Alicia Ault

One of the nation's largest health care quality coalitions is launching a program that would provide bonuses of up to $100,000 annually to physicians who meet criteria showing that they are offering coordinated care by providing a medical home for their patients.

Announced by Bridges to Excellence in late January, the Medical Home Program has the endorsement of the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP).

So far, none of BTE's employers or payers have formally committed to the program, Mr. Francois de Brantes, CEO of the coalition, said in an interview. By late spring, however, he expects to "have a couple of exciting announcements."

Dr. Michael Barr, ACP vice president for practice advocacy and improvement, said that the program might spur physicians who are already working on practice improvement, but not documenting it, to start doing so, thereby becoming eligible for the bonuses.

The "patient ultimately benefits from better coordination" of care, Dr. Barr added in an interview.

Dr. de Brantes called the program a vote of confidence in the notion that delivering high-quality coordinated care—as described in the medical home model advocated by the ACP, AAFP, and American Academy of Pediatrics—saves money and improves quality. "We feel pretty confident that the rewards are warranted and that the savings are there to match them," Mr. de Brantes said. "Our research shows that patients who are well taken care of cost less," he said, adding that "the average potential savings per covered life would be approximately $250 a year."

The nonprofit BTE is a coalition of providers, insurers, and employers working together to advance the quality of health care. Members include Aetna, the American Board of Internal Medicine, the Blue Cross and Blue Shield Association, Cisco Systems, IBM, the Leapfrog Group, the National Business Coalition on Health, Partners Healthcare System, and Verizon Communications.

BTE has previously offered pay-for-performance incentives to physicians who use its Physician Office Link, Diabetes Care Link, Cardiac Care Link, and Spine Care Link reporting systems. Physician Office Link was developed in collaboration with the National Committee for Quality Assurance.

With the new Medical Home Program, physicians will be eligible for additional bonus payments of $125 per patient—up to a maximum $100,000 per provider—if they achieve certain performance levels on the Physician Office Link module and at least two of the condition-specific modules.

It's not yet clear when the medical home rewards will start flowing, but the structure is fairly well established, according to Mr. de Brantes.

One of the nation's largest health care quality coalitions is launching a program that would provide bonuses of up to $100,000 annually to physicians who meet criteria showing that they are offering coordinated care by providing a medical home for their patients.

Announced by Bridges to Excellence in late January, the Medical Home Program has the endorsement of the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP).

So far, none of BTE's employers or payers have formally committed to the program, Mr. Francois de Brantes, CEO of the coalition, said in an interview. By late spring, however, he expects to "have a couple of exciting announcements."

Dr. Michael Barr, ACP vice president for practice advocacy and improvement, said that the program might spur physicians who are already working on practice improvement, but not documenting it, to start doing so, thereby becoming eligible for the bonuses.

The "patient ultimately benefits from better coordination" of care, Dr. Barr added in an interview.

Dr. de Brantes called the program a vote of confidence in the notion that delivering high-quality coordinated care—as described in the medical home model advocated by the ACP, AAFP, and American Academy of Pediatrics—saves money and improves quality. "We feel pretty confident that the rewards are warranted and that the savings are there to match them," Mr. de Brantes said. "Our research shows that patients who are well taken care of cost less," he said, adding that "the average potential savings per covered life would be approximately $250 a year."

The nonprofit BTE is a coalition of providers, insurers, and employers working together to advance the quality of health care. Members include Aetna, the American Board of Internal Medicine, the Blue Cross and Blue Shield Association, Cisco Systems, IBM, the Leapfrog Group, the National Business Coalition on Health, Partners Healthcare System, and Verizon Communications.

BTE has previously offered pay-for-performance incentives to physicians who use its Physician Office Link, Diabetes Care Link, Cardiac Care Link, and Spine Care Link reporting systems. Physician Office Link was developed in collaboration with the National Committee for Quality Assurance.

With the new Medical Home Program, physicians will be eligible for additional bonus payments of $125 per patient—up to a maximum $100,000 per provider—if they achieve certain performance levels on the Physician Office Link module and at least two of the condition-specific modules.

It's not yet clear when the medical home rewards will start flowing, but the structure is fairly well established, according to Mr. de Brantes.

One of the nation's largest health care quality coalitions is launching a program that would provide bonuses of up to $100,000 annually to physicians who meet criteria showing that they are offering coordinated care by providing a medical home for their patients.

Announced by Bridges to Excellence in late January, the Medical Home Program has the endorsement of the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP).

So far, none of BTE's employers or payers have formally committed to the program, Mr. Francois de Brantes, CEO of the coalition, said in an interview. By late spring, however, he expects to "have a couple of exciting announcements."

Dr. Michael Barr, ACP vice president for practice advocacy and improvement, said that the program might spur physicians who are already working on practice improvement, but not documenting it, to start doing so, thereby becoming eligible for the bonuses.

The "patient ultimately benefits from better coordination" of care, Dr. Barr added in an interview.

Dr. de Brantes called the program a vote of confidence in the notion that delivering high-quality coordinated care—as described in the medical home model advocated by the ACP, AAFP, and American Academy of Pediatrics—saves money and improves quality. "We feel pretty confident that the rewards are warranted and that the savings are there to match them," Mr. de Brantes said. "Our research shows that patients who are well taken care of cost less," he said, adding that "the average potential savings per covered life would be approximately $250 a year."

The nonprofit BTE is a coalition of providers, insurers, and employers working together to advance the quality of health care. Members include Aetna, the American Board of Internal Medicine, the Blue Cross and Blue Shield Association, Cisco Systems, IBM, the Leapfrog Group, the National Business Coalition on Health, Partners Healthcare System, and Verizon Communications.

BTE has previously offered pay-for-performance incentives to physicians who use its Physician Office Link, Diabetes Care Link, Cardiac Care Link, and Spine Care Link reporting systems. Physician Office Link was developed in collaboration with the National Committee for Quality Assurance.

With the new Medical Home Program, physicians will be eligible for additional bonus payments of $125 per patient—up to a maximum $100,000 per provider—if they achieve certain performance levels on the Physician Office Link module and at least two of the condition-specific modules.

It's not yet clear when the medical home rewards will start flowing, but the structure is fairly well established, according to Mr. de Brantes.

The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.

E-prescribing is not required for participation in the Medicare Part D drug benefit, but under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.

Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.

The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.

The American Medical Association and other groups oppose a mandate. "From a practical side, a mandate would be premature," Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview. "We can see the benefits of it, but we can't ignore that there are costs involved."

The final e-prescribing standards should be issued by April 1.

The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.

E-prescribing is not required for participation in the Medicare Part D drug benefit, but under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.

Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.

The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.

The American Medical Association and other groups oppose a mandate. "From a practical side, a mandate would be premature," Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview. "We can see the benefits of it, but we can't ignore that there are costs involved."

The final e-prescribing standards should be issued by April 1.

The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.

E-prescribing is not required for participation in the Medicare Part D drug benefit, but under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.

Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.

The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.

The American Medical Association and other groups oppose a mandate. "From a practical side, a mandate would be premature," Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview. "We can see the benefits of it, but we can't ignore that there are costs involved."

The final e-prescribing standards should be issued by April 1.

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked by the government to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities that were identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across other states.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times and a physician on call at all times. Seven hospitals did not have an RN on duty and one did not have a physician on call or on duty on at least 1 of 8 days reviewed. Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the "appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients," according to the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have information in their written policies on how to manage a medical emergency, said the IG.

The CMS issued a written response that was included in the IG's report. The agency said it agreed with the IG's recommendations and that it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, according to the IG. Those facilities were instead accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would use its existing authority to require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish requirements for equipment and staff qualifications.

The report was requested by the Senate Finance Committee, whose leaders—Sen. Chuck Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.)—have a history of seeking restrictions on physician-owned specialty hospitals, and have successfully implemented moratoriums on new facilities.

These senators will likely introduce a new proposal to rein in specialty hospitals this spring, Molly Sandvig, executive director of Physician Hospitals of America, said in an interview.

Ms. Sandvig said that her organization—which represents 108 physician-owned facilities—believed that all hospitals should meet Medicare conditions of participation. However, not every hospital should have an emergency department, she said.

Both the American Hospital Association and the Federation of American Hospitals pounced on the report, saying that it shows physician-owned facilities are a threat to patient safety.

"The report illustrates yet another reason why Congress needs to take action in the best interests of patients and ban physician self-referral to new limited-service hospitals they own and operate," AHA Executive Vice President Rick Pollack said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked by the government to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities that were identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across other states.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times and a physician on call at all times. Seven hospitals did not have an RN on duty and one did not have a physician on call or on duty on at least 1 of 8 days reviewed. Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the "appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients," according to the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have information in their written policies on how to manage a medical emergency, said the IG.

The CMS issued a written response that was included in the IG's report. The agency said it agreed with the IG's recommendations and that it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, according to the IG. Those facilities were instead accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would use its existing authority to require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish requirements for equipment and staff qualifications.

The report was requested by the Senate Finance Committee, whose leaders—Sen. Chuck Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.)—have a history of seeking restrictions on physician-owned specialty hospitals, and have successfully implemented moratoriums on new facilities.

These senators will likely introduce a new proposal to rein in specialty hospitals this spring, Molly Sandvig, executive director of Physician Hospitals of America, said in an interview.

Ms. Sandvig said that her organization—which represents 108 physician-owned facilities—believed that all hospitals should meet Medicare conditions of participation. However, not every hospital should have an emergency department, she said.

Both the American Hospital Association and the Federation of American Hospitals pounced on the report, saying that it shows physician-owned facilities are a threat to patient safety.

"The report illustrates yet another reason why Congress needs to take action in the best interests of patients and ban physician self-referral to new limited-service hospitals they own and operate," AHA Executive Vice President Rick Pollack said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked by the government to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities that were identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across other states.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times and a physician on call at all times. Seven hospitals did not have an RN on duty and one did not have a physician on call or on duty on at least 1 of 8 days reviewed. Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the "appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients," according to the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have information in their written policies on how to manage a medical emergency, said the IG.

The CMS issued a written response that was included in the IG's report. The agency said it agreed with the IG's recommendations and that it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, according to the IG. Those facilities were instead accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would use its existing authority to require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish requirements for equipment and staff qualifications.

The report was requested by the Senate Finance Committee, whose leaders—Sen. Chuck Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.)—have a history of seeking restrictions on physician-owned specialty hospitals, and have successfully implemented moratoriums on new facilities.

These senators will likely introduce a new proposal to rein in specialty hospitals this spring, Molly Sandvig, executive director of Physician Hospitals of America, said in an interview.

Ms. Sandvig said that her organization—which represents 108 physician-owned facilities—believed that all hospitals should meet Medicare conditions of participation. However, not every hospital should have an emergency department, she said.

Both the American Hospital Association and the Federation of American Hospitals pounced on the report, saying that it shows physician-owned facilities are a threat to patient safety.

"The report illustrates yet another reason why Congress needs to take action in the best interests of patients and ban physician self-referral to new limited-service hospitals they own and operate," AHA Executive Vice President Rick Pollack said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Enbrel Sales Investigated

The New Jersey Attorney General's office is investigating Amgen for allegedly promoting Enbrel for off-label uses and for violating privacy laws to get access to potential new patients. On Jan. 14, Attorney General Anne Milgram subpoenaed Amgen for all documents relating to the marketing, sale, and prescription of Enbrel (etanercept) since July 2002. The inquiry follows a lawsuit by two former sales representatives who alleged that the company encouraged them to search physicians' records for patients with mild psoriasis who might be potential candidates for Enbrel therapy. The former employees also claimed to have directly contacted insurers to facilitate reimbursement to physicians for the cost of the biologic. An Amgen spokeswoman said that the company will cooperate fully with the investigation and that the employees' claims "are completely without merit." The company expects salespeople to follow the Code of Conduct. "Amgen does not instruct sales representatives to proactively review patient files or promote off-label for any reason," said the spokeswoman.

HHS Resists Ketek Subpoena

The Department of Health and Human Services has refused to comply with a House Energy and Commerce Committee subpoena of documents related to the March 2007 testimony by Food and Drug Administration Commissioner Andrew von Eschenbach on the approval of Ketek (telithromycin). "There appears to be a continued effort to keep secret the documents we have requested," said Rep. Bart Stupak (D-Mich.), chairman of the committee's oversight and investigation subcommittee. Rep. Stupak spoke at a February subcommittee hearing looking into a Ketek safety study by manufacturer Sanofi-Aventis U.S. LLC and a subsequent FDA inquiry into fraud allegations surrounding that trial. Subcommittee members heard testimony from Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and from FDA and independent investigators that agency officials and Sanofi-Aventis executives ignored warnings that the safety study was riddled with fraud. Both the House panel and the Senate Finance Committee want to determine what the FDA and Sanofi-Aventis knew about the alleged fraud and when. Energy and Commerce Chairman John Dingell (D-Mich.) said he would compel HHS to furnish the documents. An FDA spokeswoman said the agency has given the committee "more than 80,000 pages of information on Ketek," and that the agency has "made every effort to be responsive to the committee's requests."

Reloxin Approval Delayed

FDA has refused to accept the biologics license application filed by Medicis Pharmaceutical Corp. for Reloxin (injectable botulinum toxin type A), according to a Securities and Exchange Commission filing by the company. According to the filing, the application was deemed incomplete because it did not "address how Medicis would fulfill its responsibilities as the manufacturer of the product." The company said the agency cited only administrative, not substantive, problems with the application for approval. Medicis, which licensed Reloxin from the Ipsen Group for commercialization in the United States, Canada, and Japan, "intends to promptly work with the FDA and coordinate its activities with Ipsen to address these administrative issues," according to the filing.

Eyelash Lengthener Sales Halted

Jan Marini Skin Research Inc. has stopped selling its Age Intervention Eyelash Conditioner and Age Intervention Masses of Lashes Performance Mascara in the United States. The company cited its involvement in ongoing patent litigation with Allergan Inc. as one reason for ceasing sales. In a statement, CEO Jan Marini said the company had confidence in the products' safety profile. An older, discontinued product, Age Intervention Eyelash, was the subject of an FDA seizure last November. The agency seized $2 million worth of Age Intervention Eyelash, saying that it was misbranded because it contained bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure. However, Jan Marini had discontinued making or selling Age Intervention Eyelash in 2006. Allergan markets bimatoprost under the trade name Lumigan.

More Action Needed on MRSA

U.S. health care facilities are not doing enough to protect patients from methicillin-resistant Staphylococcus aureus (MRSA) infections, according to an online poll conducted by the Association for Professionals in Infection Control. A majority of infection control professionals (59%) responded that their health care facilities have stepped up efforts to curb MRSA in the past 6 months. But half said their facilities were "not doing as much as [they] could or should" to stop the transmission of MRSA. "MRSA could be beaten if the leadership at hospitals moved more aggressively to adopt strategies proven to protect patients from these virulent infections," said Lisa McGiffert, director of Consumers Union's Stop Hospital Infections campaign. "We need to require hospitals to report their infection rates so the public can see if they are achieving results." Consumers Union has worked to help pass laws in 20 states requiring hospitals to report their patient infection rates, and it supports a federal infection reporting law. The Centers for Disease Control and Prevention estimates that nearly 95,000 patients developed MRSA infections in 2005—most of which were acquired in health care facilities—and almost 19,000 people died.

Enbrel Sales Investigated

The New Jersey Attorney General's office is investigating Amgen for allegedly promoting Enbrel for off-label uses and for violating privacy laws to get access to potential new patients. On Jan. 14, Attorney General Anne Milgram subpoenaed Amgen for all documents relating to the marketing, sale, and prescription of Enbrel (etanercept) since July 2002. The inquiry follows a lawsuit by two former sales representatives who alleged that the company encouraged them to search physicians' records for patients with mild psoriasis who might be potential candidates for Enbrel therapy. The former employees also claimed to have directly contacted insurers to facilitate reimbursement to physicians for the cost of the biologic. An Amgen spokeswoman said that the company will cooperate fully with the investigation and that the employees' claims "are completely without merit." The company expects salespeople to follow the Code of Conduct. "Amgen does not instruct sales representatives to proactively review patient files or promote off-label for any reason," said the spokeswoman.

HHS Resists Ketek Subpoena

The Department of Health and Human Services has refused to comply with a House Energy and Commerce Committee subpoena of documents related to the March 2007 testimony by Food and Drug Administration Commissioner Andrew von Eschenbach on the approval of Ketek (telithromycin). "There appears to be a continued effort to keep secret the documents we have requested," said Rep. Bart Stupak (D-Mich.), chairman of the committee's oversight and investigation subcommittee. Rep. Stupak spoke at a February subcommittee hearing looking into a Ketek safety study by manufacturer Sanofi-Aventis U.S. LLC and a subsequent FDA inquiry into fraud allegations surrounding that trial. Subcommittee members heard testimony from Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and from FDA and independent investigators that agency officials and Sanofi-Aventis executives ignored warnings that the safety study was riddled with fraud. Both the House panel and the Senate Finance Committee want to determine what the FDA and Sanofi-Aventis knew about the alleged fraud and when. Energy and Commerce Chairman John Dingell (D-Mich.) said he would compel HHS to furnish the documents. An FDA spokeswoman said the agency has given the committee "more than 80,000 pages of information on Ketek," and that the agency has "made every effort to be responsive to the committee's requests."

Reloxin Approval Delayed

FDA has refused to accept the biologics license application filed by Medicis Pharmaceutical Corp. for Reloxin (injectable botulinum toxin type A), according to a Securities and Exchange Commission filing by the company. According to the filing, the application was deemed incomplete because it did not "address how Medicis would fulfill its responsibilities as the manufacturer of the product." The company said the agency cited only administrative, not substantive, problems with the application for approval. Medicis, which licensed Reloxin from the Ipsen Group for commercialization in the United States, Canada, and Japan, "intends to promptly work with the FDA and coordinate its activities with Ipsen to address these administrative issues," according to the filing.

Eyelash Lengthener Sales Halted

Jan Marini Skin Research Inc. has stopped selling its Age Intervention Eyelash Conditioner and Age Intervention Masses of Lashes Performance Mascara in the United States. The company cited its involvement in ongoing patent litigation with Allergan Inc. as one reason for ceasing sales. In a statement, CEO Jan Marini said the company had confidence in the products' safety profile. An older, discontinued product, Age Intervention Eyelash, was the subject of an FDA seizure last November. The agency seized $2 million worth of Age Intervention Eyelash, saying that it was misbranded because it contained bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure. However, Jan Marini had discontinued making or selling Age Intervention Eyelash in 2006. Allergan markets bimatoprost under the trade name Lumigan.

More Action Needed on MRSA

U.S. health care facilities are not doing enough to protect patients from methicillin-resistant Staphylococcus aureus (MRSA) infections, according to an online poll conducted by the Association for Professionals in Infection Control. A majority of infection control professionals (59%) responded that their health care facilities have stepped up efforts to curb MRSA in the past 6 months. But half said their facilities were "not doing as much as [they] could or should" to stop the transmission of MRSA. "MRSA could be beaten if the leadership at hospitals moved more aggressively to adopt strategies proven to protect patients from these virulent infections," said Lisa McGiffert, director of Consumers Union's Stop Hospital Infections campaign. "We need to require hospitals to report their infection rates so the public can see if they are achieving results." Consumers Union has worked to help pass laws in 20 states requiring hospitals to report their patient infection rates, and it supports a federal infection reporting law. The Centers for Disease Control and Prevention estimates that nearly 95,000 patients developed MRSA infections in 2005—most of which were acquired in health care facilities—and almost 19,000 people died.

Enbrel Sales Investigated

The New Jersey Attorney General's office is investigating Amgen for allegedly promoting Enbrel for off-label uses and for violating privacy laws to get access to potential new patients. On Jan. 14, Attorney General Anne Milgram subpoenaed Amgen for all documents relating to the marketing, sale, and prescription of Enbrel (etanercept) since July 2002. The inquiry follows a lawsuit by two former sales representatives who alleged that the company encouraged them to search physicians' records for patients with mild psoriasis who might be potential candidates for Enbrel therapy. The former employees also claimed to have directly contacted insurers to facilitate reimbursement to physicians for the cost of the biologic. An Amgen spokeswoman said that the company will cooperate fully with the investigation and that the employees' claims "are completely without merit." The company expects salespeople to follow the Code of Conduct. "Amgen does not instruct sales representatives to proactively review patient files or promote off-label for any reason," said the spokeswoman.

HHS Resists Ketek Subpoena

The Department of Health and Human Services has refused to comply with a House Energy and Commerce Committee subpoena of documents related to the March 2007 testimony by Food and Drug Administration Commissioner Andrew von Eschenbach on the approval of Ketek (telithromycin). "There appears to be a continued effort to keep secret the documents we have requested," said Rep. Bart Stupak (D-Mich.), chairman of the committee's oversight and investigation subcommittee. Rep. Stupak spoke at a February subcommittee hearing looking into a Ketek safety study by manufacturer Sanofi-Aventis U.S. LLC and a subsequent FDA inquiry into fraud allegations surrounding that trial. Subcommittee members heard testimony from Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and from FDA and independent investigators that agency officials and Sanofi-Aventis executives ignored warnings that the safety study was riddled with fraud. Both the House panel and the Senate Finance Committee want to determine what the FDA and Sanofi-Aventis knew about the alleged fraud and when. Energy and Commerce Chairman John Dingell (D-Mich.) said he would compel HHS to furnish the documents. An FDA spokeswoman said the agency has given the committee "more than 80,000 pages of information on Ketek," and that the agency has "made every effort to be responsive to the committee's requests."

Reloxin Approval Delayed

FDA has refused to accept the biologics license application filed by Medicis Pharmaceutical Corp. for Reloxin (injectable botulinum toxin type A), according to a Securities and Exchange Commission filing by the company. According to the filing, the application was deemed incomplete because it did not "address how Medicis would fulfill its responsibilities as the manufacturer of the product." The company said the agency cited only administrative, not substantive, problems with the application for approval. Medicis, which licensed Reloxin from the Ipsen Group for commercialization in the United States, Canada, and Japan, "intends to promptly work with the FDA and coordinate its activities with Ipsen to address these administrative issues," according to the filing.

Eyelash Lengthener Sales Halted

Jan Marini Skin Research Inc. has stopped selling its Age Intervention Eyelash Conditioner and Age Intervention Masses of Lashes Performance Mascara in the United States. The company cited its involvement in ongoing patent litigation with Allergan Inc. as one reason for ceasing sales. In a statement, CEO Jan Marini said the company had confidence in the products' safety profile. An older, discontinued product, Age Intervention Eyelash, was the subject of an FDA seizure last November. The agency seized $2 million worth of Age Intervention Eyelash, saying that it was misbranded because it contained bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure. However, Jan Marini had discontinued making or selling Age Intervention Eyelash in 2006. Allergan markets bimatoprost under the trade name Lumigan.

More Action Needed on MRSA

U.S. health care facilities are not doing enough to protect patients from methicillin-resistant Staphylococcus aureus (MRSA) infections, according to an online poll conducted by the Association for Professionals in Infection Control. A majority of infection control professionals (59%) responded that their health care facilities have stepped up efforts to curb MRSA in the past 6 months. But half said their facilities were "not doing as much as [they] could or should" to stop the transmission of MRSA. "MRSA could be beaten if the leadership at hospitals moved more aggressively to adopt strategies proven to protect patients from these virulent infections," said Lisa McGiffert, director of Consumers Union's Stop Hospital Infections campaign. "We need to require hospitals to report their infection rates so the public can see if they are achieving results." Consumers Union has worked to help pass laws in 20 states requiring hospitals to report their patient infection rates, and it supports a federal infection reporting law. The Centers for Disease Control and Prevention estimates that nearly 95,000 patients developed MRSA infections in 2005—most of which were acquired in health care facilities—and almost 19,000 people died.

WASHINGTON – At least 24 million Americans have diabetes, which costs the nation $174 billion in direct and indirect expenditures in 2007, according to the American Diabetes Association.

The ADA released data that were compiled from a variety of mostly federal sources, including the National Health Interview Survey, the National Health and Nutrition Examination Survey, and the Medical Expenditure Panel Survey. The Lewin Group conducted an analysis of that survey data for the ADA, drawing from the medical, public health, and economics literature.

The report currently does not split costs and incidence according to type of diabetes; those data will be available in a few months, said lead author Tim Dall, at a briefing on the analysis for congressional staff members and reporters.

According to the analysis, the cost of the disease has risen 32% since data were last tabulated in 2002. And the $174 billion figure is likely to be conservative because it doesn't include the approximately 6 million Americans with undiagnosed diabetes, said Ann L. Albright, Ph.D., president of health care and education at the ADA, at the briefing.

The cost estimate also does not include all of the expenses related to diabetes, such as over-the-counter medications or office visits to nonphysician providers other than podiatrists (such as optometrists or dentists).

“The findings reaffirm that diabetes is a public health crisis and its implications are painful and far reaching,” said Dr. Albright, who is also the director of the division of diabetes translation at the Centers for Disease Control and Prevention. “This underscores the importance of early diagnosis and treatment.”

According to the analysis, 17.5 million Americans have been diagnosed with diabetes, up from 12.1 million in 2002. The diabetes population is growing by about 1 million people a year, driven by the aging of the population, more obesity, better detection, decreasing mortality, and growth in minority populations with higher rates of the disease, according to the study, which will be published in Diabetes Care in March (2008;31:1-20).

Most people with diabetes are insured, with their costs covered primarily through government programs. About 8.5 million diabetics are Medicare beneficiaries. Two million are uninsured and a third of those are undiagnosed, estimated the authors.

On the medical expenditure side, the total direct costs were an estimated $116 billion, with $27 billion for direct treatment, $58 billion for chronic complications, and $31 billion in “excess” general medical costs. The largest component of medical spending was for inpatient hospitalization, accounting for $58 billion. The inpatient costs for diabetes-related chronic complications–such as neurologic, peripheral vascular, cardiovascular, and renal–are higher than for diabetes-specific hospitalizations, at $2,281, compared with $1,853.

Diagnosed diabetics have medical costs that are twice as high as they would be without the presence of the disease. Their expenditures average $11,744 a year, of which $6,649 is attributable directly to diabetes.

The indirect costs–pegged at $58 billion–include increased absenteeism, reduced productivity while at work and reduced productivity for those not in the labor force, unemployment from disease-related disability, and lost productive capacity because of early death.

According to the study, there were 284,000 deaths related to diabetes in 2007.

The authors said that while it appears that the disease's burden falls mostly on insurers, employers, and people with diabetes and their families, “the burden is passed along to all of society in the form of higher insurance premiums and taxes, reduced earnings, and reduced standard of living.”

Diabetes affects just under 1 in 10 people, and thus “directly or indirectly touches everyone in society,” they wrote.

WASHINGTON – At least 24 million Americans have diabetes, which costs the nation $174 billion in direct and indirect expenditures in 2007, according to the American Diabetes Association.

The ADA released data that were compiled from a variety of mostly federal sources, including the National Health Interview Survey, the National Health and Nutrition Examination Survey, and the Medical Expenditure Panel Survey. The Lewin Group conducted an analysis of that survey data for the ADA, drawing from the medical, public health, and economics literature.

The report currently does not split costs and incidence according to type of diabetes; those data will be available in a few months, said lead author Tim Dall, at a briefing on the analysis for congressional staff members and reporters.

According to the analysis, the cost of the disease has risen 32% since data were last tabulated in 2002. And the $174 billion figure is likely to be conservative because it doesn't include the approximately 6 million Americans with undiagnosed diabetes, said Ann L. Albright, Ph.D., president of health care and education at the ADA, at the briefing.

The cost estimate also does not include all of the expenses related to diabetes, such as over-the-counter medications or office visits to nonphysician providers other than podiatrists (such as optometrists or dentists).

“The findings reaffirm that diabetes is a public health crisis and its implications are painful and far reaching,” said Dr. Albright, who is also the director of the division of diabetes translation at the Centers for Disease Control and Prevention. “This underscores the importance of early diagnosis and treatment.”

According to the analysis, 17.5 million Americans have been diagnosed with diabetes, up from 12.1 million in 2002. The diabetes population is growing by about 1 million people a year, driven by the aging of the population, more obesity, better detection, decreasing mortality, and growth in minority populations with higher rates of the disease, according to the study, which will be published in Diabetes Care in March (2008;31:1-20).

Most people with diabetes are insured, with their costs covered primarily through government programs. About 8.5 million diabetics are Medicare beneficiaries. Two million are uninsured and a third of those are undiagnosed, estimated the authors.

On the medical expenditure side, the total direct costs were an estimated $116 billion, with $27 billion for direct treatment, $58 billion for chronic complications, and $31 billion in “excess” general medical costs. The largest component of medical spending was for inpatient hospitalization, accounting for $58 billion. The inpatient costs for diabetes-related chronic complications–such as neurologic, peripheral vascular, cardiovascular, and renal–are higher than for diabetes-specific hospitalizations, at $2,281, compared with $1,853.

Diagnosed diabetics have medical costs that are twice as high as they would be without the presence of the disease. Their expenditures average $11,744 a year, of which $6,649 is attributable directly to diabetes.

The indirect costs–pegged at $58 billion–include increased absenteeism, reduced productivity while at work and reduced productivity for those not in the labor force, unemployment from disease-related disability, and lost productive capacity because of early death.

According to the study, there were 284,000 deaths related to diabetes in 2007.

The authors said that while it appears that the disease's burden falls mostly on insurers, employers, and people with diabetes and their families, “the burden is passed along to all of society in the form of higher insurance premiums and taxes, reduced earnings, and reduced standard of living.”

Diabetes affects just under 1 in 10 people, and thus “directly or indirectly touches everyone in society,” they wrote.

WASHINGTON – At least 24 million Americans have diabetes, which costs the nation $174 billion in direct and indirect expenditures in 2007, according to the American Diabetes Association.

The ADA released data that were compiled from a variety of mostly federal sources, including the National Health Interview Survey, the National Health and Nutrition Examination Survey, and the Medical Expenditure Panel Survey. The Lewin Group conducted an analysis of that survey data for the ADA, drawing from the medical, public health, and economics literature.

The report currently does not split costs and incidence according to type of diabetes; those data will be available in a few months, said lead author Tim Dall, at a briefing on the analysis for congressional staff members and reporters.

According to the analysis, the cost of the disease has risen 32% since data were last tabulated in 2002. And the $174 billion figure is likely to be conservative because it doesn't include the approximately 6 million Americans with undiagnosed diabetes, said Ann L. Albright, Ph.D., president of health care and education at the ADA, at the briefing.

The cost estimate also does not include all of the expenses related to diabetes, such as over-the-counter medications or office visits to nonphysician providers other than podiatrists (such as optometrists or dentists).

“The findings reaffirm that diabetes is a public health crisis and its implications are painful and far reaching,” said Dr. Albright, who is also the director of the division of diabetes translation at the Centers for Disease Control and Prevention. “This underscores the importance of early diagnosis and treatment.”

According to the analysis, 17.5 million Americans have been diagnosed with diabetes, up from 12.1 million in 2002. The diabetes population is growing by about 1 million people a year, driven by the aging of the population, more obesity, better detection, decreasing mortality, and growth in minority populations with higher rates of the disease, according to the study, which will be published in Diabetes Care in March (2008;31:1-20).

Most people with diabetes are insured, with their costs covered primarily through government programs. About 8.5 million diabetics are Medicare beneficiaries. Two million are uninsured and a third of those are undiagnosed, estimated the authors.

On the medical expenditure side, the total direct costs were an estimated $116 billion, with $27 billion for direct treatment, $58 billion for chronic complications, and $31 billion in “excess” general medical costs. The largest component of medical spending was for inpatient hospitalization, accounting for $58 billion. The inpatient costs for diabetes-related chronic complications–such as neurologic, peripheral vascular, cardiovascular, and renal–are higher than for diabetes-specific hospitalizations, at $2,281, compared with $1,853.

Diagnosed diabetics have medical costs that are twice as high as they would be without the presence of the disease. Their expenditures average $11,744 a year, of which $6,649 is attributable directly to diabetes.

The indirect costs–pegged at $58 billion–include increased absenteeism, reduced productivity while at work and reduced productivity for those not in the labor force, unemployment from disease-related disability, and lost productive capacity because of early death.

According to the study, there were 284,000 deaths related to diabetes in 2007.

The authors said that while it appears that the disease's burden falls mostly on insurers, employers, and people with diabetes and their families, “the burden is passed along to all of society in the form of higher insurance premiums and taxes, reduced earnings, and reduced standard of living.”

Diabetes affects just under 1 in 10 people, and thus “directly or indirectly touches everyone in society,” they wrote.

The Food and Drug Administration said that it is considering, but has not yet determined, whether data from the ENHANCE study of Vytorin warrants any regulatory action.

The agency posted an “early communication” and a MedWatch safety report on its Web site alerting the public and health care practitioners that it is aware of the data but that it has not yet fully examined what appear to be equivocal results.

In a press briefing, Dr. John Jenkins, director of the FDA's Office of New Drugs, said the agency hopes to determine why the ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial results were equivocal, with the combination not affecting plaque size in carotid arteries.

Agency officials who participated in the briefing said they were scratching their heads over the results, given that both ezetimibe and simvastatin have been shown to lower LDL cholesterol levels in ENHANCE and in other studies. LDL is a validated surrogate end point, they said.

FDA reviewers will evaluate the data with an eye on potential safety issues, Dr. Jenkins said. “We don't see any reason to change the label or the approved indications based on this study,” he said.

He said it may take several months for the agency to receive the data from Merck & Co. and Schering-Plough Pharmaceuticals, the companies that conducted the ENHANCE study, and up to 6 months after that to complete the review.

A press release revealing the equivocal results issued by Merck and Schering-Plough set off a firestorm of criticism. The House Energy and Commerce Committee and the Senate Finance Committee are investigating the timing of the data release and myriad other issues around Vytorin. It also prompted a torrent of class action suits alleging marketing fraud by the two drug makers.

The agency said physicians should not stop prescribing Vytorin or Zetia (ezetimibe), but should, in conjunction with patients, “carefully consider the available data and current labeling for Zetia and Vytorin as they make individual treatment decisions.”

Dr. Jenkins pointed out that neither of these products has any data on reduction of heart attack or stroke as of yet. Cardiovascular events will be measured in the companies' ongoing Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), which will be completed in 2011.

“If a physician wants the certainty of using a product that has outcomes data, [there are] a large number of those products available,” he said.

Merck and Schering-Plough “acted with integrity and good faith in connection with the trial,” said Thomas Koestler, Ph.D., president of the Schering-Plough Research Institute. “We stand behind Vytorin and Zetia and stand behind our science,” said Peter S. Kim, Ph.D., Merck Research Laboratories president.

The Food and Drug Administration said that it is considering, but has not yet determined, whether data from the ENHANCE study of Vytorin warrants any regulatory action.

The agency posted an “early communication” and a MedWatch safety report on its Web site alerting the public and health care practitioners that it is aware of the data but that it has not yet fully examined what appear to be equivocal results.

In a press briefing, Dr. John Jenkins, director of the FDA's Office of New Drugs, said the agency hopes to determine why the ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial results were equivocal, with the combination not affecting plaque size in carotid arteries.

Agency officials who participated in the briefing said they were scratching their heads over the results, given that both ezetimibe and simvastatin have been shown to lower LDL cholesterol levels in ENHANCE and in other studies. LDL is a validated surrogate end point, they said.

FDA reviewers will evaluate the data with an eye on potential safety issues, Dr. Jenkins said. “We don't see any reason to change the label or the approved indications based on this study,” he said.

He said it may take several months for the agency to receive the data from Merck & Co. and Schering-Plough Pharmaceuticals, the companies that conducted the ENHANCE study, and up to 6 months after that to complete the review.

A press release revealing the equivocal results issued by Merck and Schering-Plough set off a firestorm of criticism. The House Energy and Commerce Committee and the Senate Finance Committee are investigating the timing of the data release and myriad other issues around Vytorin. It also prompted a torrent of class action suits alleging marketing fraud by the two drug makers.

The agency said physicians should not stop prescribing Vytorin or Zetia (ezetimibe), but should, in conjunction with patients, “carefully consider the available data and current labeling for Zetia and Vytorin as they make individual treatment decisions.”

Dr. Jenkins pointed out that neither of these products has any data on reduction of heart attack or stroke as of yet. Cardiovascular events will be measured in the companies' ongoing Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), which will be completed in 2011.

“If a physician wants the certainty of using a product that has outcomes data, [there are] a large number of those products available,” he said.

Merck and Schering-Plough “acted with integrity and good faith in connection with the trial,” said Thomas Koestler, Ph.D., president of the Schering-Plough Research Institute. “We stand behind Vytorin and Zetia and stand behind our science,” said Peter S. Kim, Ph.D., Merck Research Laboratories president.

The Food and Drug Administration said that it is considering, but has not yet determined, whether data from the ENHANCE study of Vytorin warrants any regulatory action.

The agency posted an “early communication” and a MedWatch safety report on its Web site alerting the public and health care practitioners that it is aware of the data but that it has not yet fully examined what appear to be equivocal results.

In a press briefing, Dr. John Jenkins, director of the FDA's Office of New Drugs, said the agency hopes to determine why the ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial results were equivocal, with the combination not affecting plaque size in carotid arteries.

Agency officials who participated in the briefing said they were scratching their heads over the results, given that both ezetimibe and simvastatin have been shown to lower LDL cholesterol levels in ENHANCE and in other studies. LDL is a validated surrogate end point, they said.

FDA reviewers will evaluate the data with an eye on potential safety issues, Dr. Jenkins said. “We don't see any reason to change the label or the approved indications based on this study,” he said.

He said it may take several months for the agency to receive the data from Merck & Co. and Schering-Plough Pharmaceuticals, the companies that conducted the ENHANCE study, and up to 6 months after that to complete the review.

A press release revealing the equivocal results issued by Merck and Schering-Plough set off a firestorm of criticism. The House Energy and Commerce Committee and the Senate Finance Committee are investigating the timing of the data release and myriad other issues around Vytorin. It also prompted a torrent of class action suits alleging marketing fraud by the two drug makers.

The agency said physicians should not stop prescribing Vytorin or Zetia (ezetimibe), but should, in conjunction with patients, “carefully consider the available data and current labeling for Zetia and Vytorin as they make individual treatment decisions.”

Dr. Jenkins pointed out that neither of these products has any data on reduction of heart attack or stroke as of yet. Cardiovascular events will be measured in the companies' ongoing Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), which will be completed in 2011.

“If a physician wants the certainty of using a product that has outcomes data, [there are] a large number of those products available,” he said.

Merck and Schering-Plough “acted with integrity and good faith in connection with the trial,” said Thomas Koestler, Ph.D., president of the Schering-Plough Research Institute. “We stand behind Vytorin and Zetia and stand behind our science,” said Peter S. Kim, Ph.D., Merck Research Laboratories president.

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked by the government to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities that were identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac hospitals. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across other states.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times, and a physician on call at all times. But seven hospitals did not have an RN on duty, and one hospital did not have a physician on call or on duty on at least 1 of the 8 days reviewed.

Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the “appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients,” according to the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have information in their written policies on how to manage a medical emergency, such as how to use emergency response equipment or how to follow lifesaving protocols, said the IG.

The CMS issued a written response to the IG that was included in the report. The agency said it agreed with the IG's recommendations and that it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, according to the IG. Those facilities were instead accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would use its existing authority to require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish specific requirements for equipment and staff qualifications.

The report was requested by the Senate Finance Committee, whose leaders–Sen. Chuck Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.)–have a history of seeking restrictions on physician-owned specialty hospitals, and have successfully implemented moratoriums on new facilities.

These senators will likely introduce a new proposal to rein in specialty hospitals this spring, Molly Sandvig, executive director of Physician Hospitals of America, said in an interview.

Ms. Sandvig said that her organization–which represents 108 physician-owned facilities–believed that all hospitals should meet Medicare conditions of participation. However, not every hospital should have an emergency department, she said.

And while transfers may be acceptable, “No hospital should use 911 as a substitute for providing proper care to patients,” said Ms. Sandvig. That practice, however, is very limited, she said, alleging that the IG had misrepresented facilities' policies and practices.

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked by the government to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities that were identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac hospitals. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across other states.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times, and a physician on call at all times. But seven hospitals did not have an RN on duty, and one hospital did not have a physician on call or on duty on at least 1 of the 8 days reviewed.

Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the “appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients,” according to the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have information in their written policies on how to manage a medical emergency, such as how to use emergency response equipment or how to follow lifesaving protocols, said the IG.

The CMS issued a written response to the IG that was included in the report. The agency said it agreed with the IG's recommendations and that it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, according to the IG. Those facilities were instead accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would use its existing authority to require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish specific requirements for equipment and staff qualifications.

The report was requested by the Senate Finance Committee, whose leaders–Sen. Chuck Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.)–have a history of seeking restrictions on physician-owned specialty hospitals, and have successfully implemented moratoriums on new facilities.

These senators will likely introduce a new proposal to rein in specialty hospitals this spring, Molly Sandvig, executive director of Physician Hospitals of America, said in an interview.

Ms. Sandvig said that her organization–which represents 108 physician-owned facilities–believed that all hospitals should meet Medicare conditions of participation. However, not every hospital should have an emergency department, she said.

And while transfers may be acceptable, “No hospital should use 911 as a substitute for providing proper care to patients,” said Ms. Sandvig. That practice, however, is very limited, she said, alleging that the IG had misrepresented facilities' policies and practices.

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked by the government to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities that were identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac hospitals. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across other states.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times, and a physician on call at all times. But seven hospitals did not have an RN on duty, and one hospital did not have a physician on call or on duty on at least 1 of the 8 days reviewed.

Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the “appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients,” according to the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have information in their written policies on how to manage a medical emergency, such as how to use emergency response equipment or how to follow lifesaving protocols, said the IG.

The CMS issued a written response to the IG that was included in the report. The agency said it agreed with the IG's recommendations and that it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, according to the IG. Those facilities were instead accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would use its existing authority to require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish specific requirements for equipment and staff qualifications.

The report was requested by the Senate Finance Committee, whose leaders–Sen. Chuck Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.)–have a history of seeking restrictions on physician-owned specialty hospitals, and have successfully implemented moratoriums on new facilities.

These senators will likely introduce a new proposal to rein in specialty hospitals this spring, Molly Sandvig, executive director of Physician Hospitals of America, said in an interview.

Ms. Sandvig said that her organization–which represents 108 physician-owned facilities–believed that all hospitals should meet Medicare conditions of participation. However, not every hospital should have an emergency department, she said.

And while transfers may be acceptable, “No hospital should use 911 as a substitute for providing proper care to patients,” said Ms. Sandvig. That practice, however, is very limited, she said, alleging that the IG had misrepresented facilities' policies and practices.

WASHINGTON – The Medicare Payment Advisory Commission has voted to recommend that Congress increase Medicare physician fees by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress next month but was discussed and voted on at a panel meeting in January.

The panel believes that physician fees should not be cut, said MedPAC chairman Glenn M. Hackbarth. “That's a very important message for us to convey to Congress.”

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers. “We try to zero in on the most appropriate update,” he said, adding that cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey. In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion. The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use. The reporting should be confidential for 2 years. After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla., and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% “doesn't keep up with our costs.” Dr. Castellanos said that physicians would not look happily on the recommended update.

“Quite honestly, it's insulting,” he said. “The update is a blunt tool for trying to constrain costs,” said Dr. Castellanos, who voted against the update.

Mr. Hackbarth said the panel's recommendation should not be taken to mean that the commission believed that everything was fine with the reimbursement system. But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future. Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, “It's way bigger than that.”

WASHINGTON – The Medicare Payment Advisory Commission has voted to recommend that Congress increase Medicare physician fees by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress next month but was discussed and voted on at a panel meeting in January.

The panel believes that physician fees should not be cut, said MedPAC chairman Glenn M. Hackbarth. “That's a very important message for us to convey to Congress.”

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers. “We try to zero in on the most appropriate update,” he said, adding that cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey. In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion. The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use. The reporting should be confidential for 2 years. After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla., and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% “doesn't keep up with our costs.” Dr. Castellanos said that physicians would not look happily on the recommended update.

“Quite honestly, it's insulting,” he said. “The update is a blunt tool for trying to constrain costs,” said Dr. Castellanos, who voted against the update.

Mr. Hackbarth said the panel's recommendation should not be taken to mean that the commission believed that everything was fine with the reimbursement system. But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future. Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, “It's way bigger than that.”

WASHINGTON – The Medicare Payment Advisory Commission has voted to recommend that Congress increase Medicare physician fees by 1.1% in 2009.

The recommendation will be included in MedPAC's final report to Congress next month but was discussed and voted on at a panel meeting in January.

The panel believes that physician fees should not be cut, said MedPAC chairman Glenn M. Hackbarth. “That's a very important message for us to convey to Congress.”

Before the vote, Mr. Hackbarth said the commission struggled each year to come up with the right numbers. “We try to zero in on the most appropriate update,” he said, adding that cost reports, physicians' access to capital, and beneficiaries' access to physician services all go into that calculation.

MedPAC staff member John Richardson told commissioners that it appears that most physicians continue to accept new Medicare patients, but there has been an increase in beneficiaries who said they had trouble finding a new primary care physician, according to a MedPAC survey. In 2006, 24% said they had trouble; by 2007, 30% of beneficiaries reported difficulty.

Medicare fees also are staying fairly steady as a percentage of private insurance fees, said Mr. Richardson. In 2005, Medicare paid 83% of what private insurers did, and in 2006, that had slipped slightly to 81%.

In December, Congress passed and the President signed a last-minute fix to the 2008 fee schedule, granting a 6-month, 0.5% increase for 2008. The fee increase, which included incentives for rural physicians, will cost about $3.1 billion, Mr. Richardson said.

Under current law, Medicare will cut physician fees by 5.5% in 2009. But when fees are renegotiated in July, the 2009 update could change.

MedPAC recommended that fees be increased in 2009 by the projected change in input prices (2.6%) minus the expected growth in productivity (1.5%), for a 1.1% increase. The cost: about $2 billion. The commission projected that spending would increase by another $8 billion out to 2011.

The commission also urged Congress to set up a system to measure and report physician resource use. The reporting should be confidential for 2 years. After that, the Centers for Medicare and Medicaid Services should establish a new payment system that takes into account both resource use and quality measures.

Dr. Ronald D. Castellanos, a physician in a group practice in Port Charlotte, Fla., and a MedPAC commissioner, said a recommendation for an increase was better than a cut, but that the 1.1% “doesn't keep up with our costs.” Dr. Castellanos said that physicians would not look happily on the recommended update.

“Quite honestly, it's insulting,” he said. “The update is a blunt tool for trying to constrain costs,” said Dr. Castellanos, who voted against the update.

Mr. Hackbarth said the panel's recommendation should not be taken to mean that the commission believed that everything was fine with the reimbursement system. But, he added, the problems with Medicare threatened beneficiaries, taxpayers, and even his children's future. Solutions should not be focused only on physicians, said Mr. Hackbarth, adding, “It's way bigger than that.”

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac hospitals. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across the U.S.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times, and a physician on call at all times. But seven hospitals did not have an RN on duty, and one hospital did not have a physician on call or on duty on at least 1 of the 8 days reviewed. Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the “appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients,” stated the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have written policies on how to use emergency response equipment or follow lifesaving protocols, said the IG.

The CMS issued a written response to the IG. The agency said it agreed with the IG's recommendations and it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, because those facilities were accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish specific requirements for equipment and staff qualifications.

Both the American Hospital Association and the Federation of American Hospitals pounced on the report, saying that it shows that physician-owned facilities are a threat to patient safety. Chip Kahn, president of the FAH, also called for a ban. The report, and “ongoing cherry-picking of healthier patients with good health coverage and increased utilization and associated health care costs, underscore yet another reason for Congress to pick up where it left off last year,” he said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac hospitals. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across the U.S.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times, and a physician on call at all times. But seven hospitals did not have an RN on duty, and one hospital did not have a physician on call or on duty on at least 1 of the 8 days reviewed. Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the “appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients,” stated the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have written policies on how to use emergency response equipment or follow lifesaving protocols, said the IG.

The CMS issued a written response to the IG. The agency said it agreed with the IG's recommendations and it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, because those facilities were accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish specific requirements for equipment and staff qualifications.

Both the American Hospital Association and the Federation of American Hospitals pounced on the report, saying that it shows that physician-owned facilities are a threat to patient safety. Chip Kahn, president of the FAH, also called for a ban. The report, and “ongoing cherry-picking of healthier patients with good health coverage and increased utilization and associated health care costs, underscore yet another reason for Congress to pick up where it left off last year,” he said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Physician-owned specialty hospitals are largely unprepared to handle emergencies and should be more closely tracked to ensure that they comply with Medicare rules, according to a report from the Inspector General of the Department of Health and Human Services.

The IG's office reviewed written policies for managing medical emergencies, staffing schedules, and staffing policies for 8 days at 109 physician-owned facilities identified from a list provided by the Centers for Medicare and Medicaid Services. There are an unknown number of physician-owned specialty hospitals, according to the IG, which is urging the CMS to begin compiling a list.

Of the 109 hospitals surveyed, 66 were surgical, 23 were orthopedic, and 20 were cardiac hospitals. Eighteen of the cardiac hospitals had an emergency department; only 11 of the 23 orthopedic hospitals and 31 of the surgical hospitals had an ED. Thirty-three of the 109 hospitals were in Texas, 15 were in Louisiana, 9 in Oklahoma, 9 in Kansas, and 8 in South Dakota. The rest were spread across the U.S.

While half of the physician-owned hospitals surveyed had an emergency department, more than half of those EDs only had a single bed. Only 45% of the EDs had a physician on site at all times.

Ninety-three percent of the hospitals met Medicare staffing requirements: having a registered nurse on duty at all times, and a physician on call at all times. But seven hospitals did not have an RN on duty, and one hospital did not have a physician on call or on duty on at least 1 of the 8 days reviewed. Two-thirds of the hospitals told staff to call 911 in case of emergency.

While transferring a patient with an emergent problem to another hospital's ED is acceptable, it might be a violation of Medicare conditions of participation if a hospital uses 911 to obtain medical assistance to stabilize a patient, according to the IG. Thirty-seven of the 109 hospitals (34%) engaged in that practice, the IG reported.

A hospital also is not in compliance if it uses 911 as a substitute for providing services required by the conditions of Medicare participation, noted the IG.

Almost 25% of the hospitals did not address in written policies the “appraisal of emergencies, initial treatment of emergencies, or referral and transfer of patients,” stated the report.

The IG urged the CMS to enforce Medicare staffing requirements. Hospitals should also have written policies on how to use emergency response equipment or follow lifesaving protocols, said the IG.

The CMS issued a written response to the IG. The agency said it agreed with the IG's recommendations and it would examine current compliance through its routine hospital surveys. As many as 42% of the 109 hospitals would not have been subject to CMS oversight, however, because those facilities were accredited by the Joint Commission or the American Osteopathic Association.

Finally, the CMS said it would require hospitals to have written policies and procedures on managing emergencies, but that it would also consider whether regulatory changes are needed to establish specific requirements for equipment and staff qualifications.

Both the American Hospital Association and the Federation of American Hospitals pounced on the report, saying that it shows that physician-owned facilities are a threat to patient safety. Chip Kahn, president of the FAH, also called for a ban. The report, and “ongoing cherry-picking of healthier patients with good health coverage and increased utilization and associated health care costs, underscore yet another reason for Congress to pick up where it left off last year,” he said in a statement.

ELSEVIER GLOBAL MEDICAL NEWS

Hospitals participating in a Medicare-sponsored, pay-for-performance demonstration project have sustained initial gains in quality improvement and have seen a huge decline in mortality and costs for selected conditions over the first 3 years of the project, according to data released by Premier Inc., a hospital performance improvement alliance.

Overall, the median hospital cost per patient dropped by $1,000 in the first 3 years, and the median mortality dropped by 2%. The project has 250 participating hospitals, and more than 1 million patient records were analyzed.

Premier, which is managing the Centers for Medicare and Medicaid Services-funded Hospital Quality Incentive Demonstration project, estimated that if every hospital in the United States achieved the same benchmarks, there would be 70,000 fewer deaths each year and hospital costs would drop by as much as $4.5 billion.

At a briefing to release the results, Mark Wynn, Ph.D., director of payment policy demonstrations at CMS, said that the hospital project is considered one of the agency's primary arguments in favor of value-based purchasing, a policy CMS regards as the most effective way to reward efficiency and value.

Dr. Wynn acknowledged that the financial incentives have been very small, but even so, there has been significant improvement. “Relatively modest dollars can have huge impacts,” he said.

Dr. Evan Benjamin, chief quality officer for Baystate Health System in Springfield, Mass., agreed that even small financial carrots have an effect.

Dr. Benjamin was the lead author of a study looking at earlier data from the improvement project.

He and his colleagues found that quality was higher among the 250 hospitals that were given incentives than it was in control hospitals that were required to report their data publicly but were not given pay-for-performance incentives (N. Engl. J. Med. 2007;356:486–96).

There's room for even more improvement, Dr. Benjamin said at the briefing, noting that most of the hospitals started at a relatively high level of quality and that larger financial incentives might push greater gains.

The Hospital Quality Incentive Demonstration project began in October 2003; the data released covered every quarter through June 2007.

Hospitals were given aggregate scores for each of five conditions—acute myo-cardial infarction, heart failure, coronary artery bypass graft, pneumonia, and hip and knee replacement—based on reporting for 27 process measures. Hospitals with fewer than eight cases per quarter were excluded, and all the data were adjusted using the All Patient Refined-Diagnostic Related Groups (APR-DRG) methodology created by 3M Information Systems.

Overall, hospitals improved by an average 17% on a composite quality score used by the project. Improvements were largest in pneumonia and heart failure.

For instance, only 70% of patients were receiving appropriate pneumonia care at the start, but by June 2007, 93% were.

For heart failure, the numbers rose from 64% to 93% of patients getting quality care. Savings were also greatest for heart failure, at about $1,339 per case.

There was a continuing downward trend in performance variation among the hospitals, with all moving toward the ideal, said Richard Norling, president and CEO of Premier Inc. For the hospitals that were on target 100% of the time with 100% of patients, costs and mortality were lowest, he said.

For instance, the mortality rate for coronary artery bypass graft patients was close to 6% at hospitals that met appropriate care benchmarks in only half the patients or fewer. Mortality was just under 2% for facilities that met those benchmarks in 75%-100% of the patients, Mr. Norling told reporters.

Attaining the goals of the demonstration project required huge cultural shifts and large investments in information systems, according to two hospital executives whose facilities participated in the project.

Before the project, the Aurora Health Care system was reactive and was achieving only incremental quality improvement, despite having a culture and leadership that focused on better care, said Dr. Nick Turkal, president and CEO of the Milwaukee-based nonprofit system.

Participation in the demonstration project has changed the mind-set of the health care system staff to “a pursuit of perfection,” Dr. Turkal said at the briefing. The system's 13 hospitals have 100,000 admissions annually. Data on meeting the pay-for-performance goals are given to employees every 60 days, and are updated regularly on the system's Web site for the public to see. Mortality and costs are down significantly across the system, but “we're not done yet,” he said.

The demonstration project has proved that incentives can work, said Dr. Wynn. CMS is tinkering slightly with the project, however. Starting this year, there will be incentives not just for improvement over baseline and for hitting the top 20%, but also for hospitals that show the greatest improvement. A total of $12 million will be available, he said.

Hospitals participating in a Medicare-sponsored, pay-for-performance demonstration project have sustained initial gains in quality improvement and have seen a huge decline in mortality and costs for selected conditions over the first 3 years of the project, according to data released by Premier Inc., a hospital performance improvement alliance.

Overall, the median hospital cost per patient dropped by $1,000 in the first 3 years, and the median mortality dropped by 2%. The project has 250 participating hospitals, and more than 1 million patient records were analyzed.

Premier, which is managing the Centers for Medicare and Medicaid Services-funded Hospital Quality Incentive Demonstration project, estimated that if every hospital in the United States achieved the same benchmarks, there would be 70,000 fewer deaths each year and hospital costs would drop by as much as $4.5 billion.

At a briefing to release the results, Mark Wynn, Ph.D., director of payment policy demonstrations at CMS, said that the hospital project is considered one of the agency's primary arguments in favor of value-based purchasing, a policy CMS regards as the most effective way to reward efficiency and value.

Dr. Wynn acknowledged that the financial incentives have been very small, but even so, there has been significant improvement. “Relatively modest dollars can have huge impacts,” he said.

Dr. Evan Benjamin, chief quality officer for Baystate Health System in Springfield, Mass., agreed that even small financial carrots have an effect.

Dr. Benjamin was the lead author of a study looking at earlier data from the improvement project.

He and his colleagues found that quality was higher among the 250 hospitals that were given incentives than it was in control hospitals that were required to report their data publicly but were not given pay-for-performance incentives (N. Engl. J. Med. 2007;356:486–96).

There's room for even more improvement, Dr. Benjamin said at the briefing, noting that most of the hospitals started at a relatively high level of quality and that larger financial incentives might push greater gains.

The Hospital Quality Incentive Demonstration project began in October 2003; the data released covered every quarter through June 2007.

Hospitals were given aggregate scores for each of five conditions—acute myo-cardial infarction, heart failure, coronary artery bypass graft, pneumonia, and hip and knee replacement—based on reporting for 27 process measures. Hospitals with fewer than eight cases per quarter were excluded, and all the data were adjusted using the All Patient Refined-Diagnostic Related Groups (APR-DRG) methodology created by 3M Information Systems.

Overall, hospitals improved by an average 17% on a composite quality score used by the project. Improvements were largest in pneumonia and heart failure.

For instance, only 70% of patients were receiving appropriate pneumonia care at the start, but by June 2007, 93% were.

For heart failure, the numbers rose from 64% to 93% of patients getting quality care. Savings were also greatest for heart failure, at about $1,339 per case.

There was a continuing downward trend in performance variation among the hospitals, with all moving toward the ideal, said Richard Norling, president and CEO of Premier Inc. For the hospitals that were on target 100% of the time with 100% of patients, costs and mortality were lowest, he said.

For instance, the mortality rate for coronary artery bypass graft patients was close to 6% at hospitals that met appropriate care benchmarks in only half the patients or fewer. Mortality was just under 2% for facilities that met those benchmarks in 75%-100% of the patients, Mr. Norling told reporters.

Attaining the goals of the demonstration project required huge cultural shifts and large investments in information systems, according to two hospital executives whose facilities participated in the project.

Before the project, the Aurora Health Care system was reactive and was achieving only incremental quality improvement, despite having a culture and leadership that focused on better care, said Dr. Nick Turkal, president and CEO of the Milwaukee-based nonprofit system.

Participation in the demonstration project has changed the mind-set of the health care system staff to “a pursuit of perfection,” Dr. Turkal said at the briefing. The system's 13 hospitals have 100,000 admissions annually. Data on meeting the pay-for-performance goals are given to employees every 60 days, and are updated regularly on the system's Web site for the public to see. Mortality and costs are down significantly across the system, but “we're not done yet,” he said.

The demonstration project has proved that incentives can work, said Dr. Wynn. CMS is tinkering slightly with the project, however. Starting this year, there will be incentives not just for improvement over baseline and for hitting the top 20%, but also for hospitals that show the greatest improvement. A total of $12 million will be available, he said.

Hospitals participating in a Medicare-sponsored, pay-for-performance demonstration project have sustained initial gains in quality improvement and have seen a huge decline in mortality and costs for selected conditions over the first 3 years of the project, according to data released by Premier Inc., a hospital performance improvement alliance.

Overall, the median hospital cost per patient dropped by $1,000 in the first 3 years, and the median mortality dropped by 2%. The project has 250 participating hospitals, and more than 1 million patient records were analyzed.

Premier, which is managing the Centers for Medicare and Medicaid Services-funded Hospital Quality Incentive Demonstration project, estimated that if every hospital in the United States achieved the same benchmarks, there would be 70,000 fewer deaths each year and hospital costs would drop by as much as $4.5 billion.

At a briefing to release the results, Mark Wynn, Ph.D., director of payment policy demonstrations at CMS, said that the hospital project is considered one of the agency's primary arguments in favor of value-based purchasing, a policy CMS regards as the most effective way to reward efficiency and value.

Dr. Wynn acknowledged that the financial incentives have been very small, but even so, there has been significant improvement. “Relatively modest dollars can have huge impacts,” he said.

Dr. Evan Benjamin, chief quality officer for Baystate Health System in Springfield, Mass., agreed that even small financial carrots have an effect.

Dr. Benjamin was the lead author of a study looking at earlier data from the improvement project.

He and his colleagues found that quality was higher among the 250 hospitals that were given incentives than it was in control hospitals that were required to report their data publicly but were not given pay-for-performance incentives (N. Engl. J. Med. 2007;356:486–96).

There's room for even more improvement, Dr. Benjamin said at the briefing, noting that most of the hospitals started at a relatively high level of quality and that larger financial incentives might push greater gains.

The Hospital Quality Incentive Demonstration project began in October 2003; the data released covered every quarter through June 2007.

Hospitals were given aggregate scores for each of five conditions—acute myo-cardial infarction, heart failure, coronary artery bypass graft, pneumonia, and hip and knee replacement—based on reporting for 27 process measures. Hospitals with fewer than eight cases per quarter were excluded, and all the data were adjusted using the All Patient Refined-Diagnostic Related Groups (APR-DRG) methodology created by 3M Information Systems.

Overall, hospitals improved by an average 17% on a composite quality score used by the project. Improvements were largest in pneumonia and heart failure.

For instance, only 70% of patients were receiving appropriate pneumonia care at the start, but by June 2007, 93% were.

For heart failure, the numbers rose from 64% to 93% of patients getting quality care. Savings were also greatest for heart failure, at about $1,339 per case.

There was a continuing downward trend in performance variation among the hospitals, with all moving toward the ideal, said Richard Norling, president and CEO of Premier Inc. For the hospitals that were on target 100% of the time with 100% of patients, costs and mortality were lowest, he said.

For instance, the mortality rate for coronary artery bypass graft patients was close to 6% at hospitals that met appropriate care benchmarks in only half the patients or fewer. Mortality was just under 2% for facilities that met those benchmarks in 75%-100% of the patients, Mr. Norling told reporters.

Attaining the goals of the demonstration project required huge cultural shifts and large investments in information systems, according to two hospital executives whose facilities participated in the project.

Before the project, the Aurora Health Care system was reactive and was achieving only incremental quality improvement, despite having a culture and leadership that focused on better care, said Dr. Nick Turkal, president and CEO of the Milwaukee-based nonprofit system.

Participation in the demonstration project has changed the mind-set of the health care system staff to “a pursuit of perfection,” Dr. Turkal said at the briefing. The system's 13 hospitals have 100,000 admissions annually. Data on meeting the pay-for-performance goals are given to employees every 60 days, and are updated regularly on the system's Web site for the public to see. Mortality and costs are down significantly across the system, but “we're not done yet,” he said.

The demonstration project has proved that incentives can work, said Dr. Wynn. CMS is tinkering slightly with the project, however. Starting this year, there will be incentives not just for improvement over baseline and for hitting the top 20%, but also for hospitals that show the greatest improvement. A total of $12 million will be available, he said.