Alicia Ault

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, state Medicaid programs ranked near the bottom.

The performance rankings were compiled for the second year in a row by AthenaHealth, a Watertown, Mass.-based company that collects about $2 billion a year for medical providers.

AthenaHealth used claims data from 8,000 providers, representing 28 million "charge lines," or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines and regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and Champus/Tricare.

According to AthenaHealth, there were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients, according to AthenaHealth.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program.

The Medicaid programs were laggards on all performance measures.

The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim.

In Texas, physicians resubmitted denied claims at least twice 47% of the time, according to AthenaHealth.

"We are seeing disturbing administrative process breakdowns with some state Medicaid plans that are resulting in a growing number of physicians no longer accepting new Medicaid patients, said Jonathan Bush, chairman and CEO of AthenaHealth.

The rankings are posted at www.athenapayerview.com

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, state Medicaid programs ranked near the bottom.

The performance rankings were compiled for the second year in a row by AthenaHealth, a Watertown, Mass.-based company that collects about $2 billion a year for medical providers.

AthenaHealth used claims data from 8,000 providers, representing 28 million "charge lines," or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines and regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and Champus/Tricare.

According to AthenaHealth, there were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients, according to AthenaHealth.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program.

The Medicaid programs were laggards on all performance measures.

The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim.

In Texas, physicians resubmitted denied claims at least twice 47% of the time, according to AthenaHealth.

"We are seeing disturbing administrative process breakdowns with some state Medicaid plans that are resulting in a growing number of physicians no longer accepting new Medicaid patients, said Jonathan Bush, chairman and CEO of AthenaHealth.

The rankings are posted at www.athenapayerview.com

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, state Medicaid programs ranked near the bottom.

The performance rankings were compiled for the second year in a row by AthenaHealth, a Watertown, Mass.-based company that collects about $2 billion a year for medical providers.

AthenaHealth used claims data from 8,000 providers, representing 28 million "charge lines," or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines and regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and Champus/Tricare.

According to AthenaHealth, there were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients, according to AthenaHealth.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program.

The Medicaid programs were laggards on all performance measures.

The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim.

In Texas, physicians resubmitted denied claims at least twice 47% of the time, according to AthenaHealth.

"We are seeing disturbing administrative process breakdowns with some state Medicaid plans that are resulting in a growing number of physicians no longer accepting new Medicaid patients, said Jonathan Bush, chairman and CEO of AthenaHealth.

The rankings are posted at www.athenapayerview.com

Sunscreen Claim Crackdown Urged

The Food and Drug Administration needs to stop sunscreen manufacturers from making "false and misleading" claims about their products, according to a petition filed by the Connecticut Attorney General. "Products with false labels give consumers a false sense of security—screening out UVB rays that cause burning or reddening, but possibly not UVA rays that damage deeper layers of the skin, where they can lead to melanoma and other deadly cancers," said Attorney General Richard Blumenthal in a statement. Mr. Blumenthal said the FDA was supposed to implement rules in 1999 that would have prohibited sunscreen makers from claiming their products "block all harmful rays," or are "waterproof," or have SPF ratings above 30. Also, there is no rating system for UVA rays, but many sunscreen makers advertise UVA protection, Mr. Blumenthal pointed out. While an FDA spokeswoman said the agency cannot comment on the petition, she did say a sunscreen regulation addressing UVA testing and labeling as well as other issues is in final clearance at the agency.

D.C. Tops in Sun Savvy

The nation's capital has been ranked No. 1 in terms of its population's knowledge of sun safety, according to a survey from the American Academy of Dermatology. Nearly half of Washington residents said that people do not look healthier with a tan, 66% knew that a base tan is not a healthy way to protect skin from sun damage, and 68% knew that it is not smarter to tan indoors using a tanning bed. Residents of New York City were the second-most knowledgeable, followed by Miami, Tampa, Los Angeles, Dallas, Salt Lake City, San Francisco, and a three-way tie among Idaho, Atlanta, and Philadelphia. Despite its sunny, warm climate year-round, Miami managed to come in third because 45% of residents there did not get a tan last year, according to the AAD. Attitudes and behaviors varied widely. Overall, a majority of Americans (73%) agreed that people looked more attractive with a tan, 42% said they had sunbathed in the last year, and 65% got a tan last year. But 65% knew that sun exposure during childhood is related to skin cancer in adulthood, and 58% knew that indoor tanning is not smarter. The results were based on an online survey of 3,342 randomly selected men and women in 32 U.S. metropolitan areas and states that was conducted in February.

Ranbaxy Buys BMS Derm Brands

Ranbaxy Laboratories Inc. has purchased 13 dermatology products from Bristol-Myers Squibb: Balnetar, Desquam-E, Desquam-X, Eurax, Exelderm, Halog, Kenalog Spray, Lac-Hydrin, Lowila, Pernox, Sebulex, Ultravate, and Westcort. The products are used for acne, dermatitis, psoriasis, fungal infections, and scabies. Ranbaxy, a subsidiary of the India-based Ranbaxy Laboratories Ltd., has what it calls the largest-selling isotretinoin formulation, Sotret. In a statement, Venkat Krishnan, Ranbaxy's regional director for North America said that the acquisition would help the company build its dermatology franchise, and, "it enables Ranbaxy to establish an immediate presence in the high-value segments of dermatitis, psoriasis, antifungals, and scabies," he said. Ranbaxy will start promoting the products immediately, according to a company spokeswoman.

New FDA Risk Panel

Following an Institute of Medicine recommendation, the Food and Drug Administration has created a new advisory committee that will be charged with helping the agency better communicate the risks and benefits of pharmaceuticals and other products it regulates. In 2006, the IOM's report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, urged Congress to establish a new advisory panel that would weigh in on FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, which were adopted in 2005 to address "many of the concerns publicly expressed about DTC advertising." The four volunteer panelists—a pharmacist, a nurse, and two family physicians—also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

Sunscreen Claim Crackdown Urged

The Food and Drug Administration needs to stop sunscreen manufacturers from making "false and misleading" claims about their products, according to a petition filed by the Connecticut Attorney General. "Products with false labels give consumers a false sense of security—screening out UVB rays that cause burning or reddening, but possibly not UVA rays that damage deeper layers of the skin, where they can lead to melanoma and other deadly cancers," said Attorney General Richard Blumenthal in a statement. Mr. Blumenthal said the FDA was supposed to implement rules in 1999 that would have prohibited sunscreen makers from claiming their products "block all harmful rays," or are "waterproof," or have SPF ratings above 30. Also, there is no rating system for UVA rays, but many sunscreen makers advertise UVA protection, Mr. Blumenthal pointed out. While an FDA spokeswoman said the agency cannot comment on the petition, she did say a sunscreen regulation addressing UVA testing and labeling as well as other issues is in final clearance at the agency.

D.C. Tops in Sun Savvy

The nation's capital has been ranked No. 1 in terms of its population's knowledge of sun safety, according to a survey from the American Academy of Dermatology. Nearly half of Washington residents said that people do not look healthier with a tan, 66% knew that a base tan is not a healthy way to protect skin from sun damage, and 68% knew that it is not smarter to tan indoors using a tanning bed. Residents of New York City were the second-most knowledgeable, followed by Miami, Tampa, Los Angeles, Dallas, Salt Lake City, San Francisco, and a three-way tie among Idaho, Atlanta, and Philadelphia. Despite its sunny, warm climate year-round, Miami managed to come in third because 45% of residents there did not get a tan last year, according to the AAD. Attitudes and behaviors varied widely. Overall, a majority of Americans (73%) agreed that people looked more attractive with a tan, 42% said they had sunbathed in the last year, and 65% got a tan last year. But 65% knew that sun exposure during childhood is related to skin cancer in adulthood, and 58% knew that indoor tanning is not smarter. The results were based on an online survey of 3,342 randomly selected men and women in 32 U.S. metropolitan areas and states that was conducted in February.

Ranbaxy Buys BMS Derm Brands

Ranbaxy Laboratories Inc. has purchased 13 dermatology products from Bristol-Myers Squibb: Balnetar, Desquam-E, Desquam-X, Eurax, Exelderm, Halog, Kenalog Spray, Lac-Hydrin, Lowila, Pernox, Sebulex, Ultravate, and Westcort. The products are used for acne, dermatitis, psoriasis, fungal infections, and scabies. Ranbaxy, a subsidiary of the India-based Ranbaxy Laboratories Ltd., has what it calls the largest-selling isotretinoin formulation, Sotret. In a statement, Venkat Krishnan, Ranbaxy's regional director for North America said that the acquisition would help the company build its dermatology franchise, and, "it enables Ranbaxy to establish an immediate presence in the high-value segments of dermatitis, psoriasis, antifungals, and scabies," he said. Ranbaxy will start promoting the products immediately, according to a company spokeswoman.

New FDA Risk Panel

Following an Institute of Medicine recommendation, the Food and Drug Administration has created a new advisory committee that will be charged with helping the agency better communicate the risks and benefits of pharmaceuticals and other products it regulates. In 2006, the IOM's report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, urged Congress to establish a new advisory panel that would weigh in on FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, which were adopted in 2005 to address "many of the concerns publicly expressed about DTC advertising." The four volunteer panelists—a pharmacist, a nurse, and two family physicians—also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

Sunscreen Claim Crackdown Urged

The Food and Drug Administration needs to stop sunscreen manufacturers from making "false and misleading" claims about their products, according to a petition filed by the Connecticut Attorney General. "Products with false labels give consumers a false sense of security—screening out UVB rays that cause burning or reddening, but possibly not UVA rays that damage deeper layers of the skin, where they can lead to melanoma and other deadly cancers," said Attorney General Richard Blumenthal in a statement. Mr. Blumenthal said the FDA was supposed to implement rules in 1999 that would have prohibited sunscreen makers from claiming their products "block all harmful rays," or are "waterproof," or have SPF ratings above 30. Also, there is no rating system for UVA rays, but many sunscreen makers advertise UVA protection, Mr. Blumenthal pointed out. While an FDA spokeswoman said the agency cannot comment on the petition, she did say a sunscreen regulation addressing UVA testing and labeling as well as other issues is in final clearance at the agency.

D.C. Tops in Sun Savvy

The nation's capital has been ranked No. 1 in terms of its population's knowledge of sun safety, according to a survey from the American Academy of Dermatology. Nearly half of Washington residents said that people do not look healthier with a tan, 66% knew that a base tan is not a healthy way to protect skin from sun damage, and 68% knew that it is not smarter to tan indoors using a tanning bed. Residents of New York City were the second-most knowledgeable, followed by Miami, Tampa, Los Angeles, Dallas, Salt Lake City, San Francisco, and a three-way tie among Idaho, Atlanta, and Philadelphia. Despite its sunny, warm climate year-round, Miami managed to come in third because 45% of residents there did not get a tan last year, according to the AAD. Attitudes and behaviors varied widely. Overall, a majority of Americans (73%) agreed that people looked more attractive with a tan, 42% said they had sunbathed in the last year, and 65% got a tan last year. But 65% knew that sun exposure during childhood is related to skin cancer in adulthood, and 58% knew that indoor tanning is not smarter. The results were based on an online survey of 3,342 randomly selected men and women in 32 U.S. metropolitan areas and states that was conducted in February.

Ranbaxy Buys BMS Derm Brands

Ranbaxy Laboratories Inc. has purchased 13 dermatology products from Bristol-Myers Squibb: Balnetar, Desquam-E, Desquam-X, Eurax, Exelderm, Halog, Kenalog Spray, Lac-Hydrin, Lowila, Pernox, Sebulex, Ultravate, and Westcort. The products are used for acne, dermatitis, psoriasis, fungal infections, and scabies. Ranbaxy, a subsidiary of the India-based Ranbaxy Laboratories Ltd., has what it calls the largest-selling isotretinoin formulation, Sotret. In a statement, Venkat Krishnan, Ranbaxy's regional director for North America said that the acquisition would help the company build its dermatology franchise, and, "it enables Ranbaxy to establish an immediate presence in the high-value segments of dermatitis, psoriasis, antifungals, and scabies," he said. Ranbaxy will start promoting the products immediately, according to a company spokeswoman.

New FDA Risk Panel

Following an Institute of Medicine recommendation, the Food and Drug Administration has created a new advisory committee that will be charged with helping the agency better communicate the risks and benefits of pharmaceuticals and other products it regulates. In 2006, the IOM's report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, urged Congress to establish a new advisory panel that would weigh in on FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, which were adopted in 2005 to address "many of the concerns publicly expressed about DTC advertising." The four volunteer panelists—a pharmacist, a nurse, and two family physicians—also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, state Medicaid programs ranked near the bottom.

The performance rankings were compiled for the second year in a row by AthenaHealth, a Watertown, Mass.-based company that collects about $2 billion a year for medical providers. It used claims data from 8,000 providers, representing 28 million “charge lines,” or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines and regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and Champus/Tricare.

There were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program. Medicaid programs were laggards on all performance measures. The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim. In Texas, physicians resubmitted denied claims at least twice 47% of the time.

“We are seeing disturbing administrative process breakdowns with some state Medicaid plans, resulting in a growing number of physicians no longer accepting new Medicaid patients,” said Jonathan Bush, Athena- Health chairman and CEO. The rankings are at www.athenapayerview.com

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, state Medicaid programs ranked near the bottom.

The performance rankings were compiled for the second year in a row by AthenaHealth, a Watertown, Mass.-based company that collects about $2 billion a year for medical providers. It used claims data from 8,000 providers, representing 28 million “charge lines,” or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines and regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and Champus/Tricare.

There were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program. Medicaid programs were laggards on all performance measures. The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim. In Texas, physicians resubmitted denied claims at least twice 47% of the time.

“We are seeing disturbing administrative process breakdowns with some state Medicaid plans, resulting in a growing number of physicians no longer accepting new Medicaid patients,” said Jonathan Bush, Athena- Health chairman and CEO. The rankings are at www.athenapayerview.com

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, state Medicaid programs ranked near the bottom.

The performance rankings were compiled for the second year in a row by AthenaHealth, a Watertown, Mass.-based company that collects about $2 billion a year for medical providers. It used claims data from 8,000 providers, representing 28 million “charge lines,” or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines and regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and Champus/Tricare.

There were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program. Medicaid programs were laggards on all performance measures. The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim. In Texas, physicians resubmitted denied claims at least twice 47% of the time.

“We are seeing disturbing administrative process breakdowns with some state Medicaid plans, resulting in a growing number of physicians no longer accepting new Medicaid patients,” said Jonathan Bush, Athena- Health chairman and CEO. The rankings are at www.athenapayerview.com

WASHINGTON — Proton pump inhibitors do not improve most symptoms of supraesophageal reflux, according to a community-based study presented at the annual Digestive Disease Week meeting.

The study's aim was to determine which symptoms resolve completely with PPI therapy, and thus may be reflective of supraesophageal reflux, said Dr. Laura M. Iuga, an otolaryngologist at Mayo Clinic in Rochester, Minn., who presented the study on behalf of her colleagues.

She and her colleagues recruited study subjects from southern Minnesota through radio and print advertising, and also from Mayo's outpatient primary care and otolaryngology clinics. To be eligible, patients had to have at least one of the six chronic symptoms—chronic dry hacking cough, globus sensations, hoarseness, nocturnal cough, sore throat, and throat clearing. Patients were asked to complete the Supraesophageal Reflux Questionnaire and the Reflux Symptom Index.

After randomization, 302 patients received esomeprazole (Nexium) 40 mg twice daily, and 127 received a placebo for 6 months. The study ran from March 2005 until August 2006.

In the intent-to-treat analysis, the 112 patients who withdrew or stopped early (25% of those in each arm) were labeled as incomplete responders. A complete response was lack of symptoms at 3, 4, 5, and 6 months.

As expected, many subjects had complete resolution of their heartburn with PPI therapy, Dr. Iuga noted. About half those taking esomeprazole responded. Overall, patients with heartburn at baseline were 15 times more likely to achieve complete symptom response with esomeprazole than with placebo. “This symptom served as a positive control in the study, indicating enough power to detect a treatment effect,” she said.

There was also a statistically significant difference in throat clearing among patients with that symptom, but only 7% of those in the esomeprazole arm and 1% in the placebo group had improvement, “indicating that the majority of people with throat clearing did not achieve a response,” she said.

The study was supported by a grant from AstraZeneca's Investigator-Sponsored Study Program.

WASHINGTON — Proton pump inhibitors do not improve most symptoms of supraesophageal reflux, according to a community-based study presented at the annual Digestive Disease Week meeting.

The study's aim was to determine which symptoms resolve completely with PPI therapy, and thus may be reflective of supraesophageal reflux, said Dr. Laura M. Iuga, an otolaryngologist at Mayo Clinic in Rochester, Minn., who presented the study on behalf of her colleagues.

She and her colleagues recruited study subjects from southern Minnesota through radio and print advertising, and also from Mayo's outpatient primary care and otolaryngology clinics. To be eligible, patients had to have at least one of the six chronic symptoms—chronic dry hacking cough, globus sensations, hoarseness, nocturnal cough, sore throat, and throat clearing. Patients were asked to complete the Supraesophageal Reflux Questionnaire and the Reflux Symptom Index.

After randomization, 302 patients received esomeprazole (Nexium) 40 mg twice daily, and 127 received a placebo for 6 months. The study ran from March 2005 until August 2006.

In the intent-to-treat analysis, the 112 patients who withdrew or stopped early (25% of those in each arm) were labeled as incomplete responders. A complete response was lack of symptoms at 3, 4, 5, and 6 months.

As expected, many subjects had complete resolution of their heartburn with PPI therapy, Dr. Iuga noted. About half those taking esomeprazole responded. Overall, patients with heartburn at baseline were 15 times more likely to achieve complete symptom response with esomeprazole than with placebo. “This symptom served as a positive control in the study, indicating enough power to detect a treatment effect,” she said.

There was also a statistically significant difference in throat clearing among patients with that symptom, but only 7% of those in the esomeprazole arm and 1% in the placebo group had improvement, “indicating that the majority of people with throat clearing did not achieve a response,” she said.

The study was supported by a grant from AstraZeneca's Investigator-Sponsored Study Program.

WASHINGTON — Proton pump inhibitors do not improve most symptoms of supraesophageal reflux, according to a community-based study presented at the annual Digestive Disease Week meeting.

The study's aim was to determine which symptoms resolve completely with PPI therapy, and thus may be reflective of supraesophageal reflux, said Dr. Laura M. Iuga, an otolaryngologist at Mayo Clinic in Rochester, Minn., who presented the study on behalf of her colleagues.

She and her colleagues recruited study subjects from southern Minnesota through radio and print advertising, and also from Mayo's outpatient primary care and otolaryngology clinics. To be eligible, patients had to have at least one of the six chronic symptoms—chronic dry hacking cough, globus sensations, hoarseness, nocturnal cough, sore throat, and throat clearing. Patients were asked to complete the Supraesophageal Reflux Questionnaire and the Reflux Symptom Index.

After randomization, 302 patients received esomeprazole (Nexium) 40 mg twice daily, and 127 received a placebo for 6 months. The study ran from March 2005 until August 2006.

In the intent-to-treat analysis, the 112 patients who withdrew or stopped early (25% of those in each arm) were labeled as incomplete responders. A complete response was lack of symptoms at 3, 4, 5, and 6 months.

As expected, many subjects had complete resolution of their heartburn with PPI therapy, Dr. Iuga noted. About half those taking esomeprazole responded. Overall, patients with heartburn at baseline were 15 times more likely to achieve complete symptom response with esomeprazole than with placebo. “This symptom served as a positive control in the study, indicating enough power to detect a treatment effect,” she said.

There was also a statistically significant difference in throat clearing among patients with that symptom, but only 7% of those in the esomeprazole arm and 1% in the placebo group had improvement, “indicating that the majority of people with throat clearing did not achieve a response,” she said.

The study was supported by a grant from AstraZeneca's Investigator-Sponsored Study Program.

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBAs) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest Metropolitan Statistical Areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest Metropolitan Statistical Areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located.

Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

For a list of accrediting bodies, bidding criteria, and other details, see www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Wheelchairs are among the DME items that will be subject to a new competitive bidding process being phased in by Medicare. ©Digital Stock 1996

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBAs) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest Metropolitan Statistical Areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest Metropolitan Statistical Areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located.

Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

For a list of accrediting bodies, bidding criteria, and other details, see www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Wheelchairs are among the DME items that will be subject to a new competitive bidding process being phased in by Medicare. ©Digital Stock 1996

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBAs) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest Metropolitan Statistical Areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest Metropolitan Statistical Areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located.

Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

For a list of accrediting bodies, bidding criteria, and other details, see www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Wheelchairs are among the DME items that will be subject to a new competitive bidding process being phased in by Medicare. ©Digital Stock 1996

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

The bidding opened in May and will continue until July 13. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

A list of the accrediting bodies, bidding criteria, and other details can be found at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

The bidding opened in May and will continue until July 13. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

A list of the accrediting bodies, bidding criteria, and other details can be found at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

The bidding opened in May and will continue until July 13. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

A list of the accrediting bodies, bidding criteria, and other details can be found at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment (S. 1082) that was successfully attached to the original legislation would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30-million increase for postapproval drug safety programs.

The bill would also require drug makers to publish a registry of all late-phase II and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would fund another 5 years of the Best Pharmaceuticals for Children Act. Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1. The new 5-year program will extend a drug's patent life by 3 months (instead of 6 offered under the previous law) if sales of the product are more than $1 billion, and by 6 months if sales are less than $1 billion.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the FDA has requested studies. About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing, overdosing, or previously unknown side effects.

The federal government can order manufacturers to conduct pediatric studies, but that almost never happens because the bureaucratic hurdles for making such a request are so high. The PDUFA reauthorization aims to streamline the process.

The Senate vote was hailed by the brand-name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy because it secured a promise from a group of senators to mark up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment (S. 1082) that was successfully attached to the original legislation would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30-million increase for postapproval drug safety programs.

The bill would also require drug makers to publish a registry of all late-phase II and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would fund another 5 years of the Best Pharmaceuticals for Children Act. Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1. The new 5-year program will extend a drug's patent life by 3 months (instead of 6 offered under the previous law) if sales of the product are more than $1 billion, and by 6 months if sales are less than $1 billion.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the FDA has requested studies. About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing, overdosing, or previously unknown side effects.

The federal government can order manufacturers to conduct pediatric studies, but that almost never happens because the bureaucratic hurdles for making such a request are so high. The PDUFA reauthorization aims to streamline the process.

The Senate vote was hailed by the brand-name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy because it secured a promise from a group of senators to mark up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.

The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment (S. 1082) that was successfully attached to the original legislation would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30-million increase for postapproval drug safety programs.

The bill would also require drug makers to publish a registry of all late-phase II and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would fund another 5 years of the Best Pharmaceuticals for Children Act. Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1. The new 5-year program will extend a drug's patent life by 3 months (instead of 6 offered under the previous law) if sales of the product are more than $1 billion, and by 6 months if sales are less than $1 billion.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the FDA has requested studies. About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing, overdosing, or previously unknown side effects.

The federal government can order manufacturers to conduct pediatric studies, but that almost never happens because the bureaucratic hurdles for making such a request are so high. The PDUFA reauthorization aims to streamline the process.

The Senate vote was hailed by the brand-name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy because it secured a promise from a group of senators to mark up legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing. Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to coverage for more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest metropolitan statistical areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest metropolitan statistical areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices, supplies, and accessories; hospital beds and accessories; negative pressure wound therapy pumps, supplies, and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located. Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of all of the accrediting bodies, the bidding criteria, and other key details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing. Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to coverage for more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest metropolitan statistical areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest metropolitan statistical areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices, supplies, and accessories; hospital beds and accessories; negative pressure wound therapy pumps, supplies, and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located. Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of all of the accrediting bodies, the bidding criteria, and other key details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas who sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

“The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers,” Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open from late April until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing. Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to coverage for more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest metropolitan statistical areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest metropolitan statistical areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices, supplies, and accessories; hospital beds and accessories; negative pressure wound therapy pumps, supplies, and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays). In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located. Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of all of the accrediting bodies, the bidding criteria, and other key details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Imaging Prior Notification Required

UnitedHealthcare has begun a program to require prior notification for imaging procedures. When the insurer, which covers 70 million people, announced a similar program last fall, it was derailed by a protest from the American College of Cardiology and other groups. United relaunched the program in March, announcing it via letters to providers. According to United, it is only a prior notification requirement, “not a precertification, preauthorization, or medical necessity determination,” and will be required only for outpatient advanced diagnostic imaging services. If a provider fails to get a notification number, United will deny the claim, although a number does not guarantee payment. Physicians who have United's premium quality and efficiency of care designation are exempt. United rolled out the program last month in 15 states; it goes national next month.

ACC Sanctions Leon

The American College of Cardiology has sanctioned Dr. Martin B. Leon for making “statements that resulted in the breach and consequent premature lifting of the embargo on the COURAGE trial data presented at ACC's 56th annual scientific session in March,” according to a statement issued May 22. Dr. Leon, chairman of the Cardiovascular Research Foundation and a leading drug-eluting stent investigator, allegedly said that COURAGE had been “rigged to fail, and it did” at an industry-sponsored symposium before the ACC meeting. He was quoted in the Wall Street Journal, leading the ACC and the New England Journal of Medicine to lift the embargo on the study early. The ACC has said it will bar Dr. Leon's participation as a presenter, reviewer, or panelist at its March 2008 scientific meeting. In a statement, Dr. Leon said, “I still believe that my informal remarks were exaggerated, and I regret that they were interpreted as a breach of the embargo.” He said he presented evidence to the ACC supporting his beliefs, but that, “I have great respect for the professionalism and sensitivity of the current ACC leadership. I accept their decisions and look forward to a well deserved and long awaited vacation during ACC 2008.”

ACC on Imaging Accreditation

The ACC has formulated an official response to an imaging accreditation program announced earlier this year by UnitedHealthcare. Starting in March 2008, United providers of CT, angiography, MRI, MR angiography, nuclear medicine/cardiology, positron emission tomography, and echocardiography must become accredited by the Intersocietal Accreditation Commission or the American College of Radiology. In its position statement, the ACC said that it believes that accreditation programs developed by physicians are important quality improvement tools, but that it does not support certification and accreditation programs “strictly as cost containment mechanisms.” The ACC noted that it's important that United will rely on IAC and the ACR; the College is an IAC cofounder. Even so, exceptions to United's timetable may be needed “to ensure that patients have access to care in underserved areas,” said the ACC.

Imaging Access Bills Reintroduced

Bills seeking to institute a 2-year moratorium on reductions in imaging payments that went into effect this year have been reintroduced in the House and Senate. The cuts in payments under the Medicare program are mandated under the Deficit Reduction Act of 2005. Attempts over the last 2 years to repeal or delay the cuts have not succeeded. In March, Rep. Carolyn McCarthy (D-N.Y.), Rep. Gene Green (D-Tex.), and Rep. Joseph Pitts (R-Penn.) introduced their bill, the Access to Medicare Imaging Act (H.R. 1293). In May, a companion bill was introduced in the Senate by Sen. Jay Rockefeller (D-W.Va.) and Sen. Gordon Smith (R-Ore.).

BMS Pleads Guilty on Plavix

Bristol-Myers Squibb has agreed to pay $1 million and to plead guilty to charges that it colluded with Canadian drug maker Apotex to delay introduction of Apotex's generic clopidogrel. Under the agreement, BMS has admitted that one of its executives, senior vice president for strategy Andrew Bodnar, negotiated with Apotex to delay marketing of its generic clopidogrel. However, in a statement, BMS said that there is no guarantee that the court will accept its plea deal.

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan who resigned from the CMS last year.

Imaging Prior Notification Required

UnitedHealthcare has begun a program to require prior notification for imaging procedures. When the insurer, which covers 70 million people, announced a similar program last fall, it was derailed by a protest from the American College of Cardiology and other groups. United relaunched the program in March, announcing it via letters to providers. According to United, it is only a prior notification requirement, “not a precertification, preauthorization, or medical necessity determination,” and will be required only for outpatient advanced diagnostic imaging services. If a provider fails to get a notification number, United will deny the claim, although a number does not guarantee payment. Physicians who have United's premium quality and efficiency of care designation are exempt. United rolled out the program last month in 15 states; it goes national next month.

ACC Sanctions Leon

The American College of Cardiology has sanctioned Dr. Martin B. Leon for making “statements that resulted in the breach and consequent premature lifting of the embargo on the COURAGE trial data presented at ACC's 56th annual scientific session in March,” according to a statement issued May 22. Dr. Leon, chairman of the Cardiovascular Research Foundation and a leading drug-eluting stent investigator, allegedly said that COURAGE had been “rigged to fail, and it did” at an industry-sponsored symposium before the ACC meeting. He was quoted in the Wall Street Journal, leading the ACC and the New England Journal of Medicine to lift the embargo on the study early. The ACC has said it will bar Dr. Leon's participation as a presenter, reviewer, or panelist at its March 2008 scientific meeting. In a statement, Dr. Leon said, “I still believe that my informal remarks were exaggerated, and I regret that they were interpreted as a breach of the embargo.” He said he presented evidence to the ACC supporting his beliefs, but that, “I have great respect for the professionalism and sensitivity of the current ACC leadership. I accept their decisions and look forward to a well deserved and long awaited vacation during ACC 2008.”

ACC on Imaging Accreditation

The ACC has formulated an official response to an imaging accreditation program announced earlier this year by UnitedHealthcare. Starting in March 2008, United providers of CT, angiography, MRI, MR angiography, nuclear medicine/cardiology, positron emission tomography, and echocardiography must become accredited by the Intersocietal Accreditation Commission or the American College of Radiology. In its position statement, the ACC said that it believes that accreditation programs developed by physicians are important quality improvement tools, but that it does not support certification and accreditation programs “strictly as cost containment mechanisms.” The ACC noted that it's important that United will rely on IAC and the ACR; the College is an IAC cofounder. Even so, exceptions to United's timetable may be needed “to ensure that patients have access to care in underserved areas,” said the ACC.

Imaging Access Bills Reintroduced

Bills seeking to institute a 2-year moratorium on reductions in imaging payments that went into effect this year have been reintroduced in the House and Senate. The cuts in payments under the Medicare program are mandated under the Deficit Reduction Act of 2005. Attempts over the last 2 years to repeal or delay the cuts have not succeeded. In March, Rep. Carolyn McCarthy (D-N.Y.), Rep. Gene Green (D-Tex.), and Rep. Joseph Pitts (R-Penn.) introduced their bill, the Access to Medicare Imaging Act (H.R. 1293). In May, a companion bill was introduced in the Senate by Sen. Jay Rockefeller (D-W.Va.) and Sen. Gordon Smith (R-Ore.).

BMS Pleads Guilty on Plavix

Bristol-Myers Squibb has agreed to pay $1 million and to plead guilty to charges that it colluded with Canadian drug maker Apotex to delay introduction of Apotex's generic clopidogrel. Under the agreement, BMS has admitted that one of its executives, senior vice president for strategy Andrew Bodnar, negotiated with Apotex to delay marketing of its generic clopidogrel. However, in a statement, BMS said that there is no guarantee that the court will accept its plea deal.

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan who resigned from the CMS last year.

Imaging Prior Notification Required

UnitedHealthcare has begun a program to require prior notification for imaging procedures. When the insurer, which covers 70 million people, announced a similar program last fall, it was derailed by a protest from the American College of Cardiology and other groups. United relaunched the program in March, announcing it via letters to providers. According to United, it is only a prior notification requirement, “not a precertification, preauthorization, or medical necessity determination,” and will be required only for outpatient advanced diagnostic imaging services. If a provider fails to get a notification number, United will deny the claim, although a number does not guarantee payment. Physicians who have United's premium quality and efficiency of care designation are exempt. United rolled out the program last month in 15 states; it goes national next month.

ACC Sanctions Leon

The American College of Cardiology has sanctioned Dr. Martin B. Leon for making “statements that resulted in the breach and consequent premature lifting of the embargo on the COURAGE trial data presented at ACC's 56th annual scientific session in March,” according to a statement issued May 22. Dr. Leon, chairman of the Cardiovascular Research Foundation and a leading drug-eluting stent investigator, allegedly said that COURAGE had been “rigged to fail, and it did” at an industry-sponsored symposium before the ACC meeting. He was quoted in the Wall Street Journal, leading the ACC and the New England Journal of Medicine to lift the embargo on the study early. The ACC has said it will bar Dr. Leon's participation as a presenter, reviewer, or panelist at its March 2008 scientific meeting. In a statement, Dr. Leon said, “I still believe that my informal remarks were exaggerated, and I regret that they were interpreted as a breach of the embargo.” He said he presented evidence to the ACC supporting his beliefs, but that, “I have great respect for the professionalism and sensitivity of the current ACC leadership. I accept their decisions and look forward to a well deserved and long awaited vacation during ACC 2008.”

ACC on Imaging Accreditation

The ACC has formulated an official response to an imaging accreditation program announced earlier this year by UnitedHealthcare. Starting in March 2008, United providers of CT, angiography, MRI, MR angiography, nuclear medicine/cardiology, positron emission tomography, and echocardiography must become accredited by the Intersocietal Accreditation Commission or the American College of Radiology. In its position statement, the ACC said that it believes that accreditation programs developed by physicians are important quality improvement tools, but that it does not support certification and accreditation programs “strictly as cost containment mechanisms.” The ACC noted that it's important that United will rely on IAC and the ACR; the College is an IAC cofounder. Even so, exceptions to United's timetable may be needed “to ensure that patients have access to care in underserved areas,” said the ACC.

Imaging Access Bills Reintroduced

Bills seeking to institute a 2-year moratorium on reductions in imaging payments that went into effect this year have been reintroduced in the House and Senate. The cuts in payments under the Medicare program are mandated under the Deficit Reduction Act of 2005. Attempts over the last 2 years to repeal or delay the cuts have not succeeded. In March, Rep. Carolyn McCarthy (D-N.Y.), Rep. Gene Green (D-Tex.), and Rep. Joseph Pitts (R-Penn.) introduced their bill, the Access to Medicare Imaging Act (H.R. 1293). In May, a companion bill was introduced in the Senate by Sen. Jay Rockefeller (D-W.Va.) and Sen. Gordon Smith (R-Ore.).

BMS Pleads Guilty on Plavix

Bristol-Myers Squibb has agreed to pay $1 million and to plead guilty to charges that it colluded with Canadian drug maker Apotex to delay introduction of Apotex's generic clopidogrel. Under the agreement, BMS has admitted that one of its executives, senior vice president for strategy Andrew Bodnar, negotiated with Apotex to delay marketing of its generic clopidogrel. However, in a statement, BMS said that there is no guarantee that the court will accept its plea deal.

New Medicare Leadership

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan who resigned from the CMS last year.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI yet.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI yet.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recomendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

CMS officials also heard about registries developed by the American Osteopathic Association, the Wisconsin Collaborative for Healthcare Quality, users of GE Healthcare's electronic medical records, the American Medical Group Management Association, and the American Society of Plastic Surgeons.

The ASPS launched its Tracking Operations and Outcomes in Plastic Surgery (TOPS) registry in 2002. TOPS collects data from all surgical settings, including office-based procedures. About 10% of the organization's 6,000 members use TOPS now, said an ASPS representative at the forum. The ASPS is currently redesigning the registry in the hopes that it will integrate more smoothly with PQRI, she said.

Jean Harris of the American College of Surgeons said that organization is exploring registry development through the Surgical Quality Alliance.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the group decided it was not ready to share its thoughts on registries and PQRI yet.