Thoracic Surgery News (Archived)

ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.

When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.

The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.

The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.

“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.

The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m². The mean CHA₂DS₂-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.

After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.

Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.

The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.

In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.

According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.

“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.

Dr. Parikh has no industry relationships relevant to this study.

ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.

When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.

The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.

The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.

“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.

The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m². The mean CHA₂DS₂-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.

After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.

Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.

The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.

In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.

According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.

“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.

Dr. Parikh has no industry relationships relevant to this study.

ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.

When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.

The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.

The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.

“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.

The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m². The mean CHA₂DS₂-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.

After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.

Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.

The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.

In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.

According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.

“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.

Dr. Parikh has no industry relationships relevant to this study.

After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-47 vote.

As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.

But there is much more now within Price’s purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.

“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion, and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.

Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price’s nomination was announced.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: “I don’t know if I want to brainstorm bad ideas for him to do.”

Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:

Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in two separate Supreme Court rulings, one about private firms’ rights to make religious objections, and one about nonprofit religious hospitals and schools.

As secretary, Price would have two main options. He could expand the “accommodation” that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)

Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through postsurgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay, or cancel that project, since he “has been a critic in the past,” said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.

Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women’s health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.

For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary’s leadership.

Price could also throw the weight of the department into a probe into Planned Parenthood’s ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.

Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. “The core authority is statutory,” said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.

“The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner,” Myers said.

Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations, or other procedures that violated a “religious belief or moral conviction.”

Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don’t want to provide birth control to unmarried women, or HIV treatment to homosexuals.

The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump’s website before he was inaugurated and the page was taken down. “The Administration will act to protect individual conscience in health care,” it said. Many expect the rules to be reinstated in their original form.



This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-47 vote.

As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.

But there is much more now within Price’s purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.

“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion, and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.

Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price’s nomination was announced.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: “I don’t know if I want to brainstorm bad ideas for him to do.”

Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:

Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in two separate Supreme Court rulings, one about private firms’ rights to make religious objections, and one about nonprofit religious hospitals and schools.

As secretary, Price would have two main options. He could expand the “accommodation” that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)

Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through postsurgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay, or cancel that project, since he “has been a critic in the past,” said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.

Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women’s health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.

For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary’s leadership.

Price could also throw the weight of the department into a probe into Planned Parenthood’s ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.

Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. “The core authority is statutory,” said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.

“The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner,” Myers said.

Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations, or other procedures that violated a “religious belief or moral conviction.”

Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don’t want to provide birth control to unmarried women, or HIV treatment to homosexuals.

The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump’s website before he was inaugurated and the page was taken down. “The Administration will act to protect individual conscience in health care,” it said. Many expect the rules to be reinstated in their original form.



This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-47 vote.

As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.

But there is much more now within Price’s purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.

“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion, and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.

Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price’s nomination was announced.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: “I don’t know if I want to brainstorm bad ideas for him to do.”

Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:

Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in two separate Supreme Court rulings, one about private firms’ rights to make religious objections, and one about nonprofit religious hospitals and schools.

As secretary, Price would have two main options. He could expand the “accommodation” that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)

Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through postsurgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay, or cancel that project, since he “has been a critic in the past,” said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.

Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women’s health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.

For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary’s leadership.

Price could also throw the weight of the department into a probe into Planned Parenthood’s ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.

Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. “The core authority is statutory,” said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.

“The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner,” Myers said.

Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations, or other procedures that violated a “religious belief or moral conviction.”

Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don’t want to provide birth control to unmarried women, or HIV treatment to homosexuals.

The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump’s website before he was inaugurated and the page was taken down. “The Administration will act to protect individual conscience in health care,” it said. Many expect the rules to be reinstated in their original form.



This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The U.S. Senate voted to confirm Rep. Tom Price, MD, as secretary of the Department of Health & Human Services.

The final tally, recorded in the early hours of Feb. 10, was a strict party-line vote, with all 52 Republicans voting in favor of Rep. Price (R-Ga.) and 47 Democrats voting against. One Democrat, Sen. Claire McCaskill of Missouri, did not vote. Only a simple majority is needed to confirm cabinet members to their posts.
 

The confirmation comes amid ongoing concerns presented by Senate Democrats on Dr. Price’s stock purchases, particularly of Australia-based Innate Immunotherapeutics. Dr. Price was serving as a representative from Georgia at the time of his nomination, and there have been questions of possible ethics violations related to this and other securities purchases.

Wikimedia Commons/District office of Tom Price/Creative Commons License

[email protected]

The U.S. Senate voted to confirm Rep. Tom Price, MD, as secretary of the Department of Health & Human Services.

The final tally, recorded in the early hours of Feb. 10, was a strict party-line vote, with all 52 Republicans voting in favor of Rep. Price (R-Ga.) and 47 Democrats voting against. One Democrat, Sen. Claire McCaskill of Missouri, did not vote. Only a simple majority is needed to confirm cabinet members to their posts.
 

The confirmation comes amid ongoing concerns presented by Senate Democrats on Dr. Price’s stock purchases, particularly of Australia-based Innate Immunotherapeutics. Dr. Price was serving as a representative from Georgia at the time of his nomination, and there have been questions of possible ethics violations related to this and other securities purchases.

Wikimedia Commons/District office of Tom Price/Creative Commons License

[email protected]

The U.S. Senate voted to confirm Rep. Tom Price, MD, as secretary of the Department of Health & Human Services.

The final tally, recorded in the early hours of Feb. 10, was a strict party-line vote, with all 52 Republicans voting in favor of Rep. Price (R-Ga.) and 47 Democrats voting against. One Democrat, Sen. Claire McCaskill of Missouri, did not vote. Only a simple majority is needed to confirm cabinet members to their posts.
 

The confirmation comes amid ongoing concerns presented by Senate Democrats on Dr. Price’s stock purchases, particularly of Australia-based Innate Immunotherapeutics. Dr. Price was serving as a representative from Georgia at the time of his nomination, and there have been questions of possible ethics violations related to this and other securities purchases.

Wikimedia Commons/District office of Tom Price/Creative Commons License

[email protected]

HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.

“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.

“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).

In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.

[email protected]

HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.

“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.

“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).

In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.

[email protected]

HOUSTON – Most nongrafted, moderately stenosed coronary arteries progress to severe stenosis or occlusion in the long term, results from a large, long-term study have shown.

“Not uncommonly, patients referred for coronary surgery have one or more coronary arteries with only moderate stenosis,” Joseph F. Sabik III, MD, said at the annual meeting of the Society of Thoracic Surgeons.

“There is controversy as to whether arteries with only moderate stenosis should be grafted during coronary surgery, and if it should be grafted, with what conduit?” For example, the Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease study, known as FAME, suggests not intervening on moderate stenosis, since stenting non–ischemia-producing lesions led to worse outcomes (N Engl J Med. 2012 Sep 13;367:991-1001). However, Dr. Sabik, who chairs the department of surgery at University Hospitals Cleveland Medical Center, and his associates recently reported that grafting moderately stenosed coronary arteries during surgical revascularization is not harmful and can be beneficial by improving survival if an internal thoracic artery graft is used (J. Thoracic Cardiovasc Surg. 2016 Mar;151[3]:806-11).

In an effort to determine how grafting moderately stenosed coronary arteries influences native-vessel disease progression, and whether grafting may be protective from late ischemia, Dr. Sabik and his associates evaluated the medical records of 55,567 patients who underwent primary isolated coronary artery bypass graft (CABG) surgery at the Cleveland Clinic from 1972 to 2011. Of the 55,567 patients, 1,902 had a single coronary artery with angiographically moderate stenosis (defined as a narrowing of 50%-69%) and results of at least one postoperative angiogram available. Of these moderately stenosed coronary arteries (MSCAs), 488 were not grafted, 385 were internal thoracic artery (ITA)–grafted, and 1,028 were saphenous vein (SV)–grafted. At follow-up angiograms, information about disease progression was available for 488 nongrafted, 371 ITA-grafted, and 957 SV-grafted MSCAs, and patency information was available for 376 ITA and 1,016 SV grafts to these MSCAs. Grafts were considered patent if they were not occluded. Severe occlusion was defined as a narrowing of more than 70%.

[email protected]

SNOWMASS, COLO. – The indication for primary prophylactic implantable cardioverter-defibrillator therapy in patients with nonischemic heart failure is likely to be downgraded in the next iteration of the ACC/AHA heart failure guidelines as a consequence of the negative results of the DANISH trial, William T. Abraham, MD, predicted at the Annual Cardiovascular Conference at Snowmass.

In addition to outlining where the guideline recommendations for implantable cardioverter-defibrillator (ICD) therapy stand today, and how they’re likely to change in response to the DANISH findings, he highlighted the latest patient selection criteria for cardiac resynchronization therapy (CRT), which have grown considerably more complicated over time.

Bruce Jancin/Frontline Medical News

[email protected]

SNOWMASS, COLO. – The indication for primary prophylactic implantable cardioverter-defibrillator therapy in patients with nonischemic heart failure is likely to be downgraded in the next iteration of the ACC/AHA heart failure guidelines as a consequence of the negative results of the DANISH trial, William T. Abraham, MD, predicted at the Annual Cardiovascular Conference at Snowmass.

In addition to outlining where the guideline recommendations for implantable cardioverter-defibrillator (ICD) therapy stand today, and how they’re likely to change in response to the DANISH findings, he highlighted the latest patient selection criteria for cardiac resynchronization therapy (CRT), which have grown considerably more complicated over time.

Bruce Jancin/Frontline Medical News

[email protected]

SNOWMASS, COLO. – The indication for primary prophylactic implantable cardioverter-defibrillator therapy in patients with nonischemic heart failure is likely to be downgraded in the next iteration of the ACC/AHA heart failure guidelines as a consequence of the negative results of the DANISH trial, William T. Abraham, MD, predicted at the Annual Cardiovascular Conference at Snowmass.

In addition to outlining where the guideline recommendations for implantable cardioverter-defibrillator (ICD) therapy stand today, and how they’re likely to change in response to the DANISH findings, he highlighted the latest patient selection criteria for cardiac resynchronization therapy (CRT), which have grown considerably more complicated over time.

Bruce Jancin/Frontline Medical News

[email protected]

HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.

“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”

Doug Brunk/Frontline Medical News

[email protected]

HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.

“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”

Doug Brunk/Frontline Medical News

[email protected]

HOUSTON – The use of nicardipine following cardiac surgery in children appears to be safe and effective, results from a single-center study suggest.

“There has been a traditional hesitation to use calcium channel blockers, particularly in infants, due to underdevelopment of their calcium channels,” study investigator Matthew L. Stone, MD, PhD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.

“Further, these agents have commonly lacked selectivity to the vascular smooth muscles affecting both the blood vessels and the heart. Nicardipine offers a unique advantage over other calcium channel blockers in that it has more direct effects on vascular smooth muscles than it does on the actual myocardium.”

Doug Brunk/Frontline Medical News

[email protected]

Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the 3 years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Rep. Price (Ga.) made dozens of health industry stock trades during a 3-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives. The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Rep. Price, who is a retired orthopedic surgeon, was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought. But ethics experts say Rep. Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Rep. Price’s conduct during the SEC inquiry.

As Rep. Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Rep. Price engaged in insider trading with some of his trades in health care companies. Rep. Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records. No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Rep. Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman, whose watchdog group recently filed complaints about Rep. Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Rep. Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Rep. Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Rep. Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the first year Rep. Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his 1-year break in health care trades, Rep. Price resumed investing in health care companies.

Along with investments in technology, financial services, and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns, and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Rep. Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Rep. Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Rep. Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry. Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Rep. Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter as well.

As the case unfolded, Rep. Price bought more health care-related stocks, according to his financial disclosures. He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Rep. Price held three broker-directed accounts.

Ethics experts have said that Rep. Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Rep. Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drug maker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Rep. Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Rep. Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Biogen, Bristol-Myers Squibb, Eli Lilly, and Pfizer. He also bought stock in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the 3 years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Rep. Price (Ga.) made dozens of health industry stock trades during a 3-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives. The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Rep. Price, who is a retired orthopedic surgeon, was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought. But ethics experts say Rep. Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Rep. Price’s conduct during the SEC inquiry.

As Rep. Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Rep. Price engaged in insider trading with some of his trades in health care companies. Rep. Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records. No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Rep. Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman, whose watchdog group recently filed complaints about Rep. Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Rep. Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Rep. Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Rep. Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the first year Rep. Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his 1-year break in health care trades, Rep. Price resumed investing in health care companies.

Along with investments in technology, financial services, and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns, and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Rep. Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Rep. Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Rep. Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry. Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Rep. Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter as well.

As the case unfolded, Rep. Price bought more health care-related stocks, according to his financial disclosures. He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Rep. Price held three broker-directed accounts.

Ethics experts have said that Rep. Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Rep. Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drug maker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Rep. Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Rep. Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Biogen, Bristol-Myers Squibb, Eli Lilly, and Pfizer. He also bought stock in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the 3 years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Rep. Price (Ga.) made dozens of health industry stock trades during a 3-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives. The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Rep. Price, who is a retired orthopedic surgeon, was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought. But ethics experts say Rep. Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Rep. Price’s conduct during the SEC inquiry.

As Rep. Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Rep. Price engaged in insider trading with some of his trades in health care companies. Rep. Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records. No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Rep. Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman, whose watchdog group recently filed complaints about Rep. Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Rep. Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Rep. Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Rep. Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the first year Rep. Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his 1-year break in health care trades, Rep. Price resumed investing in health care companies.

Along with investments in technology, financial services, and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns, and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Rep. Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Rep. Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Rep. Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry. Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Rep. Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter as well.

As the case unfolded, Rep. Price bought more health care-related stocks, according to his financial disclosures. He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Rep. Price held three broker-directed accounts.

Ethics experts have said that Rep. Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Rep. Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drug maker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Rep. Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Rep. Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Biogen, Bristol-Myers Squibb, Eli Lilly, and Pfizer. He also bought stock in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Younger adults who have any calcium deposited in their coronary arteries, even a small amount, are at increased risk for adverse coronary heart disease (CHD) outcomes and death, finds an analysis of the Coronary Artery Risk Development in Young Adults (CARDIA) Study.

There’s no evidence, however, that treating such patients would make a difference in outcomes, John Jeffrey Carr, MD, reported in JAMA Cardiology on Feb. 8.

In the prospective, community-based, cohort study, 5,115 black and white adults underwent coronary computed tomographic (CT) imaging between the ages of 32 and 46 years, and had a mean follow-up of 12.5 years.

Compared with counterparts not having any coronary artery calcium (CAC), those having at least some had a 5.0-fold increased risk of CHD events and a 1.6-fold increased risk of death (JAMA Cardiol. 2017 Feb 8; doi: 10.1001/jamacardio.2016.5493).

Estimates suggested that identification of individuals at elevated risk for developing CAC could inform a selective CT screening strategy whereby the number of younger adults screened could be reduced by half, and the number needing to be imaged to find one person with CAC could be reduced from 3.5 to 2.2.

“The finding that CAC present by ages 32-46 years is associated with increased risk of premature CHD and death emphasizes the need for reduction of risk factors and primordial prevention beginning in early life,” wrote Dr. Carr, professor radiology at Vanderbilt University in Nashville, Tenn.

“Whether any kind of general screening for CAC is warranted needs further study, although we suggest that a strategy in which all individuals aged 32 to 46 years are screened is not indicated. Rather, a more targeted approach based on measuring risk factors in early adult life to predict individuals at high risk for developing CAC in whom the CT scan would have the greatest value can be considered,” they propose.
 

Study details

Participants were recruited to CARDIA when aged 18-30 years, and they underwent CAC measurement at 15, 20, and 25 years after recruitment. Incident events were ascertained starting from the time of the year-15 scan.

At that year-15 scan, 10.2% of participants were found to have CAC. The geometric mean Agatston score was 21.6.

In adjusted analyses, participants with any CAC had sharply higher risks of CHD events (hazard ratio, 5.0), as well as cardiovascular disease events (HR, 3.0). The risk of CHD events increased with CAC score, with hazard ratios of 2.6, 5.8, and 9.8 for individuals with scores of 1-19, 20-99, and 100 or more, respectively.

In addition, participants with any CAC had an elevated adjusted risk of all-cause mortality (HR, 1.6). This risk similarly rose with score but was significant for those having a score of 100 or greater only (hazard ratio, 3.7); the large majority of deaths in this group were deemed to be from CHD events.

The model that the investigators developed predicted the probability of CAC by ages 32-56 years based on risk factors assessed 7 years apart, between the ages of 18 and 38 years.

When stratified by this model, 4.2% of study participants falling into the lowest-risk decile had CAC, compared with 67.8% of those falling into the highest-risk decile.

Analyses suggested that if screening were restricted to those participants having an above-median risk score, fully 77.3% of all those with coronary calcium and 95.5% of all those with CHD events would be identified. Moreover, these yields would be obtained while reducing the number of individuals recommended to be screened by 50.0%.

Younger adults who have any calcium deposited in their coronary arteries, even a small amount, are at increased risk for adverse coronary heart disease (CHD) outcomes and death, finds an analysis of the Coronary Artery Risk Development in Young Adults (CARDIA) Study.

There’s no evidence, however, that treating such patients would make a difference in outcomes, John Jeffrey Carr, MD, reported in JAMA Cardiology on Feb. 8.

In the prospective, community-based, cohort study, 5,115 black and white adults underwent coronary computed tomographic (CT) imaging between the ages of 32 and 46 years, and had a mean follow-up of 12.5 years.

Compared with counterparts not having any coronary artery calcium (CAC), those having at least some had a 5.0-fold increased risk of CHD events and a 1.6-fold increased risk of death (JAMA Cardiol. 2017 Feb 8; doi: 10.1001/jamacardio.2016.5493).

Estimates suggested that identification of individuals at elevated risk for developing CAC could inform a selective CT screening strategy whereby the number of younger adults screened could be reduced by half, and the number needing to be imaged to find one person with CAC could be reduced from 3.5 to 2.2.

“The finding that CAC present by ages 32-46 years is associated with increased risk of premature CHD and death emphasizes the need for reduction of risk factors and primordial prevention beginning in early life,” wrote Dr. Carr, professor radiology at Vanderbilt University in Nashville, Tenn.

“Whether any kind of general screening for CAC is warranted needs further study, although we suggest that a strategy in which all individuals aged 32 to 46 years are screened is not indicated. Rather, a more targeted approach based on measuring risk factors in early adult life to predict individuals at high risk for developing CAC in whom the CT scan would have the greatest value can be considered,” they propose.
 

Study details

Participants were recruited to CARDIA when aged 18-30 years, and they underwent CAC measurement at 15, 20, and 25 years after recruitment. Incident events were ascertained starting from the time of the year-15 scan.

At that year-15 scan, 10.2% of participants were found to have CAC. The geometric mean Agatston score was 21.6.

In adjusted analyses, participants with any CAC had sharply higher risks of CHD events (hazard ratio, 5.0), as well as cardiovascular disease events (HR, 3.0). The risk of CHD events increased with CAC score, with hazard ratios of 2.6, 5.8, and 9.8 for individuals with scores of 1-19, 20-99, and 100 or more, respectively.

In addition, participants with any CAC had an elevated adjusted risk of all-cause mortality (HR, 1.6). This risk similarly rose with score but was significant for those having a score of 100 or greater only (hazard ratio, 3.7); the large majority of deaths in this group were deemed to be from CHD events.

The model that the investigators developed predicted the probability of CAC by ages 32-56 years based on risk factors assessed 7 years apart, between the ages of 18 and 38 years.

When stratified by this model, 4.2% of study participants falling into the lowest-risk decile had CAC, compared with 67.8% of those falling into the highest-risk decile.

Analyses suggested that if screening were restricted to those participants having an above-median risk score, fully 77.3% of all those with coronary calcium and 95.5% of all those with CHD events would be identified. Moreover, these yields would be obtained while reducing the number of individuals recommended to be screened by 50.0%.

Younger adults who have any calcium deposited in their coronary arteries, even a small amount, are at increased risk for adverse coronary heart disease (CHD) outcomes and death, finds an analysis of the Coronary Artery Risk Development in Young Adults (CARDIA) Study.

There’s no evidence, however, that treating such patients would make a difference in outcomes, John Jeffrey Carr, MD, reported in JAMA Cardiology on Feb. 8.

In the prospective, community-based, cohort study, 5,115 black and white adults underwent coronary computed tomographic (CT) imaging between the ages of 32 and 46 years, and had a mean follow-up of 12.5 years.

Compared with counterparts not having any coronary artery calcium (CAC), those having at least some had a 5.0-fold increased risk of CHD events and a 1.6-fold increased risk of death (JAMA Cardiol. 2017 Feb 8; doi: 10.1001/jamacardio.2016.5493).

Estimates suggested that identification of individuals at elevated risk for developing CAC could inform a selective CT screening strategy whereby the number of younger adults screened could be reduced by half, and the number needing to be imaged to find one person with CAC could be reduced from 3.5 to 2.2.

“The finding that CAC present by ages 32-46 years is associated with increased risk of premature CHD and death emphasizes the need for reduction of risk factors and primordial prevention beginning in early life,” wrote Dr. Carr, professor radiology at Vanderbilt University in Nashville, Tenn.

“Whether any kind of general screening for CAC is warranted needs further study, although we suggest that a strategy in which all individuals aged 32 to 46 years are screened is not indicated. Rather, a more targeted approach based on measuring risk factors in early adult life to predict individuals at high risk for developing CAC in whom the CT scan would have the greatest value can be considered,” they propose.
 

Study details

Participants were recruited to CARDIA when aged 18-30 years, and they underwent CAC measurement at 15, 20, and 25 years after recruitment. Incident events were ascertained starting from the time of the year-15 scan.

At that year-15 scan, 10.2% of participants were found to have CAC. The geometric mean Agatston score was 21.6.

In adjusted analyses, participants with any CAC had sharply higher risks of CHD events (hazard ratio, 5.0), as well as cardiovascular disease events (HR, 3.0). The risk of CHD events increased with CAC score, with hazard ratios of 2.6, 5.8, and 9.8 for individuals with scores of 1-19, 20-99, and 100 or more, respectively.

In addition, participants with any CAC had an elevated adjusted risk of all-cause mortality (HR, 1.6). This risk similarly rose with score but was significant for those having a score of 100 or greater only (hazard ratio, 3.7); the large majority of deaths in this group were deemed to be from CHD events.

The model that the investigators developed predicted the probability of CAC by ages 32-56 years based on risk factors assessed 7 years apart, between the ages of 18 and 38 years.

When stratified by this model, 4.2% of study participants falling into the lowest-risk decile had CAC, compared with 67.8% of those falling into the highest-risk decile.

Analyses suggested that if screening were restricted to those participants having an above-median risk score, fully 77.3% of all those with coronary calcium and 95.5% of all those with CHD events would be identified. Moreover, these yields would be obtained while reducing the number of individuals recommended to be screened by 50.0%.

Live attenuated influenza vaccine should not be used on any patients during the 2016-2017 influenza season, according to the newly issued 2017 adult Recommended Immunization Schedule released by the CDC’s Advisory Committee on Immunization Practices (ACIP).

“Changes are related to concerns regarding low effectiveness of [LAIV] (FluMist, MedImmune) against influenza A(H1N1)pdm09 in the United States during the 2013-2014 and 2015-2016 influenza seasons,” wrote the authors of the report, published in Annals of Internal Medicine and led by David K. Kim, MD, of the CDC’s Immunization Services Division in Atlanta.

[email protected]

Live attenuated influenza vaccine should not be used on any patients during the 2016-2017 influenza season, according to the newly issued 2017 adult Recommended Immunization Schedule released by the CDC’s Advisory Committee on Immunization Practices (ACIP).

“Changes are related to concerns regarding low effectiveness of [LAIV] (FluMist, MedImmune) against influenza A(H1N1)pdm09 in the United States during the 2013-2014 and 2015-2016 influenza seasons,” wrote the authors of the report, published in Annals of Internal Medicine and led by David K. Kim, MD, of the CDC’s Immunization Services Division in Atlanta.

[email protected]

Live attenuated influenza vaccine should not be used on any patients during the 2016-2017 influenza season, according to the newly issued 2017 adult Recommended Immunization Schedule released by the CDC’s Advisory Committee on Immunization Practices (ACIP).

“Changes are related to concerns regarding low effectiveness of [LAIV] (FluMist, MedImmune) against influenza A(H1N1)pdm09 in the United States during the 2013-2014 and 2015-2016 influenza seasons,” wrote the authors of the report, published in Annals of Internal Medicine and led by David K. Kim, MD, of the CDC’s Immunization Services Division in Atlanta.

[email protected]

HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

[email protected]

HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

[email protected]

HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.

“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.

“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”

In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.

“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”

In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.

They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).

Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.

Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).

Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.

“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.

At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.

“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”

She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.

“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”

One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
 

[email protected]