Alicia Ault

Radiation oncologists say they could be forced to shut their doors or consolidate their practices, if the proposed cuts to radiation therapy in the 2013 Medicare physician fee schedule are allowed to stay in place.

And this is likely to hasten a shift of services out of the community and into the hospital, according to officials at the American Society for Radiation Oncology (ASTRO), which surveyed its membership in the wake of the Centers for Medicare and Medicaid Services’ proposed rule in early July.

"Some patients will likely receive their care in radiation therapy centers at a far greater distance from their home in both hospital-based facilities and larger freestanding centers that survive these cuts," said Dr. Michael L. Steinberg, president of the ASTRO’s board of directors, in an interview.

With the closure of radiation therapy centers, physicians would seek employment in surviving freestanding or hospital-based facilities, he added,

The CMS is proposing a 15% reduction in payment for IMRT (Intensity Modulated Radiation Therapy) and SBRT (Stereotactic Body Radiation Therapy). The agency also proposed a 19% cut for community-based radiation therapy centers.

IMRT and SBRT account for about a third of Medicare spending on radiation therapy, according to a spokeswoman for the ASTRO. Medicare and Medicaid are the predominant payers for radiation therapy, which is delivered to two-thirds of the nation’s 1.5 million cancer patients annually.

The ASTRO survey, which was conducted online, received about 600 responses. (There are about 4,500 radiation oncologists in the United States.) Of the 599 who participated, almost 60% were from community practices or combined community- and hospital-based practices. The results reported were only for that 60%.

Physicians were not asked about the impact of the almost-29% overall cut in physician pay called for by Medicare’s Sustainable Growth Rate (SGR) formula.

If just the close-to-20% cut for radiation therapy centers goes into effect, 35% of practices said they would probably have to close their doors, and 64% said they would consolidate. Both actions would lead to longer wait times for treatment, said ASTRO CEO Laura Thevenot in a briefing with reporters.

The consequences may also mean that physicians will spend less time with patients – that is, with those patients who would still be able to access a radiation oncologist. Some 70% of respondents said they would limit Medicare patients if the cuts go through, and 49% said they would stop accepting Medicare patients altogether.

Radiation oncologists also said they would cut back on purchases of new technology and lay off support staff and other nonphysician employees.

"The likely end result for limited access to radiation therapy – an integral form of care used in nearly 70% of all cancer patients – would be an erosion in the gains in cure rates, quality of life, and other clinical outcomes that have been achieved in our country over the last 20 years," said Dr. Constantine A. Mantz, a radiation oncologist in Ft. Myers, Fla., during the press briefing.

Ms. Thevenot said that the CMS had used faulty information to calculate the true costs of IMRT and SBRT, and that the agency should revisit the codes for both procedures.

Added Dr. Steinberg in a statement, "ASTRO welcomes a comprehensive review of these procedure codes and supports the necessary sophistication of a process, such as provided by the [American Medical Association’s Relative Value Scale Update Committee (RUC)], to value complex medical procedures including IMRT and SBRT." He is also professor and chairman of radiation oncology at the University of California, Los Angeles.

According to Ms. Thevenot, IMRT was reviewed by AMA’s RUC in fall 2010, and SBRT was reviewed in February 2011.

The ASTRO has also enlisted the support of Congress to overturn the cuts. Representatives Joe Pitts (R-Penn.) and Frank Pallone (D-N.J.), along with Rep. Mike Rogers (R-Mich.), have been circulating a letter decrying the cuts that will eventually be sent to officials at the CMS. The organization says that a "similar bipartisan letter is being drafted in the Senate."

Radiation oncologists say they could be forced to shut their doors or consolidate their practices, if the proposed cuts to radiation therapy in the 2013 Medicare physician fee schedule are allowed to stay in place.

And this is likely to hasten a shift of services out of the community and into the hospital, according to officials at the American Society for Radiation Oncology (ASTRO), which surveyed its membership in the wake of the Centers for Medicare and Medicaid Services’ proposed rule in early July.

"Some patients will likely receive their care in radiation therapy centers at a far greater distance from their home in both hospital-based facilities and larger freestanding centers that survive these cuts," said Dr. Michael L. Steinberg, president of the ASTRO’s board of directors, in an interview.

With the closure of radiation therapy centers, physicians would seek employment in surviving freestanding or hospital-based facilities, he added,

The CMS is proposing a 15% reduction in payment for IMRT (Intensity Modulated Radiation Therapy) and SBRT (Stereotactic Body Radiation Therapy). The agency also proposed a 19% cut for community-based radiation therapy centers.

IMRT and SBRT account for about a third of Medicare spending on radiation therapy, according to a spokeswoman for the ASTRO. Medicare and Medicaid are the predominant payers for radiation therapy, which is delivered to two-thirds of the nation’s 1.5 million cancer patients annually.

The ASTRO survey, which was conducted online, received about 600 responses. (There are about 4,500 radiation oncologists in the United States.) Of the 599 who participated, almost 60% were from community practices or combined community- and hospital-based practices. The results reported were only for that 60%.

Physicians were not asked about the impact of the almost-29% overall cut in physician pay called for by Medicare’s Sustainable Growth Rate (SGR) formula.

If just the close-to-20% cut for radiation therapy centers goes into effect, 35% of practices said they would probably have to close their doors, and 64% said they would consolidate. Both actions would lead to longer wait times for treatment, said ASTRO CEO Laura Thevenot in a briefing with reporters.

The consequences may also mean that physicians will spend less time with patients – that is, with those patients who would still be able to access a radiation oncologist. Some 70% of respondents said they would limit Medicare patients if the cuts go through, and 49% said they would stop accepting Medicare patients altogether.

Radiation oncologists also said they would cut back on purchases of new technology and lay off support staff and other nonphysician employees.

"The likely end result for limited access to radiation therapy – an integral form of care used in nearly 70% of all cancer patients – would be an erosion in the gains in cure rates, quality of life, and other clinical outcomes that have been achieved in our country over the last 20 years," said Dr. Constantine A. Mantz, a radiation oncologist in Ft. Myers, Fla., during the press briefing.

Ms. Thevenot said that the CMS had used faulty information to calculate the true costs of IMRT and SBRT, and that the agency should revisit the codes for both procedures.

Added Dr. Steinberg in a statement, "ASTRO welcomes a comprehensive review of these procedure codes and supports the necessary sophistication of a process, such as provided by the [American Medical Association’s Relative Value Scale Update Committee (RUC)], to value complex medical procedures including IMRT and SBRT." He is also professor and chairman of radiation oncology at the University of California, Los Angeles.

According to Ms. Thevenot, IMRT was reviewed by AMA’s RUC in fall 2010, and SBRT was reviewed in February 2011.

The ASTRO has also enlisted the support of Congress to overturn the cuts. Representatives Joe Pitts (R-Penn.) and Frank Pallone (D-N.J.), along with Rep. Mike Rogers (R-Mich.), have been circulating a letter decrying the cuts that will eventually be sent to officials at the CMS. The organization says that a "similar bipartisan letter is being drafted in the Senate."

Radiation oncologists say they could be forced to shut their doors or consolidate their practices, if the proposed cuts to radiation therapy in the 2013 Medicare physician fee schedule are allowed to stay in place.

And this is likely to hasten a shift of services out of the community and into the hospital, according to officials at the American Society for Radiation Oncology (ASTRO), which surveyed its membership in the wake of the Centers for Medicare and Medicaid Services’ proposed rule in early July.

"Some patients will likely receive their care in radiation therapy centers at a far greater distance from their home in both hospital-based facilities and larger freestanding centers that survive these cuts," said Dr. Michael L. Steinberg, president of the ASTRO’s board of directors, in an interview.

With the closure of radiation therapy centers, physicians would seek employment in surviving freestanding or hospital-based facilities, he added,

The CMS is proposing a 15% reduction in payment for IMRT (Intensity Modulated Radiation Therapy) and SBRT (Stereotactic Body Radiation Therapy). The agency also proposed a 19% cut for community-based radiation therapy centers.

IMRT and SBRT account for about a third of Medicare spending on radiation therapy, according to a spokeswoman for the ASTRO. Medicare and Medicaid are the predominant payers for radiation therapy, which is delivered to two-thirds of the nation’s 1.5 million cancer patients annually.

The ASTRO survey, which was conducted online, received about 600 responses. (There are about 4,500 radiation oncologists in the United States.) Of the 599 who participated, almost 60% were from community practices or combined community- and hospital-based practices. The results reported were only for that 60%.

Physicians were not asked about the impact of the almost-29% overall cut in physician pay called for by Medicare’s Sustainable Growth Rate (SGR) formula.

If just the close-to-20% cut for radiation therapy centers goes into effect, 35% of practices said they would probably have to close their doors, and 64% said they would consolidate. Both actions would lead to longer wait times for treatment, said ASTRO CEO Laura Thevenot in a briefing with reporters.

The consequences may also mean that physicians will spend less time with patients – that is, with those patients who would still be able to access a radiation oncologist. Some 70% of respondents said they would limit Medicare patients if the cuts go through, and 49% said they would stop accepting Medicare patients altogether.

Radiation oncologists also said they would cut back on purchases of new technology and lay off support staff and other nonphysician employees.

"The likely end result for limited access to radiation therapy – an integral form of care used in nearly 70% of all cancer patients – would be an erosion in the gains in cure rates, quality of life, and other clinical outcomes that have been achieved in our country over the last 20 years," said Dr. Constantine A. Mantz, a radiation oncologist in Ft. Myers, Fla., during the press briefing.

Ms. Thevenot said that the CMS had used faulty information to calculate the true costs of IMRT and SBRT, and that the agency should revisit the codes for both procedures.

Added Dr. Steinberg in a statement, "ASTRO welcomes a comprehensive review of these procedure codes and supports the necessary sophistication of a process, such as provided by the [American Medical Association’s Relative Value Scale Update Committee (RUC)], to value complex medical procedures including IMRT and SBRT." He is also professor and chairman of radiation oncology at the University of California, Los Angeles.

According to Ms. Thevenot, IMRT was reviewed by AMA’s RUC in fall 2010, and SBRT was reviewed in February 2011.

The ASTRO has also enlisted the support of Congress to overturn the cuts. Representatives Joe Pitts (R-Penn.) and Frank Pallone (D-N.J.), along with Rep. Mike Rogers (R-Mich.), have been circulating a letter decrying the cuts that will eventually be sent to officials at the CMS. The organization says that a "similar bipartisan letter is being drafted in the Senate."

WASHINGTON – A large international society of AIDS clinicians is endorsing the use of treatment as prevention and pre-exposure prophylaxis as a means of containing the epidemic.

With the two approaches gaining currency, primary care physicians and ob.gyns. will likely be called upon to deliver the therapies.

Alicia Ault/IMNG Medical Media

The consensus statement, issued by the International Association of Physicians in AIDS Care (IAPAC), is the end result of a gathering of experts in June.

Treatment as Prevention (TasP) gained credence after publication of the HIV Prevention Trials Network (HPTN) 052 study in the New England Journal of Medicine last August (N. Engl. J. Med. 2011;365:493-505). The trial more or less definitively proved that giving antiretroviral treatment significantly reduces the rate of sexual transmission of HIV.

Pre-Exposure Prophylaxis (PrEP) has been shown to reduce infection with the virus in heterosexuals and homosexuals who might get exposed through risky sexual activity. In July, the Food and Drug Administration approved Truvada (a drug that combines tenofovir disoproxil fumarate with emtricitabine) for use as PrEP among sexually active adults at risk for HIV infection.

Alicia Ault/IMNG Medical Media

"The group felt that the paradigm for using antiretroviral therapy as prevention had been established," said Dr. Kenneth Mayer, chairman of the IAPAC TasP/PrEP Advisory Committee, and medical research director at the Fenway Institute in Boston. "We know that this works. The issue now is implementation," he said in a press briefing at the 19th International AIDS Conference.

The consensus backs the idea of offering treatment to those who want to start. But, said Dr. Mayer, the question is, "How do we scale up training providers so they can do this in a competent way so we can manage people in an optimal way?"

Dr. Julio Montaner, also a member of the IAPAC TasP/PrEP Advisory Committee, said that studies in Africa had shown that therapy could be given by nonspecialists and even by nonphysicians. "It is abundantly clear that we have made treatment of HIV more complicated than it needs to be," said Dr. Montaner, director of the British Columbia Centre for Excellence in HIV/AIDS in Vancouver, B.C.

Now that regimens have become simpler, safer, and better tolerated, "I’m very optimistic that we are going to increasingly see treatment being supervised by people other than the specialists," he said. Dr. Montaner noted that in British Columbia, treatment is predominantly being initiated by family physicians.

Another key issue: For TasP to work, people need to know their HIV status. So the consensus backs higher levels of HIV testing.

Other challenges to implementing TasP include resource limitations; how to evaluate the quality of care; ethical issues; and how to monitor people for increases in risky behavior and suboptimal adherence, said Dr. Mayer.

Monitoring risky behavior will also be a challenge with PrEP, he said. There are also questions about the optimal dose and timing of the dose, he said, adding that much more research needs to be done on PrEP, relative to TasP.

PrEP is not a standalone therapy, he said. "It has to be part of a comprehensive prevention package," that includes behavioral interventions, said Dr. Mayer. And it is not meant to be a lifetime therapy. It should be used at a time of acute risk, he said, adding that PrEP is "a measure to get them through a period where they might otherwise become HIV infected."

The full consensus statement is available at the IAPAC website. It will also be shared with many physician groups, including the American College of Physicians, the American Academy of Family Practitioners, and the American Congress of Obstetricians and Gynecologists, said Dr. Mayer in an interview.

WASHINGTON – A large international society of AIDS clinicians is endorsing the use of treatment as prevention and pre-exposure prophylaxis as a means of containing the epidemic.

With the two approaches gaining currency, primary care physicians and ob.gyns. will likely be called upon to deliver the therapies.

Alicia Ault/IMNG Medical Media

The consensus statement, issued by the International Association of Physicians in AIDS Care (IAPAC), is the end result of a gathering of experts in June.

Treatment as Prevention (TasP) gained credence after publication of the HIV Prevention Trials Network (HPTN) 052 study in the New England Journal of Medicine last August (N. Engl. J. Med. 2011;365:493-505). The trial more or less definitively proved that giving antiretroviral treatment significantly reduces the rate of sexual transmission of HIV.

Pre-Exposure Prophylaxis (PrEP) has been shown to reduce infection with the virus in heterosexuals and homosexuals who might get exposed through risky sexual activity. In July, the Food and Drug Administration approved Truvada (a drug that combines tenofovir disoproxil fumarate with emtricitabine) for use as PrEP among sexually active adults at risk for HIV infection.

Alicia Ault/IMNG Medical Media

"The group felt that the paradigm for using antiretroviral therapy as prevention had been established," said Dr. Kenneth Mayer, chairman of the IAPAC TasP/PrEP Advisory Committee, and medical research director at the Fenway Institute in Boston. "We know that this works. The issue now is implementation," he said in a press briefing at the 19th International AIDS Conference.

The consensus backs the idea of offering treatment to those who want to start. But, said Dr. Mayer, the question is, "How do we scale up training providers so they can do this in a competent way so we can manage people in an optimal way?"

Dr. Julio Montaner, also a member of the IAPAC TasP/PrEP Advisory Committee, said that studies in Africa had shown that therapy could be given by nonspecialists and even by nonphysicians. "It is abundantly clear that we have made treatment of HIV more complicated than it needs to be," said Dr. Montaner, director of the British Columbia Centre for Excellence in HIV/AIDS in Vancouver, B.C.

Now that regimens have become simpler, safer, and better tolerated, "I’m very optimistic that we are going to increasingly see treatment being supervised by people other than the specialists," he said. Dr. Montaner noted that in British Columbia, treatment is predominantly being initiated by family physicians.

Another key issue: For TasP to work, people need to know their HIV status. So the consensus backs higher levels of HIV testing.

Other challenges to implementing TasP include resource limitations; how to evaluate the quality of care; ethical issues; and how to monitor people for increases in risky behavior and suboptimal adherence, said Dr. Mayer.

Monitoring risky behavior will also be a challenge with PrEP, he said. There are also questions about the optimal dose and timing of the dose, he said, adding that much more research needs to be done on PrEP, relative to TasP.

PrEP is not a standalone therapy, he said. "It has to be part of a comprehensive prevention package," that includes behavioral interventions, said Dr. Mayer. And it is not meant to be a lifetime therapy. It should be used at a time of acute risk, he said, adding that PrEP is "a measure to get them through a period where they might otherwise become HIV infected."

The full consensus statement is available at the IAPAC website. It will also be shared with many physician groups, including the American College of Physicians, the American Academy of Family Practitioners, and the American Congress of Obstetricians and Gynecologists, said Dr. Mayer in an interview.

WASHINGTON – A large international society of AIDS clinicians is endorsing the use of treatment as prevention and pre-exposure prophylaxis as a means of containing the epidemic.

With the two approaches gaining currency, primary care physicians and ob.gyns. will likely be called upon to deliver the therapies.

Alicia Ault/IMNG Medical Media

The consensus statement, issued by the International Association of Physicians in AIDS Care (IAPAC), is the end result of a gathering of experts in June.

Treatment as Prevention (TasP) gained credence after publication of the HIV Prevention Trials Network (HPTN) 052 study in the New England Journal of Medicine last August (N. Engl. J. Med. 2011;365:493-505). The trial more or less definitively proved that giving antiretroviral treatment significantly reduces the rate of sexual transmission of HIV.

Pre-Exposure Prophylaxis (PrEP) has been shown to reduce infection with the virus in heterosexuals and homosexuals who might get exposed through risky sexual activity. In July, the Food and Drug Administration approved Truvada (a drug that combines tenofovir disoproxil fumarate with emtricitabine) for use as PrEP among sexually active adults at risk for HIV infection.

Alicia Ault/IMNG Medical Media

"The group felt that the paradigm for using antiretroviral therapy as prevention had been established," said Dr. Kenneth Mayer, chairman of the IAPAC TasP/PrEP Advisory Committee, and medical research director at the Fenway Institute in Boston. "We know that this works. The issue now is implementation," he said in a press briefing at the 19th International AIDS Conference.

The consensus backs the idea of offering treatment to those who want to start. But, said Dr. Mayer, the question is, "How do we scale up training providers so they can do this in a competent way so we can manage people in an optimal way?"

Dr. Julio Montaner, also a member of the IAPAC TasP/PrEP Advisory Committee, said that studies in Africa had shown that therapy could be given by nonspecialists and even by nonphysicians. "It is abundantly clear that we have made treatment of HIV more complicated than it needs to be," said Dr. Montaner, director of the British Columbia Centre for Excellence in HIV/AIDS in Vancouver, B.C.

Now that regimens have become simpler, safer, and better tolerated, "I’m very optimistic that we are going to increasingly see treatment being supervised by people other than the specialists," he said. Dr. Montaner noted that in British Columbia, treatment is predominantly being initiated by family physicians.

Another key issue: For TasP to work, people need to know their HIV status. So the consensus backs higher levels of HIV testing.

Other challenges to implementing TasP include resource limitations; how to evaluate the quality of care; ethical issues; and how to monitor people for increases in risky behavior and suboptimal adherence, said Dr. Mayer.

Monitoring risky behavior will also be a challenge with PrEP, he said. There are also questions about the optimal dose and timing of the dose, he said, adding that much more research needs to be done on PrEP, relative to TasP.

PrEP is not a standalone therapy, he said. "It has to be part of a comprehensive prevention package," that includes behavioral interventions, said Dr. Mayer. And it is not meant to be a lifetime therapy. It should be used at a time of acute risk, he said, adding that PrEP is "a measure to get them through a period where they might otherwise become HIV infected."

The full consensus statement is available at the IAPAC website. It will also be shared with many physician groups, including the American College of Physicians, the American Academy of Family Practitioners, and the American Congress of Obstetricians and Gynecologists, said Dr. Mayer in an interview.

Another 89 accountable care organizations had opened their doors for business as of July 1, the Health and Human Services department announced July 9.

That brings the total to 154 groups that have agreed to be held accountable for improving the quality of care they provide while simultaneously reducing costs, including 32 participating in the pioneer ACO model announced in December, as well as six physician group practice transition demonstration organizations that began in early 2011.

Some 2.4 million Medicare beneficiaries in 40 states and Washington, D.C., now are cared for by an ACO, the department announced.

At least 400 more organizations have said they will apply to become an ACO when the Centers for Medicare and Medicaid Services (CMS) begins in August accepting applications for 2013, according to Jonathan Blum, principal deputy administrator for CMS and director of its Center for Medicare.

In a briefing with reporters, Mr. Blum did not directly address whether the program could be hurt by expected attempts to defund the Affordable Care Act. Instead, he said, "This is a program that is going to grow substantially over time."

ACOs are meant to be led by physicians, working in conjunction with hospitals and other providers to deliver more efficient and better-quality care. "We really see this being led by the physician community to improve patient care," Mr. Blum said.

Of the 89 new ACOs, "almost half are physician-driven organizations serving fewer than 10,000 beneficiaries, demonstrating that smaller organizations are interested in operating as ACOs," according to a CMS statement.

However, the requirement that an ACO serve at least 5,000 Medicare beneficiaries continues to be a difficult hurdle for physician groups that would otherwise like to participate, said Mr. Blum.

The ACO effort is also known as the Medicare Shared Savings Program. The organizations that agree to participate are given the opportunity to share in whatever savings are generated. CMS estimates that the government’s savings from the program could be up to $940 million over 4 years.

One of the newest ACOs is the Westmed Medical Group, a Westchester County, New York–based physician-owned and managed multispecialty group practice that was founded in 1996, and includes 225 physicians and 1,000 employees.

Dr. Simeon Schwartz, president and CEO, said that each of group’s nine sites generally offers primary care; surgical, specialty, radiology, and lab services; and urgent care.

Westmed expects to generate savings of 5%-10% over the course of the group’s 3-year contract, mostly by shifting care from the inpatient to the outpatient setting through better coordination, he said at the press briefing. He added that providing urgent care – keeping patients out of the emergency department – is another way to save money.

In a statement, HHS Secretary Kathleen Sebelius said that having better care coordination will be one of the keys to generating savings.

"We applaud every one of these doctors, hospitals, health centers, and others for working together to ensure millions of people with Medicare get better, more patient-centered, coordinated care," she said.

Another 89 accountable care organizations had opened their doors for business as of July 1, the Health and Human Services department announced July 9.

That brings the total to 154 groups that have agreed to be held accountable for improving the quality of care they provide while simultaneously reducing costs, including 32 participating in the pioneer ACO model announced in December, as well as six physician group practice transition demonstration organizations that began in early 2011.

Some 2.4 million Medicare beneficiaries in 40 states and Washington, D.C., now are cared for by an ACO, the department announced.

At least 400 more organizations have said they will apply to become an ACO when the Centers for Medicare and Medicaid Services (CMS) begins in August accepting applications for 2013, according to Jonathan Blum, principal deputy administrator for CMS and director of its Center for Medicare.

In a briefing with reporters, Mr. Blum did not directly address whether the program could be hurt by expected attempts to defund the Affordable Care Act. Instead, he said, "This is a program that is going to grow substantially over time."

ACOs are meant to be led by physicians, working in conjunction with hospitals and other providers to deliver more efficient and better-quality care. "We really see this being led by the physician community to improve patient care," Mr. Blum said.

Of the 89 new ACOs, "almost half are physician-driven organizations serving fewer than 10,000 beneficiaries, demonstrating that smaller organizations are interested in operating as ACOs," according to a CMS statement.

However, the requirement that an ACO serve at least 5,000 Medicare beneficiaries continues to be a difficult hurdle for physician groups that would otherwise like to participate, said Mr. Blum.

The ACO effort is also known as the Medicare Shared Savings Program. The organizations that agree to participate are given the opportunity to share in whatever savings are generated. CMS estimates that the government’s savings from the program could be up to $940 million over 4 years.

One of the newest ACOs is the Westmed Medical Group, a Westchester County, New York–based physician-owned and managed multispecialty group practice that was founded in 1996, and includes 225 physicians and 1,000 employees.

Dr. Simeon Schwartz, president and CEO, said that each of group’s nine sites generally offers primary care; surgical, specialty, radiology, and lab services; and urgent care.

Westmed expects to generate savings of 5%-10% over the course of the group’s 3-year contract, mostly by shifting care from the inpatient to the outpatient setting through better coordination, he said at the press briefing. He added that providing urgent care – keeping patients out of the emergency department – is another way to save money.

In a statement, HHS Secretary Kathleen Sebelius said that having better care coordination will be one of the keys to generating savings.

"We applaud every one of these doctors, hospitals, health centers, and others for working together to ensure millions of people with Medicare get better, more patient-centered, coordinated care," she said.

Another 89 accountable care organizations had opened their doors for business as of July 1, the Health and Human Services department announced July 9.

That brings the total to 154 groups that have agreed to be held accountable for improving the quality of care they provide while simultaneously reducing costs, including 32 participating in the pioneer ACO model announced in December, as well as six physician group practice transition demonstration organizations that began in early 2011.

Some 2.4 million Medicare beneficiaries in 40 states and Washington, D.C., now are cared for by an ACO, the department announced.

At least 400 more organizations have said they will apply to become an ACO when the Centers for Medicare and Medicaid Services (CMS) begins in August accepting applications for 2013, according to Jonathan Blum, principal deputy administrator for CMS and director of its Center for Medicare.

In a briefing with reporters, Mr. Blum did not directly address whether the program could be hurt by expected attempts to defund the Affordable Care Act. Instead, he said, "This is a program that is going to grow substantially over time."

ACOs are meant to be led by physicians, working in conjunction with hospitals and other providers to deliver more efficient and better-quality care. "We really see this being led by the physician community to improve patient care," Mr. Blum said.

Of the 89 new ACOs, "almost half are physician-driven organizations serving fewer than 10,000 beneficiaries, demonstrating that smaller organizations are interested in operating as ACOs," according to a CMS statement.

However, the requirement that an ACO serve at least 5,000 Medicare beneficiaries continues to be a difficult hurdle for physician groups that would otherwise like to participate, said Mr. Blum.

The ACO effort is also known as the Medicare Shared Savings Program. The organizations that agree to participate are given the opportunity to share in whatever savings are generated. CMS estimates that the government’s savings from the program could be up to $940 million over 4 years.

One of the newest ACOs is the Westmed Medical Group, a Westchester County, New York–based physician-owned and managed multispecialty group practice that was founded in 1996, and includes 225 physicians and 1,000 employees.

Dr. Simeon Schwartz, president and CEO, said that each of group’s nine sites generally offers primary care; surgical, specialty, radiology, and lab services; and urgent care.

Westmed expects to generate savings of 5%-10% over the course of the group’s 3-year contract, mostly by shifting care from the inpatient to the outpatient setting through better coordination, he said at the press briefing. He added that providing urgent care – keeping patients out of the emergency department – is another way to save money.

In a statement, HHS Secretary Kathleen Sebelius said that having better care coordination will be one of the keys to generating savings.

"We applaud every one of these doctors, hospitals, health centers, and others for working together to ensure millions of people with Medicare get better, more patient-centered, coordinated care," she said.

WASHINGTON – As states wrestle with tight budgets and growing Medicaid rolls, more are exploring restricting payment for emergency department visits.

California, Illinois, Iowa, New Hampshire, Tennessee, Washington, and other states have been seeking to cut back on Medicaid payments for ED care.

Iowa has instituted a tiered payment plan for nonemergency care, with reductions of 25%-100% in the prevailing rate, said Dr. Sandra Schneider, immediate past president of the American College of Emergency Physicians (ACEP) and a member of the board of directors of the New York State Chapter of ACEP. Texas has also cut rates based on the acuity of the visit. New Hampshire has proposed a four-visit yearly limit, and Illinois and Kentucky have also discussed limiting visits, Dr. Schneider said at a conference sponsored by the American College of Emergency Physicians.

In Washington state, ACEP and the state medical society and hospital association were able to negotiate a postponement of a restrictive policy that was due to go into effect last October. Efforts to prevent similar policies from going into effect in Tennessee have been marginally successful so far.

Speakers at the ACEP Leadership and Advocacy Conference outlined the success in Washington and the struggle in Tennessee, describing both as cautionary tales in the continuing tough budget environment.

"We are under attack," said Dr. Schneider, noting that proposed restrictions on EDs are disproportionate given that emergency care accounts for only 2% of all health care costs and emergency doctors comprise only 4% of the nation’s physicians.

In the early summer of 2011, the Washington state legislature passed a law to cap nonemergency visits to the ED, and directed the state Medicaid program to formulate a list of nonemergent conditions in coordination with the state’s physicians and hospitals.

But the state’s Health Care Authority (HCA) drafted its own list and moved to put the policy into place in October. The Washington State Chapter of ACEP filed suit the day before the policy was to take effect. The Washington Chapter and national ACEP contributed about $200,000 to pay for the lawsuit, said Dr. Nathaniel R. Schlicher, who is a board member of ACEP’s Washington Chapter and a clinician at St. Joseph Medical Center in Tacoma.

In November, a judge agreed with ACEP that the policy could not be implemented and enjoined the HCA from moving ahead. A new collaborative process began but quickly devolved; the state changed its position from allowing three nonemergent ED visits a year to allowing none, said Dr. Schlicher. The "do not cover" list included 515 diagnoses, with absolutely no exceptions, he said.

The Washington Chapter of ACEP, the Washington State Medical Association, and the Washington State Hospital Association combined forces to defeat the policy, but continued negotiations with the HCA, said Dr. Schlicher. The groups launched a media campaign to discredit the Medicaid policy, and members conducted grand rounds at hospitals to explain the policy’s potential impact.

Their efforts focused, however, on getting the legislature to accept an alternative plan that would produce the savings needed to meet the state’s budget without endangering patients.

The groups enlisted the help of Rep. Eileen Cody, a member of the state House from West Seattle who also was the chair of the health care committee, to broker talks with the House and Senate. The House included the alternative policy in its budget, but when the Senate failed to pass it, Gov. Christine Gregoire (D) called a special session of the legislature in March. The budget finally passed by the Senate did not include the alternative plan.

Then, in April, Gov. Gregoire suspended the zero tolerance policy and added the alternative proposal as a proviso to the state budget. Under that proposal, hospitals will commit to participating in the Emergency Department Information Exchange (EDIE), which will help them track and manage frequent ED users. With the EDIE, physicians can view previous visits and discharge plans. Much of the focus is on managing those who are drug seekers, and systems will be set up to help these patients access primary care providers and to help physicians follow ACEP guidance on prescribing and monitoring narcotics.

Physicians also will be urged to participate in an online prescription database to track patients’ use of controlled substances. The goal is to have 90% of EDs participating by the end of this year.

Utilization monitoring reports – tracking rates of unnecessary visits, rates of visits by frequent users, and rates of opioid prescriptions – will be reported to the HCA. In turn, physicians will get feedback reports to help them improve their practices.

All hospitals with at least 75% of visits covered by Medicaid must participate or the state will revert to its zero visit policy.

Tennessee has also attempted to limit ED visits by Medicaid patients, said Dr. Sanford H. Herman, immediate past president of the Tennessee Chapter of ACEP and an emergency physician in Nashville. The state’s traditional Medicaid program was replaced in 1994 by a network of 12 managed care organizations called TennCare. TennCare was supposed to be more efficient and less costly, but it was on its way to consuming half of the state’s budget by the late 2000s, Dr. Herman said.

In 2005, then-Governor Phil Bredesen (D) began slashing TennCare’s funding. In 2010, about $525 million was cut and some 200,000-300,000 enrollees were dropped, said Dr. Herman.

The state proposed limiting ED visits to eight per year and eliminating pay for certain nonemergent conditions. Any other proposal – such as changing benefits or increasing cost-sharing – would have required approval from the U.S. Centers for Medicare and Medicaid Services.

The Tennessee Chapter began meeting with state officials to head off the policy. In April 2011, when the 2012 budget was being formulated, the Chapter learned that visits for nonemergent services would be reimbursed at the rate of a level 1 office visit, or $17. The list of such services was more than 200 pages long, Dr. Herman said.

Lobbying efforts resulted in the $17 becoming $50, at least for the next year. The Tennessee Chapter is working with the current governor and TennCare to come up with a larger solution to help stop the bleeding from the state’s coffers, he said.

Meanwhile, representatives of the Tennessee Chapter go to the State Capitol building every Tuesday and Wednesday to continue the campaign, Dr. Herman said.

Dr. Herman, Dr. Schneider, and Dr. Schlicher urged emergency physicians to get involved in the state Medicaid battles. "Keep your ears and eyes open," said Dr. Schneider, who also recommended that doctors alert the national ACEP organization when a potentially onerous policy is being discussed or proposed "because these people have your back," she said.

WASHINGTON – As states wrestle with tight budgets and growing Medicaid rolls, more are exploring restricting payment for emergency department visits.

California, Illinois, Iowa, New Hampshire, Tennessee, Washington, and other states have been seeking to cut back on Medicaid payments for ED care.

Iowa has instituted a tiered payment plan for nonemergency care, with reductions of 25%-100% in the prevailing rate, said Dr. Sandra Schneider, immediate past president of the American College of Emergency Physicians (ACEP) and a member of the board of directors of the New York State Chapter of ACEP. Texas has also cut rates based on the acuity of the visit. New Hampshire has proposed a four-visit yearly limit, and Illinois and Kentucky have also discussed limiting visits, Dr. Schneider said at a conference sponsored by the American College of Emergency Physicians.

In Washington state, ACEP and the state medical society and hospital association were able to negotiate a postponement of a restrictive policy that was due to go into effect last October. Efforts to prevent similar policies from going into effect in Tennessee have been marginally successful so far.

Speakers at the ACEP Leadership and Advocacy Conference outlined the success in Washington and the struggle in Tennessee, describing both as cautionary tales in the continuing tough budget environment.

"We are under attack," said Dr. Schneider, noting that proposed restrictions on EDs are disproportionate given that emergency care accounts for only 2% of all health care costs and emergency doctors comprise only 4% of the nation’s physicians.

In the early summer of 2011, the Washington state legislature passed a law to cap nonemergency visits to the ED, and directed the state Medicaid program to formulate a list of nonemergent conditions in coordination with the state’s physicians and hospitals.

But the state’s Health Care Authority (HCA) drafted its own list and moved to put the policy into place in October. The Washington State Chapter of ACEP filed suit the day before the policy was to take effect. The Washington Chapter and national ACEP contributed about $200,000 to pay for the lawsuit, said Dr. Nathaniel R. Schlicher, who is a board member of ACEP’s Washington Chapter and a clinician at St. Joseph Medical Center in Tacoma.

In November, a judge agreed with ACEP that the policy could not be implemented and enjoined the HCA from moving ahead. A new collaborative process began but quickly devolved; the state changed its position from allowing three nonemergent ED visits a year to allowing none, said Dr. Schlicher. The "do not cover" list included 515 diagnoses, with absolutely no exceptions, he said.

The Washington Chapter of ACEP, the Washington State Medical Association, and the Washington State Hospital Association combined forces to defeat the policy, but continued negotiations with the HCA, said Dr. Schlicher. The groups launched a media campaign to discredit the Medicaid policy, and members conducted grand rounds at hospitals to explain the policy’s potential impact.

Their efforts focused, however, on getting the legislature to accept an alternative plan that would produce the savings needed to meet the state’s budget without endangering patients.

The groups enlisted the help of Rep. Eileen Cody, a member of the state House from West Seattle who also was the chair of the health care committee, to broker talks with the House and Senate. The House included the alternative policy in its budget, but when the Senate failed to pass it, Gov. Christine Gregoire (D) called a special session of the legislature in March. The budget finally passed by the Senate did not include the alternative plan.

Then, in April, Gov. Gregoire suspended the zero tolerance policy and added the alternative proposal as a proviso to the state budget. Under that proposal, hospitals will commit to participating in the Emergency Department Information Exchange (EDIE), which will help them track and manage frequent ED users. With the EDIE, physicians can view previous visits and discharge plans. Much of the focus is on managing those who are drug seekers, and systems will be set up to help these patients access primary care providers and to help physicians follow ACEP guidance on prescribing and monitoring narcotics.

Physicians also will be urged to participate in an online prescription database to track patients’ use of controlled substances. The goal is to have 90% of EDs participating by the end of this year.

Utilization monitoring reports – tracking rates of unnecessary visits, rates of visits by frequent users, and rates of opioid prescriptions – will be reported to the HCA. In turn, physicians will get feedback reports to help them improve their practices.

All hospitals with at least 75% of visits covered by Medicaid must participate or the state will revert to its zero visit policy.

Tennessee has also attempted to limit ED visits by Medicaid patients, said Dr. Sanford H. Herman, immediate past president of the Tennessee Chapter of ACEP and an emergency physician in Nashville. The state’s traditional Medicaid program was replaced in 1994 by a network of 12 managed care organizations called TennCare. TennCare was supposed to be more efficient and less costly, but it was on its way to consuming half of the state’s budget by the late 2000s, Dr. Herman said.

In 2005, then-Governor Phil Bredesen (D) began slashing TennCare’s funding. In 2010, about $525 million was cut and some 200,000-300,000 enrollees were dropped, said Dr. Herman.

The state proposed limiting ED visits to eight per year and eliminating pay for certain nonemergent conditions. Any other proposal – such as changing benefits or increasing cost-sharing – would have required approval from the U.S. Centers for Medicare and Medicaid Services.

The Tennessee Chapter began meeting with state officials to head off the policy. In April 2011, when the 2012 budget was being formulated, the Chapter learned that visits for nonemergent services would be reimbursed at the rate of a level 1 office visit, or $17. The list of such services was more than 200 pages long, Dr. Herman said.

Lobbying efforts resulted in the $17 becoming $50, at least for the next year. The Tennessee Chapter is working with the current governor and TennCare to come up with a larger solution to help stop the bleeding from the state’s coffers, he said.

Meanwhile, representatives of the Tennessee Chapter go to the State Capitol building every Tuesday and Wednesday to continue the campaign, Dr. Herman said.

Dr. Herman, Dr. Schneider, and Dr. Schlicher urged emergency physicians to get involved in the state Medicaid battles. "Keep your ears and eyes open," said Dr. Schneider, who also recommended that doctors alert the national ACEP organization when a potentially onerous policy is being discussed or proposed "because these people have your back," she said.

WASHINGTON – As states wrestle with tight budgets and growing Medicaid rolls, more are exploring restricting payment for emergency department visits.

California, Illinois, Iowa, New Hampshire, Tennessee, Washington, and other states have been seeking to cut back on Medicaid payments for ED care.

Iowa has instituted a tiered payment plan for nonemergency care, with reductions of 25%-100% in the prevailing rate, said Dr. Sandra Schneider, immediate past president of the American College of Emergency Physicians (ACEP) and a member of the board of directors of the New York State Chapter of ACEP. Texas has also cut rates based on the acuity of the visit. New Hampshire has proposed a four-visit yearly limit, and Illinois and Kentucky have also discussed limiting visits, Dr. Schneider said at a conference sponsored by the American College of Emergency Physicians.

In Washington state, ACEP and the state medical society and hospital association were able to negotiate a postponement of a restrictive policy that was due to go into effect last October. Efforts to prevent similar policies from going into effect in Tennessee have been marginally successful so far.

Speakers at the ACEP Leadership and Advocacy Conference outlined the success in Washington and the struggle in Tennessee, describing both as cautionary tales in the continuing tough budget environment.

"We are under attack," said Dr. Schneider, noting that proposed restrictions on EDs are disproportionate given that emergency care accounts for only 2% of all health care costs and emergency doctors comprise only 4% of the nation’s physicians.

In the early summer of 2011, the Washington state legislature passed a law to cap nonemergency visits to the ED, and directed the state Medicaid program to formulate a list of nonemergent conditions in coordination with the state’s physicians and hospitals.

But the state’s Health Care Authority (HCA) drafted its own list and moved to put the policy into place in October. The Washington State Chapter of ACEP filed suit the day before the policy was to take effect. The Washington Chapter and national ACEP contributed about $200,000 to pay for the lawsuit, said Dr. Nathaniel R. Schlicher, who is a board member of ACEP’s Washington Chapter and a clinician at St. Joseph Medical Center in Tacoma.

In November, a judge agreed with ACEP that the policy could not be implemented and enjoined the HCA from moving ahead. A new collaborative process began but quickly devolved; the state changed its position from allowing three nonemergent ED visits a year to allowing none, said Dr. Schlicher. The "do not cover" list included 515 diagnoses, with absolutely no exceptions, he said.

The Washington Chapter of ACEP, the Washington State Medical Association, and the Washington State Hospital Association combined forces to defeat the policy, but continued negotiations with the HCA, said Dr. Schlicher. The groups launched a media campaign to discredit the Medicaid policy, and members conducted grand rounds at hospitals to explain the policy’s potential impact.

Their efforts focused, however, on getting the legislature to accept an alternative plan that would produce the savings needed to meet the state’s budget without endangering patients.

The groups enlisted the help of Rep. Eileen Cody, a member of the state House from West Seattle who also was the chair of the health care committee, to broker talks with the House and Senate. The House included the alternative policy in its budget, but when the Senate failed to pass it, Gov. Christine Gregoire (D) called a special session of the legislature in March. The budget finally passed by the Senate did not include the alternative plan.

Then, in April, Gov. Gregoire suspended the zero tolerance policy and added the alternative proposal as a proviso to the state budget. Under that proposal, hospitals will commit to participating in the Emergency Department Information Exchange (EDIE), which will help them track and manage frequent ED users. With the EDIE, physicians can view previous visits and discharge plans. Much of the focus is on managing those who are drug seekers, and systems will be set up to help these patients access primary care providers and to help physicians follow ACEP guidance on prescribing and monitoring narcotics.

Physicians also will be urged to participate in an online prescription database to track patients’ use of controlled substances. The goal is to have 90% of EDs participating by the end of this year.

Utilization monitoring reports – tracking rates of unnecessary visits, rates of visits by frequent users, and rates of opioid prescriptions – will be reported to the HCA. In turn, physicians will get feedback reports to help them improve their practices.

All hospitals with at least 75% of visits covered by Medicaid must participate or the state will revert to its zero visit policy.

Tennessee has also attempted to limit ED visits by Medicaid patients, said Dr. Sanford H. Herman, immediate past president of the Tennessee Chapter of ACEP and an emergency physician in Nashville. The state’s traditional Medicaid program was replaced in 1994 by a network of 12 managed care organizations called TennCare. TennCare was supposed to be more efficient and less costly, but it was on its way to consuming half of the state’s budget by the late 2000s, Dr. Herman said.

In 2005, then-Governor Phil Bredesen (D) began slashing TennCare’s funding. In 2010, about $525 million was cut and some 200,000-300,000 enrollees were dropped, said Dr. Herman.

The state proposed limiting ED visits to eight per year and eliminating pay for certain nonemergent conditions. Any other proposal – such as changing benefits or increasing cost-sharing – would have required approval from the U.S. Centers for Medicare and Medicaid Services.

The Tennessee Chapter began meeting with state officials to head off the policy. In April 2011, when the 2012 budget was being formulated, the Chapter learned that visits for nonemergent services would be reimbursed at the rate of a level 1 office visit, or $17. The list of such services was more than 200 pages long, Dr. Herman said.

Lobbying efforts resulted in the $17 becoming $50, at least for the next year. The Tennessee Chapter is working with the current governor and TennCare to come up with a larger solution to help stop the bleeding from the state’s coffers, he said.

Meanwhile, representatives of the Tennessee Chapter go to the State Capitol building every Tuesday and Wednesday to continue the campaign, Dr. Herman said.

Dr. Herman, Dr. Schneider, and Dr. Schlicher urged emergency physicians to get involved in the state Medicaid battles. "Keep your ears and eyes open," said Dr. Schneider, who also recommended that doctors alert the national ACEP organization when a potentially onerous policy is being discussed or proposed "because these people have your back," she said.

Rhode Island joins California and Vermont to become the third state to institute restrictions on the use of tanning beds by minors.

There had been an effort to completely ban the use of tanning beds by anyone under the age of 18, but a compromise was struck. In the final bill, which passed into law without the governor's signature, minors cannot use indoor tanning beds without a prescription from a physician for ultraviolet radiation therapy or a signed consent from a parent or guardian. The parental consent has to be signed in the presence of a tanning salon employee, and it essentially has the parent acknowledge that UV radiation is a carcinogen and that exposure increases the probability of developing melanoma.

The American Academy of Dermatology applauded the state's action, and noted that in Rhode Island the incidence of melanoma in women 15 years and older increased by 24% between 2004 and 2008.

"Prevention is one of the most valuable tools that we have as dermatologists. We need to continue educating patients about the risks of indoor tanning and encouraging healthy decisions to help prevent skin cancer," Dr. Daniel M. Siegel, president of the AAD, said in a statement.

"This law is similar to bans in California and Vermont that will protect children and adolescents from the health hazards of indoor tanning and sends a strong message from the state that tanning is a dangerous behavior and should be avoided," said Dr. Siegel.

Rhode Island joins California and Vermont to become the third state to institute restrictions on the use of tanning beds by minors.

There had been an effort to completely ban the use of tanning beds by anyone under the age of 18, but a compromise was struck. In the final bill, which passed into law without the governor's signature, minors cannot use indoor tanning beds without a prescription from a physician for ultraviolet radiation therapy or a signed consent from a parent or guardian. The parental consent has to be signed in the presence of a tanning salon employee, and it essentially has the parent acknowledge that UV radiation is a carcinogen and that exposure increases the probability of developing melanoma.

The American Academy of Dermatology applauded the state's action, and noted that in Rhode Island the incidence of melanoma in women 15 years and older increased by 24% between 2004 and 2008.

"Prevention is one of the most valuable tools that we have as dermatologists. We need to continue educating patients about the risks of indoor tanning and encouraging healthy decisions to help prevent skin cancer," Dr. Daniel M. Siegel, president of the AAD, said in a statement.

"This law is similar to bans in California and Vermont that will protect children and adolescents from the health hazards of indoor tanning and sends a strong message from the state that tanning is a dangerous behavior and should be avoided," said Dr. Siegel.

Rhode Island joins California and Vermont to become the third state to institute restrictions on the use of tanning beds by minors.

There had been an effort to completely ban the use of tanning beds by anyone under the age of 18, but a compromise was struck. In the final bill, which passed into law without the governor's signature, minors cannot use indoor tanning beds without a prescription from a physician for ultraviolet radiation therapy or a signed consent from a parent or guardian. The parental consent has to be signed in the presence of a tanning salon employee, and it essentially has the parent acknowledge that UV radiation is a carcinogen and that exposure increases the probability of developing melanoma.

The American Academy of Dermatology applauded the state's action, and noted that in Rhode Island the incidence of melanoma in women 15 years and older increased by 24% between 2004 and 2008.

"Prevention is one of the most valuable tools that we have as dermatologists. We need to continue educating patients about the risks of indoor tanning and encouraging healthy decisions to help prevent skin cancer," Dr. Daniel M. Siegel, president of the AAD, said in a statement.

"This law is similar to bans in California and Vermont that will protect children and adolescents from the health hazards of indoor tanning and sends a strong message from the state that tanning is a dangerous behavior and should be avoided," said Dr. Siegel.

WASHINGTON – In a voluminous, complex, and divergent set of opinions, the U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28.

The court's decision that the law’s expansion of Medicaid is not lawful – but that any state that wishes to take federal matching funds to bring on more enrollees can do so – may result in reduced access to health coverage and more uninsured patients seeking care in 2014.

*In a statement from the American Academy of Dermatology, President Dr. Daniel M. Siegel said, "While, in many respects, the health system reform law does not fully align with the AADA's health reform principles, there were some positive changes with respect to insurance reform, the expansion of health care coverage to more Americans, and strengthening of wellness efforts that were included. Unfortunately, the ACA missed an opportunity to permanently fix the flawed Medicare physician payment formula or enact meaningful liability reform, and created the Independent Payment Advisory Board (IPAB), all of which threaten to undermine access to care and destabilize health care delivery."

Alicia Ault/IMNG Medical Media

The majority, in a 59-page opinion, said that "the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people."

In their opinion, the majority found that the ACA’s individual mandate was a violation of the Constitution’s Commerce Clause. Chief Justice John Roberts, who wrote the opinion, said that the mandate "does not regulate existing commercial activity."

According to Justice Roberts, "it instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce."

The opinion jibed with the argument made by plaintiffs that the government should not be allowed to compel Americans into commerce.

The majority, however, also found that requiring Americans to pay a penalty if they did not buy health insurance was constitutional. The government did not call the penalty a "tax," but the court found that it is indeed a tax, and thus, within Congress’ powers.

The majority also agreed with the plaintiffs that the federal requirement that states either accept the money offered to expand Medicaid or forego all Medicaid funds was unduly coercive. Justice Roberts characterized the requirement as "a gun to the head."

He said that the ACA transforms Medicaid into an entirely new program and thus violates Congress’ spending power under the Constitution and also violates states’ sovereignty. However, "nothing in our opinion precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care."

Essentially, the majority opinion says that states could accept the funds to expand their Medicaid programs but the federal government could not withdraw existing Medicaid funds from those states that choose not to take the money.

Multiple dissenting opinions were issued. Justices Antonin Scalia, Anthony Kennedy, Clarence Thomas, and Samuel Alito offered a 66-page opinion that the entire ACA is unconstitutional. In an impassioned reading from the bench, Justice Kennedy accused the majority Justices of not just ruling on the law, but of essentially rewriting it for Congress.

The majority ruling "creates a debilitated, inoperable version of health care regulation that Congress did not enact and the public does not expect," said Justice Kennedy, reading from the dissent. "It makes enactment of sensible health care regulation more difficult, since Congress cannot start afresh but must take as its point of departure a jumble of now senseless provisions, provisions that certain interests favored under the Court’s new design will struggle to retain," he said.

The dissent also took issue with the ruling on Medicaid expansion, saying that states declining federal funds would end up subsidizing the expansion in other states through their residents’ tax dollars.

Justices Ruth Bader Ginsburg, Sonia Sotomayor, Stephen Breyer, and Elena Kagan also offered a dissent. Writing for that group, Justice Ginsburg said that the individual mandate was valid under the Commerce Clause. In the dissent, only Justice Ginsburg said that the Medicaid expansion was a proper use of Congress’ authority.

Outside the court and across Washington, supporters and opponents of the ACA gave their views on the decision.

"This is a hallelujah moment for American families," said Families USA Executive Director Ron Pollack, who spoke on the court steps.

Rep. Michael Burgess (R-Tex.), a physician, issued a statement condemning the Affordable Care Act.

"This decision by the Supreme Court is paramount and signals to the House of Representatives that it is our responsibility to repeal this over burdensome law which increases taxes on middle class families, and replace it with common-sense policies that encourage economic growth and protect Americans’ access to care. The House has voted to repeal the legislation and will do so again next month," said Rep. Burgess.

Dr. Jeremy A. Lazarus, president of the American Medical Association, praised the court’s decision. "This decision protects important improvements, such as ending coverage denials due to pre-existing conditions and lifetime caps on insurance, and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents’ health insurance policies," he said in a statement. "The decision upholds funding for important research on the effectiveness of drugs and treatments and protects expanded coverage for prevention and wellness care, which has already benefited about 54 million Americans."

Rep. Tom Price (R-Ga.), who has introduced H.R. 3000, a bill to replace the ACA, said that the court "has set a dangerous precedent.

"We have no choice but to exercise every possible legislative option to repeal this disastrous law, and the American people should know that House Republicans will continue to advocate on their behalf to restore personal control over health care decisions," he said in a statement.

*This story was updated on 6/29/2012.

WASHINGTON – In a voluminous, complex, and divergent set of opinions, the U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28.

The court's decision that the law’s expansion of Medicaid is not lawful – but that any state that wishes to take federal matching funds to bring on more enrollees can do so – may result in reduced access to health coverage and more uninsured patients seeking care in 2014.

*In a statement from the American Academy of Dermatology, President Dr. Daniel M. Siegel said, "While, in many respects, the health system reform law does not fully align with the AADA's health reform principles, there were some positive changes with respect to insurance reform, the expansion of health care coverage to more Americans, and strengthening of wellness efforts that were included. Unfortunately, the ACA missed an opportunity to permanently fix the flawed Medicare physician payment formula or enact meaningful liability reform, and created the Independent Payment Advisory Board (IPAB), all of which threaten to undermine access to care and destabilize health care delivery."

Alicia Ault/IMNG Medical Media

The majority, in a 59-page opinion, said that "the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people."

In their opinion, the majority found that the ACA’s individual mandate was a violation of the Constitution’s Commerce Clause. Chief Justice John Roberts, who wrote the opinion, said that the mandate "does not regulate existing commercial activity."

According to Justice Roberts, "it instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce."

The opinion jibed with the argument made by plaintiffs that the government should not be allowed to compel Americans into commerce.

The majority, however, also found that requiring Americans to pay a penalty if they did not buy health insurance was constitutional. The government did not call the penalty a "tax," but the court found that it is indeed a tax, and thus, within Congress’ powers.

The majority also agreed with the plaintiffs that the federal requirement that states either accept the money offered to expand Medicaid or forego all Medicaid funds was unduly coercive. Justice Roberts characterized the requirement as "a gun to the head."

He said that the ACA transforms Medicaid into an entirely new program and thus violates Congress’ spending power under the Constitution and also violates states’ sovereignty. However, "nothing in our opinion precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care."

Essentially, the majority opinion says that states could accept the funds to expand their Medicaid programs but the federal government could not withdraw existing Medicaid funds from those states that choose not to take the money.

Multiple dissenting opinions were issued. Justices Antonin Scalia, Anthony Kennedy, Clarence Thomas, and Samuel Alito offered a 66-page opinion that the entire ACA is unconstitutional. In an impassioned reading from the bench, Justice Kennedy accused the majority Justices of not just ruling on the law, but of essentially rewriting it for Congress.

The majority ruling "creates a debilitated, inoperable version of health care regulation that Congress did not enact and the public does not expect," said Justice Kennedy, reading from the dissent. "It makes enactment of sensible health care regulation more difficult, since Congress cannot start afresh but must take as its point of departure a jumble of now senseless provisions, provisions that certain interests favored under the Court’s new design will struggle to retain," he said.

The dissent also took issue with the ruling on Medicaid expansion, saying that states declining federal funds would end up subsidizing the expansion in other states through their residents’ tax dollars.

Justices Ruth Bader Ginsburg, Sonia Sotomayor, Stephen Breyer, and Elena Kagan also offered a dissent. Writing for that group, Justice Ginsburg said that the individual mandate was valid under the Commerce Clause. In the dissent, only Justice Ginsburg said that the Medicaid expansion was a proper use of Congress’ authority.

Outside the court and across Washington, supporters and opponents of the ACA gave their views on the decision.

"This is a hallelujah moment for American families," said Families USA Executive Director Ron Pollack, who spoke on the court steps.

Rep. Michael Burgess (R-Tex.), a physician, issued a statement condemning the Affordable Care Act.

"This decision by the Supreme Court is paramount and signals to the House of Representatives that it is our responsibility to repeal this over burdensome law which increases taxes on middle class families, and replace it with common-sense policies that encourage economic growth and protect Americans’ access to care. The House has voted to repeal the legislation and will do so again next month," said Rep. Burgess.

Dr. Jeremy A. Lazarus, president of the American Medical Association, praised the court’s decision. "This decision protects important improvements, such as ending coverage denials due to pre-existing conditions and lifetime caps on insurance, and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents’ health insurance policies," he said in a statement. "The decision upholds funding for important research on the effectiveness of drugs and treatments and protects expanded coverage for prevention and wellness care, which has already benefited about 54 million Americans."

Rep. Tom Price (R-Ga.), who has introduced H.R. 3000, a bill to replace the ACA, said that the court "has set a dangerous precedent.

"We have no choice but to exercise every possible legislative option to repeal this disastrous law, and the American people should know that House Republicans will continue to advocate on their behalf to restore personal control over health care decisions," he said in a statement.

*This story was updated on 6/29/2012.

WASHINGTON – In a voluminous, complex, and divergent set of opinions, the U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28.

The court's decision that the law’s expansion of Medicaid is not lawful – but that any state that wishes to take federal matching funds to bring on more enrollees can do so – may result in reduced access to health coverage and more uninsured patients seeking care in 2014.

*In a statement from the American Academy of Dermatology, President Dr. Daniel M. Siegel said, "While, in many respects, the health system reform law does not fully align with the AADA's health reform principles, there were some positive changes with respect to insurance reform, the expansion of health care coverage to more Americans, and strengthening of wellness efforts that were included. Unfortunately, the ACA missed an opportunity to permanently fix the flawed Medicare physician payment formula or enact meaningful liability reform, and created the Independent Payment Advisory Board (IPAB), all of which threaten to undermine access to care and destabilize health care delivery."

Alicia Ault/IMNG Medical Media

The majority, in a 59-page opinion, said that "the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people."

In their opinion, the majority found that the ACA’s individual mandate was a violation of the Constitution’s Commerce Clause. Chief Justice John Roberts, who wrote the opinion, said that the mandate "does not regulate existing commercial activity."

According to Justice Roberts, "it instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce."

The opinion jibed with the argument made by plaintiffs that the government should not be allowed to compel Americans into commerce.

The majority, however, also found that requiring Americans to pay a penalty if they did not buy health insurance was constitutional. The government did not call the penalty a "tax," but the court found that it is indeed a tax, and thus, within Congress’ powers.

The majority also agreed with the plaintiffs that the federal requirement that states either accept the money offered to expand Medicaid or forego all Medicaid funds was unduly coercive. Justice Roberts characterized the requirement as "a gun to the head."

He said that the ACA transforms Medicaid into an entirely new program and thus violates Congress’ spending power under the Constitution and also violates states’ sovereignty. However, "nothing in our opinion precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care."

Essentially, the majority opinion says that states could accept the funds to expand their Medicaid programs but the federal government could not withdraw existing Medicaid funds from those states that choose not to take the money.

Multiple dissenting opinions were issued. Justices Antonin Scalia, Anthony Kennedy, Clarence Thomas, and Samuel Alito offered a 66-page opinion that the entire ACA is unconstitutional. In an impassioned reading from the bench, Justice Kennedy accused the majority Justices of not just ruling on the law, but of essentially rewriting it for Congress.

The majority ruling "creates a debilitated, inoperable version of health care regulation that Congress did not enact and the public does not expect," said Justice Kennedy, reading from the dissent. "It makes enactment of sensible health care regulation more difficult, since Congress cannot start afresh but must take as its point of departure a jumble of now senseless provisions, provisions that certain interests favored under the Court’s new design will struggle to retain," he said.

The dissent also took issue with the ruling on Medicaid expansion, saying that states declining federal funds would end up subsidizing the expansion in other states through their residents’ tax dollars.

Justices Ruth Bader Ginsburg, Sonia Sotomayor, Stephen Breyer, and Elena Kagan also offered a dissent. Writing for that group, Justice Ginsburg said that the individual mandate was valid under the Commerce Clause. In the dissent, only Justice Ginsburg said that the Medicaid expansion was a proper use of Congress’ authority.

Outside the court and across Washington, supporters and opponents of the ACA gave their views on the decision.

"This is a hallelujah moment for American families," said Families USA Executive Director Ron Pollack, who spoke on the court steps.

Rep. Michael Burgess (R-Tex.), a physician, issued a statement condemning the Affordable Care Act.

"This decision by the Supreme Court is paramount and signals to the House of Representatives that it is our responsibility to repeal this over burdensome law which increases taxes on middle class families, and replace it with common-sense policies that encourage economic growth and protect Americans’ access to care. The House has voted to repeal the legislation and will do so again next month," said Rep. Burgess.

Dr. Jeremy A. Lazarus, president of the American Medical Association, praised the court’s decision. "This decision protects important improvements, such as ending coverage denials due to pre-existing conditions and lifetime caps on insurance, and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents’ health insurance policies," he said in a statement. "The decision upholds funding for important research on the effectiveness of drugs and treatments and protects expanded coverage for prevention and wellness care, which has already benefited about 54 million Americans."

Rep. Tom Price (R-Ga.), who has introduced H.R. 3000, a bill to replace the ACA, said that the court "has set a dangerous precedent.

"We have no choice but to exercise every possible legislative option to repeal this disastrous law, and the American people should know that House Republicans will continue to advocate on their behalf to restore personal control over health care decisions," he said in a statement.

*This story was updated on 6/29/2012.

WASHINGTON – In a voluminous, complex, and divergent set of opinions, the U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28.

The court’s decision that the law’s expansion of Medicaid is not lawful – but that any state that wishes to take federal matching funds to bring on more enrollees can do so – may result in reduced access to health coverage and more uninsured patients seeking care in 2014.

Alicia Ault/IMNG Medical Media

The majority, in a 59-page opinion, said that "the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people."

In their opinion, the majority found that the ACA’s individual mandate was a violation of the Constitution’s Commerce Clause. Chief Justice John Roberts, who wrote the opinion, said that the mandate "does not regulate existing commercial activity."

According to Justice Roberts, "it instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce."

The opinion jibed with the argument made by plaintiffs that the government should not be allowed to compel Americans into commerce.

The majority, however, also found that requiring Americans to pay a penalty if they did not buy health insurance was constitutional. The government did not call the penalty a "tax," but the court found that it is indeed a tax, and thus, within Congress’ powers.

The majority also agreed with the plaintiffs that the federal requirement that states either accept the money offered to expand Medicaid or forego all Medicaid funds was unduly coercive. Justice Roberts characterized the requirement as "a gun to the head."

He said that the ACA transforms Medicaid into an entirely new program and thus violates Congress’ spending power under the Constitution and also violates states’ sovereignty. However, "nothing in our opinion precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care."

Essentially, the majority opinion says that states could accept the funds to expand their Medicaid programs but the federal government could not withdraw existing Medicaid funds from those states that choose not to take the money.

Multiple dissenting opinions were issued. Justices Antonin Scalia, Anthony Kennedy, Clarence Thomas, and Samuel Alito offered a 66-page opinion that the entire ACA is unconstitutional. In an impassioned reading from the bench, Justice Kennedy accused the majority Justices of not just ruling on the law, but of essentially rewriting it for Congress.

The majority ruling "creates a debilitated, inoperable version of health care regulation that Congress did not enact and the public does not expect," said Justice Kennedy, reading from the dissent. "It makes enactment of sensible health care regulation more difficult, since Congress cannot start afresh but must take as its point of departure a jumble of now senseless provisions, provisions that certain interests favored under the Court’s new design will struggle to retain," he said.

The dissent also took issue with the ruling on Medicaid expansion, saying that states declining federal funds would end up subsidizing the expansion in other states through their residents’ tax dollars.

Justices Ruth Bader Ginsburg, Sonia Sotomayor, Stephen Breyer, and Elena Kagan also offered a dissent. Writing for that group, Justice Ginsburg said that the individual mandate was valid under the Commerce Clause. In the dissent, only Justice Ginsburg said that the Medicaid expansion was a proper use of Congress’ authority.

Outside the court and across Washington, supporters and opponents of the ACA gave their views on the decision.

"This is a hallelujah moment for American families," said Families USA Executive Director Ron Pollack, who spoke on the court steps.

Rep. Michael Burgess (R-Tex.), a physician, issued a statement condemning the Affordable Care Act.

"This decision by the Supreme Court is paramount and signals to the House of Representatives that it is our responsibility to repeal this over burdensome law which increases taxes on middle class families, and replace it with common-sense policies that encourage economic growth and protect Americans’ access to care. The House has voted to repeal the legislation and will do so again next month," said Rep. Burgess.

Dr. Jeremy A. Lazarus, president of the American Medical Association, praised the court’s decision. "This decision protects important improvements, such as ending coverage denials due to pre-existing conditions and lifetime caps on insurance, and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents’ health insurance policies," he said in a statement. "The decision upholds funding for important research on the effectiveness of drugs and treatments and protects expanded coverage for prevention and wellness care, which has already benefited about 54 million Americans."

Rep. Tom Price (R-Ga.), who has introduced H.R. 3000, a bill to replace the ACA, said that the court "has set a dangerous precedent.

"We have no choice but to exercise every possible legislative option to repeal this disastrous law, and the American people should know that House Republicans will continue to advocate on their behalf to restore personal control over health care decisions," he said in a statement.

WASHINGTON – In a voluminous, complex, and divergent set of opinions, the U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28.

The court’s decision that the law’s expansion of Medicaid is not lawful – but that any state that wishes to take federal matching funds to bring on more enrollees can do so – may result in reduced access to health coverage and more uninsured patients seeking care in 2014.

Alicia Ault/IMNG Medical Media

The majority, in a 59-page opinion, said that "the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people."

In their opinion, the majority found that the ACA’s individual mandate was a violation of the Constitution’s Commerce Clause. Chief Justice John Roberts, who wrote the opinion, said that the mandate "does not regulate existing commercial activity."

According to Justice Roberts, "it instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce."

The opinion jibed with the argument made by plaintiffs that the government should not be allowed to compel Americans into commerce.

The majority, however, also found that requiring Americans to pay a penalty if they did not buy health insurance was constitutional. The government did not call the penalty a "tax," but the court found that it is indeed a tax, and thus, within Congress’ powers.

The majority also agreed with the plaintiffs that the federal requirement that states either accept the money offered to expand Medicaid or forego all Medicaid funds was unduly coercive. Justice Roberts characterized the requirement as "a gun to the head."

He said that the ACA transforms Medicaid into an entirely new program and thus violates Congress’ spending power under the Constitution and also violates states’ sovereignty. However, "nothing in our opinion precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care."

Essentially, the majority opinion says that states could accept the funds to expand their Medicaid programs but the federal government could not withdraw existing Medicaid funds from those states that choose not to take the money.

Multiple dissenting opinions were issued. Justices Antonin Scalia, Anthony Kennedy, Clarence Thomas, and Samuel Alito offered a 66-page opinion that the entire ACA is unconstitutional. In an impassioned reading from the bench, Justice Kennedy accused the majority Justices of not just ruling on the law, but of essentially rewriting it for Congress.

The majority ruling "creates a debilitated, inoperable version of health care regulation that Congress did not enact and the public does not expect," said Justice Kennedy, reading from the dissent. "It makes enactment of sensible health care regulation more difficult, since Congress cannot start afresh but must take as its point of departure a jumble of now senseless provisions, provisions that certain interests favored under the Court’s new design will struggle to retain," he said.

The dissent also took issue with the ruling on Medicaid expansion, saying that states declining federal funds would end up subsidizing the expansion in other states through their residents’ tax dollars.

Justices Ruth Bader Ginsburg, Sonia Sotomayor, Stephen Breyer, and Elena Kagan also offered a dissent. Writing for that group, Justice Ginsburg said that the individual mandate was valid under the Commerce Clause. In the dissent, only Justice Ginsburg said that the Medicaid expansion was a proper use of Congress’ authority.

Outside the court and across Washington, supporters and opponents of the ACA gave their views on the decision.

"This is a hallelujah moment for American families," said Families USA Executive Director Ron Pollack, who spoke on the court steps.

Rep. Michael Burgess (R-Tex.), a physician, issued a statement condemning the Affordable Care Act.

"This decision by the Supreme Court is paramount and signals to the House of Representatives that it is our responsibility to repeal this over burdensome law which increases taxes on middle class families, and replace it with common-sense policies that encourage economic growth and protect Americans’ access to care. The House has voted to repeal the legislation and will do so again next month," said Rep. Burgess.

Dr. Jeremy A. Lazarus, president of the American Medical Association, praised the court’s decision. "This decision protects important improvements, such as ending coverage denials due to pre-existing conditions and lifetime caps on insurance, and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents’ health insurance policies," he said in a statement. "The decision upholds funding for important research on the effectiveness of drugs and treatments and protects expanded coverage for prevention and wellness care, which has already benefited about 54 million Americans."

Rep. Tom Price (R-Ga.), who has introduced H.R. 3000, a bill to replace the ACA, said that the court "has set a dangerous precedent.

"We have no choice but to exercise every possible legislative option to repeal this disastrous law, and the American people should know that House Republicans will continue to advocate on their behalf to restore personal control over health care decisions," he said in a statement.

WASHINGTON – In a voluminous, complex, and divergent set of opinions, the U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28.

The court’s decision that the law’s expansion of Medicaid is not lawful – but that any state that wishes to take federal matching funds to bring on more enrollees can do so – may result in reduced access to health coverage and more uninsured patients seeking care in 2014.

Alicia Ault/IMNG Medical Media

The majority, in a 59-page opinion, said that "the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people."

In their opinion, the majority found that the ACA’s individual mandate was a violation of the Constitution’s Commerce Clause. Chief Justice John Roberts, who wrote the opinion, said that the mandate "does not regulate existing commercial activity."

According to Justice Roberts, "it instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce."

The opinion jibed with the argument made by plaintiffs that the government should not be allowed to compel Americans into commerce.

The majority, however, also found that requiring Americans to pay a penalty if they did not buy health insurance was constitutional. The government did not call the penalty a "tax," but the court found that it is indeed a tax, and thus, within Congress’ powers.

The majority also agreed with the plaintiffs that the federal requirement that states either accept the money offered to expand Medicaid or forego all Medicaid funds was unduly coercive. Justice Roberts characterized the requirement as "a gun to the head."

He said that the ACA transforms Medicaid into an entirely new program and thus violates Congress’ spending power under the Constitution and also violates states’ sovereignty. However, "nothing in our opinion precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care."

Essentially, the majority opinion says that states could accept the funds to expand their Medicaid programs but the federal government could not withdraw existing Medicaid funds from those states that choose not to take the money.

Multiple dissenting opinions were issued. Justices Antonin Scalia, Anthony Kennedy, Clarence Thomas, and Samuel Alito offered a 66-page opinion that the entire ACA is unconstitutional. In an impassioned reading from the bench, Justice Kennedy accused the majority Justices of not just ruling on the law, but of essentially rewriting it for Congress.

The majority ruling "creates a debilitated, inoperable version of health care regulation that Congress did not enact and the public does not expect," said Justice Kennedy, reading from the dissent. "It makes enactment of sensible health care regulation more difficult, since Congress cannot start afresh but must take as its point of departure a jumble of now senseless provisions, provisions that certain interests favored under the Court’s new design will struggle to retain," he said.

The dissent also took issue with the ruling on Medicaid expansion, saying that states declining federal funds would end up subsidizing the expansion in other states through their residents’ tax dollars.

Justices Ruth Bader Ginsburg, Sonia Sotomayor, Stephen Breyer, and Elena Kagan also offered a dissent. Writing for that group, Justice Ginsburg said that the individual mandate was valid under the Commerce Clause. In the dissent, only Justice Ginsburg said that the Medicaid expansion was a proper use of Congress’ authority.

Outside the court and across Washington, supporters and opponents of the ACA gave their views on the decision.

"This is a hallelujah moment for American families," said Families USA Executive Director Ron Pollack, who spoke on the court steps.

Rep. Michael Burgess (R-Tex.), a physician, issued a statement condemning the Affordable Care Act.

"This decision by the Supreme Court is paramount and signals to the House of Representatives that it is our responsibility to repeal this over burdensome law which increases taxes on middle class families, and replace it with common-sense policies that encourage economic growth and protect Americans’ access to care. The House has voted to repeal the legislation and will do so again next month," said Rep. Burgess.

Dr. Jeremy A. Lazarus, president of the American Medical Association, praised the court’s decision. "This decision protects important improvements, such as ending coverage denials due to pre-existing conditions and lifetime caps on insurance, and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents’ health insurance policies," he said in a statement. "The decision upholds funding for important research on the effectiveness of drugs and treatments and protects expanded coverage for prevention and wellness care, which has already benefited about 54 million Americans."

Rep. Tom Price (R-Ga.), who has introduced H.R. 3000, a bill to replace the ACA, said that the court "has set a dangerous precedent.

"We have no choice but to exercise every possible legislative option to repeal this disastrous law, and the American people should know that House Republicans will continue to advocate on their behalf to restore personal control over health care decisions," he said in a statement.

The Food and Drug Administration on June 27 approved the obesity drug lorcaserin hydrochloride despite concerns that it might increase the risk of valvulopathy.

Lorcaserin (Belviq), a selective serotonin 2C receptor agonist manufactured by Swiss drug maker Arena Pharmaceuticals, was approved at a dosage of 10 mg twice a day as an adjunct to diet and exercise for weight management in adults with a body mass index of at least 30 kg/m² or at least 27 kg/m² with weight-related comorbidities.

More than one-third of American adults are considered obese, defined as having a BMI of at least 30, according to the Centers for Disease Control and Prevention.

According to Arena and Eisai Inc., which will distribute the drug, the FDA has recommended that lorcaserin be classified by the U.S. Drug Enforcement Administration as a scheduled drug.

The companies said in a statement that once the DEA has determined the final scheduling, Eisai will say when the drug will be available to patients and physicians.

The approval is a long time in coming, and after two advisory committee meetings were held about the drug. In September 2010, the majority of the committee voted against approval, expressing concerns about marginal weight loss and about a trial population that did not reflect the likely real-world use of the drug. In May of 2012, the committee met again. Although a majority was in favor of approval, there were lengthy discussions about the higher rate of valvulopathy associated with lorcaserin treatment in trials. Many called for further study of that issue, and the panel also recommended that patients be monitored with echocardiography at baseline and periodically during treatment.

Citing those concerns, Public Citizen’s Health Research Group sent a letter to the FDA on the eve of approval, urging the agency to reject the drug.

The FDA said it took safety issues into account, and noted in a press release announcing the approval that when the drug is used at the approved dose, it "does not appear to activate the serotonin 2B receptor." Activation of that receptor on heart tissue appears to have been the reason for valvulopathy that occurred in patients who took the weight loss drugs fenfluramine and dexfenfluramine, which were removed from the market in 1997.

The agency also said that valve function was assessed by echocardiography in 8,000 patients in lorcaserin trials and that there "was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients." However, the drug will be labeled to be used with caution in patients with heart failure.

Arena is also being required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial.

In studies, when compared with those taking a placebo, patients taking lorcaserin for up to a year had an average weight loss of 3%-3.7%, said the FDA. Almost half of nondiabetic patients lost at least 5% of their body weight, compared with less than a quarter of those taking a placebo. Of the subjects with type 2 diabetes, 38% taking lorcaserin lost at least 5% of their body weight, compared with 16% taking a placebo.

The labeling recommends that lorcaserin be discontinued in patients who fail to lose 5% of their body weight after 12 weeks. They are "unlikely to achieve clinically meaningful weight loss with continued treatment," according to the FDA.

The drug also should not be used during pregnancy. Side effects may include serotonin syndrome, particularly when lorcaserin is taken with therapies that increase serotonin levels or activate serotonin receptors, such as antimigraine drugs or antidepressants.

According to Arena and Eisai, lorcaserin may also cause problems with thinking, sleepiness, confusion, and, in higher doses, hallucinations, euphoria, or disassociation. It may also cause priapism, so it should be used with caution in men who are predisposed to the condition, said the companies.

The Food and Drug Administration on June 27 approved the obesity drug lorcaserin hydrochloride despite concerns that it might increase the risk of valvulopathy.

Lorcaserin (Belviq), a selective serotonin 2C receptor agonist manufactured by Swiss drug maker Arena Pharmaceuticals, was approved at a dosage of 10 mg twice a day as an adjunct to diet and exercise for weight management in adults with a body mass index of at least 30 kg/m² or at least 27 kg/m² with weight-related comorbidities.

More than one-third of American adults are considered obese, defined as having a BMI of at least 30, according to the Centers for Disease Control and Prevention.

According to Arena and Eisai Inc., which will distribute the drug, the FDA has recommended that lorcaserin be classified by the U.S. Drug Enforcement Administration as a scheduled drug.

The companies said in a statement that once the DEA has determined the final scheduling, Eisai will say when the drug will be available to patients and physicians.

The approval is a long time in coming, and after two advisory committee meetings were held about the drug. In September 2010, the majority of the committee voted against approval, expressing concerns about marginal weight loss and about a trial population that did not reflect the likely real-world use of the drug. In May of 2012, the committee met again. Although a majority was in favor of approval, there were lengthy discussions about the higher rate of valvulopathy associated with lorcaserin treatment in trials. Many called for further study of that issue, and the panel also recommended that patients be monitored with echocardiography at baseline and periodically during treatment.

Citing those concerns, Public Citizen’s Health Research Group sent a letter to the FDA on the eve of approval, urging the agency to reject the drug.

The FDA said it took safety issues into account, and noted in a press release announcing the approval that when the drug is used at the approved dose, it "does not appear to activate the serotonin 2B receptor." Activation of that receptor on heart tissue appears to have been the reason for valvulopathy that occurred in patients who took the weight loss drugs fenfluramine and dexfenfluramine, which were removed from the market in 1997.

The agency also said that valve function was assessed by echocardiography in 8,000 patients in lorcaserin trials and that there "was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients." However, the drug will be labeled to be used with caution in patients with heart failure.

Arena is also being required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial.

In studies, when compared with those taking a placebo, patients taking lorcaserin for up to a year had an average weight loss of 3%-3.7%, said the FDA. Almost half of nondiabetic patients lost at least 5% of their body weight, compared with less than a quarter of those taking a placebo. Of the subjects with type 2 diabetes, 38% taking lorcaserin lost at least 5% of their body weight, compared with 16% taking a placebo.

The labeling recommends that lorcaserin be discontinued in patients who fail to lose 5% of their body weight after 12 weeks. They are "unlikely to achieve clinically meaningful weight loss with continued treatment," according to the FDA.

The drug also should not be used during pregnancy. Side effects may include serotonin syndrome, particularly when lorcaserin is taken with therapies that increase serotonin levels or activate serotonin receptors, such as antimigraine drugs or antidepressants.

According to Arena and Eisai, lorcaserin may also cause problems with thinking, sleepiness, confusion, and, in higher doses, hallucinations, euphoria, or disassociation. It may also cause priapism, so it should be used with caution in men who are predisposed to the condition, said the companies.

The Food and Drug Administration on June 27 approved the obesity drug lorcaserin hydrochloride despite concerns that it might increase the risk of valvulopathy.

Lorcaserin (Belviq), a selective serotonin 2C receptor agonist manufactured by Swiss drug maker Arena Pharmaceuticals, was approved at a dosage of 10 mg twice a day as an adjunct to diet and exercise for weight management in adults with a body mass index of at least 30 kg/m² or at least 27 kg/m² with weight-related comorbidities.

More than one-third of American adults are considered obese, defined as having a BMI of at least 30, according to the Centers for Disease Control and Prevention.

According to Arena and Eisai Inc., which will distribute the drug, the FDA has recommended that lorcaserin be classified by the U.S. Drug Enforcement Administration as a scheduled drug.

The companies said in a statement that once the DEA has determined the final scheduling, Eisai will say when the drug will be available to patients and physicians.

The approval is a long time in coming, and after two advisory committee meetings were held about the drug. In September 2010, the majority of the committee voted against approval, expressing concerns about marginal weight loss and about a trial population that did not reflect the likely real-world use of the drug. In May of 2012, the committee met again. Although a majority was in favor of approval, there were lengthy discussions about the higher rate of valvulopathy associated with lorcaserin treatment in trials. Many called for further study of that issue, and the panel also recommended that patients be monitored with echocardiography at baseline and periodically during treatment.

Citing those concerns, Public Citizen’s Health Research Group sent a letter to the FDA on the eve of approval, urging the agency to reject the drug.

The FDA said it took safety issues into account, and noted in a press release announcing the approval that when the drug is used at the approved dose, it "does not appear to activate the serotonin 2B receptor." Activation of that receptor on heart tissue appears to have been the reason for valvulopathy that occurred in patients who took the weight loss drugs fenfluramine and dexfenfluramine, which were removed from the market in 1997.

The agency also said that valve function was assessed by echocardiography in 8,000 patients in lorcaserin trials and that there "was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients." However, the drug will be labeled to be used with caution in patients with heart failure.

Arena is also being required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial.

In studies, when compared with those taking a placebo, patients taking lorcaserin for up to a year had an average weight loss of 3%-3.7%, said the FDA. Almost half of nondiabetic patients lost at least 5% of their body weight, compared with less than a quarter of those taking a placebo. Of the subjects with type 2 diabetes, 38% taking lorcaserin lost at least 5% of their body weight, compared with 16% taking a placebo.

The labeling recommends that lorcaserin be discontinued in patients who fail to lose 5% of their body weight after 12 weeks. They are "unlikely to achieve clinically meaningful weight loss with continued treatment," according to the FDA.

The drug also should not be used during pregnancy. Side effects may include serotonin syndrome, particularly when lorcaserin is taken with therapies that increase serotonin levels or activate serotonin receptors, such as antimigraine drugs or antidepressants.

According to Arena and Eisai, lorcaserin may also cause problems with thinking, sleepiness, confusion, and, in higher doses, hallucinations, euphoria, or disassociation. It may also cause priapism, so it should be used with caution in men who are predisposed to the condition, said the companies.

It’s a central tenet of being a physician: Do all you can to help the patient. But so is "first, do no harm," and often, the harm comes from doing too much, too often. That’s the message from a growing number of physicians and organizations pushing for a sea change in how medicine is delivered, starting with the individual doctor.

In late April, many of the interested parties met in Boston to outline the problem and strategize on how to shore up evidence-based medicine and prevent knee-jerk test ordering and unnecessary treatment. "Avoiding Avoidable Care" was organized by the Lown Cardiovascular Research Foundation and the New America Foundation, and was cohosted by the Institute of Medicine.

The drivers of such avoidable or unnecessary care have been widely described: malpractice fears (so-called "defensive" medicine), and the economics of the health care system, in which volume is rewarded with greater income. But there also is "perhaps a misunderstanding of what is the ethical obligation to patients," said Dr. Vikas Saini, an organizer of the conference, codirector of the Lown Center, and president of the Lown Foundation.

Both patients and physicians tend to operate within the cultural framework that says more is better, he added. For physicians who are pressed for time, or uncertain, often "the best way forward is to order tests or pursue procedures," said Dr. Saini in an interview.

"If we start thinking differently about each of these [drivers], we’ll be going a long way towards reducing avoidable care," he said.

"We all have patients who have ideas that are completely outlandish," he said. However, most patients can be steered away from unnecessary procedures by clarifying what is appropriate and inappropriate, especially when the advice is tailored to an individual’s situation.

One strategy for the patient who demands certain tests is to talk about the potential for false positives. "Just pointing that out and reviewing the dilemma and the risk of triggering a cascade of more tests and procedures while increasing the risk of a side effect or adverse outcome [are] usually enough if the patient feels you have thought about it and given it a considered review," said Dr. Saini.

Often, the demands for tests or procedures are about seeking certainty and wanting to know that the physician cares, he said. Sometimes, it’s just about satisfying a patient’s curiosity; he or she may just "want to know."

But results can just as often lead to false knowledge. The key is to convincingly explain why conducting a test or procedure should be done only if it has the potential to change the course of care, he said.

Dr. Saini said that many patients show up at his office seeking a battery of 5 or 10 biomarker tests. The results don’t trigger recommendations for any specific therapy. "Instead, we recommend doing what they need to do anyway: eat right, exercise, and don’t smoke," he said.

To make progress in reducing unnecessary care, the physician has to be sensitive to the patient’s needs and be able to hold a conversation about what works and what doesn’t, said Dr. Saini. Patients will understand and accept what you have to say "if they feel you are on their side," he said.

This concept of shared decision making is important for another reason: It can help reduce malpractice risk. "The best protection is to be able to talk to the patient, understand their needs and concerns, and establish enough trust in the relationship" so that if something does not go according to plan, "there is not an immediate view that this is an error," said Dr. Saini.

And while physicians may interpret the Hippocratic oath to mean "do everything possible," that can actually create more harm. Clinical trials of screening tests or procedures discuss the "numbers needed to treat," but "we need to be more aware of the numbers needed to harm," he said.

Dr. Alan R. Schroeder, chief of pediatric inpatient services at Santa Clara Valley Medical Center, San Jose, Calif., said the problem is that the short-term harm from doing nothing often seems more tangible than the long-term harm. For instance, if antibiotics are withheld, the patient could get an overwhelming infection. The long-term threat of antibiotic resistance is far down the road, and not of great concern when the individual patient is being treated, said Dr. Schroeder, who has written and lectured on what he calls "safely doing less."

"Your job and your role and professional obligation is to do what is right for the patient."

This "more is better" concept takes root in medical school and is usually firmly ingrained by the time a physician goes into practice, he said. The thrust of medical education is that learning comes by way of making differential diagnoses; but generating those diagnoses requires extensive work-ups with lots of tests, or trying out different therapies to see what works, said Dr. Schroeder. Students and residents are taught that "if you miss something, you’ve failed miserably," he said.

Getting Out of a Practice Rut

As a teacher and a researcher, Dr. Schroeder has observed firsthand how those attitudes carry over into practice. He has taken a special interest in producing research that will help physicians practice less from habit and more from proven experience.

For instance, in 2008, Santa Clara Valley Medical Center decided to adopt recommendations from the U.K. National Institute for Health and Clinical Excellence 2007 clinical guideline that employed an algorithm for doing less imaging of the urinary tract in children who presented with a fever. As at most institutions, urinary tract imaging was routine for all febrile children with urinary tract infections, as a means of ruling out any underlying abnormalities.

But there was no clinical basis for imaging all children, Dr. Schroeder said. He studied the impact of the guideline and found that by letting the 90 pediatricians in the group know that it was acceptable to do less, the rates of imaging went down dramatically, he said. Also, the use of voiding cystourethrography and prophylactic antibiotics went down substantially "without increasing the risk of UTI recurrence within 6 months and without an apparent decrease in detection of high-grade vesicoureteral reflux (VUR)," according to his study (Arch Pediatr Adolesc Med. 2011;165:1027-32).

Similarly, at Atrius Health, physician behavior changed in response to some education and data showing that screening colonoscopy was being ordered at intervals that weren’t supported by any evidence, said Dr. Tom Denberg, vice president for quality and patient safety at Harvard Vanguard Physician Associates and Atrius Health. Atrius is a nonprofit alliance of six physician groups in eastern and central Massachusetts.

There was a huge amount of variation in how frequently gastroenterologists were urging patients to come back for repeat colonoscopies – even though there were at least a half-dozen guidelines that should have been informing their recommendations, said Dr. Denberg.

Why weren’t they following the guidelines? In part, because the physicians thought that the colonoscopies would give absolute certainty, and that if patients were brought back more often, nothing would fall through the cracks, such as a flat polyp, which is harder to detect, said Dr. Denberg.

Atrius brought in an expert GI specialist who reviewed the guidelines on screening intervals and also discussed the costs associated with repeat tests. The expert said that screening more often did not prolong life in most cases, or detect flat polyps more often. A malpractice attorney addressed the group, explaining that their litigation risk from not screening – even if a cancer developed – was minimal, especially if the physicians were following the guidelines and documenting procedures and results.

The conversations alleviated physicians’ concerns, and ultimately adherence to the guidelines more than doubled to acceptable levels, Dr. Denberg said.

Global Change Starts Locally

For many physicians – especially those practicing in a fee-for-service environment and in smaller practices that don’t have access to a lot of resources – there might not be much motivation to reduce unnecessary care. In those cases, "we have to appeal to physicians to do the right thing," said Dr. Denberg.

A motivated group of physicians – whether it’s 2 or 20 – who want to reduce inappropriate care can get together and conduct chart reviews to compare how they practice. This exercise illuminates variations in practice and lack of adherence to established guidelines. Reducing variation translates to less waste. Dr. Denberg said that it also gives physicians the leverage they need to dissuade patients from having certain tests or procedures that aren’t backed by clinical evidence, such as MRI for low back pain.

He also talks to primary care physicians about how much administrative time they can save by ordering fewer tests, especially when there is an absence of clear-cut symptoms or any clear clinical rationale. With every set of tests, the physician has to review the results and discuss them with the patient. Often, there are false positives, which require additional tests, or there are abnormal results that aren’t clinically relevant.

"A lot of that is avoidable," said Dr. Denberg.

Dr. Saini agrees that testing that is done in part to ward off malpractice suits often leads to more resource use, not more clarity. "Your job and your role and professional obligation is to do what is right for the patient," he said. "If you find yourself ordering a test or procedure because you think it could be a malpractice issue, then you’re thinking about yourself, not the patient."

Physicians are safe if they stick to the evidence, Dr. Schroeder said. "If you are doing less and it’s evidence based, your risk of malpractice goes down dramatically," he said.

Another key is to be skeptical of doing things just because it is an existing practice, said Dr. Schroeder. "Physicians need to keep challenging existing practices," he said.

It’s a central tenet of being a physician: Do all you can to help the patient. But so is "first, do no harm," and often, the harm comes from doing too much, too often. That’s the message from a growing number of physicians and organizations pushing for a sea change in how medicine is delivered, starting with the individual doctor.

In late April, many of the interested parties met in Boston to outline the problem and strategize on how to shore up evidence-based medicine and prevent knee-jerk test ordering and unnecessary treatment. "Avoiding Avoidable Care" was organized by the Lown Cardiovascular Research Foundation and the New America Foundation, and was cohosted by the Institute of Medicine.

The drivers of such avoidable or unnecessary care have been widely described: malpractice fears (so-called "defensive" medicine), and the economics of the health care system, in which volume is rewarded with greater income. But there also is "perhaps a misunderstanding of what is the ethical obligation to patients," said Dr. Vikas Saini, an organizer of the conference, codirector of the Lown Center, and president of the Lown Foundation.

Both patients and physicians tend to operate within the cultural framework that says more is better, he added. For physicians who are pressed for time, or uncertain, often "the best way forward is to order tests or pursue procedures," said Dr. Saini in an interview.

"If we start thinking differently about each of these [drivers], we’ll be going a long way towards reducing avoidable care," he said.

"We all have patients who have ideas that are completely outlandish," he said. However, most patients can be steered away from unnecessary procedures by clarifying what is appropriate and inappropriate, especially when the advice is tailored to an individual’s situation.

One strategy for the patient who demands certain tests is to talk about the potential for false positives. "Just pointing that out and reviewing the dilemma and the risk of triggering a cascade of more tests and procedures while increasing the risk of a side effect or adverse outcome [are] usually enough if the patient feels you have thought about it and given it a considered review," said Dr. Saini.

Often, the demands for tests or procedures are about seeking certainty and wanting to know that the physician cares, he said. Sometimes, it’s just about satisfying a patient’s curiosity; he or she may just "want to know."

But results can just as often lead to false knowledge. The key is to convincingly explain why conducting a test or procedure should be done only if it has the potential to change the course of care, he said.

Dr. Saini said that many patients show up at his office seeking a battery of 5 or 10 biomarker tests. The results don’t trigger recommendations for any specific therapy. "Instead, we recommend doing what they need to do anyway: eat right, exercise, and don’t smoke," he said.

To make progress in reducing unnecessary care, the physician has to be sensitive to the patient’s needs and be able to hold a conversation about what works and what doesn’t, said Dr. Saini. Patients will understand and accept what you have to say "if they feel you are on their side," he said.

This concept of shared decision making is important for another reason: It can help reduce malpractice risk. "The best protection is to be able to talk to the patient, understand their needs and concerns, and establish enough trust in the relationship" so that if something does not go according to plan, "there is not an immediate view that this is an error," said Dr. Saini.

And while physicians may interpret the Hippocratic oath to mean "do everything possible," that can actually create more harm. Clinical trials of screening tests or procedures discuss the "numbers needed to treat," but "we need to be more aware of the numbers needed to harm," he said.

Dr. Alan R. Schroeder, chief of pediatric inpatient services at Santa Clara Valley Medical Center, San Jose, Calif., said the problem is that the short-term harm from doing nothing often seems more tangible than the long-term harm. For instance, if antibiotics are withheld, the patient could get an overwhelming infection. The long-term threat of antibiotic resistance is far down the road, and not of great concern when the individual patient is being treated, said Dr. Schroeder, who has written and lectured on what he calls "safely doing less."

"Your job and your role and professional obligation is to do what is right for the patient."

This "more is better" concept takes root in medical school and is usually firmly ingrained by the time a physician goes into practice, he said. The thrust of medical education is that learning comes by way of making differential diagnoses; but generating those diagnoses requires extensive work-ups with lots of tests, or trying out different therapies to see what works, said Dr. Schroeder. Students and residents are taught that "if you miss something, you’ve failed miserably," he said.

Getting Out of a Practice Rut

As a teacher and a researcher, Dr. Schroeder has observed firsthand how those attitudes carry over into practice. He has taken a special interest in producing research that will help physicians practice less from habit and more from proven experience.

For instance, in 2008, Santa Clara Valley Medical Center decided to adopt recommendations from the U.K. National Institute for Health and Clinical Excellence 2007 clinical guideline that employed an algorithm for doing less imaging of the urinary tract in children who presented with a fever. As at most institutions, urinary tract imaging was routine for all febrile children with urinary tract infections, as a means of ruling out any underlying abnormalities.

But there was no clinical basis for imaging all children, Dr. Schroeder said. He studied the impact of the guideline and found that by letting the 90 pediatricians in the group know that it was acceptable to do less, the rates of imaging went down dramatically, he said. Also, the use of voiding cystourethrography and prophylactic antibiotics went down substantially "without increasing the risk of UTI recurrence within 6 months and without an apparent decrease in detection of high-grade vesicoureteral reflux (VUR)," according to his study (Arch Pediatr Adolesc Med. 2011;165:1027-32).

Similarly, at Atrius Health, physician behavior changed in response to some education and data showing that screening colonoscopy was being ordered at intervals that weren’t supported by any evidence, said Dr. Tom Denberg, vice president for quality and patient safety at Harvard Vanguard Physician Associates and Atrius Health. Atrius is a nonprofit alliance of six physician groups in eastern and central Massachusetts.

There was a huge amount of variation in how frequently gastroenterologists were urging patients to come back for repeat colonoscopies – even though there were at least a half-dozen guidelines that should have been informing their recommendations, said Dr. Denberg.

Why weren’t they following the guidelines? In part, because the physicians thought that the colonoscopies would give absolute certainty, and that if patients were brought back more often, nothing would fall through the cracks, such as a flat polyp, which is harder to detect, said Dr. Denberg.

Atrius brought in an expert GI specialist who reviewed the guidelines on screening intervals and also discussed the costs associated with repeat tests. The expert said that screening more often did not prolong life in most cases, or detect flat polyps more often. A malpractice attorney addressed the group, explaining that their litigation risk from not screening – even if a cancer developed – was minimal, especially if the physicians were following the guidelines and documenting procedures and results.

The conversations alleviated physicians’ concerns, and ultimately adherence to the guidelines more than doubled to acceptable levels, Dr. Denberg said.

Global Change Starts Locally

For many physicians – especially those practicing in a fee-for-service environment and in smaller practices that don’t have access to a lot of resources – there might not be much motivation to reduce unnecessary care. In those cases, "we have to appeal to physicians to do the right thing," said Dr. Denberg.

A motivated group of physicians – whether it’s 2 or 20 – who want to reduce inappropriate care can get together and conduct chart reviews to compare how they practice. This exercise illuminates variations in practice and lack of adherence to established guidelines. Reducing variation translates to less waste. Dr. Denberg said that it also gives physicians the leverage they need to dissuade patients from having certain tests or procedures that aren’t backed by clinical evidence, such as MRI for low back pain.

He also talks to primary care physicians about how much administrative time they can save by ordering fewer tests, especially when there is an absence of clear-cut symptoms or any clear clinical rationale. With every set of tests, the physician has to review the results and discuss them with the patient. Often, there are false positives, which require additional tests, or there are abnormal results that aren’t clinically relevant.

"A lot of that is avoidable," said Dr. Denberg.

Dr. Saini agrees that testing that is done in part to ward off malpractice suits often leads to more resource use, not more clarity. "Your job and your role and professional obligation is to do what is right for the patient," he said. "If you find yourself ordering a test or procedure because you think it could be a malpractice issue, then you’re thinking about yourself, not the patient."

Physicians are safe if they stick to the evidence, Dr. Schroeder said. "If you are doing less and it’s evidence based, your risk of malpractice goes down dramatically," he said.

Another key is to be skeptical of doing things just because it is an existing practice, said Dr. Schroeder. "Physicians need to keep challenging existing practices," he said.

It’s a central tenet of being a physician: Do all you can to help the patient. But so is "first, do no harm," and often, the harm comes from doing too much, too often. That’s the message from a growing number of physicians and organizations pushing for a sea change in how medicine is delivered, starting with the individual doctor.

In late April, many of the interested parties met in Boston to outline the problem and strategize on how to shore up evidence-based medicine and prevent knee-jerk test ordering and unnecessary treatment. "Avoiding Avoidable Care" was organized by the Lown Cardiovascular Research Foundation and the New America Foundation, and was cohosted by the Institute of Medicine.

The drivers of such avoidable or unnecessary care have been widely described: malpractice fears (so-called "defensive" medicine), and the economics of the health care system, in which volume is rewarded with greater income. But there also is "perhaps a misunderstanding of what is the ethical obligation to patients," said Dr. Vikas Saini, an organizer of the conference, codirector of the Lown Center, and president of the Lown Foundation.

Both patients and physicians tend to operate within the cultural framework that says more is better, he added. For physicians who are pressed for time, or uncertain, often "the best way forward is to order tests or pursue procedures," said Dr. Saini in an interview.

"If we start thinking differently about each of these [drivers], we’ll be going a long way towards reducing avoidable care," he said.

"We all have patients who have ideas that are completely outlandish," he said. However, most patients can be steered away from unnecessary procedures by clarifying what is appropriate and inappropriate, especially when the advice is tailored to an individual’s situation.

One strategy for the patient who demands certain tests is to talk about the potential for false positives. "Just pointing that out and reviewing the dilemma and the risk of triggering a cascade of more tests and procedures while increasing the risk of a side effect or adverse outcome [are] usually enough if the patient feels you have thought about it and given it a considered review," said Dr. Saini.

Often, the demands for tests or procedures are about seeking certainty and wanting to know that the physician cares, he said. Sometimes, it’s just about satisfying a patient’s curiosity; he or she may just "want to know."

But results can just as often lead to false knowledge. The key is to convincingly explain why conducting a test or procedure should be done only if it has the potential to change the course of care, he said.

Dr. Saini said that many patients show up at his office seeking a battery of 5 or 10 biomarker tests. The results don’t trigger recommendations for any specific therapy. "Instead, we recommend doing what they need to do anyway: eat right, exercise, and don’t smoke," he said.

To make progress in reducing unnecessary care, the physician has to be sensitive to the patient’s needs and be able to hold a conversation about what works and what doesn’t, said Dr. Saini. Patients will understand and accept what you have to say "if they feel you are on their side," he said.

This concept of shared decision making is important for another reason: It can help reduce malpractice risk. "The best protection is to be able to talk to the patient, understand their needs and concerns, and establish enough trust in the relationship" so that if something does not go according to plan, "there is not an immediate view that this is an error," said Dr. Saini.

And while physicians may interpret the Hippocratic oath to mean "do everything possible," that can actually create more harm. Clinical trials of screening tests or procedures discuss the "numbers needed to treat," but "we need to be more aware of the numbers needed to harm," he said.

Dr. Alan R. Schroeder, chief of pediatric inpatient services at Santa Clara Valley Medical Center, San Jose, Calif., said the problem is that the short-term harm from doing nothing often seems more tangible than the long-term harm. For instance, if antibiotics are withheld, the patient could get an overwhelming infection. The long-term threat of antibiotic resistance is far down the road, and not of great concern when the individual patient is being treated, said Dr. Schroeder, who has written and lectured on what he calls "safely doing less."

"Your job and your role and professional obligation is to do what is right for the patient."

This "more is better" concept takes root in medical school and is usually firmly ingrained by the time a physician goes into practice, he said. The thrust of medical education is that learning comes by way of making differential diagnoses; but generating those diagnoses requires extensive work-ups with lots of tests, or trying out different therapies to see what works, said Dr. Schroeder. Students and residents are taught that "if you miss something, you’ve failed miserably," he said.

Getting Out of a Practice Rut

As a teacher and a researcher, Dr. Schroeder has observed firsthand how those attitudes carry over into practice. He has taken a special interest in producing research that will help physicians practice less from habit and more from proven experience.

For instance, in 2008, Santa Clara Valley Medical Center decided to adopt recommendations from the U.K. National Institute for Health and Clinical Excellence 2007 clinical guideline that employed an algorithm for doing less imaging of the urinary tract in children who presented with a fever. As at most institutions, urinary tract imaging was routine for all febrile children with urinary tract infections, as a means of ruling out any underlying abnormalities.

But there was no clinical basis for imaging all children, Dr. Schroeder said. He studied the impact of the guideline and found that by letting the 90 pediatricians in the group know that it was acceptable to do less, the rates of imaging went down dramatically, he said. Also, the use of voiding cystourethrography and prophylactic antibiotics went down substantially "without increasing the risk of UTI recurrence within 6 months and without an apparent decrease in detection of high-grade vesicoureteral reflux (VUR)," according to his study (Arch Pediatr Adolesc Med. 2011;165:1027-32).

Similarly, at Atrius Health, physician behavior changed in response to some education and data showing that screening colonoscopy was being ordered at intervals that weren’t supported by any evidence, said Dr. Tom Denberg, vice president for quality and patient safety at Harvard Vanguard Physician Associates and Atrius Health. Atrius is a nonprofit alliance of six physician groups in eastern and central Massachusetts.

There was a huge amount of variation in how frequently gastroenterologists were urging patients to come back for repeat colonoscopies – even though there were at least a half-dozen guidelines that should have been informing their recommendations, said Dr. Denberg.

Why weren’t they following the guidelines? In part, because the physicians thought that the colonoscopies would give absolute certainty, and that if patients were brought back more often, nothing would fall through the cracks, such as a flat polyp, which is harder to detect, said Dr. Denberg.

Atrius brought in an expert GI specialist who reviewed the guidelines on screening intervals and also discussed the costs associated with repeat tests. The expert said that screening more often did not prolong life in most cases, or detect flat polyps more often. A malpractice attorney addressed the group, explaining that their litigation risk from not screening – even if a cancer developed – was minimal, especially if the physicians were following the guidelines and documenting procedures and results.

The conversations alleviated physicians’ concerns, and ultimately adherence to the guidelines more than doubled to acceptable levels, Dr. Denberg said.

Global Change Starts Locally

For many physicians – especially those practicing in a fee-for-service environment and in smaller practices that don’t have access to a lot of resources – there might not be much motivation to reduce unnecessary care. In those cases, "we have to appeal to physicians to do the right thing," said Dr. Denberg.

A motivated group of physicians – whether it’s 2 or 20 – who want to reduce inappropriate care can get together and conduct chart reviews to compare how they practice. This exercise illuminates variations in practice and lack of adherence to established guidelines. Reducing variation translates to less waste. Dr. Denberg said that it also gives physicians the leverage they need to dissuade patients from having certain tests or procedures that aren’t backed by clinical evidence, such as MRI for low back pain.

He also talks to primary care physicians about how much administrative time they can save by ordering fewer tests, especially when there is an absence of clear-cut symptoms or any clear clinical rationale. With every set of tests, the physician has to review the results and discuss them with the patient. Often, there are false positives, which require additional tests, or there are abnormal results that aren’t clinically relevant.

"A lot of that is avoidable," said Dr. Denberg.

Dr. Saini agrees that testing that is done in part to ward off malpractice suits often leads to more resource use, not more clarity. "Your job and your role and professional obligation is to do what is right for the patient," he said. "If you find yourself ordering a test or procedure because you think it could be a malpractice issue, then you’re thinking about yourself, not the patient."

Physicians are safe if they stick to the evidence, Dr. Schroeder said. "If you are doing less and it’s evidence based, your risk of malpractice goes down dramatically," he said.

Another key is to be skeptical of doing things just because it is an existing practice, said Dr. Schroeder. "Physicians need to keep challenging existing practices," he said.

WASHINGTON – With liability reform more or less stalled on the federal level, emergency physicians have been working at the nation’s statehouses to promote legislation important to the specialty.

At a session of ACEP’s Leadership and Advocacy Conference, physicians from three states – Ohio, North Carolina, and Michigan – shared their experiences in developing liability legislation and working to get it made into law. All emphasized the importance of developing a presence in the statehouses and forging relationships with legislators.

Dr. Gary R. Katz, a former president of the Ohio Chapter of ACEP and director of patient satisfaction quality for Premier Physician Services, had several words of warning, as well. Expanding your circle of allies can weaken the focus on protecting against EMTALA [Emergency Medical Treatment and Active Labor Act]-related lawsuits, he cautioned.

It’s also important to know your enemies, Dr. Katz added. When tort reform was being debated in Ohio, a former ACEP Chapter president testified in the state Senate in support of the plaintiffs’ attorneys’ arguments, he said. That was not only unexpected, but it also "took the wind out of our sails," Dr. Katz said.

Ohio passed a wave of reforms in 2003, which helped reduce the number of lawsuits filed. But the Ohio ACEP Chapter argued that EMTALA created a unique situation that still needed to be remedied. In pushing for new legislation, the group decided to shift the focus away from torts. Instead, they argued, the risk of litigation was causing physician shortages and raising costs and, thus, reducing access to care.

In the 2008-2009 legislative session, the Ohio ACEP Chapter copied the language from the Texas tort reform law and found a legislator to sponsor the bill. Other physician groups, including the Ohio State Medical Association, also supported the effort.

The legislation was well received in several committee hearings and was passed by the Senate, but it did not win the vote in the House, Dr. Katz said.

In 2010, the Ohio House was more strongly Republican. "We felt better about our chances," he said. The model legislation was introduced in March 2011 but has not had any hearings yet.

In North Carolina, the battle for liability reform began in 2004 when one of the largest malpractice insurers in the state ceased operations there, said Dr. Gregory Cannon, president-elect of the N.C. ACEP Chapter and a staff physician at the WakeMed hospital system with Wake Emergency Physicians, Raleigh.

It was important to determine the lay of the land – most importantly, that Democrats, who have traditionally opposed liability reform, had dominated the state legislature for more than 100 years, said Dr. Cannon. In addition, the state’s governors had been Democrats for the past 2 decades.

The N.C. ACEP Chapter began working closely with the hospital association and with state medical and specialty societies, Dr. Cannon said. The Chapter also increased its political action committee activities and targeted its contributions on legislators who were supportive. Building relationships with the lawmakers was key, as was educating them with model legislation, Dr. Cannon said.

By the 2010 session, there was a subtle shift in the legislature, as it tilted Republican. A reform bill (Senate Bill 33) was introduced in 2011. It included a $250,000 cap on noneconomic damages and a gross negligence standard for EMTALA-related suits. Eventually, as the bill made its way through the legislature, the cap was raised to $500,000 and the gross negligence standard was removed. Although the bill passed the House and Senate, Gov. Beverly Perdue (D) vetoed it, saying that it did not go far enough to protect patients.

The N.C. Chapter and state physician groups unleashed a lobbying campaign to override the veto and won. The reform law took effect in October 2011. It includes the $500,000 cap, protection for EMTALA-related care, and separate trials for negligence and damages.

Since October, malpractice claims have declined by 30%, said Dr. Cannon, who added that his malpractice premiums have been reduced by 8%.

He said that the physicians learned from the effort that "it’s easier to play defense than offense."

Bottom line: "Wait for your pitch, but once you have it, be ready to hit the ball," he said.

Physicians in Michigan did not wait for a pitch – instead, they made one, using the Georgia reform bill as a model, said Dr. Bradley J. Uren, president-elect of the Michigan College of Emergency Physicians and a clinical instructor at the University of Michigan, Ann Arbor.

But they have not had much success. In part, it’s because there is a perception that the malpractice crisis has passed, Dr. Uren said. Two reform laws put into place in the late 1980s and early 1990s included caps on noneconomic damages that have adjusted upward every year and a shorter statute of limitations. Physicians have to be given at least 6 months’ notice they will be sued, and an affidavit of merit is required.

Lawsuits have been vastly diminished, which means physicians had to find another way to make their case for additional reform, Dr. Uren said. For instance, emergency physicians sought protection for EMTALA-related care, arguing that it is a unique situation, but the state medical society saw that as a special carve-out that did not benefit other physicians, he said.

The fight continues, with a variety of bills being introduced to address different aspects of malpractice, said Dr. Uren. One bill proposed that the same malpractice standard used for attorneys be applied to physicians. It is almost impossible to sue an attorney for malpractice, he said.

On May 3, a bill was introduced in the Michigan Senate that would use the gross negligence standard to protect physicians who provide emergency care. It is the same bill, based on the Georgia law, that was originally introduced in 2009, Dr. Uren said.

The Michigan physicians have learned to be patient, he said. They have also learned to "never let a good crisis pass you by," he added.

WASHINGTON – With liability reform more or less stalled on the federal level, emergency physicians have been working at the nation’s statehouses to promote legislation important to the specialty.

At a session of ACEP’s Leadership and Advocacy Conference, physicians from three states – Ohio, North Carolina, and Michigan – shared their experiences in developing liability legislation and working to get it made into law. All emphasized the importance of developing a presence in the statehouses and forging relationships with legislators.

Dr. Gary R. Katz, a former president of the Ohio Chapter of ACEP and director of patient satisfaction quality for Premier Physician Services, had several words of warning, as well. Expanding your circle of allies can weaken the focus on protecting against EMTALA [Emergency Medical Treatment and Active Labor Act]-related lawsuits, he cautioned.

It’s also important to know your enemies, Dr. Katz added. When tort reform was being debated in Ohio, a former ACEP Chapter president testified in the state Senate in support of the plaintiffs’ attorneys’ arguments, he said. That was not only unexpected, but it also "took the wind out of our sails," Dr. Katz said.

Ohio passed a wave of reforms in 2003, which helped reduce the number of lawsuits filed. But the Ohio ACEP Chapter argued that EMTALA created a unique situation that still needed to be remedied. In pushing for new legislation, the group decided to shift the focus away from torts. Instead, they argued, the risk of litigation was causing physician shortages and raising costs and, thus, reducing access to care.

In the 2008-2009 legislative session, the Ohio ACEP Chapter copied the language from the Texas tort reform law and found a legislator to sponsor the bill. Other physician groups, including the Ohio State Medical Association, also supported the effort.

The legislation was well received in several committee hearings and was passed by the Senate, but it did not win the vote in the House, Dr. Katz said.

In 2010, the Ohio House was more strongly Republican. "We felt better about our chances," he said. The model legislation was introduced in March 2011 but has not had any hearings yet.

In North Carolina, the battle for liability reform began in 2004 when one of the largest malpractice insurers in the state ceased operations there, said Dr. Gregory Cannon, president-elect of the N.C. ACEP Chapter and a staff physician at the WakeMed hospital system with Wake Emergency Physicians, Raleigh.

It was important to determine the lay of the land – most importantly, that Democrats, who have traditionally opposed liability reform, had dominated the state legislature for more than 100 years, said Dr. Cannon. In addition, the state’s governors had been Democrats for the past 2 decades.

The N.C. ACEP Chapter began working closely with the hospital association and with state medical and specialty societies, Dr. Cannon said. The Chapter also increased its political action committee activities and targeted its contributions on legislators who were supportive. Building relationships with the lawmakers was key, as was educating them with model legislation, Dr. Cannon said.

By the 2010 session, there was a subtle shift in the legislature, as it tilted Republican. A reform bill (Senate Bill 33) was introduced in 2011. It included a $250,000 cap on noneconomic damages and a gross negligence standard for EMTALA-related suits. Eventually, as the bill made its way through the legislature, the cap was raised to $500,000 and the gross negligence standard was removed. Although the bill passed the House and Senate, Gov. Beverly Perdue (D) vetoed it, saying that it did not go far enough to protect patients.

The N.C. Chapter and state physician groups unleashed a lobbying campaign to override the veto and won. The reform law took effect in October 2011. It includes the $500,000 cap, protection for EMTALA-related care, and separate trials for negligence and damages.

Since October, malpractice claims have declined by 30%, said Dr. Cannon, who added that his malpractice premiums have been reduced by 8%.

He said that the physicians learned from the effort that "it’s easier to play defense than offense."

Bottom line: "Wait for your pitch, but once you have it, be ready to hit the ball," he said.

Physicians in Michigan did not wait for a pitch – instead, they made one, using the Georgia reform bill as a model, said Dr. Bradley J. Uren, president-elect of the Michigan College of Emergency Physicians and a clinical instructor at the University of Michigan, Ann Arbor.

But they have not had much success. In part, it’s because there is a perception that the malpractice crisis has passed, Dr. Uren said. Two reform laws put into place in the late 1980s and early 1990s included caps on noneconomic damages that have adjusted upward every year and a shorter statute of limitations. Physicians have to be given at least 6 months’ notice they will be sued, and an affidavit of merit is required.

Lawsuits have been vastly diminished, which means physicians had to find another way to make their case for additional reform, Dr. Uren said. For instance, emergency physicians sought protection for EMTALA-related care, arguing that it is a unique situation, but the state medical society saw that as a special carve-out that did not benefit other physicians, he said.

The fight continues, with a variety of bills being introduced to address different aspects of malpractice, said Dr. Uren. One bill proposed that the same malpractice standard used for attorneys be applied to physicians. It is almost impossible to sue an attorney for malpractice, he said.

On May 3, a bill was introduced in the Michigan Senate that would use the gross negligence standard to protect physicians who provide emergency care. It is the same bill, based on the Georgia law, that was originally introduced in 2009, Dr. Uren said.

The Michigan physicians have learned to be patient, he said. They have also learned to "never let a good crisis pass you by," he added.

WASHINGTON – With liability reform more or less stalled on the federal level, emergency physicians have been working at the nation’s statehouses to promote legislation important to the specialty.

At a session of ACEP’s Leadership and Advocacy Conference, physicians from three states – Ohio, North Carolina, and Michigan – shared their experiences in developing liability legislation and working to get it made into law. All emphasized the importance of developing a presence in the statehouses and forging relationships with legislators.

Dr. Gary R. Katz, a former president of the Ohio Chapter of ACEP and director of patient satisfaction quality for Premier Physician Services, had several words of warning, as well. Expanding your circle of allies can weaken the focus on protecting against EMTALA [Emergency Medical Treatment and Active Labor Act]-related lawsuits, he cautioned.

It’s also important to know your enemies, Dr. Katz added. When tort reform was being debated in Ohio, a former ACEP Chapter president testified in the state Senate in support of the plaintiffs’ attorneys’ arguments, he said. That was not only unexpected, but it also "took the wind out of our sails," Dr. Katz said.

Ohio passed a wave of reforms in 2003, which helped reduce the number of lawsuits filed. But the Ohio ACEP Chapter argued that EMTALA created a unique situation that still needed to be remedied. In pushing for new legislation, the group decided to shift the focus away from torts. Instead, they argued, the risk of litigation was causing physician shortages and raising costs and, thus, reducing access to care.

In the 2008-2009 legislative session, the Ohio ACEP Chapter copied the language from the Texas tort reform law and found a legislator to sponsor the bill. Other physician groups, including the Ohio State Medical Association, also supported the effort.

The legislation was well received in several committee hearings and was passed by the Senate, but it did not win the vote in the House, Dr. Katz said.

In 2010, the Ohio House was more strongly Republican. "We felt better about our chances," he said. The model legislation was introduced in March 2011 but has not had any hearings yet.

In North Carolina, the battle for liability reform began in 2004 when one of the largest malpractice insurers in the state ceased operations there, said Dr. Gregory Cannon, president-elect of the N.C. ACEP Chapter and a staff physician at the WakeMed hospital system with Wake Emergency Physicians, Raleigh.

It was important to determine the lay of the land – most importantly, that Democrats, who have traditionally opposed liability reform, had dominated the state legislature for more than 100 years, said Dr. Cannon. In addition, the state’s governors had been Democrats for the past 2 decades.

The N.C. ACEP Chapter began working closely with the hospital association and with state medical and specialty societies, Dr. Cannon said. The Chapter also increased its political action committee activities and targeted its contributions on legislators who were supportive. Building relationships with the lawmakers was key, as was educating them with model legislation, Dr. Cannon said.

By the 2010 session, there was a subtle shift in the legislature, as it tilted Republican. A reform bill (Senate Bill 33) was introduced in 2011. It included a $250,000 cap on noneconomic damages and a gross negligence standard for EMTALA-related suits. Eventually, as the bill made its way through the legislature, the cap was raised to $500,000 and the gross negligence standard was removed. Although the bill passed the House and Senate, Gov. Beverly Perdue (D) vetoed it, saying that it did not go far enough to protect patients.

The N.C. Chapter and state physician groups unleashed a lobbying campaign to override the veto and won. The reform law took effect in October 2011. It includes the $500,000 cap, protection for EMTALA-related care, and separate trials for negligence and damages.

Since October, malpractice claims have declined by 30%, said Dr. Cannon, who added that his malpractice premiums have been reduced by 8%.

He said that the physicians learned from the effort that "it’s easier to play defense than offense."

Bottom line: "Wait for your pitch, but once you have it, be ready to hit the ball," he said.

Physicians in Michigan did not wait for a pitch – instead, they made one, using the Georgia reform bill as a model, said Dr. Bradley J. Uren, president-elect of the Michigan College of Emergency Physicians and a clinical instructor at the University of Michigan, Ann Arbor.

But they have not had much success. In part, it’s because there is a perception that the malpractice crisis has passed, Dr. Uren said. Two reform laws put into place in the late 1980s and early 1990s included caps on noneconomic damages that have adjusted upward every year and a shorter statute of limitations. Physicians have to be given at least 6 months’ notice they will be sued, and an affidavit of merit is required.

Lawsuits have been vastly diminished, which means physicians had to find another way to make their case for additional reform, Dr. Uren said. For instance, emergency physicians sought protection for EMTALA-related care, arguing that it is a unique situation, but the state medical society saw that as a special carve-out that did not benefit other physicians, he said.

The fight continues, with a variety of bills being introduced to address different aspects of malpractice, said Dr. Uren. One bill proposed that the same malpractice standard used for attorneys be applied to physicians. It is almost impossible to sue an attorney for malpractice, he said.

On May 3, a bill was introduced in the Michigan Senate that would use the gross negligence standard to protect physicians who provide emergency care. It is the same bill, based on the Georgia law, that was originally introduced in 2009, Dr. Uren said.

The Michigan physicians have learned to be patient, he said. They have also learned to "never let a good crisis pass you by," he added.