Dermatology Lexicon Web Site to Be Launched by AAD

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Dermatology Lexicon Web Site to Be Launched by AAD

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education, said Dr. Pittelkow.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow. The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

Currently, DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions for all the terms.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

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The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education, said Dr. Pittelkow.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow. The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

Currently, DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions for all the terms.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education, said Dr. Pittelkow.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow. The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

Currently, DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions for all the terms.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

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Online Skin Term Dictionary May Facilitate Payment

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The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Muscoloskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education.

“Hopefully, it will be facilitating documentation, as well,” he said, noting that the push for electronic health records is likely to accelerate in the Obama administration.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow.

The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

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The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Muscoloskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education.

“Hopefully, it will be facilitating documentation, as well,” he said, noting that the push for electronic health records is likely to accelerate in the Obama administration.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow.

The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Muscoloskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education.

“Hopefully, it will be facilitating documentation, as well,” he said, noting that the push for electronic health records is likely to accelerate in the Obama administration.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow.

The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

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Genetic Factors, PPIs May Alter Effectiveness of Clopidogrel

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Genetic Factors, PPIs May Alter Effectiveness of Clopidogrel

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” the agency said.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. However, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a PPI or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

One found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363-75). Another found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354-62). A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel was less effective (Lancet 2009;373:309-17).

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The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” the agency said.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. However, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a PPI or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

One found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363-75). Another found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354-62). A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel was less effective (Lancet 2009;373:309-17).

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” the agency said.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. However, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a PPI or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

One found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363-75). Another found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354-62). A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel was less effective (Lancet 2009;373:309-17).

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FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article should not be highlighted, otherwise marked up, or attached to promotional materials.

Device Makers Update Ethics Code

The Advanced Medical Technology Association (AdvaMed) has revised its ethics code covering equipment manufacturers' dealings with health care professionals. New rules explicitly prohibit manufacturers from providing entertainment, recreation, or gifts of any type to physicians. The document also describes acceptable royalty arrangements between companies and providers. The update is the first since 2005.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial and set a similar price when it launched NeoProfen in July 2006, according to the FTC. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

Clinic Discloses Industry Ties

The Cleveland Clinic has begun public disclosure of the business relationships its staff physicians and scientists have with drug and medical device makers. The organization said its Web site will list the names of companies with which each staff professional has collaborations. It also will identify whether a physician or scientist owns equity or has the right to royalties, a fiduciary position, or a consulting relationship that pays $5,000 or more per year. “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations,” said Dr. Joseph Hahn, Cleveland Clinic chief of staff. He added that to the best of his knowledge, Cleveland Clinic is the first academic medical center in the United States to disclose these ties.

Lawmaker Asks for Heparin Review

Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee, has asked the Government Accountability Office for a thorough review of the Food and Drug Administration's handling of the recent problems with tainted heparin coming from China. In February 2008, Baxter Healthcare Corp. recalled several heparin products and the FDA identified a previously unknown contaminant in the heparin. According to the FDA, 246 people died after heparin administration between Jan. 1, 2007, and May 31, 2008, and 149 of those deaths involved allergic symptoms or the appearance of hypotension. Rep. Barton's letter to the FDA challenges the agency's attribution of several deaths to heparin and questions whether the FDA used “all of the tools available” to investigate the deaths.

GAO Slams FDA on Device Reviews

The FDA is allowing too many high-risk medical devices to go through its least stringent approval process, called 510(k), the GAO reported in January. After Department of Health and Human Services officials read the report, they agreed. Class III devices include pacemakers and heart valves. Under 510(k), the manufacturer simply proves that the device is substantially equivalent to one already on the market. A 1990 law gave the FDA 5 years to determine which class III devices should require premarket approval applications, which are stricter than 510(k) clearances, but the agency hasn't done so, the GAO reported. The FDA approved 228 of 342 applications for class III devices submitted through the 510(k) process during fiscal years 2003–2007.

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FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article should not be highlighted, otherwise marked up, or attached to promotional materials.

Device Makers Update Ethics Code

The Advanced Medical Technology Association (AdvaMed) has revised its ethics code covering equipment manufacturers' dealings with health care professionals. New rules explicitly prohibit manufacturers from providing entertainment, recreation, or gifts of any type to physicians. The document also describes acceptable royalty arrangements between companies and providers. The update is the first since 2005.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial and set a similar price when it launched NeoProfen in July 2006, according to the FTC. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

Clinic Discloses Industry Ties

The Cleveland Clinic has begun public disclosure of the business relationships its staff physicians and scientists have with drug and medical device makers. The organization said its Web site will list the names of companies with which each staff professional has collaborations. It also will identify whether a physician or scientist owns equity or has the right to royalties, a fiduciary position, or a consulting relationship that pays $5,000 or more per year. “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations,” said Dr. Joseph Hahn, Cleveland Clinic chief of staff. He added that to the best of his knowledge, Cleveland Clinic is the first academic medical center in the United States to disclose these ties.

Lawmaker Asks for Heparin Review

Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee, has asked the Government Accountability Office for a thorough review of the Food and Drug Administration's handling of the recent problems with tainted heparin coming from China. In February 2008, Baxter Healthcare Corp. recalled several heparin products and the FDA identified a previously unknown contaminant in the heparin. According to the FDA, 246 people died after heparin administration between Jan. 1, 2007, and May 31, 2008, and 149 of those deaths involved allergic symptoms or the appearance of hypotension. Rep. Barton's letter to the FDA challenges the agency's attribution of several deaths to heparin and questions whether the FDA used “all of the tools available” to investigate the deaths.

GAO Slams FDA on Device Reviews

The FDA is allowing too many high-risk medical devices to go through its least stringent approval process, called 510(k), the GAO reported in January. After Department of Health and Human Services officials read the report, they agreed. Class III devices include pacemakers and heart valves. Under 510(k), the manufacturer simply proves that the device is substantially equivalent to one already on the market. A 1990 law gave the FDA 5 years to determine which class III devices should require premarket approval applications, which are stricter than 510(k) clearances, but the agency hasn't done so, the GAO reported. The FDA approved 228 of 342 applications for class III devices submitted through the 510(k) process during fiscal years 2003–2007.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article should not be highlighted, otherwise marked up, or attached to promotional materials.

Device Makers Update Ethics Code

The Advanced Medical Technology Association (AdvaMed) has revised its ethics code covering equipment manufacturers' dealings with health care professionals. New rules explicitly prohibit manufacturers from providing entertainment, recreation, or gifts of any type to physicians. The document also describes acceptable royalty arrangements between companies and providers. The update is the first since 2005.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial and set a similar price when it launched NeoProfen in July 2006, according to the FTC. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

Clinic Discloses Industry Ties

The Cleveland Clinic has begun public disclosure of the business relationships its staff physicians and scientists have with drug and medical device makers. The organization said its Web site will list the names of companies with which each staff professional has collaborations. It also will identify whether a physician or scientist owns equity or has the right to royalties, a fiduciary position, or a consulting relationship that pays $5,000 or more per year. “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations,” said Dr. Joseph Hahn, Cleveland Clinic chief of staff. He added that to the best of his knowledge, Cleveland Clinic is the first academic medical center in the United States to disclose these ties.

Lawmaker Asks for Heparin Review

Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee, has asked the Government Accountability Office for a thorough review of the Food and Drug Administration's handling of the recent problems with tainted heparin coming from China. In February 2008, Baxter Healthcare Corp. recalled several heparin products and the FDA identified a previously unknown contaminant in the heparin. According to the FDA, 246 people died after heparin administration between Jan. 1, 2007, and May 31, 2008, and 149 of those deaths involved allergic symptoms or the appearance of hypotension. Rep. Barton's letter to the FDA challenges the agency's attribution of several deaths to heparin and questions whether the FDA used “all of the tools available” to investigate the deaths.

GAO Slams FDA on Device Reviews

The FDA is allowing too many high-risk medical devices to go through its least stringent approval process, called 510(k), the GAO reported in January. After Department of Health and Human Services officials read the report, they agreed. Class III devices include pacemakers and heart valves. Under 510(k), the manufacturer simply proves that the device is substantially equivalent to one already on the market. A 1990 law gave the FDA 5 years to determine which class III devices should require premarket approval applications, which are stricter than 510(k) clearances, but the agency hasn't done so, the GAO reported. The FDA approved 228 of 342 applications for class III devices submitted through the 510(k) process during fiscal years 2003–2007.

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Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but will pay $800 million to settle those charges. Of that, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The company also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most believe it's okay for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors queried 1,515 people aged 51 years and older who were randomly selected from the government-funded National Health and Retirement Survey. Group members responded to questions about a family member's consenting to a patient's joining one of four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, said the authors. Their survey results are in the Jan. 13 issue of Neurology.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits–important because the Medicaid population smokes at a rate 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the Food and Drug Administration in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements that are funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in the recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis Corp. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

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Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but will pay $800 million to settle those charges. Of that, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The company also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most believe it's okay for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors queried 1,515 people aged 51 years and older who were randomly selected from the government-funded National Health and Retirement Survey. Group members responded to questions about a family member's consenting to a patient's joining one of four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, said the authors. Their survey results are in the Jan. 13 issue of Neurology.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits–important because the Medicaid population smokes at a rate 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the Food and Drug Administration in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements that are funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in the recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis Corp. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

Lilly Settles Zyprexa Charges

As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but will pay $800 million to settle those charges. Of that, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The company also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of its policies and procedures.

Most Favor Family Consent

University of Michigan health researchers say that a nationally representative survey of older adults shows that most believe it's okay for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors queried 1,515 people aged 51 years and older who were randomly selected from the government-funded National Health and Retirement Survey. Group members responded to questions about a family member's consenting to a patient's joining one of four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, said the authors. Their survey results are in the Jan. 13 issue of Neurology.

Mixed Grades on Tobacco Control

In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits–important because the Medicaid population smokes at a rate 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.

Jump in Singulair Psych Reports

Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the Food and Drug Administration in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements that are funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in the recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis Corp. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.

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Medicare Selects Demo Sites for Testing Bundled Payments

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Five hospitals have been selected to be demonstration sites for Medicare's test run of bundling payments for physicians and hospitals for a selected set of inpatient episodes of care.

The Centers for Medicare and Medicaid Services (CMS) says the goal of the 3-year Acute Care Episode demonstration project is to “better align the incentives for both hospitals and physicians, leading to better quality and greater efficiency in the care that is delivered.”

In its June 2008 report to Congress, the Medicare Payment Advisory Commission recommended a voluntary pilot program to test the feasibility of bundling. The commission's staff said that such a demonstration project could give the CMS valuable data on how hospitals and physicians share payments and on how Medicare might share in the savings generated by bundling.

In announcing the selected sites, Acting CMS Administrator Kerry Weems said that with the demonstration project, Medicare “expects to demonstrate how to better coordinate inpatient care and achieve savings in the delivery of that care that can ultimately be shared between hospitals, physician, beneficiaries, and Medicare.”

The demonstration will cover 28 cardiac surgical services—pertaining to valve replacement, defibrillator and pacemaker implantation, percutaneous coronary angioplasty, and coronary artery bypass graft—and 9 orthopedic surgical services—all related to hip, knee, and other major joint replacement. The CMS chose these procedures because they are high volume, easy to specify, and have quality metrics.

Medicare will make a single payment to the hospital for both Part A and Part B. The payment will be reviewed each year in October when inpatient and outpatient payment rates are set. The bundled payment will cover the same time window as that covered by a traditional inpatient payment, which includes preadmission testing. All physician services in the hospital from admission through the date of discharge are also covered.

The CMS sought applicants from Colorado, New Mexico, Oklahoma, and Texas. The selected sites are Exempla Saint Joseph Hospital in Denver, Lovelace Health System in Albuquerque, Hillcrest Medical Center in Tulsa, Oklahoma Heart Hospital in Oklahoma City, and Baptist Health System in San Antonio. Each hospital will be designated as a “valued-based care center” and promoted that way to Medicare beneficiaries.

Oklahoma Heart Hospital and Exempla Saint Joseph Hospital will be designated as value-based centers for cardiac procedures, Lovelace Health System will be a center for orthopedic procedures, and Baptist and Hillcrest for both orthopedic and heart procedures.

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Five hospitals have been selected to be demonstration sites for Medicare's test run of bundling payments for physicians and hospitals for a selected set of inpatient episodes of care.

The Centers for Medicare and Medicaid Services (CMS) says the goal of the 3-year Acute Care Episode demonstration project is to “better align the incentives for both hospitals and physicians, leading to better quality and greater efficiency in the care that is delivered.”

In its June 2008 report to Congress, the Medicare Payment Advisory Commission recommended a voluntary pilot program to test the feasibility of bundling. The commission's staff said that such a demonstration project could give the CMS valuable data on how hospitals and physicians share payments and on how Medicare might share in the savings generated by bundling.

In announcing the selected sites, Acting CMS Administrator Kerry Weems said that with the demonstration project, Medicare “expects to demonstrate how to better coordinate inpatient care and achieve savings in the delivery of that care that can ultimately be shared between hospitals, physician, beneficiaries, and Medicare.”

The demonstration will cover 28 cardiac surgical services—pertaining to valve replacement, defibrillator and pacemaker implantation, percutaneous coronary angioplasty, and coronary artery bypass graft—and 9 orthopedic surgical services—all related to hip, knee, and other major joint replacement. The CMS chose these procedures because they are high volume, easy to specify, and have quality metrics.

Medicare will make a single payment to the hospital for both Part A and Part B. The payment will be reviewed each year in October when inpatient and outpatient payment rates are set. The bundled payment will cover the same time window as that covered by a traditional inpatient payment, which includes preadmission testing. All physician services in the hospital from admission through the date of discharge are also covered.

The CMS sought applicants from Colorado, New Mexico, Oklahoma, and Texas. The selected sites are Exempla Saint Joseph Hospital in Denver, Lovelace Health System in Albuquerque, Hillcrest Medical Center in Tulsa, Oklahoma Heart Hospital in Oklahoma City, and Baptist Health System in San Antonio. Each hospital will be designated as a “valued-based care center” and promoted that way to Medicare beneficiaries.

Oklahoma Heart Hospital and Exempla Saint Joseph Hospital will be designated as value-based centers for cardiac procedures, Lovelace Health System will be a center for orthopedic procedures, and Baptist and Hillcrest for both orthopedic and heart procedures.

Five hospitals have been selected to be demonstration sites for Medicare's test run of bundling payments for physicians and hospitals for a selected set of inpatient episodes of care.

The Centers for Medicare and Medicaid Services (CMS) says the goal of the 3-year Acute Care Episode demonstration project is to “better align the incentives for both hospitals and physicians, leading to better quality and greater efficiency in the care that is delivered.”

In its June 2008 report to Congress, the Medicare Payment Advisory Commission recommended a voluntary pilot program to test the feasibility of bundling. The commission's staff said that such a demonstration project could give the CMS valuable data on how hospitals and physicians share payments and on how Medicare might share in the savings generated by bundling.

In announcing the selected sites, Acting CMS Administrator Kerry Weems said that with the demonstration project, Medicare “expects to demonstrate how to better coordinate inpatient care and achieve savings in the delivery of that care that can ultimately be shared between hospitals, physician, beneficiaries, and Medicare.”

The demonstration will cover 28 cardiac surgical services—pertaining to valve replacement, defibrillator and pacemaker implantation, percutaneous coronary angioplasty, and coronary artery bypass graft—and 9 orthopedic surgical services—all related to hip, knee, and other major joint replacement. The CMS chose these procedures because they are high volume, easy to specify, and have quality metrics.

Medicare will make a single payment to the hospital for both Part A and Part B. The payment will be reviewed each year in October when inpatient and outpatient payment rates are set. The bundled payment will cover the same time window as that covered by a traditional inpatient payment, which includes preadmission testing. All physician services in the hospital from admission through the date of discharge are also covered.

The CMS sought applicants from Colorado, New Mexico, Oklahoma, and Texas. The selected sites are Exempla Saint Joseph Hospital in Denver, Lovelace Health System in Albuquerque, Hillcrest Medical Center in Tulsa, Oklahoma Heart Hospital in Oklahoma City, and Baptist Health System in San Antonio. Each hospital will be designated as a “valued-based care center” and promoted that way to Medicare beneficiaries.

Oklahoma Heart Hospital and Exempla Saint Joseph Hospital will be designated as value-based centers for cardiac procedures, Lovelace Health System will be a center for orthopedic procedures, and Baptist and Hillcrest for both orthopedic and heart procedures.

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MedPAC Recommendations Would Increase Payments

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WASHINGTON — Medicare advisers voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

The panel agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would “negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians,” AHA Vice President for Policy Don May said in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise. The Centers for Medicare and Medicaid Services estimates that ASC spending will grow from $2.9 billion in 2007 to $3.9 billion in 2009.

MedPAC recommended that ASC payments increase by 0.6% in 2010, but also that the facilities be required to report on cost and quality data so that the CMS can better evaluate the adequacy of payments. The data collection had been recommended in 2004, but was put on hold as a new payment system was introduced for 2008.

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WASHINGTON — Medicare advisers voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

The panel agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would “negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians,” AHA Vice President for Policy Don May said in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise. The Centers for Medicare and Medicaid Services estimates that ASC spending will grow from $2.9 billion in 2007 to $3.9 billion in 2009.

MedPAC recommended that ASC payments increase by 0.6% in 2010, but also that the facilities be required to report on cost and quality data so that the CMS can better evaluate the adequacy of payments. The data collection had been recommended in 2004, but was put on hold as a new payment system was introduced for 2008.

WASHINGTON — Medicare advisers voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

The panel agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would “negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians,” AHA Vice President for Policy Don May said in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise. The Centers for Medicare and Medicaid Services estimates that ASC spending will grow from $2.9 billion in 2007 to $3.9 billion in 2009.

MedPAC recommended that ASC payments increase by 0.6% in 2010, but also that the facilities be required to report on cost and quality data so that the CMS can better evaluate the adequacy of payments. The data collection had been recommended in 2004, but was put on hold as a new payment system was introduced for 2008.

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Medicare Payment Policy Excludes Wrong-Site Surgery

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Medicare Payment Policy Excludes Wrong-Site Surgery

As expected, the Center for Medicare and Medicaid Services has issued a final decision that it will not pay for wrong surgery performed on a patient, surgery performed on the wrong body part, or surgery performed on the wrong patient.

The agency issued the proposal for nonpayment in December. The three surgical errors are considered preventable and are on the National Quality Forum's list of serious reportable events, the CMS said.

“These policies have the potential to reduce causes of serious illness or deaths to beneficiaries and reduce unnecessary costs to Medicare,” CMS Acting Administrator Kerry Weems said in a statement.

Efforts to reduce wrong-site surgeries are widespread. The Joint Commission established a Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery in 2004. An updated version went into effect on Jan. 1.

There are few data on the frequency of surgical never events. The CMS cited a 9-year study that reported an incidence of 1 in 112,994 for wrong-site surgeries not involving the spine (Arch. Surg. 2006;141:353–7). Extrapolating data reported to the Pennsylvania Patient Safety Authority by facilities in that state, Dr. John Clarke, clinical director of the reporting system, estimates that there are four or five wrong-site surgeries each day in the United States. The Pennsylvania data are in the Quarterly Update on the Preventing Wrong-Site Surgery Project, posted on the authority's Web site, www.patientsafetyauthority.org

After the CMS published its proposal, it received comments from 17 individuals and groups. Some said that the agency should establish an appeals process for procedures that are medically necessary but do not exactly match the informed consent. The agency said that the appeals process is the same as for any other noncovered item or service.

The American College of Cardiology, the American Medical Association, the American College of Surgeons, and the American Association of Neurological Surgeons all commented that the CMS needed to clarify how physicians could appeal a noncoverage decision.

These organizations also objected to the CMS using the national coverage decision process to determine payment policy for wrong-site surgery. The ACS wrote that the CMS should develop “a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare.” Both the ACS and the AANS also urged the agency to remove wrong spine level from the noncoverage determination.

The CMS said that it believes that the national coverage decision process “is appropriate.” The noncoverage decision is effective immediately. Instructions on how to process claims will be issued in the future, the agency said.

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As expected, the Center for Medicare and Medicaid Services has issued a final decision that it will not pay for wrong surgery performed on a patient, surgery performed on the wrong body part, or surgery performed on the wrong patient.

The agency issued the proposal for nonpayment in December. The three surgical errors are considered preventable and are on the National Quality Forum's list of serious reportable events, the CMS said.

“These policies have the potential to reduce causes of serious illness or deaths to beneficiaries and reduce unnecessary costs to Medicare,” CMS Acting Administrator Kerry Weems said in a statement.

Efforts to reduce wrong-site surgeries are widespread. The Joint Commission established a Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery in 2004. An updated version went into effect on Jan. 1.

There are few data on the frequency of surgical never events. The CMS cited a 9-year study that reported an incidence of 1 in 112,994 for wrong-site surgeries not involving the spine (Arch. Surg. 2006;141:353–7). Extrapolating data reported to the Pennsylvania Patient Safety Authority by facilities in that state, Dr. John Clarke, clinical director of the reporting system, estimates that there are four or five wrong-site surgeries each day in the United States. The Pennsylvania data are in the Quarterly Update on the Preventing Wrong-Site Surgery Project, posted on the authority's Web site, www.patientsafetyauthority.org

After the CMS published its proposal, it received comments from 17 individuals and groups. Some said that the agency should establish an appeals process for procedures that are medically necessary but do not exactly match the informed consent. The agency said that the appeals process is the same as for any other noncovered item or service.

The American College of Cardiology, the American Medical Association, the American College of Surgeons, and the American Association of Neurological Surgeons all commented that the CMS needed to clarify how physicians could appeal a noncoverage decision.

These organizations also objected to the CMS using the national coverage decision process to determine payment policy for wrong-site surgery. The ACS wrote that the CMS should develop “a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare.” Both the ACS and the AANS also urged the agency to remove wrong spine level from the noncoverage determination.

The CMS said that it believes that the national coverage decision process “is appropriate.” The noncoverage decision is effective immediately. Instructions on how to process claims will be issued in the future, the agency said.

As expected, the Center for Medicare and Medicaid Services has issued a final decision that it will not pay for wrong surgery performed on a patient, surgery performed on the wrong body part, or surgery performed on the wrong patient.

The agency issued the proposal for nonpayment in December. The three surgical errors are considered preventable and are on the National Quality Forum's list of serious reportable events, the CMS said.

“These policies have the potential to reduce causes of serious illness or deaths to beneficiaries and reduce unnecessary costs to Medicare,” CMS Acting Administrator Kerry Weems said in a statement.

Efforts to reduce wrong-site surgeries are widespread. The Joint Commission established a Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery in 2004. An updated version went into effect on Jan. 1.

There are few data on the frequency of surgical never events. The CMS cited a 9-year study that reported an incidence of 1 in 112,994 for wrong-site surgeries not involving the spine (Arch. Surg. 2006;141:353–7). Extrapolating data reported to the Pennsylvania Patient Safety Authority by facilities in that state, Dr. John Clarke, clinical director of the reporting system, estimates that there are four or five wrong-site surgeries each day in the United States. The Pennsylvania data are in the Quarterly Update on the Preventing Wrong-Site Surgery Project, posted on the authority's Web site, www.patientsafetyauthority.org

After the CMS published its proposal, it received comments from 17 individuals and groups. Some said that the agency should establish an appeals process for procedures that are medically necessary but do not exactly match the informed consent. The agency said that the appeals process is the same as for any other noncovered item or service.

The American College of Cardiology, the American Medical Association, the American College of Surgeons, and the American Association of Neurological Surgeons all commented that the CMS needed to clarify how physicians could appeal a noncoverage decision.

These organizations also objected to the CMS using the national coverage decision process to determine payment policy for wrong-site surgery. The ACS wrote that the CMS should develop “a clear payment policy outlining circumstances under which surgery claims would not be payable by Medicare.” Both the ACS and the AANS also urged the agency to remove wrong spine level from the noncoverage determination.

The CMS said that it believes that the national coverage decision process “is appropriate.” The noncoverage decision is effective immediately. Instructions on how to process claims will be issued in the future, the agency said.

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CT Colonography Endorsed, With Caveats

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BALTIMORE — A panel of Medicare advisers has tentatively expressed support for the use of computed tomographic colonography to screen for co-lorectal cancer in average-risk Medicare beneficiaries.

Based on an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to cover CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March 2008, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology issued new cancer screening guidelines that called CTC an acceptable option.

Most of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6–10 mm and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were concerned about those extracolonic findings, which they said could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found it comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy may cause serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. CTC has no significant harms per 18,000 patients, but there is uncertainty about radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of the U.S. Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

CTC should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

'It's premature to endorse CTC for average-risk Medicare beneficiaries at this time.' DR. DOMINITZ

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BALTIMORE — A panel of Medicare advisers has tentatively expressed support for the use of computed tomographic colonography to screen for co-lorectal cancer in average-risk Medicare beneficiaries.

Based on an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to cover CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March 2008, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology issued new cancer screening guidelines that called CTC an acceptable option.

Most of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6–10 mm and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were concerned about those extracolonic findings, which they said could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found it comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy may cause serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. CTC has no significant harms per 18,000 patients, but there is uncertainty about radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of the U.S. Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

CTC should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

'It's premature to endorse CTC for average-risk Medicare beneficiaries at this time.' DR. DOMINITZ

BALTIMORE — A panel of Medicare advisers has tentatively expressed support for the use of computed tomographic colonography to screen for co-lorectal cancer in average-risk Medicare beneficiaries.

Based on an overview of existing evidence on sensitivity, specificity, and cost-effectiveness of the technology, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) was asked to vote on a series of questions gauging panelists' level of confidence in computed tomographic colonography (CTC) as a screening tool, compared with optical colonoscopy.

The Centers for Medicare and Medicaid Services is considering whether to cover CTC. The agency already pays for colorectal cancer screening for average-risk individuals aged 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema. In March 2008, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology issued new cancer screening guidelines that called CTC an acceptable option.

Most of the MEDCAC panelists were moderately to highly confident that there is sufficient evidence to determine sensitivity and specificity of CTC in screening for polyps that measure 6–10 mm and for polyps larger than 10 mm. They were less confident that the evidence could determine specificity and sensitivity for polyps smaller than 6 mm.

Most panelists said that CTC would provide a net health benefit for average-risk Medicare beneficiaries—that is, a decrease in morbidity and mortality from identification and removal of polyps, when balanced against the risks of the procedure and the identification of extracolonic abnormalities.

But many committee members said they were concerned about those extracolonic findings, which they said could skew both the health benefits of the procedure and its potential cost-effectiveness.

Dr. Mary Barton, scientific director of the U.S. Preventive Services Task Force, told the panel that the task force's systematic review of CTC found it comparable to optical colonoscopy in sensitivity and specificity for lesions larger than 10 mm, but not quite similar for lesions larger than 6 mm.

Colonoscopy may cause serious harm in 28 per 10,000 patients, partly because of the risk of perforation, Dr. Barton said. CTC has no significant harms per 18,000 patients, but there is uncertainty about radiation exposure, extracolonic findings, and false positives, she said.

Dr. Ned Calonge, chairman of the U.S. Preventive Services Task Force and chief medical officer of the Colorado Department of Public Health and Environment, said that the unknowns about these potential harms led the group to give CTC a grade of “I,” for insufficient evidence. “This is really a call for further research,” Dr. Calonge told the Medicare advisers.

Dr. Jason Dominitz of the University of Washington, Seattle, who spoke on behalf of the American Society for Gastrointestinal Endoscopy, agreed that the jury was still out on CTC. “It's our overall belief that it's premature to endorse CTC for average-risk Medicare beneficiaries at this time,” Dr. Dominitz told the committee.

CTC should be offered to people with incomplete colonoscopies or to those who refuse to undergo that test, but otherwise, there are too many questions, including questions about its sensitivity for small and flat polyps, how to manage extracolonic findings, the radiation risk, and the appropriate intervals for CTC screening, he said.

'It's premature to endorse CTC for average-risk Medicare beneficiaries at this time.' DR. DOMINITZ

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MedPAC Proposes 1.1% Fee Increase for 2010

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WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they “never” had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti.

Medicare fees are about 80% of private pay fees, she said.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. “Primary care is in a huge state of crisis,” Ms. Kane said. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. “That may not be fast enough,” she said, adding that the demonstration is a “drop in the pond. We need to move a whole ocean.”

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that “we're talking about a significant amount of time, still.” He said he expected that interim data might support quicker action.

The panel also voted unanimously to reiterate its June 2008 recommendation that Congress establish a budget-neutral payment adjustment for primary care services.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, Mr. Winter said. If the recommendation is adopted, the money could be reallocated to primary care pay and other physician services.

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WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they “never” had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti.

Medicare fees are about 80% of private pay fees, she said.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. “Primary care is in a huge state of crisis,” Ms. Kane said. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. “That may not be fast enough,” she said, adding that the demonstration is a “drop in the pond. We need to move a whole ocean.”

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that “we're talking about a significant amount of time, still.” He said he expected that interim data might support quicker action.

The panel also voted unanimously to reiterate its June 2008 recommendation that Congress establish a budget-neutral payment adjustment for primary care services.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, Mr. Winter said. If the recommendation is adopted, the money could be reallocated to primary care pay and other physician services.

WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers. Its recommendations are included in twice-yearly reports issued in March and June.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they “never” had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti.

Medicare fees are about 80% of private pay fees, she said.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. “Primary care is in a huge state of crisis,” Ms. Kane said. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. “That may not be fast enough,” she said, adding that the demonstration is a “drop in the pond. We need to move a whole ocean.”

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that “we're talking about a significant amount of time, still.” He said he expected that interim data might support quicker action.

The panel also voted unanimously to reiterate its June 2008 recommendation that Congress establish a budget-neutral payment adjustment for primary care services.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, Mr. Winter said. If the recommendation is adopted, the money could be reallocated to primary care pay and other physician services.

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