Mary Ellen Schneider

The federal government and some private groups have been conducting comparative effectiveness research for years. Despite those efforts, physicians and patients still have many unanswered questions about how to choose between treatments and procedures.

The Affordable Care Act aims to answer some of those questions by funding new research into the comparative benefits and harms of treatments, tests, and care delivery approaches.

Section 6301 of the 2010 health law establishes the Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit organization charged with funding research into the comparative health outcomes and clinical effectiveness of medical treatments, as well as studies into whether those treatments are appropriate in certain patient populations. PCORI is scheduled to receive an estimated $3.5 billion from a trust fund created by Congress to fund patient-centered outcomes research through Sept. 30, 2019.

PCORI’s executive director, Dr. Joe V. Selby, discussed how the organization’s work will help answer the questions that clinicians and patients say are most important to them.

Question: PCORI has awarded more than $150 million for research. How long will it be until we see the first round of results, and will that information be immediately useful to physicians in their practices?

Dr. Selby: As of May 7, PCORI has approved more than $129 million in funding for patient-centered comparative effectiveness research projects that address the first four of the institute’s five National Priorities for Research and Research Agenda. In addition, PCORI has committed another $30 million in funding for a series of pilot projects. These are 2- to 3-year studies, with results expected beginning in 2014.

To speed the adoption of useful results in clinical practice, PCORI is monitoring the projects to determine if actionable information arises before a project is completed. When that happens, we’ll report the findings to the community. PCORI also is developing strong dissemination processes that will enable us to communicate findings quickly and effectively to clinicians, patients, and other key stakeholders.

Question: How can physicians use the information from PCORI in their practices?

Dr. Selby: It’s not always easy to get new research findings adopted by practicing physicians. We’re specifically aiming to fund research that answers questions faced by physicians and patients, so we work hard, in collaboration with physicians, to be sure that we’re asking the right questions. We then encourage researchers to maintain close contact with physicians and other relevant stakeholder groups as the research is conducted so that they will be there when results emerge.

We think that will increase the chances that these studies’ findings will be picked up by physicians and, if warranted, adopted into practice.

For example, PCORI is funding a randomized controlled trial of three antiepilepsy medications frequently prescribed for children. The outcomes focus on cognitive effects – how these medications affect learning. The investigators are a network of pediatric neurologists who specialize in epilepsy. Prior to launching the study, they began engaging online communities of patients and parents, as well as two major professional societies dedicated to treatment of epilepsy. This active engagement increases the chances that the trial’s results will be noted and adopted.

Question: There are a lot of unanswered research questions in the area of clinical comparative effectiveness. How do you choose which studies to fund?

Dr. Selby: PCORI’s National Priorities for Research and Research Agenda provides a framework to guide the funding of studies that will give patients and those who care for them the ability to make better-informed health decisions. Through our new advisory panels, roundtables, and other activities, the institute is actively engaging patients, clinicians, caregivers, and other stakeholders in identifying the research topics of greatest value to them and guiding our efforts in designing and implementing studies. We are looking specifically for questions that have been raised by patients and clinicians, questions that, when answered, are likely to change decision-making and improve patient outcomes.

Applications for PCORI funding are reviewed by scientists, patients, caregivers, and other stakeholders, who assess the proposed projects’ methodological rigor, how well they engage patients and other stakeholders, and how well they fit within PCORI’s national research priorities. As you can see, we’re ensuring that the patient’s voice is represented throughout the research process.

Question: The ACA specifically bars PCORI from funding studies that compare cost effectiveness. Was that the right move?

Dr. Selby: The legislation that established PCORI called on us to pay close attention to disease incidence, prevalence, burden (including costs to individuals and society), chronic conditions, and disparities when choosing research questions. We focus on studying clinical outcomes – the information that is most frequently missing and that can be most difficult to obtain. With enhanced information on options and outcomes, doing the math on costs is something that patients, clinicians, and their health care systems can do from their own perspectives, taking into account the individual patient’s needs and preferences.

Moreover, many studies suggest that, when patients have good evidence on clinical effectiveness, they tend to make different decisions about what they think is the best course, including choices that, in some cases, can lead to lower utilization.

Question: Comparative effectiveness research was controversial when the ACA was being debated. Has that died down now that PCORI is up and running?

Dr. Selby: Comparative effectiveness research, or CER, has been carried out in the United States for years, mainly through the sponsorship of the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Department of Veterans Affairs. CER has traditionally had bipartisan support. We are mindful of concerns that the results of these studies not be used to inappropriately limit patient or physician choices. The expansive involvement of stakeholders in PCORI’s activities and its independence from government as a private nonprofit make it ideally suited to lead the way in this important field of health research.

Since PCORI has been increasing its activities, we’ve received a lot of interest and feedback from many stakeholders who have become actively involved in our work. We’re hearing a lot of enthusiasm from health care professionals, the pharmaceutical and biotechnology industries, patients and patient advocates, clinical researchers, and many others.

I believe that, as people follow PCORI’s ongoing work and the efforts of our many partners across the health community, they will gain ever greater assurance that patient-centered CER is providing data and evidence that will help them make better decisions about their health and health care.

Dr. Selby is a family physician, clinical epidemiologist, and health services researcher who has worked on comparative effectiveness research for many years. Before PCORI, he was the director of the division of research at Kaiser Permanente, Northern California.

The federal government and some private groups have been conducting comparative effectiveness research for years. Despite those efforts, physicians and patients still have many unanswered questions about how to choose between treatments and procedures.

The Affordable Care Act aims to answer some of those questions by funding new research into the comparative benefits and harms of treatments, tests, and care delivery approaches.

Section 6301 of the 2010 health law establishes the Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit organization charged with funding research into the comparative health outcomes and clinical effectiveness of medical treatments, as well as studies into whether those treatments are appropriate in certain patient populations. PCORI is scheduled to receive an estimated $3.5 billion from a trust fund created by Congress to fund patient-centered outcomes research through Sept. 30, 2019.

PCORI’s executive director, Dr. Joe V. Selby, discussed how the organization’s work will help answer the questions that clinicians and patients say are most important to them.

Question: PCORI has awarded more than $150 million for research. How long will it be until we see the first round of results, and will that information be immediately useful to physicians in their practices?

Dr. Selby: As of May 7, PCORI has approved more than $129 million in funding for patient-centered comparative effectiveness research projects that address the first four of the institute’s five National Priorities for Research and Research Agenda. In addition, PCORI has committed another $30 million in funding for a series of pilot projects. These are 2- to 3-year studies, with results expected beginning in 2014.

To speed the adoption of useful results in clinical practice, PCORI is monitoring the projects to determine if actionable information arises before a project is completed. When that happens, we’ll report the findings to the community. PCORI also is developing strong dissemination processes that will enable us to communicate findings quickly and effectively to clinicians, patients, and other key stakeholders.

Question: How can physicians use the information from PCORI in their practices?

Dr. Selby: It’s not always easy to get new research findings adopted by practicing physicians. We’re specifically aiming to fund research that answers questions faced by physicians and patients, so we work hard, in collaboration with physicians, to be sure that we’re asking the right questions. We then encourage researchers to maintain close contact with physicians and other relevant stakeholder groups as the research is conducted so that they will be there when results emerge.

We think that will increase the chances that these studies’ findings will be picked up by physicians and, if warranted, adopted into practice.

For example, PCORI is funding a randomized controlled trial of three antiepilepsy medications frequently prescribed for children. The outcomes focus on cognitive effects – how these medications affect learning. The investigators are a network of pediatric neurologists who specialize in epilepsy. Prior to launching the study, they began engaging online communities of patients and parents, as well as two major professional societies dedicated to treatment of epilepsy. This active engagement increases the chances that the trial’s results will be noted and adopted.

Question: There are a lot of unanswered research questions in the area of clinical comparative effectiveness. How do you choose which studies to fund?

Dr. Selby: PCORI’s National Priorities for Research and Research Agenda provides a framework to guide the funding of studies that will give patients and those who care for them the ability to make better-informed health decisions. Through our new advisory panels, roundtables, and other activities, the institute is actively engaging patients, clinicians, caregivers, and other stakeholders in identifying the research topics of greatest value to them and guiding our efforts in designing and implementing studies. We are looking specifically for questions that have been raised by patients and clinicians, questions that, when answered, are likely to change decision-making and improve patient outcomes.

Applications for PCORI funding are reviewed by scientists, patients, caregivers, and other stakeholders, who assess the proposed projects’ methodological rigor, how well they engage patients and other stakeholders, and how well they fit within PCORI’s national research priorities. As you can see, we’re ensuring that the patient’s voice is represented throughout the research process.

Question: The ACA specifically bars PCORI from funding studies that compare cost effectiveness. Was that the right move?

Dr. Selby: The legislation that established PCORI called on us to pay close attention to disease incidence, prevalence, burden (including costs to individuals and society), chronic conditions, and disparities when choosing research questions. We focus on studying clinical outcomes – the information that is most frequently missing and that can be most difficult to obtain. With enhanced information on options and outcomes, doing the math on costs is something that patients, clinicians, and their health care systems can do from their own perspectives, taking into account the individual patient’s needs and preferences.

Moreover, many studies suggest that, when patients have good evidence on clinical effectiveness, they tend to make different decisions about what they think is the best course, including choices that, in some cases, can lead to lower utilization.

Question: Comparative effectiveness research was controversial when the ACA was being debated. Has that died down now that PCORI is up and running?

Dr. Selby: Comparative effectiveness research, or CER, has been carried out in the United States for years, mainly through the sponsorship of the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Department of Veterans Affairs. CER has traditionally had bipartisan support. We are mindful of concerns that the results of these studies not be used to inappropriately limit patient or physician choices. The expansive involvement of stakeholders in PCORI’s activities and its independence from government as a private nonprofit make it ideally suited to lead the way in this important field of health research.

Since PCORI has been increasing its activities, we’ve received a lot of interest and feedback from many stakeholders who have become actively involved in our work. We’re hearing a lot of enthusiasm from health care professionals, the pharmaceutical and biotechnology industries, patients and patient advocates, clinical researchers, and many others.

I believe that, as people follow PCORI’s ongoing work and the efforts of our many partners across the health community, they will gain ever greater assurance that patient-centered CER is providing data and evidence that will help them make better decisions about their health and health care.

Dr. Selby is a family physician, clinical epidemiologist, and health services researcher who has worked on comparative effectiveness research for many years. Before PCORI, he was the director of the division of research at Kaiser Permanente, Northern California.

The federal government and some private groups have been conducting comparative effectiveness research for years. Despite those efforts, physicians and patients still have many unanswered questions about how to choose between treatments and procedures.

The Affordable Care Act aims to answer some of those questions by funding new research into the comparative benefits and harms of treatments, tests, and care delivery approaches.

Section 6301 of the 2010 health law establishes the Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit organization charged with funding research into the comparative health outcomes and clinical effectiveness of medical treatments, as well as studies into whether those treatments are appropriate in certain patient populations. PCORI is scheduled to receive an estimated $3.5 billion from a trust fund created by Congress to fund patient-centered outcomes research through Sept. 30, 2019.

PCORI’s executive director, Dr. Joe V. Selby, discussed how the organization’s work will help answer the questions that clinicians and patients say are most important to them.

Question: PCORI has awarded more than $150 million for research. How long will it be until we see the first round of results, and will that information be immediately useful to physicians in their practices?

Dr. Selby: As of May 7, PCORI has approved more than $129 million in funding for patient-centered comparative effectiveness research projects that address the first four of the institute’s five National Priorities for Research and Research Agenda. In addition, PCORI has committed another $30 million in funding for a series of pilot projects. These are 2- to 3-year studies, with results expected beginning in 2014.

To speed the adoption of useful results in clinical practice, PCORI is monitoring the projects to determine if actionable information arises before a project is completed. When that happens, we’ll report the findings to the community. PCORI also is developing strong dissemination processes that will enable us to communicate findings quickly and effectively to clinicians, patients, and other key stakeholders.

Question: How can physicians use the information from PCORI in their practices?

Dr. Selby: It’s not always easy to get new research findings adopted by practicing physicians. We’re specifically aiming to fund research that answers questions faced by physicians and patients, so we work hard, in collaboration with physicians, to be sure that we’re asking the right questions. We then encourage researchers to maintain close contact with physicians and other relevant stakeholder groups as the research is conducted so that they will be there when results emerge.

We think that will increase the chances that these studies’ findings will be picked up by physicians and, if warranted, adopted into practice.

For example, PCORI is funding a randomized controlled trial of three antiepilepsy medications frequently prescribed for children. The outcomes focus on cognitive effects – how these medications affect learning. The investigators are a network of pediatric neurologists who specialize in epilepsy. Prior to launching the study, they began engaging online communities of patients and parents, as well as two major professional societies dedicated to treatment of epilepsy. This active engagement increases the chances that the trial’s results will be noted and adopted.

Question: There are a lot of unanswered research questions in the area of clinical comparative effectiveness. How do you choose which studies to fund?

Dr. Selby: PCORI’s National Priorities for Research and Research Agenda provides a framework to guide the funding of studies that will give patients and those who care for them the ability to make better-informed health decisions. Through our new advisory panels, roundtables, and other activities, the institute is actively engaging patients, clinicians, caregivers, and other stakeholders in identifying the research topics of greatest value to them and guiding our efforts in designing and implementing studies. We are looking specifically for questions that have been raised by patients and clinicians, questions that, when answered, are likely to change decision-making and improve patient outcomes.

Applications for PCORI funding are reviewed by scientists, patients, caregivers, and other stakeholders, who assess the proposed projects’ methodological rigor, how well they engage patients and other stakeholders, and how well they fit within PCORI’s national research priorities. As you can see, we’re ensuring that the patient’s voice is represented throughout the research process.

Question: The ACA specifically bars PCORI from funding studies that compare cost effectiveness. Was that the right move?

Dr. Selby: The legislation that established PCORI called on us to pay close attention to disease incidence, prevalence, burden (including costs to individuals and society), chronic conditions, and disparities when choosing research questions. We focus on studying clinical outcomes – the information that is most frequently missing and that can be most difficult to obtain. With enhanced information on options and outcomes, doing the math on costs is something that patients, clinicians, and their health care systems can do from their own perspectives, taking into account the individual patient’s needs and preferences.

Moreover, many studies suggest that, when patients have good evidence on clinical effectiveness, they tend to make different decisions about what they think is the best course, including choices that, in some cases, can lead to lower utilization.

Question: Comparative effectiveness research was controversial when the ACA was being debated. Has that died down now that PCORI is up and running?

Dr. Selby: Comparative effectiveness research, or CER, has been carried out in the United States for years, mainly through the sponsorship of the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Department of Veterans Affairs. CER has traditionally had bipartisan support. We are mindful of concerns that the results of these studies not be used to inappropriately limit patient or physician choices. The expansive involvement of stakeholders in PCORI’s activities and its independence from government as a private nonprofit make it ideally suited to lead the way in this important field of health research.

Since PCORI has been increasing its activities, we’ve received a lot of interest and feedback from many stakeholders who have become actively involved in our work. We’re hearing a lot of enthusiasm from health care professionals, the pharmaceutical and biotechnology industries, patients and patient advocates, clinical researchers, and many others.

I believe that, as people follow PCORI’s ongoing work and the efforts of our many partners across the health community, they will gain ever greater assurance that patient-centered CER is providing data and evidence that will help them make better decisions about their health and health care.

Dr. Selby is a family physician, clinical epidemiologist, and health services researcher who has worked on comparative effectiveness research for many years. Before PCORI, he was the director of the division of research at Kaiser Permanente, Northern California.

President Obama is proposing to cut more than $370 billion from the Medicare program over the next decade, a move aimed at reducing the federal deficit and putting the program on firmer financial footing.

The president’s fiscal year 2014 budget proposal, sent to Congress April 10, includes cuts for physicians, drug companies, hospitals, and long-term facilities, as well as increased cost-sharing for some Medicare beneficiaries.

The part of the budget with the potential to have the biggest impact on doctors is the increased authority for the Independent Payment Advisory Board (IPAB). The 15-member board was created under the Affordable Care Act (ACA) and is charged with recommending to Congress how to reduce spending growth in Medicare. Under current law, IPAB would make recommendations only if the projected Medicare per capita growth rate exceeded the gross domestic product (GDP) plus 1%. In the president’s budget proposal, that target would be triggered early, when Medicare spending was projected to exceed GDP plus 0.5%.

This change is projected to save the federal government $4.1 billion over the next decade.

The bulk of the Medicare savings will come from proposals to cut payments to drug companies, long-term care facilities, and increases in cost sharing by beneficiaries.

For instance, the administration estimates it will save about $123 billion over 10 years by allowing the Medicare Part D program to pay the lower Medicaid rate for prescription drugs for its low-income beneficiaries.

A change involving post–acute care providers would save $79 billion. The administration wants to reduce the market basket updates for inpatient rehabilitation facilities, long-term care hospitals, skilled nursing facilities, and home health agencies by 1.1% starting in 2014 and running through 2023.

Beneficiaries also would contribute more for their Medicare premiums under the Obama budget proposal. Starting in 2017, certain Medicare beneficiaries will pay more for their Part B and D premiums, which is expected to generate $50 billion in savings over 10 years.

The budget also includes about $22.1 billion in cuts to Medicaid over 10 years.

The budget also includes a little good news for physicians: It assumes that the Congress will eliminate the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

The American Medical Association praised the administration for its commitment to move toward new ways to pay for health care.

"The President’s proposals align with many of the principles developed by the AMA and 110 other physician organizations on transitioning Medicare to include an array of accountable payment models," Dr. Jeremy A. Lazarus, AMA president, said in a statement. "It is critical for physicians to have a period of stability and the flexibility to choose options that will help them lower costs and improve the quality of care for their patients. We are encouraged that the president and members of Congress are focused this year on eliminating this failed formula and strengthening Medicare for patients now and in the future."

The cost-cutting proposals aren’t new; President Obama included some of them in last year’s budget proposal. He also called for cuts to Medicare when negotiating for a deficit reduction deal with House Speaker John Boehner (R-Ohio) late last year.

President Obama said his proposed budget would lower the federal deficit in a "balanced way," allowing more targeted cuts to replace the across-the-board budget cuts set out in the sequester, which took effect in March. Overall, the Obama administration estimates that the new budget would achieve $1.8 trillion in deficit reduction over the next 10 years.

But the budget is already getting a cool reception from Republicans on Capitol Hill. House Budget Committee Chairman Paul Ryan (R-Wisc.) said that after eliminating the sequester, there is only about $119 billion in deficit reduction over the next decade in the president’s proposed budget.

"I’m disappointed by the president’s proposal because it merely ratifies the status quo," Rep. Ryan said in a statement. "It doesn’t break new ground; it goes over old ground."

Both the House and the Senate have already passed their own budget proposals for fiscal year 2014.

In addition to the Medicare and Medicaid cuts, the President’s budget offers some targeted increases.

For instance, the Centers for Medicare and Medicaid Services is seeking about $1.5 billion in new funding to help support operations and outreach related to the ACA’s health insurance exchanges. The funds would support the federally operated exchanges and offer assistance to states that are running their own exchanges. The exchanges will open for enrollment on Oct. 1, 2013, the first day of fiscal year 2014. Coverage under the exchanges is set to begin on Jan. 1, 2014.

Health and Human Services Secretary Kathleen Sebelius said she is hopeful that Congress will come through with the money to help launch the new program. "We intend to implement the law," she said during a press conference April 10.

The budget also includes funding for mental health. The proposal invests $130 million to add 5,000 mental health professionals to the behavioral health workforce. The money will also fund Project AWARE (Advancing Wellness and Resilience in Education), which trains teachers to detect and respond to mental illness in their students.

The Centers for Disease Control and Prevention would get an additional $30 million to track gun violence and research ways to prevent it under the budget proposal sent to Congress.

The American Psychiatric Association supported the administration’s effort to identify at-risk individuals early through Project AWARE. But the APA said in a statement that it was concerned that the effort to expand the supply of mental health professionals seems to stop at nonphysician providers.

"We recognize the growing need for mental health providers; however, providing a small amount of training to lesser-qualified health professionals at the expense of utilizing veteran medical psychiatrists will only serve to exacerbate the problem we are trying to solve," the APA wrote. "As a nation, we should ensure that patients have access to the full range of services, from physician care to hospital care to outpatient clinics and long-term follow-up."

The National Institutes of Health would receive a $471 million funding increase over its fiscal year 2012 funding, bringing its total budget to $31.1 billion. That includes about $40 billion toward an effort to map the human brain. The agency will also invest $80 million to speed up drug development and the testing of new therapies for Alzheimer’s disease.

[email protected]

President Obama is proposing to cut more than $370 billion from the Medicare program over the next decade, a move aimed at reducing the federal deficit and putting the program on firmer financial footing.

The president’s fiscal year 2014 budget proposal, sent to Congress April 10, includes cuts for physicians, drug companies, hospitals, and long-term facilities, as well as increased cost-sharing for some Medicare beneficiaries.

The part of the budget with the potential to have the biggest impact on doctors is the increased authority for the Independent Payment Advisory Board (IPAB). The 15-member board was created under the Affordable Care Act (ACA) and is charged with recommending to Congress how to reduce spending growth in Medicare. Under current law, IPAB would make recommendations only if the projected Medicare per capita growth rate exceeded the gross domestic product (GDP) plus 1%. In the president’s budget proposal, that target would be triggered early, when Medicare spending was projected to exceed GDP plus 0.5%.

This change is projected to save the federal government $4.1 billion over the next decade.

The bulk of the Medicare savings will come from proposals to cut payments to drug companies, long-term care facilities, and increases in cost sharing by beneficiaries.

For instance, the administration estimates it will save about $123 billion over 10 years by allowing the Medicare Part D program to pay the lower Medicaid rate for prescription drugs for its low-income beneficiaries.

A change involving post–acute care providers would save $79 billion. The administration wants to reduce the market basket updates for inpatient rehabilitation facilities, long-term care hospitals, skilled nursing facilities, and home health agencies by 1.1% starting in 2014 and running through 2023.

Beneficiaries also would contribute more for their Medicare premiums under the Obama budget proposal. Starting in 2017, certain Medicare beneficiaries will pay more for their Part B and D premiums, which is expected to generate $50 billion in savings over 10 years.

The budget also includes about $22.1 billion in cuts to Medicaid over 10 years.

The budget also includes a little good news for physicians: It assumes that the Congress will eliminate the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

The American Medical Association praised the administration for its commitment to move toward new ways to pay for health care.

"The President’s proposals align with many of the principles developed by the AMA and 110 other physician organizations on transitioning Medicare to include an array of accountable payment models," Dr. Jeremy A. Lazarus, AMA president, said in a statement. "It is critical for physicians to have a period of stability and the flexibility to choose options that will help them lower costs and improve the quality of care for their patients. We are encouraged that the president and members of Congress are focused this year on eliminating this failed formula and strengthening Medicare for patients now and in the future."

The cost-cutting proposals aren’t new; President Obama included some of them in last year’s budget proposal. He also called for cuts to Medicare when negotiating for a deficit reduction deal with House Speaker John Boehner (R-Ohio) late last year.

President Obama said his proposed budget would lower the federal deficit in a "balanced way," allowing more targeted cuts to replace the across-the-board budget cuts set out in the sequester, which took effect in March. Overall, the Obama administration estimates that the new budget would achieve $1.8 trillion in deficit reduction over the next 10 years.

But the budget is already getting a cool reception from Republicans on Capitol Hill. House Budget Committee Chairman Paul Ryan (R-Wisc.) said that after eliminating the sequester, there is only about $119 billion in deficit reduction over the next decade in the president’s proposed budget.

"I’m disappointed by the president’s proposal because it merely ratifies the status quo," Rep. Ryan said in a statement. "It doesn’t break new ground; it goes over old ground."

Both the House and the Senate have already passed their own budget proposals for fiscal year 2014.

In addition to the Medicare and Medicaid cuts, the President’s budget offers some targeted increases.

For instance, the Centers for Medicare and Medicaid Services is seeking about $1.5 billion in new funding to help support operations and outreach related to the ACA’s health insurance exchanges. The funds would support the federally operated exchanges and offer assistance to states that are running their own exchanges. The exchanges will open for enrollment on Oct. 1, 2013, the first day of fiscal year 2014. Coverage under the exchanges is set to begin on Jan. 1, 2014.

Health and Human Services Secretary Kathleen Sebelius said she is hopeful that Congress will come through with the money to help launch the new program. "We intend to implement the law," she said during a press conference April 10.

The budget also includes funding for mental health. The proposal invests $130 million to add 5,000 mental health professionals to the behavioral health workforce. The money will also fund Project AWARE (Advancing Wellness and Resilience in Education), which trains teachers to detect and respond to mental illness in their students.

The Centers for Disease Control and Prevention would get an additional $30 million to track gun violence and research ways to prevent it under the budget proposal sent to Congress.

The American Psychiatric Association supported the administration’s effort to identify at-risk individuals early through Project AWARE. But the APA said in a statement that it was concerned that the effort to expand the supply of mental health professionals seems to stop at nonphysician providers.

"We recognize the growing need for mental health providers; however, providing a small amount of training to lesser-qualified health professionals at the expense of utilizing veteran medical psychiatrists will only serve to exacerbate the problem we are trying to solve," the APA wrote. "As a nation, we should ensure that patients have access to the full range of services, from physician care to hospital care to outpatient clinics and long-term follow-up."

The National Institutes of Health would receive a $471 million funding increase over its fiscal year 2012 funding, bringing its total budget to $31.1 billion. That includes about $40 billion toward an effort to map the human brain. The agency will also invest $80 million to speed up drug development and the testing of new therapies for Alzheimer’s disease.

[email protected]

President Obama is proposing to cut more than $370 billion from the Medicare program over the next decade, a move aimed at reducing the federal deficit and putting the program on firmer financial footing.

The president’s fiscal year 2014 budget proposal, sent to Congress April 10, includes cuts for physicians, drug companies, hospitals, and long-term facilities, as well as increased cost-sharing for some Medicare beneficiaries.

The part of the budget with the potential to have the biggest impact on doctors is the increased authority for the Independent Payment Advisory Board (IPAB). The 15-member board was created under the Affordable Care Act (ACA) and is charged with recommending to Congress how to reduce spending growth in Medicare. Under current law, IPAB would make recommendations only if the projected Medicare per capita growth rate exceeded the gross domestic product (GDP) plus 1%. In the president’s budget proposal, that target would be triggered early, when Medicare spending was projected to exceed GDP plus 0.5%.

This change is projected to save the federal government $4.1 billion over the next decade.

The bulk of the Medicare savings will come from proposals to cut payments to drug companies, long-term care facilities, and increases in cost sharing by beneficiaries.

For instance, the administration estimates it will save about $123 billion over 10 years by allowing the Medicare Part D program to pay the lower Medicaid rate for prescription drugs for its low-income beneficiaries.

A change involving post–acute care providers would save $79 billion. The administration wants to reduce the market basket updates for inpatient rehabilitation facilities, long-term care hospitals, skilled nursing facilities, and home health agencies by 1.1% starting in 2014 and running through 2023.

Beneficiaries also would contribute more for their Medicare premiums under the Obama budget proposal. Starting in 2017, certain Medicare beneficiaries will pay more for their Part B and D premiums, which is expected to generate $50 billion in savings over 10 years.

The budget also includes about $22.1 billion in cuts to Medicaid over 10 years.

The budget also includes a little good news for physicians: It assumes that the Congress will eliminate the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

The American Medical Association praised the administration for its commitment to move toward new ways to pay for health care.

"The President’s proposals align with many of the principles developed by the AMA and 110 other physician organizations on transitioning Medicare to include an array of accountable payment models," Dr. Jeremy A. Lazarus, AMA president, said in a statement. "It is critical for physicians to have a period of stability and the flexibility to choose options that will help them lower costs and improve the quality of care for their patients. We are encouraged that the president and members of Congress are focused this year on eliminating this failed formula and strengthening Medicare for patients now and in the future."

The cost-cutting proposals aren’t new; President Obama included some of them in last year’s budget proposal. He also called for cuts to Medicare when negotiating for a deficit reduction deal with House Speaker John Boehner (R-Ohio) late last year.

President Obama said his proposed budget would lower the federal deficit in a "balanced way," allowing more targeted cuts to replace the across-the-board budget cuts set out in the sequester, which took effect in March. Overall, the Obama administration estimates that the new budget would achieve $1.8 trillion in deficit reduction over the next 10 years.

But the budget is already getting a cool reception from Republicans on Capitol Hill. House Budget Committee Chairman Paul Ryan (R-Wisc.) said that after eliminating the sequester, there is only about $119 billion in deficit reduction over the next decade in the president’s proposed budget.

"I’m disappointed by the president’s proposal because it merely ratifies the status quo," Rep. Ryan said in a statement. "It doesn’t break new ground; it goes over old ground."

Both the House and the Senate have already passed their own budget proposals for fiscal year 2014.

In addition to the Medicare and Medicaid cuts, the President’s budget offers some targeted increases.

For instance, the Centers for Medicare and Medicaid Services is seeking about $1.5 billion in new funding to help support operations and outreach related to the ACA’s health insurance exchanges. The funds would support the federally operated exchanges and offer assistance to states that are running their own exchanges. The exchanges will open for enrollment on Oct. 1, 2013, the first day of fiscal year 2014. Coverage under the exchanges is set to begin on Jan. 1, 2014.

Health and Human Services Secretary Kathleen Sebelius said she is hopeful that Congress will come through with the money to help launch the new program. "We intend to implement the law," she said during a press conference April 10.

The budget also includes funding for mental health. The proposal invests $130 million to add 5,000 mental health professionals to the behavioral health workforce. The money will also fund Project AWARE (Advancing Wellness and Resilience in Education), which trains teachers to detect and respond to mental illness in their students.

The Centers for Disease Control and Prevention would get an additional $30 million to track gun violence and research ways to prevent it under the budget proposal sent to Congress.

The American Psychiatric Association supported the administration’s effort to identify at-risk individuals early through Project AWARE. But the APA said in a statement that it was concerned that the effort to expand the supply of mental health professionals seems to stop at nonphysician providers.

"We recognize the growing need for mental health providers; however, providing a small amount of training to lesser-qualified health professionals at the expense of utilizing veteran medical psychiatrists will only serve to exacerbate the problem we are trying to solve," the APA wrote. "As a nation, we should ensure that patients have access to the full range of services, from physician care to hospital care to outpatient clinics and long-term follow-up."

The National Institutes of Health would receive a $471 million funding increase over its fiscal year 2012 funding, bringing its total budget to $31.1 billion. That includes about $40 billion toward an effort to map the human brain. The agency will also invest $80 million to speed up drug development and the testing of new therapies for Alzheimer’s disease.

[email protected]

After years of research, debate, and revision, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders is hitting the shelves.

The release of the DSM-5 marks the first time the influential diagnostic manual has been updated in nearly 20 years. The goal in putting together the fifth edition was not to do anything radical, said Dr. Dilip V. Jeste, president of the American Psychiatric Association, but to bring the science up to date and to make it more user friendly for clinicians.

Courtesy APA/David Hathcox

"The goal is to make sure that we have more accurate diagnoses so we can get better mental health services and improve patient outcomes," Dr. Jeste said.

The DSM-5 moves from a multiaxial system to a single axis format. It didn’t make sense to separate the disorders in that way, Dr. Jeste said, and the change makes it simpler for psychiatrists to use. The DSM-5 also puts a greater focus on the roles of age, gender, and culture. Every chapter will include a section on how to apply these factors when making a diagnosis.

Overall, the DSM-5 is not significantly different from the DSM-IV, said Dr. Joel Paris, a professor of psychiatry at McGill University, Montreal, and author of the "The Intelligent Clinician’s Guide to the DSM-5" (New York: Oxford University Press, 2013). Psychiatrists do not need to worry that they will be dealing with a completely new manual, he said, because most of the controversial changes were not accepted in the final version of the manual.

Dr. Paris, who was not involved in the DSM revision, said some those big changes were rejected by the DSM-5’s Scientific Review Committee because they did not have enough scientific data to back them up. "We’re just starting the science of psychiatry," he said. "It’s early days."

But there are some notable changes in the new manual. Experts who worked on the DSM-5 highlighted some of the revisions most likely to affect the way in which how psychiatrists practice.

Mild neurocognitive disorder

In the DSM-5, neurocognitive disorders are divided into two subtypes: mild and major. Major neurocognitive disorder lines up with the DSM-IV definition of dementia. But the DSM-5 Neurocognitive Disorders Work Group created a new subtype to describe mild neurocognitive decline that is more severe than the normal forgetfulness of aging but doesn’t rise to the level of dementia.

The DSM-5 includes specific criteria to help make the diagnosis of mild neurocognitive disorder, said Dr. Dan G. Blazer, cochair of the Neurocognitive Disorders Work Group and a professor of psychiatry and behavioral sciences at Duke University in Durham, N.C.

A patient with mild neurocognitive disorder is likely to complain of memory problems but will not have significant cognitive problems and would not meet the criteria for major neurocognitive disorder. Such patients often are able to complete their daily tasks, but it takes significantly more time and effort. For instance, a patient with mild neurocognitive disorder might take 2 hours to balance a checkbook, when it took just 10 minutes in the past.

Patients with mild neurocognitive disorder should fall somewhere between 1-2 standard deviations below normal on neuropsychological tests, Dr. Blazer said. While the DSM-5 does not recommend a specific test, Dr. Blazer said using some type of standardized test is important. "As we move along in this field, it’s going to be very important to objectively document the level of cognitive impairment that individuals have," Dr. Blazer said.

One of the challenges with this diagnosis is the question of whether these patients will progress and develop dementia. The answer is not necessarily, Dr. Blazer said. While this group has a higher likelihood of progressing to more severe problems, it is not a diagnosis of "pre-dementia," he said.

For many psychiatrists, the biggest change will be to begin asking patients about their level of functioning when they come in with memory complaints. That’s something that can be easily overlooked in a busy practice, Dr. Blazer said.

Major neurocognitive disorder

Previously memory impairment was essential to making a diagnosis of dementia, now called major neurocognitive disorder. But the DSM-5 no longer requires memory impairment to be present, said Dr. Jeste, who served on the Neurocognitive Disorders Work Group and is a professor of psychiatry and neurosciences at the University of California, San Diego.

The change was made to acknowledge that there are major neurocognitive disorders in which memory impairment is not present until late in the course of the illness. For instance, with frontotemporal dementia, which can occur when the patient is aged 50 years, memory impairment does not become apparent until much later in life. Instead, the main symptom is a change in personality. The change will likely reduce the number of patients who receive a "not otherwise specified" (NOS) diagnosis, Dr. Jeste said.

Intellectual disabilities

The DSM-5 removes the term "mental retardation" in favor of a diagnosis of intellectual disability. But the revisions go beyond the name change, according to Dr. Susan E. Swedo, who chaired the Neurodevelopmental Disorders Work Group for DSM-5.

The new definition is based not only on cognitive capacity, but also on adaptive functioning. The DSM-IV included four diagnostic codes for mental retardation: mild, moderate, severe, and profound. But the DSM-5 has only a single diagnosis of intellectual disability. The manual includes specifiers to use when grading the severity level. The specifiers also are based on both cognitive capacity and adaptive functioning.

Dr. Swedo predicted that because the new criteria are "real-world based," it will make it easier for primary care physicians to make a tentative diagnosis.

Autism spectrum disorder

The APA got a lot of attention when it announced plans to combine autistic disorder, Asperger’s disorder, and pervasive developmental disorder NOS into single spectrum called autism spectrum disorder (ASD). But the big change for psychiatrists will be the new criteria for assessing the severity of ASD.

The DSM-5 does not have an overall severity score for autism. Instead of mild, moderate, and severe, ASD is defined in terms of the level of support required. "We had grave concerns that if somebody got a mild autism diagnosis that it would deny [the patient] services," Dr. Swedo said. "If you meet threshold criteria for autism, you have an impairing condition and deserve help."

The DSM-5 also includes a specifier for when ASD is associated with a known medical or genetic condition or an environmental factor. This new specifier was included to encourage clinicians to include information about potential etiologic associations such as Fragile X syndrome, fetal alcohol exposure, and epilepsy.

The DSM-5 also includes a new diagnostic category outside of ASD called social communication disorder. The diagnosis is likely to be a good fit for children with severe attention-deficit/hyperactivity disorder (ADHD) and social skills deficits, Dr. Swedo said. One of the criteria for the disorder is that ASD must be ruled out.

Dr. Swedo said she does not expect psychiatrists to experience any confusion about which patients should receive a diagnosis of social communication disorder vs. ASD. During the pediatric field trials for the DSM-5, physicians moved very few children and adolescents with a pervasive developmental disorder (not otherwise specified) diagnosis into the social communication disorder category. Instead, they pick up a significant fraction of new patients, she said.

Somatic symptom disorders

The DSM-5 revamps the diagnostic criteria for somatic symptom disorders, bringing many different somatic conditions into a new disorder known as somatic symptom disorder. In previous versions of the DSM, the different diagnoses had overlapping boundaries, and the criteria ranged from too stringent to too loose, said Dr. Joel E. Dimsdale, chair of the Somatic Symptoms Work Group and professor emeritus of psychiatry at the University of California, San Diego. The result is that physicians felt uncomfortable using the somatoform diagnoses, and patients often went unrecognized and untreated, he said.

Another problem with the old versions of the DSM is that the focus for these conditions was on medically unexplained symptoms, Dr. Dimsdale said.

"It’s not a reliable distinction that clinicians agree about," he said. "It tends to foster an antagonism between the doctor and patient, and furthermore, it really encourages a mind-body split or dualism."

In the DSM-5, the new disorder known as somatic symptom disorder does not make medically unexplained symptoms central to the diagnosis. The major criteria for somatic symptom disorder are persistent (lasting 6 months or more), significant somatic symptoms that are associated with disproportionate thoughts, feelings, and behaviors, such as extreme levels of anxiety.

"I think doctors will have more confidence when they make that diagnosis," Dr. Dimsdale said.

And the new approach will be less alienating to patients, he said. "You will no longer be suggesting to a patient that his or her medical problems are imaginary, and that’s a significant improvement."

Commentary – Independent research review needed for DSM 5.1

Future editions of the DSM need to consider how outside social and economic forces are influencing mental health diagnosis, according to a commentary published in Health Affairs.

In the article, published on April 24, a group of experts in psychiatry, epidemiology, and social science called for the creation of an independent research review body to examine the scientific evidence on how institutional, social, and cultural factors contribute to variations in psychiatric diagnosis (doi:10.1377/hlthaff.2011.0596).

The experts assembled to revise the DSM have the necessary clinical expertise, but another group is needed to look at societal factors, such as how direct-to-consumer pharmaceutical advertising can affect the spikes in diagnoses or how insurance reimbursement rates can incentivize the diagnosis of more serious conditions, they wrote. The proposed research group also could look at the impact of environmental factors, such as the stress of living during a time of war.

"Research along these lines can clarify whether differences in disease diagnosis across groups results from diagnostic criteria, the way the criteria are applied, or environmental factors that influence people’s susceptibility to disorders," wrote the experts, led by Dr. Helena B. Hansen of the departments of psychiatry and anthropology at New York University.

The independent review body would consider differences in rates of diagnoses by sex, ethnicity, income, or geographic area, as well as rapid increase in a specific diagnosis. The review body also would be tasked with recommending changes to the DSM when its diagnostic criteria led to under- or overdiagnosis of a disorder.

The authors of the commentary received financial support from the Robert Wood Johnson Foundation Health and Society Scholars Program.

[email protected]

On Twitter @MaryEllenNY

After years of research, debate, and revision, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders is hitting the shelves.

The release of the DSM-5 marks the first time the influential diagnostic manual has been updated in nearly 20 years. The goal in putting together the fifth edition was not to do anything radical, said Dr. Dilip V. Jeste, president of the American Psychiatric Association, but to bring the science up to date and to make it more user friendly for clinicians.

Courtesy APA/David Hathcox

"The goal is to make sure that we have more accurate diagnoses so we can get better mental health services and improve patient outcomes," Dr. Jeste said.

The DSM-5 moves from a multiaxial system to a single axis format. It didn’t make sense to separate the disorders in that way, Dr. Jeste said, and the change makes it simpler for psychiatrists to use. The DSM-5 also puts a greater focus on the roles of age, gender, and culture. Every chapter will include a section on how to apply these factors when making a diagnosis.

Overall, the DSM-5 is not significantly different from the DSM-IV, said Dr. Joel Paris, a professor of psychiatry at McGill University, Montreal, and author of the "The Intelligent Clinician’s Guide to the DSM-5" (New York: Oxford University Press, 2013). Psychiatrists do not need to worry that they will be dealing with a completely new manual, he said, because most of the controversial changes were not accepted in the final version of the manual.

Dr. Paris, who was not involved in the DSM revision, said some those big changes were rejected by the DSM-5’s Scientific Review Committee because they did not have enough scientific data to back them up. "We’re just starting the science of psychiatry," he said. "It’s early days."

But there are some notable changes in the new manual. Experts who worked on the DSM-5 highlighted some of the revisions most likely to affect the way in which how psychiatrists practice.

Mild neurocognitive disorder

In the DSM-5, neurocognitive disorders are divided into two subtypes: mild and major. Major neurocognitive disorder lines up with the DSM-IV definition of dementia. But the DSM-5 Neurocognitive Disorders Work Group created a new subtype to describe mild neurocognitive decline that is more severe than the normal forgetfulness of aging but doesn’t rise to the level of dementia.

The DSM-5 includes specific criteria to help make the diagnosis of mild neurocognitive disorder, said Dr. Dan G. Blazer, cochair of the Neurocognitive Disorders Work Group and a professor of psychiatry and behavioral sciences at Duke University in Durham, N.C.

A patient with mild neurocognitive disorder is likely to complain of memory problems but will not have significant cognitive problems and would not meet the criteria for major neurocognitive disorder. Such patients often are able to complete their daily tasks, but it takes significantly more time and effort. For instance, a patient with mild neurocognitive disorder might take 2 hours to balance a checkbook, when it took just 10 minutes in the past.

Patients with mild neurocognitive disorder should fall somewhere between 1-2 standard deviations below normal on neuropsychological tests, Dr. Blazer said. While the DSM-5 does not recommend a specific test, Dr. Blazer said using some type of standardized test is important. "As we move along in this field, it’s going to be very important to objectively document the level of cognitive impairment that individuals have," Dr. Blazer said.

One of the challenges with this diagnosis is the question of whether these patients will progress and develop dementia. The answer is not necessarily, Dr. Blazer said. While this group has a higher likelihood of progressing to more severe problems, it is not a diagnosis of "pre-dementia," he said.

For many psychiatrists, the biggest change will be to begin asking patients about their level of functioning when they come in with memory complaints. That’s something that can be easily overlooked in a busy practice, Dr. Blazer said.

Major neurocognitive disorder

Previously memory impairment was essential to making a diagnosis of dementia, now called major neurocognitive disorder. But the DSM-5 no longer requires memory impairment to be present, said Dr. Jeste, who served on the Neurocognitive Disorders Work Group and is a professor of psychiatry and neurosciences at the University of California, San Diego.

The change was made to acknowledge that there are major neurocognitive disorders in which memory impairment is not present until late in the course of the illness. For instance, with frontotemporal dementia, which can occur when the patient is aged 50 years, memory impairment does not become apparent until much later in life. Instead, the main symptom is a change in personality. The change will likely reduce the number of patients who receive a "not otherwise specified" (NOS) diagnosis, Dr. Jeste said.

Intellectual disabilities

The DSM-5 removes the term "mental retardation" in favor of a diagnosis of intellectual disability. But the revisions go beyond the name change, according to Dr. Susan E. Swedo, who chaired the Neurodevelopmental Disorders Work Group for DSM-5.

The new definition is based not only on cognitive capacity, but also on adaptive functioning. The DSM-IV included four diagnostic codes for mental retardation: mild, moderate, severe, and profound. But the DSM-5 has only a single diagnosis of intellectual disability. The manual includes specifiers to use when grading the severity level. The specifiers also are based on both cognitive capacity and adaptive functioning.

Dr. Swedo predicted that because the new criteria are "real-world based," it will make it easier for primary care physicians to make a tentative diagnosis.

Autism spectrum disorder

The APA got a lot of attention when it announced plans to combine autistic disorder, Asperger’s disorder, and pervasive developmental disorder NOS into single spectrum called autism spectrum disorder (ASD). But the big change for psychiatrists will be the new criteria for assessing the severity of ASD.

The DSM-5 does not have an overall severity score for autism. Instead of mild, moderate, and severe, ASD is defined in terms of the level of support required. "We had grave concerns that if somebody got a mild autism diagnosis that it would deny [the patient] services," Dr. Swedo said. "If you meet threshold criteria for autism, you have an impairing condition and deserve help."

The DSM-5 also includes a specifier for when ASD is associated with a known medical or genetic condition or an environmental factor. This new specifier was included to encourage clinicians to include information about potential etiologic associations such as Fragile X syndrome, fetal alcohol exposure, and epilepsy.

The DSM-5 also includes a new diagnostic category outside of ASD called social communication disorder. The diagnosis is likely to be a good fit for children with severe attention-deficit/hyperactivity disorder (ADHD) and social skills deficits, Dr. Swedo said. One of the criteria for the disorder is that ASD must be ruled out.

Dr. Swedo said she does not expect psychiatrists to experience any confusion about which patients should receive a diagnosis of social communication disorder vs. ASD. During the pediatric field trials for the DSM-5, physicians moved very few children and adolescents with a pervasive developmental disorder (not otherwise specified) diagnosis into the social communication disorder category. Instead, they pick up a significant fraction of new patients, she said.

Somatic symptom disorders

The DSM-5 revamps the diagnostic criteria for somatic symptom disorders, bringing many different somatic conditions into a new disorder known as somatic symptom disorder. In previous versions of the DSM, the different diagnoses had overlapping boundaries, and the criteria ranged from too stringent to too loose, said Dr. Joel E. Dimsdale, chair of the Somatic Symptoms Work Group and professor emeritus of psychiatry at the University of California, San Diego. The result is that physicians felt uncomfortable using the somatoform diagnoses, and patients often went unrecognized and untreated, he said.

Another problem with the old versions of the DSM is that the focus for these conditions was on medically unexplained symptoms, Dr. Dimsdale said.

"It’s not a reliable distinction that clinicians agree about," he said. "It tends to foster an antagonism between the doctor and patient, and furthermore, it really encourages a mind-body split or dualism."

In the DSM-5, the new disorder known as somatic symptom disorder does not make medically unexplained symptoms central to the diagnosis. The major criteria for somatic symptom disorder are persistent (lasting 6 months or more), significant somatic symptoms that are associated with disproportionate thoughts, feelings, and behaviors, such as extreme levels of anxiety.

"I think doctors will have more confidence when they make that diagnosis," Dr. Dimsdale said.

And the new approach will be less alienating to patients, he said. "You will no longer be suggesting to a patient that his or her medical problems are imaginary, and that’s a significant improvement."

Commentary – Independent research review needed for DSM 5.1

Future editions of the DSM need to consider how outside social and economic forces are influencing mental health diagnosis, according to a commentary published in Health Affairs.

In the article, published on April 24, a group of experts in psychiatry, epidemiology, and social science called for the creation of an independent research review body to examine the scientific evidence on how institutional, social, and cultural factors contribute to variations in psychiatric diagnosis (doi:10.1377/hlthaff.2011.0596).

The experts assembled to revise the DSM have the necessary clinical expertise, but another group is needed to look at societal factors, such as how direct-to-consumer pharmaceutical advertising can affect the spikes in diagnoses or how insurance reimbursement rates can incentivize the diagnosis of more serious conditions, they wrote. The proposed research group also could look at the impact of environmental factors, such as the stress of living during a time of war.

"Research along these lines can clarify whether differences in disease diagnosis across groups results from diagnostic criteria, the way the criteria are applied, or environmental factors that influence people’s susceptibility to disorders," wrote the experts, led by Dr. Helena B. Hansen of the departments of psychiatry and anthropology at New York University.

The independent review body would consider differences in rates of diagnoses by sex, ethnicity, income, or geographic area, as well as rapid increase in a specific diagnosis. The review body also would be tasked with recommending changes to the DSM when its diagnostic criteria led to under- or overdiagnosis of a disorder.

The authors of the commentary received financial support from the Robert Wood Johnson Foundation Health and Society Scholars Program.

[email protected]

On Twitter @MaryEllenNY

After years of research, debate, and revision, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders is hitting the shelves.

The release of the DSM-5 marks the first time the influential diagnostic manual has been updated in nearly 20 years. The goal in putting together the fifth edition was not to do anything radical, said Dr. Dilip V. Jeste, president of the American Psychiatric Association, but to bring the science up to date and to make it more user friendly for clinicians.

Courtesy APA/David Hathcox

"The goal is to make sure that we have more accurate diagnoses so we can get better mental health services and improve patient outcomes," Dr. Jeste said.

The DSM-5 moves from a multiaxial system to a single axis format. It didn’t make sense to separate the disorders in that way, Dr. Jeste said, and the change makes it simpler for psychiatrists to use. The DSM-5 also puts a greater focus on the roles of age, gender, and culture. Every chapter will include a section on how to apply these factors when making a diagnosis.

Overall, the DSM-5 is not significantly different from the DSM-IV, said Dr. Joel Paris, a professor of psychiatry at McGill University, Montreal, and author of the "The Intelligent Clinician’s Guide to the DSM-5" (New York: Oxford University Press, 2013). Psychiatrists do not need to worry that they will be dealing with a completely new manual, he said, because most of the controversial changes were not accepted in the final version of the manual.

Dr. Paris, who was not involved in the DSM revision, said some those big changes were rejected by the DSM-5’s Scientific Review Committee because they did not have enough scientific data to back them up. "We’re just starting the science of psychiatry," he said. "It’s early days."

But there are some notable changes in the new manual. Experts who worked on the DSM-5 highlighted some of the revisions most likely to affect the way in which how psychiatrists practice.

Mild neurocognitive disorder

In the DSM-5, neurocognitive disorders are divided into two subtypes: mild and major. Major neurocognitive disorder lines up with the DSM-IV definition of dementia. But the DSM-5 Neurocognitive Disorders Work Group created a new subtype to describe mild neurocognitive decline that is more severe than the normal forgetfulness of aging but doesn’t rise to the level of dementia.

The DSM-5 includes specific criteria to help make the diagnosis of mild neurocognitive disorder, said Dr. Dan G. Blazer, cochair of the Neurocognitive Disorders Work Group and a professor of psychiatry and behavioral sciences at Duke University in Durham, N.C.

A patient with mild neurocognitive disorder is likely to complain of memory problems but will not have significant cognitive problems and would not meet the criteria for major neurocognitive disorder. Such patients often are able to complete their daily tasks, but it takes significantly more time and effort. For instance, a patient with mild neurocognitive disorder might take 2 hours to balance a checkbook, when it took just 10 minutes in the past.

Patients with mild neurocognitive disorder should fall somewhere between 1-2 standard deviations below normal on neuropsychological tests, Dr. Blazer said. While the DSM-5 does not recommend a specific test, Dr. Blazer said using some type of standardized test is important. "As we move along in this field, it’s going to be very important to objectively document the level of cognitive impairment that individuals have," Dr. Blazer said.

One of the challenges with this diagnosis is the question of whether these patients will progress and develop dementia. The answer is not necessarily, Dr. Blazer said. While this group has a higher likelihood of progressing to more severe problems, it is not a diagnosis of "pre-dementia," he said.

For many psychiatrists, the biggest change will be to begin asking patients about their level of functioning when they come in with memory complaints. That’s something that can be easily overlooked in a busy practice, Dr. Blazer said.

Major neurocognitive disorder

Previously memory impairment was essential to making a diagnosis of dementia, now called major neurocognitive disorder. But the DSM-5 no longer requires memory impairment to be present, said Dr. Jeste, who served on the Neurocognitive Disorders Work Group and is a professor of psychiatry and neurosciences at the University of California, San Diego.

The change was made to acknowledge that there are major neurocognitive disorders in which memory impairment is not present until late in the course of the illness. For instance, with frontotemporal dementia, which can occur when the patient is aged 50 years, memory impairment does not become apparent until much later in life. Instead, the main symptom is a change in personality. The change will likely reduce the number of patients who receive a "not otherwise specified" (NOS) diagnosis, Dr. Jeste said.

Intellectual disabilities

The DSM-5 removes the term "mental retardation" in favor of a diagnosis of intellectual disability. But the revisions go beyond the name change, according to Dr. Susan E. Swedo, who chaired the Neurodevelopmental Disorders Work Group for DSM-5.

The new definition is based not only on cognitive capacity, but also on adaptive functioning. The DSM-IV included four diagnostic codes for mental retardation: mild, moderate, severe, and profound. But the DSM-5 has only a single diagnosis of intellectual disability. The manual includes specifiers to use when grading the severity level. The specifiers also are based on both cognitive capacity and adaptive functioning.

Dr. Swedo predicted that because the new criteria are "real-world based," it will make it easier for primary care physicians to make a tentative diagnosis.

Autism spectrum disorder

The APA got a lot of attention when it announced plans to combine autistic disorder, Asperger’s disorder, and pervasive developmental disorder NOS into single spectrum called autism spectrum disorder (ASD). But the big change for psychiatrists will be the new criteria for assessing the severity of ASD.

The DSM-5 does not have an overall severity score for autism. Instead of mild, moderate, and severe, ASD is defined in terms of the level of support required. "We had grave concerns that if somebody got a mild autism diagnosis that it would deny [the patient] services," Dr. Swedo said. "If you meet threshold criteria for autism, you have an impairing condition and deserve help."

The DSM-5 also includes a specifier for when ASD is associated with a known medical or genetic condition or an environmental factor. This new specifier was included to encourage clinicians to include information about potential etiologic associations such as Fragile X syndrome, fetal alcohol exposure, and epilepsy.

The DSM-5 also includes a new diagnostic category outside of ASD called social communication disorder. The diagnosis is likely to be a good fit for children with severe attention-deficit/hyperactivity disorder (ADHD) and social skills deficits, Dr. Swedo said. One of the criteria for the disorder is that ASD must be ruled out.

Dr. Swedo said she does not expect psychiatrists to experience any confusion about which patients should receive a diagnosis of social communication disorder vs. ASD. During the pediatric field trials for the DSM-5, physicians moved very few children and adolescents with a pervasive developmental disorder (not otherwise specified) diagnosis into the social communication disorder category. Instead, they pick up a significant fraction of new patients, she said.

Somatic symptom disorders

The DSM-5 revamps the diagnostic criteria for somatic symptom disorders, bringing many different somatic conditions into a new disorder known as somatic symptom disorder. In previous versions of the DSM, the different diagnoses had overlapping boundaries, and the criteria ranged from too stringent to too loose, said Dr. Joel E. Dimsdale, chair of the Somatic Symptoms Work Group and professor emeritus of psychiatry at the University of California, San Diego. The result is that physicians felt uncomfortable using the somatoform diagnoses, and patients often went unrecognized and untreated, he said.

Another problem with the old versions of the DSM is that the focus for these conditions was on medically unexplained symptoms, Dr. Dimsdale said.

"It’s not a reliable distinction that clinicians agree about," he said. "It tends to foster an antagonism between the doctor and patient, and furthermore, it really encourages a mind-body split or dualism."

In the DSM-5, the new disorder known as somatic symptom disorder does not make medically unexplained symptoms central to the diagnosis. The major criteria for somatic symptom disorder are persistent (lasting 6 months or more), significant somatic symptoms that are associated with disproportionate thoughts, feelings, and behaviors, such as extreme levels of anxiety.

"I think doctors will have more confidence when they make that diagnosis," Dr. Dimsdale said.

And the new approach will be less alienating to patients, he said. "You will no longer be suggesting to a patient that his or her medical problems are imaginary, and that’s a significant improvement."

Commentary – Independent research review needed for DSM 5.1

Future editions of the DSM need to consider how outside social and economic forces are influencing mental health diagnosis, according to a commentary published in Health Affairs.

In the article, published on April 24, a group of experts in psychiatry, epidemiology, and social science called for the creation of an independent research review body to examine the scientific evidence on how institutional, social, and cultural factors contribute to variations in psychiatric diagnosis (doi:10.1377/hlthaff.2011.0596).

The experts assembled to revise the DSM have the necessary clinical expertise, but another group is needed to look at societal factors, such as how direct-to-consumer pharmaceutical advertising can affect the spikes in diagnoses or how insurance reimbursement rates can incentivize the diagnosis of more serious conditions, they wrote. The proposed research group also could look at the impact of environmental factors, such as the stress of living during a time of war.

"Research along these lines can clarify whether differences in disease diagnosis across groups results from diagnostic criteria, the way the criteria are applied, or environmental factors that influence people’s susceptibility to disorders," wrote the experts, led by Dr. Helena B. Hansen of the departments of psychiatry and anthropology at New York University.

The independent review body would consider differences in rates of diagnoses by sex, ethnicity, income, or geographic area, as well as rapid increase in a specific diagnosis. The review body also would be tasked with recommending changes to the DSM when its diagnostic criteria led to under- or overdiagnosis of a disorder.

The authors of the commentary received financial support from the Robert Wood Johnson Foundation Health and Society Scholars Program.

[email protected]

On Twitter @MaryEllenNY

Dr. Patrick J. Torcson has always been passionate about caring for the sickest patients and about ensuring the highest quality of care. So when he read Dr. Bob Wachter’s article in JAMA in 2002 showing that the movement to the hospitalist model was saving money without sacrificing quality or patient satisfaction, it led him to make the jump to become a full-time hospitalist (JAMA 2002;287:487-94).

Dr. Torcson established the hospital medicine program at St. Tammany Parish Hospital in Covington, La., in 2005, and still runs the program today. He’s also involved in the public policy and performance measurement committees at the Society of Hospital Medicine and serves as the SHM representative to the American Medical Association’s Physician Consortium for Performance Improvement, efforts aimed at ensuring that quality reporting programs are fair and relevant.

Courtesy St. Tammany Parish Hospital

In an interview with Hospitalist News, Dr. Torcson shared his thoughts on the current quality reporting programs and the ones coming down the pike.

Hospitalist News: Physicians are doing more quality reporting now than ever before, do you think this leads to improved care?

Dr. Torcson: The evidence is mixed as to whether quality reporting and pay for performance actually improve outcomes. It’s important at the outset to distinguish between hospital-level reporting and pay for performance, and physician-level reporting and pay for performance. On the hospital side, we do actually have some results mainly from Medicare’s Hospital Quality Improvement Demonstration Project that showed that when you do public reporting, like on the Hospital Compare website, and you throw some money at the hospitals, that you will get improved quality as determined by adherence to the various performance measures.

On the physician side, there really isn’t any strong evidence showing that paying physicians on a differential basis actually improves quality. It’s hard to have good objective studies of that, but the ones that we have so far, mainly on the outpatient side, really do not show a clear distinction between quality reporting and pay for performance and actually improving quality of care. The lesson there is that maybe trying to do individual-level accountability for what really is systemic care may not work. But clearly we have to do something. We know that the U.S. health care system has tremendous variability in quality and unsustainable costs, so something has to be done to drive a performance agenda to fix this problem.

HN: How relevant are programs like Medicare’s Physician Quality Reporting System (PQRS) to hospitalists?

Dr. Torcson: In some respects it has to be relevant because hospitalists now provide more inpatient care than any other medical specialty. We know that hospitalized patients are the sickest and use the most resources. So performance improvement and performance accountability has to be relevant for hospitalists because of the importance of what we do.

That being said, the PQRS program as it’s currently designed has few relevant performance measures for hospitalists. Most of it was designed around an outpatient focus with that traditional model of doctors in the office also taking care of hospital patients and wasn’t geared toward the model that we have now where most inpatient care is provided by hospitalists. And the actual platform for how the performance reporting is done is not very easy for hospitalists to work with because we rely mainly on hospital-level billing systems to report data.

HN: The physician value-based modifier program is coming soon. What do hospitalists need to keep in mind about this program?

Dr. Torcson: If hospitalists are part of a group of greater than 100 providers, they are under a deadline of October 2013 to establish how they’re going to participate in this program, which will impact their reimbursement starting in 2015. This is something we’ve seen coming down the pike for a number of years. It’s important to remember that the Centers for Medicare and Medicaid Services has put only 1% of our Medicare allowable charges at risk with this pay-for-performance program. And for right now it’s only going to apply to large groups of greater than 100 providers.

The reporting period for the quality measures that will be used in this first iteration is 2013 for the payment adjustment that will occur in 2015. For the rest of us in groups less than 100, the performance period is probably going to be 2014 or 2015 for the payment adjustments beginning in 2017. It’s a small amount of money at risk for right now and it only applies to groups of greater than 100 providers. But definitely stay tuned.

HN: Do you have any tips for how to make quality reporting programs like PQRS less onerous for hospitalists?

Dr. Torcson: Hospitalists should try to take off their clinical hats and even their quality improvement hats and think in terms of practice management. For now, PQRS is voluntary, pay-for-reporting only. So the focus for now is getting your reporting infrastructure in place and that is tied to how you do your billing. It’s a matter of doing the administrative work to see how you submit your claims to Medicare and getting used to reporting the quality data codes, which are part of the PQRS, to those billing codes.

For PQRS, you only have to choose three performance measures. The PQRS has over 260 measures in the program and only 10 are really applicable to hospitalists. You don’t have to hit a home run. Just choose the three measures and figure out from a practice management standpoint how you’re going to attach the quality data codes to your billing codes to get in the reporting game. That’s the best starting point.

HN: Do you think we’ll ever see a payment system based completely on quality rather than volume?

Dr. Torcson: The U.S. health care system is going to be doing a lot of experimentation with alternative payment models. A driving force is to shift financial risk from insurance plans and other payers to providers. That’s going to happen in various payment models like bundling or capitation or the accountable care shared savings methodology.

Pay for performance isn’t necessarily the key to improving care, and regulating change doesn’t seem to work either. What we hope is going to happen is that we’re going to figure out better ways to manage chronic illness and to perform care coordination for the 5% of the population that accounts for 50% of the health care resources.

Looking forward, I think that success for an individual hospitalist is really going to be achieved by aligning with the hospital-level performance agenda. Don’t just think in terms of the individual physician and how you’re going to perform, but really think at the system level.

For hospitalists, in particular, we have a great opportunity through alignment with the hospital-level agenda to really make a difference in terms of how we improve the quality of care and are accountable for costs.

Dr. Patrick J. Torcson has always been passionate about caring for the sickest patients and about ensuring the highest quality of care. So when he read Dr. Bob Wachter’s article in JAMA in 2002 showing that the movement to the hospitalist model was saving money without sacrificing quality or patient satisfaction, it led him to make the jump to become a full-time hospitalist (JAMA 2002;287:487-94).

Dr. Torcson established the hospital medicine program at St. Tammany Parish Hospital in Covington, La., in 2005, and still runs the program today. He’s also involved in the public policy and performance measurement committees at the Society of Hospital Medicine and serves as the SHM representative to the American Medical Association’s Physician Consortium for Performance Improvement, efforts aimed at ensuring that quality reporting programs are fair and relevant.

Courtesy St. Tammany Parish Hospital

In an interview with Hospitalist News, Dr. Torcson shared his thoughts on the current quality reporting programs and the ones coming down the pike.

Hospitalist News: Physicians are doing more quality reporting now than ever before, do you think this leads to improved care?

Dr. Torcson: The evidence is mixed as to whether quality reporting and pay for performance actually improve outcomes. It’s important at the outset to distinguish between hospital-level reporting and pay for performance, and physician-level reporting and pay for performance. On the hospital side, we do actually have some results mainly from Medicare’s Hospital Quality Improvement Demonstration Project that showed that when you do public reporting, like on the Hospital Compare website, and you throw some money at the hospitals, that you will get improved quality as determined by adherence to the various performance measures.

On the physician side, there really isn’t any strong evidence showing that paying physicians on a differential basis actually improves quality. It’s hard to have good objective studies of that, but the ones that we have so far, mainly on the outpatient side, really do not show a clear distinction between quality reporting and pay for performance and actually improving quality of care. The lesson there is that maybe trying to do individual-level accountability for what really is systemic care may not work. But clearly we have to do something. We know that the U.S. health care system has tremendous variability in quality and unsustainable costs, so something has to be done to drive a performance agenda to fix this problem.

HN: How relevant are programs like Medicare’s Physician Quality Reporting System (PQRS) to hospitalists?

Dr. Torcson: In some respects it has to be relevant because hospitalists now provide more inpatient care than any other medical specialty. We know that hospitalized patients are the sickest and use the most resources. So performance improvement and performance accountability has to be relevant for hospitalists because of the importance of what we do.

That being said, the PQRS program as it’s currently designed has few relevant performance measures for hospitalists. Most of it was designed around an outpatient focus with that traditional model of doctors in the office also taking care of hospital patients and wasn’t geared toward the model that we have now where most inpatient care is provided by hospitalists. And the actual platform for how the performance reporting is done is not very easy for hospitalists to work with because we rely mainly on hospital-level billing systems to report data.

HN: The physician value-based modifier program is coming soon. What do hospitalists need to keep in mind about this program?

Dr. Torcson: If hospitalists are part of a group of greater than 100 providers, they are under a deadline of October 2013 to establish how they’re going to participate in this program, which will impact their reimbursement starting in 2015. This is something we’ve seen coming down the pike for a number of years. It’s important to remember that the Centers for Medicare and Medicaid Services has put only 1% of our Medicare allowable charges at risk with this pay-for-performance program. And for right now it’s only going to apply to large groups of greater than 100 providers.

The reporting period for the quality measures that will be used in this first iteration is 2013 for the payment adjustment that will occur in 2015. For the rest of us in groups less than 100, the performance period is probably going to be 2014 or 2015 for the payment adjustments beginning in 2017. It’s a small amount of money at risk for right now and it only applies to groups of greater than 100 providers. But definitely stay tuned.

HN: Do you have any tips for how to make quality reporting programs like PQRS less onerous for hospitalists?

Dr. Torcson: Hospitalists should try to take off their clinical hats and even their quality improvement hats and think in terms of practice management. For now, PQRS is voluntary, pay-for-reporting only. So the focus for now is getting your reporting infrastructure in place and that is tied to how you do your billing. It’s a matter of doing the administrative work to see how you submit your claims to Medicare and getting used to reporting the quality data codes, which are part of the PQRS, to those billing codes.

For PQRS, you only have to choose three performance measures. The PQRS has over 260 measures in the program and only 10 are really applicable to hospitalists. You don’t have to hit a home run. Just choose the three measures and figure out from a practice management standpoint how you’re going to attach the quality data codes to your billing codes to get in the reporting game. That’s the best starting point.

HN: Do you think we’ll ever see a payment system based completely on quality rather than volume?

Dr. Torcson: The U.S. health care system is going to be doing a lot of experimentation with alternative payment models. A driving force is to shift financial risk from insurance plans and other payers to providers. That’s going to happen in various payment models like bundling or capitation or the accountable care shared savings methodology.

Pay for performance isn’t necessarily the key to improving care, and regulating change doesn’t seem to work either. What we hope is going to happen is that we’re going to figure out better ways to manage chronic illness and to perform care coordination for the 5% of the population that accounts for 50% of the health care resources.

Looking forward, I think that success for an individual hospitalist is really going to be achieved by aligning with the hospital-level performance agenda. Don’t just think in terms of the individual physician and how you’re going to perform, but really think at the system level.

For hospitalists, in particular, we have a great opportunity through alignment with the hospital-level agenda to really make a difference in terms of how we improve the quality of care and are accountable for costs.

Dr. Patrick J. Torcson has always been passionate about caring for the sickest patients and about ensuring the highest quality of care. So when he read Dr. Bob Wachter’s article in JAMA in 2002 showing that the movement to the hospitalist model was saving money without sacrificing quality or patient satisfaction, it led him to make the jump to become a full-time hospitalist (JAMA 2002;287:487-94).

Dr. Torcson established the hospital medicine program at St. Tammany Parish Hospital in Covington, La., in 2005, and still runs the program today. He’s also involved in the public policy and performance measurement committees at the Society of Hospital Medicine and serves as the SHM representative to the American Medical Association’s Physician Consortium for Performance Improvement, efforts aimed at ensuring that quality reporting programs are fair and relevant.

Courtesy St. Tammany Parish Hospital

In an interview with Hospitalist News, Dr. Torcson shared his thoughts on the current quality reporting programs and the ones coming down the pike.

Hospitalist News: Physicians are doing more quality reporting now than ever before, do you think this leads to improved care?

Dr. Torcson: The evidence is mixed as to whether quality reporting and pay for performance actually improve outcomes. It’s important at the outset to distinguish between hospital-level reporting and pay for performance, and physician-level reporting and pay for performance. On the hospital side, we do actually have some results mainly from Medicare’s Hospital Quality Improvement Demonstration Project that showed that when you do public reporting, like on the Hospital Compare website, and you throw some money at the hospitals, that you will get improved quality as determined by adherence to the various performance measures.

On the physician side, there really isn’t any strong evidence showing that paying physicians on a differential basis actually improves quality. It’s hard to have good objective studies of that, but the ones that we have so far, mainly on the outpatient side, really do not show a clear distinction between quality reporting and pay for performance and actually improving quality of care. The lesson there is that maybe trying to do individual-level accountability for what really is systemic care may not work. But clearly we have to do something. We know that the U.S. health care system has tremendous variability in quality and unsustainable costs, so something has to be done to drive a performance agenda to fix this problem.

HN: How relevant are programs like Medicare’s Physician Quality Reporting System (PQRS) to hospitalists?

Dr. Torcson: In some respects it has to be relevant because hospitalists now provide more inpatient care than any other medical specialty. We know that hospitalized patients are the sickest and use the most resources. So performance improvement and performance accountability has to be relevant for hospitalists because of the importance of what we do.

That being said, the PQRS program as it’s currently designed has few relevant performance measures for hospitalists. Most of it was designed around an outpatient focus with that traditional model of doctors in the office also taking care of hospital patients and wasn’t geared toward the model that we have now where most inpatient care is provided by hospitalists. And the actual platform for how the performance reporting is done is not very easy for hospitalists to work with because we rely mainly on hospital-level billing systems to report data.

HN: The physician value-based modifier program is coming soon. What do hospitalists need to keep in mind about this program?

Dr. Torcson: If hospitalists are part of a group of greater than 100 providers, they are under a deadline of October 2013 to establish how they’re going to participate in this program, which will impact their reimbursement starting in 2015. This is something we’ve seen coming down the pike for a number of years. It’s important to remember that the Centers for Medicare and Medicaid Services has put only 1% of our Medicare allowable charges at risk with this pay-for-performance program. And for right now it’s only going to apply to large groups of greater than 100 providers.

The reporting period for the quality measures that will be used in this first iteration is 2013 for the payment adjustment that will occur in 2015. For the rest of us in groups less than 100, the performance period is probably going to be 2014 or 2015 for the payment adjustments beginning in 2017. It’s a small amount of money at risk for right now and it only applies to groups of greater than 100 providers. But definitely stay tuned.

HN: Do you have any tips for how to make quality reporting programs like PQRS less onerous for hospitalists?

Dr. Torcson: Hospitalists should try to take off their clinical hats and even their quality improvement hats and think in terms of practice management. For now, PQRS is voluntary, pay-for-reporting only. So the focus for now is getting your reporting infrastructure in place and that is tied to how you do your billing. It’s a matter of doing the administrative work to see how you submit your claims to Medicare and getting used to reporting the quality data codes, which are part of the PQRS, to those billing codes.

For PQRS, you only have to choose three performance measures. The PQRS has over 260 measures in the program and only 10 are really applicable to hospitalists. You don’t have to hit a home run. Just choose the three measures and figure out from a practice management standpoint how you’re going to attach the quality data codes to your billing codes to get in the reporting game. That’s the best starting point.

HN: Do you think we’ll ever see a payment system based completely on quality rather than volume?

Dr. Torcson: The U.S. health care system is going to be doing a lot of experimentation with alternative payment models. A driving force is to shift financial risk from insurance plans and other payers to providers. That’s going to happen in various payment models like bundling or capitation or the accountable care shared savings methodology.

Pay for performance isn’t necessarily the key to improving care, and regulating change doesn’t seem to work either. What we hope is going to happen is that we’re going to figure out better ways to manage chronic illness and to perform care coordination for the 5% of the population that accounts for 50% of the health care resources.

Looking forward, I think that success for an individual hospitalist is really going to be achieved by aligning with the hospital-level performance agenda. Don’t just think in terms of the individual physician and how you’re going to perform, but really think at the system level.

For hospitalists, in particular, we have a great opportunity through alignment with the hospital-level agenda to really make a difference in terms of how we improve the quality of care and are accountable for costs.

The federal government is continuing its court battle to try to limit over-the-counter sale of levonorgestrel-based emergency contraception to adolescents under age 15 years.

On May 13, the U.S. Department of Justice requested that the Second U.S. Circuit Court of Appeals temporarily halt the implementation of a court order to lift all point-of-sale age restrictions on emergency contraception, pending an appeal of the case.

That original ruling, which was handed down by Judge Edward Korman of the Eastern District of New York in April, was set to go into effect in early May. The government requested a stay of the ruling from Judge Korman, which he denied on May 10. But he gave the government until May 13 to request a stay from the Court of Appeals.

Judge Korman, who has harshly criticized the government’s regulation of emergency contraception, wrote in his latest ruling that the attempt to appeal his order was "frivolous" and another attempt to "delay."

The Justice Department argues that there is no need to implement the ruling because the Food and Drug Administration recently approved Plan B One-Step (levonorgestrel tablet, 1.5-mg, for oral use) without prescription for young women aged 15-16 years, provided they can verify their age. Previously, the emergency contraceptive product was only available OTC to women aged 17 years and older.

[email protected]

The federal government is continuing its court battle to try to limit over-the-counter sale of levonorgestrel-based emergency contraception to adolescents under age 15 years.

On May 13, the U.S. Department of Justice requested that the Second U.S. Circuit Court of Appeals temporarily halt the implementation of a court order to lift all point-of-sale age restrictions on emergency contraception, pending an appeal of the case.

That original ruling, which was handed down by Judge Edward Korman of the Eastern District of New York in April, was set to go into effect in early May. The government requested a stay of the ruling from Judge Korman, which he denied on May 10. But he gave the government until May 13 to request a stay from the Court of Appeals.

Judge Korman, who has harshly criticized the government’s regulation of emergency contraception, wrote in his latest ruling that the attempt to appeal his order was "frivolous" and another attempt to "delay."

The Justice Department argues that there is no need to implement the ruling because the Food and Drug Administration recently approved Plan B One-Step (levonorgestrel tablet, 1.5-mg, for oral use) without prescription for young women aged 15-16 years, provided they can verify their age. Previously, the emergency contraceptive product was only available OTC to women aged 17 years and older.

[email protected]

The federal government is continuing its court battle to try to limit over-the-counter sale of levonorgestrel-based emergency contraception to adolescents under age 15 years.

On May 13, the U.S. Department of Justice requested that the Second U.S. Circuit Court of Appeals temporarily halt the implementation of a court order to lift all point-of-sale age restrictions on emergency contraception, pending an appeal of the case.

That original ruling, which was handed down by Judge Edward Korman of the Eastern District of New York in April, was set to go into effect in early May. The government requested a stay of the ruling from Judge Korman, which he denied on May 10. But he gave the government until May 13 to request a stay from the Court of Appeals.

Judge Korman, who has harshly criticized the government’s regulation of emergency contraception, wrote in his latest ruling that the attempt to appeal his order was "frivolous" and another attempt to "delay."

The Justice Department argues that there is no need to implement the ruling because the Food and Drug Administration recently approved Plan B One-Step (levonorgestrel tablet, 1.5-mg, for oral use) without prescription for young women aged 15-16 years, provided they can verify their age. Previously, the emergency contraceptive product was only available OTC to women aged 17 years and older.

[email protected]

The fee-for-service payment system has contributed to high health care costs and inconsistent quality of care and should be replaced with a blended payment model that includes fixed payments, according to a new report from a panel of physicians and health care experts.

In a report released in March, the National Commission on Physician Payment Reform recommended phasing out the current fee-for-service system over 5 years in favor of bundled payments, capitation, and increased financial risk-sharing.

"We can’t control runaway medical spending without changing how doctors get paid," Dr. Bill Frist, honorary chair of the commission and former Senate majority leader, said in a statement. "This is a bipartisan issue. We all want to get the most from our health care dollars and that requires rethinking the way we pay for health care."

But the 14-member commission predicted that fee-for-service would continue to play a large role. By the end of the decade, they called for a blended system of fee-for-service, fixed payments, and salary.

The commission also recommended eliminating the Sustainable Growth Rate (SGR) formula, which ties Medicare physician payments to changes in the gross domestic product (GDP). The Congressional Budget Office (CBO) recently estimated the price of eliminating the SGR at $138 billion over 10 years, which the commission said could be paid for by reducing overutilization of Medicare services and cutting down on fraud.

The commission, which was convened by the Society of General Internal Medicine, is chaired by Dr. Steven A. Schroeder, former president of the Robert Wood Johnson Foundation. The other members include physicians from various specialties, as well as experts in health care policy. The commission is funded in part by the Robert Wood Johnson Foundation and the California HealthCare Foundation.

Some of the other recommendations include:

• Increasing payments for evaluation and management codes, while freezing procedural diagnosis codes for 3 years.

• Eliminating higher payments for facility-based services that can be performed in lower-cost settings of care.

• Incorporating quality metrics into fee-for-service contracts.

• Using fixed payment models in areas such as the management of multiple chronic diseases and in-hospital procedures and follow-up.

• Changing the membership of the Relative Value Scale Update Committee (RUC) to make it more representative of the medical profession.

[email protected]

The fee-for-service payment system has contributed to high health care costs and inconsistent quality of care and should be replaced with a blended payment model that includes fixed payments, according to a new report from a panel of physicians and health care experts.

In a report released in March, the National Commission on Physician Payment Reform recommended phasing out the current fee-for-service system over 5 years in favor of bundled payments, capitation, and increased financial risk-sharing.

"We can’t control runaway medical spending without changing how doctors get paid," Dr. Bill Frist, honorary chair of the commission and former Senate majority leader, said in a statement. "This is a bipartisan issue. We all want to get the most from our health care dollars and that requires rethinking the way we pay for health care."

But the 14-member commission predicted that fee-for-service would continue to play a large role. By the end of the decade, they called for a blended system of fee-for-service, fixed payments, and salary.

The commission also recommended eliminating the Sustainable Growth Rate (SGR) formula, which ties Medicare physician payments to changes in the gross domestic product (GDP). The Congressional Budget Office (CBO) recently estimated the price of eliminating the SGR at $138 billion over 10 years, which the commission said could be paid for by reducing overutilization of Medicare services and cutting down on fraud.

The commission, which was convened by the Society of General Internal Medicine, is chaired by Dr. Steven A. Schroeder, former president of the Robert Wood Johnson Foundation. The other members include physicians from various specialties, as well as experts in health care policy. The commission is funded in part by the Robert Wood Johnson Foundation and the California HealthCare Foundation.

Some of the other recommendations include:

• Increasing payments for evaluation and management codes, while freezing procedural diagnosis codes for 3 years.

• Eliminating higher payments for facility-based services that can be performed in lower-cost settings of care.

• Incorporating quality metrics into fee-for-service contracts.

• Using fixed payment models in areas such as the management of multiple chronic diseases and in-hospital procedures and follow-up.

• Changing the membership of the Relative Value Scale Update Committee (RUC) to make it more representative of the medical profession.

[email protected]

The fee-for-service payment system has contributed to high health care costs and inconsistent quality of care and should be replaced with a blended payment model that includes fixed payments, according to a new report from a panel of physicians and health care experts.

In a report released in March, the National Commission on Physician Payment Reform recommended phasing out the current fee-for-service system over 5 years in favor of bundled payments, capitation, and increased financial risk-sharing.

"We can’t control runaway medical spending without changing how doctors get paid," Dr. Bill Frist, honorary chair of the commission and former Senate majority leader, said in a statement. "This is a bipartisan issue. We all want to get the most from our health care dollars and that requires rethinking the way we pay for health care."

But the 14-member commission predicted that fee-for-service would continue to play a large role. By the end of the decade, they called for a blended system of fee-for-service, fixed payments, and salary.

The commission also recommended eliminating the Sustainable Growth Rate (SGR) formula, which ties Medicare physician payments to changes in the gross domestic product (GDP). The Congressional Budget Office (CBO) recently estimated the price of eliminating the SGR at $138 billion over 10 years, which the commission said could be paid for by reducing overutilization of Medicare services and cutting down on fraud.

The commission, which was convened by the Society of General Internal Medicine, is chaired by Dr. Steven A. Schroeder, former president of the Robert Wood Johnson Foundation. The other members include physicians from various specialties, as well as experts in health care policy. The commission is funded in part by the Robert Wood Johnson Foundation and the California HealthCare Foundation.

Some of the other recommendations include:

• Increasing payments for evaluation and management codes, while freezing procedural diagnosis codes for 3 years.

• Eliminating higher payments for facility-based services that can be performed in lower-cost settings of care.

• Incorporating quality metrics into fee-for-service contracts.

• Using fixed payment models in areas such as the management of multiple chronic diseases and in-hospital procedures and follow-up.

• Changing the membership of the Relative Value Scale Update Committee (RUC) to make it more representative of the medical profession.

[email protected]

The Obama administration plans to appeal a federal court ruling that makes levonorgestrel-based emergency contraception available to all without a prescription.

On May 1, the U.S. Justice Department sent a letter to Judge Edward Korman of the Eastern District of New York advising him of the plan to appeal and seeking to halt implementation of his April 5 ruling, pending the appeal’s outcome. In the April 5 decision, Judge Korman ordered the federal government to lift all age restrictions on emergency contraceptives within 30 days.

The news from the Justice Department came just a day after the Food and Drug Administration approved Plan B One-Step (levonorgestrel tablet, 1.5-mg, for oral use) without a prescription for young women aged 15-16 years, provided they can verify their age. Previously, the emergency contraceptive was available over the counter only to women aged 17 years and older.

Although the FDA approval of Plan B One-Step was not related to Judge Korman’s ruling, it means that all of the plaintiffs in the original lawsuit (Tummino v. Hamburg) would have access to emergency contraception without a prescription, Lorette E. Lynch, U.S. Attorney for the Eastern District of New York, wrote in a letter to Judge Korman.

But the availability of Plan B One-Step to more adolescents was not enough to stop many physician groups from blasting the plan to appeal. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine all came out against the Justice Department’s position.

"The Justice Department’s decision defies the medical community’s consensus opinion that emergency contraception is completely safe and effective for young women of any reproductive age," Dr. Thomas K. McInerny, president of the American Academy of Pediatrics, said in a statement. "Nearly 80% of pregnancies in adolescents are unintended, and if the administration’s appeal is successful, not all adolescents will be able to easily access a product that can prevent unintended pregnancies and protect their health."

And the organizations said that the FDA’s move to approve Plan B One-Step for young women aged 15 years and older was only a small step forward. There may also be problems with implementing the new policy since 15-year-olds often don’t have identification that would provide proof of age, they said.

Under the approval issued by the FDA on April 30, Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product, according to the FDA announcement. The product will be available in the family planning or women’s health aisles of stores that have a pharmacy and will be accessible "whether the pharmacy is open or not," the FDA statement said.

There are also concerns that the age restrictions will create confusion, especially since Plan B One-Step and the original Plan B now have different age requirements for OTC access, in addition to different dosing schedules. Access to the original Plan B remains limited to women aged 17 years and older without a prescription. There’s also a third emergency contraceptive on the market – Ella – which is available only be prescription.

"Confusion usually winds up reducing access" as pharmacists, unsure of the rules, err on the side of caution, said Dr. Eve Espey of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

But it’s important to remember that, overall, "access to emergency contraception is being liberalized and hopefully will continue to get easier for women. Talking to women about emergency contraception and continuing to advocate for increased access [both] remain really important," she said.

Dr. Espey said that she had no financial conflicts of interest.

[email protected]

The Obama administration plans to appeal a federal court ruling that makes levonorgestrel-based emergency contraception available to all without a prescription.

On May 1, the U.S. Justice Department sent a letter to Judge Edward Korman of the Eastern District of New York advising him of the plan to appeal and seeking to halt implementation of his April 5 ruling, pending the appeal’s outcome. In the April 5 decision, Judge Korman ordered the federal government to lift all age restrictions on emergency contraceptives within 30 days.

The news from the Justice Department came just a day after the Food and Drug Administration approved Plan B One-Step (levonorgestrel tablet, 1.5-mg, for oral use) without a prescription for young women aged 15-16 years, provided they can verify their age. Previously, the emergency contraceptive was available over the counter only to women aged 17 years and older.

Although the FDA approval of Plan B One-Step was not related to Judge Korman’s ruling, it means that all of the plaintiffs in the original lawsuit (Tummino v. Hamburg) would have access to emergency contraception without a prescription, Lorette E. Lynch, U.S. Attorney for the Eastern District of New York, wrote in a letter to Judge Korman.

But the availability of Plan B One-Step to more adolescents was not enough to stop many physician groups from blasting the plan to appeal. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine all came out against the Justice Department’s position.

"The Justice Department’s decision defies the medical community’s consensus opinion that emergency contraception is completely safe and effective for young women of any reproductive age," Dr. Thomas K. McInerny, president of the American Academy of Pediatrics, said in a statement. "Nearly 80% of pregnancies in adolescents are unintended, and if the administration’s appeal is successful, not all adolescents will be able to easily access a product that can prevent unintended pregnancies and protect their health."

And the organizations said that the FDA’s move to approve Plan B One-Step for young women aged 15 years and older was only a small step forward. There may also be problems with implementing the new policy since 15-year-olds often don’t have identification that would provide proof of age, they said.

Under the approval issued by the FDA on April 30, Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product, according to the FDA announcement. The product will be available in the family planning or women’s health aisles of stores that have a pharmacy and will be accessible "whether the pharmacy is open or not," the FDA statement said.

There are also concerns that the age restrictions will create confusion, especially since Plan B One-Step and the original Plan B now have different age requirements for OTC access, in addition to different dosing schedules. Access to the original Plan B remains limited to women aged 17 years and older without a prescription. There’s also a third emergency contraceptive on the market – Ella – which is available only be prescription.

"Confusion usually winds up reducing access" as pharmacists, unsure of the rules, err on the side of caution, said Dr. Eve Espey of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

But it’s important to remember that, overall, "access to emergency contraception is being liberalized and hopefully will continue to get easier for women. Talking to women about emergency contraception and continuing to advocate for increased access [both] remain really important," she said.

Dr. Espey said that she had no financial conflicts of interest.

[email protected]

The Obama administration plans to appeal a federal court ruling that makes levonorgestrel-based emergency contraception available to all without a prescription.

On May 1, the U.S. Justice Department sent a letter to Judge Edward Korman of the Eastern District of New York advising him of the plan to appeal and seeking to halt implementation of his April 5 ruling, pending the appeal’s outcome. In the April 5 decision, Judge Korman ordered the federal government to lift all age restrictions on emergency contraceptives within 30 days.

The news from the Justice Department came just a day after the Food and Drug Administration approved Plan B One-Step (levonorgestrel tablet, 1.5-mg, for oral use) without a prescription for young women aged 15-16 years, provided they can verify their age. Previously, the emergency contraceptive was available over the counter only to women aged 17 years and older.

Although the FDA approval of Plan B One-Step was not related to Judge Korman’s ruling, it means that all of the plaintiffs in the original lawsuit (Tummino v. Hamburg) would have access to emergency contraception without a prescription, Lorette E. Lynch, U.S. Attorney for the Eastern District of New York, wrote in a letter to Judge Korman.

But the availability of Plan B One-Step to more adolescents was not enough to stop many physician groups from blasting the plan to appeal. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine all came out against the Justice Department’s position.

"The Justice Department’s decision defies the medical community’s consensus opinion that emergency contraception is completely safe and effective for young women of any reproductive age," Dr. Thomas K. McInerny, president of the American Academy of Pediatrics, said in a statement. "Nearly 80% of pregnancies in adolescents are unintended, and if the administration’s appeal is successful, not all adolescents will be able to easily access a product that can prevent unintended pregnancies and protect their health."

And the organizations said that the FDA’s move to approve Plan B One-Step for young women aged 15 years and older was only a small step forward. There may also be problems with implementing the new policy since 15-year-olds often don’t have identification that would provide proof of age, they said.

Under the approval issued by the FDA on April 30, Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product, according to the FDA announcement. The product will be available in the family planning or women’s health aisles of stores that have a pharmacy and will be accessible "whether the pharmacy is open or not," the FDA statement said.

There are also concerns that the age restrictions will create confusion, especially since Plan B One-Step and the original Plan B now have different age requirements for OTC access, in addition to different dosing schedules. Access to the original Plan B remains limited to women aged 17 years and older without a prescription. There’s also a third emergency contraceptive on the market – Ella – which is available only be prescription.

"Confusion usually winds up reducing access" as pharmacists, unsure of the rules, err on the side of caution, said Dr. Eve Espey of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque.

But it’s important to remember that, overall, "access to emergency contraception is being liberalized and hopefully will continue to get easier for women. Talking to women about emergency contraception and continuing to advocate for increased access [both] remain really important," she said.

Dr. Espey said that she had no financial conflicts of interest.

[email protected]

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.

The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

[email protected]

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.

The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

[email protected]

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule released April 26.

The proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures. Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget. At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement. "This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program. The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first domain are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate. CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well. Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," Mr. Johnson said. "Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff."

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

[email protected]

An estimated 55 million U.S. adults – or 30% of those aged 19-64 years – were without health insurance coverage at some point last year, according to the Commonwealth Fund’s biennial survey of health insurance.

Another 30 million (16%) were considered underinsured because their out-of-pocket health care costs were high relative to income.

Many uninsured and underinsured adults also faced significant medical debt or had trouble affording health care visits and prescriptions, according to the report.

"The costs of health care and health coverage in the United States have been on an unsustainable upward trajectory over several decades, straining family and government budgets," Dr. David Blumenthal, president of the Commonwealth Fund, said during a press conference April 25.

When it comes to young adults, those aged 19-25 years, the rate of uninsurance has actually fallen – from 48% in 2010 to 41% in 2012. The researchers said the Affordable Care Act (ACA), which includes a provision allowing adults under age 26 to stay on their parents’ health plan if they can’t gain employer-sponsored insurance, is likely the reason behind the upswing in coverage in this group.

Other Americans are likely to gain coverage starting in January 2014, when most of the insurance coverage expansions of the ACA begin to take effect, Dr. Blumenthal said.

"Our expectation is that we will begin to see positive changes in our health care system when the major coverage provisions of the law launch in 2014," Dr. Blumenthal said. "But the changes won’t happen overnight."

Of the 55 million adults who were uninsured in the 2012 survey, about 87% would be eligible either for Medicaid or for a federal subsidy to help with the purchase of insurance under the ACA, according to the Commonwealth Fund. However, not everyone who is eligible for the benefits will take advantage of them because either they do not know they are eligible, they can’t find a premium they can afford, or they choose not to enroll. Also, following the Supreme Court decision on the ACA in 2012, states are not required to expand their Medicaid programs up to 133% of the federal poverty level, so there is likely to be patchwork of Medicaid coverage across the country.

In the meantime, U.S. adults who are uninsured or underinsured are having problems accessing care and paying medical bills.

The survey found that 43% of U.S. adults were missing out on necessary care due to cost, up from 37% in 2003. For instance, some people reported that they didn’t visit a doctor when they were sick, skipped recommended tests, or failed to fill prescriptions because of concerns about the cost.

The cost of health care was a significant barrier to access for Americans who were uninsured or underinsured. But it was also a problem for some adults with adequate insurance. Among those with adequate insurance, 28% reported cost-related problems.

Medical debt also continues to be a problem. In 2012, 41% of U.S. adults reported problems paying their medical bills or said they were paying off medical debt over time. Of those adults who had trouble paying their medical bills, 42% said they had received a lower credit rating as a result and 37% reported that they had used all of their savings in an attempt to pay off their medical bills.

The findings are based on a telephone survey conducted from April 26 to Aug. 19, 2012, of a nationally representative sample of more than 4,400 adults aged 19-64 years.

[email protected]

An estimated 55 million U.S. adults – or 30% of those aged 19-64 years – were without health insurance coverage at some point last year, according to the Commonwealth Fund’s biennial survey of health insurance.

Another 30 million (16%) were considered underinsured because their out-of-pocket health care costs were high relative to income.

Many uninsured and underinsured adults also faced significant medical debt or had trouble affording health care visits and prescriptions, according to the report.

"The costs of health care and health coverage in the United States have been on an unsustainable upward trajectory over several decades, straining family and government budgets," Dr. David Blumenthal, president of the Commonwealth Fund, said during a press conference April 25.

When it comes to young adults, those aged 19-25 years, the rate of uninsurance has actually fallen – from 48% in 2010 to 41% in 2012. The researchers said the Affordable Care Act (ACA), which includes a provision allowing adults under age 26 to stay on their parents’ health plan if they can’t gain employer-sponsored insurance, is likely the reason behind the upswing in coverage in this group.

Other Americans are likely to gain coverage starting in January 2014, when most of the insurance coverage expansions of the ACA begin to take effect, Dr. Blumenthal said.

"Our expectation is that we will begin to see positive changes in our health care system when the major coverage provisions of the law launch in 2014," Dr. Blumenthal said. "But the changes won’t happen overnight."

Of the 55 million adults who were uninsured in the 2012 survey, about 87% would be eligible either for Medicaid or for a federal subsidy to help with the purchase of insurance under the ACA, according to the Commonwealth Fund. However, not everyone who is eligible for the benefits will take advantage of them because either they do not know they are eligible, they can’t find a premium they can afford, or they choose not to enroll. Also, following the Supreme Court decision on the ACA in 2012, states are not required to expand their Medicaid programs up to 133% of the federal poverty level, so there is likely to be patchwork of Medicaid coverage across the country.

In the meantime, U.S. adults who are uninsured or underinsured are having problems accessing care and paying medical bills.

The survey found that 43% of U.S. adults were missing out on necessary care due to cost, up from 37% in 2003. For instance, some people reported that they didn’t visit a doctor when they were sick, skipped recommended tests, or failed to fill prescriptions because of concerns about the cost.

The cost of health care was a significant barrier to access for Americans who were uninsured or underinsured. But it was also a problem for some adults with adequate insurance. Among those with adequate insurance, 28% reported cost-related problems.

Medical debt also continues to be a problem. In 2012, 41% of U.S. adults reported problems paying their medical bills or said they were paying off medical debt over time. Of those adults who had trouble paying their medical bills, 42% said they had received a lower credit rating as a result and 37% reported that they had used all of their savings in an attempt to pay off their medical bills.

The findings are based on a telephone survey conducted from April 26 to Aug. 19, 2012, of a nationally representative sample of more than 4,400 adults aged 19-64 years.

[email protected]

An estimated 55 million U.S. adults – or 30% of those aged 19-64 years – were without health insurance coverage at some point last year, according to the Commonwealth Fund’s biennial survey of health insurance.

Another 30 million (16%) were considered underinsured because their out-of-pocket health care costs were high relative to income.

Many uninsured and underinsured adults also faced significant medical debt or had trouble affording health care visits and prescriptions, according to the report.

"The costs of health care and health coverage in the United States have been on an unsustainable upward trajectory over several decades, straining family and government budgets," Dr. David Blumenthal, president of the Commonwealth Fund, said during a press conference April 25.

When it comes to young adults, those aged 19-25 years, the rate of uninsurance has actually fallen – from 48% in 2010 to 41% in 2012. The researchers said the Affordable Care Act (ACA), which includes a provision allowing adults under age 26 to stay on their parents’ health plan if they can’t gain employer-sponsored insurance, is likely the reason behind the upswing in coverage in this group.

Other Americans are likely to gain coverage starting in January 2014, when most of the insurance coverage expansions of the ACA begin to take effect, Dr. Blumenthal said.

"Our expectation is that we will begin to see positive changes in our health care system when the major coverage provisions of the law launch in 2014," Dr. Blumenthal said. "But the changes won’t happen overnight."

Of the 55 million adults who were uninsured in the 2012 survey, about 87% would be eligible either for Medicaid or for a federal subsidy to help with the purchase of insurance under the ACA, according to the Commonwealth Fund. However, not everyone who is eligible for the benefits will take advantage of them because either they do not know they are eligible, they can’t find a premium they can afford, or they choose not to enroll. Also, following the Supreme Court decision on the ACA in 2012, states are not required to expand their Medicaid programs up to 133% of the federal poverty level, so there is likely to be patchwork of Medicaid coverage across the country.

In the meantime, U.S. adults who are uninsured or underinsured are having problems accessing care and paying medical bills.

The survey found that 43% of U.S. adults were missing out on necessary care due to cost, up from 37% in 2003. For instance, some people reported that they didn’t visit a doctor when they were sick, skipped recommended tests, or failed to fill prescriptions because of concerns about the cost.

The cost of health care was a significant barrier to access for Americans who were uninsured or underinsured. But it was also a problem for some adults with adequate insurance. Among those with adequate insurance, 28% reported cost-related problems.

Medical debt also continues to be a problem. In 2012, 41% of U.S. adults reported problems paying their medical bills or said they were paying off medical debt over time. Of those adults who had trouble paying their medical bills, 42% said they had received a lower credit rating as a result and 37% reported that they had used all of their savings in an attempt to pay off their medical bills.

The findings are based on a telephone survey conducted from April 26 to Aug. 19, 2012, of a nationally representative sample of more than 4,400 adults aged 19-64 years.

[email protected]

The American Urogynecologic Society is pushing back against attempts to ban transvaginal mesh surgery in the treatment of pelvic floor disorders.

In a recent position statement, officials at the American Urogynecologic Society (AUGS) voiced their strong opposition to restrictions on the use of transvaginal mesh surgery when performed by qualified, credentialed surgeons. The policy statement comes after a state medical organization, a health care system, and a medical malpractice company have considered or adopted bans on the use of transvaginal mesh for pelvic organ prolapse or stress urinary incontinence.

"We really feel that the best decision making is left between the patient and her physician without outside interference," Dr. Anthony G. Visco, AUGS president and division chief of urogynecology at Duke University, Durham, N.C. said in an interview.

Rather than an across-the-board ban, AUGS is urging hospitals to do a better job in assessing the competence of the surgeons performing these procedures.

"Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures," Dr. Visco said.

Some hospitals have already adopted guidelines issued by AUGS that outline how to credential and audit surgeons who perform transvaginal placement of surgical mesh for pelvic organ prolapse and sacrocolpopexy for pelvic organ prolapse, he said. AUGS also recommends that hospitals form a group of pelvic floor reconstructive experts who can review cases and complications in both mesh and nonmesh prolapse repair. Additionally AUGS has released an informed consent toolkit that it recommends to hospitals to help standardize the process of reviewing risks and benefits with patients.

The use of transvaginal mesh to treat pelvic organ prolapse and stress urinary continence has been controversial in recent years as reports of adverse events from the devices have mounted. In July 2011, the Food and Drug Administration issued a safety notice warning that serious complications associated with surgical mesh for the transvaginal repair of pelvic organ prolapse are "not rare." The surgery may expose patients to greater risks without the benefit of being more effective than traditional nonmesh repairs, the FDA wrote.

The agency advised physicians to obtain specialized training for each mesh placement technique and to be vigilant about potential adverse events including mesh erosion and infection. In the same 2011 notice, the FDA said it was still evaluating the impact of transvaginal mesh in the treatment of stress urinary incontinence.

While the FDA has not acted to remove these devices from the market, it has ordered manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies to look at the safety and effectiveness of surgical mesh used for transvaginal repair of pelvic organ prolapse and mini-sling devices used to treat stress urinary incontinence.

In December 2011, AUGS and the American College of Obstetricians and Gynecologists issued their own statement recommending that pelvic organ prolapse vaginal mesh repair be reserved for high-risk cases such as women with recurrent prolapse or who have medical comorbidities that prevent more invasive endoscopic procedures (Obstet. Gynecol. 2011;118:1459-64).

The safety warnings from the FDA don’t warrant a ban on the procedure, Dr. Visco said. But enacting such a ban could have a number of negative consequences from limiting women’s medical options or limiting the ability of researchers to gather and analyze safety data, he said.

In certain cases, the use of transvaginal mesh for pelvic organ prolapse could be the patient’s best surgical option, according to AUGS. For example, patients with recurrent prolapse after a nonmesh, native tissue repair would be good candidates. Also, the use of transvaginal mesh might be preferred in patients with significant intra-abdominal adhesions because an abdominal approach would pose greater surgical risks.

Dr. Visco said he’s also concerned that news of bans on the procedure, combined with all the advertising about transvaginal mesh lawsuits, could lead some women to leave pelvic floor disorders untreated.

"I think patients are afraid," he said. "We’re worried that they’re so afraid that they may not even seek care."

Bans on transvaginal mesh surgeries could also put a stop to critical research on the products, according to AUGS. For instance, the Pelvic Floor Disorders Network, a clinical trials network funded by the National Institutes of Health, is preparing to launch a randomized trial of transvaginal mesh vs. nonmesh, native tissue repair for uterine prolapse.

And AUGS is building a national registry for pelvic floor disorders with the FDA, the NIH, and ACOG. The registry, which will include data from at least four major device manufacturers, is slated to launch later in 2013. Once the registry is up and running, surgeons will be able to track their outcomes and compare themselves to others.

"Our concern is that we don’t prematurely make a decision about these procedures before there’s a full assessment out there," Dr. Visco said.

[email protected]

On Twitter @MaryEllenNY

The American Urogynecologic Society is pushing back against attempts to ban transvaginal mesh surgery in the treatment of pelvic floor disorders.

In a recent position statement, officials at the American Urogynecologic Society (AUGS) voiced their strong opposition to restrictions on the use of transvaginal mesh surgery when performed by qualified, credentialed surgeons. The policy statement comes after a state medical organization, a health care system, and a medical malpractice company have considered or adopted bans on the use of transvaginal mesh for pelvic organ prolapse or stress urinary incontinence.

"We really feel that the best decision making is left between the patient and her physician without outside interference," Dr. Anthony G. Visco, AUGS president and division chief of urogynecology at Duke University, Durham, N.C. said in an interview.

Rather than an across-the-board ban, AUGS is urging hospitals to do a better job in assessing the competence of the surgeons performing these procedures.

"Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures," Dr. Visco said.

Some hospitals have already adopted guidelines issued by AUGS that outline how to credential and audit surgeons who perform transvaginal placement of surgical mesh for pelvic organ prolapse and sacrocolpopexy for pelvic organ prolapse, he said. AUGS also recommends that hospitals form a group of pelvic floor reconstructive experts who can review cases and complications in both mesh and nonmesh prolapse repair. Additionally AUGS has released an informed consent toolkit that it recommends to hospitals to help standardize the process of reviewing risks and benefits with patients.

The use of transvaginal mesh to treat pelvic organ prolapse and stress urinary continence has been controversial in recent years as reports of adverse events from the devices have mounted. In July 2011, the Food and Drug Administration issued a safety notice warning that serious complications associated with surgical mesh for the transvaginal repair of pelvic organ prolapse are "not rare." The surgery may expose patients to greater risks without the benefit of being more effective than traditional nonmesh repairs, the FDA wrote.

The agency advised physicians to obtain specialized training for each mesh placement technique and to be vigilant about potential adverse events including mesh erosion and infection. In the same 2011 notice, the FDA said it was still evaluating the impact of transvaginal mesh in the treatment of stress urinary incontinence.

While the FDA has not acted to remove these devices from the market, it has ordered manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies to look at the safety and effectiveness of surgical mesh used for transvaginal repair of pelvic organ prolapse and mini-sling devices used to treat stress urinary incontinence.

In December 2011, AUGS and the American College of Obstetricians and Gynecologists issued their own statement recommending that pelvic organ prolapse vaginal mesh repair be reserved for high-risk cases such as women with recurrent prolapse or who have medical comorbidities that prevent more invasive endoscopic procedures (Obstet. Gynecol. 2011;118:1459-64).

The safety warnings from the FDA don’t warrant a ban on the procedure, Dr. Visco said. But enacting such a ban could have a number of negative consequences from limiting women’s medical options or limiting the ability of researchers to gather and analyze safety data, he said.

In certain cases, the use of transvaginal mesh for pelvic organ prolapse could be the patient’s best surgical option, according to AUGS. For example, patients with recurrent prolapse after a nonmesh, native tissue repair would be good candidates. Also, the use of transvaginal mesh might be preferred in patients with significant intra-abdominal adhesions because an abdominal approach would pose greater surgical risks.

Dr. Visco said he’s also concerned that news of bans on the procedure, combined with all the advertising about transvaginal mesh lawsuits, could lead some women to leave pelvic floor disorders untreated.

"I think patients are afraid," he said. "We’re worried that they’re so afraid that they may not even seek care."

Bans on transvaginal mesh surgeries could also put a stop to critical research on the products, according to AUGS. For instance, the Pelvic Floor Disorders Network, a clinical trials network funded by the National Institutes of Health, is preparing to launch a randomized trial of transvaginal mesh vs. nonmesh, native tissue repair for uterine prolapse.

And AUGS is building a national registry for pelvic floor disorders with the FDA, the NIH, and ACOG. The registry, which will include data from at least four major device manufacturers, is slated to launch later in 2013. Once the registry is up and running, surgeons will be able to track their outcomes and compare themselves to others.

"Our concern is that we don’t prematurely make a decision about these procedures before there’s a full assessment out there," Dr. Visco said.

[email protected]

On Twitter @MaryEllenNY

The American Urogynecologic Society is pushing back against attempts to ban transvaginal mesh surgery in the treatment of pelvic floor disorders.

In a recent position statement, officials at the American Urogynecologic Society (AUGS) voiced their strong opposition to restrictions on the use of transvaginal mesh surgery when performed by qualified, credentialed surgeons. The policy statement comes after a state medical organization, a health care system, and a medical malpractice company have considered or adopted bans on the use of transvaginal mesh for pelvic organ prolapse or stress urinary incontinence.

"We really feel that the best decision making is left between the patient and her physician without outside interference," Dr. Anthony G. Visco, AUGS president and division chief of urogynecology at Duke University, Durham, N.C. said in an interview.

Rather than an across-the-board ban, AUGS is urging hospitals to do a better job in assessing the competence of the surgeons performing these procedures.

"Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures," Dr. Visco said.

Some hospitals have already adopted guidelines issued by AUGS that outline how to credential and audit surgeons who perform transvaginal placement of surgical mesh for pelvic organ prolapse and sacrocolpopexy for pelvic organ prolapse, he said. AUGS also recommends that hospitals form a group of pelvic floor reconstructive experts who can review cases and complications in both mesh and nonmesh prolapse repair. Additionally AUGS has released an informed consent toolkit that it recommends to hospitals to help standardize the process of reviewing risks and benefits with patients.

The use of transvaginal mesh to treat pelvic organ prolapse and stress urinary continence has been controversial in recent years as reports of adverse events from the devices have mounted. In July 2011, the Food and Drug Administration issued a safety notice warning that serious complications associated with surgical mesh for the transvaginal repair of pelvic organ prolapse are "not rare." The surgery may expose patients to greater risks without the benefit of being more effective than traditional nonmesh repairs, the FDA wrote.

The agency advised physicians to obtain specialized training for each mesh placement technique and to be vigilant about potential adverse events including mesh erosion and infection. In the same 2011 notice, the FDA said it was still evaluating the impact of transvaginal mesh in the treatment of stress urinary incontinence.

While the FDA has not acted to remove these devices from the market, it has ordered manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies to look at the safety and effectiveness of surgical mesh used for transvaginal repair of pelvic organ prolapse and mini-sling devices used to treat stress urinary incontinence.

In December 2011, AUGS and the American College of Obstetricians and Gynecologists issued their own statement recommending that pelvic organ prolapse vaginal mesh repair be reserved for high-risk cases such as women with recurrent prolapse or who have medical comorbidities that prevent more invasive endoscopic procedures (Obstet. Gynecol. 2011;118:1459-64).

The safety warnings from the FDA don’t warrant a ban on the procedure, Dr. Visco said. But enacting such a ban could have a number of negative consequences from limiting women’s medical options or limiting the ability of researchers to gather and analyze safety data, he said.

In certain cases, the use of transvaginal mesh for pelvic organ prolapse could be the patient’s best surgical option, according to AUGS. For example, patients with recurrent prolapse after a nonmesh, native tissue repair would be good candidates. Also, the use of transvaginal mesh might be preferred in patients with significant intra-abdominal adhesions because an abdominal approach would pose greater surgical risks.

Dr. Visco said he’s also concerned that news of bans on the procedure, combined with all the advertising about transvaginal mesh lawsuits, could lead some women to leave pelvic floor disorders untreated.

"I think patients are afraid," he said. "We’re worried that they’re so afraid that they may not even seek care."

Bans on transvaginal mesh surgeries could also put a stop to critical research on the products, according to AUGS. For instance, the Pelvic Floor Disorders Network, a clinical trials network funded by the National Institutes of Health, is preparing to launch a randomized trial of transvaginal mesh vs. nonmesh, native tissue repair for uterine prolapse.

And AUGS is building a national registry for pelvic floor disorders with the FDA, the NIH, and ACOG. The registry, which will include data from at least four major device manufacturers, is slated to launch later in 2013. Once the registry is up and running, surgeons will be able to track their outcomes and compare themselves to others.

"Our concern is that we don’t prematurely make a decision about these procedures before there’s a full assessment out there," Dr. Visco said.

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