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Waiving Medicare coinsurance for positive colorectal screening likely beneficial
Currently, Medicare covers colorectal screening at no charge to the patient, but if a polyp is removed upon discovery during the procedure, the patient would then be subject to Medicare’s coinsurance payments for both the colonoscopy and the removal.
Researchers used the Microsimulation Screening Analysis–Colon model to estimate the cost-effectiveness of waiving coinsurance for every component of colorectal cancer screening. They estimated that, currently, using the colonoscopy regimen with coinsurance, 12.8 colorectal cancer deaths occurred per 1,000 people aged 65 years and 124.1 QALYs were gained per 1,000 people aged 65 years. The total number of procedures per 1,000 Medicare beneficiaries was 1,132, of which 410 (36%) were potentially subject to coinsurance requirements.
“We estimated that the total lifetime costs for [the Centers for Medicare & Medicaid], which included colorectal cancer screening, surveillance, and treatment with coinsurance, to be $2.675 million per 1,000 65-year-olds,” Ms. Peterse and her colleagues wrote.
Researchers noted that if the coinsurance was waived but there was no follow-on increase in the screening rate, the benefits of screening would not change but the total cost of screening and treatment would increase to $2.726 million per 1,000 people aged 65 years.
However, “an assumed 5-percentage-point increase in the rates of first colonoscopy screening and surveillance decreased the number of colorectal cancer deaths by 0.9 (6.4%), accompanied by an increase of $33,000 (1.2%) in total costs, with a cost per QALY gained (or cost-effectiveness ratio) of $4,086.”
They added that estimated screening benefits were similar when fecal testing was the primary screening method.
“In general, [fecal testing] screening was associated with lower number of procedures subject to coinsurance,” the researchers added. “If [fecal testing] screening becomes more popular in the United States, following trends observed in several settings, the costs of waiving coinsurance would be even lower.” The researchers also suggest that it could lead to reducing disparities of colorectal cancer in the United States as well.
gtwachtman@frontlinemedcom.com
SOURCE: Peterse EFP et al. Health Affairs. 2017 Dec;36(12):2151-9.
Currently, Medicare covers colorectal screening at no charge to the patient, but if a polyp is removed upon discovery during the procedure, the patient would then be subject to Medicare’s coinsurance payments for both the colonoscopy and the removal.
Researchers used the Microsimulation Screening Analysis–Colon model to estimate the cost-effectiveness of waiving coinsurance for every component of colorectal cancer screening. They estimated that, currently, using the colonoscopy regimen with coinsurance, 12.8 colorectal cancer deaths occurred per 1,000 people aged 65 years and 124.1 QALYs were gained per 1,000 people aged 65 years. The total number of procedures per 1,000 Medicare beneficiaries was 1,132, of which 410 (36%) were potentially subject to coinsurance requirements.
“We estimated that the total lifetime costs for [the Centers for Medicare & Medicaid], which included colorectal cancer screening, surveillance, and treatment with coinsurance, to be $2.675 million per 1,000 65-year-olds,” Ms. Peterse and her colleagues wrote.
Researchers noted that if the coinsurance was waived but there was no follow-on increase in the screening rate, the benefits of screening would not change but the total cost of screening and treatment would increase to $2.726 million per 1,000 people aged 65 years.
However, “an assumed 5-percentage-point increase in the rates of first colonoscopy screening and surveillance decreased the number of colorectal cancer deaths by 0.9 (6.4%), accompanied by an increase of $33,000 (1.2%) in total costs, with a cost per QALY gained (or cost-effectiveness ratio) of $4,086.”
They added that estimated screening benefits were similar when fecal testing was the primary screening method.
“In general, [fecal testing] screening was associated with lower number of procedures subject to coinsurance,” the researchers added. “If [fecal testing] screening becomes more popular in the United States, following trends observed in several settings, the costs of waiving coinsurance would be even lower.” The researchers also suggest that it could lead to reducing disparities of colorectal cancer in the United States as well.
gtwachtman@frontlinemedcom.com
SOURCE: Peterse EFP et al. Health Affairs. 2017 Dec;36(12):2151-9.
Currently, Medicare covers colorectal screening at no charge to the patient, but if a polyp is removed upon discovery during the procedure, the patient would then be subject to Medicare’s coinsurance payments for both the colonoscopy and the removal.
Researchers used the Microsimulation Screening Analysis–Colon model to estimate the cost-effectiveness of waiving coinsurance for every component of colorectal cancer screening. They estimated that, currently, using the colonoscopy regimen with coinsurance, 12.8 colorectal cancer deaths occurred per 1,000 people aged 65 years and 124.1 QALYs were gained per 1,000 people aged 65 years. The total number of procedures per 1,000 Medicare beneficiaries was 1,132, of which 410 (36%) were potentially subject to coinsurance requirements.
“We estimated that the total lifetime costs for [the Centers for Medicare & Medicaid], which included colorectal cancer screening, surveillance, and treatment with coinsurance, to be $2.675 million per 1,000 65-year-olds,” Ms. Peterse and her colleagues wrote.
Researchers noted that if the coinsurance was waived but there was no follow-on increase in the screening rate, the benefits of screening would not change but the total cost of screening and treatment would increase to $2.726 million per 1,000 people aged 65 years.
However, “an assumed 5-percentage-point increase in the rates of first colonoscopy screening and surveillance decreased the number of colorectal cancer deaths by 0.9 (6.4%), accompanied by an increase of $33,000 (1.2%) in total costs, with a cost per QALY gained (or cost-effectiveness ratio) of $4,086.”
They added that estimated screening benefits were similar when fecal testing was the primary screening method.
“In general, [fecal testing] screening was associated with lower number of procedures subject to coinsurance,” the researchers added. “If [fecal testing] screening becomes more popular in the United States, following trends observed in several settings, the costs of waiving coinsurance would be even lower.” The researchers also suggest that it could lead to reducing disparities of colorectal cancer in the United States as well.
gtwachtman@frontlinemedcom.com
SOURCE: Peterse EFP et al. Health Affairs. 2017 Dec;36(12):2151-9.
FROM HEALTH AFFAIRS
CMS launches advanced APM focused on bundled payments
The Centers for Medicare & Medicaid Services is launching a new voluntary bundled payment demonstration project that for the first time will qualify as an advanced alternative payment model under the Quality Payment Program.
The Bundled Payments for Care Improvement Advanced (BPCI Advanced) “builds on the earlier success of bundled payment models and is an important step in the move away from fee-for-service and towards paying for value,” CMS Administrator Seema Verma said in a statement. “Under this model, providers will have an incentive to deliver high-quality care.”
Both categories of participants may enter into agreements with individual physicians and nonphysician providers to furnish care under the bundled payment model.
It will cover 29 in-patient episodes and three outpatient clinical episodes. Payment will be tied to performance on quality measures.
The 29 in-patient clinical episodes cover a range of conditions, including liver disorders (excluding malignancy, cirrhosis, and alcoholic hepatitis); various cardiac conditions; chronic obstructive pulmonary disease, bronchitis, and asthma; spinal fusion; joint replacements; femur, hip, or pelvis fractures; gastrointestinal hemorrhage or obstruction; renal failure; sepsis; simple pneumonia and respiratory infections; stroke; and urinary tract infections.
The three outpatient clinical episodes include percutaneous coronary intervention, cardiac defibrillator implantation, and back and neck surgery except spinal fusion.
Seven quality measures will be tracked as part of the payment. For all clinical episodes, measurement of all-cause hospital readmissions and advance care plan will be required.
The other five will be applied to the payment when appropriate, as follows:
- Perioperative care: selection of prophylactic antibiotic: first- or second-generation cephalosporin.
- Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty.
- Hospital 30-day, all-cause, risk-standardized mortality rate following coronary artery bypass graft surgery.
- Excess days in acute care after hospitalization for acute myocardial infarction; and AHRQ patient safety indicators.
CMS has scheduled an open-door forum for those interested in participating in BPCI Advanced on Jan. 30.
Applications for participation will be accepted through March 12.
The Centers for Medicare & Medicaid Services is launching a new voluntary bundled payment demonstration project that for the first time will qualify as an advanced alternative payment model under the Quality Payment Program.
The Bundled Payments for Care Improvement Advanced (BPCI Advanced) “builds on the earlier success of bundled payment models and is an important step in the move away from fee-for-service and towards paying for value,” CMS Administrator Seema Verma said in a statement. “Under this model, providers will have an incentive to deliver high-quality care.”
Both categories of participants may enter into agreements with individual physicians and nonphysician providers to furnish care under the bundled payment model.
It will cover 29 in-patient episodes and three outpatient clinical episodes. Payment will be tied to performance on quality measures.
The 29 in-patient clinical episodes cover a range of conditions, including liver disorders (excluding malignancy, cirrhosis, and alcoholic hepatitis); various cardiac conditions; chronic obstructive pulmonary disease, bronchitis, and asthma; spinal fusion; joint replacements; femur, hip, or pelvis fractures; gastrointestinal hemorrhage or obstruction; renal failure; sepsis; simple pneumonia and respiratory infections; stroke; and urinary tract infections.
The three outpatient clinical episodes include percutaneous coronary intervention, cardiac defibrillator implantation, and back and neck surgery except spinal fusion.
Seven quality measures will be tracked as part of the payment. For all clinical episodes, measurement of all-cause hospital readmissions and advance care plan will be required.
The other five will be applied to the payment when appropriate, as follows:
- Perioperative care: selection of prophylactic antibiotic: first- or second-generation cephalosporin.
- Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty.
- Hospital 30-day, all-cause, risk-standardized mortality rate following coronary artery bypass graft surgery.
- Excess days in acute care after hospitalization for acute myocardial infarction; and AHRQ patient safety indicators.
CMS has scheduled an open-door forum for those interested in participating in BPCI Advanced on Jan. 30.
Applications for participation will be accepted through March 12.
The Centers for Medicare & Medicaid Services is launching a new voluntary bundled payment demonstration project that for the first time will qualify as an advanced alternative payment model under the Quality Payment Program.
The Bundled Payments for Care Improvement Advanced (BPCI Advanced) “builds on the earlier success of bundled payment models and is an important step in the move away from fee-for-service and towards paying for value,” CMS Administrator Seema Verma said in a statement. “Under this model, providers will have an incentive to deliver high-quality care.”
Both categories of participants may enter into agreements with individual physicians and nonphysician providers to furnish care under the bundled payment model.
It will cover 29 in-patient episodes and three outpatient clinical episodes. Payment will be tied to performance on quality measures.
The 29 in-patient clinical episodes cover a range of conditions, including liver disorders (excluding malignancy, cirrhosis, and alcoholic hepatitis); various cardiac conditions; chronic obstructive pulmonary disease, bronchitis, and asthma; spinal fusion; joint replacements; femur, hip, or pelvis fractures; gastrointestinal hemorrhage or obstruction; renal failure; sepsis; simple pneumonia and respiratory infections; stroke; and urinary tract infections.
The three outpatient clinical episodes include percutaneous coronary intervention, cardiac defibrillator implantation, and back and neck surgery except spinal fusion.
Seven quality measures will be tracked as part of the payment. For all clinical episodes, measurement of all-cause hospital readmissions and advance care plan will be required.
The other five will be applied to the payment when appropriate, as follows:
- Perioperative care: selection of prophylactic antibiotic: first- or second-generation cephalosporin.
- Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty.
- Hospital 30-day, all-cause, risk-standardized mortality rate following coronary artery bypass graft surgery.
- Excess days in acute care after hospitalization for acute myocardial infarction; and AHRQ patient safety indicators.
CMS has scheduled an open-door forum for those interested in participating in BPCI Advanced on Jan. 30.
Applications for participation will be accepted through March 12.
HHS nominee Azar open to price negotiations for Part B drugs
Negotiating Medicare Part B drug prices could be on the agenda if Alex Azar, President Trump’s nominee to run the Health and Human Services department, gets confirmed.
before the Senate Finance Committee on Jan. 9. “In Part D, we do significant negotiation through pharmacy benefit managers that get the best rates of any commercial payers. We don’t do that in Part B. ... We basically pay sales price plus 6% or some other number. ... In Part B, we should be looking at those approaches” to price negotiations.
Mr. Azar added that in specific cases, such as when the government buys naloxone for use by first responders, “there is absolutely nothing wrong with the government negotiating that.”
The tone at Mr. Azar’s confirmation hearing generally was more conversational and less adversarial than that of his predecessor, Tom Price, MD, although contentious exchanges did occur, particularly around drug pricing.
“Across the board, drug prices are too high,” said Mr. Azar, who previously was president of Eli Lilly’s U.S. operations. “This is what is so bizarre about the way this system is organized that those price increases happen and ... during that same period, the net realized price by the company stayed flat. So just to cover for increased rebates, the patient who walks into the pharmacy whose insurance may not be paying for that is absorbing that cost and that is what I want to work with you to try and solve.”
Echoing comments made at a courtesy hearing before the Senate Health, Education, Labor and Pensions Committee on Nov. 29, Mr. Azar suggested the need for patent reform to push generic competition as a price-lowering tool.
The cordial tone to the hearing does not guarantee bipartisan support for Mr. Azar’s confirmation.
Sen. Maria Cantwell (D-Wash.) made it explicitly clear that her vote would be based on Mr. Azar’s thoughts about Medicaid expansion and on Mr. Azar’s suggested use of block grants “in the interest of sustainability.”
Regarding Medicaid, Mr. Azar sidestepped questions related to requiring “able-bodied” recipients to work.
“I don’t have a definition [of able-bodied] in hand,” Mr. Azar responded to Sen. Sherrod Brown (D-Ohio). “It would be something we’d work on with Congress.”
“You have no definition of ‘able-bodied adult’ that would be appropriate for differentiating between and among Medicaid recipients that you can share with us?” Sen. Brown replied, to which Mr. Azar had no specific answer.
Mr. Azar testified that said he was “a big supporter of telehealth and alternative means of providing care, especially in rural communities. I think sometimes we can be penny-wise [and] pound-foolish in these areas.”
Mr. Azar also voiced support to wellness incentive programs.
In the area of insurance access and premiums, Mr. Azar said that, as secretary, “I [would] have a very important obligation to make whatever program that I am entrusted with work as well as possible. What we have now is not working for people. It is not working for the 10 million who are in that individual market right now. For many of those people, it can be a false insurance card. It can be insurance, but a very high deductible or not having access to providers, so it’s unaffordable use of care. I want to solve the program for them,” as well as for the 28 million who are not in the individual market, to make it more affordable for all.
Regarding the contentious Center for Medicare and Medicaid Innovation, Mr. Azar voiced support of its use of mandatory participation demonstration projects and said that, depending on the circumstance, sometimes the use of mandatory participation is necessary to test out ideas, and if it is, he said, “so be it.”
Mr. Azar said he was interested in learning more about ensuring access to long-acting reversible contraception. He declined to answer questions on this because of his lack of knowledge but said he wanted more information.
A committee vote on Mr. Azar’s nomination had not been scheduled at press time. Should the committee support him, the full Senate would then consider his nomination.
Negotiating Medicare Part B drug prices could be on the agenda if Alex Azar, President Trump’s nominee to run the Health and Human Services department, gets confirmed.
before the Senate Finance Committee on Jan. 9. “In Part D, we do significant negotiation through pharmacy benefit managers that get the best rates of any commercial payers. We don’t do that in Part B. ... We basically pay sales price plus 6% or some other number. ... In Part B, we should be looking at those approaches” to price negotiations.
Mr. Azar added that in specific cases, such as when the government buys naloxone for use by first responders, “there is absolutely nothing wrong with the government negotiating that.”
The tone at Mr. Azar’s confirmation hearing generally was more conversational and less adversarial than that of his predecessor, Tom Price, MD, although contentious exchanges did occur, particularly around drug pricing.
“Across the board, drug prices are too high,” said Mr. Azar, who previously was president of Eli Lilly’s U.S. operations. “This is what is so bizarre about the way this system is organized that those price increases happen and ... during that same period, the net realized price by the company stayed flat. So just to cover for increased rebates, the patient who walks into the pharmacy whose insurance may not be paying for that is absorbing that cost and that is what I want to work with you to try and solve.”
Echoing comments made at a courtesy hearing before the Senate Health, Education, Labor and Pensions Committee on Nov. 29, Mr. Azar suggested the need for patent reform to push generic competition as a price-lowering tool.
The cordial tone to the hearing does not guarantee bipartisan support for Mr. Azar’s confirmation.
Sen. Maria Cantwell (D-Wash.) made it explicitly clear that her vote would be based on Mr. Azar’s thoughts about Medicaid expansion and on Mr. Azar’s suggested use of block grants “in the interest of sustainability.”
Regarding Medicaid, Mr. Azar sidestepped questions related to requiring “able-bodied” recipients to work.
“I don’t have a definition [of able-bodied] in hand,” Mr. Azar responded to Sen. Sherrod Brown (D-Ohio). “It would be something we’d work on with Congress.”
“You have no definition of ‘able-bodied adult’ that would be appropriate for differentiating between and among Medicaid recipients that you can share with us?” Sen. Brown replied, to which Mr. Azar had no specific answer.
Mr. Azar testified that said he was “a big supporter of telehealth and alternative means of providing care, especially in rural communities. I think sometimes we can be penny-wise [and] pound-foolish in these areas.”
Mr. Azar also voiced support to wellness incentive programs.
In the area of insurance access and premiums, Mr. Azar said that, as secretary, “I [would] have a very important obligation to make whatever program that I am entrusted with work as well as possible. What we have now is not working for people. It is not working for the 10 million who are in that individual market right now. For many of those people, it can be a false insurance card. It can be insurance, but a very high deductible or not having access to providers, so it’s unaffordable use of care. I want to solve the program for them,” as well as for the 28 million who are not in the individual market, to make it more affordable for all.
Regarding the contentious Center for Medicare and Medicaid Innovation, Mr. Azar voiced support of its use of mandatory participation demonstration projects and said that, depending on the circumstance, sometimes the use of mandatory participation is necessary to test out ideas, and if it is, he said, “so be it.”
Mr. Azar said he was interested in learning more about ensuring access to long-acting reversible contraception. He declined to answer questions on this because of his lack of knowledge but said he wanted more information.
A committee vote on Mr. Azar’s nomination had not been scheduled at press time. Should the committee support him, the full Senate would then consider his nomination.
Negotiating Medicare Part B drug prices could be on the agenda if Alex Azar, President Trump’s nominee to run the Health and Human Services department, gets confirmed.
before the Senate Finance Committee on Jan. 9. “In Part D, we do significant negotiation through pharmacy benefit managers that get the best rates of any commercial payers. We don’t do that in Part B. ... We basically pay sales price plus 6% or some other number. ... In Part B, we should be looking at those approaches” to price negotiations.
Mr. Azar added that in specific cases, such as when the government buys naloxone for use by first responders, “there is absolutely nothing wrong with the government negotiating that.”
The tone at Mr. Azar’s confirmation hearing generally was more conversational and less adversarial than that of his predecessor, Tom Price, MD, although contentious exchanges did occur, particularly around drug pricing.
“Across the board, drug prices are too high,” said Mr. Azar, who previously was president of Eli Lilly’s U.S. operations. “This is what is so bizarre about the way this system is organized that those price increases happen and ... during that same period, the net realized price by the company stayed flat. So just to cover for increased rebates, the patient who walks into the pharmacy whose insurance may not be paying for that is absorbing that cost and that is what I want to work with you to try and solve.”
Echoing comments made at a courtesy hearing before the Senate Health, Education, Labor and Pensions Committee on Nov. 29, Mr. Azar suggested the need for patent reform to push generic competition as a price-lowering tool.
The cordial tone to the hearing does not guarantee bipartisan support for Mr. Azar’s confirmation.
Sen. Maria Cantwell (D-Wash.) made it explicitly clear that her vote would be based on Mr. Azar’s thoughts about Medicaid expansion and on Mr. Azar’s suggested use of block grants “in the interest of sustainability.”
Regarding Medicaid, Mr. Azar sidestepped questions related to requiring “able-bodied” recipients to work.
“I don’t have a definition [of able-bodied] in hand,” Mr. Azar responded to Sen. Sherrod Brown (D-Ohio). “It would be something we’d work on with Congress.”
“You have no definition of ‘able-bodied adult’ that would be appropriate for differentiating between and among Medicaid recipients that you can share with us?” Sen. Brown replied, to which Mr. Azar had no specific answer.
Mr. Azar testified that said he was “a big supporter of telehealth and alternative means of providing care, especially in rural communities. I think sometimes we can be penny-wise [and] pound-foolish in these areas.”
Mr. Azar also voiced support to wellness incentive programs.
In the area of insurance access and premiums, Mr. Azar said that, as secretary, “I [would] have a very important obligation to make whatever program that I am entrusted with work as well as possible. What we have now is not working for people. It is not working for the 10 million who are in that individual market right now. For many of those people, it can be a false insurance card. It can be insurance, but a very high deductible or not having access to providers, so it’s unaffordable use of care. I want to solve the program for them,” as well as for the 28 million who are not in the individual market, to make it more affordable for all.
Regarding the contentious Center for Medicare and Medicaid Innovation, Mr. Azar voiced support of its use of mandatory participation demonstration projects and said that, depending on the circumstance, sometimes the use of mandatory participation is necessary to test out ideas, and if it is, he said, “so be it.”
Mr. Azar said he was interested in learning more about ensuring access to long-acting reversible contraception. He declined to answer questions on this because of his lack of knowledge but said he wanted more information.
A committee vote on Mr. Azar’s nomination had not been scheduled at press time. Should the committee support him, the full Senate would then consider his nomination.
REPORTING FROM A SENATE FINANCE COMMITTEE HEARING
Government insurance linked with lower likelihood of radiation therapy for limited-stage small cell lung cancer
Researchers looked at utilization rates and factors associated with chemotherapy and radiation therapy delivery for limited-stage small cell lung cancer cases from 2004 through 2013 in the National Cancer Database.
Researchers suggest that programs such as 340B and the Medicaid Drug Discount Program allow for improved access to chemotherapy.
“However, these programs provide no financial assistance for radiation therapy delivered to this high-risk population, which may partially explain why patients with government insurance were significantly less likely to receive radiation therapy,” Dr. Pezzi and his colleagues noted.
“Our findings suggest the need for targeted access improvement to radiation therapy for this population,” they added.
gtwachtman@frontlinemedcom.com
SOURCE: Todd Pezzi, MD, et al. JAMA Oncol. doi: 10.1001/jamaoncol.2017.4504.
Researchers looked at utilization rates and factors associated with chemotherapy and radiation therapy delivery for limited-stage small cell lung cancer cases from 2004 through 2013 in the National Cancer Database.
Researchers suggest that programs such as 340B and the Medicaid Drug Discount Program allow for improved access to chemotherapy.
“However, these programs provide no financial assistance for radiation therapy delivered to this high-risk population, which may partially explain why patients with government insurance were significantly less likely to receive radiation therapy,” Dr. Pezzi and his colleagues noted.
“Our findings suggest the need for targeted access improvement to radiation therapy for this population,” they added.
gtwachtman@frontlinemedcom.com
SOURCE: Todd Pezzi, MD, et al. JAMA Oncol. doi: 10.1001/jamaoncol.2017.4504.
Researchers looked at utilization rates and factors associated with chemotherapy and radiation therapy delivery for limited-stage small cell lung cancer cases from 2004 through 2013 in the National Cancer Database.
Researchers suggest that programs such as 340B and the Medicaid Drug Discount Program allow for improved access to chemotherapy.
“However, these programs provide no financial assistance for radiation therapy delivered to this high-risk population, which may partially explain why patients with government insurance were significantly less likely to receive radiation therapy,” Dr. Pezzi and his colleagues noted.
“Our findings suggest the need for targeted access improvement to radiation therapy for this population,” they added.
gtwachtman@frontlinemedcom.com
SOURCE: Todd Pezzi, MD, et al. JAMA Oncol. doi: 10.1001/jamaoncol.2017.4504.
FROM JAMA ONCOLOGY
Analysis: Hospital pay for performance not significantly improving Medicare outcomes
for Medicare beneficiaries, according to an analysis of Medicare claims data.
“No evidence that hospitals [that were] operating under pay for performance programs for more than a decade had better process scores or lower mortality than other hospitals was found,” Igna Bonfrer, PhD, of Erasmus University, Rotterdam, the Netherlands, and colleagues wrote in a study published Jan. 4, 2018, in BMJ.
Researchers looked at Medicare claims data from nearly 1.4 million patients aged 65 years and older across 1,189 hospitals. That total included 214 hospitals that were early adopters of pay for performance (PFP) programs, including the Hospital Quality Incentive Demonstration (HQID) and the current Hospital Value-Based Purchasing (HVBP) program, and 975 hospitals that adopted the programs at a later date. The study authors examined clinical process scores and 30-day mortality rates from 2003 to 2013.
Hospitals that were early adopters of a PFP program typically started from a higher baseline process measure score (91.5), compared with late adopters (89.9).
However, improvements among the early adopters “were smaller during the HQID period, although early adopters continued to perform at a slightly higher level than the late adopters during the pre-HVBP period,” the researchers explained. “Over the HVBP period, early and late adopters no longer differed in their clinical process scores.”
Indeed, a ceiling was ultimately reached, with early and late adopters approaching the same level (98.5 vs. 98.2).
For the 30-day mortality rates, both groups “started from a similar baseline (14.9% and 14.8% for the early and late adopters in the fourth quarter of 2003) and ended at the same rate of 9.9% for both groups in the fourth quarter of 2013,” Dr. Bonfrer and colleagues wrote.
The researchers suggested that the programs did not yield better results because of small financial incentives, coupled with program complexities that made it “difficult for hospitals to meaningfully engage in the program.” They also suggested that having to wait until year end to receive any financial incentives could have limited the impact.
“We found that hospitals that have been under financial incentives for more than a decade have not been able to reduce patient mortality more than late adopters, which had only been under financial incentives for less than 3 years,” the researchers concluded. “Given its cost, policymakers in the [United States] should consider one of two things: revise the current program or potentially end it.”
The changes suggested include increasing financial incentives and focusing on process measures that matter most to patients (mortality, patient experience, and functional status), rather than the current measure set that is larger and more difficult to track.
The researchers did not report any financial conflicts of interest.
gtwachtman@frontlinemedcom.com
SOURCE: Dr. Igna Bonfrer et al. BMJ 2018;360:j5622.
for Medicare beneficiaries, according to an analysis of Medicare claims data.
“No evidence that hospitals [that were] operating under pay for performance programs for more than a decade had better process scores or lower mortality than other hospitals was found,” Igna Bonfrer, PhD, of Erasmus University, Rotterdam, the Netherlands, and colleagues wrote in a study published Jan. 4, 2018, in BMJ.
Researchers looked at Medicare claims data from nearly 1.4 million patients aged 65 years and older across 1,189 hospitals. That total included 214 hospitals that were early adopters of pay for performance (PFP) programs, including the Hospital Quality Incentive Demonstration (HQID) and the current Hospital Value-Based Purchasing (HVBP) program, and 975 hospitals that adopted the programs at a later date. The study authors examined clinical process scores and 30-day mortality rates from 2003 to 2013.
Hospitals that were early adopters of a PFP program typically started from a higher baseline process measure score (91.5), compared with late adopters (89.9).
However, improvements among the early adopters “were smaller during the HQID period, although early adopters continued to perform at a slightly higher level than the late adopters during the pre-HVBP period,” the researchers explained. “Over the HVBP period, early and late adopters no longer differed in their clinical process scores.”
Indeed, a ceiling was ultimately reached, with early and late adopters approaching the same level (98.5 vs. 98.2).
For the 30-day mortality rates, both groups “started from a similar baseline (14.9% and 14.8% for the early and late adopters in the fourth quarter of 2003) and ended at the same rate of 9.9% for both groups in the fourth quarter of 2013,” Dr. Bonfrer and colleagues wrote.
The researchers suggested that the programs did not yield better results because of small financial incentives, coupled with program complexities that made it “difficult for hospitals to meaningfully engage in the program.” They also suggested that having to wait until year end to receive any financial incentives could have limited the impact.
“We found that hospitals that have been under financial incentives for more than a decade have not been able to reduce patient mortality more than late adopters, which had only been under financial incentives for less than 3 years,” the researchers concluded. “Given its cost, policymakers in the [United States] should consider one of two things: revise the current program or potentially end it.”
The changes suggested include increasing financial incentives and focusing on process measures that matter most to patients (mortality, patient experience, and functional status), rather than the current measure set that is larger and more difficult to track.
The researchers did not report any financial conflicts of interest.
gtwachtman@frontlinemedcom.com
SOURCE: Dr. Igna Bonfrer et al. BMJ 2018;360:j5622.
for Medicare beneficiaries, according to an analysis of Medicare claims data.
“No evidence that hospitals [that were] operating under pay for performance programs for more than a decade had better process scores or lower mortality than other hospitals was found,” Igna Bonfrer, PhD, of Erasmus University, Rotterdam, the Netherlands, and colleagues wrote in a study published Jan. 4, 2018, in BMJ.
Researchers looked at Medicare claims data from nearly 1.4 million patients aged 65 years and older across 1,189 hospitals. That total included 214 hospitals that were early adopters of pay for performance (PFP) programs, including the Hospital Quality Incentive Demonstration (HQID) and the current Hospital Value-Based Purchasing (HVBP) program, and 975 hospitals that adopted the programs at a later date. The study authors examined clinical process scores and 30-day mortality rates from 2003 to 2013.
Hospitals that were early adopters of a PFP program typically started from a higher baseline process measure score (91.5), compared with late adopters (89.9).
However, improvements among the early adopters “were smaller during the HQID period, although early adopters continued to perform at a slightly higher level than the late adopters during the pre-HVBP period,” the researchers explained. “Over the HVBP period, early and late adopters no longer differed in their clinical process scores.”
Indeed, a ceiling was ultimately reached, with early and late adopters approaching the same level (98.5 vs. 98.2).
For the 30-day mortality rates, both groups “started from a similar baseline (14.9% and 14.8% for the early and late adopters in the fourth quarter of 2003) and ended at the same rate of 9.9% for both groups in the fourth quarter of 2013,” Dr. Bonfrer and colleagues wrote.
The researchers suggested that the programs did not yield better results because of small financial incentives, coupled with program complexities that made it “difficult for hospitals to meaningfully engage in the program.” They also suggested that having to wait until year end to receive any financial incentives could have limited the impact.
“We found that hospitals that have been under financial incentives for more than a decade have not been able to reduce patient mortality more than late adopters, which had only been under financial incentives for less than 3 years,” the researchers concluded. “Given its cost, policymakers in the [United States] should consider one of two things: revise the current program or potentially end it.”
The changes suggested include increasing financial incentives and focusing on process measures that matter most to patients (mortality, patient experience, and functional status), rather than the current measure set that is larger and more difficult to track.
The researchers did not report any financial conflicts of interest.
gtwachtman@frontlinemedcom.com
SOURCE: Dr. Igna Bonfrer et al. BMJ 2018;360:j5622.
FROM BMJ
FDA bans 24 ingredients from OTC health care antiseptic products
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
More Medicaid pay leads to more pediatric participation
If you provide better Medicaid payment, pediatricians will participate.
“Office-based primary care pediatricians, who had historically been more resistant to [Medicaid] participation than either their subspecialist or safety net and institution-based peers, increased their participation in the Medicaid program nationally from before to after the 2013 to 2014 Medicaid payment increase,” noted Suk-fong S. Tang, PhD, research analyst at American Academy of Pediatrics, and colleagues.
“That we found participation increases in 4 of 5 indicators nationally and by different measures in the majority of studied states speaks to the robustness of our conclusions,” they wrote.
The researchers looked at office-based primary care pediatricians’ participation in Medicaid between 2011 to 2012 and 2015 to 2016 (prior to and following the temporary Medicaid pay increases provided by the Affordable Care Act) across 27 states and found that those accepting at least some new patients insured by Medicaid increased by 3% to 77%. Pediatricians accepting all new patients insured by Medicaid increased by 6% to 43% and those accepting these patients at least as often as new privately insured patients increased by 6% to 56%. The average percentage of patients insured by Medicaid per provider panel increased by 6% to 31%.
“In light of such findings, the cost and benefits of recruiting new participants versus incentivizing existing participants to increase their Medicaid capacity merit further investigation and the potential for both strategies to improve access should be considered,” the authors wrote.
The AAP Friends of Children Fund supported the study. The researchers reported no relevant financial conflicts of interest.
gtwachtman@frontlinemedcom.com
SOURCE: Tang S et al. Pediatrics 2018 Jan. doi: 10.1542/peds.2017-2570.
There are a number of ways to use payments as the carrot to increase pediatrician participation in Medicaid: raising rates for preventive care as with private insurance, fully covering the cost of vaccines, paying for developmental screening, and providing incentives for up-to-date immunization rates and meeting targets for developmental and lead screening.
Payments should be done as a per-member-per-month care coordination payment and claims should be simplified so they can be paid in a timely manner.
Stephen Berman, MD, of the University of Colorado, expressed his views in a commentary accompanying Dr. Suk-fong’s study (Pediatrics 2018 Jan. doi: 10.1542/peds.2017-3241 ).
There are a number of ways to use payments as the carrot to increase pediatrician participation in Medicaid: raising rates for preventive care as with private insurance, fully covering the cost of vaccines, paying for developmental screening, and providing incentives for up-to-date immunization rates and meeting targets for developmental and lead screening.
Payments should be done as a per-member-per-month care coordination payment and claims should be simplified so they can be paid in a timely manner.
Stephen Berman, MD, of the University of Colorado, expressed his views in a commentary accompanying Dr. Suk-fong’s study (Pediatrics 2018 Jan. doi: 10.1542/peds.2017-3241 ).
There are a number of ways to use payments as the carrot to increase pediatrician participation in Medicaid: raising rates for preventive care as with private insurance, fully covering the cost of vaccines, paying for developmental screening, and providing incentives for up-to-date immunization rates and meeting targets for developmental and lead screening.
Payments should be done as a per-member-per-month care coordination payment and claims should be simplified so they can be paid in a timely manner.
Stephen Berman, MD, of the University of Colorado, expressed his views in a commentary accompanying Dr. Suk-fong’s study (Pediatrics 2018 Jan. doi: 10.1542/peds.2017-3241 ).
If you provide better Medicaid payment, pediatricians will participate.
“Office-based primary care pediatricians, who had historically been more resistant to [Medicaid] participation than either their subspecialist or safety net and institution-based peers, increased their participation in the Medicaid program nationally from before to after the 2013 to 2014 Medicaid payment increase,” noted Suk-fong S. Tang, PhD, research analyst at American Academy of Pediatrics, and colleagues.
“That we found participation increases in 4 of 5 indicators nationally and by different measures in the majority of studied states speaks to the robustness of our conclusions,” they wrote.
The researchers looked at office-based primary care pediatricians’ participation in Medicaid between 2011 to 2012 and 2015 to 2016 (prior to and following the temporary Medicaid pay increases provided by the Affordable Care Act) across 27 states and found that those accepting at least some new patients insured by Medicaid increased by 3% to 77%. Pediatricians accepting all new patients insured by Medicaid increased by 6% to 43% and those accepting these patients at least as often as new privately insured patients increased by 6% to 56%. The average percentage of patients insured by Medicaid per provider panel increased by 6% to 31%.
“In light of such findings, the cost and benefits of recruiting new participants versus incentivizing existing participants to increase their Medicaid capacity merit further investigation and the potential for both strategies to improve access should be considered,” the authors wrote.
The AAP Friends of Children Fund supported the study. The researchers reported no relevant financial conflicts of interest.
gtwachtman@frontlinemedcom.com
SOURCE: Tang S et al. Pediatrics 2018 Jan. doi: 10.1542/peds.2017-2570.
If you provide better Medicaid payment, pediatricians will participate.
“Office-based primary care pediatricians, who had historically been more resistant to [Medicaid] participation than either their subspecialist or safety net and institution-based peers, increased their participation in the Medicaid program nationally from before to after the 2013 to 2014 Medicaid payment increase,” noted Suk-fong S. Tang, PhD, research analyst at American Academy of Pediatrics, and colleagues.
“That we found participation increases in 4 of 5 indicators nationally and by different measures in the majority of studied states speaks to the robustness of our conclusions,” they wrote.
The researchers looked at office-based primary care pediatricians’ participation in Medicaid between 2011 to 2012 and 2015 to 2016 (prior to and following the temporary Medicaid pay increases provided by the Affordable Care Act) across 27 states and found that those accepting at least some new patients insured by Medicaid increased by 3% to 77%. Pediatricians accepting all new patients insured by Medicaid increased by 6% to 43% and those accepting these patients at least as often as new privately insured patients increased by 6% to 56%. The average percentage of patients insured by Medicaid per provider panel increased by 6% to 31%.
“In light of such findings, the cost and benefits of recruiting new participants versus incentivizing existing participants to increase their Medicaid capacity merit further investigation and the potential for both strategies to improve access should be considered,” the authors wrote.
The AAP Friends of Children Fund supported the study. The researchers reported no relevant financial conflicts of interest.
gtwachtman@frontlinemedcom.com
SOURCE: Tang S et al. Pediatrics 2018 Jan. doi: 10.1542/peds.2017-2570.
FROM PEDIATRICS
Key clinical point: Better Medicaid pay increases physician participation in the program.
Major finding: Percentage of pediatricians accepting some Medicaid patients increased from 3% to 77% during the temporary increase.
Study details: A study of office-based primary care pediatricians’ participation in Medicaid between the periods of 2011-2012 and 2015-2016 in 27 states, before and after temporary Medicaid pay increases provided by the ACA.
Disclosures: The AAP Friends of Children Fund supported the study. The researchers reported no relevant financial conflicts of interest.
Source: Tang S et al. Pediatrics 2018 Jan. doi:10.1542/peds.2017-2570.
A three-track concept proposed for regulating fecal microbiota transplantation
FROM SCIENCE
Researchers are proposing a three-track regulatory framework to help ensure that using fecal microbiota transplantations (FMTs) to treat recurring Clostridium difficile infection (CDI) can be done in a more safe and effective manner.
The need for better regulation is arising because, although FMT is considered by many to be the standard of care, samples are inconsistently screened for infectious pathogens.
“The use of prescreened stool obtained from a stool bank and shipped to a physician is increasing, but the stool banks are not regulated,” Diane Hoffmann, the Jacob A. France Professor of Health Care Law at the University of Maryland, Baltimore, and her colleagues wrote in Science.
The authors noted that the Food and Drug Administration has struggled with regulating FMT; so far, it has tried to use the drug approval pathway as a tool to oversee FMT.
However, the authors note that the transplanted material “is not a ‘typical’ drug, and thus may not be appropriate for the drug regulatory pathway.” To that end, Ms. Hoffmann and her colleagues offered three paths that the FDA could implement to regulate FMT.
The first track would cover instances in which a physician obtains the stool from a donor the patient or physician already know. In this case, “FMT would be regulated as the ‘practice of medicine’ subject primarily to state regulation,” the authors proposed. “Physicians performing FMT for CDI would be able to do so based on their scope of practice using clinical judgment and the relevant standard of care.” In this track, the investigational new drug (IND) pathway would be applied when FMT is used for any indication other than CDI unless the use meets clinical innovation requirements.
The second track covers stool obtained from stool banks. In this scenario, it would be “regulated in the same manner as human cell-tissue establishments with some additional oversight,” Ms. Hoffmann and her colleagues wrote. “This would include registering annually with the FDA and complying with rules for donor screening and testing and ‘good manufacturing processes.’ ” Physicians using stool from these banks would be required to report back any adverse events stemming from stool supplied by the banks, and the banks would submit that data to the FDA. Unless operating under an IND, stool banks would only be able to provide samples to treat CDI.
The third track deals with “modified stool-based products” (stool processed in such a way that the original relevant characteristics of the transferred community of microorganisms have been altered). “These products would be regulated as biological products or drugs with some alteration of IND requirements (i.e., elimination of some phase I IND requirements and modification of characterization specifications),” the authors wrote.
“Our proposal improves on the FDA’s current and proposed regulatory scheme as it allows stool banks to continue to provide stool but only under an approved regulatory framework,” Ms. Hoffmann and her colleagues wrote.
They believe that implementation of this three-track structure would not be difficult: “FDA would need to change its position and determine that microbiota derived from stool is a tissue, not a drug or biological product. The framework could be implemented through new guidance or by issuing formal regulations and no statutory changes would be required. The scheme would serve as a useful starting point for regulation of other types of [microbiota transplants].”
gtwachtman@frontlinemedcom.com
FROM SCIENCE
Researchers are proposing a three-track regulatory framework to help ensure that using fecal microbiota transplantations (FMTs) to treat recurring Clostridium difficile infection (CDI) can be done in a more safe and effective manner.
The need for better regulation is arising because, although FMT is considered by many to be the standard of care, samples are inconsistently screened for infectious pathogens.
“The use of prescreened stool obtained from a stool bank and shipped to a physician is increasing, but the stool banks are not regulated,” Diane Hoffmann, the Jacob A. France Professor of Health Care Law at the University of Maryland, Baltimore, and her colleagues wrote in Science.
The authors noted that the Food and Drug Administration has struggled with regulating FMT; so far, it has tried to use the drug approval pathway as a tool to oversee FMT.
However, the authors note that the transplanted material “is not a ‘typical’ drug, and thus may not be appropriate for the drug regulatory pathway.” To that end, Ms. Hoffmann and her colleagues offered three paths that the FDA could implement to regulate FMT.
The first track would cover instances in which a physician obtains the stool from a donor the patient or physician already know. In this case, “FMT would be regulated as the ‘practice of medicine’ subject primarily to state regulation,” the authors proposed. “Physicians performing FMT for CDI would be able to do so based on their scope of practice using clinical judgment and the relevant standard of care.” In this track, the investigational new drug (IND) pathway would be applied when FMT is used for any indication other than CDI unless the use meets clinical innovation requirements.
The second track covers stool obtained from stool banks. In this scenario, it would be “regulated in the same manner as human cell-tissue establishments with some additional oversight,” Ms. Hoffmann and her colleagues wrote. “This would include registering annually with the FDA and complying with rules for donor screening and testing and ‘good manufacturing processes.’ ” Physicians using stool from these banks would be required to report back any adverse events stemming from stool supplied by the banks, and the banks would submit that data to the FDA. Unless operating under an IND, stool banks would only be able to provide samples to treat CDI.
The third track deals with “modified stool-based products” (stool processed in such a way that the original relevant characteristics of the transferred community of microorganisms have been altered). “These products would be regulated as biological products or drugs with some alteration of IND requirements (i.e., elimination of some phase I IND requirements and modification of characterization specifications),” the authors wrote.
“Our proposal improves on the FDA’s current and proposed regulatory scheme as it allows stool banks to continue to provide stool but only under an approved regulatory framework,” Ms. Hoffmann and her colleagues wrote.
They believe that implementation of this three-track structure would not be difficult: “FDA would need to change its position and determine that microbiota derived from stool is a tissue, not a drug or biological product. The framework could be implemented through new guidance or by issuing formal regulations and no statutory changes would be required. The scheme would serve as a useful starting point for regulation of other types of [microbiota transplants].”
gtwachtman@frontlinemedcom.com
FROM SCIENCE
Researchers are proposing a three-track regulatory framework to help ensure that using fecal microbiota transplantations (FMTs) to treat recurring Clostridium difficile infection (CDI) can be done in a more safe and effective manner.
The need for better regulation is arising because, although FMT is considered by many to be the standard of care, samples are inconsistently screened for infectious pathogens.
“The use of prescreened stool obtained from a stool bank and shipped to a physician is increasing, but the stool banks are not regulated,” Diane Hoffmann, the Jacob A. France Professor of Health Care Law at the University of Maryland, Baltimore, and her colleagues wrote in Science.
The authors noted that the Food and Drug Administration has struggled with regulating FMT; so far, it has tried to use the drug approval pathway as a tool to oversee FMT.
However, the authors note that the transplanted material “is not a ‘typical’ drug, and thus may not be appropriate for the drug regulatory pathway.” To that end, Ms. Hoffmann and her colleagues offered three paths that the FDA could implement to regulate FMT.
The first track would cover instances in which a physician obtains the stool from a donor the patient or physician already know. In this case, “FMT would be regulated as the ‘practice of medicine’ subject primarily to state regulation,” the authors proposed. “Physicians performing FMT for CDI would be able to do so based on their scope of practice using clinical judgment and the relevant standard of care.” In this track, the investigational new drug (IND) pathway would be applied when FMT is used for any indication other than CDI unless the use meets clinical innovation requirements.
The second track covers stool obtained from stool banks. In this scenario, it would be “regulated in the same manner as human cell-tissue establishments with some additional oversight,” Ms. Hoffmann and her colleagues wrote. “This would include registering annually with the FDA and complying with rules for donor screening and testing and ‘good manufacturing processes.’ ” Physicians using stool from these banks would be required to report back any adverse events stemming from stool supplied by the banks, and the banks would submit that data to the FDA. Unless operating under an IND, stool banks would only be able to provide samples to treat CDI.
The third track deals with “modified stool-based products” (stool processed in such a way that the original relevant characteristics of the transferred community of microorganisms have been altered). “These products would be regulated as biological products or drugs with some alteration of IND requirements (i.e., elimination of some phase I IND requirements and modification of characterization specifications),” the authors wrote.
“Our proposal improves on the FDA’s current and proposed regulatory scheme as it allows stool banks to continue to provide stool but only under an approved regulatory framework,” Ms. Hoffmann and her colleagues wrote.
They believe that implementation of this three-track structure would not be difficult: “FDA would need to change its position and determine that microbiota derived from stool is a tissue, not a drug or biological product. The framework could be implemented through new guidance or by issuing formal regulations and no statutory changes would be required. The scheme would serve as a useful starting point for regulation of other types of [microbiota transplants].”
gtwachtman@frontlinemedcom.com
Maternal mortality is set to be a top issue for 2018
Addressing issues around maternal mortality is going to be the top focus for the American Congress of Obstetricians and Gynecologists in 2018.
“It is will be the priority of my presidency here at ACOG,” President-elect Lisa Hollier, MD, said in an interview. Her term as president begins at the end of April 2018.
Rates of maternal mortality – defined as rates of death within 365 days of pregnancy – have become an increasingly prominent issue in the United States. Many states have created dedicated committees to examine the causes of increasing mortality and look for solutions. California, in particular, has had some success in reducing these rates.
To address the maternal mortality issue, ACOG is working on passing legislation through Congress that would give the federal government a role in funding these state-level committees.
“The main crux of the bill is to provide authorization for state maternal mortality, for funds to support state maternal mortality review committees,” said Rachel Tetlow, the director of federal affairs at ACOG. “We know that while a majority of states do have committees, there are still some who are struggling to stand them up and others that are struggling to fund them at full capacity. This legislation looks to support those state efforts to ensure that states really are able to move forward with reviewing maternal deaths and in some cases near misses in their states and recommend local state-based solutions.”
Another hot button issue that could affect maternal mortality is access to abortion.
“It is going to be interesting to see how those numbers shift as abortion providers are no longer available,” said Constance J. Bohon, MD, an ob.gyn. in Washington, D.C., and the ACOG state legislative chair from the District of Columbia. “For example, there is a concern that in states such as Texas, the maternal mortality rates may rise because of a lack of abortion providers.”
Attacks on abortion rights at both the state and federal level are expected in the coming year as well, Dr. Bohon said. She also expressed concerns over initiatives moving through some state houses that would hold doctors criminally liable for performing an abortion.
“What we have seen in the past is that these [abortion] bills come up really quickly without a whole lot of warning, so it’s difficult to say the specific legislation that we will see,” Ms. Tetlow said. “I am fairly confident that we will see at least one more vote in the House of Representatives and potentially one in the Senate ... before the 2018 elections.”
Maternal mortality could be symptomatic of another key issue in women’s health – an overall lack of access to adequate health care.
“One big issue is going to be how we get obstetrical care to women in communities where there is limited access,” she said. “We have got to figure out how to get all women, especially women in underserved areas who could be high risk into pregnancy care early on.”
Beyond that, ACOG is expecting that the women’s health services that have been in the cross hairs recently will continue to be so in 2018.
“2017 has been a year of just challenges and challenges and challenges for practicing ob.gyns. and patients, and we are expecting pretty much the same in 2018,” said Lucia DiVenere, a government and political affairs officer at ACOG.
Cuts to Medicaid, which House Speaker Paul Ryan (R-Wisc.) has identified as a key legislative priority for 2018, could create some significant issues for patients’ access to services.
“Roughly about 50% of deliveries are paid for by Medicaid,” Dr. Bohon said, noting that, for some states, that number can reach as high as 64%. “If those women don’t have access to care, it will be a disaster.”
The American Academy of Family Physicians will also be looking to maintain coverage of women’s health services in the Affordable Care Act.
“I think that our focus in 2018 is going to be around women’s continued access to comprehensive reproductive health care,” said AAFP President Michael Munger, MD. “Not only ensuring they have access to their breast, uterine, and cervical cancer screenings, prenatal maternity and postnatal care, but also preventive services.”
Dr. Munger singled out the Trump administration’s 2017 regulations allowing employers to opt out of providing contraception coverage for moral or religious reasons. “I think that is going to be a continued focus moving forward.”
“Three-quarters of women of childbearing age are in the workforce,” said Kandice Kapinos, PhD, of the Rand Corporation. “The studies on maternity leave show really positive effects of maternity leave on a wide range of child and maternal health outcomes.”
Not having an adequate amount of maternity leave can affect a woman’s ability to breastfeed her newborn, Dr. Kapinos added. “Breastfeeding can be difficult when you return to work,” she said. “Paid maternity leave would result in increases in breastfeeding. That has pretty big implications for health for women and children, which translates into pretty big cost savings.”
gtwachtman@frontlinemedcom.com
Addressing issues around maternal mortality is going to be the top focus for the American Congress of Obstetricians and Gynecologists in 2018.
“It is will be the priority of my presidency here at ACOG,” President-elect Lisa Hollier, MD, said in an interview. Her term as president begins at the end of April 2018.
Rates of maternal mortality – defined as rates of death within 365 days of pregnancy – have become an increasingly prominent issue in the United States. Many states have created dedicated committees to examine the causes of increasing mortality and look for solutions. California, in particular, has had some success in reducing these rates.
To address the maternal mortality issue, ACOG is working on passing legislation through Congress that would give the federal government a role in funding these state-level committees.
“The main crux of the bill is to provide authorization for state maternal mortality, for funds to support state maternal mortality review committees,” said Rachel Tetlow, the director of federal affairs at ACOG. “We know that while a majority of states do have committees, there are still some who are struggling to stand them up and others that are struggling to fund them at full capacity. This legislation looks to support those state efforts to ensure that states really are able to move forward with reviewing maternal deaths and in some cases near misses in their states and recommend local state-based solutions.”
Another hot button issue that could affect maternal mortality is access to abortion.
“It is going to be interesting to see how those numbers shift as abortion providers are no longer available,” said Constance J. Bohon, MD, an ob.gyn. in Washington, D.C., and the ACOG state legislative chair from the District of Columbia. “For example, there is a concern that in states such as Texas, the maternal mortality rates may rise because of a lack of abortion providers.”
Attacks on abortion rights at both the state and federal level are expected in the coming year as well, Dr. Bohon said. She also expressed concerns over initiatives moving through some state houses that would hold doctors criminally liable for performing an abortion.
“What we have seen in the past is that these [abortion] bills come up really quickly without a whole lot of warning, so it’s difficult to say the specific legislation that we will see,” Ms. Tetlow said. “I am fairly confident that we will see at least one more vote in the House of Representatives and potentially one in the Senate ... before the 2018 elections.”
Maternal mortality could be symptomatic of another key issue in women’s health – an overall lack of access to adequate health care.
“One big issue is going to be how we get obstetrical care to women in communities where there is limited access,” she said. “We have got to figure out how to get all women, especially women in underserved areas who could be high risk into pregnancy care early on.”
Beyond that, ACOG is expecting that the women’s health services that have been in the cross hairs recently will continue to be so in 2018.
“2017 has been a year of just challenges and challenges and challenges for practicing ob.gyns. and patients, and we are expecting pretty much the same in 2018,” said Lucia DiVenere, a government and political affairs officer at ACOG.
Cuts to Medicaid, which House Speaker Paul Ryan (R-Wisc.) has identified as a key legislative priority for 2018, could create some significant issues for patients’ access to services.
“Roughly about 50% of deliveries are paid for by Medicaid,” Dr. Bohon said, noting that, for some states, that number can reach as high as 64%. “If those women don’t have access to care, it will be a disaster.”
The American Academy of Family Physicians will also be looking to maintain coverage of women’s health services in the Affordable Care Act.
“I think that our focus in 2018 is going to be around women’s continued access to comprehensive reproductive health care,” said AAFP President Michael Munger, MD. “Not only ensuring they have access to their breast, uterine, and cervical cancer screenings, prenatal maternity and postnatal care, but also preventive services.”
Dr. Munger singled out the Trump administration’s 2017 regulations allowing employers to opt out of providing contraception coverage for moral or religious reasons. “I think that is going to be a continued focus moving forward.”
“Three-quarters of women of childbearing age are in the workforce,” said Kandice Kapinos, PhD, of the Rand Corporation. “The studies on maternity leave show really positive effects of maternity leave on a wide range of child and maternal health outcomes.”
Not having an adequate amount of maternity leave can affect a woman’s ability to breastfeed her newborn, Dr. Kapinos added. “Breastfeeding can be difficult when you return to work,” she said. “Paid maternity leave would result in increases in breastfeeding. That has pretty big implications for health for women and children, which translates into pretty big cost savings.”
gtwachtman@frontlinemedcom.com
Addressing issues around maternal mortality is going to be the top focus for the American Congress of Obstetricians and Gynecologists in 2018.
“It is will be the priority of my presidency here at ACOG,” President-elect Lisa Hollier, MD, said in an interview. Her term as president begins at the end of April 2018.
Rates of maternal mortality – defined as rates of death within 365 days of pregnancy – have become an increasingly prominent issue in the United States. Many states have created dedicated committees to examine the causes of increasing mortality and look for solutions. California, in particular, has had some success in reducing these rates.
To address the maternal mortality issue, ACOG is working on passing legislation through Congress that would give the federal government a role in funding these state-level committees.
“The main crux of the bill is to provide authorization for state maternal mortality, for funds to support state maternal mortality review committees,” said Rachel Tetlow, the director of federal affairs at ACOG. “We know that while a majority of states do have committees, there are still some who are struggling to stand them up and others that are struggling to fund them at full capacity. This legislation looks to support those state efforts to ensure that states really are able to move forward with reviewing maternal deaths and in some cases near misses in their states and recommend local state-based solutions.”
Another hot button issue that could affect maternal mortality is access to abortion.
“It is going to be interesting to see how those numbers shift as abortion providers are no longer available,” said Constance J. Bohon, MD, an ob.gyn. in Washington, D.C., and the ACOG state legislative chair from the District of Columbia. “For example, there is a concern that in states such as Texas, the maternal mortality rates may rise because of a lack of abortion providers.”
Attacks on abortion rights at both the state and federal level are expected in the coming year as well, Dr. Bohon said. She also expressed concerns over initiatives moving through some state houses that would hold doctors criminally liable for performing an abortion.
“What we have seen in the past is that these [abortion] bills come up really quickly without a whole lot of warning, so it’s difficult to say the specific legislation that we will see,” Ms. Tetlow said. “I am fairly confident that we will see at least one more vote in the House of Representatives and potentially one in the Senate ... before the 2018 elections.”
Maternal mortality could be symptomatic of another key issue in women’s health – an overall lack of access to adequate health care.
“One big issue is going to be how we get obstetrical care to women in communities where there is limited access,” she said. “We have got to figure out how to get all women, especially women in underserved areas who could be high risk into pregnancy care early on.”
Beyond that, ACOG is expecting that the women’s health services that have been in the cross hairs recently will continue to be so in 2018.
“2017 has been a year of just challenges and challenges and challenges for practicing ob.gyns. and patients, and we are expecting pretty much the same in 2018,” said Lucia DiVenere, a government and political affairs officer at ACOG.
Cuts to Medicaid, which House Speaker Paul Ryan (R-Wisc.) has identified as a key legislative priority for 2018, could create some significant issues for patients’ access to services.
“Roughly about 50% of deliveries are paid for by Medicaid,” Dr. Bohon said, noting that, for some states, that number can reach as high as 64%. “If those women don’t have access to care, it will be a disaster.”
The American Academy of Family Physicians will also be looking to maintain coverage of women’s health services in the Affordable Care Act.
“I think that our focus in 2018 is going to be around women’s continued access to comprehensive reproductive health care,” said AAFP President Michael Munger, MD. “Not only ensuring they have access to their breast, uterine, and cervical cancer screenings, prenatal maternity and postnatal care, but also preventive services.”
Dr. Munger singled out the Trump administration’s 2017 regulations allowing employers to opt out of providing contraception coverage for moral or religious reasons. “I think that is going to be a continued focus moving forward.”
“Three-quarters of women of childbearing age are in the workforce,” said Kandice Kapinos, PhD, of the Rand Corporation. “The studies on maternity leave show really positive effects of maternity leave on a wide range of child and maternal health outcomes.”
Not having an adequate amount of maternity leave can affect a woman’s ability to breastfeed her newborn, Dr. Kapinos added. “Breastfeeding can be difficult when you return to work,” she said. “Paid maternity leave would result in increases in breastfeeding. That has pretty big implications for health for women and children, which translates into pretty big cost savings.”
gtwachtman@frontlinemedcom.com
ABIM to allow do-overs for all subspecialties with Knowledge Check-In
ABIM previously announced that, beginning in 2018, physicians taking the Knowledge Check-In in 2018 would get another chance to take it in 2 years if they were unsuccessful, even if they were due to pass the maintenance of certification (MOC) exam later that year. In 2018, Knowledge Check-Ins will be offered in internal medicine and nephrology.
“Based on feedback ABIM has received from the physician community, we are happy to let you know that we are extending this policy to include all other internal medicine subspecialties in the future,” ABIM said in a Dec. 4 announcement on its website. “This means that if a physician takes the Knowledge Check-In in the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take and pass it 2 years later.”
The Knowledge Check-In is an alternative to the traditional MOC process, and is administered every 2 years rather than the standard decade between MOC exams. ABIM noted that a single failure on a Knowledge Check-In will not result in a status change to a physician’s certification status.
Separately, ABIM also announced that it will continue to make practice assessment activities (part IV of the MOC program) a part of the portfolio of options that can be used to satisfy MOC requirements but that practice assessment is not a required part of maintenance of certification.
“Our intent is to support physicians completing MOC activities that are most meaningful to their practice, including those that enhance and improve medical knowledge, as well as many existing quality improvement activities, and those that blend both,” ABIM said in its announcement.
AGA will continue to work with ABIM and advocate for a recertification pathway that reduces the burden of recertifying, emphasizes learning over testing and assesses diplomates in their areas of practice.
ABIM previously announced that, beginning in 2018, physicians taking the Knowledge Check-In in 2018 would get another chance to take it in 2 years if they were unsuccessful, even if they were due to pass the maintenance of certification (MOC) exam later that year. In 2018, Knowledge Check-Ins will be offered in internal medicine and nephrology.
“Based on feedback ABIM has received from the physician community, we are happy to let you know that we are extending this policy to include all other internal medicine subspecialties in the future,” ABIM said in a Dec. 4 announcement on its website. “This means that if a physician takes the Knowledge Check-In in the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take and pass it 2 years later.”
The Knowledge Check-In is an alternative to the traditional MOC process, and is administered every 2 years rather than the standard decade between MOC exams. ABIM noted that a single failure on a Knowledge Check-In will not result in a status change to a physician’s certification status.
Separately, ABIM also announced that it will continue to make practice assessment activities (part IV of the MOC program) a part of the portfolio of options that can be used to satisfy MOC requirements but that practice assessment is not a required part of maintenance of certification.
“Our intent is to support physicians completing MOC activities that are most meaningful to their practice, including those that enhance and improve medical knowledge, as well as many existing quality improvement activities, and those that blend both,” ABIM said in its announcement.
AGA will continue to work with ABIM and advocate for a recertification pathway that reduces the burden of recertifying, emphasizes learning over testing and assesses diplomates in their areas of practice.
ABIM previously announced that, beginning in 2018, physicians taking the Knowledge Check-In in 2018 would get another chance to take it in 2 years if they were unsuccessful, even if they were due to pass the maintenance of certification (MOC) exam later that year. In 2018, Knowledge Check-Ins will be offered in internal medicine and nephrology.
“Based on feedback ABIM has received from the physician community, we are happy to let you know that we are extending this policy to include all other internal medicine subspecialties in the future,” ABIM said in a Dec. 4 announcement on its website. “This means that if a physician takes the Knowledge Check-In in the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take and pass it 2 years later.”
The Knowledge Check-In is an alternative to the traditional MOC process, and is administered every 2 years rather than the standard decade between MOC exams. ABIM noted that a single failure on a Knowledge Check-In will not result in a status change to a physician’s certification status.
Separately, ABIM also announced that it will continue to make practice assessment activities (part IV of the MOC program) a part of the portfolio of options that can be used to satisfy MOC requirements but that practice assessment is not a required part of maintenance of certification.
“Our intent is to support physicians completing MOC activities that are most meaningful to their practice, including those that enhance and improve medical knowledge, as well as many existing quality improvement activities, and those that blend both,” ABIM said in its announcement.
AGA will continue to work with ABIM and advocate for a recertification pathway that reduces the burden of recertifying, emphasizes learning over testing and assesses diplomates in their areas of practice.