Alicia Ault

President Obama in April issued a call for equal hospital visitation rights for all patients, a move he said would be beneficial especially to childless widows and widowers and to gays and lesbians.

Mr. Obama's memorandum will require the Department of Health and Human Services to create new rules for hospitals that participate in Medicare and Medicaid to make it clear that a patient's designated visitor has the same visitation rights as a family member. Hospitals will not be able to deny visitation privileges based on “race, color, national origin, sex, sexual orientation, gender identity, or disability.”

Visits can be restricted for medically appropriate reasons. The Centers for Medicare and Medicaid Services (CMS) will be charged with enforcing the new regulations, and with ensuring that patients' advance directives are respected.

For patients whose friends or partners are denied visitation rights, President Obama said in a statement, “the failure to have their wishes respected concerning who may visit them or make medical decisions on their behalf has real consequences,” including that physicians and nurses may not have current information about medications and medical histories.

“All too often, people are made to suffer or even to pass away alone, denied the comfort of companionship in their final moments while a loved one is left worrying and pacing down the hall,” he added.

The Human Rights Campaign, a Washington-based advocacy group for gays and lesbians, said that it had worked with the White House and HHS “in support” of the memorandum.

“Discrimination touches every facet of the lives of lesbian, gay, bisexual, and transgender people, including at times of crisis and illness, when we need our loved ones with us more than ever,” HRC President Joe Solmonese said in a statement.

In a statement issued in the wake of the memorandum, the American Hospital Association said “we recognize how important family support is to a patient's well-being, and we work hard to involve patients and their loved ones in their care.” The organization added that it “will look forward to details of the new regulations as well as direction on coordinating with state laws.”

President Obama in April issued a call for equal hospital visitation rights for all patients, a move he said would be beneficial especially to childless widows and widowers and to gays and lesbians.

Mr. Obama's memorandum will require the Department of Health and Human Services to create new rules for hospitals that participate in Medicare and Medicaid to make it clear that a patient's designated visitor has the same visitation rights as a family member. Hospitals will not be able to deny visitation privileges based on “race, color, national origin, sex, sexual orientation, gender identity, or disability.”

Visits can be restricted for medically appropriate reasons. The Centers for Medicare and Medicaid Services (CMS) will be charged with enforcing the new regulations, and with ensuring that patients' advance directives are respected.

For patients whose friends or partners are denied visitation rights, President Obama said in a statement, “the failure to have their wishes respected concerning who may visit them or make medical decisions on their behalf has real consequences,” including that physicians and nurses may not have current information about medications and medical histories.

“All too often, people are made to suffer or even to pass away alone, denied the comfort of companionship in their final moments while a loved one is left worrying and pacing down the hall,” he added.

The Human Rights Campaign, a Washington-based advocacy group for gays and lesbians, said that it had worked with the White House and HHS “in support” of the memorandum.

“Discrimination touches every facet of the lives of lesbian, gay, bisexual, and transgender people, including at times of crisis and illness, when we need our loved ones with us more than ever,” HRC President Joe Solmonese said in a statement.

In a statement issued in the wake of the memorandum, the American Hospital Association said “we recognize how important family support is to a patient's well-being, and we work hard to involve patients and their loved ones in their care.” The organization added that it “will look forward to details of the new regulations as well as direction on coordinating with state laws.”

President Obama in April issued a call for equal hospital visitation rights for all patients, a move he said would be beneficial especially to childless widows and widowers and to gays and lesbians.

Mr. Obama's memorandum will require the Department of Health and Human Services to create new rules for hospitals that participate in Medicare and Medicaid to make it clear that a patient's designated visitor has the same visitation rights as a family member. Hospitals will not be able to deny visitation privileges based on “race, color, national origin, sex, sexual orientation, gender identity, or disability.”

Visits can be restricted for medically appropriate reasons. The Centers for Medicare and Medicaid Services (CMS) will be charged with enforcing the new regulations, and with ensuring that patients' advance directives are respected.

For patients whose friends or partners are denied visitation rights, President Obama said in a statement, “the failure to have their wishes respected concerning who may visit them or make medical decisions on their behalf has real consequences,” including that physicians and nurses may not have current information about medications and medical histories.

“All too often, people are made to suffer or even to pass away alone, denied the comfort of companionship in their final moments while a loved one is left worrying and pacing down the hall,” he added.

The Human Rights Campaign, a Washington-based advocacy group for gays and lesbians, said that it had worked with the White House and HHS “in support” of the memorandum.

“Discrimination touches every facet of the lives of lesbian, gay, bisexual, and transgender people, including at times of crisis and illness, when we need our loved ones with us more than ever,” HRC President Joe Solmonese said in a statement.

In a statement issued in the wake of the memorandum, the American Hospital Association said “we recognize how important family support is to a patient's well-being, and we work hard to involve patients and their loved ones in their care.” The organization added that it “will look forward to details of the new regulations as well as direction on coordinating with state laws.”

Fourteen medical specialty societies have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit companies in the health care field.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), was the result of at least a year of negotiations, said Dr. Allen S. Lichter, who is chair of the CMSS Task Force on Professionalism and Conflict of Interest and the chief executive officer of the American Society of Clinical Oncology (ASCO).

The 14 societies adopting the CMSS Code for Interactions with Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence.

They also must disclose corporate contributions, board members' financial relationships with companies, and prohibit financial relationships for key association leaders.

The initial signers included the Accreditation Council for Continuing Medical Education (ACCME), American Academy of Family Physicians (AAFP), American Academy of Neurology (AAN), American Academy of Ophthalmology (AAO), American Academy of Pediatrics (AAP), American Academy of Physical Medicine and Rehabilitation (AAPMR), American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American College of Preventive Medicine (ACPM), American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and ASCO.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none.

Many previous efforts to reduce conflicts have been done in private, but this effort is very much a public undertaking, designed to reassure the public and regulators that professional societies are acting ethically..

It is also, however, just a first step, he said. The code is not meant to be the last word; it represents a minimum set of guidelines.

Some organizations may choose to be more restrictive.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The 25-page code is available on the CMSS Web site at www.cmss.org/codeforinteractions.aspx

Fourteen medical specialty societies have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit companies in the health care field.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), was the result of at least a year of negotiations, said Dr. Allen S. Lichter, who is chair of the CMSS Task Force on Professionalism and Conflict of Interest and the chief executive officer of the American Society of Clinical Oncology (ASCO).

The 14 societies adopting the CMSS Code for Interactions with Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence.

They also must disclose corporate contributions, board members' financial relationships with companies, and prohibit financial relationships for key association leaders.

The initial signers included the Accreditation Council for Continuing Medical Education (ACCME), American Academy of Family Physicians (AAFP), American Academy of Neurology (AAN), American Academy of Ophthalmology (AAO), American Academy of Pediatrics (AAP), American Academy of Physical Medicine and Rehabilitation (AAPMR), American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American College of Preventive Medicine (ACPM), American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and ASCO.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none.

Many previous efforts to reduce conflicts have been done in private, but this effort is very much a public undertaking, designed to reassure the public and regulators that professional societies are acting ethically..

It is also, however, just a first step, he said. The code is not meant to be the last word; it represents a minimum set of guidelines.

Some organizations may choose to be more restrictive.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The 25-page code is available on the CMSS Web site at www.cmss.org/codeforinteractions.aspx

Fourteen medical specialty societies have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit companies in the health care field.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), was the result of at least a year of negotiations, said Dr. Allen S. Lichter, who is chair of the CMSS Task Force on Professionalism and Conflict of Interest and the chief executive officer of the American Society of Clinical Oncology (ASCO).

The 14 societies adopting the CMSS Code for Interactions with Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence.

They also must disclose corporate contributions, board members' financial relationships with companies, and prohibit financial relationships for key association leaders.

The initial signers included the Accreditation Council for Continuing Medical Education (ACCME), American Academy of Family Physicians (AAFP), American Academy of Neurology (AAN), American Academy of Ophthalmology (AAO), American Academy of Pediatrics (AAP), American Academy of Physical Medicine and Rehabilitation (AAPMR), American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American College of Preventive Medicine (ACPM), American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and ASCO.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none.

Many previous efforts to reduce conflicts have been done in private, but this effort is very much a public undertaking, designed to reassure the public and regulators that professional societies are acting ethically..

It is also, however, just a first step, he said. The code is not meant to be the last word; it represents a minimum set of guidelines.

Some organizations may choose to be more restrictive.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The 25-page code is available on the CMSS Web site at www.cmss.org/codeforinteractions.aspx

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

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

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

Backbone of Health Reform

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

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

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

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

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

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

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier.

These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states.

In the first year, member hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success.

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

Patients Partner With Care Team

Dr. Nicholas Wolter, the CEO of the Billings Clinic, which is part of the ACO collaborative, said although accountable care organizations may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high quality care.

“In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers,” he commented.

Members of the Collaborative

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

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

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

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

Presbyterian Healthcare Services, Albuquerque, N.M.

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis, Mo.

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

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

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

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

Backbone of Health Reform

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

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

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

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

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

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

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier.

These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states.

In the first year, member hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success.

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

Patients Partner With Care Team

Dr. Nicholas Wolter, the CEO of the Billings Clinic, which is part of the ACO collaborative, said although accountable care organizations may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high quality care.

“In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers,” he commented.

Members of the Collaborative

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

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

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

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

Presbyterian Healthcare Services, Albuquerque, N.M.

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis, Mo.

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

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

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

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

Backbone of Health Reform

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

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

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

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

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

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

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier.

These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states.

In the first year, member hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success.

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

Patients Partner With Care Team

Dr. Nicholas Wolter, the CEO of the Billings Clinic, which is part of the ACO collaborative, said although accountable care organizations may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high quality care.

“In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers,” he commented.

Members of the Collaborative

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

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

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

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

Presbyterian Healthcare Services, Albuquerque, N.M.

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis, Mo.

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

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

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

The last time the insurance industry issued any kind of internal standards was 15 years ago, according to the AMA.

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

Americas Health Insurance Plans, the industry trade organization, did not directly address the AMA code. But AHIP spokesman Robert Zirkelbach said that many of the principles are covered under the health reform law—formally, the Affordable Care Act.

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

“We will continue to work with policymakers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system.”

The code addresses topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

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

The health insurance industry has a crisis of credibility and needs to recommit to fair business practices.

Source DR. ROHACK

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

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

The last time the insurance industry issued any kind of internal standards was 15 years ago, according to the AMA.

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

Americas Health Insurance Plans, the industry trade organization, did not directly address the AMA code. But AHIP spokesman Robert Zirkelbach said that many of the principles are covered under the health reform law—formally, the Affordable Care Act.

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

“We will continue to work with policymakers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system.”

The code addresses topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

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

The health insurance industry has a crisis of credibility and needs to recommit to fair business practices.

Source DR. ROHACK

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

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

The last time the insurance industry issued any kind of internal standards was 15 years ago, according to the AMA.

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

Americas Health Insurance Plans, the industry trade organization, did not directly address the AMA code. But AHIP spokesman Robert Zirkelbach said that many of the principles are covered under the health reform law—formally, the Affordable Care Act.

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

“We will continue to work with policymakers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system.”

The code addresses topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

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

The health insurance industry has a crisis of credibility and needs to recommit to fair business practices.

Source DR. ROHACK

Fourteen medical specialty societies have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit companies in the health care field.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), was the result of at least a year of negotiations, said Dr. Allen S. Lichter, who is chair of the CMSS Task Force on Professionalism and Conflict of Interest and the chief executive officer of the American Society of Clinical Oncology (ASCO).

“CMSS is committed to encouraging and supporting a culture of integrity, voluntary self-regulation, and transparency,” said Dr. James H. Scully Jr., CMSS president and chief executive officer of the American Psychiatric Association. “This code provides a clear benchmark for maintaining integrity and independence.”

The 14 societies adopting the CMSS Code for Interactions with Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence. They also must disclose corporate contributions, board members' financial relationships with companies, and prohibit financial relationships for key association leaders.

The initial signers included the American Academy of Family Physicians (AAFP), American Academy of Neurology (AAN), American Academy of Ophthalmology (AAO), American Academy of Pediatrics (AAP), American College of Cardiology (ACC), Accreditation Council for Continuing Medical Education (ACCME), American College of Emergency Physicians (ACEP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American College of Preventive Medicine (ACPM), American Academy of Physical Medicine and Rehabilitation (AAPMR), American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and ASCO.

Dr. Daniel J. Ostergaard, the AAFP's vice president for professional activities, said that the CMSS code gives his organization a chance to see where it might improve its current policies on disclosure and ethical conflicts. He said that the AAFP has a long history of seeking to conduct itself ethically. “I feel very confident that my academy has always been addressing the issues pretty directly and with transparency,” Dr. Ostergaard said in an interview.

The AAFP's board members and counsel will spend the next few months determining how to bring its policies into compliance with the CMSS code, he added.

Adoption of the code will not impact the controversial alliance the AAFP struck with Coca-Cola in the fall of 2009 to conduct a consumer awareness campaign about beverages and sweeteners. Dr. Ostergaard said that the code related specifically to health-related companies and that Coca-Cola did not purport to be health related.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none. Many previous efforts to reduce conflicts have been done in private, but this effort is very much a public undertaking, designed to reassure the public and regulators that professional societies are acting ethically, Dr. Lichter said.

It is also, however, just a first step, he said. The code is not meant to be the last word; it represents a minimum set of guidelines. Some organizations may choose to be more restrictive, Dr. Lichter said.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The 25-page code is available on the CMSS Web site at www.cmss.org/codeforinteractions.aspx

Fourteen medical specialty societies have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit companies in the health care field.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), was the result of at least a year of negotiations, said Dr. Allen S. Lichter, who is chair of the CMSS Task Force on Professionalism and Conflict of Interest and the chief executive officer of the American Society of Clinical Oncology (ASCO).

“CMSS is committed to encouraging and supporting a culture of integrity, voluntary self-regulation, and transparency,” said Dr. James H. Scully Jr., CMSS president and chief executive officer of the American Psychiatric Association. “This code provides a clear benchmark for maintaining integrity and independence.”

The 14 societies adopting the CMSS Code for Interactions with Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence. They also must disclose corporate contributions, board members' financial relationships with companies, and prohibit financial relationships for key association leaders.

The initial signers included the American Academy of Family Physicians (AAFP), American Academy of Neurology (AAN), American Academy of Ophthalmology (AAO), American Academy of Pediatrics (AAP), American College of Cardiology (ACC), Accreditation Council for Continuing Medical Education (ACCME), American College of Emergency Physicians (ACEP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American College of Preventive Medicine (ACPM), American Academy of Physical Medicine and Rehabilitation (AAPMR), American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and ASCO.

Dr. Daniel J. Ostergaard, the AAFP's vice president for professional activities, said that the CMSS code gives his organization a chance to see where it might improve its current policies on disclosure and ethical conflicts. He said that the AAFP has a long history of seeking to conduct itself ethically. “I feel very confident that my academy has always been addressing the issues pretty directly and with transparency,” Dr. Ostergaard said in an interview.

The AAFP's board members and counsel will spend the next few months determining how to bring its policies into compliance with the CMSS code, he added.

Adoption of the code will not impact the controversial alliance the AAFP struck with Coca-Cola in the fall of 2009 to conduct a consumer awareness campaign about beverages and sweeteners. Dr. Ostergaard said that the code related specifically to health-related companies and that Coca-Cola did not purport to be health related.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none. Many previous efforts to reduce conflicts have been done in private, but this effort is very much a public undertaking, designed to reassure the public and regulators that professional societies are acting ethically, Dr. Lichter said.

It is also, however, just a first step, he said. The code is not meant to be the last word; it represents a minimum set of guidelines. Some organizations may choose to be more restrictive, Dr. Lichter said.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The 25-page code is available on the CMSS Web site at www.cmss.org/codeforinteractions.aspx

Fourteen medical specialty societies have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit companies in the health care field.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), was the result of at least a year of negotiations, said Dr. Allen S. Lichter, who is chair of the CMSS Task Force on Professionalism and Conflict of Interest and the chief executive officer of the American Society of Clinical Oncology (ASCO).

“CMSS is committed to encouraging and supporting a culture of integrity, voluntary self-regulation, and transparency,” said Dr. James H. Scully Jr., CMSS president and chief executive officer of the American Psychiatric Association. “This code provides a clear benchmark for maintaining integrity and independence.”

The 14 societies adopting the CMSS Code for Interactions with Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence. They also must disclose corporate contributions, board members' financial relationships with companies, and prohibit financial relationships for key association leaders.

The initial signers included the American Academy of Family Physicians (AAFP), American Academy of Neurology (AAN), American Academy of Ophthalmology (AAO), American Academy of Pediatrics (AAP), American College of Cardiology (ACC), Accreditation Council for Continuing Medical Education (ACCME), American College of Emergency Physicians (ACEP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American College of Preventive Medicine (ACPM), American Academy of Physical Medicine and Rehabilitation (AAPMR), American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and ASCO.

Dr. Daniel J. Ostergaard, the AAFP's vice president for professional activities, said that the CMSS code gives his organization a chance to see where it might improve its current policies on disclosure and ethical conflicts. He said that the AAFP has a long history of seeking to conduct itself ethically. “I feel very confident that my academy has always been addressing the issues pretty directly and with transparency,” Dr. Ostergaard said in an interview.

The AAFP's board members and counsel will spend the next few months determining how to bring its policies into compliance with the CMSS code, he added.

Adoption of the code will not impact the controversial alliance the AAFP struck with Coca-Cola in the fall of 2009 to conduct a consumer awareness campaign about beverages and sweeteners. Dr. Ostergaard said that the code related specifically to health-related companies and that Coca-Cola did not purport to be health related.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none. Many previous efforts to reduce conflicts have been done in private, but this effort is very much a public undertaking, designed to reassure the public and regulators that professional societies are acting ethically, Dr. Lichter said.

It is also, however, just a first step, he said. The code is not meant to be the last word; it represents a minimum set of guidelines. Some organizations may choose to be more restrictive, Dr. Lichter said.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The 25-page code is available on the CMSS Web site at www.cmss.org/codeforinteractions.aspx

Manufacturers of computed tomography machines have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or a recent House Energy & Commerce Health Subcommittee hearing.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

There are three new main safety features. First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.

Manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed. The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, he said.

Manufacturers of computed tomography machines have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or a recent House Energy & Commerce Health Subcommittee hearing.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

There are three new main safety features. First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.

Manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed. The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, he said.

Manufacturers of computed tomography machines have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or a recent House Energy & Commerce Health Subcommittee hearing.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

There are three new main safety features. First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.

Manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed. The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, he said.

House Inquiry on Heparin

Two House Republicans are seeking more information from the Food and Drug Administration on its investigation of contaminated heparin from China. Joe Barton (R-Tex.) and Michael Burgess (R-Tex.), each a ranking minority member on a powerful health panel, said their investigators have uncovered new information that “warrants further review of Chongqing Imperial for direct involvement in, or knowledge about, the contamination of heparin.” In a letter to FDA Commissioner Margaret A. Hamburg, the House members said that the FDA has not “adequately” followed up on pertinent evidence and asked Dr. Hamburg to respond.

Device Claims Called Illegal

The FDA has warned device maker St. Jude Medical about illegal promotion of its Epicor LP Cardiac Ablation System and Epicor UltraCinch LP Ablation Device. A Web site aimed at physicians claimed that the Epicor LP system could “create the critical Cox Maze III lesions entirely epicardially” and that the UltraCinch device could “safely, effectively and reproducibly create a classic box lesion in a single step.” These amount to unapproved claims for treatment of atrial fibrillation, the FDA stated in its letter. Also, sales reps were giving presentations to physicians that promoted use of the devices for atrial fibrillation, the agency claimed. It asked St. Jude to cease and desist. By press time, the cited Web site had been taken down.

AARP Tallies Big Drug Price Rise

The AARP said that brand name prescription drug prices rose almost 10% in the year ended March 31, compared with a 0.3% rise in general inflation over the same period. The seniors' advocacy group said that the increase for the 25 brand-name drugs prescribed most often to Medicare beneficiaries for chronic conditions was the largest since the organization began tracking such data in 2002. The report said that prices for a sample of generic drugs declined by about 10% over the same period. Prices of specialty drugs rose by about 9%. That was less of an increase than in the 3 previous years. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

New Tobacco-Science Chief

The FDA has named a director for the Office of Science within its new Center for Tobacco Products. Dr. David L. Ashley will assume the position sometime this month. Currently, he is the chief of the Emergency Response and Air Toxicants Branch of the Centers for Disease Control and Prevention. Dr. Ashley also is a member of the World Health Organization's study group on tobacco regulation. At the new center, he will oversee science, product review, epidemiology and metrics, and social and behavioral sciences, according to the FDA.

Billions Wasted on Medications

Americans are wasting $163 billion a year on medications, primarily because of lack of adherence to prescriptions, the pharmacy-benefit management company Express Scripts estimates. The company came up with its tally as part of its annual report on drug spending. In 2009, $106 billion in waste was caused by nonadherence, $51 billion by failure to use lower-cost alternatives, and $6 billion by people choosing retail over mail-order delivery, said Express Scripts, which has a mail-order subsidiary. The biggest two areas of waste are in treating high cholesterol and hypertension. The company said that 35% of the annual spending on lipid medications could be saved if people behaved better.

Providers Asked to Find 'Bad Ads'

The FDA has launched a program to get health care providers to detect and report misleading drug ads. The “Bad Ad” program seeks to educate health care providers about their role in ensuring that prescription drug advertising is truthful and not misleading, the agency said. Initially, FDA officials will meet with providers at selected medical conventions and will partner with a handful of medical groups to distribute educational materials. The agency said it will then expand its collaborations with medical societies. The announcement encouraged health care professionals to report any potential violation in drug promotion by sending an e-mail to

badad@fda.gov

FDA Proposed New Ad Rules

The FDA wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it is not overshadowed by other parts of either type of ad. The FDA said it will accept comments on the proposed rule until June 28.

House Inquiry on Heparin

Two House Republicans are seeking more information from the Food and Drug Administration on its investigation of contaminated heparin from China. Joe Barton (R-Tex.) and Michael Burgess (R-Tex.), each a ranking minority member on a powerful health panel, said their investigators have uncovered new information that “warrants further review of Chongqing Imperial for direct involvement in, or knowledge about, the contamination of heparin.” In a letter to FDA Commissioner Margaret A. Hamburg, the House members said that the FDA has not “adequately” followed up on pertinent evidence and asked Dr. Hamburg to respond.

Device Claims Called Illegal

The FDA has warned device maker St. Jude Medical about illegal promotion of its Epicor LP Cardiac Ablation System and Epicor UltraCinch LP Ablation Device. A Web site aimed at physicians claimed that the Epicor LP system could “create the critical Cox Maze III lesions entirely epicardially” and that the UltraCinch device could “safely, effectively and reproducibly create a classic box lesion in a single step.” These amount to unapproved claims for treatment of atrial fibrillation, the FDA stated in its letter. Also, sales reps were giving presentations to physicians that promoted use of the devices for atrial fibrillation, the agency claimed. It asked St. Jude to cease and desist. By press time, the cited Web site had been taken down.

AARP Tallies Big Drug Price Rise

The AARP said that brand name prescription drug prices rose almost 10% in the year ended March 31, compared with a 0.3% rise in general inflation over the same period. The seniors' advocacy group said that the increase for the 25 brand-name drugs prescribed most often to Medicare beneficiaries for chronic conditions was the largest since the organization began tracking such data in 2002. The report said that prices for a sample of generic drugs declined by about 10% over the same period. Prices of specialty drugs rose by about 9%. That was less of an increase than in the 3 previous years. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

New Tobacco-Science Chief

The FDA has named a director for the Office of Science within its new Center for Tobacco Products. Dr. David L. Ashley will assume the position sometime this month. Currently, he is the chief of the Emergency Response and Air Toxicants Branch of the Centers for Disease Control and Prevention. Dr. Ashley also is a member of the World Health Organization's study group on tobacco regulation. At the new center, he will oversee science, product review, epidemiology and metrics, and social and behavioral sciences, according to the FDA.

Billions Wasted on Medications

Americans are wasting $163 billion a year on medications, primarily because of lack of adherence to prescriptions, the pharmacy-benefit management company Express Scripts estimates. The company came up with its tally as part of its annual report on drug spending. In 2009, $106 billion in waste was caused by nonadherence, $51 billion by failure to use lower-cost alternatives, and $6 billion by people choosing retail over mail-order delivery, said Express Scripts, which has a mail-order subsidiary. The biggest two areas of waste are in treating high cholesterol and hypertension. The company said that 35% of the annual spending on lipid medications could be saved if people behaved better.

Providers Asked to Find 'Bad Ads'

The FDA has launched a program to get health care providers to detect and report misleading drug ads. The “Bad Ad” program seeks to educate health care providers about their role in ensuring that prescription drug advertising is truthful and not misleading, the agency said. Initially, FDA officials will meet with providers at selected medical conventions and will partner with a handful of medical groups to distribute educational materials. The agency said it will then expand its collaborations with medical societies. The announcement encouraged health care professionals to report any potential violation in drug promotion by sending an e-mail to

badad@fda.gov

FDA Proposed New Ad Rules

The FDA wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it is not overshadowed by other parts of either type of ad. The FDA said it will accept comments on the proposed rule until June 28.

House Inquiry on Heparin

Two House Republicans are seeking more information from the Food and Drug Administration on its investigation of contaminated heparin from China. Joe Barton (R-Tex.) and Michael Burgess (R-Tex.), each a ranking minority member on a powerful health panel, said their investigators have uncovered new information that “warrants further review of Chongqing Imperial for direct involvement in, or knowledge about, the contamination of heparin.” In a letter to FDA Commissioner Margaret A. Hamburg, the House members said that the FDA has not “adequately” followed up on pertinent evidence and asked Dr. Hamburg to respond.

Device Claims Called Illegal

The FDA has warned device maker St. Jude Medical about illegal promotion of its Epicor LP Cardiac Ablation System and Epicor UltraCinch LP Ablation Device. A Web site aimed at physicians claimed that the Epicor LP system could “create the critical Cox Maze III lesions entirely epicardially” and that the UltraCinch device could “safely, effectively and reproducibly create a classic box lesion in a single step.” These amount to unapproved claims for treatment of atrial fibrillation, the FDA stated in its letter. Also, sales reps were giving presentations to physicians that promoted use of the devices for atrial fibrillation, the agency claimed. It asked St. Jude to cease and desist. By press time, the cited Web site had been taken down.

AARP Tallies Big Drug Price Rise

The AARP said that brand name prescription drug prices rose almost 10% in the year ended March 31, compared with a 0.3% rise in general inflation over the same period. The seniors' advocacy group said that the increase for the 25 brand-name drugs prescribed most often to Medicare beneficiaries for chronic conditions was the largest since the organization began tracking such data in 2002. The report said that prices for a sample of generic drugs declined by about 10% over the same period. Prices of specialty drugs rose by about 9%. That was less of an increase than in the 3 previous years. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

New Tobacco-Science Chief

The FDA has named a director for the Office of Science within its new Center for Tobacco Products. Dr. David L. Ashley will assume the position sometime this month. Currently, he is the chief of the Emergency Response and Air Toxicants Branch of the Centers for Disease Control and Prevention. Dr. Ashley also is a member of the World Health Organization's study group on tobacco regulation. At the new center, he will oversee science, product review, epidemiology and metrics, and social and behavioral sciences, according to the FDA.

Billions Wasted on Medications

Americans are wasting $163 billion a year on medications, primarily because of lack of adherence to prescriptions, the pharmacy-benefit management company Express Scripts estimates. The company came up with its tally as part of its annual report on drug spending. In 2009, $106 billion in waste was caused by nonadherence, $51 billion by failure to use lower-cost alternatives, and $6 billion by people choosing retail over mail-order delivery, said Express Scripts, which has a mail-order subsidiary. The biggest two areas of waste are in treating high cholesterol and hypertension. The company said that 35% of the annual spending on lipid medications could be saved if people behaved better.

Providers Asked to Find 'Bad Ads'

The FDA has launched a program to get health care providers to detect and report misleading drug ads. The “Bad Ad” program seeks to educate health care providers about their role in ensuring that prescription drug advertising is truthful and not misleading, the agency said. Initially, FDA officials will meet with providers at selected medical conventions and will partner with a handful of medical groups to distribute educational materials. The agency said it will then expand its collaborations with medical societies. The announcement encouraged health care professionals to report any potential violation in drug promotion by sending an e-mail to

badad@fda.gov

FDA Proposed New Ad Rules

The FDA wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it is not overshadowed by other parts of either type of ad. The FDA said it will accept comments on the proposed rule until June 28.

The American College of Cardiology is one of several medical specialty societies that have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit health care companies.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), capped a year of negotiations, said Dr. Allen S. Lichter, chair of the CMSS Task Force on Professionalism and Conflict of Interest and the CEO of the American Society of Clinical Oncology.

“CMSS is committed to encouraging and supporting a culture of integrity, voluntary self-regulation, and transparency,” said Dr. James H. Scully Jr., CMSS president and chief executive officer of the American Psychiatric Association. “This code provides a clear benchmark for maintaining integrity and independence.”

The societies adopting the CMSS Code for Interactions With Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence. They must disclose corporate contributions and board members' financial relationships with companies, and must prohibit financial relationships for key association leaders.

“Properly managed partnerships with industry are absolutely critical to maintaining scientific progress in cardiology and other specialties,” Dr. Jack Lewin, CEO of the ACC said in a statement. “This code is a step in the right direction for specialty societies and reaffirms our commitment to the highest ethical standards as we continue to move toward responsible, transparent relationships that will allow us to maintain quality education and research in cardiovascular medicine.”

The ACC noted that it posts funding sources as well as disclosures for all trustees, committee chairs, and state chapter governors on its Web site.

Other signers include the American Academy of Family Physicians, American Academy of Neurology, American Academy of Pediatrics, American College of Emergency Physicians, American College of Obstetricians and Gynecologists, American College of Physicians, American Society for Radiation Oncology, American Society for Reproductive Medicine, American Society of Clinical Oncology, and the Society of Critical Care Medicine.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none and because it is a public undertaking.

The code represents a minimum set of guidelines. Some organizations may choose to be more restrictive, he said.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The code is available at www.cmss.org/codeforinteractions.aspx

The American College of Cardiology is one of several medical specialty societies that have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit health care companies.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), capped a year of negotiations, said Dr. Allen S. Lichter, chair of the CMSS Task Force on Professionalism and Conflict of Interest and the CEO of the American Society of Clinical Oncology.

“CMSS is committed to encouraging and supporting a culture of integrity, voluntary self-regulation, and transparency,” said Dr. James H. Scully Jr., CMSS president and chief executive officer of the American Psychiatric Association. “This code provides a clear benchmark for maintaining integrity and independence.”

The societies adopting the CMSS Code for Interactions With Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence. They must disclose corporate contributions and board members' financial relationships with companies, and must prohibit financial relationships for key association leaders.

“Properly managed partnerships with industry are absolutely critical to maintaining scientific progress in cardiology and other specialties,” Dr. Jack Lewin, CEO of the ACC said in a statement. “This code is a step in the right direction for specialty societies and reaffirms our commitment to the highest ethical standards as we continue to move toward responsible, transparent relationships that will allow us to maintain quality education and research in cardiovascular medicine.”

The ACC noted that it posts funding sources as well as disclosures for all trustees, committee chairs, and state chapter governors on its Web site.

Other signers include the American Academy of Family Physicians, American Academy of Neurology, American Academy of Pediatrics, American College of Emergency Physicians, American College of Obstetricians and Gynecologists, American College of Physicians, American Society for Radiation Oncology, American Society for Reproductive Medicine, American Society of Clinical Oncology, and the Society of Critical Care Medicine.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none and because it is a public undertaking.

The code represents a minimum set of guidelines. Some organizations may choose to be more restrictive, he said.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The code is available at www.cmss.org/codeforinteractions.aspx

The American College of Cardiology is one of several medical specialty societies that have signed a voluntary pledge to be more transparent in dealings with pharmaceutical and medical device manufacturers and other for-profit health care companies.

The pledge, issued by the Council of Medical Specialty Societies (CMSS), capped a year of negotiations, said Dr. Allen S. Lichter, chair of the CMSS Task Force on Professionalism and Conflict of Interest and the CEO of the American Society of Clinical Oncology.

“CMSS is committed to encouraging and supporting a culture of integrity, voluntary self-regulation, and transparency,” said Dr. James H. Scully Jr., CMSS president and chief executive officer of the American Psychiatric Association. “This code provides a clear benchmark for maintaining integrity and independence.”

The societies adopting the CMSS Code for Interactions With Companies agree to establish and publish conflict of interest policies as well as policies and procedures to ensure separation of program development from sponsor influence. They must disclose corporate contributions and board members' financial relationships with companies, and must prohibit financial relationships for key association leaders.

“Properly managed partnerships with industry are absolutely critical to maintaining scientific progress in cardiology and other specialties,” Dr. Jack Lewin, CEO of the ACC said in a statement. “This code is a step in the right direction for specialty societies and reaffirms our commitment to the highest ethical standards as we continue to move toward responsible, transparent relationships that will allow us to maintain quality education and research in cardiovascular medicine.”

The ACC noted that it posts funding sources as well as disclosures for all trustees, committee chairs, and state chapter governors on its Web site.

Other signers include the American Academy of Family Physicians, American Academy of Neurology, American Academy of Pediatrics, American College of Emergency Physicians, American College of Obstetricians and Gynecologists, American College of Physicians, American Society for Radiation Oncology, American Society for Reproductive Medicine, American Society of Clinical Oncology, and the Society of Critical Care Medicine.

Dr. Lichter called the code a “very important milestone” because it will create consistency where there has been none and because it is a public undertaking.

The code represents a minimum set of guidelines. Some organizations may choose to be more restrictive, he said.

According to the CMSS, the code was developed by a 30-member task force. More of the 32 members of the CMSS plan to adopt the code in the next few months.

The code is available at www.cmss.org/codeforinteractions.aspx

The Food and Drug Administration has approved a biodegradable sealant patch, TachoSil, for cardiovascular surgery.

The sealant, a dry collagen sponge coated with fibrinogen and thrombin, is manufactured by Nycomed Austria GmbH of Linz, Austria, and is already available in 30 countries.

When placed in a wound, the fibrinogen and thrombin become activated and convert into fibrin. That allows a clot to form, preventing bleeding and sealing the tissue. According to the FDA, the sponge breaks down within the body in 4–6 months.

“This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical,” Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

According to data submitted to the agency by Nycomed, TachoSil stopped bleeding within 3 minutes in 75% of 119 cardiovascular surgery patients given the sponge, vs. 33% in the control group.

The FDA said that the sponge can cause allergic reactions, but that such reactions were not statistically higher for TachoSil study patients.

In data submitted to support European approval, the most common side effect was fever. The European Medicines Agency cautioned that thromboembolic complications were possible if TachoSil was unintentionally placed within a blood vessel. The FDA warned that TachoSil is not intended for such use.

The Food and Drug Administration has approved a biodegradable sealant patch, TachoSil, for cardiovascular surgery.

The sealant, a dry collagen sponge coated with fibrinogen and thrombin, is manufactured by Nycomed Austria GmbH of Linz, Austria, and is already available in 30 countries.

When placed in a wound, the fibrinogen and thrombin become activated and convert into fibrin. That allows a clot to form, preventing bleeding and sealing the tissue. According to the FDA, the sponge breaks down within the body in 4–6 months.

“This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical,” Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

According to data submitted to the agency by Nycomed, TachoSil stopped bleeding within 3 minutes in 75% of 119 cardiovascular surgery patients given the sponge, vs. 33% in the control group.

The FDA said that the sponge can cause allergic reactions, but that such reactions were not statistically higher for TachoSil study patients.

In data submitted to support European approval, the most common side effect was fever. The European Medicines Agency cautioned that thromboembolic complications were possible if TachoSil was unintentionally placed within a blood vessel. The FDA warned that TachoSil is not intended for such use.

The Food and Drug Administration has approved a biodegradable sealant patch, TachoSil, for cardiovascular surgery.

The sealant, a dry collagen sponge coated with fibrinogen and thrombin, is manufactured by Nycomed Austria GmbH of Linz, Austria, and is already available in 30 countries.

When placed in a wound, the fibrinogen and thrombin become activated and convert into fibrin. That allows a clot to form, preventing bleeding and sealing the tissue. According to the FDA, the sponge breaks down within the body in 4–6 months.

“This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical,” Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

According to data submitted to the agency by Nycomed, TachoSil stopped bleeding within 3 minutes in 75% of 119 cardiovascular surgery patients given the sponge, vs. 33% in the control group.

The FDA said that the sponge can cause allergic reactions, but that such reactions were not statistically higher for TachoSil study patients.

In data submitted to support European approval, the most common side effect was fever. The European Medicines Agency cautioned that thromboembolic complications were possible if TachoSil was unintentionally placed within a blood vessel. The FDA warned that TachoSil is not intended for such use.

A little-noticed provision of the health reform law will let physicians use data collected and reported as part of the maintenance of certification process as an alternative to the Medicare Physician Quality Reporting Initiative.

The details have yet to be worked out, but it would mean that physicians likely would have at least one fewer process to report quality data, said Dr. Christine Cassel, president and CEO of the American Board of Internal Medicine.

The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate in this process, Dr. Cassel said in an interview.

Physicians have been eligible to receive bonuses for participation in the Medicare PQRI, but they have complained about it as a redundant, burdensome, and confusing process, and have bemoaned botched or missing payments.

Even the Centers for Medicare and Medicaid Services has acknowledged problems with the reporting program.

In a statement, Dr. Kevin B. Weiss, president and CEO of the American Board of Medical Specialties, said that “MOC reporting will give patients, health plans, and others the information they need to choose physicians based on performance and other key qualifications, including diagnostic acumen, clinical reasoning, and medical knowledge.

“This [law] is a significant step forward in recognizing the value of MOC in advancing health care quality for the benefit of patients.”

Under the Patient Protection and Affordable Care Act of 2010—one of the two major health reform laws—the Health and Human Services secretary will decide how MOC will fit into the PQRI process. The hope is that this will be clarified within the year, ABIM's Dr. Cassel said.

ABIM and other medical specialty boards seek to meet with CMS officials to help write the regulations for implementing the process, she said in the interview.

“Our concept is that it would be kind of an alternative pathway' and “would include all the same conditions and measures as PQRI, but be even more comprehensive,” said Dr. Cassel.

Family physicians already have some experience with using MOC as an alternative to PQRI.

The American Board of Family Medicine received approval from Medicare to use its MOC registry for the PQRI process, according to Dr. Michael Hagen, ABFM's senior vice president.

Instead of using Medicare “G” codes, physicians report actual patient data.

In 2008 (the first year of the registry), 260 family physicians participated. Participants could report on 15 patients over a 6-month period to receive half of the bonus, or 30 patients over a year to receive the full bonus, Dr. Hagen said in an interview.

Last year, all participants were required to report on the full year; about 720 family physicians participated, he said.

Dr. Hagen said that he doesn't expect the ABFM process to change anytime soon. “Our PQRI process will continue as it is until we see the final rules and regulations” regarding implementation of the new law.

Dr. Hagen said that he envisions a future in which physicians can submit data for PQRI, for MOC, and for meaningful electronic health records in one fell swoop.

That will be a big relief, he said. As the three programs are currently structured, “nobody wants the same information in the same way, and it's just driving people nuts.”

Most doctors are familiar with the MOC process, said Dr. Christine Cassel, shown here at a 2009 Senate hearing.

Source Courtesy senate.gov

A little-noticed provision of the health reform law will let physicians use data collected and reported as part of the maintenance of certification process as an alternative to the Medicare Physician Quality Reporting Initiative.

The details have yet to be worked out, but it would mean that physicians likely would have at least one fewer process to report quality data, said Dr. Christine Cassel, president and CEO of the American Board of Internal Medicine.

The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate in this process, Dr. Cassel said in an interview.

Physicians have been eligible to receive bonuses for participation in the Medicare PQRI, but they have complained about it as a redundant, burdensome, and confusing process, and have bemoaned botched or missing payments.

Even the Centers for Medicare and Medicaid Services has acknowledged problems with the reporting program.

In a statement, Dr. Kevin B. Weiss, president and CEO of the American Board of Medical Specialties, said that “MOC reporting will give patients, health plans, and others the information they need to choose physicians based on performance and other key qualifications, including diagnostic acumen, clinical reasoning, and medical knowledge.

“This [law] is a significant step forward in recognizing the value of MOC in advancing health care quality for the benefit of patients.”

Under the Patient Protection and Affordable Care Act of 2010—one of the two major health reform laws—the Health and Human Services secretary will decide how MOC will fit into the PQRI process. The hope is that this will be clarified within the year, ABIM's Dr. Cassel said.

ABIM and other medical specialty boards seek to meet with CMS officials to help write the regulations for implementing the process, she said in the interview.

“Our concept is that it would be kind of an alternative pathway' and “would include all the same conditions and measures as PQRI, but be even more comprehensive,” said Dr. Cassel.

Family physicians already have some experience with using MOC as an alternative to PQRI.

The American Board of Family Medicine received approval from Medicare to use its MOC registry for the PQRI process, according to Dr. Michael Hagen, ABFM's senior vice president.

Instead of using Medicare “G” codes, physicians report actual patient data.

In 2008 (the first year of the registry), 260 family physicians participated. Participants could report on 15 patients over a 6-month period to receive half of the bonus, or 30 patients over a year to receive the full bonus, Dr. Hagen said in an interview.

Last year, all participants were required to report on the full year; about 720 family physicians participated, he said.

Dr. Hagen said that he doesn't expect the ABFM process to change anytime soon. “Our PQRI process will continue as it is until we see the final rules and regulations” regarding implementation of the new law.

Dr. Hagen said that he envisions a future in which physicians can submit data for PQRI, for MOC, and for meaningful electronic health records in one fell swoop.

That will be a big relief, he said. As the three programs are currently structured, “nobody wants the same information in the same way, and it's just driving people nuts.”

Most doctors are familiar with the MOC process, said Dr. Christine Cassel, shown here at a 2009 Senate hearing.

Source Courtesy senate.gov

A little-noticed provision of the health reform law will let physicians use data collected and reported as part of the maintenance of certification process as an alternative to the Medicare Physician Quality Reporting Initiative.

The details have yet to be worked out, but it would mean that physicians likely would have at least one fewer process to report quality data, said Dr. Christine Cassel, president and CEO of the American Board of Internal Medicine.

The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate in this process, Dr. Cassel said in an interview.

Physicians have been eligible to receive bonuses for participation in the Medicare PQRI, but they have complained about it as a redundant, burdensome, and confusing process, and have bemoaned botched or missing payments.

Even the Centers for Medicare and Medicaid Services has acknowledged problems with the reporting program.

In a statement, Dr. Kevin B. Weiss, president and CEO of the American Board of Medical Specialties, said that “MOC reporting will give patients, health plans, and others the information they need to choose physicians based on performance and other key qualifications, including diagnostic acumen, clinical reasoning, and medical knowledge.

“This [law] is a significant step forward in recognizing the value of MOC in advancing health care quality for the benefit of patients.”

Under the Patient Protection and Affordable Care Act of 2010—one of the two major health reform laws—the Health and Human Services secretary will decide how MOC will fit into the PQRI process. The hope is that this will be clarified within the year, ABIM's Dr. Cassel said.

ABIM and other medical specialty boards seek to meet with CMS officials to help write the regulations for implementing the process, she said in the interview.

“Our concept is that it would be kind of an alternative pathway' and “would include all the same conditions and measures as PQRI, but be even more comprehensive,” said Dr. Cassel.

Family physicians already have some experience with using MOC as an alternative to PQRI.

The American Board of Family Medicine received approval from Medicare to use its MOC registry for the PQRI process, according to Dr. Michael Hagen, ABFM's senior vice president.

Instead of using Medicare “G” codes, physicians report actual patient data.

In 2008 (the first year of the registry), 260 family physicians participated. Participants could report on 15 patients over a 6-month period to receive half of the bonus, or 30 patients over a year to receive the full bonus, Dr. Hagen said in an interview.

Last year, all participants were required to report on the full year; about 720 family physicians participated, he said.

Dr. Hagen said that he doesn't expect the ABFM process to change anytime soon. “Our PQRI process will continue as it is until we see the final rules and regulations” regarding implementation of the new law.

Dr. Hagen said that he envisions a future in which physicians can submit data for PQRI, for MOC, and for meaningful electronic health records in one fell swoop.

That will be a big relief, he said. As the three programs are currently structured, “nobody wants the same information in the same way, and it's just driving people nuts.”

Most doctors are familiar with the MOC process, said Dr. Christine Cassel, shown here at a 2009 Senate hearing.

Source Courtesy senate.gov