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One of the challenges a new academic hospitalist faces is trying to become a valued member of the teaching faculty. You are intent on becoming that next great attending you have always aspired to be; however, no one has clearly guided you on making this transition. In our experience, a handful of common teaching pitfalls frequently unravel the best efforts of young hospitalists. Below, you will find five strategies to take your teaching to the next level.

1. Don’t Try to Be Attending AND Resident.

Being a hospitalist attending is distinctly different than being a resident. It certainly is not being a “super-resident,” PGY-4, or PGY-17 for the team. When challenged with a new role and greater responsibility, it is natural to default to a more comfortable position (i.e., the hands-on mindset of the resident), but by doing so, you encroach on the work of the actual resident on your team. Adult learning theory teaches that it is responsibility that is the cornerstone of adult motivation. Trainees must have a chance to perform the work expected of their position without interference.

Let the resident be the resident. To reach this goal, set clear expectations and discuss the expectations up front. Make sure that you draw a sharp line between where the responsibility of the resident ends and yours begins. Have your resident help set her own expectations for the team, as well. This empowers the resident and also gives you insight into her view of the team dynamics. Your expectations should vary with the ability of the learner and the time of year. For example, the degree of autonomy that you may give a second-year resident in July is much less than what you might give a ready-to-graduate, third-year resident in June.

If granting autonomy makes you uncomfortable, observe your trainees from a distance for your own reassurance. Read the electronic medical record in depth; follow up on orders after attending rounds. If you don’t like a treatment decision, step in without inducing undue shame. After all, this is why residents are still in training, and it gives you the chance to demonstrate how to turn good care into great care.

2. Make Sure You Get to Know Your Trainees

Getting to know your trainees seems so simple that it often gets overlooked. Yet this may be the way your teaching and role modeling make their greatest impact. For adults to thrive in a learning environment, inclusion is key. There is no better way to feel included than to feel known. Inclusion allows learners to feel comfortable with being vulnerable by answering questions, asking questions, interacting, and participating in a meaningful manner on rounds. Consider your own behavior: How comfortable are you asking a question among a large audience of strangers versus asking the same question in a small group of friends? Inclusion will affect behavior.

Engage in “biographic rounds” near the start of your time together. As the attending, set the example by telling your trainees about yourself. Let them know where you are from, where you trained, what led you to choose hospital medicine, and some details about what you do in your spare time. Personal information will help break down the artificial walls that separate attendings from trainees.

Allow every member of your team to tell his or her story. It may not seem like much to you, but the effect on learners has been well established. If you invest in them, they will invest in the team.

3. Make Time to Observe Your Learners

You are responsible for evaluation and feedback of all your learners. Many factors contribute to poor feedback, but one of the most important is that new attendings often do not make a conscious effort to observe their learners. These attendings struggle to give meaningful feedback.

Take time and take notes:

• Take the time to watch your resident respond when the student is presenting her patient.
• Take time to allow the resident or intern to conduct bedside rounds on his patient.
• Take time to stop by on call to watch a student, intern, or resident take a history and perform a physical exam.

Even if you are unable to observe the whole encounter, there is little that gives you as much insight into your trainees as seeing them perform even part of a history and physical exam on a new patient. With time, a series of small observations will add up to a large number of specific comments.

Take notes on your trainees’ actions as you might do for your patients. This way, you have a record of what they did well and what needs work. Specific feedback will show that you paid attention and took the time to care about them as you would your patients.

4. Don’t Keep Your Thoughts to Yourself

Your job is akin to that of a syndicated columnist who is paid to give an informed narrative on the facts of the day. You must explain how the facts actually matter to patient care.

Think out loud. Explain your thoughts as much as possible. Do not assume that even your most senior trainees understand why you recommend a certain test or treatment. It is like algebra, where the teacher would never accept your answer unless you showed your work. For the sake of your learners, you must always “show your thinking.” They will learn as much from your clinical reasoning as they can from any canned talk on a subject.

5. Explicitly Plan Time for Teaching

“Thinking out loud” is a great way to teach, but a prepared talk can go into more depth on a topic. Yet how to find the time? The demands of a busy clinical service can overwhelm the best of intentions. Preparation is key. Good teaching does not happen by chance.

Set aside time for formal teaching outside of rounds. Be explicit as to when this will happen. Tell your team a day before, so they can prepare themselves or clear their time.

Have a handful of “canned” talks that you can give on topics related to common situations encountered in the hospital. They need not last more than 10 minutes. Always leave time for questions, and do your best to make them interactive. Even on a busy service, 10-15 minutes is reasonable for a brief, focused teaching session.

In Sum

Being an academic hospitalist with teaching responsibilities is highly rewarding. But becoming that next “great attending” requires an ongoing commitment to acquiring and developing your teaching skills.

Consider attending the SHM annual meeting or the Academic Hospitalist Academy to gain further knowledge on how to enhance your teaching career. In the meantime, try and practice some of the above tips—your learners may thank you. TH

Dr. Burger is associate program director of internal medicine residency in the Department of Medicine at Mount Sinai Beth Israel and assistant professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York City. Dr. Miller is chief of the division of general internal medicine, associate chair of education, and associate professor in the Department of Internal Medicine at Saint Louis University.

One of the challenges a new academic hospitalist faces is trying to become a valued member of the teaching faculty. You are intent on becoming that next great attending you have always aspired to be; however, no one has clearly guided you on making this transition. In our experience, a handful of common teaching pitfalls frequently unravel the best efforts of young hospitalists. Below, you will find five strategies to take your teaching to the next level.

1. Don’t Try to Be Attending AND Resident.

Being a hospitalist attending is distinctly different than being a resident. It certainly is not being a “super-resident,” PGY-4, or PGY-17 for the team. When challenged with a new role and greater responsibility, it is natural to default to a more comfortable position (i.e., the hands-on mindset of the resident), but by doing so, you encroach on the work of the actual resident on your team. Adult learning theory teaches that it is responsibility that is the cornerstone of adult motivation. Trainees must have a chance to perform the work expected of their position without interference.

Let the resident be the resident. To reach this goal, set clear expectations and discuss the expectations up front. Make sure that you draw a sharp line between where the responsibility of the resident ends and yours begins. Have your resident help set her own expectations for the team, as well. This empowers the resident and also gives you insight into her view of the team dynamics. Your expectations should vary with the ability of the learner and the time of year. For example, the degree of autonomy that you may give a second-year resident in July is much less than what you might give a ready-to-graduate, third-year resident in June.

If granting autonomy makes you uncomfortable, observe your trainees from a distance for your own reassurance. Read the electronic medical record in depth; follow up on orders after attending rounds. If you don’t like a treatment decision, step in without inducing undue shame. After all, this is why residents are still in training, and it gives you the chance to demonstrate how to turn good care into great care.

2. Make Sure You Get to Know Your Trainees

Getting to know your trainees seems so simple that it often gets overlooked. Yet this may be the way your teaching and role modeling make their greatest impact. For adults to thrive in a learning environment, inclusion is key. There is no better way to feel included than to feel known. Inclusion allows learners to feel comfortable with being vulnerable by answering questions, asking questions, interacting, and participating in a meaningful manner on rounds. Consider your own behavior: How comfortable are you asking a question among a large audience of strangers versus asking the same question in a small group of friends? Inclusion will affect behavior.

Engage in “biographic rounds” near the start of your time together. As the attending, set the example by telling your trainees about yourself. Let them know where you are from, where you trained, what led you to choose hospital medicine, and some details about what you do in your spare time. Personal information will help break down the artificial walls that separate attendings from trainees.

Allow every member of your team to tell his or her story. It may not seem like much to you, but the effect on learners has been well established. If you invest in them, they will invest in the team.

3. Make Time to Observe Your Learners

You are responsible for evaluation and feedback of all your learners. Many factors contribute to poor feedback, but one of the most important is that new attendings often do not make a conscious effort to observe their learners. These attendings struggle to give meaningful feedback.

Take time and take notes:

• Take the time to watch your resident respond when the student is presenting her patient.
• Take time to allow the resident or intern to conduct bedside rounds on his patient.
• Take time to stop by on call to watch a student, intern, or resident take a history and perform a physical exam.

Even if you are unable to observe the whole encounter, there is little that gives you as much insight into your trainees as seeing them perform even part of a history and physical exam on a new patient. With time, a series of small observations will add up to a large number of specific comments.

Take notes on your trainees’ actions as you might do for your patients. This way, you have a record of what they did well and what needs work. Specific feedback will show that you paid attention and took the time to care about them as you would your patients.

4. Don’t Keep Your Thoughts to Yourself

Your job is akin to that of a syndicated columnist who is paid to give an informed narrative on the facts of the day. You must explain how the facts actually matter to patient care.

Think out loud. Explain your thoughts as much as possible. Do not assume that even your most senior trainees understand why you recommend a certain test or treatment. It is like algebra, where the teacher would never accept your answer unless you showed your work. For the sake of your learners, you must always “show your thinking.” They will learn as much from your clinical reasoning as they can from any canned talk on a subject.

5. Explicitly Plan Time for Teaching

“Thinking out loud” is a great way to teach, but a prepared talk can go into more depth on a topic. Yet how to find the time? The demands of a busy clinical service can overwhelm the best of intentions. Preparation is key. Good teaching does not happen by chance.

Set aside time for formal teaching outside of rounds. Be explicit as to when this will happen. Tell your team a day before, so they can prepare themselves or clear their time.

Have a handful of “canned” talks that you can give on topics related to common situations encountered in the hospital. They need not last more than 10 minutes. Always leave time for questions, and do your best to make them interactive. Even on a busy service, 10-15 minutes is reasonable for a brief, focused teaching session.

In Sum

Being an academic hospitalist with teaching responsibilities is highly rewarding. But becoming that next “great attending” requires an ongoing commitment to acquiring and developing your teaching skills.

Consider attending the SHM annual meeting or the Academic Hospitalist Academy to gain further knowledge on how to enhance your teaching career. In the meantime, try and practice some of the above tips—your learners may thank you. TH

Dr. Burger is associate program director of internal medicine residency in the Department of Medicine at Mount Sinai Beth Israel and assistant professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York City. Dr. Miller is chief of the division of general internal medicine, associate chair of education, and associate professor in the Department of Internal Medicine at Saint Louis University.

One of the challenges a new academic hospitalist faces is trying to become a valued member of the teaching faculty. You are intent on becoming that next great attending you have always aspired to be; however, no one has clearly guided you on making this transition. In our experience, a handful of common teaching pitfalls frequently unravel the best efforts of young hospitalists. Below, you will find five strategies to take your teaching to the next level.

1. Don’t Try to Be Attending AND Resident.

Being a hospitalist attending is distinctly different than being a resident. It certainly is not being a “super-resident,” PGY-4, or PGY-17 for the team. When challenged with a new role and greater responsibility, it is natural to default to a more comfortable position (i.e., the hands-on mindset of the resident), but by doing so, you encroach on the work of the actual resident on your team. Adult learning theory teaches that it is responsibility that is the cornerstone of adult motivation. Trainees must have a chance to perform the work expected of their position without interference.

Let the resident be the resident. To reach this goal, set clear expectations and discuss the expectations up front. Make sure that you draw a sharp line between where the responsibility of the resident ends and yours begins. Have your resident help set her own expectations for the team, as well. This empowers the resident and also gives you insight into her view of the team dynamics. Your expectations should vary with the ability of the learner and the time of year. For example, the degree of autonomy that you may give a second-year resident in July is much less than what you might give a ready-to-graduate, third-year resident in June.

If granting autonomy makes you uncomfortable, observe your trainees from a distance for your own reassurance. Read the electronic medical record in depth; follow up on orders after attending rounds. If you don’t like a treatment decision, step in without inducing undue shame. After all, this is why residents are still in training, and it gives you the chance to demonstrate how to turn good care into great care.

2. Make Sure You Get to Know Your Trainees

Getting to know your trainees seems so simple that it often gets overlooked. Yet this may be the way your teaching and role modeling make their greatest impact. For adults to thrive in a learning environment, inclusion is key. There is no better way to feel included than to feel known. Inclusion allows learners to feel comfortable with being vulnerable by answering questions, asking questions, interacting, and participating in a meaningful manner on rounds. Consider your own behavior: How comfortable are you asking a question among a large audience of strangers versus asking the same question in a small group of friends? Inclusion will affect behavior.

Engage in “biographic rounds” near the start of your time together. As the attending, set the example by telling your trainees about yourself. Let them know where you are from, where you trained, what led you to choose hospital medicine, and some details about what you do in your spare time. Personal information will help break down the artificial walls that separate attendings from trainees.

Allow every member of your team to tell his or her story. It may not seem like much to you, but the effect on learners has been well established. If you invest in them, they will invest in the team.

3. Make Time to Observe Your Learners

You are responsible for evaluation and feedback of all your learners. Many factors contribute to poor feedback, but one of the most important is that new attendings often do not make a conscious effort to observe their learners. These attendings struggle to give meaningful feedback.

Take time and take notes:

• Take the time to watch your resident respond when the student is presenting her patient.
• Take time to allow the resident or intern to conduct bedside rounds on his patient.
• Take time to stop by on call to watch a student, intern, or resident take a history and perform a physical exam.

Even if you are unable to observe the whole encounter, there is little that gives you as much insight into your trainees as seeing them perform even part of a history and physical exam on a new patient. With time, a series of small observations will add up to a large number of specific comments.

Take notes on your trainees’ actions as you might do for your patients. This way, you have a record of what they did well and what needs work. Specific feedback will show that you paid attention and took the time to care about them as you would your patients.

4. Don’t Keep Your Thoughts to Yourself

Your job is akin to that of a syndicated columnist who is paid to give an informed narrative on the facts of the day. You must explain how the facts actually matter to patient care.

Think out loud. Explain your thoughts as much as possible. Do not assume that even your most senior trainees understand why you recommend a certain test or treatment. It is like algebra, where the teacher would never accept your answer unless you showed your work. For the sake of your learners, you must always “show your thinking.” They will learn as much from your clinical reasoning as they can from any canned talk on a subject.

5. Explicitly Plan Time for Teaching

“Thinking out loud” is a great way to teach, but a prepared talk can go into more depth on a topic. Yet how to find the time? The demands of a busy clinical service can overwhelm the best of intentions. Preparation is key. Good teaching does not happen by chance.

Set aside time for formal teaching outside of rounds. Be explicit as to when this will happen. Tell your team a day before, so they can prepare themselves or clear their time.

Have a handful of “canned” talks that you can give on topics related to common situations encountered in the hospital. They need not last more than 10 minutes. Always leave time for questions, and do your best to make them interactive. Even on a busy service, 10-15 minutes is reasonable for a brief, focused teaching session.

In Sum

Being an academic hospitalist with teaching responsibilities is highly rewarding. But becoming that next “great attending” requires an ongoing commitment to acquiring and developing your teaching skills.

Consider attending the SHM annual meeting or the Academic Hospitalist Academy to gain further knowledge on how to enhance your teaching career. In the meantime, try and practice some of the above tips—your learners may thank you. TH

Dr. Burger is associate program director of internal medicine residency in the Department of Medicine at Mount Sinai Beth Israel and assistant professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York City. Dr. Miller is chief of the division of general internal medicine, associate chair of education, and associate professor in the Department of Internal Medicine at Saint Louis University.

 

 

Micrograph showing DLBCL

 

ORLANDO, FL—Updated results of a phase 1 study suggest the EZH2 inhibitor tazemetostat (EPZ-6438) can produce durable responses in patients with advanced non-Hodgkin lymphoma (NHL).

The drug has demonstrated activity against diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and marginal zone lymphoma (MZL).

The overall response rate among NHL patients in this study was 56%, and 1 patient has maintained a response for more than 21 months.

In addition, the drug’s safety profile is “still acceptable,” according to Vincent Ribrag, MD, of Institut Gustave Roussy in Villejuif, France.

Dr Ribrag presented the results of this study at the 2015 ASH Annual Meeting (abstract 473*). The research, which was previously presented at the 13th International Conference on Malignant Lymphoma, was sponsored by Epizyme, Inc., the company developing tazemetostat.

The trial has enrolled 58 patients, 21 with relapsed or refractory B-cell NHL and 37 with advanced solid tumors. The NHL cohort includes 5 patients with germinal center B-cell (GCB) DLBCL, 6 cases of non-GCB DLBCL, 3 DLBCL cases of an undetermined subtype, 6 patients with FL, and 1 case of MZL.

At baseline, the NHL patients had a median age of 63 (range, 24-84) and were heavily pretreated. Eighty-five percent of patients had received 3 or more prior therapies, and 33% had received 5 or more. Thirty-eight percent of patients had undergone an autologous transplant, and 57% had received radiotherapy.

The patients received tazemetostat twice daily at a range of doses. For the dose-escalation portion of the trial, they received 100 mg, 200 mg, 400 mg, 800 mg, or 1600 mg. For the dose-expansion phase, they received 800 mg or 1600 mg.

The researchers are now conducting a drug-drug interaction substudy in which patients receive 800 mg of tazemetostat twice daily and a food-effect substudy in which patients receive the drug at 400 mg twice daily.

Dr Ribrag said the recommended phase 2 dose of tazemetostat is 800 mg twice daily.

Safety

At the data cutoff point (November 7, 2015), 55 patients—20 with NHL and 35 with solid tumors—were evaluable for safety.

Treatment-related adverse events in these patients included asthenia (n=13), nausea (n=8), thrombocytopenia (n=7), dysgeusia (n=5), vomiting (n=5), dry skin (n=4), decreased appetite (n=4), diarrhea (n=4), muscle spasms (n=3), neutropenia (n=3), anemia (n=3), night sweats (n=3), hypertension (n=2), constipation (n=2), peripheral edema (n=2), hypophosphatemia (n=1), anxiety (n=1), depression (n=1), abdominal pain (n=1), and hepatocellular injury (n=1).

There were 4 grade 3 or higher adverse events that were considered treatment-related, including nausea, hypertension, neutropenia, and hepatocellular injury.

Efficacy

Sixteen of the NHL patients were evaluable for efficacy. Nine patients responded to treatment, 2 with complete responses (CRs) and 7 with partial responses (PRs).

Five of the 10 DLBCL patients responded, 4 with PRs and 1 with a CR. Three of the 5 FL patients responded, 2 with PRs and 1 with a CR. The patient with MZL achieved a PR.

Four responders remain on study—2 with DLBCL and 2 with FL.

One DLBCL patient with an EZH2 mutation (Y646H) had relapsed after or was refractory to 6 previous treatment regimens. This patient achieved a PR after 16 weeks of tazemetostat. The patient is still in PR at week 44 and remains on study.

Based on these results, Epizyme is currently enrolling patients in a phase 2 study of tazemetostat monotherapy. The trial is open to patients with DLBCL or FL in France, Australia, and the UK.

*Data in the abstract differ from the presentation.

 

 

Micrograph showing DLBCL

 

ORLANDO, FL—Updated results of a phase 1 study suggest the EZH2 inhibitor tazemetostat (EPZ-6438) can produce durable responses in patients with advanced non-Hodgkin lymphoma (NHL).

The drug has demonstrated activity against diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and marginal zone lymphoma (MZL).

The overall response rate among NHL patients in this study was 56%, and 1 patient has maintained a response for more than 21 months.

In addition, the drug’s safety profile is “still acceptable,” according to Vincent Ribrag, MD, of Institut Gustave Roussy in Villejuif, France.

Dr Ribrag presented the results of this study at the 2015 ASH Annual Meeting (abstract 473*). The research, which was previously presented at the 13th International Conference on Malignant Lymphoma, was sponsored by Epizyme, Inc., the company developing tazemetostat.

The trial has enrolled 58 patients, 21 with relapsed or refractory B-cell NHL and 37 with advanced solid tumors. The NHL cohort includes 5 patients with germinal center B-cell (GCB) DLBCL, 6 cases of non-GCB DLBCL, 3 DLBCL cases of an undetermined subtype, 6 patients with FL, and 1 case of MZL.

At baseline, the NHL patients had a median age of 63 (range, 24-84) and were heavily pretreated. Eighty-five percent of patients had received 3 or more prior therapies, and 33% had received 5 or more. Thirty-eight percent of patients had undergone an autologous transplant, and 57% had received radiotherapy.

The patients received tazemetostat twice daily at a range of doses. For the dose-escalation portion of the trial, they received 100 mg, 200 mg, 400 mg, 800 mg, or 1600 mg. For the dose-expansion phase, they received 800 mg or 1600 mg.

The researchers are now conducting a drug-drug interaction substudy in which patients receive 800 mg of tazemetostat twice daily and a food-effect substudy in which patients receive the drug at 400 mg twice daily.

Dr Ribrag said the recommended phase 2 dose of tazemetostat is 800 mg twice daily.

Safety

At the data cutoff point (November 7, 2015), 55 patients—20 with NHL and 35 with solid tumors—were evaluable for safety.

Treatment-related adverse events in these patients included asthenia (n=13), nausea (n=8), thrombocytopenia (n=7), dysgeusia (n=5), vomiting (n=5), dry skin (n=4), decreased appetite (n=4), diarrhea (n=4), muscle spasms (n=3), neutropenia (n=3), anemia (n=3), night sweats (n=3), hypertension (n=2), constipation (n=2), peripheral edema (n=2), hypophosphatemia (n=1), anxiety (n=1), depression (n=1), abdominal pain (n=1), and hepatocellular injury (n=1).

There were 4 grade 3 or higher adverse events that were considered treatment-related, including nausea, hypertension, neutropenia, and hepatocellular injury.

Efficacy

Sixteen of the NHL patients were evaluable for efficacy. Nine patients responded to treatment, 2 with complete responses (CRs) and 7 with partial responses (PRs).

Five of the 10 DLBCL patients responded, 4 with PRs and 1 with a CR. Three of the 5 FL patients responded, 2 with PRs and 1 with a CR. The patient with MZL achieved a PR.

Four responders remain on study—2 with DLBCL and 2 with FL.

One DLBCL patient with an EZH2 mutation (Y646H) had relapsed after or was refractory to 6 previous treatment regimens. This patient achieved a PR after 16 weeks of tazemetostat. The patient is still in PR at week 44 and remains on study.

Based on these results, Epizyme is currently enrolling patients in a phase 2 study of tazemetostat monotherapy. The trial is open to patients with DLBCL or FL in France, Australia, and the UK.

*Data in the abstract differ from the presentation.

 

 

Micrograph showing DLBCL

 

ORLANDO, FL—Updated results of a phase 1 study suggest the EZH2 inhibitor tazemetostat (EPZ-6438) can produce durable responses in patients with advanced non-Hodgkin lymphoma (NHL).

The drug has demonstrated activity against diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and marginal zone lymphoma (MZL).

The overall response rate among NHL patients in this study was 56%, and 1 patient has maintained a response for more than 21 months.

In addition, the drug’s safety profile is “still acceptable,” according to Vincent Ribrag, MD, of Institut Gustave Roussy in Villejuif, France.

Dr Ribrag presented the results of this study at the 2015 ASH Annual Meeting (abstract 473*). The research, which was previously presented at the 13th International Conference on Malignant Lymphoma, was sponsored by Epizyme, Inc., the company developing tazemetostat.

The trial has enrolled 58 patients, 21 with relapsed or refractory B-cell NHL and 37 with advanced solid tumors. The NHL cohort includes 5 patients with germinal center B-cell (GCB) DLBCL, 6 cases of non-GCB DLBCL, 3 DLBCL cases of an undetermined subtype, 6 patients with FL, and 1 case of MZL.

At baseline, the NHL patients had a median age of 63 (range, 24-84) and were heavily pretreated. Eighty-five percent of patients had received 3 or more prior therapies, and 33% had received 5 or more. Thirty-eight percent of patients had undergone an autologous transplant, and 57% had received radiotherapy.

The patients received tazemetostat twice daily at a range of doses. For the dose-escalation portion of the trial, they received 100 mg, 200 mg, 400 mg, 800 mg, or 1600 mg. For the dose-expansion phase, they received 800 mg or 1600 mg.

The researchers are now conducting a drug-drug interaction substudy in which patients receive 800 mg of tazemetostat twice daily and a food-effect substudy in which patients receive the drug at 400 mg twice daily.

Dr Ribrag said the recommended phase 2 dose of tazemetostat is 800 mg twice daily.

Safety

At the data cutoff point (November 7, 2015), 55 patients—20 with NHL and 35 with solid tumors—were evaluable for safety.

Treatment-related adverse events in these patients included asthenia (n=13), nausea (n=8), thrombocytopenia (n=7), dysgeusia (n=5), vomiting (n=5), dry skin (n=4), decreased appetite (n=4), diarrhea (n=4), muscle spasms (n=3), neutropenia (n=3), anemia (n=3), night sweats (n=3), hypertension (n=2), constipation (n=2), peripheral edema (n=2), hypophosphatemia (n=1), anxiety (n=1), depression (n=1), abdominal pain (n=1), and hepatocellular injury (n=1).

There were 4 grade 3 or higher adverse events that were considered treatment-related, including nausea, hypertension, neutropenia, and hepatocellular injury.

Efficacy

Sixteen of the NHL patients were evaluable for efficacy. Nine patients responded to treatment, 2 with complete responses (CRs) and 7 with partial responses (PRs).

Five of the 10 DLBCL patients responded, 4 with PRs and 1 with a CR. Three of the 5 FL patients responded, 2 with PRs and 1 with a CR. The patient with MZL achieved a PR.

Four responders remain on study—2 with DLBCL and 2 with FL.

One DLBCL patient with an EZH2 mutation (Y646H) had relapsed after or was refractory to 6 previous treatment regimens. This patient achieved a PR after 16 weeks of tazemetostat. The patient is still in PR at week 44 and remains on study.

Based on these results, Epizyme is currently enrolling patients in a phase 2 study of tazemetostat monotherapy. The trial is open to patients with DLBCL or FL in France, Australia, and the UK.

*Data in the abstract differ from the presentation.

Micrograph showing PMF

ORLANDO, FL—Having a higher grade of bone marrow (BM) fibrosis may confer inferior overall survival (OS) in patients with primary myelofibrosis (PMF), according to a retrospective study.

Investigators found that having a fibrosis grade of 2 or higher at diagnosis was associated with “unique clinical and molecular variables” that suggested a more aggressive disease phenotype.

And the median OS was significantly shorter in patients with higher grades of fibrosis.

However, when the investigators divided patients according to their International Prognostic Scoring System (IPSS) risk group, having a fibrosis grade of 2 or higher was only significantly associated with reduced OS among patients in the low-risk or intermediate-1-risk categories.

Paola Guglielmelli, MD, PhD, of the University of Florence in Italy, presented these findings at the 2015 ASH Annual Meeting (abstract 351*).

Dr Guglielmelli noted that the prognostic significance of BM fibrosis grade in PMF has been debated. So she and her colleagues set out to analyze the prognostic impact of fibrosis in 540 PMF patients from 6 Italian centers belonging to AGIMM (AIRC-Gruppo Italiano Malattie Mieloproliferative).

BM biopsies were obtained at diagnosis and evaluated by local pathologists according to 2008 World Health Organization criteria. The European consensus scoring system was used to grade fibrosis on a scale of MF-0 to MF-3.

Fifty patients were classified as MF-0 (9.3%), 180 were MF-1 (33.3%), 196 were MF-2 (36.3%), and 114 were MF-3 (21.1%).

Patients in the MF-2 and MF-3 groups were significantly more likely to have constitutional symptoms (P<0.0001), splenomegaly ≥10 cm from left costal margin (P<0.0001), a peripheral blast count ≥1% (P<0.0001), a greater risk of anemia (P<0.0001) or thrombocytopenia (P=0.001), and belong to the intermediate-2 or high-risk IPSS categories (P<0.0001).

In addition, patients in the MF-2 and MF-3 groups were significantly more likely to qualify as high-molecular-risk (HMR), which was defined as having at least 1 mutation in ASXL1, EZH2, SRSF2, or IDH1/2 (P<0.0001). The frequency of HMR patients increased progressively according to fibrosis grade: MF-0 (16%), MF-1 (25.6%), MF-2 (33.7%), and MF-3 (44.7%).

Patients with 2 or more HMR mutated genes were preferentially MF-2 or MF-3. None of the MF-0 patients fell into this category, compared to 4.4% for MF-1, 10.2% for MF-2, and 10.5% for MF-3 (P<0.0001).

Survival

The median OS was significantly shorter in patients with higher BM fibrosis grades (P<0.0001). The median OS was 7.2 years in the MF-3 group (hazard ratio [HR]=8.7), 6.7 years in the MF-2 group (HR=7.3), 14.7 years in the MF-1 group (HR=3.9), and not reached in the MF-0 group (reference).

In multivariable analysis, having a BM fibrosis grade of 2 or greater was significantly associated with reduced OS (HR=3.8, P=0.01).

Other variables significantly associated with reduced OS were being in the intermediate-1 (HR=2.9, P<0.0001), intermedicate-2 (HR=10.0, P<0.0001), or high-risk IPSS categories (HR=9.7, P<0.0001); having CALR type 2 mutation (HR=3.4, P=0.010), JAK2/MPL mutation (HR=2.4, P=0.003), or being triple-negative (HR=4.5, P<0.0001); being classified as HMR (HR=2.4, P<0.0001); and having 2 or more HMR mutations (HR=4.3, P=0.009).

Dr Guglielmelli and her colleagues also assessed the impact of BM fibrosis grade according to IPSS risk score.

They found that, for patients in the low/intermediate-1-risk categories, the median OS was not reached in the MF-0 group, was 22.8 years in the MF-1 group (HR=3.9), and was 15.4 years in the MF-2 and -3 groups combined (HR=7.4, P=0.001).

In the intermediate-2/high-risk categories, the median OS was 11 years for the MF-0 group, 3.6 years for the MF-1 group (HR=2.2), and 3.6 years in the MF-2 and -3 groups (HR=2.7, P=0.28).

Dr Guglielmelli therefore concluded that BM fibrosis grade might help refine prognostic stratification for PMF patients in the lower-risk IPSS categories. However, she noted that this study had limitations, and the results should be confirmed with prospective research.

*Data in the abstract differ from the presentation.

Micrograph showing PMF

ORLANDO, FL—Having a higher grade of bone marrow (BM) fibrosis may confer inferior overall survival (OS) in patients with primary myelofibrosis (PMF), according to a retrospective study.

Investigators found that having a fibrosis grade of 2 or higher at diagnosis was associated with “unique clinical and molecular variables” that suggested a more aggressive disease phenotype.

And the median OS was significantly shorter in patients with higher grades of fibrosis.

However, when the investigators divided patients according to their International Prognostic Scoring System (IPSS) risk group, having a fibrosis grade of 2 or higher was only significantly associated with reduced OS among patients in the low-risk or intermediate-1-risk categories.

Paola Guglielmelli, MD, PhD, of the University of Florence in Italy, presented these findings at the 2015 ASH Annual Meeting (abstract 351*).

Dr Guglielmelli noted that the prognostic significance of BM fibrosis grade in PMF has been debated. So she and her colleagues set out to analyze the prognostic impact of fibrosis in 540 PMF patients from 6 Italian centers belonging to AGIMM (AIRC-Gruppo Italiano Malattie Mieloproliferative).

BM biopsies were obtained at diagnosis and evaluated by local pathologists according to 2008 World Health Organization criteria. The European consensus scoring system was used to grade fibrosis on a scale of MF-0 to MF-3.

Fifty patients were classified as MF-0 (9.3%), 180 were MF-1 (33.3%), 196 were MF-2 (36.3%), and 114 were MF-3 (21.1%).

Patients in the MF-2 and MF-3 groups were significantly more likely to have constitutional symptoms (P<0.0001), splenomegaly ≥10 cm from left costal margin (P<0.0001), a peripheral blast count ≥1% (P<0.0001), a greater risk of anemia (P<0.0001) or thrombocytopenia (P=0.001), and belong to the intermediate-2 or high-risk IPSS categories (P<0.0001).

In addition, patients in the MF-2 and MF-3 groups were significantly more likely to qualify as high-molecular-risk (HMR), which was defined as having at least 1 mutation in ASXL1, EZH2, SRSF2, or IDH1/2 (P<0.0001). The frequency of HMR patients increased progressively according to fibrosis grade: MF-0 (16%), MF-1 (25.6%), MF-2 (33.7%), and MF-3 (44.7%).

Patients with 2 or more HMR mutated genes were preferentially MF-2 or MF-3. None of the MF-0 patients fell into this category, compared to 4.4% for MF-1, 10.2% for MF-2, and 10.5% for MF-3 (P<0.0001).

Survival

The median OS was significantly shorter in patients with higher BM fibrosis grades (P<0.0001). The median OS was 7.2 years in the MF-3 group (hazard ratio [HR]=8.7), 6.7 years in the MF-2 group (HR=7.3), 14.7 years in the MF-1 group (HR=3.9), and not reached in the MF-0 group (reference).

In multivariable analysis, having a BM fibrosis grade of 2 or greater was significantly associated with reduced OS (HR=3.8, P=0.01).

Other variables significantly associated with reduced OS were being in the intermediate-1 (HR=2.9, P<0.0001), intermedicate-2 (HR=10.0, P<0.0001), or high-risk IPSS categories (HR=9.7, P<0.0001); having CALR type 2 mutation (HR=3.4, P=0.010), JAK2/MPL mutation (HR=2.4, P=0.003), or being triple-negative (HR=4.5, P<0.0001); being classified as HMR (HR=2.4, P<0.0001); and having 2 or more HMR mutations (HR=4.3, P=0.009).

Dr Guglielmelli and her colleagues also assessed the impact of BM fibrosis grade according to IPSS risk score.

They found that, for patients in the low/intermediate-1-risk categories, the median OS was not reached in the MF-0 group, was 22.8 years in the MF-1 group (HR=3.9), and was 15.4 years in the MF-2 and -3 groups combined (HR=7.4, P=0.001).

In the intermediate-2/high-risk categories, the median OS was 11 years for the MF-0 group, 3.6 years for the MF-1 group (HR=2.2), and 3.6 years in the MF-2 and -3 groups (HR=2.7, P=0.28).

Dr Guglielmelli therefore concluded that BM fibrosis grade might help refine prognostic stratification for PMF patients in the lower-risk IPSS categories. However, she noted that this study had limitations, and the results should be confirmed with prospective research.

*Data in the abstract differ from the presentation.

Micrograph showing PMF

ORLANDO, FL—Having a higher grade of bone marrow (BM) fibrosis may confer inferior overall survival (OS) in patients with primary myelofibrosis (PMF), according to a retrospective study.

Investigators found that having a fibrosis grade of 2 or higher at diagnosis was associated with “unique clinical and molecular variables” that suggested a more aggressive disease phenotype.

And the median OS was significantly shorter in patients with higher grades of fibrosis.

However, when the investigators divided patients according to their International Prognostic Scoring System (IPSS) risk group, having a fibrosis grade of 2 or higher was only significantly associated with reduced OS among patients in the low-risk or intermediate-1-risk categories.

Paola Guglielmelli, MD, PhD, of the University of Florence in Italy, presented these findings at the 2015 ASH Annual Meeting (abstract 351*).

Dr Guglielmelli noted that the prognostic significance of BM fibrosis grade in PMF has been debated. So she and her colleagues set out to analyze the prognostic impact of fibrosis in 540 PMF patients from 6 Italian centers belonging to AGIMM (AIRC-Gruppo Italiano Malattie Mieloproliferative).

BM biopsies were obtained at diagnosis and evaluated by local pathologists according to 2008 World Health Organization criteria. The European consensus scoring system was used to grade fibrosis on a scale of MF-0 to MF-3.

Fifty patients were classified as MF-0 (9.3%), 180 were MF-1 (33.3%), 196 were MF-2 (36.3%), and 114 were MF-3 (21.1%).

Patients in the MF-2 and MF-3 groups were significantly more likely to have constitutional symptoms (P<0.0001), splenomegaly ≥10 cm from left costal margin (P<0.0001), a peripheral blast count ≥1% (P<0.0001), a greater risk of anemia (P<0.0001) or thrombocytopenia (P=0.001), and belong to the intermediate-2 or high-risk IPSS categories (P<0.0001).

In addition, patients in the MF-2 and MF-3 groups were significantly more likely to qualify as high-molecular-risk (HMR), which was defined as having at least 1 mutation in ASXL1, EZH2, SRSF2, or IDH1/2 (P<0.0001). The frequency of HMR patients increased progressively according to fibrosis grade: MF-0 (16%), MF-1 (25.6%), MF-2 (33.7%), and MF-3 (44.7%).

Patients with 2 or more HMR mutated genes were preferentially MF-2 or MF-3. None of the MF-0 patients fell into this category, compared to 4.4% for MF-1, 10.2% for MF-2, and 10.5% for MF-3 (P<0.0001).

Survival

The median OS was significantly shorter in patients with higher BM fibrosis grades (P<0.0001). The median OS was 7.2 years in the MF-3 group (hazard ratio [HR]=8.7), 6.7 years in the MF-2 group (HR=7.3), 14.7 years in the MF-1 group (HR=3.9), and not reached in the MF-0 group (reference).

In multivariable analysis, having a BM fibrosis grade of 2 or greater was significantly associated with reduced OS (HR=3.8, P=0.01).

Other variables significantly associated with reduced OS were being in the intermediate-1 (HR=2.9, P<0.0001), intermedicate-2 (HR=10.0, P<0.0001), or high-risk IPSS categories (HR=9.7, P<0.0001); having CALR type 2 mutation (HR=3.4, P=0.010), JAK2/MPL mutation (HR=2.4, P=0.003), or being triple-negative (HR=4.5, P<0.0001); being classified as HMR (HR=2.4, P<0.0001); and having 2 or more HMR mutations (HR=4.3, P=0.009).

Dr Guglielmelli and her colleagues also assessed the impact of BM fibrosis grade according to IPSS risk score.

They found that, for patients in the low/intermediate-1-risk categories, the median OS was not reached in the MF-0 group, was 22.8 years in the MF-1 group (HR=3.9), and was 15.4 years in the MF-2 and -3 groups combined (HR=7.4, P=0.001).

In the intermediate-2/high-risk categories, the median OS was 11 years for the MF-0 group, 3.6 years for the MF-1 group (HR=2.2), and 3.6 years in the MF-2 and -3 groups (HR=2.7, P=0.28).

Dr Guglielmelli therefore concluded that BM fibrosis grade might help refine prognostic stratification for PMF patients in the lower-risk IPSS categories. However, she noted that this study had limitations, and the results should be confirmed with prospective research.

*Data in the abstract differ from the presentation.

Jinghui Zhang, PhD, (left)

and Xin Zhou, PhD

Photo by Peter Barta/St. Jude

Children’s Research Hospital

Researchers say they have developed a tool that may advance our understanding of the mutations that drive pediatric cancers.

The tool, called ProteinPaint, is a web application that allows the user to visualize genetic lesions and RNA expression in pediatric cancers.

ProteinPaint’s infographics let users see all mutations in individual genes and their corresponding proteins, including detailed information about mutation type, frequency in cancer subtype, and location in the protein domain.

That information provides clues about how a change might contribute to cancer’s start, progression, or relapse.

Jinghui Zhang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and her colleagues described ProteinPaint in a letter to Nature Genetics.

ProteinPaint currently integrates information from 5 studies, but Dr Zhang and her colleagues said the data will be updated as new studies are published.

ProteinPaint now includes information on almost 27,500 mutations discovered in more than 1000 pediatric patients with 21 cancer subtypes. The application also includes RNA-sequencing data from 928 pediatric tumors belonging to 36 different subtypes.

Xin Zhou, PhD, also of St. Jude, developed ProteinPaint’s infographics to display the genomic information in an interactive format. A click of the mouse gives users additional details about the mutations listed, including the pediatric cancer subtype where the change has been validated and a link to the publication.

“ProteinPaint’s focus on pediatric cancer and presentation of mutations at the gene level complements existing cancer genome data portals,” Dr Zhang said. “For St. Jude, the application is the foundation for developing a global reference database for information about pediatric cancer.”

Dr Zhou added that the ProteinPaint software has the potential to help researchers studying other disorders, including sickle cell disease, that involve a mutation that affects protein function.

ProteinPaint is available at no cost to academic researchers who are free to use the tool to analyze their own data. The application also lets researchers compare information about pediatric and adult cancer genomes by providing a parallel view of data from COSMIC, the world’s largest database of somatic mutations, primarily from adult cancer.

ProteinPaint has already been used to study the role played by germline mutations in pediatric cancers. That research was published in NEJM in November.

More information about ProteinPaint is available on the St. Jude PeCan Data Portal.

Jinghui Zhang, PhD, (left)

and Xin Zhou, PhD

Photo by Peter Barta/St. Jude

Children’s Research Hospital

Researchers say they have developed a tool that may advance our understanding of the mutations that drive pediatric cancers.

The tool, called ProteinPaint, is a web application that allows the user to visualize genetic lesions and RNA expression in pediatric cancers.

ProteinPaint’s infographics let users see all mutations in individual genes and their corresponding proteins, including detailed information about mutation type, frequency in cancer subtype, and location in the protein domain.

That information provides clues about how a change might contribute to cancer’s start, progression, or relapse.

Jinghui Zhang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and her colleagues described ProteinPaint in a letter to Nature Genetics.

ProteinPaint currently integrates information from 5 studies, but Dr Zhang and her colleagues said the data will be updated as new studies are published.

ProteinPaint now includes information on almost 27,500 mutations discovered in more than 1000 pediatric patients with 21 cancer subtypes. The application also includes RNA-sequencing data from 928 pediatric tumors belonging to 36 different subtypes.

Xin Zhou, PhD, also of St. Jude, developed ProteinPaint’s infographics to display the genomic information in an interactive format. A click of the mouse gives users additional details about the mutations listed, including the pediatric cancer subtype where the change has been validated and a link to the publication.

“ProteinPaint’s focus on pediatric cancer and presentation of mutations at the gene level complements existing cancer genome data portals,” Dr Zhang said. “For St. Jude, the application is the foundation for developing a global reference database for information about pediatric cancer.”

Dr Zhou added that the ProteinPaint software has the potential to help researchers studying other disorders, including sickle cell disease, that involve a mutation that affects protein function.

ProteinPaint is available at no cost to academic researchers who are free to use the tool to analyze their own data. The application also lets researchers compare information about pediatric and adult cancer genomes by providing a parallel view of data from COSMIC, the world’s largest database of somatic mutations, primarily from adult cancer.

ProteinPaint has already been used to study the role played by germline mutations in pediatric cancers. That research was published in NEJM in November.

More information about ProteinPaint is available on the St. Jude PeCan Data Portal.

Jinghui Zhang, PhD, (left)

and Xin Zhou, PhD

Photo by Peter Barta/St. Jude

Children’s Research Hospital

Researchers say they have developed a tool that may advance our understanding of the mutations that drive pediatric cancers.

The tool, called ProteinPaint, is a web application that allows the user to visualize genetic lesions and RNA expression in pediatric cancers.

ProteinPaint’s infographics let users see all mutations in individual genes and their corresponding proteins, including detailed information about mutation type, frequency in cancer subtype, and location in the protein domain.

That information provides clues about how a change might contribute to cancer’s start, progression, or relapse.

Jinghui Zhang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and her colleagues described ProteinPaint in a letter to Nature Genetics.

ProteinPaint currently integrates information from 5 studies, but Dr Zhang and her colleagues said the data will be updated as new studies are published.

ProteinPaint now includes information on almost 27,500 mutations discovered in more than 1000 pediatric patients with 21 cancer subtypes. The application also includes RNA-sequencing data from 928 pediatric tumors belonging to 36 different subtypes.

Xin Zhou, PhD, also of St. Jude, developed ProteinPaint’s infographics to display the genomic information in an interactive format. A click of the mouse gives users additional details about the mutations listed, including the pediatric cancer subtype where the change has been validated and a link to the publication.

“ProteinPaint’s focus on pediatric cancer and presentation of mutations at the gene level complements existing cancer genome data portals,” Dr Zhang said. “For St. Jude, the application is the foundation for developing a global reference database for information about pediatric cancer.”

Dr Zhou added that the ProteinPaint software has the potential to help researchers studying other disorders, including sickle cell disease, that involve a mutation that affects protein function.

ProteinPaint is available at no cost to academic researchers who are free to use the tool to analyze their own data. The application also lets researchers compare information about pediatric and adult cancer genomes by providing a parallel view of data from COSMIC, the world’s largest database of somatic mutations, primarily from adult cancer.

ProteinPaint has already been used to study the role played by germline mutations in pediatric cancers. That research was published in NEJM in November.

More information about ProteinPaint is available on the St. Jude PeCan Data Portal.

Researcher on a computer

Photo by Darren Baker

A computer model that employs techniques used to analyze social networks could aid the development of new cancer treatments, according to researchers.

The model analyzes the unique behaviors of cancer-causing proteins, spotting what makes them different from normal proteins and mapping out molecular targets for drugs that could potentially be developed to treat cancers.

The researchers described this model in PLOS Computational Biology.

Bissan Al-Lazikani, PhD, of The Institute of Cancer Research in London, UK, and her colleagues compared proteins to members of an enormous social network, mapping the ways they interact. This allowed the team to predict which proteins might be most effectively targeted with drugs.

Cancer-causing proteins that have already been successfully targeted tended to have particular “social” characteristics that differed from non-cancer proteins. “Hub-like” proteins that were shown to “communicate” with lots of other proteins were more likely to cause cancers.

The researchers said this suggests that previously unexplored cancer proteins with similar characteristics could make good drug targets.

“Our study is the first to identify the rules of social behavior of cancer proteins and use it to predict new targets for potential cancer drugs,” Dr Al-Lazikani said.

“It shows that cancer drug targets behave very differently from normal proteins and often have a complex web of social interactions. Finding new targets is one of the most important steps in drug discovery, but it can be a lengthy, expensive process.”

“The map that we’ve made will help researchers design better new drugs, more quickly, saving time and money. It also sheds light on how resistance to treatments may occur and, in just a few years, could help doctors choose the best drug combinations to suit individual patients.”

All of the researchers’ target predictions are available on the canSAR website. The underlying data and tools are also available on the site.

Researcher on a computer

Photo by Darren Baker

A computer model that employs techniques used to analyze social networks could aid the development of new cancer treatments, according to researchers.

The model analyzes the unique behaviors of cancer-causing proteins, spotting what makes them different from normal proteins and mapping out molecular targets for drugs that could potentially be developed to treat cancers.

The researchers described this model in PLOS Computational Biology.

Bissan Al-Lazikani, PhD, of The Institute of Cancer Research in London, UK, and her colleagues compared proteins to members of an enormous social network, mapping the ways they interact. This allowed the team to predict which proteins might be most effectively targeted with drugs.

Cancer-causing proteins that have already been successfully targeted tended to have particular “social” characteristics that differed from non-cancer proteins. “Hub-like” proteins that were shown to “communicate” with lots of other proteins were more likely to cause cancers.

The researchers said this suggests that previously unexplored cancer proteins with similar characteristics could make good drug targets.

“Our study is the first to identify the rules of social behavior of cancer proteins and use it to predict new targets for potential cancer drugs,” Dr Al-Lazikani said.

“It shows that cancer drug targets behave very differently from normal proteins and often have a complex web of social interactions. Finding new targets is one of the most important steps in drug discovery, but it can be a lengthy, expensive process.”

“The map that we’ve made will help researchers design better new drugs, more quickly, saving time and money. It also sheds light on how resistance to treatments may occur and, in just a few years, could help doctors choose the best drug combinations to suit individual patients.”

All of the researchers’ target predictions are available on the canSAR website. The underlying data and tools are also available on the site.

Researcher on a computer

Photo by Darren Baker

A computer model that employs techniques used to analyze social networks could aid the development of new cancer treatments, according to researchers.

The model analyzes the unique behaviors of cancer-causing proteins, spotting what makes them different from normal proteins and mapping out molecular targets for drugs that could potentially be developed to treat cancers.

The researchers described this model in PLOS Computational Biology.

Bissan Al-Lazikani, PhD, of The Institute of Cancer Research in London, UK, and her colleagues compared proteins to members of an enormous social network, mapping the ways they interact. This allowed the team to predict which proteins might be most effectively targeted with drugs.

Cancer-causing proteins that have already been successfully targeted tended to have particular “social” characteristics that differed from non-cancer proteins. “Hub-like” proteins that were shown to “communicate” with lots of other proteins were more likely to cause cancers.

The researchers said this suggests that previously unexplored cancer proteins with similar characteristics could make good drug targets.

“Our study is the first to identify the rules of social behavior of cancer proteins and use it to predict new targets for potential cancer drugs,” Dr Al-Lazikani said.

“It shows that cancer drug targets behave very differently from normal proteins and often have a complex web of social interactions. Finding new targets is one of the most important steps in drug discovery, but it can be a lengthy, expensive process.”

“The map that we’ve made will help researchers design better new drugs, more quickly, saving time and money. It also sheds light on how resistance to treatments may occur and, in just a few years, could help doctors choose the best drug combinations to suit individual patients.”

All of the researchers’ target predictions are available on the canSAR website. The underlying data and tools are also available on the site.

When the Affordable Care Act (ACA) was passed in 2010, it represented an intended shift from reactive medicine, with its focus on acute and urgent needs, to a model focused on disease prevention.

OBG Management readers know about the important women’s health services ensured by the ACA, including well-woman care, as well as the key role played by the American Congress of Obstetricians and Gynecologists (ACOG) in winning this coverage. ACOG worked closely with the Institute of Medicine (IOM) to help define this set of services. And the ACA ensured that women have access to these services, often without copays and deductibles.

ACOG and the National Women’s Law Center (NWLC) work closely on many issues. At first independently and then together, the 2 organizations set out to explore some fundamental issues:

• How does a woman experience the new well-woman benefit when she visits her doctor?
• Does she receive a consistent care set?
• Do some patients have copays while patients in other clinics do not for the same services?
• What does well-woman care mean from one doctor to another, from an ObGyn to an internist to a family physician?

This article explores these issues.

2 initiatives focused on components of women’s health care
During her tenure as president of ACOG, Jeanne Conry, MD, PhD, decided to tackle clinical issues associated with well-woman care. She convened a Well-Woman Task Force, led by Haywood Brown, MD, and included the NWLC among other partner organizations (TABLE).

Table. Partipating organizations of the ACOG Well-Woman Task Force
• American Academy of Family Physicians
• American Academy of Pediatrics
• American Academy of Physician Assistants
• American College of Nurse–Midwives
• American College of Osteopathic Obstetricians and Gynecologists
• Association of Reproductive Health Professionals
• Association of Women’s Health, Obstetric, and Neonatal Nurses
• National Association of Nurse Practitioners in Women’s Health
• National Medical Association
• National Women’s Law Center
• Planned Parenthood Federation of America
• Society for Maternal-Fetal Medicine
• Society of Academic Specialists in General Obstetrics and Gynecology
• Society of Gynecologic Oncology

The NWLC and Brigham and Women’s Hospital also partnered with ACOG and others to help ensure a consistent patient experience. These 2 closely related initiatives were designed to work together to help patients and physicians understand and benefit from new coverage under the ACA.

1. How does a woman experience well-woman care?
Experts associated with these 2 initiatives recognized that well-woman care includes attention to the history, physical examination, counseling, and screening intended to maintain physical, mental, and social wellbeing and general health throughout a woman’s lifespan. Experts also recognized that the ACA guarantees coverage of at least one annual well-woman visit, although not all of the recommended components necessarily would be performed at the same visit or by the same provider.

For many women who have gained insurance coverage under the ACA, the well-woman visit represents their entry into the insured health care system. These women may have limited understanding of the services they should receive during this visit.

To address this issue, the NWLC invited ACOG to participate in its initiative with Brigham and Women’s Hospital to understand the well-woman visit from the patient’s point of view. This effort yielded patient education materials in English and Spanish that help women understand:

• that their health insurance now covers a well-woman visit
• what care is included in that visit
• that there is no deductible or copay for this visit
• how to prepare for this visit
• what questions to ask during the visit.

These materials help women understand that the purpose of the well-woman visit is to provide them with a chance to:

• “receive care and counseling that is appropriate, based on age, cognitive development, and life experience
• review their current health and risks to their health with their health care professional
• ask any questions they may have about their health or risk factors
• talk about what they can do to prevent future health problems
• build a trusting relationship with their health care provider, with an emphasis on confidentiality
• receive appropriate preventive screenings and immunizations and make sure they know which screenings and immunizations they should receive in the future
• review their reproductive plan and contraceptive choices.”¹                 

The materials also advise patients that they may be asked about:

• current health concerns
• current medications, both prescription and over the counter
• family history on both the mother’s and father’s sides
• life management, including family relationships, work, and stress
• substance use habits, including alcohol and tobacco
• sexual activity
• eating habits and physical activity
• past reproductive health experience and any pregnancy complications
• any memory problems (older women)
• screening for depression, anxiety, substance use disorders, and interpersonal violence.

To view some of these materials, visit http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf.

2. Does each woman receive consistent well-woman care?
ACOG’s Well-Woman Task Force was shaped by an awareness that many medical societies and government agencies provide recommendations and guidelines about the basic elements of women’s health. While these recommendations and guidelines all may be based on evidence and expert opinion, the recommendations vary. A goal of the task force was to work with providers across the women’s health spectrum to find consensus and provide guidance to women and clinicians with age-appropriate recommendations for a well-woman visit.

In the fall of 2015, the task force’s findings were published in an article entitled “Components of the well-woman visit” in the journal Obstetrics & Gynecology.² Those findings outline a core set of well-woman care practices across a woman’s lifespan, from adolescence through the reproductive years and into maturity, and they are usable by any provider who cares for adolescent girls or women.

ACOG has summarized its well-woman recommendations, by age, on its website,³ at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.

3. Do all women have a copay for the well-woman visit?
Because research has revealed that any type of copay or deductible for preventive care significantly lessens the likelihood that patients will seek out such care, the ACA sought to make basic preventive care available without cost sharing.⁴

The US Department of Health and Human Services notes that: “The Affordable Care Act requires most health plans to cover recommended preventive services without cost sharing. In 2011 and 2012, 71 million Americans with private health insurance gained access to preventive services with no cost sharing because of the law.”⁴

Grandfathered plans (those created or sold before March 23, 2010) are exempt from this requirement, as are Medicare, TRICARE, and traditional Medicaid plans.

4. What does well-woman care mean from one doctor to another?
Under the ACA, well-woman care can be provided by a “wide range of providers, including family physicians, internists, nurse–midwives, nurse practitioners, obstetrician-gynecologists, pediatricians, and physician assistants,” depending on the age of the patient, her particular needs and preferences, and access to health services.²

The ACOG Well-Woman Task Force “focused on delineating the well-woman visit throughout the lifespan, across all providers and health plans.”²

In determining the components of well-woman care, ACOG’s task force compiled existing guidelines from many sources, including the Department of Health and Human Services, the IOM, the US Preventive Services Task Force, and each member organization.

Members categorized guidelines as:

• single source (eg, abdominal examination)
• no agreement (breast cancer/mammography screening)
• limited agreement (pelvic examination)
• general agreement (hypertension, osteoporosis)
• sound agreement (screening for sexually transmitted infections)

The task force also agreed that final recommendations would rely on evidence-based guidelines, evidence-informed guidelines, and uniform expert agreement. Recommendations were considered “strong” if they relied primarily on evidence-based or evidence-informed guidelines and “qualified” if they relied primarily on expert consensus.

Guidelines were further separated into age bands:

• adolescents (13–18 years)
• reproductive-aged women (19–45 years)
• mature women (46–64 years)
• women older than 64 years.

The task force recommended that, during the well-woman visit, health care professionals educate patients about:

• healthy eating habits and maintenance of healthy weight
• exercise and physical activity
• seat belt use
• risk factors for certain types of cancer
• heart health
• breast health
• bone health
• safer sex practices and prevention of sexually transmitted infections
• healthy interpersonal relationships
• prevention and management of chronic disease
• resources for the patient (online, written, community, patient groups)
• medication use
• fall prevention.

Health care providers also should counsel patients regarding:

• recommended preventive screenings and immunizations
• any concerns about mood, such as prolonged periods of sadness, a failure to enjoy what they usually find pleasant, or anxiety or irritability that seems out of proportion to events
• what to expect in terms of effects on mood and anxiety at reproductive life transitions, including menarche, pregnancy, the postpartum period, and perimenopause
• body image issues
• what to expect in terms of the menstrual cycle during perimenopause and menopause
• reproductive health or fertility concerns
• reproductive life planning (contraception appropriate for life stage, reproductive plans, and risk factors, including risk factors for breast and ovarian cancer and cardiovascular disease)
• pregnancy planning, including attaining and maintaining a healthy weight and managing any chronic conditions before or during pregnancy
• what to expect during menopause, including signs and symptoms and options for addressing symptoms (midlife and older women)
• symptoms of cardiovascular disease
• urinary incontinence.

The task force acknowledged that not all of these recommendations can be carried out at a single well-woman visit or by a single provider.

See, again, ACOG’s specific well-woman recommendations, by age range, at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.³

How to winnow a long list of recommendations to determine the most pressing issues for a specific patient
In an editorial accompanying the ACOG Well-Woman Task Force report, entitled “Re-envisioning the annual well-woman visit: the task forward,” George F. Sawaya, MD, of the University of California, San Francisco, devised a plan to determine the most pressing well-woman needs for a specific patient.¹ He chose as an example a 41-year-old sexually active woman who does not smoke.

While Dr. Sawaya praised the Well-Woman Task Force recommendations for their “comprehensive scope,” he also noted that the sheer number of recommendations might be “overwhelming and difficult to navigate.”¹ One tool for winnowing the recommendations comes from the Agency for Healthcare Research and Quality, which offers an Electronic Preventive Services Selector (http://epss.ahrq.gov/PDA/index.jsp), available both online and as a smartphone app. Once the clinician plugs in the patient’s age and a few risk factors, the tool generates a list of recommended preventive services. This list of services has been evaluated by the US Preventive Services Task Force, with each recommendation graded “A” through “D,” based on benefits versus harms.

Back to that 41-year-old sexually active woman: Using the Electronic Preventive Services Selector, a list of as many as 20 grade A and B recommendations would be generated. However, only 3 of them would be grade A (screening for cervical cancer, HIV, and high blood pressure). An additional 2 grade B recommendations might apply to an average-risk patient such as this: screening for alcohol misuse and depression. All 5 services fall within the Well-Woman Task Force’s recommendations. They also have “good face validity with clinicians as being important, so it seems reasonable that these be prioritized above the others, at least at the first visit,” Dr. Sawaya says.¹

Clinicians can use a similar strategy for patients of various ages and risk factors.

Reference
1. Sawaya GF. Re-envisioning the annual well-woman visit: the task forward [editorial]. Obstet Gynecol. 2015;126(4):695–696.

The bottom line
By defining and implementing the foundational elements of women’s health, we can improve care for all women and ensure, as Dr. Conry emphasized during her tenure as ACOG president, “that every woman gets the care she needs, every time.”

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

When the Affordable Care Act (ACA) was passed in 2010, it represented an intended shift from reactive medicine, with its focus on acute and urgent needs, to a model focused on disease prevention.

OBG Management readers know about the important women’s health services ensured by the ACA, including well-woman care, as well as the key role played by the American Congress of Obstetricians and Gynecologists (ACOG) in winning this coverage. ACOG worked closely with the Institute of Medicine (IOM) to help define this set of services. And the ACA ensured that women have access to these services, often without copays and deductibles.

ACOG and the National Women’s Law Center (NWLC) work closely on many issues. At first independently and then together, the 2 organizations set out to explore some fundamental issues:

• How does a woman experience the new well-woman benefit when she visits her doctor?
• Does she receive a consistent care set?
• Do some patients have copays while patients in other clinics do not for the same services?
• What does well-woman care mean from one doctor to another, from an ObGyn to an internist to a family physician?

This article explores these issues.

2 initiatives focused on components of women’s health care
During her tenure as president of ACOG, Jeanne Conry, MD, PhD, decided to tackle clinical issues associated with well-woman care. She convened a Well-Woman Task Force, led by Haywood Brown, MD, and included the NWLC among other partner organizations (TABLE).

Table. Partipating organizations of the ACOG Well-Woman Task Force
• American Academy of Family Physicians
• American Academy of Pediatrics
• American Academy of Physician Assistants
• American College of Nurse–Midwives
• American College of Osteopathic Obstetricians and Gynecologists
• Association of Reproductive Health Professionals
• Association of Women’s Health, Obstetric, and Neonatal Nurses
• National Association of Nurse Practitioners in Women’s Health
• National Medical Association
• National Women’s Law Center
• Planned Parenthood Federation of America
• Society for Maternal-Fetal Medicine
• Society of Academic Specialists in General Obstetrics and Gynecology
• Society of Gynecologic Oncology

The NWLC and Brigham and Women’s Hospital also partnered with ACOG and others to help ensure a consistent patient experience. These 2 closely related initiatives were designed to work together to help patients and physicians understand and benefit from new coverage under the ACA.

1. How does a woman experience well-woman care?
Experts associated with these 2 initiatives recognized that well-woman care includes attention to the history, physical examination, counseling, and screening intended to maintain physical, mental, and social wellbeing and general health throughout a woman’s lifespan. Experts also recognized that the ACA guarantees coverage of at least one annual well-woman visit, although not all of the recommended components necessarily would be performed at the same visit or by the same provider.

For many women who have gained insurance coverage under the ACA, the well-woman visit represents their entry into the insured health care system. These women may have limited understanding of the services they should receive during this visit.

To address this issue, the NWLC invited ACOG to participate in its initiative with Brigham and Women’s Hospital to understand the well-woman visit from the patient’s point of view. This effort yielded patient education materials in English and Spanish that help women understand:

• that their health insurance now covers a well-woman visit
• what care is included in that visit
• that there is no deductible or copay for this visit
• how to prepare for this visit
• what questions to ask during the visit.

These materials help women understand that the purpose of the well-woman visit is to provide them with a chance to:

• “receive care and counseling that is appropriate, based on age, cognitive development, and life experience
• review their current health and risks to their health with their health care professional
• ask any questions they may have about their health or risk factors
• talk about what they can do to prevent future health problems
• build a trusting relationship with their health care provider, with an emphasis on confidentiality
• receive appropriate preventive screenings and immunizations and make sure they know which screenings and immunizations they should receive in the future
• review their reproductive plan and contraceptive choices.”¹                 

The materials also advise patients that they may be asked about:

• current health concerns
• current medications, both prescription and over the counter
• family history on both the mother’s and father’s sides
• life management, including family relationships, work, and stress
• substance use habits, including alcohol and tobacco
• sexual activity
• eating habits and physical activity
• past reproductive health experience and any pregnancy complications
• any memory problems (older women)
• screening for depression, anxiety, substance use disorders, and interpersonal violence.

To view some of these materials, visit http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf.

2. Does each woman receive consistent well-woman care?
ACOG’s Well-Woman Task Force was shaped by an awareness that many medical societies and government agencies provide recommendations and guidelines about the basic elements of women’s health. While these recommendations and guidelines all may be based on evidence and expert opinion, the recommendations vary. A goal of the task force was to work with providers across the women’s health spectrum to find consensus and provide guidance to women and clinicians with age-appropriate recommendations for a well-woman visit.

In the fall of 2015, the task force’s findings were published in an article entitled “Components of the well-woman visit” in the journal Obstetrics & Gynecology.² Those findings outline a core set of well-woman care practices across a woman’s lifespan, from adolescence through the reproductive years and into maturity, and they are usable by any provider who cares for adolescent girls or women.

ACOG has summarized its well-woman recommendations, by age, on its website,³ at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.

3. Do all women have a copay for the well-woman visit?
Because research has revealed that any type of copay or deductible for preventive care significantly lessens the likelihood that patients will seek out such care, the ACA sought to make basic preventive care available without cost sharing.⁴

The US Department of Health and Human Services notes that: “The Affordable Care Act requires most health plans to cover recommended preventive services without cost sharing. In 2011 and 2012, 71 million Americans with private health insurance gained access to preventive services with no cost sharing because of the law.”⁴

Grandfathered plans (those created or sold before March 23, 2010) are exempt from this requirement, as are Medicare, TRICARE, and traditional Medicaid plans.

4. What does well-woman care mean from one doctor to another?
Under the ACA, well-woman care can be provided by a “wide range of providers, including family physicians, internists, nurse–midwives, nurse practitioners, obstetrician-gynecologists, pediatricians, and physician assistants,” depending on the age of the patient, her particular needs and preferences, and access to health services.²

The ACOG Well-Woman Task Force “focused on delineating the well-woman visit throughout the lifespan, across all providers and health plans.”²

In determining the components of well-woman care, ACOG’s task force compiled existing guidelines from many sources, including the Department of Health and Human Services, the IOM, the US Preventive Services Task Force, and each member organization.

Members categorized guidelines as:

• single source (eg, abdominal examination)
• no agreement (breast cancer/mammography screening)
• limited agreement (pelvic examination)
• general agreement (hypertension, osteoporosis)
• sound agreement (screening for sexually transmitted infections)

The task force also agreed that final recommendations would rely on evidence-based guidelines, evidence-informed guidelines, and uniform expert agreement. Recommendations were considered “strong” if they relied primarily on evidence-based or evidence-informed guidelines and “qualified” if they relied primarily on expert consensus.

Guidelines were further separated into age bands:

• adolescents (13–18 years)
• reproductive-aged women (19–45 years)
• mature women (46–64 years)
• women older than 64 years.

The task force recommended that, during the well-woman visit, health care professionals educate patients about:

• healthy eating habits and maintenance of healthy weight
• exercise and physical activity
• seat belt use
• risk factors for certain types of cancer
• heart health
• breast health
• bone health
• safer sex practices and prevention of sexually transmitted infections
• healthy interpersonal relationships
• prevention and management of chronic disease
• resources for the patient (online, written, community, patient groups)
• medication use
• fall prevention.

Health care providers also should counsel patients regarding:

• recommended preventive screenings and immunizations
• any concerns about mood, such as prolonged periods of sadness, a failure to enjoy what they usually find pleasant, or anxiety or irritability that seems out of proportion to events
• what to expect in terms of effects on mood and anxiety at reproductive life transitions, including menarche, pregnancy, the postpartum period, and perimenopause
• body image issues
• what to expect in terms of the menstrual cycle during perimenopause and menopause
• reproductive health or fertility concerns
• reproductive life planning (contraception appropriate for life stage, reproductive plans, and risk factors, including risk factors for breast and ovarian cancer and cardiovascular disease)
• pregnancy planning, including attaining and maintaining a healthy weight and managing any chronic conditions before or during pregnancy
• what to expect during menopause, including signs and symptoms and options for addressing symptoms (midlife and older women)
• symptoms of cardiovascular disease
• urinary incontinence.

The task force acknowledged that not all of these recommendations can be carried out at a single well-woman visit or by a single provider.

See, again, ACOG’s specific well-woman recommendations, by age range, at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.³

How to winnow a long list of recommendations to determine the most pressing issues for a specific patient
In an editorial accompanying the ACOG Well-Woman Task Force report, entitled “Re-envisioning the annual well-woman visit: the task forward,” George F. Sawaya, MD, of the University of California, San Francisco, devised a plan to determine the most pressing well-woman needs for a specific patient.¹ He chose as an example a 41-year-old sexually active woman who does not smoke.

While Dr. Sawaya praised the Well-Woman Task Force recommendations for their “comprehensive scope,” he also noted that the sheer number of recommendations might be “overwhelming and difficult to navigate.”¹ One tool for winnowing the recommendations comes from the Agency for Healthcare Research and Quality, which offers an Electronic Preventive Services Selector (http://epss.ahrq.gov/PDA/index.jsp), available both online and as a smartphone app. Once the clinician plugs in the patient’s age and a few risk factors, the tool generates a list of recommended preventive services. This list of services has been evaluated by the US Preventive Services Task Force, with each recommendation graded “A” through “D,” based on benefits versus harms.

Back to that 41-year-old sexually active woman: Using the Electronic Preventive Services Selector, a list of as many as 20 grade A and B recommendations would be generated. However, only 3 of them would be grade A (screening for cervical cancer, HIV, and high blood pressure). An additional 2 grade B recommendations might apply to an average-risk patient such as this: screening for alcohol misuse and depression. All 5 services fall within the Well-Woman Task Force’s recommendations. They also have “good face validity with clinicians as being important, so it seems reasonable that these be prioritized above the others, at least at the first visit,” Dr. Sawaya says.¹

Clinicians can use a similar strategy for patients of various ages and risk factors.

Reference
1. Sawaya GF. Re-envisioning the annual well-woman visit: the task forward [editorial]. Obstet Gynecol. 2015;126(4):695–696.

The bottom line
By defining and implementing the foundational elements of women’s health, we can improve care for all women and ensure, as Dr. Conry emphasized during her tenure as ACOG president, “that every woman gets the care she needs, every time.”

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

When the Affordable Care Act (ACA) was passed in 2010, it represented an intended shift from reactive medicine, with its focus on acute and urgent needs, to a model focused on disease prevention.

OBG Management readers know about the important women’s health services ensured by the ACA, including well-woman care, as well as the key role played by the American Congress of Obstetricians and Gynecologists (ACOG) in winning this coverage. ACOG worked closely with the Institute of Medicine (IOM) to help define this set of services. And the ACA ensured that women have access to these services, often without copays and deductibles.

ACOG and the National Women’s Law Center (NWLC) work closely on many issues. At first independently and then together, the 2 organizations set out to explore some fundamental issues:

• How does a woman experience the new well-woman benefit when she visits her doctor?
• Does she receive a consistent care set?
• Do some patients have copays while patients in other clinics do not for the same services?
• What does well-woman care mean from one doctor to another, from an ObGyn to an internist to a family physician?

This article explores these issues.

2 initiatives focused on components of women’s health care
During her tenure as president of ACOG, Jeanne Conry, MD, PhD, decided to tackle clinical issues associated with well-woman care. She convened a Well-Woman Task Force, led by Haywood Brown, MD, and included the NWLC among other partner organizations (TABLE).

Table. Partipating organizations of the ACOG Well-Woman Task Force
• American Academy of Family Physicians
• American Academy of Pediatrics
• American Academy of Physician Assistants
• American College of Nurse–Midwives
• American College of Osteopathic Obstetricians and Gynecologists
• Association of Reproductive Health Professionals
• Association of Women’s Health, Obstetric, and Neonatal Nurses
• National Association of Nurse Practitioners in Women’s Health
• National Medical Association
• National Women’s Law Center
• Planned Parenthood Federation of America
• Society for Maternal-Fetal Medicine
• Society of Academic Specialists in General Obstetrics and Gynecology
• Society of Gynecologic Oncology

The NWLC and Brigham and Women’s Hospital also partnered with ACOG and others to help ensure a consistent patient experience. These 2 closely related initiatives were designed to work together to help patients and physicians understand and benefit from new coverage under the ACA.

1. How does a woman experience well-woman care?
Experts associated with these 2 initiatives recognized that well-woman care includes attention to the history, physical examination, counseling, and screening intended to maintain physical, mental, and social wellbeing and general health throughout a woman’s lifespan. Experts also recognized that the ACA guarantees coverage of at least one annual well-woman visit, although not all of the recommended components necessarily would be performed at the same visit or by the same provider.

For many women who have gained insurance coverage under the ACA, the well-woman visit represents their entry into the insured health care system. These women may have limited understanding of the services they should receive during this visit.

To address this issue, the NWLC invited ACOG to participate in its initiative with Brigham and Women’s Hospital to understand the well-woman visit from the patient’s point of view. This effort yielded patient education materials in English and Spanish that help women understand:

• that their health insurance now covers a well-woman visit
• what care is included in that visit
• that there is no deductible or copay for this visit
• how to prepare for this visit
• what questions to ask during the visit.

These materials help women understand that the purpose of the well-woman visit is to provide them with a chance to:

• “receive care and counseling that is appropriate, based on age, cognitive development, and life experience
• review their current health and risks to their health with their health care professional
• ask any questions they may have about their health or risk factors
• talk about what they can do to prevent future health problems
• build a trusting relationship with their health care provider, with an emphasis on confidentiality
• receive appropriate preventive screenings and immunizations and make sure they know which screenings and immunizations they should receive in the future
• review their reproductive plan and contraceptive choices.”¹                 

The materials also advise patients that they may be asked about:

• current health concerns
• current medications, both prescription and over the counter
• family history on both the mother’s and father’s sides
• life management, including family relationships, work, and stress
• substance use habits, including alcohol and tobacco
• sexual activity
• eating habits and physical activity
• past reproductive health experience and any pregnancy complications
• any memory problems (older women)
• screening for depression, anxiety, substance use disorders, and interpersonal violence.

To view some of these materials, visit http://www.nwlc.org/sites/default/files/final_well-womanbrochure.pdf.

2. Does each woman receive consistent well-woman care?
ACOG’s Well-Woman Task Force was shaped by an awareness that many medical societies and government agencies provide recommendations and guidelines about the basic elements of women’s health. While these recommendations and guidelines all may be based on evidence and expert opinion, the recommendations vary. A goal of the task force was to work with providers across the women’s health spectrum to find consensus and provide guidance to women and clinicians with age-appropriate recommendations for a well-woman visit.

In the fall of 2015, the task force’s findings were published in an article entitled “Components of the well-woman visit” in the journal Obstetrics & Gynecology.² Those findings outline a core set of well-woman care practices across a woman’s lifespan, from adolescence through the reproductive years and into maturity, and they are usable by any provider who cares for adolescent girls or women.

ACOG has summarized its well-woman recommendations, by age, on its website,³ at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.

3. Do all women have a copay for the well-woman visit?
Because research has revealed that any type of copay or deductible for preventive care significantly lessens the likelihood that patients will seek out such care, the ACA sought to make basic preventive care available without cost sharing.⁴

The US Department of Health and Human Services notes that: “The Affordable Care Act requires most health plans to cover recommended preventive services without cost sharing. In 2011 and 2012, 71 million Americans with private health insurance gained access to preventive services with no cost sharing because of the law.”⁴

Grandfathered plans (those created or sold before March 23, 2010) are exempt from this requirement, as are Medicare, TRICARE, and traditional Medicaid plans.

4. What does well-woman care mean from one doctor to another?
Under the ACA, well-woman care can be provided by a “wide range of providers, including family physicians, internists, nurse–midwives, nurse practitioners, obstetrician-gynecologists, pediatricians, and physician assistants,” depending on the age of the patient, her particular needs and preferences, and access to health services.²

The ACOG Well-Woman Task Force “focused on delineating the well-woman visit throughout the lifespan, across all providers and health plans.”²

In determining the components of well-woman care, ACOG’s task force compiled existing guidelines from many sources, including the Department of Health and Human Services, the IOM, the US Preventive Services Task Force, and each member organization.

Members categorized guidelines as:

• single source (eg, abdominal examination)
• no agreement (breast cancer/mammography screening)
• limited agreement (pelvic examination)
• general agreement (hypertension, osteoporosis)
• sound agreement (screening for sexually transmitted infections)

The task force also agreed that final recommendations would rely on evidence-based guidelines, evidence-informed guidelines, and uniform expert agreement. Recommendations were considered “strong” if they relied primarily on evidence-based or evidence-informed guidelines and “qualified” if they relied primarily on expert consensus.

Guidelines were further separated into age bands:

• adolescents (13–18 years)
• reproductive-aged women (19–45 years)
• mature women (46–64 years)
• women older than 64 years.

The task force recommended that, during the well-woman visit, health care professionals educate patients about:

• healthy eating habits and maintenance of healthy weight
• exercise and physical activity
• seat belt use
• risk factors for certain types of cancer
• heart health
• breast health
• bone health
• safer sex practices and prevention of sexually transmitted infections
• healthy interpersonal relationships
• prevention and management of chronic disease
• resources for the patient (online, written, community, patient groups)
• medication use
• fall prevention.

Health care providers also should counsel patients regarding:

• recommended preventive screenings and immunizations
• any concerns about mood, such as prolonged periods of sadness, a failure to enjoy what they usually find pleasant, or anxiety or irritability that seems out of proportion to events
• what to expect in terms of effects on mood and anxiety at reproductive life transitions, including menarche, pregnancy, the postpartum period, and perimenopause
• body image issues
• what to expect in terms of the menstrual cycle during perimenopause and menopause
• reproductive health or fertility concerns
• reproductive life planning (contraception appropriate for life stage, reproductive plans, and risk factors, including risk factors for breast and ovarian cancer and cardiovascular disease)
• pregnancy planning, including attaining and maintaining a healthy weight and managing any chronic conditions before or during pregnancy
• what to expect during menopause, including signs and symptoms and options for addressing symptoms (midlife and older women)
• symptoms of cardiovascular disease
• urinary incontinence.

The task force acknowledged that not all of these recommendations can be carried out at a single well-woman visit or by a single provider.

See, again, ACOG’s specific well-woman recommendations, by age range, at http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Well-Woman-Recommendations.³

How to winnow a long list of recommendations to determine the most pressing issues for a specific patient
In an editorial accompanying the ACOG Well-Woman Task Force report, entitled “Re-envisioning the annual well-woman visit: the task forward,” George F. Sawaya, MD, of the University of California, San Francisco, devised a plan to determine the most pressing well-woman needs for a specific patient.¹ He chose as an example a 41-year-old sexually active woman who does not smoke.

While Dr. Sawaya praised the Well-Woman Task Force recommendations for their “comprehensive scope,” he also noted that the sheer number of recommendations might be “overwhelming and difficult to navigate.”¹ One tool for winnowing the recommendations comes from the Agency for Healthcare Research and Quality, which offers an Electronic Preventive Services Selector (http://epss.ahrq.gov/PDA/index.jsp), available both online and as a smartphone app. Once the clinician plugs in the patient’s age and a few risk factors, the tool generates a list of recommended preventive services. This list of services has been evaluated by the US Preventive Services Task Force, with each recommendation graded “A” through “D,” based on benefits versus harms.

Back to that 41-year-old sexually active woman: Using the Electronic Preventive Services Selector, a list of as many as 20 grade A and B recommendations would be generated. However, only 3 of them would be grade A (screening for cervical cancer, HIV, and high blood pressure). An additional 2 grade B recommendations might apply to an average-risk patient such as this: screening for alcohol misuse and depression. All 5 services fall within the Well-Woman Task Force’s recommendations. They also have “good face validity with clinicians as being important, so it seems reasonable that these be prioritized above the others, at least at the first visit,” Dr. Sawaya says.¹

Clinicians can use a similar strategy for patients of various ages and risk factors.

Reference
1. Sawaya GF. Re-envisioning the annual well-woman visit: the task forward [editorial]. Obstet Gynecol. 2015;126(4):695–696.

The bottom line
By defining and implementing the foundational elements of women’s health, we can improve care for all women and ensure, as Dr. Conry emphasized during her tenure as ACOG president, “that every woman gets the care she needs, every time.”

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).

1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.¹
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.

Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.

The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).¹ This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.

The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”

The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.

2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.²

The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.

Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:

1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)

2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.

The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”²

Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.

This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.

3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”³ Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.

At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,_⁴ so the question in this case was whether or not there was an implied right to do so.

Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.⁴ As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.

4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.

The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)

At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.⁵ This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.

Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”⁵ The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.

It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.

5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”

At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.⁶

Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.

6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.⁷

Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.

At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.

Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.⁷ Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.

The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.

Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.¹ (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.²
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.^2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.⁴
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.⁵
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.⁶

References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.

What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).

1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.¹
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.

Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.

The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).¹ This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.

The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”

The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.

2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.²

The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.

Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:

1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)

2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.

The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”²

Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.

This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.

3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”³ Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.

At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,_⁴ so the question in this case was whether or not there was an implied right to do so.

Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.⁴ As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.

4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.

The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)

At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.⁵ This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.

Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”⁵ The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.

It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.

5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”

At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.⁶

Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.

6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.⁷

Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.

At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.

Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.⁷ Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.

The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.

Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.¹ (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.²
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.^2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.⁴
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.⁵
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.⁶

References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.

What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).

1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.¹
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.

Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.

The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).¹ This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.

The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”

The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.

2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.²

The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.

Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:

1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)

2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.

The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”²

Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.

This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.

3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”³ Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.

At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,_⁴ so the question in this case was whether or not there was an implied right to do so.

Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.⁴ As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.

4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.

The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)

At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.⁵ This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.

Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”⁵ The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.

It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.

5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”

At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.⁶

Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.

6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.⁷

Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.

At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.

Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.⁷ Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.

The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.

Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.¹ (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.²
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.^2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.⁴
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.⁵
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.⁶

References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.

What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.