Alicia Ault

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) study showing that patients in the United States did not fare as well as those in overseas sites.

“That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said they also found a higher rate of bleeding after CABG.

But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion. The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) study showing that patients in the United States did not fare as well as those in overseas sites.

“That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said they also found a higher rate of bleeding after CABG.

But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion. The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) study showing that patients in the United States did not fare as well as those in overseas sites.

“That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said they also found a higher rate of bleeding after CABG.

But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion. The agency is due to make a decision on the application for approval by Sept. 18.

The Food and Drug Administration on July 29 warned physicians and patients that children exposed to a mist form of estradiol might experience hormonally fueled side effects such as breast enlargement.

The topical estrogen, Evamist, is sprayed on the skin on the inside of the forearm.

The FDA said that, since Evamist was approved in 2007, the agency has received eight reports in children aged 3-5 years who had been exposed to the drug through skin contact. The girls experienced premature puberty, including development of breast buds and breast mass, while the boys reported effects consistent with gynecomastia, the agency said in a safety announcement.

These effects occurred several weeks to several months after the adult relative had started Evamist therapy. In some cases, symptoms resolved after the estrogen was discontinued or when the child’s exposure was minimized.

The agency also said that it had received exposure reports in two spayed female dogs that had licked the Evamist users’ forearm. One animal experienced mammary/nipple enlargement, vulvar swelling, and liver failure, and the other had vaginal prolapse and elevated estrogen levels.

The FDA is working with Evamist maker Ther-Rx to identify factors contributing to the exposures.

The Food and Drug Administration on July 29 warned physicians and patients that children exposed to a mist form of estradiol might experience hormonally fueled side effects such as breast enlargement.

The topical estrogen, Evamist, is sprayed on the skin on the inside of the forearm.

The FDA said that, since Evamist was approved in 2007, the agency has received eight reports in children aged 3-5 years who had been exposed to the drug through skin contact. The girls experienced premature puberty, including development of breast buds and breast mass, while the boys reported effects consistent with gynecomastia, the agency said in a safety announcement.

These effects occurred several weeks to several months after the adult relative had started Evamist therapy. In some cases, symptoms resolved after the estrogen was discontinued or when the child’s exposure was minimized.

The agency also said that it had received exposure reports in two spayed female dogs that had licked the Evamist users’ forearm. One animal experienced mammary/nipple enlargement, vulvar swelling, and liver failure, and the other had vaginal prolapse and elevated estrogen levels.

The FDA is working with Evamist maker Ther-Rx to identify factors contributing to the exposures.

The Food and Drug Administration on July 29 warned physicians and patients that children exposed to a mist form of estradiol might experience hormonally fueled side effects such as breast enlargement.

The topical estrogen, Evamist, is sprayed on the skin on the inside of the forearm.

The FDA said that, since Evamist was approved in 2007, the agency has received eight reports in children aged 3-5 years who had been exposed to the drug through skin contact. The girls experienced premature puberty, including development of breast buds and breast mass, while the boys reported effects consistent with gynecomastia, the agency said in a safety announcement.

These effects occurred several weeks to several months after the adult relative had started Evamist therapy. In some cases, symptoms resolved after the estrogen was discontinued or when the child’s exposure was minimized.

The agency also said that it had received exposure reports in two spayed female dogs that had licked the Evamist users’ forearm. One animal experienced mammary/nipple enlargement, vulvar swelling, and liver failure, and the other had vaginal prolapse and elevated estrogen levels.

The FDA is working with Evamist maker Ther-Rx to identify factors contributing to the exposures.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug's label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug's label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug's label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

WASHINGTON – Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report released on July 22 at a hearing of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the DTC tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics that it had to get approval for its genetic health report, which it was going to sell at Walgreen's stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreen's "lit a fire" at FDA, said Dr. Shuren. "We thought at this point, it's time to take action," he said.

In June, the FDA sent similar warnings to four other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe and, on July 19, the agency warned 15 more companies.

The GAO investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more "reputable." The agency bought 10 tests each from four companies – 23andMe, deCODE genetics, Pathway Genomics, and Navigenics – using five volunteer DNA donors. Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audits and Special Investigations. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

"These results show that these tests aren't ready for prime time," said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and growing some 20%-30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that "a consumer's DNA could be used to create personalized supplements that would cure diseases," said the GAO in its report.

Two companies claimed they could predict at which sports a child would excel, and two companies offered to help a consumer secretly test her fiancé's DNA and "surprise" him with the results. Mr. Kutz said this practice is restricted in 33 states.

Many of the House members in attendance said they believed the tests should not be marketed to consumers. Rep. Parker Griffith (R-Ala.) said, "This is all bogus," adding, "this is nothing more than the snake oil salesman revisited in a high-tech community and in a high-tech way."

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

WASHINGTON – Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report released on July 22 at a hearing of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the DTC tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics that it had to get approval for its genetic health report, which it was going to sell at Walgreen's stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreen's "lit a fire" at FDA, said Dr. Shuren. "We thought at this point, it's time to take action," he said.

In June, the FDA sent similar warnings to four other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe and, on July 19, the agency warned 15 more companies.

The GAO investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more "reputable." The agency bought 10 tests each from four companies – 23andMe, deCODE genetics, Pathway Genomics, and Navigenics – using five volunteer DNA donors. Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audits and Special Investigations. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

"These results show that these tests aren't ready for prime time," said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and growing some 20%-30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that "a consumer's DNA could be used to create personalized supplements that would cure diseases," said the GAO in its report.

Two companies claimed they could predict at which sports a child would excel, and two companies offered to help a consumer secretly test her fiancé's DNA and "surprise" him with the results. Mr. Kutz said this practice is restricted in 33 states.

Many of the House members in attendance said they believed the tests should not be marketed to consumers. Rep. Parker Griffith (R-Ala.) said, "This is all bogus," adding, "this is nothing more than the snake oil salesman revisited in a high-tech community and in a high-tech way."

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

WASHINGTON – Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report released on July 22 at a hearing of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the DTC tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics that it had to get approval for its genetic health report, which it was going to sell at Walgreen's stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreen's "lit a fire" at FDA, said Dr. Shuren. "We thought at this point, it's time to take action," he said.

In June, the FDA sent similar warnings to four other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe and, on July 19, the agency warned 15 more companies.

The GAO investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more "reputable." The agency bought 10 tests each from four companies – 23andMe, deCODE genetics, Pathway Genomics, and Navigenics – using five volunteer DNA donors. Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audits and Special Investigations. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

"These results show that these tests aren't ready for prime time," said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and growing some 20%-30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that "a consumer's DNA could be used to create personalized supplements that would cure diseases," said the GAO in its report.

Two companies claimed they could predict at which sports a child would excel, and two companies offered to help a consumer secretly test her fiancé's DNA and "surprise" him with the results. Mr. Kutz said this practice is restricted in 33 states.

Many of the House members in attendance said they believed the tests should not be marketed to consumers. Rep. Parker Griffith (R-Ala.) said, "This is all bogus," adding, "this is nothing more than the snake oil salesman revisited in a high-tech community and in a high-tech way."

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

President Obama on July 7 announced the recess appointment of Dr. Donald Berwick to be the Administrator of the Centers for Medicare and Medicaid Services (CMS), bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, the President said in a statement, “It’s unfortunate that, at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

The White House announced President Obama’s intention to make the recess appointment on its blog on July 6. White House spokesman Dan Pfeiffer wrote that the move was necessary because, “Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points.”

Dr. Berwick, a pediatrician who is a nationally known leader in health care quality, is supported by many health care and consumer groups, Mr. Pfeiffer noted. Dr. Berwick is president and CEO of the Cambridge, Mass.-based Institute for Healthcare Improvement.

The American Hospital Association (AHA) and others leaped to support Dr. Berwick.

“Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” AHA President Rich Umbdenstock said in a statement. “A physician and innovator in health care quality, his knowledge of the health care system makes him the right choice.”

Sen. John Kerry (D-Mass.) also issued a statement, chiding Republicans for their “lockstep stalling” of Dr. Berwick’s nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He’s first rate all the way, and throughout Massachusetts’ landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven’t scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the President nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the President to make such appointments without Senate confirmation if Congress is in recess, as it currently is for the Independence Day holiday.

While the purpose of a recess appointment is to ensure the continuity of the government, over the years, such appointments have been used to evade political battles

Until Dr. Berwick’s appointment, CMS was without a permanent administrator since 2006.

President Obama on July 7 announced the recess appointment of Dr. Donald Berwick to be the Administrator of the Centers for Medicare and Medicaid Services (CMS), bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, the President said in a statement, “It’s unfortunate that, at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

The White House announced President Obama’s intention to make the recess appointment on its blog on July 6. White House spokesman Dan Pfeiffer wrote that the move was necessary because, “Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points.”

Dr. Berwick, a pediatrician who is a nationally known leader in health care quality, is supported by many health care and consumer groups, Mr. Pfeiffer noted. Dr. Berwick is president and CEO of the Cambridge, Mass.-based Institute for Healthcare Improvement.

The American Hospital Association (AHA) and others leaped to support Dr. Berwick.

“Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” AHA President Rich Umbdenstock said in a statement. “A physician and innovator in health care quality, his knowledge of the health care system makes him the right choice.”

Sen. John Kerry (D-Mass.) also issued a statement, chiding Republicans for their “lockstep stalling” of Dr. Berwick’s nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He’s first rate all the way, and throughout Massachusetts’ landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven’t scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the President nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the President to make such appointments without Senate confirmation if Congress is in recess, as it currently is for the Independence Day holiday.

While the purpose of a recess appointment is to ensure the continuity of the government, over the years, such appointments have been used to evade political battles

Until Dr. Berwick’s appointment, CMS was without a permanent administrator since 2006.

President Obama on July 7 announced the recess appointment of Dr. Donald Berwick to be the Administrator of the Centers for Medicare and Medicaid Services (CMS), bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, the President said in a statement, “It’s unfortunate that, at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

The White House announced President Obama’s intention to make the recess appointment on its blog on July 6. White House spokesman Dan Pfeiffer wrote that the move was necessary because, “Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points.”

Dr. Berwick, a pediatrician who is a nationally known leader in health care quality, is supported by many health care and consumer groups, Mr. Pfeiffer noted. Dr. Berwick is president and CEO of the Cambridge, Mass.-based Institute for Healthcare Improvement.

The American Hospital Association (AHA) and others leaped to support Dr. Berwick.

“Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” AHA President Rich Umbdenstock said in a statement. “A physician and innovator in health care quality, his knowledge of the health care system makes him the right choice.”

Sen. John Kerry (D-Mass.) also issued a statement, chiding Republicans for their “lockstep stalling” of Dr. Berwick’s nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He’s first rate all the way, and throughout Massachusetts’ landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven’t scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the President nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the President to make such appointments without Senate confirmation if Congress is in recess, as it currently is for the Independence Day holiday.

While the purpose of a recess appointment is to ensure the continuity of the government, over the years, such appointments have been used to evade political battles

Until Dr. Berwick’s appointment, CMS was without a permanent administrator since 2006.

Patients with preexisting conditions can now get insurance coverage through their states or through the U.S. Health and Human Services department, the federal agency announced July 1.

The Pre-Existing Condition Insurance Plan is a stopgap program that will exist until 2014 when insurance companies will be prohibited from denying coverage to, or discriminating against, anyone who has had a previous serious illness or chronic condition.

The plan, established as part of the Affordable Care Act, was hailed by patient advocacy organizations.

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, said in a statement that the program will “give at least hundreds of thousands of uninsured people with cancer and other preexisting conditions access to health care.” Dr. Seffrin said that the program was not likely to be able to enroll everyone who needed coverage, but that it “is an important first step toward transforming the health care system to one that provides meaningful coverage to all Americans.”

American Heart Association CEO Nancy Brown said in a statement that the program provides a “valuable new alternative for coverage.” She noted that the “exact terms and coverage will vary depending upon the state in which a person lives.”

That is because states were given the option of letting the HHS administer the plan or running it themselves. Twenty-one states chose the former, while 29 states and the District of Columbia are running their own programs. Enrollment has begun for the HHS plan and will possibly begin by the end of the summer for the state-run programs. Coverage begins Aug. 1 for the HHS plan.

To receive coverage, people must be U.S. citizens or legal residents, and must have been uninsured for at least 6 months, or unable to purchase coverage because of a preexisting condition.

The plan is supported by $5 billion in federal money, but some states have been concerned that the money won’t last and that they would end up having to subsidize the program. Many of those states, like Louisiana, which has an estimated 700,000 uninsured residents, decided to let the federal government run their plans.

The program will cover primary and specialty care, hospitalization, and prescription drugs. Premiums may not exceed the standard individual premium for a policy in that particular state and age may be used to help determine premium rates. The HHS estimated, for instance, that in its plan, the premium for a 50-year-old would range from $320 to $570, depending on where the patient lives. More details on premium pricing will be available in mid-July.

Also on July 1, the federal government launched an online tool that lets anyone seeking insurance see what options are available – from public programs such as Medicaid, to state-run plans, to private insurance. After answering a series of questions, the tool, at www.healthcare.gov, gives the user concrete data on where and how to purchase coverage or to sign up for federal or state-run programs.

This, too, is valuable, said the AHA’s Ms. Brown. “For the first time, consumers faced with an array of choices will have a single site to go to help them understand their coverage options,” she said.

Patients with preexisting conditions can now get insurance coverage through their states or through the U.S. Health and Human Services department, the federal agency announced July 1.

The Pre-Existing Condition Insurance Plan is a stopgap program that will exist until 2014 when insurance companies will be prohibited from denying coverage to, or discriminating against, anyone who has had a previous serious illness or chronic condition.

The plan, established as part of the Affordable Care Act, was hailed by patient advocacy organizations.

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, said in a statement that the program will “give at least hundreds of thousands of uninsured people with cancer and other preexisting conditions access to health care.” Dr. Seffrin said that the program was not likely to be able to enroll everyone who needed coverage, but that it “is an important first step toward transforming the health care system to one that provides meaningful coverage to all Americans.”

American Heart Association CEO Nancy Brown said in a statement that the program provides a “valuable new alternative for coverage.” She noted that the “exact terms and coverage will vary depending upon the state in which a person lives.”

That is because states were given the option of letting the HHS administer the plan or running it themselves. Twenty-one states chose the former, while 29 states and the District of Columbia are running their own programs. Enrollment has begun for the HHS plan and will possibly begin by the end of the summer for the state-run programs. Coverage begins Aug. 1 for the HHS plan.

To receive coverage, people must be U.S. citizens or legal residents, and must have been uninsured for at least 6 months, or unable to purchase coverage because of a preexisting condition.

The plan is supported by $5 billion in federal money, but some states have been concerned that the money won’t last and that they would end up having to subsidize the program. Many of those states, like Louisiana, which has an estimated 700,000 uninsured residents, decided to let the federal government run their plans.

The program will cover primary and specialty care, hospitalization, and prescription drugs. Premiums may not exceed the standard individual premium for a policy in that particular state and age may be used to help determine premium rates. The HHS estimated, for instance, that in its plan, the premium for a 50-year-old would range from $320 to $570, depending on where the patient lives. More details on premium pricing will be available in mid-July.

Also on July 1, the federal government launched an online tool that lets anyone seeking insurance see what options are available – from public programs such as Medicaid, to state-run plans, to private insurance. After answering a series of questions, the tool, at www.healthcare.gov, gives the user concrete data on where and how to purchase coverage or to sign up for federal or state-run programs.

This, too, is valuable, said the AHA’s Ms. Brown. “For the first time, consumers faced with an array of choices will have a single site to go to help them understand their coverage options,” she said.

Patients with preexisting conditions can now get insurance coverage through their states or through the U.S. Health and Human Services department, the federal agency announced July 1.

The Pre-Existing Condition Insurance Plan is a stopgap program that will exist until 2014 when insurance companies will be prohibited from denying coverage to, or discriminating against, anyone who has had a previous serious illness or chronic condition.

The plan, established as part of the Affordable Care Act, was hailed by patient advocacy organizations.

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, said in a statement that the program will “give at least hundreds of thousands of uninsured people with cancer and other preexisting conditions access to health care.” Dr. Seffrin said that the program was not likely to be able to enroll everyone who needed coverage, but that it “is an important first step toward transforming the health care system to one that provides meaningful coverage to all Americans.”

American Heart Association CEO Nancy Brown said in a statement that the program provides a “valuable new alternative for coverage.” She noted that the “exact terms and coverage will vary depending upon the state in which a person lives.”

That is because states were given the option of letting the HHS administer the plan or running it themselves. Twenty-one states chose the former, while 29 states and the District of Columbia are running their own programs. Enrollment has begun for the HHS plan and will possibly begin by the end of the summer for the state-run programs. Coverage begins Aug. 1 for the HHS plan.

To receive coverage, people must be U.S. citizens or legal residents, and must have been uninsured for at least 6 months, or unable to purchase coverage because of a preexisting condition.

The plan is supported by $5 billion in federal money, but some states have been concerned that the money won’t last and that they would end up having to subsidize the program. Many of those states, like Louisiana, which has an estimated 700,000 uninsured residents, decided to let the federal government run their plans.

The program will cover primary and specialty care, hospitalization, and prescription drugs. Premiums may not exceed the standard individual premium for a policy in that particular state and age may be used to help determine premium rates. The HHS estimated, for instance, that in its plan, the premium for a 50-year-old would range from $320 to $570, depending on where the patient lives. More details on premium pricing will be available in mid-July.

Also on July 1, the federal government launched an online tool that lets anyone seeking insurance see what options are available – from public programs such as Medicaid, to state-run plans, to private insurance. After answering a series of questions, the tool, at www.healthcare.gov, gives the user concrete data on where and how to purchase coverage or to sign up for federal or state-run programs.

This, too, is valuable, said the AHA’s Ms. Brown. “For the first time, consumers faced with an array of choices will have a single site to go to help them understand their coverage options,” she said.

The American Medical Association on May 25 called on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved out of a resolution put forward and unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting. The New York Delegation called on the AMA to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has already been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

It has been 15 years since the insurance industry issued any kind of internal standards, according to the AMA, adding in a statement that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to recommit to patients' best interests and the fair business practices necessary to reestablish trust with the patient and physician communities.”

America's Health Insurance Plans, the industry trade organization, did not directly address the AMA code. AHIP spokesman Robert Zirkelbach said many of the principles are covered in the health reform law—the Affordable Care Act.

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” Mr. Zirkelbach said.

The code's principles address topics such as cancellations and rescissions; medical loss ratios andcfair premium calculations; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

Physicians should also have more opportunity to review and challenge their ratings in those systems, according to the principles. The systems are used to select physicians for preferential networks.

The AMA said that it has written to the eight largest health insurers seeking their pledge to comply with the code.

For details, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'The health insurance industry has a crisis of credibility' and must reestablish trust with patients.

Source DR. ROHACK

The American Medical Association on May 25 called on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved out of a resolution put forward and unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting. The New York Delegation called on the AMA to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has already been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

It has been 15 years since the insurance industry issued any kind of internal standards, according to the AMA, adding in a statement that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to recommit to patients' best interests and the fair business practices necessary to reestablish trust with the patient and physician communities.”

America's Health Insurance Plans, the industry trade organization, did not directly address the AMA code. AHIP spokesman Robert Zirkelbach said many of the principles are covered in the health reform law—the Affordable Care Act.

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” Mr. Zirkelbach said.

The code's principles address topics such as cancellations and rescissions; medical loss ratios andcfair premium calculations; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

Physicians should also have more opportunity to review and challenge their ratings in those systems, according to the principles. The systems are used to select physicians for preferential networks.

The AMA said that it has written to the eight largest health insurers seeking their pledge to comply with the code.

For details, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'The health insurance industry has a crisis of credibility' and must reestablish trust with patients.

Source DR. ROHACK

The American Medical Association on May 25 called on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved out of a resolution put forward and unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting. The New York Delegation called on the AMA to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has already been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

It has been 15 years since the insurance industry issued any kind of internal standards, according to the AMA, adding in a statement that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to recommit to patients' best interests and the fair business practices necessary to reestablish trust with the patient and physician communities.”

America's Health Insurance Plans, the industry trade organization, did not directly address the AMA code. AHIP spokesman Robert Zirkelbach said many of the principles are covered in the health reform law—the Affordable Care Act.

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” Mr. Zirkelbach said.

The code's principles address topics such as cancellations and rescissions; medical loss ratios andcfair premium calculations; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

Physicians should also have more opportunity to review and challenge their ratings in those systems, according to the principles. The systems are used to select physicians for preferential networks.

The AMA said that it has written to the eight largest health insurers seeking their pledge to comply with the code.

For details, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'The health insurance industry has a crisis of credibility' and must reestablish trust with patients.

Source DR. ROHACK

The number of uninsured Americans rose last year, with 21% of all adults aged 18-64 years reporting that they were uninsured at the time that they were interviewed for the National Health Interview Survey, federal officials reported June 16.

That's up from 19.7% the previous year and reflects a trend over the past decade of an increasing lack of health insurance, at least among adults, according to a survey by the National Center for Health Statistics, a part of the Centers for Disease Control and Prevention. Rates of coverage for children, on the other hand, have mostly improved.

Since 1999, increasing proportions of people have reported that they were uninsured at the time of the annual survey, for part of the year prior to their interviews, and for a year or more, said the NCHS in its report, which was released early and will be published in CDC's Morbidity and Mortality Weekly Report.

Overall, 46.3 million people—or 15.4% of the population—were uninsured at the time they were interviewed in 2009. The survey found that even greater numbers of people reported that they were uninsured for at least part of the year before the interview—some 58.5 million—but that a slightly smaller number, 32.8 million, had been uninsured for more than a year at the time they were queried.

A greater proportion of children than adults were covered by public health plans, which could explain the children's higher rate of coverage, according to the survey. In 2009, 37.7% of children under age 18 were covered by a public plan, up from 34.2% the previous year. Rates of public coverage for low-income children increased. Federal officials in both the Obama and Bush administrations have emphasized enrolling more eligible children in the public Children's Health Insurance Plan, which is administered by states.

Conversely, only 14.4% of adults aged 18-64 years had public coverage. And private coverage for adults declined from 68% in 2008 to 66% in 2009, according to the survey. There was no significant change in private coverage for children of any income level.

Hispanics were least likely to have insurance, with one-third reporting no insurance at the time of the interview or for part of the past year. A quarter had had no coverage for more than a year.

Not surprisingly, states with larger Hispanic populations had greater proportions of uninsured. One-quarter of Texas and Florida residents under age 65 years were uninsured at the time of the interview. One-fifth did not have coverage in California and Georgia. In Florida, 13% of children lacked coverage when interviewed, and in Texas, that number was almost 17%.

Nine states had lower rates of uninsured than the national average of 17.5%: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Washington, and Wisconsin.

For more information, go to www.cdc.gov/nchs

The number of uninsured Americans rose last year, with 21% of all adults aged 18-64 years reporting that they were uninsured at the time that they were interviewed for the National Health Interview Survey, federal officials reported June 16.

That's up from 19.7% the previous year and reflects a trend over the past decade of an increasing lack of health insurance, at least among adults, according to a survey by the National Center for Health Statistics, a part of the Centers for Disease Control and Prevention. Rates of coverage for children, on the other hand, have mostly improved.

Since 1999, increasing proportions of people have reported that they were uninsured at the time of the annual survey, for part of the year prior to their interviews, and for a year or more, said the NCHS in its report, which was released early and will be published in CDC's Morbidity and Mortality Weekly Report.

Overall, 46.3 million people—or 15.4% of the population—were uninsured at the time they were interviewed in 2009. The survey found that even greater numbers of people reported that they were uninsured for at least part of the year before the interview—some 58.5 million—but that a slightly smaller number, 32.8 million, had been uninsured for more than a year at the time they were queried.

A greater proportion of children than adults were covered by public health plans, which could explain the children's higher rate of coverage, according to the survey. In 2009, 37.7% of children under age 18 were covered by a public plan, up from 34.2% the previous year. Rates of public coverage for low-income children increased. Federal officials in both the Obama and Bush administrations have emphasized enrolling more eligible children in the public Children's Health Insurance Plan, which is administered by states.

Conversely, only 14.4% of adults aged 18-64 years had public coverage. And private coverage for adults declined from 68% in 2008 to 66% in 2009, according to the survey. There was no significant change in private coverage for children of any income level.

Hispanics were least likely to have insurance, with one-third reporting no insurance at the time of the interview or for part of the past year. A quarter had had no coverage for more than a year.

Not surprisingly, states with larger Hispanic populations had greater proportions of uninsured. One-quarter of Texas and Florida residents under age 65 years were uninsured at the time of the interview. One-fifth did not have coverage in California and Georgia. In Florida, 13% of children lacked coverage when interviewed, and in Texas, that number was almost 17%.

Nine states had lower rates of uninsured than the national average of 17.5%: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Washington, and Wisconsin.

For more information, go to www.cdc.gov/nchs

The number of uninsured Americans rose last year, with 21% of all adults aged 18-64 years reporting that they were uninsured at the time that they were interviewed for the National Health Interview Survey, federal officials reported June 16.

That's up from 19.7% the previous year and reflects a trend over the past decade of an increasing lack of health insurance, at least among adults, according to a survey by the National Center for Health Statistics, a part of the Centers for Disease Control and Prevention. Rates of coverage for children, on the other hand, have mostly improved.

Since 1999, increasing proportions of people have reported that they were uninsured at the time of the annual survey, for part of the year prior to their interviews, and for a year or more, said the NCHS in its report, which was released early and will be published in CDC's Morbidity and Mortality Weekly Report.

Overall, 46.3 million people—or 15.4% of the population—were uninsured at the time they were interviewed in 2009. The survey found that even greater numbers of people reported that they were uninsured for at least part of the year before the interview—some 58.5 million—but that a slightly smaller number, 32.8 million, had been uninsured for more than a year at the time they were queried.

A greater proportion of children than adults were covered by public health plans, which could explain the children's higher rate of coverage, according to the survey. In 2009, 37.7% of children under age 18 were covered by a public plan, up from 34.2% the previous year. Rates of public coverage for low-income children increased. Federal officials in both the Obama and Bush administrations have emphasized enrolling more eligible children in the public Children's Health Insurance Plan, which is administered by states.

Conversely, only 14.4% of adults aged 18-64 years had public coverage. And private coverage for adults declined from 68% in 2008 to 66% in 2009, according to the survey. There was no significant change in private coverage for children of any income level.

Hispanics were least likely to have insurance, with one-third reporting no insurance at the time of the interview or for part of the past year. A quarter had had no coverage for more than a year.

Not surprisingly, states with larger Hispanic populations had greater proportions of uninsured. One-quarter of Texas and Florida residents under age 65 years were uninsured at the time of the interview. One-fifth did not have coverage in California and Georgia. In Florida, 13% of children lacked coverage when interviewed, and in Texas, that number was almost 17%.

Nine states had lower rates of uninsured than the national average of 17.5%: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Washington, and Wisconsin.

For more information, go to www.cdc.gov/nchs

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act).

ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At a Capitol Hill briefing, Sen. Max Baucus (D-Mont.), and Rep. Earl Pomeroy (D-N.D.) and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed up transformation of the health care system into one that values quality over quantity.

Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.”

Rep. Boustany, who is a cardiovascular surgeon, said that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success.

The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, the CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

Members of the Premier ACO to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J. Bay

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C. and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore–LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque, N.M.

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis, Mo.

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act).

ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At a Capitol Hill briefing, Sen. Max Baucus (D-Mont.), and Rep. Earl Pomeroy (D-N.D.) and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed up transformation of the health care system into one that values quality over quantity.

Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.”

Rep. Boustany, who is a cardiovascular surgeon, said that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success.

The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, the CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

Members of the Premier ACO to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J. Bay

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C. and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore–LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque, N.M.

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis, Mo.

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act).

ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At a Capitol Hill briefing, Sen. Max Baucus (D-Mont.), and Rep. Earl Pomeroy (D-N.D.) and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed up transformation of the health care system into one that values quality over quantity.

Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.”

Rep. Boustany, who is a cardiovascular surgeon, said that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success.

The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, the CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

Members of the Premier ACO to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J. Bay

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C. and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore–LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque, N.M.

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis, Mo.

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

President Obama announced the recess appointment of Dr. Donald Berwick to be the administrator of the Centers for Medicare and Medicaid Services, bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, which has been vacant since 2006, the president said in a statement, “It's unfortunate that at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

Dr. Berwick said he was flattered that the president had appointed him to head the CMS, especially at this time. “I have never felt more excited about what is possible for what we all care about—a healthier nation, a healthier system of care, and a healthier world,” he said in a statement. “In moving to CMS as a member of a strong governmental team, I will pursue those aims as hard as I can.” Dr. Berwick is president and CEO of the Cambridge, Mass.–based Institute for Healthcare Improvement.

The American College of Physicians President J. Fred Ralston Jr. said that “Dr. Berwick's career and work at the Institute for Healthcare Improvement illustrates the drive to provide patient-centered care, patient safety, quality improvement, and care coordination in health care.” Dr. Ralston added that the ACP believed that “Dr. Berwick will be an able administrator and partner for change.”

Others also leaped to support Dr. Berwick. “Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” American Hospital Association President Rich Umbdenstock said in a statement.

In a statment, Sen. John Kerry (D-Mass.) chided Republicans for their “lockstep stalling” of Dr. Berwick's nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He's first rate all the way, and throughout Massachusetts's landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven't scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the president nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the president to make such appointments without Senate confirmation if Congress is in recess, as it was for the Independence Day holiday.

Dr. Donald Berwick has been a leader in health care quality improvement.

Source Courtesy Institute for Healthcare Improvement

President Obama announced the recess appointment of Dr. Donald Berwick to be the administrator of the Centers for Medicare and Medicaid Services, bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, which has been vacant since 2006, the president said in a statement, “It's unfortunate that at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

Dr. Berwick said he was flattered that the president had appointed him to head the CMS, especially at this time. “I have never felt more excited about what is possible for what we all care about—a healthier nation, a healthier system of care, and a healthier world,” he said in a statement. “In moving to CMS as a member of a strong governmental team, I will pursue those aims as hard as I can.” Dr. Berwick is president and CEO of the Cambridge, Mass.–based Institute for Healthcare Improvement.

The American College of Physicians President J. Fred Ralston Jr. said that “Dr. Berwick's career and work at the Institute for Healthcare Improvement illustrates the drive to provide patient-centered care, patient safety, quality improvement, and care coordination in health care.” Dr. Ralston added that the ACP believed that “Dr. Berwick will be an able administrator and partner for change.”

Others also leaped to support Dr. Berwick. “Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” American Hospital Association President Rich Umbdenstock said in a statement.

In a statment, Sen. John Kerry (D-Mass.) chided Republicans for their “lockstep stalling” of Dr. Berwick's nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He's first rate all the way, and throughout Massachusetts's landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven't scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the president nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the president to make such appointments without Senate confirmation if Congress is in recess, as it was for the Independence Day holiday.

Dr. Donald Berwick has been a leader in health care quality improvement.

Source Courtesy Institute for Healthcare Improvement

President Obama announced the recess appointment of Dr. Donald Berwick to be the administrator of the Centers for Medicare and Medicaid Services, bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, which has been vacant since 2006, the president said in a statement, “It's unfortunate that at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

Dr. Berwick said he was flattered that the president had appointed him to head the CMS, especially at this time. “I have never felt more excited about what is possible for what we all care about—a healthier nation, a healthier system of care, and a healthier world,” he said in a statement. “In moving to CMS as a member of a strong governmental team, I will pursue those aims as hard as I can.” Dr. Berwick is president and CEO of the Cambridge, Mass.–based Institute for Healthcare Improvement.

The American College of Physicians President J. Fred Ralston Jr. said that “Dr. Berwick's career and work at the Institute for Healthcare Improvement illustrates the drive to provide patient-centered care, patient safety, quality improvement, and care coordination in health care.” Dr. Ralston added that the ACP believed that “Dr. Berwick will be an able administrator and partner for change.”

Others also leaped to support Dr. Berwick. “Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” American Hospital Association President Rich Umbdenstock said in a statement.

In a statment, Sen. John Kerry (D-Mass.) chided Republicans for their “lockstep stalling” of Dr. Berwick's nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He's first rate all the way, and throughout Massachusetts's landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven't scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the president nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the president to make such appointments without Senate confirmation if Congress is in recess, as it was for the Independence Day holiday.

Dr. Donald Berwick has been a leader in health care quality improvement.

Source Courtesy Institute for Healthcare Improvement