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Telehealth appears to help speed front end of liver transplant process
The incorporation of telehealth in the liver transplantation process is demonstrating the potential to expedite the evaluation of patients and get them listed on the transplant wait list.
New research shows “a ,” Binu V. John, MD, of McGuire VA Medical Center, Richmond, and colleagues wrote in a report published in Clinical Gastroenterology and Hepatology (2019 Dec 27. doi: 10.1016/j.cgh.2019.12.021).
Researchers looked at 465 patients who had evaluations for liver transplants at the Richmond Veterans Affairs Medical Center from 2005 through 2017. Nearly half (232 patients) were evaluated via telehealth, with the remaining 233 evaluated with traditional in-person evaluations.
“Patients in the telehealth group were evaluated significantly faster than patients in the usual care group (22 vs. 54 days, P less than .001),” Dr. John and colleagues wrote, adding that, after conducting a propensity-matched analysis, “telehealth was associated with an 85% reduction in time from referral to evaluation.”
Additionally, patients “who underwent the initial evaluation by telehealth were listed significantly earlier than the usual care group (95 vs. 149 days; P less than .001),” the authors stated, adding that “telehealth was associated with a 74% reduction in time to listing” after conducting a propensity-matched analysis.
However, while speeding up time to referral and listing, “the median time to transplant was not significantly different between the two groups on unadjusted (218 vs. 244 days; P = .084) or adjusted analysis (325 vs. 409 days; P = .08),” they added.
Additionally, “there was no difference in pretransplant mortality between [those] evaluated by telehealth or usual care in unadjusted analysis,” Dr. John and colleagues observed, noting that 169 of 465 patients (51 on the waiting list for a transplant and 118 who were not listed) who were referred died without receiving a liver transplant.
Researchers suggested that while evaluation times may have been shorter with the use of telehealth, they did not translate to shorter transplantation times “likely because the latter is a complex metric that is driven primarily by organ availability.”
Dr. John and colleagues cautioned that the centralized nature of the VA medical system could make the results of this study not generalizable across private care settings, particularly when care needs to cross state lines, which does not present an issue within the VA medical system.
That being said, the “ability to successfully evaluate and list patients via telehealth and obtain the same outcomes in terms of time to transplant and pretransplant mortality is significant because of the numerous advantages that telehealth offers to improve overall access to transplantation,” they stated, adding that more studies are needed, both in and out of the VA system, “to confirm that telehealth is a safe and effective way to expand access for patients undergoing evaluation for liver transplantation.”
Lead author Dr. Binu John serves on medical advisory boards for Gilead and Eisai and received research funding from a number of pharmaceutical manufacturers. No conflicts of interest were reported by the other authors.
SOURCE: John BV et al. Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2019.12.021.
The incorporation of telehealth in the liver transplantation process is demonstrating the potential to expedite the evaluation of patients and get them listed on the transplant wait list.
New research shows “a ,” Binu V. John, MD, of McGuire VA Medical Center, Richmond, and colleagues wrote in a report published in Clinical Gastroenterology and Hepatology (2019 Dec 27. doi: 10.1016/j.cgh.2019.12.021).
Researchers looked at 465 patients who had evaluations for liver transplants at the Richmond Veterans Affairs Medical Center from 2005 through 2017. Nearly half (232 patients) were evaluated via telehealth, with the remaining 233 evaluated with traditional in-person evaluations.
“Patients in the telehealth group were evaluated significantly faster than patients in the usual care group (22 vs. 54 days, P less than .001),” Dr. John and colleagues wrote, adding that, after conducting a propensity-matched analysis, “telehealth was associated with an 85% reduction in time from referral to evaluation.”
Additionally, patients “who underwent the initial evaluation by telehealth were listed significantly earlier than the usual care group (95 vs. 149 days; P less than .001),” the authors stated, adding that “telehealth was associated with a 74% reduction in time to listing” after conducting a propensity-matched analysis.
However, while speeding up time to referral and listing, “the median time to transplant was not significantly different between the two groups on unadjusted (218 vs. 244 days; P = .084) or adjusted analysis (325 vs. 409 days; P = .08),” they added.
Additionally, “there was no difference in pretransplant mortality between [those] evaluated by telehealth or usual care in unadjusted analysis,” Dr. John and colleagues observed, noting that 169 of 465 patients (51 on the waiting list for a transplant and 118 who were not listed) who were referred died without receiving a liver transplant.
Researchers suggested that while evaluation times may have been shorter with the use of telehealth, they did not translate to shorter transplantation times “likely because the latter is a complex metric that is driven primarily by organ availability.”
Dr. John and colleagues cautioned that the centralized nature of the VA medical system could make the results of this study not generalizable across private care settings, particularly when care needs to cross state lines, which does not present an issue within the VA medical system.
That being said, the “ability to successfully evaluate and list patients via telehealth and obtain the same outcomes in terms of time to transplant and pretransplant mortality is significant because of the numerous advantages that telehealth offers to improve overall access to transplantation,” they stated, adding that more studies are needed, both in and out of the VA system, “to confirm that telehealth is a safe and effective way to expand access for patients undergoing evaluation for liver transplantation.”
Lead author Dr. Binu John serves on medical advisory boards for Gilead and Eisai and received research funding from a number of pharmaceutical manufacturers. No conflicts of interest were reported by the other authors.
SOURCE: John BV et al. Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2019.12.021.
The incorporation of telehealth in the liver transplantation process is demonstrating the potential to expedite the evaluation of patients and get them listed on the transplant wait list.
New research shows “a ,” Binu V. John, MD, of McGuire VA Medical Center, Richmond, and colleagues wrote in a report published in Clinical Gastroenterology and Hepatology (2019 Dec 27. doi: 10.1016/j.cgh.2019.12.021).
Researchers looked at 465 patients who had evaluations for liver transplants at the Richmond Veterans Affairs Medical Center from 2005 through 2017. Nearly half (232 patients) were evaluated via telehealth, with the remaining 233 evaluated with traditional in-person evaluations.
“Patients in the telehealth group were evaluated significantly faster than patients in the usual care group (22 vs. 54 days, P less than .001),” Dr. John and colleagues wrote, adding that, after conducting a propensity-matched analysis, “telehealth was associated with an 85% reduction in time from referral to evaluation.”
Additionally, patients “who underwent the initial evaluation by telehealth were listed significantly earlier than the usual care group (95 vs. 149 days; P less than .001),” the authors stated, adding that “telehealth was associated with a 74% reduction in time to listing” after conducting a propensity-matched analysis.
However, while speeding up time to referral and listing, “the median time to transplant was not significantly different between the two groups on unadjusted (218 vs. 244 days; P = .084) or adjusted analysis (325 vs. 409 days; P = .08),” they added.
Additionally, “there was no difference in pretransplant mortality between [those] evaluated by telehealth or usual care in unadjusted analysis,” Dr. John and colleagues observed, noting that 169 of 465 patients (51 on the waiting list for a transplant and 118 who were not listed) who were referred died without receiving a liver transplant.
Researchers suggested that while evaluation times may have been shorter with the use of telehealth, they did not translate to shorter transplantation times “likely because the latter is a complex metric that is driven primarily by organ availability.”
Dr. John and colleagues cautioned that the centralized nature of the VA medical system could make the results of this study not generalizable across private care settings, particularly when care needs to cross state lines, which does not present an issue within the VA medical system.
That being said, the “ability to successfully evaluate and list patients via telehealth and obtain the same outcomes in terms of time to transplant and pretransplant mortality is significant because of the numerous advantages that telehealth offers to improve overall access to transplantation,” they stated, adding that more studies are needed, both in and out of the VA system, “to confirm that telehealth is a safe and effective way to expand access for patients undergoing evaluation for liver transplantation.”
Lead author Dr. Binu John serves on medical advisory boards for Gilead and Eisai and received research funding from a number of pharmaceutical manufacturers. No conflicts of interest were reported by the other authors.
SOURCE: John BV et al. Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2019.12.021.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Medicaid spending on MS drugs rose despite introduction of generic glatiramer
Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.
“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.
Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.
Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.
The researchers attributed the increased Medicaid spending to rising prices of DMTs.
“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”
In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”
Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.
“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”
These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.
The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.
SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.
Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.
“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.
Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.
Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.
The researchers attributed the increased Medicaid spending to rising prices of DMTs.
“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”
In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”
Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.
“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”
These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.
The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.
SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.
Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.
“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.
Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.
Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.
The researchers attributed the increased Medicaid spending to rising prices of DMTs.
“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”
In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”
Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.
“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”
These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.
The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.
SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.
FROM NEUROLOGY
Key clinical point: Medicaid spending on MS DMTs continues to rise in spite of generic introduction.
Major finding: Cost is the major factor in spending as utilization has remained stable.
Study details: Researchers examined quarterly Medicaid State Drug Utilization Data from 2011 to 2017, examining spending, utilization and cost per prescription for 15 MS DMTs, including brand and generic versions of glatiramer acetate.
Disclosures: The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.
Source: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.
Expedited review programs not shortening drug development
Drug development times are not showing any signs of decreasing even though application review times at the Food and Drug Administration are improving, new research has shown.
“Despite the accumulation of expedited programs that have reduced FDA review times, overall clinical development times have not become shorter, although it is not possible to know what role these programs may have played in preventing an increase in development times,” Jonathan Darrow of Harvard Medical School, Boston, and colleagues wrote in a study published Jan. 14 in JAMA.
Researchers noted that FDA approval times declined from more than 3 years in 1983 to less than 1 year in 2017, although total time from the authorization of clinical testing to approval has remained steady across that period at about 8 years.
“The resistance of total development times to efforts to shorten them could be the result of more submissions of applications for rare disease drugs, which can sometimes pose trial recruitment challenges; a shifting emphasis to more challenging therapeutic categories, such as central nervous system disorder treatments; longer time horizons needed to establish efficacy when early intervention is important (e.g., cancer); or other factors,” wrote Mr. Darrow and colleagues.
The authors also note that the value of the expanded review toolbox the FDA now employs is “unclear” as “the number of new drug approvals has not increased substantially over the past three decades.” This observation does not count biologics or generic approvals.
Research revealed that the mean annual number of new drug approvals (including biologics) was 34 from 1990 to 1999, 25 from 2000 to 2009, and 41 from 2010 to 2018. In addition, while the number of new drug approvals has remained at or below 60 per year, the portion of drugs using at least one expedited review program increased over time, with more than 80% of the 59 new drugs approved in 2018 being subject to at least one expedited review program.
“Although the FDA has on average applied its expedited programs to drugs offering larger health gains, it is difficult to assess whether these programs have incentivized greater therapeutic innovation or merely allowed more appropriate agency prioritization,” noted Mr. Darrow and colleagues.
And while it may be hard to truly understand the impact of the many expedited review programs that have been introduced at the FDA, there is still room for improvement in the process.
In an editorial published in JAMA, Joshua Sharfstein, MD, of Johns Hopkins University, Baltimore, suggested four reforms the FDA could examine.
“First, Congress and the FDA should rationalize the various programs for expedited review,” he wrote, noting that companies are using the Orphan Drug Act to prevent competition. “Fixing the system requires, at a minimum, promoting meaningful competition for non-orphan uses.”
Second, he wrote, the FDA needs to strengthen oversight of postmarket safety though more diligence in the operation of its Risk Evaluation and Management Strategies (REMS) program.
“Third, Congress should recalibrate the programs that provide companies with special marketing protections,” added Dr. Sharfstein, former FDA principal deputy commissioner. “One place to look is pediatric exclusivity, which has been estimated to cost the health care system more than $6 for every $1 spent by a company on a pediatric trial.”
And finally, “Congress should use patent and pricing incentives to accelerate the generation of definitive evidence under accelerated approval,” citing proposals to limit pricing or market exclusivity until companies complete studies that assess clinically relevant endpoints.
“These changes would reflect an evolution, not a revolution, of the FDA’s approach to new drug approval,” Dr. Sharfstein said. “These reforms could also bring greater order and thoughtfulness to the regulation of important new therapies, while enhancing safety and creating greater capability to afford truly transformative medical products.”
SOURCE: Jonathan Darrow et al. JAMA 2020 Jan 14. doi: 10.1001/jama.2019.20288.
Drug development times are not showing any signs of decreasing even though application review times at the Food and Drug Administration are improving, new research has shown.
“Despite the accumulation of expedited programs that have reduced FDA review times, overall clinical development times have not become shorter, although it is not possible to know what role these programs may have played in preventing an increase in development times,” Jonathan Darrow of Harvard Medical School, Boston, and colleagues wrote in a study published Jan. 14 in JAMA.
Researchers noted that FDA approval times declined from more than 3 years in 1983 to less than 1 year in 2017, although total time from the authorization of clinical testing to approval has remained steady across that period at about 8 years.
“The resistance of total development times to efforts to shorten them could be the result of more submissions of applications for rare disease drugs, which can sometimes pose trial recruitment challenges; a shifting emphasis to more challenging therapeutic categories, such as central nervous system disorder treatments; longer time horizons needed to establish efficacy when early intervention is important (e.g., cancer); or other factors,” wrote Mr. Darrow and colleagues.
The authors also note that the value of the expanded review toolbox the FDA now employs is “unclear” as “the number of new drug approvals has not increased substantially over the past three decades.” This observation does not count biologics or generic approvals.
Research revealed that the mean annual number of new drug approvals (including biologics) was 34 from 1990 to 1999, 25 from 2000 to 2009, and 41 from 2010 to 2018. In addition, while the number of new drug approvals has remained at or below 60 per year, the portion of drugs using at least one expedited review program increased over time, with more than 80% of the 59 new drugs approved in 2018 being subject to at least one expedited review program.
“Although the FDA has on average applied its expedited programs to drugs offering larger health gains, it is difficult to assess whether these programs have incentivized greater therapeutic innovation or merely allowed more appropriate agency prioritization,” noted Mr. Darrow and colleagues.
And while it may be hard to truly understand the impact of the many expedited review programs that have been introduced at the FDA, there is still room for improvement in the process.
In an editorial published in JAMA, Joshua Sharfstein, MD, of Johns Hopkins University, Baltimore, suggested four reforms the FDA could examine.
“First, Congress and the FDA should rationalize the various programs for expedited review,” he wrote, noting that companies are using the Orphan Drug Act to prevent competition. “Fixing the system requires, at a minimum, promoting meaningful competition for non-orphan uses.”
Second, he wrote, the FDA needs to strengthen oversight of postmarket safety though more diligence in the operation of its Risk Evaluation and Management Strategies (REMS) program.
“Third, Congress should recalibrate the programs that provide companies with special marketing protections,” added Dr. Sharfstein, former FDA principal deputy commissioner. “One place to look is pediatric exclusivity, which has been estimated to cost the health care system more than $6 for every $1 spent by a company on a pediatric trial.”
And finally, “Congress should use patent and pricing incentives to accelerate the generation of definitive evidence under accelerated approval,” citing proposals to limit pricing or market exclusivity until companies complete studies that assess clinically relevant endpoints.
“These changes would reflect an evolution, not a revolution, of the FDA’s approach to new drug approval,” Dr. Sharfstein said. “These reforms could also bring greater order and thoughtfulness to the regulation of important new therapies, while enhancing safety and creating greater capability to afford truly transformative medical products.”
SOURCE: Jonathan Darrow et al. JAMA 2020 Jan 14. doi: 10.1001/jama.2019.20288.
Drug development times are not showing any signs of decreasing even though application review times at the Food and Drug Administration are improving, new research has shown.
“Despite the accumulation of expedited programs that have reduced FDA review times, overall clinical development times have not become shorter, although it is not possible to know what role these programs may have played in preventing an increase in development times,” Jonathan Darrow of Harvard Medical School, Boston, and colleagues wrote in a study published Jan. 14 in JAMA.
Researchers noted that FDA approval times declined from more than 3 years in 1983 to less than 1 year in 2017, although total time from the authorization of clinical testing to approval has remained steady across that period at about 8 years.
“The resistance of total development times to efforts to shorten them could be the result of more submissions of applications for rare disease drugs, which can sometimes pose trial recruitment challenges; a shifting emphasis to more challenging therapeutic categories, such as central nervous system disorder treatments; longer time horizons needed to establish efficacy when early intervention is important (e.g., cancer); or other factors,” wrote Mr. Darrow and colleagues.
The authors also note that the value of the expanded review toolbox the FDA now employs is “unclear” as “the number of new drug approvals has not increased substantially over the past three decades.” This observation does not count biologics or generic approvals.
Research revealed that the mean annual number of new drug approvals (including biologics) was 34 from 1990 to 1999, 25 from 2000 to 2009, and 41 from 2010 to 2018. In addition, while the number of new drug approvals has remained at or below 60 per year, the portion of drugs using at least one expedited review program increased over time, with more than 80% of the 59 new drugs approved in 2018 being subject to at least one expedited review program.
“Although the FDA has on average applied its expedited programs to drugs offering larger health gains, it is difficult to assess whether these programs have incentivized greater therapeutic innovation or merely allowed more appropriate agency prioritization,” noted Mr. Darrow and colleagues.
And while it may be hard to truly understand the impact of the many expedited review programs that have been introduced at the FDA, there is still room for improvement in the process.
In an editorial published in JAMA, Joshua Sharfstein, MD, of Johns Hopkins University, Baltimore, suggested four reforms the FDA could examine.
“First, Congress and the FDA should rationalize the various programs for expedited review,” he wrote, noting that companies are using the Orphan Drug Act to prevent competition. “Fixing the system requires, at a minimum, promoting meaningful competition for non-orphan uses.”
Second, he wrote, the FDA needs to strengthen oversight of postmarket safety though more diligence in the operation of its Risk Evaluation and Management Strategies (REMS) program.
“Third, Congress should recalibrate the programs that provide companies with special marketing protections,” added Dr. Sharfstein, former FDA principal deputy commissioner. “One place to look is pediatric exclusivity, which has been estimated to cost the health care system more than $6 for every $1 spent by a company on a pediatric trial.”
And finally, “Congress should use patent and pricing incentives to accelerate the generation of definitive evidence under accelerated approval,” citing proposals to limit pricing or market exclusivity until companies complete studies that assess clinically relevant endpoints.
“These changes would reflect an evolution, not a revolution, of the FDA’s approach to new drug approval,” Dr. Sharfstein said. “These reforms could also bring greater order and thoughtfulness to the regulation of important new therapies, while enhancing safety and creating greater capability to afford truly transformative medical products.”
SOURCE: Jonathan Darrow et al. JAMA 2020 Jan 14. doi: 10.1001/jama.2019.20288.
FROM JAMA
Insurance coverage mediates racial disparities in breast cancer
according to new study.
Insurance coverage “mediates nearly half of the increased risk for later-stage breast cancer diagnosis seen among racial/ethnic minorities,” Naomi Ko, MD, of Boston University and colleagues wrote in a research report published in JAMA Oncology.
With Surveillance, Epidemiology, and End Results Program data, the researchers looked at patient records on 177,075 women (148,124 insured and 28,951 uninsured or on Medicaid) aged 40-64 years who received a breast cancer diagnosis between Jan. 1, 2010, and Dec. 31, 2016. They found that a higher proportion of women (20%) uninsured or on Medicaid received a diagnosis of a higher-stage breast cancer (stage III), compared with women who had health insurance (11%).
More non-Hispanic black women (17%), American Indian or Alaskan native (15%), and Hispanic women (16%) received a stage III breast cancer diagnosis, compared with non-Hispanic white women (12%). Non-Hispanic white women were more likely to have insurance coverage at the time of diagnosis (89%), compared with non-Hispanic black women (75%), American Indian or Alaskan native (58%), and Hispanic women (67%).
“Without insurance coverage, the lack of prevention, screening, and access to care, as well as delays in diagnosis, lead to later stage of disease at diagnosis and thus worse survival,” Dr. Ko and colleagues wrote, adding that patients with a diagnosis of later-stage cancer require more intensive treatment and are at higher risk for treatment-associated morbidity and poorer overall quality of life.
Another consequence of the later-stage diagnosis is increased financial costs related to treatment for these patients, according to the investigator. They cite research that shows stage III cancer was 58% more costly to treat than was stage I or II breast cancer.
“Overall, earlier stage at diagnosis of breast cancer is not only beneficial for individual patients and families but also on society as a whole to decrease costs and equity among all populations,” Dr. Ko and colleagues added.
The researchers noted some of the limitations of the study, which include the source of data (the Surveillance, Epidemiology, and End Results Program, which covers 18 regions and might not be generalizable to all populations), as well as the age range of the studied population.
That being said, the authors also acknowledged that the findings “do not suggest that insurance alone will eliminate racial/ethnic disparities in breast cancer,” but “the ability to quantify the association that insurance has with breast cancer stage is relevant to potential policy changes regarding insurance and a prioritization of solutions for the increased burden of cancer mortality and morbidity disproportionately placed on racial/ethnic minority populations.”
Funding sources include the National Institutes of Health, National Center for Advancing Translational Sciences, National Cancer Institute, and National Institute on Minority Health and Health Disparities. The authors reported no conflicts of interest related to this study.
SOURCE: Ko N et al. JAMA Onc. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5672.
according to new study.
Insurance coverage “mediates nearly half of the increased risk for later-stage breast cancer diagnosis seen among racial/ethnic minorities,” Naomi Ko, MD, of Boston University and colleagues wrote in a research report published in JAMA Oncology.
With Surveillance, Epidemiology, and End Results Program data, the researchers looked at patient records on 177,075 women (148,124 insured and 28,951 uninsured or on Medicaid) aged 40-64 years who received a breast cancer diagnosis between Jan. 1, 2010, and Dec. 31, 2016. They found that a higher proportion of women (20%) uninsured or on Medicaid received a diagnosis of a higher-stage breast cancer (stage III), compared with women who had health insurance (11%).
More non-Hispanic black women (17%), American Indian or Alaskan native (15%), and Hispanic women (16%) received a stage III breast cancer diagnosis, compared with non-Hispanic white women (12%). Non-Hispanic white women were more likely to have insurance coverage at the time of diagnosis (89%), compared with non-Hispanic black women (75%), American Indian or Alaskan native (58%), and Hispanic women (67%).
“Without insurance coverage, the lack of prevention, screening, and access to care, as well as delays in diagnosis, lead to later stage of disease at diagnosis and thus worse survival,” Dr. Ko and colleagues wrote, adding that patients with a diagnosis of later-stage cancer require more intensive treatment and are at higher risk for treatment-associated morbidity and poorer overall quality of life.
Another consequence of the later-stage diagnosis is increased financial costs related to treatment for these patients, according to the investigator. They cite research that shows stage III cancer was 58% more costly to treat than was stage I or II breast cancer.
“Overall, earlier stage at diagnosis of breast cancer is not only beneficial for individual patients and families but also on society as a whole to decrease costs and equity among all populations,” Dr. Ko and colleagues added.
The researchers noted some of the limitations of the study, which include the source of data (the Surveillance, Epidemiology, and End Results Program, which covers 18 regions and might not be generalizable to all populations), as well as the age range of the studied population.
That being said, the authors also acknowledged that the findings “do not suggest that insurance alone will eliminate racial/ethnic disparities in breast cancer,” but “the ability to quantify the association that insurance has with breast cancer stage is relevant to potential policy changes regarding insurance and a prioritization of solutions for the increased burden of cancer mortality and morbidity disproportionately placed on racial/ethnic minority populations.”
Funding sources include the National Institutes of Health, National Center for Advancing Translational Sciences, National Cancer Institute, and National Institute on Minority Health and Health Disparities. The authors reported no conflicts of interest related to this study.
SOURCE: Ko N et al. JAMA Onc. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5672.
according to new study.
Insurance coverage “mediates nearly half of the increased risk for later-stage breast cancer diagnosis seen among racial/ethnic minorities,” Naomi Ko, MD, of Boston University and colleagues wrote in a research report published in JAMA Oncology.
With Surveillance, Epidemiology, and End Results Program data, the researchers looked at patient records on 177,075 women (148,124 insured and 28,951 uninsured or on Medicaid) aged 40-64 years who received a breast cancer diagnosis between Jan. 1, 2010, and Dec. 31, 2016. They found that a higher proportion of women (20%) uninsured or on Medicaid received a diagnosis of a higher-stage breast cancer (stage III), compared with women who had health insurance (11%).
More non-Hispanic black women (17%), American Indian or Alaskan native (15%), and Hispanic women (16%) received a stage III breast cancer diagnosis, compared with non-Hispanic white women (12%). Non-Hispanic white women were more likely to have insurance coverage at the time of diagnosis (89%), compared with non-Hispanic black women (75%), American Indian or Alaskan native (58%), and Hispanic women (67%).
“Without insurance coverage, the lack of prevention, screening, and access to care, as well as delays in diagnosis, lead to later stage of disease at diagnosis and thus worse survival,” Dr. Ko and colleagues wrote, adding that patients with a diagnosis of later-stage cancer require more intensive treatment and are at higher risk for treatment-associated morbidity and poorer overall quality of life.
Another consequence of the later-stage diagnosis is increased financial costs related to treatment for these patients, according to the investigator. They cite research that shows stage III cancer was 58% more costly to treat than was stage I or II breast cancer.
“Overall, earlier stage at diagnosis of breast cancer is not only beneficial for individual patients and families but also on society as a whole to decrease costs and equity among all populations,” Dr. Ko and colleagues added.
The researchers noted some of the limitations of the study, which include the source of data (the Surveillance, Epidemiology, and End Results Program, which covers 18 regions and might not be generalizable to all populations), as well as the age range of the studied population.
That being said, the authors also acknowledged that the findings “do not suggest that insurance alone will eliminate racial/ethnic disparities in breast cancer,” but “the ability to quantify the association that insurance has with breast cancer stage is relevant to potential policy changes regarding insurance and a prioritization of solutions for the increased burden of cancer mortality and morbidity disproportionately placed on racial/ethnic minority populations.”
Funding sources include the National Institutes of Health, National Center for Advancing Translational Sciences, National Cancer Institute, and National Institute on Minority Health and Health Disparities. The authors reported no conflicts of interest related to this study.
SOURCE: Ko N et al. JAMA Onc. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5672.
FROM JAMA ONCOLOGY
Big practices outpace small ones in Medicare pay bonuses
More physician practices are earning positive payments under Medicare’s Merit-Based Incentive Payment System, but smaller practices won’t fare quite as well as larger ones in 2020.
Under the Quality Payment Program, 97% of MIPS-eligible clinicians are scheduled to receive an incentive payment this year, based on meeting performance criteria in 2018. That’s up five percentage points from the 2017 performance year, the Centers for Medicare & Medicaid Services reported Jan. 6. But 2% of clinicians will see a negative adjustment for not having met those criteria.
Among small practices, however, the rate of MIPS-eligible clinicians earning a positive payment adjustment in 2020 is about 84%. While lower than the overall rate, that’s still a 10 percentage point improvement from the previous performance year. But 13% of MIPS-eligible clinicians in small practices face a negative adjustment.
The bonus rate among rural practices mirrors the national rate, with more than 97% of rural practices eligible to receive a bonus in 2020. In 2019, 93% of MIPS-eligible clinicians in rural settings received a positive adjustment.
More small and rural practices will see positive payment adjustments in 2020, compared with 2019, CMS Administrator Seema Verma said. “This shows we are making strides toward making MIPS a practical program for every clinician, regardless of size.”
While most clinicians earned a positive adjustment, Ms. Verma acknowledged that the dollar value of the adjustment remains relatively small.
For clinicians who met the exceptional performance criteria for 2020 based on work in 2018, the maximum adjustment will be 1.68%. For those who failed to meet the exceptional performance threshold, the maximum positive adjustment will be 0.2%. The range of negative payment adjustments will be between –0.01% and –5%.
Those positive payment adjustments are modest in part because adjustments overall must be budget neutral, Ms. Verma explained. But CMS expects that to change in future years. As the program matures, increased performance thresholds will shrink distribution of positive payment adjustments for high-performing clinicians. That will lead to larger positive payment adjustments for those who do earn them.
More physician practices are earning positive payments under Medicare’s Merit-Based Incentive Payment System, but smaller practices won’t fare quite as well as larger ones in 2020.
Under the Quality Payment Program, 97% of MIPS-eligible clinicians are scheduled to receive an incentive payment this year, based on meeting performance criteria in 2018. That’s up five percentage points from the 2017 performance year, the Centers for Medicare & Medicaid Services reported Jan. 6. But 2% of clinicians will see a negative adjustment for not having met those criteria.
Among small practices, however, the rate of MIPS-eligible clinicians earning a positive payment adjustment in 2020 is about 84%. While lower than the overall rate, that’s still a 10 percentage point improvement from the previous performance year. But 13% of MIPS-eligible clinicians in small practices face a negative adjustment.
The bonus rate among rural practices mirrors the national rate, with more than 97% of rural practices eligible to receive a bonus in 2020. In 2019, 93% of MIPS-eligible clinicians in rural settings received a positive adjustment.
More small and rural practices will see positive payment adjustments in 2020, compared with 2019, CMS Administrator Seema Verma said. “This shows we are making strides toward making MIPS a practical program for every clinician, regardless of size.”
While most clinicians earned a positive adjustment, Ms. Verma acknowledged that the dollar value of the adjustment remains relatively small.
For clinicians who met the exceptional performance criteria for 2020 based on work in 2018, the maximum adjustment will be 1.68%. For those who failed to meet the exceptional performance threshold, the maximum positive adjustment will be 0.2%. The range of negative payment adjustments will be between –0.01% and –5%.
Those positive payment adjustments are modest in part because adjustments overall must be budget neutral, Ms. Verma explained. But CMS expects that to change in future years. As the program matures, increased performance thresholds will shrink distribution of positive payment adjustments for high-performing clinicians. That will lead to larger positive payment adjustments for those who do earn them.
More physician practices are earning positive payments under Medicare’s Merit-Based Incentive Payment System, but smaller practices won’t fare quite as well as larger ones in 2020.
Under the Quality Payment Program, 97% of MIPS-eligible clinicians are scheduled to receive an incentive payment this year, based on meeting performance criteria in 2018. That’s up five percentage points from the 2017 performance year, the Centers for Medicare & Medicaid Services reported Jan. 6. But 2% of clinicians will see a negative adjustment for not having met those criteria.
Among small practices, however, the rate of MIPS-eligible clinicians earning a positive payment adjustment in 2020 is about 84%. While lower than the overall rate, that’s still a 10 percentage point improvement from the previous performance year. But 13% of MIPS-eligible clinicians in small practices face a negative adjustment.
The bonus rate among rural practices mirrors the national rate, with more than 97% of rural practices eligible to receive a bonus in 2020. In 2019, 93% of MIPS-eligible clinicians in rural settings received a positive adjustment.
More small and rural practices will see positive payment adjustments in 2020, compared with 2019, CMS Administrator Seema Verma said. “This shows we are making strides toward making MIPS a practical program for every clinician, regardless of size.”
While most clinicians earned a positive adjustment, Ms. Verma acknowledged that the dollar value of the adjustment remains relatively small.
For clinicians who met the exceptional performance criteria for 2020 based on work in 2018, the maximum adjustment will be 1.68%. For those who failed to meet the exceptional performance threshold, the maximum positive adjustment will be 0.2%. The range of negative payment adjustments will be between –0.01% and –5%.
Those positive payment adjustments are modest in part because adjustments overall must be budget neutral, Ms. Verma explained. But CMS expects that to change in future years. As the program matures, increased performance thresholds will shrink distribution of positive payment adjustments for high-performing clinicians. That will lead to larger positive payment adjustments for those who do earn them.
FDA targets flavored cartridge-based e-cigarettes, but says it is not a ‘ban’
but states it is not a “ban.”
On Jan. 2, the agency issued enforcement guidance alerting companies that manufacture, distribute, and sell unauthorized flavored cartridge-based e-cigarettes within the next 30 days will risk FDA enforcement action.
FDA has had the authority to require premarket authorization of all e-cigarettes and other electronic nicotine delivery systems (ENDS) since August 2016, but thus far has exercised enforcement discretion regarding the need for premarket authorization for these types of products.
“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth,” Department of Health & Human Services Secretary Alex Azar said in a statement.
The action comes in the wake of more than 2,500 vaping-related injuries being reported, including more than 50 deaths associated with vaping reported by the Centers for Disease Control and Prevention (although many are related to the use of tetrahydrocannabinol [THC] within vaping products) and a continued rise in youth use of e-cigarettes noted in government surveys.
The agency noted in a Jan. 2 statement announcing the enforcement action that, to date, no ENDS products have received a premarket authorization, “meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.”
FDA said it is prioritizing enforcement in 30 days against:
- Any flavored, cartridge-based ENDS product, other than those with a tobacco or menthol flavoring.
- All other ENDS products for which manufacturers are failing to take adequate measures to prevent access by minors.
- Any ENDS product that is targeted to minors or is likely to promote use by minors.
In the last category, this might include labeling or advertising resembling “kid-friendly food and drinks such as juice boxes or kid-friendly cereal; products marketed directly to minors by promoting ease of concealing the product or disguising it as another product; and products marketed with characters designed to appeal to youth,” according to the FDA statement.
As of May 12, FDA also will prioritize enforcement against any ENDS product for which the manufacturer has not submitted a premarket application. The agency will continue to exercise enforcement discretion for up to 1 year on these products if an application has been submitted, pending the review of that application.
“By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with consideration regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products,” the agency stated, adding that cartridge-based ENDS products are most commonly used among youth.
The FDA statement noted that the enforcement priorities outlined in the guidance document were not a “ban” on flavored or cartridge-based ENDS, noting the agency “has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act. ... If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.”
“Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery,” FDA Commissioner Stephen Hahn, MD, said in a statement. “While we expect that responsible members of industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”
The American Medical Association criticized the action as not going far enough, even though it was a step in the right direction.
“The AMA is disappointed that menthol flavors, one of the most popular, will still be allowed, and that flavored e-liquids will remain on the market, leaving young people with easy access to alternative flavored e-cigarette products,” AMA President Patrice A. Harris, MD, said in a statement. “If we are serious about tackling this epidemic and keeping these harmful products out of the hands of young people, a total ban on all flavored e-cigarettes, in all forms and at all locations, is prudent and urgently needed. We are pleased the administration committed today to closely monitoring the situation and trends in e-cigarette use among young people, and to taking further action if needed.”
but states it is not a “ban.”
On Jan. 2, the agency issued enforcement guidance alerting companies that manufacture, distribute, and sell unauthorized flavored cartridge-based e-cigarettes within the next 30 days will risk FDA enforcement action.
FDA has had the authority to require premarket authorization of all e-cigarettes and other electronic nicotine delivery systems (ENDS) since August 2016, but thus far has exercised enforcement discretion regarding the need for premarket authorization for these types of products.
“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth,” Department of Health & Human Services Secretary Alex Azar said in a statement.
The action comes in the wake of more than 2,500 vaping-related injuries being reported, including more than 50 deaths associated with vaping reported by the Centers for Disease Control and Prevention (although many are related to the use of tetrahydrocannabinol [THC] within vaping products) and a continued rise in youth use of e-cigarettes noted in government surveys.
The agency noted in a Jan. 2 statement announcing the enforcement action that, to date, no ENDS products have received a premarket authorization, “meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.”
FDA said it is prioritizing enforcement in 30 days against:
- Any flavored, cartridge-based ENDS product, other than those with a tobacco or menthol flavoring.
- All other ENDS products for which manufacturers are failing to take adequate measures to prevent access by minors.
- Any ENDS product that is targeted to minors or is likely to promote use by minors.
In the last category, this might include labeling or advertising resembling “kid-friendly food and drinks such as juice boxes or kid-friendly cereal; products marketed directly to minors by promoting ease of concealing the product or disguising it as another product; and products marketed with characters designed to appeal to youth,” according to the FDA statement.
As of May 12, FDA also will prioritize enforcement against any ENDS product for which the manufacturer has not submitted a premarket application. The agency will continue to exercise enforcement discretion for up to 1 year on these products if an application has been submitted, pending the review of that application.
“By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with consideration regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products,” the agency stated, adding that cartridge-based ENDS products are most commonly used among youth.
The FDA statement noted that the enforcement priorities outlined in the guidance document were not a “ban” on flavored or cartridge-based ENDS, noting the agency “has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act. ... If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.”
“Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery,” FDA Commissioner Stephen Hahn, MD, said in a statement. “While we expect that responsible members of industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”
The American Medical Association criticized the action as not going far enough, even though it was a step in the right direction.
“The AMA is disappointed that menthol flavors, one of the most popular, will still be allowed, and that flavored e-liquids will remain on the market, leaving young people with easy access to alternative flavored e-cigarette products,” AMA President Patrice A. Harris, MD, said in a statement. “If we are serious about tackling this epidemic and keeping these harmful products out of the hands of young people, a total ban on all flavored e-cigarettes, in all forms and at all locations, is prudent and urgently needed. We are pleased the administration committed today to closely monitoring the situation and trends in e-cigarette use among young people, and to taking further action if needed.”
but states it is not a “ban.”
On Jan. 2, the agency issued enforcement guidance alerting companies that manufacture, distribute, and sell unauthorized flavored cartridge-based e-cigarettes within the next 30 days will risk FDA enforcement action.
FDA has had the authority to require premarket authorization of all e-cigarettes and other electronic nicotine delivery systems (ENDS) since August 2016, but thus far has exercised enforcement discretion regarding the need for premarket authorization for these types of products.
“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth,” Department of Health & Human Services Secretary Alex Azar said in a statement.
The action comes in the wake of more than 2,500 vaping-related injuries being reported, including more than 50 deaths associated with vaping reported by the Centers for Disease Control and Prevention (although many are related to the use of tetrahydrocannabinol [THC] within vaping products) and a continued rise in youth use of e-cigarettes noted in government surveys.
The agency noted in a Jan. 2 statement announcing the enforcement action that, to date, no ENDS products have received a premarket authorization, “meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.”
FDA said it is prioritizing enforcement in 30 days against:
- Any flavored, cartridge-based ENDS product, other than those with a tobacco or menthol flavoring.
- All other ENDS products for which manufacturers are failing to take adequate measures to prevent access by minors.
- Any ENDS product that is targeted to minors or is likely to promote use by minors.
In the last category, this might include labeling or advertising resembling “kid-friendly food and drinks such as juice boxes or kid-friendly cereal; products marketed directly to minors by promoting ease of concealing the product or disguising it as another product; and products marketed with characters designed to appeal to youth,” according to the FDA statement.
As of May 12, FDA also will prioritize enforcement against any ENDS product for which the manufacturer has not submitted a premarket application. The agency will continue to exercise enforcement discretion for up to 1 year on these products if an application has been submitted, pending the review of that application.
“By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with consideration regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products,” the agency stated, adding that cartridge-based ENDS products are most commonly used among youth.
The FDA statement noted that the enforcement priorities outlined in the guidance document were not a “ban” on flavored or cartridge-based ENDS, noting the agency “has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act. ... If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.”
“Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery,” FDA Commissioner Stephen Hahn, MD, said in a statement. “While we expect that responsible members of industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”
The American Medical Association criticized the action as not going far enough, even though it was a step in the right direction.
“The AMA is disappointed that menthol flavors, one of the most popular, will still be allowed, and that flavored e-liquids will remain on the market, leaving young people with easy access to alternative flavored e-cigarette products,” AMA President Patrice A. Harris, MD, said in a statement. “If we are serious about tackling this epidemic and keeping these harmful products out of the hands of young people, a total ban on all flavored e-cigarettes, in all forms and at all locations, is prudent and urgently needed. We are pleased the administration committed today to closely monitoring the situation and trends in e-cigarette use among young people, and to taking further action if needed.”
Appropriations bill, now law, eliminates ACA taxes, raises tobacco age
Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.
The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.
The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.
The appropriations bill offers no offset for the lost revenue.
The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.
Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.
H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.
The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.
There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.
One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.
Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.
“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.
However, ACP called for more action in this area.
“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”
H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.
Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.
The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.
The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.
The appropriations bill offers no offset for the lost revenue.
The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.
Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.
H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.
The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.
There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.
One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.
Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.
“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.
However, ACP called for more action in this area.
“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”
H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.
Congress took steps to permanently eliminate three taxes from within the Affordable Care Act that were enacted to help offset the law’s cost, but have been sporadically implemented.
The appropriations bill, H.R. 1865, signed into law Dec. 20 by President Trump, includes a number of other health-related provisions, including increasing the minimum age for purchasing tobacco to 21.
The repealed ACA-related taxes include the medical device tax (which previously had been delayed twice); the health insurance tax (which taxed insurers that offered fully insured health coverage in the individual market and has been under sporadic moratorium); and the so-called Cadillac tax on high-cost health plans, which is currently under suspension until the end of 2022.
The appropriations bill offers no offset for the lost revenue.
The tax repeals come on the heels of the U.S. Fifth Circuit Court of Appeals’ ruling that the ACA’s individual mandate is unconstitutional, which is putting the ACA in its entirety in jeopardy should the district court rule that the individual mandate is not severable from the rest of the law, which would invalidate the ACA.
Other key provisions in H.R. 1865 include the short-term extension of a number of federal programs, including a delay in Medicaid disproportionate share hospital payment reductions, payments to community health centers, funding for teaching health centers, and the special diabetes program. Funding for these extenders will go through May 22, 2020.
H.R. 1865 is also notable for what is missing, including any broad provisions that address the price of prescription drugs and surprise billing.
The House of Representatives earlier this month passed a bill, H.R. 3, aimed at lowering the cost of prescription drugs, but that bill was essentially dead on arrival in the Senate, with Speaker Mitch McConnell (R-Ky.) saying he would not bring it to the floor for consideration. There was also a veto threat from the White House hanging over it on the off chance it got past the upper chamber.
There was some optimism that surprise billing would be addressed in the appropriations bill after a bipartisan agreement was reached with the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee, but that stalled after a different bipartisan agreement forged in the House Ways and Means Committee was introduced. More work is expected on surprise billing in the coming year.
One portion of H.R. 1865 that does address the cost of drugs is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which is designed to allow generic manufacturers easier access to brand-name samples to help bring more generic drugs to market.
Another provision that gained applause from the American College of Physicians is the funding for research into gun violence.
“We are particularly encouraged that the legislation authorizes funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence and safety for the first time in decades,” ACP President Robert McLean, MD, said in a statement. “The key to solving any public health crisis is knowledge, and our efforts to prevent firearms-related injuries and deaths have been hampered by inadequate research. This funding is a promising first step.
However, ACP called for more action in this area.
“Congress should do more to reduce injuries and deaths from firearms,” Dr. McLean said. “The Senate should pass the Bipartisan Background Check Act and reauthorize the Violence Against Women Act, which would close the ‘domestic violence’ loophole in the background check system, as passed by the House of Representatives.”
H.R. 1865 also reauthorizes the Patient-Centered Outcomes Research Institute for 10 additional years.
Four new programs, new slots added to rheumatology Specialty Match Day
This year’s Specialty Match Day was highlighted by the addition of four new programs and 13 new fellowship positions for future rheumatologists.
For the 2020 appointment year, there were 249 fellowships in rheumatology available, up from 236 in the previous year. It continues a trend of an increasing number of fellowship slots. There were 221 slots available in the 2018 appointment year.
There were 242 slots filled in the 2020 appointment year, up from 233 in the previous year and 218 from two appointment years ago.
“The overall message from the match this year in rheumatology is that it really was a very good, very successful match,” Beth Jonas, MD, chair of the American College of Rheumatology’s Committee on Training and Workforce Issues, said in an interview. “Rheumatology continues to be extremely strong in terms of its ability to attract excellent physicians to the subspecialty, so we are really very, very happy about that.”
She also applauded the addition of the four new programs and 13 new fellowship slots.
“We’ve been working very hard to try and figure out ways to increase slots,” said Dr. Jonas, a professor at the University of North Carolina, Chapel Hill. She noted that while more needs to be done to address future workforce needs, even the small increases “are meaningful. There is the knowledge out there that there is a workforce shortage in rheumatology. There certainly are a lot of people who would like to become rheumatologists. There is a little bit of a bottleneck here at the level of training slots to get interested and qualified applicants into the match and matched with programs, so we’ve had some marginal increases there.”
One number that decreased this year was the number of specialty applicants who stated they preferred to be in a rheumatology program, which decreased to 335 applicants in the 2020 appointment year from 358 in the 2019 application year. Of the 335 applicants that stated rheumatology as the preferred specialty, 239 received fellowships in rheumatology, 2 were matched to other specialties, and 94 did not match into any program.
The decrease in applicants did not concern Dr. Jonas.
“It is still pretty robust and our match rate is in the low 70s, which makes it one of the most competitive subspecialties in internal medicine, up there with cardiology and gastroenterology,” she said. “It doesn’t really worry me.”
She opined that the reason could be that the “people who might have been not strong candidates might have just not applied because it is so competitive now,” but she cautioned that it is just musings with no specific data to say exactly what is causing the decrease in applications.
She also was not concerned that the number of unfulfilled slots increased this year compared with the previous 2 years.
“The programs that did not fill tended to be the ones that were highly focused on research,” she said. “It is not surprising that there were a couple of slots left empty. We know for certain that of all of the people who applied to rheumatology fellowships, the vast majority are interested in clinical rheumatology, in clinical care, so there are fewer applicants out there that are really interested in research slots.”
Overall across all specialties, there were 6,286 applicants with rank for 5,576 positions in appointment year 2020, of which 4,909 were matched to a specialty program. The fill rate increased slightly to 88% from 87.8% in the previous year, when there were 5,881 applicants for 5,125 program slots with 4,579 positions filled.
SOURCE: National Resident Matching Program.
This year’s Specialty Match Day was highlighted by the addition of four new programs and 13 new fellowship positions for future rheumatologists.
For the 2020 appointment year, there were 249 fellowships in rheumatology available, up from 236 in the previous year. It continues a trend of an increasing number of fellowship slots. There were 221 slots available in the 2018 appointment year.
There were 242 slots filled in the 2020 appointment year, up from 233 in the previous year and 218 from two appointment years ago.
“The overall message from the match this year in rheumatology is that it really was a very good, very successful match,” Beth Jonas, MD, chair of the American College of Rheumatology’s Committee on Training and Workforce Issues, said in an interview. “Rheumatology continues to be extremely strong in terms of its ability to attract excellent physicians to the subspecialty, so we are really very, very happy about that.”
She also applauded the addition of the four new programs and 13 new fellowship slots.
“We’ve been working very hard to try and figure out ways to increase slots,” said Dr. Jonas, a professor at the University of North Carolina, Chapel Hill. She noted that while more needs to be done to address future workforce needs, even the small increases “are meaningful. There is the knowledge out there that there is a workforce shortage in rheumatology. There certainly are a lot of people who would like to become rheumatologists. There is a little bit of a bottleneck here at the level of training slots to get interested and qualified applicants into the match and matched with programs, so we’ve had some marginal increases there.”
One number that decreased this year was the number of specialty applicants who stated they preferred to be in a rheumatology program, which decreased to 335 applicants in the 2020 appointment year from 358 in the 2019 application year. Of the 335 applicants that stated rheumatology as the preferred specialty, 239 received fellowships in rheumatology, 2 were matched to other specialties, and 94 did not match into any program.
The decrease in applicants did not concern Dr. Jonas.
“It is still pretty robust and our match rate is in the low 70s, which makes it one of the most competitive subspecialties in internal medicine, up there with cardiology and gastroenterology,” she said. “It doesn’t really worry me.”
She opined that the reason could be that the “people who might have been not strong candidates might have just not applied because it is so competitive now,” but she cautioned that it is just musings with no specific data to say exactly what is causing the decrease in applications.
She also was not concerned that the number of unfulfilled slots increased this year compared with the previous 2 years.
“The programs that did not fill tended to be the ones that were highly focused on research,” she said. “It is not surprising that there were a couple of slots left empty. We know for certain that of all of the people who applied to rheumatology fellowships, the vast majority are interested in clinical rheumatology, in clinical care, so there are fewer applicants out there that are really interested in research slots.”
Overall across all specialties, there were 6,286 applicants with rank for 5,576 positions in appointment year 2020, of which 4,909 were matched to a specialty program. The fill rate increased slightly to 88% from 87.8% in the previous year, when there were 5,881 applicants for 5,125 program slots with 4,579 positions filled.
SOURCE: National Resident Matching Program.
This year’s Specialty Match Day was highlighted by the addition of four new programs and 13 new fellowship positions for future rheumatologists.
For the 2020 appointment year, there were 249 fellowships in rheumatology available, up from 236 in the previous year. It continues a trend of an increasing number of fellowship slots. There were 221 slots available in the 2018 appointment year.
There were 242 slots filled in the 2020 appointment year, up from 233 in the previous year and 218 from two appointment years ago.
“The overall message from the match this year in rheumatology is that it really was a very good, very successful match,” Beth Jonas, MD, chair of the American College of Rheumatology’s Committee on Training and Workforce Issues, said in an interview. “Rheumatology continues to be extremely strong in terms of its ability to attract excellent physicians to the subspecialty, so we are really very, very happy about that.”
She also applauded the addition of the four new programs and 13 new fellowship slots.
“We’ve been working very hard to try and figure out ways to increase slots,” said Dr. Jonas, a professor at the University of North Carolina, Chapel Hill. She noted that while more needs to be done to address future workforce needs, even the small increases “are meaningful. There is the knowledge out there that there is a workforce shortage in rheumatology. There certainly are a lot of people who would like to become rheumatologists. There is a little bit of a bottleneck here at the level of training slots to get interested and qualified applicants into the match and matched with programs, so we’ve had some marginal increases there.”
One number that decreased this year was the number of specialty applicants who stated they preferred to be in a rheumatology program, which decreased to 335 applicants in the 2020 appointment year from 358 in the 2019 application year. Of the 335 applicants that stated rheumatology as the preferred specialty, 239 received fellowships in rheumatology, 2 were matched to other specialties, and 94 did not match into any program.
The decrease in applicants did not concern Dr. Jonas.
“It is still pretty robust and our match rate is in the low 70s, which makes it one of the most competitive subspecialties in internal medicine, up there with cardiology and gastroenterology,” she said. “It doesn’t really worry me.”
She opined that the reason could be that the “people who might have been not strong candidates might have just not applied because it is so competitive now,” but she cautioned that it is just musings with no specific data to say exactly what is causing the decrease in applications.
She also was not concerned that the number of unfulfilled slots increased this year compared with the previous 2 years.
“The programs that did not fill tended to be the ones that were highly focused on research,” she said. “It is not surprising that there were a couple of slots left empty. We know for certain that of all of the people who applied to rheumatology fellowships, the vast majority are interested in clinical rheumatology, in clinical care, so there are fewer applicants out there that are really interested in research slots.”
Overall across all specialties, there were 6,286 applicants with rank for 5,576 positions in appointment year 2020, of which 4,909 were matched to a specialty program. The fill rate increased slightly to 88% from 87.8% in the previous year, when there were 5,881 applicants for 5,125 program slots with 4,579 positions filled.
SOURCE: National Resident Matching Program.
Out-of-network billing in in-network hospitals adds $40 billion in spending
As the debate over how best to address surprise billing continues, new research shows that billing from out-of-network physicians at in-network facilities is adding $40 billion in costs.
Researchers focused on four different types of physicians that account for out-of-network billing: anesthesiologists, pathologists, radiologists, and cases involving an assistant surgeon, which had out-of-network bills in about 10% of claims that were examined as part of the research.
“To give a rough estimate of the savings that could be achieved by eliminating the ability of these four types of specialists to readily bill out of network, we simulated what would happen if all of these specialists received the same average payments as orthopedic surgeons did (164% of Medicare rates),” Zack Cooper, PhD, associate professor of health policy at Yale University, New Haven, Conn., and colleagues wrote in a research report published in Health Affairs.
“We estimated that if these physicians were paid the same average rate as orthopedists for all of the services that they delivered in our sample, spending would be lowered on anesthesiologists by 53.5%, on pathologists by 47.4%, on radiologists by 16.3%, and on assistant surgeons by 46.2%,” the authors wrote.
Researchers said that physician spending for these four specialties would be lowered by 13.4% and would lower total spending for people with employer-sponsored insurance by about 3.4%, or $40 billion. If spending on these four specialties were lowered to 150% of Medicare rates, it would lower spending on physicians by 15.3%.
To help combat the issues of surprise billing in a way that lowers total commercial health care spending and helps to preserve a competitive price for physician services, Dr. Cooper and colleagues recommended an approach that would regulate the contracts of physicians who work in hospitals and are not chosen by patients. It would establish a bundled package for services that include the emergency department physicians and the four specialists examined as part of the research and would use the fee associated with the package of services to recruit specialists to work at the hospital.
The authors said this kind of policy would eliminate the possibility of patients seeing out-of-network providers at in-network hospitals and, unlike arbitration (a favored solution among physician groups if it is set up in an agreeable manner), patients are protected without being required to take any action. The policy also sets a competitive rate for these services.
“Under this bundled care approach, physicians would compete to offer their services on the basis of price and quality,” Dr. Cooper and colleagues stated. “Hospitals would compete with one another on the price and quality of their care, including the services provided by the physicians they recruited. Hospitals would also need to compete to retain physicians.”
This approach is not included in any current surprise billing legislation. There was hope that surprise billing would be addressed in a government spending bill that would be signed before year’s end. But a second bipartisan plan was introduced in the House Ways and Means Committee after a bipartisan compromise was reached by the House Energy and Commerce and the Senate Health, Education, Labor, and Pensions committees. This has postponed a decision on surprise billing legislation into the coming year.
gtwachtman@mdedge.com
SOURCE: Cooper Z et al. Health Aff. 2019 Dec 16. doi: 10.1377/hlthaff.2019.00507.
As the debate over how best to address surprise billing continues, new research shows that billing from out-of-network physicians at in-network facilities is adding $40 billion in costs.
Researchers focused on four different types of physicians that account for out-of-network billing: anesthesiologists, pathologists, radiologists, and cases involving an assistant surgeon, which had out-of-network bills in about 10% of claims that were examined as part of the research.
“To give a rough estimate of the savings that could be achieved by eliminating the ability of these four types of specialists to readily bill out of network, we simulated what would happen if all of these specialists received the same average payments as orthopedic surgeons did (164% of Medicare rates),” Zack Cooper, PhD, associate professor of health policy at Yale University, New Haven, Conn., and colleagues wrote in a research report published in Health Affairs.
“We estimated that if these physicians were paid the same average rate as orthopedists for all of the services that they delivered in our sample, spending would be lowered on anesthesiologists by 53.5%, on pathologists by 47.4%, on radiologists by 16.3%, and on assistant surgeons by 46.2%,” the authors wrote.
Researchers said that physician spending for these four specialties would be lowered by 13.4% and would lower total spending for people with employer-sponsored insurance by about 3.4%, or $40 billion. If spending on these four specialties were lowered to 150% of Medicare rates, it would lower spending on physicians by 15.3%.
To help combat the issues of surprise billing in a way that lowers total commercial health care spending and helps to preserve a competitive price for physician services, Dr. Cooper and colleagues recommended an approach that would regulate the contracts of physicians who work in hospitals and are not chosen by patients. It would establish a bundled package for services that include the emergency department physicians and the four specialists examined as part of the research and would use the fee associated with the package of services to recruit specialists to work at the hospital.
The authors said this kind of policy would eliminate the possibility of patients seeing out-of-network providers at in-network hospitals and, unlike arbitration (a favored solution among physician groups if it is set up in an agreeable manner), patients are protected without being required to take any action. The policy also sets a competitive rate for these services.
“Under this bundled care approach, physicians would compete to offer their services on the basis of price and quality,” Dr. Cooper and colleagues stated. “Hospitals would compete with one another on the price and quality of their care, including the services provided by the physicians they recruited. Hospitals would also need to compete to retain physicians.”
This approach is not included in any current surprise billing legislation. There was hope that surprise billing would be addressed in a government spending bill that would be signed before year’s end. But a second bipartisan plan was introduced in the House Ways and Means Committee after a bipartisan compromise was reached by the House Energy and Commerce and the Senate Health, Education, Labor, and Pensions committees. This has postponed a decision on surprise billing legislation into the coming year.
gtwachtman@mdedge.com
SOURCE: Cooper Z et al. Health Aff. 2019 Dec 16. doi: 10.1377/hlthaff.2019.00507.
As the debate over how best to address surprise billing continues, new research shows that billing from out-of-network physicians at in-network facilities is adding $40 billion in costs.
Researchers focused on four different types of physicians that account for out-of-network billing: anesthesiologists, pathologists, radiologists, and cases involving an assistant surgeon, which had out-of-network bills in about 10% of claims that were examined as part of the research.
“To give a rough estimate of the savings that could be achieved by eliminating the ability of these four types of specialists to readily bill out of network, we simulated what would happen if all of these specialists received the same average payments as orthopedic surgeons did (164% of Medicare rates),” Zack Cooper, PhD, associate professor of health policy at Yale University, New Haven, Conn., and colleagues wrote in a research report published in Health Affairs.
“We estimated that if these physicians were paid the same average rate as orthopedists for all of the services that they delivered in our sample, spending would be lowered on anesthesiologists by 53.5%, on pathologists by 47.4%, on radiologists by 16.3%, and on assistant surgeons by 46.2%,” the authors wrote.
Researchers said that physician spending for these four specialties would be lowered by 13.4% and would lower total spending for people with employer-sponsored insurance by about 3.4%, or $40 billion. If spending on these four specialties were lowered to 150% of Medicare rates, it would lower spending on physicians by 15.3%.
To help combat the issues of surprise billing in a way that lowers total commercial health care spending and helps to preserve a competitive price for physician services, Dr. Cooper and colleagues recommended an approach that would regulate the contracts of physicians who work in hospitals and are not chosen by patients. It would establish a bundled package for services that include the emergency department physicians and the four specialists examined as part of the research and would use the fee associated with the package of services to recruit specialists to work at the hospital.
The authors said this kind of policy would eliminate the possibility of patients seeing out-of-network providers at in-network hospitals and, unlike arbitration (a favored solution among physician groups if it is set up in an agreeable manner), patients are protected without being required to take any action. The policy also sets a competitive rate for these services.
“Under this bundled care approach, physicians would compete to offer their services on the basis of price and quality,” Dr. Cooper and colleagues stated. “Hospitals would compete with one another on the price and quality of their care, including the services provided by the physicians they recruited. Hospitals would also need to compete to retain physicians.”
This approach is not included in any current surprise billing legislation. There was hope that surprise billing would be addressed in a government spending bill that would be signed before year’s end. But a second bipartisan plan was introduced in the House Ways and Means Committee after a bipartisan compromise was reached by the House Energy and Commerce and the Senate Health, Education, Labor, and Pensions committees. This has postponed a decision on surprise billing legislation into the coming year.
gtwachtman@mdedge.com
SOURCE: Cooper Z et al. Health Aff. 2019 Dec 16. doi: 10.1377/hlthaff.2019.00507.
FROM HEALTH AFFAIRS
HHS drug importation proposals aim to address high costs
The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.
HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.
“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”
The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.
He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”
The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.
Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.
Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.
Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.
States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.
Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”
The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.
The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.
“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.
Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.
The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.
The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.
“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.
The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.
HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.
“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”
The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.
He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”
The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.
Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.
Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.
Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.
States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.
Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”
The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.
The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.
“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.
Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.
The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.
The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.
“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.
The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.
HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.
“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”
The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.
He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”
The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.
Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.
Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.
Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.
States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.
Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”
The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.
The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.
“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.
Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.
The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.
The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.
“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.