Alicia Ault

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated total of 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers now spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule “will drive insurers to become more efficient,” and “incentivize them to not raise premiums more than necessary,” Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

“These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders,” said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated total of 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers now spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule “will drive insurers to become more efficient,” and “incentivize them to not raise premiums more than necessary,” Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

“These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders,” said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have “to return nearly $3,500 to every family they insure.” Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated total of 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers now spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule “will drive insurers to become more efficient,” and “incentivize them to not raise premiums more than necessary,” Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

“These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders,” said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

The Department of Health and Human Services issued a sweeping new tobacco control strategy that would require cigarette makers to place photographs and graphic depictions of the harms of smoking prominently on the packages or in advertising.

The graphic warnings – which will be regulated by the Food and Drug Administration – were part of a proposed rule issued by the agency. They were required by the Family Smoking Prevention and Tobacco Control Act and are the centerpiece of the 66-page strategy released by the HHS.

“Every day, almost 4,000 youth try a cigarette for the first time and 1,000 youth become regular, daily smokers,” HHS Secretary Kathleen Sebelius said in a statement. “Today marks an important milestone in protecting our children and the health of the American public.”

HHS estimates that 443,000 Americans die from tobacco-related diseases each year, with 50,000 of those deaths caused by secondhand smoke. Some 8.6 million Americans have smoking-related chronic diseases.

FDA Commissioner Margaret Hamburg said, “When this rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes.”

The agency is going to require a disturbing photograph or cartoon graphic that takes up half a package of cigarettes or is prominently placed in an ad. The graphic would depict one of the following warnings: “Cigarettes are addictive,” “Tobacco smoke can harm your children,” “Cigarettes cause fatal lung disease,” “Cigarettes cause cancer,” “Cigarettes cause strokes and heart disease,” “Smoking during pregnancy can harm your baby,” “Smoking can kill you,” “Tobacco smoke causes fatal lung disease in nonsmokers,” and “Quitting smoking now greatly reduces serious risks to your health.”

The cancer warning might have a photograph of an obviously terminally ill person in a hospital bed, or a close-up of a mouth riddled with rotting teeth and sores. The heart disease warning might have a photograph of a man clutching his chest, in the throes of a myocardial infarction.

The FDA is seeking the public's input on which graphic depiction to use for each warning. It is accepting comments until early January. Then, the agency will select one graphic for each of the nine warnings and publish the choices in a final rule to be issued by June 22, 2011. Manufacturers would have 15 months from that time – by October 2012 – to come into compliance. If they do not comply, their product will be banned from sale in the United States.

Public health advocacy groups applauded the HHS plan and the FDA proposal. “The new warnings represent the most significant change in U.S. cigarette warnings since they were first required in 1965,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

The American Cancer Society Cancer Action Network said that current warnings are ineffective “because of their inability to attract attention due to their size and placement on the packaging.” The group said that the proposal is important and timely. “The FDA has the opportunity to make an enormous impact on effectively informing the public of the actual harms of using tobacco products and inducing the desire to quit among users,” ACSCAN said in a statement.

The HHS strategy paper recommended expanding tobacco cessation services, including Medicare and Medicaid; accelerating the adoption of smoke-free laws across the country; increasing the number of tobacco-free workplaces and campuses; and adopting evidence-based intervention strategies. Health care providers should receive enhanced incentives for offering interventions and treatments, and federal agencies should increase research into tobacco cessation strategies and treatments and surveillance and monitoring of control efforts, said the HHS strategic paper.

The HHS also called for a national media campaign to prevent kids from smoking, which Mr. Myers characterized as a critical element of tobacco control.

“The administration and Congress must now provide sufficient funding for these initiatives if they are to succeed,” he said.

According to the HHS, if the agency receives funding and all of the initiatives were to go forward, the country could meet the Healthy People 2010 objective to reduce the smoking rate to 12% of U.S. adults.

The FDA says graphic depictions of the dangers of smoking should take up half a cigarette package.

Source Courtesy FDA

The Department of Health and Human Services issued a sweeping new tobacco control strategy that would require cigarette makers to place photographs and graphic depictions of the harms of smoking prominently on the packages or in advertising.

The graphic warnings – which will be regulated by the Food and Drug Administration – were part of a proposed rule issued by the agency. They were required by the Family Smoking Prevention and Tobacco Control Act and are the centerpiece of the 66-page strategy released by the HHS.

“Every day, almost 4,000 youth try a cigarette for the first time and 1,000 youth become regular, daily smokers,” HHS Secretary Kathleen Sebelius said in a statement. “Today marks an important milestone in protecting our children and the health of the American public.”

HHS estimates that 443,000 Americans die from tobacco-related diseases each year, with 50,000 of those deaths caused by secondhand smoke. Some 8.6 million Americans have smoking-related chronic diseases.

FDA Commissioner Margaret Hamburg said, “When this rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes.”

The agency is going to require a disturbing photograph or cartoon graphic that takes up half a package of cigarettes or is prominently placed in an ad. The graphic would depict one of the following warnings: “Cigarettes are addictive,” “Tobacco smoke can harm your children,” “Cigarettes cause fatal lung disease,” “Cigarettes cause cancer,” “Cigarettes cause strokes and heart disease,” “Smoking during pregnancy can harm your baby,” “Smoking can kill you,” “Tobacco smoke causes fatal lung disease in nonsmokers,” and “Quitting smoking now greatly reduces serious risks to your health.”

The cancer warning might have a photograph of an obviously terminally ill person in a hospital bed, or a close-up of a mouth riddled with rotting teeth and sores. The heart disease warning might have a photograph of a man clutching his chest, in the throes of a myocardial infarction.

The FDA is seeking the public's input on which graphic depiction to use for each warning. It is accepting comments until early January. Then, the agency will select one graphic for each of the nine warnings and publish the choices in a final rule to be issued by June 22, 2011. Manufacturers would have 15 months from that time – by October 2012 – to come into compliance. If they do not comply, their product will be banned from sale in the United States.

Public health advocacy groups applauded the HHS plan and the FDA proposal. “The new warnings represent the most significant change in U.S. cigarette warnings since they were first required in 1965,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

The American Cancer Society Cancer Action Network said that current warnings are ineffective “because of their inability to attract attention due to their size and placement on the packaging.” The group said that the proposal is important and timely. “The FDA has the opportunity to make an enormous impact on effectively informing the public of the actual harms of using tobacco products and inducing the desire to quit among users,” ACSCAN said in a statement.

The HHS strategy paper recommended expanding tobacco cessation services, including Medicare and Medicaid; accelerating the adoption of smoke-free laws across the country; increasing the number of tobacco-free workplaces and campuses; and adopting evidence-based intervention strategies. Health care providers should receive enhanced incentives for offering interventions and treatments, and federal agencies should increase research into tobacco cessation strategies and treatments and surveillance and monitoring of control efforts, said the HHS strategic paper.

The HHS also called for a national media campaign to prevent kids from smoking, which Mr. Myers characterized as a critical element of tobacco control.

“The administration and Congress must now provide sufficient funding for these initiatives if they are to succeed,” he said.

According to the HHS, if the agency receives funding and all of the initiatives were to go forward, the country could meet the Healthy People 2010 objective to reduce the smoking rate to 12% of U.S. adults.

The FDA says graphic depictions of the dangers of smoking should take up half a cigarette package.

Source Courtesy FDA

The Department of Health and Human Services issued a sweeping new tobacco control strategy that would require cigarette makers to place photographs and graphic depictions of the harms of smoking prominently on the packages or in advertising.

The graphic warnings – which will be regulated by the Food and Drug Administration – were part of a proposed rule issued by the agency. They were required by the Family Smoking Prevention and Tobacco Control Act and are the centerpiece of the 66-page strategy released by the HHS.

“Every day, almost 4,000 youth try a cigarette for the first time and 1,000 youth become regular, daily smokers,” HHS Secretary Kathleen Sebelius said in a statement. “Today marks an important milestone in protecting our children and the health of the American public.”

HHS estimates that 443,000 Americans die from tobacco-related diseases each year, with 50,000 of those deaths caused by secondhand smoke. Some 8.6 million Americans have smoking-related chronic diseases.

FDA Commissioner Margaret Hamburg said, “When this rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes.”

The agency is going to require a disturbing photograph or cartoon graphic that takes up half a package of cigarettes or is prominently placed in an ad. The graphic would depict one of the following warnings: “Cigarettes are addictive,” “Tobacco smoke can harm your children,” “Cigarettes cause fatal lung disease,” “Cigarettes cause cancer,” “Cigarettes cause strokes and heart disease,” “Smoking during pregnancy can harm your baby,” “Smoking can kill you,” “Tobacco smoke causes fatal lung disease in nonsmokers,” and “Quitting smoking now greatly reduces serious risks to your health.”

The cancer warning might have a photograph of an obviously terminally ill person in a hospital bed, or a close-up of a mouth riddled with rotting teeth and sores. The heart disease warning might have a photograph of a man clutching his chest, in the throes of a myocardial infarction.

The FDA is seeking the public's input on which graphic depiction to use for each warning. It is accepting comments until early January. Then, the agency will select one graphic for each of the nine warnings and publish the choices in a final rule to be issued by June 22, 2011. Manufacturers would have 15 months from that time – by October 2012 – to come into compliance. If they do not comply, their product will be banned from sale in the United States.

Public health advocacy groups applauded the HHS plan and the FDA proposal. “The new warnings represent the most significant change in U.S. cigarette warnings since they were first required in 1965,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

The American Cancer Society Cancer Action Network said that current warnings are ineffective “because of their inability to attract attention due to their size and placement on the packaging.” The group said that the proposal is important and timely. “The FDA has the opportunity to make an enormous impact on effectively informing the public of the actual harms of using tobacco products and inducing the desire to quit among users,” ACSCAN said in a statement.

The HHS strategy paper recommended expanding tobacco cessation services, including Medicare and Medicaid; accelerating the adoption of smoke-free laws across the country; increasing the number of tobacco-free workplaces and campuses; and adopting evidence-based intervention strategies. Health care providers should receive enhanced incentives for offering interventions and treatments, and federal agencies should increase research into tobacco cessation strategies and treatments and surveillance and monitoring of control efforts, said the HHS strategic paper.

The HHS also called for a national media campaign to prevent kids from smoking, which Mr. Myers characterized as a critical element of tobacco control.

“The administration and Congress must now provide sufficient funding for these initiatives if they are to succeed,” he said.

According to the HHS, if the agency receives funding and all of the initiatives were to go forward, the country could meet the Healthy People 2010 objective to reduce the smoking rate to 12% of U.S. adults.

The FDA says graphic depictions of the dangers of smoking should take up half a cigarette package.

Source Courtesy FDA

APA Backs Same-Sex Marriage

The American Psychiatric Association has filed a brief in support of same-sex marriage in the California case focusing on the state's Proposition 8. The case is an appeal of the August ruling that the proposition's ban on such marriages is unconstitutional. Scientific evidence shows that homosexuality is a normal expression of sexuality and that sexual orientation is not the result of choice, the APA noted, adding that there is no evidence that lesbians and gay men have less stable relationships or that they are less capable parents than heterosexuals. The ban denies homosexuals “the social, psychological and health benefits that are associated with marriage,” Dr. James H. Scully Jr., the association's CEO, said in a statement. In filing the brief, the psychiatrists joined the American Psychological Association, the California Psychological Association, and the American Association for Marriage and Family Therapy.

Institute Urges Oil Spill Study

The Institute of Medicine has urged the Department of Health and Human Services to make the study of the behavioral health effects of the BP oil spill in the Gulf of Mexico a top priority. Researchers should identify factors associated with individuals' vulnerability or resilience during oil spills and other natural disasters, said the institute. It also urged study of the health effects of exposure to oil, dispersants, and other chemicals associated with clean-up, and a thorough assessment of seafood safety.

Ex Pharma Lawyer Is Charged

The U.S. Department of Justice issued a six-count indictment in early November against Lauren Stevens of Durham, N.C., a former pharmaceutical company executive, charging her with obstruction and making false statements. The charge included no company, and the department declined to disclose Ms. Stevens' employer, but GlaxoSmithKline confirmed that she was employed there until her retirement. An industry directory identifies Ms. Stevens as a GlaxoSmithKline vice president and attorney. Ms. Stevens allegedly helped the company promote a drug (reportedly the antidepressant Wellbutrin SR) for unapproved, off-label uses. She also failed to provide the Food and Drug Administration with slide sets that had been used by physicians “who were paid by the company to promote the drug,” according to a Justice Department press release.

Company Pays Huge Fine

GlaxoSmithKline pled guilty to charges that it manufactured and distributed drugs contaminated with microorganisms. The company will pay $750 million to settle federal and state government claims. The Department of Justice announced the agreement in late October. The drugs, manufactured in Puerto Rico between 2001 and 2005, included the antinausea drug Kytril, the antidepressant Paxil CR, the diabetes medication Avandamet, and the anti-infection ointment Bactroban. GlaxoSmithKline will pay the federal government $600 million, and a whistleblower will receive $96 million for having tipped the government to the manufacturing issues. The states are eligible to receive up to $163 million from Glaxo. The complaint alleged that the company knowingly caused false claims to be submitted to state Medicaid programs. “FDA and its law enforcement partners will continue to aggressively pursue those companies that place the public health at risk by distributing products that do not comply with all FDA requirements,” Mark Dragonetti, special agent in charge, FDA New York Field Office, said in a statement.

Top Fraud Cases Involve Health

Pharmaceutical companies paid large fines in 8 of the top 10 fraud cases settled by the Department of Justice in 2010, according to the Taxpayers Against Fraud Education Fund. An insurer and a hospital rounded out the top 10 largest fine payers, making all 10 of the top settlements health care related. Allergan Inc., which in September settled allegations that it had marketed Botox (onabotulinumtoxinA) for off-label uses, accounted for the largest settlement ($600 million). AstraZeneca International came in second with its $520 million payment for illegally marketing the antipsychotic Seroquel (quetiapine). About 80% of all fraud recoveries under the False Claims Act occur in the health care area, the group said.

Drug-Related Hospitalizations Up

Hospitalizations for drug-induced conditions more than doubled between 1997 and 2008 for Americans aged 45 years and older, according to the Agency for Healthcare Research and Quality. Meanwhile, admissions related to prescription- and illicit-drug problems grew by 96% for people aged 65–84 years and by 87% for those older than 85, the agency said. By comparison, the number of drug-related hospital admissions declined by 11% among adults aged 18–44 years. In the older groups, hospitalizations increased most for drug-induced delirium; poisoning or overdose by codeine, meperidine, and other opiate-based pain medicines; and withdrawal from drug addictions, the AHRQ said. Medicare and Medicaid paid 54% of the $1.1 billion tab for these hospitalizations.

APA Backs Same-Sex Marriage

The American Psychiatric Association has filed a brief in support of same-sex marriage in the California case focusing on the state's Proposition 8. The case is an appeal of the August ruling that the proposition's ban on such marriages is unconstitutional. Scientific evidence shows that homosexuality is a normal expression of sexuality and that sexual orientation is not the result of choice, the APA noted, adding that there is no evidence that lesbians and gay men have less stable relationships or that they are less capable parents than heterosexuals. The ban denies homosexuals “the social, psychological and health benefits that are associated with marriage,” Dr. James H. Scully Jr., the association's CEO, said in a statement. In filing the brief, the psychiatrists joined the American Psychological Association, the California Psychological Association, and the American Association for Marriage and Family Therapy.

Institute Urges Oil Spill Study

The Institute of Medicine has urged the Department of Health and Human Services to make the study of the behavioral health effects of the BP oil spill in the Gulf of Mexico a top priority. Researchers should identify factors associated with individuals' vulnerability or resilience during oil spills and other natural disasters, said the institute. It also urged study of the health effects of exposure to oil, dispersants, and other chemicals associated with clean-up, and a thorough assessment of seafood safety.

Ex Pharma Lawyer Is Charged

The U.S. Department of Justice issued a six-count indictment in early November against Lauren Stevens of Durham, N.C., a former pharmaceutical company executive, charging her with obstruction and making false statements. The charge included no company, and the department declined to disclose Ms. Stevens' employer, but GlaxoSmithKline confirmed that she was employed there until her retirement. An industry directory identifies Ms. Stevens as a GlaxoSmithKline vice president and attorney. Ms. Stevens allegedly helped the company promote a drug (reportedly the antidepressant Wellbutrin SR) for unapproved, off-label uses. She also failed to provide the Food and Drug Administration with slide sets that had been used by physicians “who were paid by the company to promote the drug,” according to a Justice Department press release.

Company Pays Huge Fine

GlaxoSmithKline pled guilty to charges that it manufactured and distributed drugs contaminated with microorganisms. The company will pay $750 million to settle federal and state government claims. The Department of Justice announced the agreement in late October. The drugs, manufactured in Puerto Rico between 2001 and 2005, included the antinausea drug Kytril, the antidepressant Paxil CR, the diabetes medication Avandamet, and the anti-infection ointment Bactroban. GlaxoSmithKline will pay the federal government $600 million, and a whistleblower will receive $96 million for having tipped the government to the manufacturing issues. The states are eligible to receive up to $163 million from Glaxo. The complaint alleged that the company knowingly caused false claims to be submitted to state Medicaid programs. “FDA and its law enforcement partners will continue to aggressively pursue those companies that place the public health at risk by distributing products that do not comply with all FDA requirements,” Mark Dragonetti, special agent in charge, FDA New York Field Office, said in a statement.

Top Fraud Cases Involve Health

Pharmaceutical companies paid large fines in 8 of the top 10 fraud cases settled by the Department of Justice in 2010, according to the Taxpayers Against Fraud Education Fund. An insurer and a hospital rounded out the top 10 largest fine payers, making all 10 of the top settlements health care related. Allergan Inc., which in September settled allegations that it had marketed Botox (onabotulinumtoxinA) for off-label uses, accounted for the largest settlement ($600 million). AstraZeneca International came in second with its $520 million payment for illegally marketing the antipsychotic Seroquel (quetiapine). About 80% of all fraud recoveries under the False Claims Act occur in the health care area, the group said.

Drug-Related Hospitalizations Up

Hospitalizations for drug-induced conditions more than doubled between 1997 and 2008 for Americans aged 45 years and older, according to the Agency for Healthcare Research and Quality. Meanwhile, admissions related to prescription- and illicit-drug problems grew by 96% for people aged 65–84 years and by 87% for those older than 85, the agency said. By comparison, the number of drug-related hospital admissions declined by 11% among adults aged 18–44 years. In the older groups, hospitalizations increased most for drug-induced delirium; poisoning or overdose by codeine, meperidine, and other opiate-based pain medicines; and withdrawal from drug addictions, the AHRQ said. Medicare and Medicaid paid 54% of the $1.1 billion tab for these hospitalizations.

APA Backs Same-Sex Marriage

The American Psychiatric Association has filed a brief in support of same-sex marriage in the California case focusing on the state's Proposition 8. The case is an appeal of the August ruling that the proposition's ban on such marriages is unconstitutional. Scientific evidence shows that homosexuality is a normal expression of sexuality and that sexual orientation is not the result of choice, the APA noted, adding that there is no evidence that lesbians and gay men have less stable relationships or that they are less capable parents than heterosexuals. The ban denies homosexuals “the social, psychological and health benefits that are associated with marriage,” Dr. James H. Scully Jr., the association's CEO, said in a statement. In filing the brief, the psychiatrists joined the American Psychological Association, the California Psychological Association, and the American Association for Marriage and Family Therapy.

Institute Urges Oil Spill Study

The Institute of Medicine has urged the Department of Health and Human Services to make the study of the behavioral health effects of the BP oil spill in the Gulf of Mexico a top priority. Researchers should identify factors associated with individuals' vulnerability or resilience during oil spills and other natural disasters, said the institute. It also urged study of the health effects of exposure to oil, dispersants, and other chemicals associated with clean-up, and a thorough assessment of seafood safety.

Ex Pharma Lawyer Is Charged

The U.S. Department of Justice issued a six-count indictment in early November against Lauren Stevens of Durham, N.C., a former pharmaceutical company executive, charging her with obstruction and making false statements. The charge included no company, and the department declined to disclose Ms. Stevens' employer, but GlaxoSmithKline confirmed that she was employed there until her retirement. An industry directory identifies Ms. Stevens as a GlaxoSmithKline vice president and attorney. Ms. Stevens allegedly helped the company promote a drug (reportedly the antidepressant Wellbutrin SR) for unapproved, off-label uses. She also failed to provide the Food and Drug Administration with slide sets that had been used by physicians “who were paid by the company to promote the drug,” according to a Justice Department press release.

Company Pays Huge Fine

GlaxoSmithKline pled guilty to charges that it manufactured and distributed drugs contaminated with microorganisms. The company will pay $750 million to settle federal and state government claims. The Department of Justice announced the agreement in late October. The drugs, manufactured in Puerto Rico between 2001 and 2005, included the antinausea drug Kytril, the antidepressant Paxil CR, the diabetes medication Avandamet, and the anti-infection ointment Bactroban. GlaxoSmithKline will pay the federal government $600 million, and a whistleblower will receive $96 million for having tipped the government to the manufacturing issues. The states are eligible to receive up to $163 million from Glaxo. The complaint alleged that the company knowingly caused false claims to be submitted to state Medicaid programs. “FDA and its law enforcement partners will continue to aggressively pursue those companies that place the public health at risk by distributing products that do not comply with all FDA requirements,” Mark Dragonetti, special agent in charge, FDA New York Field Office, said in a statement.

Top Fraud Cases Involve Health

Pharmaceutical companies paid large fines in 8 of the top 10 fraud cases settled by the Department of Justice in 2010, according to the Taxpayers Against Fraud Education Fund. An insurer and a hospital rounded out the top 10 largest fine payers, making all 10 of the top settlements health care related. Allergan Inc., which in September settled allegations that it had marketed Botox (onabotulinumtoxinA) for off-label uses, accounted for the largest settlement ($600 million). AstraZeneca International came in second with its $520 million payment for illegally marketing the antipsychotic Seroquel (quetiapine). About 80% of all fraud recoveries under the False Claims Act occur in the health care area, the group said.

Drug-Related Hospitalizations Up

Hospitalizations for drug-induced conditions more than doubled between 1997 and 2008 for Americans aged 45 years and older, according to the Agency for Healthcare Research and Quality. Meanwhile, admissions related to prescription- and illicit-drug problems grew by 96% for people aged 65–84 years and by 87% for those older than 85, the agency said. By comparison, the number of drug-related hospital admissions declined by 11% among adults aged 18–44 years. In the older groups, hospitalizations increased most for drug-induced delirium; poisoning or overdose by codeine, meperidine, and other opiate-based pain medicines; and withdrawal from drug addictions, the AHRQ said. Medicare and Medicaid paid 54% of the $1.1 billion tab for these hospitalizations.

WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act. But now the law will probably undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the House. Republican members of the Senate are still in the minority, but the current Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the Affordable Care Act if they regained the majority. A Republican-led House will not be able to make that happen alone, and the Democratic-led Senate is unlikely to pass repeal legislation.

Meanwhile, President Obama would likely veto any bill sent to him.

But Rep. John Boehner (R-Ohio), elected by Republicans as House speaker when the 112th Congress convenes in January, has indicated that the health reform law will be challenged in his chamber.

At a postelection press briefing, President Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said he expected to see a repeal proposal.

“The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen, but they're going to have to do that probably to satisfy political demand,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the Affordable Care Act.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said she expected to see many oversight and investigative hearings on the Affordable Care Act.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Rep. Boehner and other congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage.

That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685–7).

Unless most Americans are covered, insurers might be bankrupted by the reforms, he said. “In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia also has filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties might revolt against the mandate, Ms. Johnson said. “If you look at the basis on which states are challenging the mandate, it's in part that it abrogates the federal-state partnership, because it imposes burdens they can't fulfill.”

Back on Capitol Hill, the GOP-led House also will likely take a close look at the Affordable Care Act-created Independent Payment Advisory Board, Ms. Johnson said.

The IPAB, which is charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans also could tinker with the Affordable Care Act by cutting off funding for implementation via the appropriations process, or even trying to prohibit the Health and Human Services department from writing regulations.

Some of those regulations are due to come out in the next few weeks – before the start of the 112th Congress.

WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act. But now the law will probably undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the House. Republican members of the Senate are still in the minority, but the current Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the Affordable Care Act if they regained the majority. A Republican-led House will not be able to make that happen alone, and the Democratic-led Senate is unlikely to pass repeal legislation.

Meanwhile, President Obama would likely veto any bill sent to him.

But Rep. John Boehner (R-Ohio), elected by Republicans as House speaker when the 112th Congress convenes in January, has indicated that the health reform law will be challenged in his chamber.

At a postelection press briefing, President Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said he expected to see a repeal proposal.

“The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen, but they're going to have to do that probably to satisfy political demand,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the Affordable Care Act.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said she expected to see many oversight and investigative hearings on the Affordable Care Act.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Rep. Boehner and other congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage.

That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685–7).

Unless most Americans are covered, insurers might be bankrupted by the reforms, he said. “In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia also has filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties might revolt against the mandate, Ms. Johnson said. “If you look at the basis on which states are challenging the mandate, it's in part that it abrogates the federal-state partnership, because it imposes burdens they can't fulfill.”

Back on Capitol Hill, the GOP-led House also will likely take a close look at the Affordable Care Act-created Independent Payment Advisory Board, Ms. Johnson said.

The IPAB, which is charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans also could tinker with the Affordable Care Act by cutting off funding for implementation via the appropriations process, or even trying to prohibit the Health and Human Services department from writing regulations.

Some of those regulations are due to come out in the next few weeks – before the start of the 112th Congress.

WASHINGTON – The historic midterm election victory by Republicans does not signal the end of the Affordable Care Act. But now the law will probably undergo the scrutiny that many in the GOP say it did not get as it made its way through Congress.

The GOP now holds a majority in the House. Republican members of the Senate are still in the minority, but the current Democratic margin is much slimmer than before the election.

Earlier this year, House Republican leaders and Senate Minority Leader Mitch McConnell (R-Ky.) vowed to “repeal and replace” the Affordable Care Act if they regained the majority. A Republican-led House will not be able to make that happen alone, and the Democratic-led Senate is unlikely to pass repeal legislation.

Meanwhile, President Obama would likely veto any bill sent to him.

But Rep. John Boehner (R-Ohio), elected by Republicans as House speaker when the 112th Congress convenes in January, has indicated that the health reform law will be challenged in his chamber.

At a postelection press briefing, President Obama said he welcomed GOP input. “If the Republicans have ideas for how to improve our health care system, if they want to suggest modifications that would deliver faster and more effective reform to a health care system that has been widely expensive for too many families, businesses, and certainly our federal government, I'm happy to consider some of those ideas,” he said.

But he said the White House would not entertain a repeal debate.

Speaking at a postelection forum, Jim Slattery, a former six-term Democratic congressman from Kansas, said he expected to see a repeal proposal.

“The new Tea Party congresspeople and the leadership in the House will probably have to introduce some kind of resolution that would call for the repeal of ACA, and I think they know it's going nowhere and it's not going to happen, but they're going to have to do that probably to satisfy political demand,” said Mr. Slattery, now a lobbyist with Wiley Rein.

Mr. Slattery said President Obama mainly has himself to blame for the Democrats' poor showing in the election and for polling data indicating that half of Americans want to repeal the Affordable Care Act.

At the same forum, Nancy Johnson, a former Republican House member from Connecticut, said she expected to see many oversight and investigative hearings on the Affordable Care Act.

“The one thing that has to be done [in the next Congress] is, people have to regain their confidence in government and that's not about policy, that's about process,” said Ms. Johnson, a senior public policy adviser at Baker Donelson. “Half the bill is terrific. But the other half wasn't seen, and that created suspicion.”

Rep. Boehner and other congressional Republicans have said they will keep some of the insurance market reforms – such as the prohibition on denying coverage for preexisting conditions – but will seek to throw out the mandate that individuals have health insurance coverage.

That is a formula for disaster for the law – and for insurance companies, wrote Henry Aaron, a senior fellow at the Brookings Institution, in a perspective article published in the New England Journal of Medicine (2010;18:1685–7).

Unless most Americans are covered, insurers might be bankrupted by the reforms, he said. “In brief, the pledge to keep insurance-market reforms without both mandated coverage and subsidies is untenable,” Mr. Aaron wrote.

Mr. Slattery agreed. “If you're going to really reform the insurance industry with the preexisting-condition reforms, we have to have a mandate of some kind,” he said.

The requirement that individuals carry insurance or pay a penalty, however, is the central issue being challenged by 20 states involved in a lawsuit against the federal government in the U.S. District Court in Florida. Virginia also has filed its own suit, a case that Mr. Slattery said he expected to rise to the Supreme Court.

And governors and attorneys general elected in five states also campaigned on the promise that they, too, would support overturning the mandate.

With money tight and millions of potential new Medicaid enrollees, governors from all parties might revolt against the mandate, Ms. Johnson said. “If you look at the basis on which states are challenging the mandate, it's in part that it abrogates the federal-state partnership, because it imposes burdens they can't fulfill.”

Back on Capitol Hill, the GOP-led House also will likely take a close look at the Affordable Care Act-created Independent Payment Advisory Board, Ms. Johnson said.

The IPAB, which is charged with looking at how the federal government pays physicians, hospitals, pharmaceutical companies, and other health providers, would have broad powers that make many Republicans uncomfortable, she said.

In his perspective piece, Mr. Aaron wrote that that Republicans also could tinker with the Affordable Care Act by cutting off funding for implementation via the appropriations process, or even trying to prohibit the Health and Human Services department from writing regulations.

Some of those regulations are due to come out in the next few weeks – before the start of the 112th Congress.

The House of Representatives voted Nov. 29 to approve a 1-month extension of current Medicare physician fee schedule.

If signed by President Obama, which is expected, physicians will avoid a 23% reduction in fees mandated by Medicare's Sustainable Growth Rate (SGR) and slated to go into effect Dec. 1.

However, unless Congress takes additional action before the Christmas recess, physicians face a 25% cut in fees on January 1.

The House vote follows the Senate's Nov. 18 approval of a 1-month extension contained in the Physician Payment and Therapy Relief Act of 2010. That bill was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa).

The estimated cost for the 1-month extension is $1 billion. The Senate legislation pays for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sen. Baucus and Sen. Grassley.

In a statement, American Medical Association President Cecil B. Wilson said that the short-term delay "helps ensure that physicians can continue to care for seniors for the next month." But he added "the AMA urges Congress to build on the bipartisan action that delayed this year’s cut and act in December to stop the cut for 1 year so that Congress has time to work on a long-term solution."

The House of Representatives voted Nov. 29 to approve a 1-month extension of current Medicare physician fee schedule.

If signed by President Obama, which is expected, physicians will avoid a 23% reduction in fees mandated by Medicare's Sustainable Growth Rate (SGR) and slated to go into effect Dec. 1.

However, unless Congress takes additional action before the Christmas recess, physicians face a 25% cut in fees on January 1.

The House vote follows the Senate's Nov. 18 approval of a 1-month extension contained in the Physician Payment and Therapy Relief Act of 2010. That bill was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa).

The estimated cost for the 1-month extension is $1 billion. The Senate legislation pays for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sen. Baucus and Sen. Grassley.

In a statement, American Medical Association President Cecil B. Wilson said that the short-term delay "helps ensure that physicians can continue to care for seniors for the next month." But he added "the AMA urges Congress to build on the bipartisan action that delayed this year’s cut and act in December to stop the cut for 1 year so that Congress has time to work on a long-term solution."

The House of Representatives voted Nov. 29 to approve a 1-month extension of current Medicare physician fee schedule.

If signed by President Obama, which is expected, physicians will avoid a 23% reduction in fees mandated by Medicare's Sustainable Growth Rate (SGR) and slated to go into effect Dec. 1.

However, unless Congress takes additional action before the Christmas recess, physicians face a 25% cut in fees on January 1.

The House vote follows the Senate's Nov. 18 approval of a 1-month extension contained in the Physician Payment and Therapy Relief Act of 2010. That bill was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa).

The estimated cost for the 1-month extension is $1 billion. The Senate legislation pays for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sen. Baucus and Sen. Grassley.

In a statement, American Medical Association President Cecil B. Wilson said that the short-term delay "helps ensure that physicians can continue to care for seniors for the next month." But he added "the AMA urges Congress to build on the bipartisan action that delayed this year’s cut and act in December to stop the cut for 1 year so that Congress has time to work on a long-term solution."

The House of Representatives voted Nov. 29 to approve a 1-month extension of current Medicare physician fee schedule.

If signed by President Obama, which is expected, physicians will avoid a 23% reduction in fees mandated by Medicare's Sustainable Growth Rate (SGR) and slated to go into effect Dec. 1.

However, unless Congress takes additional action before the Christmas recess, physicians face a 25% cut in fees on January 1.

The House vote follows the Senate’s Nov. 18 approval of a 1-month extension contained in the Physician Payment and Therapy Relief Act of 2010. That bill was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa).

The estimated cost for the 1-month extension is $1 billion. The Senate legislation pays for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sen. Baucus and Sen. Grassley.

In a statement, American Medical Association President Cecil B. Wilson said that the short-term delay "helps ensure that physicians can continue to care for seniors for the next month." But he added "the AMA urges Congress to build on the bipartisan action that delayed this year’s cut and act in December to stop the cut for 1 year so that Congress has time to work on a long-term solution."

The House of Representatives voted Nov. 29 to approve a 1-month extension of current Medicare physician fee schedule.

If signed by President Obama, which is expected, physicians will avoid a 23% reduction in fees mandated by Medicare's Sustainable Growth Rate (SGR) and slated to go into effect Dec. 1.

However, unless Congress takes additional action before the Christmas recess, physicians face a 25% cut in fees on January 1.

The House vote follows the Senate’s Nov. 18 approval of a 1-month extension contained in the Physician Payment and Therapy Relief Act of 2010. That bill was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa).

The estimated cost for the 1-month extension is $1 billion. The Senate legislation pays for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sen. Baucus and Sen. Grassley.

In a statement, American Medical Association President Cecil B. Wilson said that the short-term delay "helps ensure that physicians can continue to care for seniors for the next month." But he added "the AMA urges Congress to build on the bipartisan action that delayed this year’s cut and act in December to stop the cut for 1 year so that Congress has time to work on a long-term solution."

The House of Representatives voted Nov. 29 to approve a 1-month extension of current Medicare physician fee schedule.

If signed by President Obama, which is expected, physicians will avoid a 23% reduction in fees mandated by Medicare's Sustainable Growth Rate (SGR) and slated to go into effect Dec. 1.

However, unless Congress takes additional action before the Christmas recess, physicians face a 25% cut in fees on January 1.

The House vote follows the Senate’s Nov. 18 approval of a 1-month extension contained in the Physician Payment and Therapy Relief Act of 2010. That bill was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa).

The estimated cost for the 1-month extension is $1 billion. The Senate legislation pays for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sen. Baucus and Sen. Grassley.

In a statement, American Medical Association President Cecil B. Wilson said that the short-term delay "helps ensure that physicians can continue to care for seniors for the next month." But he added "the AMA urges Congress to build on the bipartisan action that delayed this year’s cut and act in December to stop the cut for 1 year so that Congress has time to work on a long-term solution."

Provectus Pharmaceuticals announced on Nov. 23 that it has enrolled at least 40 patients in its compassionate use program for PV-10, an experimental drug being studied primarily for melanoma.

PV-10 is an injectable form of Rose Bengal, a small molecule staining agent used to assess eye damage and liver ailments. Provectus determined that the drug selectively kills cancer cells and has been studying it in nonvisceral cancers.

Under the compassionate use program, patients who are not eligible for clinical trials and have certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers, and melanoma can receive PV-10, the company announced.

Phase II studies of PV-10 in metastatic melanoma have just been completed, and 10 of the patients from the study joined the compassionate use program.

Patients in the program will have more frequent and extensive treatment over a longer duration than did those who received the drug in the phase II studies. The company hopes that the compassionate use program might help pinpoint a dosing regimen that can be used in a phase III trial in metastatic melanoma.

Provectus will also pursue the study of PV-10 for liver cancer.

Provectus Pharmaceuticals announced on Nov. 23 that it has enrolled at least 40 patients in its compassionate use program for PV-10, an experimental drug being studied primarily for melanoma.

PV-10 is an injectable form of Rose Bengal, a small molecule staining agent used to assess eye damage and liver ailments. Provectus determined that the drug selectively kills cancer cells and has been studying it in nonvisceral cancers.

Under the compassionate use program, patients who are not eligible for clinical trials and have certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers, and melanoma can receive PV-10, the company announced.

Phase II studies of PV-10 in metastatic melanoma have just been completed, and 10 of the patients from the study joined the compassionate use program.

Patients in the program will have more frequent and extensive treatment over a longer duration than did those who received the drug in the phase II studies. The company hopes that the compassionate use program might help pinpoint a dosing regimen that can be used in a phase III trial in metastatic melanoma.

Provectus will also pursue the study of PV-10 for liver cancer.

Provectus Pharmaceuticals announced on Nov. 23 that it has enrolled at least 40 patients in its compassionate use program for PV-10, an experimental drug being studied primarily for melanoma.

PV-10 is an injectable form of Rose Bengal, a small molecule staining agent used to assess eye damage and liver ailments. Provectus determined that the drug selectively kills cancer cells and has been studying it in nonvisceral cancers.

Under the compassionate use program, patients who are not eligible for clinical trials and have certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers, and melanoma can receive PV-10, the company announced.

Phase II studies of PV-10 in metastatic melanoma have just been completed, and 10 of the patients from the study joined the compassionate use program.

Patients in the program will have more frequent and extensive treatment over a longer duration than did those who received the drug in the phase II studies. The company hopes that the compassionate use program might help pinpoint a dosing regimen that can be used in a phase III trial in metastatic melanoma.

Provectus will also pursue the study of PV-10 for liver cancer.

Provectus Pharmaceuticals announced on Nov. 23 that it has enrolled at least 40 patients in its compassionate use program for PV-10, an experimental drug being studied primarily for melanoma.

PV-10 is an injectable form of Rose Bengal, a small molecule staining agent used to assess eye damage and liver ailments. Provectus determined that the drug selectively kills cancer cells and has been studying it in nonvisceral cancers.

Under the compassionate use program, patients who are not eligible for clinical trials and have certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers, and melanoma can receive PV-10, the company announced.

Phase II studies of PV-10 in metastatic melanoma have just been completed, and 10 of the patients from the study joined the compassionate use program.

Patients in the program will have more frequent and extensive treatment over a longer duration than did those who received the drug in the phase II studies. The company hopes that the compassionate use program might help pinpoint a dosing regimen that can be used in a phase III trial in metastatic melanoma.

Provectus will also pursue the study of PV-10 for liver cancer.

Provectus Pharmaceuticals announced on Nov. 23 that it has enrolled at least 40 patients in its compassionate use program for PV-10, an experimental drug being studied primarily for melanoma.

PV-10 is an injectable form of Rose Bengal, a small molecule staining agent used to assess eye damage and liver ailments. Provectus determined that the drug selectively kills cancer cells and has been studying it in nonvisceral cancers.

Under the compassionate use program, patients who are not eligible for clinical trials and have certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers, and melanoma can receive PV-10, the company announced.

Phase II studies of PV-10 in metastatic melanoma have just been completed, and 10 of the patients from the study joined the compassionate use program.

Patients in the program will have more frequent and extensive treatment over a longer duration than did those who received the drug in the phase II studies. The company hopes that the compassionate use program might help pinpoint a dosing regimen that can be used in a phase III trial in metastatic melanoma.

Provectus will also pursue the study of PV-10 for liver cancer.

Provectus Pharmaceuticals announced on Nov. 23 that it has enrolled at least 40 patients in its compassionate use program for PV-10, an experimental drug being studied primarily for melanoma.

PV-10 is an injectable form of Rose Bengal, a small molecule staining agent used to assess eye damage and liver ailments. Provectus determined that the drug selectively kills cancer cells and has been studying it in nonvisceral cancers.

Under the compassionate use program, patients who are not eligible for clinical trials and have certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers, and melanoma can receive PV-10, the company announced.

Phase II studies of PV-10 in metastatic melanoma have just been completed, and 10 of the patients from the study joined the compassionate use program.

Patients in the program will have more frequent and extensive treatment over a longer duration than did those who received the drug in the phase II studies. The company hopes that the compassionate use program might help pinpoint a dosing regimen that can be used in a phase III trial in metastatic melanoma.

Provectus will also pursue the study of PV-10 for liver cancer.

The National Committee for Quality Assurance has issued draft criteria to define the core capabilities of an accountable care organization.

The accountable care organization (ACO) concept is central to the health system reform envisioned by the Affordable Care Act, but what it would look like or how it would work has been variously and loosely defined. The nonprofit NCQA has stepped in to offer a set of parameters that might standardize the ACO model.

"Our goal is to help people be confident that ACOs meeting the final criteria actually can contain costs without compromising quality," said NCQA President Margaret O'Kane in a statement.

The NCQA has been a leader in establishing quality performance measurement tools that are widely used by health care providers, insurers, and employers. The group receives funding and support from a variety of organizations, including the American College of Physicians and the American Academy of Family Physicians; insurers and pharmaceutical companies also contribute.

The organization has posted the ACO draft criteria on its Web site and is accepting public comments until Nov. 19. According to the NCQA, each ACO should have core capabilities in seven categories: program structure operations; access and availability; primary care; care management; care coordination and transitions; patient rights and responsibilities; and performance reporting.

The criteria were developed by the organization’s ACO task force, which was headed by Dr. Robert Margolis, CEO of the California-based HealthCare Partners Medical Group; the 18 other task force members included Dr. Duane Davis, vice president and chief medical officer of the Pennsylvania-based Geisinger Health Plan, and Dr. Nicholas Wolter, CEO of the Billings (Mont.) Clinic.

ACOs that participate in the NCQA process also will eventually report outcomes on performance measurements. That is important, Dr. Margolis said in a statement, adding that, "most potential ACOs do not have data that can be used from the start to evaluate performance."

He added that "public feedback will help with finalizing the criteria that will start these organizations to a firm foundation."

After the comment period closes, the task force led by Dr. Margolis will review the comments and make revisions, as appropriate, according to a spokesperson for NCQA.

The group will also align the criteria with any regulations pertaining to ACOs. The criteria will likely be made final by March 2011 and then will be released in the second quarter of 2011, the spokesperson said.

The National Committee for Quality Assurance has issued draft criteria to define the core capabilities of an accountable care organization.

The accountable care organization (ACO) concept is central to the health system reform envisioned by the Affordable Care Act, but what it would look like or how it would work has been variously and loosely defined. The nonprofit NCQA has stepped in to offer a set of parameters that might standardize the ACO model.

"Our goal is to help people be confident that ACOs meeting the final criteria actually can contain costs without compromising quality," said NCQA President Margaret O'Kane in a statement.

The NCQA has been a leader in establishing quality performance measurement tools that are widely used by health care providers, insurers, and employers. The group receives funding and support from a variety of organizations, including the American College of Physicians and the American Academy of Family Physicians; insurers and pharmaceutical companies also contribute.

The organization has posted the ACO draft criteria on its Web site and is accepting public comments until Nov. 19. According to the NCQA, each ACO should have core capabilities in seven categories: program structure operations; access and availability; primary care; care management; care coordination and transitions; patient rights and responsibilities; and performance reporting.

The criteria were developed by the organization’s ACO task force, which was headed by Dr. Robert Margolis, CEO of the California-based HealthCare Partners Medical Group; the 18 other task force members included Dr. Duane Davis, vice president and chief medical officer of the Pennsylvania-based Geisinger Health Plan, and Dr. Nicholas Wolter, CEO of the Billings (Mont.) Clinic.

ACOs that participate in the NCQA process also will eventually report outcomes on performance measurements. That is important, Dr. Margolis said in a statement, adding that, "most potential ACOs do not have data that can be used from the start to evaluate performance."

He added that "public feedback will help with finalizing the criteria that will start these organizations to a firm foundation."

After the comment period closes, the task force led by Dr. Margolis will review the comments and make revisions, as appropriate, according to a spokesperson for NCQA.

The group will also align the criteria with any regulations pertaining to ACOs. The criteria will likely be made final by March 2011 and then will be released in the second quarter of 2011, the spokesperson said.

The National Committee for Quality Assurance has issued draft criteria to define the core capabilities of an accountable care organization.

The accountable care organization (ACO) concept is central to the health system reform envisioned by the Affordable Care Act, but what it would look like or how it would work has been variously and loosely defined. The nonprofit NCQA has stepped in to offer a set of parameters that might standardize the ACO model.

"Our goal is to help people be confident that ACOs meeting the final criteria actually can contain costs without compromising quality," said NCQA President Margaret O'Kane in a statement.

The NCQA has been a leader in establishing quality performance measurement tools that are widely used by health care providers, insurers, and employers. The group receives funding and support from a variety of organizations, including the American College of Physicians and the American Academy of Family Physicians; insurers and pharmaceutical companies also contribute.

The organization has posted the ACO draft criteria on its Web site and is accepting public comments until Nov. 19. According to the NCQA, each ACO should have core capabilities in seven categories: program structure operations; access and availability; primary care; care management; care coordination and transitions; patient rights and responsibilities; and performance reporting.

The criteria were developed by the organization’s ACO task force, which was headed by Dr. Robert Margolis, CEO of the California-based HealthCare Partners Medical Group; the 18 other task force members included Dr. Duane Davis, vice president and chief medical officer of the Pennsylvania-based Geisinger Health Plan, and Dr. Nicholas Wolter, CEO of the Billings (Mont.) Clinic.

ACOs that participate in the NCQA process also will eventually report outcomes on performance measurements. That is important, Dr. Margolis said in a statement, adding that, "most potential ACOs do not have data that can be used from the start to evaluate performance."

He added that "public feedback will help with finalizing the criteria that will start these organizations to a firm foundation."

After the comment period closes, the task force led by Dr. Margolis will review the comments and make revisions, as appropriate, according to a spokesperson for NCQA.

The group will also align the criteria with any regulations pertaining to ACOs. The criteria will likely be made final by March 2011 and then will be released in the second quarter of 2011, the spokesperson said.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers’ medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers’ medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers’ medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.