Alicia Ault

The Food and Drug Administration has given full approval for ibrutinib (Imbruvica) for patients with chronic lymphocytic leukemia who have received at least one prior therapy and for those who have a deletion in chromosome 17 (17p deletion) and may or may not have received previous treatment.

The drug received conditional, accelerated approval from the FDA in February for CLL. The agency said that new trial results that looked at overall survival and progression-free survival confirmed the drug’s benefit. Ibrutinib’s label will be updated to show that it has a confirmed survival benefit.

The FDA also designated ibrutinib as a breakthrough therapy for CLL with 17p deletion.

"Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation, reflecting the promise of the breakthrough therapy designation program and demonstrating the FDA’s commitment to working cooperatively with companies to expedite the development, review, and approval of these important new drugs," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

"This FDA approval for Imbruvica is a major step toward chemo-free treatment in CLL," said Dr. John Byrd, director of the hematology division at the Ohio State University Comprehensive Cancer Center, Columbus, in a statement issued by Pharmacyclics, the Sunnyvale, Calif.–based company that is comarketing the drug with Janssen Biotech.

"I continue to be awed by the duration of my patients’ responses to Imbruvica and am grateful Imbruvica now is available to a broader group of CLL patients," said Dr. Byrd, who was a lead investigator for the main trial evaluating ibrutinib, RESONATE.

Three other drugs for CLL have also received breakthrough designations: obinutuzumab (Gazyva), ofatumumab (Arzerra), and most recently, idelalisib (Zydelig), earlier in July.

CLL is a non-Hodgkin’s lymphoma that primarily affects older individuals. The National Cancer Institute estimates that 15,720 Americans will be diagnosed and 4,600 will die from CLL in 2014, the FDA said.

In RESONATE, 391 previously treated patients received either ibrutinib or ofatumumab. Of those, 127 patients had a 17p deletion. The trial was stopped early because overall, patients receiving ibrutinib had a 78% reduction in the risk of disease progression or death, and a 57% reduction in risk of death. For the patients with 17p, there was a 75% reduction in the risk of disease progression or death.

This is the third FDA approval for ibrutinib. In addition to the accelerated approval for CLL in February, the drug was approved for mantle cell lymphoma in November 2013.

Dr. Byrd has served as an unpaid adviser to both Pharmacyclics and Janssen. He reported no financial interest in either company.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has given full approval for ibrutinib (Imbruvica) for patients with chronic lymphocytic leukemia who have received at least one prior therapy and for those who have a deletion in chromosome 17 (17p deletion) and may or may not have received previous treatment.

The drug received conditional, accelerated approval from the FDA in February for CLL. The agency said that new trial results that looked at overall survival and progression-free survival confirmed the drug’s benefit. Ibrutinib’s label will be updated to show that it has a confirmed survival benefit.

The FDA also designated ibrutinib as a breakthrough therapy for CLL with 17p deletion.

"Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation, reflecting the promise of the breakthrough therapy designation program and demonstrating the FDA’s commitment to working cooperatively with companies to expedite the development, review, and approval of these important new drugs," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

"This FDA approval for Imbruvica is a major step toward chemo-free treatment in CLL," said Dr. John Byrd, director of the hematology division at the Ohio State University Comprehensive Cancer Center, Columbus, in a statement issued by Pharmacyclics, the Sunnyvale, Calif.–based company that is comarketing the drug with Janssen Biotech.

"I continue to be awed by the duration of my patients’ responses to Imbruvica and am grateful Imbruvica now is available to a broader group of CLL patients," said Dr. Byrd, who was a lead investigator for the main trial evaluating ibrutinib, RESONATE.

Three other drugs for CLL have also received breakthrough designations: obinutuzumab (Gazyva), ofatumumab (Arzerra), and most recently, idelalisib (Zydelig), earlier in July.

CLL is a non-Hodgkin’s lymphoma that primarily affects older individuals. The National Cancer Institute estimates that 15,720 Americans will be diagnosed and 4,600 will die from CLL in 2014, the FDA said.

In RESONATE, 391 previously treated patients received either ibrutinib or ofatumumab. Of those, 127 patients had a 17p deletion. The trial was stopped early because overall, patients receiving ibrutinib had a 78% reduction in the risk of disease progression or death, and a 57% reduction in risk of death. For the patients with 17p, there was a 75% reduction in the risk of disease progression or death.

This is the third FDA approval for ibrutinib. In addition to the accelerated approval for CLL in February, the drug was approved for mantle cell lymphoma in November 2013.

Dr. Byrd has served as an unpaid adviser to both Pharmacyclics and Janssen. He reported no financial interest in either company.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has given full approval for ibrutinib (Imbruvica) for patients with chronic lymphocytic leukemia who have received at least one prior therapy and for those who have a deletion in chromosome 17 (17p deletion) and may or may not have received previous treatment.

The drug received conditional, accelerated approval from the FDA in February for CLL. The agency said that new trial results that looked at overall survival and progression-free survival confirmed the drug’s benefit. Ibrutinib’s label will be updated to show that it has a confirmed survival benefit.

The FDA also designated ibrutinib as a breakthrough therapy for CLL with 17p deletion.

"Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation, reflecting the promise of the breakthrough therapy designation program and demonstrating the FDA’s commitment to working cooperatively with companies to expedite the development, review, and approval of these important new drugs," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

"This FDA approval for Imbruvica is a major step toward chemo-free treatment in CLL," said Dr. John Byrd, director of the hematology division at the Ohio State University Comprehensive Cancer Center, Columbus, in a statement issued by Pharmacyclics, the Sunnyvale, Calif.–based company that is comarketing the drug with Janssen Biotech.

"I continue to be awed by the duration of my patients’ responses to Imbruvica and am grateful Imbruvica now is available to a broader group of CLL patients," said Dr. Byrd, who was a lead investigator for the main trial evaluating ibrutinib, RESONATE.

Three other drugs for CLL have also received breakthrough designations: obinutuzumab (Gazyva), ofatumumab (Arzerra), and most recently, idelalisib (Zydelig), earlier in July.

CLL is a non-Hodgkin’s lymphoma that primarily affects older individuals. The National Cancer Institute estimates that 15,720 Americans will be diagnosed and 4,600 will die from CLL in 2014, the FDA said.

In RESONATE, 391 previously treated patients received either ibrutinib or ofatumumab. Of those, 127 patients had a 17p deletion. The trial was stopped early because overall, patients receiving ibrutinib had a 78% reduction in the risk of disease progression or death, and a 57% reduction in risk of death. For the patients with 17p, there was a 75% reduction in the risk of disease progression or death.

This is the third FDA approval for ibrutinib. In addition to the accelerated approval for CLL in February, the drug was approved for mantle cell lymphoma in November 2013.

Dr. Byrd has served as an unpaid adviser to both Pharmacyclics and Janssen. He reported no financial interest in either company.

[email protected]

On Twitter @aliciaault

Two conflicting appeals court decisions issued July 22 seem to put the tax subsidies offered by the Affordable Care Act – and potentially, the entire law itself – on either shaky or firm legal footing, depending on who’s doing the analysis.

Both cases were originally brought by plaintiffs who contended that the Obama Administration did not have the legal authority to issue subsidies to low-income individuals who buy insurance on the federal marketplace. They said that the ACA explicitly said that credits were only available to "state-established exchanges." When lower courts ruled against them, they appealed.

©jsmith/iStockphoto

The District of Columbia Circuit of the U.S. Court of Appeals sided with the plaintiffs in Halbig v. Burwell, 2-1. The 4th Circuit of the U.S. Court of Appeals, on the other hand, sided unanimously with the government in King v. Burwell.

An estimated 5 million people have received subsidies from the 36 federal marketplaces, putting them at risk for losing those tax credits. For the time being, however, people who have been deemed eligible for subsidies will continue to receive them. And those who sign up for insurance in the next open enrollment period beginning Nov. 15 will also likely get subsidies.

"This ruling does not have any practical impact on Americans’ ability to receive tax credits right now," White House spokesman Josh Earnest said about the ruling in Halbig v. Burwell. In a briefing after both decisions were handed down, Mr. Earnest also said that the administration would essentially appeal that ruling by seeking a decision by the full panel of 11 judges who sit on the D.C. Circuit.

"You don’t need a fancy legal degree to understand that Congress intended for every eligible American to have access to tax credits that would lower their health care costs," whether state or federal officials were running the marketplace, Mr. Earnest said.

The lead plaintiff in the case heard by the D.C. Circuit was brought by Jacqueline Halbig, a senior policy adviser in the Department of Health & Human Services under President George W. Bush. The two judges ruling for her and her coplaintiffs said that their reading of the ACA "plainly makes subsidies available only on exchanges established by the states." The "legislative record provides little indication one way or the other of congressional intent, but the statutory text does," they said, adding that the language in the law is "conclusive evidence of Congress’ intent."

They said they reached their conclusion "with reluctance," because "our ruling will likely have significant consequences both for the millions of individuals receiving tax credits through federal exchanges and for health insurance markets more broadly."

Judge Harry Edwards dissented. "This case is about appellants’ not-so-veiled attempt to gut the Patient Protection and Affordable Care Act." The argument that Congress only intended to pay subsidies on state exchanges as a way to encourage states to run their own exchanges "is nonsense, made up out of whole cloth."

Judge Edwards added, "There is no credible evidence in the record that Congress intended to condition subsidies on whether a state, as opposed to HHS, established the exchange. Nor is there credible evidence that any state even considered the possibility that its taxpayers would be denied subsidies if the state opted to allow HHS to establish an exchange on its behalf."

Those who support premium subsidies said they were dismayed by the D.C. Circuit’s ruling, but that it would not likely stand.

"Today’s decision represents the high-water mark for Affordable Care Act opponents, but the water will recede very quickly," said Ron Pollack, Executive Director of Families USA, in a statement.

The American Cancer Society, American Cancer Society Cancer Action Network, American Diabetes Association, and American Heart Association filed a joint statement saying that they believed the Halbig decision could be disastrous. "On behalf of the tens of millions of people nationwide who have experienced cancer, diabetes, heart disease, and stroke, we are deeply disappointed with the decision of the U.S. Court of Appeals for the D.C. Circuit, which denies premium tax credits that make health coverage more affordable to people who buy a plan in the federally facilitated marketplace," they said. But, they added that it would not likely be upheld.

Others who opposed the ACA and the subsidy scheme applauded the Halbig decision.

"The president has been spending money illegally, the court has ruled," said Michael Cannon, director of Health Policy Studies at the Washington, D.C.-based Cato Institute, in a briefing. An article by Mr. Cannon and economist Jonathan Adler led to the Halbig filing.

In a statement, Sen. Ted Cruz (R-Tex.), who filed a friend of the court brief in King v. Burwell, said that the D.C. Circuit’s decision "is a repudiation of Obamacare and all the lawlessness that has come with it."

The plaintiffs in King v. Burwell, however, were handed a setback by the 4th Circuit. The four individual plaintiffs, all of whom live in Virginia, which does not have a state-run exchange, did not want to be forced to buy health insurance, but said that if they didn’t, they’d be penalized. Since the ACA will give them a subsidy to buy coverage, they would be forced either to buy insurance or pay a penalty for not having coverage, they said.

They added that Congress said that only state-run marketplaces could receive federal subsidies.

The judges ruled against them, saying "we are not persuaded by the plaintiffs’ ‘coercion’ argument." They did say, however, that there was some confusion in the law. "We cannot discern whether Congress intended one way or another to make the tax credits available on HHS-facilitated exchanges," they wrote, adding that "the relevant statutory sections appear to conflict with one another, yielding different possible interpretations."

But in the end, the judges concluded that it was "clear that widely available tax credits are essential to fulfilling the Act’s primary goals and that Congress was aware of their importance when drafting the bill." Therefore, the Internal Revenue Service’s rule authorizing tax credits was "a permissible exercise of the agency’s discretion."

Mr. Cannon of the Cato Institute said that he views the 4th Circuit ruling as a kind of loss for the Obama administration because the judges said that the language in the ACA was ambiguous on the subsidies.

Families USA’s Ron Pollack, however, said that he thought the administration would ultimately prevail.

"As of today, eight judges – two federal district court judges and six appellate judges – have ruled on these challenges. Altogether, six judges have ruled that the cases should be dismissed, and only two have upheld plaintiffs’ claims," he said in a statement.

There are still more legal proceedings to be decided before there is a definitive answer on whether the subsidies – and the ACA itself – are legal. The full D.C. Circuit has to choose whether to hear the Halbig case, and the plaintiffs in the 4th Circuit could also ask for a hearing by the full panel of judges.

There are two additional major cases questioning the legality of the subsidies pending at the appeals court level.

One or all of the cases could be taken to the U.S. Supreme Court.

[email protected]

On Twitter @aliciaault

Two conflicting appeals court decisions issued July 22 seem to put the tax subsidies offered by the Affordable Care Act – and potentially, the entire law itself – on either shaky or firm legal footing, depending on who’s doing the analysis.

Both cases were originally brought by plaintiffs who contended that the Obama Administration did not have the legal authority to issue subsidies to low-income individuals who buy insurance on the federal marketplace. They said that the ACA explicitly said that credits were only available to "state-established exchanges." When lower courts ruled against them, they appealed.

©jsmith/iStockphoto

The District of Columbia Circuit of the U.S. Court of Appeals sided with the plaintiffs in Halbig v. Burwell, 2-1. The 4th Circuit of the U.S. Court of Appeals, on the other hand, sided unanimously with the government in King v. Burwell.

An estimated 5 million people have received subsidies from the 36 federal marketplaces, putting them at risk for losing those tax credits. For the time being, however, people who have been deemed eligible for subsidies will continue to receive them. And those who sign up for insurance in the next open enrollment period beginning Nov. 15 will also likely get subsidies.

"This ruling does not have any practical impact on Americans’ ability to receive tax credits right now," White House spokesman Josh Earnest said about the ruling in Halbig v. Burwell. In a briefing after both decisions were handed down, Mr. Earnest also said that the administration would essentially appeal that ruling by seeking a decision by the full panel of 11 judges who sit on the D.C. Circuit.

"You don’t need a fancy legal degree to understand that Congress intended for every eligible American to have access to tax credits that would lower their health care costs," whether state or federal officials were running the marketplace, Mr. Earnest said.

The lead plaintiff in the case heard by the D.C. Circuit was brought by Jacqueline Halbig, a senior policy adviser in the Department of Health & Human Services under President George W. Bush. The two judges ruling for her and her coplaintiffs said that their reading of the ACA "plainly makes subsidies available only on exchanges established by the states." The "legislative record provides little indication one way or the other of congressional intent, but the statutory text does," they said, adding that the language in the law is "conclusive evidence of Congress’ intent."

They said they reached their conclusion "with reluctance," because "our ruling will likely have significant consequences both for the millions of individuals receiving tax credits through federal exchanges and for health insurance markets more broadly."

Judge Harry Edwards dissented. "This case is about appellants’ not-so-veiled attempt to gut the Patient Protection and Affordable Care Act." The argument that Congress only intended to pay subsidies on state exchanges as a way to encourage states to run their own exchanges "is nonsense, made up out of whole cloth."

Judge Edwards added, "There is no credible evidence in the record that Congress intended to condition subsidies on whether a state, as opposed to HHS, established the exchange. Nor is there credible evidence that any state even considered the possibility that its taxpayers would be denied subsidies if the state opted to allow HHS to establish an exchange on its behalf."

Those who support premium subsidies said they were dismayed by the D.C. Circuit’s ruling, but that it would not likely stand.

"Today’s decision represents the high-water mark for Affordable Care Act opponents, but the water will recede very quickly," said Ron Pollack, Executive Director of Families USA, in a statement.

The American Cancer Society, American Cancer Society Cancer Action Network, American Diabetes Association, and American Heart Association filed a joint statement saying that they believed the Halbig decision could be disastrous. "On behalf of the tens of millions of people nationwide who have experienced cancer, diabetes, heart disease, and stroke, we are deeply disappointed with the decision of the U.S. Court of Appeals for the D.C. Circuit, which denies premium tax credits that make health coverage more affordable to people who buy a plan in the federally facilitated marketplace," they said. But, they added that it would not likely be upheld.

Others who opposed the ACA and the subsidy scheme applauded the Halbig decision.

"The president has been spending money illegally, the court has ruled," said Michael Cannon, director of Health Policy Studies at the Washington, D.C.-based Cato Institute, in a briefing. An article by Mr. Cannon and economist Jonathan Adler led to the Halbig filing.

In a statement, Sen. Ted Cruz (R-Tex.), who filed a friend of the court brief in King v. Burwell, said that the D.C. Circuit’s decision "is a repudiation of Obamacare and all the lawlessness that has come with it."

The plaintiffs in King v. Burwell, however, were handed a setback by the 4th Circuit. The four individual plaintiffs, all of whom live in Virginia, which does not have a state-run exchange, did not want to be forced to buy health insurance, but said that if they didn’t, they’d be penalized. Since the ACA will give them a subsidy to buy coverage, they would be forced either to buy insurance or pay a penalty for not having coverage, they said.

They added that Congress said that only state-run marketplaces could receive federal subsidies.

The judges ruled against them, saying "we are not persuaded by the plaintiffs’ ‘coercion’ argument." They did say, however, that there was some confusion in the law. "We cannot discern whether Congress intended one way or another to make the tax credits available on HHS-facilitated exchanges," they wrote, adding that "the relevant statutory sections appear to conflict with one another, yielding different possible interpretations."

But in the end, the judges concluded that it was "clear that widely available tax credits are essential to fulfilling the Act’s primary goals and that Congress was aware of their importance when drafting the bill." Therefore, the Internal Revenue Service’s rule authorizing tax credits was "a permissible exercise of the agency’s discretion."

Mr. Cannon of the Cato Institute said that he views the 4th Circuit ruling as a kind of loss for the Obama administration because the judges said that the language in the ACA was ambiguous on the subsidies.

Families USA’s Ron Pollack, however, said that he thought the administration would ultimately prevail.

"As of today, eight judges – two federal district court judges and six appellate judges – have ruled on these challenges. Altogether, six judges have ruled that the cases should be dismissed, and only two have upheld plaintiffs’ claims," he said in a statement.

There are still more legal proceedings to be decided before there is a definitive answer on whether the subsidies – and the ACA itself – are legal. The full D.C. Circuit has to choose whether to hear the Halbig case, and the plaintiffs in the 4th Circuit could also ask for a hearing by the full panel of judges.

There are two additional major cases questioning the legality of the subsidies pending at the appeals court level.

One or all of the cases could be taken to the U.S. Supreme Court.

[email protected]

On Twitter @aliciaault

Two conflicting appeals court decisions issued July 22 seem to put the tax subsidies offered by the Affordable Care Act – and potentially, the entire law itself – on either shaky or firm legal footing, depending on who’s doing the analysis.

Both cases were originally brought by plaintiffs who contended that the Obama Administration did not have the legal authority to issue subsidies to low-income individuals who buy insurance on the federal marketplace. They said that the ACA explicitly said that credits were only available to "state-established exchanges." When lower courts ruled against them, they appealed.

©jsmith/iStockphoto

The District of Columbia Circuit of the U.S. Court of Appeals sided with the plaintiffs in Halbig v. Burwell, 2-1. The 4th Circuit of the U.S. Court of Appeals, on the other hand, sided unanimously with the government in King v. Burwell.

An estimated 5 million people have received subsidies from the 36 federal marketplaces, putting them at risk for losing those tax credits. For the time being, however, people who have been deemed eligible for subsidies will continue to receive them. And those who sign up for insurance in the next open enrollment period beginning Nov. 15 will also likely get subsidies.

"This ruling does not have any practical impact on Americans’ ability to receive tax credits right now," White House spokesman Josh Earnest said about the ruling in Halbig v. Burwell. In a briefing after both decisions were handed down, Mr. Earnest also said that the administration would essentially appeal that ruling by seeking a decision by the full panel of 11 judges who sit on the D.C. Circuit.

"You don’t need a fancy legal degree to understand that Congress intended for every eligible American to have access to tax credits that would lower their health care costs," whether state or federal officials were running the marketplace, Mr. Earnest said.

The lead plaintiff in the case heard by the D.C. Circuit was brought by Jacqueline Halbig, a senior policy adviser in the Department of Health & Human Services under President George W. Bush. The two judges ruling for her and her coplaintiffs said that their reading of the ACA "plainly makes subsidies available only on exchanges established by the states." The "legislative record provides little indication one way or the other of congressional intent, but the statutory text does," they said, adding that the language in the law is "conclusive evidence of Congress’ intent."

They said they reached their conclusion "with reluctance," because "our ruling will likely have significant consequences both for the millions of individuals receiving tax credits through federal exchanges and for health insurance markets more broadly."

Judge Harry Edwards dissented. "This case is about appellants’ not-so-veiled attempt to gut the Patient Protection and Affordable Care Act." The argument that Congress only intended to pay subsidies on state exchanges as a way to encourage states to run their own exchanges "is nonsense, made up out of whole cloth."

Judge Edwards added, "There is no credible evidence in the record that Congress intended to condition subsidies on whether a state, as opposed to HHS, established the exchange. Nor is there credible evidence that any state even considered the possibility that its taxpayers would be denied subsidies if the state opted to allow HHS to establish an exchange on its behalf."

Those who support premium subsidies said they were dismayed by the D.C. Circuit’s ruling, but that it would not likely stand.

"Today’s decision represents the high-water mark for Affordable Care Act opponents, but the water will recede very quickly," said Ron Pollack, Executive Director of Families USA, in a statement.

The American Cancer Society, American Cancer Society Cancer Action Network, American Diabetes Association, and American Heart Association filed a joint statement saying that they believed the Halbig decision could be disastrous. "On behalf of the tens of millions of people nationwide who have experienced cancer, diabetes, heart disease, and stroke, we are deeply disappointed with the decision of the U.S. Court of Appeals for the D.C. Circuit, which denies premium tax credits that make health coverage more affordable to people who buy a plan in the federally facilitated marketplace," they said. But, they added that it would not likely be upheld.

Others who opposed the ACA and the subsidy scheme applauded the Halbig decision.

"The president has been spending money illegally, the court has ruled," said Michael Cannon, director of Health Policy Studies at the Washington, D.C.-based Cato Institute, in a briefing. An article by Mr. Cannon and economist Jonathan Adler led to the Halbig filing.

In a statement, Sen. Ted Cruz (R-Tex.), who filed a friend of the court brief in King v. Burwell, said that the D.C. Circuit’s decision "is a repudiation of Obamacare and all the lawlessness that has come with it."

The plaintiffs in King v. Burwell, however, were handed a setback by the 4th Circuit. The four individual plaintiffs, all of whom live in Virginia, which does not have a state-run exchange, did not want to be forced to buy health insurance, but said that if they didn’t, they’d be penalized. Since the ACA will give them a subsidy to buy coverage, they would be forced either to buy insurance or pay a penalty for not having coverage, they said.

They added that Congress said that only state-run marketplaces could receive federal subsidies.

The judges ruled against them, saying "we are not persuaded by the plaintiffs’ ‘coercion’ argument." They did say, however, that there was some confusion in the law. "We cannot discern whether Congress intended one way or another to make the tax credits available on HHS-facilitated exchanges," they wrote, adding that "the relevant statutory sections appear to conflict with one another, yielding different possible interpretations."

But in the end, the judges concluded that it was "clear that widely available tax credits are essential to fulfilling the Act’s primary goals and that Congress was aware of their importance when drafting the bill." Therefore, the Internal Revenue Service’s rule authorizing tax credits was "a permissible exercise of the agency’s discretion."

Mr. Cannon of the Cato Institute said that he views the 4th Circuit ruling as a kind of loss for the Obama administration because the judges said that the language in the ACA was ambiguous on the subsidies.

Families USA’s Ron Pollack, however, said that he thought the administration would ultimately prevail.

"As of today, eight judges – two federal district court judges and six appellate judges – have ruled on these challenges. Altogether, six judges have ruled that the cases should be dismissed, and only two have upheld plaintiffs’ claims," he said in a statement.

There are still more legal proceedings to be decided before there is a definitive answer on whether the subsidies – and the ACA itself – are legal. The full D.C. Circuit has to choose whether to hear the Halbig case, and the plaintiffs in the 4th Circuit could also ask for a hearing by the full panel of judges.

There are two additional major cases questioning the legality of the subsidies pending at the appeals court level.

One or all of the cases could be taken to the U.S. Supreme Court.

[email protected]

On Twitter @aliciaault

CHICAGO – The American Medical Association should continue to work with the American Board of Medical Specialties to address physicians’ concerns about Maintenance of Certification – that was the consensus at the annual meeting of the AMA House of Delegates.

The AMA’s delegates defeated a resolution that asked the organization to put a moratorium on MOC until it was proven to improve the quality of care and patient outcomes. However, they did agree to a new policy that directs the AMA to:

Alicia Ault/Frontline Medical News

• Explore with independent entities the feasibility of conducting a study to evaluate the effect MOC requirements and Maintenance of Licensure principles have on workforce, practice costs, patient outcomes, patient safety, and patient access.

• Work with the American Board of Medical Specialties and its 24 member boards to collect data on why physicians choose to maintain or discontinue their board certification.

• Work with the ABMS and the Federation of State Medical Boards to study whether MOC and the principles of Maintenance of Licensure are important factors to physicians when deciding whether to retire and whether they have a direct effect on workforce.

• Oppose making MOC mandatory as a condition of medical licensure, and encourage physicians to strive constantly to improve their care of patients by the means they find most effective.

The new policy applies to both the ABMS MOC process and the Osteopathic Continuous Certification (OCC) process.

Physicians have increasingly voiced their concerns about MOC. Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., launched a petition drive to overhaul the American Board of Internal Medicine’s MOC process. The petition has more than 17,000 signatures.

The ABIM says that it is listening to physicians and is making changes in the process, but also recently said that more than 150,000 physicians had participated in its MOC process – making the May 1 deadline to be listed on the ABIM website as having met the MOC criteria.

But anger is still bubbling up, and was expressed at the AMA’s meeting.

"Practicing physicians on the front lines are increasingly burdened, hassled, and confused by the onerous and expensive process of Maintenance of Certification and Maintenance of Licensure," said Dr. James A. Goodyear, a delegate from Pennsylvania.

Dr. Goodyear introduced the resolution to seek a moratorium on the MOC.

But Dr. Darlyne Menscer, a member of the AMA Council on Medical Education, told the delegates that such a moratorium would put a wedge in the close working relationship the AMA has had with the ABMS. "This is more prescriptive than we can commit to as a council, although we definitely do hear the concerns of the House," added Dr. Menscer.

The AMA has been discussing the concerns about MOC with the ABMS, most recently holding a meeting in Chicago in early June.

Dr. Joshua Cohen, a delegate from the American Academy of Neurology, and a member of the AMA Foundation’s Board of Directors, who attended that meeting, also argued against a moratorium. "It would make it impossible for the AMA to improve the process going forward," said Dr. Cohen.

Dr. Chuck Wilson, a pediatrician and delegate from the North Carolina delegation, also opposed any major change in direction for the AMA. He noted that if the AMA was seen as opposed to MOC, it might not be viewed well. "We all want it to be less onerous," said Dr. Wilson. But, he noted, "the Council on Medical Education is working in that direction. Let’s give them a chance to be successful."

In a statement after the HOD meeting, the AMA said that it "continues to ensure the MOC process does not disrupt physician practice or reduce the capacity of the overall physician workforce." Concerns about MOC "center around the need for relevance to the daily practice of physicians and the better integration into physician practices to optimally support learning and improvement."

[email protected]

On Twitter @aliciaault

CHICAGO – The American Medical Association should continue to work with the American Board of Medical Specialties to address physicians’ concerns about Maintenance of Certification – that was the consensus at the annual meeting of the AMA House of Delegates.

The AMA’s delegates defeated a resolution that asked the organization to put a moratorium on MOC until it was proven to improve the quality of care and patient outcomes. However, they did agree to a new policy that directs the AMA to:

Alicia Ault/Frontline Medical News

• Explore with independent entities the feasibility of conducting a study to evaluate the effect MOC requirements and Maintenance of Licensure principles have on workforce, practice costs, patient outcomes, patient safety, and patient access.

• Work with the American Board of Medical Specialties and its 24 member boards to collect data on why physicians choose to maintain or discontinue their board certification.

• Work with the ABMS and the Federation of State Medical Boards to study whether MOC and the principles of Maintenance of Licensure are important factors to physicians when deciding whether to retire and whether they have a direct effect on workforce.

• Oppose making MOC mandatory as a condition of medical licensure, and encourage physicians to strive constantly to improve their care of patients by the means they find most effective.

The new policy applies to both the ABMS MOC process and the Osteopathic Continuous Certification (OCC) process.

Physicians have increasingly voiced their concerns about MOC. Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., launched a petition drive to overhaul the American Board of Internal Medicine’s MOC process. The petition has more than 17,000 signatures.

The ABIM says that it is listening to physicians and is making changes in the process, but also recently said that more than 150,000 physicians had participated in its MOC process – making the May 1 deadline to be listed on the ABIM website as having met the MOC criteria.

But anger is still bubbling up, and was expressed at the AMA’s meeting.

"Practicing physicians on the front lines are increasingly burdened, hassled, and confused by the onerous and expensive process of Maintenance of Certification and Maintenance of Licensure," said Dr. James A. Goodyear, a delegate from Pennsylvania.

Dr. Goodyear introduced the resolution to seek a moratorium on the MOC.

But Dr. Darlyne Menscer, a member of the AMA Council on Medical Education, told the delegates that such a moratorium would put a wedge in the close working relationship the AMA has had with the ABMS. "This is more prescriptive than we can commit to as a council, although we definitely do hear the concerns of the House," added Dr. Menscer.

The AMA has been discussing the concerns about MOC with the ABMS, most recently holding a meeting in Chicago in early June.

Dr. Joshua Cohen, a delegate from the American Academy of Neurology, and a member of the AMA Foundation’s Board of Directors, who attended that meeting, also argued against a moratorium. "It would make it impossible for the AMA to improve the process going forward," said Dr. Cohen.

Dr. Chuck Wilson, a pediatrician and delegate from the North Carolina delegation, also opposed any major change in direction for the AMA. He noted that if the AMA was seen as opposed to MOC, it might not be viewed well. "We all want it to be less onerous," said Dr. Wilson. But, he noted, "the Council on Medical Education is working in that direction. Let’s give them a chance to be successful."

In a statement after the HOD meeting, the AMA said that it "continues to ensure the MOC process does not disrupt physician practice or reduce the capacity of the overall physician workforce." Concerns about MOC "center around the need for relevance to the daily practice of physicians and the better integration into physician practices to optimally support learning and improvement."

[email protected]

On Twitter @aliciaault

CHICAGO – The American Medical Association should continue to work with the American Board of Medical Specialties to address physicians’ concerns about Maintenance of Certification – that was the consensus at the annual meeting of the AMA House of Delegates.

The AMA’s delegates defeated a resolution that asked the organization to put a moratorium on MOC until it was proven to improve the quality of care and patient outcomes. However, they did agree to a new policy that directs the AMA to:

Alicia Ault/Frontline Medical News

• Explore with independent entities the feasibility of conducting a study to evaluate the effect MOC requirements and Maintenance of Licensure principles have on workforce, practice costs, patient outcomes, patient safety, and patient access.

• Work with the American Board of Medical Specialties and its 24 member boards to collect data on why physicians choose to maintain or discontinue their board certification.

• Work with the ABMS and the Federation of State Medical Boards to study whether MOC and the principles of Maintenance of Licensure are important factors to physicians when deciding whether to retire and whether they have a direct effect on workforce.

• Oppose making MOC mandatory as a condition of medical licensure, and encourage physicians to strive constantly to improve their care of patients by the means they find most effective.

The new policy applies to both the ABMS MOC process and the Osteopathic Continuous Certification (OCC) process.

Physicians have increasingly voiced their concerns about MOC. Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., launched a petition drive to overhaul the American Board of Internal Medicine’s MOC process. The petition has more than 17,000 signatures.

The ABIM says that it is listening to physicians and is making changes in the process, but also recently said that more than 150,000 physicians had participated in its MOC process – making the May 1 deadline to be listed on the ABIM website as having met the MOC criteria.

But anger is still bubbling up, and was expressed at the AMA’s meeting.

"Practicing physicians on the front lines are increasingly burdened, hassled, and confused by the onerous and expensive process of Maintenance of Certification and Maintenance of Licensure," said Dr. James A. Goodyear, a delegate from Pennsylvania.

Dr. Goodyear introduced the resolution to seek a moratorium on the MOC.

But Dr. Darlyne Menscer, a member of the AMA Council on Medical Education, told the delegates that such a moratorium would put a wedge in the close working relationship the AMA has had with the ABMS. "This is more prescriptive than we can commit to as a council, although we definitely do hear the concerns of the House," added Dr. Menscer.

The AMA has been discussing the concerns about MOC with the ABMS, most recently holding a meeting in Chicago in early June.

Dr. Joshua Cohen, a delegate from the American Academy of Neurology, and a member of the AMA Foundation’s Board of Directors, who attended that meeting, also argued against a moratorium. "It would make it impossible for the AMA to improve the process going forward," said Dr. Cohen.

Dr. Chuck Wilson, a pediatrician and delegate from the North Carolina delegation, also opposed any major change in direction for the AMA. He noted that if the AMA was seen as opposed to MOC, it might not be viewed well. "We all want it to be less onerous," said Dr. Wilson. But, he noted, "the Council on Medical Education is working in that direction. Let’s give them a chance to be successful."

In a statement after the HOD meeting, the AMA said that it "continues to ensure the MOC process does not disrupt physician practice or reduce the capacity of the overall physician workforce." Concerns about MOC "center around the need for relevance to the daily practice of physicians and the better integration into physician practices to optimally support learning and improvement."

[email protected]

On Twitter @aliciaault

MINNEAPOLIS – Teens who do not sleep enough may be at risk for gaining weight and increased insulin resistance.

That’s the conclusion of a small pilot study conducted by Dr. Dorit Koren and her colleagues at the University of Chicago.

There is already considerable epidemiologic data that lack of sleep is a risk factor for obesity in children and young adults, said Dr. Koren who is with the departments of pediatrics and medicine in the pediatric endocrinology department at the University of Chicago.

There have been studies examining the risk of type 2 diabetes with sleep deprivation in adults, but there has been no population-based data in children examining the risk of type 2 diabetes in children and adolescents – and that’s important because they are not just small adults, she said.

Adolescents tend to be more insulin resistant because of the pubertal growth spurt, and they have a different sleep architecture than do adults, as they tend to be late to bed and late to rise, said Dr. Koren.

Previous studies looking at glucose homeostasis in adolescents have mostly looked at fasting rather than dynamic measures of glucose homeostasis and that is a limitation because fasting measures reflect primarily hepatic insulin sensitivity, she said. Most studies also were conducted in a sleep lab, which is not a natural environment.

She and her colleagues wanted to study adolescents at home and also gauge postprandial glucose metabolism. They enrolled 10 adolescents, aged 13-18 years. A total of 70% were black and 30% were non-Hispanic white. Just under half were male. They were mostly overweight, as measured by body mass index, although some were very lean, and some were very obese, said Dr. Koren.

The patients were first given an overnight polysomnogram, and then told to measure sleep at home through an actigraphy device, and sleep diaries. The actigraphy helped back up the diaries, which are known to be "remarkably inaccurate" among adolescents, said Dr. Koren. They kept track of their sleep for 2 weeks.

The teens then returned for a second visit to the clinic. The researchers analyzed the average bedtime and waking time, and then asked them to restrict their sleep by going to bed an hour later. After returning again, the new measures after sleep restriction were compared with the earlier measures.

There was a strong correlation between weight and sleep duration, with longer sleep associated with less weight. They also saw a trend toward a greater waist circumference in adolescents who slept less.

There was a significant negative association between sleep duration and the 90-minute oral glucose tolerance test, with a P = .036. Restricted sleep also led to greater insulin resistance as measured by the homeostasis model assessment of insulin resistance (P = .091), and the whole-body insulin sensitivity index (P = .091).

Dr. Koren and her colleagues also performed linear regression analyses, controlling for either waist circumference or weight. Sleep deprivation was still the most significant factor as measured on the 90-minute glucose tolerance test and by the whole-body insulin sensitivity index.

"The model suggests that these relationships between home sleep deprivation and insulin resistance or hyperglycemia are independent of obesity, generalized or central," said Dr. Koren.

She cited the example of a 15-year-old female subject, who was lean. Her sleep went from 8.7 hours at baseline to 7.9 hours with the restriction. Her glucose values did not change significantly between baseline and restriction, but her insulin levels were noticeably higher in the sleep-restricted state, said Dr. Koren. Those levels rose an hour into the 90-minute tolerance test, which suggests that she was insulin resistant and needed to secrete more insulin to maintain glycemia.

Dr. Koren and her colleagues hope to replicate the study in a larger cohort.

Dr. Koren reported no relevant financial conflicts.

[email protected]

On Twitter @aliciaault

MINNEAPOLIS – Teens who do not sleep enough may be at risk for gaining weight and increased insulin resistance.

That’s the conclusion of a small pilot study conducted by Dr. Dorit Koren and her colleagues at the University of Chicago.

There is already considerable epidemiologic data that lack of sleep is a risk factor for obesity in children and young adults, said Dr. Koren who is with the departments of pediatrics and medicine in the pediatric endocrinology department at the University of Chicago.

There have been studies examining the risk of type 2 diabetes with sleep deprivation in adults, but there has been no population-based data in children examining the risk of type 2 diabetes in children and adolescents – and that’s important because they are not just small adults, she said.

Adolescents tend to be more insulin resistant because of the pubertal growth spurt, and they have a different sleep architecture than do adults, as they tend to be late to bed and late to rise, said Dr. Koren.

Previous studies looking at glucose homeostasis in adolescents have mostly looked at fasting rather than dynamic measures of glucose homeostasis and that is a limitation because fasting measures reflect primarily hepatic insulin sensitivity, she said. Most studies also were conducted in a sleep lab, which is not a natural environment.

She and her colleagues wanted to study adolescents at home and also gauge postprandial glucose metabolism. They enrolled 10 adolescents, aged 13-18 years. A total of 70% were black and 30% were non-Hispanic white. Just under half were male. They were mostly overweight, as measured by body mass index, although some were very lean, and some were very obese, said Dr. Koren.

The patients were first given an overnight polysomnogram, and then told to measure sleep at home through an actigraphy device, and sleep diaries. The actigraphy helped back up the diaries, which are known to be "remarkably inaccurate" among adolescents, said Dr. Koren. They kept track of their sleep for 2 weeks.

The teens then returned for a second visit to the clinic. The researchers analyzed the average bedtime and waking time, and then asked them to restrict their sleep by going to bed an hour later. After returning again, the new measures after sleep restriction were compared with the earlier measures.

There was a strong correlation between weight and sleep duration, with longer sleep associated with less weight. They also saw a trend toward a greater waist circumference in adolescents who slept less.

There was a significant negative association between sleep duration and the 90-minute oral glucose tolerance test, with a P = .036. Restricted sleep also led to greater insulin resistance as measured by the homeostasis model assessment of insulin resistance (P = .091), and the whole-body insulin sensitivity index (P = .091).

Dr. Koren and her colleagues also performed linear regression analyses, controlling for either waist circumference or weight. Sleep deprivation was still the most significant factor as measured on the 90-minute glucose tolerance test and by the whole-body insulin sensitivity index.

"The model suggests that these relationships between home sleep deprivation and insulin resistance or hyperglycemia are independent of obesity, generalized or central," said Dr. Koren.

She cited the example of a 15-year-old female subject, who was lean. Her sleep went from 8.7 hours at baseline to 7.9 hours with the restriction. Her glucose values did not change significantly between baseline and restriction, but her insulin levels were noticeably higher in the sleep-restricted state, said Dr. Koren. Those levels rose an hour into the 90-minute tolerance test, which suggests that she was insulin resistant and needed to secrete more insulin to maintain glycemia.

Dr. Koren and her colleagues hope to replicate the study in a larger cohort.

Dr. Koren reported no relevant financial conflicts.

[email protected]

On Twitter @aliciaault

MINNEAPOLIS – Teens who do not sleep enough may be at risk for gaining weight and increased insulin resistance.

That’s the conclusion of a small pilot study conducted by Dr. Dorit Koren and her colleagues at the University of Chicago.

There is already considerable epidemiologic data that lack of sleep is a risk factor for obesity in children and young adults, said Dr. Koren who is with the departments of pediatrics and medicine in the pediatric endocrinology department at the University of Chicago.

There have been studies examining the risk of type 2 diabetes with sleep deprivation in adults, but there has been no population-based data in children examining the risk of type 2 diabetes in children and adolescents – and that’s important because they are not just small adults, she said.

Adolescents tend to be more insulin resistant because of the pubertal growth spurt, and they have a different sleep architecture than do adults, as they tend to be late to bed and late to rise, said Dr. Koren.

Previous studies looking at glucose homeostasis in adolescents have mostly looked at fasting rather than dynamic measures of glucose homeostasis and that is a limitation because fasting measures reflect primarily hepatic insulin sensitivity, she said. Most studies also were conducted in a sleep lab, which is not a natural environment.

She and her colleagues wanted to study adolescents at home and also gauge postprandial glucose metabolism. They enrolled 10 adolescents, aged 13-18 years. A total of 70% were black and 30% were non-Hispanic white. Just under half were male. They were mostly overweight, as measured by body mass index, although some were very lean, and some were very obese, said Dr. Koren.

The patients were first given an overnight polysomnogram, and then told to measure sleep at home through an actigraphy device, and sleep diaries. The actigraphy helped back up the diaries, which are known to be "remarkably inaccurate" among adolescents, said Dr. Koren. They kept track of their sleep for 2 weeks.

The teens then returned for a second visit to the clinic. The researchers analyzed the average bedtime and waking time, and then asked them to restrict their sleep by going to bed an hour later. After returning again, the new measures after sleep restriction were compared with the earlier measures.

There was a strong correlation between weight and sleep duration, with longer sleep associated with less weight. They also saw a trend toward a greater waist circumference in adolescents who slept less.

There was a significant negative association between sleep duration and the 90-minute oral glucose tolerance test, with a P = .036. Restricted sleep also led to greater insulin resistance as measured by the homeostasis model assessment of insulin resistance (P = .091), and the whole-body insulin sensitivity index (P = .091).

Dr. Koren and her colleagues also performed linear regression analyses, controlling for either waist circumference or weight. Sleep deprivation was still the most significant factor as measured on the 90-minute glucose tolerance test and by the whole-body insulin sensitivity index.

"The model suggests that these relationships between home sleep deprivation and insulin resistance or hyperglycemia are independent of obesity, generalized or central," said Dr. Koren.

She cited the example of a 15-year-old female subject, who was lean. Her sleep went from 8.7 hours at baseline to 7.9 hours with the restriction. Her glucose values did not change significantly between baseline and restriction, but her insulin levels were noticeably higher in the sleep-restricted state, said Dr. Koren. Those levels rose an hour into the 90-minute tolerance test, which suggests that she was insulin resistant and needed to secrete more insulin to maintain glycemia.

Dr. Koren and her colleagues hope to replicate the study in a larger cohort.

Dr. Koren reported no relevant financial conflicts.

[email protected]

On Twitter @aliciaault

MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.

Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.

An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.

The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). The two congressmen introduced a bill (H.R. 4695) that would do just that on May 21.

"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.

Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.

The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign.

The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish. Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.

The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said. It would allow board-certified specialists to provide the continuum of care from start to finish, including durable medical equipment such as continuous positive airway pressure devices.

Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.

[email protected]

On Twitter @aliciaault

MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.

Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.

An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.

The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). The two congressmen introduced a bill (H.R. 4695) that would do just that on May 21.

"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.

Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.

The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign.

The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish. Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.

The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said. It would allow board-certified specialists to provide the continuum of care from start to finish, including durable medical equipment such as continuous positive airway pressure devices.

Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.

[email protected]

On Twitter @aliciaault

MINNEAPOLIS – The American Academy of Sleep Medicine is pushing to have a simple sleep apnea questionnaire included in the initial Welcome to Medicare preventive care visit.

Including such a screening tool would help identify obstructive sleep apnea (OSA) when patients first join the Medicare program and thus improve the odds of diagnosing and treating the condition, said Dr. Timothy Morgenthaler, president of the AASM. Getting a handle on OSA could also reduce the potential that the beneficiary will develop related chronic conditions, and that will help Medicare curb expenditures, he said.

An estimated 20% of current Medicare beneficiaries have OSA. That number is expected to grow with the rising obesity rates, he said. Untreated OSA can increase the risk of hypertension, heart disease, type 2 diabetes, and stroke, said Dr. Morgenthaler, who is professor of medicine at the Mayo Clinic in Rochester, Minn.

The AASM has been lobbying Congress to include a validated OSA screen in the initial Medicare visit and found sponsors in Rep. Michael Burgess (R-Tex.) and Rep. Bobby Rush (D-Ill.). The two congressmen introduced a bill (H.R. 4695) that would do just that on May 21.

"This important legislation addresses the barriers that prevent new Medicare beneficiaries from receiving what we know to be required sleep apnea services," Dr. Morgenthaler said at the annual meeting of the Associated Professional Sleep Societies.

Rep. Erik Paulsen (R-Minn.), who recently signed on to the bill as a cosponsor, told AASM attendees that adding an OSA screen to the initial Medicare visit would help increase detection of disease, raise patient awareness, and "improve health care quality and reduce costs to the Medicare program," over the long term.

The AASM is asking its members to back the legislation and educate local lawmakers and patients through the group’s Seniors Sleep Campaign.

The association also wants to make it easier for board-certified sleep medicine specialists to care for Medicare patients from start to finish. Currently, antikickback laws prevent sleep specialists and sleep centers from directly providing therapeutic durable medical equipment to Medicare patients, said Dr. Morgenthaler.

The AASM has developed model language for an exception to that statute, which it hopes legislators or regulators will approve, he said. It would allow board-certified specialists to provide the continuum of care from start to finish, including durable medical equipment such as continuous positive airway pressure devices.

Eliminating the current fragmented system of care would eliminate waste, simplify the work flow, and improve the quality of care and reduce costs, said Dr. Morgenthaler.

[email protected]

On Twitter @aliciaault

It may be months, even years before it’s clear whether access to and payment for contraception will be limited in the wake of the U.S. Supreme Court’s decision that for-profit companies can forego health insurance coverage of birth control methods that violate their religious belief.

At this point, only the two plaintiffs in the case – Hobby Lobby and Conestoga Wood Specialties – can change their health insurance coverage of contraception, based on the June 30 decision by the U.S. Supreme Court.

Courtesy Physicians for Reproductive Health

In the meantime, there is a lot of confusion among patients – and uncertainty among doctors -- about what the ruling means.

"We’re all scratching our heads and saying, ‘Now what?’ " said Dr. Anne Davis, medical director of Physicians for Reproductive Health. "All of us are very used to hurdles with coverage, but this is a new one."

Now, ob.gyns and other physicians may have to figure out if a patient works for an employer whose insurance will not cover certain types of contraception, or perhaps all birth control, said Dr. Davis of the department of clinical obstetrics and gynecology at Columbia University, New York.

The Supreme Court ruling is "a huge step backward," said Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. For physicians, a key concern is whether they will be paid for inserting an IUD or providing another service; for patients, it’s whether they can get the contraception and if they can afford it, she said.

When concerns mount, "those services tend to not happen," Dr. Espey said.

Ob.gyns. also expressed concern that the ruling had opened the door to interference in the physician-patient relationship.

Clinicians need the freedom to select the birth control method that makes the most sense for the patient, said Dr. Davis. "It’s going to be really unfortunate if you and the patient agree, and it’s the right thing and you find out that her employer has decided it’s not the right kind of birth control because of their beliefs," she said.

Dr. Jeanne Conry, immediate past president of the American Congress of Obstetricians and Gynecologists (ACOG), said that if she has decided that an IUD is best for a 34-year-old diabetic patient, but her employer says it won’t pay for that method, "that’s not in her best interest."

"They’ve just interfered with my best treatment for the patient," said Dr. Conry, an ob.gyn with Kaiser Permanente in Roseville, Calif.

Courtesy ACOG

Dr. Mitchell Creinin, chair of the obstetrics and gynecology department at University of California, Davis, said that the ruling could return contraception to a means-tested environment, in which only those who have the means will get the most effective methods, like the IUD. Instead, he said, it should be a benefit for all. Preventing pregnancy "is a public health issue and we’ve got to look at it that way," Dr. Creinin said.

Just after the ruling, ACOG President John Jennings agreed, expressing dismay that the Court was overlooking what had been firmly established. "The value of family planning – including contraception – has been clearly demonstrated," he said, in a statement.

But pro-life groups, including Americans United for Life and the Association of Pro-Life Obstetricians and Gynecologists, applauded the Hobby Lobby decision, saying that it helps preserve the right to practice according to conscience.

"Respect for the constitutionally guaranteed rights of conscience – whether held by business owners or medical professionals – must and should be protected," said Dr. Monique Chireau, AUL board member, with the department of ob.gyn at Duke University, Durham, N.C.

Dr. Gene Rudd, senior vice president for the Christian Medical and Dental Associations (CMDA), said that he did not think the decision would have any direct impact on ob.gyns.’ practices. However, he said, "Had the Justices allowed the government to force business owners to act against their conscience, that could establish a legal precedent by which the government might one day force physicians to act against their consciences."

The CMDA’s membership view the ACA’s mandate that women receive contraceptives free of charge as a potential infringement on their right to practice according to their beliefs, said Dr. Rudd, an ob.gyn.

In a CMDA survey, "95% of our members said they’d leave medicine before being required to violate their conscience," he said. They want "women free to pursue getting the contraceptive of their choice," but not to force either individual physicians or religiously affiliated organizations or small private employers to do things that are against their beliefs.

Who might be affected?

For now, there is no definitive answer on how many women could potentially lose coverage of contraception as a result of the Supreme Court decision. Hobby Lobby has 500 stores and 13,000 employees. Conestoga Wood Specialties has 950 employees. There are 90-100 cases challenging the contraception requirement, with about half them from nonprofit organizations and half from for-profit companies. And there’s motivation to sue: Companies that do not comply with the ACA requirement face fines of $100 per day per enrollee.

According to the Dept. of Health & Human Services, about 48 million women are eligible for preventive services because they are in "non-grandfathered" health plans.

Millions of women receive family planning services outside of employer-sponsored insurance, and thus may not be directly affected. A Guttmacher Institute report shows that 19 million women need publicly funded services and supplies because they are low income or are assumed to have a low income because they are under age 20 years. Family planning services provided through federal and state government funding helped women avoid 2.2 million unintended pregnancies in 2010, according to Guttmacher.

Reversing the decision

A handful of Democrats in the House and Senate introduced legislation July 9 to reverse the Supreme Court’s decision. The Protect Women's Health From Corporate Interference Act, introduced by Sen. Patty Murray (D-Wash.), would eliminate the loophole given by the court to companies that are not religiously affiliated.

ACOG praised the effort and applauded the legislators "for recognizing that contraceptives and other essential health care services should not be treated differently than other forms of health care.

"We look forward to working with them and other Congressional leaders to ensure that the ability of physicians to provide care for women is no longer subject to outside interference," Dr. Jennings said in a statement.

The White House said in an official Statement of Administration Policy that it strongly supported the legislation, saying that it "would prevent owners of for-profit companies from asserting their personal religious views to deny their employees federally-required health benefits."

Senate Democrats attempted to bring the bill to the floor on July 16, but failed to secure enough votes for debate. Republican Senators in the meantime introduced their own legislation to guarantee that employers could not bar "access" to contraceptives. The Preserving Religious Freedom and a Woman’s Access to Contraception Act (S. 2605) was introduced by Sen. Kelly Ayotte (R-N.H.).

Neither of the bills are expected to gain much traction in either the Senate or the House.

ACOG has asked its members to report coverage problems to their regional chapters, Dr. Conry said.

The federal government also could pursue several methods of reinstating the coverage. It could give for-profit employers the same accommodation that it has given nonprofit religiously affiliated employers like schools or charities. If these employers self-attest that paying for birth control violates their beliefs, then the employer’s insurer pays for the contraception. For self-insured employers, the exemption is not as easily navigated, because they would have to pay for the coverage.

That accommodation is being challenged by at least 45 legal cases that argue filling out the form violates plaintiffs’ religious beliefs because it means they are facilitating access to birth control.

The government could also pay directly for contraception for women whose employers receive an exemption. Supreme Court Justice Samuel Alito suggested such a possibility in his majority opinion in the Hobby Lobby case.

Dr. Davis said that, ideally, gynecologists would be able to give patients the contraception of choice on the same day of a visit and that the physician would be reimbursed for the cost of the device plus a fee for placing it. And, physicians should be able to counsel patients without thought of potential oversight from an employer or anyone else.

But, she said, "We are very far away from that right now."

[email protected]

On Twitter @aliciaault

It may be months, even years before it’s clear whether access to and payment for contraception will be limited in the wake of the U.S. Supreme Court’s decision that for-profit companies can forego health insurance coverage of birth control methods that violate their religious belief.

At this point, only the two plaintiffs in the case – Hobby Lobby and Conestoga Wood Specialties – can change their health insurance coverage of contraception, based on the June 30 decision by the U.S. Supreme Court.

Courtesy Physicians for Reproductive Health

In the meantime, there is a lot of confusion among patients – and uncertainty among doctors -- about what the ruling means.

"We’re all scratching our heads and saying, ‘Now what?’ " said Dr. Anne Davis, medical director of Physicians for Reproductive Health. "All of us are very used to hurdles with coverage, but this is a new one."

Now, ob.gyns and other physicians may have to figure out if a patient works for an employer whose insurance will not cover certain types of contraception, or perhaps all birth control, said Dr. Davis of the department of clinical obstetrics and gynecology at Columbia University, New York.

The Supreme Court ruling is "a huge step backward," said Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. For physicians, a key concern is whether they will be paid for inserting an IUD or providing another service; for patients, it’s whether they can get the contraception and if they can afford it, she said.

When concerns mount, "those services tend to not happen," Dr. Espey said.

Ob.gyns. also expressed concern that the ruling had opened the door to interference in the physician-patient relationship.

Clinicians need the freedom to select the birth control method that makes the most sense for the patient, said Dr. Davis. "It’s going to be really unfortunate if you and the patient agree, and it’s the right thing and you find out that her employer has decided it’s not the right kind of birth control because of their beliefs," she said.

Dr. Jeanne Conry, immediate past president of the American Congress of Obstetricians and Gynecologists (ACOG), said that if she has decided that an IUD is best for a 34-year-old diabetic patient, but her employer says it won’t pay for that method, "that’s not in her best interest."

"They’ve just interfered with my best treatment for the patient," said Dr. Conry, an ob.gyn with Kaiser Permanente in Roseville, Calif.

Courtesy ACOG

Dr. Mitchell Creinin, chair of the obstetrics and gynecology department at University of California, Davis, said that the ruling could return contraception to a means-tested environment, in which only those who have the means will get the most effective methods, like the IUD. Instead, he said, it should be a benefit for all. Preventing pregnancy "is a public health issue and we’ve got to look at it that way," Dr. Creinin said.

Just after the ruling, ACOG President John Jennings agreed, expressing dismay that the Court was overlooking what had been firmly established. "The value of family planning – including contraception – has been clearly demonstrated," he said, in a statement.

But pro-life groups, including Americans United for Life and the Association of Pro-Life Obstetricians and Gynecologists, applauded the Hobby Lobby decision, saying that it helps preserve the right to practice according to conscience.

"Respect for the constitutionally guaranteed rights of conscience – whether held by business owners or medical professionals – must and should be protected," said Dr. Monique Chireau, AUL board member, with the department of ob.gyn at Duke University, Durham, N.C.

Dr. Gene Rudd, senior vice president for the Christian Medical and Dental Associations (CMDA), said that he did not think the decision would have any direct impact on ob.gyns.’ practices. However, he said, "Had the Justices allowed the government to force business owners to act against their conscience, that could establish a legal precedent by which the government might one day force physicians to act against their consciences."

The CMDA’s membership view the ACA’s mandate that women receive contraceptives free of charge as a potential infringement on their right to practice according to their beliefs, said Dr. Rudd, an ob.gyn.

In a CMDA survey, "95% of our members said they’d leave medicine before being required to violate their conscience," he said. They want "women free to pursue getting the contraceptive of their choice," but not to force either individual physicians or religiously affiliated organizations or small private employers to do things that are against their beliefs.

Who might be affected?

For now, there is no definitive answer on how many women could potentially lose coverage of contraception as a result of the Supreme Court decision. Hobby Lobby has 500 stores and 13,000 employees. Conestoga Wood Specialties has 950 employees. There are 90-100 cases challenging the contraception requirement, with about half them from nonprofit organizations and half from for-profit companies. And there’s motivation to sue: Companies that do not comply with the ACA requirement face fines of $100 per day per enrollee.

According to the Dept. of Health & Human Services, about 48 million women are eligible for preventive services because they are in "non-grandfathered" health plans.

Millions of women receive family planning services outside of employer-sponsored insurance, and thus may not be directly affected. A Guttmacher Institute report shows that 19 million women need publicly funded services and supplies because they are low income or are assumed to have a low income because they are under age 20 years. Family planning services provided through federal and state government funding helped women avoid 2.2 million unintended pregnancies in 2010, according to Guttmacher.

Reversing the decision

A handful of Democrats in the House and Senate introduced legislation July 9 to reverse the Supreme Court’s decision. The Protect Women's Health From Corporate Interference Act, introduced by Sen. Patty Murray (D-Wash.), would eliminate the loophole given by the court to companies that are not religiously affiliated.

ACOG praised the effort and applauded the legislators "for recognizing that contraceptives and other essential health care services should not be treated differently than other forms of health care.

"We look forward to working with them and other Congressional leaders to ensure that the ability of physicians to provide care for women is no longer subject to outside interference," Dr. Jennings said in a statement.

The White House said in an official Statement of Administration Policy that it strongly supported the legislation, saying that it "would prevent owners of for-profit companies from asserting their personal religious views to deny their employees federally-required health benefits."

Senate Democrats attempted to bring the bill to the floor on July 16, but failed to secure enough votes for debate. Republican Senators in the meantime introduced their own legislation to guarantee that employers could not bar "access" to contraceptives. The Preserving Religious Freedom and a Woman’s Access to Contraception Act (S. 2605) was introduced by Sen. Kelly Ayotte (R-N.H.).

Neither of the bills are expected to gain much traction in either the Senate or the House.

ACOG has asked its members to report coverage problems to their regional chapters, Dr. Conry said.

The federal government also could pursue several methods of reinstating the coverage. It could give for-profit employers the same accommodation that it has given nonprofit religiously affiliated employers like schools or charities. If these employers self-attest that paying for birth control violates their beliefs, then the employer’s insurer pays for the contraception. For self-insured employers, the exemption is not as easily navigated, because they would have to pay for the coverage.

That accommodation is being challenged by at least 45 legal cases that argue filling out the form violates plaintiffs’ religious beliefs because it means they are facilitating access to birth control.

The government could also pay directly for contraception for women whose employers receive an exemption. Supreme Court Justice Samuel Alito suggested such a possibility in his majority opinion in the Hobby Lobby case.

Dr. Davis said that, ideally, gynecologists would be able to give patients the contraception of choice on the same day of a visit and that the physician would be reimbursed for the cost of the device plus a fee for placing it. And, physicians should be able to counsel patients without thought of potential oversight from an employer or anyone else.

But, she said, "We are very far away from that right now."

[email protected]

On Twitter @aliciaault

It may be months, even years before it’s clear whether access to and payment for contraception will be limited in the wake of the U.S. Supreme Court’s decision that for-profit companies can forego health insurance coverage of birth control methods that violate their religious belief.

At this point, only the two plaintiffs in the case – Hobby Lobby and Conestoga Wood Specialties – can change their health insurance coverage of contraception, based on the June 30 decision by the U.S. Supreme Court.

Courtesy Physicians for Reproductive Health

In the meantime, there is a lot of confusion among patients – and uncertainty among doctors -- about what the ruling means.

"We’re all scratching our heads and saying, ‘Now what?’ " said Dr. Anne Davis, medical director of Physicians for Reproductive Health. "All of us are very used to hurdles with coverage, but this is a new one."

Now, ob.gyns and other physicians may have to figure out if a patient works for an employer whose insurance will not cover certain types of contraception, or perhaps all birth control, said Dr. Davis of the department of clinical obstetrics and gynecology at Columbia University, New York.

The Supreme Court ruling is "a huge step backward," said Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. For physicians, a key concern is whether they will be paid for inserting an IUD or providing another service; for patients, it’s whether they can get the contraception and if they can afford it, she said.

When concerns mount, "those services tend to not happen," Dr. Espey said.

Ob.gyns. also expressed concern that the ruling had opened the door to interference in the physician-patient relationship.

Clinicians need the freedom to select the birth control method that makes the most sense for the patient, said Dr. Davis. "It’s going to be really unfortunate if you and the patient agree, and it’s the right thing and you find out that her employer has decided it’s not the right kind of birth control because of their beliefs," she said.

Dr. Jeanne Conry, immediate past president of the American Congress of Obstetricians and Gynecologists (ACOG), said that if she has decided that an IUD is best for a 34-year-old diabetic patient, but her employer says it won’t pay for that method, "that’s not in her best interest."

"They’ve just interfered with my best treatment for the patient," said Dr. Conry, an ob.gyn with Kaiser Permanente in Roseville, Calif.

Courtesy ACOG

Dr. Mitchell Creinin, chair of the obstetrics and gynecology department at University of California, Davis, said that the ruling could return contraception to a means-tested environment, in which only those who have the means will get the most effective methods, like the IUD. Instead, he said, it should be a benefit for all. Preventing pregnancy "is a public health issue and we’ve got to look at it that way," Dr. Creinin said.

Just after the ruling, ACOG President John Jennings agreed, expressing dismay that the Court was overlooking what had been firmly established. "The value of family planning – including contraception – has been clearly demonstrated," he said, in a statement.

But pro-life groups, including Americans United for Life and the Association of Pro-Life Obstetricians and Gynecologists, applauded the Hobby Lobby decision, saying that it helps preserve the right to practice according to conscience.

"Respect for the constitutionally guaranteed rights of conscience – whether held by business owners or medical professionals – must and should be protected," said Dr. Monique Chireau, AUL board member, with the department of ob.gyn at Duke University, Durham, N.C.

Dr. Gene Rudd, senior vice president for the Christian Medical and Dental Associations (CMDA), said that he did not think the decision would have any direct impact on ob.gyns.’ practices. However, he said, "Had the Justices allowed the government to force business owners to act against their conscience, that could establish a legal precedent by which the government might one day force physicians to act against their consciences."

The CMDA’s membership view the ACA’s mandate that women receive contraceptives free of charge as a potential infringement on their right to practice according to their beliefs, said Dr. Rudd, an ob.gyn.

In a CMDA survey, "95% of our members said they’d leave medicine before being required to violate their conscience," he said. They want "women free to pursue getting the contraceptive of their choice," but not to force either individual physicians or religiously affiliated organizations or small private employers to do things that are against their beliefs.

Who might be affected?

For now, there is no definitive answer on how many women could potentially lose coverage of contraception as a result of the Supreme Court decision. Hobby Lobby has 500 stores and 13,000 employees. Conestoga Wood Specialties has 950 employees. There are 90-100 cases challenging the contraception requirement, with about half them from nonprofit organizations and half from for-profit companies. And there’s motivation to sue: Companies that do not comply with the ACA requirement face fines of $100 per day per enrollee.

According to the Dept. of Health & Human Services, about 48 million women are eligible for preventive services because they are in "non-grandfathered" health plans.

Millions of women receive family planning services outside of employer-sponsored insurance, and thus may not be directly affected. A Guttmacher Institute report shows that 19 million women need publicly funded services and supplies because they are low income or are assumed to have a low income because they are under age 20 years. Family planning services provided through federal and state government funding helped women avoid 2.2 million unintended pregnancies in 2010, according to Guttmacher.

Reversing the decision

A handful of Democrats in the House and Senate introduced legislation July 9 to reverse the Supreme Court’s decision. The Protect Women's Health From Corporate Interference Act, introduced by Sen. Patty Murray (D-Wash.), would eliminate the loophole given by the court to companies that are not religiously affiliated.

ACOG praised the effort and applauded the legislators "for recognizing that contraceptives and other essential health care services should not be treated differently than other forms of health care.

"We look forward to working with them and other Congressional leaders to ensure that the ability of physicians to provide care for women is no longer subject to outside interference," Dr. Jennings said in a statement.

The White House said in an official Statement of Administration Policy that it strongly supported the legislation, saying that it "would prevent owners of for-profit companies from asserting their personal religious views to deny their employees federally-required health benefits."

Senate Democrats attempted to bring the bill to the floor on July 16, but failed to secure enough votes for debate. Republican Senators in the meantime introduced their own legislation to guarantee that employers could not bar "access" to contraceptives. The Preserving Religious Freedom and a Woman’s Access to Contraception Act (S. 2605) was introduced by Sen. Kelly Ayotte (R-N.H.).

Neither of the bills are expected to gain much traction in either the Senate or the House.

ACOG has asked its members to report coverage problems to their regional chapters, Dr. Conry said.

The federal government also could pursue several methods of reinstating the coverage. It could give for-profit employers the same accommodation that it has given nonprofit religiously affiliated employers like schools or charities. If these employers self-attest that paying for birth control violates their beliefs, then the employer’s insurer pays for the contraception. For self-insured employers, the exemption is not as easily navigated, because they would have to pay for the coverage.

That accommodation is being challenged by at least 45 legal cases that argue filling out the form violates plaintiffs’ religious beliefs because it means they are facilitating access to birth control.

The government could also pay directly for contraception for women whose employers receive an exemption. Supreme Court Justice Samuel Alito suggested such a possibility in his majority opinion in the Hobby Lobby case.

Dr. Davis said that, ideally, gynecologists would be able to give patients the contraception of choice on the same day of a visit and that the physician would be reimbursed for the cost of the device plus a fee for placing it. And, physicians should be able to counsel patients without thought of potential oversight from an employer or anyone else.

But, she said, "We are very far away from that right now."

[email protected]

On Twitter @aliciaault

WASHINGTON – Senate Democrats are pushing a bill to overturn most state restrictions on abortion services.

The Women's Health Protection Act (S. 1696) was introduced last November by Sen. Richard Blumenthal (D-Conn.) and was the subject of a Judiciary Committee hearing July 15. At press time, the bill had 35 cosponsors – 34 Democrats and Sen. Bernie Sanders (I-Vt.).

Alicia Ault/Frontline Medical News

The American Congress of Obstetricians and Gynecologists submitted written testimony in support of the bill. Dr. Hal Lawrence III, executive vice president and CEO, said that many state laws "put physicians in the terrible predicament of either adhering to medical ethics by providing high-quality care that’s in the best interest of their patients, or facing legal punishments which may include fines, loss of licensure, and even jail time."

Among those he cited were laws that restrict the use of or prescribe potentially outdated clinical protocols for medication abortions, laws that prohibit the use of telemedicine to assist in medication abortions, laws that require abortion providers to have admitting privileges at local hospitals, and laws that require tests and procedures that are not medically necessary.

S. 1696 would overturn such state laws, and also ones that specify office setup, equipment, staffing, and hospital transfer arrangements; require medically unnecessary visits before an abortion; or limit training for abortion services.

The law also would declare illegal any restrictions on when an abortion provider could choose to perform the procedure.

Pro-life organizations and physicians said the proposed legislation would actually strip away protections for women.

"This bill would not protect the rights of patients because it would remove the rights of states to regulate the practice of medicine," said Dr. Monique Chireau, a board member of Americans United for Life who is also with the department of obstetrics and gynecology at Duke University, Durham, N.C. She also said that it "would endanger freedom of conscience."

The bill "seeks to strip away from elected lawmakers the ability to provide even the most minimal protections for unborn children, at any stage of their prenatal development," said Carol Tobias, president of the National Right to Life Committee. She said the proposed legislation was "sweeping and extreme" and that "calling the bill the ‘Abortion Without Limits Until Birth Act’ would be more in line with truth-in-advertising standards."

Dr. Willie Parker, who provides abortion services at the Jackson (Miss.) Women’s Health Organization, said that a state law in Mississippi – if it stands – will effectively shut the clinic because it restricts the provision of abortion to ob.gyns. with local hospital admitting privileges. He flies from Chicago to provide the services, and is a plaintiff in a suit challenging the Mississippi law.

Abortion services should be provided because the state has high teen and unintended pregnancy rates, high infant mortality rates, high maternal mortality rates, and a high poverty rate, he said. "We know that when women have access to abortion, contraception, and medically accurate sex education, they thrive," he said. "It should be the same for all women, no matter where they live."

It’s unclear whether the Senate will take up the bill. There is a companion bill in the House, H.R. 3471, which was introduced by Rep. Judy Chu (D-Calif.) and was cosponsored by 124 Democrats at press time.

[email protected]

On Twitter @aliciaault

WASHINGTON – Senate Democrats are pushing a bill to overturn most state restrictions on abortion services.

The Women's Health Protection Act (S. 1696) was introduced last November by Sen. Richard Blumenthal (D-Conn.) and was the subject of a Judiciary Committee hearing July 15. At press time, the bill had 35 cosponsors – 34 Democrats and Sen. Bernie Sanders (I-Vt.).

Alicia Ault/Frontline Medical News

The American Congress of Obstetricians and Gynecologists submitted written testimony in support of the bill. Dr. Hal Lawrence III, executive vice president and CEO, said that many state laws "put physicians in the terrible predicament of either adhering to medical ethics by providing high-quality care that’s in the best interest of their patients, or facing legal punishments which may include fines, loss of licensure, and even jail time."

Among those he cited were laws that restrict the use of or prescribe potentially outdated clinical protocols for medication abortions, laws that prohibit the use of telemedicine to assist in medication abortions, laws that require abortion providers to have admitting privileges at local hospitals, and laws that require tests and procedures that are not medically necessary.

S. 1696 would overturn such state laws, and also ones that specify office setup, equipment, staffing, and hospital transfer arrangements; require medically unnecessary visits before an abortion; or limit training for abortion services.

The law also would declare illegal any restrictions on when an abortion provider could choose to perform the procedure.

Pro-life organizations and physicians said the proposed legislation would actually strip away protections for women.

"This bill would not protect the rights of patients because it would remove the rights of states to regulate the practice of medicine," said Dr. Monique Chireau, a board member of Americans United for Life who is also with the department of obstetrics and gynecology at Duke University, Durham, N.C. She also said that it "would endanger freedom of conscience."

The bill "seeks to strip away from elected lawmakers the ability to provide even the most minimal protections for unborn children, at any stage of their prenatal development," said Carol Tobias, president of the National Right to Life Committee. She said the proposed legislation was "sweeping and extreme" and that "calling the bill the ‘Abortion Without Limits Until Birth Act’ would be more in line with truth-in-advertising standards."

Dr. Willie Parker, who provides abortion services at the Jackson (Miss.) Women’s Health Organization, said that a state law in Mississippi – if it stands – will effectively shut the clinic because it restricts the provision of abortion to ob.gyns. with local hospital admitting privileges. He flies from Chicago to provide the services, and is a plaintiff in a suit challenging the Mississippi law.

Abortion services should be provided because the state has high teen and unintended pregnancy rates, high infant mortality rates, high maternal mortality rates, and a high poverty rate, he said. "We know that when women have access to abortion, contraception, and medically accurate sex education, they thrive," he said. "It should be the same for all women, no matter where they live."

It’s unclear whether the Senate will take up the bill. There is a companion bill in the House, H.R. 3471, which was introduced by Rep. Judy Chu (D-Calif.) and was cosponsored by 124 Democrats at press time.

[email protected]

On Twitter @aliciaault

WASHINGTON – Senate Democrats are pushing a bill to overturn most state restrictions on abortion services.

The Women's Health Protection Act (S. 1696) was introduced last November by Sen. Richard Blumenthal (D-Conn.) and was the subject of a Judiciary Committee hearing July 15. At press time, the bill had 35 cosponsors – 34 Democrats and Sen. Bernie Sanders (I-Vt.).

Alicia Ault/Frontline Medical News

The American Congress of Obstetricians and Gynecologists submitted written testimony in support of the bill. Dr. Hal Lawrence III, executive vice president and CEO, said that many state laws "put physicians in the terrible predicament of either adhering to medical ethics by providing high-quality care that’s in the best interest of their patients, or facing legal punishments which may include fines, loss of licensure, and even jail time."

Among those he cited were laws that restrict the use of or prescribe potentially outdated clinical protocols for medication abortions, laws that prohibit the use of telemedicine to assist in medication abortions, laws that require abortion providers to have admitting privileges at local hospitals, and laws that require tests and procedures that are not medically necessary.

S. 1696 would overturn such state laws, and also ones that specify office setup, equipment, staffing, and hospital transfer arrangements; require medically unnecessary visits before an abortion; or limit training for abortion services.

The law also would declare illegal any restrictions on when an abortion provider could choose to perform the procedure.

Pro-life organizations and physicians said the proposed legislation would actually strip away protections for women.

"This bill would not protect the rights of patients because it would remove the rights of states to regulate the practice of medicine," said Dr. Monique Chireau, a board member of Americans United for Life who is also with the department of obstetrics and gynecology at Duke University, Durham, N.C. She also said that it "would endanger freedom of conscience."

The bill "seeks to strip away from elected lawmakers the ability to provide even the most minimal protections for unborn children, at any stage of their prenatal development," said Carol Tobias, president of the National Right to Life Committee. She said the proposed legislation was "sweeping and extreme" and that "calling the bill the ‘Abortion Without Limits Until Birth Act’ would be more in line with truth-in-advertising standards."

Dr. Willie Parker, who provides abortion services at the Jackson (Miss.) Women’s Health Organization, said that a state law in Mississippi – if it stands – will effectively shut the clinic because it restricts the provision of abortion to ob.gyns. with local hospital admitting privileges. He flies from Chicago to provide the services, and is a plaintiff in a suit challenging the Mississippi law.

Abortion services should be provided because the state has high teen and unintended pregnancy rates, high infant mortality rates, high maternal mortality rates, and a high poverty rate, he said. "We know that when women have access to abortion, contraception, and medically accurate sex education, they thrive," he said. "It should be the same for all women, no matter where they live."

It’s unclear whether the Senate will take up the bill. There is a companion bill in the House, H.R. 3471, which was introduced by Rep. Judy Chu (D-Calif.) and was cosponsored by 124 Democrats at press time.

[email protected]

On Twitter @aliciaault

Medical societies are joining the call for better support for telemedicine, stating that when appropriately used, it can help address physician shortages and improve quality of care.

The American Medical Association’s policy-making body – the House of Delegates – approved a set of guiding principles at its annual meeting in June, including the following:

• A physician should have a valid face-to-face relationship with the patient before telemedicine services are provided, except in the instance of on-call or cross-coverage situations.

Courtesy AMA

• Those who deliver telemedicine services must abide by state practice and licensure laws and should be licensed in the state where the patient receives services.

• Delivery of services should be consistent with in-person services in scope and standards and follow evidence-based practice guidelines.

• Services should be documented, including providing a visit summary to the patient and a copy of the record sent to a primary or referring physician.

"We believe that a patient-physician relationship must be established to ensure proper diagnoses and appropriate follow-up care," AMA President Robert M. Wah said in a statement. "This new policy establishes a foundation for physicians to utilize telemedicine to help maintain an ongoing relationship with their patients, and as a means to enhance follow-up care, better coordinate care and manage chronic conditions."

The AMA delegates also called for a study of the issues associated with the state-based licensure and the portability of state licensure for telemedicine services.

The Federation of State Medical Boards (FSMB) has drafted model legislation that would expedite licensing in multiple states in an effort to address the concerns of medical practices that straddle state lines.

Currently, according to the American Telemedicine Association, some states restrict the practice of telemedicine across state borders, while others have varying license requirements. The FSMB is hoping to complete a final draft of the model legislation within a few months; it will then work to convince state legislatures to adopt the model.

The American Academy of Neurology also seeks a streamlined licensing process, according to a recent position paper.

The AAN weighed in on telemedicine partly because neurologists are increasingly including the service as part of their practices, most often in emergency stroke care and other acute neurologic conditions. It also is being employed more often for treatment of chronic conditions, including migraines and epilepsy, according to the paper.

The policy also calls for clear liability policies. "The decision to administer or not administer thrombolysis for acute stroke is a prominent source of malpractice claims for neurologists, and telemedicine physicians managing acute stroke patients may be exposed to complex liability issues," the AAN said in the statement. Both physicians and patients need to be protected, it noted.

The organization also called for reimbursement that’s on par with traditional services.

The American Academy of Family Physicians recently said in a letter to members of the House Energy & Commerce Subcommittee on Health that, while it agrees with removing barriers to delivering telemedicine across state lines, it opposes a federal license. It is backing the FSMB process.

Payment Issues

More private insurers are starting to cover telemedicine, with 21 states and Washington, D.C., requiring coverage of the service and reimbursement on par with in-person visits, according to the American Telemedicine Association: Arizona, California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Oklahoma, Oregon, Tennessee, Texas, Vermont, Virginia.

Five states – Massachusetts, Michigan, North Dakota, Pennsylvania, and South Dakota – do not allow out-of-state physician-to-physician consultations.

Licensure requirements vary. Maryland, New York, Virginia, and Washington, D.C., have licensure reciprocity for bordering states.

Ten states – Alabama, Louisiana, Minnesota, Montana, Nevada, New Mexico, Ohio, Oregon, Tennessee, and Texas – allow physicians to practice with a conditional license or a specific telemedicine license.

Medicaid coverage varies on a state-by-state basis but is better than Medicare in many states, according to the ATA. Medicare only pays for telemedicine services if a beneficiary lives in a rural Health Professional Shortage area; several additional requirements must be met:

• The service must be furnished via an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

• The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.

• The individual receiving the services must be in an eligible "originating" site.

Medicare then pays a fee to the originating site and a separate fee to the distant site practitioner.

Family physicians’ offices are "ideally suited" to be originating sites for the delivery of telemedicine, according to the AAFP, but the current originating site fee ($24.63) doesn’t begin to cover the investment needed to ensure that telemedicine equipment is in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The originating site also should be defined broadly, so that the patient’s home can be considered one of the eligible telemedicine sites, according to the academy.

The Telehealth Enhancement Act of 2013 (H.R. 3306) would expand the definition to include all critical access and sole community hospitals and home-based video services for hospice care, home dialysis, and homebound beneficiaries. The AAFP said that it supports the bill, which was introduced by Rep. Gregg Harper (R-Miss.), Rep. Mike Thompson (D-Calif.), Rep. Devin Nunes (R-Calif.), and Rep. Peter Welch (D-Vt.). The bill has no companion in the Senate, and no hearings have been scheduled.

For 2015, Medicare proposed to expand the types of services it will cover. Barring any changes in the final rule for the 2015 physician fee schedule, Medicare will cover several psychotherapy services, including psychoanalysis (CPT code 90845), family psychotherapy without the patient present (90846), and family psychotherapy with patient present (90847).

The agency also proposes to cover prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service (99354 and 99355), and the HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service, initial visit), and G0439, the subsequent annual wellness visit.

Other requests for coverage have been declined by Medicare, including various types of echocardiography interpretation, psychological testing, colposcopy, brief visit to monitor or change medications for mental illness, and urgent dermatologic conditions and wound care.

[email protected]

On Twitter @aliciaault

Medical societies are joining the call for better support for telemedicine, stating that when appropriately used, it can help address physician shortages and improve quality of care.

The American Medical Association’s policy-making body – the House of Delegates – approved a set of guiding principles at its annual meeting in June, including the following:

• A physician should have a valid face-to-face relationship with the patient before telemedicine services are provided, except in the instance of on-call or cross-coverage situations.

Courtesy AMA

• Those who deliver telemedicine services must abide by state practice and licensure laws and should be licensed in the state where the patient receives services.

• Delivery of services should be consistent with in-person services in scope and standards and follow evidence-based practice guidelines.

• Services should be documented, including providing a visit summary to the patient and a copy of the record sent to a primary or referring physician.

"We believe that a patient-physician relationship must be established to ensure proper diagnoses and appropriate follow-up care," AMA President Robert M. Wah said in a statement. "This new policy establishes a foundation for physicians to utilize telemedicine to help maintain an ongoing relationship with their patients, and as a means to enhance follow-up care, better coordinate care and manage chronic conditions."

The AMA delegates also called for a study of the issues associated with the state-based licensure and the portability of state licensure for telemedicine services.

The Federation of State Medical Boards (FSMB) has drafted model legislation that would expedite licensing in multiple states in an effort to address the concerns of medical practices that straddle state lines.

Currently, according to the American Telemedicine Association, some states restrict the practice of telemedicine across state borders, while others have varying license requirements. The FSMB is hoping to complete a final draft of the model legislation within a few months; it will then work to convince state legislatures to adopt the model.

The American Academy of Neurology also seeks a streamlined licensing process, according to a recent position paper.

The AAN weighed in on telemedicine partly because neurologists are increasingly including the service as part of their practices, most often in emergency stroke care and other acute neurologic conditions. It also is being employed more often for treatment of chronic conditions, including migraines and epilepsy, according to the paper.

The policy also calls for clear liability policies. "The decision to administer or not administer thrombolysis for acute stroke is a prominent source of malpractice claims for neurologists, and telemedicine physicians managing acute stroke patients may be exposed to complex liability issues," the AAN said in the statement. Both physicians and patients need to be protected, it noted.

The organization also called for reimbursement that’s on par with traditional services.

The American Academy of Family Physicians recently said in a letter to members of the House Energy & Commerce Subcommittee on Health that, while it agrees with removing barriers to delivering telemedicine across state lines, it opposes a federal license. It is backing the FSMB process.

Payment Issues

More private insurers are starting to cover telemedicine, with 21 states and Washington, D.C., requiring coverage of the service and reimbursement on par with in-person visits, according to the American Telemedicine Association: Arizona, California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Oklahoma, Oregon, Tennessee, Texas, Vermont, Virginia.

Five states – Massachusetts, Michigan, North Dakota, Pennsylvania, and South Dakota – do not allow out-of-state physician-to-physician consultations.

Licensure requirements vary. Maryland, New York, Virginia, and Washington, D.C., have licensure reciprocity for bordering states.

Ten states – Alabama, Louisiana, Minnesota, Montana, Nevada, New Mexico, Ohio, Oregon, Tennessee, and Texas – allow physicians to practice with a conditional license or a specific telemedicine license.

Medicaid coverage varies on a state-by-state basis but is better than Medicare in many states, according to the ATA. Medicare only pays for telemedicine services if a beneficiary lives in a rural Health Professional Shortage area; several additional requirements must be met:

• The service must be furnished via an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

• The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.

• The individual receiving the services must be in an eligible "originating" site.

Medicare then pays a fee to the originating site and a separate fee to the distant site practitioner.

Family physicians’ offices are "ideally suited" to be originating sites for the delivery of telemedicine, according to the AAFP, but the current originating site fee ($24.63) doesn’t begin to cover the investment needed to ensure that telemedicine equipment is in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The originating site also should be defined broadly, so that the patient’s home can be considered one of the eligible telemedicine sites, according to the academy.

The Telehealth Enhancement Act of 2013 (H.R. 3306) would expand the definition to include all critical access and sole community hospitals and home-based video services for hospice care, home dialysis, and homebound beneficiaries. The AAFP said that it supports the bill, which was introduced by Rep. Gregg Harper (R-Miss.), Rep. Mike Thompson (D-Calif.), Rep. Devin Nunes (R-Calif.), and Rep. Peter Welch (D-Vt.). The bill has no companion in the Senate, and no hearings have been scheduled.

For 2015, Medicare proposed to expand the types of services it will cover. Barring any changes in the final rule for the 2015 physician fee schedule, Medicare will cover several psychotherapy services, including psychoanalysis (CPT code 90845), family psychotherapy without the patient present (90846), and family psychotherapy with patient present (90847).

The agency also proposes to cover prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service (99354 and 99355), and the HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service, initial visit), and G0439, the subsequent annual wellness visit.

Other requests for coverage have been declined by Medicare, including various types of echocardiography interpretation, psychological testing, colposcopy, brief visit to monitor or change medications for mental illness, and urgent dermatologic conditions and wound care.

[email protected]

On Twitter @aliciaault

Medical societies are joining the call for better support for telemedicine, stating that when appropriately used, it can help address physician shortages and improve quality of care.

The American Medical Association’s policy-making body – the House of Delegates – approved a set of guiding principles at its annual meeting in June, including the following:

• A physician should have a valid face-to-face relationship with the patient before telemedicine services are provided, except in the instance of on-call or cross-coverage situations.

Courtesy AMA

• Those who deliver telemedicine services must abide by state practice and licensure laws and should be licensed in the state where the patient receives services.

• Delivery of services should be consistent with in-person services in scope and standards and follow evidence-based practice guidelines.

• Services should be documented, including providing a visit summary to the patient and a copy of the record sent to a primary or referring physician.

"We believe that a patient-physician relationship must be established to ensure proper diagnoses and appropriate follow-up care," AMA President Robert M. Wah said in a statement. "This new policy establishes a foundation for physicians to utilize telemedicine to help maintain an ongoing relationship with their patients, and as a means to enhance follow-up care, better coordinate care and manage chronic conditions."

The AMA delegates also called for a study of the issues associated with the state-based licensure and the portability of state licensure for telemedicine services.

The Federation of State Medical Boards (FSMB) has drafted model legislation that would expedite licensing in multiple states in an effort to address the concerns of medical practices that straddle state lines.

Currently, according to the American Telemedicine Association, some states restrict the practice of telemedicine across state borders, while others have varying license requirements. The FSMB is hoping to complete a final draft of the model legislation within a few months; it will then work to convince state legislatures to adopt the model.

The American Academy of Neurology also seeks a streamlined licensing process, according to a recent position paper.

The AAN weighed in on telemedicine partly because neurologists are increasingly including the service as part of their practices, most often in emergency stroke care and other acute neurologic conditions. It also is being employed more often for treatment of chronic conditions, including migraines and epilepsy, according to the paper.

The policy also calls for clear liability policies. "The decision to administer or not administer thrombolysis for acute stroke is a prominent source of malpractice claims for neurologists, and telemedicine physicians managing acute stroke patients may be exposed to complex liability issues," the AAN said in the statement. Both physicians and patients need to be protected, it noted.

The organization also called for reimbursement that’s on par with traditional services.

The American Academy of Family Physicians recently said in a letter to members of the House Energy & Commerce Subcommittee on Health that, while it agrees with removing barriers to delivering telemedicine across state lines, it opposes a federal license. It is backing the FSMB process.

Payment Issues

More private insurers are starting to cover telemedicine, with 21 states and Washington, D.C., requiring coverage of the service and reimbursement on par with in-person visits, according to the American Telemedicine Association: Arizona, California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Oklahoma, Oregon, Tennessee, Texas, Vermont, Virginia.

Five states – Massachusetts, Michigan, North Dakota, Pennsylvania, and South Dakota – do not allow out-of-state physician-to-physician consultations.

Licensure requirements vary. Maryland, New York, Virginia, and Washington, D.C., have licensure reciprocity for bordering states.

Ten states – Alabama, Louisiana, Minnesota, Montana, Nevada, New Mexico, Ohio, Oregon, Tennessee, and Texas – allow physicians to practice with a conditional license or a specific telemedicine license.

Medicaid coverage varies on a state-by-state basis but is better than Medicare in many states, according to the ATA. Medicare only pays for telemedicine services if a beneficiary lives in a rural Health Professional Shortage area; several additional requirements must be met:

• The service must be furnished via an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

• The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.

• The individual receiving the services must be in an eligible "originating" site.

Medicare then pays a fee to the originating site and a separate fee to the distant site practitioner.

Family physicians’ offices are "ideally suited" to be originating sites for the delivery of telemedicine, according to the AAFP, but the current originating site fee ($24.63) doesn’t begin to cover the investment needed to ensure that telemedicine equipment is in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The originating site also should be defined broadly, so that the patient’s home can be considered one of the eligible telemedicine sites, according to the academy.

The Telehealth Enhancement Act of 2013 (H.R. 3306) would expand the definition to include all critical access and sole community hospitals and home-based video services for hospice care, home dialysis, and homebound beneficiaries. The AAFP said that it supports the bill, which was introduced by Rep. Gregg Harper (R-Miss.), Rep. Mike Thompson (D-Calif.), Rep. Devin Nunes (R-Calif.), and Rep. Peter Welch (D-Vt.). The bill has no companion in the Senate, and no hearings have been scheduled.

For 2015, Medicare proposed to expand the types of services it will cover. Barring any changes in the final rule for the 2015 physician fee schedule, Medicare will cover several psychotherapy services, including psychoanalysis (CPT code 90845), family psychotherapy without the patient present (90846), and family psychotherapy with patient present (90847).

The agency also proposes to cover prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service (99354 and 99355), and the HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service, initial visit), and G0439, the subsequent annual wellness visit.

Other requests for coverage have been declined by Medicare, including various types of echocardiography interpretation, psychological testing, colposcopy, brief visit to monitor or change medications for mental illness, and urgent dermatologic conditions and wound care.

[email protected]

On Twitter @aliciaault

The House Energy & Commerce Committee has approved a bill that aims to speed up Food and Drug Administration approval of new sunscreen ingredients and eliminate the backlog that has kept some ingredients off the market for a decade.

The Sunscreen Innovation Act (H.R. 4250) was approved by the committee on a voice vote. An amendment to establish timeframes for how quickly the FDA must initially review applications and provide final decisions was added by one of the bill’s main sponsors, Rep. Ed Whitfield (R-Ky.).

© Vesna Andjic/iStockphoto.com

"We thought it was essential we try to resolve and speed up this approval process while at same time still protecting the health of the American people," said Rep. Whitfield at the meeting convened to vote on the legislation. He said that the timeframes in his amendment had been agreed upon by the FDA, the Public Access to SunScreens (PASS) Coalition, and various manufacturers and consumer advocates.

The bill now would require the FDA to notify the manufacturer within 60 days of submission whether its application was acceptable, or whether more data were needed. It would then allow a public comment period for 45 days. Overall, the FDA would have 300 days to review a new sunscreen ingredient. If the agency deemed it not approvable, it would be required to hold an advisory committee meeting within that 300-day period.

At a June meeting on the legislation, Energy & Commerce Committee chairman Fred Upton (R-Mich.) noted that there had not been a new sunscreen ingredient approved in the United States in 20 years.

Before the full committee vote, Rep. Bob Latta (R-Ohio) said that eight new ingredients had been awaiting review at the FDA for a dozen years and that many of those products were produced in the United States but shipped overseas "because of the regulatory inaction by the FDA." The bill will help eliminate that backlog and bring sunscreens available in foreign markets to America, said Rep. Latta.

The legislation also is "extremely important as melanoma is a prevalent form of cancer in this country," he said, noting a 400% increase in the last several decades. He also noted that Ohio ranks in top 10 states for melanoma deaths in the United States.

"Americans should have access to the best products to protect themselves from this terrible disease," he said.

The bill now awaits the approval of the full House, and then must be approved by the Senate.

[email protected]

The House Energy & Commerce Committee has approved a bill that aims to speed up Food and Drug Administration approval of new sunscreen ingredients and eliminate the backlog that has kept some ingredients off the market for a decade.

The Sunscreen Innovation Act (H.R. 4250) was approved by the committee on a voice vote. An amendment to establish timeframes for how quickly the FDA must initially review applications and provide final decisions was added by one of the bill’s main sponsors, Rep. Ed Whitfield (R-Ky.).

© Vesna Andjic/iStockphoto.com

"We thought it was essential we try to resolve and speed up this approval process while at same time still protecting the health of the American people," said Rep. Whitfield at the meeting convened to vote on the legislation. He said that the timeframes in his amendment had been agreed upon by the FDA, the Public Access to SunScreens (PASS) Coalition, and various manufacturers and consumer advocates.

The bill now would require the FDA to notify the manufacturer within 60 days of submission whether its application was acceptable, or whether more data were needed. It would then allow a public comment period for 45 days. Overall, the FDA would have 300 days to review a new sunscreen ingredient. If the agency deemed it not approvable, it would be required to hold an advisory committee meeting within that 300-day period.

At a June meeting on the legislation, Energy & Commerce Committee chairman Fred Upton (R-Mich.) noted that there had not been a new sunscreen ingredient approved in the United States in 20 years.

Before the full committee vote, Rep. Bob Latta (R-Ohio) said that eight new ingredients had been awaiting review at the FDA for a dozen years and that many of those products were produced in the United States but shipped overseas "because of the regulatory inaction by the FDA." The bill will help eliminate that backlog and bring sunscreens available in foreign markets to America, said Rep. Latta.

The legislation also is "extremely important as melanoma is a prevalent form of cancer in this country," he said, noting a 400% increase in the last several decades. He also noted that Ohio ranks in top 10 states for melanoma deaths in the United States.

"Americans should have access to the best products to protect themselves from this terrible disease," he said.

The bill now awaits the approval of the full House, and then must be approved by the Senate.

[email protected]

The House Energy & Commerce Committee has approved a bill that aims to speed up Food and Drug Administration approval of new sunscreen ingredients and eliminate the backlog that has kept some ingredients off the market for a decade.

The Sunscreen Innovation Act (H.R. 4250) was approved by the committee on a voice vote. An amendment to establish timeframes for how quickly the FDA must initially review applications and provide final decisions was added by one of the bill’s main sponsors, Rep. Ed Whitfield (R-Ky.).

© Vesna Andjic/iStockphoto.com

"We thought it was essential we try to resolve and speed up this approval process while at same time still protecting the health of the American people," said Rep. Whitfield at the meeting convened to vote on the legislation. He said that the timeframes in his amendment had been agreed upon by the FDA, the Public Access to SunScreens (PASS) Coalition, and various manufacturers and consumer advocates.

The bill now would require the FDA to notify the manufacturer within 60 days of submission whether its application was acceptable, or whether more data were needed. It would then allow a public comment period for 45 days. Overall, the FDA would have 300 days to review a new sunscreen ingredient. If the agency deemed it not approvable, it would be required to hold an advisory committee meeting within that 300-day period.

At a June meeting on the legislation, Energy & Commerce Committee chairman Fred Upton (R-Mich.) noted that there had not been a new sunscreen ingredient approved in the United States in 20 years.

Before the full committee vote, Rep. Bob Latta (R-Ohio) said that eight new ingredients had been awaiting review at the FDA for a dozen years and that many of those products were produced in the United States but shipped overseas "because of the regulatory inaction by the FDA." The bill will help eliminate that backlog and bring sunscreens available in foreign markets to America, said Rep. Latta.

The legislation also is "extremely important as melanoma is a prevalent form of cancer in this country," he said, noting a 400% increase in the last several decades. He also noted that Ohio ranks in top 10 states for melanoma deaths in the United States.

"Americans should have access to the best products to protect themselves from this terrible disease," he said.

The bill now awaits the approval of the full House, and then must be approved by the Senate.

[email protected]

The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.

The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.

"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."

Courtesy HHS

The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.

HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.

The 27 new awardees named on July 9 include:

• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.

• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.

• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.

HHS does not anticipate making any further innovation awards, according to the agency.

Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.

[email protected]

On Twitter @aliciaault

The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.

The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.

"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."

Courtesy HHS

The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.

HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.

The 27 new awardees named on July 9 include:

• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.

• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.

• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.

HHS does not anticipate making any further innovation awards, according to the agency.

Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.

[email protected]

On Twitter @aliciaault

The federal government has announced another round of awards to health care organizations that have designed innovative ways to provide better-quality care at a lower cost.

The latest group includes 27 health care organizations, receiving awards of $2 million to $24 million over 3 years.

"The Health Care Innovation Awards support our ongoing work to drive down health care costs while providing high-quality care," Sylvia Mathews Burwell, secretary of the Department of Health & Human Services (HHS), said in a statement. "These awards advance innovative solutions in delivering and improving care from all across our nation."

Courtesy HHS

The awards are funded with up to $1 billion in money authorized by the Affordable Care Act. HHS began seeking awardees in late 2011, soliciting a broad range of proposals. The Centers for Medicare & Medicaid Services Innovation Center ultimately gave out 107 3-year awards in May and June 2012.

HHS started soliciting applicants for a second round of awards last year, this time looking for innovations that would focus on four areas: rapidly reducing costs in the outpatient and postacute setting for patients with Medicare, Medicaid, and/or the Children’s Health Insurance Program; improving care for populations with specialized needs; testing improved financial and clinical models for specific types of providers, including specialists; and models that improve the health of populations – such as a community, or those with specific diseases – through prevention, wellness, and comprehensive care that extends beyond the clinical setting.

The 27 new awardees named on July 9 include:

• $6 million for a care coordination project at the Boston Medical Center that will pair a complex care nurse, a care coordinator, and pediatricians in the community in Boston and Springfield, with the goal of providing a medical home for children with complex conditions.

• $10 million for the Detroit Medical Center, which will establish patient-centered medical home clinics next to emergency departments (EDs) at four inner-city hospitals, in an attempt to make primary care immediately available to patients seeking nonurgent care. The initial focus will be on improving diabetes or asthma, and targeting so-called ED superutilizers, who have 10 or more visits a year.

• $15 million for the University of New Mexico Health Sciences Center, Albuquerque, which will expand its 11-hospital telehealth system to 30 hospitals, to test providing remote emergency neurological consultation using inexpensive audiovisual equipment and software.

HHS does not anticipate making any further innovation awards, according to the agency.

Awardees still have to meet certain criteria to receive their funds. Final award notices will be sent in a few months.

[email protected]

On Twitter @aliciaault