Mary Ellen Schneider

More information on the postponement of the CAP is at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs, including some infused biologics.

The program was put on hold because of “contractual issues” with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The CMS has not announced a time line for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or “buy-and-bill” system.

The voluntary program took the purchase of these drugs out of the hands of physicians. Those physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by the CMS later. Instead, they received drugs from an approved vendor who was selected by the CMS through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

BioScrip Inc., an Elmsford, N.Y.-based specialty pharmaceutical health care organization, has been the only approved CAP vendor throughout the history of the program. The company announced over the summer that it would not sign a new contact with CMS for CAP because the terms of the contract presented an “unacceptable short- and long-term profit risk.”

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is “totally untenable,” said Dr. Karen Kolba, a solo rheumatologist in Santa Maria, Calif., and a member of the American College of Rheumatology's Committee on Rheumatologic Care. The delay in the program will give the CMS time to consider changes that could encourage participation from rheumatologists, she said.

Dr. Kolba, who has not signed up for CAP, said the biggest problem with the program is the “all-or-nothing” requirement for ordering drugs. Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. “It becomes something of an accounting nightmare,” she said.

Dr. R. Mack Harrell, an endocrinologist in Fort Lauderdale, Fla., said postponement of the CAP is likely to result in serious access problems for patients. Many endocrinologists rely on the CAP for expensive injectable drugs like thyrotropin alfa (Thyrogen), used to test for recurrence in thyroid cancer patients.

Without the CAP as a source of these drugs, Dr. Harrell said he fears that endocrinologists won't be able to provide these drugs in the office, forcing patients to go off their thyroid hormones for weeks at a time in order to undergo necessary testing.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008. Any drugs that will be administered on or after Jan. 1, 2009, must be obtained through the regular ASP method.

If a physician has unused Part B drugs obtained through the CAP after Dec. 31, 2008, they are considered the property of the vendor and must be purchased through the ASP system or returned to BioScrip. They cannot be given to the physician by BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they will be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and should not use the CAP modifiers (J1, J2, J3, and M2) on claims. The CMS is advising physicians to contact BioScrip to minimize the amount of unused drugs.

While the program is on hold, the CMS is asking physicians to provide feedback on the program. Agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more attractive for vendors and physicians.

More information on the postponement of the CAP is at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs, including some infused biologics.

The program was put on hold because of “contractual issues” with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The CMS has not announced a time line for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or “buy-and-bill” system.

The voluntary program took the purchase of these drugs out of the hands of physicians. Those physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by the CMS later. Instead, they received drugs from an approved vendor who was selected by the CMS through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

BioScrip Inc., an Elmsford, N.Y.-based specialty pharmaceutical health care organization, has been the only approved CAP vendor throughout the history of the program. The company announced over the summer that it would not sign a new contact with CMS for CAP because the terms of the contract presented an “unacceptable short- and long-term profit risk.”

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is “totally untenable,” said Dr. Karen Kolba, a solo rheumatologist in Santa Maria, Calif., and a member of the American College of Rheumatology's Committee on Rheumatologic Care. The delay in the program will give the CMS time to consider changes that could encourage participation from rheumatologists, she said.

Dr. Kolba, who has not signed up for CAP, said the biggest problem with the program is the “all-or-nothing” requirement for ordering drugs. Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. “It becomes something of an accounting nightmare,” she said.

Dr. R. Mack Harrell, an endocrinologist in Fort Lauderdale, Fla., said postponement of the CAP is likely to result in serious access problems for patients. Many endocrinologists rely on the CAP for expensive injectable drugs like thyrotropin alfa (Thyrogen), used to test for recurrence in thyroid cancer patients.

Without the CAP as a source of these drugs, Dr. Harrell said he fears that endocrinologists won't be able to provide these drugs in the office, forcing patients to go off their thyroid hormones for weeks at a time in order to undergo necessary testing.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008. Any drugs that will be administered on or after Jan. 1, 2009, must be obtained through the regular ASP method.

If a physician has unused Part B drugs obtained through the CAP after Dec. 31, 2008, they are considered the property of the vendor and must be purchased through the ASP system or returned to BioScrip. They cannot be given to the physician by BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they will be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and should not use the CAP modifiers (J1, J2, J3, and M2) on claims. The CMS is advising physicians to contact BioScrip to minimize the amount of unused drugs.

While the program is on hold, the CMS is asking physicians to provide feedback on the program. Agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more attractive for vendors and physicians.

More information on the postponement of the CAP is at www.cms.hhs.gov/CompetitiveAcquisforBios

Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs, including some infused biologics.

The program was put on hold because of “contractual issues” with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The CMS has not announced a time line for resuming the program.

The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or “buy-and-bill” system.

The voluntary program took the purchase of these drugs out of the hands of physicians. Those physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by the CMS later. Instead, they received drugs from an approved vendor who was selected by the CMS through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

BioScrip Inc., an Elmsford, N.Y.-based specialty pharmaceutical health care organization, has been the only approved CAP vendor throughout the history of the program. The company announced over the summer that it would not sign a new contact with CMS for CAP because the terms of the contract presented an “unacceptable short- and long-term profit risk.”

For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.

As currently designed, the CAP is “totally untenable,” said Dr. Karen Kolba, a solo rheumatologist in Santa Maria, Calif., and a member of the American College of Rheumatology's Committee on Rheumatologic Care. The delay in the program will give the CMS time to consider changes that could encourage participation from rheumatologists, she said.

Dr. Kolba, who has not signed up for CAP, said the biggest problem with the program is the “all-or-nothing” requirement for ordering drugs. Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. “It becomes something of an accounting nightmare,” she said.

Dr. R. Mack Harrell, an endocrinologist in Fort Lauderdale, Fla., said postponement of the CAP is likely to result in serious access problems for patients. Many endocrinologists rely on the CAP for expensive injectable drugs like thyrotropin alfa (Thyrogen), used to test for recurrence in thyroid cancer patients.

Without the CAP as a source of these drugs, Dr. Harrell said he fears that endocrinologists won't be able to provide these drugs in the office, forcing patients to go off their thyroid hormones for weeks at a time in order to undergo necessary testing.

Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008. Any drugs that will be administered on or after Jan. 1, 2009, must be obtained through the regular ASP method.

If a physician has unused Part B drugs obtained through the CAP after Dec. 31, 2008, they are considered the property of the vendor and must be purchased through the ASP system or returned to BioScrip. They cannot be given to the physician by BioScrip.

As physicians return to the ASP method of procuring drugs in 2009, they will be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and should not use the CAP modifiers (J1, J2, J3, and M2) on claims. The CMS is advising physicians to contact BioScrip to minimize the amount of unused drugs.

While the program is on hold, the CMS is asking physicians to provide feedback on the program. Agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more attractive for vendors and physicians.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the guidelines is still up for debate.

The voluntary guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. The new guidelines update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policy makers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value.

For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under PhRMA's new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make.

However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities.

Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution.

The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges, which recently released its own report on industry funding of medical education.

Although the PhRMA guidelines don't go as far as some academic medical institution policies, they are significant because they appear to have the full backing of the industry, Dr. Korn said. It shows that the pharmaceutical industry has heard the concerns of the public and has deemed some interactions to be unacceptable. “What we're talking about really is a culture change,” he said.

In the AAMC report, released in June, the organization calls on medical schools and teaching hospitals to prohibit the acceptance of any gifts from industry. The AAMC also instructs academic medical institutions to set up a central CME office to coordinate the distribution of industry funds, and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But other physicians criticized PhRMA for leaving open loopholes that allow for much of their marketing activities to continue. “They are too little, too late,” said Dr. Carey Chisholm, residency program director for emergency medicine and professor of emergency medicine at Indiana University, Indianapolis.

The first major loophole is that the policy is voluntary, Dr. Chisholm said. It also continues to allow for a significant amount of marketing through the “modest” on-campus meals and through off-campus meals with industry consultants, he said.

The changes are primarily cosmetic, said Dr. Daniel Carlat, of the psychiatry department at Tufts University, Boston. PhRMA appears to be decreasing marketing activities, he said, but in fact they are keeping the tactics that are most successful.

The visible items like mugs, clocks, and pens don't tend to influence physicians, he said. However, the voluntary guidelines still give pharmaceutical sales representatives plenty of chances to get valuable “face time” with physicians.

Time will tell whether the guidelines will result in any real changes, said Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. All physicians should start thinking about how to get educated about new treatments without meeting with sales representatives, foregoing samples, and saying no to free lunches provided by pharmaceutical companies, he said.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the guidelines is still up for debate.

The voluntary guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. The new guidelines update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policy makers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value.

For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under PhRMA's new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make.

However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities.

Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution.

The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges, which recently released its own report on industry funding of medical education.

Although the PhRMA guidelines don't go as far as some academic medical institution policies, they are significant because they appear to have the full backing of the industry, Dr. Korn said. It shows that the pharmaceutical industry has heard the concerns of the public and has deemed some interactions to be unacceptable. “What we're talking about really is a culture change,” he said.

In the AAMC report, released in June, the organization calls on medical schools and teaching hospitals to prohibit the acceptance of any gifts from industry. The AAMC also instructs academic medical institutions to set up a central CME office to coordinate the distribution of industry funds, and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But other physicians criticized PhRMA for leaving open loopholes that allow for much of their marketing activities to continue. “They are too little, too late,” said Dr. Carey Chisholm, residency program director for emergency medicine and professor of emergency medicine at Indiana University, Indianapolis.

The first major loophole is that the policy is voluntary, Dr. Chisholm said. It also continues to allow for a significant amount of marketing through the “modest” on-campus meals and through off-campus meals with industry consultants, he said.

The changes are primarily cosmetic, said Dr. Daniel Carlat, of the psychiatry department at Tufts University, Boston. PhRMA appears to be decreasing marketing activities, he said, but in fact they are keeping the tactics that are most successful.

The visible items like mugs, clocks, and pens don't tend to influence physicians, he said. However, the voluntary guidelines still give pharmaceutical sales representatives plenty of chances to get valuable “face time” with physicians.

Time will tell whether the guidelines will result in any real changes, said Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. All physicians should start thinking about how to get educated about new treatments without meeting with sales representatives, foregoing samples, and saying no to free lunches provided by pharmaceutical companies, he said.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the guidelines is still up for debate.

The voluntary guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. The new guidelines update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policy makers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value.

For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under PhRMA's new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make.

However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities.

Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution.

The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges, which recently released its own report on industry funding of medical education.

Although the PhRMA guidelines don't go as far as some academic medical institution policies, they are significant because they appear to have the full backing of the industry, Dr. Korn said. It shows that the pharmaceutical industry has heard the concerns of the public and has deemed some interactions to be unacceptable. “What we're talking about really is a culture change,” he said.

In the AAMC report, released in June, the organization calls on medical schools and teaching hospitals to prohibit the acceptance of any gifts from industry. The AAMC also instructs academic medical institutions to set up a central CME office to coordinate the distribution of industry funds, and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But other physicians criticized PhRMA for leaving open loopholes that allow for much of their marketing activities to continue. “They are too little, too late,” said Dr. Carey Chisholm, residency program director for emergency medicine and professor of emergency medicine at Indiana University, Indianapolis.

The first major loophole is that the policy is voluntary, Dr. Chisholm said. It also continues to allow for a significant amount of marketing through the “modest” on-campus meals and through off-campus meals with industry consultants, he said.

The changes are primarily cosmetic, said Dr. Daniel Carlat, of the psychiatry department at Tufts University, Boston. PhRMA appears to be decreasing marketing activities, he said, but in fact they are keeping the tactics that are most successful.

The visible items like mugs, clocks, and pens don't tend to influence physicians, he said. However, the voluntary guidelines still give pharmaceutical sales representatives plenty of chances to get valuable “face time” with physicians.

Time will tell whether the guidelines will result in any real changes, said Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. All physicians should start thinking about how to get educated about new treatments without meeting with sales representatives, foregoing samples, and saying no to free lunches provided by pharmaceutical companies, he said.

The Joint Commission has issued new requirements for hospitals in an effort to prevent infections from multidrug-resistant organisms, central line-associated bloodstream infections, and surgical site infections.

The requirements, which are part of the 2009 National Patient Safety Goals for hospitals, include a 1-year phase-in period with full implementation by Jan. 1, 2010.

It is critical for hospitals to begin addressing the issue of health care-associated infections and to try to keep the problem from worsening, said Dr. Peter Angood, vice president and chief patient safety officer for the Joint Commission. “We're in a bit of a tight spot and we need to work our way out of it,” he said.

The new infection control requirements build on an existing National Patient Safety Goal on health care-associated infections that had previously included only requirements for compliance with hand hygiene guidelines and had called on hospitals to manage serious infections as sentinel events. Those requirements will remain in place along with the new elements of the goal. “Infection control is high on our priority list overall,” Dr. Angood said.

Under the new 2009 requirements, hospitals are being asked to begin preparing to prevent infections resulting from multidrug-resistant organisms such as methicillin-resistant Staphylococcus aureus, Clostridium difficile, vancomycin-resistant enterococci, multidrug-resistant gram- negative bacteria, and other epidemiologically important organisms.

Starting in January 2010, hospitals will need to conduct periodic risk assessments for acquisition and transmission of multidrug-resistant organisms, and educate staff and independent providers about prevention strategies and their roles. Hospitals also will be required to provide education about infection control strategies to patients and families who are infected or colonized with multidrug-resistant organisms.

Hospitals will be required to have a surveillance program up and running by Jan. 1, 2010, that is based on the hospital's risk assessment. When indicated by the risk assessment, hospitals will need to implement a laboratory-based alert system to identify new patients with multidrug-resistant organisms, and an alert system to identify readmitted or transferred patients who have multidrug-resistant organisms.

The Joint Commission also has put new requirements in place to prevent central line-associated bloodstream infections and surgical site infections.

Related to the bloodstream infections, hospitals will be expected to use a catheter checklist and a standardized protocol for central venous catheter insertion and an all-inclusive standardized supply cart or kit for insertion of the catheters.

Also required is use of standardized protocols for maximum sterile barrier precautions during insertion of a central venous catheter and when disinfecting catheter hubs and injection ports before accessing the ports.

To prevent surgical site infections, the Joint Commission is requiring hospitals to conduct periodic risk assessments, select surgical site infection measures based on evidence, and evaluate the effectiveness of their prevention efforts. Also, hospital staff will need to measure infection rates for the first 30 days following most procedures and for the first year after procedures involving implantable devices.

The surgical site infection requirements were developed to be in line with well-established guidelines and should help organizations move toward compliance with those guidelines, Dr. Angood said.

All of the new requirements related to health care-associated infections include a 1-year phase-in period, with milestones for planning, development, and testing throughout 2009. Allowing organizations to phase in complex requirements over the course of a year helps them to perform better by achieving concrete goals before full compliance is expected, Dr. Angood said.

Addressing health care-associated infections is a worthy goal, said Dr. Franklin Michota, director of academic affairs for the department of hospital medicine at the Cleveland Clinic. There is sufficient evidence to show a clinical benefit from implementing infection control strategies. “It's not an experiment to see if these things work,” he said.

Hospitals are likely to face some up-front costs when implementing the new requirements, Dr. Michota said, especially if they need to put a new educational process in place to prepare staff. For that reason, hospitals may be looking to involve hospitalists, who are already on the payroll, in a variety of activities related to preventing health care-associated infections, he said.

Hospitalists may be involved in developing process improvement plans, tracking requirements, or tracking infections. Those who are not involved on the quality side may be asked to champion changes at the floor level by modeling appropriate hand hygiene or compliance with contact precautions.

“Shining additional light on [health care-associated infections] is good,” said Dr. Patrick J. Cawley, president of the Society of Hospital Medicine and executive medical director at the Medical University of South Carolina, Charleston.

The requirements for central line-associated bloodstream infections, in particular, are a significant step forward, he said. There is clear evidence in the literature that compliance with central line placement protocols can significantly drive down infection rates, he said. “This is something we all should be doing anyway,” Dr. Cawley said.

The Joint Commission also has added new requirements to the goal for medication reconciliation. Hospitals are advised to provide a complete and reconciled list of the patient's medications directly to the patient and explain the list at the time of discharge. In those settings where medications were used minimally or for a short duration, such as the emergency department, the hospital is required to perform a modified medication reconciliation process.

Also new in 2009 is a requirement to eliminate transfusion errors related to patient misidentification. Before beginning a blood or blood component transfusion, hospital staff must match the patient to the blood during a two-person bedside verification process.

Hospitalists, who are already on the payroll, are likely to be involved in implementing the new requirements. DR. MICHOTA

The Joint Commission has issued new requirements for hospitals in an effort to prevent infections from multidrug-resistant organisms, central line-associated bloodstream infections, and surgical site infections.

The requirements, which are part of the 2009 National Patient Safety Goals for hospitals, include a 1-year phase-in period with full implementation by Jan. 1, 2010.

It is critical for hospitals to begin addressing the issue of health care-associated infections and to try to keep the problem from worsening, said Dr. Peter Angood, vice president and chief patient safety officer for the Joint Commission. “We're in a bit of a tight spot and we need to work our way out of it,” he said.

The new infection control requirements build on an existing National Patient Safety Goal on health care-associated infections that had previously included only requirements for compliance with hand hygiene guidelines and had called on hospitals to manage serious infections as sentinel events. Those requirements will remain in place along with the new elements of the goal. “Infection control is high on our priority list overall,” Dr. Angood said.

Under the new 2009 requirements, hospitals are being asked to begin preparing to prevent infections resulting from multidrug-resistant organisms such as methicillin-resistant Staphylococcus aureus, Clostridium difficile, vancomycin-resistant enterococci, multidrug-resistant gram- negative bacteria, and other epidemiologically important organisms.

Starting in January 2010, hospitals will need to conduct periodic risk assessments for acquisition and transmission of multidrug-resistant organisms, and educate staff and independent providers about prevention strategies and their roles. Hospitals also will be required to provide education about infection control strategies to patients and families who are infected or colonized with multidrug-resistant organisms.

Hospitals will be required to have a surveillance program up and running by Jan. 1, 2010, that is based on the hospital's risk assessment. When indicated by the risk assessment, hospitals will need to implement a laboratory-based alert system to identify new patients with multidrug-resistant organisms, and an alert system to identify readmitted or transferred patients who have multidrug-resistant organisms.

The Joint Commission also has put new requirements in place to prevent central line-associated bloodstream infections and surgical site infections.

Related to the bloodstream infections, hospitals will be expected to use a catheter checklist and a standardized protocol for central venous catheter insertion and an all-inclusive standardized supply cart or kit for insertion of the catheters.

Also required is use of standardized protocols for maximum sterile barrier precautions during insertion of a central venous catheter and when disinfecting catheter hubs and injection ports before accessing the ports.

To prevent surgical site infections, the Joint Commission is requiring hospitals to conduct periodic risk assessments, select surgical site infection measures based on evidence, and evaluate the effectiveness of their prevention efforts. Also, hospital staff will need to measure infection rates for the first 30 days following most procedures and for the first year after procedures involving implantable devices.

The surgical site infection requirements were developed to be in line with well-established guidelines and should help organizations move toward compliance with those guidelines, Dr. Angood said.

All of the new requirements related to health care-associated infections include a 1-year phase-in period, with milestones for planning, development, and testing throughout 2009. Allowing organizations to phase in complex requirements over the course of a year helps them to perform better by achieving concrete goals before full compliance is expected, Dr. Angood said.

Addressing health care-associated infections is a worthy goal, said Dr. Franklin Michota, director of academic affairs for the department of hospital medicine at the Cleveland Clinic. There is sufficient evidence to show a clinical benefit from implementing infection control strategies. “It's not an experiment to see if these things work,” he said.

Hospitals are likely to face some up-front costs when implementing the new requirements, Dr. Michota said, especially if they need to put a new educational process in place to prepare staff. For that reason, hospitals may be looking to involve hospitalists, who are already on the payroll, in a variety of activities related to preventing health care-associated infections, he said.

Hospitalists may be involved in developing process improvement plans, tracking requirements, or tracking infections. Those who are not involved on the quality side may be asked to champion changes at the floor level by modeling appropriate hand hygiene or compliance with contact precautions.

“Shining additional light on [health care-associated infections] is good,” said Dr. Patrick J. Cawley, president of the Society of Hospital Medicine and executive medical director at the Medical University of South Carolina, Charleston.

The requirements for central line-associated bloodstream infections, in particular, are a significant step forward, he said. There is clear evidence in the literature that compliance with central line placement protocols can significantly drive down infection rates, he said. “This is something we all should be doing anyway,” Dr. Cawley said.

The Joint Commission also has added new requirements to the goal for medication reconciliation. Hospitals are advised to provide a complete and reconciled list of the patient's medications directly to the patient and explain the list at the time of discharge. In those settings where medications were used minimally or for a short duration, such as the emergency department, the hospital is required to perform a modified medication reconciliation process.

Also new in 2009 is a requirement to eliminate transfusion errors related to patient misidentification. Before beginning a blood or blood component transfusion, hospital staff must match the patient to the blood during a two-person bedside verification process.

Hospitalists, who are already on the payroll, are likely to be involved in implementing the new requirements. DR. MICHOTA

The Joint Commission has issued new requirements for hospitals in an effort to prevent infections from multidrug-resistant organisms, central line-associated bloodstream infections, and surgical site infections.

The requirements, which are part of the 2009 National Patient Safety Goals for hospitals, include a 1-year phase-in period with full implementation by Jan. 1, 2010.

It is critical for hospitals to begin addressing the issue of health care-associated infections and to try to keep the problem from worsening, said Dr. Peter Angood, vice president and chief patient safety officer for the Joint Commission. “We're in a bit of a tight spot and we need to work our way out of it,” he said.

The new infection control requirements build on an existing National Patient Safety Goal on health care-associated infections that had previously included only requirements for compliance with hand hygiene guidelines and had called on hospitals to manage serious infections as sentinel events. Those requirements will remain in place along with the new elements of the goal. “Infection control is high on our priority list overall,” Dr. Angood said.

Under the new 2009 requirements, hospitals are being asked to begin preparing to prevent infections resulting from multidrug-resistant organisms such as methicillin-resistant Staphylococcus aureus, Clostridium difficile, vancomycin-resistant enterococci, multidrug-resistant gram- negative bacteria, and other epidemiologically important organisms.

Starting in January 2010, hospitals will need to conduct periodic risk assessments for acquisition and transmission of multidrug-resistant organisms, and educate staff and independent providers about prevention strategies and their roles. Hospitals also will be required to provide education about infection control strategies to patients and families who are infected or colonized with multidrug-resistant organisms.

Hospitals will be required to have a surveillance program up and running by Jan. 1, 2010, that is based on the hospital's risk assessment. When indicated by the risk assessment, hospitals will need to implement a laboratory-based alert system to identify new patients with multidrug-resistant organisms, and an alert system to identify readmitted or transferred patients who have multidrug-resistant organisms.

The Joint Commission also has put new requirements in place to prevent central line-associated bloodstream infections and surgical site infections.

Related to the bloodstream infections, hospitals will be expected to use a catheter checklist and a standardized protocol for central venous catheter insertion and an all-inclusive standardized supply cart or kit for insertion of the catheters.

Also required is use of standardized protocols for maximum sterile barrier precautions during insertion of a central venous catheter and when disinfecting catheter hubs and injection ports before accessing the ports.

To prevent surgical site infections, the Joint Commission is requiring hospitals to conduct periodic risk assessments, select surgical site infection measures based on evidence, and evaluate the effectiveness of their prevention efforts. Also, hospital staff will need to measure infection rates for the first 30 days following most procedures and for the first year after procedures involving implantable devices.

The surgical site infection requirements were developed to be in line with well-established guidelines and should help organizations move toward compliance with those guidelines, Dr. Angood said.

All of the new requirements related to health care-associated infections include a 1-year phase-in period, with milestones for planning, development, and testing throughout 2009. Allowing organizations to phase in complex requirements over the course of a year helps them to perform better by achieving concrete goals before full compliance is expected, Dr. Angood said.

Addressing health care-associated infections is a worthy goal, said Dr. Franklin Michota, director of academic affairs for the department of hospital medicine at the Cleveland Clinic. There is sufficient evidence to show a clinical benefit from implementing infection control strategies. “It's not an experiment to see if these things work,” he said.

Hospitals are likely to face some up-front costs when implementing the new requirements, Dr. Michota said, especially if they need to put a new educational process in place to prepare staff. For that reason, hospitals may be looking to involve hospitalists, who are already on the payroll, in a variety of activities related to preventing health care-associated infections, he said.

Hospitalists may be involved in developing process improvement plans, tracking requirements, or tracking infections. Those who are not involved on the quality side may be asked to champion changes at the floor level by modeling appropriate hand hygiene or compliance with contact precautions.

“Shining additional light on [health care-associated infections] is good,” said Dr. Patrick J. Cawley, president of the Society of Hospital Medicine and executive medical director at the Medical University of South Carolina, Charleston.

The requirements for central line-associated bloodstream infections, in particular, are a significant step forward, he said. There is clear evidence in the literature that compliance with central line placement protocols can significantly drive down infection rates, he said. “This is something we all should be doing anyway,” Dr. Cawley said.

The Joint Commission also has added new requirements to the goal for medication reconciliation. Hospitals are advised to provide a complete and reconciled list of the patient's medications directly to the patient and explain the list at the time of discharge. In those settings where medications were used minimally or for a short duration, such as the emergency department, the hospital is required to perform a modified medication reconciliation process.

Also new in 2009 is a requirement to eliminate transfusion errors related to patient misidentification. Before beginning a blood or blood component transfusion, hospital staff must match the patient to the blood during a two-person bedside verification process.

Hospitalists, who are already on the payroll, are likely to be involved in implementing the new requirements. DR. MICHOTA

The Joint Commission on the Accreditation of Healthcare Organizations, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress recently eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted in July. That means that the Joint Commission, like other accrediting bodies, will need to apply to the Centers for Medicare and Medicaid Services in order for its accredited hospitals to be deemed to have met the conditions of participation in Medicare. Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by the CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care, laboratory, and ambulatory surgery accreditation programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized. During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving the CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the Joint Commission and found that the Joint Commission had missed most of the serious deficiencies picked up during the state reviews.

The Joint Commission on the Accreditation of Healthcare Organizations, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress recently eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted in July. That means that the Joint Commission, like other accrediting bodies, will need to apply to the Centers for Medicare and Medicaid Services in order for its accredited hospitals to be deemed to have met the conditions of participation in Medicare. Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by the CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care, laboratory, and ambulatory surgery accreditation programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized. During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving the CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the Joint Commission and found that the Joint Commission had missed most of the serious deficiencies picked up during the state reviews.

The Joint Commission on the Accreditation of Healthcare Organizations, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress recently eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted in July. That means that the Joint Commission, like other accrediting bodies, will need to apply to the Centers for Medicare and Medicaid Services in order for its accredited hospitals to be deemed to have met the conditions of participation in Medicare. Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by the CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care, laboratory, and ambulatory surgery accreditation programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized. During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving the CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the Joint Commission and found that the Joint Commission had missed most of the serious deficiencies picked up during the state reviews.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, CMS is proposing to require entities covered under The Health Insurance Portability and Accountability Act of 1996 to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to CMS.

The two proposed regulations were published in the Federal Register on Aug. 22. CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to CMS. Because many of the ICD-9-CM chapters are full, CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The ICD-9-CM also fails to provide adequate clinical details, according to CMS. For example, the ICD-9-CM has a single procedure code that describes endovascular repair or occlusion of the head and neck vessels. But the code leaves out details such as a description of the artery or vein on which the repair was performed, the precise nature of the repair, or whether it was a percutaneous procedure or was transluminal with a catheter.

“Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted,” CMS officials wrote in the proposed regulation. “This code set is no longer able to respond to additional classification specificity, newly identified disease entities, and other advances.”

CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that because it continues to use ICD-9-CM it has problems identifying emerging recent global health threats such as anthrax, Severe Acute Respiratory Syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within the ICD-9-CM.

Beyond size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body related to the diagnosis or procedure. The more detailed information available with the ICD-10 codes will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, they said that 3 years is not enough time for the industry to implement the new system. Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to CMS in January 2007, ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians, especially those in small practices. For some practices, the adoption of ICD-10 would require purchasing a completely new practice management system, which could cost anywhere from $5,000 to $30,000.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, CMS is proposing to require entities covered under The Health Insurance Portability and Accountability Act of 1996 to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to CMS.

The two proposed regulations were published in the Federal Register on Aug. 22. CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to CMS. Because many of the ICD-9-CM chapters are full, CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The ICD-9-CM also fails to provide adequate clinical details, according to CMS. For example, the ICD-9-CM has a single procedure code that describes endovascular repair or occlusion of the head and neck vessels. But the code leaves out details such as a description of the artery or vein on which the repair was performed, the precise nature of the repair, or whether it was a percutaneous procedure or was transluminal with a catheter.

“Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted,” CMS officials wrote in the proposed regulation. “This code set is no longer able to respond to additional classification specificity, newly identified disease entities, and other advances.”

CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that because it continues to use ICD-9-CM it has problems identifying emerging recent global health threats such as anthrax, Severe Acute Respiratory Syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within the ICD-9-CM.

Beyond size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body related to the diagnosis or procedure. The more detailed information available with the ICD-10 codes will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, they said that 3 years is not enough time for the industry to implement the new system. Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to CMS in January 2007, ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians, especially those in small practices. For some practices, the adoption of ICD-10 would require purchasing a completely new practice management system, which could cost anywhere from $5,000 to $30,000.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, CMS is proposing to require entities covered under The Health Insurance Portability and Accountability Act of 1996 to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to CMS.

The two proposed regulations were published in the Federal Register on Aug. 22. CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to CMS. Because many of the ICD-9-CM chapters are full, CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The ICD-9-CM also fails to provide adequate clinical details, according to CMS. For example, the ICD-9-CM has a single procedure code that describes endovascular repair or occlusion of the head and neck vessels. But the code leaves out details such as a description of the artery or vein on which the repair was performed, the precise nature of the repair, or whether it was a percutaneous procedure or was transluminal with a catheter.

“Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted,” CMS officials wrote in the proposed regulation. “This code set is no longer able to respond to additional classification specificity, newly identified disease entities, and other advances.”

CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that because it continues to use ICD-9-CM it has problems identifying emerging recent global health threats such as anthrax, Severe Acute Respiratory Syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within the ICD-9-CM.

Beyond size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body related to the diagnosis or procedure. The more detailed information available with the ICD-10 codes will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, they said that 3 years is not enough time for the industry to implement the new system. Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to CMS in January 2007, ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians, especially those in small practices. For some practices, the adoption of ICD-10 would require purchasing a completely new practice management system, which could cost anywhere from $5,000 to $30,000.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes–the ICD-10–by Oct. 1, 2011.

Physician groups, however, are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, the CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards–the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to the CMS.

The two proposed regulations were published in the Federal Register on Aug. 22. The CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to the CMS. Because many of the ICD-9-CM chapters are full, the CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that because it continues to use ICD-9-CM it has problems identifying emerging recent global health threats such as anthrax, Severe Acute Respiratory Syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, the AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers–steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, they said that 3 years is not enough time for the industry to implement the new system.

Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to buy software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes–the ICD-10–by Oct. 1, 2011.

Physician groups, however, are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, the CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards–the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to the CMS.

The two proposed regulations were published in the Federal Register on Aug. 22. The CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to the CMS. Because many of the ICD-9-CM chapters are full, the CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that because it continues to use ICD-9-CM it has problems identifying emerging recent global health threats such as anthrax, Severe Acute Respiratory Syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, the AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers–steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, they said that 3 years is not enough time for the industry to implement the new system.

Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to buy software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes–the ICD-10–by Oct. 1, 2011.

Physician groups, however, are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, the CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards–the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to the CMS.

The two proposed regulations were published in the Federal Register on Aug. 22. The CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to the CMS. Because many of the ICD-9-CM chapters are full, the CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that because it continues to use ICD-9-CM it has problems identifying emerging recent global health threats such as anthrax, Severe Acute Respiratory Syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, the AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers–steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, they said that 3 years is not enough time for the industry to implement the new system.

Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to buy software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10.

The Joint Commission, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress has eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted over the summer.

That means that the Joint Commission will need to apply to the Centers for Medicare and Medicaid Services in order for its accredited hospitals to be deemed to have met the conditions of participation in Medicare.

Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by the CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital-deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized.

During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving the CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the commission and found that it had missed most of the serious deficiencies picked up during the state reviews.

The Joint Commission, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress has eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted over the summer.

That means that the Joint Commission will need to apply to the Centers for Medicare and Medicaid Services in order for its accredited hospitals to be deemed to have met the conditions of participation in Medicare.

Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by the CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital-deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized.

During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving the CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the commission and found that it had missed most of the serious deficiencies picked up during the state reviews.

The Joint Commission, which provides the standard in hospital accreditation in the United States, will soon be subjected to greater federal oversight.

Congress has eliminated the Joint Commission's “unique deeming authority” for hospitals as part of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which was enacted over the summer.

That means that the Joint Commission will need to apply to the Centers for Medicare and Medicaid Services in order for its accredited hospitals to be deemed to have met the conditions of participation in Medicare.

Previously, the Joint Commission's deeming authority had been automatic and was not subject to oversight by the CMS.

Officials at the Joint Commission supported the intention of the change, and plan to apply to CMS for hospital-deeming authority. The Joint Commission and other accrediting bodies already apply to CMS for deeming authority in other areas, such as home care programs.

Under the new law, the Joint Commission will have 24 months to apply to CMS for deeming authority and to be recognized.

During the transition period, accredited hospitals will not be affected by this change, according to the Joint Commission.

In 2004, the U.S. Government Accountability Office (GAO) issued a report that called on Congress to consider giving the CMS greater authority over the Joint Commission's hospital accreditation program. GAO investigators examined state agency validation surveys for 500 hospitals accredited by the commission and found that it had missed most of the serious deficiencies picked up during the state reviews.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to CMS.

CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to CMS. Because many of the ICD-9-CM chapters are full, CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The ICD-9-CM also fails to provide adequate clinical details, according to CMS. For example, the ICD-9-CM has a single procedure code that describes endovascular repair or occlusion of the head and neck vessels. But the code leaves out details such as a description of the artery or vein on which the repair was performed, the precise nature of the repair, or whether it was a percutaneous procedure or was transluminal with a catheter.

“Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted,” CMS officials wrote in the proposed regulation. “This code set is no longer able to respond to additional classification specificity, newly identified disease entities, and other advances.”

CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that, because it continues to use ICD-9-CM, it has problems identifying emerging recent global health threats such as anthrax, severe acute respiratory syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within the ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, the AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, it said that 3 years is not enough time for the industry to implement the new system.

Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to CMS in January 2007, ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians, especially those in small practices. For some practices, the adoption of ICD-10 would require purchasing a completely new practice management system, which could cost anywhere from $5,000 to $30,000.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to CMS.

CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to CMS. Because many of the ICD-9-CM chapters are full, CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The ICD-9-CM also fails to provide adequate clinical details, according to CMS. For example, the ICD-9-CM has a single procedure code that describes endovascular repair or occlusion of the head and neck vessels. But the code leaves out details such as a description of the artery or vein on which the repair was performed, the precise nature of the repair, or whether it was a percutaneous procedure or was transluminal with a catheter.

“Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted,” CMS officials wrote in the proposed regulation. “This code set is no longer able to respond to additional classification specificity, newly identified disease entities, and other advances.”

CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that, because it continues to use ICD-9-CM, it has problems identifying emerging recent global health threats such as anthrax, severe acute respiratory syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within the ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, the AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, it said that 3 years is not enough time for the industry to implement the new system.

Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to CMS in January 2007, ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians, especially those in small practices. For some practices, the adoption of ICD-10 would require purchasing a completely new practice management system, which could cost anywhere from $5,000 to $30,000.

Officials at the Centers for Medicare and Medicaid Services plan to replace the ICD-9-CM diagnosis and procedure code set with a significantly expanded set of codes—the ICD-10—by Oct. 1, 2011.

But physician groups are calling the agency's plan rushed and unworkable and want the agency to reconsider its compliance date.

In addition to the requirements for using the ICD-10 code sets, CMS also is proposing to require entities covered under HIPAA to implement updated versions of electronic transmission standards—the Accredited Standards Committee X12 Version 5010 and the National Council for Prescription Drug Programs Version D.0. Both electronic standards have a compliance date of April 1, 2010. The X12 Version 5010 must be in place before the ICD-10 codes can be used, according to CMS.

CMS will accept comments on the proposals until Oct. 21.

The switch to ICD-10 has been under consideration by the Department of Health and Human Services since 1997. Size and specificity are two of the biggest drawbacks of the ICD-9-CM code set, according to CMS. Because many of the ICD-9-CM chapters are full, CMS has begun to assign codes to unrelated chapters, so that, for example, cardiac procedures have been put in the eye chapter.

The ICD-9-CM also fails to provide adequate clinical details, according to CMS. For example, the ICD-9-CM has a single procedure code that describes endovascular repair or occlusion of the head and neck vessels. But the code leaves out details such as a description of the artery or vein on which the repair was performed, the precise nature of the repair, or whether it was a percutaneous procedure or was transluminal with a catheter.

“Because of the new and changing medical advancements during the past 20-plus years, the functionality of the ICD-9-CM code set has been exhausted,” CMS officials wrote in the proposed regulation. “This code set is no longer able to respond to additional classification specificity, newly identified disease entities, and other advances.”

CMS also is urging a switch to the ICD-10 code sets in an effort to keep in step with other countries. As of October 2002, 99 countries had adopted ICD-10 or a clinical modification for coding and reporting morbidity data. And CMS contends that, because it continues to use ICD-9-CM, it has problems identifying emerging recent global health threats such as anthrax, severe acute respiratory syndrome (SARS), and monkeypox.

Under the proposal, physicians, hospitals, health plans, and other covered health care entities would be required to use the ICD-10-CM for reporting diagnoses and the ICD-10-PCS for reporting procedures. The ICD-10 code sets offer significantly more codes, about 155,000 across the two sets, compared with about 17,000 for diagnosis and procedure codes within the ICD-9-CM.

In addition to size, the ICD-10 code sets also provide greater specificity, such as being able to reflect the side of the body that is related to the diagnosis or procedure. The more detailed information available through the ICD-10 codes also will aid in the implementation of electronic health records and transmission of data for biosurveillance or pay-for-performance programs, according to CMS.

But physician groups say CMS is asking physicians and other health care providers to do too much too fast.

The American Medical Association balked at the idea of implementation of both the updated X12 Version 5010 electronic transaction standard and the ICD-10 coding system in just 3 years. The X12 Version 5010 standard should first be pilot tested before physicians and others are asked to implement it, the AMA said.

“This is a massive administrative undertaking for physicians and must be implemented in a time frame that allows for physician education, software vendor updates, coder training, and testing with payers—steps that cannot be rushed and are needed for a smooth transition,” Dr. Joseph Heyman, AMA board chair, said in a statement.

The Medical Group Management Association also objected. While MGMA supports the switch to the ICD-10 code sets, it said that 3 years is not enough time for the industry to implement the new system.

Instead of a simultaneous implementation of the X12 Version 5010 standard and the ICD-10 code sets, MGMA is asking CMS to wait at least 3 years after the switch to X12 Version 5010 before implementing the ICD-10.

The switch to ICD-10 needs to be done separately because it will require significant changes from medical groups, according to MGMA. Recent MGMA research indicates that most medical practices will have to purchase software upgrades for their practice management systems or buy all new software in order to implement the transition to ICD-10.

“Moving to these new code sets has the potential to be the most complex change for the U.S. health care system in decades,” Dr. William F. Jessee, president and CEO of MGMA, said in a statement.

Officials at the American College of Physicians were still analyzing the CMS proposal at press time, but said they continue to have concerns about the switch to ICD-10. In a letter to CMS in January 2007, ACP said it opposes the change to ICD-10 for outpatient diagnosis coding and that such a switch would be expensive and time consuming for physicians, especially those in small practices. For some practices, the adoption of ICD-10 would require purchasing a completely new practice management system, which could cost anywhere from $5,000 to $30,000.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the guidelines is still up for debate.

The voluntary guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. The new guidelines update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policymakers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under PhRMA's new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider, who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution.

The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges, which recently released its own report on industry funding of medical education.

The PhRMA guidelines don't go as far as some academic medical institution policies, but they are significant because they appear to have the full backing of the industry, Dr. Korn said. It shows that the pharmaceutical industry has heard the concerns of the public and has deemed some interactions to be unacceptable. “What we're talking about really is a culture change,” he said.

The AAMC report calls on medical schools and teaching hospitals to prohibit any gifts from industry. The AAMC also instructs academic institutions to set up a central CME office to distribute industry funds, and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But other physicians criticized PhRMA for leaving open loopholes that allow for much of their marketing activities to continue.

The changes are primarily cosmetic, said Dr. Daniel Carlat, of the psychiatry department at Tufts University, Boston. PhRMA appears to be decreasing marketing activities, he said, but in fact they are keeping the tactics that are most successful.

The visible items like mugs, clocks, and pens don't tend to influence physicians, he said. However, the voluntary guidelines still give pharmaceutical sales representatives plenty of chances to get valuable face-time with physicians.

For example, the guidelines still allow sales representatives to provide free lunches in the physician's office or the hospital. And the code does not place any restrictions on dinners with pharmaceutical company consultants, Dr. Carlat said.

Time will tell whether the guidelines will result in any real changes, said Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.

Ultimately, it's up to the medical profession to make these changes, he said. Every single drug sale representative in the country would be looking for a new job if physicians refused to see them, Dr. Brody said. All physicians should start thinking about how to get educated about new treatments without meeting with sales representatives, he said.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the guidelines is still up for debate.

The voluntary guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. The new guidelines update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policymakers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under PhRMA's new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider, who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution.

The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges, which recently released its own report on industry funding of medical education.

The PhRMA guidelines don't go as far as some academic medical institution policies, but they are significant because they appear to have the full backing of the industry, Dr. Korn said. It shows that the pharmaceutical industry has heard the concerns of the public and has deemed some interactions to be unacceptable. “What we're talking about really is a culture change,” he said.

The AAMC report calls on medical schools and teaching hospitals to prohibit any gifts from industry. The AAMC also instructs academic institutions to set up a central CME office to distribute industry funds, and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But other physicians criticized PhRMA for leaving open loopholes that allow for much of their marketing activities to continue.

The changes are primarily cosmetic, said Dr. Daniel Carlat, of the psychiatry department at Tufts University, Boston. PhRMA appears to be decreasing marketing activities, he said, but in fact they are keeping the tactics that are most successful.

The visible items like mugs, clocks, and pens don't tend to influence physicians, he said. However, the voluntary guidelines still give pharmaceutical sales representatives plenty of chances to get valuable face-time with physicians.

For example, the guidelines still allow sales representatives to provide free lunches in the physician's office or the hospital. And the code does not place any restrictions on dinners with pharmaceutical company consultants, Dr. Carlat said.

Time will tell whether the guidelines will result in any real changes, said Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.

Ultimately, it's up to the medical profession to make these changes, he said. Every single drug sale representative in the country would be looking for a new job if physicians refused to see them, Dr. Brody said. All physicians should start thinking about how to get educated about new treatments without meeting with sales representatives, he said.

The free pens and mugs adorned with the names of commonly prescribed drugs are soon to be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufacturers of America.

But the real impact of the guidelines is still up for debate.

The voluntary guidelines, which will go into effect in January, were released this summer as pressure mounted from Congress and the academic medical community for industry to rein in its marketing practices. The new guidelines update the 2002 PhRMA Code on Interactions with Healthcare Professionals.

“Although our member companies have long been committed to responsible marketing of the life-enhancing and life-saving medicines they develop, we have heard the voices of policymakers, health care professionals, and others telling us we can do better,” Billy Tauzin, PhRMA president and CEO, said in a statement.

Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, the ubiquitous pens and mugs given out by pharmaceutical representatives are no longer acceptable under PhRMA's new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis.

The guidelines also prohibit sales representatives and their immediate managers from taking physicians out for dinner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as pizza, in the office or at the hospital if they stay to provide their educational session there. The voluntary guidelines also prohibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips, even if the item is inexpensive.

In terms of continuing medical education (CME), the guidelines call on pharmaceutical companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be given directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider, who can use the money to reduce fees for all attendees. Companies are also not allowed to provide meals directly at CME events.

The guidelines continue to allow pharmaceutical companies to provide scholarships to medical students and others in training so they can attend educational conferences, as long as the recipients are chosen by the academic or training institution.

The guidelines also call for greater transparency among physicians who work as industry consultants. Physicians who serve as company consultants or speakers and also serve on committees that set formularies or clinical practice guidelines should disclose their industry relationships, according to the PhRMA guidelines.

The changes were praised by some in the medical community as progress on the part of the pharmaceutical industry to respond to criticisms and police itself.

“It's a big step forward,” said Dr. David Korn, chief scientific officer for the Association of American Medical Colleges, which recently released its own report on industry funding of medical education.

The PhRMA guidelines don't go as far as some academic medical institution policies, but they are significant because they appear to have the full backing of the industry, Dr. Korn said. It shows that the pharmaceutical industry has heard the concerns of the public and has deemed some interactions to be unacceptable. “What we're talking about really is a culture change,” he said.

The AAMC report calls on medical schools and teaching hospitals to prohibit any gifts from industry. The AAMC also instructs academic institutions to set up a central CME office to distribute industry funds, and strongly discourages participation by faculty in industry-sponsored speakers bureaus.

But other physicians criticized PhRMA for leaving open loopholes that allow for much of their marketing activities to continue.

The changes are primarily cosmetic, said Dr. Daniel Carlat, of the psychiatry department at Tufts University, Boston. PhRMA appears to be decreasing marketing activities, he said, but in fact they are keeping the tactics that are most successful.

The visible items like mugs, clocks, and pens don't tend to influence physicians, he said. However, the voluntary guidelines still give pharmaceutical sales representatives plenty of chances to get valuable face-time with physicians.

For example, the guidelines still allow sales representatives to provide free lunches in the physician's office or the hospital. And the code does not place any restrictions on dinners with pharmaceutical company consultants, Dr. Carlat said.

Time will tell whether the guidelines will result in any real changes, said Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.

Ultimately, it's up to the medical profession to make these changes, he said. Every single drug sale representative in the country would be looking for a new job if physicians refused to see them, Dr. Brody said. All physicians should start thinking about how to get educated about new treatments without meeting with sales representatives, he said.

The Commonwealth Fund is gearing up to turn 50 safety net clinics into models of the patient-centered medical home.

The demonstration project, called the Safety Net Medical Home Initiative, will run for 5 years with the goal of creating an implementation plan that can be replicated at practices and clinics across the country.

The Commonwealth Fund is funding the project, which will be run by the Seattle-based quality improvement organization Qualis Health, along with the MacColl Institute for Healthcare Innovation. In the first year of the project, the Commonwealth Fund is providing nearly $700,000; total 5-year funding for expected to reach $6.7 million.

Qualis Health and the MacColl Institute for Healthcare Innovation will offer technical assistance to participating clinics on aspects of the patient-centered medical home including timely access to primary care services, enhanced communication, and team-based care.

The Commonwealth Fund and its partners currently are seeking applications for four regional coordinating centers.

The staff at these four centers would provide assistance to 12–15 local safety net clinics as well as promote the concept of the patient-centered medical home with state Medicaid officials.

Eligible entities include community clinic consortia, state primary care associations, regional health care alliances, community hospitals with outpatient services, public health departments, state Medicaid agencies, and Medicaid managed care plans, among others.

Applications, due by Nov. 3, can be downloaded at http://qhmedicalhome.org/safety-net/index.cfm

The Commonwealth Fund is gearing up to turn 50 safety net clinics into models of the patient-centered medical home.

The demonstration project, called the Safety Net Medical Home Initiative, will run for 5 years with the goal of creating an implementation plan that can be replicated at practices and clinics across the country.

The Commonwealth Fund is funding the project, which will be run by the Seattle-based quality improvement organization Qualis Health, along with the MacColl Institute for Healthcare Innovation. In the first year of the project, the Commonwealth Fund is providing nearly $700,000; total 5-year funding for expected to reach $6.7 million.

Qualis Health and the MacColl Institute for Healthcare Innovation will offer technical assistance to participating clinics on aspects of the patient-centered medical home including timely access to primary care services, enhanced communication, and team-based care.

The Commonwealth Fund and its partners currently are seeking applications for four regional coordinating centers.

The staff at these four centers would provide assistance to 12–15 local safety net clinics as well as promote the concept of the patient-centered medical home with state Medicaid officials.

Eligible entities include community clinic consortia, state primary care associations, regional health care alliances, community hospitals with outpatient services, public health departments, state Medicaid agencies, and Medicaid managed care plans, among others.

Applications, due by Nov. 3, can be downloaded at http://qhmedicalhome.org/safety-net/index.cfm

The Commonwealth Fund is gearing up to turn 50 safety net clinics into models of the patient-centered medical home.

The demonstration project, called the Safety Net Medical Home Initiative, will run for 5 years with the goal of creating an implementation plan that can be replicated at practices and clinics across the country.

The Commonwealth Fund is funding the project, which will be run by the Seattle-based quality improvement organization Qualis Health, along with the MacColl Institute for Healthcare Innovation. In the first year of the project, the Commonwealth Fund is providing nearly $700,000; total 5-year funding for expected to reach $6.7 million.

Qualis Health and the MacColl Institute for Healthcare Innovation will offer technical assistance to participating clinics on aspects of the patient-centered medical home including timely access to primary care services, enhanced communication, and team-based care.

The Commonwealth Fund and its partners currently are seeking applications for four regional coordinating centers.

The staff at these four centers would provide assistance to 12–15 local safety net clinics as well as promote the concept of the patient-centered medical home with state Medicaid officials.

Eligible entities include community clinic consortia, state primary care associations, regional health care alliances, community hospitals with outpatient services, public health departments, state Medicaid agencies, and Medicaid managed care plans, among others.

Applications, due by Nov. 3, can be downloaded at http://qhmedicalhome.org/safety-net/index.cfm