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CMS releases data on $3.5B in industry payments to doctors, teaching hospitals
The federal government publicly released the first data about drug and device industry payments to physicians and hospitals, part of a push toward greater transparency that was mandated under the Affordable Care Act.
On Sept. 30, the Centers for Medicare & Medicaid Services published 4.4 million records of payments to about 546,000 individual physicians and nearly 1,360 teaching hospitals. In total, the records represent $3.5 billion in financial transactions between industry and health care providers.
The Open Payments program, known previously as the Sunshine Act, requires medical device manufacturers and pharmaceutical companies to report payments and transfers of value to physicians and teaching hospitals, including consulting fees, research grants, travel reimbursements, ownership interests, and other gifts.
The data released on Sept. 30 cover only payments made from August through December 2013. Data on payments made in 2014 are slated to be published in June 2015.
“We are taking a big step forward in shining the light on these financial arrangements between physicians and the health care industry,” said Dr. Shantanu Agrawal, director of the CMS Center for Program Integrity. “Using [these] new data, it is now possible to conduct a wide range of analyses of payments made by drug and device manufacturers that were never possible before.”
But the program has been plagued by delays and technical problems. CMS had to extend multiple times the 45-day “review and dispute” period, during which physicians could check the accuracy of data reported about them. It took the agency days to correct technical problems that had caused data to be intermingled, matching the wrong records to physicians with similar names.
Of the 4.4 million records released on Sept. 30, about 40% had to be deidentified either because of data inconsistencies that kept CMS from being able to match them to an individual physician or teaching hospital, or because the data were not available for review for the full 45-day period. CMS expects the data to be fully identified in 2015 once the manufacturers submit corrected information.
Another 199,000 records that were reported to the agency were not published at all, according to CMS. The vast majority of those records were unpublished at the request of the industry, since they related to ongoing research of unapproved treatments. About 9,000 records were not published because they are under active dispute, according to Dr. Agrawal.
While physicians and the industry have been generally supportive of CMS’s move toward greater openness about payments, there has been plenty of criticism of the implementation of the Open Payments program. The American Medical Association has said repeatedly that physicians have not had enough time to review the accuracy of the payments and that CMS is not providing adequate context about what the payments actually say about physician-industry relationships.
“Publicly reporting industry payments to individual physicians can imply, wrongly, that such payments are always inappropriate,” the AMA wrote in a guide for reporters covering the release of Open Payments data. “Some may be, but to be able to make an informed judgment, it is vital to be able to set the financial information in context. Just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately.”
The AMA also said that the process of registering and later reviewing payments was confusing and overly cumbersome for physicians. Only about 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review their data, according to CMS.
On Twitter @maryellenny
The federal government publicly released the first data about drug and device industry payments to physicians and hospitals, part of a push toward greater transparency that was mandated under the Affordable Care Act.
On Sept. 30, the Centers for Medicare & Medicaid Services published 4.4 million records of payments to about 546,000 individual physicians and nearly 1,360 teaching hospitals. In total, the records represent $3.5 billion in financial transactions between industry and health care providers.
The Open Payments program, known previously as the Sunshine Act, requires medical device manufacturers and pharmaceutical companies to report payments and transfers of value to physicians and teaching hospitals, including consulting fees, research grants, travel reimbursements, ownership interests, and other gifts.
The data released on Sept. 30 cover only payments made from August through December 2013. Data on payments made in 2014 are slated to be published in June 2015.
“We are taking a big step forward in shining the light on these financial arrangements between physicians and the health care industry,” said Dr. Shantanu Agrawal, director of the CMS Center for Program Integrity. “Using [these] new data, it is now possible to conduct a wide range of analyses of payments made by drug and device manufacturers that were never possible before.”
But the program has been plagued by delays and technical problems. CMS had to extend multiple times the 45-day “review and dispute” period, during which physicians could check the accuracy of data reported about them. It took the agency days to correct technical problems that had caused data to be intermingled, matching the wrong records to physicians with similar names.
Of the 4.4 million records released on Sept. 30, about 40% had to be deidentified either because of data inconsistencies that kept CMS from being able to match them to an individual physician or teaching hospital, or because the data were not available for review for the full 45-day period. CMS expects the data to be fully identified in 2015 once the manufacturers submit corrected information.
Another 199,000 records that were reported to the agency were not published at all, according to CMS. The vast majority of those records were unpublished at the request of the industry, since they related to ongoing research of unapproved treatments. About 9,000 records were not published because they are under active dispute, according to Dr. Agrawal.
While physicians and the industry have been generally supportive of CMS’s move toward greater openness about payments, there has been plenty of criticism of the implementation of the Open Payments program. The American Medical Association has said repeatedly that physicians have not had enough time to review the accuracy of the payments and that CMS is not providing adequate context about what the payments actually say about physician-industry relationships.
“Publicly reporting industry payments to individual physicians can imply, wrongly, that such payments are always inappropriate,” the AMA wrote in a guide for reporters covering the release of Open Payments data. “Some may be, but to be able to make an informed judgment, it is vital to be able to set the financial information in context. Just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately.”
The AMA also said that the process of registering and later reviewing payments was confusing and overly cumbersome for physicians. Only about 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review their data, according to CMS.
On Twitter @maryellenny
The federal government publicly released the first data about drug and device industry payments to physicians and hospitals, part of a push toward greater transparency that was mandated under the Affordable Care Act.
On Sept. 30, the Centers for Medicare & Medicaid Services published 4.4 million records of payments to about 546,000 individual physicians and nearly 1,360 teaching hospitals. In total, the records represent $3.5 billion in financial transactions between industry and health care providers.
The Open Payments program, known previously as the Sunshine Act, requires medical device manufacturers and pharmaceutical companies to report payments and transfers of value to physicians and teaching hospitals, including consulting fees, research grants, travel reimbursements, ownership interests, and other gifts.
The data released on Sept. 30 cover only payments made from August through December 2013. Data on payments made in 2014 are slated to be published in June 2015.
“We are taking a big step forward in shining the light on these financial arrangements between physicians and the health care industry,” said Dr. Shantanu Agrawal, director of the CMS Center for Program Integrity. “Using [these] new data, it is now possible to conduct a wide range of analyses of payments made by drug and device manufacturers that were never possible before.”
But the program has been plagued by delays and technical problems. CMS had to extend multiple times the 45-day “review and dispute” period, during which physicians could check the accuracy of data reported about them. It took the agency days to correct technical problems that had caused data to be intermingled, matching the wrong records to physicians with similar names.
Of the 4.4 million records released on Sept. 30, about 40% had to be deidentified either because of data inconsistencies that kept CMS from being able to match them to an individual physician or teaching hospital, or because the data were not available for review for the full 45-day period. CMS expects the data to be fully identified in 2015 once the manufacturers submit corrected information.
Another 199,000 records that were reported to the agency were not published at all, according to CMS. The vast majority of those records were unpublished at the request of the industry, since they related to ongoing research of unapproved treatments. About 9,000 records were not published because they are under active dispute, according to Dr. Agrawal.
While physicians and the industry have been generally supportive of CMS’s move toward greater openness about payments, there has been plenty of criticism of the implementation of the Open Payments program. The American Medical Association has said repeatedly that physicians have not had enough time to review the accuracy of the payments and that CMS is not providing adequate context about what the payments actually say about physician-industry relationships.
“Publicly reporting industry payments to individual physicians can imply, wrongly, that such payments are always inappropriate,” the AMA wrote in a guide for reporters covering the release of Open Payments data. “Some may be, but to be able to make an informed judgment, it is vital to be able to set the financial information in context. Just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately.”
The AMA also said that the process of registering and later reviewing payments was confusing and overly cumbersome for physicians. Only about 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review their data, according to CMS.
On Twitter @maryellenny
Simvastatin shows no benefit for ARDS
Simvastatin did not improve clinical outcomes in adults with respiratory distress syndrome, compared with placebo, according to investigators.
The report was published online Sept. 30 in the New England Journal of Medicine.
Despite positive findings in early-phase studies, large clinical trials have failed to show that statins benefit patients with ARDS, said Dr. Daniel McAuley of Queen’s University of Belfast, Ireland, and his associates. The earlier studies used surrogate measures that do not clearly correlate with patient-specific outcomes, the researchers said. “Surrogate outcomes that more closely track patient outcomes need to be identified,” they added (N. Engl. J. Med. 2014 Sept. 30 [doi: 10.1056/NEJMoa1403285]).
The multicenter, double-blind trial comprised 540 adults with ARDS from 40 intensive care units in the United Kingdom and Ireland. Patients were randomized to enteral simvastatin or placebo, and the groups did not differ significantly in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%), the investigators reported. Adverse effects also were similar between the groups, they said.
The researchers recruited a heterogeneous cohort of patients with ARDS resulting from any cause so that findings would be generalizable, they wrote. Because recent research suggests that identification of specific phenotypes within ARDS may be possible, future studies “may identify a subpopulation of patients with ARDS who might have a greater response to simvastatin than was observed in our study,” they noted.
The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint partnership of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.
Simvastatin did not improve clinical outcomes in adults with respiratory distress syndrome, compared with placebo, according to investigators.
The report was published online Sept. 30 in the New England Journal of Medicine.
Despite positive findings in early-phase studies, large clinical trials have failed to show that statins benefit patients with ARDS, said Dr. Daniel McAuley of Queen’s University of Belfast, Ireland, and his associates. The earlier studies used surrogate measures that do not clearly correlate with patient-specific outcomes, the researchers said. “Surrogate outcomes that more closely track patient outcomes need to be identified,” they added (N. Engl. J. Med. 2014 Sept. 30 [doi: 10.1056/NEJMoa1403285]).
The multicenter, double-blind trial comprised 540 adults with ARDS from 40 intensive care units in the United Kingdom and Ireland. Patients were randomized to enteral simvastatin or placebo, and the groups did not differ significantly in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%), the investigators reported. Adverse effects also were similar between the groups, they said.
The researchers recruited a heterogeneous cohort of patients with ARDS resulting from any cause so that findings would be generalizable, they wrote. Because recent research suggests that identification of specific phenotypes within ARDS may be possible, future studies “may identify a subpopulation of patients with ARDS who might have a greater response to simvastatin than was observed in our study,” they noted.
The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint partnership of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.
Simvastatin did not improve clinical outcomes in adults with respiratory distress syndrome, compared with placebo, according to investigators.
The report was published online Sept. 30 in the New England Journal of Medicine.
Despite positive findings in early-phase studies, large clinical trials have failed to show that statins benefit patients with ARDS, said Dr. Daniel McAuley of Queen’s University of Belfast, Ireland, and his associates. The earlier studies used surrogate measures that do not clearly correlate with patient-specific outcomes, the researchers said. “Surrogate outcomes that more closely track patient outcomes need to be identified,” they added (N. Engl. J. Med. 2014 Sept. 30 [doi: 10.1056/NEJMoa1403285]).
The multicenter, double-blind trial comprised 540 adults with ARDS from 40 intensive care units in the United Kingdom and Ireland. Patients were randomized to enteral simvastatin or placebo, and the groups did not differ significantly in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%), the investigators reported. Adverse effects also were similar between the groups, they said.
The researchers recruited a heterogeneous cohort of patients with ARDS resulting from any cause so that findings would be generalizable, they wrote. Because recent research suggests that identification of specific phenotypes within ARDS may be possible, future studies “may identify a subpopulation of patients with ARDS who might have a greater response to simvastatin than was observed in our study,” they noted.
The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint partnership of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.
Key clinical point: Simvastatin did not improve clinical outcomes in adults with acute respiratory distress syndrome.
Major finding: The simvastatin and placebo groups did not significantly differ in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%).
Data source: Multicenter double-blind randomized trial of enteral simvastatin or placebo in 540 adults with ARDS.
Disclosures: The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint parternship of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.
High-dose treatment did not benefit ICU patients with vitamin D deficiency
High-dose vitamin D did not improve outcomes in critically ill, vitamin D–deficient patients, compared with placebo, researchers reported in JAMA and at the annual congress of the European Society of Intensive Care Medicine.
Although the study was adequately powered, length of stay did not differ between the vitamin D and placebo groups, said Dr. Karin Amrein of the Medical University of Graz, Austria, and her associates. “In the overall cohort, hospital and 6-month mortality rates were numerically lower in the vitamin D3 group, but these differences were not significant,” the researchers said.
A subgroup of patients with severe vitamin D deficiency did have significantly lower hospital mortality when treated with vitamin D, compared with placebo, but the effect “should be considered hypothesis generating and requires further study,” the investigators concluded (JAMA 2014 Sept. 29 [doi:10.1001/jama.2014.13204]).
The randomized, double-blind, single-center trial enrolled 492 critically ill medical and surgical patients with serum vitamin D levels of 20 ng/mL or less. Patients received placebo or vitamin D3 at a loading dose of 540,000 IU, followed by a monthly maintenance dose of 90,000 IU for 5 months, the researchers said.
Length of hospital stay averaged 20.1 days for patients who received vitamin D and 19.3 days for the placebo group, the investigators reported.
Among patients who received vitamin D3, 28.3% died in the hospital, compared with 35.3% of the placebo group (hazard ratio, 0.81; 95% confidence interval, 0.58 to 1.11), they said. Six-month mortality was 35.0% for the vitamin D3 group, compared with 42.9% for the placebo group (HR, 0.78; 95% CI, 0.58-1.04), they said.
Among 200 patients with severe vitamin D deficiencies of 12 ng/mL or less, vitamin D3 treatment was linked to a 44% drop in risk of dying in the hospital, the researchers said (28.6% vs. 46.1% for placebo; HR, 0.56; 95% CI, 0.35 to 0.90; P = .04).But length of hospital stay and 6-month mortality rates were similar between the two groups, they reported.
Drug maker Fresenius Kabi provided study medication and a grant to support the research. The European Society for Clinical Nutrition and Metabolism and the Austrian National Bank also funded the study.
Dr Amrein reported and one coauthor reported receiving lecture fees from Fresenius Kabi. The authors reported no other relevant financial conflicts of interest.
High-dose vitamin D did not improve outcomes in critically ill, vitamin D–deficient patients, compared with placebo, researchers reported in JAMA and at the annual congress of the European Society of Intensive Care Medicine.
Although the study was adequately powered, length of stay did not differ between the vitamin D and placebo groups, said Dr. Karin Amrein of the Medical University of Graz, Austria, and her associates. “In the overall cohort, hospital and 6-month mortality rates were numerically lower in the vitamin D3 group, but these differences were not significant,” the researchers said.
A subgroup of patients with severe vitamin D deficiency did have significantly lower hospital mortality when treated with vitamin D, compared with placebo, but the effect “should be considered hypothesis generating and requires further study,” the investigators concluded (JAMA 2014 Sept. 29 [doi:10.1001/jama.2014.13204]).
The randomized, double-blind, single-center trial enrolled 492 critically ill medical and surgical patients with serum vitamin D levels of 20 ng/mL or less. Patients received placebo or vitamin D3 at a loading dose of 540,000 IU, followed by a monthly maintenance dose of 90,000 IU for 5 months, the researchers said.
Length of hospital stay averaged 20.1 days for patients who received vitamin D and 19.3 days for the placebo group, the investigators reported.
Among patients who received vitamin D3, 28.3% died in the hospital, compared with 35.3% of the placebo group (hazard ratio, 0.81; 95% confidence interval, 0.58 to 1.11), they said. Six-month mortality was 35.0% for the vitamin D3 group, compared with 42.9% for the placebo group (HR, 0.78; 95% CI, 0.58-1.04), they said.
Among 200 patients with severe vitamin D deficiencies of 12 ng/mL or less, vitamin D3 treatment was linked to a 44% drop in risk of dying in the hospital, the researchers said (28.6% vs. 46.1% for placebo; HR, 0.56; 95% CI, 0.35 to 0.90; P = .04).But length of hospital stay and 6-month mortality rates were similar between the two groups, they reported.
Drug maker Fresenius Kabi provided study medication and a grant to support the research. The European Society for Clinical Nutrition and Metabolism and the Austrian National Bank also funded the study.
Dr Amrein reported and one coauthor reported receiving lecture fees from Fresenius Kabi. The authors reported no other relevant financial conflicts of interest.
High-dose vitamin D did not improve outcomes in critically ill, vitamin D–deficient patients, compared with placebo, researchers reported in JAMA and at the annual congress of the European Society of Intensive Care Medicine.
Although the study was adequately powered, length of stay did not differ between the vitamin D and placebo groups, said Dr. Karin Amrein of the Medical University of Graz, Austria, and her associates. “In the overall cohort, hospital and 6-month mortality rates were numerically lower in the vitamin D3 group, but these differences were not significant,” the researchers said.
A subgroup of patients with severe vitamin D deficiency did have significantly lower hospital mortality when treated with vitamin D, compared with placebo, but the effect “should be considered hypothesis generating and requires further study,” the investigators concluded (JAMA 2014 Sept. 29 [doi:10.1001/jama.2014.13204]).
The randomized, double-blind, single-center trial enrolled 492 critically ill medical and surgical patients with serum vitamin D levels of 20 ng/mL or less. Patients received placebo or vitamin D3 at a loading dose of 540,000 IU, followed by a monthly maintenance dose of 90,000 IU for 5 months, the researchers said.
Length of hospital stay averaged 20.1 days for patients who received vitamin D and 19.3 days for the placebo group, the investigators reported.
Among patients who received vitamin D3, 28.3% died in the hospital, compared with 35.3% of the placebo group (hazard ratio, 0.81; 95% confidence interval, 0.58 to 1.11), they said. Six-month mortality was 35.0% for the vitamin D3 group, compared with 42.9% for the placebo group (HR, 0.78; 95% CI, 0.58-1.04), they said.
Among 200 patients with severe vitamin D deficiencies of 12 ng/mL or less, vitamin D3 treatment was linked to a 44% drop in risk of dying in the hospital, the researchers said (28.6% vs. 46.1% for placebo; HR, 0.56; 95% CI, 0.35 to 0.90; P = .04).But length of hospital stay and 6-month mortality rates were similar between the two groups, they reported.
Drug maker Fresenius Kabi provided study medication and a grant to support the research. The European Society for Clinical Nutrition and Metabolism and the Austrian National Bank also funded the study.
Dr Amrein reported and one coauthor reported receiving lecture fees from Fresenius Kabi. The authors reported no other relevant financial conflicts of interest.
Key clinical point: Vitamin D3 treatment did not reduce hospital length of stay or mortality in critically ill patients with vitamin D deficiency.
Major finding: Length of hospital stay averaged 20.1 days for patients who received vitamin D and 19.3 days for the placebo group (P = 0.98).
Data source: Randomized, double-blind, placebo-controlled, single-center trial of 492 critically ill medical and surgical patients with vitamin D deficiency of 20 ng per mL or less.
Disclosures: Drug maker Fresenius Kabi provided study medication and a grant to support the research. The European Society for Clinical Nutrition and Metabolism and the Austrian National Bank also funded the study. Dr Amrein reported and one coauthor reported receiving lecture fees from Fresenius Kabi. The authors reported no other relevant financial conflicts of interest.
Fenoldopam missed renal endpoint, caused hypotension in cardiac surgery patients
In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.
Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.
The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).
Fenoldopam is a selective dopamine receptor D1 agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.
In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.
Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.
The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).
Fenoldopam is a selective dopamine receptor D1 agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.
In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.
Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.
The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).
Fenoldopam is a selective dopamine receptor D1 agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.
Key clinical point: Fenoldopam did not lessen early kidney injury after cardiac surgery and caused hypotension.
Major finding: Fenoldopam did not reduce the rate of dialysis or 30-day mortality after cardiac surgery, and 26% of treated patients developed hypotension compared with 15% of the placebo group (P = .001).
Data source: Randomized, double-blind, multicenter trial of 667 patients with early acute kidney injury after cardiac surgery.
Disclosures: The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.
Hydrocodone rescheduling takes effect Oct. 6
Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.
After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.
That rule takes effect on Oct. 6.
After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.
Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.
The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.
In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.
The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.
Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.
He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.
Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.
Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.
“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.
He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.
The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.
Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.
On Twitter @aliciaault
Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.
After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.
That rule takes effect on Oct. 6.
After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.
Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.
The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.
In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.
The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.
Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.
He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.
Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.
Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.
“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.
He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.
The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.
Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.
On Twitter @aliciaault
Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.
After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.
That rule takes effect on Oct. 6.
After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.
Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.
The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.
In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.
The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.
Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.
He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.
Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.
Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.
“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.
He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.
The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.
Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.
On Twitter @aliciaault
Members of Congress urge physician pay for end-of-life counseling
Physicians should be paid for the time they spend counseling Medicare patients on end-of-life matters, according to several dozen members of Congress.
Rep. Earl Blumenauer (D-Ore.) and 33 other House members have written to the Centers for Medicare & Medicaid Services, urging the agency to adopt new CPT codes created by the American Medical Association’s Relative Value Update Committee. The codes – 99497 and 99498 – would reimburse physicians for discussing advance care planning.
Code 99497 would be used for advance care planning, including the explanation and discussion of advance directives, such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional, and would cover the first 30 minutes, face to face with the patient, family member(s), and/or surrogate. Code 99498 would be employed for each additional 30 minutes of counseling.
The codes are included the 2015 CPT code set and can be used as of Jan. 1, if they are accepted and published in the Medicare physician fee schedule. The fee schedule is scheduled to be published by Nov. 1.
“Patients who wish to make clear their goals, values, and wishes through discussions with their trusted providers should have the opportunity to do so,” Rep. Blumenauer said in a statement. “In order to have these conversations, providers must have the adequate time, space, and reimbursement to conduct the complex and time-consuming discussions necessary to learn about the goals and values held by their patients and plan appropriately for their care.”
The Institute of Medicine also recently issued a report that called for reimbursement for physicians who talk to their patients about end-of-life issues.
On Twitter @aliciaault
Physicians should be paid for the time they spend counseling Medicare patients on end-of-life matters, according to several dozen members of Congress.
Rep. Earl Blumenauer (D-Ore.) and 33 other House members have written to the Centers for Medicare & Medicaid Services, urging the agency to adopt new CPT codes created by the American Medical Association’s Relative Value Update Committee. The codes – 99497 and 99498 – would reimburse physicians for discussing advance care planning.
Code 99497 would be used for advance care planning, including the explanation and discussion of advance directives, such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional, and would cover the first 30 minutes, face to face with the patient, family member(s), and/or surrogate. Code 99498 would be employed for each additional 30 minutes of counseling.
The codes are included the 2015 CPT code set and can be used as of Jan. 1, if they are accepted and published in the Medicare physician fee schedule. The fee schedule is scheduled to be published by Nov. 1.
“Patients who wish to make clear their goals, values, and wishes through discussions with their trusted providers should have the opportunity to do so,” Rep. Blumenauer said in a statement. “In order to have these conversations, providers must have the adequate time, space, and reimbursement to conduct the complex and time-consuming discussions necessary to learn about the goals and values held by their patients and plan appropriately for their care.”
The Institute of Medicine also recently issued a report that called for reimbursement for physicians who talk to their patients about end-of-life issues.
On Twitter @aliciaault
Physicians should be paid for the time they spend counseling Medicare patients on end-of-life matters, according to several dozen members of Congress.
Rep. Earl Blumenauer (D-Ore.) and 33 other House members have written to the Centers for Medicare & Medicaid Services, urging the agency to adopt new CPT codes created by the American Medical Association’s Relative Value Update Committee. The codes – 99497 and 99498 – would reimburse physicians for discussing advance care planning.
Code 99497 would be used for advance care planning, including the explanation and discussion of advance directives, such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional, and would cover the first 30 minutes, face to face with the patient, family member(s), and/or surrogate. Code 99498 would be employed for each additional 30 minutes of counseling.
The codes are included the 2015 CPT code set and can be used as of Jan. 1, if they are accepted and published in the Medicare physician fee schedule. The fee schedule is scheduled to be published by Nov. 1.
“Patients who wish to make clear their goals, values, and wishes through discussions with their trusted providers should have the opportunity to do so,” Rep. Blumenauer said in a statement. “In order to have these conversations, providers must have the adequate time, space, and reimbursement to conduct the complex and time-consuming discussions necessary to learn about the goals and values held by their patients and plan appropriately for their care.”
The Institute of Medicine also recently issued a report that called for reimbursement for physicians who talk to their patients about end-of-life issues.
On Twitter @aliciaault
Later transplant for renal failure in lupus nephritis may raise graft failure risk
Delaying kidney transplantation to allow for quiescence of systemic lupus erythematosus–related immune activity in patients with lupus nephritis and end-stage renal disease does not appear to improve graft outcomes, according to an analysis of national surveillance data.
Of 4,743 transplant recipients with lupus nephritis and end-stage renal disease (LN-ESRD), 1,239 experienced graft failure. Overall, wait times of 3-12 months and 12-24 months were associated with 25% and 37% increased risk of graft failure, respectively, compared with wait times of less than 3 months, after adjustment for age, race, insurance, hemoglobin, and donor type.
A similar pattern was seen in white patients, except that wait times of more than 36 months in white patients were associated with a near doubling of graft failure risk (hazard ratio, 1.98), Laura C. Plantinga of Emory University, Atlanta, and her colleagues reported (Arthritis Care Res. 2014 Sept. 23 [doi:10.1002/acr.22482]).
Among black patients, longer wait times were not associated with graft failure in the adjusted analysis, and, in fact, there was a nonstatistically significant suggestion of a protective effect for wait time of 2 years or more. This finding may reflect unexplained differences in disease pathology between white and black LN-ESRD patients, the investigators said, adding that there was no increased risk of graft failure in black patients who were transplanted early.
“Our results suggest U.S. recommendations for transplantation in LN-ESRD may not align with evidence from the target population,” they said, noting that the results should be considered hypotheses-generating because of the limitations of the study and that additional study is needed to examine the potential confounding effects of clinically recognized SLE activity on the associations observed in this study.
Some of the investigators were supported through grants from the National Institutes of Health.
Delaying kidney transplantation to allow for quiescence of systemic lupus erythematosus–related immune activity in patients with lupus nephritis and end-stage renal disease does not appear to improve graft outcomes, according to an analysis of national surveillance data.
Of 4,743 transplant recipients with lupus nephritis and end-stage renal disease (LN-ESRD), 1,239 experienced graft failure. Overall, wait times of 3-12 months and 12-24 months were associated with 25% and 37% increased risk of graft failure, respectively, compared with wait times of less than 3 months, after adjustment for age, race, insurance, hemoglobin, and donor type.
A similar pattern was seen in white patients, except that wait times of more than 36 months in white patients were associated with a near doubling of graft failure risk (hazard ratio, 1.98), Laura C. Plantinga of Emory University, Atlanta, and her colleagues reported (Arthritis Care Res. 2014 Sept. 23 [doi:10.1002/acr.22482]).
Among black patients, longer wait times were not associated with graft failure in the adjusted analysis, and, in fact, there was a nonstatistically significant suggestion of a protective effect for wait time of 2 years or more. This finding may reflect unexplained differences in disease pathology between white and black LN-ESRD patients, the investigators said, adding that there was no increased risk of graft failure in black patients who were transplanted early.
“Our results suggest U.S. recommendations for transplantation in LN-ESRD may not align with evidence from the target population,” they said, noting that the results should be considered hypotheses-generating because of the limitations of the study and that additional study is needed to examine the potential confounding effects of clinically recognized SLE activity on the associations observed in this study.
Some of the investigators were supported through grants from the National Institutes of Health.
Delaying kidney transplantation to allow for quiescence of systemic lupus erythematosus–related immune activity in patients with lupus nephritis and end-stage renal disease does not appear to improve graft outcomes, according to an analysis of national surveillance data.
Of 4,743 transplant recipients with lupus nephritis and end-stage renal disease (LN-ESRD), 1,239 experienced graft failure. Overall, wait times of 3-12 months and 12-24 months were associated with 25% and 37% increased risk of graft failure, respectively, compared with wait times of less than 3 months, after adjustment for age, race, insurance, hemoglobin, and donor type.
A similar pattern was seen in white patients, except that wait times of more than 36 months in white patients were associated with a near doubling of graft failure risk (hazard ratio, 1.98), Laura C. Plantinga of Emory University, Atlanta, and her colleagues reported (Arthritis Care Res. 2014 Sept. 23 [doi:10.1002/acr.22482]).
Among black patients, longer wait times were not associated with graft failure in the adjusted analysis, and, in fact, there was a nonstatistically significant suggestion of a protective effect for wait time of 2 years or more. This finding may reflect unexplained differences in disease pathology between white and black LN-ESRD patients, the investigators said, adding that there was no increased risk of graft failure in black patients who were transplanted early.
“Our results suggest U.S. recommendations for transplantation in LN-ESRD may not align with evidence from the target population,” they said, noting that the results should be considered hypotheses-generating because of the limitations of the study and that additional study is needed to examine the potential confounding effects of clinically recognized SLE activity on the associations observed in this study.
Some of the investigators were supported through grants from the National Institutes of Health.
Key clinical point: Delaying transplantation in LN-ESRD patients may do more harm than good, although future studies should determine if longer wait times remain associated with increased risk of graft failure, independent of clinically recognized SLE activity.
Major finding: Overall risk of graft failure was increased by 25% and 37% with wait times of 3-12 months and 12-24 months, respectively (vs. less than 3 months).
Data source: National ESRD surveillance data (U.S. Renal Data System) for 4,743 LN-ESRD transplant recipients.
Disclosures: Some of the investigators were supported through grants from the National Institutes of Health.
HHS: ACA drops uncompensated hospital care by $5.7B
Hospitals are projected to save $5.7 billion in 2014 because of a drop in uncompensated care, in large part due to the expansion of Medicaid, according to an analysis by the Department of Health & Human Services.
Hospitals are also benefiting from the growth in private coverage obtained through the Affordable Care Act marketplaces. Overall, hospitals are expected to see a 16% drop in uncompensated care, compared with original projections for the year.
Medicaid, however, is the biggest driver in the savings for hospitals. In states that have expanded eligibility for Medicaid, hospitals could save as much as $4.2 billion, nearly three-quarters of the national savings projected. To date, 27 states plus the District of Columbia have expanded Medicaid, according to HHS.
The American Hospital Association seized on the HHS report as a chance to call on more states to expand their Medicaid eligibility under the ACA.
“The ACA is accomplishing its objective in some, but not all states,” said Marie Watteau, an AHA spokeswoman. “Today’s report offers a limited estimate of the level of uncompensated care. As the report states, it’s too early to know what the impact will be on a national level. Our members are counting on uncompensated care reductions and we continue to support the expansion of coverage.”
The decline in uncompensated care was anticipated with the increased insurance coverage under the ACA. As a result, the health law cuts hospital payments that have traditionally been used to offset uncompensated care costs. For instance, federal Medicaid Disproportionate Share Hospital (DSH) payments are scheduled to be cut $1.2 billion in fiscal year 2016 and a total of $17.6 billion by fiscal year 2020.
The HHS estimates are based in part on hospital cost reports from 2011 and 2012. The HHS defined uncompensated care as the combination of charity care to uninsured patients and costs from non-Medicare bad debt.
On Twitter @maryellenny
Hospitals are projected to save $5.7 billion in 2014 because of a drop in uncompensated care, in large part due to the expansion of Medicaid, according to an analysis by the Department of Health & Human Services.
Hospitals are also benefiting from the growth in private coverage obtained through the Affordable Care Act marketplaces. Overall, hospitals are expected to see a 16% drop in uncompensated care, compared with original projections for the year.
Medicaid, however, is the biggest driver in the savings for hospitals. In states that have expanded eligibility for Medicaid, hospitals could save as much as $4.2 billion, nearly three-quarters of the national savings projected. To date, 27 states plus the District of Columbia have expanded Medicaid, according to HHS.
The American Hospital Association seized on the HHS report as a chance to call on more states to expand their Medicaid eligibility under the ACA.
“The ACA is accomplishing its objective in some, but not all states,” said Marie Watteau, an AHA spokeswoman. “Today’s report offers a limited estimate of the level of uncompensated care. As the report states, it’s too early to know what the impact will be on a national level. Our members are counting on uncompensated care reductions and we continue to support the expansion of coverage.”
The decline in uncompensated care was anticipated with the increased insurance coverage under the ACA. As a result, the health law cuts hospital payments that have traditionally been used to offset uncompensated care costs. For instance, federal Medicaid Disproportionate Share Hospital (DSH) payments are scheduled to be cut $1.2 billion in fiscal year 2016 and a total of $17.6 billion by fiscal year 2020.
The HHS estimates are based in part on hospital cost reports from 2011 and 2012. The HHS defined uncompensated care as the combination of charity care to uninsured patients and costs from non-Medicare bad debt.
On Twitter @maryellenny
Hospitals are projected to save $5.7 billion in 2014 because of a drop in uncompensated care, in large part due to the expansion of Medicaid, according to an analysis by the Department of Health & Human Services.
Hospitals are also benefiting from the growth in private coverage obtained through the Affordable Care Act marketplaces. Overall, hospitals are expected to see a 16% drop in uncompensated care, compared with original projections for the year.
Medicaid, however, is the biggest driver in the savings for hospitals. In states that have expanded eligibility for Medicaid, hospitals could save as much as $4.2 billion, nearly three-quarters of the national savings projected. To date, 27 states plus the District of Columbia have expanded Medicaid, according to HHS.
The American Hospital Association seized on the HHS report as a chance to call on more states to expand their Medicaid eligibility under the ACA.
“The ACA is accomplishing its objective in some, but not all states,” said Marie Watteau, an AHA spokeswoman. “Today’s report offers a limited estimate of the level of uncompensated care. As the report states, it’s too early to know what the impact will be on a national level. Our members are counting on uncompensated care reductions and we continue to support the expansion of coverage.”
The decline in uncompensated care was anticipated with the increased insurance coverage under the ACA. As a result, the health law cuts hospital payments that have traditionally been used to offset uncompensated care costs. For instance, federal Medicaid Disproportionate Share Hospital (DSH) payments are scheduled to be cut $1.2 billion in fiscal year 2016 and a total of $17.6 billion by fiscal year 2020.
The HHS estimates are based in part on hospital cost reports from 2011 and 2012. The HHS defined uncompensated care as the combination of charity care to uninsured patients and costs from non-Medicare bad debt.
On Twitter @maryellenny
FDA clears use of glucose testing system for critically ill
For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.
The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.
The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.
The system is manufactured by Nova Biomedical.
For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.
The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.
The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.
The system is manufactured by Nova Biomedical.
For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.
The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.
The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.
The system is manufactured by Nova Biomedical.
Watchdog finds security lacking at healthcare.gov, two state marketplaces
Health insurance marketplace websites and databases – including healthcare.gov – need stronger security controls to protect personally identifiable information (PII), according to an audit by the Office of Inspector General (OIG) at the Department of Health & Human Services.
The OIG reviewed information technology (IT) controls within healthcare.gov as well as the state marketplaces in New Mexico and Kentucky. They conducted vulnerability scans and simulated cyberattacks from February to June 2014. While the OIG noted that database administrators had taken steps to ensure PII data protection, auditors identified security vulnerabilities within all three systems.
In a September report summarizing their findings, auditors said healthcare.gov administrators at the Centers for Medicare & Medicaid Services had failed to:
• Implement a process to use automated tools to test database security configuration settings.
• Implement an effective enterprise scanning tool to test for website vulnerabilities.
• Maintain adequate documentation on encryption.
• Detect and defend against website vulnerability scanning and simulated cyberattacks directed at healthcare.gov.
The auditors also found room for improvement in the Kentucky and New Mexico systems. Administrators at the Kentucky Health Benefit Exchange (KHBE) sufficiently protected PII on its websites and databases in accordance with federal requirements, the OIG report found. However, KHBE administrators had not sufficiently restricted user and group access to authorized roles and functions and had not fully addressed federal requirements for its system security planning, risk assessment, and flaw remediation, among others items.
Meanwhile, the OIG found IT policies that control the New Mexico Health Insurance Exchange (NMHIX) website and databases did not always conform to federal requirements and recommendations to secure sensitive information.
The OIG’s public report did not include details of the systems’ vulnerabilities because of the information’s sensitivity; however, detailed information and recommendations was provided to the CMS and the states. The CMS and New Mexico agreed with all of the OIG’s recommendations and described actions they have taken and plan to take to remedy the problems, according to the OIG report. Kentucky leaders concurred with most recommendations and detailed how they would improve their systems.
On Twitter @legal_med
Health insurance marketplace websites and databases – including healthcare.gov – need stronger security controls to protect personally identifiable information (PII), according to an audit by the Office of Inspector General (OIG) at the Department of Health & Human Services.
The OIG reviewed information technology (IT) controls within healthcare.gov as well as the state marketplaces in New Mexico and Kentucky. They conducted vulnerability scans and simulated cyberattacks from February to June 2014. While the OIG noted that database administrators had taken steps to ensure PII data protection, auditors identified security vulnerabilities within all three systems.
In a September report summarizing their findings, auditors said healthcare.gov administrators at the Centers for Medicare & Medicaid Services had failed to:
• Implement a process to use automated tools to test database security configuration settings.
• Implement an effective enterprise scanning tool to test for website vulnerabilities.
• Maintain adequate documentation on encryption.
• Detect and defend against website vulnerability scanning and simulated cyberattacks directed at healthcare.gov.
The auditors also found room for improvement in the Kentucky and New Mexico systems. Administrators at the Kentucky Health Benefit Exchange (KHBE) sufficiently protected PII on its websites and databases in accordance with federal requirements, the OIG report found. However, KHBE administrators had not sufficiently restricted user and group access to authorized roles and functions and had not fully addressed federal requirements for its system security planning, risk assessment, and flaw remediation, among others items.
Meanwhile, the OIG found IT policies that control the New Mexico Health Insurance Exchange (NMHIX) website and databases did not always conform to federal requirements and recommendations to secure sensitive information.
The OIG’s public report did not include details of the systems’ vulnerabilities because of the information’s sensitivity; however, detailed information and recommendations was provided to the CMS and the states. The CMS and New Mexico agreed with all of the OIG’s recommendations and described actions they have taken and plan to take to remedy the problems, according to the OIG report. Kentucky leaders concurred with most recommendations and detailed how they would improve their systems.
On Twitter @legal_med
Health insurance marketplace websites and databases – including healthcare.gov – need stronger security controls to protect personally identifiable information (PII), according to an audit by the Office of Inspector General (OIG) at the Department of Health & Human Services.
The OIG reviewed information technology (IT) controls within healthcare.gov as well as the state marketplaces in New Mexico and Kentucky. They conducted vulnerability scans and simulated cyberattacks from February to June 2014. While the OIG noted that database administrators had taken steps to ensure PII data protection, auditors identified security vulnerabilities within all three systems.
In a September report summarizing their findings, auditors said healthcare.gov administrators at the Centers for Medicare & Medicaid Services had failed to:
• Implement a process to use automated tools to test database security configuration settings.
• Implement an effective enterprise scanning tool to test for website vulnerabilities.
• Maintain adequate documentation on encryption.
• Detect and defend against website vulnerability scanning and simulated cyberattacks directed at healthcare.gov.
The auditors also found room for improvement in the Kentucky and New Mexico systems. Administrators at the Kentucky Health Benefit Exchange (KHBE) sufficiently protected PII on its websites and databases in accordance with federal requirements, the OIG report found. However, KHBE administrators had not sufficiently restricted user and group access to authorized roles and functions and had not fully addressed federal requirements for its system security planning, risk assessment, and flaw remediation, among others items.
Meanwhile, the OIG found IT policies that control the New Mexico Health Insurance Exchange (NMHIX) website and databases did not always conform to federal requirements and recommendations to secure sensitive information.
The OIG’s public report did not include details of the systems’ vulnerabilities because of the information’s sensitivity; however, detailed information and recommendations was provided to the CMS and the states. The CMS and New Mexico agreed with all of the OIG’s recommendations and described actions they have taken and plan to take to remedy the problems, according to the OIG report. Kentucky leaders concurred with most recommendations and detailed how they would improve their systems.
On Twitter @legal_med
