedics, Rheumatology, and Musculoskeletal Sciences and the Kennedy Institute of Rheumatology at the University of Oxford (England), and his associates.

Oral baricitinib, when added to standard rheumatoid arthritis treatment, improved symptoms and slowed the progression of joint damage, compared with both placebo and adalimumab, according to a report published online Feb. 15 in the New England Journal of Medicine.

The JAK inhibitor’s beneficial effects were noted as early as the first week of treatment and persisted throughout 1 year of follow-up in an international manufacturer-sponsored phase III trial (RA-BEAM) involving 1,305 adults with moderate to severe active rheumatoid arthritis (RA). The study participants had not responded to methotrexate and had never been treated with biologics; the majority had previously received at least two conventional synthetic disease-modifying antirheumatic drugs (DMARDs), said Peter C. Taylor, MD, PhD, of the Nuffield Department of Orthopedics, Rheumatology, and Musculoskeletal Sciences and the Kennedy Institute of Rheumatology at the University of Oxford (England), and his associates.

Among periviable infants born at 11 tertiary care centers in 2000 through 2011, the rate of survival without neurodevelopmental impairment increased a small but significant 4%, according to a report published online Feb. 16 in the New England Journal of Medicine.

The rate of survival with neurodevelopmental impairment also increased, although to a lesser extent (1%).

herjua/Thinkstock

This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, the National Center for Research Resources, and the National Center for Advancing Translational Sciences for the Neonatal Research Network’s Generic Database and Follow-up Studies. Dr. Younge reported having no relevant financial disclosures; two of her associates reported ties to Pediatrix Medical Group and rEVO Biologics.

Among periviable infants born at 11 tertiary care centers in 2000 through 2011, the rate of survival without neurodevelopmental impairment increased a small but significant 4%, according to a report published online Feb. 16 in the New England Journal of Medicine.

The rate of survival with neurodevelopmental impairment also increased, although to a lesser extent (1%).

herjua/Thinkstock

This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, the National Center for Research Resources, and the National Center for Advancing Translational Sciences for the Neonatal Research Network’s Generic Database and Follow-up Studies. Dr. Younge reported having no relevant financial disclosures; two of her associates reported ties to Pediatrix Medical Group and rEVO Biologics.

Among periviable infants born at 11 tertiary care centers in 2000 through 2011, the rate of survival without neurodevelopmental impairment increased a small but significant 4%, according to a report published online Feb. 16 in the New England Journal of Medicine.

The rate of survival with neurodevelopmental impairment also increased, although to a lesser extent (1%).

herjua/Thinkstock

This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, the National Center for Research Resources, and the National Center for Advancing Translational Sciences for the Neonatal Research Network’s Generic Database and Follow-up Studies. Dr. Younge reported having no relevant financial disclosures; two of her associates reported ties to Pediatrix Medical Group and rEVO Biologics.

ORLANDO – Some people with advanced kidney cancer who respond to immune checkpoint inhibitor therapy and subsequently stop because of immune-related adverse events may continue to see a clinical benefit for 6 months or longer, a retrospective, multicenter study reveals.

In fact, investigators labeled 42% of 19 patients with metastatic renal cell carcinoma (mRCC) “durable responders” to checkpoint inhibitor blockade. “What we’ve demonstrated is that, despite patients stopping their treatment, there is a subset who continue to have disease in check and controlled despite [their] not being on any therapy,” Rana R. McKay, MD, of the University of California, San Diego, said.

“Our subset was small, only 19 patients, so the next step is to validate our findings in larger study, and actually conduct a prospective trial to assess if discontinuation of therapy is worthwhile to investigate in this population,” Dr. McKay said during a press briefing prior to the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.

PD-1/PDL-1 inhibitors demonstrate efficacy against an expanding list of malignancies, Dr. McKay said. The current standard is to administer these agents on a continuous basis until cancer progression or toxicity occurs. However, the study raises the possibility of intentionally discontinuing their use in some patients in the future, primarily because PD-1/PD-L1 inhibitors are associated with a wide range of side effects. Most concerning are immune-related adverse events “which are thought to be due to immune system activation,” she said.

“These drugs work to reinvigorate the immune response, and one of the unintended consequences is … they may also elicit an autoimmune response against one or more organs in the body,” said Sumanta Pal, MD, of City of Hope Medical Center in Duarte, Calif. and moderator of the press briefing.

“There was a wide spectrum of adverse events affecting different organ systems,” Dr. McKay said, “including pneumonitis, myositis, nephritis, hepatitis, pericarditis, and myocarditis, just to name a few.” A total of 84% of patients required steroids to treat immune-related adverse events, 11% needed additional immunosuppressant agents to treat their symptoms, and 53% have ongoing toxicity.

“If a patient has immune-related side effects, the impact can be serious,” Dr. Pal said. “This [study] certainly supports the premise that those individuals who experience immune related side effects could have a tangible benefit from the drug nonetheless.”

Median patient age was 68 years, 74% were male and 26% had aggressive disease. In the durable responders group, the median time on treatment was 11 months and median time off treatment was 20 months. In contrast, the patients whose cancer worsened immediately after therapy cessation were treated a median 4 months and were off treatment a median of only 2 months. A total of 63% received either PD-1 or PD-L1 monotherapy and the remainder received one of these inhibitors in combination with other systemic therapies.

Prospective studies are warranted to determine approaches to customize immunotherapy based on response, Dr. McKay said. A phase II study is planned to assess optimized management of nivolumab therapy based on response in patients with mRCC, she added

op@frontlinemedcom.com

ORLANDO – Some people with advanced kidney cancer who respond to immune checkpoint inhibitor therapy and subsequently stop because of immune-related adverse events may continue to see a clinical benefit for 6 months or longer, a retrospective, multicenter study reveals.

In fact, investigators labeled 42% of 19 patients with metastatic renal cell carcinoma (mRCC) “durable responders” to checkpoint inhibitor blockade. “What we’ve demonstrated is that, despite patients stopping their treatment, there is a subset who continue to have disease in check and controlled despite [their] not being on any therapy,” Rana R. McKay, MD, of the University of California, San Diego, said.

“Our subset was small, only 19 patients, so the next step is to validate our findings in larger study, and actually conduct a prospective trial to assess if discontinuation of therapy is worthwhile to investigate in this population,” Dr. McKay said during a press briefing prior to the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.

PD-1/PDL-1 inhibitors demonstrate efficacy against an expanding list of malignancies, Dr. McKay said. The current standard is to administer these agents on a continuous basis until cancer progression or toxicity occurs. However, the study raises the possibility of intentionally discontinuing their use in some patients in the future, primarily because PD-1/PD-L1 inhibitors are associated with a wide range of side effects. Most concerning are immune-related adverse events “which are thought to be due to immune system activation,” she said.

“These drugs work to reinvigorate the immune response, and one of the unintended consequences is … they may also elicit an autoimmune response against one or more organs in the body,” said Sumanta Pal, MD, of City of Hope Medical Center in Duarte, Calif. and moderator of the press briefing.

“There was a wide spectrum of adverse events affecting different organ systems,” Dr. McKay said, “including pneumonitis, myositis, nephritis, hepatitis, pericarditis, and myocarditis, just to name a few.” A total of 84% of patients required steroids to treat immune-related adverse events, 11% needed additional immunosuppressant agents to treat their symptoms, and 53% have ongoing toxicity.

“If a patient has immune-related side effects, the impact can be serious,” Dr. Pal said. “This [study] certainly supports the premise that those individuals who experience immune related side effects could have a tangible benefit from the drug nonetheless.”

Median patient age was 68 years, 74% were male and 26% had aggressive disease. In the durable responders group, the median time on treatment was 11 months and median time off treatment was 20 months. In contrast, the patients whose cancer worsened immediately after therapy cessation were treated a median 4 months and were off treatment a median of only 2 months. A total of 63% received either PD-1 or PD-L1 monotherapy and the remainder received one of these inhibitors in combination with other systemic therapies.

Prospective studies are warranted to determine approaches to customize immunotherapy based on response, Dr. McKay said. A phase II study is planned to assess optimized management of nivolumab therapy based on response in patients with mRCC, she added

op@frontlinemedcom.com

ORLANDO – Some people with advanced kidney cancer who respond to immune checkpoint inhibitor therapy and subsequently stop because of immune-related adverse events may continue to see a clinical benefit for 6 months or longer, a retrospective, multicenter study reveals.

In fact, investigators labeled 42% of 19 patients with metastatic renal cell carcinoma (mRCC) “durable responders” to checkpoint inhibitor blockade. “What we’ve demonstrated is that, despite patients stopping their treatment, there is a subset who continue to have disease in check and controlled despite [their] not being on any therapy,” Rana R. McKay, MD, of the University of California, San Diego, said.

“Our subset was small, only 19 patients, so the next step is to validate our findings in larger study, and actually conduct a prospective trial to assess if discontinuation of therapy is worthwhile to investigate in this population,” Dr. McKay said during a press briefing prior to the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.

PD-1/PDL-1 inhibitors demonstrate efficacy against an expanding list of malignancies, Dr. McKay said. The current standard is to administer these agents on a continuous basis until cancer progression or toxicity occurs. However, the study raises the possibility of intentionally discontinuing their use in some patients in the future, primarily because PD-1/PD-L1 inhibitors are associated with a wide range of side effects. Most concerning are immune-related adverse events “which are thought to be due to immune system activation,” she said.

“These drugs work to reinvigorate the immune response, and one of the unintended consequences is … they may also elicit an autoimmune response against one or more organs in the body,” said Sumanta Pal, MD, of City of Hope Medical Center in Duarte, Calif. and moderator of the press briefing.

“There was a wide spectrum of adverse events affecting different organ systems,” Dr. McKay said, “including pneumonitis, myositis, nephritis, hepatitis, pericarditis, and myocarditis, just to name a few.” A total of 84% of patients required steroids to treat immune-related adverse events, 11% needed additional immunosuppressant agents to treat their symptoms, and 53% have ongoing toxicity.

“If a patient has immune-related side effects, the impact can be serious,” Dr. Pal said. “This [study] certainly supports the premise that those individuals who experience immune related side effects could have a tangible benefit from the drug nonetheless.”

Median patient age was 68 years, 74% were male and 26% had aggressive disease. In the durable responders group, the median time on treatment was 11 months and median time off treatment was 20 months. In contrast, the patients whose cancer worsened immediately after therapy cessation were treated a median 4 months and were off treatment a median of only 2 months. A total of 63% received either PD-1 or PD-L1 monotherapy and the remainder received one of these inhibitors in combination with other systemic therapies.

Prospective studies are warranted to determine approaches to customize immunotherapy based on response, Dr. McKay said. A phase II study is planned to assess optimized management of nivolumab therapy based on response in patients with mRCC, she added

op@frontlinemedcom.com

Proposed regulations from the Centers for Medicare & Medicaid Services aim to provide short-term stabilization to the individual and small group insurance markets under the Affordable Care Act.

The proposal issued Feb. 15 would make changes to special enrollment periods, open enrollment, guaranteed availability, network adequacy rules, essential community providers, and actuarial value requirements. It also changes the timeline for when insurers would need to get their qualified health plan certification. It represents a first step toward fulfilling President Trump’s Inauguration Day executive order to “minimize the unwarranted economic and regulatory burdens of the [ACA], and prepare to afford the states more flexibility and control to create a more free and open health care market.”

tupungato/Thinkstock

Proposed regulations from the Centers for Medicare & Medicaid Services aim to provide short-term stabilization to the individual and small group insurance markets under the Affordable Care Act.

The proposal issued Feb. 15 would make changes to special enrollment periods, open enrollment, guaranteed availability, network adequacy rules, essential community providers, and actuarial value requirements. It also changes the timeline for when insurers would need to get their qualified health plan certification. It represents a first step toward fulfilling President Trump’s Inauguration Day executive order to “minimize the unwarranted economic and regulatory burdens of the [ACA], and prepare to afford the states more flexibility and control to create a more free and open health care market.”

tupungato/Thinkstock

Proposed regulations from the Centers for Medicare & Medicaid Services aim to provide short-term stabilization to the individual and small group insurance markets under the Affordable Care Act.

The proposal issued Feb. 15 would make changes to special enrollment periods, open enrollment, guaranteed availability, network adequacy rules, essential community providers, and actuarial value requirements. It also changes the timeline for when insurers would need to get their qualified health plan certification. It represents a first step toward fulfilling President Trump’s Inauguration Day executive order to “minimize the unwarranted economic and regulatory burdens of the [ACA], and prepare to afford the states more flexibility and control to create a more free and open health care market.”

tupungato/Thinkstock

A wide range of attitudes and practices for the process of withdrawing medications in pediatric patients with clinically inactive juvenile idiopathic arthritis (JIA) exist among clinician members of the Childhood Arthritis and Rheumatology Research Alliance (CARRA), according to findings from an anonymous survey.

The cross-sectional, electronic survey found that respondents varied in the amount of time they thought was necessary to spend in clinically inactive disease before beginning withdrawal of medications and in the amount of time to spend during tapering or stopping medications, for both methotrexate and biologics.

• JIA duration before attaining clinically inactive disease.
• Patient/family preferences.
• Presence of JIA-related damage.
• JIA category.

The factors that consistently appeared in responses fit into three clusters that included JIA features and time spent in clinically inactive disease (JIA category and total disease duration), JIA severity and resistance to treatment (disease duration before clinically inactive disease, number of drugs needed to attain inactivity, joint damage, and a history of sacroiliac or temporomandibular disease), and the patient’s experience (drug toxicity and family preference).

The respondents indicated that they would be least likely to stop medications for children with rheumatoid factor (RF)–positive polyarthritis (85%), which is “consistent with prior studies showing that RF-positive polyarthritis is associated with higher rates of flares than other JIA categories,” the investigators wrote. However, respondents said they would be most likely to stop medications for children with persistent oligoarthritis (87%) “even though rates of flares in this category appear similar to other JIA types. This method may reflect a belief that flares in children with persistent oligoarticular JIA will be less severe and easier to control.”

When patients met all criteria for clinically inactive disease for a “sufficient amount of time” and families were interested in stopping medications, some factors continued to make respondents reluctant to withdraw medications. These factors were most often a history of erosions (81%), asymptomatic joint abnormalities on ultrasound or MRI (72%), and failure of multiple prior disease-modifying antirheumatic drugs or biologics to control disease (64%). The definition of clinically inactive disease is a composite of no active arthritis, uveitis, or systemic JIA symptoms; the best possible clinical global assessment; inflammatory markers normal or elevated for reasons other than JIA; and no more than 15 minutes of joint stiffness.

A little over half of respondents said they would wait until clinically inactive disease had lasted 12 months before considering stopping or tapering methotrexate or biologic monotherapy, but a substantial minority said they would wait for only 6 months for methotrexate (31%) or biologic monotherapy (23%). A smaller number would wait for 18 months for methotrexate (13%) or biologics (18%), and another 3%-5% said they could not give a time frame.

The strategies varied for how actual withdrawing of medications occurred. Most methotrexate monotherapy withdrawals involved tapering over 2-6 months, one-third over longer periods, and the fewest reported tapering for less than 2 months (7%) or immediate withdrawal (17%).

Withdrawal of biologics was generally said to occur more gradually than with methotrexate, with one-third of respondents citing over 2-6 months, a quarter more slowly, and another 29% in less than 2 months or immediately. Some wrote that they preferred spacing out the interval between doses, but none decreased the dose. When children took combination therapy with methotrexate plus a biologic, 63% said that they began tapering or stopping methotrexate first, but a quarter said that the order was strongly context dependent, and the most commonly cited reason for deciding was history of toxicity or intolerance.

Imaging played a role in less than half of the decisions to withdraw medications, with it being used often by 9% and sometimes by 36%. And while it’s assumed that patients and family consideration played an important role in decision making, only 25% of respondents reported using specific patient-reported outcomes in deciding to withdraw medications.

The study was funded by grants from Rutgers Biomedical and Health Sciences and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

jevans@frontlinemedcom.com

A wide range of attitudes and practices for the process of withdrawing medications in pediatric patients with clinically inactive juvenile idiopathic arthritis (JIA) exist among clinician members of the Childhood Arthritis and Rheumatology Research Alliance (CARRA), according to findings from an anonymous survey.

The cross-sectional, electronic survey found that respondents varied in the amount of time they thought was necessary to spend in clinically inactive disease before beginning withdrawal of medications and in the amount of time to spend during tapering or stopping medications, for both methotrexate and biologics.

• JIA duration before attaining clinically inactive disease.
• Patient/family preferences.
• Presence of JIA-related damage.
• JIA category.

The factors that consistently appeared in responses fit into three clusters that included JIA features and time spent in clinically inactive disease (JIA category and total disease duration), JIA severity and resistance to treatment (disease duration before clinically inactive disease, number of drugs needed to attain inactivity, joint damage, and a history of sacroiliac or temporomandibular disease), and the patient’s experience (drug toxicity and family preference).

The respondents indicated that they would be least likely to stop medications for children with rheumatoid factor (RF)–positive polyarthritis (85%), which is “consistent with prior studies showing that RF-positive polyarthritis is associated with higher rates of flares than other JIA categories,” the investigators wrote. However, respondents said they would be most likely to stop medications for children with persistent oligoarthritis (87%) “even though rates of flares in this category appear similar to other JIA types. This method may reflect a belief that flares in children with persistent oligoarticular JIA will be less severe and easier to control.”

When patients met all criteria for clinically inactive disease for a “sufficient amount of time” and families were interested in stopping medications, some factors continued to make respondents reluctant to withdraw medications. These factors were most often a history of erosions (81%), asymptomatic joint abnormalities on ultrasound or MRI (72%), and failure of multiple prior disease-modifying antirheumatic drugs or biologics to control disease (64%). The definition of clinically inactive disease is a composite of no active arthritis, uveitis, or systemic JIA symptoms; the best possible clinical global assessment; inflammatory markers normal or elevated for reasons other than JIA; and no more than 15 minutes of joint stiffness.

A little over half of respondents said they would wait until clinically inactive disease had lasted 12 months before considering stopping or tapering methotrexate or biologic monotherapy, but a substantial minority said they would wait for only 6 months for methotrexate (31%) or biologic monotherapy (23%). A smaller number would wait for 18 months for methotrexate (13%) or biologics (18%), and another 3%-5% said they could not give a time frame.

The strategies varied for how actual withdrawing of medications occurred. Most methotrexate monotherapy withdrawals involved tapering over 2-6 months, one-third over longer periods, and the fewest reported tapering for less than 2 months (7%) or immediate withdrawal (17%).

Withdrawal of biologics was generally said to occur more gradually than with methotrexate, with one-third of respondents citing over 2-6 months, a quarter more slowly, and another 29% in less than 2 months or immediately. Some wrote that they preferred spacing out the interval between doses, but none decreased the dose. When children took combination therapy with methotrexate plus a biologic, 63% said that they began tapering or stopping methotrexate first, but a quarter said that the order was strongly context dependent, and the most commonly cited reason for deciding was history of toxicity or intolerance.

Imaging played a role in less than half of the decisions to withdraw medications, with it being used often by 9% and sometimes by 36%. And while it’s assumed that patients and family consideration played an important role in decision making, only 25% of respondents reported using specific patient-reported outcomes in deciding to withdraw medications.

The study was funded by grants from Rutgers Biomedical and Health Sciences and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

jevans@frontlinemedcom.com

A wide range of attitudes and practices for the process of withdrawing medications in pediatric patients with clinically inactive juvenile idiopathic arthritis (JIA) exist among clinician members of the Childhood Arthritis and Rheumatology Research Alliance (CARRA), according to findings from an anonymous survey.

The cross-sectional, electronic survey found that respondents varied in the amount of time they thought was necessary to spend in clinically inactive disease before beginning withdrawal of medications and in the amount of time to spend during tapering or stopping medications, for both methotrexate and biologics.

• JIA duration before attaining clinically inactive disease.
• Patient/family preferences.
• Presence of JIA-related damage.
• JIA category.

The factors that consistently appeared in responses fit into three clusters that included JIA features and time spent in clinically inactive disease (JIA category and total disease duration), JIA severity and resistance to treatment (disease duration before clinically inactive disease, number of drugs needed to attain inactivity, joint damage, and a history of sacroiliac or temporomandibular disease), and the patient’s experience (drug toxicity and family preference).

The respondents indicated that they would be least likely to stop medications for children with rheumatoid factor (RF)–positive polyarthritis (85%), which is “consistent with prior studies showing that RF-positive polyarthritis is associated with higher rates of flares than other JIA categories,” the investigators wrote. However, respondents said they would be most likely to stop medications for children with persistent oligoarthritis (87%) “even though rates of flares in this category appear similar to other JIA types. This method may reflect a belief that flares in children with persistent oligoarticular JIA will be less severe and easier to control.”

When patients met all criteria for clinically inactive disease for a “sufficient amount of time” and families were interested in stopping medications, some factors continued to make respondents reluctant to withdraw medications. These factors were most often a history of erosions (81%), asymptomatic joint abnormalities on ultrasound or MRI (72%), and failure of multiple prior disease-modifying antirheumatic drugs or biologics to control disease (64%). The definition of clinically inactive disease is a composite of no active arthritis, uveitis, or systemic JIA symptoms; the best possible clinical global assessment; inflammatory markers normal or elevated for reasons other than JIA; and no more than 15 minutes of joint stiffness.

A little over half of respondents said they would wait until clinically inactive disease had lasted 12 months before considering stopping or tapering methotrexate or biologic monotherapy, but a substantial minority said they would wait for only 6 months for methotrexate (31%) or biologic monotherapy (23%). A smaller number would wait for 18 months for methotrexate (13%) or biologics (18%), and another 3%-5% said they could not give a time frame.

The strategies varied for how actual withdrawing of medications occurred. Most methotrexate monotherapy withdrawals involved tapering over 2-6 months, one-third over longer periods, and the fewest reported tapering for less than 2 months (7%) or immediate withdrawal (17%).

Withdrawal of biologics was generally said to occur more gradually than with methotrexate, with one-third of respondents citing over 2-6 months, a quarter more slowly, and another 29% in less than 2 months or immediately. Some wrote that they preferred spacing out the interval between doses, but none decreased the dose. When children took combination therapy with methotrexate plus a biologic, 63% said that they began tapering or stopping methotrexate first, but a quarter said that the order was strongly context dependent, and the most commonly cited reason for deciding was history of toxicity or intolerance.

Imaging played a role in less than half of the decisions to withdraw medications, with it being used often by 9% and sometimes by 36%. And while it’s assumed that patients and family consideration played an important role in decision making, only 25% of respondents reported using specific patient-reported outcomes in deciding to withdraw medications.

The study was funded by grants from Rutgers Biomedical and Health Sciences and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

jevans@frontlinemedcom.com

The Medicare Access and Chips Reauthorization Act (MACRA) is now law; it passed with bipartisan, virtually unanimous support in both chambers of Congress. MACRA replaced the Sustainable Growth Rate formula for physician reimbursement and replaced it with a pathway to value-based payment. This law will alter our practices more than the Affordable Care Act and to an extent not seen since the passage of the original Medicare Act. Practices that continue to hang on to our traditional colonoscopy-based fee-for-service reimbursement model will increasingly be marginalized (or discounted) by Medicare, commercial payers, and regional health systems. To thrive in the coming decade, innovative practices will move toward alternative payment models. Many practices have risk-linked bundled payments for colonoscopy, but this step is only for the interim. Long-term success will come to practices that understand the implications of episode payments, specialty medical homes, and total cost of care. Do not wait for the finances to magically appear – start now to build infrastructure. In this month’s article, Dr. Mehta provides a detailed description of how a practice might construct a bundled payment for a common inpatient disorder. No one is paying for this yet, but it will come. Now is not the time to be a “WIMP” (Gastroenterology. 2016;150:295-9).

John I. Allen, MD, MBA, AGAF

Editor in Chief

In January 2016, the Centers for Medicare & Medicaid Services (CMS) launched the Comprehensive Care for Joint Replacement (CJR) model. This payment model aims to improve the value of care provided to Medicare beneficiaries for hip and knee replacement surgery during the inpatient stay and 90-day period after discharge by holding hospitals accountable for cost and quality.¹ It includes hospitals in 67 geographic areas across the United States and marks the first time that a postacute bundled payment model is mandatory for traditional Medicare patients. Although this may not seem to be relevant for gastroenterology, it marks an important signal by CMS that there will likely be more episode-payment models in the future.

Inpatient and postacute bundled payments

A bundled payment refers to a situation in which hospitals and physicians are incentivized to coordinate care for an episode of care across the continuum and eliminate unnecessary spending. In 1983, Medicare initiated a type of bundled payment for Part A spending on inpatient hospital care by creating prospective payment that is based on diagnosis-related groups (DRGs). This was a response to the rising cost of inpatient care resulting from retrospective payment that is based on hospital charges. Because hospitals would get paid the same amount for similar conditions, it resulted in shortened length of stay and reduction in the rise of inpatient costs, along with no measurable impact on quality of care.⁶ This was followed by prospective payment for outpatient hospital fees and skilled nursing facility (SNF) care as a result of the Balanced Budget Act of 1997. Medicare built on this by bundling physician and hospital fees through demonstration projects in coronary artery bypass graft surgery from 1991 to 1996 and orthopedic and cardiovascular surgery from 2009 to 2012, both resulting in reduced costs and no measurable impact on quality.

The Bundled Payment for Care Improvement (BPCI) program built on these results in 2013 by expanding to include Part A and B services rendered up to 90 days after discharge, and as of January 2016, it includes 1,574 participants across the country. On a voluntary basis, hospitals, physician groups, and postacute providers and conveners were able to participate in 1 of 4 bundled payment models that were anchored on an inpatient for any of 48 clinical conditions that were based on MS-DRG (Table 1).

• Model 1 defined the episode as the inpatient hospital stay and bundled the facility and physician fees, similar to prior demonstration projects.

• Model 2 is a retrospective bundled payment for Part A and B services in the inpatient hospital stay and up to 90 days after discharge.

• Model 3 is a retrospective model that starts after hospital discharge and includes up to 90 days. (Models 1-3 maintain the current payment structure and retrospectively compare the actual reimbursement with target values that are based on historical data for that hospital with a 2%-3% payment reduction.)

• Model 4 makes a single, prospectively determined global payment to a hospital that encompasses all services during the hospital stay.

Opportunities in inpatient and postacute bundled payments

Participation in bundled payments requires a new set of analytic and organizational capabilities.

• The first step is to identify the patient population on the basis of inclusion and exclusion criteria and to measure the current cost of care through external claims data and internal hospital data. This includes payments for hospital inpatient services, physician fees, postacute care, readmissions, other Part B services, and home health services. The biggest opportunity for postacute bundles is shifting site of service from postacute care to lower-cost settings and reducing readmission rates.

• Subsequently, they need to identify areas of opportunity to reduce expenditure, while also demonstrating consistent or improved quality and outcomes.

• On the basis of this, the team can identify variation in care within the cohort and in comparison with benchmarks across the country.

• After identifying areas of opportunity, the team needs to develop strategies to improve value such as care pathways, information technology tools, care coordination, and remote services.

Of the 48 clinical conditions in BPCI, 4 could be described as related to GI: esophagitis, gastroenteritis, and other digestive disorders (Medicare Severity–Diagnosis Related Group [MS-DRG] 391, 392); gastrointestinal hemorrhage (MS-DRG 377, 378, 379); gastrointestinal obstruction (MS-DRG 388, 389, 390); and major bowel procedure (MS-DRG 329, 330, 331). After evaluating the GI bundles, it was apparent that these were created for billing purposes and were not clinically intuitive, which is why our institution immediately excluded the broad category of esophagitis, gastroenteritis, and other digestive disorders. GI obstruction and major bowel surgery relate to the care of gastroenterologists, but surgeons are typically primary drivers of care for these patients. Thus, we believed that GI hemorrhage was most appropriate because gastroenterologists drive care for this condition, and there is substantial evidence about established guidelines and pathways during this episode.

Bundled payment for gastrointestinal hemorrhage

We built a multidisciplinary team of physicians, data analysts, clinical documentation specialists, and care managers to start developing a plan for improving the value of care in this population. This included data about readmissions and site of postacute care for this population, which were supplemented by chart review of financial outliers and readmissions. We quickly learned about some of the challenges to medical bundles and the GI hemorrhage bundle in particular. It is difficult to identify these patients early in the hospital stay because inclusion is based on a billing code. Many of these patients also have cardiovascular disease, cancer, or cirrhosis, which makes it hard to identify which patients will end up with primary GI hemorrhage coding until after the patient is discharged. They are also on many different inpatient services; in our hospital, there were at least 12 different admitting services. In addition, almost one-third of the patients actually had an admission before this hospitalization, often for different clinical conditions.

Most importantly, it was very challenging to develop protocols to improve the value of care in this population. Most of the patients had many comorbid conditions, so a GI hemorrhage pathway alone would not be sufficient to alter care. The two main areas of opportunity for cost savings in postacute bundled payments are postacute site of service and readmissions, both of which are hard to change for medical GI patients. For medical patients, they have many comorbidities before admission, so postacute site of service is typically driven by which site they were admitted from. This is different from surgical patients who are in SNF or rehabilitation facilities for limited time frames, and there may be more discretion to shift to lower cost settings. In addition, readmissions have not been studied much in GI hemorrhage, so it is not clear how to improve them. On the basis of these factors and the limited sample size for this condition, our health system opted to stop taking financial risk for this population.

Future opportunities for gastroenterology

However, the latest CMS Inpatient Prospective Payment System rule describes the implementation of a new quality metric for hospital IQR called the Gastrointestinal Hemorrhage Clinical Episode-Based Payment. This would hold hospitals accountable for the cost of care for GI hemorrhage admissions plus the 90 days after discharge, similar to model 2 of BPCI. This announcement, as well as the launch of mandatory orthopedic bundles, demonstrates that hospital reimbursement is shifting toward an expansion of bundled payments to include the postacute time frame. This is manifested in postacute bundles, episode-based payment, and readmission penalties. This reignited our GI hemorrhage episode team’s efforts, but with a broader purpose.

Gastroenterologists can take a leadership role in responding to episode-based payments as a way for us to demonstrate value in our collaboration with hospitals, health systems, and payers. The focus on cardiovascular disease as part of readmission penalties and core measures has allowed our cardiology colleagues to partner closely with service lines, learn about episode-based care, and garner resources to build and lead disease and episode teams. Because patients do not fit into the different clinical areas in mutually exclusive categories, we will need to collaborate with other specialties to care for the overlap with other conditions. Many heart failure and myocardial infarction patients will get readmitted for GI hemorrhage, and many GI hemorrhage patients will have concomitant cardiovascular disease or cancer. This suggests that future strategies need to integrate efforts of service lines and that there is greater opportunity for gastroenterologists than just the GI bundles.

Gastroenterologists should also participate in a proactive way. Any new payment mechanism will have some flaws in implementation, so it is more important to do what is right from a clinical standpoint rather than focusing too much on the specific billing code or payment model. These models are evolving, and we have an opportunity to have impact on future implementation. This starts with identifying and including patients from a clinical perspective rather than focusing on specific insurance types that participate in bundled payments. Some examples to improve the value of care in GI hemorrhage include creating evidence-based care pathways that span the episode of care, structured documentation after endoscopy for risk stratification, integrating pathways into the workflow of providers through the electronic health record, and increased coordination between specialties across the continuum of care. Other diagnoses that might be included in future bundles include cirrhosis, bowel obstruction, and inflammatory bowel disease. We can also learn from successful efforts in other clinical specialties that have identified variations in care and implemented a multi-modal strategy to improving care and measuring impact.

References

1. Mechanic, R.E. Mandatory Medicare bundled payment: Is it ready for prime time? N Engl J Med. 2015;373[14]:1291-3.

2. U.S. Department of Health and Human Services. Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. January 26, 2015. Available from: http://www.hhs.gov/about/news/2015/01/26/better-smarter-healthier-in-historic-announcement-hhs-sets-clear-goals-and-timeline-for-shifting-medicare-reimbursements-from-volume-to-value.html. Accessed June 28, 2016.

3. Patel, K., Presser, E., George, M., et al. Shifting away from fee-for-service: Alternative approaches to payment in gastroenterology. Clin Gastroenterol Hepatol. 2016;14[4]:497-506.

4. Medicare FY 2016 IPPS final rule. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page.html. Accessed June 28, 2016.

5. Ketover, S.R. Bundled payment for colonoscopy. Clin Gastroenterol Hepatol. 2013;11[5]:454-7.

6. Coulam, R.F., Gaumer, G.L. Medicare’s prospective payment system: a critical appraisal. Health Care Financ Rev Annu Suppl. 1991:45-77.

Dr. Mehta is in the division of gastroenterology, Perelman School of Medicine, University of Pennsylvania, and Penn Medicine Center for Health Care Innovation, University of Pennsylvania, Philadelphia. The author discloses no conflicts of interest.

The Medicare Access and Chips Reauthorization Act (MACRA) is now law; it passed with bipartisan, virtually unanimous support in both chambers of Congress. MACRA replaced the Sustainable Growth Rate formula for physician reimbursement and replaced it with a pathway to value-based payment. This law will alter our practices more than the Affordable Care Act and to an extent not seen since the passage of the original Medicare Act. Practices that continue to hang on to our traditional colonoscopy-based fee-for-service reimbursement model will increasingly be marginalized (or discounted) by Medicare, commercial payers, and regional health systems. To thrive in the coming decade, innovative practices will move toward alternative payment models. Many practices have risk-linked bundled payments for colonoscopy, but this step is only for the interim. Long-term success will come to practices that understand the implications of episode payments, specialty medical homes, and total cost of care. Do not wait for the finances to magically appear – start now to build infrastructure. In this month’s article, Dr. Mehta provides a detailed description of how a practice might construct a bundled payment for a common inpatient disorder. No one is paying for this yet, but it will come. Now is not the time to be a “WIMP” (Gastroenterology. 2016;150:295-9).

John I. Allen, MD, MBA, AGAF

Editor in Chief

In January 2016, the Centers for Medicare & Medicaid Services (CMS) launched the Comprehensive Care for Joint Replacement (CJR) model. This payment model aims to improve the value of care provided to Medicare beneficiaries for hip and knee replacement surgery during the inpatient stay and 90-day period after discharge by holding hospitals accountable for cost and quality.¹ It includes hospitals in 67 geographic areas across the United States and marks the first time that a postacute bundled payment model is mandatory for traditional Medicare patients. Although this may not seem to be relevant for gastroenterology, it marks an important signal by CMS that there will likely be more episode-payment models in the future.

Inpatient and postacute bundled payments

A bundled payment refers to a situation in which hospitals and physicians are incentivized to coordinate care for an episode of care across the continuum and eliminate unnecessary spending. In 1983, Medicare initiated a type of bundled payment for Part A spending on inpatient hospital care by creating prospective payment that is based on diagnosis-related groups (DRGs). This was a response to the rising cost of inpatient care resulting from retrospective payment that is based on hospital charges. Because hospitals would get paid the same amount for similar conditions, it resulted in shortened length of stay and reduction in the rise of inpatient costs, along with no measurable impact on quality of care.⁶ This was followed by prospective payment for outpatient hospital fees and skilled nursing facility (SNF) care as a result of the Balanced Budget Act of 1997. Medicare built on this by bundling physician and hospital fees through demonstration projects in coronary artery bypass graft surgery from 1991 to 1996 and orthopedic and cardiovascular surgery from 2009 to 2012, both resulting in reduced costs and no measurable impact on quality.

The Bundled Payment for Care Improvement (BPCI) program built on these results in 2013 by expanding to include Part A and B services rendered up to 90 days after discharge, and as of January 2016, it includes 1,574 participants across the country. On a voluntary basis, hospitals, physician groups, and postacute providers and conveners were able to participate in 1 of 4 bundled payment models that were anchored on an inpatient for any of 48 clinical conditions that were based on MS-DRG (Table 1).

• Model 1 defined the episode as the inpatient hospital stay and bundled the facility and physician fees, similar to prior demonstration projects.

• Model 2 is a retrospective bundled payment for Part A and B services in the inpatient hospital stay and up to 90 days after discharge.

• Model 3 is a retrospective model that starts after hospital discharge and includes up to 90 days. (Models 1-3 maintain the current payment structure and retrospectively compare the actual reimbursement with target values that are based on historical data for that hospital with a 2%-3% payment reduction.)

• Model 4 makes a single, prospectively determined global payment to a hospital that encompasses all services during the hospital stay.

Opportunities in inpatient and postacute bundled payments

Participation in bundled payments requires a new set of analytic and organizational capabilities.

• The first step is to identify the patient population on the basis of inclusion and exclusion criteria and to measure the current cost of care through external claims data and internal hospital data. This includes payments for hospital inpatient services, physician fees, postacute care, readmissions, other Part B services, and home health services. The biggest opportunity for postacute bundles is shifting site of service from postacute care to lower-cost settings and reducing readmission rates.

• Subsequently, they need to identify areas of opportunity to reduce expenditure, while also demonstrating consistent or improved quality and outcomes.

• On the basis of this, the team can identify variation in care within the cohort and in comparison with benchmarks across the country.

• After identifying areas of opportunity, the team needs to develop strategies to improve value such as care pathways, information technology tools, care coordination, and remote services.

Of the 48 clinical conditions in BPCI, 4 could be described as related to GI: esophagitis, gastroenteritis, and other digestive disorders (Medicare Severity–Diagnosis Related Group [MS-DRG] 391, 392); gastrointestinal hemorrhage (MS-DRG 377, 378, 379); gastrointestinal obstruction (MS-DRG 388, 389, 390); and major bowel procedure (MS-DRG 329, 330, 331). After evaluating the GI bundles, it was apparent that these were created for billing purposes and were not clinically intuitive, which is why our institution immediately excluded the broad category of esophagitis, gastroenteritis, and other digestive disorders. GI obstruction and major bowel surgery relate to the care of gastroenterologists, but surgeons are typically primary drivers of care for these patients. Thus, we believed that GI hemorrhage was most appropriate because gastroenterologists drive care for this condition, and there is substantial evidence about established guidelines and pathways during this episode.

Bundled payment for gastrointestinal hemorrhage

We built a multidisciplinary team of physicians, data analysts, clinical documentation specialists, and care managers to start developing a plan for improving the value of care in this population. This included data about readmissions and site of postacute care for this population, which were supplemented by chart review of financial outliers and readmissions. We quickly learned about some of the challenges to medical bundles and the GI hemorrhage bundle in particular. It is difficult to identify these patients early in the hospital stay because inclusion is based on a billing code. Many of these patients also have cardiovascular disease, cancer, or cirrhosis, which makes it hard to identify which patients will end up with primary GI hemorrhage coding until after the patient is discharged. They are also on many different inpatient services; in our hospital, there were at least 12 different admitting services. In addition, almost one-third of the patients actually had an admission before this hospitalization, often for different clinical conditions.

Most importantly, it was very challenging to develop protocols to improve the value of care in this population. Most of the patients had many comorbid conditions, so a GI hemorrhage pathway alone would not be sufficient to alter care. The two main areas of opportunity for cost savings in postacute bundled payments are postacute site of service and readmissions, both of which are hard to change for medical GI patients. For medical patients, they have many comorbidities before admission, so postacute site of service is typically driven by which site they were admitted from. This is different from surgical patients who are in SNF or rehabilitation facilities for limited time frames, and there may be more discretion to shift to lower cost settings. In addition, readmissions have not been studied much in GI hemorrhage, so it is not clear how to improve them. On the basis of these factors and the limited sample size for this condition, our health system opted to stop taking financial risk for this population.

Future opportunities for gastroenterology

However, the latest CMS Inpatient Prospective Payment System rule describes the implementation of a new quality metric for hospital IQR called the Gastrointestinal Hemorrhage Clinical Episode-Based Payment. This would hold hospitals accountable for the cost of care for GI hemorrhage admissions plus the 90 days after discharge, similar to model 2 of BPCI. This announcement, as well as the launch of mandatory orthopedic bundles, demonstrates that hospital reimbursement is shifting toward an expansion of bundled payments to include the postacute time frame. This is manifested in postacute bundles, episode-based payment, and readmission penalties. This reignited our GI hemorrhage episode team’s efforts, but with a broader purpose.

Gastroenterologists can take a leadership role in responding to episode-based payments as a way for us to demonstrate value in our collaboration with hospitals, health systems, and payers. The focus on cardiovascular disease as part of readmission penalties and core measures has allowed our cardiology colleagues to partner closely with service lines, learn about episode-based care, and garner resources to build and lead disease and episode teams. Because patients do not fit into the different clinical areas in mutually exclusive categories, we will need to collaborate with other specialties to care for the overlap with other conditions. Many heart failure and myocardial infarction patients will get readmitted for GI hemorrhage, and many GI hemorrhage patients will have concomitant cardiovascular disease or cancer. This suggests that future strategies need to integrate efforts of service lines and that there is greater opportunity for gastroenterologists than just the GI bundles.

Gastroenterologists should also participate in a proactive way. Any new payment mechanism will have some flaws in implementation, so it is more important to do what is right from a clinical standpoint rather than focusing too much on the specific billing code or payment model. These models are evolving, and we have an opportunity to have impact on future implementation. This starts with identifying and including patients from a clinical perspective rather than focusing on specific insurance types that participate in bundled payments. Some examples to improve the value of care in GI hemorrhage include creating evidence-based care pathways that span the episode of care, structured documentation after endoscopy for risk stratification, integrating pathways into the workflow of providers through the electronic health record, and increased coordination between specialties across the continuum of care. Other diagnoses that might be included in future bundles include cirrhosis, bowel obstruction, and inflammatory bowel disease. We can also learn from successful efforts in other clinical specialties that have identified variations in care and implemented a multi-modal strategy to improving care and measuring impact.

References

1. Mechanic, R.E. Mandatory Medicare bundled payment: Is it ready for prime time? N Engl J Med. 2015;373[14]:1291-3.

2. U.S. Department of Health and Human Services. Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. January 26, 2015. Available from: http://www.hhs.gov/about/news/2015/01/26/better-smarter-healthier-in-historic-announcement-hhs-sets-clear-goals-and-timeline-for-shifting-medicare-reimbursements-from-volume-to-value.html. Accessed June 28, 2016.

3. Patel, K., Presser, E., George, M., et al. Shifting away from fee-for-service: Alternative approaches to payment in gastroenterology. Clin Gastroenterol Hepatol. 2016;14[4]:497-506.

4. Medicare FY 2016 IPPS final rule. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page.html. Accessed June 28, 2016.

5. Ketover, S.R. Bundled payment for colonoscopy. Clin Gastroenterol Hepatol. 2013;11[5]:454-7.

6. Coulam, R.F., Gaumer, G.L. Medicare’s prospective payment system: a critical appraisal. Health Care Financ Rev Annu Suppl. 1991:45-77.

Dr. Mehta is in the division of gastroenterology, Perelman School of Medicine, University of Pennsylvania, and Penn Medicine Center for Health Care Innovation, University of Pennsylvania, Philadelphia. The author discloses no conflicts of interest.

The Medicare Access and Chips Reauthorization Act (MACRA) is now law; it passed with bipartisan, virtually unanimous support in both chambers of Congress. MACRA replaced the Sustainable Growth Rate formula for physician reimbursement and replaced it with a pathway to value-based payment. This law will alter our practices more than the Affordable Care Act and to an extent not seen since the passage of the original Medicare Act. Practices that continue to hang on to our traditional colonoscopy-based fee-for-service reimbursement model will increasingly be marginalized (or discounted) by Medicare, commercial payers, and regional health systems. To thrive in the coming decade, innovative practices will move toward alternative payment models. Many practices have risk-linked bundled payments for colonoscopy, but this step is only for the interim. Long-term success will come to practices that understand the implications of episode payments, specialty medical homes, and total cost of care. Do not wait for the finances to magically appear – start now to build infrastructure. In this month’s article, Dr. Mehta provides a detailed description of how a practice might construct a bundled payment for a common inpatient disorder. No one is paying for this yet, but it will come. Now is not the time to be a “WIMP” (Gastroenterology. 2016;150:295-9).

John I. Allen, MD, MBA, AGAF

Editor in Chief

In January 2016, the Centers for Medicare & Medicaid Services (CMS) launched the Comprehensive Care for Joint Replacement (CJR) model. This payment model aims to improve the value of care provided to Medicare beneficiaries for hip and knee replacement surgery during the inpatient stay and 90-day period after discharge by holding hospitals accountable for cost and quality.¹ It includes hospitals in 67 geographic areas across the United States and marks the first time that a postacute bundled payment model is mandatory for traditional Medicare patients. Although this may not seem to be relevant for gastroenterology, it marks an important signal by CMS that there will likely be more episode-payment models in the future.

Inpatient and postacute bundled payments

A bundled payment refers to a situation in which hospitals and physicians are incentivized to coordinate care for an episode of care across the continuum and eliminate unnecessary spending. In 1983, Medicare initiated a type of bundled payment for Part A spending on inpatient hospital care by creating prospective payment that is based on diagnosis-related groups (DRGs). This was a response to the rising cost of inpatient care resulting from retrospective payment that is based on hospital charges. Because hospitals would get paid the same amount for similar conditions, it resulted in shortened length of stay and reduction in the rise of inpatient costs, along with no measurable impact on quality of care.⁶ This was followed by prospective payment for outpatient hospital fees and skilled nursing facility (SNF) care as a result of the Balanced Budget Act of 1997. Medicare built on this by bundling physician and hospital fees through demonstration projects in coronary artery bypass graft surgery from 1991 to 1996 and orthopedic and cardiovascular surgery from 2009 to 2012, both resulting in reduced costs and no measurable impact on quality.

The Bundled Payment for Care Improvement (BPCI) program built on these results in 2013 by expanding to include Part A and B services rendered up to 90 days after discharge, and as of January 2016, it includes 1,574 participants across the country. On a voluntary basis, hospitals, physician groups, and postacute providers and conveners were able to participate in 1 of 4 bundled payment models that were anchored on an inpatient for any of 48 clinical conditions that were based on MS-DRG (Table 1).

• Model 1 defined the episode as the inpatient hospital stay and bundled the facility and physician fees, similar to prior demonstration projects.

• Model 2 is a retrospective bundled payment for Part A and B services in the inpatient hospital stay and up to 90 days after discharge.

• Model 3 is a retrospective model that starts after hospital discharge and includes up to 90 days. (Models 1-3 maintain the current payment structure and retrospectively compare the actual reimbursement with target values that are based on historical data for that hospital with a 2%-3% payment reduction.)

• Model 4 makes a single, prospectively determined global payment to a hospital that encompasses all services during the hospital stay.

Opportunities in inpatient and postacute bundled payments

Participation in bundled payments requires a new set of analytic and organizational capabilities.

• The first step is to identify the patient population on the basis of inclusion and exclusion criteria and to measure the current cost of care through external claims data and internal hospital data. This includes payments for hospital inpatient services, physician fees, postacute care, readmissions, other Part B services, and home health services. The biggest opportunity for postacute bundles is shifting site of service from postacute care to lower-cost settings and reducing readmission rates.

• Subsequently, they need to identify areas of opportunity to reduce expenditure, while also demonstrating consistent or improved quality and outcomes.

• On the basis of this, the team can identify variation in care within the cohort and in comparison with benchmarks across the country.

• After identifying areas of opportunity, the team needs to develop strategies to improve value such as care pathways, information technology tools, care coordination, and remote services.

Of the 48 clinical conditions in BPCI, 4 could be described as related to GI: esophagitis, gastroenteritis, and other digestive disorders (Medicare Severity–Diagnosis Related Group [MS-DRG] 391, 392); gastrointestinal hemorrhage (MS-DRG 377, 378, 379); gastrointestinal obstruction (MS-DRG 388, 389, 390); and major bowel procedure (MS-DRG 329, 330, 331). After evaluating the GI bundles, it was apparent that these were created for billing purposes and were not clinically intuitive, which is why our institution immediately excluded the broad category of esophagitis, gastroenteritis, and other digestive disorders. GI obstruction and major bowel surgery relate to the care of gastroenterologists, but surgeons are typically primary drivers of care for these patients. Thus, we believed that GI hemorrhage was most appropriate because gastroenterologists drive care for this condition, and there is substantial evidence about established guidelines and pathways during this episode.

Bundled payment for gastrointestinal hemorrhage

We built a multidisciplinary team of physicians, data analysts, clinical documentation specialists, and care managers to start developing a plan for improving the value of care in this population. This included data about readmissions and site of postacute care for this population, which were supplemented by chart review of financial outliers and readmissions. We quickly learned about some of the challenges to medical bundles and the GI hemorrhage bundle in particular. It is difficult to identify these patients early in the hospital stay because inclusion is based on a billing code. Many of these patients also have cardiovascular disease, cancer, or cirrhosis, which makes it hard to identify which patients will end up with primary GI hemorrhage coding until after the patient is discharged. They are also on many different inpatient services; in our hospital, there were at least 12 different admitting services. In addition, almost one-third of the patients actually had an admission before this hospitalization, often for different clinical conditions.

Most importantly, it was very challenging to develop protocols to improve the value of care in this population. Most of the patients had many comorbid conditions, so a GI hemorrhage pathway alone would not be sufficient to alter care. The two main areas of opportunity for cost savings in postacute bundled payments are postacute site of service and readmissions, both of which are hard to change for medical GI patients. For medical patients, they have many comorbidities before admission, so postacute site of service is typically driven by which site they were admitted from. This is different from surgical patients who are in SNF or rehabilitation facilities for limited time frames, and there may be more discretion to shift to lower cost settings. In addition, readmissions have not been studied much in GI hemorrhage, so it is not clear how to improve them. On the basis of these factors and the limited sample size for this condition, our health system opted to stop taking financial risk for this population.

Future opportunities for gastroenterology

However, the latest CMS Inpatient Prospective Payment System rule describes the implementation of a new quality metric for hospital IQR called the Gastrointestinal Hemorrhage Clinical Episode-Based Payment. This would hold hospitals accountable for the cost of care for GI hemorrhage admissions plus the 90 days after discharge, similar to model 2 of BPCI. This announcement, as well as the launch of mandatory orthopedic bundles, demonstrates that hospital reimbursement is shifting toward an expansion of bundled payments to include the postacute time frame. This is manifested in postacute bundles, episode-based payment, and readmission penalties. This reignited our GI hemorrhage episode team’s efforts, but with a broader purpose.

Gastroenterologists can take a leadership role in responding to episode-based payments as a way for us to demonstrate value in our collaboration with hospitals, health systems, and payers. The focus on cardiovascular disease as part of readmission penalties and core measures has allowed our cardiology colleagues to partner closely with service lines, learn about episode-based care, and garner resources to build and lead disease and episode teams. Because patients do not fit into the different clinical areas in mutually exclusive categories, we will need to collaborate with other specialties to care for the overlap with other conditions. Many heart failure and myocardial infarction patients will get readmitted for GI hemorrhage, and many GI hemorrhage patients will have concomitant cardiovascular disease or cancer. This suggests that future strategies need to integrate efforts of service lines and that there is greater opportunity for gastroenterologists than just the GI bundles.

Gastroenterologists should also participate in a proactive way. Any new payment mechanism will have some flaws in implementation, so it is more important to do what is right from a clinical standpoint rather than focusing too much on the specific billing code or payment model. These models are evolving, and we have an opportunity to have impact on future implementation. This starts with identifying and including patients from a clinical perspective rather than focusing on specific insurance types that participate in bundled payments. Some examples to improve the value of care in GI hemorrhage include creating evidence-based care pathways that span the episode of care, structured documentation after endoscopy for risk stratification, integrating pathways into the workflow of providers through the electronic health record, and increased coordination between specialties across the continuum of care. Other diagnoses that might be included in future bundles include cirrhosis, bowel obstruction, and inflammatory bowel disease. We can also learn from successful efforts in other clinical specialties that have identified variations in care and implemented a multi-modal strategy to improving care and measuring impact.

References

1. Mechanic, R.E. Mandatory Medicare bundled payment: Is it ready for prime time? N Engl J Med. 2015;373[14]:1291-3.

2. U.S. Department of Health and Human Services. Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. January 26, 2015. Available from: http://www.hhs.gov/about/news/2015/01/26/better-smarter-healthier-in-historic-announcement-hhs-sets-clear-goals-and-timeline-for-shifting-medicare-reimbursements-from-volume-to-value.html. Accessed June 28, 2016.

3. Patel, K., Presser, E., George, M., et al. Shifting away from fee-for-service: Alternative approaches to payment in gastroenterology. Clin Gastroenterol Hepatol. 2016;14[4]:497-506.

4. Medicare FY 2016 IPPS final rule. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page.html. Accessed June 28, 2016.

5. Ketover, S.R. Bundled payment for colonoscopy. Clin Gastroenterol Hepatol. 2013;11[5]:454-7.

6. Coulam, R.F., Gaumer, G.L. Medicare’s prospective payment system: a critical appraisal. Health Care Financ Rev Annu Suppl. 1991:45-77.

Dr. Mehta is in the division of gastroenterology, Perelman School of Medicine, University of Pennsylvania, and Penn Medicine Center for Health Care Innovation, University of Pennsylvania, Philadelphia. The author discloses no conflicts of interest.

Malpractice reforms long espoused by Thomas E. Price, MD, Health & Human Services secretary, are fostering debate on whether national fixes are necessary in an improving liability landscape. Claims against health providers have decreased twofold and doctors nationwide have seen their premiums decrease steadily for a decade. But the numbers tell just part of the story, liability experts say.

“Most health policy and medical malpractice scholars would not describe the environment we’re in right now as a state of crisis, at least not compared to what we observed a decade ago,” said Anupam B. Jena, MD, PhD, health care policy professor at Harvard University, Boston, and a medical liability researcher.“But I would argue that malpractice is still a salient fact for most physicians. What’s much more important than focusing on changes over time is taking a static perspective and understanding the risk that a physician faces when it comes to malpractice.”

Courtesy Dr. Jena

Data show lawsuits down

Claims data however, show that lawsuits against doctors are on the decline – and have been for more than 10 years. The rate of paid claims against physicians dropped from 18.6 to 9.9 paid claims per 1,000 physicians between 2002 and 2013, according to 2014 study by Michelle Mello of Stanford (Calif.) University and colleagues (JAMA. 2014;312(20):2146-2155. doi:10.1001/jama.2014.10705). Another analysis found that claims decreased from 12 claims per 100 doctors in 2003 to 6 per 100 doctors in 2016, according to a study of claims from The Doctors Company database.

The sharp decline in claims is directly affecting premiums, which have remained nearly unchanged for years, said Michael Matray, editor of the Medical Liability Monitor (MLM), which tracks premium rates. In 2003, rate increases of 49% were commonplace, he noted, with some states reporting rises of 100%. But premiums started to fall in 2006, he said.
“We are in the midst of a 10-year soft market, the longest we’ve ever had,” Mr. Matray said in an interview. “In 2006, we started to soften. We have been soft or flat with no change since. It’s definitely unprecedented.”

State reforms driving lawsuit decline

A combination of state reforms and patient safety initiatives are fueling the lawsuit down slide, said Paul A. Greve Jr. senior vice president/senior consultant for Willis Towers Watson Health Care Practice and coauthor of the 2016 MLM Survey report.

More than 25 states now have laws that enforce caps on noneconomic damages in medical liability cases, and in the last 15 years, a large majority have upheld such limits, Mr. Greve said. In addition, a number of states require a certificate of merit before suits can move forward, which mandate that a qualified physician verify that a defendant’s actions were likely negligent.

Patient safety programs such as internal patient safety committees, enhanced provider education, safety protocols, and communication and resolution programs, are also making an impact.

“There have been many efforts toward thinking innovatively about how we should be compensating patients more fairly and more quickly,” said Harvard’s Dr. Jena, who practices at Massachusetts General Hospital. “There are early disclosure programs that many hospitals have adopted as a movement toward that goal. The system is evolving.”
The high expense of filing a medical malpractice lawsuit is another factor detouring lawsuits, Mr. Greve added.

Malpractice system remains broken

While lawsuit and premium data paint a positive picture, the medical malpractice system remains dysfunctional for doctors and patients, said PIAA’s Mr. Stinson.

A majority of medical malpractice claims against physicians are determined to be nonmeritorious yet an average lawsuit takes roughly 4 years to resolve, he noted. Suits against doctors are dismissed by the court 54% of the time across all specialties, and among cases that go to trial, 80% end in the physician’s favor, according to a 2012 study by Dr. Jena and colleagues (JAMA Intern Med. 2012 Jun. 11 doi: 10.1001/jamainternmed.2012.1416)
“We think that’s a huge amount of resources both in time and money and human capital to get poured into cases where no payment is ever deemed appropriate,” Mr. Stinson said. “We would like to see [malpractice] reforms in part because we think you can weed out some of these claims in advance, so more of the resources can be used to determine whether or not there was negligence and if so, making that patient whole as fast as possible.”
Regardless of declining claims, most physicians will still be sued in their lifetime, Dr. Jena said. By age 65, 75% of physicians in low-risk specialties have faced a malpractice claim, and 99% of doctors in high-risk specialties have been sued, according to a 2011 study by Dr. Jena and colleagues (N Engl J Med. 2011 Aug. 18. doi: 10.1056/NEJMsa1012370)

“What really matters for physicians is not only whether they win or lose a malpractice suit, but whether they are sued in the first place,” Dr. Jena said. “Lawsuits happen quite often and over the course of a physician’s career they are quite common. So whether or not we’re in a state of malpractice crisis or not, the lifetime risk for physicians is quite real.”
The cost of defending claims continues to rise, noted Richard E. Anderson, MD, chair and CEO of The Doctors Company. At the same time, multi-million dollar malpractice verdicts have become more common.
“There’s still way too much malpractice litigation,” Dr. Anderson said. “The majority of it is fruitless, and the total cost burden borne by physicians has not decreased as much as the frequency because of the ongoing increase in severity.”

Courtesy Mr. McKinney

What would Dr. Price do?

Opinions are mixed about whether Dr. Price’s proposed reforms are the right changes for the medical liability system.

Wikimedia Commons/District office of Tom Price/Creative Commons License

Expert panels to review claims for validity are a promising suggestion, Dr. Jena said. “Administrative courts to help identify malpractice cases that are truly malpractice early on is a good idea,” he said. “We want to have a system that prevents less meritorious cases from soaking up resources.”

But the idea may be easier said than done, said Dr. Anderson of The Doctors Company. “The devil is always in the details There is a lot of merit in [health courts] and they make a lot of sense. However, the notion of going from where we are today to an untested system, which would have to be a compromise between adversaries, would be a very challenging one.”

National clinical standards for physicians to follow and use as a safeguard could backfire, Mr. Stinson said. Bureaucracy could slow the guidelines from being promptly updated, and the standards could fail to keep up with the latest medical developments. As doctors know, medicine is not a one-size-fits-all approach, he added.

“[Guidelines] could encourage doctors to practice cookbook medicine, where they’re just going to follow the standard along without being given the opportunity to use their training and clinical experience to see whether that’s actually in the patient’s best interest,” Mr. Stinson said. “We certainly wouldn’t want to see a situation where a doctor feels diverting from a guidelines is in a patient’s best interest, but they don’t dare do it because it could subject them to a lawsuit.”

When enacting malpractice reforms, it will be critical to evaluate the intervention first to ensure the right objections are met, Dr. Jena added.

“At the end of the day, if the [legal] environment is such that it’s uncomfortable to practice medicine, that’s going to have implications for who goes into medicine and implications for ordering tests and procedures,” he said. “Any reform that attempts to make the process more efficient is a good idea because it lowers cost to the system and makes the experience better for patients and physicians.”

This article was updated 2/15/17.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Malpractice reforms long espoused by Thomas E. Price, MD, Health & Human Services secretary, are fostering debate on whether national fixes are necessary in an improving liability landscape. Claims against health providers have decreased twofold and doctors nationwide have seen their premiums decrease steadily for a decade. But the numbers tell just part of the story, liability experts say.

“Most health policy and medical malpractice scholars would not describe the environment we’re in right now as a state of crisis, at least not compared to what we observed a decade ago,” said Anupam B. Jena, MD, PhD, health care policy professor at Harvard University, Boston, and a medical liability researcher.“But I would argue that malpractice is still a salient fact for most physicians. What’s much more important than focusing on changes over time is taking a static perspective and understanding the risk that a physician faces when it comes to malpractice.”

Courtesy Dr. Jena

Data show lawsuits down

Claims data however, show that lawsuits against doctors are on the decline – and have been for more than 10 years. The rate of paid claims against physicians dropped from 18.6 to 9.9 paid claims per 1,000 physicians between 2002 and 2013, according to 2014 study by Michelle Mello of Stanford (Calif.) University and colleagues (JAMA. 2014;312(20):2146-2155. doi:10.1001/jama.2014.10705). Another analysis found that claims decreased from 12 claims per 100 doctors in 2003 to 6 per 100 doctors in 2016, according to a study of claims from The Doctors Company database.

The sharp decline in claims is directly affecting premiums, which have remained nearly unchanged for years, said Michael Matray, editor of the Medical Liability Monitor (MLM), which tracks premium rates. In 2003, rate increases of 49% were commonplace, he noted, with some states reporting rises of 100%. But premiums started to fall in 2006, he said.
“We are in the midst of a 10-year soft market, the longest we’ve ever had,” Mr. Matray said in an interview. “In 2006, we started to soften. We have been soft or flat with no change since. It’s definitely unprecedented.”

State reforms driving lawsuit decline

A combination of state reforms and patient safety initiatives are fueling the lawsuit down slide, said Paul A. Greve Jr. senior vice president/senior consultant for Willis Towers Watson Health Care Practice and coauthor of the 2016 MLM Survey report.

More than 25 states now have laws that enforce caps on noneconomic damages in medical liability cases, and in the last 15 years, a large majority have upheld such limits, Mr. Greve said. In addition, a number of states require a certificate of merit before suits can move forward, which mandate that a qualified physician verify that a defendant’s actions were likely negligent.

Patient safety programs such as internal patient safety committees, enhanced provider education, safety protocols, and communication and resolution programs, are also making an impact.

“There have been many efforts toward thinking innovatively about how we should be compensating patients more fairly and more quickly,” said Harvard’s Dr. Jena, who practices at Massachusetts General Hospital. “There are early disclosure programs that many hospitals have adopted as a movement toward that goal. The system is evolving.”
The high expense of filing a medical malpractice lawsuit is another factor detouring lawsuits, Mr. Greve added.

Malpractice system remains broken

While lawsuit and premium data paint a positive picture, the medical malpractice system remains dysfunctional for doctors and patients, said PIAA’s Mr. Stinson.

A majority of medical malpractice claims against physicians are determined to be nonmeritorious yet an average lawsuit takes roughly 4 years to resolve, he noted. Suits against doctors are dismissed by the court 54% of the time across all specialties, and among cases that go to trial, 80% end in the physician’s favor, according to a 2012 study by Dr. Jena and colleagues (JAMA Intern Med. 2012 Jun. 11 doi: 10.1001/jamainternmed.2012.1416)
“We think that’s a huge amount of resources both in time and money and human capital to get poured into cases where no payment is ever deemed appropriate,” Mr. Stinson said. “We would like to see [malpractice] reforms in part because we think you can weed out some of these claims in advance, so more of the resources can be used to determine whether or not there was negligence and if so, making that patient whole as fast as possible.”
Regardless of declining claims, most physicians will still be sued in their lifetime, Dr. Jena said. By age 65, 75% of physicians in low-risk specialties have faced a malpractice claim, and 99% of doctors in high-risk specialties have been sued, according to a 2011 study by Dr. Jena and colleagues (N Engl J Med. 2011 Aug. 18. doi: 10.1056/NEJMsa1012370)

“What really matters for physicians is not only whether they win or lose a malpractice suit, but whether they are sued in the first place,” Dr. Jena said. “Lawsuits happen quite often and over the course of a physician’s career they are quite common. So whether or not we’re in a state of malpractice crisis or not, the lifetime risk for physicians is quite real.”
The cost of defending claims continues to rise, noted Richard E. Anderson, MD, chair and CEO of The Doctors Company. At the same time, multi-million dollar malpractice verdicts have become more common.
“There’s still way too much malpractice litigation,” Dr. Anderson said. “The majority of it is fruitless, and the total cost burden borne by physicians has not decreased as much as the frequency because of the ongoing increase in severity.”

Courtesy Mr. McKinney

What would Dr. Price do?

Opinions are mixed about whether Dr. Price’s proposed reforms are the right changes for the medical liability system.

Wikimedia Commons/District office of Tom Price/Creative Commons License

Expert panels to review claims for validity are a promising suggestion, Dr. Jena said. “Administrative courts to help identify malpractice cases that are truly malpractice early on is a good idea,” he said. “We want to have a system that prevents less meritorious cases from soaking up resources.”

But the idea may be easier said than done, said Dr. Anderson of The Doctors Company. “The devil is always in the details There is a lot of merit in [health courts] and they make a lot of sense. However, the notion of going from where we are today to an untested system, which would have to be a compromise between adversaries, would be a very challenging one.”

National clinical standards for physicians to follow and use as a safeguard could backfire, Mr. Stinson said. Bureaucracy could slow the guidelines from being promptly updated, and the standards could fail to keep up with the latest medical developments. As doctors know, medicine is not a one-size-fits-all approach, he added.

“[Guidelines] could encourage doctors to practice cookbook medicine, where they’re just going to follow the standard along without being given the opportunity to use their training and clinical experience to see whether that’s actually in the patient’s best interest,” Mr. Stinson said. “We certainly wouldn’t want to see a situation where a doctor feels diverting from a guidelines is in a patient’s best interest, but they don’t dare do it because it could subject them to a lawsuit.”

When enacting malpractice reforms, it will be critical to evaluate the intervention first to ensure the right objections are met, Dr. Jena added.

“At the end of the day, if the [legal] environment is such that it’s uncomfortable to practice medicine, that’s going to have implications for who goes into medicine and implications for ordering tests and procedures,” he said. “Any reform that attempts to make the process more efficient is a good idea because it lowers cost to the system and makes the experience better for patients and physicians.”

This article was updated 2/15/17.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Malpractice reforms long espoused by Thomas E. Price, MD, Health & Human Services secretary, are fostering debate on whether national fixes are necessary in an improving liability landscape. Claims against health providers have decreased twofold and doctors nationwide have seen their premiums decrease steadily for a decade. But the numbers tell just part of the story, liability experts say.

“Most health policy and medical malpractice scholars would not describe the environment we’re in right now as a state of crisis, at least not compared to what we observed a decade ago,” said Anupam B. Jena, MD, PhD, health care policy professor at Harvard University, Boston, and a medical liability researcher.“But I would argue that malpractice is still a salient fact for most physicians. What’s much more important than focusing on changes over time is taking a static perspective and understanding the risk that a physician faces when it comes to malpractice.”

Courtesy Dr. Jena

Data show lawsuits down

Claims data however, show that lawsuits against doctors are on the decline – and have been for more than 10 years. The rate of paid claims against physicians dropped from 18.6 to 9.9 paid claims per 1,000 physicians between 2002 and 2013, according to 2014 study by Michelle Mello of Stanford (Calif.) University and colleagues (JAMA. 2014;312(20):2146-2155. doi:10.1001/jama.2014.10705). Another analysis found that claims decreased from 12 claims per 100 doctors in 2003 to 6 per 100 doctors in 2016, according to a study of claims from The Doctors Company database.

The sharp decline in claims is directly affecting premiums, which have remained nearly unchanged for years, said Michael Matray, editor of the Medical Liability Monitor (MLM), which tracks premium rates. In 2003, rate increases of 49% were commonplace, he noted, with some states reporting rises of 100%. But premiums started to fall in 2006, he said.
“We are in the midst of a 10-year soft market, the longest we’ve ever had,” Mr. Matray said in an interview. “In 2006, we started to soften. We have been soft or flat with no change since. It’s definitely unprecedented.”

State reforms driving lawsuit decline

A combination of state reforms and patient safety initiatives are fueling the lawsuit down slide, said Paul A. Greve Jr. senior vice president/senior consultant for Willis Towers Watson Health Care Practice and coauthor of the 2016 MLM Survey report.

More than 25 states now have laws that enforce caps on noneconomic damages in medical liability cases, and in the last 15 years, a large majority have upheld such limits, Mr. Greve said. In addition, a number of states require a certificate of merit before suits can move forward, which mandate that a qualified physician verify that a defendant’s actions were likely negligent.

Patient safety programs such as internal patient safety committees, enhanced provider education, safety protocols, and communication and resolution programs, are also making an impact.

“There have been many efforts toward thinking innovatively about how we should be compensating patients more fairly and more quickly,” said Harvard’s Dr. Jena, who practices at Massachusetts General Hospital. “There are early disclosure programs that many hospitals have adopted as a movement toward that goal. The system is evolving.”
The high expense of filing a medical malpractice lawsuit is another factor detouring lawsuits, Mr. Greve added.

Malpractice system remains broken

While lawsuit and premium data paint a positive picture, the medical malpractice system remains dysfunctional for doctors and patients, said PIAA’s Mr. Stinson.

A majority of medical malpractice claims against physicians are determined to be nonmeritorious yet an average lawsuit takes roughly 4 years to resolve, he noted. Suits against doctors are dismissed by the court 54% of the time across all specialties, and among cases that go to trial, 80% end in the physician’s favor, according to a 2012 study by Dr. Jena and colleagues (JAMA Intern Med. 2012 Jun. 11 doi: 10.1001/jamainternmed.2012.1416)
“We think that’s a huge amount of resources both in time and money and human capital to get poured into cases where no payment is ever deemed appropriate,” Mr. Stinson said. “We would like to see [malpractice] reforms in part because we think you can weed out some of these claims in advance, so more of the resources can be used to determine whether or not there was negligence and if so, making that patient whole as fast as possible.”
Regardless of declining claims, most physicians will still be sued in their lifetime, Dr. Jena said. By age 65, 75% of physicians in low-risk specialties have faced a malpractice claim, and 99% of doctors in high-risk specialties have been sued, according to a 2011 study by Dr. Jena and colleagues (N Engl J Med. 2011 Aug. 18. doi: 10.1056/NEJMsa1012370)

“What really matters for physicians is not only whether they win or lose a malpractice suit, but whether they are sued in the first place,” Dr. Jena said. “Lawsuits happen quite often and over the course of a physician’s career they are quite common. So whether or not we’re in a state of malpractice crisis or not, the lifetime risk for physicians is quite real.”
The cost of defending claims continues to rise, noted Richard E. Anderson, MD, chair and CEO of The Doctors Company. At the same time, multi-million dollar malpractice verdicts have become more common.
“There’s still way too much malpractice litigation,” Dr. Anderson said. “The majority of it is fruitless, and the total cost burden borne by physicians has not decreased as much as the frequency because of the ongoing increase in severity.”

Courtesy Mr. McKinney

What would Dr. Price do?

Opinions are mixed about whether Dr. Price’s proposed reforms are the right changes for the medical liability system.

Wikimedia Commons/District office of Tom Price/Creative Commons License

Expert panels to review claims for validity are a promising suggestion, Dr. Jena said. “Administrative courts to help identify malpractice cases that are truly malpractice early on is a good idea,” he said. “We want to have a system that prevents less meritorious cases from soaking up resources.”

But the idea may be easier said than done, said Dr. Anderson of The Doctors Company. “The devil is always in the details There is a lot of merit in [health courts] and they make a lot of sense. However, the notion of going from where we are today to an untested system, which would have to be a compromise between adversaries, would be a very challenging one.”

National clinical standards for physicians to follow and use as a safeguard could backfire, Mr. Stinson said. Bureaucracy could slow the guidelines from being promptly updated, and the standards could fail to keep up with the latest medical developments. As doctors know, medicine is not a one-size-fits-all approach, he added.

“[Guidelines] could encourage doctors to practice cookbook medicine, where they’re just going to follow the standard along without being given the opportunity to use their training and clinical experience to see whether that’s actually in the patient’s best interest,” Mr. Stinson said. “We certainly wouldn’t want to see a situation where a doctor feels diverting from a guidelines is in a patient’s best interest, but they don’t dare do it because it could subject them to a lawsuit.”

When enacting malpractice reforms, it will be critical to evaluate the intervention first to ensure the right objections are met, Dr. Jena added.

“At the end of the day, if the [legal] environment is such that it’s uncomfortable to practice medicine, that’s going to have implications for who goes into medicine and implications for ordering tests and procedures,” he said. “Any reform that attempts to make the process more efficient is a good idea because it lowers cost to the system and makes the experience better for patients and physicians.”

This article was updated 2/15/17.

agallegos@frontlinemedcom.com

On Twitter @legal_med

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering the major hepatitis viruses.

Hepatitis A virus vaccine provides protective antibody levels 20 years after childhood vaccination, according to a study of Alaska Native persons.

vchal/Thinkstock

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering the major hepatitis viruses.

Hepatitis A virus vaccine provides protective antibody levels 20 years after childhood vaccination, according to a study of Alaska Native persons.

vchal/Thinkstock

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering the major hepatitis viruses.

Hepatitis A virus vaccine provides protective antibody levels 20 years after childhood vaccination, according to a study of Alaska Native persons.

vchal/Thinkstock

rpizzi@frontlinemedcom.com

On Twitter @richpizzi