Alicia Ault

Does tanning increase the risk of melanoma? Not according to the Indoor Tanning Association, which has launched a print and TV advertising campaign in seven major cities claiming there is no compelling scientific evidence linking tanning to melanoma. “Both the sun and tanning beds have been unnecessarily demonized by special interests using junk science and scare tactics,” Sarah Longwell, ITA spokeswoman, claimed in a statement.

The organization, which represents manufacturers of tanning beds and tanning salons, cited recent research in the Proceedings of the National Academy of Sciences showing that higher vitamin D levels increased survival in certain types of cancer. A reference was not supplied.

According to the ITA's press release, the association will be running TV commercials in New York, Boston, Washington, Chicago, San Francisco, Seattle, and Pittsburgh—all areas in which the ITA says vitamin D deficiency is common. The ITA is also challenging what it calls “myths” about tanning at two new Web sites (www.sunlightscam.comwww.trusttanning.com

The association did not respond to multiple requests for comment.

The American Academy of Dermatology issued a statement on the same day in wake of the ITA release. “While the health benefits of vitamin D are well known, it also is well known that exposure to [UV] radiation can cause skin cancer,” AAD president Dr. C. William Hanke said in a statement.

In a follow-up interview, Dr. Hanke said, “You really don't need to destroy your skin to get adequate vitamin D.” A few minutes of sun exposure is generally enough for vitamin D intake. Dietary sources of vitamin D are superior, he said.

“There is no evidence whatsoever that indoor tanning is safe,” said Dr. Hanke, adding, “We're not going to put our patients at risk by condoning indoor tanning.” In addition, said Dr. Hanke, “there is substantial evidence that excessive exposure to any form of UV radiation increases the risk of developing melanoma and nonmelanoma skin cancer.”

Melanoma incidence has stayed steady since 2000, after rising for almost 30 years, according to the American Cancer Society's latest statistics. In 2008, there will be an estimated 62,480 cases in the United States and 8,420 deaths.

The ITA also is accusing dermatologists—and specifically the AAD—of being corrupt because of money the organization receives from sunscreen manufacturers. On its Web sites, the ITA attacks both the AAD and its current officers, and the Skin Cancer Foundation, which it calls a front group for the sunscreen industry.

Dr. Hanke said that if taking money from manufacturers was the bar, then most medical societies would be considered corrupt. Support from pharmaceutical companies and sunscreen manufacturers is essential to carrying out the educational mission of the AAD, he said.

Does tanning increase the risk of melanoma? Not according to the Indoor Tanning Association, which has launched a print and TV advertising campaign in seven major cities claiming there is no compelling scientific evidence linking tanning to melanoma. “Both the sun and tanning beds have been unnecessarily demonized by special interests using junk science and scare tactics,” Sarah Longwell, ITA spokeswoman, claimed in a statement.

The organization, which represents manufacturers of tanning beds and tanning salons, cited recent research in the Proceedings of the National Academy of Sciences showing that higher vitamin D levels increased survival in certain types of cancer. A reference was not supplied.

According to the ITA's press release, the association will be running TV commercials in New York, Boston, Washington, Chicago, San Francisco, Seattle, and Pittsburgh—all areas in which the ITA says vitamin D deficiency is common. The ITA is also challenging what it calls “myths” about tanning at two new Web sites (www.sunlightscam.comwww.trusttanning.com

The association did not respond to multiple requests for comment.

The American Academy of Dermatology issued a statement on the same day in wake of the ITA release. “While the health benefits of vitamin D are well known, it also is well known that exposure to [UV] radiation can cause skin cancer,” AAD president Dr. C. William Hanke said in a statement.

In a follow-up interview, Dr. Hanke said, “You really don't need to destroy your skin to get adequate vitamin D.” A few minutes of sun exposure is generally enough for vitamin D intake. Dietary sources of vitamin D are superior, he said.

“There is no evidence whatsoever that indoor tanning is safe,” said Dr. Hanke, adding, “We're not going to put our patients at risk by condoning indoor tanning.” In addition, said Dr. Hanke, “there is substantial evidence that excessive exposure to any form of UV radiation increases the risk of developing melanoma and nonmelanoma skin cancer.”

Melanoma incidence has stayed steady since 2000, after rising for almost 30 years, according to the American Cancer Society's latest statistics. In 2008, there will be an estimated 62,480 cases in the United States and 8,420 deaths.

The ITA also is accusing dermatologists—and specifically the AAD—of being corrupt because of money the organization receives from sunscreen manufacturers. On its Web sites, the ITA attacks both the AAD and its current officers, and the Skin Cancer Foundation, which it calls a front group for the sunscreen industry.

Dr. Hanke said that if taking money from manufacturers was the bar, then most medical societies would be considered corrupt. Support from pharmaceutical companies and sunscreen manufacturers is essential to carrying out the educational mission of the AAD, he said.

Does tanning increase the risk of melanoma? Not according to the Indoor Tanning Association, which has launched a print and TV advertising campaign in seven major cities claiming there is no compelling scientific evidence linking tanning to melanoma. “Both the sun and tanning beds have been unnecessarily demonized by special interests using junk science and scare tactics,” Sarah Longwell, ITA spokeswoman, claimed in a statement.

The organization, which represents manufacturers of tanning beds and tanning salons, cited recent research in the Proceedings of the National Academy of Sciences showing that higher vitamin D levels increased survival in certain types of cancer. A reference was not supplied.

According to the ITA's press release, the association will be running TV commercials in New York, Boston, Washington, Chicago, San Francisco, Seattle, and Pittsburgh—all areas in which the ITA says vitamin D deficiency is common. The ITA is also challenging what it calls “myths” about tanning at two new Web sites (www.sunlightscam.comwww.trusttanning.com

The association did not respond to multiple requests for comment.

The American Academy of Dermatology issued a statement on the same day in wake of the ITA release. “While the health benefits of vitamin D are well known, it also is well known that exposure to [UV] radiation can cause skin cancer,” AAD president Dr. C. William Hanke said in a statement.

In a follow-up interview, Dr. Hanke said, “You really don't need to destroy your skin to get adequate vitamin D.” A few minutes of sun exposure is generally enough for vitamin D intake. Dietary sources of vitamin D are superior, he said.

“There is no evidence whatsoever that indoor tanning is safe,” said Dr. Hanke, adding, “We're not going to put our patients at risk by condoning indoor tanning.” In addition, said Dr. Hanke, “there is substantial evidence that excessive exposure to any form of UV radiation increases the risk of developing melanoma and nonmelanoma skin cancer.”

Melanoma incidence has stayed steady since 2000, after rising for almost 30 years, according to the American Cancer Society's latest statistics. In 2008, there will be an estimated 62,480 cases in the United States and 8,420 deaths.

The ITA also is accusing dermatologists—and specifically the AAD—of being corrupt because of money the organization receives from sunscreen manufacturers. On its Web sites, the ITA attacks both the AAD and its current officers, and the Skin Cancer Foundation, which it calls a front group for the sunscreen industry.

Dr. Hanke said that if taking money from manufacturers was the bar, then most medical societies would be considered corrupt. Support from pharmaceutical companies and sunscreen manufacturers is essential to carrying out the educational mission of the AAD, he said.

FDA Clears Generic Wellbutrin

The generic formulation of Wellbutrin XL (300 mg) is bioequivalent to the brand, the Food and Drug Administration has determined. The agency began a review of generic bupropion after receiving 85 adverse event reports in the first 6 months of 2007. Seventy-eight patients said they had experienced loss of antidepressant effect when they were switched from the branded product to the generic manufactured by Teva Pharmaceutical Industries Ltd. The Teva product was approved in 2006, but at the 150-mg dose and based on bioequivalence to 150 mg of Wellbutrin XL, according to the FDA, which noted that the pharmacokinetic profile was not expected to differ between the 150-mg and 300-mg doses. After the rash of adverse event reports, the agency again reviewed the bioequivalence data and the literature on natural history of depression. The FDA concluded that there was no difference between the two products. Also, if there was a link to the generic, there should have been many more reports, said the FDA, noting that by early 2007, at least 40% of bupropion prescriptions were for the generic. The agency added, “The recurrent nature of major depressive disorder offers a scientifically reasonable explanation for the reports of lack of efficacy following a switch to a generic product.”

Teva to Market Generic Risperdal

A U.S. District Court judge in Washington, has ruled that Teva Pharmaceutical Industries Ltd. has the right to make and sell a generic version of Risperdal (risperidone). Unless the ruling is challenged, Teva can begin exclusive sales of risperidone on June 29, the date Johnson & Johnson's patent for Risperdal expires. The FDA and generic pharmaceutical manufacturer Mylan Inc. had argued that Teva should not be allowed to have exclusive rights to the generic version of the drug. But U.S. District Court Judge Royce Lamberth disagreed. In the meantime, J&J and its partner Alkermes Inc. have applied to the FDA to sell a long-acting form of the drug, Risperdal Consta, for frequently relapsing bipolar disorder, defined as four or more manic episodes in the previous year. Alkermes estimates that 10%–20% of people with bipolar disorder worldwide meet that criterion.

Zyprexa Lawsuits March On

Eli Lilly & Co. agreed to pay the state of Alaska $15 million to settle charges that it was not forthcoming about side effects such as weight gain, hyperglycemia, and diabetes related to Zyprexa (olanzapine). But the company is facing a separate suit filed by Connecticut Attorney General Richard Blumenthal in mid-March, alleging concealment of side effects and illegal promotion of off-label uses. Lilly is also negotiating with the U.S. Attorney for the Eastern District of Pennsylvania in an inquiry related to marketing practices. The Alaska settlement came several weeks into a suit brought on behalf of the state's Medicaid program. The company said in a statement that it settled to avoid the cost of a lengthy trial. Zyprexa has been prescribed to 23 million people since its 1996 approval and is approved in 80 other countries. In 2007, sales were $4.8 billion worldwide.

Social Anxiety's Serious Impact

A survey commissioned by the Anxiety Disorders Association of America has found that about a third of the respondents with social anxiety disorder said that they had symptoms for 10 years or more before seeking help. The survey portrayed individuals who had difficulty finding or keeping friends or romantic partners. Thirty-four percent said the disorder led to serious fights with significant others, and 77% said that when they are not treated, the disorder has a negative impact on romantic relationships. Seventy-five percent said social anxiety inhibited their ability to function normally. Fifty-eight percent said they were embarrassed by their disorder. Patients with social anxiety disorder typically try to hide their condition, and therefore become more anxious and isolated, according to the association. Survey respondents indicated that treatment seems to help: 59% who were treated said it helped them have romantic relationships. The survey was conducted in December; 578 people with anxiety, 276 people with obsessive-compulsive disorder, and 287 with social anxiety disorder were queried by Harris Interactive. All agreed to be invited to participate. The ADAA received an unrestricted educational grant from Jazz Pharmaceuticals Inc. to support public awareness efforts about the disorder.

Side Effects Underreported

One in six Americans who have taken a prescription drug experienced a side effect serious enough to send them to the doctor or hospital, but only 35% of consumers said they know they can report these side effects to the FDA, according to a Consumer Reports poll. Additionally, 81% of respondents said they had seen or heard an ad for prescription drugs within the last 30 days, almost all on television. The Consumers Union, the nonprofit publisher of the magazine, gave the FDA a petition signed by nearly 56,000 consumers asking that a toll-free number and Web site be included in all television drug ads so people can easily report their serious side effects. “What better way for the FDA to let consumers know how to report serious problems with their medications than putting a toll-free number and Web site in all those drug ads we're bombarded by each day?” asked Liz Foley, campaign coordinator with Consumers Union, in a statement.

FDA Clears Generic Wellbutrin

The generic formulation of Wellbutrin XL (300 mg) is bioequivalent to the brand, the Food and Drug Administration has determined. The agency began a review of generic bupropion after receiving 85 adverse event reports in the first 6 months of 2007. Seventy-eight patients said they had experienced loss of antidepressant effect when they were switched from the branded product to the generic manufactured by Teva Pharmaceutical Industries Ltd. The Teva product was approved in 2006, but at the 150-mg dose and based on bioequivalence to 150 mg of Wellbutrin XL, according to the FDA, which noted that the pharmacokinetic profile was not expected to differ between the 150-mg and 300-mg doses. After the rash of adverse event reports, the agency again reviewed the bioequivalence data and the literature on natural history of depression. The FDA concluded that there was no difference between the two products. Also, if there was a link to the generic, there should have been many more reports, said the FDA, noting that by early 2007, at least 40% of bupropion prescriptions were for the generic. The agency added, “The recurrent nature of major depressive disorder offers a scientifically reasonable explanation for the reports of lack of efficacy following a switch to a generic product.”

Teva to Market Generic Risperdal

A U.S. District Court judge in Washington, has ruled that Teva Pharmaceutical Industries Ltd. has the right to make and sell a generic version of Risperdal (risperidone). Unless the ruling is challenged, Teva can begin exclusive sales of risperidone on June 29, the date Johnson & Johnson's patent for Risperdal expires. The FDA and generic pharmaceutical manufacturer Mylan Inc. had argued that Teva should not be allowed to have exclusive rights to the generic version of the drug. But U.S. District Court Judge Royce Lamberth disagreed. In the meantime, J&J and its partner Alkermes Inc. have applied to the FDA to sell a long-acting form of the drug, Risperdal Consta, for frequently relapsing bipolar disorder, defined as four or more manic episodes in the previous year. Alkermes estimates that 10%–20% of people with bipolar disorder worldwide meet that criterion.

Zyprexa Lawsuits March On

Eli Lilly & Co. agreed to pay the state of Alaska $15 million to settle charges that it was not forthcoming about side effects such as weight gain, hyperglycemia, and diabetes related to Zyprexa (olanzapine). But the company is facing a separate suit filed by Connecticut Attorney General Richard Blumenthal in mid-March, alleging concealment of side effects and illegal promotion of off-label uses. Lilly is also negotiating with the U.S. Attorney for the Eastern District of Pennsylvania in an inquiry related to marketing practices. The Alaska settlement came several weeks into a suit brought on behalf of the state's Medicaid program. The company said in a statement that it settled to avoid the cost of a lengthy trial. Zyprexa has been prescribed to 23 million people since its 1996 approval and is approved in 80 other countries. In 2007, sales were $4.8 billion worldwide.

Social Anxiety's Serious Impact

A survey commissioned by the Anxiety Disorders Association of America has found that about a third of the respondents with social anxiety disorder said that they had symptoms for 10 years or more before seeking help. The survey portrayed individuals who had difficulty finding or keeping friends or romantic partners. Thirty-four percent said the disorder led to serious fights with significant others, and 77% said that when they are not treated, the disorder has a negative impact on romantic relationships. Seventy-five percent said social anxiety inhibited their ability to function normally. Fifty-eight percent said they were embarrassed by their disorder. Patients with social anxiety disorder typically try to hide their condition, and therefore become more anxious and isolated, according to the association. Survey respondents indicated that treatment seems to help: 59% who were treated said it helped them have romantic relationships. The survey was conducted in December; 578 people with anxiety, 276 people with obsessive-compulsive disorder, and 287 with social anxiety disorder were queried by Harris Interactive. All agreed to be invited to participate. The ADAA received an unrestricted educational grant from Jazz Pharmaceuticals Inc. to support public awareness efforts about the disorder.

Side Effects Underreported

One in six Americans who have taken a prescription drug experienced a side effect serious enough to send them to the doctor or hospital, but only 35% of consumers said they know they can report these side effects to the FDA, according to a Consumer Reports poll. Additionally, 81% of respondents said they had seen or heard an ad for prescription drugs within the last 30 days, almost all on television. The Consumers Union, the nonprofit publisher of the magazine, gave the FDA a petition signed by nearly 56,000 consumers asking that a toll-free number and Web site be included in all television drug ads so people can easily report their serious side effects. “What better way for the FDA to let consumers know how to report serious problems with their medications than putting a toll-free number and Web site in all those drug ads we're bombarded by each day?” asked Liz Foley, campaign coordinator with Consumers Union, in a statement.

FDA Clears Generic Wellbutrin

The generic formulation of Wellbutrin XL (300 mg) is bioequivalent to the brand, the Food and Drug Administration has determined. The agency began a review of generic bupropion after receiving 85 adverse event reports in the first 6 months of 2007. Seventy-eight patients said they had experienced loss of antidepressant effect when they were switched from the branded product to the generic manufactured by Teva Pharmaceutical Industries Ltd. The Teva product was approved in 2006, but at the 150-mg dose and based on bioequivalence to 150 mg of Wellbutrin XL, according to the FDA, which noted that the pharmacokinetic profile was not expected to differ between the 150-mg and 300-mg doses. After the rash of adverse event reports, the agency again reviewed the bioequivalence data and the literature on natural history of depression. The FDA concluded that there was no difference between the two products. Also, if there was a link to the generic, there should have been many more reports, said the FDA, noting that by early 2007, at least 40% of bupropion prescriptions were for the generic. The agency added, “The recurrent nature of major depressive disorder offers a scientifically reasonable explanation for the reports of lack of efficacy following a switch to a generic product.”

Teva to Market Generic Risperdal

A U.S. District Court judge in Washington, has ruled that Teva Pharmaceutical Industries Ltd. has the right to make and sell a generic version of Risperdal (risperidone). Unless the ruling is challenged, Teva can begin exclusive sales of risperidone on June 29, the date Johnson & Johnson's patent for Risperdal expires. The FDA and generic pharmaceutical manufacturer Mylan Inc. had argued that Teva should not be allowed to have exclusive rights to the generic version of the drug. But U.S. District Court Judge Royce Lamberth disagreed. In the meantime, J&J and its partner Alkermes Inc. have applied to the FDA to sell a long-acting form of the drug, Risperdal Consta, for frequently relapsing bipolar disorder, defined as four or more manic episodes in the previous year. Alkermes estimates that 10%–20% of people with bipolar disorder worldwide meet that criterion.

Zyprexa Lawsuits March On

Eli Lilly & Co. agreed to pay the state of Alaska $15 million to settle charges that it was not forthcoming about side effects such as weight gain, hyperglycemia, and diabetes related to Zyprexa (olanzapine). But the company is facing a separate suit filed by Connecticut Attorney General Richard Blumenthal in mid-March, alleging concealment of side effects and illegal promotion of off-label uses. Lilly is also negotiating with the U.S. Attorney for the Eastern District of Pennsylvania in an inquiry related to marketing practices. The Alaska settlement came several weeks into a suit brought on behalf of the state's Medicaid program. The company said in a statement that it settled to avoid the cost of a lengthy trial. Zyprexa has been prescribed to 23 million people since its 1996 approval and is approved in 80 other countries. In 2007, sales were $4.8 billion worldwide.

Social Anxiety's Serious Impact

A survey commissioned by the Anxiety Disorders Association of America has found that about a third of the respondents with social anxiety disorder said that they had symptoms for 10 years or more before seeking help. The survey portrayed individuals who had difficulty finding or keeping friends or romantic partners. Thirty-four percent said the disorder led to serious fights with significant others, and 77% said that when they are not treated, the disorder has a negative impact on romantic relationships. Seventy-five percent said social anxiety inhibited their ability to function normally. Fifty-eight percent said they were embarrassed by their disorder. Patients with social anxiety disorder typically try to hide their condition, and therefore become more anxious and isolated, according to the association. Survey respondents indicated that treatment seems to help: 59% who were treated said it helped them have romantic relationships. The survey was conducted in December; 578 people with anxiety, 276 people with obsessive-compulsive disorder, and 287 with social anxiety disorder were queried by Harris Interactive. All agreed to be invited to participate. The ADAA received an unrestricted educational grant from Jazz Pharmaceuticals Inc. to support public awareness efforts about the disorder.

Side Effects Underreported

One in six Americans who have taken a prescription drug experienced a side effect serious enough to send them to the doctor or hospital, but only 35% of consumers said they know they can report these side effects to the FDA, according to a Consumer Reports poll. Additionally, 81% of respondents said they had seen or heard an ad for prescription drugs within the last 30 days, almost all on television. The Consumers Union, the nonprofit publisher of the magazine, gave the FDA a petition signed by nearly 56,000 consumers asking that a toll-free number and Web site be included in all television drug ads so people can easily report their serious side effects. “What better way for the FDA to let consumers know how to report serious problems with their medications than putting a toll-free number and Web site in all those drug ads we're bombarded by each day?” asked Liz Foley, campaign coordinator with Consumers Union, in a statement.

The Centers for Medicare and Medicaid Services has proposed an overall 3% increase in payments for outpatient hospital care in 2009, almost a full percent below the update for 2008. As expected, reporting on quality of care is being tied to the amount of increase hospitals and other outpatient providers will receive.

For the first time, hospitals and other recipients of payments under the outpatient system that do not report data on seven quality measures on emergency department and perioperative care will see only a 1% increase.

The proposed rule, issued in July, also outlines changes for ambulatory surgery centers (ASCs) that are part of a 4-year transition to a new payment system that began this year. In 2009, as was the case this year, ASCs would be paid 65% of the rate paid for the same service in an outpatient hospital department.

The agency estimates it will spend $29 billion in 2009 on payments to acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute-care hospitals, community mental health centers, children's hospitals, and cancer hospitals. That's a $2 billion increase from the estimated $27 billion CMS will spend on outpatient services this year. Payments to ambulatory surgery centers will increase from an estimated $3.5 billion in 2008 to $3.9 billion in 2009, according to CMS.

“The changes proposed for 2009 are intended to give hospitals greater flexibility to manage their resources and give them incentives to improve efficiency so that both beneficiaries and taxpayers get the most value for their health care dollar,” said CMS Acting Administrator Kerry Weems in a statement.

CMS is proposing to more aggressively penalize hospitals and other outpatient providers that do not report quality data. Providers must report on 7 measures in 2008 and on 11 in 2009, including 4 imaging efficiency measures. In addition, the agency is seeking to reduce copayments for beneficiaries who are treated at hospitals that do not report quality data.

By law, Medicare is gradually changing the payment system so that beneficiaries will be liable for only 20% of a covered service. The coinsurance rate has varied widely over the last 8-10 years. In 2009, about 25% of services will be subject to the 20% coinsurance, up from 23% in 2008, CMS said.

For imaging—a huge and growing portion of Medicare expenditures—CMS would make a single payment for multiple imaging procedures performed in a single hospital session, including ultrasound, CT, and MRI.

CMS also proposes reducing pay for some of the higher-cost device-oriented procedures: a 48% reduction in pay for the placing of left ventricular pacing add-on leads; a 3% decrease for replacing pacemakers, electrodes, or pulse generators; 4% for stent placement; and just 1% for drug-eluting stents.

A small increase is proposed for most neurology devices, as well as for urologic and gynecologic procedures and drug infusion devices, but placement of neurostimulator electrodes would be slashed by 52%.

For ASCs, reimbursement would decrease for 92 procedures, but increase for 2,475 procedures, according to the Ambulatory Surgery Center Association. Gastrointestinal procedures as a whole are slated for a 6% reduction, and nervous system procedures and pain management would be reduced by 3%, according to Washington Analysis, a firm that advises investors on health policy developments.

CMS proposes adding nine surgical procedures to the list of services covered at an ASC. Three have brand new current procedural terminology (CPT) codes, and six—nasal/sinus endoscopy surgery; removal of vein clot; blood exchange/transfuse, non-nb; laparoscopic insertion of a permanent intraperitoneal catheter; laparoscopic revision of a permanent intraperitoneal catheter; and laparoscopy with omentopexy add-on—were previously excluded from coverage. Five procedures will be added to the list of office-based procedures, which are paid at either the ASC rate or the office practice expense payment rate, whichever is lower.

CMS is accepting public comments on the outpatient and ASC proposals until Sept. 2 and expects to issue the final rule Nov. 1.

The Centers for Medicare and Medicaid Services has proposed an overall 3% increase in payments for outpatient hospital care in 2009, almost a full percent below the update for 2008. As expected, reporting on quality of care is being tied to the amount of increase hospitals and other outpatient providers will receive.

For the first time, hospitals and other recipients of payments under the outpatient system that do not report data on seven quality measures on emergency department and perioperative care will see only a 1% increase.

The proposed rule, issued in July, also outlines changes for ambulatory surgery centers (ASCs) that are part of a 4-year transition to a new payment system that began this year. In 2009, as was the case this year, ASCs would be paid 65% of the rate paid for the same service in an outpatient hospital department.

The agency estimates it will spend $29 billion in 2009 on payments to acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute-care hospitals, community mental health centers, children's hospitals, and cancer hospitals. That's a $2 billion increase from the estimated $27 billion CMS will spend on outpatient services this year. Payments to ambulatory surgery centers will increase from an estimated $3.5 billion in 2008 to $3.9 billion in 2009, according to CMS.

“The changes proposed for 2009 are intended to give hospitals greater flexibility to manage their resources and give them incentives to improve efficiency so that both beneficiaries and taxpayers get the most value for their health care dollar,” said CMS Acting Administrator Kerry Weems in a statement.

CMS is proposing to more aggressively penalize hospitals and other outpatient providers that do not report quality data. Providers must report on 7 measures in 2008 and on 11 in 2009, including 4 imaging efficiency measures. In addition, the agency is seeking to reduce copayments for beneficiaries who are treated at hospitals that do not report quality data.

By law, Medicare is gradually changing the payment system so that beneficiaries will be liable for only 20% of a covered service. The coinsurance rate has varied widely over the last 8-10 years. In 2009, about 25% of services will be subject to the 20% coinsurance, up from 23% in 2008, CMS said.

For imaging—a huge and growing portion of Medicare expenditures—CMS would make a single payment for multiple imaging procedures performed in a single hospital session, including ultrasound, CT, and MRI.

CMS also proposes reducing pay for some of the higher-cost device-oriented procedures: a 48% reduction in pay for the placing of left ventricular pacing add-on leads; a 3% decrease for replacing pacemakers, electrodes, or pulse generators; 4% for stent placement; and just 1% for drug-eluting stents.

A small increase is proposed for most neurology devices, as well as for urologic and gynecologic procedures and drug infusion devices, but placement of neurostimulator electrodes would be slashed by 52%.

For ASCs, reimbursement would decrease for 92 procedures, but increase for 2,475 procedures, according to the Ambulatory Surgery Center Association. Gastrointestinal procedures as a whole are slated for a 6% reduction, and nervous system procedures and pain management would be reduced by 3%, according to Washington Analysis, a firm that advises investors on health policy developments.

CMS proposes adding nine surgical procedures to the list of services covered at an ASC. Three have brand new current procedural terminology (CPT) codes, and six—nasal/sinus endoscopy surgery; removal of vein clot; blood exchange/transfuse, non-nb; laparoscopic insertion of a permanent intraperitoneal catheter; laparoscopic revision of a permanent intraperitoneal catheter; and laparoscopy with omentopexy add-on—were previously excluded from coverage. Five procedures will be added to the list of office-based procedures, which are paid at either the ASC rate or the office practice expense payment rate, whichever is lower.

CMS is accepting public comments on the outpatient and ASC proposals until Sept. 2 and expects to issue the final rule Nov. 1.

The Centers for Medicare and Medicaid Services has proposed an overall 3% increase in payments for outpatient hospital care in 2009, almost a full percent below the update for 2008. As expected, reporting on quality of care is being tied to the amount of increase hospitals and other outpatient providers will receive.

For the first time, hospitals and other recipients of payments under the outpatient system that do not report data on seven quality measures on emergency department and perioperative care will see only a 1% increase.

The proposed rule, issued in July, also outlines changes for ambulatory surgery centers (ASCs) that are part of a 4-year transition to a new payment system that began this year. In 2009, as was the case this year, ASCs would be paid 65% of the rate paid for the same service in an outpatient hospital department.

The agency estimates it will spend $29 billion in 2009 on payments to acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute-care hospitals, community mental health centers, children's hospitals, and cancer hospitals. That's a $2 billion increase from the estimated $27 billion CMS will spend on outpatient services this year. Payments to ambulatory surgery centers will increase from an estimated $3.5 billion in 2008 to $3.9 billion in 2009, according to CMS.

“The changes proposed for 2009 are intended to give hospitals greater flexibility to manage their resources and give them incentives to improve efficiency so that both beneficiaries and taxpayers get the most value for their health care dollar,” said CMS Acting Administrator Kerry Weems in a statement.

CMS is proposing to more aggressively penalize hospitals and other outpatient providers that do not report quality data. Providers must report on 7 measures in 2008 and on 11 in 2009, including 4 imaging efficiency measures. In addition, the agency is seeking to reduce copayments for beneficiaries who are treated at hospitals that do not report quality data.

By law, Medicare is gradually changing the payment system so that beneficiaries will be liable for only 20% of a covered service. The coinsurance rate has varied widely over the last 8-10 years. In 2009, about 25% of services will be subject to the 20% coinsurance, up from 23% in 2008, CMS said.

For imaging—a huge and growing portion of Medicare expenditures—CMS would make a single payment for multiple imaging procedures performed in a single hospital session, including ultrasound, CT, and MRI.

CMS also proposes reducing pay for some of the higher-cost device-oriented procedures: a 48% reduction in pay for the placing of left ventricular pacing add-on leads; a 3% decrease for replacing pacemakers, electrodes, or pulse generators; 4% for stent placement; and just 1% for drug-eluting stents.

A small increase is proposed for most neurology devices, as well as for urologic and gynecologic procedures and drug infusion devices, but placement of neurostimulator electrodes would be slashed by 52%.

For ASCs, reimbursement would decrease for 92 procedures, but increase for 2,475 procedures, according to the Ambulatory Surgery Center Association. Gastrointestinal procedures as a whole are slated for a 6% reduction, and nervous system procedures and pain management would be reduced by 3%, according to Washington Analysis, a firm that advises investors on health policy developments.

CMS proposes adding nine surgical procedures to the list of services covered at an ASC. Three have brand new current procedural terminology (CPT) codes, and six—nasal/sinus endoscopy surgery; removal of vein clot; blood exchange/transfuse, non-nb; laparoscopic insertion of a permanent intraperitoneal catheter; laparoscopic revision of a permanent intraperitoneal catheter; and laparoscopy with omentopexy add-on—were previously excluded from coverage. Five procedures will be added to the list of office-based procedures, which are paid at either the ASC rate or the office practice expense payment rate, whichever is lower.

CMS is accepting public comments on the outpatient and ASC proposals until Sept. 2 and expects to issue the final rule Nov. 1.

The Centers for Medicare and Medicaid Services has expanded coverage of home prothrombin time (or International Normalized Ratio, INR) testing to include patients who are taking anticoagulation therapy for chronic atrial fibrillation and venous thromboembolism.

Patients must meet certain other criteria, and the home tests can't be used more than once a week, according to the final decision issued by the CMS.

Medicare has covered home prothrombin time testing since 2002, but only for patients with mechanical heart valves. The request for expanded coverage was made in June 2007 by the three main manufacturers of home testing devices—Roche Diagnostics, International Technidyne Corp., and HemoSense Inc. The companies said that there was plenty of new evidence to support home testing for the two other conditions. The CMS agreed.

“Medicare's coverage extension of home blood testing of prothrombin time International Normalized Ratio is based on current evidence for these two conditions,” CMS Acting Administrator Kerry Weems said in a statement. Currently, prothrombin testing is conducted about every 4–6 weeks, primarily in physicians' offices, according to the CMS. Fewer than 5% of patients on anticoagulation therapy monitor prothrombin at home.

“Those Medicare beneficiaries and their physicians managing conditions related to chronic atrial fibrillation or venous thromboembolism will benefit greatly through the use of the home test,” Mr. Weems said.

Roche estimated that Medicare beneficiaries would pay $35 for training in use of at-home devices, and about $30 a month for test strips. Patients who have supplemental Medicare insurance might not have any out-of-pocket costs, the company said in a statement.

The Centers for Medicare and Medicaid Services has expanded coverage of home prothrombin time (or International Normalized Ratio, INR) testing to include patients who are taking anticoagulation therapy for chronic atrial fibrillation and venous thromboembolism.

Patients must meet certain other criteria, and the home tests can't be used more than once a week, according to the final decision issued by the CMS.

Medicare has covered home prothrombin time testing since 2002, but only for patients with mechanical heart valves. The request for expanded coverage was made in June 2007 by the three main manufacturers of home testing devices—Roche Diagnostics, International Technidyne Corp., and HemoSense Inc. The companies said that there was plenty of new evidence to support home testing for the two other conditions. The CMS agreed.

“Medicare's coverage extension of home blood testing of prothrombin time International Normalized Ratio is based on current evidence for these two conditions,” CMS Acting Administrator Kerry Weems said in a statement. Currently, prothrombin testing is conducted about every 4–6 weeks, primarily in physicians' offices, according to the CMS. Fewer than 5% of patients on anticoagulation therapy monitor prothrombin at home.

“Those Medicare beneficiaries and their physicians managing conditions related to chronic atrial fibrillation or venous thromboembolism will benefit greatly through the use of the home test,” Mr. Weems said.

Roche estimated that Medicare beneficiaries would pay $35 for training in use of at-home devices, and about $30 a month for test strips. Patients who have supplemental Medicare insurance might not have any out-of-pocket costs, the company said in a statement.

The Centers for Medicare and Medicaid Services has expanded coverage of home prothrombin time (or International Normalized Ratio, INR) testing to include patients who are taking anticoagulation therapy for chronic atrial fibrillation and venous thromboembolism.

Patients must meet certain other criteria, and the home tests can't be used more than once a week, according to the final decision issued by the CMS.

Medicare has covered home prothrombin time testing since 2002, but only for patients with mechanical heart valves. The request for expanded coverage was made in June 2007 by the three main manufacturers of home testing devices—Roche Diagnostics, International Technidyne Corp., and HemoSense Inc. The companies said that there was plenty of new evidence to support home testing for the two other conditions. The CMS agreed.

“Medicare's coverage extension of home blood testing of prothrombin time International Normalized Ratio is based on current evidence for these two conditions,” CMS Acting Administrator Kerry Weems said in a statement. Currently, prothrombin testing is conducted about every 4–6 weeks, primarily in physicians' offices, according to the CMS. Fewer than 5% of patients on anticoagulation therapy monitor prothrombin at home.

“Those Medicare beneficiaries and their physicians managing conditions related to chronic atrial fibrillation or venous thromboembolism will benefit greatly through the use of the home test,” Mr. Weems said.

Roche estimated that Medicare beneficiaries would pay $35 for training in use of at-home devices, and about $30 a month for test strips. Patients who have supplemental Medicare insurance might not have any out-of-pocket costs, the company said in a statement.

WASHINGTON — The concept of a medical home is a step closer to reality for Medicare patients, after it received strong backing from the Medicare Payment Advisory Commission at its April meeting.

All 17 commissioners present at the meeting voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners recommended a larger pilot with clear thresholds.

The commissioners' criteria for a medical home included the ability to provide primary care, use information technology for clinical decision support, conduct care management, offer 24-hour communication with patients, maintain up-to-date records of patients' advance directives, and operate a formal quality improvement program. Also, beneficiaries should agree to adhere to medical home principles by respecting the idea that someone is in charge of coordinating their care, and communicating with the physician when they seek care elsewhere.

There was some debate over whether patients should be allowed to access other providers without a referral, which is permitted under current fee-for-service Medicare. Most commissioners wanted some restrictions, or at least a way to track when patients see specialists, to facilitate assessment of the program.

The medical home would not be limited to primary care physicians; specialists likely would be able to fulfill criteria for participation, according to the commission.

The program would cost $50-$250 million in the first year, and cost less than $1 billion over the first 5 years, MedPAC staffers estimated. The estimate included monthly fees to medical homes, but not anticipated savings, said MedPAC staffer Christine Boccuti.

Dr. Francis Jay Crosson, a commissioner and senior medical director of Permanente Federation in Oakland, Calif., called the proposal a “significant evolution” from what had been presented to the panel in 2007. “I think it's a good evolution,” he said.

“This is a very exciting recommendation,” said Commissioner Jack Ebeler, a health policy consultant in Reston, Va. Promotion of the medical home approach is a direct way to reform the health care delivery system, he added.

Commissioners also said that the medical home recommendation dovetailed with MedPAC's support of increased pay for primary care services.

An adjustment to the fee schedule is “long overdue,” said Dr. Ronald Castellanos, a commissioner and urologist in private practice in Fort Myers, Fla. Increased pay might lure more residents into primary care and help those currently practicing to stay in the workplace, he said.

The commissioners debated how CMS could determine which physicians or other health providers—such as nurse practitioners—would receive the update. MedPAC staff presented the increase as budget neutral, which made some panelists uneasy.

Dr. Nicholas Wolter of the Billings (Mont.) Clinic suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians. “I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. She said that she often provided what would be considered primary care to her breast cancer patients.

Dr. Borman ended up voting against the recommendation for increased pay for primary care.

WASHINGTON — The concept of a medical home is a step closer to reality for Medicare patients, after it received strong backing from the Medicare Payment Advisory Commission at its April meeting.

All 17 commissioners present at the meeting voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners recommended a larger pilot with clear thresholds.

The commissioners' criteria for a medical home included the ability to provide primary care, use information technology for clinical decision support, conduct care management, offer 24-hour communication with patients, maintain up-to-date records of patients' advance directives, and operate a formal quality improvement program. Also, beneficiaries should agree to adhere to medical home principles by respecting the idea that someone is in charge of coordinating their care, and communicating with the physician when they seek care elsewhere.

There was some debate over whether patients should be allowed to access other providers without a referral, which is permitted under current fee-for-service Medicare. Most commissioners wanted some restrictions, or at least a way to track when patients see specialists, to facilitate assessment of the program.

The medical home would not be limited to primary care physicians; specialists likely would be able to fulfill criteria for participation, according to the commission.

The program would cost $50-$250 million in the first year, and cost less than $1 billion over the first 5 years, MedPAC staffers estimated. The estimate included monthly fees to medical homes, but not anticipated savings, said MedPAC staffer Christine Boccuti.

Dr. Francis Jay Crosson, a commissioner and senior medical director of Permanente Federation in Oakland, Calif., called the proposal a “significant evolution” from what had been presented to the panel in 2007. “I think it's a good evolution,” he said.

“This is a very exciting recommendation,” said Commissioner Jack Ebeler, a health policy consultant in Reston, Va. Promotion of the medical home approach is a direct way to reform the health care delivery system, he added.

Commissioners also said that the medical home recommendation dovetailed with MedPAC's support of increased pay for primary care services.

An adjustment to the fee schedule is “long overdue,” said Dr. Ronald Castellanos, a commissioner and urologist in private practice in Fort Myers, Fla. Increased pay might lure more residents into primary care and help those currently practicing to stay in the workplace, he said.

The commissioners debated how CMS could determine which physicians or other health providers—such as nurse practitioners—would receive the update. MedPAC staff presented the increase as budget neutral, which made some panelists uneasy.

Dr. Nicholas Wolter of the Billings (Mont.) Clinic suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians. “I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. She said that she often provided what would be considered primary care to her breast cancer patients.

Dr. Borman ended up voting against the recommendation for increased pay for primary care.

WASHINGTON — The concept of a medical home is a step closer to reality for Medicare patients, after it received strong backing from the Medicare Payment Advisory Commission at its April meeting.

All 17 commissioners present at the meeting voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners recommended a larger pilot with clear thresholds.

The commissioners' criteria for a medical home included the ability to provide primary care, use information technology for clinical decision support, conduct care management, offer 24-hour communication with patients, maintain up-to-date records of patients' advance directives, and operate a formal quality improvement program. Also, beneficiaries should agree to adhere to medical home principles by respecting the idea that someone is in charge of coordinating their care, and communicating with the physician when they seek care elsewhere.

There was some debate over whether patients should be allowed to access other providers without a referral, which is permitted under current fee-for-service Medicare. Most commissioners wanted some restrictions, or at least a way to track when patients see specialists, to facilitate assessment of the program.

The medical home would not be limited to primary care physicians; specialists likely would be able to fulfill criteria for participation, according to the commission.

The program would cost $50-$250 million in the first year, and cost less than $1 billion over the first 5 years, MedPAC staffers estimated. The estimate included monthly fees to medical homes, but not anticipated savings, said MedPAC staffer Christine Boccuti.

Dr. Francis Jay Crosson, a commissioner and senior medical director of Permanente Federation in Oakland, Calif., called the proposal a “significant evolution” from what had been presented to the panel in 2007. “I think it's a good evolution,” he said.

“This is a very exciting recommendation,” said Commissioner Jack Ebeler, a health policy consultant in Reston, Va. Promotion of the medical home approach is a direct way to reform the health care delivery system, he added.

Commissioners also said that the medical home recommendation dovetailed with MedPAC's support of increased pay for primary care services.

An adjustment to the fee schedule is “long overdue,” said Dr. Ronald Castellanos, a commissioner and urologist in private practice in Fort Myers, Fla. Increased pay might lure more residents into primary care and help those currently practicing to stay in the workplace, he said.

The commissioners debated how CMS could determine which physicians or other health providers—such as nurse practitioners—would receive the update. MedPAC staff presented the increase as budget neutral, which made some panelists uneasy.

Dr. Nicholas Wolter of the Billings (Mont.) Clinic suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians. “I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. She said that she often provided what would be considered primary care to her breast cancer patients.

Dr. Borman ended up voting against the recommendation for increased pay for primary care.

One day after the full ENHANCE data were presented at the ACC meeting, Sen. Chuck Grassley sent Merck & Co. and Schering-Plough Corp. executives a letter asking for the names of “key opinion leaders” who advised the companies on development and marketing of their cholesterol-lowering drug ezetimibe/simvastatin (Vytorin). The letter also called for a full accounting of payments made to these medical professionals and of how much was spent in total on advertising and marketing for Vytorin and/or ezetimibe (Zetia).

Sen. Grassley (R-Iowa) is the ranking minority member on the Senate Finance Committee, which has been investigating an alleged delay of the release of pivotal data from the ENHANCE study.

“Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government,” Sen. Grassley said in his letter, adding that since the trial's completion in 2006, the federal government has paid “hundreds of millions of dollars for Vytorin,” a drug which now seems to be of limited utility.

ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) showed that in patients with heterozygous familial hypercholesterolemia, a combination of ezetimibe and simvastatin was substantially more potent than simvastatin alone for reducing levels of LDL cholesterol and high-sensitivity C-reactive protein. But the combination had absolutely no advantage over the statin alone for slowing the progression of carotid atherosclerosis during 2 years of follow-up.

According to Sen. Grassley's letter, the Finance Committee staff has unearthed e-mail correspondence between Schering-Plough and Dr. John Kastelein, the ENHANCE primary investigator.

In July 2007, Dr. Kastelein wrote to a Schering-Plough executive, saying, “Is it correct that SP has decided not to present at AHA [the American Heart Association annual meeting], but to await the two other, completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??” Dr. Kastelein added, “If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over. … This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.”

Just a day later, Dr. Kastelein wrote again to a Schering-Plough executive that he had been “cleared to say that ENHANCE would be presented at AHA” when he was presenting ezetimibe data at meetings he attended on behalf of the company over 6 months. “There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!”

Sen. Grassley also said he was disturbed by a Merck/Schering-Plough public relations campaign, the “49 plan,” which was “designed to wine and dine doctors and convince them to prescribe Vytorin.” The campaign budget was at least $3.5 million, said Sen. Grassley, adding, “This seems like a great deal of money for free lunches and dinners.”

A Schering-Plough spokeswoman said that the letter from Sen. Grassley is one of a series the company has received from the committee. “We are cooperating fully with the committee, and we stand behind our products, as we have done nothing wrong,” Rosemarie Yancosek said in an interview.

The Iowa senator also wrote to the American College of Cardiology, saying that he was hopeful that the college was hewing to its own conflicts-of-interest policies but that he was concerned, noting that ACC had received $5 million from Merck since 2003, $1 million from Schering-Plough, and $5 million from the joint venture.

Soon after the ENHANCE data were released in January, ACC issued a statement saying that “there is no reason for patients to panic” and advising concerned patients to talk to their health care professional. ACC also said that further research was needed to determine Vytorin's usefulness. Sen. Grassley noted that in internal e-mails, both Merck and Schering-Plough officials had pointed to the ACC statement as evidence of Vytorin's effectiveness.

“It would not be unreasonable for an independent third party to conclude that the Merck and Schering-Plough payments to ACC influenced ACC's comments about Vytorin, especially now that experts are calling for doctors to use this drug only as a last resort,” Sen. Grassley said in his letter.

One day after the full ENHANCE data were presented at the ACC meeting, Sen. Chuck Grassley sent Merck & Co. and Schering-Plough Corp. executives a letter asking for the names of “key opinion leaders” who advised the companies on development and marketing of their cholesterol-lowering drug ezetimibe/simvastatin (Vytorin). The letter also called for a full accounting of payments made to these medical professionals and of how much was spent in total on advertising and marketing for Vytorin and/or ezetimibe (Zetia).

Sen. Grassley (R-Iowa) is the ranking minority member on the Senate Finance Committee, which has been investigating an alleged delay of the release of pivotal data from the ENHANCE study.

“Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government,” Sen. Grassley said in his letter, adding that since the trial's completion in 2006, the federal government has paid “hundreds of millions of dollars for Vytorin,” a drug which now seems to be of limited utility.

ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) showed that in patients with heterozygous familial hypercholesterolemia, a combination of ezetimibe and simvastatin was substantially more potent than simvastatin alone for reducing levels of LDL cholesterol and high-sensitivity C-reactive protein. But the combination had absolutely no advantage over the statin alone for slowing the progression of carotid atherosclerosis during 2 years of follow-up.

According to Sen. Grassley's letter, the Finance Committee staff has unearthed e-mail correspondence between Schering-Plough and Dr. John Kastelein, the ENHANCE primary investigator.

In July 2007, Dr. Kastelein wrote to a Schering-Plough executive, saying, “Is it correct that SP has decided not to present at AHA [the American Heart Association annual meeting], but to await the two other, completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??” Dr. Kastelein added, “If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over. … This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.”

Just a day later, Dr. Kastelein wrote again to a Schering-Plough executive that he had been “cleared to say that ENHANCE would be presented at AHA” when he was presenting ezetimibe data at meetings he attended on behalf of the company over 6 months. “There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!”

Sen. Grassley also said he was disturbed by a Merck/Schering-Plough public relations campaign, the “49 plan,” which was “designed to wine and dine doctors and convince them to prescribe Vytorin.” The campaign budget was at least $3.5 million, said Sen. Grassley, adding, “This seems like a great deal of money for free lunches and dinners.”

A Schering-Plough spokeswoman said that the letter from Sen. Grassley is one of a series the company has received from the committee. “We are cooperating fully with the committee, and we stand behind our products, as we have done nothing wrong,” Rosemarie Yancosek said in an interview.

The Iowa senator also wrote to the American College of Cardiology, saying that he was hopeful that the college was hewing to its own conflicts-of-interest policies but that he was concerned, noting that ACC had received $5 million from Merck since 2003, $1 million from Schering-Plough, and $5 million from the joint venture.

Soon after the ENHANCE data were released in January, ACC issued a statement saying that “there is no reason for patients to panic” and advising concerned patients to talk to their health care professional. ACC also said that further research was needed to determine Vytorin's usefulness. Sen. Grassley noted that in internal e-mails, both Merck and Schering-Plough officials had pointed to the ACC statement as evidence of Vytorin's effectiveness.

“It would not be unreasonable for an independent third party to conclude that the Merck and Schering-Plough payments to ACC influenced ACC's comments about Vytorin, especially now that experts are calling for doctors to use this drug only as a last resort,” Sen. Grassley said in his letter.

One day after the full ENHANCE data were presented at the ACC meeting, Sen. Chuck Grassley sent Merck & Co. and Schering-Plough Corp. executives a letter asking for the names of “key opinion leaders” who advised the companies on development and marketing of their cholesterol-lowering drug ezetimibe/simvastatin (Vytorin). The letter also called for a full accounting of payments made to these medical professionals and of how much was spent in total on advertising and marketing for Vytorin and/or ezetimibe (Zetia).

Sen. Grassley (R-Iowa) is the ranking minority member on the Senate Finance Committee, which has been investigating an alleged delay of the release of pivotal data from the ENHANCE study.

“Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government,” Sen. Grassley said in his letter, adding that since the trial's completion in 2006, the federal government has paid “hundreds of millions of dollars for Vytorin,” a drug which now seems to be of limited utility.

ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) showed that in patients with heterozygous familial hypercholesterolemia, a combination of ezetimibe and simvastatin was substantially more potent than simvastatin alone for reducing levels of LDL cholesterol and high-sensitivity C-reactive protein. But the combination had absolutely no advantage over the statin alone for slowing the progression of carotid atherosclerosis during 2 years of follow-up.

According to Sen. Grassley's letter, the Finance Committee staff has unearthed e-mail correspondence between Schering-Plough and Dr. John Kastelein, the ENHANCE primary investigator.

In July 2007, Dr. Kastelein wrote to a Schering-Plough executive, saying, “Is it correct that SP has decided not to present at AHA [the American Heart Association annual meeting], but to await the two other, completely unvalidated, endpoints, which analysis is going to take us straight into 2008??!!??” Dr. Kastelein added, “If this is true, SP must have taken this decision without even the semblance of decency to consult me as PI of the study. I can tell you that if this is the case, our collaboration is over. … This starts smelling like extending the publication for no other [than] political reasons and I cannot live with that.”

Just a day later, Dr. Kastelein wrote again to a Schering-Plough executive that he had been “cleared to say that ENHANCE would be presented at AHA” when he was presenting ezetimibe data at meetings he attended on behalf of the company over 6 months. “There is no reason whatsoever to include femorals; you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!”

Sen. Grassley also said he was disturbed by a Merck/Schering-Plough public relations campaign, the “49 plan,” which was “designed to wine and dine doctors and convince them to prescribe Vytorin.” The campaign budget was at least $3.5 million, said Sen. Grassley, adding, “This seems like a great deal of money for free lunches and dinners.”

A Schering-Plough spokeswoman said that the letter from Sen. Grassley is one of a series the company has received from the committee. “We are cooperating fully with the committee, and we stand behind our products, as we have done nothing wrong,” Rosemarie Yancosek said in an interview.

The Iowa senator also wrote to the American College of Cardiology, saying that he was hopeful that the college was hewing to its own conflicts-of-interest policies but that he was concerned, noting that ACC had received $5 million from Merck since 2003, $1 million from Schering-Plough, and $5 million from the joint venture.

Soon after the ENHANCE data were released in January, ACC issued a statement saying that “there is no reason for patients to panic” and advising concerned patients to talk to their health care professional. ACC also said that further research was needed to determine Vytorin's usefulness. Sen. Grassley noted that in internal e-mails, both Merck and Schering-Plough officials had pointed to the ACC statement as evidence of Vytorin's effectiveness.

“It would not be unreasonable for an independent third party to conclude that the Merck and Schering-Plough payments to ACC influenced ACC's comments about Vytorin, especially now that experts are calling for doctors to use this drug only as a last resort,” Sen. Grassley said in his letter.

WASHINGTON — The explosive growth of hospitalists has caught the notice of the Medicare Payment Advisory Commission, which advises Congress on cost, quality, and access issues affecting the federal health program.

The number of hospitalists has nearly doubled in the last 5 years and will rise to 24,000 in 2008, according to information presented by MedPAC staff at a recent meeting. Citing figures from the Society for Hospital Medicine, the staff said that 40% of Medicare beneficiaries will receive care from a hospitalist by 2010, which is double the current number.

The MedPAC staff and some of the commissioners expressed concern that the explosion of hospitalist care could increase Medicare's overall spending. According to the staff, hospitalists are usually compensated through a combination of fixed salary and volume-based bonus incentives.

Those volume-based incentives may be driving hospitalists to admit and consult more often, said Zach Gaumer, a MedPAC staff member—and currently, he continued, Medicare's payment system rewards volume, not quality and efficiency.

Hospitalists have shown that they can "create measurable efficiency gains," he said, citing a study that showed that patients treated by hospitalists had a shorter length of stay and lower costs than those who were looked after by a general internist or family physician (N. Engl. J. Med. 2007;357:2589–600). There seemed to be no impact, however, on mortality or readmissions, said Mr. Gaumer.

The consistent presence of a hospitalist, however, may improve patient safety and lead to quicker adoption of process-improvement initiatives, he added.

On balance, the collaboration between hospitals and physicians can be a plus for providers and patients, said MedPAC staff member Ann Mutti.

The commission should aim for Medicare incentives that encourage appropriate care and the right mix of care, she said.

WASHINGTON — The explosive growth of hospitalists has caught the notice of the Medicare Payment Advisory Commission, which advises Congress on cost, quality, and access issues affecting the federal health program.

The number of hospitalists has nearly doubled in the last 5 years and will rise to 24,000 in 2008, according to information presented by MedPAC staff at a recent meeting. Citing figures from the Society for Hospital Medicine, the staff said that 40% of Medicare beneficiaries will receive care from a hospitalist by 2010, which is double the current number.

The MedPAC staff and some of the commissioners expressed concern that the explosion of hospitalist care could increase Medicare's overall spending. According to the staff, hospitalists are usually compensated through a combination of fixed salary and volume-based bonus incentives.

Those volume-based incentives may be driving hospitalists to admit and consult more often, said Zach Gaumer, a MedPAC staff member—and currently, he continued, Medicare's payment system rewards volume, not quality and efficiency.

Hospitalists have shown that they can "create measurable efficiency gains," he said, citing a study that showed that patients treated by hospitalists had a shorter length of stay and lower costs than those who were looked after by a general internist or family physician (N. Engl. J. Med. 2007;357:2589–600). There seemed to be no impact, however, on mortality or readmissions, said Mr. Gaumer.

The consistent presence of a hospitalist, however, may improve patient safety and lead to quicker adoption of process-improvement initiatives, he added.

On balance, the collaboration between hospitals and physicians can be a plus for providers and patients, said MedPAC staff member Ann Mutti.

The commission should aim for Medicare incentives that encourage appropriate care and the right mix of care, she said.

WASHINGTON — The explosive growth of hospitalists has caught the notice of the Medicare Payment Advisory Commission, which advises Congress on cost, quality, and access issues affecting the federal health program.

The number of hospitalists has nearly doubled in the last 5 years and will rise to 24,000 in 2008, according to information presented by MedPAC staff at a recent meeting. Citing figures from the Society for Hospital Medicine, the staff said that 40% of Medicare beneficiaries will receive care from a hospitalist by 2010, which is double the current number.

The MedPAC staff and some of the commissioners expressed concern that the explosion of hospitalist care could increase Medicare's overall spending. According to the staff, hospitalists are usually compensated through a combination of fixed salary and volume-based bonus incentives.

Those volume-based incentives may be driving hospitalists to admit and consult more often, said Zach Gaumer, a MedPAC staff member—and currently, he continued, Medicare's payment system rewards volume, not quality and efficiency.

Hospitalists have shown that they can "create measurable efficiency gains," he said, citing a study that showed that patients treated by hospitalists had a shorter length of stay and lower costs than those who were looked after by a general internist or family physician (N. Engl. J. Med. 2007;357:2589–600). There seemed to be no impact, however, on mortality or readmissions, said Mr. Gaumer.

The consistent presence of a hospitalist, however, may improve patient safety and lead to quicker adoption of process-improvement initiatives, he added.

On balance, the collaboration between hospitals and physicians can be a plus for providers and patients, said MedPAC staff member Ann Mutti.

The commission should aim for Medicare incentives that encourage appropriate care and the right mix of care, she said.

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

"While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage," Mike Leavitt, Health and Human Services secretary, said in a statement. "Toward that end, we will continue to work with Congress on the reauthorization of this vital program."

That comment is "disingenuous," Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

"The administration did everything possible to stand in the way of the reauthorization," Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized.

And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, "We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid."

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year, as states face harsh budget realities.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations. According to estimates they cite from the Congressional Budget Office, the regulations could translate to $20 billion in cuts to Medicaid over the next 5 years.

The National Governors Association, the National Association of State Medicaid Directors, and the American Public Human Services Association, have all expressed their opposition to the regulations in letters to HHS.

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

"While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage," Mike Leavitt, Health and Human Services secretary, said in a statement. "Toward that end, we will continue to work with Congress on the reauthorization of this vital program."

That comment is "disingenuous," Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

"The administration did everything possible to stand in the way of the reauthorization," Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized.

And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, "We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid."

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year, as states face harsh budget realities.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations. According to estimates they cite from the Congressional Budget Office, the regulations could translate to $20 billion in cuts to Medicaid over the next 5 years.

The National Governors Association, the National Association of State Medicaid Directors, and the American Public Human Services Association, have all expressed their opposition to the regulations in letters to HHS.

The federal government's portrayal of enrollment growth in the State Children's Health Insurance Program in 2007 is disingenuous and somewhat misleading, advocates for children's programs said.

According to the Centers for Medicare and Medicaid Services, 7.1 million children were enrolled in the program (SCHIP) in 2007, up from 6.7 million in 2006.

"While we are pleased that SCHIP continues to grow, we must do more to reach those at the lowest income levels who still need this coverage," Mike Leavitt, Health and Human Services secretary, said in a statement. "Toward that end, we will continue to work with Congress on the reauthorization of this vital program."

That comment is "disingenuous," Dr. Steve Wegner, chairman of the child health funding committee at the American Academy of Pediatrics, said in an interview. He noted that President Bush vetoed a compromise agreement to reauthorize SCHIP not once, but twice, in 2007.

"The administration did everything possible to stand in the way of the reauthorization," Jenny Sullivan, a health policy analyst with Families USA, said in an interview.

SCHIP was finally given a reprieve, with Congress passing, and the president signing, a funding extension through March 2009. But the program still has not been formally reauthorized.

And, said Ms. Sullivan and Dr. Wegner, many millions more children would have been covered in 2007 if the reauthorization had been approved when it was first taken up early in the year.

CMS spokeswoman Mary Kahn said that it was not accurate to imply that the Bush administration did not want to continue the SCHIP program. The administration did, however, want to fund it at a lower level, she said in an interview.

Also in the HHS statement, Kerry Weems, CMS acting administrator, said, "We continue to work with states to [ensure] that as many eligible, uninsured children as possible are enrolled in SCHIP and Medicaid."

Dr. Wegner took exception to that statement as well, noting that a CMS directive issued in August 2007 has effectively prevented states from expanding eligibility. The CMS said it would limit states' ability to expand coverage to children in families who had incomes at 250% of the poverty level or above. Ms. Sullivan said that the directive had, in many cases, reversed expansion plans previously approved by the CMS.

Twenty-three states are expected to be affected by the directive, according to the Kaiser Family Foundation. Nine already cover children in families with incomes above 250%, and 13 states had received approval to expand eligibility at or above that level. In addition, Washington was covering children at the 250% level and had gotten approval to raise that cap.

The directive is consistent with the administration's belief that every effort should be made to enroll 95% of children eligible at the lowest income levels before expanding it to those who are in higher-income families, said Ms. Kahn.

The increase in SCHIP enrollment was not unusually high for the program, said Ms. Sullivan. And, she said, U.S. Census Bureau figures indicate that the overall number of uninsured children actually increased in the last 2 years.

There are approximately 9 million uninsured children in the United States, according to a Families USA analysis. Both Ms. Sullivan and Dr. Wegner said they expect that number to grow in the current year, as states face harsh budget realities.

A much larger number of children are covered under traditional Medicaid programs—about 28 million in 2005, according to Kaiser—but their coverage is also being threatened because of a series of CMS regulations taking effect this year. Rep. John Dingell (D-Mich.) and Rep. Tim Murphy (R-Penn.) introduced a bill in March (H.R. 5613) that would place a 1-year moratorium on seven of those regulations. According to estimates they cite from the Congressional Budget Office, the regulations could translate to $20 billion in cuts to Medicaid over the next 5 years.

The National Governors Association, the National Association of State Medicaid Directors, and the American Public Human Services Association, have all expressed their opposition to the regulations in letters to HHS.

Market Swing to Noninjectables?

The number of botulinum toxin injections in 2007 far exceeded any other cosmetic procedure—surgical or nonsurgical—according to the American Society for Aesthetic Plastic Surgery's annual accounting of Americans' cosmetic predilections. However, the 2.7 million Botox injections were slightly down from 2006, when 3.1 million procedures were performed. The number of hyaluronic acid injections also dropped slightly to 1.4 million, as did injections of collagen and polyactate (Sculptra). Injections of calcium hydroxylapatite (Radiesse) increased by 55% to 119,000. And there was rapid uptake of noninjectables: Fraxel (167,000 procedures), IPL (647,000), and noninvasive tightening (258,000). Laser hair removal was still popular, at 1.4 million procedures, as was microdermabrasion (829,000 procedures). By comparison, the top surgical procedure—liposuction—was performed about 450,000 times. There's been a continued trend away from surgery. In 2007, nonsurgical procedures were 82% of the total cosmetic procedures. The sweet spot is the 35- to 50-year-old demographic, which accounted for 46% of all cosmetic procedures (surgical and nonsurgical). Women accounted for 91% of the total.

NSF-Gadolinium Cases Centralized

Discovery for 66 suits alleging that gadolinium-based contrast led to nephrogenic systemic fibrosis (NSF) has been consolidated in a federal court in Ohio. The plaintiffs allege that the gadolinium-based contrast agent used during magnetic resonance imaging led to NSF. NSF has occurred only in patients with preexisting renal compromise. The Food and Drug Administration has issued several warnings about gadolinium and NSF; in May 2007, the agency requested new black box warnings about the risk of NSF for the five products on the market. The discovery process for the product liability suits is now consolidated as multidistrict litigation 1909 in the U.S. District Court, Northern District of Ohio.

QLT to Divest Aczone

Vancouver, B.C.-based QLT Inc. said in mid-March that it would divest its acne therapy Aczone. The company made the announcement in the wake of the Food and Drug Administration's decision to remove a requirement for glucose-6-phosphate dehydrogenase screening and blood monitoring for users. The FDA decision was based on results of a postmarketing study submitted by the manufacturer. Aczone (dapsone 5% aqueous gel) was approved in July 2005. QLT owns worldwide marketing rights, but says it will now divest the product, as planned. "Management believed in the product and took the necessary steps to address the FDA's needs, ultimately dramatically enhancing the value of Aczone," said QLT CEO Bob Butchofsky in a statement.

Judge Rules for Journals

A federal judge in Chicago last month ruled that JAMA and the Archives of Internal Medicine do not need to release documents related to the confidential peer review process for studies on cyclooxygenase-2 inhibitors. Attorneys for drugmaker Pfizer Inc. had issued subpoenas last year to obtain all documents relating to the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and their comments, and editors' comments regarding manuscripts, peer review, and publication decisions. But U.S. District Court Judge Arlander Keys of the Northern District of Illinois ruled that the journals can keep the documents confidential. "It is not unreasonable to believe that compelling production of peer review documents would compromise the process," Judge Keys wrote. Dr. Catherine DeAngelis, JAMA's editor-in-chief, and JAMA's editorial counsel, Joseph Thornton, wrote in an online editorial released March 24 that the ruling supports the confidential peer review process. "For months, JAMA and [Archives of Internal Medicine] consistently argued that the sanctity of the confidential peer review process should not be violated," they wrote. "JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment." A federal judge in Boston has not yet ruled on a similar request by Pfizer to force the release of documents from the New England Journal of Medicine.

Trouble Paying for Rx

Four in 10 Americans—and half those regularly taking at least one medication—reported that they have trouble paying for drugs, skip prescriptions, or cut pills because of the cost of their prescriptions, a poll jointly conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health showed. People were most likely to report one of those three issues if they lack drug coverage, if they have low incomes, or if they take four or more drugs regularly. The survey found that while the public values the products drug companies produce, they do not like what they charge and are suspicious of their motivation. Nearly 80% of Americans said that the cost of prescription drugs is unreasonable, and about 70% said pharmaceutical companies are too concerned about making profits and not concerned enough about helping people. But at the same time, the public overwhelmingly believes that recent advances in prescription drugs provide benefits, the survey found.

Market Swing to Noninjectables?

The number of botulinum toxin injections in 2007 far exceeded any other cosmetic procedure—surgical or nonsurgical—according to the American Society for Aesthetic Plastic Surgery's annual accounting of Americans' cosmetic predilections. However, the 2.7 million Botox injections were slightly down from 2006, when 3.1 million procedures were performed. The number of hyaluronic acid injections also dropped slightly to 1.4 million, as did injections of collagen and polyactate (Sculptra). Injections of calcium hydroxylapatite (Radiesse) increased by 55% to 119,000. And there was rapid uptake of noninjectables: Fraxel (167,000 procedures), IPL (647,000), and noninvasive tightening (258,000). Laser hair removal was still popular, at 1.4 million procedures, as was microdermabrasion (829,000 procedures). By comparison, the top surgical procedure—liposuction—was performed about 450,000 times. There's been a continued trend away from surgery. In 2007, nonsurgical procedures were 82% of the total cosmetic procedures. The sweet spot is the 35- to 50-year-old demographic, which accounted for 46% of all cosmetic procedures (surgical and nonsurgical). Women accounted for 91% of the total.

NSF-Gadolinium Cases Centralized

Discovery for 66 suits alleging that gadolinium-based contrast led to nephrogenic systemic fibrosis (NSF) has been consolidated in a federal court in Ohio. The plaintiffs allege that the gadolinium-based contrast agent used during magnetic resonance imaging led to NSF. NSF has occurred only in patients with preexisting renal compromise. The Food and Drug Administration has issued several warnings about gadolinium and NSF; in May 2007, the agency requested new black box warnings about the risk of NSF for the five products on the market. The discovery process for the product liability suits is now consolidated as multidistrict litigation 1909 in the U.S. District Court, Northern District of Ohio.

QLT to Divest Aczone

Vancouver, B.C.-based QLT Inc. said in mid-March that it would divest its acne therapy Aczone. The company made the announcement in the wake of the Food and Drug Administration's decision to remove a requirement for glucose-6-phosphate dehydrogenase screening and blood monitoring for users. The FDA decision was based on results of a postmarketing study submitted by the manufacturer. Aczone (dapsone 5% aqueous gel) was approved in July 2005. QLT owns worldwide marketing rights, but says it will now divest the product, as planned. "Management believed in the product and took the necessary steps to address the FDA's needs, ultimately dramatically enhancing the value of Aczone," said QLT CEO Bob Butchofsky in a statement.

Judge Rules for Journals

A federal judge in Chicago last month ruled that JAMA and the Archives of Internal Medicine do not need to release documents related to the confidential peer review process for studies on cyclooxygenase-2 inhibitors. Attorneys for drugmaker Pfizer Inc. had issued subpoenas last year to obtain all documents relating to the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and their comments, and editors' comments regarding manuscripts, peer review, and publication decisions. But U.S. District Court Judge Arlander Keys of the Northern District of Illinois ruled that the journals can keep the documents confidential. "It is not unreasonable to believe that compelling production of peer review documents would compromise the process," Judge Keys wrote. Dr. Catherine DeAngelis, JAMA's editor-in-chief, and JAMA's editorial counsel, Joseph Thornton, wrote in an online editorial released March 24 that the ruling supports the confidential peer review process. "For months, JAMA and [Archives of Internal Medicine] consistently argued that the sanctity of the confidential peer review process should not be violated," they wrote. "JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment." A federal judge in Boston has not yet ruled on a similar request by Pfizer to force the release of documents from the New England Journal of Medicine.

Trouble Paying for Rx

Four in 10 Americans—and half those regularly taking at least one medication—reported that they have trouble paying for drugs, skip prescriptions, or cut pills because of the cost of their prescriptions, a poll jointly conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health showed. People were most likely to report one of those three issues if they lack drug coverage, if they have low incomes, or if they take four or more drugs regularly. The survey found that while the public values the products drug companies produce, they do not like what they charge and are suspicious of their motivation. Nearly 80% of Americans said that the cost of prescription drugs is unreasonable, and about 70% said pharmaceutical companies are too concerned about making profits and not concerned enough about helping people. But at the same time, the public overwhelmingly believes that recent advances in prescription drugs provide benefits, the survey found.

Market Swing to Noninjectables?

The number of botulinum toxin injections in 2007 far exceeded any other cosmetic procedure—surgical or nonsurgical—according to the American Society for Aesthetic Plastic Surgery's annual accounting of Americans' cosmetic predilections. However, the 2.7 million Botox injections were slightly down from 2006, when 3.1 million procedures were performed. The number of hyaluronic acid injections also dropped slightly to 1.4 million, as did injections of collagen and polyactate (Sculptra). Injections of calcium hydroxylapatite (Radiesse) increased by 55% to 119,000. And there was rapid uptake of noninjectables: Fraxel (167,000 procedures), IPL (647,000), and noninvasive tightening (258,000). Laser hair removal was still popular, at 1.4 million procedures, as was microdermabrasion (829,000 procedures). By comparison, the top surgical procedure—liposuction—was performed about 450,000 times. There's been a continued trend away from surgery. In 2007, nonsurgical procedures were 82% of the total cosmetic procedures. The sweet spot is the 35- to 50-year-old demographic, which accounted for 46% of all cosmetic procedures (surgical and nonsurgical). Women accounted for 91% of the total.

NSF-Gadolinium Cases Centralized

Discovery for 66 suits alleging that gadolinium-based contrast led to nephrogenic systemic fibrosis (NSF) has been consolidated in a federal court in Ohio. The plaintiffs allege that the gadolinium-based contrast agent used during magnetic resonance imaging led to NSF. NSF has occurred only in patients with preexisting renal compromise. The Food and Drug Administration has issued several warnings about gadolinium and NSF; in May 2007, the agency requested new black box warnings about the risk of NSF for the five products on the market. The discovery process for the product liability suits is now consolidated as multidistrict litigation 1909 in the U.S. District Court, Northern District of Ohio.

QLT to Divest Aczone

Vancouver, B.C.-based QLT Inc. said in mid-March that it would divest its acne therapy Aczone. The company made the announcement in the wake of the Food and Drug Administration's decision to remove a requirement for glucose-6-phosphate dehydrogenase screening and blood monitoring for users. The FDA decision was based on results of a postmarketing study submitted by the manufacturer. Aczone (dapsone 5% aqueous gel) was approved in July 2005. QLT owns worldwide marketing rights, but says it will now divest the product, as planned. "Management believed in the product and took the necessary steps to address the FDA's needs, ultimately dramatically enhancing the value of Aczone," said QLT CEO Bob Butchofsky in a statement.

Judge Rules for Journals

A federal judge in Chicago last month ruled that JAMA and the Archives of Internal Medicine do not need to release documents related to the confidential peer review process for studies on cyclooxygenase-2 inhibitors. Attorneys for drugmaker Pfizer Inc. had issued subpoenas last year to obtain all documents relating to the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and their comments, and editors' comments regarding manuscripts, peer review, and publication decisions. But U.S. District Court Judge Arlander Keys of the Northern District of Illinois ruled that the journals can keep the documents confidential. "It is not unreasonable to believe that compelling production of peer review documents would compromise the process," Judge Keys wrote. Dr. Catherine DeAngelis, JAMA's editor-in-chief, and JAMA's editorial counsel, Joseph Thornton, wrote in an online editorial released March 24 that the ruling supports the confidential peer review process. "For months, JAMA and [Archives of Internal Medicine] consistently argued that the sanctity of the confidential peer review process should not be violated," they wrote. "JAMA and our Archives journals have historically and deliberately kept unpublished manuscripts and peer review comments confidential. This promise to reviewers and authors allows the peer review process to work in an unrestrained environment." A federal judge in Boston has not yet ruled on a similar request by Pfizer to force the release of documents from the New England Journal of Medicine.

Trouble Paying for Rx

Four in 10 Americans—and half those regularly taking at least one medication—reported that they have trouble paying for drugs, skip prescriptions, or cut pills because of the cost of their prescriptions, a poll jointly conducted by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health showed. People were most likely to report one of those three issues if they lack drug coverage, if they have low incomes, or if they take four or more drugs regularly. The survey found that while the public values the products drug companies produce, they do not like what they charge and are suspicious of their motivation. Nearly 80% of Americans said that the cost of prescription drugs is unreasonable, and about 70% said pharmaceutical companies are too concerned about making profits and not concerned enough about helping people. But at the same time, the public overwhelmingly believes that recent advances in prescription drugs provide benefits, the survey found.

WASHINGTON — Several members of Congress who spoke at a medical specialty conference said they were hopeful that their colleagues would enact legislation quickly to increase physician fees for at least 18 months.

The current legislation, enacted at the end of last year, is due to expire in June. The 6-month fix was a slap in the face to physicians, said Rep. Mike Burgess (R-Tex.).

“What an insult,” said Rep. Burgess, who is an ob.gyn. He introduced a bill last month to reset the sustainable growth rate formula baseline to the year of 2007 and to eliminate it in 2010. The bill, H.R. 5545, would also improve incentives for e-prescribing and for participation in the Physicians Quality Reporting Initiative. At press time, the bill had no cosponsors. It had been referred to the House Ways and Means Committee and the House Energy and Commerce Committee.

Rep. Bart Gordon (R-Tenn.), a senior member of the Energy and Commerce Health Subcommittee, said he was hopeful that corrective legislation would be passed, including a fee increase through 2009. By then, there will be a new president and a new Congress, providing a fresh perspective on how to get away from the sustainable growth rate target that's been ruling Medicare physician pay, he said at the meeting sponsored by the American Academy of Otolaryngology-Head and Neck Surgery.

The Ways and Means Health Subcommittee chairman, Rep. Pete Stark (D-Calif.), seemed less sanguine about quick action this year. However, he pointed out that the Senate had promised to have a bill by April. The most likely scenario is a reimbursement fix that follows the Medicare Payment Advisory Commission's recommendation of a 1%–2% increase over the next few years, he said.

The next 4–6 years will be incredibly exciting for the health reform movement, Rep. Stark said.

Rep. Tom Price (R-Ga.), a physician and fellow of the American College of Surgeons, agreed with Rep. Stark that the next few years would be significant.

“The next few years will be pivotal to the future of American medicine,” Rep. Price told meeting attendees.

He introduced a bill in mid-February (H.R. 5445) to increase physician fees by 1% for the remainder of 2008, and 1.8% for 2009.

That bill was referred to the Ways and Means Committee and to the Energy and Commerce Committee. At press time, the bill had approximately two dozen cosponsors.

WASHINGTON — Several members of Congress who spoke at a medical specialty conference said they were hopeful that their colleagues would enact legislation quickly to increase physician fees for at least 18 months.

The current legislation, enacted at the end of last year, is due to expire in June. The 6-month fix was a slap in the face to physicians, said Rep. Mike Burgess (R-Tex.).

“What an insult,” said Rep. Burgess, who is an ob.gyn. He introduced a bill last month to reset the sustainable growth rate formula baseline to the year of 2007 and to eliminate it in 2010. The bill, H.R. 5545, would also improve incentives for e-prescribing and for participation in the Physicians Quality Reporting Initiative. At press time, the bill had no cosponsors. It had been referred to the House Ways and Means Committee and the House Energy and Commerce Committee.

Rep. Bart Gordon (R-Tenn.), a senior member of the Energy and Commerce Health Subcommittee, said he was hopeful that corrective legislation would be passed, including a fee increase through 2009. By then, there will be a new president and a new Congress, providing a fresh perspective on how to get away from the sustainable growth rate target that's been ruling Medicare physician pay, he said at the meeting sponsored by the American Academy of Otolaryngology-Head and Neck Surgery.

The Ways and Means Health Subcommittee chairman, Rep. Pete Stark (D-Calif.), seemed less sanguine about quick action this year. However, he pointed out that the Senate had promised to have a bill by April. The most likely scenario is a reimbursement fix that follows the Medicare Payment Advisory Commission's recommendation of a 1%–2% increase over the next few years, he said.

The next 4–6 years will be incredibly exciting for the health reform movement, Rep. Stark said.

Rep. Tom Price (R-Ga.), a physician and fellow of the American College of Surgeons, agreed with Rep. Stark that the next few years would be significant.

“The next few years will be pivotal to the future of American medicine,” Rep. Price told meeting attendees.

He introduced a bill in mid-February (H.R. 5445) to increase physician fees by 1% for the remainder of 2008, and 1.8% for 2009.

That bill was referred to the Ways and Means Committee and to the Energy and Commerce Committee. At press time, the bill had approximately two dozen cosponsors.

WASHINGTON — Several members of Congress who spoke at a medical specialty conference said they were hopeful that their colleagues would enact legislation quickly to increase physician fees for at least 18 months.

The current legislation, enacted at the end of last year, is due to expire in June. The 6-month fix was a slap in the face to physicians, said Rep. Mike Burgess (R-Tex.).

“What an insult,” said Rep. Burgess, who is an ob.gyn. He introduced a bill last month to reset the sustainable growth rate formula baseline to the year of 2007 and to eliminate it in 2010. The bill, H.R. 5545, would also improve incentives for e-prescribing and for participation in the Physicians Quality Reporting Initiative. At press time, the bill had no cosponsors. It had been referred to the House Ways and Means Committee and the House Energy and Commerce Committee.

Rep. Bart Gordon (R-Tenn.), a senior member of the Energy and Commerce Health Subcommittee, said he was hopeful that corrective legislation would be passed, including a fee increase through 2009. By then, there will be a new president and a new Congress, providing a fresh perspective on how to get away from the sustainable growth rate target that's been ruling Medicare physician pay, he said at the meeting sponsored by the American Academy of Otolaryngology-Head and Neck Surgery.

The Ways and Means Health Subcommittee chairman, Rep. Pete Stark (D-Calif.), seemed less sanguine about quick action this year. However, he pointed out that the Senate had promised to have a bill by April. The most likely scenario is a reimbursement fix that follows the Medicare Payment Advisory Commission's recommendation of a 1%–2% increase over the next few years, he said.

The next 4–6 years will be incredibly exciting for the health reform movement, Rep. Stark said.

Rep. Tom Price (R-Ga.), a physician and fellow of the American College of Surgeons, agreed with Rep. Stark that the next few years would be significant.

“The next few years will be pivotal to the future of American medicine,” Rep. Price told meeting attendees.

He introduced a bill in mid-February (H.R. 5445) to increase physician fees by 1% for the remainder of 2008, and 1.8% for 2009.

That bill was referred to the Ways and Means Committee and to the Energy and Commerce Committee. At press time, the bill had approximately two dozen cosponsors.