Alicia Ault

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

Physicians may find themselves under increased scrutiny as a result of provisions in the Affordable Care Act—one of the health reform laws—giving government agencies new funding and enforcement powers to go after fraud and abuse.

The Affordable Care Act will require providers and suppliers to meet new compliance criteria, said Daniel Levinson, inspector general for the Department of Health and Human Services. After the criteria are issued, his office will provide training to health care providers, he added at a briefing.

HHS Secretary Kathleen Sebelius said that the Affordable Care Act provides $600 million over the next 10 years to combat fraud and abuse. In 2009, the federal government recovered $2.5 billion in fraudulent Medicare payments, officials said at the briefing.

Potential Medicare or Medicaid providers will be categorized as at high, medium, or low risk of fraud at the time of enrollment. More face-to-face checks will be used to verify a provider's legitimacy, Ms. Sebelius said. The law increases penalties for fraud, and puts more emphasis on real-time detection of fraud and abuse, she noted, as opposed to the current “pay and chase” model.

The HHS and the Department of Justice also will be adopting strategies used by credit card companies to flag aberrant charges and stop fraud in its tracks. “For years, we've tolerated health care fraud,” she said. “We've accepted that with any big enterprise there was going to be some waste and abuse, but those days are coming to an end. As we try to bring down skyrocketing costs across our health care system, we can't afford to ignore the billions of dollars we lose to fraud and theft,” she said.

In 2009, the federal government received about $1.6 billion in settlements and judgments from hospitals, health care providers, drug and device makers, and non–health providers found to have illegally billed federal health care programs. With penalties and settlements, $2.5 billion was returned to the Medicare Trust Fund and $441 million to Medicaid, according to the Health Care Fraud and Abuse Control Program Report.

A total of 583 individuals were convicted of health care fraud in 2009. On the civil side, the Department of Justice opened 886 new investigations and had 1,155 civil fraud matters pending.

Physicians were among those convicted or fined for fraud and abuse schemes, including a California physician who paid $2.2 million to settle allegations that between 2002 and 2006, he allowed his universal provider identification number to be used to bill Medicare for respiratory therapy. A Kansas cardiologist paid $1.3 million to settle allegations that his group submitted claims for services not provided.

Ms. Sebelius and Attorney General Eric Holder highlighted efforts by the Health Care Fraud Prevention and Enforcement Action Team (HEAT) Medicare Fraud Strike Force, which was formed in 2007 to address durable medical equipment fraud and abuse in south Florida.

The strike force has been expanded to focus on potential hot spots of potential fraud, identified by claims patterns. Los Angeles, Detroit, and Houston were added in 2009. The strike force now also operates in Brooklyn, N.Y.; Baton Rouge, La.; and Tampa.

New types of scams are emerging as criminals try to take advantage of seniors who may not understand the health reform laws. Scam artists have gone door-to-door in some states selling bogus “ObamaCare” policies, or asking Medicare beneficiaries for identifying information to issue “new Medicare cards,” Ms. Sebelius said.

Other scams are tied to the issuance of rebate checks to Medicare beneficiaries whose Medicare Part D drug expenditures push them into the so-called doughnut hole that limits coverage, she said.

The HHS is working with advocacy organizations to educate laypeople who can train their peers how to recognize illegal schemes, she said.

Physicians may find themselves under increased scrutiny as a result of provisions in the Affordable Care Act—one of the health reform laws—giving government agencies new funding and enforcement powers to go after fraud and abuse.

The Affordable Care Act will require providers and suppliers to meet new compliance criteria, said Daniel Levinson, inspector general for the Department of Health and Human Services. After the criteria are issued, his office will provide training to health care providers, he added at a briefing.

HHS Secretary Kathleen Sebelius said that the Affordable Care Act provides $600 million over the next 10 years to combat fraud and abuse. In 2009, the federal government recovered $2.5 billion in fraudulent Medicare payments, officials said at the briefing.

Potential Medicare or Medicaid providers will be categorized as at high, medium, or low risk of fraud at the time of enrollment. More face-to-face checks will be used to verify a provider's legitimacy, Ms. Sebelius said. The law increases penalties for fraud, and puts more emphasis on real-time detection of fraud and abuse, she noted, as opposed to the current “pay and chase” model.

The HHS and the Department of Justice also will be adopting strategies used by credit card companies to flag aberrant charges and stop fraud in its tracks. “For years, we've tolerated health care fraud,” she said. “We've accepted that with any big enterprise there was going to be some waste and abuse, but those days are coming to an end. As we try to bring down skyrocketing costs across our health care system, we can't afford to ignore the billions of dollars we lose to fraud and theft,” she said.

In 2009, the federal government received about $1.6 billion in settlements and judgments from hospitals, health care providers, drug and device makers, and non–health providers found to have illegally billed federal health care programs. With penalties and settlements, $2.5 billion was returned to the Medicare Trust Fund and $441 million to Medicaid, according to the Health Care Fraud and Abuse Control Program Report.

A total of 583 individuals were convicted of health care fraud in 2009. On the civil side, the Department of Justice opened 886 new investigations and had 1,155 civil fraud matters pending.

Physicians were among those convicted or fined for fraud and abuse schemes, including a California physician who paid $2.2 million to settle allegations that between 2002 and 2006, he allowed his universal provider identification number to be used to bill Medicare for respiratory therapy. A Kansas cardiologist paid $1.3 million to settle allegations that his group submitted claims for services not provided.

Ms. Sebelius and Attorney General Eric Holder highlighted efforts by the Health Care Fraud Prevention and Enforcement Action Team (HEAT) Medicare Fraud Strike Force, which was formed in 2007 to address durable medical equipment fraud and abuse in south Florida.

The strike force has been expanded to focus on potential hot spots of potential fraud, identified by claims patterns. Los Angeles, Detroit, and Houston were added in 2009. The strike force now also operates in Brooklyn, N.Y.; Baton Rouge, La.; and Tampa.

New types of scams are emerging as criminals try to take advantage of seniors who may not understand the health reform laws. Scam artists have gone door-to-door in some states selling bogus “ObamaCare” policies, or asking Medicare beneficiaries for identifying information to issue “new Medicare cards,” Ms. Sebelius said.

Other scams are tied to the issuance of rebate checks to Medicare beneficiaries whose Medicare Part D drug expenditures push them into the so-called doughnut hole that limits coverage, she said.

The HHS is working with advocacy organizations to educate laypeople who can train their peers how to recognize illegal schemes, she said.

Physicians may find themselves under increased scrutiny as a result of provisions in the Affordable Care Act—one of the health reform laws—giving government agencies new funding and enforcement powers to go after fraud and abuse.

The Affordable Care Act will require providers and suppliers to meet new compliance criteria, said Daniel Levinson, inspector general for the Department of Health and Human Services. After the criteria are issued, his office will provide training to health care providers, he added at a briefing.

HHS Secretary Kathleen Sebelius said that the Affordable Care Act provides $600 million over the next 10 years to combat fraud and abuse. In 2009, the federal government recovered $2.5 billion in fraudulent Medicare payments, officials said at the briefing.

Potential Medicare or Medicaid providers will be categorized as at high, medium, or low risk of fraud at the time of enrollment. More face-to-face checks will be used to verify a provider's legitimacy, Ms. Sebelius said. The law increases penalties for fraud, and puts more emphasis on real-time detection of fraud and abuse, she noted, as opposed to the current “pay and chase” model.

The HHS and the Department of Justice also will be adopting strategies used by credit card companies to flag aberrant charges and stop fraud in its tracks. “For years, we've tolerated health care fraud,” she said. “We've accepted that with any big enterprise there was going to be some waste and abuse, but those days are coming to an end. As we try to bring down skyrocketing costs across our health care system, we can't afford to ignore the billions of dollars we lose to fraud and theft,” she said.

In 2009, the federal government received about $1.6 billion in settlements and judgments from hospitals, health care providers, drug and device makers, and non–health providers found to have illegally billed federal health care programs. With penalties and settlements, $2.5 billion was returned to the Medicare Trust Fund and $441 million to Medicaid, according to the Health Care Fraud and Abuse Control Program Report.

A total of 583 individuals were convicted of health care fraud in 2009. On the civil side, the Department of Justice opened 886 new investigations and had 1,155 civil fraud matters pending.

Physicians were among those convicted or fined for fraud and abuse schemes, including a California physician who paid $2.2 million to settle allegations that between 2002 and 2006, he allowed his universal provider identification number to be used to bill Medicare for respiratory therapy. A Kansas cardiologist paid $1.3 million to settle allegations that his group submitted claims for services not provided.

Ms. Sebelius and Attorney General Eric Holder highlighted efforts by the Health Care Fraud Prevention and Enforcement Action Team (HEAT) Medicare Fraud Strike Force, which was formed in 2007 to address durable medical equipment fraud and abuse in south Florida.

The strike force has been expanded to focus on potential hot spots of potential fraud, identified by claims patterns. Los Angeles, Detroit, and Houston were added in 2009. The strike force now also operates in Brooklyn, N.Y.; Baton Rouge, La.; and Tampa.

New types of scams are emerging as criminals try to take advantage of seniors who may not understand the health reform laws. Scam artists have gone door-to-door in some states selling bogus “ObamaCare” policies, or asking Medicare beneficiaries for identifying information to issue “new Medicare cards,” Ms. Sebelius said.

Other scams are tied to the issuance of rebate checks to Medicare beneficiaries whose Medicare Part D drug expenditures push them into the so-called doughnut hole that limits coverage, she said.

The HHS is working with advocacy organizations to educate laypeople who can train their peers how to recognize illegal schemes, she said.

The federal government recovered $2.5 billion in fraudulent Medicare payments in 2009, according to government officials.

The Affordable Care Act–one of the health reform laws–gives government agencies new enforcement powers and new funding to go after fraud and abuse and physicians may find themselves under increased scrutiny as a result.

Daniel Levinson, the Health and Human Services Department Inspector General, said that the Affordable Care Act will require providers and suppliers to adopt compliance programs that meet core criteria. He added that his office will provide training to health care providers once those criteria are issued.

According to HHS Secretary Kathleen Sebelius, the Affordable Care Act provides $600 million over the next 10 years to combat fraud and abuse.

The law will make it more difficult to become enrolled as a Medicare or Medicaid provider as potential providers will be categorized as high, medium, or low risk of fraud at the time of enrollment. More face-to-face checks will be used to verify a provider's legitimacy, she said, adding that the law increases penalties for fraud and puts more emphasis on real-time detection of fraud and abuse as opposed to the “pay and chase” model used now.

HHS and the Department of Justice also will look closely at adopting strategies used by credit card companies to immediately flag aberrant charges to stop fraud in its tracks, said Ms. Sebelius. Preventing waste, fraud, and abuse is especially important as the cost of health care continues to rise, Ms. Sebelius said.

“For years, we've tolerated health care fraud,” she said. “We've accepted that with any big enterprise there was going to be some waste and abuse, but those days are coming to an end. As we try to bring down skyrocketing costs across our health care system, we can't afford to ignore the billions of dollars we lose to fraud and theft.”

In 2009, the federal government received about $1.6 billion in settlements and judgments from hospitals, physicians and other health care providers, drug and device makers, and non-health providers that were found to have illegally billed federal health care programs. With penalties and settlements, $2.5 billion was returned to the Medicare Trust Fund and $441 million to Medicaid, according to the Health Care Fraud and Abuse Control Program Report.

A total of 583 individuals were convicted of health care fraud in 2009, by U.S. Attorneys' Offices and federal prosecutors. On the civil side, the Department of Justice opened 886 new investigations and had 1,155 civil fraud matters pending.

Physicians were among those convicted or fined for fraud and abuse schemes, including a California physician who paid $2.2 million to settle allegations that between 2002 and 2006, he allowed his universal provider identification number to be used to bill Medicare for respiratory therapy. A Kansas cardiologist paid $1.3 million to settle allegations that his group submitted claims for services not provided.

Ms. Sebelius and Attorney General Eric Holder highlighted efforts by the Health Care Fraud Prevention and Enforcement Action Team Medicare Fraud Strike Force, which was begun in 2007 to address durable medical equipment fraud and abuse in south Florida.

The strike force has since been expanded to focus on potential hot spots of potential fraud, identified by claims patterns. In 2009, Los Angeles, Detroit, and Houston, were added; now the strike force also operates in Brooklyn, N.Y., Baton Rouge, La., and Tampa, Fla.

Ms. Sebelius said that new types of scams are emerging, as criminals attempt to take advantage of seniors who may not understand the health reform laws. Scam artists have gone door-to-door in some states selling bogus “ObamaCare” policies, or asking Medicare beneficiaries for identifying information to issue “new Medicare cards,” she said.

Other scams are tied to the issuance of rebate checks to Medicare beneficiaries whose Medicare Part D drug expenditures push them into the doughnut hole, Ms. Sebelius said.

The HHS is working with advocacy organizations to educate laypersons who can train their peers how to recognize illegal and inappropriate come-ons, she added.

The federal government recovered $2.5 billion in fraudulent Medicare payments in 2009, according to government officials.

The Affordable Care Act–one of the health reform laws–gives government agencies new enforcement powers and new funding to go after fraud and abuse and physicians may find themselves under increased scrutiny as a result.

Daniel Levinson, the Health and Human Services Department Inspector General, said that the Affordable Care Act will require providers and suppliers to adopt compliance programs that meet core criteria. He added that his office will provide training to health care providers once those criteria are issued.

According to HHS Secretary Kathleen Sebelius, the Affordable Care Act provides $600 million over the next 10 years to combat fraud and abuse.

The law will make it more difficult to become enrolled as a Medicare or Medicaid provider as potential providers will be categorized as high, medium, or low risk of fraud at the time of enrollment. More face-to-face checks will be used to verify a provider's legitimacy, she said, adding that the law increases penalties for fraud and puts more emphasis on real-time detection of fraud and abuse as opposed to the “pay and chase” model used now.

HHS and the Department of Justice also will look closely at adopting strategies used by credit card companies to immediately flag aberrant charges to stop fraud in its tracks, said Ms. Sebelius. Preventing waste, fraud, and abuse is especially important as the cost of health care continues to rise, Ms. Sebelius said.

“For years, we've tolerated health care fraud,” she said. “We've accepted that with any big enterprise there was going to be some waste and abuse, but those days are coming to an end. As we try to bring down skyrocketing costs across our health care system, we can't afford to ignore the billions of dollars we lose to fraud and theft.”

In 2009, the federal government received about $1.6 billion in settlements and judgments from hospitals, physicians and other health care providers, drug and device makers, and non-health providers that were found to have illegally billed federal health care programs. With penalties and settlements, $2.5 billion was returned to the Medicare Trust Fund and $441 million to Medicaid, according to the Health Care Fraud and Abuse Control Program Report.

A total of 583 individuals were convicted of health care fraud in 2009, by U.S. Attorneys' Offices and federal prosecutors. On the civil side, the Department of Justice opened 886 new investigations and had 1,155 civil fraud matters pending.

Physicians were among those convicted or fined for fraud and abuse schemes, including a California physician who paid $2.2 million to settle allegations that between 2002 and 2006, he allowed his universal provider identification number to be used to bill Medicare for respiratory therapy. A Kansas cardiologist paid $1.3 million to settle allegations that his group submitted claims for services not provided.

Ms. Sebelius and Attorney General Eric Holder highlighted efforts by the Health Care Fraud Prevention and Enforcement Action Team Medicare Fraud Strike Force, which was begun in 2007 to address durable medical equipment fraud and abuse in south Florida.

The strike force has since been expanded to focus on potential hot spots of potential fraud, identified by claims patterns. In 2009, Los Angeles, Detroit, and Houston, were added; now the strike force also operates in Brooklyn, N.Y., Baton Rouge, La., and Tampa, Fla.

Ms. Sebelius said that new types of scams are emerging, as criminals attempt to take advantage of seniors who may not understand the health reform laws. Scam artists have gone door-to-door in some states selling bogus “ObamaCare” policies, or asking Medicare beneficiaries for identifying information to issue “new Medicare cards,” she said.

Other scams are tied to the issuance of rebate checks to Medicare beneficiaries whose Medicare Part D drug expenditures push them into the doughnut hole, Ms. Sebelius said.

The HHS is working with advocacy organizations to educate laypersons who can train their peers how to recognize illegal and inappropriate come-ons, she added.

The federal government recovered $2.5 billion in fraudulent Medicare payments in 2009, according to government officials.

The Affordable Care Act–one of the health reform laws–gives government agencies new enforcement powers and new funding to go after fraud and abuse and physicians may find themselves under increased scrutiny as a result.

Daniel Levinson, the Health and Human Services Department Inspector General, said that the Affordable Care Act will require providers and suppliers to adopt compliance programs that meet core criteria. He added that his office will provide training to health care providers once those criteria are issued.

According to HHS Secretary Kathleen Sebelius, the Affordable Care Act provides $600 million over the next 10 years to combat fraud and abuse.

The law will make it more difficult to become enrolled as a Medicare or Medicaid provider as potential providers will be categorized as high, medium, or low risk of fraud at the time of enrollment. More face-to-face checks will be used to verify a provider's legitimacy, she said, adding that the law increases penalties for fraud and puts more emphasis on real-time detection of fraud and abuse as opposed to the “pay and chase” model used now.

HHS and the Department of Justice also will look closely at adopting strategies used by credit card companies to immediately flag aberrant charges to stop fraud in its tracks, said Ms. Sebelius. Preventing waste, fraud, and abuse is especially important as the cost of health care continues to rise, Ms. Sebelius said.

“For years, we've tolerated health care fraud,” she said. “We've accepted that with any big enterprise there was going to be some waste and abuse, but those days are coming to an end. As we try to bring down skyrocketing costs across our health care system, we can't afford to ignore the billions of dollars we lose to fraud and theft.”

In 2009, the federal government received about $1.6 billion in settlements and judgments from hospitals, physicians and other health care providers, drug and device makers, and non-health providers that were found to have illegally billed federal health care programs. With penalties and settlements, $2.5 billion was returned to the Medicare Trust Fund and $441 million to Medicaid, according to the Health Care Fraud and Abuse Control Program Report.

A total of 583 individuals were convicted of health care fraud in 2009, by U.S. Attorneys' Offices and federal prosecutors. On the civil side, the Department of Justice opened 886 new investigations and had 1,155 civil fraud matters pending.

Physicians were among those convicted or fined for fraud and abuse schemes, including a California physician who paid $2.2 million to settle allegations that between 2002 and 2006, he allowed his universal provider identification number to be used to bill Medicare for respiratory therapy. A Kansas cardiologist paid $1.3 million to settle allegations that his group submitted claims for services not provided.

Ms. Sebelius and Attorney General Eric Holder highlighted efforts by the Health Care Fraud Prevention and Enforcement Action Team Medicare Fraud Strike Force, which was begun in 2007 to address durable medical equipment fraud and abuse in south Florida.

The strike force has since been expanded to focus on potential hot spots of potential fraud, identified by claims patterns. In 2009, Los Angeles, Detroit, and Houston, were added; now the strike force also operates in Brooklyn, N.Y., Baton Rouge, La., and Tampa, Fla.

Ms. Sebelius said that new types of scams are emerging, as criminals attempt to take advantage of seniors who may not understand the health reform laws. Scam artists have gone door-to-door in some states selling bogus “ObamaCare” policies, or asking Medicare beneficiaries for identifying information to issue “new Medicare cards,” she said.

Other scams are tied to the issuance of rebate checks to Medicare beneficiaries whose Medicare Part D drug expenditures push them into the doughnut hole, Ms. Sebelius said.

The HHS is working with advocacy organizations to educate laypersons who can train their peers how to recognize illegal and inappropriate come-ons, she added.

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 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, American Academy of Neurology, American Academy of Ophthalmology, American Academy of Pediatrics, American College of Cardiology, Accreditation Council for Continuing Medical Education, American College of Emergency Physicians, American College of Obstetricians and Gynecologists, American College of Physicians, American College of Preventive Medicine, American Academy of Physical Medicine and Rehabilitation, American College of Radiology, American Society for Radiation Oncology, and ASCO.

In an interview, Dr. Scully said that the APA had been working on its own transparency, disclosure, and ethical conflict code in parallel to the CMSS process and would address the CMSS code at its board meeting in September.

As with the CMSS code, the APA requires that its key leaders and guideline committee chairs not have links with the industry. However, Dr. Scully noted that that condition could be waived if a person's participation on a guidelines committee, for example, was deemed important. In such a case, the decision process and the finding would be transparent, and that person's reviews would be subject to peer review.

He said that the problem with the specialty's relationship with drug companies lies in “the overlap between marketing and education.” Ideally, pooled funding from drug companies should be used for services or research that the association would control independently. For example, the APA's study on Part D was funded by drug companies, as are two services it is associated with–the Typical or Troubled? school mental health program that trains high school teachers to identify the warning signs of mental illness in teens; and the Give an Hour volunteer program aimed at military personnel and their families.

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.

CMSS said 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.

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 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, American Academy of Neurology, American Academy of Ophthalmology, American Academy of Pediatrics, American College of Cardiology, Accreditation Council for Continuing Medical Education, American College of Emergency Physicians, American College of Obstetricians and Gynecologists, American College of Physicians, American College of Preventive Medicine, American Academy of Physical Medicine and Rehabilitation, American College of Radiology, American Society for Radiation Oncology, and ASCO.

In an interview, Dr. Scully said that the APA had been working on its own transparency, disclosure, and ethical conflict code in parallel to the CMSS process and would address the CMSS code at its board meeting in September.

As with the CMSS code, the APA requires that its key leaders and guideline committee chairs not have links with the industry. However, Dr. Scully noted that that condition could be waived if a person's participation on a guidelines committee, for example, was deemed important. In such a case, the decision process and the finding would be transparent, and that person's reviews would be subject to peer review.

He said that the problem with the specialty's relationship with drug companies lies in “the overlap between marketing and education.” Ideally, pooled funding from drug companies should be used for services or research that the association would control independently. For example, the APA's study on Part D was funded by drug companies, as are two services it is associated with–the Typical or Troubled? school mental health program that trains high school teachers to identify the warning signs of mental illness in teens; and the Give an Hour volunteer program aimed at military personnel and their families.

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.

CMSS said 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.

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 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, American Academy of Neurology, American Academy of Ophthalmology, American Academy of Pediatrics, American College of Cardiology, Accreditation Council for Continuing Medical Education, American College of Emergency Physicians, American College of Obstetricians and Gynecologists, American College of Physicians, American College of Preventive Medicine, American Academy of Physical Medicine and Rehabilitation, American College of Radiology, American Society for Radiation Oncology, and ASCO.

In an interview, Dr. Scully said that the APA had been working on its own transparency, disclosure, and ethical conflict code in parallel to the CMSS process and would address the CMSS code at its board meeting in September.

As with the CMSS code, the APA requires that its key leaders and guideline committee chairs not have links with the industry. However, Dr. Scully noted that that condition could be waived if a person's participation on a guidelines committee, for example, was deemed important. In such a case, the decision process and the finding would be transparent, and that person's reviews would be subject to peer review.

He said that the problem with the specialty's relationship with drug companies lies in “the overlap between marketing and education.” Ideally, pooled funding from drug companies should be used for services or research that the association would control independently. For example, the APA's study on Part D was funded by drug companies, as are two services it is associated with–the Typical or Troubled? school mental health program that trains high school teachers to identify the warning signs of mental illness in teens; and the Give an Hour volunteer program aimed at military personnel and their families.

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.

CMSS said 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.

No Smoking in Michigan

As of May 1, smoking was banned in Michigan workplaces, including bars and restaurants. According to the American Cancer Society's Cancer Action Network, Michigan is the 20th state to adopt such restrictions, with Wisconsin and Kansas ready to soon implement similar laws. With smoke-free workplaces, “workers can make a living without risking their health, patrons and tourists can enjoy time out without the hazards of second hand smoke, and bar and restaurant owners can promote healthy environments,” said the cancer network's chief executive officer John Seffrin, Ph.D. A statement from the cancer network said that almost three-quarters of the United States population is now covered by state, local, or municipal laws that restrict smoking.

Shift in Substance Abuse Patterns

From 1998 to 2008, the pattern of admissions for treatment of substance abuse changed markedly, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Admissions for alcohol abuse alone dropped from 27% of admissions to 23%, while admissions for drug abuse alone rose from 26% to 37%. Concurrent abuse of alcohol and drugs is still widespvread, but admissions for the combination declined from 44% of all admissions to 38% over the decade. Opiate-, stimulant-, and marijuana-related admissions rose, while cocaine-related admissions decreased from 15% to 11%. The majority of adolescent treatment admissions were for marijuana, and half of those admissions came through the criminal justice system. The data also revealed an economic change: In 2000 only 24% of people in treatment were unemployed, while that figure rose to 37% by in 2008. The Treatment Episode Data Set report is available at

wwwdasis.samhsa.gov/teds08/teds2k8natweb.pdf

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer selling ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases.

Awards to Fight Kids' Trauma

SAMHSA will award $5.4 million over the next 3 years to three centers investigating treatments and services for children who experience traumatic events such as violence, natural disasters, and terrorism. Northwestern University Medical School, Evanston, Ill.; Children's Hospital, San Diego; and the Yale Child Study Center, New Haven, Conn., will receive the grants as part of the National Child Traumatic Stress Initiative. “By investing resources in improving the services offered, we can replace a lifetime of despair and disability with resiliency and hope,” Pamela S. Hyde, SAMHSA administrator, said in a statement.

Providers Asked to Find 'Bad Ads'

The Food and Drug Administration 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 FDA said. Initially, agency 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 a potential violation in drug promotion by sending e-mails to

badad@fda.gov

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–which include injectables and biologics used to treat cancer, rheumatoid arthritis, and other chronic diseases–rose by about 9%. That was less of an increase than in the previous 3 years. Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

No Smoking in Michigan

As of May 1, smoking was banned in Michigan workplaces, including bars and restaurants. According to the American Cancer Society's Cancer Action Network, Michigan is the 20th state to adopt such restrictions, with Wisconsin and Kansas ready to soon implement similar laws. With smoke-free workplaces, “workers can make a living without risking their health, patrons and tourists can enjoy time out without the hazards of second hand smoke, and bar and restaurant owners can promote healthy environments,” said the cancer network's chief executive officer John Seffrin, Ph.D. A statement from the cancer network said that almost three-quarters of the United States population is now covered by state, local, or municipal laws that restrict smoking.

Shift in Substance Abuse Patterns

From 1998 to 2008, the pattern of admissions for treatment of substance abuse changed markedly, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Admissions for alcohol abuse alone dropped from 27% of admissions to 23%, while admissions for drug abuse alone rose from 26% to 37%. Concurrent abuse of alcohol and drugs is still widespvread, but admissions for the combination declined from 44% of all admissions to 38% over the decade. Opiate-, stimulant-, and marijuana-related admissions rose, while cocaine-related admissions decreased from 15% to 11%. The majority of adolescent treatment admissions were for marijuana, and half of those admissions came through the criminal justice system. The data also revealed an economic change: In 2000 only 24% of people in treatment were unemployed, while that figure rose to 37% by in 2008. The Treatment Episode Data Set report is available at

wwwdasis.samhsa.gov/teds08/teds2k8natweb.pdf

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer selling ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases.

Awards to Fight Kids' Trauma

SAMHSA will award $5.4 million over the next 3 years to three centers investigating treatments and services for children who experience traumatic events such as violence, natural disasters, and terrorism. Northwestern University Medical School, Evanston, Ill.; Children's Hospital, San Diego; and the Yale Child Study Center, New Haven, Conn., will receive the grants as part of the National Child Traumatic Stress Initiative. “By investing resources in improving the services offered, we can replace a lifetime of despair and disability with resiliency and hope,” Pamela S. Hyde, SAMHSA administrator, said in a statement.

Providers Asked to Find 'Bad Ads'

The Food and Drug Administration 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 FDA said. Initially, agency 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 a potential violation in drug promotion by sending e-mails to

badad@fda.gov

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–which include injectables and biologics used to treat cancer, rheumatoid arthritis, and other chronic diseases–rose by about 9%. That was less of an increase than in the previous 3 years. Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

No Smoking in Michigan

As of May 1, smoking was banned in Michigan workplaces, including bars and restaurants. According to the American Cancer Society's Cancer Action Network, Michigan is the 20th state to adopt such restrictions, with Wisconsin and Kansas ready to soon implement similar laws. With smoke-free workplaces, “workers can make a living without risking their health, patrons and tourists can enjoy time out without the hazards of second hand smoke, and bar and restaurant owners can promote healthy environments,” said the cancer network's chief executive officer John Seffrin, Ph.D. A statement from the cancer network said that almost three-quarters of the United States population is now covered by state, local, or municipal laws that restrict smoking.

Shift in Substance Abuse Patterns

From 1998 to 2008, the pattern of admissions for treatment of substance abuse changed markedly, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Admissions for alcohol abuse alone dropped from 27% of admissions to 23%, while admissions for drug abuse alone rose from 26% to 37%. Concurrent abuse of alcohol and drugs is still widespvread, but admissions for the combination declined from 44% of all admissions to 38% over the decade. Opiate-, stimulant-, and marijuana-related admissions rose, while cocaine-related admissions decreased from 15% to 11%. The majority of adolescent treatment admissions were for marijuana, and half of those admissions came through the criminal justice system. The data also revealed an economic change: In 2000 only 24% of people in treatment were unemployed, while that figure rose to 37% by in 2008. The Treatment Episode Data Set report is available at

wwwdasis.samhsa.gov/teds08/teds2k8natweb.pdf

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer selling ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases.

Awards to Fight Kids' Trauma

SAMHSA will award $5.4 million over the next 3 years to three centers investigating treatments and services for children who experience traumatic events such as violence, natural disasters, and terrorism. Northwestern University Medical School, Evanston, Ill.; Children's Hospital, San Diego; and the Yale Child Study Center, New Haven, Conn., will receive the grants as part of the National Child Traumatic Stress Initiative. “By investing resources in improving the services offered, we can replace a lifetime of despair and disability with resiliency and hope,” Pamela S. Hyde, SAMHSA administrator, said in a statement.

Providers Asked to Find 'Bad Ads'

The Food and Drug Administration 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 FDA said. Initially, agency 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 a potential violation in drug promotion by sending e-mails to

badad@fda.gov

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–which include injectables and biologics used to treat cancer, rheumatoid arthritis, and other chronic diseases–rose by about 9%. That was less of an increase than in the previous 3 years. Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, said in a statement that the report is “based on incomplete information” because prices don't take into account discounts and rebates.

NATIONAL HARBOR, MD. — Hospitalists within a practice most likely know which of their colleagues want time off on nights and weekends, but they probably haven't given a lot of thought to how to efficiently assign new patients, Dr. John Nelson said.

Managing patient assignments successfully improves physician and patient satisfaction, said Dr. Nelson of Nelson Flores Hospital Medicine Consultants, La Quinta, Calif., and Dr. Troy W. Ahlstrom, chief financial officer of Hospitalists of Northern Michigan, Traverse City.

A successful assignment system feels fair to the hospitalist, supports continuity of care, and allows other physicians in the hospital to always know which hospitalist is caring for a patient, said Dr. Nelson, who also is the medical director for the hospitalist practice at Overlake Hospital, Bellevue, Wash.

One commonly used method involves distributing patients sequentially and assigning based on location—for instance, one physician takes floors 1 and 3, and another floors 2 and 4. Load leveling also is common, but can be time consuming to manage, Dr. Nelson said. With that method, the next patient is assigned to the physician with the lightest patient load at that time.

Less common is uneven assignment, when one physician might take all the admissions on one day and none the next. Another method is for a hospitalist to be paired with a primary care physician, taking all of his or her patients. With this approach, the primary care physician will always know who is covering his or her patients, and patients who are admitted repeatedly will always have the same hospitalist. A variation is for repeat patients to always be admitted by the same physician.

Even with an assignment scheme in place, hospitalists have to be prepared to cope with special cases, such as “bounce backs”—patients readmitted shortly after discharge. Dr. Nelson suggested establishing a formal policy on how to handle such situations. Formal policies should also be in place for assignment exceptions when one hospitalist is at the cap for new admissions and the others in the practice are not, or when other physicians request a consultation with a specific hospitalist. Finally, practices should anticipate what to do when a patient “fires” a particular hospitalist, and they should have a policy for that, he said.

Using a “triage” or “hot” pager, in which all patients are routed first through the pager operator, usually a hospitalist, can also help with assignments, Dr. Nelson said.

Another option is exempting hospitalists from taking any new admissions the day before they rotate off shift. Assuming that the average length of stay is 4 days and that hospitalists work 7 consecutive days, this method of assignment means that 71% of patients will see the same physician throughout their stay, Dr. Nelson said. If, instead, the physician gets the same patient load every day, including the day before going off shift, only 57% of patients will see the same hospitalist for the duration of their stay.

The advantages of the exemption scheme include better continuity of care, fewer handoffs, and more time for the physician to “tee up” patients for the incoming hospitalist, Dr. Nelson said. However, it also means that the other physicians in the practice will need to take more patients on some days.

Dr. Ahlstrom said the traditional model of 7 days on/7 days off did not work well at his practice at the Alpena (Mich.) Regional Medical Center. So the Alpena practice instituted a flexible full-time equivalent (FTE)–based work schedule that allows each hospitalist to tailor his or her patient load each day.

It's a somewhat complicated approach, however. The FTE is defined by the number of patients seen per day—for instance, if the FTE is defined as 16 patients a day, and the practice admits about 160 patients daily, 10 FTE physicians are needed to cover each day. Physicians are queried about how many patients they want to take on each day. They are assigned FTE numbers based on patient load and then scheduled accordingly so that the entire practice has coverage for all of the anticipated admissions.

The flexible schedule lets the physician work in a pattern that is optimal for his or her lifestyle and compensation needs, Dr. Ahlstrom said. Finally, although it's a great retention tool because it allows physicians to maintain a work-life balance, it can make recruitment more difficult because there can be some initial resistance to nontraditional scheduling, he added.

Compensation is based solely on productivity, which may give some hospitalists pause. Because it is so complicated, the Alpena practice has a dedicated employee who works 20–40 hours a week solely on scheduling at the three hospitals it serves. Start-up costs are about $20,000, primarily for the software and hardware needed, he said.

Disclosures: Dr. Ahlstrom disclosed that he is a consultant with Hospital Solutions of Michigan. Dr. Nelson reported that in addition to his consultancy, he is a stockholder in Ingenious Med.

NATIONAL HARBOR, MD. — Hospitalists within a practice most likely know which of their colleagues want time off on nights and weekends, but they probably haven't given a lot of thought to how to efficiently assign new patients, Dr. John Nelson said.

Managing patient assignments successfully improves physician and patient satisfaction, said Dr. Nelson of Nelson Flores Hospital Medicine Consultants, La Quinta, Calif., and Dr. Troy W. Ahlstrom, chief financial officer of Hospitalists of Northern Michigan, Traverse City.

A successful assignment system feels fair to the hospitalist, supports continuity of care, and allows other physicians in the hospital to always know which hospitalist is caring for a patient, said Dr. Nelson, who also is the medical director for the hospitalist practice at Overlake Hospital, Bellevue, Wash.

One commonly used method involves distributing patients sequentially and assigning based on location—for instance, one physician takes floors 1 and 3, and another floors 2 and 4. Load leveling also is common, but can be time consuming to manage, Dr. Nelson said. With that method, the next patient is assigned to the physician with the lightest patient load at that time.

Less common is uneven assignment, when one physician might take all the admissions on one day and none the next. Another method is for a hospitalist to be paired with a primary care physician, taking all of his or her patients. With this approach, the primary care physician will always know who is covering his or her patients, and patients who are admitted repeatedly will always have the same hospitalist. A variation is for repeat patients to always be admitted by the same physician.

Even with an assignment scheme in place, hospitalists have to be prepared to cope with special cases, such as “bounce backs”—patients readmitted shortly after discharge. Dr. Nelson suggested establishing a formal policy on how to handle such situations. Formal policies should also be in place for assignment exceptions when one hospitalist is at the cap for new admissions and the others in the practice are not, or when other physicians request a consultation with a specific hospitalist. Finally, practices should anticipate what to do when a patient “fires” a particular hospitalist, and they should have a policy for that, he said.

Using a “triage” or “hot” pager, in which all patients are routed first through the pager operator, usually a hospitalist, can also help with assignments, Dr. Nelson said.

Another option is exempting hospitalists from taking any new admissions the day before they rotate off shift. Assuming that the average length of stay is 4 days and that hospitalists work 7 consecutive days, this method of assignment means that 71% of patients will see the same physician throughout their stay, Dr. Nelson said. If, instead, the physician gets the same patient load every day, including the day before going off shift, only 57% of patients will see the same hospitalist for the duration of their stay.

The advantages of the exemption scheme include better continuity of care, fewer handoffs, and more time for the physician to “tee up” patients for the incoming hospitalist, Dr. Nelson said. However, it also means that the other physicians in the practice will need to take more patients on some days.

Dr. Ahlstrom said the traditional model of 7 days on/7 days off did not work well at his practice at the Alpena (Mich.) Regional Medical Center. So the Alpena practice instituted a flexible full-time equivalent (FTE)–based work schedule that allows each hospitalist to tailor his or her patient load each day.

It's a somewhat complicated approach, however. The FTE is defined by the number of patients seen per day—for instance, if the FTE is defined as 16 patients a day, and the practice admits about 160 patients daily, 10 FTE physicians are needed to cover each day. Physicians are queried about how many patients they want to take on each day. They are assigned FTE numbers based on patient load and then scheduled accordingly so that the entire practice has coverage for all of the anticipated admissions.

The flexible schedule lets the physician work in a pattern that is optimal for his or her lifestyle and compensation needs, Dr. Ahlstrom said. Finally, although it's a great retention tool because it allows physicians to maintain a work-life balance, it can make recruitment more difficult because there can be some initial resistance to nontraditional scheduling, he added.

Compensation is based solely on productivity, which may give some hospitalists pause. Because it is so complicated, the Alpena practice has a dedicated employee who works 20–40 hours a week solely on scheduling at the three hospitals it serves. Start-up costs are about $20,000, primarily for the software and hardware needed, he said.

Disclosures: Dr. Ahlstrom disclosed that he is a consultant with Hospital Solutions of Michigan. Dr. Nelson reported that in addition to his consultancy, he is a stockholder in Ingenious Med.

NATIONAL HARBOR, MD. — Hospitalists within a practice most likely know which of their colleagues want time off on nights and weekends, but they probably haven't given a lot of thought to how to efficiently assign new patients, Dr. John Nelson said.

Managing patient assignments successfully improves physician and patient satisfaction, said Dr. Nelson of Nelson Flores Hospital Medicine Consultants, La Quinta, Calif., and Dr. Troy W. Ahlstrom, chief financial officer of Hospitalists of Northern Michigan, Traverse City.

A successful assignment system feels fair to the hospitalist, supports continuity of care, and allows other physicians in the hospital to always know which hospitalist is caring for a patient, said Dr. Nelson, who also is the medical director for the hospitalist practice at Overlake Hospital, Bellevue, Wash.

One commonly used method involves distributing patients sequentially and assigning based on location—for instance, one physician takes floors 1 and 3, and another floors 2 and 4. Load leveling also is common, but can be time consuming to manage, Dr. Nelson said. With that method, the next patient is assigned to the physician with the lightest patient load at that time.

Less common is uneven assignment, when one physician might take all the admissions on one day and none the next. Another method is for a hospitalist to be paired with a primary care physician, taking all of his or her patients. With this approach, the primary care physician will always know who is covering his or her patients, and patients who are admitted repeatedly will always have the same hospitalist. A variation is for repeat patients to always be admitted by the same physician.

Even with an assignment scheme in place, hospitalists have to be prepared to cope with special cases, such as “bounce backs”—patients readmitted shortly after discharge. Dr. Nelson suggested establishing a formal policy on how to handle such situations. Formal policies should also be in place for assignment exceptions when one hospitalist is at the cap for new admissions and the others in the practice are not, or when other physicians request a consultation with a specific hospitalist. Finally, practices should anticipate what to do when a patient “fires” a particular hospitalist, and they should have a policy for that, he said.

Using a “triage” or “hot” pager, in which all patients are routed first through the pager operator, usually a hospitalist, can also help with assignments, Dr. Nelson said.

Another option is exempting hospitalists from taking any new admissions the day before they rotate off shift. Assuming that the average length of stay is 4 days and that hospitalists work 7 consecutive days, this method of assignment means that 71% of patients will see the same physician throughout their stay, Dr. Nelson said. If, instead, the physician gets the same patient load every day, including the day before going off shift, only 57% of patients will see the same hospitalist for the duration of their stay.

The advantages of the exemption scheme include better continuity of care, fewer handoffs, and more time for the physician to “tee up” patients for the incoming hospitalist, Dr. Nelson said. However, it also means that the other physicians in the practice will need to take more patients on some days.

Dr. Ahlstrom said the traditional model of 7 days on/7 days off did not work well at his practice at the Alpena (Mich.) Regional Medical Center. So the Alpena practice instituted a flexible full-time equivalent (FTE)–based work schedule that allows each hospitalist to tailor his or her patient load each day.

It's a somewhat complicated approach, however. The FTE is defined by the number of patients seen per day—for instance, if the FTE is defined as 16 patients a day, and the practice admits about 160 patients daily, 10 FTE physicians are needed to cover each day. Physicians are queried about how many patients they want to take on each day. They are assigned FTE numbers based on patient load and then scheduled accordingly so that the entire practice has coverage for all of the anticipated admissions.

The flexible schedule lets the physician work in a pattern that is optimal for his or her lifestyle and compensation needs, Dr. Ahlstrom said. Finally, although it's a great retention tool because it allows physicians to maintain a work-life balance, it can make recruitment more difficult because there can be some initial resistance to nontraditional scheduling, he added.

Compensation is based solely on productivity, which may give some hospitalists pause. Because it is so complicated, the Alpena practice has a dedicated employee who works 20–40 hours a week solely on scheduling at the three hospitals it serves. Start-up costs are about $20,000, primarily for the software and hardware needed, he said.

Disclosures: Dr. Ahlstrom disclosed that he is a consultant with Hospital Solutions of Michigan. Dr. Nelson reported that in addition to his consultancy, he is a stockholder in Ingenious Med.