Government and Regulations

GAITHERSBURG, MD. – The benefit-risk profile of the PCSK9 inhibitor evolocumab, injected subcutaneously once or twice a month, supports its approval for treating hypercholesterolemia in certain high-risk populations, a Food and Drug Administration advisory panel has agreed.

At a meeting on June 10, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 that evolocumab should be approved for treating patients aged 12 years and older and adults with homozygous familial hypercholesterolemia (HoFH), based on its impact on lowering low-density lipoprotein cholesterol (LDL-C) in patients and what is currently known about its safety profile.

In a separate vote on other populations included in the indication proposed by Amgen, the panel voted 11-4 to recommend approval for treating other types of patients but limited it to patients at higher CVD risk and elevated LDL-C levels, particularly those with heterozygous FH. There also was support for approval for other higher-risk patients, such as those at high risk for CVD and high LDL-C levels and those with high LDL-C levels on maximum statin doses, but there was not support for approval for lower-risk groups, such as those with mixed hyperlipidemia.

Amgen has proposed that evolocumab be approved for patients with HoFH, as well as adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

With these votes, it is likely that evolocumab will be approved this year since the FDA usually follows the recommendations of its advisory panels. Evolocumab and another PCSK9 inhibitor, alirocumab – which the majority of the panel recommended for approval the day before – will be the first in this new class of lipid-lowering agents to be approved in the United States. The recommended doses for adults with primary hyperlipidemia and mixed dyslipidemia are 140 mg every 2 weeks or 420 mg once a month; 420 mg every 2 or 4 weeks is recommended for those with HoFH.

PCSK9 inhibitors are human monoclonal antibodies that bind to proprotein convertase subtilisin kexin type 9 (PCSK9), a serine protease that is involved in the regulation of LDL receptor (LDL-R). Inactivation of PCSK9 results in an increase of LDL-R available to clear LDL-C, reducing LDL-C levels.

The data presented by Amgen include four 12-week, phase III double-blind randomized studies comparing the two doses of evolocumab to placebo and/or ezetimibe in about 3,100 patients. The four studies involved patients with HoFH, patients at high CV risk on background statin therapy, patients on monotherapy with diet as background therapy, and patients intolerant to statins who were on no or low-dose statin. The primary efficacy endpoint was reduction n LDL-C at 10-12 weeks.

Both dosing regimens resulted in significantly lower LDL-C levels from baseline, compared with placebo and ezetimibe. Treatment with the two doses resulted in “consistent, clinically equivalent” LDL-C reductions in patients with primary hyperlipidemia and those with mixed dyslipidemia, with reductions of 55%-75% compared with placebo and 35%-45% compared with ezetimibe. Effects were maintained over 2 years in an open-label extension study in different subgroups, including gender and region, according to Amgen.

In a phase III study of 49 patients with HoFH treated with 420 mg once a month or placebo, evolocumab was associated with LDL-C reductions of about 31%, compared with placebo. In phase II and III studies of almost 5,000 patients who received evolocumab, the overall incidence of adverse events was similar to the comparators, and adverse events in long-term studies were similar to those seen in the initial studies, according to Amgen. To date, no major safety issues have been associated with evolocumab, including in patients with very low LDL-C levels (below 25 mg/dL or 40 mg/dL), compared with levels of 40 mg/dL or greater, according to the company.

Adverse events of interest include neurocognitive events and glycemic changes, recently reported with statins. The incidence of new-onset diabetes was low and similar between those on evolocumab and comparators, although there was a “small imbalance” in glycemic changes in patients on evolocumab, a risk that cannot be ruled out and will be monitored in ongoing studies, including the CV outcomes study, according to Amgen. In phase II and III studies, over a median exposure of about 3 months, the rate of neurocognitive adverse events was low and there was no association between low and very low LDL-C levels and neurocognitive events. Most adverse events were rash and eczema and were mild to moderate.

Although the panel agreed there was no major safety signal of concern in the studies, which was reassuring, the members said that safety issues should continue to be followed and that whether very low levels of LDL-C may be associated with adverse events remained an open question and needed to be studied on a long-term basis, including in the CV outcomes study. The concern was raised that, if LDL-C levels dropped to low levels, some clinicians might reduce or withdraw the statin.

As with alirocumab, the panel was asked to discuss whether the impact on LDL-C with evolocumab was sufficient to demonstrate an effect on clinical outcomes; historically, the FDA has considered reductions in LDL-C sufficient to establish the effectiveness of a lipid-lowering drug and does not require that benefit be shown in a CV outcomes trial before approval, “provided the reduction is sufficiently robust” and the product does not have any safety issues that raise concerns about the benefit-risk profile, according to the FDA. Although several panelists said that, while the drug targets LDL-C via a mechanism that is fairly close to the statin target, which provided more confidence in using LDL-C as a surrogate for CV benefit, they said this question can only be answered definitely with the CV outcomes trial.

The CV outcomes study, the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), has been fully enrolled, with about 27,500 patients, and is expected to be completed no later than 2017, according to Amgen. The study also will provide safety data in more than 5,000 patients with LDL-C levels below 40 mg/dL.

The FDA usually follows the recommendations of its advisory panels. The FDA panelists had no potential conflicts of interest. A decision is expected by Aug. 27. If approved, Amgen plans to market evolocumab as Repatha.

[email protected]

GAITHERSBURG, MD. – The benefit-risk profile of the PCSK9 inhibitor evolocumab, injected subcutaneously once or twice a month, supports its approval for treating hypercholesterolemia in certain high-risk populations, a Food and Drug Administration advisory panel has agreed.

At a meeting on June 10, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 that evolocumab should be approved for treating patients aged 12 years and older and adults with homozygous familial hypercholesterolemia (HoFH), based on its impact on lowering low-density lipoprotein cholesterol (LDL-C) in patients and what is currently known about its safety profile.

In a separate vote on other populations included in the indication proposed by Amgen, the panel voted 11-4 to recommend approval for treating other types of patients but limited it to patients at higher CVD risk and elevated LDL-C levels, particularly those with heterozygous FH. There also was support for approval for other higher-risk patients, such as those at high risk for CVD and high LDL-C levels and those with high LDL-C levels on maximum statin doses, but there was not support for approval for lower-risk groups, such as those with mixed hyperlipidemia.

Amgen has proposed that evolocumab be approved for patients with HoFH, as well as adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

With these votes, it is likely that evolocumab will be approved this year since the FDA usually follows the recommendations of its advisory panels. Evolocumab and another PCSK9 inhibitor, alirocumab – which the majority of the panel recommended for approval the day before – will be the first in this new class of lipid-lowering agents to be approved in the United States. The recommended doses for adults with primary hyperlipidemia and mixed dyslipidemia are 140 mg every 2 weeks or 420 mg once a month; 420 mg every 2 or 4 weeks is recommended for those with HoFH.

PCSK9 inhibitors are human monoclonal antibodies that bind to proprotein convertase subtilisin kexin type 9 (PCSK9), a serine protease that is involved in the regulation of LDL receptor (LDL-R). Inactivation of PCSK9 results in an increase of LDL-R available to clear LDL-C, reducing LDL-C levels.

The data presented by Amgen include four 12-week, phase III double-blind randomized studies comparing the two doses of evolocumab to placebo and/or ezetimibe in about 3,100 patients. The four studies involved patients with HoFH, patients at high CV risk on background statin therapy, patients on monotherapy with diet as background therapy, and patients intolerant to statins who were on no or low-dose statin. The primary efficacy endpoint was reduction n LDL-C at 10-12 weeks.

Both dosing regimens resulted in significantly lower LDL-C levels from baseline, compared with placebo and ezetimibe. Treatment with the two doses resulted in “consistent, clinically equivalent” LDL-C reductions in patients with primary hyperlipidemia and those with mixed dyslipidemia, with reductions of 55%-75% compared with placebo and 35%-45% compared with ezetimibe. Effects were maintained over 2 years in an open-label extension study in different subgroups, including gender and region, according to Amgen.

In a phase III study of 49 patients with HoFH treated with 420 mg once a month or placebo, evolocumab was associated with LDL-C reductions of about 31%, compared with placebo. In phase II and III studies of almost 5,000 patients who received evolocumab, the overall incidence of adverse events was similar to the comparators, and adverse events in long-term studies were similar to those seen in the initial studies, according to Amgen. To date, no major safety issues have been associated with evolocumab, including in patients with very low LDL-C levels (below 25 mg/dL or 40 mg/dL), compared with levels of 40 mg/dL or greater, according to the company.

Adverse events of interest include neurocognitive events and glycemic changes, recently reported with statins. The incidence of new-onset diabetes was low and similar between those on evolocumab and comparators, although there was a “small imbalance” in glycemic changes in patients on evolocumab, a risk that cannot be ruled out and will be monitored in ongoing studies, including the CV outcomes study, according to Amgen. In phase II and III studies, over a median exposure of about 3 months, the rate of neurocognitive adverse events was low and there was no association between low and very low LDL-C levels and neurocognitive events. Most adverse events were rash and eczema and were mild to moderate.

Although the panel agreed there was no major safety signal of concern in the studies, which was reassuring, the members said that safety issues should continue to be followed and that whether very low levels of LDL-C may be associated with adverse events remained an open question and needed to be studied on a long-term basis, including in the CV outcomes study. The concern was raised that, if LDL-C levels dropped to low levels, some clinicians might reduce or withdraw the statin.

As with alirocumab, the panel was asked to discuss whether the impact on LDL-C with evolocumab was sufficient to demonstrate an effect on clinical outcomes; historically, the FDA has considered reductions in LDL-C sufficient to establish the effectiveness of a lipid-lowering drug and does not require that benefit be shown in a CV outcomes trial before approval, “provided the reduction is sufficiently robust” and the product does not have any safety issues that raise concerns about the benefit-risk profile, according to the FDA. Although several panelists said that, while the drug targets LDL-C via a mechanism that is fairly close to the statin target, which provided more confidence in using LDL-C as a surrogate for CV benefit, they said this question can only be answered definitely with the CV outcomes trial.

The CV outcomes study, the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), has been fully enrolled, with about 27,500 patients, and is expected to be completed no later than 2017, according to Amgen. The study also will provide safety data in more than 5,000 patients with LDL-C levels below 40 mg/dL.

The FDA usually follows the recommendations of its advisory panels. The FDA panelists had no potential conflicts of interest. A decision is expected by Aug. 27. If approved, Amgen plans to market evolocumab as Repatha.

[email protected]

GAITHERSBURG, MD. – The benefit-risk profile of the PCSK9 inhibitor evolocumab, injected subcutaneously once or twice a month, supports its approval for treating hypercholesterolemia in certain high-risk populations, a Food and Drug Administration advisory panel has agreed.

At a meeting on June 10, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 that evolocumab should be approved for treating patients aged 12 years and older and adults with homozygous familial hypercholesterolemia (HoFH), based on its impact on lowering low-density lipoprotein cholesterol (LDL-C) in patients and what is currently known about its safety profile.

In a separate vote on other populations included in the indication proposed by Amgen, the panel voted 11-4 to recommend approval for treating other types of patients but limited it to patients at higher CVD risk and elevated LDL-C levels, particularly those with heterozygous FH. There also was support for approval for other higher-risk patients, such as those at high risk for CVD and high LDL-C levels and those with high LDL-C levels on maximum statin doses, but there was not support for approval for lower-risk groups, such as those with mixed hyperlipidemia.

Amgen has proposed that evolocumab be approved for patients with HoFH, as well as adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

With these votes, it is likely that evolocumab will be approved this year since the FDA usually follows the recommendations of its advisory panels. Evolocumab and another PCSK9 inhibitor, alirocumab – which the majority of the panel recommended for approval the day before – will be the first in this new class of lipid-lowering agents to be approved in the United States. The recommended doses for adults with primary hyperlipidemia and mixed dyslipidemia are 140 mg every 2 weeks or 420 mg once a month; 420 mg every 2 or 4 weeks is recommended for those with HoFH.

PCSK9 inhibitors are human monoclonal antibodies that bind to proprotein convertase subtilisin kexin type 9 (PCSK9), a serine protease that is involved in the regulation of LDL receptor (LDL-R). Inactivation of PCSK9 results in an increase of LDL-R available to clear LDL-C, reducing LDL-C levels.

The data presented by Amgen include four 12-week, phase III double-blind randomized studies comparing the two doses of evolocumab to placebo and/or ezetimibe in about 3,100 patients. The four studies involved patients with HoFH, patients at high CV risk on background statin therapy, patients on monotherapy with diet as background therapy, and patients intolerant to statins who were on no or low-dose statin. The primary efficacy endpoint was reduction n LDL-C at 10-12 weeks.

Both dosing regimens resulted in significantly lower LDL-C levels from baseline, compared with placebo and ezetimibe. Treatment with the two doses resulted in “consistent, clinically equivalent” LDL-C reductions in patients with primary hyperlipidemia and those with mixed dyslipidemia, with reductions of 55%-75% compared with placebo and 35%-45% compared with ezetimibe. Effects were maintained over 2 years in an open-label extension study in different subgroups, including gender and region, according to Amgen.

In a phase III study of 49 patients with HoFH treated with 420 mg once a month or placebo, evolocumab was associated with LDL-C reductions of about 31%, compared with placebo. In phase II and III studies of almost 5,000 patients who received evolocumab, the overall incidence of adverse events was similar to the comparators, and adverse events in long-term studies were similar to those seen in the initial studies, according to Amgen. To date, no major safety issues have been associated with evolocumab, including in patients with very low LDL-C levels (below 25 mg/dL or 40 mg/dL), compared with levels of 40 mg/dL or greater, according to the company.

Adverse events of interest include neurocognitive events and glycemic changes, recently reported with statins. The incidence of new-onset diabetes was low and similar between those on evolocumab and comparators, although there was a “small imbalance” in glycemic changes in patients on evolocumab, a risk that cannot be ruled out and will be monitored in ongoing studies, including the CV outcomes study, according to Amgen. In phase II and III studies, over a median exposure of about 3 months, the rate of neurocognitive adverse events was low and there was no association between low and very low LDL-C levels and neurocognitive events. Most adverse events were rash and eczema and were mild to moderate.

Although the panel agreed there was no major safety signal of concern in the studies, which was reassuring, the members said that safety issues should continue to be followed and that whether very low levels of LDL-C may be associated with adverse events remained an open question and needed to be studied on a long-term basis, including in the CV outcomes study. The concern was raised that, if LDL-C levels dropped to low levels, some clinicians might reduce or withdraw the statin.

As with alirocumab, the panel was asked to discuss whether the impact on LDL-C with evolocumab was sufficient to demonstrate an effect on clinical outcomes; historically, the FDA has considered reductions in LDL-C sufficient to establish the effectiveness of a lipid-lowering drug and does not require that benefit be shown in a CV outcomes trial before approval, “provided the reduction is sufficiently robust” and the product does not have any safety issues that raise concerns about the benefit-risk profile, according to the FDA. Although several panelists said that, while the drug targets LDL-C via a mechanism that is fairly close to the statin target, which provided more confidence in using LDL-C as a surrogate for CV benefit, they said this question can only be answered definitely with the CV outcomes trial.

The CV outcomes study, the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), has been fully enrolled, with about 27,500 patients, and is expected to be completed no later than 2017, according to Amgen. The study also will provide safety data in more than 5,000 patients with LDL-C levels below 40 mg/dL.

The FDA usually follows the recommendations of its advisory panels. The FDA panelists had no potential conflicts of interest. A decision is expected by Aug. 27. If approved, Amgen plans to market evolocumab as Repatha.

[email protected]

“There is no medically valid reason to exclude transgender individuals from service in the U.S. military,” the American Medical Association (AMA) announced in its June 8 resolution on “Military Medical Policies Affecting Transgender Individuals.”

Currently, there are an estimated 700,000 transgender persons in the U.S., about 15,500 of whom are serving in the U.S. military. Yet according to military medical regulations, doctors are prohibited from providing medically necessary treatment for gender dysphoria, the diagnostic term for individuals who see and feel themselves to be a different gender than that which they were assigned at birth.

Among its many conclusions, AMA notes that a commission cochaired by Major General (Ret) Gale S. Pollock, former acting U.S. Army Surgeon General, determined that “providing transgender personnel with medically necessary health care would not be excessively burdensome.”

So far this year, both the Army and Air Force have revised their procedures for involuntary discharge of transgender service members. In March, the Army issued a directive that protects transgender soldiers from being dismissed by mid-level officers. Under the directive, officers must explain to a high-ranking civilian leader their decision to discharge a transgender solider.

Army Regulation 40-501, Standards of Medical Fitness, has remained unchanged since its 2011 revision to accommodate the Don’t Ask, Don’t Tell Repeal Act of 2010, with chapter 3 outlining the various medical conditions and physical defects that may render a soldier unfit for further military service. Section 3-35 states that certain disorders, as defined by the Army, including transsexual and the outdated term of gender identity disorder, “render an individual administratively unfit.” Despite the revised procedures, this policy remains in effect.

The Air Force’s revised procedures are similar to that of the Army’s, elevating decision-making authority from field commanders to the Air Force Review Boards Agency director. This will ensure “the ability to consistently apply the existing policy,” according to Daniel Sitterly, the principal deputy assistant secretary of the Air Force for Manpower and Reserve Affairs, in a June 4 Air Force press release.

The Air Force also stated in the release that a service member’s identification as transgender, absent a record of poor duty performance, misconduct, or a medically disqualifying condition, is not a basis for involuntary separation.

“Discrimination of any kind has no place in America’s armed forces,” said Defense Secretary Ash Carter, keynote speaker at the Pentagon’s annual Gay, Lesbian, Bisexual and Transgender Pride event Tuesday.

The U.S. military has previously faced similar scrutiny for its discriminatory policies regarding race, gender, and sexual orientation, all of which have been revised. The most recent policy revision came in 2011 when the Pentagon rescinded the Don’t Ask, Don’t Tell policy, whereby homosexual men and women serving in the military were not permitted to talk about their sexual orientation or engage in sexual activity, and commanding officers were not allowed to question service members about their sexual orientation.

The DoD isn’t the only government agency rethinking its treatment of transgendered individuals—VA is also experiencing a learning curve for transgendered care. The VHA Office of Patient Care Services and the Office of Health Equity updated its Lesbian, Gay, Bisexual & Transgender (LGBT) Veteran Health Care Fact Sheet, which covers some of the most common challenges LGBT veterans are likely to face, policies that promote high-quality LGBT health care experience, and what VHA is doing to provide information, guidance, and education to its providers about LGBT health issues.

Cecile A. Unger, MD, spoke on the gynecologist’s role in transgender patient care at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. In a follow-up interview with OBG Management, Dr. Unger discussed pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient. Dr. Unger also offered clinical guidance on screening transgender patients and how to accomplish patient-provider trust. Click here for the complete interview.

“There is no medically valid reason to exclude transgender individuals from service in the U.S. military,” the American Medical Association (AMA) announced in its June 8 resolution on “Military Medical Policies Affecting Transgender Individuals.”

Currently, there are an estimated 700,000 transgender persons in the U.S., about 15,500 of whom are serving in the U.S. military. Yet according to military medical regulations, doctors are prohibited from providing medically necessary treatment for gender dysphoria, the diagnostic term for individuals who see and feel themselves to be a different gender than that which they were assigned at birth.

Among its many conclusions, AMA notes that a commission cochaired by Major General (Ret) Gale S. Pollock, former acting U.S. Army Surgeon General, determined that “providing transgender personnel with medically necessary health care would not be excessively burdensome.”

So far this year, both the Army and Air Force have revised their procedures for involuntary discharge of transgender service members. In March, the Army issued a directive that protects transgender soldiers from being dismissed by mid-level officers. Under the directive, officers must explain to a high-ranking civilian leader their decision to discharge a transgender solider.

Army Regulation 40-501, Standards of Medical Fitness, has remained unchanged since its 2011 revision to accommodate the Don’t Ask, Don’t Tell Repeal Act of 2010, with chapter 3 outlining the various medical conditions and physical defects that may render a soldier unfit for further military service. Section 3-35 states that certain disorders, as defined by the Army, including transsexual and the outdated term of gender identity disorder, “render an individual administratively unfit.” Despite the revised procedures, this policy remains in effect.

The Air Force’s revised procedures are similar to that of the Army’s, elevating decision-making authority from field commanders to the Air Force Review Boards Agency director. This will ensure “the ability to consistently apply the existing policy,” according to Daniel Sitterly, the principal deputy assistant secretary of the Air Force for Manpower and Reserve Affairs, in a June 4 Air Force press release.

The Air Force also stated in the release that a service member’s identification as transgender, absent a record of poor duty performance, misconduct, or a medically disqualifying condition, is not a basis for involuntary separation.

“Discrimination of any kind has no place in America’s armed forces,” said Defense Secretary Ash Carter, keynote speaker at the Pentagon’s annual Gay, Lesbian, Bisexual and Transgender Pride event Tuesday.

The U.S. military has previously faced similar scrutiny for its discriminatory policies regarding race, gender, and sexual orientation, all of which have been revised. The most recent policy revision came in 2011 when the Pentagon rescinded the Don’t Ask, Don’t Tell policy, whereby homosexual men and women serving in the military were not permitted to talk about their sexual orientation or engage in sexual activity, and commanding officers were not allowed to question service members about their sexual orientation.

The DoD isn’t the only government agency rethinking its treatment of transgendered individuals—VA is also experiencing a learning curve for transgendered care. The VHA Office of Patient Care Services and the Office of Health Equity updated its Lesbian, Gay, Bisexual & Transgender (LGBT) Veteran Health Care Fact Sheet, which covers some of the most common challenges LGBT veterans are likely to face, policies that promote high-quality LGBT health care experience, and what VHA is doing to provide information, guidance, and education to its providers about LGBT health issues.

Cecile A. Unger, MD, spoke on the gynecologist’s role in transgender patient care at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. In a follow-up interview with OBG Management, Dr. Unger discussed pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient. Dr. Unger also offered clinical guidance on screening transgender patients and how to accomplish patient-provider trust. Click here for the complete interview.

“There is no medically valid reason to exclude transgender individuals from service in the U.S. military,” the American Medical Association (AMA) announced in its June 8 resolution on “Military Medical Policies Affecting Transgender Individuals.”

Currently, there are an estimated 700,000 transgender persons in the U.S., about 15,500 of whom are serving in the U.S. military. Yet according to military medical regulations, doctors are prohibited from providing medically necessary treatment for gender dysphoria, the diagnostic term for individuals who see and feel themselves to be a different gender than that which they were assigned at birth.

Among its many conclusions, AMA notes that a commission cochaired by Major General (Ret) Gale S. Pollock, former acting U.S. Army Surgeon General, determined that “providing transgender personnel with medically necessary health care would not be excessively burdensome.”

So far this year, both the Army and Air Force have revised their procedures for involuntary discharge of transgender service members. In March, the Army issued a directive that protects transgender soldiers from being dismissed by mid-level officers. Under the directive, officers must explain to a high-ranking civilian leader their decision to discharge a transgender solider.

Army Regulation 40-501, Standards of Medical Fitness, has remained unchanged since its 2011 revision to accommodate the Don’t Ask, Don’t Tell Repeal Act of 2010, with chapter 3 outlining the various medical conditions and physical defects that may render a soldier unfit for further military service. Section 3-35 states that certain disorders, as defined by the Army, including transsexual and the outdated term of gender identity disorder, “render an individual administratively unfit.” Despite the revised procedures, this policy remains in effect.

The Air Force’s revised procedures are similar to that of the Army’s, elevating decision-making authority from field commanders to the Air Force Review Boards Agency director. This will ensure “the ability to consistently apply the existing policy,” according to Daniel Sitterly, the principal deputy assistant secretary of the Air Force for Manpower and Reserve Affairs, in a June 4 Air Force press release.

The Air Force also stated in the release that a service member’s identification as transgender, absent a record of poor duty performance, misconduct, or a medically disqualifying condition, is not a basis for involuntary separation.

“Discrimination of any kind has no place in America’s armed forces,” said Defense Secretary Ash Carter, keynote speaker at the Pentagon’s annual Gay, Lesbian, Bisexual and Transgender Pride event Tuesday.

The U.S. military has previously faced similar scrutiny for its discriminatory policies regarding race, gender, and sexual orientation, all of which have been revised. The most recent policy revision came in 2011 when the Pentagon rescinded the Don’t Ask, Don’t Tell policy, whereby homosexual men and women serving in the military were not permitted to talk about their sexual orientation or engage in sexual activity, and commanding officers were not allowed to question service members about their sexual orientation.

The DoD isn’t the only government agency rethinking its treatment of transgendered individuals—VA is also experiencing a learning curve for transgendered care. The VHA Office of Patient Care Services and the Office of Health Equity updated its Lesbian, Gay, Bisexual & Transgender (LGBT) Veteran Health Care Fact Sheet, which covers some of the most common challenges LGBT veterans are likely to face, policies that promote high-quality LGBT health care experience, and what VHA is doing to provide information, guidance, and education to its providers about LGBT health issues.

Cecile A. Unger, MD, spoke on the gynecologist’s role in transgender patient care at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. In a follow-up interview with OBG Management, Dr. Unger discussed pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient. Dr. Unger also offered clinical guidance on screening transgender patients and how to accomplish patient-provider trust. Click here for the complete interview.

“I fear they do not comprehend the full weight of the burden we carry or the price we pay when we return from battle,” said ADM Mike Mullen, chairman of the Joint Chiefs of Staff, in a speech several years ago. That’s one reason VA and DoD have developed a free online continuing education course to help health care providers learn more about what it’s like to serve in the military. “Understanding the influence of military culture upon health-related behaviors will help the provider appropriately plan treatment,” according to the Center for Deployment Psychology website (http://deploymentpsych.org), which supports and enhances the online course.

Related: Empathic Disclosure of Adverse Events to Patients

The 8-hour course, “Military Culture: Core Competencies for Health Care Professionals,” uses interactive features, video vignettes, case examples, and treatment-planning scenarios. Each of the 4 modules was developed using research, surveys, and extensive interviews with service members and veterans, the VA says. The modules address (1) self-awareness and introduction to military ethos; (2) military organization and roles; (3) military-specific stressors and resources; and (4) treatment resources, prevention, and tools.

Related: Sleeping Well After Deployment

The course is offered through the VHA’s Training Finder Real-time Affiliated Integrated Network (TRAIN), which launched in April 2015. The VHA TRAIN is part of TRAIN National, a comprehensive catalog of public health learning products in a variety of areas, such as chronic diseases and HIV/AIDS.

“I fear they do not comprehend the full weight of the burden we carry or the price we pay when we return from battle,” said ADM Mike Mullen, chairman of the Joint Chiefs of Staff, in a speech several years ago. That’s one reason VA and DoD have developed a free online continuing education course to help health care providers learn more about what it’s like to serve in the military. “Understanding the influence of military culture upon health-related behaviors will help the provider appropriately plan treatment,” according to the Center for Deployment Psychology website (http://deploymentpsych.org), which supports and enhances the online course.

Related: Empathic Disclosure of Adverse Events to Patients

The 8-hour course, “Military Culture: Core Competencies for Health Care Professionals,” uses interactive features, video vignettes, case examples, and treatment-planning scenarios. Each of the 4 modules was developed using research, surveys, and extensive interviews with service members and veterans, the VA says. The modules address (1) self-awareness and introduction to military ethos; (2) military organization and roles; (3) military-specific stressors and resources; and (4) treatment resources, prevention, and tools.

Related: Sleeping Well After Deployment

The course is offered through the VHA’s Training Finder Real-time Affiliated Integrated Network (TRAIN), which launched in April 2015. The VHA TRAIN is part of TRAIN National, a comprehensive catalog of public health learning products in a variety of areas, such as chronic diseases and HIV/AIDS.

“I fear they do not comprehend the full weight of the burden we carry or the price we pay when we return from battle,” said ADM Mike Mullen, chairman of the Joint Chiefs of Staff, in a speech several years ago. That’s one reason VA and DoD have developed a free online continuing education course to help health care providers learn more about what it’s like to serve in the military. “Understanding the influence of military culture upon health-related behaviors will help the provider appropriately plan treatment,” according to the Center for Deployment Psychology website (http://deploymentpsych.org), which supports and enhances the online course.

Related: Empathic Disclosure of Adverse Events to Patients

The 8-hour course, “Military Culture: Core Competencies for Health Care Professionals,” uses interactive features, video vignettes, case examples, and treatment-planning scenarios. Each of the 4 modules was developed using research, surveys, and extensive interviews with service members and veterans, the VA says. The modules address (1) self-awareness and introduction to military ethos; (2) military organization and roles; (3) military-specific stressors and resources; and (4) treatment resources, prevention, and tools.

Related: Sleeping Well After Deployment

The course is offered through the VHA’s Training Finder Real-time Affiliated Integrated Network (TRAIN), which launched in April 2015. The VHA TRAIN is part of TRAIN National, a comprehensive catalog of public health learning products in a variety of areas, such as chronic diseases and HIV/AIDS.

A reconstituted, federally chartered 11-member Special Medical Advisory Group (SMAG) of leading medical experts will advise the secretary of Veterans Affairs, via the under secretary for health, on a variety of health matters, including health care delivery, research, education, training of health care staff, and planning on shared care issues facing VA and DoD.

Related: VHA Under Harsh Criticism From OIG, GAO

“We want the best of the best to work on behalf of our nation’s veterans,” said Secretary of Veterans Affairs Robert A. McDonald. The announcement of the SMAG follows in line with VHA’s Blueprint for Excellence, a 10-strategy approach to sustained excellence among a unified veteran-focused health care system.

Related: Carolyn Clancy on Implementing the Blueprint for Excellence

Jonathan B. Perlin, MD, PhD, will serve as SMAG committee chair. Currently, Dr. Perlin is chief medical officer and president of Clinical Services for Hospital Corporation of America in Nashville, Tennessee. He also served previously as VA under secretary for health from 2004 to 2006.

Related: Committed to Showing Results at the VA

“We are honored these respected leaders from the private, nonprofit and government sectors have agreed to join in our mission to improve how we provide the quality health care our nation’s veterans need and deserve,” commented Secretary McDonald.

A reconstituted, federally chartered 11-member Special Medical Advisory Group (SMAG) of leading medical experts will advise the secretary of Veterans Affairs, via the under secretary for health, on a variety of health matters, including health care delivery, research, education, training of health care staff, and planning on shared care issues facing VA and DoD.

Related: VHA Under Harsh Criticism From OIG, GAO

“We want the best of the best to work on behalf of our nation’s veterans,” said Secretary of Veterans Affairs Robert A. McDonald. The announcement of the SMAG follows in line with VHA’s Blueprint for Excellence, a 10-strategy approach to sustained excellence among a unified veteran-focused health care system.

Related: Carolyn Clancy on Implementing the Blueprint for Excellence

Jonathan B. Perlin, MD, PhD, will serve as SMAG committee chair. Currently, Dr. Perlin is chief medical officer and president of Clinical Services for Hospital Corporation of America in Nashville, Tennessee. He also served previously as VA under secretary for health from 2004 to 2006.

Related: Committed to Showing Results at the VA

“We are honored these respected leaders from the private, nonprofit and government sectors have agreed to join in our mission to improve how we provide the quality health care our nation’s veterans need and deserve,” commented Secretary McDonald.

A reconstituted, federally chartered 11-member Special Medical Advisory Group (SMAG) of leading medical experts will advise the secretary of Veterans Affairs, via the under secretary for health, on a variety of health matters, including health care delivery, research, education, training of health care staff, and planning on shared care issues facing VA and DoD.

Related: VHA Under Harsh Criticism From OIG, GAO

“We want the best of the best to work on behalf of our nation’s veterans,” said Secretary of Veterans Affairs Robert A. McDonald. The announcement of the SMAG follows in line with VHA’s Blueprint for Excellence, a 10-strategy approach to sustained excellence among a unified veteran-focused health care system.

Related: Carolyn Clancy on Implementing the Blueprint for Excellence

Jonathan B. Perlin, MD, PhD, will serve as SMAG committee chair. Currently, Dr. Perlin is chief medical officer and president of Clinical Services for Hospital Corporation of America in Nashville, Tennessee. He also served previously as VA under secretary for health from 2004 to 2006.

Related: Committed to Showing Results at the VA

“We are honored these respected leaders from the private, nonprofit and government sectors have agreed to join in our mission to improve how we provide the quality health care our nation’s veterans need and deserve,” commented Secretary McDonald.

A government watchdog report suggests that the Centers for Medicare & Medicaid Services may be setting Medicare payment rates inaccurately based on biased recommendations from its panel of physician experts.

The Government Accountability Office (GAO) questions the transparency of the CMS’ rate calculation process and suggests that members of the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) have conflicts of interest that affect their ability to fairly value physician services, according to a report published May 21.

©sndr/istockphoto.com

The GAO report recommends that the CMS better document its process for establishing relative values and develop a process to inform the public of potentially misvalued services identified by the RUC. The CMS also should develop a plan for using funds appropriated for the collection and use of information on physicians’ services in the determination of relative values, the report stated.

In response, the American Medical Association defended the expertise and objectivity of the RUC, stressing that there is no substitute for input from experienced physicians regarding the time and resources that go into medical services.

“The RUC’s valuable expertise is balanced with the oversight of government officials who have the final say,” an AMA spokesperson said in an interview. “When CMS’ initial efforts to identify potentially misvalued services were unable to obtain reliable data from government contractors, physicians on the RUC took on this important task. When gauging how much time and resources go into one medical service compared with another, no one knows more about what is involved in providing services to Medicare patients than the physicians who care for them.”

Dr. Robert L. Wergin, president of the American Academy of Family Physicians (AAFP) said the GAO report findings are consistent with previous concerns raised by the AAFP about the RUC.

“We have advocated for more transparency” in the past, Dr. Wergin said in an interview. “We have requested that the RUC expose the survey process, and we’ve also given input that we improve it [and] make it more accurate. Adding transparency to the process might be a way to improve it.”

In its review, the GAO – a nonpartisan investigational agency of Congress – cited several weaknesses in the data collected by the RUC, including that some RUC survey data had low response rates, a low total number of responses, and large ranges in responses.

For example, the GAO found that the median number of responses to surveys for payment year 2015 was 52 but the median response rate was only 2%, and that 23 of the 231 surveys had under 30 respondents.

The report also questions the transparency of the CMS process for establishing relative values. Although the CMS states that it complies with statutory requirements to review all Medicare services every 5 years, the agency does not maintain a database to track when a service was last valued or have a documented standardized process for prioritizing its reviews, according to the GAO report.

The CMS also does not publish the potentially misvalued services identified by the RUC, so stakeholders are unaware that these services will be reviewed and payment rates for these services may change.

The report found that the CMS provides some information about its process in its rule-making but does not document the methods used to review specific RUC recommendations. For example, the CMS does not document which resources were considered during its review of RUC recommendations for specific services. The GAO report said the CMS relies too heavily on RUC recommendations when establishing relative values.

“GAO found that, in the majority of cases, CMS accepts the RUC’s recommendations, and participation by other stakeholders is limited,” the report authors said. “Given the process- and data-related weaknesses associated with the RUC’s recommendations, such heavy reliance on the RUC could result in inaccurate Medicare payment rates.”

The AMA argued that the GAO report should have better acknowledged the difficulty in obtaining data on services that are infrequently performed. For example, 80% of services paid with work valuation on the Medicare physician payment schedule have fewer than 10,000 Medicare claims per year, the association noted.

“A service performed 10,000 times per year, is done, on average, less than once per day in any state,” the AMA spokesperson said. “It would be nearly impossible to do accurate direct observation or time/motion studies to collect time data on these low volume services. The survey methodology, followed by rigorous cross-specialty RUC review, is the best way to accomplish this data collection.”

The current GAO report is far from the first to criticize the RUC. The AAFP has long argued that the RUC should include more family physicians, health plans, consumers, employers, and health care economists on its panel. In 2012, the committee added another seat for geriatric medicine and another rotating primary care seat.

In an interview, Dr. Wergin said these additions helped, but that the AAFP would like to see at least one more primary care slot, as well as slots for other stakeholders. In a January 2014 letter, the AAFP called on the CMS to correct what the AAFP referred to as “a disturbing trend seen in the recommendations of RUC.” Specifically, the AAFP urged the CMS to address undervalued services, such as office-based evaluation and management (E/M) codes.

The Medicare Payment Advisory Commission (MedPAC), an independent advisory commission to Congress, has also issued several reports questioning the effectiveness of the RUC, including a 2011 white paper that expressed skepticism about the way in which data is collected by the panel. In 2013, MedPAC executive director Mark E. Miller, in testimony before the Senate Finance Committee, criticized how the RUC operated.

In the last Congress, Rep. Jim McDermott (D-Wash.), ranking member of the Ways and Means Committee’s Subcommittee on Health, introduced the Accuracy in Medicare Physician Payment Act of 2013, which would supplement the work of RUC by establishing an expert panel within Medicare to oversee the valuation of physician services and to help correct distortions in the physician fee schedule. The bill was not considered by the House.

[email protected]

On Twitter @legal_med

A government watchdog report suggests that the Centers for Medicare & Medicaid Services may be setting Medicare payment rates inaccurately based on biased recommendations from its panel of physician experts.

The Government Accountability Office (GAO) questions the transparency of the CMS’ rate calculation process and suggests that members of the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) have conflicts of interest that affect their ability to fairly value physician services, according to a report published May 21.

©sndr/istockphoto.com

The GAO report recommends that the CMS better document its process for establishing relative values and develop a process to inform the public of potentially misvalued services identified by the RUC. The CMS also should develop a plan for using funds appropriated for the collection and use of information on physicians’ services in the determination of relative values, the report stated.

In response, the American Medical Association defended the expertise and objectivity of the RUC, stressing that there is no substitute for input from experienced physicians regarding the time and resources that go into medical services.

“The RUC’s valuable expertise is balanced with the oversight of government officials who have the final say,” an AMA spokesperson said in an interview. “When CMS’ initial efforts to identify potentially misvalued services were unable to obtain reliable data from government contractors, physicians on the RUC took on this important task. When gauging how much time and resources go into one medical service compared with another, no one knows more about what is involved in providing services to Medicare patients than the physicians who care for them.”

Dr. Robert L. Wergin, president of the American Academy of Family Physicians (AAFP) said the GAO report findings are consistent with previous concerns raised by the AAFP about the RUC.

“We have advocated for more transparency” in the past, Dr. Wergin said in an interview. “We have requested that the RUC expose the survey process, and we’ve also given input that we improve it [and] make it more accurate. Adding transparency to the process might be a way to improve it.”

In its review, the GAO – a nonpartisan investigational agency of Congress – cited several weaknesses in the data collected by the RUC, including that some RUC survey data had low response rates, a low total number of responses, and large ranges in responses.

For example, the GAO found that the median number of responses to surveys for payment year 2015 was 52 but the median response rate was only 2%, and that 23 of the 231 surveys had under 30 respondents.

The report also questions the transparency of the CMS process for establishing relative values. Although the CMS states that it complies with statutory requirements to review all Medicare services every 5 years, the agency does not maintain a database to track when a service was last valued or have a documented standardized process for prioritizing its reviews, according to the GAO report.

The CMS also does not publish the potentially misvalued services identified by the RUC, so stakeholders are unaware that these services will be reviewed and payment rates for these services may change.

The report found that the CMS provides some information about its process in its rule-making but does not document the methods used to review specific RUC recommendations. For example, the CMS does not document which resources were considered during its review of RUC recommendations for specific services. The GAO report said the CMS relies too heavily on RUC recommendations when establishing relative values.

“GAO found that, in the majority of cases, CMS accepts the RUC’s recommendations, and participation by other stakeholders is limited,” the report authors said. “Given the process- and data-related weaknesses associated with the RUC’s recommendations, such heavy reliance on the RUC could result in inaccurate Medicare payment rates.”

The AMA argued that the GAO report should have better acknowledged the difficulty in obtaining data on services that are infrequently performed. For example, 80% of services paid with work valuation on the Medicare physician payment schedule have fewer than 10,000 Medicare claims per year, the association noted.

“A service performed 10,000 times per year, is done, on average, less than once per day in any state,” the AMA spokesperson said. “It would be nearly impossible to do accurate direct observation or time/motion studies to collect time data on these low volume services. The survey methodology, followed by rigorous cross-specialty RUC review, is the best way to accomplish this data collection.”

The current GAO report is far from the first to criticize the RUC. The AAFP has long argued that the RUC should include more family physicians, health plans, consumers, employers, and health care economists on its panel. In 2012, the committee added another seat for geriatric medicine and another rotating primary care seat.

In an interview, Dr. Wergin said these additions helped, but that the AAFP would like to see at least one more primary care slot, as well as slots for other stakeholders. In a January 2014 letter, the AAFP called on the CMS to correct what the AAFP referred to as “a disturbing trend seen in the recommendations of RUC.” Specifically, the AAFP urged the CMS to address undervalued services, such as office-based evaluation and management (E/M) codes.

The Medicare Payment Advisory Commission (MedPAC), an independent advisory commission to Congress, has also issued several reports questioning the effectiveness of the RUC, including a 2011 white paper that expressed skepticism about the way in which data is collected by the panel. In 2013, MedPAC executive director Mark E. Miller, in testimony before the Senate Finance Committee, criticized how the RUC operated.

In the last Congress, Rep. Jim McDermott (D-Wash.), ranking member of the Ways and Means Committee’s Subcommittee on Health, introduced the Accuracy in Medicare Physician Payment Act of 2013, which would supplement the work of RUC by establishing an expert panel within Medicare to oversee the valuation of physician services and to help correct distortions in the physician fee schedule. The bill was not considered by the House.

[email protected]

On Twitter @legal_med

A government watchdog report suggests that the Centers for Medicare & Medicaid Services may be setting Medicare payment rates inaccurately based on biased recommendations from its panel of physician experts.

The Government Accountability Office (GAO) questions the transparency of the CMS’ rate calculation process and suggests that members of the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) have conflicts of interest that affect their ability to fairly value physician services, according to a report published May 21.

©sndr/istockphoto.com

The GAO report recommends that the CMS better document its process for establishing relative values and develop a process to inform the public of potentially misvalued services identified by the RUC. The CMS also should develop a plan for using funds appropriated for the collection and use of information on physicians’ services in the determination of relative values, the report stated.

In response, the American Medical Association defended the expertise and objectivity of the RUC, stressing that there is no substitute for input from experienced physicians regarding the time and resources that go into medical services.

“The RUC’s valuable expertise is balanced with the oversight of government officials who have the final say,” an AMA spokesperson said in an interview. “When CMS’ initial efforts to identify potentially misvalued services were unable to obtain reliable data from government contractors, physicians on the RUC took on this important task. When gauging how much time and resources go into one medical service compared with another, no one knows more about what is involved in providing services to Medicare patients than the physicians who care for them.”

Dr. Robert L. Wergin, president of the American Academy of Family Physicians (AAFP) said the GAO report findings are consistent with previous concerns raised by the AAFP about the RUC.

“We have advocated for more transparency” in the past, Dr. Wergin said in an interview. “We have requested that the RUC expose the survey process, and we’ve also given input that we improve it [and] make it more accurate. Adding transparency to the process might be a way to improve it.”

In its review, the GAO – a nonpartisan investigational agency of Congress – cited several weaknesses in the data collected by the RUC, including that some RUC survey data had low response rates, a low total number of responses, and large ranges in responses.

For example, the GAO found that the median number of responses to surveys for payment year 2015 was 52 but the median response rate was only 2%, and that 23 of the 231 surveys had under 30 respondents.

The report also questions the transparency of the CMS process for establishing relative values. Although the CMS states that it complies with statutory requirements to review all Medicare services every 5 years, the agency does not maintain a database to track when a service was last valued or have a documented standardized process for prioritizing its reviews, according to the GAO report.

The CMS also does not publish the potentially misvalued services identified by the RUC, so stakeholders are unaware that these services will be reviewed and payment rates for these services may change.

The report found that the CMS provides some information about its process in its rule-making but does not document the methods used to review specific RUC recommendations. For example, the CMS does not document which resources were considered during its review of RUC recommendations for specific services. The GAO report said the CMS relies too heavily on RUC recommendations when establishing relative values.

“GAO found that, in the majority of cases, CMS accepts the RUC’s recommendations, and participation by other stakeholders is limited,” the report authors said. “Given the process- and data-related weaknesses associated with the RUC’s recommendations, such heavy reliance on the RUC could result in inaccurate Medicare payment rates.”

The AMA argued that the GAO report should have better acknowledged the difficulty in obtaining data on services that are infrequently performed. For example, 80% of services paid with work valuation on the Medicare physician payment schedule have fewer than 10,000 Medicare claims per year, the association noted.

“A service performed 10,000 times per year, is done, on average, less than once per day in any state,” the AMA spokesperson said. “It would be nearly impossible to do accurate direct observation or time/motion studies to collect time data on these low volume services. The survey methodology, followed by rigorous cross-specialty RUC review, is the best way to accomplish this data collection.”

The current GAO report is far from the first to criticize the RUC. The AAFP has long argued that the RUC should include more family physicians, health plans, consumers, employers, and health care economists on its panel. In 2012, the committee added another seat for geriatric medicine and another rotating primary care seat.

In an interview, Dr. Wergin said these additions helped, but that the AAFP would like to see at least one more primary care slot, as well as slots for other stakeholders. In a January 2014 letter, the AAFP called on the CMS to correct what the AAFP referred to as “a disturbing trend seen in the recommendations of RUC.” Specifically, the AAFP urged the CMS to address undervalued services, such as office-based evaluation and management (E/M) codes.

The Medicare Payment Advisory Commission (MedPAC), an independent advisory commission to Congress, has also issued several reports questioning the effectiveness of the RUC, including a 2011 white paper that expressed skepticism about the way in which data is collected by the panel. In 2013, MedPAC executive director Mark E. Miller, in testimony before the Senate Finance Committee, criticized how the RUC operated.

In the last Congress, Rep. Jim McDermott (D-Wash.), ranking member of the Ways and Means Committee’s Subcommittee on Health, introduced the Accuracy in Medicare Physician Payment Act of 2013, which would supplement the work of RUC by establishing an expert panel within Medicare to oversee the valuation of physician services and to help correct distortions in the physician fee schedule. The bill was not considered by the House.

[email protected]

On Twitter @legal_med

As Medicare celebrates its 50th anniversary, federal officials are beginning one of the most significant shifts in the program’s history – paying physicians based on quality and efficiency rather than for the volume of services they provide. The shift to so-called value-based payment will be phased in, but it is coming soon.

Earlier this year, federal officials announced their goal to tie 85% of all Medicare fee-for-service payments to quality or value by 2016 and 90% by 2018, relying heavily on the use of alternative payment models such as Accountable Care Organizations (ACOs) and bundled payments. The shift also is being driven by the recent repeal of Medicare’s Sustainable Growth Rate formula. The law that removed the SGR from physicians’ lives also created alternative payment pathways that tie payments to performance on certain quality metrics or successful participation as part of an ACO.

How will these changes affect how physicians deliver care in the future? We invited physicians in various practice settings to offer their perspectives on how the new payment paradigm will drive practice changes.

‘Value’ payment system is arbitrary

BY JOSEPH S. EASTERN, M.D.

While much has been written about the Centers for Medicare & Medicaid Services’ plan to shift its payment system away from fee-for-service and toward a “value-based” structure, most physicians in small and solo private settings have given little if any thought to its potential impact on their practices. That is about to change.

The principal vehicle for the CMS’s plan is something called the value-based payment modifier (VBPM), a component of the Affordable Care Act. The VBPM has not been on the radar of smaller private practices because up until now it has only applied to groups with more than 10 providers. Beginning this year, it applies to everyone. If you accept Medicare patients, regardless of the size of your practice, VBPM will become part of your life – because your 2017 Medicare payments will be adjusted based on your 2015 VBPM “score.”

It will adjust your reimbursements based on quality of care as defined by the CMS and cost, compared to other physicians. Your “score” will have a quality component and a cost component, and will be calculated based on measures reported through the Physician Quality Reporting System (PQRS). And the ACA requires that the program be budget neutral, which means that all rewards to physicians who pull the highest scores must be offset by penalties, or “negative adjustments,” to those who don’t score as well. In essence, the VBPM establishes arbitrary practice standards and spending ceilings; physicians who have the temerity to practice medicine as they see fit, or spend too much relative to their peers, will be punished.

Beyond the obvious and very real possibility of significant financial hardship, there are serious potential consequences inherent in this unprecedented new system. Health care is already among the most regulated industries in the country; the VBPM creates new incentives to practice “cookbook” medicine, and new disincentives to order tests, consults, or medications, even when doing so would clearly be in a patient’s best interest. The inevitable result will be compromised care and further limitation of patient access.

The VBPM’s potential effects on physician-patient relations and legal liability are additional serious concerns. Many patients will object to their physicians’ new reluctance to recommend appropriate interventions for fear of generating excessive costs; and should a less-than-thorough work-up lead to a missed diagnosis, the ACA offers no protection at all from any resulting malpractice litigation.

The already strained relationship between physicians and their hospitals will likely deteriorate as well. Hospital administrators will be scrutinizing each medical decision from admission to discharge, particularly in those institutions already in financial trouble, as is all too often the case. The constant necessity of justifying every significant order and consult will not be in anyone’s best interest, least of all that of patients.

For all the talk that the transition from fee-for-service to value-based reimbursement would result in better care at a lower cost, there is little evidence that care is improving, and even less that costs are decreasing. Conversely, there are plenty of warning signs that physicians in small private practices who can’t meet the new performance standards may face a significant financial burden because of the resulting penalties and lower reimbursements.

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

Staying independent may prove costly

BY PETER M.G. DEANE, M.D.

The changes announced for Medicare and Medicaid, to be implemented over the next few years, are breathtaking in scope and ambition. A system based on payment for services is to become a system based on payment for individual health and population health outcomes. This will require enormous changes in the way health care is delivered, and this is an intended effect. Private payers will certainly desire the same results and savings.

I am a partner in a multiphysician, single-specialty private group practice. We have two hospital systems locally. Both of these are now health systems, in that they either employ or closely interact with many physicians.

Just a few years ago, our practice could comfortably make decisions about how we went about delivering care without much consideration of the plans of larger local institutions. Then came the rise of our local accountable care networks. These were created by the local health care systems to provide the overall organizational infrastructure to move from the current payment model to the coming one. We delayed for awhile but have now signed up with both. It can only be a matter of months before each of them pursues a meaningful degree of clinical integration. In other words, they will be analyzing data from our electronic medical record about our individual practice patterns and results, and giving us the results along with feedback on how to improve care.

For this to happen, our EMR system needs to be up to the task. We are unsure it will be. It has been difficult for some of us to adapt to electronic records systems. Now we need to see if our existing system can interoperate effectively. If not, we may be paying quite a bit for another one soon.

Our physicians are not accustomed to seeing report cards about their practice patterns. It will be a shock to see comparisons and rankings. But patients will be enrolled in and referred to us by the networks, and it will not be possible to ignore the reports we get.

Likely this radical change in the practice of medicine will drive some to retire, affecting the size of our group. We intend to remain in private practice, but independence may prove increasingly costly.

Already, patients see that their physicians make less eye contact with them and more time documenting care. This will likely get worse. We worry that if increased expenses cause staff cuts, the personal service we provide will suffer.

Redesigning medical practice will be a serious challenge for us. But our goal has always been to provide the best care, and in a value-based system, that should be what sustains us all.

Dr. Deane specializes in allergy, immunology, and rheumatology and is a partner in a private group practice with eight physicians and five offices in greater Rochester, N.Y. He is also the chief of allergy, immunology, and rheumatology at Unity Hospital in Rochester.

Value shift brings irreparable change to private practice

BY ROBERT SHOR, M.D.

The simple truth is that we are in transition. The current health system, for the most part, rewards “making widgets” (volume). That is, being paid for units of work actually being done. The more patients you see, the more procedures you do, the more you are compensated. We are moving from “volume” to “value” as we try to move away from “widgets” to management of population health. How do we get there? What can we as physicians and providers do?

I am part of a 40-person, single-specialty private cardiology practice in the Washington, D.C., suburbs. In the coming years, the CMS will reward (the euphemism for payment) practices that meet their definitions for quality and penalize those that don’t meet those metrics.

We have participated in PQRS/PQRI, Meaningful Use (MU), and other Medicare programs for which we are compensated. But how do you truly determine what are quality metrics and what is truly meaningful use of health system resources? How do we impact health on an individual and population view?

For us to be compliant with the Medicare rules and get paid, we have had to heavily invest in not only EHRs (we were an early adopter around 2000), but personnel costs to make sure all of the paperwork is completed appropriately for submission and for the audit that precedes the CMS payment for MU.

So how do we proceed going forward? In my opinion, what is clear is that private practice has been irreparably changed. The notion of an individual physician or a small practice surviving without some arrangement with a health system, an ACO, or a Clinical Integrated Network (CIN) is rapidly dwindling.

I have seen a variety of actions taken as providers try to survive and jockey for position to their advantage and we have explored a wide range of options. For an ACO to succeed in the shared risk model, it usually is part of a larger health care system. Thus many practices – primary care and subspecialty – have integrated with these health systems. Indeed, about 70% of the cardiology community is now integrated. To manage costs, you need to know your costs and most of the cost remains in the hospital care.

What do you do if you want to stay independent or do not feel you have a reliable health system with which you can integrate? Many practices may merge in a formal or looser network of practices to create a CIN where EHR access to patient records within the network is streamlined and care can be more effectively given. This has benefits, but also limitations. I believe that any future in which cost is contained on a larger scale will require close collaboration with hospitals given the disproportionate cost incurred during hospital care. Some practices have decided to form Physician Service Agreements with hospital systems to help manage product lines within the health system and to establish more meaningful relationships in an effort to coordinate care more effectively. This provides an opportunity to impact inpatient care, to contribute to programs that reduce hospital readmissions, and to reach the holy grail of preventing disease by better outpatient care. This would truly help with population health care management.

Some of the challenges, at least in large metropolitan areas, are that practices may work at several hospitals with different health systems. They may want to continue providing care at all of the hospitals in their community, but may be forced to choose. This does not appear to me to be in the best interest of our patients, many of whom we have cared for many years. However, the choice may be forced upon them as the health systems force the issue and make the decision for us.

The future holds much uncertainty, but also opportunity. Will our practice survive in its current form in 5 years? For now we are trying to read the tea leaves, like so many others, to make the best decisions on behalf of our patients to allow us to be able to continue to provide care in our community.

We are still reading the tea leaves.

Dr. Shor is vice president of Virginia Heart, which has nine offices in the northern Virginia region. He is the chair of the board of governors of the American College of Cardiology.

Leaving behind fee-for-service battles

BY ROBERT FIELDS, M.D.

Many of us in health care received with a mix of excitement and fear the recent news from the CMS regarding the transition to 90% value-based payments by 2018. For me, an employed family medicine physician and medical director of a new ACO in western North Carolina, I applaud the ambitious goal and understand the sentiment behind it. But, I also worry about the ability of most providers to adapt to this change in such a short time span.

The rationale behind value-based payments couldn’t be clearer – we spend too much on health care. Way too much. So much, that if we continue on this track our country will break under the financial pressures of providing care in a fee-for-service system. In addition, U.S. medical outcomes lag behind most other industrialized nations, which leads to the conclusion that the system at large is not providing the value it should.

As I put on my rose-colored glasses, I hope this restructuring encourages the system at large to coordinate care better, to improve our information systems to share relevant clinical data, and to encourage quality improvement at the practice level so that we move toward improved outcomes for our patient populations.

When talking to providers about our ACO and adding value in health care, they think we are saying that THEY are not delivering high value care. I keep reiterating, and will continue to do so, that value-based payments are not a criticism of our individual abilities as physicians or a comment on our interactions with our patients, but acknowledgment that how we communicate with and manage our populations as a network of hospitals, providers, and agencies lacks the efficiencies and coordination of services that patients deserve.

Ultimately, we are moving toward a patient-centered health care system that requires a fundamental transformation in how we pay for and deliver care. Measurement and quality improvement, although new to health care, has existed in every other industry for years.

In the end, I hope patients feel they are getting more efficient, coordinated care and that providers can start to see improvements in outcomes without the daily battle of the fee-for-service world.

Dr. Fields is a family physician and the medical director of Mission Health Partners, a physician led ACO in Asheville, N.C.

As Medicare celebrates its 50th anniversary, federal officials are beginning one of the most significant shifts in the program’s history – paying physicians based on quality and efficiency rather than for the volume of services they provide. The shift to so-called value-based payment will be phased in, but it is coming soon.

Earlier this year, federal officials announced their goal to tie 85% of all Medicare fee-for-service payments to quality or value by 2016 and 90% by 2018, relying heavily on the use of alternative payment models such as Accountable Care Organizations (ACOs) and bundled payments. The shift also is being driven by the recent repeal of Medicare’s Sustainable Growth Rate formula. The law that removed the SGR from physicians’ lives also created alternative payment pathways that tie payments to performance on certain quality metrics or successful participation as part of an ACO.

How will these changes affect how physicians deliver care in the future? We invited physicians in various practice settings to offer their perspectives on how the new payment paradigm will drive practice changes.

‘Value’ payment system is arbitrary

BY JOSEPH S. EASTERN, M.D.

While much has been written about the Centers for Medicare & Medicaid Services’ plan to shift its payment system away from fee-for-service and toward a “value-based” structure, most physicians in small and solo private settings have given little if any thought to its potential impact on their practices. That is about to change.

The principal vehicle for the CMS’s plan is something called the value-based payment modifier (VBPM), a component of the Affordable Care Act. The VBPM has not been on the radar of smaller private practices because up until now it has only applied to groups with more than 10 providers. Beginning this year, it applies to everyone. If you accept Medicare patients, regardless of the size of your practice, VBPM will become part of your life – because your 2017 Medicare payments will be adjusted based on your 2015 VBPM “score.”

It will adjust your reimbursements based on quality of care as defined by the CMS and cost, compared to other physicians. Your “score” will have a quality component and a cost component, and will be calculated based on measures reported through the Physician Quality Reporting System (PQRS). And the ACA requires that the program be budget neutral, which means that all rewards to physicians who pull the highest scores must be offset by penalties, or “negative adjustments,” to those who don’t score as well. In essence, the VBPM establishes arbitrary practice standards and spending ceilings; physicians who have the temerity to practice medicine as they see fit, or spend too much relative to their peers, will be punished.

Beyond the obvious and very real possibility of significant financial hardship, there are serious potential consequences inherent in this unprecedented new system. Health care is already among the most regulated industries in the country; the VBPM creates new incentives to practice “cookbook” medicine, and new disincentives to order tests, consults, or medications, even when doing so would clearly be in a patient’s best interest. The inevitable result will be compromised care and further limitation of patient access.

The VBPM’s potential effects on physician-patient relations and legal liability are additional serious concerns. Many patients will object to their physicians’ new reluctance to recommend appropriate interventions for fear of generating excessive costs; and should a less-than-thorough work-up lead to a missed diagnosis, the ACA offers no protection at all from any resulting malpractice litigation.

The already strained relationship between physicians and their hospitals will likely deteriorate as well. Hospital administrators will be scrutinizing each medical decision from admission to discharge, particularly in those institutions already in financial trouble, as is all too often the case. The constant necessity of justifying every significant order and consult will not be in anyone’s best interest, least of all that of patients.

For all the talk that the transition from fee-for-service to value-based reimbursement would result in better care at a lower cost, there is little evidence that care is improving, and even less that costs are decreasing. Conversely, there are plenty of warning signs that physicians in small private practices who can’t meet the new performance standards may face a significant financial burden because of the resulting penalties and lower reimbursements.

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

Staying independent may prove costly

BY PETER M.G. DEANE, M.D.

The changes announced for Medicare and Medicaid, to be implemented over the next few years, are breathtaking in scope and ambition. A system based on payment for services is to become a system based on payment for individual health and population health outcomes. This will require enormous changes in the way health care is delivered, and this is an intended effect. Private payers will certainly desire the same results and savings.

I am a partner in a multiphysician, single-specialty private group practice. We have two hospital systems locally. Both of these are now health systems, in that they either employ or closely interact with many physicians.

Just a few years ago, our practice could comfortably make decisions about how we went about delivering care without much consideration of the plans of larger local institutions. Then came the rise of our local accountable care networks. These were created by the local health care systems to provide the overall organizational infrastructure to move from the current payment model to the coming one. We delayed for awhile but have now signed up with both. It can only be a matter of months before each of them pursues a meaningful degree of clinical integration. In other words, they will be analyzing data from our electronic medical record about our individual practice patterns and results, and giving us the results along with feedback on how to improve care.

For this to happen, our EMR system needs to be up to the task. We are unsure it will be. It has been difficult for some of us to adapt to electronic records systems. Now we need to see if our existing system can interoperate effectively. If not, we may be paying quite a bit for another one soon.

Our physicians are not accustomed to seeing report cards about their practice patterns. It will be a shock to see comparisons and rankings. But patients will be enrolled in and referred to us by the networks, and it will not be possible to ignore the reports we get.

Likely this radical change in the practice of medicine will drive some to retire, affecting the size of our group. We intend to remain in private practice, but independence may prove increasingly costly.

Already, patients see that their physicians make less eye contact with them and more time documenting care. This will likely get worse. We worry that if increased expenses cause staff cuts, the personal service we provide will suffer.

Redesigning medical practice will be a serious challenge for us. But our goal has always been to provide the best care, and in a value-based system, that should be what sustains us all.

Dr. Deane specializes in allergy, immunology, and rheumatology and is a partner in a private group practice with eight physicians and five offices in greater Rochester, N.Y. He is also the chief of allergy, immunology, and rheumatology at Unity Hospital in Rochester.

Value shift brings irreparable change to private practice

BY ROBERT SHOR, M.D.

The simple truth is that we are in transition. The current health system, for the most part, rewards “making widgets” (volume). That is, being paid for units of work actually being done. The more patients you see, the more procedures you do, the more you are compensated. We are moving from “volume” to “value” as we try to move away from “widgets” to management of population health. How do we get there? What can we as physicians and providers do?

I am part of a 40-person, single-specialty private cardiology practice in the Washington, D.C., suburbs. In the coming years, the CMS will reward (the euphemism for payment) practices that meet their definitions for quality and penalize those that don’t meet those metrics.

We have participated in PQRS/PQRI, Meaningful Use (MU), and other Medicare programs for which we are compensated. But how do you truly determine what are quality metrics and what is truly meaningful use of health system resources? How do we impact health on an individual and population view?

For us to be compliant with the Medicare rules and get paid, we have had to heavily invest in not only EHRs (we were an early adopter around 2000), but personnel costs to make sure all of the paperwork is completed appropriately for submission and for the audit that precedes the CMS payment for MU.

So how do we proceed going forward? In my opinion, what is clear is that private practice has been irreparably changed. The notion of an individual physician or a small practice surviving without some arrangement with a health system, an ACO, or a Clinical Integrated Network (CIN) is rapidly dwindling.

I have seen a variety of actions taken as providers try to survive and jockey for position to their advantage and we have explored a wide range of options. For an ACO to succeed in the shared risk model, it usually is part of a larger health care system. Thus many practices – primary care and subspecialty – have integrated with these health systems. Indeed, about 70% of the cardiology community is now integrated. To manage costs, you need to know your costs and most of the cost remains in the hospital care.

What do you do if you want to stay independent or do not feel you have a reliable health system with which you can integrate? Many practices may merge in a formal or looser network of practices to create a CIN where EHR access to patient records within the network is streamlined and care can be more effectively given. This has benefits, but also limitations. I believe that any future in which cost is contained on a larger scale will require close collaboration with hospitals given the disproportionate cost incurred during hospital care. Some practices have decided to form Physician Service Agreements with hospital systems to help manage product lines within the health system and to establish more meaningful relationships in an effort to coordinate care more effectively. This provides an opportunity to impact inpatient care, to contribute to programs that reduce hospital readmissions, and to reach the holy grail of preventing disease by better outpatient care. This would truly help with population health care management.

Some of the challenges, at least in large metropolitan areas, are that practices may work at several hospitals with different health systems. They may want to continue providing care at all of the hospitals in their community, but may be forced to choose. This does not appear to me to be in the best interest of our patients, many of whom we have cared for many years. However, the choice may be forced upon them as the health systems force the issue and make the decision for us.

The future holds much uncertainty, but also opportunity. Will our practice survive in its current form in 5 years? For now we are trying to read the tea leaves, like so many others, to make the best decisions on behalf of our patients to allow us to be able to continue to provide care in our community.

We are still reading the tea leaves.

Dr. Shor is vice president of Virginia Heart, which has nine offices in the northern Virginia region. He is the chair of the board of governors of the American College of Cardiology.

Leaving behind fee-for-service battles

BY ROBERT FIELDS, M.D.

Many of us in health care received with a mix of excitement and fear the recent news from the CMS regarding the transition to 90% value-based payments by 2018. For me, an employed family medicine physician and medical director of a new ACO in western North Carolina, I applaud the ambitious goal and understand the sentiment behind it. But, I also worry about the ability of most providers to adapt to this change in such a short time span.

The rationale behind value-based payments couldn’t be clearer – we spend too much on health care. Way too much. So much, that if we continue on this track our country will break under the financial pressures of providing care in a fee-for-service system. In addition, U.S. medical outcomes lag behind most other industrialized nations, which leads to the conclusion that the system at large is not providing the value it should.

As I put on my rose-colored glasses, I hope this restructuring encourages the system at large to coordinate care better, to improve our information systems to share relevant clinical data, and to encourage quality improvement at the practice level so that we move toward improved outcomes for our patient populations.

When talking to providers about our ACO and adding value in health care, they think we are saying that THEY are not delivering high value care. I keep reiterating, and will continue to do so, that value-based payments are not a criticism of our individual abilities as physicians or a comment on our interactions with our patients, but acknowledgment that how we communicate with and manage our populations as a network of hospitals, providers, and agencies lacks the efficiencies and coordination of services that patients deserve.

Ultimately, we are moving toward a patient-centered health care system that requires a fundamental transformation in how we pay for and deliver care. Measurement and quality improvement, although new to health care, has existed in every other industry for years.

In the end, I hope patients feel they are getting more efficient, coordinated care and that providers can start to see improvements in outcomes without the daily battle of the fee-for-service world.

Dr. Fields is a family physician and the medical director of Mission Health Partners, a physician led ACO in Asheville, N.C.

As Medicare celebrates its 50th anniversary, federal officials are beginning one of the most significant shifts in the program’s history – paying physicians based on quality and efficiency rather than for the volume of services they provide. The shift to so-called value-based payment will be phased in, but it is coming soon.

Earlier this year, federal officials announced their goal to tie 85% of all Medicare fee-for-service payments to quality or value by 2016 and 90% by 2018, relying heavily on the use of alternative payment models such as Accountable Care Organizations (ACOs) and bundled payments. The shift also is being driven by the recent repeal of Medicare’s Sustainable Growth Rate formula. The law that removed the SGR from physicians’ lives also created alternative payment pathways that tie payments to performance on certain quality metrics or successful participation as part of an ACO.

How will these changes affect how physicians deliver care in the future? We invited physicians in various practice settings to offer their perspectives on how the new payment paradigm will drive practice changes.

‘Value’ payment system is arbitrary

BY JOSEPH S. EASTERN, M.D.

While much has been written about the Centers for Medicare & Medicaid Services’ plan to shift its payment system away from fee-for-service and toward a “value-based” structure, most physicians in small and solo private settings have given little if any thought to its potential impact on their practices. That is about to change.

The principal vehicle for the CMS’s plan is something called the value-based payment modifier (VBPM), a component of the Affordable Care Act. The VBPM has not been on the radar of smaller private practices because up until now it has only applied to groups with more than 10 providers. Beginning this year, it applies to everyone. If you accept Medicare patients, regardless of the size of your practice, VBPM will become part of your life – because your 2017 Medicare payments will be adjusted based on your 2015 VBPM “score.”

It will adjust your reimbursements based on quality of care as defined by the CMS and cost, compared to other physicians. Your “score” will have a quality component and a cost component, and will be calculated based on measures reported through the Physician Quality Reporting System (PQRS). And the ACA requires that the program be budget neutral, which means that all rewards to physicians who pull the highest scores must be offset by penalties, or “negative adjustments,” to those who don’t score as well. In essence, the VBPM establishes arbitrary practice standards and spending ceilings; physicians who have the temerity to practice medicine as they see fit, or spend too much relative to their peers, will be punished.

Beyond the obvious and very real possibility of significant financial hardship, there are serious potential consequences inherent in this unprecedented new system. Health care is already among the most regulated industries in the country; the VBPM creates new incentives to practice “cookbook” medicine, and new disincentives to order tests, consults, or medications, even when doing so would clearly be in a patient’s best interest. The inevitable result will be compromised care and further limitation of patient access.

The VBPM’s potential effects on physician-patient relations and legal liability are additional serious concerns. Many patients will object to their physicians’ new reluctance to recommend appropriate interventions for fear of generating excessive costs; and should a less-than-thorough work-up lead to a missed diagnosis, the ACA offers no protection at all from any resulting malpractice litigation.

The already strained relationship between physicians and their hospitals will likely deteriorate as well. Hospital administrators will be scrutinizing each medical decision from admission to discharge, particularly in those institutions already in financial trouble, as is all too often the case. The constant necessity of justifying every significant order and consult will not be in anyone’s best interest, least of all that of patients.

For all the talk that the transition from fee-for-service to value-based reimbursement would result in better care at a lower cost, there is little evidence that care is improving, and even less that costs are decreasing. Conversely, there are plenty of warning signs that physicians in small private practices who can’t meet the new performance standards may face a significant financial burden because of the resulting penalties and lower reimbursements.

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

Staying independent may prove costly

BY PETER M.G. DEANE, M.D.

The changes announced for Medicare and Medicaid, to be implemented over the next few years, are breathtaking in scope and ambition. A system based on payment for services is to become a system based on payment for individual health and population health outcomes. This will require enormous changes in the way health care is delivered, and this is an intended effect. Private payers will certainly desire the same results and savings.

I am a partner in a multiphysician, single-specialty private group practice. We have two hospital systems locally. Both of these are now health systems, in that they either employ or closely interact with many physicians.

Just a few years ago, our practice could comfortably make decisions about how we went about delivering care without much consideration of the plans of larger local institutions. Then came the rise of our local accountable care networks. These were created by the local health care systems to provide the overall organizational infrastructure to move from the current payment model to the coming one. We delayed for awhile but have now signed up with both. It can only be a matter of months before each of them pursues a meaningful degree of clinical integration. In other words, they will be analyzing data from our electronic medical record about our individual practice patterns and results, and giving us the results along with feedback on how to improve care.

For this to happen, our EMR system needs to be up to the task. We are unsure it will be. It has been difficult for some of us to adapt to electronic records systems. Now we need to see if our existing system can interoperate effectively. If not, we may be paying quite a bit for another one soon.

Our physicians are not accustomed to seeing report cards about their practice patterns. It will be a shock to see comparisons and rankings. But patients will be enrolled in and referred to us by the networks, and it will not be possible to ignore the reports we get.

Likely this radical change in the practice of medicine will drive some to retire, affecting the size of our group. We intend to remain in private practice, but independence may prove increasingly costly.

Already, patients see that their physicians make less eye contact with them and more time documenting care. This will likely get worse. We worry that if increased expenses cause staff cuts, the personal service we provide will suffer.

Redesigning medical practice will be a serious challenge for us. But our goal has always been to provide the best care, and in a value-based system, that should be what sustains us all.

Dr. Deane specializes in allergy, immunology, and rheumatology and is a partner in a private group practice with eight physicians and five offices in greater Rochester, N.Y. He is also the chief of allergy, immunology, and rheumatology at Unity Hospital in Rochester.

Value shift brings irreparable change to private practice

BY ROBERT SHOR, M.D.

The simple truth is that we are in transition. The current health system, for the most part, rewards “making widgets” (volume). That is, being paid for units of work actually being done. The more patients you see, the more procedures you do, the more you are compensated. We are moving from “volume” to “value” as we try to move away from “widgets” to management of population health. How do we get there? What can we as physicians and providers do?

I am part of a 40-person, single-specialty private cardiology practice in the Washington, D.C., suburbs. In the coming years, the CMS will reward (the euphemism for payment) practices that meet their definitions for quality and penalize those that don’t meet those metrics.

We have participated in PQRS/PQRI, Meaningful Use (MU), and other Medicare programs for which we are compensated. But how do you truly determine what are quality metrics and what is truly meaningful use of health system resources? How do we impact health on an individual and population view?

For us to be compliant with the Medicare rules and get paid, we have had to heavily invest in not only EHRs (we were an early adopter around 2000), but personnel costs to make sure all of the paperwork is completed appropriately for submission and for the audit that precedes the CMS payment for MU.

So how do we proceed going forward? In my opinion, what is clear is that private practice has been irreparably changed. The notion of an individual physician or a small practice surviving without some arrangement with a health system, an ACO, or a Clinical Integrated Network (CIN) is rapidly dwindling.

I have seen a variety of actions taken as providers try to survive and jockey for position to their advantage and we have explored a wide range of options. For an ACO to succeed in the shared risk model, it usually is part of a larger health care system. Thus many practices – primary care and subspecialty – have integrated with these health systems. Indeed, about 70% of the cardiology community is now integrated. To manage costs, you need to know your costs and most of the cost remains in the hospital care.

What do you do if you want to stay independent or do not feel you have a reliable health system with which you can integrate? Many practices may merge in a formal or looser network of practices to create a CIN where EHR access to patient records within the network is streamlined and care can be more effectively given. This has benefits, but also limitations. I believe that any future in which cost is contained on a larger scale will require close collaboration with hospitals given the disproportionate cost incurred during hospital care. Some practices have decided to form Physician Service Agreements with hospital systems to help manage product lines within the health system and to establish more meaningful relationships in an effort to coordinate care more effectively. This provides an opportunity to impact inpatient care, to contribute to programs that reduce hospital readmissions, and to reach the holy grail of preventing disease by better outpatient care. This would truly help with population health care management.

Some of the challenges, at least in large metropolitan areas, are that practices may work at several hospitals with different health systems. They may want to continue providing care at all of the hospitals in their community, but may be forced to choose. This does not appear to me to be in the best interest of our patients, many of whom we have cared for many years. However, the choice may be forced upon them as the health systems force the issue and make the decision for us.

The future holds much uncertainty, but also opportunity. Will our practice survive in its current form in 5 years? For now we are trying to read the tea leaves, like so many others, to make the best decisions on behalf of our patients to allow us to be able to continue to provide care in our community.

We are still reading the tea leaves.

Dr. Shor is vice president of Virginia Heart, which has nine offices in the northern Virginia region. He is the chair of the board of governors of the American College of Cardiology.

Leaving behind fee-for-service battles

BY ROBERT FIELDS, M.D.

Many of us in health care received with a mix of excitement and fear the recent news from the CMS regarding the transition to 90% value-based payments by 2018. For me, an employed family medicine physician and medical director of a new ACO in western North Carolina, I applaud the ambitious goal and understand the sentiment behind it. But, I also worry about the ability of most providers to adapt to this change in such a short time span.

The rationale behind value-based payments couldn’t be clearer – we spend too much on health care. Way too much. So much, that if we continue on this track our country will break under the financial pressures of providing care in a fee-for-service system. In addition, U.S. medical outcomes lag behind most other industrialized nations, which leads to the conclusion that the system at large is not providing the value it should.

As I put on my rose-colored glasses, I hope this restructuring encourages the system at large to coordinate care better, to improve our information systems to share relevant clinical data, and to encourage quality improvement at the practice level so that we move toward improved outcomes for our patient populations.

When talking to providers about our ACO and adding value in health care, they think we are saying that THEY are not delivering high value care. I keep reiterating, and will continue to do so, that value-based payments are not a criticism of our individual abilities as physicians or a comment on our interactions with our patients, but acknowledgment that how we communicate with and manage our populations as a network of hospitals, providers, and agencies lacks the efficiencies and coordination of services that patients deserve.

Ultimately, we are moving toward a patient-centered health care system that requires a fundamental transformation in how we pay for and deliver care. Measurement and quality improvement, although new to health care, has existed in every other industry for years.

In the end, I hope patients feel they are getting more efficient, coordinated care and that providers can start to see improvements in outcomes without the daily battle of the fee-for-service world.

Dr. Fields is a family physician and the medical director of Mission Health Partners, a physician led ACO in Asheville, N.C.

To enhance the “flow of health information at the community level,” HHS is offering $1 million in grants to fund community projects for the Community Interoperability and Health Information Exchange (HIE) Program. The program will provide funds to up to 10 community organizations, state or local government agencies, or other community groups. Awardees will demonstrate the use of health information technology to a wide range of health care providers, such as long-term and postacute care providers, individuals and their caregivers, and behavioral health care providers.

Related: A Medical Tower of Babel

“The flow of health information across the entire care continuum is a critical step to realizing a learning health system that results in not only better care, but healthier people and communities,” said Karen B. DeSalvo, MD, MPH, MSc, national coordinator for health information technology. The program, she said, will promote a “more comprehensive digital data picture of health for people and their communities.”

Related: The Rapid Rise of e-Consults Across Specialty Care

The deadline to submit applications is June 15, 2015. Applications are available at http://www.grants.gov/web/grants/view-opportunity.html?oppId=275875.

To enhance the “flow of health information at the community level,” HHS is offering $1 million in grants to fund community projects for the Community Interoperability and Health Information Exchange (HIE) Program. The program will provide funds to up to 10 community organizations, state or local government agencies, or other community groups. Awardees will demonstrate the use of health information technology to a wide range of health care providers, such as long-term and postacute care providers, individuals and their caregivers, and behavioral health care providers.

Related: A Medical Tower of Babel

“The flow of health information across the entire care continuum is a critical step to realizing a learning health system that results in not only better care, but healthier people and communities,” said Karen B. DeSalvo, MD, MPH, MSc, national coordinator for health information technology. The program, she said, will promote a “more comprehensive digital data picture of health for people and their communities.”

Related: The Rapid Rise of e-Consults Across Specialty Care

The deadline to submit applications is June 15, 2015. Applications are available at http://www.grants.gov/web/grants/view-opportunity.html?oppId=275875.

To enhance the “flow of health information at the community level,” HHS is offering $1 million in grants to fund community projects for the Community Interoperability and Health Information Exchange (HIE) Program. The program will provide funds to up to 10 community organizations, state or local government agencies, or other community groups. Awardees will demonstrate the use of health information technology to a wide range of health care providers, such as long-term and postacute care providers, individuals and their caregivers, and behavioral health care providers.

Related: A Medical Tower of Babel

“The flow of health information across the entire care continuum is a critical step to realizing a learning health system that results in not only better care, but healthier people and communities,” said Karen B. DeSalvo, MD, MPH, MSc, national coordinator for health information technology. The program, she said, will promote a “more comprehensive digital data picture of health for people and their communities.”

Related: The Rapid Rise of e-Consults Across Specialty Care

The deadline to submit applications is June 15, 2015. Applications are available at http://www.grants.gov/web/grants/view-opportunity.html?oppId=275875.

It’s value over volume for Medicare now that the Medicare Access and CHIP Reauthorization Act of 2015 is law.

“This shift in what the country faces in a disease burden really aligns and is helped and facilitated by this updating Medicare to this new disease environment,” Dr. James Madara, CEO of the American Medical Association, said April 15, the day after the Senate passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

“There are a lot of evolving issues to take care of in this migration toward models of payment delivery that work positively toward impacting quality of care,” Dr. Madara said. “Any time a complex bill as helpful as this one is passed, there are implementation problems that sometimes arise, so one of the areas that we will be strongly attentive to at the AMA is keeping our finger on the pulse of the implementation and working with the federal government to make sure that this tracks in a correct way.”

Courtesy whitehouse.gov

President Obama signed the bill into law on April 16.

The new law repeals the Medicare Sustainable Growth Rate formula, negating the 21% physician fee cut that was to go into effect April 1. In its place, the law provides a 0.5% pay increase yearly for 5 years as the Medicare program makes the transition away from fee-for-service and to value-based payment.

To help get to a point of value over volume, the bill consolidates existing quality programs – including those regarding the meaningful use of electronic health records – into a single value-based performance program.

“We studied that, along with some of the other physician organizations and our House of Delegates, and the conclusion was that this was not just an improvement, but a significant improvement, over the current set of measurements,” Dr. Madara said.

The new law also incentivizes physicians to use alternate payment models that focus on care coordination and preventive care with a 5% payment bonus. It pushes for more transparency of Medicare data for physicians, providers, and patients.

MACRA also includes funding to help smaller practices participate in alternative payment models or the streamlined quality measurement program, as well as funding to help in the development of quality measures.

“The provisions that allow for continued funding of the quality measurement enterprise in H.R. 2 are a key building block of this important transition and will also facilitate work to continue advancing measurement science,” the National Quality Forum said in a statement. “Ultimately, these efforts will not only help people get better healthcare, but also will reduce costs that strain patients, purchasers, and the system overall.”

Other important provisions in the new law include the reauthorization of several key programs. CHIP (the Children’s Health Insurance Program), the Community Health Center program, the National Health Service Corps, and the Teaching Health Centers program were all reauthorized for 2 years; they had been scheduled to expire later this year. Additionally, the law continues a partial delay of the Medicare two-midnights ruleuntil Sept. 30.

Physicians also cheered provisions of the new law that allay malpractice concerns. The law specifies that the development, recognition, or implementation of any federal health care guideline or standard does not establish a duty of care in medical malpractice claims.

The provision helps distinguish government quality guidelines and payment rules from medical liability standards, according to Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical malpractice liability insurers.

“None of these rules or guidelines were created with the intent to establish a legal standard for negligence, and so it makes sense for Congress to clarify that fact,” Mr. Atchinson said in an interview. “The standard of care provision in the SGR fix bill does just that, and nothing more. It does not shift the playing field to either plaintiffs or defendants. Instead, it ensures that these federal rules are not misused for purposes for which they were never intended.”

H.R. 2 ran into some trouble in the Senate because it does not have a dedicated funding mechanism to cover its full cost. The Congressional Budget Office estimated that enactment of the law will increase the deficit by $141 billion over 10 years. The CBO’s score also found that the legislation would save money, compared with the price of continued patches.

A total of $73 billion of the $214 billion cost of package is offset through spending reductions and revenue increases included in the bill, the CBO found. These include income-related premium adjustments for Medicare Parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital changes until 2018, and a 1% market basket update for postacute care providers.

Enactment of the law also looked a bit shaky when the Office of the Actuary for the Centers for Medicare & Medicaid Services released a report April 9 that suggested physicians would see future payment cuts under the law.

“Physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter,” according to the report. “Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2.”

However, the AMA’s Dr. Madara said that he was not concerned about the projections because the report assumes no changes in coming years. “One does not make linear trajectories over a periods of decades or more and assume that that’s where we are going to end up because that assumption is that nothing happens in the interim and, as we all know, that’s just simply not the way life works,” he said.

AMA President Robert Wah noted that the report “fails to take into account the long-range impact such a drastic payment cut [due to the SGR] would have on quality and access for Medicare beneficiaries, or the many options H.R. 2 will make available to physicians for avoiding onerous penalties under current law and the significant positive updates that high performers can earn.”

The American College of Physicians applauded the Senate action.

“We all witnessed something quite extraordinary and historic today when the Senate followed the House in passing comprehensive legislation to repeal Medicare’s Sustainable Growth Rate formula (H.R. 2) and transition us to a new value-based system,” ACP President David Flemming said in a statement.

American Society of Clinical Oncology President Peter Paul Yu said in a statement that “Medicare beneficiaries and their physicians can breathe easier knowing they will no longer face the perennial threat of payment cuts that risk disruption of care and cause anxiety among patients. ... [ASCO] looks forward to working with policymakers to ensure that this new law is effectively implemented and paves the way to new payment models that foster high-quality, value-based health care for all Americans with cancer.”

Similarly, the American Society for Radiation Oncology praised the effort. “Permanently repealing the SGR and replacing it with a stabilized reimbursement plan focused on quality will strengthen Medicare and allow us to enhance cancer care for the more than one million patients treated with radiation therapy each year,” Dr. Bruce G. Haffty, chair of ASTRO’s board of directors, said in a statement.

American College of Cardiology President Kim Allan Williams Sr., in a statement applauding the actions of the Senate, noted that the members “accomplished a major feat by passing legislation that ends a cycle of delays and patches in the law, which created uncertainty for Medicare patients and clinicians for more than an decade.”

The American College of Surgeons lauded the Senate action.

“The reforms set in place by Tuesday’s historic Senate passage of H.R. 2 offers peace of mind to America’s seniors, whose access to medical care through the Medicare program has been threatened for more than 10 years,” Dr. David B. Hoyt, executive director of the American College of Surgeons, said in a statement. “The College is committed to working with policymakers to further develop policies authorized in the legislation that stress quality of care for Medicare beneficiaries.”

The American Psychiatric Association praised the work of the Senate to pass the bill. “The Senate passage of the SGR reform bill is a major step toward a reliable and rational payment system for Medicare beneficiaries and their physicians,” APA President Paul Summergrad said in a statement. “It is long overdue.”

“It is time for a health care system in America that is focused on delivery of quality care, rather than quantity of care,” Dr. John C. Jennings, president of the American Congress of Obstetricians and Gynecologists, said in a statement. “By strengthening the ability of providers to focus on prevention, this bill will help to ensure that more Americans are able to stay healthy, avoiding serious illnesses and their related costs.”

The American College of Emergency Physicians called the move away from the SGR and toward a value-based system “essential to emergency departments. Elderly patients are more likely to need emergency care than any other age group, and the fastest growing segment of the U.S. population is people over 85 years of age. It represents a significant accomplishment for all the emergency physicians who actively made their voices heard in Congress.”

[email protected]

It’s value over volume for Medicare now that the Medicare Access and CHIP Reauthorization Act of 2015 is law.

“This shift in what the country faces in a disease burden really aligns and is helped and facilitated by this updating Medicare to this new disease environment,” Dr. James Madara, CEO of the American Medical Association, said April 15, the day after the Senate passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

“There are a lot of evolving issues to take care of in this migration toward models of payment delivery that work positively toward impacting quality of care,” Dr. Madara said. “Any time a complex bill as helpful as this one is passed, there are implementation problems that sometimes arise, so one of the areas that we will be strongly attentive to at the AMA is keeping our finger on the pulse of the implementation and working with the federal government to make sure that this tracks in a correct way.”

Courtesy whitehouse.gov

President Obama signed the bill into law on April 16.

The new law repeals the Medicare Sustainable Growth Rate formula, negating the 21% physician fee cut that was to go into effect April 1. In its place, the law provides a 0.5% pay increase yearly for 5 years as the Medicare program makes the transition away from fee-for-service and to value-based payment.

To help get to a point of value over volume, the bill consolidates existing quality programs – including those regarding the meaningful use of electronic health records – into a single value-based performance program.

“We studied that, along with some of the other physician organizations and our House of Delegates, and the conclusion was that this was not just an improvement, but a significant improvement, over the current set of measurements,” Dr. Madara said.

The new law also incentivizes physicians to use alternate payment models that focus on care coordination and preventive care with a 5% payment bonus. It pushes for more transparency of Medicare data for physicians, providers, and patients.

MACRA also includes funding to help smaller practices participate in alternative payment models or the streamlined quality measurement program, as well as funding to help in the development of quality measures.

“The provisions that allow for continued funding of the quality measurement enterprise in H.R. 2 are a key building block of this important transition and will also facilitate work to continue advancing measurement science,” the National Quality Forum said in a statement. “Ultimately, these efforts will not only help people get better healthcare, but also will reduce costs that strain patients, purchasers, and the system overall.”

Other important provisions in the new law include the reauthorization of several key programs. CHIP (the Children’s Health Insurance Program), the Community Health Center program, the National Health Service Corps, and the Teaching Health Centers program were all reauthorized for 2 years; they had been scheduled to expire later this year. Additionally, the law continues a partial delay of the Medicare two-midnights ruleuntil Sept. 30.

Physicians also cheered provisions of the new law that allay malpractice concerns. The law specifies that the development, recognition, or implementation of any federal health care guideline or standard does not establish a duty of care in medical malpractice claims.

The provision helps distinguish government quality guidelines and payment rules from medical liability standards, according to Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical malpractice liability insurers.

“None of these rules or guidelines were created with the intent to establish a legal standard for negligence, and so it makes sense for Congress to clarify that fact,” Mr. Atchinson said in an interview. “The standard of care provision in the SGR fix bill does just that, and nothing more. It does not shift the playing field to either plaintiffs or defendants. Instead, it ensures that these federal rules are not misused for purposes for which they were never intended.”

H.R. 2 ran into some trouble in the Senate because it does not have a dedicated funding mechanism to cover its full cost. The Congressional Budget Office estimated that enactment of the law will increase the deficit by $141 billion over 10 years. The CBO’s score also found that the legislation would save money, compared with the price of continued patches.

A total of $73 billion of the $214 billion cost of package is offset through spending reductions and revenue increases included in the bill, the CBO found. These include income-related premium adjustments for Medicare Parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital changes until 2018, and a 1% market basket update for postacute care providers.

Enactment of the law also looked a bit shaky when the Office of the Actuary for the Centers for Medicare & Medicaid Services released a report April 9 that suggested physicians would see future payment cuts under the law.

“Physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter,” according to the report. “Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2.”

However, the AMA’s Dr. Madara said that he was not concerned about the projections because the report assumes no changes in coming years. “One does not make linear trajectories over a periods of decades or more and assume that that’s where we are going to end up because that assumption is that nothing happens in the interim and, as we all know, that’s just simply not the way life works,” he said.

AMA President Robert Wah noted that the report “fails to take into account the long-range impact such a drastic payment cut [due to the SGR] would have on quality and access for Medicare beneficiaries, or the many options H.R. 2 will make available to physicians for avoiding onerous penalties under current law and the significant positive updates that high performers can earn.”

The American College of Physicians applauded the Senate action.

“We all witnessed something quite extraordinary and historic today when the Senate followed the House in passing comprehensive legislation to repeal Medicare’s Sustainable Growth Rate formula (H.R. 2) and transition us to a new value-based system,” ACP President David Flemming said in a statement.

American Society of Clinical Oncology President Peter Paul Yu said in a statement that “Medicare beneficiaries and their physicians can breathe easier knowing they will no longer face the perennial threat of payment cuts that risk disruption of care and cause anxiety among patients. ... [ASCO] looks forward to working with policymakers to ensure that this new law is effectively implemented and paves the way to new payment models that foster high-quality, value-based health care for all Americans with cancer.”

Similarly, the American Society for Radiation Oncology praised the effort. “Permanently repealing the SGR and replacing it with a stabilized reimbursement plan focused on quality will strengthen Medicare and allow us to enhance cancer care for the more than one million patients treated with radiation therapy each year,” Dr. Bruce G. Haffty, chair of ASTRO’s board of directors, said in a statement.

American College of Cardiology President Kim Allan Williams Sr., in a statement applauding the actions of the Senate, noted that the members “accomplished a major feat by passing legislation that ends a cycle of delays and patches in the law, which created uncertainty for Medicare patients and clinicians for more than an decade.”

The American College of Surgeons lauded the Senate action.

“The reforms set in place by Tuesday’s historic Senate passage of H.R. 2 offers peace of mind to America’s seniors, whose access to medical care through the Medicare program has been threatened for more than 10 years,” Dr. David B. Hoyt, executive director of the American College of Surgeons, said in a statement. “The College is committed to working with policymakers to further develop policies authorized in the legislation that stress quality of care for Medicare beneficiaries.”

The American Psychiatric Association praised the work of the Senate to pass the bill. “The Senate passage of the SGR reform bill is a major step toward a reliable and rational payment system for Medicare beneficiaries and their physicians,” APA President Paul Summergrad said in a statement. “It is long overdue.”

“It is time for a health care system in America that is focused on delivery of quality care, rather than quantity of care,” Dr. John C. Jennings, president of the American Congress of Obstetricians and Gynecologists, said in a statement. “By strengthening the ability of providers to focus on prevention, this bill will help to ensure that more Americans are able to stay healthy, avoiding serious illnesses and their related costs.”

The American College of Emergency Physicians called the move away from the SGR and toward a value-based system “essential to emergency departments. Elderly patients are more likely to need emergency care than any other age group, and the fastest growing segment of the U.S. population is people over 85 years of age. It represents a significant accomplishment for all the emergency physicians who actively made their voices heard in Congress.”

[email protected]

It’s value over volume for Medicare now that the Medicare Access and CHIP Reauthorization Act of 2015 is law.

“This shift in what the country faces in a disease burden really aligns and is helped and facilitated by this updating Medicare to this new disease environment,” Dr. James Madara, CEO of the American Medical Association, said April 15, the day after the Senate passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

“There are a lot of evolving issues to take care of in this migration toward models of payment delivery that work positively toward impacting quality of care,” Dr. Madara said. “Any time a complex bill as helpful as this one is passed, there are implementation problems that sometimes arise, so one of the areas that we will be strongly attentive to at the AMA is keeping our finger on the pulse of the implementation and working with the federal government to make sure that this tracks in a correct way.”

Courtesy whitehouse.gov

President Obama signed the bill into law on April 16.

The new law repeals the Medicare Sustainable Growth Rate formula, negating the 21% physician fee cut that was to go into effect April 1. In its place, the law provides a 0.5% pay increase yearly for 5 years as the Medicare program makes the transition away from fee-for-service and to value-based payment.

To help get to a point of value over volume, the bill consolidates existing quality programs – including those regarding the meaningful use of electronic health records – into a single value-based performance program.

“We studied that, along with some of the other physician organizations and our House of Delegates, and the conclusion was that this was not just an improvement, but a significant improvement, over the current set of measurements,” Dr. Madara said.

The new law also incentivizes physicians to use alternate payment models that focus on care coordination and preventive care with a 5% payment bonus. It pushes for more transparency of Medicare data for physicians, providers, and patients.

MACRA also includes funding to help smaller practices participate in alternative payment models or the streamlined quality measurement program, as well as funding to help in the development of quality measures.

“The provisions that allow for continued funding of the quality measurement enterprise in H.R. 2 are a key building block of this important transition and will also facilitate work to continue advancing measurement science,” the National Quality Forum said in a statement. “Ultimately, these efforts will not only help people get better healthcare, but also will reduce costs that strain patients, purchasers, and the system overall.”

Other important provisions in the new law include the reauthorization of several key programs. CHIP (the Children’s Health Insurance Program), the Community Health Center program, the National Health Service Corps, and the Teaching Health Centers program were all reauthorized for 2 years; they had been scheduled to expire later this year. Additionally, the law continues a partial delay of the Medicare two-midnights ruleuntil Sept. 30.

Physicians also cheered provisions of the new law that allay malpractice concerns. The law specifies that the development, recognition, or implementation of any federal health care guideline or standard does not establish a duty of care in medical malpractice claims.

The provision helps distinguish government quality guidelines and payment rules from medical liability standards, according to Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical malpractice liability insurers.

“None of these rules or guidelines were created with the intent to establish a legal standard for negligence, and so it makes sense for Congress to clarify that fact,” Mr. Atchinson said in an interview. “The standard of care provision in the SGR fix bill does just that, and nothing more. It does not shift the playing field to either plaintiffs or defendants. Instead, it ensures that these federal rules are not misused for purposes for which they were never intended.”

H.R. 2 ran into some trouble in the Senate because it does not have a dedicated funding mechanism to cover its full cost. The Congressional Budget Office estimated that enactment of the law will increase the deficit by $141 billion over 10 years. The CBO’s score also found that the legislation would save money, compared with the price of continued patches.

A total of $73 billion of the $214 billion cost of package is offset through spending reductions and revenue increases included in the bill, the CBO found. These include income-related premium adjustments for Medicare Parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital changes until 2018, and a 1% market basket update for postacute care providers.

Enactment of the law also looked a bit shaky when the Office of the Actuary for the Centers for Medicare & Medicaid Services released a report April 9 that suggested physicians would see future payment cuts under the law.

“Physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter,” according to the report. “Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2.”

However, the AMA’s Dr. Madara said that he was not concerned about the projections because the report assumes no changes in coming years. “One does not make linear trajectories over a periods of decades or more and assume that that’s where we are going to end up because that assumption is that nothing happens in the interim and, as we all know, that’s just simply not the way life works,” he said.

AMA President Robert Wah noted that the report “fails to take into account the long-range impact such a drastic payment cut [due to the SGR] would have on quality and access for Medicare beneficiaries, or the many options H.R. 2 will make available to physicians for avoiding onerous penalties under current law and the significant positive updates that high performers can earn.”

The American College of Physicians applauded the Senate action.

“We all witnessed something quite extraordinary and historic today when the Senate followed the House in passing comprehensive legislation to repeal Medicare’s Sustainable Growth Rate formula (H.R. 2) and transition us to a new value-based system,” ACP President David Flemming said in a statement.

American Society of Clinical Oncology President Peter Paul Yu said in a statement that “Medicare beneficiaries and their physicians can breathe easier knowing they will no longer face the perennial threat of payment cuts that risk disruption of care and cause anxiety among patients. ... [ASCO] looks forward to working with policymakers to ensure that this new law is effectively implemented and paves the way to new payment models that foster high-quality, value-based health care for all Americans with cancer.”

Similarly, the American Society for Radiation Oncology praised the effort. “Permanently repealing the SGR and replacing it with a stabilized reimbursement plan focused on quality will strengthen Medicare and allow us to enhance cancer care for the more than one million patients treated with radiation therapy each year,” Dr. Bruce G. Haffty, chair of ASTRO’s board of directors, said in a statement.

American College of Cardiology President Kim Allan Williams Sr., in a statement applauding the actions of the Senate, noted that the members “accomplished a major feat by passing legislation that ends a cycle of delays and patches in the law, which created uncertainty for Medicare patients and clinicians for more than an decade.”

The American College of Surgeons lauded the Senate action.

“The reforms set in place by Tuesday’s historic Senate passage of H.R. 2 offers peace of mind to America’s seniors, whose access to medical care through the Medicare program has been threatened for more than 10 years,” Dr. David B. Hoyt, executive director of the American College of Surgeons, said in a statement. “The College is committed to working with policymakers to further develop policies authorized in the legislation that stress quality of care for Medicare beneficiaries.”

The American Psychiatric Association praised the work of the Senate to pass the bill. “The Senate passage of the SGR reform bill is a major step toward a reliable and rational payment system for Medicare beneficiaries and their physicians,” APA President Paul Summergrad said in a statement. “It is long overdue.”

“It is time for a health care system in America that is focused on delivery of quality care, rather than quantity of care,” Dr. John C. Jennings, president of the American Congress of Obstetricians and Gynecologists, said in a statement. “By strengthening the ability of providers to focus on prevention, this bill will help to ensure that more Americans are able to stay healthy, avoiding serious illnesses and their related costs.”

The American College of Emergency Physicians called the move away from the SGR and toward a value-based system “essential to emergency departments. Elderly patients are more likely to need emergency care than any other age group, and the fastest growing segment of the U.S. population is people over 85 years of age. It represents a significant accomplishment for all the emergency physicians who actively made their voices heard in Congress.”

[email protected]

Almost half of those who commit suicide visit a primary care provider in the month prior to their death, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). But many health care providers are not trained to assess and manage potentially suicidal patients. SAMHSA aims to change that with a free mobile application, “Suicide Safe,” based on SAMHSA’s Suicide Assessment Five-Step Evaluation and Triage (SAFE-T). The app offers guidance on assessing the patient’s condition quickly and comprehensively. Users can get help with determining whether the patient is in crisis and how to decide what the best next steps are. Key features include SAMHSA’s Behavioral Health Treatment Services Locator, patient education materials, and conversation starters for talking with patients about suicidal ideation.

Related: The American Foundation for Suicide Prevention

The new app is apparently quickly filling a gap—it was reportedly downloaded 12,500 times in the first week after it was launched in early March. The app is proving popular because it was designed with busy primary practices in mind, keeping it as “seamless and efficient as possible,” according to Richard T. McKeon, PhD, MPH, chief of the Suicide Prevention Branch at SAMHSA.

Related: Helping Native Communities Strengthen Mental Health Programs

One group of practitioners in particular may welcome the app. Although the suicide rate in the U.S. is high (the second leading cause of preventable death among people aged 10-42 years), suicide is 1.6 times higher among American Indians and Alaska Natives than among all other U.S. populations.

“We are looking forward to the contributions this mobile app will provide to IHS, tribal, and urban Indian health programs,” said Robert G. McSwain, MPA, acting director of the IHS.

Related: SAMHSA Awards Funds for Tribal Youth Programs

One of the downloadable tribal publications accessible through the app is To Live to See the Great Day That Dawns: Preventing Suicide by American Indian and Alaska Native Youth and Young Adults. This guide offers comprehensive suicide prevention planning and addresses what to do in the event of a suicide to help heal and prevent related suicidal behaviors.

The app can be downloaded on Apple and Android mobile devices by clicking here.

Almost half of those who commit suicide visit a primary care provider in the month prior to their death, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). But many health care providers are not trained to assess and manage potentially suicidal patients. SAMHSA aims to change that with a free mobile application, “Suicide Safe,” based on SAMHSA’s Suicide Assessment Five-Step Evaluation and Triage (SAFE-T). The app offers guidance on assessing the patient’s condition quickly and comprehensively. Users can get help with determining whether the patient is in crisis and how to decide what the best next steps are. Key features include SAMHSA’s Behavioral Health Treatment Services Locator, patient education materials, and conversation starters for talking with patients about suicidal ideation.

Related: The American Foundation for Suicide Prevention

The new app is apparently quickly filling a gap—it was reportedly downloaded 12,500 times in the first week after it was launched in early March. The app is proving popular because it was designed with busy primary practices in mind, keeping it as “seamless and efficient as possible,” according to Richard T. McKeon, PhD, MPH, chief of the Suicide Prevention Branch at SAMHSA.

Related: Helping Native Communities Strengthen Mental Health Programs

One group of practitioners in particular may welcome the app. Although the suicide rate in the U.S. is high (the second leading cause of preventable death among people aged 10-42 years), suicide is 1.6 times higher among American Indians and Alaska Natives than among all other U.S. populations.

“We are looking forward to the contributions this mobile app will provide to IHS, tribal, and urban Indian health programs,” said Robert G. McSwain, MPA, acting director of the IHS.

Related: SAMHSA Awards Funds for Tribal Youth Programs

One of the downloadable tribal publications accessible through the app is To Live to See the Great Day That Dawns: Preventing Suicide by American Indian and Alaska Native Youth and Young Adults. This guide offers comprehensive suicide prevention planning and addresses what to do in the event of a suicide to help heal and prevent related suicidal behaviors.

The app can be downloaded on Apple and Android mobile devices by clicking here.

Almost half of those who commit suicide visit a primary care provider in the month prior to their death, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). But many health care providers are not trained to assess and manage potentially suicidal patients. SAMHSA aims to change that with a free mobile application, “Suicide Safe,” based on SAMHSA’s Suicide Assessment Five-Step Evaluation and Triage (SAFE-T). The app offers guidance on assessing the patient’s condition quickly and comprehensively. Users can get help with determining whether the patient is in crisis and how to decide what the best next steps are. Key features include SAMHSA’s Behavioral Health Treatment Services Locator, patient education materials, and conversation starters for talking with patients about suicidal ideation.

Related: The American Foundation for Suicide Prevention

The new app is apparently quickly filling a gap—it was reportedly downloaded 12,500 times in the first week after it was launched in early March. The app is proving popular because it was designed with busy primary practices in mind, keeping it as “seamless and efficient as possible,” according to Richard T. McKeon, PhD, MPH, chief of the Suicide Prevention Branch at SAMHSA.

Related: Helping Native Communities Strengthen Mental Health Programs

One group of practitioners in particular may welcome the app. Although the suicide rate in the U.S. is high (the second leading cause of preventable death among people aged 10-42 years), suicide is 1.6 times higher among American Indians and Alaska Natives than among all other U.S. populations.

“We are looking forward to the contributions this mobile app will provide to IHS, tribal, and urban Indian health programs,” said Robert G. McSwain, MPA, acting director of the IHS.

Related: SAMHSA Awards Funds for Tribal Youth Programs

One of the downloadable tribal publications accessible through the app is To Live to See the Great Day That Dawns: Preventing Suicide by American Indian and Alaska Native Youth and Young Adults. This guide offers comprehensive suicide prevention planning and addresses what to do in the event of a suicide to help heal and prevent related suicidal behaviors.

The app can be downloaded on Apple and Android mobile devices by clicking here.