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CMS proposing more flexibility in Medicare Advantage, Part D
More flexibility in benefits design could be coming to Medicare Advantage and the Part D prescription drug benefit if proposals offered by the Centers for Medicare & Medicaid Services are finalized.
The agency issued its proposed update for both programs for the 2020 plan year, which would allow Medicare Advantage plan sponsors to offer more specialized supplemental benefits for beneficiaries with chronic illnesses.
“For the 2020 plan year and beyond, Medicare Advantage plans will have greater flexibility to offer chronically ill patients any benefit that improves or maintains their health,” Demetrios Kouzoukas, CMS principal deputy administrator for Medicare and director of the Center for Medicare, said during a Jan. 30 press teleconference. “For example, plans could provide home-delivered or special meals in a far broader set of circumstances than what is allowed today.”
He noted that it would be up to the plans to determine what kinds of supplemental benefits would be offered and added that the offering of these benefits would not require a waiver, but would be evaluated as part of the plan’s overall bid submitted to the agency.
“We recognize that Medicare beneficiaries frequently have multiple chronic conditions,” Mr. Kouzoukas said. “We are excited that these changes will allow these beneficiaries to have new options for improving their health as a result of innovative health plan benefits.”
For Medicare Part D, the agency is specifically encouraging plan sponsors “to provide lower cost sharing for opioid reversal agents such as naloxone,” he added. The proposal also offers additional flexibility for plans to offer targeted benefits and cost sharing reductions to patients with chronic pain or those undergoing addiction treatment, according to a fact sheet highlighting key proposals.
Comments on the proposals are due by March 1. CMS expects to finalize the changes by the beginning of April.
More flexibility in benefits design could be coming to Medicare Advantage and the Part D prescription drug benefit if proposals offered by the Centers for Medicare & Medicaid Services are finalized.
The agency issued its proposed update for both programs for the 2020 plan year, which would allow Medicare Advantage plan sponsors to offer more specialized supplemental benefits for beneficiaries with chronic illnesses.
“For the 2020 plan year and beyond, Medicare Advantage plans will have greater flexibility to offer chronically ill patients any benefit that improves or maintains their health,” Demetrios Kouzoukas, CMS principal deputy administrator for Medicare and director of the Center for Medicare, said during a Jan. 30 press teleconference. “For example, plans could provide home-delivered or special meals in a far broader set of circumstances than what is allowed today.”
He noted that it would be up to the plans to determine what kinds of supplemental benefits would be offered and added that the offering of these benefits would not require a waiver, but would be evaluated as part of the plan’s overall bid submitted to the agency.
“We recognize that Medicare beneficiaries frequently have multiple chronic conditions,” Mr. Kouzoukas said. “We are excited that these changes will allow these beneficiaries to have new options for improving their health as a result of innovative health plan benefits.”
For Medicare Part D, the agency is specifically encouraging plan sponsors “to provide lower cost sharing for opioid reversal agents such as naloxone,” he added. The proposal also offers additional flexibility for plans to offer targeted benefits and cost sharing reductions to patients with chronic pain or those undergoing addiction treatment, according to a fact sheet highlighting key proposals.
Comments on the proposals are due by March 1. CMS expects to finalize the changes by the beginning of April.
More flexibility in benefits design could be coming to Medicare Advantage and the Part D prescription drug benefit if proposals offered by the Centers for Medicare & Medicaid Services are finalized.
The agency issued its proposed update for both programs for the 2020 plan year, which would allow Medicare Advantage plan sponsors to offer more specialized supplemental benefits for beneficiaries with chronic illnesses.
“For the 2020 plan year and beyond, Medicare Advantage plans will have greater flexibility to offer chronically ill patients any benefit that improves or maintains their health,” Demetrios Kouzoukas, CMS principal deputy administrator for Medicare and director of the Center for Medicare, said during a Jan. 30 press teleconference. “For example, plans could provide home-delivered or special meals in a far broader set of circumstances than what is allowed today.”
He noted that it would be up to the plans to determine what kinds of supplemental benefits would be offered and added that the offering of these benefits would not require a waiver, but would be evaluated as part of the plan’s overall bid submitted to the agency.
“We recognize that Medicare beneficiaries frequently have multiple chronic conditions,” Mr. Kouzoukas said. “We are excited that these changes will allow these beneficiaries to have new options for improving their health as a result of innovative health plan benefits.”
For Medicare Part D, the agency is specifically encouraging plan sponsors “to provide lower cost sharing for opioid reversal agents such as naloxone,” he added. The proposal also offers additional flexibility for plans to offer targeted benefits and cost sharing reductions to patients with chronic pain or those undergoing addiction treatment, according to a fact sheet highlighting key proposals.
Comments on the proposals are due by March 1. CMS expects to finalize the changes by the beginning of April.
Shifting drugs from Part B to Part D could be costly to patients
A shift in Medicare drug coverage from Part B to Part D might save the government some money but could end up costing some patients in the long run.
Analysis of the 75 brand-name drugs with the highest Part B expenditures ($21.6 billion annually at 2018 prices) indicated that the government could save between $17.6 billion and $20.1 billion after rebates by switching coverage to Part D, Thomas J. Hwang of Harvard Medical School, Boston, and his associates said.
The potential for greater overall savings, however, “was constrained by the fact that 33 (44%) of the studied brand-name drugs were in protected classes, which HHS has reported precludes meaningful price negotiation by Part D plans,” they wrote.
The proposal also could have a “material impact” on patient out-of-pocket costs, although the impact would vary based on the drug as well as patients’ insurance coverage in addition to Medicare (JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417).
For example, moving drug coverage to Part D would lower out-of-pocket costs for the majority of the 75 drugs for patients with Medigap supplemental insurance, but out-of-pocket costs could go up for almost 40% of products. Patients who would benefit most from the shift would be those who qualify for the low-income subsidy, which can eliminate coinsurance requirements.
“By contrast, for patients with Medigap insurance, out-of-pocket costs in Part D were estimated to exceed the annual premium costs for supplemental insurance [approximately 47-56 of the 75 drugs],” Mr. Hwang and his colleagues added. “Out-of-pocket costs would be increased under the proposed policy for beneficiaries with Medigap but without Part D coverage.”
The analysis was limited by the inability to predict the proposed transition’s impact on insurance premiums or drug utilization. Patients who were dually eligible for Medicare and Medicaid were excluded.
SOURCE: Hwang TJ et al. JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417.
Policy analysts need to be careful and do their due diligence to ensure all consequences of the policy options are fully understood, especially as pharmaceuticals account for greater costs in the Medicare program. Future policy analyses must, like Mr. Hwang and his associates did, account for changes to Medicare costs as well as beneficiary costs to understand the overall effects of policy changes.
Francis Crosson, MD, chairman of the Medicare Payment Advisory Commission, and Jon Christianson, PhD, vice chairman of MedPAC, made these comments in an accompanying editorial (JAMA Int Med. doi: 10.1001/jamainternmed.2018.6146 ).
Policy analysts need to be careful and do their due diligence to ensure all consequences of the policy options are fully understood, especially as pharmaceuticals account for greater costs in the Medicare program. Future policy analyses must, like Mr. Hwang and his associates did, account for changes to Medicare costs as well as beneficiary costs to understand the overall effects of policy changes.
Francis Crosson, MD, chairman of the Medicare Payment Advisory Commission, and Jon Christianson, PhD, vice chairman of MedPAC, made these comments in an accompanying editorial (JAMA Int Med. doi: 10.1001/jamainternmed.2018.6146 ).
Policy analysts need to be careful and do their due diligence to ensure all consequences of the policy options are fully understood, especially as pharmaceuticals account for greater costs in the Medicare program. Future policy analyses must, like Mr. Hwang and his associates did, account for changes to Medicare costs as well as beneficiary costs to understand the overall effects of policy changes.
Francis Crosson, MD, chairman of the Medicare Payment Advisory Commission, and Jon Christianson, PhD, vice chairman of MedPAC, made these comments in an accompanying editorial (JAMA Int Med. doi: 10.1001/jamainternmed.2018.6146 ).
A shift in Medicare drug coverage from Part B to Part D might save the government some money but could end up costing some patients in the long run.
Analysis of the 75 brand-name drugs with the highest Part B expenditures ($21.6 billion annually at 2018 prices) indicated that the government could save between $17.6 billion and $20.1 billion after rebates by switching coverage to Part D, Thomas J. Hwang of Harvard Medical School, Boston, and his associates said.
The potential for greater overall savings, however, “was constrained by the fact that 33 (44%) of the studied brand-name drugs were in protected classes, which HHS has reported precludes meaningful price negotiation by Part D plans,” they wrote.
The proposal also could have a “material impact” on patient out-of-pocket costs, although the impact would vary based on the drug as well as patients’ insurance coverage in addition to Medicare (JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417).
For example, moving drug coverage to Part D would lower out-of-pocket costs for the majority of the 75 drugs for patients with Medigap supplemental insurance, but out-of-pocket costs could go up for almost 40% of products. Patients who would benefit most from the shift would be those who qualify for the low-income subsidy, which can eliminate coinsurance requirements.
“By contrast, for patients with Medigap insurance, out-of-pocket costs in Part D were estimated to exceed the annual premium costs for supplemental insurance [approximately 47-56 of the 75 drugs],” Mr. Hwang and his colleagues added. “Out-of-pocket costs would be increased under the proposed policy for beneficiaries with Medigap but without Part D coverage.”
The analysis was limited by the inability to predict the proposed transition’s impact on insurance premiums or drug utilization. Patients who were dually eligible for Medicare and Medicaid were excluded.
SOURCE: Hwang TJ et al. JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417.
A shift in Medicare drug coverage from Part B to Part D might save the government some money but could end up costing some patients in the long run.
Analysis of the 75 brand-name drugs with the highest Part B expenditures ($21.6 billion annually at 2018 prices) indicated that the government could save between $17.6 billion and $20.1 billion after rebates by switching coverage to Part D, Thomas J. Hwang of Harvard Medical School, Boston, and his associates said.
The potential for greater overall savings, however, “was constrained by the fact that 33 (44%) of the studied brand-name drugs were in protected classes, which HHS has reported precludes meaningful price negotiation by Part D plans,” they wrote.
The proposal also could have a “material impact” on patient out-of-pocket costs, although the impact would vary based on the drug as well as patients’ insurance coverage in addition to Medicare (JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417).
For example, moving drug coverage to Part D would lower out-of-pocket costs for the majority of the 75 drugs for patients with Medigap supplemental insurance, but out-of-pocket costs could go up for almost 40% of products. Patients who would benefit most from the shift would be those who qualify for the low-income subsidy, which can eliminate coinsurance requirements.
“By contrast, for patients with Medigap insurance, out-of-pocket costs in Part D were estimated to exceed the annual premium costs for supplemental insurance [approximately 47-56 of the 75 drugs],” Mr. Hwang and his colleagues added. “Out-of-pocket costs would be increased under the proposed policy for beneficiaries with Medigap but without Part D coverage.”
The analysis was limited by the inability to predict the proposed transition’s impact on insurance premiums or drug utilization. Patients who were dually eligible for Medicare and Medicaid were excluded.
SOURCE: Hwang TJ et al. JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Shifting drug coverage to Part D would save the government money.
Major finding: For patients with Medigap plans, costs could increase on as many as 40% of the drugs studied.
Study details: Researchers examined the 75 drugs with the highest Part B expenditures in 2016 and, using 2018 prices, estimated the effect of moving these drugs into the Part D prescription drug program.
Disclosures: No relevant conflicts of interest were reported.
Source: Hwang TJ et al. JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417.
Outcomes could improve with Oncology Care Model treatment plans
Treatment plans derived under the Oncology Care Model (OCM) improved performance on some quality measures and patient-reported outcomes, according to a study performed at three cancer centers.
Physicians and care teams at the University of Alabama, Birmingham; University of South Alabama, Monroeville; and AtlantiCare Cancer Care Institute, Egg Harbor Township, N.J., applied for participation in the Oncology Care Model introduced by the Centers for Medicare & Medicaid Services’ Center for Medicare & Medicaid Innovation.
“The goal of OCM is to utilize appropriately aligned financial incentives to enable improved care coordination, appropriateness of care, and access to care for beneficiaries undergoing chemotherapy,” according to CMS. “OCM encourages participating practices to improve care and lower costs through an episode-based payment model that financially incentivizes high-quality, coordinated care.”
Lead author Gabrielle Rocque, MD, assistant professor at the University of Alabama, Birmingham, noted that “these three cancer centers believed that leveraging the OCM requirement of treatment plan delivery would create an opportunity to improve care quality.”
They found that “implementation of OCM [treatment plans] has provided an opportunity to improve performance quality measures,” the authors concluded.
The project engaged 33 clinical providers and 171 women with breast cancer. The intervention group included 74 women aged 18 years and older with stage I to III breast cancer who were either planning on or already receiving chemotherapy; they were compared with a historical control group of 86 patients who received chemotherapy (J Oncol Pract. 2019. doi: 10.1200/JOP.18.00390).
Clinical providers engaged in self-study CME courses on quality standards relevant to human epidermal growth factor receptor 2 (HER2)–positive breast cancer and on psychosocial distress, then prepared patient treatment plans including patient-reported outcomes surveys that were connected to the clinical data platform. Fifteen American Society of Clinical Oncology Quality Oncology Practice Initiative measures were selected to compare the treatment and outcomes of the intervention and control groups.
“Statistically significant differences were found on nine measures, with performance higher among those in the intervention group,” Dr. Rocque and her colleagues noted. “Responses to questions that pertained to management of pain, emotional distress, and documentation of advanced directives had the greatest difference.” The areas that showed improvement aligned with indications linked to performance-based payments.
The study has several limitations. AtlantiCare Cancer Care Institute transitioned from a research phase to standard of care after 12 patients, altering the desired accrual of patients for the study. Additionally, “the quality improvement driver is not known because no manner existed to discern differences on the basis of documentation versus change in practice,” the investigators wrote.
That being said, the study authors stated that “the incorporation of technology solutions to meet requirements for participation in payment reform initiatives may provide a platform to effect patient outcomes.”
The study was supported by grants from the American Cancer Society and Genentech. Dr. Rocque reported support from Genentech and Pfizer.
SOURCE: Rocque G et al. J Oncol Pract. 2019. doi: 10.1200/JOP.18.00390.
Treatment plans derived under the Oncology Care Model (OCM) improved performance on some quality measures and patient-reported outcomes, according to a study performed at three cancer centers.
Physicians and care teams at the University of Alabama, Birmingham; University of South Alabama, Monroeville; and AtlantiCare Cancer Care Institute, Egg Harbor Township, N.J., applied for participation in the Oncology Care Model introduced by the Centers for Medicare & Medicaid Services’ Center for Medicare & Medicaid Innovation.
“The goal of OCM is to utilize appropriately aligned financial incentives to enable improved care coordination, appropriateness of care, and access to care for beneficiaries undergoing chemotherapy,” according to CMS. “OCM encourages participating practices to improve care and lower costs through an episode-based payment model that financially incentivizes high-quality, coordinated care.”
Lead author Gabrielle Rocque, MD, assistant professor at the University of Alabama, Birmingham, noted that “these three cancer centers believed that leveraging the OCM requirement of treatment plan delivery would create an opportunity to improve care quality.”
They found that “implementation of OCM [treatment plans] has provided an opportunity to improve performance quality measures,” the authors concluded.
The project engaged 33 clinical providers and 171 women with breast cancer. The intervention group included 74 women aged 18 years and older with stage I to III breast cancer who were either planning on or already receiving chemotherapy; they were compared with a historical control group of 86 patients who received chemotherapy (J Oncol Pract. 2019. doi: 10.1200/JOP.18.00390).
Clinical providers engaged in self-study CME courses on quality standards relevant to human epidermal growth factor receptor 2 (HER2)–positive breast cancer and on psychosocial distress, then prepared patient treatment plans including patient-reported outcomes surveys that were connected to the clinical data platform. Fifteen American Society of Clinical Oncology Quality Oncology Practice Initiative measures were selected to compare the treatment and outcomes of the intervention and control groups.
“Statistically significant differences were found on nine measures, with performance higher among those in the intervention group,” Dr. Rocque and her colleagues noted. “Responses to questions that pertained to management of pain, emotional distress, and documentation of advanced directives had the greatest difference.” The areas that showed improvement aligned with indications linked to performance-based payments.
The study has several limitations. AtlantiCare Cancer Care Institute transitioned from a research phase to standard of care after 12 patients, altering the desired accrual of patients for the study. Additionally, “the quality improvement driver is not known because no manner existed to discern differences on the basis of documentation versus change in practice,” the investigators wrote.
That being said, the study authors stated that “the incorporation of technology solutions to meet requirements for participation in payment reform initiatives may provide a platform to effect patient outcomes.”
The study was supported by grants from the American Cancer Society and Genentech. Dr. Rocque reported support from Genentech and Pfizer.
SOURCE: Rocque G et al. J Oncol Pract. 2019. doi: 10.1200/JOP.18.00390.
Treatment plans derived under the Oncology Care Model (OCM) improved performance on some quality measures and patient-reported outcomes, according to a study performed at three cancer centers.
Physicians and care teams at the University of Alabama, Birmingham; University of South Alabama, Monroeville; and AtlantiCare Cancer Care Institute, Egg Harbor Township, N.J., applied for participation in the Oncology Care Model introduced by the Centers for Medicare & Medicaid Services’ Center for Medicare & Medicaid Innovation.
“The goal of OCM is to utilize appropriately aligned financial incentives to enable improved care coordination, appropriateness of care, and access to care for beneficiaries undergoing chemotherapy,” according to CMS. “OCM encourages participating practices to improve care and lower costs through an episode-based payment model that financially incentivizes high-quality, coordinated care.”
Lead author Gabrielle Rocque, MD, assistant professor at the University of Alabama, Birmingham, noted that “these three cancer centers believed that leveraging the OCM requirement of treatment plan delivery would create an opportunity to improve care quality.”
They found that “implementation of OCM [treatment plans] has provided an opportunity to improve performance quality measures,” the authors concluded.
The project engaged 33 clinical providers and 171 women with breast cancer. The intervention group included 74 women aged 18 years and older with stage I to III breast cancer who were either planning on or already receiving chemotherapy; they were compared with a historical control group of 86 patients who received chemotherapy (J Oncol Pract. 2019. doi: 10.1200/JOP.18.00390).
Clinical providers engaged in self-study CME courses on quality standards relevant to human epidermal growth factor receptor 2 (HER2)–positive breast cancer and on psychosocial distress, then prepared patient treatment plans including patient-reported outcomes surveys that were connected to the clinical data platform. Fifteen American Society of Clinical Oncology Quality Oncology Practice Initiative measures were selected to compare the treatment and outcomes of the intervention and control groups.
“Statistically significant differences were found on nine measures, with performance higher among those in the intervention group,” Dr. Rocque and her colleagues noted. “Responses to questions that pertained to management of pain, emotional distress, and documentation of advanced directives had the greatest difference.” The areas that showed improvement aligned with indications linked to performance-based payments.
The study has several limitations. AtlantiCare Cancer Care Institute transitioned from a research phase to standard of care after 12 patients, altering the desired accrual of patients for the study. Additionally, “the quality improvement driver is not known because no manner existed to discern differences on the basis of documentation versus change in practice,” the investigators wrote.
That being said, the study authors stated that “the incorporation of technology solutions to meet requirements for participation in payment reform initiatives may provide a platform to effect patient outcomes.”
The study was supported by grants from the American Cancer Society and Genentech. Dr. Rocque reported support from Genentech and Pfizer.
SOURCE: Rocque G et al. J Oncol Pract. 2019. doi: 10.1200/JOP.18.00390.
FROM JOURNAL OF ONCOLOGY PRACTICE
Key clinical point: The CMS Oncology Care Model is showing promise to improve care.
Major finding: Intervention group saw statistically significant improvement in 9 of 15 quality measures, most notably those pertaining to pain management, emotional distress, and documentation of advanced directives.
Study details: A quality improvement project involving 171 breast cancer patients and 33 clinical providers.
Disclosures: The study was supported by grants from the American Cancer Society and Genentech. Dr. Rocque reported support from Genentech and Pfizer.
Source: Rocque G et al. J Oncol Pract. 2019. doi: 10. 1200/JOP.18.00390.
The ongoing issue of gender disparities in interventional cardiology
As gender disparities persist in interventional cardiology, a new survey is shedding light on what is keeping women away from the field.
With women representing only 9% of interventional cardiologists in the United States as of 2017, researchers under the direction of the American College of Cardiology Women in Cardiology Leadership Council sought to asses the perspectives of fellows-in-training (FIT) regarding the factors influencing their cardiology subspecialty decisions.
A total of 574 FIT completed the survey, with 190 respondents anticipating pursuit of a career in interventional cardiology. The results of the survey were published online in JACC: Cardiovascular Interventions. According to the report, unlike other studies that looked at gender disparities in interventional cardiology that focused on the training (residency) or later (practicing cardiologists), this is the first to look at the time when the decision is made during general cardiology fellowship.
The goal of the survey was “to try to understand in the current realm of our millennials who are studying and are in fellowship and in training and in the trenches, what is dissuading them to be in the subspecialty of interventional cardiology,” Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, and coauthor of the study, said in an interview.
Lead author Celina Yong, MD, and her colleagues wrote in their report on the survey that women “were more likely to express interest in all other cardiovascular specialties (general/clinical cardiology, advanced imaging, heart failure/transplant, adult congenital, and other), with the exception of electrophysiology (13% women vs. 87% men, P = .001).”
Researchers analyzed the 504 remaining survey responses after excluding those considering electrophysiology to get a better understanding about the influencing factors related to the decision to pursue interventional cardiology.
“Logistic regression of all demographic characteristics revealed that male sex was the most significant predictor of a career choice in interventional cardiology [odds ratio, 3.98; P less than 0.001],” the authors noted.
All respondents who intended to pursue a career in interventional cardiology had a list of 15 options to select the reasons for choosing this path. The top five, in descending order, were the opportunity to pursue hands-on procedures, personal interest in the specialty subject area, the opportunity for immediate gratification or sense of accomplishment, the thrill of treating ill patients in critical situations, and having mentors or role models the respondent identified with.
“When disaggregated by gender, there were six attributes that were significantly different between men and women in terms of reasons for pursuing” interventional cardiology, the authors stated. “Men were more likely to be driven by innovation in the field, importance of being an expert, likelihood of employment after completion of training, financial advantages, and prestige. Women were more likely to be driven by having a female mentor or role model.”
For those not pursuing a career in interventional cardiology, the top five reasons, in descending order, were an uncontrollable or unpredictable lifestyle, concern over long work hours and poor work/life balance, greater interest in another field, a desire for different type of patient contact, and wanting to have children in the next 5 years.
“There were seven attributes identified that negatively influenced IC choice differently by sex,” noted Dr. Yong, of VA Palo Alto (Calif.) Medical Center, and her colleagues. “Women were more likely to be negatively influenced by all seven of these factors compared to men (in descending order)”:
1) Greater interest in another field.
2) Little flexibility in job prospects/opportunities over a lifetime.
3) Physically demanding nature of job (e.g., wearing heavy lead).
4) Radiation exposure concerns during childbearing.
5) “Old boys club” culture.
6) Lack of female role models.
7) Gender discrimination or harassment.
Dr. Mehran said that despite some limitations, the survey results were not surprising.
“Unfortunately, surveys are very subjective,” she said. Also, one can question how biased some of these questions are. “But nonetheless, I think the result is very similar to what we had expected and have been talking about.”
She noted that the subspecialty of interventional cardiology needs to be more family friendly.
“I think we are going to lose a lot of good men also who are not choosing interventional cardiology,” she said. “There is no question that we have to think about how we can enhance and improve and pave the way for men and women, but mostly women because there are hardly any women and that’s important. The family friendly environment is very, very important in interventional cardiology.”
The patriarchal culture is another area that needs to be addressed, she said.
“I feel that, hopefully, that’s a perception and not much of a reality,” Dr. Mehran said, though she did note that there are plenty of examples where female doctors do not get shown the same level of respect their male counterparts do. She noted, for example, at scientific meetings, when a woman is on a panel and speaking, audience members can be seen tuning out, using it as opportunity to look at phones. Sometimes the women on the panels are not even referred to as “doctor.”
“I think we have to have a standard that those kinds of things will not be tolerated, that people will be called out if they didn’t do the extra work to find the best women for those important panels and leadership roles. There has to be a code of conduct that is equal and gender neutral,” she said, adding: “I think we are trying to work very hard to equalize the playing field but we have to come up with solutions.”
To that end, Dr. Mehran created a not-for-profit organization, Women As One, to tackle these gender disparities.
“We are really looking for solutions,” she said. “We will hold several think tanks with key opinion leaders, men and women, to come up with how best can academic organizations make sure that there is gender equality, good representation, and no discrimination on the basis of sex. ... We have to come up with solutions. Otherwise we just keep showing the same statistics over and over again and its not improving.”
SOURCE: JACC: Cardiovasc Interven. 2019 Jan; doi: 10.1016/j.jcin.2018.09.036
As gender disparities persist in interventional cardiology, a new survey is shedding light on what is keeping women away from the field.
With women representing only 9% of interventional cardiologists in the United States as of 2017, researchers under the direction of the American College of Cardiology Women in Cardiology Leadership Council sought to asses the perspectives of fellows-in-training (FIT) regarding the factors influencing their cardiology subspecialty decisions.
A total of 574 FIT completed the survey, with 190 respondents anticipating pursuit of a career in interventional cardiology. The results of the survey were published online in JACC: Cardiovascular Interventions. According to the report, unlike other studies that looked at gender disparities in interventional cardiology that focused on the training (residency) or later (practicing cardiologists), this is the first to look at the time when the decision is made during general cardiology fellowship.
The goal of the survey was “to try to understand in the current realm of our millennials who are studying and are in fellowship and in training and in the trenches, what is dissuading them to be in the subspecialty of interventional cardiology,” Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, and coauthor of the study, said in an interview.
Lead author Celina Yong, MD, and her colleagues wrote in their report on the survey that women “were more likely to express interest in all other cardiovascular specialties (general/clinical cardiology, advanced imaging, heart failure/transplant, adult congenital, and other), with the exception of electrophysiology (13% women vs. 87% men, P = .001).”
Researchers analyzed the 504 remaining survey responses after excluding those considering electrophysiology to get a better understanding about the influencing factors related to the decision to pursue interventional cardiology.
“Logistic regression of all demographic characteristics revealed that male sex was the most significant predictor of a career choice in interventional cardiology [odds ratio, 3.98; P less than 0.001],” the authors noted.
All respondents who intended to pursue a career in interventional cardiology had a list of 15 options to select the reasons for choosing this path. The top five, in descending order, were the opportunity to pursue hands-on procedures, personal interest in the specialty subject area, the opportunity for immediate gratification or sense of accomplishment, the thrill of treating ill patients in critical situations, and having mentors or role models the respondent identified with.
“When disaggregated by gender, there were six attributes that were significantly different between men and women in terms of reasons for pursuing” interventional cardiology, the authors stated. “Men were more likely to be driven by innovation in the field, importance of being an expert, likelihood of employment after completion of training, financial advantages, and prestige. Women were more likely to be driven by having a female mentor or role model.”
For those not pursuing a career in interventional cardiology, the top five reasons, in descending order, were an uncontrollable or unpredictable lifestyle, concern over long work hours and poor work/life balance, greater interest in another field, a desire for different type of patient contact, and wanting to have children in the next 5 years.
“There were seven attributes identified that negatively influenced IC choice differently by sex,” noted Dr. Yong, of VA Palo Alto (Calif.) Medical Center, and her colleagues. “Women were more likely to be negatively influenced by all seven of these factors compared to men (in descending order)”:
1) Greater interest in another field.
2) Little flexibility in job prospects/opportunities over a lifetime.
3) Physically demanding nature of job (e.g., wearing heavy lead).
4) Radiation exposure concerns during childbearing.
5) “Old boys club” culture.
6) Lack of female role models.
7) Gender discrimination or harassment.
Dr. Mehran said that despite some limitations, the survey results were not surprising.
“Unfortunately, surveys are very subjective,” she said. Also, one can question how biased some of these questions are. “But nonetheless, I think the result is very similar to what we had expected and have been talking about.”
She noted that the subspecialty of interventional cardiology needs to be more family friendly.
“I think we are going to lose a lot of good men also who are not choosing interventional cardiology,” she said. “There is no question that we have to think about how we can enhance and improve and pave the way for men and women, but mostly women because there are hardly any women and that’s important. The family friendly environment is very, very important in interventional cardiology.”
The patriarchal culture is another area that needs to be addressed, she said.
“I feel that, hopefully, that’s a perception and not much of a reality,” Dr. Mehran said, though she did note that there are plenty of examples where female doctors do not get shown the same level of respect their male counterparts do. She noted, for example, at scientific meetings, when a woman is on a panel and speaking, audience members can be seen tuning out, using it as opportunity to look at phones. Sometimes the women on the panels are not even referred to as “doctor.”
“I think we have to have a standard that those kinds of things will not be tolerated, that people will be called out if they didn’t do the extra work to find the best women for those important panels and leadership roles. There has to be a code of conduct that is equal and gender neutral,” she said, adding: “I think we are trying to work very hard to equalize the playing field but we have to come up with solutions.”
To that end, Dr. Mehran created a not-for-profit organization, Women As One, to tackle these gender disparities.
“We are really looking for solutions,” she said. “We will hold several think tanks with key opinion leaders, men and women, to come up with how best can academic organizations make sure that there is gender equality, good representation, and no discrimination on the basis of sex. ... We have to come up with solutions. Otherwise we just keep showing the same statistics over and over again and its not improving.”
SOURCE: JACC: Cardiovasc Interven. 2019 Jan; doi: 10.1016/j.jcin.2018.09.036
As gender disparities persist in interventional cardiology, a new survey is shedding light on what is keeping women away from the field.
With women representing only 9% of interventional cardiologists in the United States as of 2017, researchers under the direction of the American College of Cardiology Women in Cardiology Leadership Council sought to asses the perspectives of fellows-in-training (FIT) regarding the factors influencing their cardiology subspecialty decisions.
A total of 574 FIT completed the survey, with 190 respondents anticipating pursuit of a career in interventional cardiology. The results of the survey were published online in JACC: Cardiovascular Interventions. According to the report, unlike other studies that looked at gender disparities in interventional cardiology that focused on the training (residency) or later (practicing cardiologists), this is the first to look at the time when the decision is made during general cardiology fellowship.
The goal of the survey was “to try to understand in the current realm of our millennials who are studying and are in fellowship and in training and in the trenches, what is dissuading them to be in the subspecialty of interventional cardiology,” Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, and coauthor of the study, said in an interview.
Lead author Celina Yong, MD, and her colleagues wrote in their report on the survey that women “were more likely to express interest in all other cardiovascular specialties (general/clinical cardiology, advanced imaging, heart failure/transplant, adult congenital, and other), with the exception of electrophysiology (13% women vs. 87% men, P = .001).”
Researchers analyzed the 504 remaining survey responses after excluding those considering electrophysiology to get a better understanding about the influencing factors related to the decision to pursue interventional cardiology.
“Logistic regression of all demographic characteristics revealed that male sex was the most significant predictor of a career choice in interventional cardiology [odds ratio, 3.98; P less than 0.001],” the authors noted.
All respondents who intended to pursue a career in interventional cardiology had a list of 15 options to select the reasons for choosing this path. The top five, in descending order, were the opportunity to pursue hands-on procedures, personal interest in the specialty subject area, the opportunity for immediate gratification or sense of accomplishment, the thrill of treating ill patients in critical situations, and having mentors or role models the respondent identified with.
“When disaggregated by gender, there were six attributes that were significantly different between men and women in terms of reasons for pursuing” interventional cardiology, the authors stated. “Men were more likely to be driven by innovation in the field, importance of being an expert, likelihood of employment after completion of training, financial advantages, and prestige. Women were more likely to be driven by having a female mentor or role model.”
For those not pursuing a career in interventional cardiology, the top five reasons, in descending order, were an uncontrollable or unpredictable lifestyle, concern over long work hours and poor work/life balance, greater interest in another field, a desire for different type of patient contact, and wanting to have children in the next 5 years.
“There were seven attributes identified that negatively influenced IC choice differently by sex,” noted Dr. Yong, of VA Palo Alto (Calif.) Medical Center, and her colleagues. “Women were more likely to be negatively influenced by all seven of these factors compared to men (in descending order)”:
1) Greater interest in another field.
2) Little flexibility in job prospects/opportunities over a lifetime.
3) Physically demanding nature of job (e.g., wearing heavy lead).
4) Radiation exposure concerns during childbearing.
5) “Old boys club” culture.
6) Lack of female role models.
7) Gender discrimination or harassment.
Dr. Mehran said that despite some limitations, the survey results were not surprising.
“Unfortunately, surveys are very subjective,” she said. Also, one can question how biased some of these questions are. “But nonetheless, I think the result is very similar to what we had expected and have been talking about.”
She noted that the subspecialty of interventional cardiology needs to be more family friendly.
“I think we are going to lose a lot of good men also who are not choosing interventional cardiology,” she said. “There is no question that we have to think about how we can enhance and improve and pave the way for men and women, but mostly women because there are hardly any women and that’s important. The family friendly environment is very, very important in interventional cardiology.”
The patriarchal culture is another area that needs to be addressed, she said.
“I feel that, hopefully, that’s a perception and not much of a reality,” Dr. Mehran said, though she did note that there are plenty of examples where female doctors do not get shown the same level of respect their male counterparts do. She noted, for example, at scientific meetings, when a woman is on a panel and speaking, audience members can be seen tuning out, using it as opportunity to look at phones. Sometimes the women on the panels are not even referred to as “doctor.”
“I think we have to have a standard that those kinds of things will not be tolerated, that people will be called out if they didn’t do the extra work to find the best women for those important panels and leadership roles. There has to be a code of conduct that is equal and gender neutral,” she said, adding: “I think we are trying to work very hard to equalize the playing field but we have to come up with solutions.”
To that end, Dr. Mehran created a not-for-profit organization, Women As One, to tackle these gender disparities.
“We are really looking for solutions,” she said. “We will hold several think tanks with key opinion leaders, men and women, to come up with how best can academic organizations make sure that there is gender equality, good representation, and no discrimination on the basis of sex. ... We have to come up with solutions. Otherwise we just keep showing the same statistics over and over again and its not improving.”
SOURCE: JACC: Cardiovasc Interven. 2019 Jan; doi: 10.1016/j.jcin.2018.09.036
FROM JACC: CARDIOVASCULAR INTERVENTIONS
Key clinical point: Men are more likely to pursue a career in interventional cardiology than are women.
Major finding: Logistical regression of all demographic characteristics revealed being male was the most significant predictor of a career choice in IC .
Study details: Researchers analyzed survey responses from 574 fellows-in-training to determine the likelihood of pursuing a career in interventional cardiology.
Disclosures: The study was funded by the American College of Cardiology and the Women in Cardiology section of the ACC. The authors reported no financial disclosures.
Source: JACC: Cardiovasc Interven. 2019 Jan. doi: 10.1016/j.jcin.2018.09.036.
Doc groups pushing back on Part B drug reimbursement proposal
The Centers for Medicare & Medicaid Services in October 2018 issued an ”advance notice of proposed rulemaking with comment” outlining a test that would pay for Part B drugs with price points more closely aligned with international rates through the use of private sector vendors that would negotiate drug prices, procure the products, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare.
Although the so-called International Pricing Index (IPI) model is not fully fleshed out in the regulatory filing, one of the key details that has been announced is that the demonstration project would have mandatory participation. This did not sit well with medical societies offering feedback to CMS.
The American Gastroenterological Association stated in comments filed with the agency that “AGA opposes mandatory physician participation and we urge CMS to implement the model on a voluntary basis.” AGA further noted that, while they support the Administration’s goal of reducing drug costs, “we are concerned that the model, as described, will make acquisition of Part B drugs more complex and will shift costs to physicians and practices, increasing administrative burden. Moreover, we are concerned that the IPI model may restrict access to clinically appropriate therapies for people with digestive diseases.”
And while the Community Oncology Alliance also spoke against making participation in the IPI model demonstration project mandatory, it went further with its criticism of the proposal.
“COA does not support the IPI Model as proposed in the pre-proposed rule published by [CMS] because we have serious concerns about its impact on cancer patient care and even its legality,” the group said on Dec. 31, 2018, comments filed with the agency, adding that “mandatory demonstration projects are clearly not in the charter of CMMI [Center for Medicare & Medicaid Innovation] as written into law by Congress. ... That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
The AGA, like other groups, also took exception to CMS’s “insinuation” in its regulatory preproposal that physicians select treatments based on reimbursement ahead of patient need. “CMS has repeatedly suggested that physicians prescribe therapies to patients not based on clinical evidence and judgment, but rather based on how much Medicare revenue it will generate for them. AGA objects to this premise. There is no objective evidence to support this idea.”
While none of the groups offered support for the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advanced noticed of proposed rulemaking. AGA made recommendations, including making IPI Model participation voluntary; allowing individual physicians and physician groups to become model vendors, even if they intend to serve only their own practice or their own geographic region; prohibiting model vendors from implementing utilization management; and making model vendors responsible for collecting beneficiary cost-sharing. The American Medical Association in Dec. 20, 2018, comments to the agency took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues and have immediate adverse patient impacts.
The Centers for Medicare & Medicaid Services in October 2018 issued an ”advance notice of proposed rulemaking with comment” outlining a test that would pay for Part B drugs with price points more closely aligned with international rates through the use of private sector vendors that would negotiate drug prices, procure the products, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare.
Although the so-called International Pricing Index (IPI) model is not fully fleshed out in the regulatory filing, one of the key details that has been announced is that the demonstration project would have mandatory participation. This did not sit well with medical societies offering feedback to CMS.
The American Gastroenterological Association stated in comments filed with the agency that “AGA opposes mandatory physician participation and we urge CMS to implement the model on a voluntary basis.” AGA further noted that, while they support the Administration’s goal of reducing drug costs, “we are concerned that the model, as described, will make acquisition of Part B drugs more complex and will shift costs to physicians and practices, increasing administrative burden. Moreover, we are concerned that the IPI model may restrict access to clinically appropriate therapies for people with digestive diseases.”
And while the Community Oncology Alliance also spoke against making participation in the IPI model demonstration project mandatory, it went further with its criticism of the proposal.
“COA does not support the IPI Model as proposed in the pre-proposed rule published by [CMS] because we have serious concerns about its impact on cancer patient care and even its legality,” the group said on Dec. 31, 2018, comments filed with the agency, adding that “mandatory demonstration projects are clearly not in the charter of CMMI [Center for Medicare & Medicaid Innovation] as written into law by Congress. ... That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
The AGA, like other groups, also took exception to CMS’s “insinuation” in its regulatory preproposal that physicians select treatments based on reimbursement ahead of patient need. “CMS has repeatedly suggested that physicians prescribe therapies to patients not based on clinical evidence and judgment, but rather based on how much Medicare revenue it will generate for them. AGA objects to this premise. There is no objective evidence to support this idea.”
While none of the groups offered support for the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advanced noticed of proposed rulemaking. AGA made recommendations, including making IPI Model participation voluntary; allowing individual physicians and physician groups to become model vendors, even if they intend to serve only their own practice or their own geographic region; prohibiting model vendors from implementing utilization management; and making model vendors responsible for collecting beneficiary cost-sharing. The American Medical Association in Dec. 20, 2018, comments to the agency took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues and have immediate adverse patient impacts.
The Centers for Medicare & Medicaid Services in October 2018 issued an ”advance notice of proposed rulemaking with comment” outlining a test that would pay for Part B drugs with price points more closely aligned with international rates through the use of private sector vendors that would negotiate drug prices, procure the products, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare.
Although the so-called International Pricing Index (IPI) model is not fully fleshed out in the regulatory filing, one of the key details that has been announced is that the demonstration project would have mandatory participation. This did not sit well with medical societies offering feedback to CMS.
The American Gastroenterological Association stated in comments filed with the agency that “AGA opposes mandatory physician participation and we urge CMS to implement the model on a voluntary basis.” AGA further noted that, while they support the Administration’s goal of reducing drug costs, “we are concerned that the model, as described, will make acquisition of Part B drugs more complex and will shift costs to physicians and practices, increasing administrative burden. Moreover, we are concerned that the IPI model may restrict access to clinically appropriate therapies for people with digestive diseases.”
And while the Community Oncology Alliance also spoke against making participation in the IPI model demonstration project mandatory, it went further with its criticism of the proposal.
“COA does not support the IPI Model as proposed in the pre-proposed rule published by [CMS] because we have serious concerns about its impact on cancer patient care and even its legality,” the group said on Dec. 31, 2018, comments filed with the agency, adding that “mandatory demonstration projects are clearly not in the charter of CMMI [Center for Medicare & Medicaid Innovation] as written into law by Congress. ... That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
The AGA, like other groups, also took exception to CMS’s “insinuation” in its regulatory preproposal that physicians select treatments based on reimbursement ahead of patient need. “CMS has repeatedly suggested that physicians prescribe therapies to patients not based on clinical evidence and judgment, but rather based on how much Medicare revenue it will generate for them. AGA objects to this premise. There is no objective evidence to support this idea.”
While none of the groups offered support for the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advanced noticed of proposed rulemaking. AGA made recommendations, including making IPI Model participation voluntary; allowing individual physicians and physician groups to become model vendors, even if they intend to serve only their own practice or their own geographic region; prohibiting model vendors from implementing utilization management; and making model vendors responsible for collecting beneficiary cost-sharing. The American Medical Association in Dec. 20, 2018, comments to the agency took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues and have immediate adverse patient impacts.
Revised ACA premium calculator could up uninsured rate
– changes that critics caution could leave more people uninsured.
But the Centers for Medicare & Medicaid Services says the changes would lower premiums and give enrollees the option to choose a plan that doesn’t offer abortion services.
The CMS released the proposed rule online Jan. 17, and it’s expected to be published in the Federal Register Jan. 24. (A fact sheet highlighting the changes can be found here.)
Under one of the proposals, the CMS would alter the risk-adjustment model used to determine premium growth beginning in 2020.
But the proposed rule’s regulatory impact statement notes that the risk-adjustment change could reduce enrollment in health insurance products through the federal exchanges by 100,000 people in each of the years from 2020 through 2023. And the revised risk-adjustment model could reduce federal spending on premium tax credits by $900 million in both 2020 and 2021, and by $1 billion in 2022 and 2023.
“Some of the 100,000 individuals estimated to enroll in exchange coverage as a result of the proposed change ... may purchase short-term, limited-duration insurance, though a majority is likely to become uninsured,” the CMS stated in its proposed rule. “Either transition may result in greater exposure to health care costs, which previous research suggests reduces utilization of health care services.”
Matt Fiedler, fellow at the Brookings Institution’s Center for Health Policy, highlighted the potential effect a drop in premium tax credits could have on potential enrollees.
According to Mr. Fiedler, a single person at 300% of the federal poverty level (FPL) would lose $92 per year in premium tax credits. And a family of four at 300% of FPL would lose $189 per year in premium tax credits, he calculated. He predicted “smaller effects at lower income levels and larger effects at higher income levels.”
The proposed rule would also require issuers of qualified health plans that offer abortion services to provide at least one “mirror” plan that omits abortion coverage. That could lead insurers to drop abortion coverage in their qualified health plans, the CMS noted, but it didn’t estimate how many issuers are expected to drop abortion coverage.
The agency said the proposed requirement “would increase consumer choice by offering additional plan options to potential enrollees who may refuse to enroll in, or may be discouraged from enrolling in, qualified health plans because the plans in their service area cover non-Hyde abortion services.” The CMS conceded that the existence of two such plans could confuse consumers, and “research has shown that offering consumers additional health plan options may result in consumers opting to not purchase a plan at all.”
The CMS also is seeking comment on changes to the automatic re-enrollment policy.
“Most current enrollees receive significant government subsidies, making them potentially less sensitive to premiums and premium changes,” the agency stated in the proposed rule. “Some consumers who are automatically re-enrolled in their current plan may be shielded from changes to their coverage, which may result in consumers being less aware of their options from year to year.”
Comments on the proposed rule are due by Feb. 19.
– changes that critics caution could leave more people uninsured.
But the Centers for Medicare & Medicaid Services says the changes would lower premiums and give enrollees the option to choose a plan that doesn’t offer abortion services.
The CMS released the proposed rule online Jan. 17, and it’s expected to be published in the Federal Register Jan. 24. (A fact sheet highlighting the changes can be found here.)
Under one of the proposals, the CMS would alter the risk-adjustment model used to determine premium growth beginning in 2020.
But the proposed rule’s regulatory impact statement notes that the risk-adjustment change could reduce enrollment in health insurance products through the federal exchanges by 100,000 people in each of the years from 2020 through 2023. And the revised risk-adjustment model could reduce federal spending on premium tax credits by $900 million in both 2020 and 2021, and by $1 billion in 2022 and 2023.
“Some of the 100,000 individuals estimated to enroll in exchange coverage as a result of the proposed change ... may purchase short-term, limited-duration insurance, though a majority is likely to become uninsured,” the CMS stated in its proposed rule. “Either transition may result in greater exposure to health care costs, which previous research suggests reduces utilization of health care services.”
Matt Fiedler, fellow at the Brookings Institution’s Center for Health Policy, highlighted the potential effect a drop in premium tax credits could have on potential enrollees.
According to Mr. Fiedler, a single person at 300% of the federal poverty level (FPL) would lose $92 per year in premium tax credits. And a family of four at 300% of FPL would lose $189 per year in premium tax credits, he calculated. He predicted “smaller effects at lower income levels and larger effects at higher income levels.”
The proposed rule would also require issuers of qualified health plans that offer abortion services to provide at least one “mirror” plan that omits abortion coverage. That could lead insurers to drop abortion coverage in their qualified health plans, the CMS noted, but it didn’t estimate how many issuers are expected to drop abortion coverage.
The agency said the proposed requirement “would increase consumer choice by offering additional plan options to potential enrollees who may refuse to enroll in, or may be discouraged from enrolling in, qualified health plans because the plans in their service area cover non-Hyde abortion services.” The CMS conceded that the existence of two such plans could confuse consumers, and “research has shown that offering consumers additional health plan options may result in consumers opting to not purchase a plan at all.”
The CMS also is seeking comment on changes to the automatic re-enrollment policy.
“Most current enrollees receive significant government subsidies, making them potentially less sensitive to premiums and premium changes,” the agency stated in the proposed rule. “Some consumers who are automatically re-enrolled in their current plan may be shielded from changes to their coverage, which may result in consumers being less aware of their options from year to year.”
Comments on the proposed rule are due by Feb. 19.
– changes that critics caution could leave more people uninsured.
But the Centers for Medicare & Medicaid Services says the changes would lower premiums and give enrollees the option to choose a plan that doesn’t offer abortion services.
The CMS released the proposed rule online Jan. 17, and it’s expected to be published in the Federal Register Jan. 24. (A fact sheet highlighting the changes can be found here.)
Under one of the proposals, the CMS would alter the risk-adjustment model used to determine premium growth beginning in 2020.
But the proposed rule’s regulatory impact statement notes that the risk-adjustment change could reduce enrollment in health insurance products through the federal exchanges by 100,000 people in each of the years from 2020 through 2023. And the revised risk-adjustment model could reduce federal spending on premium tax credits by $900 million in both 2020 and 2021, and by $1 billion in 2022 and 2023.
“Some of the 100,000 individuals estimated to enroll in exchange coverage as a result of the proposed change ... may purchase short-term, limited-duration insurance, though a majority is likely to become uninsured,” the CMS stated in its proposed rule. “Either transition may result in greater exposure to health care costs, which previous research suggests reduces utilization of health care services.”
Matt Fiedler, fellow at the Brookings Institution’s Center for Health Policy, highlighted the potential effect a drop in premium tax credits could have on potential enrollees.
According to Mr. Fiedler, a single person at 300% of the federal poverty level (FPL) would lose $92 per year in premium tax credits. And a family of four at 300% of FPL would lose $189 per year in premium tax credits, he calculated. He predicted “smaller effects at lower income levels and larger effects at higher income levels.”
The proposed rule would also require issuers of qualified health plans that offer abortion services to provide at least one “mirror” plan that omits abortion coverage. That could lead insurers to drop abortion coverage in their qualified health plans, the CMS noted, but it didn’t estimate how many issuers are expected to drop abortion coverage.
The agency said the proposed requirement “would increase consumer choice by offering additional plan options to potential enrollees who may refuse to enroll in, or may be discouraged from enrolling in, qualified health plans because the plans in their service area cover non-Hyde abortion services.” The CMS conceded that the existence of two such plans could confuse consumers, and “research has shown that offering consumers additional health plan options may result in consumers opting to not purchase a plan at all.”
The CMS also is seeking comment on changes to the automatic re-enrollment policy.
“Most current enrollees receive significant government subsidies, making them potentially less sensitive to premiums and premium changes,” the agency stated in the proposed rule. “Some consumers who are automatically re-enrolled in their current plan may be shielded from changes to their coverage, which may result in consumers being less aware of their options from year to year.”
Comments on the proposed rule are due by Feb. 19.
New or existing drugs? Both fuel price inflation
Inflation in existing drugs’ prices and the debut of new drugs are both contributing to the overall rising costs of pharmaceuticals.
.
For oral and injectable specialty drugs, costs increased 20.6% and 12.5%, respectively, with 71.1% and 52.4% attributable to new drugs. Costs of oral and injectable generic drugs grew by 4.4% and 7.3%, also driven by entrants into the market.
Researchers looked at monthly wholesale acquisition costs of 24,877 National Drug Codes for oral drugs and 3,049 injectable drugs from 2005 to 2016. They compared them with pharmacy claims from the UPMC Health Plan, which offers insurance products to more than 3.2 million members across the spectrum of private and public arenas.
“Our analyses yielded three main findings,” explained Inmaculada Hernandez, PharmD, PhD, University of Pittsburgh, and her colleagues in a report published in the January 2019 issue of Health Affairs.
“First, costs increased considerably faster than inflation across all drug classes, and increases were highest for oral specialty drugs and lowest for oral generics,” Dr. Hernandez and her colleagues wrote.
“Second, rising costs of brand-name drugs were driven by inflation in the prices of widely used existing drugs,” they added. A combination of new products and price inflation in existing drugs drove the rising costs of specialty drugs, with new drugs accounting for a larger share of the price increases.
Third, “existing generics tended to decrease the average cost of generic drugs,” Dr. Hernandez noted. However, new generic products cost more than those already on the market, which fueled the annual increases in average costs.
The authors noted that their estimates demonstrate the role of inflation on pharmaceutical cost increases and support policy efforts to control that inflation.
“In the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes,” Dr. Hernandez and colleagues stated. “However, rising costs due to inflation do not reflect improved value for patients.”
The researchers noted that the data are limited by the lack of rebate information, which is generally proprietary. Thus, “the contribution of existing drugs may have been lower than we estimated,” they noted. In addition, “because the magnitude of rebates has increased in the past decade, our findings likely overestimated cost increases for brand-name drugs.” The researchers also didn’t examine the effect of drugs transitioning from brand to generic offerings.
The authors provided no disclosures.
SOURCE: Hernandez I et al. Health Aff (Millwood). 2019 Jan 2019. doi: 10.1377/hlthaff.2018.05147.
Inflation in existing drugs’ prices and the debut of new drugs are both contributing to the overall rising costs of pharmaceuticals.
.
For oral and injectable specialty drugs, costs increased 20.6% and 12.5%, respectively, with 71.1% and 52.4% attributable to new drugs. Costs of oral and injectable generic drugs grew by 4.4% and 7.3%, also driven by entrants into the market.
Researchers looked at monthly wholesale acquisition costs of 24,877 National Drug Codes for oral drugs and 3,049 injectable drugs from 2005 to 2016. They compared them with pharmacy claims from the UPMC Health Plan, which offers insurance products to more than 3.2 million members across the spectrum of private and public arenas.
“Our analyses yielded three main findings,” explained Inmaculada Hernandez, PharmD, PhD, University of Pittsburgh, and her colleagues in a report published in the January 2019 issue of Health Affairs.
“First, costs increased considerably faster than inflation across all drug classes, and increases were highest for oral specialty drugs and lowest for oral generics,” Dr. Hernandez and her colleagues wrote.
“Second, rising costs of brand-name drugs were driven by inflation in the prices of widely used existing drugs,” they added. A combination of new products and price inflation in existing drugs drove the rising costs of specialty drugs, with new drugs accounting for a larger share of the price increases.
Third, “existing generics tended to decrease the average cost of generic drugs,” Dr. Hernandez noted. However, new generic products cost more than those already on the market, which fueled the annual increases in average costs.
The authors noted that their estimates demonstrate the role of inflation on pharmaceutical cost increases and support policy efforts to control that inflation.
“In the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes,” Dr. Hernandez and colleagues stated. “However, rising costs due to inflation do not reflect improved value for patients.”
The researchers noted that the data are limited by the lack of rebate information, which is generally proprietary. Thus, “the contribution of existing drugs may have been lower than we estimated,” they noted. In addition, “because the magnitude of rebates has increased in the past decade, our findings likely overestimated cost increases for brand-name drugs.” The researchers also didn’t examine the effect of drugs transitioning from brand to generic offerings.
The authors provided no disclosures.
SOURCE: Hernandez I et al. Health Aff (Millwood). 2019 Jan 2019. doi: 10.1377/hlthaff.2018.05147.
Inflation in existing drugs’ prices and the debut of new drugs are both contributing to the overall rising costs of pharmaceuticals.
.
For oral and injectable specialty drugs, costs increased 20.6% and 12.5%, respectively, with 71.1% and 52.4% attributable to new drugs. Costs of oral and injectable generic drugs grew by 4.4% and 7.3%, also driven by entrants into the market.
Researchers looked at monthly wholesale acquisition costs of 24,877 National Drug Codes for oral drugs and 3,049 injectable drugs from 2005 to 2016. They compared them with pharmacy claims from the UPMC Health Plan, which offers insurance products to more than 3.2 million members across the spectrum of private and public arenas.
“Our analyses yielded three main findings,” explained Inmaculada Hernandez, PharmD, PhD, University of Pittsburgh, and her colleagues in a report published in the January 2019 issue of Health Affairs.
“First, costs increased considerably faster than inflation across all drug classes, and increases were highest for oral specialty drugs and lowest for oral generics,” Dr. Hernandez and her colleagues wrote.
“Second, rising costs of brand-name drugs were driven by inflation in the prices of widely used existing drugs,” they added. A combination of new products and price inflation in existing drugs drove the rising costs of specialty drugs, with new drugs accounting for a larger share of the price increases.
Third, “existing generics tended to decrease the average cost of generic drugs,” Dr. Hernandez noted. However, new generic products cost more than those already on the market, which fueled the annual increases in average costs.
The authors noted that their estimates demonstrate the role of inflation on pharmaceutical cost increases and support policy efforts to control that inflation.
“In the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes,” Dr. Hernandez and colleagues stated. “However, rising costs due to inflation do not reflect improved value for patients.”
The researchers noted that the data are limited by the lack of rebate information, which is generally proprietary. Thus, “the contribution of existing drugs may have been lower than we estimated,” they noted. In addition, “because the magnitude of rebates has increased in the past decade, our findings likely overestimated cost increases for brand-name drugs.” The researchers also didn’t examine the effect of drugs transitioning from brand to generic offerings.
The authors provided no disclosures.
SOURCE: Hernandez I et al. Health Aff (Millwood). 2019 Jan 2019. doi: 10.1377/hlthaff.2018.05147.
FROM HEALTH AFFAIRS
Key clinical point: Price inflation in existing drugs and new product introductions are driving increases in pharmaceutical costs.
Major finding: 71% of oral specialty drug price increases during 2005-2019 are attributable to new products.
Study details: Researchers analyzed the wholesale acquisition prices of 24,877 oral drugs and 3,049 injectable drugs and compared them with pharmacy claims across all public and private insurance products offered by the UPMC Health Plan.
Disclosures: The authors provided no disclosures.
Source: Hernandez I et al. Health Aff (Millwood). 2019 Jan. doi: 10.1377/hlthaff.2018.05147.
Doc groups pushing back on Part B drug reimbursement proposal
The Centers for Medicare & Medicaid Services in October 2018 issued an “advance notice of proposed rulemaking with comment” outlining a test that would pay for Part B drugs with price points more closely aligned with international rates through the use of private sector vendors that would negotiate drug prices, procure the products, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare.
Although the so-called International Pricing Index (IPI) model is not fully fleshed out in the regulatory filing, one of the key details that has been announced is that the demonstration project would have mandatory participation. This did not sit well with medical societies offering feedback to CMS.
The American College of Rheumatology stated in comments filed with the agency that “we do not support mandatory demonstration projects.”
The American Society of Clinical Oncology echoed that sentiment in Dec. 31, 2018, comments filed with the agency. “ASCO cannot support a mandatory demonstration program,” the group noted. “We are concerned about losing access points to oncology care provided by oncology practices, especially in rural, underserved, and low-income areas that are already struggling to deliver care.”
And while the Community Oncology Alliance also spoke against making participation in the IPI model demonstration project mandatory, it went further with its criticism of the proposal.
“COA does not support the IPI Model as proposed in the pre-proposed rule published by [CMS] because we have serious concerns about its impact on cancer patient care and even its legality,” the group said in Dec. 31, 2018, comments filed with the agency, adding that “mandatory demonstration projects are clearly not in the charter of CMMI [Center for Medicare & Medicaid Innovation] as written into law by Congress. If CMS believes that CMMI has the power via statute to effectively amend Medicare law – in this case the Part B drug reimbursement rate for at least 50% of Part B providers – it (CMS representing the Executive branch) either has overstepped its constitutional boundaries separating the powers of government branches or Congress has effectively handed over its powers to the Executive branch. That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
While none of the groups offered support to the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advance notice of proposed rulemaking.
The American Academy of Dermatology Association, which like other groups took exception to CMS’ “insinuation” in its regulatory pre-proposal that physicians select treatments based on reimbursement ahead of patient need, suggested in Dec. 19, 2018, comments to the agency that drugs on the Food and Drug Administration’s drug shortage list be excluded from the list.
It also expressed concerns regarding access if a drug goes without international reference pricing because a manufacturer chooses not to sell in certain countries.
“AADA is concerned that this model could result in patients losing access to some drugs when a distributor and manufacturer are unable to agree on a price,” the group said. Similarly, the lag in setting a reference price after a new product is introduced could also create access issues.
AADA also took issue with the fact that vendors could not offer physicians and hospitals volume-based incentive payments or rebates but did not have the same prohibition from vendors receiving such incentives. “Under this proposal, CMS should prohibit vendors from prioritizing drug availability or excluding some drugs from distribution to physicians based on discounts provided by manufacturers. CMS will need to monitor utilization to ensure access to necessary treatments is not delayed or impeded.”
AADA also wants more clarity in how providers will be selected to participate.
The American College of Rheumatology expressed concern that “the administrative difficulties that would be associated with utilizing vendors could lead some practices to lose the ability to provide infusion services. Specifically, we are concerned that the added administrative burden of proposed interactions with the vendors in the model exceeds any inherent benefits to practice.” It added that CMS needs to look at how a potentially mandatory participation could affect specialty physician shortages.
The ACR made a number of recommendations, including making the IPI model participation voluntary; allowing for an exit for participants if the program is not working for them; providing incentives that could increase gross reimbursement; increasing provider reimbursement to cover the expenses associated with dealing with vendors; and making sure the agency is adequately tracking the effect on patient access.
ASCO used its comments to reiterate previous comments provided to the agency on revising the competitive acquisition program (CAP), a failed program that used third-party vendors as suppliers for Part B drugs. Among its suggestions were making the program voluntary; ensuring it does not result in an aggregate reduction in payments to oncology practices; ensuring a CAP does not result in interruption in care; and restricting its burdensome utilization management requirements.
The Community Oncology Alliance said it is working on an alternative to the IPI model, one that could contain a number of provisions, such as tiered average sales price-based reimbursement; clinically appropriate utilization management techniques; and drug prices that are lowered without artificial international price indexing.
The American Medical Association in Dec. 20, 2018, comments to the agency outlined a number of principles that any new vendor-based program needs to include, such as being voluntary; providing supplemental payments to cover the cost of special handling and storage of Part B drugs; flexibility to ensure various ordering issues; preventing variation in treatments for patients; and prohibiting vendors from restricting access using utilization management techniques.
The AMA also offered a range of suggestions for the IPI model, including measuring timeliness of deliveries in hours, not days; prohibiting vendors from withholding shipments of subsequent treatments if the initial claim has not been processed; making all treatment options available, even for off-label use; and getting guarantees from vendors on the availability of next-day delivery to any location where the patient is being treated.
Likewise, the AMA suggested that CMS should not set unreasonable deadlines for claims submissions and should provide an adequate number of vendors to ensure choice and access.
“We are also concerned about the impact of the proposed IPI model and its overall impact on costs to physician practices,” the AMA said in its comment letter. “The Administration proposes to allow the vendors to charge administrative fees to physician practices as part of their agreement to provide drug products to those practices included in the model. While we understand that third-party vendors must have a financial incentive in order to participate in the program, allowing vendors to charge physician practices administrative fees would add new, potentially significant increased costs to physicians in acquiring and providing treatments to patients without adequate changes to the reimbursement model to compensate for these costs.”
The AMA said that lower reimbursement combined with administrative fees would likely make the model untenable for physician practices unless changes to the reimbursement model were made.
The AMA also took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues.
“We urge CMS to undertake modeling and simulation of the impact if vendors are unable to obtain these drugs at the reimbursement amount,” the AMA stated in its comment letter. “There is a distinct possibility of immediate adverse patient impact if none of the vendors are able to secure needed clinical treatments.”
The Centers for Medicare & Medicaid Services in October 2018 issued an “advance notice of proposed rulemaking with comment” outlining a test that would pay for Part B drugs with price points more closely aligned with international rates through the use of private sector vendors that would negotiate drug prices, procure the products, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare.
Although the so-called International Pricing Index (IPI) model is not fully fleshed out in the regulatory filing, one of the key details that has been announced is that the demonstration project would have mandatory participation. This did not sit well with medical societies offering feedback to CMS.
The American College of Rheumatology stated in comments filed with the agency that “we do not support mandatory demonstration projects.”
The American Society of Clinical Oncology echoed that sentiment in Dec. 31, 2018, comments filed with the agency. “ASCO cannot support a mandatory demonstration program,” the group noted. “We are concerned about losing access points to oncology care provided by oncology practices, especially in rural, underserved, and low-income areas that are already struggling to deliver care.”
And while the Community Oncology Alliance also spoke against making participation in the IPI model demonstration project mandatory, it went further with its criticism of the proposal.
“COA does not support the IPI Model as proposed in the pre-proposed rule published by [CMS] because we have serious concerns about its impact on cancer patient care and even its legality,” the group said in Dec. 31, 2018, comments filed with the agency, adding that “mandatory demonstration projects are clearly not in the charter of CMMI [Center for Medicare & Medicaid Innovation] as written into law by Congress. If CMS believes that CMMI has the power via statute to effectively amend Medicare law – in this case the Part B drug reimbursement rate for at least 50% of Part B providers – it (CMS representing the Executive branch) either has overstepped its constitutional boundaries separating the powers of government branches or Congress has effectively handed over its powers to the Executive branch. That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
While none of the groups offered support to the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advance notice of proposed rulemaking.
The American Academy of Dermatology Association, which like other groups took exception to CMS’ “insinuation” in its regulatory pre-proposal that physicians select treatments based on reimbursement ahead of patient need, suggested in Dec. 19, 2018, comments to the agency that drugs on the Food and Drug Administration’s drug shortage list be excluded from the list.
It also expressed concerns regarding access if a drug goes without international reference pricing because a manufacturer chooses not to sell in certain countries.
“AADA is concerned that this model could result in patients losing access to some drugs when a distributor and manufacturer are unable to agree on a price,” the group said. Similarly, the lag in setting a reference price after a new product is introduced could also create access issues.
AADA also took issue with the fact that vendors could not offer physicians and hospitals volume-based incentive payments or rebates but did not have the same prohibition from vendors receiving such incentives. “Under this proposal, CMS should prohibit vendors from prioritizing drug availability or excluding some drugs from distribution to physicians based on discounts provided by manufacturers. CMS will need to monitor utilization to ensure access to necessary treatments is not delayed or impeded.”
AADA also wants more clarity in how providers will be selected to participate.
The American College of Rheumatology expressed concern that “the administrative difficulties that would be associated with utilizing vendors could lead some practices to lose the ability to provide infusion services. Specifically, we are concerned that the added administrative burden of proposed interactions with the vendors in the model exceeds any inherent benefits to practice.” It added that CMS needs to look at how a potentially mandatory participation could affect specialty physician shortages.
The ACR made a number of recommendations, including making the IPI model participation voluntary; allowing for an exit for participants if the program is not working for them; providing incentives that could increase gross reimbursement; increasing provider reimbursement to cover the expenses associated with dealing with vendors; and making sure the agency is adequately tracking the effect on patient access.
ASCO used its comments to reiterate previous comments provided to the agency on revising the competitive acquisition program (CAP), a failed program that used third-party vendors as suppliers for Part B drugs. Among its suggestions were making the program voluntary; ensuring it does not result in an aggregate reduction in payments to oncology practices; ensuring a CAP does not result in interruption in care; and restricting its burdensome utilization management requirements.
The Community Oncology Alliance said it is working on an alternative to the IPI model, one that could contain a number of provisions, such as tiered average sales price-based reimbursement; clinically appropriate utilization management techniques; and drug prices that are lowered without artificial international price indexing.
The American Medical Association in Dec. 20, 2018, comments to the agency outlined a number of principles that any new vendor-based program needs to include, such as being voluntary; providing supplemental payments to cover the cost of special handling and storage of Part B drugs; flexibility to ensure various ordering issues; preventing variation in treatments for patients; and prohibiting vendors from restricting access using utilization management techniques.
The AMA also offered a range of suggestions for the IPI model, including measuring timeliness of deliveries in hours, not days; prohibiting vendors from withholding shipments of subsequent treatments if the initial claim has not been processed; making all treatment options available, even for off-label use; and getting guarantees from vendors on the availability of next-day delivery to any location where the patient is being treated.
Likewise, the AMA suggested that CMS should not set unreasonable deadlines for claims submissions and should provide an adequate number of vendors to ensure choice and access.
“We are also concerned about the impact of the proposed IPI model and its overall impact on costs to physician practices,” the AMA said in its comment letter. “The Administration proposes to allow the vendors to charge administrative fees to physician practices as part of their agreement to provide drug products to those practices included in the model. While we understand that third-party vendors must have a financial incentive in order to participate in the program, allowing vendors to charge physician practices administrative fees would add new, potentially significant increased costs to physicians in acquiring and providing treatments to patients without adequate changes to the reimbursement model to compensate for these costs.”
The AMA said that lower reimbursement combined with administrative fees would likely make the model untenable for physician practices unless changes to the reimbursement model were made.
The AMA also took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues.
“We urge CMS to undertake modeling and simulation of the impact if vendors are unable to obtain these drugs at the reimbursement amount,” the AMA stated in its comment letter. “There is a distinct possibility of immediate adverse patient impact if none of the vendors are able to secure needed clinical treatments.”
The Centers for Medicare & Medicaid Services in October 2018 issued an “advance notice of proposed rulemaking with comment” outlining a test that would pay for Part B drugs with price points more closely aligned with international rates through the use of private sector vendors that would negotiate drug prices, procure the products, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare.
Although the so-called International Pricing Index (IPI) model is not fully fleshed out in the regulatory filing, one of the key details that has been announced is that the demonstration project would have mandatory participation. This did not sit well with medical societies offering feedback to CMS.
The American College of Rheumatology stated in comments filed with the agency that “we do not support mandatory demonstration projects.”
The American Society of Clinical Oncology echoed that sentiment in Dec. 31, 2018, comments filed with the agency. “ASCO cannot support a mandatory demonstration program,” the group noted. “We are concerned about losing access points to oncology care provided by oncology practices, especially in rural, underserved, and low-income areas that are already struggling to deliver care.”
And while the Community Oncology Alliance also spoke against making participation in the IPI model demonstration project mandatory, it went further with its criticism of the proposal.
“COA does not support the IPI Model as proposed in the pre-proposed rule published by [CMS] because we have serious concerns about its impact on cancer patient care and even its legality,” the group said in Dec. 31, 2018, comments filed with the agency, adding that “mandatory demonstration projects are clearly not in the charter of CMMI [Center for Medicare & Medicaid Innovation] as written into law by Congress. If CMS believes that CMMI has the power via statute to effectively amend Medicare law – in this case the Part B drug reimbursement rate for at least 50% of Part B providers – it (CMS representing the Executive branch) either has overstepped its constitutional boundaries separating the powers of government branches or Congress has effectively handed over its powers to the Executive branch. That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
While none of the groups offered support to the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advance notice of proposed rulemaking.
The American Academy of Dermatology Association, which like other groups took exception to CMS’ “insinuation” in its regulatory pre-proposal that physicians select treatments based on reimbursement ahead of patient need, suggested in Dec. 19, 2018, comments to the agency that drugs on the Food and Drug Administration’s drug shortage list be excluded from the list.
It also expressed concerns regarding access if a drug goes without international reference pricing because a manufacturer chooses not to sell in certain countries.
“AADA is concerned that this model could result in patients losing access to some drugs when a distributor and manufacturer are unable to agree on a price,” the group said. Similarly, the lag in setting a reference price after a new product is introduced could also create access issues.
AADA also took issue with the fact that vendors could not offer physicians and hospitals volume-based incentive payments or rebates but did not have the same prohibition from vendors receiving such incentives. “Under this proposal, CMS should prohibit vendors from prioritizing drug availability or excluding some drugs from distribution to physicians based on discounts provided by manufacturers. CMS will need to monitor utilization to ensure access to necessary treatments is not delayed or impeded.”
AADA also wants more clarity in how providers will be selected to participate.
The American College of Rheumatology expressed concern that “the administrative difficulties that would be associated with utilizing vendors could lead some practices to lose the ability to provide infusion services. Specifically, we are concerned that the added administrative burden of proposed interactions with the vendors in the model exceeds any inherent benefits to practice.” It added that CMS needs to look at how a potentially mandatory participation could affect specialty physician shortages.
The ACR made a number of recommendations, including making the IPI model participation voluntary; allowing for an exit for participants if the program is not working for them; providing incentives that could increase gross reimbursement; increasing provider reimbursement to cover the expenses associated with dealing with vendors; and making sure the agency is adequately tracking the effect on patient access.
ASCO used its comments to reiterate previous comments provided to the agency on revising the competitive acquisition program (CAP), a failed program that used third-party vendors as suppliers for Part B drugs. Among its suggestions were making the program voluntary; ensuring it does not result in an aggregate reduction in payments to oncology practices; ensuring a CAP does not result in interruption in care; and restricting its burdensome utilization management requirements.
The Community Oncology Alliance said it is working on an alternative to the IPI model, one that could contain a number of provisions, such as tiered average sales price-based reimbursement; clinically appropriate utilization management techniques; and drug prices that are lowered without artificial international price indexing.
The American Medical Association in Dec. 20, 2018, comments to the agency outlined a number of principles that any new vendor-based program needs to include, such as being voluntary; providing supplemental payments to cover the cost of special handling and storage of Part B drugs; flexibility to ensure various ordering issues; preventing variation in treatments for patients; and prohibiting vendors from restricting access using utilization management techniques.
The AMA also offered a range of suggestions for the IPI model, including measuring timeliness of deliveries in hours, not days; prohibiting vendors from withholding shipments of subsequent treatments if the initial claim has not been processed; making all treatment options available, even for off-label use; and getting guarantees from vendors on the availability of next-day delivery to any location where the patient is being treated.
Likewise, the AMA suggested that CMS should not set unreasonable deadlines for claims submissions and should provide an adequate number of vendors to ensure choice and access.
“We are also concerned about the impact of the proposed IPI model and its overall impact on costs to physician practices,” the AMA said in its comment letter. “The Administration proposes to allow the vendors to charge administrative fees to physician practices as part of their agreement to provide drug products to those practices included in the model. While we understand that third-party vendors must have a financial incentive in order to participate in the program, allowing vendors to charge physician practices administrative fees would add new, potentially significant increased costs to physicians in acquiring and providing treatments to patients without adequate changes to the reimbursement model to compensate for these costs.”
The AMA said that lower reimbursement combined with administrative fees would likely make the model untenable for physician practices unless changes to the reimbursement model were made.
The AMA also took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues.
“We urge CMS to undertake modeling and simulation of the impact if vendors are unable to obtain these drugs at the reimbursement amount,” the AMA stated in its comment letter. “There is a distinct possibility of immediate adverse patient impact if none of the vendors are able to secure needed clinical treatments.”
Financial returns more than cover cancer drug R&D
Cancer pharmaceutical manufacturers are making profits that more than cover their research and development costs, calling into question the need for these products to carry a high price tag, limiting access.
“Based on a risk-adjusted R&D cost of $794 million [$219 million to $2.8 billion], by the end of 2017, $1 (risk-adjusted) invested for R&D of the 99 drugs had generated a median of $14.50 (range, $3.30-$55.10) in sales income for the originator companies” wrote Kiu Tay-Teo, PhD, of the World Health Organization, Geneva, Switzerland, and colleagues. The report is in JAMA Network Open.
“Assuming the upper threshold R&D cost of [$2.8 billion], rituximab, trastuzumab, bevacizumab, pegfilgrastim, and imatinib have brought in for the originator companies, $33.20, $31.20, $29.50, $22.60, and $22.60, respectively, for every risk adjusted dollar that went into their R&D.”
The study authors looked at all cancer drugs approved by the Food and Drug Administration from 1989 to 2017 (156 total) and narrowed the analysis down to the 99 products that had sales data on more than half of the years since being approved.
The analysis shows that compared with the risk-adjusted R&D cost of $794 million (with a range of $219 million to $2.8 billion) per medicine, by the end of 2017, the median cumulative sales income was $14.50 (range, $3.30-$55.10) per dollar invested for R&D. “Median time to fully recover the maximum possible risk-adjusted cost of R&D [$2.8 billion] was 5 years (range, 2-10 years; n = 56),” the authors stated.
“By the end of 2017, the cumulative sales of 73 cancer drugs (73.7%) included in the analysis had fully recovered the median R&D costs of $794 million,” Dr. Tay-Teo and colleagues reported.
The authors argue that such high prices and high profits, while far exceeding even the upper bound of R&D costs, could also be hindering access to drugs.
“The high incomes and supernormal returns would be less worrying if patients were able to access cancer drugs at affordable prices,” Dr. Tay-Teo and colleagues stated. “However, the existing evidence suggests otherwise: Access to cancer drugs globally remains low and the number of cancer drugs with annual costs at least in the tens of thousands is increasing fast. The resulting expenditure effects have compelled insurance schemes to exclude patients from coverage, restrict access, or impose high out-of-pocket costs.”
They suggest that for these reasons, the high price tags on cancer drugs is reducing patient access worldwide.
The analysis was limited to the information on sales and R&D costs that was made public by manufacturers in annual reports and did not estimate cumulative profits due to lack of information on year-over-year variations on production costs of cancer drugs.
SOURCE: Kiu Tay-Teo, PhD, et al. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2018.6875.
Cancer pharmaceutical manufacturers are making profits that more than cover their research and development costs, calling into question the need for these products to carry a high price tag, limiting access.
“Based on a risk-adjusted R&D cost of $794 million [$219 million to $2.8 billion], by the end of 2017, $1 (risk-adjusted) invested for R&D of the 99 drugs had generated a median of $14.50 (range, $3.30-$55.10) in sales income for the originator companies” wrote Kiu Tay-Teo, PhD, of the World Health Organization, Geneva, Switzerland, and colleagues. The report is in JAMA Network Open.
“Assuming the upper threshold R&D cost of [$2.8 billion], rituximab, trastuzumab, bevacizumab, pegfilgrastim, and imatinib have brought in for the originator companies, $33.20, $31.20, $29.50, $22.60, and $22.60, respectively, for every risk adjusted dollar that went into their R&D.”
The study authors looked at all cancer drugs approved by the Food and Drug Administration from 1989 to 2017 (156 total) and narrowed the analysis down to the 99 products that had sales data on more than half of the years since being approved.
The analysis shows that compared with the risk-adjusted R&D cost of $794 million (with a range of $219 million to $2.8 billion) per medicine, by the end of 2017, the median cumulative sales income was $14.50 (range, $3.30-$55.10) per dollar invested for R&D. “Median time to fully recover the maximum possible risk-adjusted cost of R&D [$2.8 billion] was 5 years (range, 2-10 years; n = 56),” the authors stated.
“By the end of 2017, the cumulative sales of 73 cancer drugs (73.7%) included in the analysis had fully recovered the median R&D costs of $794 million,” Dr. Tay-Teo and colleagues reported.
The authors argue that such high prices and high profits, while far exceeding even the upper bound of R&D costs, could also be hindering access to drugs.
“The high incomes and supernormal returns would be less worrying if patients were able to access cancer drugs at affordable prices,” Dr. Tay-Teo and colleagues stated. “However, the existing evidence suggests otherwise: Access to cancer drugs globally remains low and the number of cancer drugs with annual costs at least in the tens of thousands is increasing fast. The resulting expenditure effects have compelled insurance schemes to exclude patients from coverage, restrict access, or impose high out-of-pocket costs.”
They suggest that for these reasons, the high price tags on cancer drugs is reducing patient access worldwide.
The analysis was limited to the information on sales and R&D costs that was made public by manufacturers in annual reports and did not estimate cumulative profits due to lack of information on year-over-year variations on production costs of cancer drugs.
SOURCE: Kiu Tay-Teo, PhD, et al. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2018.6875.
Cancer pharmaceutical manufacturers are making profits that more than cover their research and development costs, calling into question the need for these products to carry a high price tag, limiting access.
“Based on a risk-adjusted R&D cost of $794 million [$219 million to $2.8 billion], by the end of 2017, $1 (risk-adjusted) invested for R&D of the 99 drugs had generated a median of $14.50 (range, $3.30-$55.10) in sales income for the originator companies” wrote Kiu Tay-Teo, PhD, of the World Health Organization, Geneva, Switzerland, and colleagues. The report is in JAMA Network Open.
“Assuming the upper threshold R&D cost of [$2.8 billion], rituximab, trastuzumab, bevacizumab, pegfilgrastim, and imatinib have brought in for the originator companies, $33.20, $31.20, $29.50, $22.60, and $22.60, respectively, for every risk adjusted dollar that went into their R&D.”
The study authors looked at all cancer drugs approved by the Food and Drug Administration from 1989 to 2017 (156 total) and narrowed the analysis down to the 99 products that had sales data on more than half of the years since being approved.
The analysis shows that compared with the risk-adjusted R&D cost of $794 million (with a range of $219 million to $2.8 billion) per medicine, by the end of 2017, the median cumulative sales income was $14.50 (range, $3.30-$55.10) per dollar invested for R&D. “Median time to fully recover the maximum possible risk-adjusted cost of R&D [$2.8 billion] was 5 years (range, 2-10 years; n = 56),” the authors stated.
“By the end of 2017, the cumulative sales of 73 cancer drugs (73.7%) included in the analysis had fully recovered the median R&D costs of $794 million,” Dr. Tay-Teo and colleagues reported.
The authors argue that such high prices and high profits, while far exceeding even the upper bound of R&D costs, could also be hindering access to drugs.
“The high incomes and supernormal returns would be less worrying if patients were able to access cancer drugs at affordable prices,” Dr. Tay-Teo and colleagues stated. “However, the existing evidence suggests otherwise: Access to cancer drugs globally remains low and the number of cancer drugs with annual costs at least in the tens of thousands is increasing fast. The resulting expenditure effects have compelled insurance schemes to exclude patients from coverage, restrict access, or impose high out-of-pocket costs.”
They suggest that for these reasons, the high price tags on cancer drugs is reducing patient access worldwide.
The analysis was limited to the information on sales and R&D costs that was made public by manufacturers in annual reports and did not estimate cumulative profits due to lack of information on year-over-year variations on production costs of cancer drugs.
SOURCE: Kiu Tay-Teo, PhD, et al. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2018.6875.
FROM JAMA NETWORK OPEN
Key clinical point: Profits from cancer drugs far exceed R&D costs.
Major finding: $1 of R&D investment generated a median $14.50 in sales income for originator companies.
Study details: Researchers did an analysis of 99 cancer drugs approved by the FDA between 1989 and 2017 that had sales data for more than half of the years the drugs were approved.
Disclosures: The researchers reported no conflicts of interest.
Source: Kiu Tay-Teo, PhD, et al. JAMA Netw Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.6875.
Hospital Readmissions Reduction Program may be doing more harm than good
A Medicare program aimed at lowering readmissions to hospitals could be having an adverse effect on mortality.
Results from a retrospective cohort study of hospitalizations for heart failure, acute myocardial infarction, and pneumonia among Medicare beneficiaries aged 65 years and older between April 1, 2005 and March 31, 2015 (covering the period before and after the Medicare Hospital Readmissions Reduction Program was announced in April 2010 and implemented in October 2012) found a significant increase in 30-day post discharge mortality among heart failure and pneumonia patients.
“Most concerning, however, is the possibility that the relationship between the HRRP and postdischarge mortality for heart failure and pneumonia is causal, indicating that the HRRP led to changes in quality of care that adversely affected patients,” Rishi Wadhera, MD, Harvard Medical School, Boston, and his colleagues wrote in a report published Dec. 25, 2018, in JAMA.
They looked at 8.3 million hospitalizations for heart failure, acute MI, and pneumonia, among whom 7.9 million were alive at the time of discharge. There were roughly 270,000 deaths within 30 days of discharge for heart failure; 128,000 for acute MI; and 246,000 for pneumonia.
To examine trends, the timing was divided into four periods: two prior to the announcement of the HRRP (April 2005–September 2007 and October 2007–March 2010); a third covering the time when the HRRP was announced (April 2010–September 2012); and the fourth when HRRP was implemented (October 2012–March 2015).
They found that among patients discharged with heart failure, 30-day mortality was rising even before the announcement of the HRRP, by 0.27% from the first period to the second period. That baseline trend continued when the HRRP was announced, by 0.49%, from second period to third. The difference in change between those periods was 0.22%. After implementation, 30-day mortality increased by 0.52%, with a difference in change from the third period of 0.25%. Both changes were statistically significant.
Among pneumonia patients, postdischarge mortality was stable before HRRP, but significantly increased after HRRP announcement, by 0.26%, with a difference in change from the second period to the third period of 0.22%. After implementation, the 30-day postdischarge mortality was 0.44%, with a significant difference in change of 0.40%.
Acute MI was a different story. Postdischarge mortality decreased significantly after the implementation of the HRRP, by 0.22%. The difference in change was –0.26%.
The authors suggested that “some hospitals may have focused more resources and efforts on reducing or avoiding readmissions than on prioritizing survival.” They add that the increases in heart failure morbidity could be related to patients with more severe heart conditions.
They noted that “although hospitals that reduce readmissions also appear to reduce mortality, this hospital-level concordance does not reflect the change in readmissions and mortality at the level of the patient population, which is arguably of greater importance to individual patients and to public health.”
Further research is needed to understand whether the increase in 30-day postdischarge mortality is a result of the HRRP, the authors concluded.
SOURCE: Wadhera R et al. JAMA. 2018 Dec 25. doi: 10.1001/jama.2018.19232.
Evidence in this study shows that while the Hospital Readmissions Reduction Program my be succeeding in reducing hospital admissions, little evidence is available to show that it is having a positive effect on patient outcomes.
The Centers for Medicare & Medicaid Services needs to reexamine the program and find alternative methods that are both effective at reducing hospital readmissions while at the same time protect patients from unintentional harm, including death.
Gregg C. Fonarow, MD , University of California Medical Center, Los Angeles, in an editorial published in JAMA, Dec. 25, 2018. doi:10.1001/jama.2018.19325 .
Evidence in this study shows that while the Hospital Readmissions Reduction Program my be succeeding in reducing hospital admissions, little evidence is available to show that it is having a positive effect on patient outcomes.
The Centers for Medicare & Medicaid Services needs to reexamine the program and find alternative methods that are both effective at reducing hospital readmissions while at the same time protect patients from unintentional harm, including death.
Gregg C. Fonarow, MD , University of California Medical Center, Los Angeles, in an editorial published in JAMA, Dec. 25, 2018. doi:10.1001/jama.2018.19325 .
Evidence in this study shows that while the Hospital Readmissions Reduction Program my be succeeding in reducing hospital admissions, little evidence is available to show that it is having a positive effect on patient outcomes.
The Centers for Medicare & Medicaid Services needs to reexamine the program and find alternative methods that are both effective at reducing hospital readmissions while at the same time protect patients from unintentional harm, including death.
Gregg C. Fonarow, MD , University of California Medical Center, Los Angeles, in an editorial published in JAMA, Dec. 25, 2018. doi:10.1001/jama.2018.19325 .
A Medicare program aimed at lowering readmissions to hospitals could be having an adverse effect on mortality.
Results from a retrospective cohort study of hospitalizations for heart failure, acute myocardial infarction, and pneumonia among Medicare beneficiaries aged 65 years and older between April 1, 2005 and March 31, 2015 (covering the period before and after the Medicare Hospital Readmissions Reduction Program was announced in April 2010 and implemented in October 2012) found a significant increase in 30-day post discharge mortality among heart failure and pneumonia patients.
“Most concerning, however, is the possibility that the relationship between the HRRP and postdischarge mortality for heart failure and pneumonia is causal, indicating that the HRRP led to changes in quality of care that adversely affected patients,” Rishi Wadhera, MD, Harvard Medical School, Boston, and his colleagues wrote in a report published Dec. 25, 2018, in JAMA.
They looked at 8.3 million hospitalizations for heart failure, acute MI, and pneumonia, among whom 7.9 million were alive at the time of discharge. There were roughly 270,000 deaths within 30 days of discharge for heart failure; 128,000 for acute MI; and 246,000 for pneumonia.
To examine trends, the timing was divided into four periods: two prior to the announcement of the HRRP (April 2005–September 2007 and October 2007–March 2010); a third covering the time when the HRRP was announced (April 2010–September 2012); and the fourth when HRRP was implemented (October 2012–March 2015).
They found that among patients discharged with heart failure, 30-day mortality was rising even before the announcement of the HRRP, by 0.27% from the first period to the second period. That baseline trend continued when the HRRP was announced, by 0.49%, from second period to third. The difference in change between those periods was 0.22%. After implementation, 30-day mortality increased by 0.52%, with a difference in change from the third period of 0.25%. Both changes were statistically significant.
Among pneumonia patients, postdischarge mortality was stable before HRRP, but significantly increased after HRRP announcement, by 0.26%, with a difference in change from the second period to the third period of 0.22%. After implementation, the 30-day postdischarge mortality was 0.44%, with a significant difference in change of 0.40%.
Acute MI was a different story. Postdischarge mortality decreased significantly after the implementation of the HRRP, by 0.22%. The difference in change was –0.26%.
The authors suggested that “some hospitals may have focused more resources and efforts on reducing or avoiding readmissions than on prioritizing survival.” They add that the increases in heart failure morbidity could be related to patients with more severe heart conditions.
They noted that “although hospitals that reduce readmissions also appear to reduce mortality, this hospital-level concordance does not reflect the change in readmissions and mortality at the level of the patient population, which is arguably of greater importance to individual patients and to public health.”
Further research is needed to understand whether the increase in 30-day postdischarge mortality is a result of the HRRP, the authors concluded.
SOURCE: Wadhera R et al. JAMA. 2018 Dec 25. doi: 10.1001/jama.2018.19232.
A Medicare program aimed at lowering readmissions to hospitals could be having an adverse effect on mortality.
Results from a retrospective cohort study of hospitalizations for heart failure, acute myocardial infarction, and pneumonia among Medicare beneficiaries aged 65 years and older between April 1, 2005 and March 31, 2015 (covering the period before and after the Medicare Hospital Readmissions Reduction Program was announced in April 2010 and implemented in October 2012) found a significant increase in 30-day post discharge mortality among heart failure and pneumonia patients.
“Most concerning, however, is the possibility that the relationship between the HRRP and postdischarge mortality for heart failure and pneumonia is causal, indicating that the HRRP led to changes in quality of care that adversely affected patients,” Rishi Wadhera, MD, Harvard Medical School, Boston, and his colleagues wrote in a report published Dec. 25, 2018, in JAMA.
They looked at 8.3 million hospitalizations for heart failure, acute MI, and pneumonia, among whom 7.9 million were alive at the time of discharge. There were roughly 270,000 deaths within 30 days of discharge for heart failure; 128,000 for acute MI; and 246,000 for pneumonia.
To examine trends, the timing was divided into four periods: two prior to the announcement of the HRRP (April 2005–September 2007 and October 2007–March 2010); a third covering the time when the HRRP was announced (April 2010–September 2012); and the fourth when HRRP was implemented (October 2012–March 2015).
They found that among patients discharged with heart failure, 30-day mortality was rising even before the announcement of the HRRP, by 0.27% from the first period to the second period. That baseline trend continued when the HRRP was announced, by 0.49%, from second period to third. The difference in change between those periods was 0.22%. After implementation, 30-day mortality increased by 0.52%, with a difference in change from the third period of 0.25%. Both changes were statistically significant.
Among pneumonia patients, postdischarge mortality was stable before HRRP, but significantly increased after HRRP announcement, by 0.26%, with a difference in change from the second period to the third period of 0.22%. After implementation, the 30-day postdischarge mortality was 0.44%, with a significant difference in change of 0.40%.
Acute MI was a different story. Postdischarge mortality decreased significantly after the implementation of the HRRP, by 0.22%. The difference in change was –0.26%.
The authors suggested that “some hospitals may have focused more resources and efforts on reducing or avoiding readmissions than on prioritizing survival.” They add that the increases in heart failure morbidity could be related to patients with more severe heart conditions.
They noted that “although hospitals that reduce readmissions also appear to reduce mortality, this hospital-level concordance does not reflect the change in readmissions and mortality at the level of the patient population, which is arguably of greater importance to individual patients and to public health.”
Further research is needed to understand whether the increase in 30-day postdischarge mortality is a result of the HRRP, the authors concluded.
SOURCE: Wadhera R et al. JAMA. 2018 Dec 25. doi: 10.1001/jama.2018.19232.
FROM JAMA
Key clinical point:
Major finding: Heart failure patients saw mortality increase 0.52% after HRRP launched.
Study details: A retrospective cohort study across 10 years, including time before and after the implementation of the HRRP.
Disclosures: The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology funded the study. No relevant conflicts of interest were disclosed.
Source: Wadhera R et al. JAMA 2018 Dec 25. doi: 10.1001/jama.2018.19232.