Alicia Ault

Computed tomographic colonography could get a boost, thanks to the Centers for Medicare and Medicaid Services' proposal to pay for the nascent colorectal cancer screening technology.

Colonoscopy is one of the most commonly performed medical procedures in the United States, with estimates of up to 14 million procedures performed in 2003, according to the American Cancer Society.

Computed tomographic colonography (CTC) is relatively new, but it was identified as a viable alternative to colonoscopy and other colorectal cancer screening methods in guidelines compiled by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology (http://caonline.amcancersoc.org/cgi/content/full/CA.2007.0018v1

Medicare currently covers colorectal screening for average-risk individuals aged 50 years and older through colonoscopy, fecal occult blood testing, sigmoidoscopy, and barium enema. The new screening guidelines prompted the CMS proposal.

The guidelines state that CTC screening of average-risk adults should start after age 50, but noted that the interval for repeat exams was uncertain. The guidelines urged a colonoscopy exam when polyps of 6 mm or greater were discovered with CTC.

The CMS will make a decision by Nov. 19, according to the agency.

Private insurers generally follow Medicare payment policy, said Dr. Joel V. Brill, a fellow of the American Gastroenterological Association and chair of the AGA Institute practice management and economics committee. “Commercial insurers are also poised to begin coverage of screening CTC this year,” he said, speaking at Digestive Disease Week in San Diego.

CTC has not been assigned a current procedural terminology code; that is not likely to happen until 2010, said Dr. Brill, who is also chief medical officer of Predictive Health LLC, a medical management company in Phoenix.

Computed tomographic colonography could get a boost, thanks to the Centers for Medicare and Medicaid Services' proposal to pay for the nascent colorectal cancer screening technology.

Colonoscopy is one of the most commonly performed medical procedures in the United States, with estimates of up to 14 million procedures performed in 2003, according to the American Cancer Society.

Computed tomographic colonography (CTC) is relatively new, but it was identified as a viable alternative to colonoscopy and other colorectal cancer screening methods in guidelines compiled by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology (http://caonline.amcancersoc.org/cgi/content/full/CA.2007.0018v1

Medicare currently covers colorectal screening for average-risk individuals aged 50 years and older through colonoscopy, fecal occult blood testing, sigmoidoscopy, and barium enema. The new screening guidelines prompted the CMS proposal.

The guidelines state that CTC screening of average-risk adults should start after age 50, but noted that the interval for repeat exams was uncertain. The guidelines urged a colonoscopy exam when polyps of 6 mm or greater were discovered with CTC.

The CMS will make a decision by Nov. 19, according to the agency.

Private insurers generally follow Medicare payment policy, said Dr. Joel V. Brill, a fellow of the American Gastroenterological Association and chair of the AGA Institute practice management and economics committee. “Commercial insurers are also poised to begin coverage of screening CTC this year,” he said, speaking at Digestive Disease Week in San Diego.

CTC has not been assigned a current procedural terminology code; that is not likely to happen until 2010, said Dr. Brill, who is also chief medical officer of Predictive Health LLC, a medical management company in Phoenix.

Computed tomographic colonography could get a boost, thanks to the Centers for Medicare and Medicaid Services' proposal to pay for the nascent colorectal cancer screening technology.

Colonoscopy is one of the most commonly performed medical procedures in the United States, with estimates of up to 14 million procedures performed in 2003, according to the American Cancer Society.

Computed tomographic colonography (CTC) is relatively new, but it was identified as a viable alternative to colonoscopy and other colorectal cancer screening methods in guidelines compiled by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology (http://caonline.amcancersoc.org/cgi/content/full/CA.2007.0018v1

Medicare currently covers colorectal screening for average-risk individuals aged 50 years and older through colonoscopy, fecal occult blood testing, sigmoidoscopy, and barium enema. The new screening guidelines prompted the CMS proposal.

The guidelines state that CTC screening of average-risk adults should start after age 50, but noted that the interval for repeat exams was uncertain. The guidelines urged a colonoscopy exam when polyps of 6 mm or greater were discovered with CTC.

The CMS will make a decision by Nov. 19, according to the agency.

Private insurers generally follow Medicare payment policy, said Dr. Joel V. Brill, a fellow of the American Gastroenterological Association and chair of the AGA Institute practice management and economics committee. “Commercial insurers are also poised to begin coverage of screening CTC this year,” he said, speaking at Digestive Disease Week in San Diego.

CTC has not been assigned a current procedural terminology code; that is not likely to happen until 2010, said Dr. Brill, who is also chief medical officer of Predictive Health LLC, a medical management company in Phoenix.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third trial suggested diagnostic criteria for the disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder that is characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. It affects about 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction being developed by Alba Therapeutics Corp. in Baltimore.

Dr. Daniel Leffler and his colleagues—from Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. They were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. None of the the 69 patients who completed the study met the primary outcome in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, said Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion. Twenty celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and so avoid inflammation and symptoms. After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study indicating that celiac disease damage occurs gradually with clinical symptoms appearing well before histologic damage.

He and his colleagues at Tampere and the University of Helsinki identified 23 patients (out of 145 consecutive cases) who had only intraepithelial lymphocytosis with or without crypt hyperplasia and randomized them either to a gluten-free diet or a normal diet.

A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group, whereas symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten.

He urged more studies before changing diagnostic criteria, but urged considering celiac disease in all symptomatic patients and a trial of dietary restriction.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third trial suggested diagnostic criteria for the disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder that is characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. It affects about 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction being developed by Alba Therapeutics Corp. in Baltimore.

Dr. Daniel Leffler and his colleagues—from Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. They were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. None of the the 69 patients who completed the study met the primary outcome in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, said Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion. Twenty celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and so avoid inflammation and symptoms. After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study indicating that celiac disease damage occurs gradually with clinical symptoms appearing well before histologic damage.

He and his colleagues at Tampere and the University of Helsinki identified 23 patients (out of 145 consecutive cases) who had only intraepithelial lymphocytosis with or without crypt hyperplasia and randomized them either to a gluten-free diet or a normal diet.

A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group, whereas symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten.

He urged more studies before changing diagnostic criteria, but urged considering celiac disease in all symptomatic patients and a trial of dietary restriction.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third trial suggested diagnostic criteria for the disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder that is characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. It affects about 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction being developed by Alba Therapeutics Corp. in Baltimore.

Dr. Daniel Leffler and his colleagues—from Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. They were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. None of the the 69 patients who completed the study met the primary outcome in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, said Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion. Twenty celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and so avoid inflammation and symptoms. After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study indicating that celiac disease damage occurs gradually with clinical symptoms appearing well before histologic damage.

He and his colleagues at Tampere and the University of Helsinki identified 23 patients (out of 145 consecutive cases) who had only intraepithelial lymphocytosis with or without crypt hyperplasia and randomized them either to a gluten-free diet or a normal diet.

A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group, whereas symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten.

He urged more studies before changing diagnostic criteria, but urged considering celiac disease in all symptomatic patients and a trial of dietary restriction.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third small trial indicated that the diagnostic criteria for celiac disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. Celiac disease affects about 6.5 million people worldwide and 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a wide range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction and is being developed by Baltimore-based Alba Therapeutics Corp. Dr. Daniel Leffler and his colleagues—from the Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. Subjects were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily with meals.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. Among the 69 patients who completed the study, the primary outcome was not met in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, reported Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet, said Dr. Leffler.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion.

For the study, 20 celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and thus avoid inflammation and symptoms, said Dr. Watson.

After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Dr. Peter H. Green, director of the celiac disease center at Columbia University, New York, hailed the two studies, saying that they indicated a potential for patients to have a treatment besides diet, which is notoriously difficult to follow. “It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this,” he said.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III).

But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study that indicate damage from celiac disease occurs gradually, with clinical symptoms appearing well before histologic damage.

Dr. Mäki and his colleagues at Tampere and the University of Helsinki identified 23 patients out of 145 consecutive cases who had only intraepithelial lymphocytosis with or without crypt hyperplasia. These 23 patients were randomized either to a gluten-free diet or a normal diet. A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group.

Symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten, Dr. Mäki said.

Dr. Mäki urged more studies before changing diagnostic criteria, but recommended considering celiac disease in all symptomatic patients and a trial of dietary restriction.

Dr. Green said that until a serum-based diagnostic test was available, intestinal biopsies were likely to remain the diagnostic standard.

Fewer than 5% of Americans with celiac disease have been diagnosed, Dr. Green estimated. “We're all looking for an easier way [than biopsy] to diagnose this disorder.”

'It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this.' DR. GREEN

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third small trial indicated that the diagnostic criteria for celiac disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. Celiac disease affects about 6.5 million people worldwide and 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a wide range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction and is being developed by Baltimore-based Alba Therapeutics Corp. Dr. Daniel Leffler and his colleagues—from the Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. Subjects were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily with meals.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. Among the 69 patients who completed the study, the primary outcome was not met in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, reported Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet, said Dr. Leffler.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion.

For the study, 20 celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and thus avoid inflammation and symptoms, said Dr. Watson.

After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Dr. Peter H. Green, director of the celiac disease center at Columbia University, New York, hailed the two studies, saying that they indicated a potential for patients to have a treatment besides diet, which is notoriously difficult to follow. “It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this,” he said.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III).

But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study that indicate damage from celiac disease occurs gradually, with clinical symptoms appearing well before histologic damage.

Dr. Mäki and his colleagues at Tampere and the University of Helsinki identified 23 patients out of 145 consecutive cases who had only intraepithelial lymphocytosis with or without crypt hyperplasia. These 23 patients were randomized either to a gluten-free diet or a normal diet. A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group.

Symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten, Dr. Mäki said.

Dr. Mäki urged more studies before changing diagnostic criteria, but recommended considering celiac disease in all symptomatic patients and a trial of dietary restriction.

Dr. Green said that until a serum-based diagnostic test was available, intestinal biopsies were likely to remain the diagnostic standard.

Fewer than 5% of Americans with celiac disease have been diagnosed, Dr. Green estimated. “We're all looking for an easier way [than biopsy] to diagnose this disorder.”

'It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this.' DR. GREEN

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third small trial indicated that the diagnostic criteria for celiac disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. Celiac disease affects about 6.5 million people worldwide and 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a wide range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction and is being developed by Baltimore-based Alba Therapeutics Corp. Dr. Daniel Leffler and his colleagues—from the Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. Subjects were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily with meals.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. Among the 69 patients who completed the study, the primary outcome was not met in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, reported Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet, said Dr. Leffler.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion.

For the study, 20 celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and thus avoid inflammation and symptoms, said Dr. Watson.

After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Dr. Peter H. Green, director of the celiac disease center at Columbia University, New York, hailed the two studies, saying that they indicated a potential for patients to have a treatment besides diet, which is notoriously difficult to follow. “It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this,” he said.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III).

But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study that indicate damage from celiac disease occurs gradually, with clinical symptoms appearing well before histologic damage.

Dr. Mäki and his colleagues at Tampere and the University of Helsinki identified 23 patients out of 145 consecutive cases who had only intraepithelial lymphocytosis with or without crypt hyperplasia. These 23 patients were randomized either to a gluten-free diet or a normal diet. A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group.

Symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten, Dr. Mäki said.

Dr. Mäki urged more studies before changing diagnostic criteria, but recommended considering celiac disease in all symptomatic patients and a trial of dietary restriction.

Dr. Green said that until a serum-based diagnostic test was available, intestinal biopsies were likely to remain the diagnostic standard.

Fewer than 5% of Americans with celiac disease have been diagnosed, Dr. Green estimated. “We're all looking for an easier way [than biopsy] to diagnose this disorder.”

'It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this.' DR. GREEN

LAS VEGAS — As more of the agreements signed by several large insurers to settle a class action suit alleging inappropriate billing practices expire, the possibility is increasing that the companies will return to the same behavior, especially given that many are being accused of violating the terms already, reported a compliance expert at a physicians' meeting.

Several of the health plans have said they will continue to comply with the terms of their settlements once they expire, but “not all have said that,” said Edward R. Gaines III, vice president and chief compliance officer for Healthcare Business Resources in Durham, N.C., who spoke at a meeting on reimbursement sponsored by the American College of Emergency Physicians (ACEP).

Mr. Gaines said that noncompliance among all the plans that have settled has continued to be an issue, which is being dealt with in the courts and administratively. But, “the problem is, once the settlement agreement expires, I can't go back into federal court through an easy process to make my complaint heard,” he said.

The settlements were struck in response to Multidistrict Litigation 1334, which was certified as a class action in U.S. District Court for the Southern District of Florida in 2002 and named Aetna Inc., Anthem Insurance Cos. Inc., Cigna, Coventry Health Care Inc., Health Net Inc., Humana Inc., PacifiCare Health Systems Inc., Prudential Insurance Co. of America, United Healthcare, and WellPoint Health Networks Inc. as defendants.

The suits alleged that the insurers violated the federal Racketeer Influenced and Corrupt Organizations Act by engaging in fraud and extortion in a common scheme to wrongfully deny payment to physicians.

Several state and county medical societies filed the suits on behalf of virtually every physician in the nation—about 900,000 doctors.

United Healthcare and Coventry both were summarily released from the litigation. Their release has been upheld on appeal.

Aetna and Cigna struck agreements that entailed an immediate payout in response to claims filed by physicians, some changes in billing behavior, and an agreement to provide prospective relief—$300 million from Aetna and $400 million from Cigna.

Cigna's 4-year agreement has now expired, and Aetna's 4-year agreement expired in June 2007; but Aetna's agreement was extended through this month because of compliance disputes. After an investigation, the New Jersey insurance department fined Aetna $9.5 million in June 2007 for failing to properly pay for out-of-network providers. The insurer is paying nonparticipating physicians only 125% of Medicare rates and informing patients that they are not responsible for the difference.

The national-level ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society all subsequently followed up with a complaint to the North Carolina insurance department in November, said Mr. Gaines. The North Carolina group is challenging bundling of 12-lead ECGs into evaluation and management codes, and bundling of other procedures that use the CPT-25 modifier codes.

“If we don't get prompt action from Aetna, we're going back to court [to] ask for an extension of the settlement agreement term,” he said.

The American Medical Association and Aetna recently announced that they are working together to resolve outstanding complaints.

Prudential's agreement expires in 2009, and agreements with three other insurers expire in 2010: HealthNet, Anthem/WellPoint, and Humana.

Agreements were reached with 90% of the nation's Blue Cross and Blue Shield plans. The Blues plans agreed to similar terms as did the other payers, with one exception: Anthem/WellPoint and the Blues plans refused to accept assignment of benefits. In fact, the Blues plans were willing to walk away from the settlement if they did not win that concession, said Mr. Gaines.

Mr. Gaines urged physicians to hold the health plans that settled accountable to their agreements.

Information on settlement terms and how to dispute claims can be found at www.hmosettlements.com

LAS VEGAS — As more of the agreements signed by several large insurers to settle a class action suit alleging inappropriate billing practices expire, the possibility is increasing that the companies will return to the same behavior, especially given that many are being accused of violating the terms already, reported a compliance expert at a physicians' meeting.

Several of the health plans have said they will continue to comply with the terms of their settlements once they expire, but “not all have said that,” said Edward R. Gaines III, vice president and chief compliance officer for Healthcare Business Resources in Durham, N.C., who spoke at a meeting on reimbursement sponsored by the American College of Emergency Physicians (ACEP).

Mr. Gaines said that noncompliance among all the plans that have settled has continued to be an issue, which is being dealt with in the courts and administratively. But, “the problem is, once the settlement agreement expires, I can't go back into federal court through an easy process to make my complaint heard,” he said.

The settlements were struck in response to Multidistrict Litigation 1334, which was certified as a class action in U.S. District Court for the Southern District of Florida in 2002 and named Aetna Inc., Anthem Insurance Cos. Inc., Cigna, Coventry Health Care Inc., Health Net Inc., Humana Inc., PacifiCare Health Systems Inc., Prudential Insurance Co. of America, United Healthcare, and WellPoint Health Networks Inc. as defendants.

The suits alleged that the insurers violated the federal Racketeer Influenced and Corrupt Organizations Act by engaging in fraud and extortion in a common scheme to wrongfully deny payment to physicians.

Several state and county medical societies filed the suits on behalf of virtually every physician in the nation—about 900,000 doctors.

United Healthcare and Coventry both were summarily released from the litigation. Their release has been upheld on appeal.

Aetna and Cigna struck agreements that entailed an immediate payout in response to claims filed by physicians, some changes in billing behavior, and an agreement to provide prospective relief—$300 million from Aetna and $400 million from Cigna.

Cigna's 4-year agreement has now expired, and Aetna's 4-year agreement expired in June 2007; but Aetna's agreement was extended through this month because of compliance disputes. After an investigation, the New Jersey insurance department fined Aetna $9.5 million in June 2007 for failing to properly pay for out-of-network providers. The insurer is paying nonparticipating physicians only 125% of Medicare rates and informing patients that they are not responsible for the difference.

The national-level ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society all subsequently followed up with a complaint to the North Carolina insurance department in November, said Mr. Gaines. The North Carolina group is challenging bundling of 12-lead ECGs into evaluation and management codes, and bundling of other procedures that use the CPT-25 modifier codes.

“If we don't get prompt action from Aetna, we're going back to court [to] ask for an extension of the settlement agreement term,” he said.

The American Medical Association and Aetna recently announced that they are working together to resolve outstanding complaints.

Prudential's agreement expires in 2009, and agreements with three other insurers expire in 2010: HealthNet, Anthem/WellPoint, and Humana.

Agreements were reached with 90% of the nation's Blue Cross and Blue Shield plans. The Blues plans agreed to similar terms as did the other payers, with one exception: Anthem/WellPoint and the Blues plans refused to accept assignment of benefits. In fact, the Blues plans were willing to walk away from the settlement if they did not win that concession, said Mr. Gaines.

Mr. Gaines urged physicians to hold the health plans that settled accountable to their agreements.

Information on settlement terms and how to dispute claims can be found at www.hmosettlements.com

LAS VEGAS — As more of the agreements signed by several large insurers to settle a class action suit alleging inappropriate billing practices expire, the possibility is increasing that the companies will return to the same behavior, especially given that many are being accused of violating the terms already, reported a compliance expert at a physicians' meeting.

Several of the health plans have said they will continue to comply with the terms of their settlements once they expire, but “not all have said that,” said Edward R. Gaines III, vice president and chief compliance officer for Healthcare Business Resources in Durham, N.C., who spoke at a meeting on reimbursement sponsored by the American College of Emergency Physicians (ACEP).

Mr. Gaines said that noncompliance among all the plans that have settled has continued to be an issue, which is being dealt with in the courts and administratively. But, “the problem is, once the settlement agreement expires, I can't go back into federal court through an easy process to make my complaint heard,” he said.

The settlements were struck in response to Multidistrict Litigation 1334, which was certified as a class action in U.S. District Court for the Southern District of Florida in 2002 and named Aetna Inc., Anthem Insurance Cos. Inc., Cigna, Coventry Health Care Inc., Health Net Inc., Humana Inc., PacifiCare Health Systems Inc., Prudential Insurance Co. of America, United Healthcare, and WellPoint Health Networks Inc. as defendants.

The suits alleged that the insurers violated the federal Racketeer Influenced and Corrupt Organizations Act by engaging in fraud and extortion in a common scheme to wrongfully deny payment to physicians.

Several state and county medical societies filed the suits on behalf of virtually every physician in the nation—about 900,000 doctors.

United Healthcare and Coventry both were summarily released from the litigation. Their release has been upheld on appeal.

Aetna and Cigna struck agreements that entailed an immediate payout in response to claims filed by physicians, some changes in billing behavior, and an agreement to provide prospective relief—$300 million from Aetna and $400 million from Cigna.

Cigna's 4-year agreement has now expired, and Aetna's 4-year agreement expired in June 2007; but Aetna's agreement was extended through this month because of compliance disputes. After an investigation, the New Jersey insurance department fined Aetna $9.5 million in June 2007 for failing to properly pay for out-of-network providers. The insurer is paying nonparticipating physicians only 125% of Medicare rates and informing patients that they are not responsible for the difference.

The national-level ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society all subsequently followed up with a complaint to the North Carolina insurance department in November, said Mr. Gaines. The North Carolina group is challenging bundling of 12-lead ECGs into evaluation and management codes, and bundling of other procedures that use the CPT-25 modifier codes.

“If we don't get prompt action from Aetna, we're going back to court [to] ask for an extension of the settlement agreement term,” he said.

The American Medical Association and Aetna recently announced that they are working together to resolve outstanding complaints.

Prudential's agreement expires in 2009, and agreements with three other insurers expire in 2010: HealthNet, Anthem/WellPoint, and Humana.

Agreements were reached with 90% of the nation's Blue Cross and Blue Shield plans. The Blues plans agreed to similar terms as did the other payers, with one exception: Anthem/WellPoint and the Blues plans refused to accept assignment of benefits. In fact, the Blues plans were willing to walk away from the settlement if they did not win that concession, said Mr. Gaines.

Mr. Gaines urged physicians to hold the health plans that settled accountable to their agreements.

Information on settlement terms and how to dispute claims can be found at www.hmosettlements.com

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who have difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns. and family physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview. “This message is meant for the generalist, not the reproductive endocrinologist,” Dr. Masood Khatamee of New York University said in an interview. “And it's a very, very appropriate statement,” he said.

Dr. Fritz agreed that the ASRM was aiming for a broader audience. He said the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said.

Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for a while.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment in instances where they haven't in the past, Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. He said women are often told they have plenty of time to conceive. “That's not what they want to hear,” he said.

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee said he tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

The ASRM favors early evaluation and treatment based on natural history and physical findings. DR. FRITZ

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who have difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns. and family physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview. “This message is meant for the generalist, not the reproductive endocrinologist,” Dr. Masood Khatamee of New York University said in an interview. “And it's a very, very appropriate statement,” he said.

Dr. Fritz agreed that the ASRM was aiming for a broader audience. He said the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said.

Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for a while.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment in instances where they haven't in the past, Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. He said women are often told they have plenty of time to conceive. “That's not what they want to hear,” he said.

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee said he tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

The ASRM favors early evaluation and treatment based on natural history and physical findings. DR. FRITZ

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who have difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns. and family physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview. “This message is meant for the generalist, not the reproductive endocrinologist,” Dr. Masood Khatamee of New York University said in an interview. “And it's a very, very appropriate statement,” he said.

Dr. Fritz agreed that the ASRM was aiming for a broader audience. He said the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said.

Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for a while.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment in instances where they haven't in the past, Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. He said women are often told they have plenty of time to conceive. “That's not what they want to hear,” he said.

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee said he tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

The ASRM favors early evaluation and treatment based on natural history and physical findings. DR. FRITZ

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

All 17 commissioners present at the meeting voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. The recommendation will be included in MedPAC's June report to Congress.

Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued at previous meetings.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners said that a larger pilot with clear thresholds could accelerate the evaluation process, and could easily be discontinued or expanded.

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

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

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

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

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

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

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

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

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

Dr. Nicholas Wolter of the Billings (Mont.) Clinic, suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians.

“I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. She said that she often provided what would be considered primary care to her breast cancer patients. Dr. Borman ended up voting against the recommendation for increased pay for primary care.

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

All 17 commissioners present at the meeting voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. The recommendation will be included in MedPAC's June report to Congress.

Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued at previous meetings.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners said that a larger pilot with clear thresholds could accelerate the evaluation process, and could easily be discontinued or expanded.

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

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

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

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

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

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

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

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

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

Dr. Nicholas Wolter of the Billings (Mont.) Clinic, suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians.

“I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. She said that she often provided what would be considered primary care to her breast cancer patients. Dr. Borman ended up voting against the recommendation for increased pay for primary care.

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

All 17 commissioners present at the meeting voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. The recommendation will be included in MedPAC's June report to Congress.

Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued at previous meetings.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners said that a larger pilot with clear thresholds could accelerate the evaluation process, and could easily be discontinued or expanded.

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

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

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

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

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

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

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

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

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

Dr. Nicholas Wolter of the Billings (Mont.) Clinic, suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians.

“I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. She said that she often provided what would be considered primary care to her breast cancer patients. Dr. Borman ended up voting against the recommendation for increased pay for primary care.

Ezetimibe Troubles Hit Home

Schering-Plough reported in its most recent quarterly filing with the Securities and Exchange Commission that its joint venture with Merck & Co. on ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin) is the subject of multiple lawsuits and legal inquiries. In a May 6 filing, Schering stated that it has received “several subpoenas from state officials, including state attorneys general, and requests for information from U.S. Attorneys,” all seeking information on the ENHANCE clinical trial, the sale and promotion of ezetimibe/simvastatin, and stock sales by corporate officer since April 2006, when ENHANCE was completed. Since mid-January, the company has been served with class action lawsuits alleging fraud in conjunction with the sale and marketing of the two products. The company is also looking at several securities-related class action suits, according to the filing.

CMS Covers Artificial Heart

Artificial hearts will be covered by Medicare when they are implanted as part of a study, according to a national coverage decision issued in May. The decision was not a surprise, as CMS telegraphed its intention to do so in a February proposal. According to a statement, the agency “believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage of these devices for beneficiaries in the carefully controlled clinical environment of an [Food and Drug Administration]-approved study.” The devices are for use in severe heart failure, where patients are at imminent risk of death.

Gainsharing Cuts Stent Costs

A study of gainsharing programs sanctioned by CMS at six cardiac catheterization labs has found that costs declined for coronary stent patients relative to nongainsharing hospitals. The gainsharing hospitals reduced costs by 7.4% per patient; 91% of the savings came from lower prices, and 9% from lower utilization, according to authors Jonathan Ketcham, Ph.D., and Michael Furukawa, Ph.D., of Arizona State University, Tempe. Under the programs, savings are shared equally by the hospital and the physician practice. From 2001 to 2006, the average cost per patient increased from $3,338 to $4,644, but the gainsharing hospitals were able to reduce that by $315 per patient, or 7.4%. The study appears in the May/June 2008 issue of Health Affairs.

Self-Referrals Drive Imaging Hike

Physicians who refer patients to their own facilities or machines for scans account for much of the increase in diagnostic imaging ordered for privately insured patients, according to a commentary in the journal Medical Care. The increases in imaging were seen mainly in privately insured patients with fee-for-service plans, according to by Dr. Vivian Ho, professor of medicine at Baylor College of Medicine, Houston. “Physicians seem to choose the self-referral option, meaning they do the imaging in their own office, because they are reimbursed by private insurance companies,” Dr. Ho wrote. If they don't have the equipment in their office, she said, they lease an imaging center's facilities and employees for a fixed period each week. This creates revenue for both parties involved, but raises questions about the necessity of the testing conducted, Dr. Ho wrote, adding, “The current reimbursement system lacks incentives to provide high quality imaging in a cost-effective manner.”

Ezetimibe Troubles Hit Home

Schering-Plough reported in its most recent quarterly filing with the Securities and Exchange Commission that its joint venture with Merck & Co. on ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin) is the subject of multiple lawsuits and legal inquiries. In a May 6 filing, Schering stated that it has received “several subpoenas from state officials, including state attorneys general, and requests for information from U.S. Attorneys,” all seeking information on the ENHANCE clinical trial, the sale and promotion of ezetimibe/simvastatin, and stock sales by corporate officer since April 2006, when ENHANCE was completed. Since mid-January, the company has been served with class action lawsuits alleging fraud in conjunction with the sale and marketing of the two products. The company is also looking at several securities-related class action suits, according to the filing.

CMS Covers Artificial Heart

Artificial hearts will be covered by Medicare when they are implanted as part of a study, according to a national coverage decision issued in May. The decision was not a surprise, as CMS telegraphed its intention to do so in a February proposal. According to a statement, the agency “believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage of these devices for beneficiaries in the carefully controlled clinical environment of an [Food and Drug Administration]-approved study.” The devices are for use in severe heart failure, where patients are at imminent risk of death.

Gainsharing Cuts Stent Costs

A study of gainsharing programs sanctioned by CMS at six cardiac catheterization labs has found that costs declined for coronary stent patients relative to nongainsharing hospitals. The gainsharing hospitals reduced costs by 7.4% per patient; 91% of the savings came from lower prices, and 9% from lower utilization, according to authors Jonathan Ketcham, Ph.D., and Michael Furukawa, Ph.D., of Arizona State University, Tempe. Under the programs, savings are shared equally by the hospital and the physician practice. From 2001 to 2006, the average cost per patient increased from $3,338 to $4,644, but the gainsharing hospitals were able to reduce that by $315 per patient, or 7.4%. The study appears in the May/June 2008 issue of Health Affairs.

Self-Referrals Drive Imaging Hike

Physicians who refer patients to their own facilities or machines for scans account for much of the increase in diagnostic imaging ordered for privately insured patients, according to a commentary in the journal Medical Care. The increases in imaging were seen mainly in privately insured patients with fee-for-service plans, according to by Dr. Vivian Ho, professor of medicine at Baylor College of Medicine, Houston. “Physicians seem to choose the self-referral option, meaning they do the imaging in their own office, because they are reimbursed by private insurance companies,” Dr. Ho wrote. If they don't have the equipment in their office, she said, they lease an imaging center's facilities and employees for a fixed period each week. This creates revenue for both parties involved, but raises questions about the necessity of the testing conducted, Dr. Ho wrote, adding, “The current reimbursement system lacks incentives to provide high quality imaging in a cost-effective manner.”

Ezetimibe Troubles Hit Home

Schering-Plough reported in its most recent quarterly filing with the Securities and Exchange Commission that its joint venture with Merck & Co. on ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin) is the subject of multiple lawsuits and legal inquiries. In a May 6 filing, Schering stated that it has received “several subpoenas from state officials, including state attorneys general, and requests for information from U.S. Attorneys,” all seeking information on the ENHANCE clinical trial, the sale and promotion of ezetimibe/simvastatin, and stock sales by corporate officer since April 2006, when ENHANCE was completed. Since mid-January, the company has been served with class action lawsuits alleging fraud in conjunction with the sale and marketing of the two products. The company is also looking at several securities-related class action suits, according to the filing.

CMS Covers Artificial Heart

Artificial hearts will be covered by Medicare when they are implanted as part of a study, according to a national coverage decision issued in May. The decision was not a surprise, as CMS telegraphed its intention to do so in a February proposal. According to a statement, the agency “believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage of these devices for beneficiaries in the carefully controlled clinical environment of an [Food and Drug Administration]-approved study.” The devices are for use in severe heart failure, where patients are at imminent risk of death.

Gainsharing Cuts Stent Costs

A study of gainsharing programs sanctioned by CMS at six cardiac catheterization labs has found that costs declined for coronary stent patients relative to nongainsharing hospitals. The gainsharing hospitals reduced costs by 7.4% per patient; 91% of the savings came from lower prices, and 9% from lower utilization, according to authors Jonathan Ketcham, Ph.D., and Michael Furukawa, Ph.D., of Arizona State University, Tempe. Under the programs, savings are shared equally by the hospital and the physician practice. From 2001 to 2006, the average cost per patient increased from $3,338 to $4,644, but the gainsharing hospitals were able to reduce that by $315 per patient, or 7.4%. The study appears in the May/June 2008 issue of Health Affairs.

Self-Referrals Drive Imaging Hike

Physicians who refer patients to their own facilities or machines for scans account for much of the increase in diagnostic imaging ordered for privately insured patients, according to a commentary in the journal Medical Care. The increases in imaging were seen mainly in privately insured patients with fee-for-service plans, according to by Dr. Vivian Ho, professor of medicine at Baylor College of Medicine, Houston. “Physicians seem to choose the self-referral option, meaning they do the imaging in their own office, because they are reimbursed by private insurance companies,” Dr. Ho wrote. If they don't have the equipment in their office, she said, they lease an imaging center's facilities and employees for a fixed period each week. This creates revenue for both parties involved, but raises questions about the necessity of the testing conducted, Dr. Ho wrote, adding, “The current reimbursement system lacks incentives to provide high quality imaging in a cost-effective manner.”

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who are having difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns., family physicians, and other physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview.

“This message is meant for the generalist, not the reproductive endocrinologist,” said Dr. Masood Khatamee of New York University and founder of the Society for the Prevention of Infertility in an interview. “And it's a very, very appropriate statement.”

Dr. Fritz agreed that the ASRM was aiming for a broader audience.

According to Dr. Fritz, the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said. Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for awhile.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment—in instances where they haven't in the past—Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. Women are often told they have plenty of time to conceive, but “that's not what they want to hear.”

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee agreed that the ASRM statement could promote more understanding. He tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

For the first time, recurrent pregnancy loss is being defined as a disease distinct from infertility. DR. FRITZ

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who are having difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns., family physicians, and other physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview.

“This message is meant for the generalist, not the reproductive endocrinologist,” said Dr. Masood Khatamee of New York University and founder of the Society for the Prevention of Infertility in an interview. “And it's a very, very appropriate statement.”

Dr. Fritz agreed that the ASRM was aiming for a broader audience.

According to Dr. Fritz, the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said. Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for awhile.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment—in instances where they haven't in the past—Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. Women are often told they have plenty of time to conceive, but “that's not what they want to hear.”

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee agreed that the ASRM statement could promote more understanding. He tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

For the first time, recurrent pregnancy loss is being defined as a disease distinct from infertility. DR. FRITZ

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who are having difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns., family physicians, and other physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview.

“This message is meant for the generalist, not the reproductive endocrinologist,” said Dr. Masood Khatamee of New York University and founder of the Society for the Prevention of Infertility in an interview. “And it's a very, very appropriate statement.”

Dr. Fritz agreed that the ASRM was aiming for a broader audience.

According to Dr. Fritz, the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said. Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for awhile.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment—in instances where they haven't in the past—Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. Women are often told they have plenty of time to conceive, but “that's not what they want to hear.”

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee agreed that the ASRM statement could promote more understanding. He tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

For the first time, recurrent pregnancy loss is being defined as a disease distinct from infertility. DR. FRITZ

WASHINGTON – The concept of a medical home is one step closer to reality for Medicare patients, after it received strong backing from the Medicare Payment Advisory Commission.

All 17 commissioners present at the meeting in April voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. The recommendation will be included in MedPAC's June report to Congress.

Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued at previous meetings.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners said that a larger pilot with clear thresholds could accelerate the evaluation process, and could easily be discontinued or expanded.

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

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

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

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

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

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

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

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

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

Dr. Nicholas Wolter of the Billings (Mont.) Clinic, suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians.

“I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. Dr. Borman ended up voting against the recommendation for increased pay for primary care.

WASHINGTON – The concept of a medical home is one step closer to reality for Medicare patients, after it received strong backing from the Medicare Payment Advisory Commission.

All 17 commissioners present at the meeting in April voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. The recommendation will be included in MedPAC's June report to Congress.

Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued at previous meetings.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners said that a larger pilot with clear thresholds could accelerate the evaluation process, and could easily be discontinued or expanded.

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

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

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

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

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

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

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

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

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

Dr. Nicholas Wolter of the Billings (Mont.) Clinic, suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians.

“I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. Dr. Borman ended up voting against the recommendation for increased pay for primary care.

WASHINGTON – The concept of a medical home is one step closer to reality for Medicare patients, after it received strong backing from the Medicare Payment Advisory Commission.

All 17 commissioners present at the meeting in April voted to urge Congress to instruct the Centers for Medicare and Medicaid Services to develop a large pilot study of medical homes for Medicare beneficiaries. The recommendation will be included in MedPAC's June report to Congress.

Most of the commissioners also voted to adjust the Medicare fee schedule to increase payment for primary care, which MedPAC has deemed as undervalued at previous meetings.

The medical home concept has been advanced by the American College of Physicians, the American Academy of Family Physicians, and the American Academy of Pediatrics. A demonstration project is authorized under the Medicare program, but the commissioners said that a larger pilot with clear thresholds could accelerate the evaluation process, and could easily be discontinued or expanded.

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

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

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

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

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

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

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

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

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

Dr. Nicholas Wolter of the Billings (Mont.) Clinic, suggested that the increase be made without trying to maintain budget neutrality. Dr. Karen Borman, professor of surgery at the University of Mississippi, Jackson, expressed concern that rewarding primary care could end up hurting other physicians.

“I have some philosophical problems here,” said Dr. Borman, adding that primary care was not always linked with a traditional primary care physician. Dr. Borman ended up voting against the recommendation for increased pay for primary care.

WASHINGTON – Staggering growth in the popularity of hospice services–and in the rise of for-profit hospice providers–has caught the attention of the Medicare Payment Assessment Commission.

At their recent meeting, MedPAC commissioners debated the potential impact of rising hospice costs on the Medicare program. The hospice benefit began in 1983 with the idea that it would cost Medicare less to provide hospice than conventional end-of-life treatment, which is usually delivered in the hospital, said MedPAC staff member James Mathews, Ph.D.

But there is some evidence indicating that hospice use may actually result in higher spending, said Dr. Mathews.

According to MedPAC's analysis of Medicare claims data, hospice spending tripled from 2000 to 2007, when Medicare spent $10 billion on hospice services. The mean length of hospice stay increased 30% from 2000 to 2005. It's not clear why length of stay is increasing, but data have shown that some illnesses–such as Alzheimer's disease and ischemic heart disease–tend to result in longer stays, said Dr. Mathews.

One explanation may be that hospice care tends to be more expensive at the beginning and the end of the service; interim days are more profitable, so there is an incentive to lengthen stay, he said.

But it appears that much of the growth in costs and length of stay is due to the huge increase in for-profit hospice facilities in the market. From 2000 to 2007, very few nonprofit hospices entered the market, while the for-profit sector grew 12% a year, Dr. Mathews said. There were a few more than 1,600 for-profit hospices in 2007, compared with about 1,200 nonprofit and 400 government-run facilities, according to the MedPAC analysis.

The analysis also determined that profit margins are much higher at for-profit hospice facilities. In 2005, the last year in the analysis, for-profit margins were about 12%, while nonprofits had negative margins. MedPAC also found that hospices that entered the market since 2000–mostly for-profit operations–had higher margins.

Some hospices, only about 9%, are subject to a cap that limits the length of stay, but even those facilities have found a way to profit from Medicare, said Dr. Mathews.

“Clearly, people see an opportunity–a financial opportunity–here,” commented MedPAC chairman Glenn Hackbarth. He said that the commission needed to find a way to keep the hospice program from spiraling out of control.

Commissioner Jack Ebeler suggested that Medicare “may need blunter instruments for slowing the growth,” but also added that the health program should not do anything to lose “an extraordinarily valuable benefit.”

MedPAC vice chairman Robert Reischauer, Ph.D., suggested that Medicare payment could be refined to buy more appropriate care. “It strikes me that there's probably an easy way to do this,” said Dr. Reischauer, who is also president of the Urban Institute.

J. Donald Schumacher, Psy.D., president and CEO of the National Hospice and Palliative Care Association, acknowledged that there has been a “huge growth spurt” in the hospice field. Facilities are worried that the Centers for Medicare and Medicaid Services or Congress might clamp down, using a “blunt instrument,” Dr. Schumacher said at the meeting.

WASHINGTON – Staggering growth in the popularity of hospice services–and in the rise of for-profit hospice providers–has caught the attention of the Medicare Payment Assessment Commission.

At their recent meeting, MedPAC commissioners debated the potential impact of rising hospice costs on the Medicare program. The hospice benefit began in 1983 with the idea that it would cost Medicare less to provide hospice than conventional end-of-life treatment, which is usually delivered in the hospital, said MedPAC staff member James Mathews, Ph.D.

But there is some evidence indicating that hospice use may actually result in higher spending, said Dr. Mathews.

According to MedPAC's analysis of Medicare claims data, hospice spending tripled from 2000 to 2007, when Medicare spent $10 billion on hospice services. The mean length of hospice stay increased 30% from 2000 to 2005. It's not clear why length of stay is increasing, but data have shown that some illnesses–such as Alzheimer's disease and ischemic heart disease–tend to result in longer stays, said Dr. Mathews.

One explanation may be that hospice care tends to be more expensive at the beginning and the end of the service; interim days are more profitable, so there is an incentive to lengthen stay, he said.

But it appears that much of the growth in costs and length of stay is due to the huge increase in for-profit hospice facilities in the market. From 2000 to 2007, very few nonprofit hospices entered the market, while the for-profit sector grew 12% a year, Dr. Mathews said. There were a few more than 1,600 for-profit hospices in 2007, compared with about 1,200 nonprofit and 400 government-run facilities, according to the MedPAC analysis.

The analysis also determined that profit margins are much higher at for-profit hospice facilities. In 2005, the last year in the analysis, for-profit margins were about 12%, while nonprofits had negative margins. MedPAC also found that hospices that entered the market since 2000–mostly for-profit operations–had higher margins.

Some hospices, only about 9%, are subject to a cap that limits the length of stay, but even those facilities have found a way to profit from Medicare, said Dr. Mathews.

“Clearly, people see an opportunity–a financial opportunity–here,” commented MedPAC chairman Glenn Hackbarth. He said that the commission needed to find a way to keep the hospice program from spiraling out of control.

Commissioner Jack Ebeler suggested that Medicare “may need blunter instruments for slowing the growth,” but also added that the health program should not do anything to lose “an extraordinarily valuable benefit.”

MedPAC vice chairman Robert Reischauer, Ph.D., suggested that Medicare payment could be refined to buy more appropriate care. “It strikes me that there's probably an easy way to do this,” said Dr. Reischauer, who is also president of the Urban Institute.

J. Donald Schumacher, Psy.D., president and CEO of the National Hospice and Palliative Care Association, acknowledged that there has been a “huge growth spurt” in the hospice field. Facilities are worried that the Centers for Medicare and Medicaid Services or Congress might clamp down, using a “blunt instrument,” Dr. Schumacher said at the meeting.

WASHINGTON – Staggering growth in the popularity of hospice services–and in the rise of for-profit hospice providers–has caught the attention of the Medicare Payment Assessment Commission.

At their recent meeting, MedPAC commissioners debated the potential impact of rising hospice costs on the Medicare program. The hospice benefit began in 1983 with the idea that it would cost Medicare less to provide hospice than conventional end-of-life treatment, which is usually delivered in the hospital, said MedPAC staff member James Mathews, Ph.D.

But there is some evidence indicating that hospice use may actually result in higher spending, said Dr. Mathews.

According to MedPAC's analysis of Medicare claims data, hospice spending tripled from 2000 to 2007, when Medicare spent $10 billion on hospice services. The mean length of hospice stay increased 30% from 2000 to 2005. It's not clear why length of stay is increasing, but data have shown that some illnesses–such as Alzheimer's disease and ischemic heart disease–tend to result in longer stays, said Dr. Mathews.

One explanation may be that hospice care tends to be more expensive at the beginning and the end of the service; interim days are more profitable, so there is an incentive to lengthen stay, he said.

But it appears that much of the growth in costs and length of stay is due to the huge increase in for-profit hospice facilities in the market. From 2000 to 2007, very few nonprofit hospices entered the market, while the for-profit sector grew 12% a year, Dr. Mathews said. There were a few more than 1,600 for-profit hospices in 2007, compared with about 1,200 nonprofit and 400 government-run facilities, according to the MedPAC analysis.

The analysis also determined that profit margins are much higher at for-profit hospice facilities. In 2005, the last year in the analysis, for-profit margins were about 12%, while nonprofits had negative margins. MedPAC also found that hospices that entered the market since 2000–mostly for-profit operations–had higher margins.

Some hospices, only about 9%, are subject to a cap that limits the length of stay, but even those facilities have found a way to profit from Medicare, said Dr. Mathews.

“Clearly, people see an opportunity–a financial opportunity–here,” commented MedPAC chairman Glenn Hackbarth. He said that the commission needed to find a way to keep the hospice program from spiraling out of control.

Commissioner Jack Ebeler suggested that Medicare “may need blunter instruments for slowing the growth,” but also added that the health program should not do anything to lose “an extraordinarily valuable benefit.”

MedPAC vice chairman Robert Reischauer, Ph.D., suggested that Medicare payment could be refined to buy more appropriate care. “It strikes me that there's probably an easy way to do this,” said Dr. Reischauer, who is also president of the Urban Institute.

J. Donald Schumacher, Psy.D., president and CEO of the National Hospice and Palliative Care Association, acknowledged that there has been a “huge growth spurt” in the hospice field. Facilities are worried that the Centers for Medicare and Medicaid Services or Congress might clamp down, using a “blunt instrument,” Dr. Schumacher said at the meeting.