User login
Studies cast doubt on FDA’s accelerated cancer drug pathway
In the first study, lead investigator Emerson Y. Chen, MD, of Oregon Health & Science University, Portland, and colleagues conducted a retrospective analysis of all drugs approved by the FDA on the basis of response rate – the percentage of patients who experience tumor shrinkage – from Jan. 1, 2006, to Sept. 30, 2018. The data set consisted of 59 oncology drugs with 85 unique indications approved by the FDA for advanced-stage metastatic cancer on the basis of a response rate (RR) endpoint during the study period.
Of the 85 indications, 32 were granted regular approval immediately with limited postmarketing efficacy requirements and 53 (62%) were granted accelerated approval. Of the accelerated approvals, 29 (55%) were later converted to regular approval.
The median RR for the 85 indications was 41%, and the median sample size of such RR trials was 117 patients, according to the analysis published in JAMA Internal Medicine.
Among all approvals, 14 of 85 (16%) had an RR less than 20%, 28 of 85 (33%) had an RR less than 30%, and 40 of 85 (47%) had an RR less than 40%.
Most approved drugs had an RR ranging from 20% to 59%, the study found. Of 81 available indications, the median complete response rate – defined as the percentage of patients with no visible disease and normalization of lymph nodes – was 6%. (Complete response data were not reported for four drug indications.)
The investigators found that many of the drugs studied have remained on the market for years without subsequent confirmatory data. For example, when the accelerated approvals based on RR were converted to full approval, 23 of 29 were made on the basis of surrogate endpoints (progression-free survival or RR), 7 of 29 were made on the basis of RR, and just 6 of 29 were made on the basis of overall survival (OS).
The findings suggest that most cancer drugs approved by the FDA based on RR have less than transformational response rates, and that such indications do not have confirmed clinical benefit, the study authors wrote.
While in some settings, a response can equal prognostic value regarding overall survival, the authors wrote that “the ability of RR to serve as a validated surrogate for OS varies among cancer types and is generally poor.”
In the second study, researchers found that confirmatory trials for only one-fifth of cancer drug indications approved via the FDA’s accelerated approval route demonstrated improvements in overall patient survival.
Lead investigator Bishal Gyawali, MD, PhD, of Queen’s University, Kingston, Ont., and colleagues examined FDA data on recent drugs and indications that received accelerated approval and were later granted full approval.
For their analysis, the investigators reviewed the FDA’s database of postmarketing requirements and commitments, as well as PubMed, to determine the current status of postmarket trials for indications labeled as “ongoing” in the original FDA data.
Of 93 cancer drug indications for which accelerated approval was granted from Dec. 11, 1992, to May 31, 2017, the FDA reported clinical benefit was adequately confirmed in 51 indications. Of these confirmations, 15 demonstrated improvement in overall survival.
In their updated analysis, the investigators determined that confirmatory trials for 19 of the 93 (20%) cancer drug approvals reported an improvement in OS, 19 trials (20%) reported improvement in the same surrogate used in the preapproval trial, and 20 trials (21%) reported improvement in a different surrogate, according to the study, also published in JAMA Internal Medicine.
Additionally, results showed that 5 confirmatory trials were delayed, 10 trials were pending, and 9 trials were ongoing.
For three recent accelerated approvals, the primary endpoints were not met in the confirmatory trials, but one of the indications still received full approval.
The findings raise several concerns about the accelerated cancer drug pathway, including whether the same surrogate efficacy measure should be used as verification of drug benefit, according to the investigators. Conversely, using a different surrogate endpoint than the original measure can cause confusion among physicians and patients about whether the cancer drug improves survival or quality of life, information that is essential in the benefit-risk evaluation for clinical decision making.
That a number of the confirmatory trials examined were delayed or pending emphasize the considerable time that can elapse between drug approval and confirmatory trial completion, they added.
“Timely planning and completion of postmarketing trials is necessary for proper implementation of the accelerated approval pathway, and the FDA should minimize the period during which patients and physicians are using drugs approved through accelerated pathways without rigorous data on their ultimate clinical benefit,” the authors wrote in the analysis.
Dr. Chen, lead author of the RR study, said both studies call into question what criteria is optimal when assessing cancer drug value, while ensuring such measurements are not too high to achieve – preventing useful drugs to market – but also not too low – allowing drugs with marginal benefit into the market.
“There has been tremendous drug development within the oncology space, and it is always important to look back to reassess and see if the process [matches] the original vision so that we can correct any misuse or concerns,” Dr. Chen said in an interview.
Dr. Chen said his study indicates the RR endpoint has been misused in scenarios with low response rate, common cancer, and/or situations with already available therapies. In the study by Dr. Gyawali, the results suggest many drugs approved on the basis of a surrogate endpoint (RR or progression-free survival) ultimately do not demonstrate survival benefit confirmation or patient-reported benefit, Dr. Chen said.
“We hope that readers of these JAMA IM studies and the accompanying commentaries will recognize that there could be a set of guidance criteria from regulatory agencies or oncology organizations to recommend use of surrogate endpoints in special situations: high response rate of the drug, very rare cancer, or highly innovative therapy not yet seen before,” he said. “The use of surrogate endpoints to justify these therapies must also have postmarketing confirmation of survival or patient-reported benefit.”
The study led by Dr. Chen was supported by the Laura and John Arnold Foundation. Dr Chen reported receiving lecture honorarium from Horizon CME; another coauthor reported receiving honorarium from universities, medical centers, and publishers. The study led by Dr. Gyawali was supported by the Arnold Ventures; one of the coauthors reported receiving grant support from the Harvard-MIT Center for Regulatory Science and the Engelberg Foundation, as well as unrelated research funding from the FDA.
SOURCES: Chen EY et al. JAMA Intern Med. 2019 May 28. doi: 10.1001/jamainternmed.2019.0583; Gyawali B et al. JAMA Intern Med. 2019 May 28. doi: 10.1001/jamainternmed.2019.0462.
In the first study, lead investigator Emerson Y. Chen, MD, of Oregon Health & Science University, Portland, and colleagues conducted a retrospective analysis of all drugs approved by the FDA on the basis of response rate – the percentage of patients who experience tumor shrinkage – from Jan. 1, 2006, to Sept. 30, 2018. The data set consisted of 59 oncology drugs with 85 unique indications approved by the FDA for advanced-stage metastatic cancer on the basis of a response rate (RR) endpoint during the study period.
Of the 85 indications, 32 were granted regular approval immediately with limited postmarketing efficacy requirements and 53 (62%) were granted accelerated approval. Of the accelerated approvals, 29 (55%) were later converted to regular approval.
The median RR for the 85 indications was 41%, and the median sample size of such RR trials was 117 patients, according to the analysis published in JAMA Internal Medicine.
Among all approvals, 14 of 85 (16%) had an RR less than 20%, 28 of 85 (33%) had an RR less than 30%, and 40 of 85 (47%) had an RR less than 40%.
Most approved drugs had an RR ranging from 20% to 59%, the study found. Of 81 available indications, the median complete response rate – defined as the percentage of patients with no visible disease and normalization of lymph nodes – was 6%. (Complete response data were not reported for four drug indications.)
The investigators found that many of the drugs studied have remained on the market for years without subsequent confirmatory data. For example, when the accelerated approvals based on RR were converted to full approval, 23 of 29 were made on the basis of surrogate endpoints (progression-free survival or RR), 7 of 29 were made on the basis of RR, and just 6 of 29 were made on the basis of overall survival (OS).
The findings suggest that most cancer drugs approved by the FDA based on RR have less than transformational response rates, and that such indications do not have confirmed clinical benefit, the study authors wrote.
While in some settings, a response can equal prognostic value regarding overall survival, the authors wrote that “the ability of RR to serve as a validated surrogate for OS varies among cancer types and is generally poor.”
In the second study, researchers found that confirmatory trials for only one-fifth of cancer drug indications approved via the FDA’s accelerated approval route demonstrated improvements in overall patient survival.
Lead investigator Bishal Gyawali, MD, PhD, of Queen’s University, Kingston, Ont., and colleagues examined FDA data on recent drugs and indications that received accelerated approval and were later granted full approval.
For their analysis, the investigators reviewed the FDA’s database of postmarketing requirements and commitments, as well as PubMed, to determine the current status of postmarket trials for indications labeled as “ongoing” in the original FDA data.
Of 93 cancer drug indications for which accelerated approval was granted from Dec. 11, 1992, to May 31, 2017, the FDA reported clinical benefit was adequately confirmed in 51 indications. Of these confirmations, 15 demonstrated improvement in overall survival.
In their updated analysis, the investigators determined that confirmatory trials for 19 of the 93 (20%) cancer drug approvals reported an improvement in OS, 19 trials (20%) reported improvement in the same surrogate used in the preapproval trial, and 20 trials (21%) reported improvement in a different surrogate, according to the study, also published in JAMA Internal Medicine.
Additionally, results showed that 5 confirmatory trials were delayed, 10 trials were pending, and 9 trials were ongoing.
For three recent accelerated approvals, the primary endpoints were not met in the confirmatory trials, but one of the indications still received full approval.
The findings raise several concerns about the accelerated cancer drug pathway, including whether the same surrogate efficacy measure should be used as verification of drug benefit, according to the investigators. Conversely, using a different surrogate endpoint than the original measure can cause confusion among physicians and patients about whether the cancer drug improves survival or quality of life, information that is essential in the benefit-risk evaluation for clinical decision making.
That a number of the confirmatory trials examined were delayed or pending emphasize the considerable time that can elapse between drug approval and confirmatory trial completion, they added.
“Timely planning and completion of postmarketing trials is necessary for proper implementation of the accelerated approval pathway, and the FDA should minimize the period during which patients and physicians are using drugs approved through accelerated pathways without rigorous data on their ultimate clinical benefit,” the authors wrote in the analysis.
Dr. Chen, lead author of the RR study, said both studies call into question what criteria is optimal when assessing cancer drug value, while ensuring such measurements are not too high to achieve – preventing useful drugs to market – but also not too low – allowing drugs with marginal benefit into the market.
“There has been tremendous drug development within the oncology space, and it is always important to look back to reassess and see if the process [matches] the original vision so that we can correct any misuse or concerns,” Dr. Chen said in an interview.
Dr. Chen said his study indicates the RR endpoint has been misused in scenarios with low response rate, common cancer, and/or situations with already available therapies. In the study by Dr. Gyawali, the results suggest many drugs approved on the basis of a surrogate endpoint (RR or progression-free survival) ultimately do not demonstrate survival benefit confirmation or patient-reported benefit, Dr. Chen said.
“We hope that readers of these JAMA IM studies and the accompanying commentaries will recognize that there could be a set of guidance criteria from regulatory agencies or oncology organizations to recommend use of surrogate endpoints in special situations: high response rate of the drug, very rare cancer, or highly innovative therapy not yet seen before,” he said. “The use of surrogate endpoints to justify these therapies must also have postmarketing confirmation of survival or patient-reported benefit.”
The study led by Dr. Chen was supported by the Laura and John Arnold Foundation. Dr Chen reported receiving lecture honorarium from Horizon CME; another coauthor reported receiving honorarium from universities, medical centers, and publishers. The study led by Dr. Gyawali was supported by the Arnold Ventures; one of the coauthors reported receiving grant support from the Harvard-MIT Center for Regulatory Science and the Engelberg Foundation, as well as unrelated research funding from the FDA.
SOURCES: Chen EY et al. JAMA Intern Med. 2019 May 28. doi: 10.1001/jamainternmed.2019.0583; Gyawali B et al. JAMA Intern Med. 2019 May 28. doi: 10.1001/jamainternmed.2019.0462.
In the first study, lead investigator Emerson Y. Chen, MD, of Oregon Health & Science University, Portland, and colleagues conducted a retrospective analysis of all drugs approved by the FDA on the basis of response rate – the percentage of patients who experience tumor shrinkage – from Jan. 1, 2006, to Sept. 30, 2018. The data set consisted of 59 oncology drugs with 85 unique indications approved by the FDA for advanced-stage metastatic cancer on the basis of a response rate (RR) endpoint during the study period.
Of the 85 indications, 32 were granted regular approval immediately with limited postmarketing efficacy requirements and 53 (62%) were granted accelerated approval. Of the accelerated approvals, 29 (55%) were later converted to regular approval.
The median RR for the 85 indications was 41%, and the median sample size of such RR trials was 117 patients, according to the analysis published in JAMA Internal Medicine.
Among all approvals, 14 of 85 (16%) had an RR less than 20%, 28 of 85 (33%) had an RR less than 30%, and 40 of 85 (47%) had an RR less than 40%.
Most approved drugs had an RR ranging from 20% to 59%, the study found. Of 81 available indications, the median complete response rate – defined as the percentage of patients with no visible disease and normalization of lymph nodes – was 6%. (Complete response data were not reported for four drug indications.)
The investigators found that many of the drugs studied have remained on the market for years without subsequent confirmatory data. For example, when the accelerated approvals based on RR were converted to full approval, 23 of 29 were made on the basis of surrogate endpoints (progression-free survival or RR), 7 of 29 were made on the basis of RR, and just 6 of 29 were made on the basis of overall survival (OS).
The findings suggest that most cancer drugs approved by the FDA based on RR have less than transformational response rates, and that such indications do not have confirmed clinical benefit, the study authors wrote.
While in some settings, a response can equal prognostic value regarding overall survival, the authors wrote that “the ability of RR to serve as a validated surrogate for OS varies among cancer types and is generally poor.”
In the second study, researchers found that confirmatory trials for only one-fifth of cancer drug indications approved via the FDA’s accelerated approval route demonstrated improvements in overall patient survival.
Lead investigator Bishal Gyawali, MD, PhD, of Queen’s University, Kingston, Ont., and colleagues examined FDA data on recent drugs and indications that received accelerated approval and were later granted full approval.
For their analysis, the investigators reviewed the FDA’s database of postmarketing requirements and commitments, as well as PubMed, to determine the current status of postmarket trials for indications labeled as “ongoing” in the original FDA data.
Of 93 cancer drug indications for which accelerated approval was granted from Dec. 11, 1992, to May 31, 2017, the FDA reported clinical benefit was adequately confirmed in 51 indications. Of these confirmations, 15 demonstrated improvement in overall survival.
In their updated analysis, the investigators determined that confirmatory trials for 19 of the 93 (20%) cancer drug approvals reported an improvement in OS, 19 trials (20%) reported improvement in the same surrogate used in the preapproval trial, and 20 trials (21%) reported improvement in a different surrogate, according to the study, also published in JAMA Internal Medicine.
Additionally, results showed that 5 confirmatory trials were delayed, 10 trials were pending, and 9 trials were ongoing.
For three recent accelerated approvals, the primary endpoints were not met in the confirmatory trials, but one of the indications still received full approval.
The findings raise several concerns about the accelerated cancer drug pathway, including whether the same surrogate efficacy measure should be used as verification of drug benefit, according to the investigators. Conversely, using a different surrogate endpoint than the original measure can cause confusion among physicians and patients about whether the cancer drug improves survival or quality of life, information that is essential in the benefit-risk evaluation for clinical decision making.
That a number of the confirmatory trials examined were delayed or pending emphasize the considerable time that can elapse between drug approval and confirmatory trial completion, they added.
“Timely planning and completion of postmarketing trials is necessary for proper implementation of the accelerated approval pathway, and the FDA should minimize the period during which patients and physicians are using drugs approved through accelerated pathways without rigorous data on their ultimate clinical benefit,” the authors wrote in the analysis.
Dr. Chen, lead author of the RR study, said both studies call into question what criteria is optimal when assessing cancer drug value, while ensuring such measurements are not too high to achieve – preventing useful drugs to market – but also not too low – allowing drugs with marginal benefit into the market.
“There has been tremendous drug development within the oncology space, and it is always important to look back to reassess and see if the process [matches] the original vision so that we can correct any misuse or concerns,” Dr. Chen said in an interview.
Dr. Chen said his study indicates the RR endpoint has been misused in scenarios with low response rate, common cancer, and/or situations with already available therapies. In the study by Dr. Gyawali, the results suggest many drugs approved on the basis of a surrogate endpoint (RR or progression-free survival) ultimately do not demonstrate survival benefit confirmation or patient-reported benefit, Dr. Chen said.
“We hope that readers of these JAMA IM studies and the accompanying commentaries will recognize that there could be a set of guidance criteria from regulatory agencies or oncology organizations to recommend use of surrogate endpoints in special situations: high response rate of the drug, very rare cancer, or highly innovative therapy not yet seen before,” he said. “The use of surrogate endpoints to justify these therapies must also have postmarketing confirmation of survival or patient-reported benefit.”
The study led by Dr. Chen was supported by the Laura and John Arnold Foundation. Dr Chen reported receiving lecture honorarium from Horizon CME; another coauthor reported receiving honorarium from universities, medical centers, and publishers. The study led by Dr. Gyawali was supported by the Arnold Ventures; one of the coauthors reported receiving grant support from the Harvard-MIT Center for Regulatory Science and the Engelberg Foundation, as well as unrelated research funding from the FDA.
SOURCES: Chen EY et al. JAMA Intern Med. 2019 May 28. doi: 10.1001/jamainternmed.2019.0583; Gyawali B et al. JAMA Intern Med. 2019 May 28. doi: 10.1001/jamainternmed.2019.0462.
FROM JAMA INTERNAL MEDICINE
Louisiana House passes 6-week abortion ban
about the time a heartbeat is usually detectable.
The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.
“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”
Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.
The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.
Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.
about the time a heartbeat is usually detectable.
The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.
“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”
Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.
The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.
Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.
about the time a heartbeat is usually detectable.
The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.
“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”
Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.
The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.
Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.
Supreme Court upholds part of Indiana abortion law
In a three-page, unsigned opinion issued May 28, justices wrote that Indiana has a legitimate interest in proper disposition of fetal remains and that the state’s burial/cremation mandate is rational. However, justices said they would not take up the second part of the law regarding abortions based on race, sex, or disability because not enough appeals courts have decided the issue. The court emphasized it was not expressing any view on the merits of the second question.
The opinion stems from an antiabortion measure signed into law by then–Indiana Governor Mike Pence (R) in 2016. According to the law, the health facility where an abortion occurred is required to dispose of fetal remains either by cremation or internment unless the woman or an associated party take possession of the remains. The measure allows the woman or associated party to choose a location of final disposition provided that the parties pay the costs for such arrangements. The second part of the law prohibits an abortion from being performed solely because of the fetus’s expected race, sex, diagnosis, or disability.
Planned Parenthood of Indiana and Kentucky sued over the law, arguing that the measure was unconstitutional. Indiana officials countered the disposal requirements provided fetuses dignity in death and that the law’s abortion restrictions prevented discrimination of particular fetuses in light of technological advances in genetic screening. In 2018, a three-judge panel of the Court of Appeals for the 7th Circuit struck down the entire law. The panel wrote that well-established Supreme Court precedent allows a woman to terminate her pregnancy for any reason and that the Indiana law invaded a woman’s privacy by examining the underlying basis of her decision for an abortion.
In the Supreme Court’s May 28 filing, Justice Ruth Bader Ginsburg and Justice Sonia Sotomayor wrote separately, each stating they would have upheld the lower court’s ban of the entire law. Justice Clarence Thomas, meanwhile, wrote a lengthy separate opinion, agreeing with the court’s decision, but expressing concern over the use of abortion as a “tool of modern-day eugenics.”
“The court will soon need to confront the constitutionality of laws like Indiana’s,” Justice Thomas wrote. “Enshrining a constitutional right to an abortion based solely on the race, sex or disability of an unborn child, as Planned Parenthood advocates, would constitutionalize the views of the 20th-century eugenics movement.”
The Supreme Court’s decision on the Indiana law comes just weeks after two other stringent state abortion measures were signed into law. On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. On May 15, Alabama Gov. Kay Ivey (R) signed a law that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion.
Analysts say the Alabama law, in particular, could land in front of the Supreme Court as a direct challenge to Roe v. Wade. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, court watchers said.
In a three-page, unsigned opinion issued May 28, justices wrote that Indiana has a legitimate interest in proper disposition of fetal remains and that the state’s burial/cremation mandate is rational. However, justices said they would not take up the second part of the law regarding abortions based on race, sex, or disability because not enough appeals courts have decided the issue. The court emphasized it was not expressing any view on the merits of the second question.
The opinion stems from an antiabortion measure signed into law by then–Indiana Governor Mike Pence (R) in 2016. According to the law, the health facility where an abortion occurred is required to dispose of fetal remains either by cremation or internment unless the woman or an associated party take possession of the remains. The measure allows the woman or associated party to choose a location of final disposition provided that the parties pay the costs for such arrangements. The second part of the law prohibits an abortion from being performed solely because of the fetus’s expected race, sex, diagnosis, or disability.
Planned Parenthood of Indiana and Kentucky sued over the law, arguing that the measure was unconstitutional. Indiana officials countered the disposal requirements provided fetuses dignity in death and that the law’s abortion restrictions prevented discrimination of particular fetuses in light of technological advances in genetic screening. In 2018, a three-judge panel of the Court of Appeals for the 7th Circuit struck down the entire law. The panel wrote that well-established Supreme Court precedent allows a woman to terminate her pregnancy for any reason and that the Indiana law invaded a woman’s privacy by examining the underlying basis of her decision for an abortion.
In the Supreme Court’s May 28 filing, Justice Ruth Bader Ginsburg and Justice Sonia Sotomayor wrote separately, each stating they would have upheld the lower court’s ban of the entire law. Justice Clarence Thomas, meanwhile, wrote a lengthy separate opinion, agreeing with the court’s decision, but expressing concern over the use of abortion as a “tool of modern-day eugenics.”
“The court will soon need to confront the constitutionality of laws like Indiana’s,” Justice Thomas wrote. “Enshrining a constitutional right to an abortion based solely on the race, sex or disability of an unborn child, as Planned Parenthood advocates, would constitutionalize the views of the 20th-century eugenics movement.”
The Supreme Court’s decision on the Indiana law comes just weeks after two other stringent state abortion measures were signed into law. On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. On May 15, Alabama Gov. Kay Ivey (R) signed a law that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion.
Analysts say the Alabama law, in particular, could land in front of the Supreme Court as a direct challenge to Roe v. Wade. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, court watchers said.
In a three-page, unsigned opinion issued May 28, justices wrote that Indiana has a legitimate interest in proper disposition of fetal remains and that the state’s burial/cremation mandate is rational. However, justices said they would not take up the second part of the law regarding abortions based on race, sex, or disability because not enough appeals courts have decided the issue. The court emphasized it was not expressing any view on the merits of the second question.
The opinion stems from an antiabortion measure signed into law by then–Indiana Governor Mike Pence (R) in 2016. According to the law, the health facility where an abortion occurred is required to dispose of fetal remains either by cremation or internment unless the woman or an associated party take possession of the remains. The measure allows the woman or associated party to choose a location of final disposition provided that the parties pay the costs for such arrangements. The second part of the law prohibits an abortion from being performed solely because of the fetus’s expected race, sex, diagnosis, or disability.
Planned Parenthood of Indiana and Kentucky sued over the law, arguing that the measure was unconstitutional. Indiana officials countered the disposal requirements provided fetuses dignity in death and that the law’s abortion restrictions prevented discrimination of particular fetuses in light of technological advances in genetic screening. In 2018, a three-judge panel of the Court of Appeals for the 7th Circuit struck down the entire law. The panel wrote that well-established Supreme Court precedent allows a woman to terminate her pregnancy for any reason and that the Indiana law invaded a woman’s privacy by examining the underlying basis of her decision for an abortion.
In the Supreme Court’s May 28 filing, Justice Ruth Bader Ginsburg and Justice Sonia Sotomayor wrote separately, each stating they would have upheld the lower court’s ban of the entire law. Justice Clarence Thomas, meanwhile, wrote a lengthy separate opinion, agreeing with the court’s decision, but expressing concern over the use of abortion as a “tool of modern-day eugenics.”
“The court will soon need to confront the constitutionality of laws like Indiana’s,” Justice Thomas wrote. “Enshrining a constitutional right to an abortion based solely on the race, sex or disability of an unborn child, as Planned Parenthood advocates, would constitutionalize the views of the 20th-century eugenics movement.”
The Supreme Court’s decision on the Indiana law comes just weeks after two other stringent state abortion measures were signed into law. On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. On May 15, Alabama Gov. Kay Ivey (R) signed a law that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion.
Analysts say the Alabama law, in particular, could land in front of the Supreme Court as a direct challenge to Roe v. Wade. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, court watchers said.
Trump administration plans to repeal transgender health care protections
In a proposed rule issued May 24, the U.S. Department of Health & Human Services outlined its plan to repeal an Obama-era policy that banned health care providers from discriminating against transgender patients. As part of the Affordable Care Act, Congress had directed HHS to apply existing civil rights and health care regulations to the health law exchanges, including rules that were consistent with Title IX, the federal law that prohibits discrimination on the basis of sex in federally funded programs. The Obama administration’s interpretation of this directive barred health care providers from denying care to transgender patients based on gender identify, defined as a patient’s “internal sense of being male, female, neither, or a combination of male and female.”
Repealing the transgender protections in the antidiscrimination policy will make the regulation more consistent with Title IX, according to HHS. In addition, revoking other provisions in the Obama-era policy associated with non–English speaking patients will reduce regulatory costs for unnecessary paperwork by $3.2 billion, according to a statement from the HHS.
“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” said Roger Severino, director of the HHS’s Office for Civil Rights, in the statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives. The proposed rule would accomplish both goals.”
In addressing the reasoning for the proposal, Mr. Severino noted two court decisions that have found the Obama-era policy unlawful. In 2016, the U.S. District Court for the Northern District of Texas temporarily barred the protections from being enacted, ruling that HHS had adopted an erroneous interpretation of “sex” under Title IX, and that the regulation was arbitrary and capricious for failing to incorporate Title IX’s religious and abortion exemptions. The U.S. District Court for the District of North Dakota agreed in a subsequent decision. Since the preliminary bans against the provisions, HHS has not enforced the protections. Removal of the discrimination protections for transgender patients would conform with the courts’ plain understanding of federal sex discrimination laws, according to HHS.
HHS emphasized that the proposed rule is not intended to remove any protections provided by Congress or to restrict states’ ability to enact health care discrimination protections that exceed Title IX requirements. Rather, the proposed rule would ensure that Title IX and corresponding regulations “follow the will of Congress with respect to the states by not expanding Title IX’s definition of ‘sex’ beyond the statutory bounds,” according to the proposed rule.
In addition to removing the transgender protections, the HHS also proposed to eliminate provisions under the Obama-era policy that required health care literature to be translated into 15 languages. The proposed revisions would eliminate $3.2 billion in unneeded paperwork burdens imposed by the translations, according to the agency. Mr. Severino indicated that the money saved could be used to more effectively address individual needs of non–English speakers such as by providing increased access to translators and interpreters.
The American College of Physicians expressed concern about the agency’s move to rewrite the discrimination rule.
“ACP believes that discrimination against patients, including those who identify as lesbian, gay, bisexual, and transgender (LGBT), creates social stigma that has been linked to negative physical and mental health outcomes, including anxiety, suicide, and substance or alcohol abuse,” ACP President Robert McLean, MD, said in a statement. “ACP strongly urges the administration to withdraw their proposal, and instead, make meaningful policy changes that will ensure nondiscrimination in health care against all patients, regardless of their sexual orientation, gender or gender identity, disability, or proficiency in the English language.”
In a proposed rule issued May 24, the U.S. Department of Health & Human Services outlined its plan to repeal an Obama-era policy that banned health care providers from discriminating against transgender patients. As part of the Affordable Care Act, Congress had directed HHS to apply existing civil rights and health care regulations to the health law exchanges, including rules that were consistent with Title IX, the federal law that prohibits discrimination on the basis of sex in federally funded programs. The Obama administration’s interpretation of this directive barred health care providers from denying care to transgender patients based on gender identify, defined as a patient’s “internal sense of being male, female, neither, or a combination of male and female.”
Repealing the transgender protections in the antidiscrimination policy will make the regulation more consistent with Title IX, according to HHS. In addition, revoking other provisions in the Obama-era policy associated with non–English speaking patients will reduce regulatory costs for unnecessary paperwork by $3.2 billion, according to a statement from the HHS.
“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” said Roger Severino, director of the HHS’s Office for Civil Rights, in the statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives. The proposed rule would accomplish both goals.”
In addressing the reasoning for the proposal, Mr. Severino noted two court decisions that have found the Obama-era policy unlawful. In 2016, the U.S. District Court for the Northern District of Texas temporarily barred the protections from being enacted, ruling that HHS had adopted an erroneous interpretation of “sex” under Title IX, and that the regulation was arbitrary and capricious for failing to incorporate Title IX’s religious and abortion exemptions. The U.S. District Court for the District of North Dakota agreed in a subsequent decision. Since the preliminary bans against the provisions, HHS has not enforced the protections. Removal of the discrimination protections for transgender patients would conform with the courts’ plain understanding of federal sex discrimination laws, according to HHS.
HHS emphasized that the proposed rule is not intended to remove any protections provided by Congress or to restrict states’ ability to enact health care discrimination protections that exceed Title IX requirements. Rather, the proposed rule would ensure that Title IX and corresponding regulations “follow the will of Congress with respect to the states by not expanding Title IX’s definition of ‘sex’ beyond the statutory bounds,” according to the proposed rule.
In addition to removing the transgender protections, the HHS also proposed to eliminate provisions under the Obama-era policy that required health care literature to be translated into 15 languages. The proposed revisions would eliminate $3.2 billion in unneeded paperwork burdens imposed by the translations, according to the agency. Mr. Severino indicated that the money saved could be used to more effectively address individual needs of non–English speakers such as by providing increased access to translators and interpreters.
The American College of Physicians expressed concern about the agency’s move to rewrite the discrimination rule.
“ACP believes that discrimination against patients, including those who identify as lesbian, gay, bisexual, and transgender (LGBT), creates social stigma that has been linked to negative physical and mental health outcomes, including anxiety, suicide, and substance or alcohol abuse,” ACP President Robert McLean, MD, said in a statement. “ACP strongly urges the administration to withdraw their proposal, and instead, make meaningful policy changes that will ensure nondiscrimination in health care against all patients, regardless of their sexual orientation, gender or gender identity, disability, or proficiency in the English language.”
In a proposed rule issued May 24, the U.S. Department of Health & Human Services outlined its plan to repeal an Obama-era policy that banned health care providers from discriminating against transgender patients. As part of the Affordable Care Act, Congress had directed HHS to apply existing civil rights and health care regulations to the health law exchanges, including rules that were consistent with Title IX, the federal law that prohibits discrimination on the basis of sex in federally funded programs. The Obama administration’s interpretation of this directive barred health care providers from denying care to transgender patients based on gender identify, defined as a patient’s “internal sense of being male, female, neither, or a combination of male and female.”
Repealing the transgender protections in the antidiscrimination policy will make the regulation more consistent with Title IX, according to HHS. In addition, revoking other provisions in the Obama-era policy associated with non–English speaking patients will reduce regulatory costs for unnecessary paperwork by $3.2 billion, according to a statement from the HHS.
“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” said Roger Severino, director of the HHS’s Office for Civil Rights, in the statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives. The proposed rule would accomplish both goals.”
In addressing the reasoning for the proposal, Mr. Severino noted two court decisions that have found the Obama-era policy unlawful. In 2016, the U.S. District Court for the Northern District of Texas temporarily barred the protections from being enacted, ruling that HHS had adopted an erroneous interpretation of “sex” under Title IX, and that the regulation was arbitrary and capricious for failing to incorporate Title IX’s religious and abortion exemptions. The U.S. District Court for the District of North Dakota agreed in a subsequent decision. Since the preliminary bans against the provisions, HHS has not enforced the protections. Removal of the discrimination protections for transgender patients would conform with the courts’ plain understanding of federal sex discrimination laws, according to HHS.
HHS emphasized that the proposed rule is not intended to remove any protections provided by Congress or to restrict states’ ability to enact health care discrimination protections that exceed Title IX requirements. Rather, the proposed rule would ensure that Title IX and corresponding regulations “follow the will of Congress with respect to the states by not expanding Title IX’s definition of ‘sex’ beyond the statutory bounds,” according to the proposed rule.
In addition to removing the transgender protections, the HHS also proposed to eliminate provisions under the Obama-era policy that required health care literature to be translated into 15 languages. The proposed revisions would eliminate $3.2 billion in unneeded paperwork burdens imposed by the translations, according to the agency. Mr. Severino indicated that the money saved could be used to more effectively address individual needs of non–English speakers such as by providing increased access to translators and interpreters.
The American College of Physicians expressed concern about the agency’s move to rewrite the discrimination rule.
“ACP believes that discrimination against patients, including those who identify as lesbian, gay, bisexual, and transgender (LGBT), creates social stigma that has been linked to negative physical and mental health outcomes, including anxiety, suicide, and substance or alcohol abuse,” ACP President Robert McLean, MD, said in a statement. “ACP strongly urges the administration to withdraw their proposal, and instead, make meaningful policy changes that will ensure nondiscrimination in health care against all patients, regardless of their sexual orientation, gender or gender identity, disability, or proficiency in the English language.”
Improved records, communication drive Oncology Care Model success
Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.
Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.
A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.
For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.
However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.
Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.
Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.
“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”
CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.
Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.
SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.
Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.
Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.
A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.
For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.
However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.
Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.
Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.
“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”
CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.
Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.
SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.
Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.
Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.
A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.
For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.
However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.
Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.
Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.
“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”
CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.
Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.
SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.
FROM THE JOURNAL OF THE NATIONAL CANCER INSTITUTE
Antiabortion measures may lead to Supreme Court showdown
The debate over abortion rights could be headed to the U.S. Supreme Court after two recent state measures that aim to restrict access to abortion.
On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. The law allows exceptions if the pregnancy poses death or serious harm to the woman, and in cases of rape or incest.
A week later, the Alabama Senate on May 14 approved a measure that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion. The Alabama bill includes an exception if a woman’s life is at risk, but not for cases of rape or incest. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
Both measures will likely be challenged in court; the Alabama law, in particular, could land in front of the U.S. Supreme Court as a direct challenge to Roe v. Wade.
Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Associate Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, according to Fatima Goss Graves, president of the National Women’s Law Center, a liberal-leaning legal firm that advocates gender equality.
“After decades of chipping away at Roe, antiabortion legislators and advocates are feeling emboldened with the addition of Justice Kavanaugh on the Supreme Court and they are exposing their true goal – to ban abortion altogether,” Ms. Graves said in a statement. “And make no mistake, [passage of the Alabama bill] is extreme overreach: The vast majority of people in this country do not support criminalizing women or doctors and want abortion to be safe and legal.”
National antiabortion group Susan B. Anthony List called Alabama’s measure a landmark victory and indicated that the bill passage may ultimately change the outcome of Roe v. Wade.
“Across the nation there is growing momentum, informed by science and compassion, and spurred on in reaction to abortion extremism in New York and Virginia, to recognize the humanity of the unborn child in the law,” Susan B. Anthony List President Marjorie Dannenfelser said in a statement. “It is clearer than ever that Roe is far from being settled law in the eyes and hearts of the American people, and this is increasingly reflected in state legislatures. ... The time is coming for the Supreme Court to let that debate go forward.”
Other states have recently passed laws similar to Georgia’s measure, dubbed the “fetal heartbeat bills,” including Kentucky, Mississippi, and Ohio.
On May 15, the American Civil Liberties Union and Planned Parenthood of Greater Ohio issued a joint legal challenge against Ohio’s law, calling it blatantly unconstitutional. Meanwhile, the Center for Reproductive Rights has pledged to sue Georgia over its law.
Ted Anderson, MD, president of the American College of Obstetricians and Gynecologists, said the many recent restrictions to abortion access across the country are harmful to women’s health and detrimental to the physician-patient relationship.
“Lawmakers must support health policies based on sound science and evidence. Politicians must seek to improve access to care, not restrict it,” Dr. Anderson said in a statement. “Legislative restrictions fundamentally interfere with the patient-provider relationship and decrease access to necessary care for all women, and particularly for low-income women and those living long distances from health care providers. Health care decisions should be made jointly only by patients and their trusted health care professionals, not by politicians.”
The debate over abortion rights could be headed to the U.S. Supreme Court after two recent state measures that aim to restrict access to abortion.
On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. The law allows exceptions if the pregnancy poses death or serious harm to the woman, and in cases of rape or incest.
A week later, the Alabama Senate on May 14 approved a measure that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion. The Alabama bill includes an exception if a woman’s life is at risk, but not for cases of rape or incest. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
Both measures will likely be challenged in court; the Alabama law, in particular, could land in front of the U.S. Supreme Court as a direct challenge to Roe v. Wade.
Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Associate Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, according to Fatima Goss Graves, president of the National Women’s Law Center, a liberal-leaning legal firm that advocates gender equality.
“After decades of chipping away at Roe, antiabortion legislators and advocates are feeling emboldened with the addition of Justice Kavanaugh on the Supreme Court and they are exposing their true goal – to ban abortion altogether,” Ms. Graves said in a statement. “And make no mistake, [passage of the Alabama bill] is extreme overreach: The vast majority of people in this country do not support criminalizing women or doctors and want abortion to be safe and legal.”
National antiabortion group Susan B. Anthony List called Alabama’s measure a landmark victory and indicated that the bill passage may ultimately change the outcome of Roe v. Wade.
“Across the nation there is growing momentum, informed by science and compassion, and spurred on in reaction to abortion extremism in New York and Virginia, to recognize the humanity of the unborn child in the law,” Susan B. Anthony List President Marjorie Dannenfelser said in a statement. “It is clearer than ever that Roe is far from being settled law in the eyes and hearts of the American people, and this is increasingly reflected in state legislatures. ... The time is coming for the Supreme Court to let that debate go forward.”
Other states have recently passed laws similar to Georgia’s measure, dubbed the “fetal heartbeat bills,” including Kentucky, Mississippi, and Ohio.
On May 15, the American Civil Liberties Union and Planned Parenthood of Greater Ohio issued a joint legal challenge against Ohio’s law, calling it blatantly unconstitutional. Meanwhile, the Center for Reproductive Rights has pledged to sue Georgia over its law.
Ted Anderson, MD, president of the American College of Obstetricians and Gynecologists, said the many recent restrictions to abortion access across the country are harmful to women’s health and detrimental to the physician-patient relationship.
“Lawmakers must support health policies based on sound science and evidence. Politicians must seek to improve access to care, not restrict it,” Dr. Anderson said in a statement. “Legislative restrictions fundamentally interfere with the patient-provider relationship and decrease access to necessary care for all women, and particularly for low-income women and those living long distances from health care providers. Health care decisions should be made jointly only by patients and their trusted health care professionals, not by politicians.”
The debate over abortion rights could be headed to the U.S. Supreme Court after two recent state measures that aim to restrict access to abortion.
On May 7, 2019, Georgia Gov. Brian Kemp (R) signed into law a statute that bars physicians from performing an abortion after a heartbeat is detected – usually at about 6 weeks of pregnancy. The law allows exceptions if the pregnancy poses death or serious harm to the woman, and in cases of rape or incest.
A week later, the Alabama Senate on May 14 approved a measure that would ban abortion at every pregnancy stage and penalize physicians with a Class A felony for performing an abortion and charge them with a Class C felony for attempting to perform an abortion. The Alabama bill includes an exception if a woman’s life is at risk, but not for cases of rape or incest. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
Both measures will likely be challenged in court; the Alabama law, in particular, could land in front of the U.S. Supreme Court as a direct challenge to Roe v. Wade.
Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Associate Justice Brett M. Kavanaugh and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe, according to Fatima Goss Graves, president of the National Women’s Law Center, a liberal-leaning legal firm that advocates gender equality.
“After decades of chipping away at Roe, antiabortion legislators and advocates are feeling emboldened with the addition of Justice Kavanaugh on the Supreme Court and they are exposing their true goal – to ban abortion altogether,” Ms. Graves said in a statement. “And make no mistake, [passage of the Alabama bill] is extreme overreach: The vast majority of people in this country do not support criminalizing women or doctors and want abortion to be safe and legal.”
National antiabortion group Susan B. Anthony List called Alabama’s measure a landmark victory and indicated that the bill passage may ultimately change the outcome of Roe v. Wade.
“Across the nation there is growing momentum, informed by science and compassion, and spurred on in reaction to abortion extremism in New York and Virginia, to recognize the humanity of the unborn child in the law,” Susan B. Anthony List President Marjorie Dannenfelser said in a statement. “It is clearer than ever that Roe is far from being settled law in the eyes and hearts of the American people, and this is increasingly reflected in state legislatures. ... The time is coming for the Supreme Court to let that debate go forward.”
Other states have recently passed laws similar to Georgia’s measure, dubbed the “fetal heartbeat bills,” including Kentucky, Mississippi, and Ohio.
On May 15, the American Civil Liberties Union and Planned Parenthood of Greater Ohio issued a joint legal challenge against Ohio’s law, calling it blatantly unconstitutional. Meanwhile, the Center for Reproductive Rights has pledged to sue Georgia over its law.
Ted Anderson, MD, president of the American College of Obstetricians and Gynecologists, said the many recent restrictions to abortion access across the country are harmful to women’s health and detrimental to the physician-patient relationship.
“Lawmakers must support health policies based on sound science and evidence. Politicians must seek to improve access to care, not restrict it,” Dr. Anderson said in a statement. “Legislative restrictions fundamentally interfere with the patient-provider relationship and decrease access to necessary care for all women, and particularly for low-income women and those living long distances from health care providers. Health care decisions should be made jointly only by patients and their trusted health care professionals, not by politicians.”
High-deductible plans do not raise out-of-pocket costs for autism care
In states that mandate coverage for autism spectrum disorder (ASD) health services, families in high-deductible health plans (HDHPs) access ASD-related services without paying more out-of-pocket expenses than traditional plan enrollees, an analysis found.
Lead author Colleen L. Barry, PhD, of Johns Hopkins University, Baltimore, and colleagues examined insurance claims between 2008 and 2012 for children covered by three large U.S. insurers (United Healthcare, Aetna, and Humana) to compare the effects of ASD-related coverage mandates on health spending. At least 47 states and Washington, D.C., have enacted mandates that require insurers to cover ASD-related health services, such as diagnostic and assessment services and behavioral and functional therapies. The final study sample included 98,639 children aged 0-21 years with at least two ASD-related service claims on different days during the study period.
The investigators found that, among HDHP enrollees, coverage mandates were associated with marked increases in average monthly spending across all service categories, but not among traditional plan enrollees. Specifically for HDHP patients, ASD coverage mandates were linked to a $98 greater increase in average monthly spending for insurers on ASD-specific outpatient services, a $142 greater increase in average monthly insurer spending on all outpatient services, and a $142 greater increase in average monthly insurer spending on all health services, according to the study published in Pediatrics. Out-of-pocket spending by patients however, was not significantly different between HDHP and traditional plan enrollees in states that mandate ASD-related coverage, the study found.
Dr. Barry and associates concluded that patients in both HDHP and traditional insurance plans spend large sums on ASD-related care in coverage mandate states, but because costs likely exceed HDHP deductibles, insurers absorb any increases. They suggested that families with regularly high health care expenditures related to ASD services consider high-deductible plans in the context of mandate laws.
“Future research is needed to better understand how features of HDHPs, such as deductible size and health savings account structure, influence the ability of families to make wise choices in obtaining care, and to examine plan premiums and financial strain associated with these plans, particularly for families with children with ASD and high expenditures,” Dr. Barry and associates wrote.
The authors reported no relevant financial disclosures. The study was supported by a National Institute of Mental Health grant and funded by the National Institutes of Health.
SOURCE: Barry CL et al. Pediatrics. 2019 May 13. doi: 10.1542/peds.2018-2391.
The analysis by Barry et al. takes a deep dive into the impact of different payment models on a family’s access to autism spectrum disorder–related services, commented David Keller, MD, and Ann Reynolds, MD.
The work emphasizes the reason that “we must continue to study how interventions in behavioral economics, such as mandates and high-deductible health plans, impact access to care for our most vulnerable children,” they wrote.
These data were from 2008 to 2012, before the Affordable Care Act was implemented. As the definition of “high deductible” has changed from $3,000 annually to $10,000 annually, “have families made different choices regarding care?” they asked.
“With the implementation of value-based payments, we will be creating competing forces through the application of behavioral economics. We need to understand how the interplay of economic forces affects families and their access to essential services,” Dr. Keller and Dr. Reynolds continued.
“We need to understand how to help families make informed decisions that balance the needs of their children with the financial realities of our complex care system so that we can support them in that process,” they wrote. “Understanding the impact of behavioral economics on consumer behavior is essential to assuring that children get the right care at the right time for the right diagnosis.”
Dr. Keller is a professor and Dr. Reynolds is an associate professor at the University of Colorado at Denver, Aurora. This is an excerpt of their editorial that accompanies the study by Barry et al. (Pediatrics. 2019 May 13. doi: 10.1542/peds.2019-0926). Dr. Keller reported no relevant financial disclosures. Dr. Reynolds reported providing consultation to Ovid Therapeutics regarding evaluation of sleep severity and improvement in clinical trials.
The analysis by Barry et al. takes a deep dive into the impact of different payment models on a family’s access to autism spectrum disorder–related services, commented David Keller, MD, and Ann Reynolds, MD.
The work emphasizes the reason that “we must continue to study how interventions in behavioral economics, such as mandates and high-deductible health plans, impact access to care for our most vulnerable children,” they wrote.
These data were from 2008 to 2012, before the Affordable Care Act was implemented. As the definition of “high deductible” has changed from $3,000 annually to $10,000 annually, “have families made different choices regarding care?” they asked.
“With the implementation of value-based payments, we will be creating competing forces through the application of behavioral economics. We need to understand how the interplay of economic forces affects families and their access to essential services,” Dr. Keller and Dr. Reynolds continued.
“We need to understand how to help families make informed decisions that balance the needs of their children with the financial realities of our complex care system so that we can support them in that process,” they wrote. “Understanding the impact of behavioral economics on consumer behavior is essential to assuring that children get the right care at the right time for the right diagnosis.”
Dr. Keller is a professor and Dr. Reynolds is an associate professor at the University of Colorado at Denver, Aurora. This is an excerpt of their editorial that accompanies the study by Barry et al. (Pediatrics. 2019 May 13. doi: 10.1542/peds.2019-0926). Dr. Keller reported no relevant financial disclosures. Dr. Reynolds reported providing consultation to Ovid Therapeutics regarding evaluation of sleep severity and improvement in clinical trials.
The analysis by Barry et al. takes a deep dive into the impact of different payment models on a family’s access to autism spectrum disorder–related services, commented David Keller, MD, and Ann Reynolds, MD.
The work emphasizes the reason that “we must continue to study how interventions in behavioral economics, such as mandates and high-deductible health plans, impact access to care for our most vulnerable children,” they wrote.
These data were from 2008 to 2012, before the Affordable Care Act was implemented. As the definition of “high deductible” has changed from $3,000 annually to $10,000 annually, “have families made different choices regarding care?” they asked.
“With the implementation of value-based payments, we will be creating competing forces through the application of behavioral economics. We need to understand how the interplay of economic forces affects families and their access to essential services,” Dr. Keller and Dr. Reynolds continued.
“We need to understand how to help families make informed decisions that balance the needs of their children with the financial realities of our complex care system so that we can support them in that process,” they wrote. “Understanding the impact of behavioral economics on consumer behavior is essential to assuring that children get the right care at the right time for the right diagnosis.”
Dr. Keller is a professor and Dr. Reynolds is an associate professor at the University of Colorado at Denver, Aurora. This is an excerpt of their editorial that accompanies the study by Barry et al. (Pediatrics. 2019 May 13. doi: 10.1542/peds.2019-0926). Dr. Keller reported no relevant financial disclosures. Dr. Reynolds reported providing consultation to Ovid Therapeutics regarding evaluation of sleep severity and improvement in clinical trials.
In states that mandate coverage for autism spectrum disorder (ASD) health services, families in high-deductible health plans (HDHPs) access ASD-related services without paying more out-of-pocket expenses than traditional plan enrollees, an analysis found.
Lead author Colleen L. Barry, PhD, of Johns Hopkins University, Baltimore, and colleagues examined insurance claims between 2008 and 2012 for children covered by three large U.S. insurers (United Healthcare, Aetna, and Humana) to compare the effects of ASD-related coverage mandates on health spending. At least 47 states and Washington, D.C., have enacted mandates that require insurers to cover ASD-related health services, such as diagnostic and assessment services and behavioral and functional therapies. The final study sample included 98,639 children aged 0-21 years with at least two ASD-related service claims on different days during the study period.
The investigators found that, among HDHP enrollees, coverage mandates were associated with marked increases in average monthly spending across all service categories, but not among traditional plan enrollees. Specifically for HDHP patients, ASD coverage mandates were linked to a $98 greater increase in average monthly spending for insurers on ASD-specific outpatient services, a $142 greater increase in average monthly insurer spending on all outpatient services, and a $142 greater increase in average monthly insurer spending on all health services, according to the study published in Pediatrics. Out-of-pocket spending by patients however, was not significantly different between HDHP and traditional plan enrollees in states that mandate ASD-related coverage, the study found.
Dr. Barry and associates concluded that patients in both HDHP and traditional insurance plans spend large sums on ASD-related care in coverage mandate states, but because costs likely exceed HDHP deductibles, insurers absorb any increases. They suggested that families with regularly high health care expenditures related to ASD services consider high-deductible plans in the context of mandate laws.
“Future research is needed to better understand how features of HDHPs, such as deductible size and health savings account structure, influence the ability of families to make wise choices in obtaining care, and to examine plan premiums and financial strain associated with these plans, particularly for families with children with ASD and high expenditures,” Dr. Barry and associates wrote.
The authors reported no relevant financial disclosures. The study was supported by a National Institute of Mental Health grant and funded by the National Institutes of Health.
SOURCE: Barry CL et al. Pediatrics. 2019 May 13. doi: 10.1542/peds.2018-2391.
In states that mandate coverage for autism spectrum disorder (ASD) health services, families in high-deductible health plans (HDHPs) access ASD-related services without paying more out-of-pocket expenses than traditional plan enrollees, an analysis found.
Lead author Colleen L. Barry, PhD, of Johns Hopkins University, Baltimore, and colleagues examined insurance claims between 2008 and 2012 for children covered by three large U.S. insurers (United Healthcare, Aetna, and Humana) to compare the effects of ASD-related coverage mandates on health spending. At least 47 states and Washington, D.C., have enacted mandates that require insurers to cover ASD-related health services, such as diagnostic and assessment services and behavioral and functional therapies. The final study sample included 98,639 children aged 0-21 years with at least two ASD-related service claims on different days during the study period.
The investigators found that, among HDHP enrollees, coverage mandates were associated with marked increases in average monthly spending across all service categories, but not among traditional plan enrollees. Specifically for HDHP patients, ASD coverage mandates were linked to a $98 greater increase in average monthly spending for insurers on ASD-specific outpatient services, a $142 greater increase in average monthly insurer spending on all outpatient services, and a $142 greater increase in average monthly insurer spending on all health services, according to the study published in Pediatrics. Out-of-pocket spending by patients however, was not significantly different between HDHP and traditional plan enrollees in states that mandate ASD-related coverage, the study found.
Dr. Barry and associates concluded that patients in both HDHP and traditional insurance plans spend large sums on ASD-related care in coverage mandate states, but because costs likely exceed HDHP deductibles, insurers absorb any increases. They suggested that families with regularly high health care expenditures related to ASD services consider high-deductible plans in the context of mandate laws.
“Future research is needed to better understand how features of HDHPs, such as deductible size and health savings account structure, influence the ability of families to make wise choices in obtaining care, and to examine plan premiums and financial strain associated with these plans, particularly for families with children with ASD and high expenditures,” Dr. Barry and associates wrote.
The authors reported no relevant financial disclosures. The study was supported by a National Institute of Mental Health grant and funded by the National Institutes of Health.
SOURCE: Barry CL et al. Pediatrics. 2019 May 13. doi: 10.1542/peds.2018-2391.
FROM PEDIATRICS
Employed physicians now outnumber independent doctors
For the first time, employed physicians outnumber independent physicians, according to a survey from the American Medical Association.
The AMA’s annual Physician Practice Benchmark Survey, which queried 3,500 doctors, showed that 47% of all physicians in 2018 were employed, compared with 46% of doctors who were self-employed that year. The number of employed physicians has risen 6 percentage points since 2012, while the number of self-employed doctors has fallen by 7 percentage points over the same period, according to the study published May 6 on the AMA website.
Younger physicians and women doctors were more likely to be employed than their counterparts. Nearly 70% of physicians under age 40 years were employees in 2018, compared with 38% of physicians 55 years and older, the study found. About 35% of physicians worked either directly for a hospital or in a practice at least partly owned by a hospital in 2018, up from 29% in 2012.
More than half of physicians surveyed (54%) worked in physician-owned practices in 2018 either as an owner, employee, or contractor, a decrease from 60% in 2012. Male physicians were more likely to be practice owners than female physicians. Among female doctors, 58% were employees, compared with 34% who were practice owners, while 52% of men physicians were practice owners, compared with 42% who were employees.
Surgical subspecialists had the highest share of owners (65%) followed by obstetrician-gynecologists (54%) and internal medicine subspecialists (52%). Emergency physicians had the lowest share of owners (26%) and the highest share of independent contractors (27%). Family physicians, meanwhile, had the highest share of employed physicians (57%).
A majority of doctors still work in small practices, the analysis found. In 2018, 57% of physicians worked in practices with 10 or fewer physicians versus 61% in 2012. However, fewer physicians work in solo practice. Between 2012 and 2018 the percentage of physicians in solo practice fell from 18% in 2012 to 15% in 2018.
“Transformational change continues in the delivery of health care and physicians are responding by reevaluating their practice arrangements,” AMA President Barbara L. McAneny, MD, said in a statement. “Physicians must assess many factors and carefully determine for themselves what settings they find professionally rewarding when considering independence or employment.”
The AMA’s Physician Practice Benchmark Survey is a nationally representative survey of post-residency physicians who provide at least 20 hours of patient care per week, are not employed by the federal government, and practice in one of the 50 states or the District of Columbia. The 2018 survey was conducted in September 2018, and the final data included 3,500 physicians.
For the first time, employed physicians outnumber independent physicians, according to a survey from the American Medical Association.
The AMA’s annual Physician Practice Benchmark Survey, which queried 3,500 doctors, showed that 47% of all physicians in 2018 were employed, compared with 46% of doctors who were self-employed that year. The number of employed physicians has risen 6 percentage points since 2012, while the number of self-employed doctors has fallen by 7 percentage points over the same period, according to the study published May 6 on the AMA website.
Younger physicians and women doctors were more likely to be employed than their counterparts. Nearly 70% of physicians under age 40 years were employees in 2018, compared with 38% of physicians 55 years and older, the study found. About 35% of physicians worked either directly for a hospital or in a practice at least partly owned by a hospital in 2018, up from 29% in 2012.
More than half of physicians surveyed (54%) worked in physician-owned practices in 2018 either as an owner, employee, or contractor, a decrease from 60% in 2012. Male physicians were more likely to be practice owners than female physicians. Among female doctors, 58% were employees, compared with 34% who were practice owners, while 52% of men physicians were practice owners, compared with 42% who were employees.
Surgical subspecialists had the highest share of owners (65%) followed by obstetrician-gynecologists (54%) and internal medicine subspecialists (52%). Emergency physicians had the lowest share of owners (26%) and the highest share of independent contractors (27%). Family physicians, meanwhile, had the highest share of employed physicians (57%).
A majority of doctors still work in small practices, the analysis found. In 2018, 57% of physicians worked in practices with 10 or fewer physicians versus 61% in 2012. However, fewer physicians work in solo practice. Between 2012 and 2018 the percentage of physicians in solo practice fell from 18% in 2012 to 15% in 2018.
“Transformational change continues in the delivery of health care and physicians are responding by reevaluating their practice arrangements,” AMA President Barbara L. McAneny, MD, said in a statement. “Physicians must assess many factors and carefully determine for themselves what settings they find professionally rewarding when considering independence or employment.”
The AMA’s Physician Practice Benchmark Survey is a nationally representative survey of post-residency physicians who provide at least 20 hours of patient care per week, are not employed by the federal government, and practice in one of the 50 states or the District of Columbia. The 2018 survey was conducted in September 2018, and the final data included 3,500 physicians.
For the first time, employed physicians outnumber independent physicians, according to a survey from the American Medical Association.
The AMA’s annual Physician Practice Benchmark Survey, which queried 3,500 doctors, showed that 47% of all physicians in 2018 were employed, compared with 46% of doctors who were self-employed that year. The number of employed physicians has risen 6 percentage points since 2012, while the number of self-employed doctors has fallen by 7 percentage points over the same period, according to the study published May 6 on the AMA website.
Younger physicians and women doctors were more likely to be employed than their counterparts. Nearly 70% of physicians under age 40 years were employees in 2018, compared with 38% of physicians 55 years and older, the study found. About 35% of physicians worked either directly for a hospital or in a practice at least partly owned by a hospital in 2018, up from 29% in 2012.
More than half of physicians surveyed (54%) worked in physician-owned practices in 2018 either as an owner, employee, or contractor, a decrease from 60% in 2012. Male physicians were more likely to be practice owners than female physicians. Among female doctors, 58% were employees, compared with 34% who were practice owners, while 52% of men physicians were practice owners, compared with 42% who were employees.
Surgical subspecialists had the highest share of owners (65%) followed by obstetrician-gynecologists (54%) and internal medicine subspecialists (52%). Emergency physicians had the lowest share of owners (26%) and the highest share of independent contractors (27%). Family physicians, meanwhile, had the highest share of employed physicians (57%).
A majority of doctors still work in small practices, the analysis found. In 2018, 57% of physicians worked in practices with 10 or fewer physicians versus 61% in 2012. However, fewer physicians work in solo practice. Between 2012 and 2018 the percentage of physicians in solo practice fell from 18% in 2012 to 15% in 2018.
“Transformational change continues in the delivery of health care and physicians are responding by reevaluating their practice arrangements,” AMA President Barbara L. McAneny, MD, said in a statement. “Physicians must assess many factors and carefully determine for themselves what settings they find professionally rewarding when considering independence or employment.”
The AMA’s Physician Practice Benchmark Survey is a nationally representative survey of post-residency physicians who provide at least 20 hours of patient care per week, are not employed by the federal government, and practice in one of the 50 states or the District of Columbia. The 2018 survey was conducted in September 2018, and the final data included 3,500 physicians.
Key clinical point: More doctors are employees vs. business owners for the first time.
Major finding: Of surveyed physicians, 47% are employees versus 46% who are self-employed.
Study details: Annual survey of 3,500 physicians.
Disclosures: The survey was conducted by the American Medical Association.
Source: Kane C. Updated Data on Physician Practice Arrangements. May 6, 2019.
CMS proposes payment increase for administering CAR T in the hospital
Hospitals could get a payment bump for administering chimeric antigen receptor (CAR) T-cell therapies under a proposed rule issued by the Centers for Medicare & Medicaid Services.
The proposal calls for raising the new technology add-on payment (NTAP) associated with the therapies from 50% of the technology to 65%, an increase from $186,500 to $242,450.
Beginning with discharges on Oct. 1, 2019, if discharge costs involving a new medical service or technology exceed the full Medicare Severity Diagnosis-Related Group (DRG) payment, Medicare would make an add-on payment of either 65% of the cost of the new medical service or technology, or 65% of the amount by which the costs of the case exceed the standard DRG payment, whichever is less.
Roy Silverstein, MD, president of the American Society of Hematology, said the group was pleased that the CMS is examining its existing payment policies to identify more realistic ways to account for the costs of administering CAR T-cell therapies.
“While ASH had originally suggested a higher [new technology] payment, any increase is an improvement,” Dr. Silverstein said in a statement. “While the proposal from CMS is promising, it is not a one-stop solution for making CAR T more accessible to patients. Just as these therapies are innovative, it is going to take some innovation on the part of CMS to develop a plan that equitably compensates providers and institutions so that offering the therapy is sustainable.”
The agency’s proposal follows an August 2018 final rule by the CMS that set a new payment scheme for inpatient administration of two CAR T-cell therapies. The rule categorized CAR T-cell therapies under the umbrella of the renamed Medicare Severity–Diagnosis Related Groups (MS-DRG) 016 – Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy – and assigned ICD-10 PCS procedure codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019, which began in October 2018.
In April 2018, the CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.
In February 2019, the CMS also proposed to cover CAR T-cell therapy for cancer patients participating in clinical trials that study the treatment’s effectiveness. A final decision on the proposal is expected in May 2019.
In the current proposal, the CMS acknowledged requests calling for the agency to create a new MS-DRG for procedures involving CAR T-cell therapies to improve payment in the inpatient setting. However, the agency declined to create a new MS-DRG for CAR T-cell cases, writing that the move is premature given the relative newness of CAR T-cell therapy and the agency’s proposal to continue new technology add-on payments for fiscal 2020 for Kymriah and Yescarta.
However, the agency is requesting public comments on whether, in light of additional experience with billing and payment for cases involving CAR T-cell therapies to Medicare patients, the CMS should consider using a specific cost-to-charge ratio for ICD-10-PCS procedure codes used to report the performance of procedures involving CAR T-cell therapies.
Comments on the proposed rule will be accepted until June 24.
Hospitals could get a payment bump for administering chimeric antigen receptor (CAR) T-cell therapies under a proposed rule issued by the Centers for Medicare & Medicaid Services.
The proposal calls for raising the new technology add-on payment (NTAP) associated with the therapies from 50% of the technology to 65%, an increase from $186,500 to $242,450.
Beginning with discharges on Oct. 1, 2019, if discharge costs involving a new medical service or technology exceed the full Medicare Severity Diagnosis-Related Group (DRG) payment, Medicare would make an add-on payment of either 65% of the cost of the new medical service or technology, or 65% of the amount by which the costs of the case exceed the standard DRG payment, whichever is less.
Roy Silverstein, MD, president of the American Society of Hematology, said the group was pleased that the CMS is examining its existing payment policies to identify more realistic ways to account for the costs of administering CAR T-cell therapies.
“While ASH had originally suggested a higher [new technology] payment, any increase is an improvement,” Dr. Silverstein said in a statement. “While the proposal from CMS is promising, it is not a one-stop solution for making CAR T more accessible to patients. Just as these therapies are innovative, it is going to take some innovation on the part of CMS to develop a plan that equitably compensates providers and institutions so that offering the therapy is sustainable.”
The agency’s proposal follows an August 2018 final rule by the CMS that set a new payment scheme for inpatient administration of two CAR T-cell therapies. The rule categorized CAR T-cell therapies under the umbrella of the renamed Medicare Severity–Diagnosis Related Groups (MS-DRG) 016 – Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy – and assigned ICD-10 PCS procedure codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019, which began in October 2018.
In April 2018, the CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.
In February 2019, the CMS also proposed to cover CAR T-cell therapy for cancer patients participating in clinical trials that study the treatment’s effectiveness. A final decision on the proposal is expected in May 2019.
In the current proposal, the CMS acknowledged requests calling for the agency to create a new MS-DRG for procedures involving CAR T-cell therapies to improve payment in the inpatient setting. However, the agency declined to create a new MS-DRG for CAR T-cell cases, writing that the move is premature given the relative newness of CAR T-cell therapy and the agency’s proposal to continue new technology add-on payments for fiscal 2020 for Kymriah and Yescarta.
However, the agency is requesting public comments on whether, in light of additional experience with billing and payment for cases involving CAR T-cell therapies to Medicare patients, the CMS should consider using a specific cost-to-charge ratio for ICD-10-PCS procedure codes used to report the performance of procedures involving CAR T-cell therapies.
Comments on the proposed rule will be accepted until June 24.
Hospitals could get a payment bump for administering chimeric antigen receptor (CAR) T-cell therapies under a proposed rule issued by the Centers for Medicare & Medicaid Services.
The proposal calls for raising the new technology add-on payment (NTAP) associated with the therapies from 50% of the technology to 65%, an increase from $186,500 to $242,450.
Beginning with discharges on Oct. 1, 2019, if discharge costs involving a new medical service or technology exceed the full Medicare Severity Diagnosis-Related Group (DRG) payment, Medicare would make an add-on payment of either 65% of the cost of the new medical service or technology, or 65% of the amount by which the costs of the case exceed the standard DRG payment, whichever is less.
Roy Silverstein, MD, president of the American Society of Hematology, said the group was pleased that the CMS is examining its existing payment policies to identify more realistic ways to account for the costs of administering CAR T-cell therapies.
“While ASH had originally suggested a higher [new technology] payment, any increase is an improvement,” Dr. Silverstein said in a statement. “While the proposal from CMS is promising, it is not a one-stop solution for making CAR T more accessible to patients. Just as these therapies are innovative, it is going to take some innovation on the part of CMS to develop a plan that equitably compensates providers and institutions so that offering the therapy is sustainable.”
The agency’s proposal follows an August 2018 final rule by the CMS that set a new payment scheme for inpatient administration of two CAR T-cell therapies. The rule categorized CAR T-cell therapies under the umbrella of the renamed Medicare Severity–Diagnosis Related Groups (MS-DRG) 016 – Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy – and assigned ICD-10 PCS procedure codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019, which began in October 2018.
In April 2018, the CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.
In February 2019, the CMS also proposed to cover CAR T-cell therapy for cancer patients participating in clinical trials that study the treatment’s effectiveness. A final decision on the proposal is expected in May 2019.
In the current proposal, the CMS acknowledged requests calling for the agency to create a new MS-DRG for procedures involving CAR T-cell therapies to improve payment in the inpatient setting. However, the agency declined to create a new MS-DRG for CAR T-cell cases, writing that the move is premature given the relative newness of CAR T-cell therapy and the agency’s proposal to continue new technology add-on payments for fiscal 2020 for Kymriah and Yescarta.
However, the agency is requesting public comments on whether, in light of additional experience with billing and payment for cases involving CAR T-cell therapies to Medicare patients, the CMS should consider using a specific cost-to-charge ratio for ICD-10-PCS procedure codes used to report the performance of procedures involving CAR T-cell therapies.
Comments on the proposed rule will be accepted until June 24.
Trump administration asks court to invalidate ACA
The Trump administration is asking an appeals court to strike down the entire Affordable Care Act (ACA), a shift from the administration’s earlier stance that had supported some elements of the law in a lawsuit challenging its constitutionality.
In a brief issued May 1 to the 5th U.S. Court of Appeals, Justice Department attorneys wrote that provisions of the health care law cannot be severed from the whole and thus, the entire ACA should be ruled invalid. The Justice Department did not specify why it changed its position in Texas v. United States, except to say the new opinion came upon further consideration and review of the lower court’s opinion.
Texas v. United States, filed by a group of 18 Republican state attorneys general and two individuals in 2018, centers on whether the ACA should stand if provisions of the law are no longer valid. The plaintiffs argue that, because budget legislation in 2017 zeroed out the penalties associated with the ACA’s individual mandate, the mandate is invalid. If the mandate is severed, the entire ACA should be struck down, the plaintiffs said. The Justice Department declined to fully defend the law and so 16 Democratic state attorneys general intervened to defend the ACA in the case.
In an initial brief, the Trump administration agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration wrote that, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. Guaranteed issue refers to insurers in the individual market offering coverage to all citizens, regardless of preexisting conditions, while community rating refers to charging equal premiums to every patient, no matter their past health status. At the time however, the Trump administration said the remainder of the ACA can stand without the three linked provisions.
In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th Circuit by the Democratic attorneys general. The circuit court froze the case in light of the federal government’s partial shutdown at the time. The case remains on hold.
The Trump administration’s new stance that the entire ACA should be declared unconstitutional was widely condemned by Democratic legislators.
“If President Trump wins against health care, families lose,” Sen. Patty Murray (D-Wash.) tweeted May 1. “They’ll lose their health care, lose protections for preexisting conditions, and lose to insurance companies who will have free rein to deny coverage and leave patients to shoulder high costs.”
The White House had not issued a statement about its new position in the case at press time.
In a separate brief filed with the appeals court on May 1, Texas Attorney General Ken Paxton, a Republican plaintiff in the case, reiterated his side’s opposition to the ACA and called for the court to uphold the lower court’s ruling striking down the law.
“Congress meant for the individual mandate to be the centerpiece of Obamacare,” Attorney General Paxton said in a statement. “Without the constitutional justification for the centerpiece, the law must go down. Obamacare is a failed social experiment. The sooner it is invalidated, the better, so each state can decide what type of health care system it wants and how best to provide for those with preexisting conditions, which is federalism that the founders intended.”
Timothy Jost, a health law professor at Washington and Lee University in Lexington, Va., said that administration’s revised position in Texas v. U.S. won’t have much impact on the case.
“The Department of Justice brief doesn’t change anything,” Mr. Jost said in an interview. “They basically make the same arguments that the individual plaintiffs and the state plaintiffs do as to the major issues in the case.
However, Mr. Jost said that the administration’s brief sounds confused and reads almost like two separate briefs. On one hand, the Justice Department argues that the entire ACA should be invalid because the mandate cannot be severed. On the other hand, the agency argues that court relief should be “limited only to those provisions that actually injure the individual plaintiffs.” Specifically, Justice Department attorneys indicate that health care fraud and abuse protections in the ACA should be preserved.
“It looks like they kind of want to have their cake and eat it, too,” Mr. Jost said. “They want to preserve the provisions of the ACA they like, but not the sections that they don’t like. That could serve to confuse the issue for the appellate court.”
Oral arguments in the case are slated for July with a possible decision expected by the end of 2019. Legal analysts expect the losing side to appeal to the Supreme Court.
The Trump administration is asking an appeals court to strike down the entire Affordable Care Act (ACA), a shift from the administration’s earlier stance that had supported some elements of the law in a lawsuit challenging its constitutionality.
In a brief issued May 1 to the 5th U.S. Court of Appeals, Justice Department attorneys wrote that provisions of the health care law cannot be severed from the whole and thus, the entire ACA should be ruled invalid. The Justice Department did not specify why it changed its position in Texas v. United States, except to say the new opinion came upon further consideration and review of the lower court’s opinion.
Texas v. United States, filed by a group of 18 Republican state attorneys general and two individuals in 2018, centers on whether the ACA should stand if provisions of the law are no longer valid. The plaintiffs argue that, because budget legislation in 2017 zeroed out the penalties associated with the ACA’s individual mandate, the mandate is invalid. If the mandate is severed, the entire ACA should be struck down, the plaintiffs said. The Justice Department declined to fully defend the law and so 16 Democratic state attorneys general intervened to defend the ACA in the case.
In an initial brief, the Trump administration agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration wrote that, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. Guaranteed issue refers to insurers in the individual market offering coverage to all citizens, regardless of preexisting conditions, while community rating refers to charging equal premiums to every patient, no matter their past health status. At the time however, the Trump administration said the remainder of the ACA can stand without the three linked provisions.
In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th Circuit by the Democratic attorneys general. The circuit court froze the case in light of the federal government’s partial shutdown at the time. The case remains on hold.
The Trump administration’s new stance that the entire ACA should be declared unconstitutional was widely condemned by Democratic legislators.
“If President Trump wins against health care, families lose,” Sen. Patty Murray (D-Wash.) tweeted May 1. “They’ll lose their health care, lose protections for preexisting conditions, and lose to insurance companies who will have free rein to deny coverage and leave patients to shoulder high costs.”
The White House had not issued a statement about its new position in the case at press time.
In a separate brief filed with the appeals court on May 1, Texas Attorney General Ken Paxton, a Republican plaintiff in the case, reiterated his side’s opposition to the ACA and called for the court to uphold the lower court’s ruling striking down the law.
“Congress meant for the individual mandate to be the centerpiece of Obamacare,” Attorney General Paxton said in a statement. “Without the constitutional justification for the centerpiece, the law must go down. Obamacare is a failed social experiment. The sooner it is invalidated, the better, so each state can decide what type of health care system it wants and how best to provide for those with preexisting conditions, which is federalism that the founders intended.”
Timothy Jost, a health law professor at Washington and Lee University in Lexington, Va., said that administration’s revised position in Texas v. U.S. won’t have much impact on the case.
“The Department of Justice brief doesn’t change anything,” Mr. Jost said in an interview. “They basically make the same arguments that the individual plaintiffs and the state plaintiffs do as to the major issues in the case.
However, Mr. Jost said that the administration’s brief sounds confused and reads almost like two separate briefs. On one hand, the Justice Department argues that the entire ACA should be invalid because the mandate cannot be severed. On the other hand, the agency argues that court relief should be “limited only to those provisions that actually injure the individual plaintiffs.” Specifically, Justice Department attorneys indicate that health care fraud and abuse protections in the ACA should be preserved.
“It looks like they kind of want to have their cake and eat it, too,” Mr. Jost said. “They want to preserve the provisions of the ACA they like, but not the sections that they don’t like. That could serve to confuse the issue for the appellate court.”
Oral arguments in the case are slated for July with a possible decision expected by the end of 2019. Legal analysts expect the losing side to appeal to the Supreme Court.
The Trump administration is asking an appeals court to strike down the entire Affordable Care Act (ACA), a shift from the administration’s earlier stance that had supported some elements of the law in a lawsuit challenging its constitutionality.
In a brief issued May 1 to the 5th U.S. Court of Appeals, Justice Department attorneys wrote that provisions of the health care law cannot be severed from the whole and thus, the entire ACA should be ruled invalid. The Justice Department did not specify why it changed its position in Texas v. United States, except to say the new opinion came upon further consideration and review of the lower court’s opinion.
Texas v. United States, filed by a group of 18 Republican state attorneys general and two individuals in 2018, centers on whether the ACA should stand if provisions of the law are no longer valid. The plaintiffs argue that, because budget legislation in 2017 zeroed out the penalties associated with the ACA’s individual mandate, the mandate is invalid. If the mandate is severed, the entire ACA should be struck down, the plaintiffs said. The Justice Department declined to fully defend the law and so 16 Democratic state attorneys general intervened to defend the ACA in the case.
In an initial brief, the Trump administration agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration wrote that, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. Guaranteed issue refers to insurers in the individual market offering coverage to all citizens, regardless of preexisting conditions, while community rating refers to charging equal premiums to every patient, no matter their past health status. At the time however, the Trump administration said the remainder of the ACA can stand without the three linked provisions.
In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th Circuit by the Democratic attorneys general. The circuit court froze the case in light of the federal government’s partial shutdown at the time. The case remains on hold.
The Trump administration’s new stance that the entire ACA should be declared unconstitutional was widely condemned by Democratic legislators.
“If President Trump wins against health care, families lose,” Sen. Patty Murray (D-Wash.) tweeted May 1. “They’ll lose their health care, lose protections for preexisting conditions, and lose to insurance companies who will have free rein to deny coverage and leave patients to shoulder high costs.”
The White House had not issued a statement about its new position in the case at press time.
In a separate brief filed with the appeals court on May 1, Texas Attorney General Ken Paxton, a Republican plaintiff in the case, reiterated his side’s opposition to the ACA and called for the court to uphold the lower court’s ruling striking down the law.
“Congress meant for the individual mandate to be the centerpiece of Obamacare,” Attorney General Paxton said in a statement. “Without the constitutional justification for the centerpiece, the law must go down. Obamacare is a failed social experiment. The sooner it is invalidated, the better, so each state can decide what type of health care system it wants and how best to provide for those with preexisting conditions, which is federalism that the founders intended.”
Timothy Jost, a health law professor at Washington and Lee University in Lexington, Va., said that administration’s revised position in Texas v. U.S. won’t have much impact on the case.
“The Department of Justice brief doesn’t change anything,” Mr. Jost said in an interview. “They basically make the same arguments that the individual plaintiffs and the state plaintiffs do as to the major issues in the case.
However, Mr. Jost said that the administration’s brief sounds confused and reads almost like two separate briefs. On one hand, the Justice Department argues that the entire ACA should be invalid because the mandate cannot be severed. On the other hand, the agency argues that court relief should be “limited only to those provisions that actually injure the individual plaintiffs.” Specifically, Justice Department attorneys indicate that health care fraud and abuse protections in the ACA should be preserved.
“It looks like they kind of want to have their cake and eat it, too,” Mr. Jost said. “They want to preserve the provisions of the ACA they like, but not the sections that they don’t like. That could serve to confuse the issue for the appellate court.”
Oral arguments in the case are slated for July with a possible decision expected by the end of 2019. Legal analysts expect the losing side to appeal to the Supreme Court.
