Government and Regulations

SVS staff worked with a group of surgical society representatives to try to rescind the elimination of the Global Surgical Packages as part of the Omnibus bill that funds the government for 2015. This elimination was included in both the Calendar Year 2015 Proposed and Final Medicare Physician Fee Schedule Rules. There was much support for rescinding this in Congress until the Congressional Budget Office estimated it would cost $700 million over 10 years.

However, appropriations bills can have report language on issues that were not included in the legislation or further explain them, so the following was included by Rep. Harris, MD (R-MD): “The agreement is concerned that CMS has not provided opportunity for public comment on changes to surgical procedures described in the annual Medicare Physician Fee Schedule (MPFS) final rules, and is concerned appropriate methodology has not been tested to ensure no negative impact on patient care, patient access, and undue administrative burdens are not placed on providers and CMS. The agreement believes additional consideration should be given to these changes prior to implementation of changes outlined in the MPFS.”

The elimination of 10-day globals would begin in 2017 and the elimination of the 90-day globals, which have a major impact on vascular surgery, would begin in 2018.

SVS is already working with the new Congress to gain support for rescinding the elimination of the Global Surgical Packages in 2015 as part of Medicare legislation.

Read our letter to Congress: 
http://vsweb.org/Sign-onLetter.

SVS staff worked with a group of surgical society representatives to try to rescind the elimination of the Global Surgical Packages as part of the Omnibus bill that funds the government for 2015. This elimination was included in both the Calendar Year 2015 Proposed and Final Medicare Physician Fee Schedule Rules. There was much support for rescinding this in Congress until the Congressional Budget Office estimated it would cost $700 million over 10 years.

However, appropriations bills can have report language on issues that were not included in the legislation or further explain them, so the following was included by Rep. Harris, MD (R-MD): “The agreement is concerned that CMS has not provided opportunity for public comment on changes to surgical procedures described in the annual Medicare Physician Fee Schedule (MPFS) final rules, and is concerned appropriate methodology has not been tested to ensure no negative impact on patient care, patient access, and undue administrative burdens are not placed on providers and CMS. The agreement believes additional consideration should be given to these changes prior to implementation of changes outlined in the MPFS.”

The elimination of 10-day globals would begin in 2017 and the elimination of the 90-day globals, which have a major impact on vascular surgery, would begin in 2018.

SVS is already working with the new Congress to gain support for rescinding the elimination of the Global Surgical Packages in 2015 as part of Medicare legislation.

Read our letter to Congress: 
http://vsweb.org/Sign-onLetter.

SVS staff worked with a group of surgical society representatives to try to rescind the elimination of the Global Surgical Packages as part of the Omnibus bill that funds the government for 2015. This elimination was included in both the Calendar Year 2015 Proposed and Final Medicare Physician Fee Schedule Rules. There was much support for rescinding this in Congress until the Congressional Budget Office estimated it would cost $700 million over 10 years.

However, appropriations bills can have report language on issues that were not included in the legislation or further explain them, so the following was included by Rep. Harris, MD (R-MD): “The agreement is concerned that CMS has not provided opportunity for public comment on changes to surgical procedures described in the annual Medicare Physician Fee Schedule (MPFS) final rules, and is concerned appropriate methodology has not been tested to ensure no negative impact on patient care, patient access, and undue administrative burdens are not placed on providers and CMS. The agreement believes additional consideration should be given to these changes prior to implementation of changes outlined in the MPFS.”

The elimination of 10-day globals would begin in 2017 and the elimination of the 90-day globals, which have a major impact on vascular surgery, would begin in 2018.

SVS is already working with the new Congress to gain support for rescinding the elimination of the Global Surgical Packages in 2015 as part of Medicare legislation.

Read our letter to Congress: 
http://vsweb.org/Sign-onLetter.

Pressure is mounting for the federal legalization of medical marijuana. As the list of states that have legalized recreational and medical marijuana continues to grow, increasing scientific evidence points to the potential efficacy of marijuana for some medical conditions and associated symptoms. Furthermore, late last year, Congress stopped the Justice Department from prosecuting medical marijuana cases in the states where it is legal.

Federal practitioners—especially those who practice in states where medical marijuana is legal—face challenging ethical and legal dilemmas when it comes to marijuana use. Little more than a month after his confirmation, Surgeon General VADM Vivek H. Murthy, MD, MBA, is already making waves on this controversial topic.

“We have some preliminary data showing that for some medical conditions and symptoms that marijuana can be helpful,” Surgeon General Murthy said in a February 4, 2015, interview with CBS. “I think we need to use that data to drive policymaking, and I’m very interested to see where that data takes us.”

Related: Legal and Clinical Evolution of Veterans Health Administration Policy on Medical Marijuana

The data from experiments in states where marijuana is legal could force the U.S. federal government to rethink the current Schedule I classification, which defines marijuana as a substance with no recognized medical use but a high risk of dependency and, thus, illegal to use and distribute.

Pressure is mounting for the federal legalization of medical marijuana. As the list of states that have legalized recreational and medical marijuana continues to grow, increasing scientific evidence points to the potential efficacy of marijuana for some medical conditions and associated symptoms. Furthermore, late last year, Congress stopped the Justice Department from prosecuting medical marijuana cases in the states where it is legal.

Federal practitioners—especially those who practice in states where medical marijuana is legal—face challenging ethical and legal dilemmas when it comes to marijuana use. Little more than a month after his confirmation, Surgeon General VADM Vivek H. Murthy, MD, MBA, is already making waves on this controversial topic.

“We have some preliminary data showing that for some medical conditions and symptoms that marijuana can be helpful,” Surgeon General Murthy said in a February 4, 2015, interview with CBS. “I think we need to use that data to drive policymaking, and I’m very interested to see where that data takes us.”

Related: Legal and Clinical Evolution of Veterans Health Administration Policy on Medical Marijuana

The data from experiments in states where marijuana is legal could force the U.S. federal government to rethink the current Schedule I classification, which defines marijuana as a substance with no recognized medical use but a high risk of dependency and, thus, illegal to use and distribute.

Pressure is mounting for the federal legalization of medical marijuana. As the list of states that have legalized recreational and medical marijuana continues to grow, increasing scientific evidence points to the potential efficacy of marijuana for some medical conditions and associated symptoms. Furthermore, late last year, Congress stopped the Justice Department from prosecuting medical marijuana cases in the states where it is legal.

Federal practitioners—especially those who practice in states where medical marijuana is legal—face challenging ethical and legal dilemmas when it comes to marijuana use. Little more than a month after his confirmation, Surgeon General VADM Vivek H. Murthy, MD, MBA, is already making waves on this controversial topic.

“We have some preliminary data showing that for some medical conditions and symptoms that marijuana can be helpful,” Surgeon General Murthy said in a February 4, 2015, interview with CBS. “I think we need to use that data to drive policymaking, and I’m very interested to see where that data takes us.”

Related: Legal and Clinical Evolution of Veterans Health Administration Policy on Medical Marijuana

The data from experiments in states where marijuana is legal could force the U.S. federal government to rethink the current Schedule I classification, which defines marijuana as a substance with no recognized medical use but a high risk of dependency and, thus, illegal to use and distribute.

President Obama has proposed a nearly $169 billion budget for the Department of Veterans Affairs in 2016 but also includes a plan to reallocate some funding from the Veterans Access, Choice, and Accountability Act (VACAA). The VACAA was passed in 2014 and allows veterans to seek care outside of the VA system.

The $168.8 billion—an increase of $5.2 billion and 7.5% over the 2015 budget—will be distributed throughout the VA, but the plan to reallocate funds from the VACAA has drawn some criticism. Rep. Jeff Miller who heads the House Veterans Affairs Committee released a statement on February 2 that said reallocating funds from the VACAA was "a complete non-starter" and that he would not support that portion of the budget proposal.

"When a near-unanimous Congress worked with President Obama last year to create the choice program, we made a promise to veterans to give them more freedom in their health care decisions," Miller said. "I will not stand idly by while the president attempts to renege on that promise."

Fifty six percent ($95.3 billion) of the budget will be mandatory spending including disability compensation and pensions. The remaining 43.5% ($73.5 billion) will be directed toward discretionary spending, largely for health care.

Related: Making an Impact: Congressionally Directed Medical Research Programs Complement Other Sources of Biomedical Funding

Eighty seven percent ($63.2 billion) of discretionary spending will be directed toward medical programs including:

• $7.5 billion for mental health
• $7.5 billion for long-term care
• $2.8 billion for prosthetics
• $556 million for spinal cord injuries
• $243 million for readjustment counseling
• $232 million for traumatic brain injuries

Discretionary spending will also focus on improving access to care by providing funding to the following programs:

• $1.2 billion in telehealth funding
• $446 million for health care services specifically designed for women
• $598 million for the activation of new and enhanced health care facilities

"VA has before it one of the greatest opportunities in its history to enhance care for veterans and build a more efficient and effective system," Secretary of Veterans Affairs Robert A. McDonald said in a VA press release. "This budget will allow us to continue important progress to better serve Veterans, their families and their survivors."

Related: Carolyn Clancy on Improving Veterans' Access to Care

Of the remaining 13% allocated for discretionary spending, $5.9 million will fund 2 new national cemeteries and $1.1 billion will fund major construction projects.

Facilities in St. Louis, Missouri; Louisville, Kentucky; American Lake, Washington; Perry Point, Maryland; Puerto Rico; Portland, Oregon; Pensacola, Florida; and 6 facilities in California will be undergoing construction if the budget passes.

The new budget also calls for advance appropriations of $63.3 billion for the agency in 2017.

President Obama has proposed a nearly $169 billion budget for the Department of Veterans Affairs in 2016 but also includes a plan to reallocate some funding from the Veterans Access, Choice, and Accountability Act (VACAA). The VACAA was passed in 2014 and allows veterans to seek care outside of the VA system.

The $168.8 billion—an increase of $5.2 billion and 7.5% over the 2015 budget—will be distributed throughout the VA, but the plan to reallocate funds from the VACAA has drawn some criticism. Rep. Jeff Miller who heads the House Veterans Affairs Committee released a statement on February 2 that said reallocating funds from the VACAA was "a complete non-starter" and that he would not support that portion of the budget proposal.

"When a near-unanimous Congress worked with President Obama last year to create the choice program, we made a promise to veterans to give them more freedom in their health care decisions," Miller said. "I will not stand idly by while the president attempts to renege on that promise."

Fifty six percent ($95.3 billion) of the budget will be mandatory spending including disability compensation and pensions. The remaining 43.5% ($73.5 billion) will be directed toward discretionary spending, largely for health care.

Related: Making an Impact: Congressionally Directed Medical Research Programs Complement Other Sources of Biomedical Funding

Eighty seven percent ($63.2 billion) of discretionary spending will be directed toward medical programs including:

• $7.5 billion for mental health
• $7.5 billion for long-term care
• $2.8 billion for prosthetics
• $556 million for spinal cord injuries
• $243 million for readjustment counseling
• $232 million for traumatic brain injuries

Discretionary spending will also focus on improving access to care by providing funding to the following programs:

• $1.2 billion in telehealth funding
• $446 million for health care services specifically designed for women
• $598 million for the activation of new and enhanced health care facilities

"VA has before it one of the greatest opportunities in its history to enhance care for veterans and build a more efficient and effective system," Secretary of Veterans Affairs Robert A. McDonald said in a VA press release. "This budget will allow us to continue important progress to better serve Veterans, their families and their survivors."

Related: Carolyn Clancy on Improving Veterans' Access to Care

Of the remaining 13% allocated for discretionary spending, $5.9 million will fund 2 new national cemeteries and $1.1 billion will fund major construction projects.

Facilities in St. Louis, Missouri; Louisville, Kentucky; American Lake, Washington; Perry Point, Maryland; Puerto Rico; Portland, Oregon; Pensacola, Florida; and 6 facilities in California will be undergoing construction if the budget passes.

The new budget also calls for advance appropriations of $63.3 billion for the agency in 2017.

President Obama has proposed a nearly $169 billion budget for the Department of Veterans Affairs in 2016 but also includes a plan to reallocate some funding from the Veterans Access, Choice, and Accountability Act (VACAA). The VACAA was passed in 2014 and allows veterans to seek care outside of the VA system.

The $168.8 billion—an increase of $5.2 billion and 7.5% over the 2015 budget—will be distributed throughout the VA, but the plan to reallocate funds from the VACAA has drawn some criticism. Rep. Jeff Miller who heads the House Veterans Affairs Committee released a statement on February 2 that said reallocating funds from the VACAA was "a complete non-starter" and that he would not support that portion of the budget proposal.

"When a near-unanimous Congress worked with President Obama last year to create the choice program, we made a promise to veterans to give them more freedom in their health care decisions," Miller said. "I will not stand idly by while the president attempts to renege on that promise."

Fifty six percent ($95.3 billion) of the budget will be mandatory spending including disability compensation and pensions. The remaining 43.5% ($73.5 billion) will be directed toward discretionary spending, largely for health care.

Related: Making an Impact: Congressionally Directed Medical Research Programs Complement Other Sources of Biomedical Funding

Eighty seven percent ($63.2 billion) of discretionary spending will be directed toward medical programs including:

• $7.5 billion for mental health
• $7.5 billion for long-term care
• $2.8 billion for prosthetics
• $556 million for spinal cord injuries
• $243 million for readjustment counseling
• $232 million for traumatic brain injuries

Discretionary spending will also focus on improving access to care by providing funding to the following programs:

• $1.2 billion in telehealth funding
• $446 million for health care services specifically designed for women
• $598 million for the activation of new and enhanced health care facilities

"VA has before it one of the greatest opportunities in its history to enhance care for veterans and build a more efficient and effective system," Secretary of Veterans Affairs Robert A. McDonald said in a VA press release. "This budget will allow us to continue important progress to better serve Veterans, their families and their survivors."

Related: Carolyn Clancy on Improving Veterans' Access to Care

Of the remaining 13% allocated for discretionary spending, $5.9 million will fund 2 new national cemeteries and $1.1 billion will fund major construction projects.

Facilities in St. Louis, Missouri; Louisville, Kentucky; American Lake, Washington; Perry Point, Maryland; Puerto Rico; Portland, Oregon; Pensacola, Florida; and 6 facilities in California will be undergoing construction if the budget passes.

The new budget also calls for advance appropriations of $63.3 billion for the agency in 2017.

Los Angeles is home to the largest population of homeless veterans with disabilities, where men, women, and children sleep wherever they can: emergency shelters, transitional housing, hospitals, cars, abandoned buildings, and other outdoor public places. Some require only temporary housing from a few weeks to a few months while they get back on their feet. Others don’t know where to turn for assistance, and some are too ill to know they can ask for help.

The settlement ended a suit accusing the VA of illegally leasing land on the sprawling campus to businesses such as UCLA, a television studio, a hotel laundry, and a parking service.

Related: Impact of Outreach and Housing Strategies on Homeless

The plan will focus on serving all veterans: particularly women veterans and those who are homeless, aging, or severely disabled. Secretary McDonald will appoint a special assistant with the necessary resources and support to oversee the plan’s implementation. 

“This agreement offers VA a historic opportunity to build new community relationships in Los Angeles and continue the work needed to end veteran homelessness here,” said Secretary McDonald. “VA is proud of the progress we’ve made in ending veteran homelessness—down 33% since 2010—but we won’t be satisfied until every veteran has a home.”

Related: Number of Homeless Veterans Still Dropping

Under the agreement, Secretary McDonald will also launch an accelerated process to develop a new long-term master plan for the future use of the West Los Angeles campus. This master plan, targeted for completion by October 16, 2015, will prioritize the provision of bridge housing and permanent supportive housing. It will also describe an exit strategy for the third-party land use agreements that do not comply with applicable laws or fit within the master plan.

But Secretary McDonald doesn’t just talk the talk. Also last week, he and a group of volunteers participated in the annual PIT (point-in-time) count in the Skid Row section of Los Angeles’s downtown.

“One of the things you learn in the Army is you never leave a buddy behind,” Secretary McDonald said to more than 100 volunteers at the LA Mission. “Unfortunately, we’ve left some people behind, and they’re our homeless veterans.”

Veterans comprise a large percentage of the overall U.S. homeless population. This past fall, Federal Practitioner published a research article on the integration of Homeless Patient Aligned Care Team (H-PACT) clinics at 3 VAMCs across the U.S., one of which was the West Los Angeles VAMC. This research team tailored services to homeless veterans’ needs by co-locating H-PACT care where it was needed most. For the West Los Angeles VAMC, this meant the emergency department.

Related: Using H-PACT to Overcome Treatment Obstacles for Homeless Veterans

The researchers also determined processes to identify and refer appropriate homeless veterans to H-PACT and noted methods of integrating distinct services, such as primary care, mental health, and addiction services, into the H-PACT model. What was evident from the research was that each of the 3 models examined were created equal but distinct from one another, due to their unique patient populations.

“When we end veteran homelessness in Los Angeles,” Secretary McDonald said, “we effectively end veterans homelessness throughout the country.”

For more insight into the special needs facing the homeless veteran population in Los Angeles, listen to Sonya Gabrielian’s exclusive audiocast, “Mutual Reinforcement of Mental Illness and Homelessness.”

Los Angeles is home to the largest population of homeless veterans with disabilities, where men, women, and children sleep wherever they can: emergency shelters, transitional housing, hospitals, cars, abandoned buildings, and other outdoor public places. Some require only temporary housing from a few weeks to a few months while they get back on their feet. Others don’t know where to turn for assistance, and some are too ill to know they can ask for help.

The settlement ended a suit accusing the VA of illegally leasing land on the sprawling campus to businesses such as UCLA, a television studio, a hotel laundry, and a parking service.

Related: Impact of Outreach and Housing Strategies on Homeless

The plan will focus on serving all veterans: particularly women veterans and those who are homeless, aging, or severely disabled. Secretary McDonald will appoint a special assistant with the necessary resources and support to oversee the plan’s implementation. 

“This agreement offers VA a historic opportunity to build new community relationships in Los Angeles and continue the work needed to end veteran homelessness here,” said Secretary McDonald. “VA is proud of the progress we’ve made in ending veteran homelessness—down 33% since 2010—but we won’t be satisfied until every veteran has a home.”

Related: Number of Homeless Veterans Still Dropping

Under the agreement, Secretary McDonald will also launch an accelerated process to develop a new long-term master plan for the future use of the West Los Angeles campus. This master plan, targeted for completion by October 16, 2015, will prioritize the provision of bridge housing and permanent supportive housing. It will also describe an exit strategy for the third-party land use agreements that do not comply with applicable laws or fit within the master plan.

But Secretary McDonald doesn’t just talk the talk. Also last week, he and a group of volunteers participated in the annual PIT (point-in-time) count in the Skid Row section of Los Angeles’s downtown.

“One of the things you learn in the Army is you never leave a buddy behind,” Secretary McDonald said to more than 100 volunteers at the LA Mission. “Unfortunately, we’ve left some people behind, and they’re our homeless veterans.”

Veterans comprise a large percentage of the overall U.S. homeless population. This past fall, Federal Practitioner published a research article on the integration of Homeless Patient Aligned Care Team (H-PACT) clinics at 3 VAMCs across the U.S., one of which was the West Los Angeles VAMC. This research team tailored services to homeless veterans’ needs by co-locating H-PACT care where it was needed most. For the West Los Angeles VAMC, this meant the emergency department.

Related: Using H-PACT to Overcome Treatment Obstacles for Homeless Veterans

The researchers also determined processes to identify and refer appropriate homeless veterans to H-PACT and noted methods of integrating distinct services, such as primary care, mental health, and addiction services, into the H-PACT model. What was evident from the research was that each of the 3 models examined were created equal but distinct from one another, due to their unique patient populations.

“When we end veteran homelessness in Los Angeles,” Secretary McDonald said, “we effectively end veterans homelessness throughout the country.”

For more insight into the special needs facing the homeless veteran population in Los Angeles, listen to Sonya Gabrielian’s exclusive audiocast, “Mutual Reinforcement of Mental Illness and Homelessness.”

Los Angeles is home to the largest population of homeless veterans with disabilities, where men, women, and children sleep wherever they can: emergency shelters, transitional housing, hospitals, cars, abandoned buildings, and other outdoor public places. Some require only temporary housing from a few weeks to a few months while they get back on their feet. Others don’t know where to turn for assistance, and some are too ill to know they can ask for help.

The settlement ended a suit accusing the VA of illegally leasing land on the sprawling campus to businesses such as UCLA, a television studio, a hotel laundry, and a parking service.

Related: Impact of Outreach and Housing Strategies on Homeless

The plan will focus on serving all veterans: particularly women veterans and those who are homeless, aging, or severely disabled. Secretary McDonald will appoint a special assistant with the necessary resources and support to oversee the plan’s implementation. 

“This agreement offers VA a historic opportunity to build new community relationships in Los Angeles and continue the work needed to end veteran homelessness here,” said Secretary McDonald. “VA is proud of the progress we’ve made in ending veteran homelessness—down 33% since 2010—but we won’t be satisfied until every veteran has a home.”

Related: Number of Homeless Veterans Still Dropping

Under the agreement, Secretary McDonald will also launch an accelerated process to develop a new long-term master plan for the future use of the West Los Angeles campus. This master plan, targeted for completion by October 16, 2015, will prioritize the provision of bridge housing and permanent supportive housing. It will also describe an exit strategy for the third-party land use agreements that do not comply with applicable laws or fit within the master plan.

But Secretary McDonald doesn’t just talk the talk. Also last week, he and a group of volunteers participated in the annual PIT (point-in-time) count in the Skid Row section of Los Angeles’s downtown.

“One of the things you learn in the Army is you never leave a buddy behind,” Secretary McDonald said to more than 100 volunteers at the LA Mission. “Unfortunately, we’ve left some people behind, and they’re our homeless veterans.”

Veterans comprise a large percentage of the overall U.S. homeless population. This past fall, Federal Practitioner published a research article on the integration of Homeless Patient Aligned Care Team (H-PACT) clinics at 3 VAMCs across the U.S., one of which was the West Los Angeles VAMC. This research team tailored services to homeless veterans’ needs by co-locating H-PACT care where it was needed most. For the West Los Angeles VAMC, this meant the emergency department.

Related: Using H-PACT to Overcome Treatment Obstacles for Homeless Veterans

The researchers also determined processes to identify and refer appropriate homeless veterans to H-PACT and noted methods of integrating distinct services, such as primary care, mental health, and addiction services, into the H-PACT model. What was evident from the research was that each of the 3 models examined were created equal but distinct from one another, due to their unique patient populations.

“When we end veteran homelessness in Los Angeles,” Secretary McDonald said, “we effectively end veterans homelessness throughout the country.”

For more insight into the special needs facing the homeless veteran population in Los Angeles, listen to Sonya Gabrielian’s exclusive audiocast, “Mutual Reinforcement of Mental Illness and Homelessness.”

Hospitals participating in a monitoring and feedback program for surgical quality showed no more improvement in patient mortality, serious complications, reoperation, or readmission than hospitals not participating in the program, according to two separate reports published online Feb. 3 in JAMA.

Both research groups concluded that feedback on outcomes alone may not be sufficient to improve surgical outcomes.

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) is an extensive clinical registry that provides participating hospitals with detailed descriptions of outcomes such as mortality, length of stay, and complications, allowing them to benchmark their performance relative to other participating hospitals and focus their efforts to improve care on the areas in which they perform poorly. The information is not reported publicly. Proponents contend that this targeting has already improved surgical outcomes as reported in several single-center studies, but others argue that any improvements noted so far might have occurred over time anyway.

©Daniel Mirer/thinkstockphotos.com

The best way to examine the question would be to compare outcomes between participating and nonparticipating hospitals, according to the two groups of investigators who did just that in these studies. However, the American College of Surgeons took issue with both study designs and released a statement taking exception to their approach to measuring surgical complications.

In the first study, researchers analyzed 30-day outcomes during a 10-year period at 263 hospitals participating in the ACS NSQIP and 526 nonparticipating propensity-matched hospitals across the United States. They focused on patients aged 65-99 years undergoing 11 high-risk general or vascular surgical procedures that are most in need of quality improvement: esophagectomy, pancreatic resection, colon resection, gastrectomy, liver resection, ventral hernia repair, cholecystectomy, appendectomy, abdominal aortic aneurysm repair, lower-extremity bypass, and carotid endarterectomy, said Dr. Nicholas H. Osborne of the Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, and a vascular surgeon at the university and his associates.

They found “slight trends toward improved outcomes” in NSQIP hospitals over time, but control hospitals showed the same trends. For example, 30-day mortality declined from 4.6% to 4.2% in participating hospitals during the study period, and similarly declined from 4.9% to 4.6% in nonparticipating hospitals. However, further analysis showed no statistically significant reductions after enrollment in the NSQIP in 30-day mortality, serious complications, reoperations, or readmissions, Dr. Osborne and his associates said (JAMA 2015 Feb. 3 [doi:10.1001/jama.2015.25]).

The underlying reasons for a lack of improvement among participating hospitals aren’t yet known, but it is possible that hospitals never implemented quality improvement efforts after being informed of their shortcomings, or that they implemented ineffective remedies. “Clinical quality improvement is challenging for hospitals. Changing physician practice requires complex, sustained, multifaceted interventions, and most hospitals may not have the expertise or resources to launch effective quality improvement interventions,” Dr. Osborne and his associates added.

In the second study, researchers analyzed surgical outcomes over a 4-year period among 113 academic hospitals in a health care system database; 39% of these hospitals participated in the NSQIP, receiving feedback on their performance, and the remaining 61% did not. This study evaluated 345,357 hospitalizations for 16 elective general and vascular surgeries, including many of the procedures covered in Dr. Osborne’s study plus mastectomy, thyroid procedures, open or laparoscopic colectomy, prostatectomy, and bariatric procedures, said Dr. David A. Etzioni, a surgeon at Mayo Clinic Arizona, Phoenix, and of the Kern Center for the Science of Health Care Delivery, and his associates.

This study also showed a slight decrease over time in postoperative complications, serious complications, and mortality at both NSQIP and non-NSQIP hospitals. “After accounting for patient risk, procedure type, underlying hospital performance, and temporal trends, the [statistical] model demonstrated no significant differences over time between NSQIP and non-NSQIP hospitals in terms of likelihood of complications, serious complications, or mortality,” Dr. Etzioni and his associates said (JAMA 2015 Feb. 3 [doi:10.1001/jama.2015.90]).

Their findings indicate that quality reports do not necessarily translate into evidence-based strategies for quality improvement and “suggest that a surgical outcomes reporting system does not provide a clear mechanism for quality improvement,” they noted.

In response to these reports, the American College of Surgeons released a statement emphasizing that claims data such as those used by both Osborne et al. and Etzioni et al. “are inaccurate and inappropriate for measuring surgical complications.” Furthermore, Dr. Clifford Ko, ACS director of the division of research and optimal patient care, called it “irresponsible to use data that are known to be an inaccurate measure of quality to determine the effectiveness of a quality improvement program.”

In addition, real-world experience shows that hospitals tend to focus on specific complications one at a time (such as surgical site infections) rather than amalgamating all complications. Hospitals also tend to address performance by separate specialties (such as urology) rather than on particular procedures (such as prostatectomy), according to the ACS statement.

Dr. Osborne’s study was supported in part by the National Institute on Aging. Dr. Osborne reported having no financial disclosures; one of his associates reported ties to Arbor Metrix. Dr. Etzioni’s study did not list any sources of financial support. Dr. Etzioni and his associates reported having no financial disclosures.

Hospitals participating in a monitoring and feedback program for surgical quality showed no more improvement in patient mortality, serious complications, reoperation, or readmission than hospitals not participating in the program, according to two separate reports published online Feb. 3 in JAMA.

Both research groups concluded that feedback on outcomes alone may not be sufficient to improve surgical outcomes.

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) is an extensive clinical registry that provides participating hospitals with detailed descriptions of outcomes such as mortality, length of stay, and complications, allowing them to benchmark their performance relative to other participating hospitals and focus their efforts to improve care on the areas in which they perform poorly. The information is not reported publicly. Proponents contend that this targeting has already improved surgical outcomes as reported in several single-center studies, but others argue that any improvements noted so far might have occurred over time anyway.

©Daniel Mirer/thinkstockphotos.com

The best way to examine the question would be to compare outcomes between participating and nonparticipating hospitals, according to the two groups of investigators who did just that in these studies. However, the American College of Surgeons took issue with both study designs and released a statement taking exception to their approach to measuring surgical complications.

In the first study, researchers analyzed 30-day outcomes during a 10-year period at 263 hospitals participating in the ACS NSQIP and 526 nonparticipating propensity-matched hospitals across the United States. They focused on patients aged 65-99 years undergoing 11 high-risk general or vascular surgical procedures that are most in need of quality improvement: esophagectomy, pancreatic resection, colon resection, gastrectomy, liver resection, ventral hernia repair, cholecystectomy, appendectomy, abdominal aortic aneurysm repair, lower-extremity bypass, and carotid endarterectomy, said Dr. Nicholas H. Osborne of the Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, and a vascular surgeon at the university and his associates.

They found “slight trends toward improved outcomes” in NSQIP hospitals over time, but control hospitals showed the same trends. For example, 30-day mortality declined from 4.6% to 4.2% in participating hospitals during the study period, and similarly declined from 4.9% to 4.6% in nonparticipating hospitals. However, further analysis showed no statistically significant reductions after enrollment in the NSQIP in 30-day mortality, serious complications, reoperations, or readmissions, Dr. Osborne and his associates said (JAMA 2015 Feb. 3 [doi:10.1001/jama.2015.25]).

The underlying reasons for a lack of improvement among participating hospitals aren’t yet known, but it is possible that hospitals never implemented quality improvement efforts after being informed of their shortcomings, or that they implemented ineffective remedies. “Clinical quality improvement is challenging for hospitals. Changing physician practice requires complex, sustained, multifaceted interventions, and most hospitals may not have the expertise or resources to launch effective quality improvement interventions,” Dr. Osborne and his associates added.

In the second study, researchers analyzed surgical outcomes over a 4-year period among 113 academic hospitals in a health care system database; 39% of these hospitals participated in the NSQIP, receiving feedback on their performance, and the remaining 61% did not. This study evaluated 345,357 hospitalizations for 16 elective general and vascular surgeries, including many of the procedures covered in Dr. Osborne’s study plus mastectomy, thyroid procedures, open or laparoscopic colectomy, prostatectomy, and bariatric procedures, said Dr. David A. Etzioni, a surgeon at Mayo Clinic Arizona, Phoenix, and of the Kern Center for the Science of Health Care Delivery, and his associates.

This study also showed a slight decrease over time in postoperative complications, serious complications, and mortality at both NSQIP and non-NSQIP hospitals. “After accounting for patient risk, procedure type, underlying hospital performance, and temporal trends, the [statistical] model demonstrated no significant differences over time between NSQIP and non-NSQIP hospitals in terms of likelihood of complications, serious complications, or mortality,” Dr. Etzioni and his associates said (JAMA 2015 Feb. 3 [doi:10.1001/jama.2015.90]).

Their findings indicate that quality reports do not necessarily translate into evidence-based strategies for quality improvement and “suggest that a surgical outcomes reporting system does not provide a clear mechanism for quality improvement,” they noted.

In response to these reports, the American College of Surgeons released a statement emphasizing that claims data such as those used by both Osborne et al. and Etzioni et al. “are inaccurate and inappropriate for measuring surgical complications.” Furthermore, Dr. Clifford Ko, ACS director of the division of research and optimal patient care, called it “irresponsible to use data that are known to be an inaccurate measure of quality to determine the effectiveness of a quality improvement program.”

In addition, real-world experience shows that hospitals tend to focus on specific complications one at a time (such as surgical site infections) rather than amalgamating all complications. Hospitals also tend to address performance by separate specialties (such as urology) rather than on particular procedures (such as prostatectomy), according to the ACS statement.

Dr. Osborne’s study was supported in part by the National Institute on Aging. Dr. Osborne reported having no financial disclosures; one of his associates reported ties to Arbor Metrix. Dr. Etzioni’s study did not list any sources of financial support. Dr. Etzioni and his associates reported having no financial disclosures.

Hospitals participating in a monitoring and feedback program for surgical quality showed no more improvement in patient mortality, serious complications, reoperation, or readmission than hospitals not participating in the program, according to two separate reports published online Feb. 3 in JAMA.

Both research groups concluded that feedback on outcomes alone may not be sufficient to improve surgical outcomes.

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) is an extensive clinical registry that provides participating hospitals with detailed descriptions of outcomes such as mortality, length of stay, and complications, allowing them to benchmark their performance relative to other participating hospitals and focus their efforts to improve care on the areas in which they perform poorly. The information is not reported publicly. Proponents contend that this targeting has already improved surgical outcomes as reported in several single-center studies, but others argue that any improvements noted so far might have occurred over time anyway.

©Daniel Mirer/thinkstockphotos.com

The best way to examine the question would be to compare outcomes between participating and nonparticipating hospitals, according to the two groups of investigators who did just that in these studies. However, the American College of Surgeons took issue with both study designs and released a statement taking exception to their approach to measuring surgical complications.

In the first study, researchers analyzed 30-day outcomes during a 10-year period at 263 hospitals participating in the ACS NSQIP and 526 nonparticipating propensity-matched hospitals across the United States. They focused on patients aged 65-99 years undergoing 11 high-risk general or vascular surgical procedures that are most in need of quality improvement: esophagectomy, pancreatic resection, colon resection, gastrectomy, liver resection, ventral hernia repair, cholecystectomy, appendectomy, abdominal aortic aneurysm repair, lower-extremity bypass, and carotid endarterectomy, said Dr. Nicholas H. Osborne of the Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, and a vascular surgeon at the university and his associates.

They found “slight trends toward improved outcomes” in NSQIP hospitals over time, but control hospitals showed the same trends. For example, 30-day mortality declined from 4.6% to 4.2% in participating hospitals during the study period, and similarly declined from 4.9% to 4.6% in nonparticipating hospitals. However, further analysis showed no statistically significant reductions after enrollment in the NSQIP in 30-day mortality, serious complications, reoperations, or readmissions, Dr. Osborne and his associates said (JAMA 2015 Feb. 3 [doi:10.1001/jama.2015.25]).

The underlying reasons for a lack of improvement among participating hospitals aren’t yet known, but it is possible that hospitals never implemented quality improvement efforts after being informed of their shortcomings, or that they implemented ineffective remedies. “Clinical quality improvement is challenging for hospitals. Changing physician practice requires complex, sustained, multifaceted interventions, and most hospitals may not have the expertise or resources to launch effective quality improvement interventions,” Dr. Osborne and his associates added.

In the second study, researchers analyzed surgical outcomes over a 4-year period among 113 academic hospitals in a health care system database; 39% of these hospitals participated in the NSQIP, receiving feedback on their performance, and the remaining 61% did not. This study evaluated 345,357 hospitalizations for 16 elective general and vascular surgeries, including many of the procedures covered in Dr. Osborne’s study plus mastectomy, thyroid procedures, open or laparoscopic colectomy, prostatectomy, and bariatric procedures, said Dr. David A. Etzioni, a surgeon at Mayo Clinic Arizona, Phoenix, and of the Kern Center for the Science of Health Care Delivery, and his associates.

This study also showed a slight decrease over time in postoperative complications, serious complications, and mortality at both NSQIP and non-NSQIP hospitals. “After accounting for patient risk, procedure type, underlying hospital performance, and temporal trends, the [statistical] model demonstrated no significant differences over time between NSQIP and non-NSQIP hospitals in terms of likelihood of complications, serious complications, or mortality,” Dr. Etzioni and his associates said (JAMA 2015 Feb. 3 [doi:10.1001/jama.2015.90]).

Their findings indicate that quality reports do not necessarily translate into evidence-based strategies for quality improvement and “suggest that a surgical outcomes reporting system does not provide a clear mechanism for quality improvement,” they noted.

In response to these reports, the American College of Surgeons released a statement emphasizing that claims data such as those used by both Osborne et al. and Etzioni et al. “are inaccurate and inappropriate for measuring surgical complications.” Furthermore, Dr. Clifford Ko, ACS director of the division of research and optimal patient care, called it “irresponsible to use data that are known to be an inaccurate measure of quality to determine the effectiveness of a quality improvement program.”

In addition, real-world experience shows that hospitals tend to focus on specific complications one at a time (such as surgical site infections) rather than amalgamating all complications. Hospitals also tend to address performance by separate specialties (such as urology) rather than on particular procedures (such as prostatectomy), according to the ACS statement.

Dr. Osborne’s study was supported in part by the National Institute on Aging. Dr. Osborne reported having no financial disclosures; one of his associates reported ties to Arbor Metrix. Dr. Etzioni’s study did not list any sources of financial support. Dr. Etzioni and his associates reported having no financial disclosures.

A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.

The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”

The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.

Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.

In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.

Zohydro ER was approved by the FDA in 2013.

emechcatie@frontlinemedcom.com

A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.

The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”

The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.

Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.

In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.

Zohydro ER was approved by the FDA in 2013.

emechcatie@frontlinemedcom.com

A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.

The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”

The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.

Zohydro ER is an opioid agonist approved for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the prescribing information.

In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.

Zohydro ER was approved by the FDA in 2013.

emechcatie@frontlinemedcom.com

After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.

“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”

Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.

“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.

Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.

Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.

However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.

Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.

But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.

“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”

Courtesy Dr. Theodore Mazer

For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.

“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”

The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.

“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”

Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”

Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.

“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”

The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.

When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.

Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.

“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”

agallegos@frontlinemedcom.com

On Twitter @legal_med

After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.

“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”

Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.

“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.

Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.

Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.

However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.

Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.

But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.

“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”

Courtesy Dr. Theodore Mazer

For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.

“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”

The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.

“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”

Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”

Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.

“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”

The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.

When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.

Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.

“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”

agallegos@frontlinemedcom.com

On Twitter @legal_med

After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.

“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”

Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.

“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.

Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.

Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.

However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.

Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.

But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.

“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”

Courtesy Dr. Theodore Mazer

For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.

“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”

The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.

“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”

Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”

Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.

“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”

The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.

When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.

Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.

“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”

agallegos@frontlinemedcom.com

On Twitter @legal_med

Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration announced on Jan. 30.

Approval was based on the results of two studies of 724 adults with moderate to severe binge-eating disorder. The studies found that the number of days per week participants engaged in binge-eating behavior decreased among those on Vyvanse, compared with those on placebo. Those on the drug also had fewer obsessive-compulsive binge-eating behaviors. Dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety were among the most common adverse effects associated with the drug in the studies.

This approval “provides physicians and patients with an effective option to help curb episodes of binge eating,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Binge eating can cause serious health problems and difficulties with work, home, and social life.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons

Lisdexamfetamine was first approved in 2007 as a treatment for attention-deficit/hyperactivity disorder in patients aged 6 years and older, and is a Schedule II controlled substance because of its high potential for abuse and dependence.

Prescriptions for the drug are dispensed with a Medication Guide, which provides information about its use and risks. “The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness,” the FDA statement said.

Vyvanse, manufactured by Shire US, has not been studied as a weight loss agent “and is not approved for, or recommended for, weight loss,” according to the statement.

Serious adverse events thought to be associated with Vyvanse should be reported to the FDA’s MedWatch program at 800-332-1088.

emechcatie@frontlinemedcom.com

Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration announced on Jan. 30.

Approval was based on the results of two studies of 724 adults with moderate to severe binge-eating disorder. The studies found that the number of days per week participants engaged in binge-eating behavior decreased among those on Vyvanse, compared with those on placebo. Those on the drug also had fewer obsessive-compulsive binge-eating behaviors. Dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety were among the most common adverse effects associated with the drug in the studies.

This approval “provides physicians and patients with an effective option to help curb episodes of binge eating,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Binge eating can cause serious health problems and difficulties with work, home, and social life.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons

Lisdexamfetamine was first approved in 2007 as a treatment for attention-deficit/hyperactivity disorder in patients aged 6 years and older, and is a Schedule II controlled substance because of its high potential for abuse and dependence.

Prescriptions for the drug are dispensed with a Medication Guide, which provides information about its use and risks. “The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness,” the FDA statement said.

Vyvanse, manufactured by Shire US, has not been studied as a weight loss agent “and is not approved for, or recommended for, weight loss,” according to the statement.

Serious adverse events thought to be associated with Vyvanse should be reported to the FDA’s MedWatch program at 800-332-1088.

emechcatie@frontlinemedcom.com

Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration announced on Jan. 30.

Approval was based on the results of two studies of 724 adults with moderate to severe binge-eating disorder. The studies found that the number of days per week participants engaged in binge-eating behavior decreased among those on Vyvanse, compared with those on placebo. Those on the drug also had fewer obsessive-compulsive binge-eating behaviors. Dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety were among the most common adverse effects associated with the drug in the studies.

This approval “provides physicians and patients with an effective option to help curb episodes of binge eating,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Binge eating can cause serious health problems and difficulties with work, home, and social life.”

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons

Lisdexamfetamine was first approved in 2007 as a treatment for attention-deficit/hyperactivity disorder in patients aged 6 years and older, and is a Schedule II controlled substance because of its high potential for abuse and dependence.

Prescriptions for the drug are dispensed with a Medication Guide, which provides information about its use and risks. “The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness,” the FDA statement said.

Vyvanse, manufactured by Shire US, has not been studied as a weight loss agent “and is not approved for, or recommended for, weight loss,” according to the statement.

Serious adverse events thought to be associated with Vyvanse should be reported to the FDA’s MedWatch program at 800-332-1088.

emechcatie@frontlinemedcom.com