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FDA approves oritavancin for skin infections
The Food and Drug Administration has approved the injectable antibiotic oritavancin (Orbactiv) to treat adults with acute bacterial skin and skin structure infections that might be caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.
Oritavancin, which is manufactured and sold by The Medicines Company of Parsippany, N.J., is given in a single 3-hour infusion, after which the treatment regimen is considered complete.
Oritavancin is the third new antibacterial drug approved by the FDA in 2014 to treat acute bacterial skin and skin structure infections (ABSSSIs). The agency approved dalbavancin (Dalvance) in May and tedizolid (Sivextro) in June.
"The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs," he added.
Like dalbavancin and tedizolid, oritavancin was given priority review by the agency because it is intended to treat a serious or life-threatening condition. All three drugs also qualify for an additional 5 years of marketing exclusivity.
In a statement issued by The Medicines Company, several clinicians said that they welcomed the addition of oritavancin to their treatment arsenal. "With a single-dose treatment regimen, Orbactiv may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections," said Dr. G. Ralph Corey, professor of medicine and infectious diseases at Duke University, Durham, N.C.
"The growing challenge of antibiotic resistance in the U.S. has had a significant impact on the clinical management decisions in the emergency department," said Dr. Charles Pollack, professor of emergency medicine at the University of Pennsylvania, Philadelphia. A single, once-only IV therapy such as Orbactiv offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by gram-positive bacteria likely due to MRSA [methicillin-resistant Staphylococcus aureus]."
The FDA based its approval on the results of the SOLO I and SOLO II clinical studies. The randomized, double-blind, multicenter trials compared a single 1,200-mg IV dose to 7-10 days of twice-daily vancomycin (1 g or 15 mg/kg) in 1,987 patients. The trials also included a subset of 405 patients with documented MRSA. Oritavancin was equivalent to vancomycin in these trials.
The most common side effects were headache, nausea, vomiting, diarrhea, and the formation of skin and soft tissue abscesses on arms and legs, according to the FDA. The drug’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin.
Oritavancin also is under review in Europe for the treatment of complicated skin and soft tissue infections.
On Twitter @aliciaault
The Food and Drug Administration has approved the injectable antibiotic oritavancin (Orbactiv) to treat adults with acute bacterial skin and skin structure infections that might be caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.
Oritavancin, which is manufactured and sold by The Medicines Company of Parsippany, N.J., is given in a single 3-hour infusion, after which the treatment regimen is considered complete.
Oritavancin is the third new antibacterial drug approved by the FDA in 2014 to treat acute bacterial skin and skin structure infections (ABSSSIs). The agency approved dalbavancin (Dalvance) in May and tedizolid (Sivextro) in June.
"The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs," he added.
Like dalbavancin and tedizolid, oritavancin was given priority review by the agency because it is intended to treat a serious or life-threatening condition. All three drugs also qualify for an additional 5 years of marketing exclusivity.
In a statement issued by The Medicines Company, several clinicians said that they welcomed the addition of oritavancin to their treatment arsenal. "With a single-dose treatment regimen, Orbactiv may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections," said Dr. G. Ralph Corey, professor of medicine and infectious diseases at Duke University, Durham, N.C.
"The growing challenge of antibiotic resistance in the U.S. has had a significant impact on the clinical management decisions in the emergency department," said Dr. Charles Pollack, professor of emergency medicine at the University of Pennsylvania, Philadelphia. A single, once-only IV therapy such as Orbactiv offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by gram-positive bacteria likely due to MRSA [methicillin-resistant Staphylococcus aureus]."
The FDA based its approval on the results of the SOLO I and SOLO II clinical studies. The randomized, double-blind, multicenter trials compared a single 1,200-mg IV dose to 7-10 days of twice-daily vancomycin (1 g or 15 mg/kg) in 1,987 patients. The trials also included a subset of 405 patients with documented MRSA. Oritavancin was equivalent to vancomycin in these trials.
The most common side effects were headache, nausea, vomiting, diarrhea, and the formation of skin and soft tissue abscesses on arms and legs, according to the FDA. The drug’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin.
Oritavancin also is under review in Europe for the treatment of complicated skin and soft tissue infections.
On Twitter @aliciaault
The Food and Drug Administration has approved the injectable antibiotic oritavancin (Orbactiv) to treat adults with acute bacterial skin and skin structure infections that might be caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.
Oritavancin, which is manufactured and sold by The Medicines Company of Parsippany, N.J., is given in a single 3-hour infusion, after which the treatment regimen is considered complete.
Oritavancin is the third new antibacterial drug approved by the FDA in 2014 to treat acute bacterial skin and skin structure infections (ABSSSIs). The agency approved dalbavancin (Dalvance) in May and tedizolid (Sivextro) in June.
"The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs," he added.
Like dalbavancin and tedizolid, oritavancin was given priority review by the agency because it is intended to treat a serious or life-threatening condition. All three drugs also qualify for an additional 5 years of marketing exclusivity.
In a statement issued by The Medicines Company, several clinicians said that they welcomed the addition of oritavancin to their treatment arsenal. "With a single-dose treatment regimen, Orbactiv may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections," said Dr. G. Ralph Corey, professor of medicine and infectious diseases at Duke University, Durham, N.C.
"The growing challenge of antibiotic resistance in the U.S. has had a significant impact on the clinical management decisions in the emergency department," said Dr. Charles Pollack, professor of emergency medicine at the University of Pennsylvania, Philadelphia. A single, once-only IV therapy such as Orbactiv offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by gram-positive bacteria likely due to MRSA [methicillin-resistant Staphylococcus aureus]."
The FDA based its approval on the results of the SOLO I and SOLO II clinical studies. The randomized, double-blind, multicenter trials compared a single 1,200-mg IV dose to 7-10 days of twice-daily vancomycin (1 g or 15 mg/kg) in 1,987 patients. The trials also included a subset of 405 patients with documented MRSA. Oritavancin was equivalent to vancomycin in these trials.
The most common side effects were headache, nausea, vomiting, diarrhea, and the formation of skin and soft tissue abscesses on arms and legs, according to the FDA. The drug’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin.
Oritavancin also is under review in Europe for the treatment of complicated skin and soft tissue infections.
On Twitter @aliciaault
2015 outpatient proposal focuses on bundled pay
The Centers for Medicare & Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
The rule published on July 14 covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery.
In GI procedures and stents, CPT codes 43274 and 43276, endoscopic retrograde cholangiopancreatography with stent placement into the biliary or pancreatic duct including dilation, guide wire passage, and sphincterotomy were reassigned to APC 0384. The single, bundled payments would begin in 2015.
The proposed rule also contains adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
The Centers for Medicare & Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
The rule published on July 14 covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery.
In GI procedures and stents, CPT codes 43274 and 43276, endoscopic retrograde cholangiopancreatography with stent placement into the biliary or pancreatic duct including dilation, guide wire passage, and sphincterotomy were reassigned to APC 0384. The single, bundled payments would begin in 2015.
The proposed rule also contains adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
The Centers for Medicare & Medicaid Services’ proposed rule on outpatient department and ambulatory surgery center payment for 2015 expands the agency’s focus on bundling pay for device-related procedures.
The Hospital Outpatient Prospective Payment System (OPPS) rule also continues the same payment rate for outpatient drug delivery such as chemotherapy. That payment rate has been a source of disappointment for oncologists.
The agency is proposing again in 2015 to continue paying average sales price plus 6% for non–pass through drugs and biologicals that are administered under Part B of Medicare.
The rule published on July 14 covers payment for 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. It also applies to 5,300 ambulatory surgery centers (ASCs) that participate in Medicare.
Overall, the government is proposing to increase payments to outpatient departments by 2%. The CMS expects to pay out $57 billion for outpatient services in 2015. Payments to ASCs will increase just over 1% to $4 billion.
The agency is proposing to expand its Comprehensive Ambulatory Payment Classification (APC) policy, which was first discussed in its 2014 rule. The idea is to give a single Medicare payment and require a single beneficiary copayment for the entire hospital stay for a group of 28 procedures, including pacemaker insertion, implantation of neurostimulators, and stereotactic radiosurgery.
In GI procedures and stents, CPT codes 43274 and 43276, endoscopic retrograde cholangiopancreatography with stent placement into the biliary or pancreatic duct including dilation, guide wire passage, and sphincterotomy were reassigned to APC 0384. The single, bundled payments would begin in 2015.
The proposed rule also contains adjustments to both the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. On the hospital side, the CMS is proposing to remove three quality measures, stating that performance has been uniformly high among reporting facilities. Those measures are aspirin at arrival (cardiac care), timing of prophylaxis antibiotics, and prophylactic antibiotic selection for surgical patients. The agency is proposing to add a claims-based measure – facility 7-day risk-standardized hospital visit rate after outpatient colonoscopy – for 2017 and beyond.
For ASCs, the agency is proposing to continue its effort to align measures with the hospital program. In 2015, ASCs will be required to report on the 7-day risk-standardized visit rate after outpatient colonoscopy measure.
The CMS is accepting comments on the proposed rule until Sept. 2, 2014. A final rule will be issued by Nov. 1.
On Twitter @aliciaault
CMS Reconsidering Coverage of HIV Screening for all Medicare Beneficiaries
The Centers for Medicare & Medicaid Services says it is considering extending coverage of HIV screening to all Medicare beneficiaries, not just those at risk.
The agency announced on Aug. 4 that it was starting a new analysis, which was prompted by a request from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership. Those groups include the American Academy of HIV Medicine, GMHC, the HIV Medicine Association, the National Alliance of State and Territorial AIDS Directors, the National Association of County and City Health Officials, and the National Viral Hepatitis Roundtable.
Medicare has covered routine HIV testing as a preventive service since 2009 for adolescents, pregnant women, and adults who are at risk for infection. That coverage decision was made in light of the U.S. Preventive Services Task Force grade A recommendation that such screening was supported by the evidence.
In 2013, the USPTF revised that recommendation, saying that all adolescents and adults aged 15-65 years should be screened, regardless of their risk. All pregnant women should still continue to be screened, said the Task Force. Adolescents younger than 15 years and adults older than 65 years who are at increased risk of HIV infection should also receive screening, it added.
Because the screening recommendation had an A grade, it must be covered by private insurers under the Affordable Care Act.
But the CMS has not updated its policy, which means that "HIV testing coverage for Medicare beneficiaries is limited to those who are perceived to be or identify themselves as at risk and to pregnant women," said the letter from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership.
"This coverage limitation does not reflect the current science or HHS’s own best practices for HIV medicine," they said.
The groups said that at least 16% of people with the infection, or 181,400 individuals, are unaware that they are HIV positive and that half of all new infections are transmitted by someone who did not know their status. They also noted that about 17% of the Medicare population is young and disabled; with routine testing, they would be more likely to receive earlier diagnosis and treatment.
"It is important for CMS to make a clear statement that HIV infection is an important issue impacting Medicare beneficiaries," added the organizations, noting that, "While only about 3% of those living with HIV are estimated to be 65 or older, the CDC estimates that by 2017 more than half of those living with HIV will be over 50 years old, approaching Medicare eligibility."
The agency is accepting public comments on expanding coverage of screening until Sept. 3.
Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.
The CMS said that it expects to issue a proposed decision in Feb. 2015, and to complete its analysis by May next year.
On Twitter @aliciaault
The Centers for Medicare & Medicaid Services says it is considering extending coverage of HIV screening to all Medicare beneficiaries, not just those at risk.
The agency announced on Aug. 4 that it was starting a new analysis, which was prompted by a request from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership. Those groups include the American Academy of HIV Medicine, GMHC, the HIV Medicine Association, the National Alliance of State and Territorial AIDS Directors, the National Association of County and City Health Officials, and the National Viral Hepatitis Roundtable.
Medicare has covered routine HIV testing as a preventive service since 2009 for adolescents, pregnant women, and adults who are at risk for infection. That coverage decision was made in light of the U.S. Preventive Services Task Force grade A recommendation that such screening was supported by the evidence.
In 2013, the USPTF revised that recommendation, saying that all adolescents and adults aged 15-65 years should be screened, regardless of their risk. All pregnant women should still continue to be screened, said the Task Force. Adolescents younger than 15 years and adults older than 65 years who are at increased risk of HIV infection should also receive screening, it added.
Because the screening recommendation had an A grade, it must be covered by private insurers under the Affordable Care Act.
But the CMS has not updated its policy, which means that "HIV testing coverage for Medicare beneficiaries is limited to those who are perceived to be or identify themselves as at risk and to pregnant women," said the letter from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership.
"This coverage limitation does not reflect the current science or HHS’s own best practices for HIV medicine," they said.
The groups said that at least 16% of people with the infection, or 181,400 individuals, are unaware that they are HIV positive and that half of all new infections are transmitted by someone who did not know their status. They also noted that about 17% of the Medicare population is young and disabled; with routine testing, they would be more likely to receive earlier diagnosis and treatment.
"It is important for CMS to make a clear statement that HIV infection is an important issue impacting Medicare beneficiaries," added the organizations, noting that, "While only about 3% of those living with HIV are estimated to be 65 or older, the CDC estimates that by 2017 more than half of those living with HIV will be over 50 years old, approaching Medicare eligibility."
The agency is accepting public comments on expanding coverage of screening until Sept. 3.
Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.
The CMS said that it expects to issue a proposed decision in Feb. 2015, and to complete its analysis by May next year.
On Twitter @aliciaault
The Centers for Medicare & Medicaid Services says it is considering extending coverage of HIV screening to all Medicare beneficiaries, not just those at risk.
The agency announced on Aug. 4 that it was starting a new analysis, which was prompted by a request from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership. Those groups include the American Academy of HIV Medicine, GMHC, the HIV Medicine Association, the National Alliance of State and Territorial AIDS Directors, the National Association of County and City Health Officials, and the National Viral Hepatitis Roundtable.
Medicare has covered routine HIV testing as a preventive service since 2009 for adolescents, pregnant women, and adults who are at risk for infection. That coverage decision was made in light of the U.S. Preventive Services Task Force grade A recommendation that such screening was supported by the evidence.
In 2013, the USPTF revised that recommendation, saying that all adolescents and adults aged 15-65 years should be screened, regardless of their risk. All pregnant women should still continue to be screened, said the Task Force. Adolescents younger than 15 years and adults older than 65 years who are at increased risk of HIV infection should also receive screening, it added.
Because the screening recommendation had an A grade, it must be covered by private insurers under the Affordable Care Act.
But the CMS has not updated its policy, which means that "HIV testing coverage for Medicare beneficiaries is limited to those who are perceived to be or identify themselves as at risk and to pregnant women," said the letter from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership.
"This coverage limitation does not reflect the current science or HHS’s own best practices for HIV medicine," they said.
The groups said that at least 16% of people with the infection, or 181,400 individuals, are unaware that they are HIV positive and that half of all new infections are transmitted by someone who did not know their status. They also noted that about 17% of the Medicare population is young and disabled; with routine testing, they would be more likely to receive earlier diagnosis and treatment.
"It is important for CMS to make a clear statement that HIV infection is an important issue impacting Medicare beneficiaries," added the organizations, noting that, "While only about 3% of those living with HIV are estimated to be 65 or older, the CDC estimates that by 2017 more than half of those living with HIV will be over 50 years old, approaching Medicare eligibility."
The agency is accepting public comments on expanding coverage of screening until Sept. 3.
Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.
The CMS said that it expects to issue a proposed decision in Feb. 2015, and to complete its analysis by May next year.
On Twitter @aliciaault
CMS reconsidering coverage of HIV screening for all Medicare beneficiaries
The Centers for Medicare & Medicaid Services says it is considering extending coverage of HIV screening to all Medicare beneficiaries, not just those at risk.
The agency announced on Aug. 4 that it was starting a new analysis, which was prompted by a request from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership. Those groups include the American Academy of HIV Medicine, GMHC, the HIV Medicine Association, the National Alliance of State and Territorial AIDS Directors, the National Association of County and City Health Officials, and the National Viral Hepatitis Roundtable.
Medicare has covered routine HIV testing as a preventive service since 2009 for adolescents, pregnant women, and adults who are at risk for infection. That coverage decision was made in light of the U.S. Preventive Services Task Force grade A recommendation that such screening was supported by the evidence.
In 2013, the USPTF revised that recommendation, saying that all adolescents and adults aged 15-65 years should be screened, regardless of their risk. All pregnant women should still continue to be screened, said the Task Force. Adolescents younger than 15 years and adults older than 65 years who are at increased risk of HIV infection should also receive screening, it added.
Because the screening recommendation had an A grade, it must be covered by private insurers under the Affordable Care Act.
But the CMS has not updated its policy, which means that "HIV testing coverage for Medicare beneficiaries is limited to those who are perceived to be or identify themselves as at risk and to pregnant women," said the letter from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership.
"This coverage limitation does not reflect the current science or HHS’s own best practices for HIV medicine," they said.
The groups said that at least 16% of people with the infection, or 181,400 individuals, are unaware that they are HIV positive and that half of all new infections are transmitted by someone who did not know their status. They also noted that about 17% of the Medicare population is young and disabled; with routine testing, they would be more likely to receive earlier diagnosis and treatment.
"It is important for CMS to make a clear statement that HIV infection is an important issue impacting Medicare beneficiaries," added the organizations, noting that, "While only about 3% of those living with HIV are estimated to be 65 or older, the CDC estimates that by 2017 more than half of those living with HIV will be over 50 years old, approaching Medicare eligibility."
The agency is accepting public comments on expanding coverage of screening until Sept. 3.
The CMS said that it expects to issue a proposed decision in Feb. 2015, and to complete its analysis by May next year.
On Twitter @aliciaault
The Centers for Medicare & Medicaid Services says it is considering extending coverage of HIV screening to all Medicare beneficiaries, not just those at risk.
The agency announced on Aug. 4 that it was starting a new analysis, which was prompted by a request from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership. Those groups include the American Academy of HIV Medicine, GMHC, the HIV Medicine Association, the National Alliance of State and Territorial AIDS Directors, the National Association of County and City Health Officials, and the National Viral Hepatitis Roundtable.
Medicare has covered routine HIV testing as a preventive service since 2009 for adolescents, pregnant women, and adults who are at risk for infection. That coverage decision was made in light of the U.S. Preventive Services Task Force grade A recommendation that such screening was supported by the evidence.
In 2013, the USPTF revised that recommendation, saying that all adolescents and adults aged 15-65 years should be screened, regardless of their risk. All pregnant women should still continue to be screened, said the Task Force. Adolescents younger than 15 years and adults older than 65 years who are at increased risk of HIV infection should also receive screening, it added.
Because the screening recommendation had an A grade, it must be covered by private insurers under the Affordable Care Act.
But the CMS has not updated its policy, which means that "HIV testing coverage for Medicare beneficiaries is limited to those who are perceived to be or identify themselves as at risk and to pregnant women," said the letter from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership.
"This coverage limitation does not reflect the current science or HHS’s own best practices for HIV medicine," they said.
The groups said that at least 16% of people with the infection, or 181,400 individuals, are unaware that they are HIV positive and that half of all new infections are transmitted by someone who did not know their status. They also noted that about 17% of the Medicare population is young and disabled; with routine testing, they would be more likely to receive earlier diagnosis and treatment.
"It is important for CMS to make a clear statement that HIV infection is an important issue impacting Medicare beneficiaries," added the organizations, noting that, "While only about 3% of those living with HIV are estimated to be 65 or older, the CDC estimates that by 2017 more than half of those living with HIV will be over 50 years old, approaching Medicare eligibility."
The agency is accepting public comments on expanding coverage of screening until Sept. 3.
The CMS said that it expects to issue a proposed decision in Feb. 2015, and to complete its analysis by May next year.
On Twitter @aliciaault
The Centers for Medicare & Medicaid Services says it is considering extending coverage of HIV screening to all Medicare beneficiaries, not just those at risk.
The agency announced on Aug. 4 that it was starting a new analysis, which was prompted by a request from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership. Those groups include the American Academy of HIV Medicine, GMHC, the HIV Medicine Association, the National Alliance of State and Territorial AIDS Directors, the National Association of County and City Health Officials, and the National Viral Hepatitis Roundtable.
Medicare has covered routine HIV testing as a preventive service since 2009 for adolescents, pregnant women, and adults who are at risk for infection. That coverage decision was made in light of the U.S. Preventive Services Task Force grade A recommendation that such screening was supported by the evidence.
In 2013, the USPTF revised that recommendation, saying that all adolescents and adults aged 15-65 years should be screened, regardless of their risk. All pregnant women should still continue to be screened, said the Task Force. Adolescents younger than 15 years and adults older than 65 years who are at increased risk of HIV infection should also receive screening, it added.
Because the screening recommendation had an A grade, it must be covered by private insurers under the Affordable Care Act.
But the CMS has not updated its policy, which means that "HIV testing coverage for Medicare beneficiaries is limited to those who are perceived to be or identify themselves as at risk and to pregnant women," said the letter from the HIV Testing Reimbursement Working Group and the Federal AIDS Policy Partnership.
"This coverage limitation does not reflect the current science or HHS’s own best practices for HIV medicine," they said.
The groups said that at least 16% of people with the infection, or 181,400 individuals, are unaware that they are HIV positive and that half of all new infections are transmitted by someone who did not know their status. They also noted that about 17% of the Medicare population is young and disabled; with routine testing, they would be more likely to receive earlier diagnosis and treatment.
"It is important for CMS to make a clear statement that HIV infection is an important issue impacting Medicare beneficiaries," added the organizations, noting that, "While only about 3% of those living with HIV are estimated to be 65 or older, the CDC estimates that by 2017 more than half of those living with HIV will be over 50 years old, approaching Medicare eligibility."
The agency is accepting public comments on expanding coverage of screening until Sept. 3.
The CMS said that it expects to issue a proposed decision in Feb. 2015, and to complete its analysis by May next year.
On Twitter @aliciaault
House bill would allow corrective action plan for DEA violators
A new bill aims to clarify the rules of the Controlled Substances Act to ensure that legitimate operators stay in business and patients get needed medication, according to congressional backers of the bill, which was approved by the House of Representatives on July 29.
The bill still has to be taken up by the Senate, where there is no companion legislation.
The Ensuring Patient Access and Effective Drug Enforcement Act of 2014 (H.R. 4709) would ensure that restrictions on distribution of controlled substances are not so onerous as to inhibit access for patients, would require the U.S. Attorney General to give DEA registrant pharmacies and physicians who violate the rules an opportunity to submit a corrective action plan that might defer suspension of their registration, and would establish a working group to make recommendations to Congress on federal policies to reduce prescription drug diversion and abuse.
These measures are among the major policy goals of the Alliance to Prevent the Abuse of Medicines. The Washington, D.C.–based group includes among its members the American Medical Association, Cardinal Health, CVS Caremark, the Health Industry Distributors Association, and Teva.
The National Association of Chain Drug Stores "and chain pharmacy are committed to partnering with federal and state agencies, law enforcement personnel, policymakers, and other stakeholders to work on viable strategies to simultaneously advance patient health and prevent prescription drug abuse," NACDS President and CEO Steven C. Anderson, said in a statement regarding the bill.
Rep. Marsha Blackburn (R-Tenn.), a cosponsor of the bill, said in a statement that simply acknowledging the epidemic of prescription drug abuse isn’t enough. "Congress has a responsibility to make sure the law is crystal clear for both the DEA and legitimate businesses who want to understand what the rules are so they can do the right thing."
In House testimony last April, DEA Deputy Assistant Administrator Joseph Rannazzisi said the agency’s job is getting tougher. The number of registrants that the DEA regulates has mushroomed from 480,000 in 1973 to 1.5 million today, he said. At the same time, diversion and abuse have risen steeply, with opioids selling on the black market for 5-10 times their retail value.
In the last 3 years, the DEA’s Tactical Diversion Squads have increased from 37 to 66, and the agency has been applying its stiffest penalty – an immediate suspension order – in a judicious manner, according to Mr. Rannazzisi. From October 2013 through March 2014, 20 suspensions were ordered.
On Twitter @aliciaault
A new bill aims to clarify the rules of the Controlled Substances Act to ensure that legitimate operators stay in business and patients get needed medication, according to congressional backers of the bill, which was approved by the House of Representatives on July 29.
The bill still has to be taken up by the Senate, where there is no companion legislation.
The Ensuring Patient Access and Effective Drug Enforcement Act of 2014 (H.R. 4709) would ensure that restrictions on distribution of controlled substances are not so onerous as to inhibit access for patients, would require the U.S. Attorney General to give DEA registrant pharmacies and physicians who violate the rules an opportunity to submit a corrective action plan that might defer suspension of their registration, and would establish a working group to make recommendations to Congress on federal policies to reduce prescription drug diversion and abuse.
These measures are among the major policy goals of the Alliance to Prevent the Abuse of Medicines. The Washington, D.C.–based group includes among its members the American Medical Association, Cardinal Health, CVS Caremark, the Health Industry Distributors Association, and Teva.
The National Association of Chain Drug Stores "and chain pharmacy are committed to partnering with federal and state agencies, law enforcement personnel, policymakers, and other stakeholders to work on viable strategies to simultaneously advance patient health and prevent prescription drug abuse," NACDS President and CEO Steven C. Anderson, said in a statement regarding the bill.
Rep. Marsha Blackburn (R-Tenn.), a cosponsor of the bill, said in a statement that simply acknowledging the epidemic of prescription drug abuse isn’t enough. "Congress has a responsibility to make sure the law is crystal clear for both the DEA and legitimate businesses who want to understand what the rules are so they can do the right thing."
In House testimony last April, DEA Deputy Assistant Administrator Joseph Rannazzisi said the agency’s job is getting tougher. The number of registrants that the DEA regulates has mushroomed from 480,000 in 1973 to 1.5 million today, he said. At the same time, diversion and abuse have risen steeply, with opioids selling on the black market for 5-10 times their retail value.
In the last 3 years, the DEA’s Tactical Diversion Squads have increased from 37 to 66, and the agency has been applying its stiffest penalty – an immediate suspension order – in a judicious manner, according to Mr. Rannazzisi. From October 2013 through March 2014, 20 suspensions were ordered.
On Twitter @aliciaault
A new bill aims to clarify the rules of the Controlled Substances Act to ensure that legitimate operators stay in business and patients get needed medication, according to congressional backers of the bill, which was approved by the House of Representatives on July 29.
The bill still has to be taken up by the Senate, where there is no companion legislation.
The Ensuring Patient Access and Effective Drug Enforcement Act of 2014 (H.R. 4709) would ensure that restrictions on distribution of controlled substances are not so onerous as to inhibit access for patients, would require the U.S. Attorney General to give DEA registrant pharmacies and physicians who violate the rules an opportunity to submit a corrective action plan that might defer suspension of their registration, and would establish a working group to make recommendations to Congress on federal policies to reduce prescription drug diversion and abuse.
These measures are among the major policy goals of the Alliance to Prevent the Abuse of Medicines. The Washington, D.C.–based group includes among its members the American Medical Association, Cardinal Health, CVS Caremark, the Health Industry Distributors Association, and Teva.
The National Association of Chain Drug Stores "and chain pharmacy are committed to partnering with federal and state agencies, law enforcement personnel, policymakers, and other stakeholders to work on viable strategies to simultaneously advance patient health and prevent prescription drug abuse," NACDS President and CEO Steven C. Anderson, said in a statement regarding the bill.
Rep. Marsha Blackburn (R-Tenn.), a cosponsor of the bill, said in a statement that simply acknowledging the epidemic of prescription drug abuse isn’t enough. "Congress has a responsibility to make sure the law is crystal clear for both the DEA and legitimate businesses who want to understand what the rules are so they can do the right thing."
In House testimony last April, DEA Deputy Assistant Administrator Joseph Rannazzisi said the agency’s job is getting tougher. The number of registrants that the DEA regulates has mushroomed from 480,000 in 1973 to 1.5 million today, he said. At the same time, diversion and abuse have risen steeply, with opioids selling on the black market for 5-10 times their retail value.
In the last 3 years, the DEA’s Tactical Diversion Squads have increased from 37 to 66, and the agency has been applying its stiffest penalty – an immediate suspension order – in a judicious manner, according to Mr. Rannazzisi. From October 2013 through March 2014, 20 suspensions were ordered.
On Twitter @aliciaault
House panel looks into rocky rollout of healthcare.gov
WASHINGTON – Despite a scathing report on past and ongoing failures with healthcare.gov, the Affordable Care Act’s website will be ready to go when enrollment begins again in November, Andy Slavitt, principal deputy administrator of the Centers for Medicare & Medicaid Services testified to a House subcommittee July 31.
Mr. Slavitt, who took his post 3 weeks ago, was called to Capitol Hill to respond to a Government Accountability Office report that is critical of both the rollout of healthcare.gov and the ongoing management of the portal. The GAO is a nonpartisan agency that serves as the investigative arm of Congress.
Mr. Slavitt acknowledged problems listed by the GAO. "Fortunately, or unfortunately, the GAO report wasn’t news to the people at CMS," he testified before the House Energy & Commerce Committee Subcommittee on Oversight and Investigations.
But many have been addressed, he said, adding that there is more accountability, better communication with contractors, and clearly defined performance goals.
"This coming year will be one of continuous and visible improvement, but not perfection," Mr. Slavitt testified.
The GAO report chronicled mismanagement, limited oversight, and a chaotic planning process within CMS during the lead-up to the launch of healthcare.gov in October 2013. Officials knew that the site was only 65% ready that spring, but put off a review of performance until September, GAO official William T. Woods testified at the hearing.
Constantly changing requirements led to huge cost increases – which appear to have continued. As of March 2014, the federal government had spent $840 million on the website. The CMS did not properly review or approve work by the contractors and "took only limited steps to hold the contractor accountable," Mr. Woods said in written testimony.
The GAO report notes that the cost of working with Accenture Federal Services – the contractor hired to replace the site’s original builder – had ballooned from $91 million to more than $175 million in the first half of 2014, because of new requirements and other changes ordered by CMS.
Despite rising costs, key parts of the website are still not functional, including the financial management module, which handles financial interactions with insurers. That contract continues, "so costs on that particular contract are almost certainly higher today than they were when we completed our audit work," Mr. Woods said.
Rep. Tim Murphy (R-Pa.), chairman of the oversight subcommittee said, "We still don’t know if the Administration has a system in place capable of handling inconsistencies, inaccurate subsidies, or whether CMS will ever put in place a functioning payments system."
Rep. Murphy and his Republican colleagues also questioned whether top CMS officials, such as Administrator Marilyn Tavenner, were aware that the site was so far behind in its performance goals and deadlines. At one point, Rep. Murphy suggested that, if they had known, they might have perjured themselves in appearances before the Energy & Commerce Committee in 2013.
Democrats on the panel said that it was important to acknowledge the failures of the site’s launch, but only to inform future solutions. "We will stipulate the rollout of the ACA was an unmitigated disaster," said Rep. Diana DeGette (D-Colo.). But she and her colleagues said it was time to move forward.
"My point is not to excuse the healthcare.gov problems but to put them in context," said Rep. Henry Waxman (D-Calif.). He said the problems were fixed, though not quick enough for his liking. But, Rep. Waxman added, "I want to learn what went wrong so CMS can do a better job for the next time."
On Twitter @aliciaault
WASHINGTON – Despite a scathing report on past and ongoing failures with healthcare.gov, the Affordable Care Act’s website will be ready to go when enrollment begins again in November, Andy Slavitt, principal deputy administrator of the Centers for Medicare & Medicaid Services testified to a House subcommittee July 31.
Mr. Slavitt, who took his post 3 weeks ago, was called to Capitol Hill to respond to a Government Accountability Office report that is critical of both the rollout of healthcare.gov and the ongoing management of the portal. The GAO is a nonpartisan agency that serves as the investigative arm of Congress.
Mr. Slavitt acknowledged problems listed by the GAO. "Fortunately, or unfortunately, the GAO report wasn’t news to the people at CMS," he testified before the House Energy & Commerce Committee Subcommittee on Oversight and Investigations.
But many have been addressed, he said, adding that there is more accountability, better communication with contractors, and clearly defined performance goals.
"This coming year will be one of continuous and visible improvement, but not perfection," Mr. Slavitt testified.
The GAO report chronicled mismanagement, limited oversight, and a chaotic planning process within CMS during the lead-up to the launch of healthcare.gov in October 2013. Officials knew that the site was only 65% ready that spring, but put off a review of performance until September, GAO official William T. Woods testified at the hearing.
Constantly changing requirements led to huge cost increases – which appear to have continued. As of March 2014, the federal government had spent $840 million on the website. The CMS did not properly review or approve work by the contractors and "took only limited steps to hold the contractor accountable," Mr. Woods said in written testimony.
The GAO report notes that the cost of working with Accenture Federal Services – the contractor hired to replace the site’s original builder – had ballooned from $91 million to more than $175 million in the first half of 2014, because of new requirements and other changes ordered by CMS.
Despite rising costs, key parts of the website are still not functional, including the financial management module, which handles financial interactions with insurers. That contract continues, "so costs on that particular contract are almost certainly higher today than they were when we completed our audit work," Mr. Woods said.
Rep. Tim Murphy (R-Pa.), chairman of the oversight subcommittee said, "We still don’t know if the Administration has a system in place capable of handling inconsistencies, inaccurate subsidies, or whether CMS will ever put in place a functioning payments system."
Rep. Murphy and his Republican colleagues also questioned whether top CMS officials, such as Administrator Marilyn Tavenner, were aware that the site was so far behind in its performance goals and deadlines. At one point, Rep. Murphy suggested that, if they had known, they might have perjured themselves in appearances before the Energy & Commerce Committee in 2013.
Democrats on the panel said that it was important to acknowledge the failures of the site’s launch, but only to inform future solutions. "We will stipulate the rollout of the ACA was an unmitigated disaster," said Rep. Diana DeGette (D-Colo.). But she and her colleagues said it was time to move forward.
"My point is not to excuse the healthcare.gov problems but to put them in context," said Rep. Henry Waxman (D-Calif.). He said the problems were fixed, though not quick enough for his liking. But, Rep. Waxman added, "I want to learn what went wrong so CMS can do a better job for the next time."
On Twitter @aliciaault
WASHINGTON – Despite a scathing report on past and ongoing failures with healthcare.gov, the Affordable Care Act’s website will be ready to go when enrollment begins again in November, Andy Slavitt, principal deputy administrator of the Centers for Medicare & Medicaid Services testified to a House subcommittee July 31.
Mr. Slavitt, who took his post 3 weeks ago, was called to Capitol Hill to respond to a Government Accountability Office report that is critical of both the rollout of healthcare.gov and the ongoing management of the portal. The GAO is a nonpartisan agency that serves as the investigative arm of Congress.
Mr. Slavitt acknowledged problems listed by the GAO. "Fortunately, or unfortunately, the GAO report wasn’t news to the people at CMS," he testified before the House Energy & Commerce Committee Subcommittee on Oversight and Investigations.
But many have been addressed, he said, adding that there is more accountability, better communication with contractors, and clearly defined performance goals.
"This coming year will be one of continuous and visible improvement, but not perfection," Mr. Slavitt testified.
The GAO report chronicled mismanagement, limited oversight, and a chaotic planning process within CMS during the lead-up to the launch of healthcare.gov in October 2013. Officials knew that the site was only 65% ready that spring, but put off a review of performance until September, GAO official William T. Woods testified at the hearing.
Constantly changing requirements led to huge cost increases – which appear to have continued. As of March 2014, the federal government had spent $840 million on the website. The CMS did not properly review or approve work by the contractors and "took only limited steps to hold the contractor accountable," Mr. Woods said in written testimony.
The GAO report notes that the cost of working with Accenture Federal Services – the contractor hired to replace the site’s original builder – had ballooned from $91 million to more than $175 million in the first half of 2014, because of new requirements and other changes ordered by CMS.
Despite rising costs, key parts of the website are still not functional, including the financial management module, which handles financial interactions with insurers. That contract continues, "so costs on that particular contract are almost certainly higher today than they were when we completed our audit work," Mr. Woods said.
Rep. Tim Murphy (R-Pa.), chairman of the oversight subcommittee said, "We still don’t know if the Administration has a system in place capable of handling inconsistencies, inaccurate subsidies, or whether CMS will ever put in place a functioning payments system."
Rep. Murphy and his Republican colleagues also questioned whether top CMS officials, such as Administrator Marilyn Tavenner, were aware that the site was so far behind in its performance goals and deadlines. At one point, Rep. Murphy suggested that, if they had known, they might have perjured themselves in appearances before the Energy & Commerce Committee in 2013.
Democrats on the panel said that it was important to acknowledge the failures of the site’s launch, but only to inform future solutions. "We will stipulate the rollout of the ACA was an unmitigated disaster," said Rep. Diana DeGette (D-Colo.). But she and her colleagues said it was time to move forward.
"My point is not to excuse the healthcare.gov problems but to put them in context," said Rep. Henry Waxman (D-Calif.). He said the problems were fixed, though not quick enough for his liking. But, Rep. Waxman added, "I want to learn what went wrong so CMS can do a better job for the next time."
On Twitter @aliciaault
FROM A HOUSE ENERGY & COMMERCE COMMITTEE HEARING
House votes to speed sunscreen approvals
The U.S. House of Representatives passed legislation to speed up Food and Drug Administration approvals of new sunscreen ingredients and to eliminate a backlog.
The Sunscreen Innovation Act (H.R. 4250) was passed by a voice vote and now awaits action by the Senate. The companion bill in the Senate, S. 2141, was introduced by Jack Reed (D-R.I.) and has been referred to the Committee on Health, Education, Labor, and Pensions but has not received a hearing yet.
Backers of the legislation are encouraging the Senate to move quickly.
"Even though the Food and Drug Administration has listed action on sunscreen ingredient applications as a priority since 2008, no new sunscreen ingredients have been approved by the FDA in 15 years," Rep. Ed Whitfield (R-Ky.), one of the lead sponsors of the House bill, said in a statement after the approval.
"The framework outlined in this legislation strikes an appropriate balance between consumer safety and access to new sunscreen products," he said, adding, "I am pleased to see my legislation pass the House of Representatives, and call on the Senate to act."
The bill requires the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more Congressional oversight of the process and makes "sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act."
Currently, according to the American Cancer Society Cancer Action Network (ACS CAN), only three of the seven UVA-blocking ingredients sold in Europe are approved in the United States.
The Sunscreen Innovation Act has many supporters in the health care field and among consumer advocates and manufacturers, many of whom belong to the PASS (Public Access to SunScreens) Coalition. In a statement issued by the coalition, the American College of Mohs Surgery said, "This important legislation will go a long way in helping prevent skin cancers by improving the availability of more effective sunscreen products, and we are committed to its passage."
The Environmental Working Group, a frequent critic of the FDA’s regulation of sunscreens and of manufacturers, also applauded House passage of the bill.
The American Cancer Society was pleased as well. "The House took a critical step today to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer," Chris Hansen, president of the ACS CAN, said in a statement.
"American consumers should have access to the broadest choice of sunscreens – including those in use for years in other countries – once they are shown to be safe and effective," he noted.
On Twitter @aliciaault
The U.S. House of Representatives passed legislation to speed up Food and Drug Administration approvals of new sunscreen ingredients and to eliminate a backlog.
The Sunscreen Innovation Act (H.R. 4250) was passed by a voice vote and now awaits action by the Senate. The companion bill in the Senate, S. 2141, was introduced by Jack Reed (D-R.I.) and has been referred to the Committee on Health, Education, Labor, and Pensions but has not received a hearing yet.
Backers of the legislation are encouraging the Senate to move quickly.
"Even though the Food and Drug Administration has listed action on sunscreen ingredient applications as a priority since 2008, no new sunscreen ingredients have been approved by the FDA in 15 years," Rep. Ed Whitfield (R-Ky.), one of the lead sponsors of the House bill, said in a statement after the approval.
"The framework outlined in this legislation strikes an appropriate balance between consumer safety and access to new sunscreen products," he said, adding, "I am pleased to see my legislation pass the House of Representatives, and call on the Senate to act."
The bill requires the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more Congressional oversight of the process and makes "sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act."
Currently, according to the American Cancer Society Cancer Action Network (ACS CAN), only three of the seven UVA-blocking ingredients sold in Europe are approved in the United States.
The Sunscreen Innovation Act has many supporters in the health care field and among consumer advocates and manufacturers, many of whom belong to the PASS (Public Access to SunScreens) Coalition. In a statement issued by the coalition, the American College of Mohs Surgery said, "This important legislation will go a long way in helping prevent skin cancers by improving the availability of more effective sunscreen products, and we are committed to its passage."
The Environmental Working Group, a frequent critic of the FDA’s regulation of sunscreens and of manufacturers, also applauded House passage of the bill.
The American Cancer Society was pleased as well. "The House took a critical step today to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer," Chris Hansen, president of the ACS CAN, said in a statement.
"American consumers should have access to the broadest choice of sunscreens – including those in use for years in other countries – once they are shown to be safe and effective," he noted.
On Twitter @aliciaault
The U.S. House of Representatives passed legislation to speed up Food and Drug Administration approvals of new sunscreen ingredients and to eliminate a backlog.
The Sunscreen Innovation Act (H.R. 4250) was passed by a voice vote and now awaits action by the Senate. The companion bill in the Senate, S. 2141, was introduced by Jack Reed (D-R.I.) and has been referred to the Committee on Health, Education, Labor, and Pensions but has not received a hearing yet.
Backers of the legislation are encouraging the Senate to move quickly.
"Even though the Food and Drug Administration has listed action on sunscreen ingredient applications as a priority since 2008, no new sunscreen ingredients have been approved by the FDA in 15 years," Rep. Ed Whitfield (R-Ky.), one of the lead sponsors of the House bill, said in a statement after the approval.
"The framework outlined in this legislation strikes an appropriate balance between consumer safety and access to new sunscreen products," he said, adding, "I am pleased to see my legislation pass the House of Representatives, and call on the Senate to act."
The bill requires the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more Congressional oversight of the process and makes "sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act."
Currently, according to the American Cancer Society Cancer Action Network (ACS CAN), only three of the seven UVA-blocking ingredients sold in Europe are approved in the United States.
The Sunscreen Innovation Act has many supporters in the health care field and among consumer advocates and manufacturers, many of whom belong to the PASS (Public Access to SunScreens) Coalition. In a statement issued by the coalition, the American College of Mohs Surgery said, "This important legislation will go a long way in helping prevent skin cancers by improving the availability of more effective sunscreen products, and we are committed to its passage."
The Environmental Working Group, a frequent critic of the FDA’s regulation of sunscreens and of manufacturers, also applauded House passage of the bill.
The American Cancer Society was pleased as well. "The House took a critical step today to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer," Chris Hansen, president of the ACS CAN, said in a statement.
"American consumers should have access to the broadest choice of sunscreens – including those in use for years in other countries – once they are shown to be safe and effective," he noted.
On Twitter @aliciaault
Surgeon General: Tanning, indoor tanning must stop
The U.S. Surgeon General’s office is calling on Americans to do more to help prevent skin cancer, saying that it is a growing public health problem.
The five-point call to action singled out ultraviolet light exposure – from indoor and outdoor tanning – as a major culprit in the growing incidence of all cancers, and melanoma, in particular.
"Tanned skin is damaged skin," Acting Surgeon General, Boris D. Lushniak, a dermatologist, said at a briefing to release the report.
"When people tan or get sunburned, they increase their risk of getting skin cancer later in life," he said, adding that the nation needs to change its cultural acceptance of tanning as a sign of health.
The report noted that about 5 million Americans are treated for skin cancer each year, at a cost of $8 billion. Melanoma is of the greatest concern; its incidence has tripled over the past 3 decades, with 63,000 new cases per year. Some 9,000 Americans die from melanoma each year, and death rates are on the rise in men, Dr. Howard Koh, assistant secretary for health at the U.S. Department of Health & Human Services, said at the briefing.
Both Dr. Koh and Dr. Lushniak singled out indoor tanning as particularly dangerous. The Surgeon General’s report cited research showing that indoor tanning may be associated with more than 400,000 cases of skin cancer, including 6,000 melanomas, per year.
Forty-four states and the District of Columbia have some type of indoor tanning laws or regulations. Eleven states – California, Delaware, Hawaii, Illinois, Louisiana, Minnesota, Nevada, Oregon, Texas, Vermont and Washington – prohibit indoor tanning by individuals under age 18. But indoor tanning remains popular: One in three white women aged 16-25 years engages in indoor tanning each year, according to the report.
In May, the Food and Drug Administration issued stricter rules for sunlamps used with indoor tanning, requiring a boxed warning that they should not be used on anyone younger than 18 years. The agency also required that more information on risks and contraindications be provided to sunlamp users, FDA Commissioner Margaret Hamburg noted in a statement on the Surgeon General’s report.
The five main points in the Surgeon General’s call to action are:
• Increase opportunities for sun protection in outdoor settings, such as increasing shade in recreational areas, and providing more protection for school children and outdoor workers.
• Give individuals information to make informed, healthy choices about UV exposure, including providing materials in workplaces and schools, and partnering with physicians and health systems.
• Promote policies that advance the goal of preventing skin cancer, such as encouraging electronic reporting of reportable skin cancers.
• Reduce harms from indoor tanning by enforcing existing laws and considering additional restrictions.
• Strengthen research, surveillance, monitoring, and evaluation.
The American Academy of Dermatology Association applauded the report.
"The American public needs to be aware that the dangers of ultraviolet radiation exposure are real," Dr. Brett M. Coldiron, president of the AADA, said in a statement. "The AADA is particularly pleased that the HHS and the Office of the Surgeon General have highlighted methods for the public to prevent skin cancer in this white paper, that include seeking shade, wearing protective clothing, applying sunscreen, and avoiding dangerous indoor tanning devices."
John Seffrin, Ph.D., chief executive officer of the American Cancer Society Cancer Action Network, noted that this is the first time there has been a national action plan regarding skin cancer.
"By bringing national attention to this growing public health crisis, the Surgeon General is calling on all of us to reinvigorate the fight against skin cancer," he said. "The Surgeon General’s Call to Action outlines achievable goals and strategies to support more Americans in making healthy choices about protecting their skin," Dr. Seffrin said.
On Twitter @aliciaault
The U.S. Surgeon General’s office is calling on Americans to do more to help prevent skin cancer, saying that it is a growing public health problem.
The five-point call to action singled out ultraviolet light exposure – from indoor and outdoor tanning – as a major culprit in the growing incidence of all cancers, and melanoma, in particular.
"Tanned skin is damaged skin," Acting Surgeon General, Boris D. Lushniak, a dermatologist, said at a briefing to release the report.
"When people tan or get sunburned, they increase their risk of getting skin cancer later in life," he said, adding that the nation needs to change its cultural acceptance of tanning as a sign of health.
The report noted that about 5 million Americans are treated for skin cancer each year, at a cost of $8 billion. Melanoma is of the greatest concern; its incidence has tripled over the past 3 decades, with 63,000 new cases per year. Some 9,000 Americans die from melanoma each year, and death rates are on the rise in men, Dr. Howard Koh, assistant secretary for health at the U.S. Department of Health & Human Services, said at the briefing.
Both Dr. Koh and Dr. Lushniak singled out indoor tanning as particularly dangerous. The Surgeon General’s report cited research showing that indoor tanning may be associated with more than 400,000 cases of skin cancer, including 6,000 melanomas, per year.
Forty-four states and the District of Columbia have some type of indoor tanning laws or regulations. Eleven states – California, Delaware, Hawaii, Illinois, Louisiana, Minnesota, Nevada, Oregon, Texas, Vermont and Washington – prohibit indoor tanning by individuals under age 18. But indoor tanning remains popular: One in three white women aged 16-25 years engages in indoor tanning each year, according to the report.
In May, the Food and Drug Administration issued stricter rules for sunlamps used with indoor tanning, requiring a boxed warning that they should not be used on anyone younger than 18 years. The agency also required that more information on risks and contraindications be provided to sunlamp users, FDA Commissioner Margaret Hamburg noted in a statement on the Surgeon General’s report.
The five main points in the Surgeon General’s call to action are:
• Increase opportunities for sun protection in outdoor settings, such as increasing shade in recreational areas, and providing more protection for school children and outdoor workers.
• Give individuals information to make informed, healthy choices about UV exposure, including providing materials in workplaces and schools, and partnering with physicians and health systems.
• Promote policies that advance the goal of preventing skin cancer, such as encouraging electronic reporting of reportable skin cancers.
• Reduce harms from indoor tanning by enforcing existing laws and considering additional restrictions.
• Strengthen research, surveillance, monitoring, and evaluation.
The American Academy of Dermatology Association applauded the report.
"The American public needs to be aware that the dangers of ultraviolet radiation exposure are real," Dr. Brett M. Coldiron, president of the AADA, said in a statement. "The AADA is particularly pleased that the HHS and the Office of the Surgeon General have highlighted methods for the public to prevent skin cancer in this white paper, that include seeking shade, wearing protective clothing, applying sunscreen, and avoiding dangerous indoor tanning devices."
John Seffrin, Ph.D., chief executive officer of the American Cancer Society Cancer Action Network, noted that this is the first time there has been a national action plan regarding skin cancer.
"By bringing national attention to this growing public health crisis, the Surgeon General is calling on all of us to reinvigorate the fight against skin cancer," he said. "The Surgeon General’s Call to Action outlines achievable goals and strategies to support more Americans in making healthy choices about protecting their skin," Dr. Seffrin said.
On Twitter @aliciaault
The U.S. Surgeon General’s office is calling on Americans to do more to help prevent skin cancer, saying that it is a growing public health problem.
The five-point call to action singled out ultraviolet light exposure – from indoor and outdoor tanning – as a major culprit in the growing incidence of all cancers, and melanoma, in particular.
"Tanned skin is damaged skin," Acting Surgeon General, Boris D. Lushniak, a dermatologist, said at a briefing to release the report.
"When people tan or get sunburned, they increase their risk of getting skin cancer later in life," he said, adding that the nation needs to change its cultural acceptance of tanning as a sign of health.
The report noted that about 5 million Americans are treated for skin cancer each year, at a cost of $8 billion. Melanoma is of the greatest concern; its incidence has tripled over the past 3 decades, with 63,000 new cases per year. Some 9,000 Americans die from melanoma each year, and death rates are on the rise in men, Dr. Howard Koh, assistant secretary for health at the U.S. Department of Health & Human Services, said at the briefing.
Both Dr. Koh and Dr. Lushniak singled out indoor tanning as particularly dangerous. The Surgeon General’s report cited research showing that indoor tanning may be associated with more than 400,000 cases of skin cancer, including 6,000 melanomas, per year.
Forty-four states and the District of Columbia have some type of indoor tanning laws or regulations. Eleven states – California, Delaware, Hawaii, Illinois, Louisiana, Minnesota, Nevada, Oregon, Texas, Vermont and Washington – prohibit indoor tanning by individuals under age 18. But indoor tanning remains popular: One in three white women aged 16-25 years engages in indoor tanning each year, according to the report.
In May, the Food and Drug Administration issued stricter rules for sunlamps used with indoor tanning, requiring a boxed warning that they should not be used on anyone younger than 18 years. The agency also required that more information on risks and contraindications be provided to sunlamp users, FDA Commissioner Margaret Hamburg noted in a statement on the Surgeon General’s report.
The five main points in the Surgeon General’s call to action are:
• Increase opportunities for sun protection in outdoor settings, such as increasing shade in recreational areas, and providing more protection for school children and outdoor workers.
• Give individuals information to make informed, healthy choices about UV exposure, including providing materials in workplaces and schools, and partnering with physicians and health systems.
• Promote policies that advance the goal of preventing skin cancer, such as encouraging electronic reporting of reportable skin cancers.
• Reduce harms from indoor tanning by enforcing existing laws and considering additional restrictions.
• Strengthen research, surveillance, monitoring, and evaluation.
The American Academy of Dermatology Association applauded the report.
"The American public needs to be aware that the dangers of ultraviolet radiation exposure are real," Dr. Brett M. Coldiron, president of the AADA, said in a statement. "The AADA is particularly pleased that the HHS and the Office of the Surgeon General have highlighted methods for the public to prevent skin cancer in this white paper, that include seeking shade, wearing protective clothing, applying sunscreen, and avoiding dangerous indoor tanning devices."
John Seffrin, Ph.D., chief executive officer of the American Cancer Society Cancer Action Network, noted that this is the first time there has been a national action plan regarding skin cancer.
"By bringing national attention to this growing public health crisis, the Surgeon General is calling on all of us to reinvigorate the fight against skin cancer," he said. "The Surgeon General’s Call to Action outlines achievable goals and strategies to support more Americans in making healthy choices about protecting their skin," Dr. Seffrin said.
On Twitter @aliciaault
FDA gives full approval to ibrutinib for CLL
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.
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.
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.
On Twitter @aliciaault
Conflicting rulings raise questions about legality of ACA premium subsidies
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.
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.
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.
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.
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.
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.
On Twitter @aliciaault
