Alicia Ault

WASHINGTON — With health care expenses accounting for the single largest expense in their budget, states are increasingly looking for solutions from within, not from the federal government, according to an annual accounting of state legislative trends compiled by the Blue Cross and Blue Shield Association.

"Health care spending represented nearly one-third of total state expenditures last fiscal year," said Susan Laudicina, BCBSA director for state research and policy at a briefing for reporters. And, she noted, as the economy weakens, health care costs will continue to rise, while tax revenues will fall. That will add to the pressure to find creative solutions, she said.

"The challenge for state lawmakers is how to avoid cutting existing programs like Medicaid and the State Children's Health Insurance Program while also finding new ways to cover the uninsured and contain costs," said Ms. Laudicina.

The most significant trend observed in the states: an attempt to expand coverage. About half of the state legislatures debated universal coverage or expansion programs for children in fiscal 2007. State mandates requiring individuals to buy insurance were introduced in 12 states. All failed, largely because they are controversial, Ms. Laudicina said.

Connecticut and New York expanded eligibility for SCHIP to 400% of the federal poverty level and seven other states raised eligibility to 300%, but those efforts are threatened by a rule change issued by the Department of Health and Human Services last August that ostensibly caps eligibility at 250% of the federal poverty level. Eight states have sued to challenge that ruling.

Eight states—Connecticut, Indiana, Kansas, Louisiana, Maryland, New York, Texas and Washington—created programs in which public funds are used to subsidize the cost of private employer-sponsored health insurance to Medicaid-eligible workers. Oklahoma expanded its subsidy program, making more people eligible.

So-called "transparency" initiatives are gaining ground, also. These are proposals that require hospitals—and in some cases, physicians—to publicly share information on infections and other adverse events, and also other quality data and pricing. Twenty-one states debated proposals that would require transparency on some level. Transparency bills were enacted in 10 states: Arkansas, Delaware, Georgia, Indiana, Minnesota, New Jersey, Oregon, Pennsylvania, Texas, and Washington.

In Texas, for instance, the state is now requiring hospitals and physicians to provide patients with estimates of charges if requested. Hospitals also will be required to tell patients if there is the possibility that an out-of-network provider will be working in an in-network facility, and to inform them there may be costs to the patient as a result.

The Texas law reflects a growing concern that patients aren't aware that they may be balance-billed, Ms. Laudicina said. Eleven states will take up transparency measures in 2008.

The annual State Legislative Health Care and Insurance Issues report compiles information from the BCBSA's survey of 39 independent Blue Cross and Blue Shield plans.

WASHINGTON — With health care expenses accounting for the single largest expense in their budget, states are increasingly looking for solutions from within, not from the federal government, according to an annual accounting of state legislative trends compiled by the Blue Cross and Blue Shield Association.

"Health care spending represented nearly one-third of total state expenditures last fiscal year," said Susan Laudicina, BCBSA director for state research and policy at a briefing for reporters. And, she noted, as the economy weakens, health care costs will continue to rise, while tax revenues will fall. That will add to the pressure to find creative solutions, she said.

"The challenge for state lawmakers is how to avoid cutting existing programs like Medicaid and the State Children's Health Insurance Program while also finding new ways to cover the uninsured and contain costs," said Ms. Laudicina.

The most significant trend observed in the states: an attempt to expand coverage. About half of the state legislatures debated universal coverage or expansion programs for children in fiscal 2007. State mandates requiring individuals to buy insurance were introduced in 12 states. All failed, largely because they are controversial, Ms. Laudicina said.

Connecticut and New York expanded eligibility for SCHIP to 400% of the federal poverty level and seven other states raised eligibility to 300%, but those efforts are threatened by a rule change issued by the Department of Health and Human Services last August that ostensibly caps eligibility at 250% of the federal poverty level. Eight states have sued to challenge that ruling.

Eight states—Connecticut, Indiana, Kansas, Louisiana, Maryland, New York, Texas and Washington—created programs in which public funds are used to subsidize the cost of private employer-sponsored health insurance to Medicaid-eligible workers. Oklahoma expanded its subsidy program, making more people eligible.

So-called "transparency" initiatives are gaining ground, also. These are proposals that require hospitals—and in some cases, physicians—to publicly share information on infections and other adverse events, and also other quality data and pricing. Twenty-one states debated proposals that would require transparency on some level. Transparency bills were enacted in 10 states: Arkansas, Delaware, Georgia, Indiana, Minnesota, New Jersey, Oregon, Pennsylvania, Texas, and Washington.

In Texas, for instance, the state is now requiring hospitals and physicians to provide patients with estimates of charges if requested. Hospitals also will be required to tell patients if there is the possibility that an out-of-network provider will be working in an in-network facility, and to inform them there may be costs to the patient as a result.

The Texas law reflects a growing concern that patients aren't aware that they may be balance-billed, Ms. Laudicina said. Eleven states will take up transparency measures in 2008.

The annual State Legislative Health Care and Insurance Issues report compiles information from the BCBSA's survey of 39 independent Blue Cross and Blue Shield plans.

WASHINGTON — With health care expenses accounting for the single largest expense in their budget, states are increasingly looking for solutions from within, not from the federal government, according to an annual accounting of state legislative trends compiled by the Blue Cross and Blue Shield Association.

"Health care spending represented nearly one-third of total state expenditures last fiscal year," said Susan Laudicina, BCBSA director for state research and policy at a briefing for reporters. And, she noted, as the economy weakens, health care costs will continue to rise, while tax revenues will fall. That will add to the pressure to find creative solutions, she said.

"The challenge for state lawmakers is how to avoid cutting existing programs like Medicaid and the State Children's Health Insurance Program while also finding new ways to cover the uninsured and contain costs," said Ms. Laudicina.

The most significant trend observed in the states: an attempt to expand coverage. About half of the state legislatures debated universal coverage or expansion programs for children in fiscal 2007. State mandates requiring individuals to buy insurance were introduced in 12 states. All failed, largely because they are controversial, Ms. Laudicina said.

Connecticut and New York expanded eligibility for SCHIP to 400% of the federal poverty level and seven other states raised eligibility to 300%, but those efforts are threatened by a rule change issued by the Department of Health and Human Services last August that ostensibly caps eligibility at 250% of the federal poverty level. Eight states have sued to challenge that ruling.

Eight states—Connecticut, Indiana, Kansas, Louisiana, Maryland, New York, Texas and Washington—created programs in which public funds are used to subsidize the cost of private employer-sponsored health insurance to Medicaid-eligible workers. Oklahoma expanded its subsidy program, making more people eligible.

So-called "transparency" initiatives are gaining ground, also. These are proposals that require hospitals—and in some cases, physicians—to publicly share information on infections and other adverse events, and also other quality data and pricing. Twenty-one states debated proposals that would require transparency on some level. Transparency bills were enacted in 10 states: Arkansas, Delaware, Georgia, Indiana, Minnesota, New Jersey, Oregon, Pennsylvania, Texas, and Washington.

In Texas, for instance, the state is now requiring hospitals and physicians to provide patients with estimates of charges if requested. Hospitals also will be required to tell patients if there is the possibility that an out-of-network provider will be working in an in-network facility, and to inform them there may be costs to the patient as a result.

The Texas law reflects a growing concern that patients aren't aware that they may be balance-billed, Ms. Laudicina said. Eleven states will take up transparency measures in 2008.

The annual State Legislative Health Care and Insurance Issues report compiles information from the BCBSA's survey of 39 independent Blue Cross and Blue Shield plans.

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.

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.

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 Health Care, 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 Health Care 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 June 2008 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.

ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society 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 and the Blue Cross and Blue Shield Association last April, but the final settlement date was being worked out at press time. 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.

The court gave preliminary approval last November to a settlement with the West Virginia-based Highmark/Mountain State Blue Cross Blue Shield. Claims could still be filed through February 2008.

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.

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.

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 Health Care, 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 Health Care 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 June 2008 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.

ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society 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 and the Blue Cross and Blue Shield Association last April, but the final settlement date was being worked out at press time. 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.

The court gave preliminary approval last November to a settlement with the West Virginia-based Highmark/Mountain State Blue Cross Blue Shield. Claims could still be filed through February 2008.

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.

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.

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 Health Care, 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 Health Care 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 June 2008 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.

ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society 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 and the Blue Cross and Blue Shield Association last April, but the final settlement date was being worked out at press time. 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.

The court gave preliminary approval last November to a settlement with the West Virginia-based Highmark/Mountain State Blue Cross Blue Shield. Claims could still be filed through February 2008.

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

Botox Promotions Investigated

The U.S. Attorney's office for the northern district of Georgia has subpoenaed Allergan, seeking documents that might show off-label promotion of Botox (botulinum toxin type A) for the treatment of headache. The company confirmed the inquiry in a statement, and said that while Allergan currently has Botox in phase III studies for headache, "it is Allergan's policy to promote its products only in a manner consistent with the FDA-approved product labeling." Allergan also intends to comply "with all applicable laws, rules, and regulations," according to the statement. Botox is Allergan's second-biggest-selling product, with $1.2 billion in sales in 2007. The company is projecting sales of about $1.3 billion this year.

Galderma Buys CollaGenex

Two dermatology powerhouses are about to combine—that is, if U.S. regulatory authorities approve the merger of Galderma Laboratories and CollaGenex Pharmaceuticals. Galderma proposes to purchase all of CollaGenex's outstanding shares for about $420 million. Galderma, a subsidiary of the Swiss drugmaker Galderma Pharma based in Newtown, Pa., has such products as Clobex, Tri-Luma, Cetaphil, and Pliaglis. It is also seeking U.S. approval for Dysport, a botulinum toxin type A injection sold in Brazil and Argentina. CollaGenex's flagship therapy is Oracea and the company is testing a vitamin D analogue for mild to moderate psoriasis. Galderma said that it expects to complete the merger before the end of the second quarter.

Supreme Court Limits Device Suits

The U.S. Supreme Court has bolstered medical device manufacturers' argument that FDA approval confers special protection against liability suits. The justices voted 8–1 in finding that the Medical Device Amendments of 1976 supersede state law. That federal law regulates devices that have gone through the premarket approval process, the most rigorous path to approval. Plaintiff Charles Riegel's estate had sued Medtronic Inc., alleging that a catheter that ruptured during cardiac surgery was designed, labeled, and manufactured in violation of New York law. But the justices said that FDA approval "bars common-law claims challenging the safety or effectiveness of a medical device. …" They upheld two previous lower court decisions; Justice Ruth Bader Ginsburg was the sole dissenter. Members of Congress involved in crafting the original amendments were not pleased. "Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," said Sen. Ted Kennedy (D-Mass.) in a statement. "Congress obviously needs to correct the court's decision," he said.

Woodcock Named CDER Head

Dr. Janet Woodcock has been named director of the FDA's Center for Drug Evaluation and Research. Dr. Woodcock, a rheumatologist, served as director of CDER once before, in the 1990s, and has served as acting director since October 2007. The drug industry's chief lobbying group, PhRMA, welcomed the appointment. Dr. Woodcock "has demonstrated willingness to work with diverse partners, including researchers, Congress, the White House, patients, and pharmaceutical research companies," said a statement from the group. But Public Citizen's health research group director Dr. Sidney Wolfe said in an interview that he's "not terribly hopeful" that Dr. Woodcock will lead the center well, because she doesn't like conflict or controversy. "I don't think she's the kind of CDER director we need right now," Dr. Wolfe said. "She's aware of a number of drugs on the market that should be taken off the market, but I don't think she has the fortitude to do something about it."

Drug, Device Promotion May Expand

FDA last month proposed draft guidance that would allow drug and medical device makers to distribute medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Drug and device makers had been allowed to disseminate such materials under guidelines set by the FDA, but that authority expired in September 2006. The FDA's new "Good Reprint Practices" draft guidance states that the article or reference should be published by an organization that has an editorial board and fully discloses conflicts of interest. In addition, articles should be peer reviewed, and manufacturers should not distribute special supplements or publications funded by product manufacturers. Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, blasted the FDA for its proposal, which he said in a statement "is great news for the drug industry but terrible for the public health."

Rx Abuse Worries Americans

The abuse of prescription drugs is as big a problem as the abuse of illegal drugs, according to respondents to a Wall Street Journal/Harris Interactive poll. Even so, less than half of those surveyed said they keep prescription medicines in a place where others can't access them. Seventy percent said they were somewhat or very concerned about the risk of addiction associated with some prescription pain medications. The vast majority of the 2,027 adults surveyed voiced the same level of concern about drug side effects and potentially harmful interactions between pain medications and other prescriptions. About 60% of the respondents said they discuss with their physician other prescriptions they are taking when they are prescribed a new medication. Smaller numbers said they told their physician about over-the-counter medications or nutritional supplements.

Botox Promotions Investigated

The U.S. Attorney's office for the northern district of Georgia has subpoenaed Allergan, seeking documents that might show off-label promotion of Botox (botulinum toxin type A) for the treatment of headache. The company confirmed the inquiry in a statement, and said that while Allergan currently has Botox in phase III studies for headache, "it is Allergan's policy to promote its products only in a manner consistent with the FDA-approved product labeling." Allergan also intends to comply "with all applicable laws, rules, and regulations," according to the statement. Botox is Allergan's second-biggest-selling product, with $1.2 billion in sales in 2007. The company is projecting sales of about $1.3 billion this year.

Galderma Buys CollaGenex

Two dermatology powerhouses are about to combine—that is, if U.S. regulatory authorities approve the merger of Galderma Laboratories and CollaGenex Pharmaceuticals. Galderma proposes to purchase all of CollaGenex's outstanding shares for about $420 million. Galderma, a subsidiary of the Swiss drugmaker Galderma Pharma based in Newtown, Pa., has such products as Clobex, Tri-Luma, Cetaphil, and Pliaglis. It is also seeking U.S. approval for Dysport, a botulinum toxin type A injection sold in Brazil and Argentina. CollaGenex's flagship therapy is Oracea and the company is testing a vitamin D analogue for mild to moderate psoriasis. Galderma said that it expects to complete the merger before the end of the second quarter.

Supreme Court Limits Device Suits

The U.S. Supreme Court has bolstered medical device manufacturers' argument that FDA approval confers special protection against liability suits. The justices voted 8–1 in finding that the Medical Device Amendments of 1976 supersede state law. That federal law regulates devices that have gone through the premarket approval process, the most rigorous path to approval. Plaintiff Charles Riegel's estate had sued Medtronic Inc., alleging that a catheter that ruptured during cardiac surgery was designed, labeled, and manufactured in violation of New York law. But the justices said that FDA approval "bars common-law claims challenging the safety or effectiveness of a medical device. …" They upheld two previous lower court decisions; Justice Ruth Bader Ginsburg was the sole dissenter. Members of Congress involved in crafting the original amendments were not pleased. "Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," said Sen. Ted Kennedy (D-Mass.) in a statement. "Congress obviously needs to correct the court's decision," he said.

Woodcock Named CDER Head

Dr. Janet Woodcock has been named director of the FDA's Center for Drug Evaluation and Research. Dr. Woodcock, a rheumatologist, served as director of CDER once before, in the 1990s, and has served as acting director since October 2007. The drug industry's chief lobbying group, PhRMA, welcomed the appointment. Dr. Woodcock "has demonstrated willingness to work with diverse partners, including researchers, Congress, the White House, patients, and pharmaceutical research companies," said a statement from the group. But Public Citizen's health research group director Dr. Sidney Wolfe said in an interview that he's "not terribly hopeful" that Dr. Woodcock will lead the center well, because she doesn't like conflict or controversy. "I don't think she's the kind of CDER director we need right now," Dr. Wolfe said. "She's aware of a number of drugs on the market that should be taken off the market, but I don't think she has the fortitude to do something about it."

Drug, Device Promotion May Expand

FDA last month proposed draft guidance that would allow drug and medical device makers to distribute medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Drug and device makers had been allowed to disseminate such materials under guidelines set by the FDA, but that authority expired in September 2006. The FDA's new "Good Reprint Practices" draft guidance states that the article or reference should be published by an organization that has an editorial board and fully discloses conflicts of interest. In addition, articles should be peer reviewed, and manufacturers should not distribute special supplements or publications funded by product manufacturers. Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, blasted the FDA for its proposal, which he said in a statement "is great news for the drug industry but terrible for the public health."

Rx Abuse Worries Americans

The abuse of prescription drugs is as big a problem as the abuse of illegal drugs, according to respondents to a Wall Street Journal/Harris Interactive poll. Even so, less than half of those surveyed said they keep prescription medicines in a place where others can't access them. Seventy percent said they were somewhat or very concerned about the risk of addiction associated with some prescription pain medications. The vast majority of the 2,027 adults surveyed voiced the same level of concern about drug side effects and potentially harmful interactions between pain medications and other prescriptions. About 60% of the respondents said they discuss with their physician other prescriptions they are taking when they are prescribed a new medication. Smaller numbers said they told their physician about over-the-counter medications or nutritional supplements.

Botox Promotions Investigated

The U.S. Attorney's office for the northern district of Georgia has subpoenaed Allergan, seeking documents that might show off-label promotion of Botox (botulinum toxin type A) for the treatment of headache. The company confirmed the inquiry in a statement, and said that while Allergan currently has Botox in phase III studies for headache, "it is Allergan's policy to promote its products only in a manner consistent with the FDA-approved product labeling." Allergan also intends to comply "with all applicable laws, rules, and regulations," according to the statement. Botox is Allergan's second-biggest-selling product, with $1.2 billion in sales in 2007. The company is projecting sales of about $1.3 billion this year.

Galderma Buys CollaGenex

Two dermatology powerhouses are about to combine—that is, if U.S. regulatory authorities approve the merger of Galderma Laboratories and CollaGenex Pharmaceuticals. Galderma proposes to purchase all of CollaGenex's outstanding shares for about $420 million. Galderma, a subsidiary of the Swiss drugmaker Galderma Pharma based in Newtown, Pa., has such products as Clobex, Tri-Luma, Cetaphil, and Pliaglis. It is also seeking U.S. approval for Dysport, a botulinum toxin type A injection sold in Brazil and Argentina. CollaGenex's flagship therapy is Oracea and the company is testing a vitamin D analogue for mild to moderate psoriasis. Galderma said that it expects to complete the merger before the end of the second quarter.

Supreme Court Limits Device Suits

The U.S. Supreme Court has bolstered medical device manufacturers' argument that FDA approval confers special protection against liability suits. The justices voted 8–1 in finding that the Medical Device Amendments of 1976 supersede state law. That federal law regulates devices that have gone through the premarket approval process, the most rigorous path to approval. Plaintiff Charles Riegel's estate had sued Medtronic Inc., alleging that a catheter that ruptured during cardiac surgery was designed, labeled, and manufactured in violation of New York law. But the justices said that FDA approval "bars common-law claims challenging the safety or effectiveness of a medical device. …" They upheld two previous lower court decisions; Justice Ruth Bader Ginsburg was the sole dissenter. Members of Congress involved in crafting the original amendments were not pleased. "Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," said Sen. Ted Kennedy (D-Mass.) in a statement. "Congress obviously needs to correct the court's decision," he said.

Woodcock Named CDER Head

Dr. Janet Woodcock has been named director of the FDA's Center for Drug Evaluation and Research. Dr. Woodcock, a rheumatologist, served as director of CDER once before, in the 1990s, and has served as acting director since October 2007. The drug industry's chief lobbying group, PhRMA, welcomed the appointment. Dr. Woodcock "has demonstrated willingness to work with diverse partners, including researchers, Congress, the White House, patients, and pharmaceutical research companies," said a statement from the group. But Public Citizen's health research group director Dr. Sidney Wolfe said in an interview that he's "not terribly hopeful" that Dr. Woodcock will lead the center well, because she doesn't like conflict or controversy. "I don't think she's the kind of CDER director we need right now," Dr. Wolfe said. "She's aware of a number of drugs on the market that should be taken off the market, but I don't think she has the fortitude to do something about it."

Drug, Device Promotion May Expand

FDA last month proposed draft guidance that would allow drug and medical device makers to distribute medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Drug and device makers had been allowed to disseminate such materials under guidelines set by the FDA, but that authority expired in September 2006. The FDA's new "Good Reprint Practices" draft guidance states that the article or reference should be published by an organization that has an editorial board and fully discloses conflicts of interest. In addition, articles should be peer reviewed, and manufacturers should not distribute special supplements or publications funded by product manufacturers. Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, blasted the FDA for its proposal, which he said in a statement "is great news for the drug industry but terrible for the public health."

Rx Abuse Worries Americans

The abuse of prescription drugs is as big a problem as the abuse of illegal drugs, according to respondents to a Wall Street Journal/Harris Interactive poll. Even so, less than half of those surveyed said they keep prescription medicines in a place where others can't access them. Seventy percent said they were somewhat or very concerned about the risk of addiction associated with some prescription pain medications. The vast majority of the 2,027 adults surveyed voiced the same level of concern about drug side effects and potentially harmful interactions between pain medications and other prescriptions. About 60% of the respondents said they discuss with their physician other prescriptions they are taking when they are prescribed a new medication. Smaller numbers said they told their physician about over-the-counter medications or nutritional supplements.

WASHINGTON — Congress is taking a tough look at the use of human growth hormone for a wide variety of conditions, which is prompting some concern that payers may react by limiting reimbursement for legitimate purposes.

Insurers are already reluctant to cover scientifically validated uses of HGH, Dr. Richard Hellman of the University of Missouri, Kansas City, said in an interview. The drug can cost $10,000-$20,000 a year. The continuing use for purposes that have little to no evidence of safety and effectiveness may ultimately endanger patients who genuinely need HGH, said Dr. Hellman, president of the American Association of Clinical Endocrinologists.

An Internet search for “HGH” shows that the drug (or an illicit or counterfeit version) is being promoted for a large number of off-label uses.

Although this has been a widely known problem, Congress decided to take a closer look at HGH and other alleged performance-enhancing substances in the wake of the December 2007 report issued by former Sen. George Mitchell that exposed a culture of acceptance for off-label and unproven uses of HGH and anabolic steroids in Major League Baseball.

In mid-February, the House Committee on Oversight and Government Reform held a hearing on what it called “myths and facts” about HGH, vitamin B12, and other substances. The hearing was essentially a warm-up for subsequent panel meetings on the use of such substances in baseball and other professional sports that were scheduled for February, but it touched on issues of interest to physicians.

The hearing was “an opportunity to provide essential and accurate information not just to professional athletes, but to high school kids, senior citizens, baby boomers turning 60, and everyone in between,” said Rep. Henry Waxman (D-Calif.), chairman of the oversight committee.

HGH has been touted as an antiaging substance, and increasingly appears to be used by athletes of all ages in the belief that it helps them improve performance and recover from injuries faster.

It has been legitimately studied for injury recovery in the elderly, and also is being investigated as a potential therapy for conditions such as fibromyalgia and chronic fatigue syndrome. But this field of inquiry is relatively new.

All of these uses are illegal. HGH is the sole Food and Drug Administration (FDA) approved product that can only be prescribed for the approved indications. In children, the approved indications are to treat growth hormone deficiency, chronic kidney disease, Turner syndrome, small-for-gestational-age infants who do not catch up to normal range, Prader-Willi syndrome, idiopathic short stature; SHOX gene haploinsufficiency, and Noonan syndrome. In adults, HGH is legal for AIDS-related wasting syndrome, short-bowel syndrome, and growth hormone deficiency.

Distribution of HGH, or possession with intent to distribute, for any off-label use is a felony, punishable with up to 5 years in prison and fines.

“Without question, those attempting to market or distribute HGH claiming it will aid healing, slow or reverse the aging process, assist in weight loss, or cure depression are scamming consumers and breaking the law,” warned Rep. Tom Davis (R-Va.), the oversight committee's ranking republican member.

And yet, some estimate that illegal HGH sales far outweigh the sanctioned market. Dr. Thomas Perls told the House committee in February that anti-aging sales amount to $2 billion a year. “I personally have found Web sites of 279 antiaging clinics that advertise HGH treatment, and 26 pharmacies that distribute the drug to these clinics or sometimes directly to users,” said Dr. Perls of Boston University. “I have certainly discovered only a fraction of what exists out there,” he added.

In a JAMA article in 2005, Dr. Perls said that legal sales of HGH in 2004 amounted to about $622 million annually, for a little more than 200,000 initial and refill prescriptions, according to data from IMS Health, a market research company (JAMA 2005:294;2086–90).

Dr. Alan Rogol, of the University of Virginia, Charlottesville, also expressed dismay at the House hearing at what appears to be the growing misuse of HGH. Off-label use comes with increased risk of side effects such as acromegaly, and increased insulin resistance or diabetes, said Dr. Rogol.

He also said that in many cases, HGH purchasers were getting something other than HGH. The prices being advertised are too low and, “many of these preparations are taken orally and cannot be the protein hormone HGH, for it is not active by this route,” said Dr. Rogol, who testified on behalf of the Endocrine Society.

Another potential danger is that many of the illicit sales are of human tissue-derived pituitary growth hormone, which has been removed from the market because it has the potential to contain the pathogen that causes Creutzfeldt-Jakob disease. And yet, some of this type of hormone is still available in Eastern Europe and through the Internet.

“It is my opinion for an adult there are no legitimate off-label uses,” Dr. Rogol emphasized in an interview.

But both Dr. Rogol and Dr. Hellman acknowledged that there are no central data on how much HGH is being used illicitly, by either nonphysician or physician prescribers. It's in the public interest to keep a registry or to create some other way to keep track of HGH use, Dr. Hellman said. Physicians legitimately using HGH “should have no problem having their work scrutinized,” he said.

Both also said they were open to considering data on new uses of HGH, as long as it came from a validated scientific process.

The Endocrine Society and AACE both have published guidelines on HGH. The Endocrine Society guidelines, published in 2006, only pertained to treating adult growth hormone deficiency (J. Clin. Endocrinol. Metab. 2006;91:1621–34).

AACE last published guidelines in 2003. That report took a broad look at HGH uses and highlighted concerns that off-label prescribing or abuse could lead to reimbursement issues for legitimate patients (Endocr. Pract. 2003;9:64–76).

WASHINGTON — Congress is taking a tough look at the use of human growth hormone for a wide variety of conditions, which is prompting some concern that payers may react by limiting reimbursement for legitimate purposes.

Insurers are already reluctant to cover scientifically validated uses of HGH, Dr. Richard Hellman of the University of Missouri, Kansas City, said in an interview. The drug can cost $10,000-$20,000 a year. The continuing use for purposes that have little to no evidence of safety and effectiveness may ultimately endanger patients who genuinely need HGH, said Dr. Hellman, president of the American Association of Clinical Endocrinologists.

An Internet search for “HGH” shows that the drug (or an illicit or counterfeit version) is being promoted for a large number of off-label uses.

Although this has been a widely known problem, Congress decided to take a closer look at HGH and other alleged performance-enhancing substances in the wake of the December 2007 report issued by former Sen. George Mitchell that exposed a culture of acceptance for off-label and unproven uses of HGH and anabolic steroids in Major League Baseball.

In mid-February, the House Committee on Oversight and Government Reform held a hearing on what it called “myths and facts” about HGH, vitamin B12, and other substances. The hearing was essentially a warm-up for subsequent panel meetings on the use of such substances in baseball and other professional sports that were scheduled for February, but it touched on issues of interest to physicians.

The hearing was “an opportunity to provide essential and accurate information not just to professional athletes, but to high school kids, senior citizens, baby boomers turning 60, and everyone in between,” said Rep. Henry Waxman (D-Calif.), chairman of the oversight committee.

HGH has been touted as an antiaging substance, and increasingly appears to be used by athletes of all ages in the belief that it helps them improve performance and recover from injuries faster.

It has been legitimately studied for injury recovery in the elderly, and also is being investigated as a potential therapy for conditions such as fibromyalgia and chronic fatigue syndrome. But this field of inquiry is relatively new.

All of these uses are illegal. HGH is the sole Food and Drug Administration (FDA) approved product that can only be prescribed for the approved indications. In children, the approved indications are to treat growth hormone deficiency, chronic kidney disease, Turner syndrome, small-for-gestational-age infants who do not catch up to normal range, Prader-Willi syndrome, idiopathic short stature; SHOX gene haploinsufficiency, and Noonan syndrome. In adults, HGH is legal for AIDS-related wasting syndrome, short-bowel syndrome, and growth hormone deficiency.

Distribution of HGH, or possession with intent to distribute, for any off-label use is a felony, punishable with up to 5 years in prison and fines.

“Without question, those attempting to market or distribute HGH claiming it will aid healing, slow or reverse the aging process, assist in weight loss, or cure depression are scamming consumers and breaking the law,” warned Rep. Tom Davis (R-Va.), the oversight committee's ranking republican member.

And yet, some estimate that illegal HGH sales far outweigh the sanctioned market. Dr. Thomas Perls told the House committee in February that anti-aging sales amount to $2 billion a year. “I personally have found Web sites of 279 antiaging clinics that advertise HGH treatment, and 26 pharmacies that distribute the drug to these clinics or sometimes directly to users,” said Dr. Perls of Boston University. “I have certainly discovered only a fraction of what exists out there,” he added.

In a JAMA article in 2005, Dr. Perls said that legal sales of HGH in 2004 amounted to about $622 million annually, for a little more than 200,000 initial and refill prescriptions, according to data from IMS Health, a market research company (JAMA 2005:294;2086–90).

Dr. Alan Rogol, of the University of Virginia, Charlottesville, also expressed dismay at the House hearing at what appears to be the growing misuse of HGH. Off-label use comes with increased risk of side effects such as acromegaly, and increased insulin resistance or diabetes, said Dr. Rogol.

He also said that in many cases, HGH purchasers were getting something other than HGH. The prices being advertised are too low and, “many of these preparations are taken orally and cannot be the protein hormone HGH, for it is not active by this route,” said Dr. Rogol, who testified on behalf of the Endocrine Society.

Another potential danger is that many of the illicit sales are of human tissue-derived pituitary growth hormone, which has been removed from the market because it has the potential to contain the pathogen that causes Creutzfeldt-Jakob disease. And yet, some of this type of hormone is still available in Eastern Europe and through the Internet.

“It is my opinion for an adult there are no legitimate off-label uses,” Dr. Rogol emphasized in an interview.

But both Dr. Rogol and Dr. Hellman acknowledged that there are no central data on how much HGH is being used illicitly, by either nonphysician or physician prescribers. It's in the public interest to keep a registry or to create some other way to keep track of HGH use, Dr. Hellman said. Physicians legitimately using HGH “should have no problem having their work scrutinized,” he said.

Both also said they were open to considering data on new uses of HGH, as long as it came from a validated scientific process.

The Endocrine Society and AACE both have published guidelines on HGH. The Endocrine Society guidelines, published in 2006, only pertained to treating adult growth hormone deficiency (J. Clin. Endocrinol. Metab. 2006;91:1621–34).

AACE last published guidelines in 2003. That report took a broad look at HGH uses and highlighted concerns that off-label prescribing or abuse could lead to reimbursement issues for legitimate patients (Endocr. Pract. 2003;9:64–76).

WASHINGTON — Congress is taking a tough look at the use of human growth hormone for a wide variety of conditions, which is prompting some concern that payers may react by limiting reimbursement for legitimate purposes.

Insurers are already reluctant to cover scientifically validated uses of HGH, Dr. Richard Hellman of the University of Missouri, Kansas City, said in an interview. The drug can cost $10,000-$20,000 a year. The continuing use for purposes that have little to no evidence of safety and effectiveness may ultimately endanger patients who genuinely need HGH, said Dr. Hellman, president of the American Association of Clinical Endocrinologists.

An Internet search for “HGH” shows that the drug (or an illicit or counterfeit version) is being promoted for a large number of off-label uses.

Although this has been a widely known problem, Congress decided to take a closer look at HGH and other alleged performance-enhancing substances in the wake of the December 2007 report issued by former Sen. George Mitchell that exposed a culture of acceptance for off-label and unproven uses of HGH and anabolic steroids in Major League Baseball.

In mid-February, the House Committee on Oversight and Government Reform held a hearing on what it called “myths and facts” about HGH, vitamin B12, and other substances. The hearing was essentially a warm-up for subsequent panel meetings on the use of such substances in baseball and other professional sports that were scheduled for February, but it touched on issues of interest to physicians.

The hearing was “an opportunity to provide essential and accurate information not just to professional athletes, but to high school kids, senior citizens, baby boomers turning 60, and everyone in between,” said Rep. Henry Waxman (D-Calif.), chairman of the oversight committee.

HGH has been touted as an antiaging substance, and increasingly appears to be used by athletes of all ages in the belief that it helps them improve performance and recover from injuries faster.

It has been legitimately studied for injury recovery in the elderly, and also is being investigated as a potential therapy for conditions such as fibromyalgia and chronic fatigue syndrome. But this field of inquiry is relatively new.

All of these uses are illegal. HGH is the sole Food and Drug Administration (FDA) approved product that can only be prescribed for the approved indications. In children, the approved indications are to treat growth hormone deficiency, chronic kidney disease, Turner syndrome, small-for-gestational-age infants who do not catch up to normal range, Prader-Willi syndrome, idiopathic short stature; SHOX gene haploinsufficiency, and Noonan syndrome. In adults, HGH is legal for AIDS-related wasting syndrome, short-bowel syndrome, and growth hormone deficiency.

Distribution of HGH, or possession with intent to distribute, for any off-label use is a felony, punishable with up to 5 years in prison and fines.

“Without question, those attempting to market or distribute HGH claiming it will aid healing, slow or reverse the aging process, assist in weight loss, or cure depression are scamming consumers and breaking the law,” warned Rep. Tom Davis (R-Va.), the oversight committee's ranking republican member.

And yet, some estimate that illegal HGH sales far outweigh the sanctioned market. Dr. Thomas Perls told the House committee in February that anti-aging sales amount to $2 billion a year. “I personally have found Web sites of 279 antiaging clinics that advertise HGH treatment, and 26 pharmacies that distribute the drug to these clinics or sometimes directly to users,” said Dr. Perls of Boston University. “I have certainly discovered only a fraction of what exists out there,” he added.

In a JAMA article in 2005, Dr. Perls said that legal sales of HGH in 2004 amounted to about $622 million annually, for a little more than 200,000 initial and refill prescriptions, according to data from IMS Health, a market research company (JAMA 2005:294;2086–90).

Dr. Alan Rogol, of the University of Virginia, Charlottesville, also expressed dismay at the House hearing at what appears to be the growing misuse of HGH. Off-label use comes with increased risk of side effects such as acromegaly, and increased insulin resistance or diabetes, said Dr. Rogol.

He also said that in many cases, HGH purchasers were getting something other than HGH. The prices being advertised are too low and, “many of these preparations are taken orally and cannot be the protein hormone HGH, for it is not active by this route,” said Dr. Rogol, who testified on behalf of the Endocrine Society.

Another potential danger is that many of the illicit sales are of human tissue-derived pituitary growth hormone, which has been removed from the market because it has the potential to contain the pathogen that causes Creutzfeldt-Jakob disease. And yet, some of this type of hormone is still available in Eastern Europe and through the Internet.

“It is my opinion for an adult there are no legitimate off-label uses,” Dr. Rogol emphasized in an interview.

But both Dr. Rogol and Dr. Hellman acknowledged that there are no central data on how much HGH is being used illicitly, by either nonphysician or physician prescribers. It's in the public interest to keep a registry or to create some other way to keep track of HGH use, Dr. Hellman said. Physicians legitimately using HGH “should have no problem having their work scrutinized,” he said.

Both also said they were open to considering data on new uses of HGH, as long as it came from a validated scientific process.

The Endocrine Society and AACE both have published guidelines on HGH. The Endocrine Society guidelines, published in 2006, only pertained to treating adult growth hormone deficiency (J. Clin. Endocrinol. Metab. 2006;91:1621–34).

AACE last published guidelines in 2003. That report took a broad look at HGH uses and highlighted concerns that off-label prescribing or abuse could lead to reimbursement issues for legitimate patients (Endocr. Pract. 2003;9:64–76).

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small increase from the previous year, America's prescription drug tab increased by 8.5%, fueled largely by the new Medicare Part D drug benefit.

Health spending as a share of the nation's gross domestic product continues to rise, hitting 16% in 2006. (See chart.)

Total spending on physician and clinical services grew 5.9% to $448 billion, which was the slowest rate of growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report, which was published in the January/February issue of Health Affairs.

Medicare had the fastest rate of growth since 1981, according to the report. Spending increased 19% in 2006 to $401 billion, driven largely by the prescription drug benefit and the cost of administration for that benefit and for Medicare Advantage, a managed care program.

Medicaid spending dropped for the first time since the program began in 1965. The 0.9% decrease was largely due to a large number of Medicaid enrollees who were shifted into Medicare for their prescription drugs.

Overall drug spending grew 8.5% in 2006—a far cry from the double-digit increases seen in the late 1990s, but still an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising given that about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising drug costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the millions of beneficiaries who shifted out of Medicaid.

The rising availability of generic drugs—and programs designed to encourage use of generics, such as smaller copays for that category—also drove an increase in pharmaceutical utilization. A $4 generic program offered by Wal-Mart contributed to that trend and also helped keep prices down, according to the CMS authors. Sixty-three percent of drugs dispensed in the United States in 2006 were generic, according to the report.

Overall, the CMS analysis shows that the largest category of health spending is still hospital care, which consumes 31% of the nation's health dollars. Other spending, which includes dental, home health, durable medical equipment, over-the-counter medications, public health, research, and capital equipment, consumes 25% of the health dollar. Physician and clinical services follow at 21%, then prescription drugs at 10%, administration at 7%, and nursing home care at 6%.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small increase from the previous year, America's prescription drug tab increased by 8.5%, fueled largely by the new Medicare Part D drug benefit.

Health spending as a share of the nation's gross domestic product continues to rise, hitting 16% in 2006. (See chart.)

Total spending on physician and clinical services grew 5.9% to $448 billion, which was the slowest rate of growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report, which was published in the January/February issue of Health Affairs.

Medicare had the fastest rate of growth since 1981, according to the report. Spending increased 19% in 2006 to $401 billion, driven largely by the prescription drug benefit and the cost of administration for that benefit and for Medicare Advantage, a managed care program.

Medicaid spending dropped for the first time since the program began in 1965. The 0.9% decrease was largely due to a large number of Medicaid enrollees who were shifted into Medicare for their prescription drugs.

Overall drug spending grew 8.5% in 2006—a far cry from the double-digit increases seen in the late 1990s, but still an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising given that about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising drug costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the millions of beneficiaries who shifted out of Medicaid.

The rising availability of generic drugs—and programs designed to encourage use of generics, such as smaller copays for that category—also drove an increase in pharmaceutical utilization. A $4 generic program offered by Wal-Mart contributed to that trend and also helped keep prices down, according to the CMS authors. Sixty-three percent of drugs dispensed in the United States in 2006 were generic, according to the report.

Overall, the CMS analysis shows that the largest category of health spending is still hospital care, which consumes 31% of the nation's health dollars. Other spending, which includes dental, home health, durable medical equipment, over-the-counter medications, public health, research, and capital equipment, consumes 25% of the health dollar. Physician and clinical services follow at 21%, then prescription drugs at 10%, administration at 7%, and nursing home care at 6%.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small increase from the previous year, America's prescription drug tab increased by 8.5%, fueled largely by the new Medicare Part D drug benefit.

Health spending as a share of the nation's gross domestic product continues to rise, hitting 16% in 2006. (See chart.)

Total spending on physician and clinical services grew 5.9% to $448 billion, which was the slowest rate of growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report, which was published in the January/February issue of Health Affairs.

Medicare had the fastest rate of growth since 1981, according to the report. Spending increased 19% in 2006 to $401 billion, driven largely by the prescription drug benefit and the cost of administration for that benefit and for Medicare Advantage, a managed care program.

Medicaid spending dropped for the first time since the program began in 1965. The 0.9% decrease was largely due to a large number of Medicaid enrollees who were shifted into Medicare for their prescription drugs.

Overall drug spending grew 8.5% in 2006—a far cry from the double-digit increases seen in the late 1990s, but still an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising given that about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising drug costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the millions of beneficiaries who shifted out of Medicaid.

The rising availability of generic drugs—and programs designed to encourage use of generics, such as smaller copays for that category—also drove an increase in pharmaceutical utilization. A $4 generic program offered by Wal-Mart contributed to that trend and also helped keep prices down, according to the CMS authors. Sixty-three percent of drugs dispensed in the United States in 2006 were generic, according to the report.

Overall, the CMS analysis shows that the largest category of health spending is still hospital care, which consumes 31% of the nation's health dollars. Other spending, which includes dental, home health, durable medical equipment, over-the-counter medications, public health, research, and capital equipment, consumes 25% of the health dollar. Physician and clinical services follow at 21%, then prescription drugs at 10%, administration at 7%, and nursing home care at 6%.

ELSEVIER GLOBAL MEDICAL NEWS

One of the nation's largest health care quality coalitions is launching a program that would provide bonuses of up to $100,000 annually to physicians who meet criteria showing that they are offering coordinated care by providing a medical home for their patients.

The Medical Home Program was announced by Bridges to Excellence in late January. So far, none of BTE's employers or payers have formally committed to the program, Mr. Francois de Brantes, CEO of the coalition, said in an interview. By late spring, however, he expects to “have a couple of exciting announcements.”

Mr. de Brantes noted that the rewards won't be limited to internists and family physicians. Being a specialist is not an obstacle. Any physician who meets the performance targets—including ob.gyns., endocrinologists, cardiologists, infectious disease specialists, and neurologists—can receive a medical home designation, he said.

Dr. Michael Barr said that the program might spur physicians who are already working on practice improvement, but not documenting it, to start doing so, thereby becoming eligible for the bonuses. The “patient ultimately benefits from better coordination” of care, Dr. Barr, vice president for practice advocacy and improvement at the American College of Physicians, added in an interview.

“We feel pretty confident that the rewards are warranted and that the savings are there to match them,” Mr. de Brantes said. “Our research shows that patients who are well taken care of cost less,” he said, adding that “the average potential savings per covered life would be approximately $250 a year.”

The nonprofit BTE is a coalition of providers, insurers, and employers working together to advance the quality of health care. Members include Aetna, the American Board of Internal Medicine, the Blue Cross and Blue Shield Association, Cisco Systems, IBM, the Leapfrog Group, the National Business Coalition on Health, Partners Healthcare System, and Verizon Communications.

BTE has previously offered pay-for-performance incentives to physicians who use its Physician Office Link, Diabetes Care Link, Cardiac Care Link, and Spine Care Link reporting systems. Physician Office Link was developed in collaboration with the National Committee for Quality Assurance.

With the new Medical Home Program, physicians will be eligible for additional bonus payments of $125 per patient—up to a maximum $100,000 per provider—if they achieve certain performance levels on the Physician Office Link module and at least two of the condition-specific modules.

It's not yet clear when the medical home rewards will start flowing, but the structure is fairly well established, according to Mr. de Brantes.

The organization is requiring high performance in two conditions—not just one—because achieving that benchmark will require “fundamentally changing your practice process flows and the way you care for patients,” he said. Once that shift occurs, quality improves for all patients. Physicians will receive rewards based on the total number of patients in the practice.

Most of the participants in the BTE coalition are committed to the notion of a medical home, Mr. de Brantes said. “Now it's a question of solidifying the implementation with those organizations and getting it done in various sites across the country,” he said.

One of the nation's largest health care quality coalitions is launching a program that would provide bonuses of up to $100,000 annually to physicians who meet criteria showing that they are offering coordinated care by providing a medical home for their patients.

The Medical Home Program was announced by Bridges to Excellence in late January. So far, none of BTE's employers or payers have formally committed to the program, Mr. Francois de Brantes, CEO of the coalition, said in an interview. By late spring, however, he expects to “have a couple of exciting announcements.”

Mr. de Brantes noted that the rewards won't be limited to internists and family physicians. Being a specialist is not an obstacle. Any physician who meets the performance targets—including ob.gyns., endocrinologists, cardiologists, infectious disease specialists, and neurologists—can receive a medical home designation, he said.

Dr. Michael Barr said that the program might spur physicians who are already working on practice improvement, but not documenting it, to start doing so, thereby becoming eligible for the bonuses. The “patient ultimately benefits from better coordination” of care, Dr. Barr, vice president for practice advocacy and improvement at the American College of Physicians, added in an interview.

“We feel pretty confident that the rewards are warranted and that the savings are there to match them,” Mr. de Brantes said. “Our research shows that patients who are well taken care of cost less,” he said, adding that “the average potential savings per covered life would be approximately $250 a year.”

The nonprofit BTE is a coalition of providers, insurers, and employers working together to advance the quality of health care. Members include Aetna, the American Board of Internal Medicine, the Blue Cross and Blue Shield Association, Cisco Systems, IBM, the Leapfrog Group, the National Business Coalition on Health, Partners Healthcare System, and Verizon Communications.

BTE has previously offered pay-for-performance incentives to physicians who use its Physician Office Link, Diabetes Care Link, Cardiac Care Link, and Spine Care Link reporting systems. Physician Office Link was developed in collaboration with the National Committee for Quality Assurance.

With the new Medical Home Program, physicians will be eligible for additional bonus payments of $125 per patient—up to a maximum $100,000 per provider—if they achieve certain performance levels on the Physician Office Link module and at least two of the condition-specific modules.

It's not yet clear when the medical home rewards will start flowing, but the structure is fairly well established, according to Mr. de Brantes.

The organization is requiring high performance in two conditions—not just one—because achieving that benchmark will require “fundamentally changing your practice process flows and the way you care for patients,” he said. Once that shift occurs, quality improves for all patients. Physicians will receive rewards based on the total number of patients in the practice.

Most of the participants in the BTE coalition are committed to the notion of a medical home, Mr. de Brantes said. “Now it's a question of solidifying the implementation with those organizations and getting it done in various sites across the country,” he said.

One of the nation's largest health care quality coalitions is launching a program that would provide bonuses of up to $100,000 annually to physicians who meet criteria showing that they are offering coordinated care by providing a medical home for their patients.

The Medical Home Program was announced by Bridges to Excellence in late January. So far, none of BTE's employers or payers have formally committed to the program, Mr. Francois de Brantes, CEO of the coalition, said in an interview. By late spring, however, he expects to “have a couple of exciting announcements.”

Mr. de Brantes noted that the rewards won't be limited to internists and family physicians. Being a specialist is not an obstacle. Any physician who meets the performance targets—including ob.gyns., endocrinologists, cardiologists, infectious disease specialists, and neurologists—can receive a medical home designation, he said.

Dr. Michael Barr said that the program might spur physicians who are already working on practice improvement, but not documenting it, to start doing so, thereby becoming eligible for the bonuses. The “patient ultimately benefits from better coordination” of care, Dr. Barr, vice president for practice advocacy and improvement at the American College of Physicians, added in an interview.

“We feel pretty confident that the rewards are warranted and that the savings are there to match them,” Mr. de Brantes said. “Our research shows that patients who are well taken care of cost less,” he said, adding that “the average potential savings per covered life would be approximately $250 a year.”

The nonprofit BTE is a coalition of providers, insurers, and employers working together to advance the quality of health care. Members include Aetna, the American Board of Internal Medicine, the Blue Cross and Blue Shield Association, Cisco Systems, IBM, the Leapfrog Group, the National Business Coalition on Health, Partners Healthcare System, and Verizon Communications.

BTE has previously offered pay-for-performance incentives to physicians who use its Physician Office Link, Diabetes Care Link, Cardiac Care Link, and Spine Care Link reporting systems. Physician Office Link was developed in collaboration with the National Committee for Quality Assurance.

With the new Medical Home Program, physicians will be eligible for additional bonus payments of $125 per patient—up to a maximum $100,000 per provider—if they achieve certain performance levels on the Physician Office Link module and at least two of the condition-specific modules.

It's not yet clear when the medical home rewards will start flowing, but the structure is fairly well established, according to Mr. de Brantes.

The organization is requiring high performance in two conditions—not just one—because achieving that benchmark will require “fundamentally changing your practice process flows and the way you care for patients,” he said. Once that shift occurs, quality improves for all patients. Physicians will receive rewards based on the total number of patients in the practice.

Most of the participants in the BTE coalition are committed to the notion of a medical home, Mr. de Brantes said. “Now it's a question of solidifying the implementation with those organizations and getting it done in various sites across the country,” he said.

Dr. Jeffrey Rich is trading in his scalpel for a bureaucrat's pen in the hope that he'll give Medicare a strong and credible push into a future that will reward those who deliver high-quality care at the best cost. The cardiothoracic surgeon took over as director of the Center for Medicare Management in February.

Dr. Rich has delved deeply into restructuring reimbursement to reward quality care through his work with the National Quality Forum, the Hospital Quality Alliance, the Surgical Quality Alliance, and the AQA alliance, among other organizations.

He also helped launch the Virginia Cardiac Surgery Quality Initiative, which was one of the initial participants in CMS's Hospital Quality Incentive Demonstration project.

Dr. Rich has served as chairman of the board of directors for the Virginia initiative and also as a member of the quality committee.

On three occasions, Dr. Rich has testified before Congress on how the federal government could construct a payment system to reward quality. He has also given a congressional briefing on pay for performance.

Even so, Dr. Rich said he's often felt like an outsider, trying to get policy makers' attention. Now, he'll be on the inside.

“I get a chance to open a door instead of knocking on it,” Dr. Rich said in an interview, noting that he's been “knocking on doors for years.”

As director of the Center for Medicare Management, he will lead several federal initiatives, such as instituting competitive bidding for durable medical equipment, implementing the Medicare Administrative Contractor program, and overseeing the development and promulgation of rules pertaining to inpatient, outpatient, and physician payments.

But his top priority is guiding the center's value-based purchasing initiative.

The Virginia Cardiac Surgery Quality Initiative ably combined the CMS administrative claims database with the Society of Thoracic Surgery registry, said Dr. Rich, adding that he'd like to do something similar while at CMS. “My hope is that we do create a value-based purchasing system with credible data and that will engender trust with providers,” he said.

The key will be to use “market-based approaches, not mandates,” Dr. Rich said.

Although he is excited about his opportunities and future with CMS, Dr. Rich did express some sadness about his forced retirement from surgery. “It didn't feel good to resign from my practice,” he said.

Dr. Rich worked as a surgeon with a group cardiothoracic surgery practice that is based at Sentara Heart Hospital in Norfolk, Va.. He also serves on the board of directors for the Society of Thoracic Surgeons.

Government ethics rules dictated that he quit, said Dr. Rich, although he added that he will be able to keep his hand in surgery by occasionally taking call when he returns home to Norfolk on the weekends after a work week split between Washington and CMS's Baltimore headquarters. That light duty has been cleared by the feds.

And, most likely, he'll be back to the operating room early next year. As with all presidential appointees, the law requires that he resign his position by the time the next president is sworn in on Jan. 20, 2009.

Although he could be kept on, Dr. Rich said “I'm not anticipating being there more than a year.”

Dr. Jeffrey Rich is trading in his scalpel for a bureaucrat's pen in the hope that he'll give Medicare a strong and credible push into a future that will reward those who deliver high-quality care at the best cost. The cardiothoracic surgeon took over as director of the Center for Medicare Management in February.

Dr. Rich has delved deeply into restructuring reimbursement to reward quality care through his work with the National Quality Forum, the Hospital Quality Alliance, the Surgical Quality Alliance, and the AQA alliance, among other organizations.

He also helped launch the Virginia Cardiac Surgery Quality Initiative, which was one of the initial participants in CMS's Hospital Quality Incentive Demonstration project.

Dr. Rich has served as chairman of the board of directors for the Virginia initiative and also as a member of the quality committee.

On three occasions, Dr. Rich has testified before Congress on how the federal government could construct a payment system to reward quality. He has also given a congressional briefing on pay for performance.

Even so, Dr. Rich said he's often felt like an outsider, trying to get policy makers' attention. Now, he'll be on the inside.

“I get a chance to open a door instead of knocking on it,” Dr. Rich said in an interview, noting that he's been “knocking on doors for years.”

As director of the Center for Medicare Management, he will lead several federal initiatives, such as instituting competitive bidding for durable medical equipment, implementing the Medicare Administrative Contractor program, and overseeing the development and promulgation of rules pertaining to inpatient, outpatient, and physician payments.

But his top priority is guiding the center's value-based purchasing initiative.

The Virginia Cardiac Surgery Quality Initiative ably combined the CMS administrative claims database with the Society of Thoracic Surgery registry, said Dr. Rich, adding that he'd like to do something similar while at CMS. “My hope is that we do create a value-based purchasing system with credible data and that will engender trust with providers,” he said.

The key will be to use “market-based approaches, not mandates,” Dr. Rich said.

Although he is excited about his opportunities and future with CMS, Dr. Rich did express some sadness about his forced retirement from surgery. “It didn't feel good to resign from my practice,” he said.

Dr. Rich worked as a surgeon with a group cardiothoracic surgery practice that is based at Sentara Heart Hospital in Norfolk, Va.. He also serves on the board of directors for the Society of Thoracic Surgeons.

Government ethics rules dictated that he quit, said Dr. Rich, although he added that he will be able to keep his hand in surgery by occasionally taking call when he returns home to Norfolk on the weekends after a work week split between Washington and CMS's Baltimore headquarters. That light duty has been cleared by the feds.

And, most likely, he'll be back to the operating room early next year. As with all presidential appointees, the law requires that he resign his position by the time the next president is sworn in on Jan. 20, 2009.

Although he could be kept on, Dr. Rich said “I'm not anticipating being there more than a year.”

Dr. Jeffrey Rich is trading in his scalpel for a bureaucrat's pen in the hope that he'll give Medicare a strong and credible push into a future that will reward those who deliver high-quality care at the best cost. The cardiothoracic surgeon took over as director of the Center for Medicare Management in February.

Dr. Rich has delved deeply into restructuring reimbursement to reward quality care through his work with the National Quality Forum, the Hospital Quality Alliance, the Surgical Quality Alliance, and the AQA alliance, among other organizations.

He also helped launch the Virginia Cardiac Surgery Quality Initiative, which was one of the initial participants in CMS's Hospital Quality Incentive Demonstration project.

Dr. Rich has served as chairman of the board of directors for the Virginia initiative and also as a member of the quality committee.

On three occasions, Dr. Rich has testified before Congress on how the federal government could construct a payment system to reward quality. He has also given a congressional briefing on pay for performance.

Even so, Dr. Rich said he's often felt like an outsider, trying to get policy makers' attention. Now, he'll be on the inside.

“I get a chance to open a door instead of knocking on it,” Dr. Rich said in an interview, noting that he's been “knocking on doors for years.”

As director of the Center for Medicare Management, he will lead several federal initiatives, such as instituting competitive bidding for durable medical equipment, implementing the Medicare Administrative Contractor program, and overseeing the development and promulgation of rules pertaining to inpatient, outpatient, and physician payments.

But his top priority is guiding the center's value-based purchasing initiative.

The Virginia Cardiac Surgery Quality Initiative ably combined the CMS administrative claims database with the Society of Thoracic Surgery registry, said Dr. Rich, adding that he'd like to do something similar while at CMS. “My hope is that we do create a value-based purchasing system with credible data and that will engender trust with providers,” he said.

The key will be to use “market-based approaches, not mandates,” Dr. Rich said.

Although he is excited about his opportunities and future with CMS, Dr. Rich did express some sadness about his forced retirement from surgery. “It didn't feel good to resign from my practice,” he said.

Dr. Rich worked as a surgeon with a group cardiothoracic surgery practice that is based at Sentara Heart Hospital in Norfolk, Va.. He also serves on the board of directors for the Society of Thoracic Surgeons.

Government ethics rules dictated that he quit, said Dr. Rich, although he added that he will be able to keep his hand in surgery by occasionally taking call when he returns home to Norfolk on the weekends after a work week split between Washington and CMS's Baltimore headquarters. That light duty has been cleared by the feds.

And, most likely, he'll be back to the operating room early next year. As with all presidential appointees, the law requires that he resign his position by the time the next president is sworn in on Jan. 20, 2009.

Although he could be kept on, Dr. Rich said “I'm not anticipating being there more than a year.”

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small hike from 2005, America's prescription drug tab grew by 8.5%.

Health spending as a share of the nation's gross domestic product hit 16% in 2006.

Total spending on physician and clinical services grew 6% to $448 billion, the slowest growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Ms. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report.

Nursing home prices dropped; spending still grew 3.5% in 2006, less than the almost 5% increase in 2005. Home health services grew almost 10% in 2006, down from a 12% increase in 2005.

Medicare spending increased 19% to $401 billion, driven largely by the prescription drug benefit, the administration cost for that benefit, and Medicare Advantage.

Overall drug spending grew 8.5% in 2006—an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising since about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the beneficiaries who shifted out of Medicaid.

Medicare spent $41 billion on Part D in 2006, with $35 billion for drug purchases and $6 billion for administration and “net cost of insurance”—the cost of subsidizing premiums for low-income beneficiaries and costs for transferring beneficiaries into private plans. Medicare paid for 18% of all retail drugs, versus only 2% in 2005. Medicare took on costs previously covered by private insurers, Medicaid, and the uninsured.

On average, each Part D enrollee received $1,700 in benefits, according to CMS.

Generics accounted for 63% of drugs dispensed in the U.S. in 2006, according to the report.

The largest category of spending is hospital care, which eats up 31% of U.S. health dollars.

Consumers Union: Private Insurers Are Gouging

Government economists have concluded that the Medicare Part D prescription drug benefit did not affect the price of pharmaceuticals in 2006, the program's first full year, but Consumers Union has issued another in a series of studies, this one making charges that drug prices are indeed rising under the program.

Each month since December 2005, the consumer advocacy group has tracked the prices of five drugs commonly used by Medicare beneficiaries in a single ZIP code in each of five states—California, New York, Illinois, Florida, and Texas.

The data are taken directly from

Medicare.gov

Consumers Union Senior Policy Analyst Bill Vaughan said in an interview the group found that prices generally rise the most from December to January—after a beneficiary has locked into a plan for the upcoming year. The average increase for the five drugs as a package (Lipitor, Celebrex, Zoloft, nifedipine ER, and Altace) was $369 from December 2007 to January 2008, according to Consumers Union.

Mr. Vaughan also noted: “These continual price hikes are Exhibit A for Congress to give renewed attention to negotiating drug prices on behalf of America's taxpayers and seniors, and offering the option of a Medicare-run drug benefit.”

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small hike from 2005, America's prescription drug tab grew by 8.5%.

Health spending as a share of the nation's gross domestic product hit 16% in 2006.

Total spending on physician and clinical services grew 6% to $448 billion, the slowest growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Ms. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report.

Nursing home prices dropped; spending still grew 3.5% in 2006, less than the almost 5% increase in 2005. Home health services grew almost 10% in 2006, down from a 12% increase in 2005.

Medicare spending increased 19% to $401 billion, driven largely by the prescription drug benefit, the administration cost for that benefit, and Medicare Advantage.

Overall drug spending grew 8.5% in 2006—an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising since about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the beneficiaries who shifted out of Medicaid.

Medicare spent $41 billion on Part D in 2006, with $35 billion for drug purchases and $6 billion for administration and “net cost of insurance”—the cost of subsidizing premiums for low-income beneficiaries and costs for transferring beneficiaries into private plans. Medicare paid for 18% of all retail drugs, versus only 2% in 2005. Medicare took on costs previously covered by private insurers, Medicaid, and the uninsured.

On average, each Part D enrollee received $1,700 in benefits, according to CMS.

Generics accounted for 63% of drugs dispensed in the U.S. in 2006, according to the report.

The largest category of spending is hospital care, which eats up 31% of U.S. health dollars.

Consumers Union: Private Insurers Are Gouging

Government economists have concluded that the Medicare Part D prescription drug benefit did not affect the price of pharmaceuticals in 2006, the program's first full year, but Consumers Union has issued another in a series of studies, this one making charges that drug prices are indeed rising under the program.

Each month since December 2005, the consumer advocacy group has tracked the prices of five drugs commonly used by Medicare beneficiaries in a single ZIP code in each of five states—California, New York, Illinois, Florida, and Texas.

The data are taken directly from

Medicare.gov

Consumers Union Senior Policy Analyst Bill Vaughan said in an interview the group found that prices generally rise the most from December to January—after a beneficiary has locked into a plan for the upcoming year. The average increase for the five drugs as a package (Lipitor, Celebrex, Zoloft, nifedipine ER, and Altace) was $369 from December 2007 to January 2008, according to Consumers Union.

Mr. Vaughan also noted: “These continual price hikes are Exhibit A for Congress to give renewed attention to negotiating drug prices on behalf of America's taxpayers and seniors, and offering the option of a Medicare-run drug benefit.”

WASHINGTON — The nation spent $2 trillion, or $7,000 per person, on health care in 2006. While that was only a small hike from 2005, America's prescription drug tab grew by 8.5%.

Health spending as a share of the nation's gross domestic product hit 16% in 2006.

Total spending on physician and clinical services grew 6% to $448 billion, the slowest growth since 1999. Physician pay crawled almost to a halt, largely because of the freeze in Medicare's reimbursement rates in 2006. Private insurers seemed to have followed suit, said Cathy Cowan, an economist at the Centers for Medicare and Medicaid Services. Ms. Cowan, a coauthor of an annual analysis of the nation's health spending, spoke at a briefing on the report.

Nursing home prices dropped; spending still grew 3.5% in 2006, less than the almost 5% increase in 2005. Home health services grew almost 10% in 2006, down from a 12% increase in 2005.

Medicare spending increased 19% to $401 billion, driven largely by the prescription drug benefit, the administration cost for that benefit, and Medicare Advantage.

Overall drug spending grew 8.5% in 2006—an increase from the 5.8% rise in spending in 2005. Half of the 2006 increase was due to greater utilization, not surprising since about 23 million Medicare beneficiaries took advantage of the new benefit. Prescription prices increased by only a little over 3%, according to an annual analysis by actuaries at the Centers for Medicare and Medicaid Services.

The change in the drug rebate picture also contributed to rising costs. Under Medicaid, states received an average 30% rebate from drugmakers. Medicare, however, got only about 5% from manufacturers for the beneficiaries who shifted out of Medicaid.

Medicare spent $41 billion on Part D in 2006, with $35 billion for drug purchases and $6 billion for administration and “net cost of insurance”—the cost of subsidizing premiums for low-income beneficiaries and costs for transferring beneficiaries into private plans. Medicare paid for 18% of all retail drugs, versus only 2% in 2005. Medicare took on costs previously covered by private insurers, Medicaid, and the uninsured.

On average, each Part D enrollee received $1,700 in benefits, according to CMS.

Generics accounted for 63% of drugs dispensed in the U.S. in 2006, according to the report.

The largest category of spending is hospital care, which eats up 31% of U.S. health dollars.

Consumers Union: Private Insurers Are Gouging

Government economists have concluded that the Medicare Part D prescription drug benefit did not affect the price of pharmaceuticals in 2006, the program's first full year, but Consumers Union has issued another in a series of studies, this one making charges that drug prices are indeed rising under the program.

Each month since December 2005, the consumer advocacy group has tracked the prices of five drugs commonly used by Medicare beneficiaries in a single ZIP code in each of five states—California, New York, Illinois, Florida, and Texas.

The data are taken directly from

Medicare.gov

Consumers Union Senior Policy Analyst Bill Vaughan said in an interview the group found that prices generally rise the most from December to January—after a beneficiary has locked into a plan for the upcoming year. The average increase for the five drugs as a package (Lipitor, Celebrex, Zoloft, nifedipine ER, and Altace) was $369 from December 2007 to January 2008, according to Consumers Union.

Mr. Vaughan also noted: “These continual price hikes are Exhibit A for Congress to give renewed attention to negotiating drug prices on behalf of America's taxpayers and seniors, and offering the option of a Medicare-run drug benefit.”

Hospitals participating in a Medicare-sponsored, pay-for-performance demonstration project have sustained initial gains in quality improvement and seen a decline in mortality and costs for selected conditions over 3 years, according to data released by Premier Inc., a hospital performance improvement alliance.

The median hospital cost per patient dropped by $1,000, and the median mortality dropped by 2%. The project has 250 participating hospitals, and more than 1 million patient records were analyzed.

Premier, which manages the Centers for Medicare and Medicaid Services-funded Hospital Quality Incentive Demonstration project, estimated that if every hospital in the U.S. achieved the same benchmarks, there would be 70,000 fewer deaths each year and hospital costs would drop by $4.5 billion.

At a briefing, Mark Wynn, Ph.D., director of payment policy demonstrations at CMS, said the project is one of the agency's primary arguments in favor of value-based purchasing, a policy CMS regards as the most effective way to reward efficiency and value. “Relatively modest dollars can have huge impacts,” he said.

Dr. Evan Benjamin, chief quality officer for Baystate Health System in Springfield, Mass., agreed. He was the lead author of a study looking at earlier data which found quality was higher among the 250 incentivized hospitals than it was in control hospitals that reported data publicly but were not given incentives (N. Engl. J. Med. 2007;356:486-96).

The demonstration project began in October 2003; data covered every quarter through June 2007.

Hospitals were given aggregate scores for each of five conditions–acute myocardial infarction, heart failure, coronary artery bypass graft, pneumonia, and hip and knee replacement–based on reporting for 27 process measures. Hospitals with fewer than eight cases per quarter were excluded, and all data were adjusted using the All Patient Refined-Diagnostic Related Groups (APR-DRG) methodology created by 3M Information Systems.

Overall, hospitals improved by an average 17% on a composite quality score used by the project.

There was a continuing downward trend in performance variation among the hospitals, with all moving toward the ideal, said Richard Norling, president and CEO of Premier Inc. Costs and mortality were lowest for the hospitals that were on target 100% of the time with 100% of patients, he said.

For instance, the mortality for coronary artery bypass graft patients was close to 6% at hospitals that met appropriate care benchmarks in only half the patients or fewer. Mortality was just under 2% for facilities that met those benchmarks in 75%-100% of the patients, Mr. Norling told reporters.

Attaining the goals of the demonstration project required cultural shifts and investments in information systems. Before the project, the Aurora Health Care system was reactive and was achieving only incremental quality improvement, said Dr. Nick Turkal, president and CEO of the Milwaukee-based nonprofit system. The system's 13 hospitals have 100,000 admissions annually. Data on meeting the pay-for-performance goals are given to employees every 60 days, and are updated regularly on the system's Web site for the public to see. Mortality and costs are down significantly, but “we're not done yet,” he said.

Hospitals participating in a Medicare-sponsored, pay-for-performance demonstration project have sustained initial gains in quality improvement and seen a decline in mortality and costs for selected conditions over 3 years, according to data released by Premier Inc., a hospital performance improvement alliance.

The median hospital cost per patient dropped by $1,000, and the median mortality dropped by 2%. The project has 250 participating hospitals, and more than 1 million patient records were analyzed.

Premier, which manages the Centers for Medicare and Medicaid Services-funded Hospital Quality Incentive Demonstration project, estimated that if every hospital in the U.S. achieved the same benchmarks, there would be 70,000 fewer deaths each year and hospital costs would drop by $4.5 billion.

At a briefing, Mark Wynn, Ph.D., director of payment policy demonstrations at CMS, said the project is one of the agency's primary arguments in favor of value-based purchasing, a policy CMS regards as the most effective way to reward efficiency and value. “Relatively modest dollars can have huge impacts,” he said.

Dr. Evan Benjamin, chief quality officer for Baystate Health System in Springfield, Mass., agreed. He was the lead author of a study looking at earlier data which found quality was higher among the 250 incentivized hospitals than it was in control hospitals that reported data publicly but were not given incentives (N. Engl. J. Med. 2007;356:486-96).

The demonstration project began in October 2003; data covered every quarter through June 2007.

Hospitals were given aggregate scores for each of five conditions–acute myocardial infarction, heart failure, coronary artery bypass graft, pneumonia, and hip and knee replacement–based on reporting for 27 process measures. Hospitals with fewer than eight cases per quarter were excluded, and all data were adjusted using the All Patient Refined-Diagnostic Related Groups (APR-DRG) methodology created by 3M Information Systems.

Overall, hospitals improved by an average 17% on a composite quality score used by the project.

There was a continuing downward trend in performance variation among the hospitals, with all moving toward the ideal, said Richard Norling, president and CEO of Premier Inc. Costs and mortality were lowest for the hospitals that were on target 100% of the time with 100% of patients, he said.

For instance, the mortality for coronary artery bypass graft patients was close to 6% at hospitals that met appropriate care benchmarks in only half the patients or fewer. Mortality was just under 2% for facilities that met those benchmarks in 75%-100% of the patients, Mr. Norling told reporters.

Attaining the goals of the demonstration project required cultural shifts and investments in information systems. Before the project, the Aurora Health Care system was reactive and was achieving only incremental quality improvement, said Dr. Nick Turkal, president and CEO of the Milwaukee-based nonprofit system. The system's 13 hospitals have 100,000 admissions annually. Data on meeting the pay-for-performance goals are given to employees every 60 days, and are updated regularly on the system's Web site for the public to see. Mortality and costs are down significantly, but “we're not done yet,” he said.

Hospitals participating in a Medicare-sponsored, pay-for-performance demonstration project have sustained initial gains in quality improvement and seen a decline in mortality and costs for selected conditions over 3 years, according to data released by Premier Inc., a hospital performance improvement alliance.

The median hospital cost per patient dropped by $1,000, and the median mortality dropped by 2%. The project has 250 participating hospitals, and more than 1 million patient records were analyzed.

Premier, which manages the Centers for Medicare and Medicaid Services-funded Hospital Quality Incentive Demonstration project, estimated that if every hospital in the U.S. achieved the same benchmarks, there would be 70,000 fewer deaths each year and hospital costs would drop by $4.5 billion.

At a briefing, Mark Wynn, Ph.D., director of payment policy demonstrations at CMS, said the project is one of the agency's primary arguments in favor of value-based purchasing, a policy CMS regards as the most effective way to reward efficiency and value. “Relatively modest dollars can have huge impacts,” he said.

Dr. Evan Benjamin, chief quality officer for Baystate Health System in Springfield, Mass., agreed. He was the lead author of a study looking at earlier data which found quality was higher among the 250 incentivized hospitals than it was in control hospitals that reported data publicly but were not given incentives (N. Engl. J. Med. 2007;356:486-96).

The demonstration project began in October 2003; data covered every quarter through June 2007.

Hospitals were given aggregate scores for each of five conditions–acute myocardial infarction, heart failure, coronary artery bypass graft, pneumonia, and hip and knee replacement–based on reporting for 27 process measures. Hospitals with fewer than eight cases per quarter were excluded, and all data were adjusted using the All Patient Refined-Diagnostic Related Groups (APR-DRG) methodology created by 3M Information Systems.

Overall, hospitals improved by an average 17% on a composite quality score used by the project.

There was a continuing downward trend in performance variation among the hospitals, with all moving toward the ideal, said Richard Norling, president and CEO of Premier Inc. Costs and mortality were lowest for the hospitals that were on target 100% of the time with 100% of patients, he said.

For instance, the mortality for coronary artery bypass graft patients was close to 6% at hospitals that met appropriate care benchmarks in only half the patients or fewer. Mortality was just under 2% for facilities that met those benchmarks in 75%-100% of the patients, Mr. Norling told reporters.

Attaining the goals of the demonstration project required cultural shifts and investments in information systems. Before the project, the Aurora Health Care system was reactive and was achieving only incremental quality improvement, said Dr. Nick Turkal, president and CEO of the Milwaukee-based nonprofit system. The system's 13 hospitals have 100,000 admissions annually. Data on meeting the pay-for-performance goals are given to employees every 60 days, and are updated regularly on the system's Web site for the public to see. Mortality and costs are down significantly, but “we're not done yet,” he said.

WASHINGTON – Congress is taking a tough look at the use of human growth hormone for a wide variety of conditions, including fibromylagia, which is prompting some concern that payers may react by limiting reimbursement for legitimate purposes.

Human growth hormone (HGH) has been touted as an antiaging cure, and increasingly appears to be used by athletes of all ages in the belief that it helps them improve performance and recover from injuries faster. It has been legitimately studied for injury recovery in the elderly, and also is being investigated as a potential therapy for conditions such as fibromyalgia and chronic fatigue syndrome. But this field of inquiry is relatively new.

Insurers are already reluctant to cover scientifically validated uses of HGH, Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists, said in an interview. The drug can cost $10,000-$20,000 a year. The continuing use for purposes that have little-to-no evidence of safety and effectiveness may ultimately endanger patients who genuinely need HGH, said Dr. Hellman, a clinical professor of medicine at the University of Missouri, Kansas City.

Congress is taking a closer look at HGH and other alleged performance-enhancing substances in the wake of the December report issued by former Sen. George Mitchell that exposed a culture of acceptance for off-label and unproven uses of HGH and anabolic steroids in Major League Baseball.

In mid-February, the House Committee on Oversight and Government Reform held a hearing on what it called “myths and facts” about HGH, vitamin B12, and other substances. The hearing was essentially a warm-up for subsequent panel meetings on the use of such substances in baseball and other professional sports that were scheduled for February, but it touched on issues of interest to physicians.

The hearing provided “an opportunity to provide essential and accurate information not just to professional athletes, but to high school kids, senior citizens, baby boomers turning 60, and everyone in between,” according to Rep. Henry Waxman (D-Calif.), chairman of the oversight committee.

All of these uses are illegal. HGH is the only Food and Drug Administration (FDA) approved product that can only be prescribed for the approved indications. In children, the approved indications are to treat: growth hormone deficiency, chronic kidney disease, Turner syndrome, small for gestational age infants who do not catch up to normal range, Prader-Willi syndrome, idiopathic short stature; SHOX gene haploinsufficiency, and Noonan syndrome. In adults, HGH is legal for AIDS-related wasting syndrome, short-bowel syndrome, and growth hormone deficiency.

Distribution of HGH, or possession with intent to distribute, for any off-label use is a felony, punishable with up to 5 years in prison and fines.

“Without question, those attempting to market or distribute HGH claiming it will aid healing, slow or reverse the aging process, assist in weight loss, or cure depression are scamming consumers and breaking the law,” warned Rep. Tom Davis (R-Va.), the oversight committee's ranking Republican member.

And yet, some estimate that illegal HGH sales far outweigh the sanctioned market. Dr. Thomas Perls told the House committee in February that anti-aging sales amount to $2 billion a year. “I personally have found Web sites of 279 antiaging clinics that advertise HGH treatment, and 26 pharmacies that distribute the drug to these clinics or sometimes directly to users,” said Dr. Perls of Boston University. “I have certainly discovered only a fraction of what exists out there,” he added.

In a JAMA article in 2005, Dr. Perls said that legal sales of HGH in 2004 amounted to about $622 million annually, for a little more than 200,000 initial and refill prescriptions, according to data from IMS Health, a market research company (JAMA 2005;294:2086-90).

Dr. Alan Rogol, a professor of clinical pediatrics at the University of Virginia, Charlottesville, also expressed dismay at the House hearing at what appears to be the growing misuse of HGH. Off-label use comes with increased risk of side effects such as acromegaly, and increased insulin resistance or diabetes, said Dr. Rogol. He also said that in many cases, HGH purchasers were getting something other than HGH. The prices being advertised are too low and, “many of these preparations are taken orally and cannot be the protein hormone HGH, for it is not active by this route,” said Dr. Rogol, who testified on behalf of the Endocrine Society.

Another potential danger is that many of the illicit sales are of human tissue-derived pituitary growth hormone, which has been removed from the market because it has the potential to contain the pathogen that causes Creutzfeldt-Jakob disease. And yet, some of this type of hormone is still available in Eastern Europe and through the Internet.

“It is my opinion for an adult there are no legitimate off-label uses,” Dr. Rogol emphasized in an interview.

But both Dr. Rogol and Dr. Hellman acknowledged that there are no central data on how much HGH is being used illicitly, by either nonphysician or physician prescribers. It's in the public interest to keep a registry or to create some other way to keep track of HGH use, Dr. Hellman said. Physicians legitimately using HGH “should have no problem having their work scrutinized,” he said.

Both endocrinologists also said they were open to considering data on new uses of HGH, as long as it came from a validated scientific process.

The Endocrine Society and AACE both have published guidelines on HGH. The Endocrine Society guidelines, published in 2006, only pertained to treating adult growth hormone deficiency (J. Clin. Endocrinol. Metab. 2006;91:1621-34).

AACE last published guidelines in 2003. That report took a broad look at HGH uses and highlighted concerns that off-label prescribing or abuse could lead to reimbursement issues for legitimate patients (Endocr. Pract. 2003;9:64-76).

WASHINGTON – Congress is taking a tough look at the use of human growth hormone for a wide variety of conditions, including fibromylagia, which is prompting some concern that payers may react by limiting reimbursement for legitimate purposes.

Human growth hormone (HGH) has been touted as an antiaging cure, and increasingly appears to be used by athletes of all ages in the belief that it helps them improve performance and recover from injuries faster. It has been legitimately studied for injury recovery in the elderly, and also is being investigated as a potential therapy for conditions such as fibromyalgia and chronic fatigue syndrome. But this field of inquiry is relatively new.

Insurers are already reluctant to cover scientifically validated uses of HGH, Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists, said in an interview. The drug can cost $10,000-$20,000 a year. The continuing use for purposes that have little-to-no evidence of safety and effectiveness may ultimately endanger patients who genuinely need HGH, said Dr. Hellman, a clinical professor of medicine at the University of Missouri, Kansas City.

Congress is taking a closer look at HGH and other alleged performance-enhancing substances in the wake of the December report issued by former Sen. George Mitchell that exposed a culture of acceptance for off-label and unproven uses of HGH and anabolic steroids in Major League Baseball.

In mid-February, the House Committee on Oversight and Government Reform held a hearing on what it called “myths and facts” about HGH, vitamin B12, and other substances. The hearing was essentially a warm-up for subsequent panel meetings on the use of such substances in baseball and other professional sports that were scheduled for February, but it touched on issues of interest to physicians.

The hearing provided “an opportunity to provide essential and accurate information not just to professional athletes, but to high school kids, senior citizens, baby boomers turning 60, and everyone in between,” according to Rep. Henry Waxman (D-Calif.), chairman of the oversight committee.

All of these uses are illegal. HGH is the only Food and Drug Administration (FDA) approved product that can only be prescribed for the approved indications. In children, the approved indications are to treat: growth hormone deficiency, chronic kidney disease, Turner syndrome, small for gestational age infants who do not catch up to normal range, Prader-Willi syndrome, idiopathic short stature; SHOX gene haploinsufficiency, and Noonan syndrome. In adults, HGH is legal for AIDS-related wasting syndrome, short-bowel syndrome, and growth hormone deficiency.

Distribution of HGH, or possession with intent to distribute, for any off-label use is a felony, punishable with up to 5 years in prison and fines.

“Without question, those attempting to market or distribute HGH claiming it will aid healing, slow or reverse the aging process, assist in weight loss, or cure depression are scamming consumers and breaking the law,” warned Rep. Tom Davis (R-Va.), the oversight committee's ranking Republican member.

And yet, some estimate that illegal HGH sales far outweigh the sanctioned market. Dr. Thomas Perls told the House committee in February that anti-aging sales amount to $2 billion a year. “I personally have found Web sites of 279 antiaging clinics that advertise HGH treatment, and 26 pharmacies that distribute the drug to these clinics or sometimes directly to users,” said Dr. Perls of Boston University. “I have certainly discovered only a fraction of what exists out there,” he added.

In a JAMA article in 2005, Dr. Perls said that legal sales of HGH in 2004 amounted to about $622 million annually, for a little more than 200,000 initial and refill prescriptions, according to data from IMS Health, a market research company (JAMA 2005;294:2086-90).

Dr. Alan Rogol, a professor of clinical pediatrics at the University of Virginia, Charlottesville, also expressed dismay at the House hearing at what appears to be the growing misuse of HGH. Off-label use comes with increased risk of side effects such as acromegaly, and increased insulin resistance or diabetes, said Dr. Rogol. He also said that in many cases, HGH purchasers were getting something other than HGH. The prices being advertised are too low and, “many of these preparations are taken orally and cannot be the protein hormone HGH, for it is not active by this route,” said Dr. Rogol, who testified on behalf of the Endocrine Society.

Another potential danger is that many of the illicit sales are of human tissue-derived pituitary growth hormone, which has been removed from the market because it has the potential to contain the pathogen that causes Creutzfeldt-Jakob disease. And yet, some of this type of hormone is still available in Eastern Europe and through the Internet.

“It is my opinion for an adult there are no legitimate off-label uses,” Dr. Rogol emphasized in an interview.

But both Dr. Rogol and Dr. Hellman acknowledged that there are no central data on how much HGH is being used illicitly, by either nonphysician or physician prescribers. It's in the public interest to keep a registry or to create some other way to keep track of HGH use, Dr. Hellman said. Physicians legitimately using HGH “should have no problem having their work scrutinized,” he said.

Both endocrinologists also said they were open to considering data on new uses of HGH, as long as it came from a validated scientific process.

The Endocrine Society and AACE both have published guidelines on HGH. The Endocrine Society guidelines, published in 2006, only pertained to treating adult growth hormone deficiency (J. Clin. Endocrinol. Metab. 2006;91:1621-34).

AACE last published guidelines in 2003. That report took a broad look at HGH uses and highlighted concerns that off-label prescribing or abuse could lead to reimbursement issues for legitimate patients (Endocr. Pract. 2003;9:64-76).

WASHINGTON – Congress is taking a tough look at the use of human growth hormone for a wide variety of conditions, including fibromylagia, which is prompting some concern that payers may react by limiting reimbursement for legitimate purposes.

Human growth hormone (HGH) has been touted as an antiaging cure, and increasingly appears to be used by athletes of all ages in the belief that it helps them improve performance and recover from injuries faster. It has been legitimately studied for injury recovery in the elderly, and also is being investigated as a potential therapy for conditions such as fibromyalgia and chronic fatigue syndrome. But this field of inquiry is relatively new.

Insurers are already reluctant to cover scientifically validated uses of HGH, Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists, said in an interview. The drug can cost $10,000-$20,000 a year. The continuing use for purposes that have little-to-no evidence of safety and effectiveness may ultimately endanger patients who genuinely need HGH, said Dr. Hellman, a clinical professor of medicine at the University of Missouri, Kansas City.

Congress is taking a closer look at HGH and other alleged performance-enhancing substances in the wake of the December report issued by former Sen. George Mitchell that exposed a culture of acceptance for off-label and unproven uses of HGH and anabolic steroids in Major League Baseball.

In mid-February, the House Committee on Oversight and Government Reform held a hearing on what it called “myths and facts” about HGH, vitamin B12, and other substances. The hearing was essentially a warm-up for subsequent panel meetings on the use of such substances in baseball and other professional sports that were scheduled for February, but it touched on issues of interest to physicians.

The hearing provided “an opportunity to provide essential and accurate information not just to professional athletes, but to high school kids, senior citizens, baby boomers turning 60, and everyone in between,” according to Rep. Henry Waxman (D-Calif.), chairman of the oversight committee.

All of these uses are illegal. HGH is the only Food and Drug Administration (FDA) approved product that can only be prescribed for the approved indications. In children, the approved indications are to treat: growth hormone deficiency, chronic kidney disease, Turner syndrome, small for gestational age infants who do not catch up to normal range, Prader-Willi syndrome, idiopathic short stature; SHOX gene haploinsufficiency, and Noonan syndrome. In adults, HGH is legal for AIDS-related wasting syndrome, short-bowel syndrome, and growth hormone deficiency.

Distribution of HGH, or possession with intent to distribute, for any off-label use is a felony, punishable with up to 5 years in prison and fines.

“Without question, those attempting to market or distribute HGH claiming it will aid healing, slow or reverse the aging process, assist in weight loss, or cure depression are scamming consumers and breaking the law,” warned Rep. Tom Davis (R-Va.), the oversight committee's ranking Republican member.

And yet, some estimate that illegal HGH sales far outweigh the sanctioned market. Dr. Thomas Perls told the House committee in February that anti-aging sales amount to $2 billion a year. “I personally have found Web sites of 279 antiaging clinics that advertise HGH treatment, and 26 pharmacies that distribute the drug to these clinics or sometimes directly to users,” said Dr. Perls of Boston University. “I have certainly discovered only a fraction of what exists out there,” he added.

In a JAMA article in 2005, Dr. Perls said that legal sales of HGH in 2004 amounted to about $622 million annually, for a little more than 200,000 initial and refill prescriptions, according to data from IMS Health, a market research company (JAMA 2005;294:2086-90).

Dr. Alan Rogol, a professor of clinical pediatrics at the University of Virginia, Charlottesville, also expressed dismay at the House hearing at what appears to be the growing misuse of HGH. Off-label use comes with increased risk of side effects such as acromegaly, and increased insulin resistance or diabetes, said Dr. Rogol. He also said that in many cases, HGH purchasers were getting something other than HGH. The prices being advertised are too low and, “many of these preparations are taken orally and cannot be the protein hormone HGH, for it is not active by this route,” said Dr. Rogol, who testified on behalf of the Endocrine Society.

Another potential danger is that many of the illicit sales are of human tissue-derived pituitary growth hormone, which has been removed from the market because it has the potential to contain the pathogen that causes Creutzfeldt-Jakob disease. And yet, some of this type of hormone is still available in Eastern Europe and through the Internet.

“It is my opinion for an adult there are no legitimate off-label uses,” Dr. Rogol emphasized in an interview.

But both Dr. Rogol and Dr. Hellman acknowledged that there are no central data on how much HGH is being used illicitly, by either nonphysician or physician prescribers. It's in the public interest to keep a registry or to create some other way to keep track of HGH use, Dr. Hellman said. Physicians legitimately using HGH “should have no problem having their work scrutinized,” he said.

Both endocrinologists also said they were open to considering data on new uses of HGH, as long as it came from a validated scientific process.

The Endocrine Society and AACE both have published guidelines on HGH. The Endocrine Society guidelines, published in 2006, only pertained to treating adult growth hormone deficiency (J. Clin. Endocrinol. Metab. 2006;91:1621-34).

AACE last published guidelines in 2003. That report took a broad look at HGH uses and highlighted concerns that off-label prescribing or abuse could lead to reimbursement issues for legitimate patients (Endocr. Pract. 2003;9:64-76).