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Senators seek answers on Gleostine price hike
The drug, which is used to treat Hodgkin lymphoma and brain cancer, has seen its price increase by 1,400% ($50 to $786) since NextSource acquired it. Gleostine, which was approved by the Food and Drug Administration in 1976 and has long been off patent, has no generic competition.
“Recent reports of price increases for off-patent drugs have demonstrated the need for continued oversight by the United States Senate,” Sen. Susan Collins (R-Maine), Sen. Claire McCaskill (D-Mo.), and Sen. Catherine Cortez Masto (D-Nev.) wrote in a letter to Tri-Source Pharma CEO Robert DiCrisci. Tri-Source is the parent company of NextSource.
The senators requested information on the gross and net revenues of the drug; expenses related to the sale of the drug; annual profit data; internal and external communications related to current and future sales of the drug, including cost estimates, profit projections, and market share analysis; and a list of other drugs sold by the company along with relevant pricing information.
The manufacturer has previously defended its price increases, citing the increased cost of a key manufacturing component, the cost of providing discounted drugs to Medicaid and uninsured patients, and higher regulatory fees, as well as the maintenance of a year’s worth of “safety stock” to prevent shortages.
The drug, which is used to treat Hodgkin lymphoma and brain cancer, has seen its price increase by 1,400% ($50 to $786) since NextSource acquired it. Gleostine, which was approved by the Food and Drug Administration in 1976 and has long been off patent, has no generic competition.
“Recent reports of price increases for off-patent drugs have demonstrated the need for continued oversight by the United States Senate,” Sen. Susan Collins (R-Maine), Sen. Claire McCaskill (D-Mo.), and Sen. Catherine Cortez Masto (D-Nev.) wrote in a letter to Tri-Source Pharma CEO Robert DiCrisci. Tri-Source is the parent company of NextSource.
The senators requested information on the gross and net revenues of the drug; expenses related to the sale of the drug; annual profit data; internal and external communications related to current and future sales of the drug, including cost estimates, profit projections, and market share analysis; and a list of other drugs sold by the company along with relevant pricing information.
The manufacturer has previously defended its price increases, citing the increased cost of a key manufacturing component, the cost of providing discounted drugs to Medicaid and uninsured patients, and higher regulatory fees, as well as the maintenance of a year’s worth of “safety stock” to prevent shortages.
The drug, which is used to treat Hodgkin lymphoma and brain cancer, has seen its price increase by 1,400% ($50 to $786) since NextSource acquired it. Gleostine, which was approved by the Food and Drug Administration in 1976 and has long been off patent, has no generic competition.
“Recent reports of price increases for off-patent drugs have demonstrated the need for continued oversight by the United States Senate,” Sen. Susan Collins (R-Maine), Sen. Claire McCaskill (D-Mo.), and Sen. Catherine Cortez Masto (D-Nev.) wrote in a letter to Tri-Source Pharma CEO Robert DiCrisci. Tri-Source is the parent company of NextSource.
The senators requested information on the gross and net revenues of the drug; expenses related to the sale of the drug; annual profit data; internal and external communications related to current and future sales of the drug, including cost estimates, profit projections, and market share analysis; and a list of other drugs sold by the company along with relevant pricing information.
The manufacturer has previously defended its price increases, citing the increased cost of a key manufacturing component, the cost of providing discounted drugs to Medicaid and uninsured patients, and higher regulatory fees, as well as the maintenance of a year’s worth of “safety stock” to prevent shortages.
Medicare Part D plans get more flexibility to make midyear changes
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Neurology faculty gender gap confirmed, but explanations remain scant
Despite a wide gap between male and female neurologists, both in terms of academic faculty rank and number of publications, there may be some good news for women in this medical field.
A recent study of the 1,712 academic neurologists across 29 top-ranked neurology programs revealed that 1,184 (69%) were men and 528 (31%) were women, and men outnumbered women in all academic faculty ranks with a gap that increased as the rank advanced. For example, at the rank of instructor/lecturer, the male-to-female ratio was 59% to 41%. The gap only widens from there: assistant professor (57% male), associate professor (70%), and professor (86%).
Additionally, unadjusted analyses showed that men had significantly more publications listed in PubMed than women at the positions of assistant professor, associate professor, and full professor.
The investigators compiled their list of programs and faculty members by combining the top 20 programs listed on either the 2016 or 2017 Doximity Residency Navigator tool with the top 20 programs listed in the U.S. News and World Report ranking of Best Graduate Schools and a search of the programs’ departmental websites between December 1, 2015, and April 30, 2016.
The study was not able to account for many potential explanations for the gender gap, suggesting that the findings may not necessarily be indicative of bad news.
The results “can be viewed as either disappointing or encouraging, depending on whether they reflect persistent barriers to women trying to achieve similar goals as men, or whether they reflect a system that supports women with different goals altogether,” Dr. McDermott and her colleagues wrote.
For example, the authors note that there are a variety of explanations for the gender gap in both rank and publication, including asymmetric home or childcare responsibilities, cultural stereotypes, professional isolation, and different career motivations, though the study was not able to account for those variables.
“Compared with men, women may be more likely to be recruited for employment positions that emphasize teaching and mentoring rather than research, or women may be more inclined to choose such positions,” the authors noted, adding that academic institutions are moving beyond traditional measures of academic productivity (publication rate, publication impact, and grant support) to recognize other factors, such as the quality and quantity of teaching, the development of educational resources, and administrative effectiveness.
If the numbers reflect persistent barriers to women, “it will be important to develop programs to heighten awareness of diversity in academic neurology,” the authors stated. On the flip side, if the numbers reflect a system that is supporting different goals, “academic neurology departments should be encouraged to foster a variety of career paths and expectations for all faculty.”
The authors reported no conflicts of interest. The study was funded by the Jerry Isler Neuromuscular Fund.
SOURCE: McDermott M et al. JAMA Neurol. 2018 Apr 2. doi: 10.1001/jamaneurol.2018.0275.
While there may be positive ways to interpret the data, challenges remain for women who want to pursue a career path that features more traditional ways of being recognized. These include ensuring that career paths that require protected time for research and depend on publication and grant support are carefully monitored; and determining that barriers do not hinder women from advancing.
Training programs also must be revisited to ensure that parity across the wider spectrum of careers in neurology is maintained and opportunities continue to exist for both men and women as the specialty continues to grow.
Frances Jensen, MD , is with the University of Pennsylvania, Philadelphia. Her remarks are derived from an editorial accompanying the report by Dr. McDermott and colleagues (JAMA Neurol. 2018 Apr 2. doi: 10.1001/jamaneurol.2018.0300). She reported no disclosures.
While there may be positive ways to interpret the data, challenges remain for women who want to pursue a career path that features more traditional ways of being recognized. These include ensuring that career paths that require protected time for research and depend on publication and grant support are carefully monitored; and determining that barriers do not hinder women from advancing.
Training programs also must be revisited to ensure that parity across the wider spectrum of careers in neurology is maintained and opportunities continue to exist for both men and women as the specialty continues to grow.
Frances Jensen, MD , is with the University of Pennsylvania, Philadelphia. Her remarks are derived from an editorial accompanying the report by Dr. McDermott and colleagues (JAMA Neurol. 2018 Apr 2. doi: 10.1001/jamaneurol.2018.0300). She reported no disclosures.
While there may be positive ways to interpret the data, challenges remain for women who want to pursue a career path that features more traditional ways of being recognized. These include ensuring that career paths that require protected time for research and depend on publication and grant support are carefully monitored; and determining that barriers do not hinder women from advancing.
Training programs also must be revisited to ensure that parity across the wider spectrum of careers in neurology is maintained and opportunities continue to exist for both men and women as the specialty continues to grow.
Frances Jensen, MD , is with the University of Pennsylvania, Philadelphia. Her remarks are derived from an editorial accompanying the report by Dr. McDermott and colleagues (JAMA Neurol. 2018 Apr 2. doi: 10.1001/jamaneurol.2018.0300). She reported no disclosures.
Despite a wide gap between male and female neurologists, both in terms of academic faculty rank and number of publications, there may be some good news for women in this medical field.
A recent study of the 1,712 academic neurologists across 29 top-ranked neurology programs revealed that 1,184 (69%) were men and 528 (31%) were women, and men outnumbered women in all academic faculty ranks with a gap that increased as the rank advanced. For example, at the rank of instructor/lecturer, the male-to-female ratio was 59% to 41%. The gap only widens from there: assistant professor (57% male), associate professor (70%), and professor (86%).
Additionally, unadjusted analyses showed that men had significantly more publications listed in PubMed than women at the positions of assistant professor, associate professor, and full professor.
The investigators compiled their list of programs and faculty members by combining the top 20 programs listed on either the 2016 or 2017 Doximity Residency Navigator tool with the top 20 programs listed in the U.S. News and World Report ranking of Best Graduate Schools and a search of the programs’ departmental websites between December 1, 2015, and April 30, 2016.
The study was not able to account for many potential explanations for the gender gap, suggesting that the findings may not necessarily be indicative of bad news.
The results “can be viewed as either disappointing or encouraging, depending on whether they reflect persistent barriers to women trying to achieve similar goals as men, or whether they reflect a system that supports women with different goals altogether,” Dr. McDermott and her colleagues wrote.
For example, the authors note that there are a variety of explanations for the gender gap in both rank and publication, including asymmetric home or childcare responsibilities, cultural stereotypes, professional isolation, and different career motivations, though the study was not able to account for those variables.
“Compared with men, women may be more likely to be recruited for employment positions that emphasize teaching and mentoring rather than research, or women may be more inclined to choose such positions,” the authors noted, adding that academic institutions are moving beyond traditional measures of academic productivity (publication rate, publication impact, and grant support) to recognize other factors, such as the quality and quantity of teaching, the development of educational resources, and administrative effectiveness.
If the numbers reflect persistent barriers to women, “it will be important to develop programs to heighten awareness of diversity in academic neurology,” the authors stated. On the flip side, if the numbers reflect a system that is supporting different goals, “academic neurology departments should be encouraged to foster a variety of career paths and expectations for all faculty.”
The authors reported no conflicts of interest. The study was funded by the Jerry Isler Neuromuscular Fund.
SOURCE: McDermott M et al. JAMA Neurol. 2018 Apr 2. doi: 10.1001/jamaneurol.2018.0275.
Despite a wide gap between male and female neurologists, both in terms of academic faculty rank and number of publications, there may be some good news for women in this medical field.
A recent study of the 1,712 academic neurologists across 29 top-ranked neurology programs revealed that 1,184 (69%) were men and 528 (31%) were women, and men outnumbered women in all academic faculty ranks with a gap that increased as the rank advanced. For example, at the rank of instructor/lecturer, the male-to-female ratio was 59% to 41%. The gap only widens from there: assistant professor (57% male), associate professor (70%), and professor (86%).
Additionally, unadjusted analyses showed that men had significantly more publications listed in PubMed than women at the positions of assistant professor, associate professor, and full professor.
The investigators compiled their list of programs and faculty members by combining the top 20 programs listed on either the 2016 or 2017 Doximity Residency Navigator tool with the top 20 programs listed in the U.S. News and World Report ranking of Best Graduate Schools and a search of the programs’ departmental websites between December 1, 2015, and April 30, 2016.
The study was not able to account for many potential explanations for the gender gap, suggesting that the findings may not necessarily be indicative of bad news.
The results “can be viewed as either disappointing or encouraging, depending on whether they reflect persistent barriers to women trying to achieve similar goals as men, or whether they reflect a system that supports women with different goals altogether,” Dr. McDermott and her colleagues wrote.
For example, the authors note that there are a variety of explanations for the gender gap in both rank and publication, including asymmetric home or childcare responsibilities, cultural stereotypes, professional isolation, and different career motivations, though the study was not able to account for those variables.
“Compared with men, women may be more likely to be recruited for employment positions that emphasize teaching and mentoring rather than research, or women may be more inclined to choose such positions,” the authors noted, adding that academic institutions are moving beyond traditional measures of academic productivity (publication rate, publication impact, and grant support) to recognize other factors, such as the quality and quantity of teaching, the development of educational resources, and administrative effectiveness.
If the numbers reflect persistent barriers to women, “it will be important to develop programs to heighten awareness of diversity in academic neurology,” the authors stated. On the flip side, if the numbers reflect a system that is supporting different goals, “academic neurology departments should be encouraged to foster a variety of career paths and expectations for all faculty.”
The authors reported no conflicts of interest. The study was funded by the Jerry Isler Neuromuscular Fund.
SOURCE: McDermott M et al. JAMA Neurol. 2018 Apr 2. doi: 10.1001/jamaneurol.2018.0275.
FROM JAMA NEUROLOGY
Major finding: Male-to-female ratio widens as rank advances, from 59% male at instructor/lecturer to 86% male at full professor.
Study details: An examination of 1,712 academic neurologists across 29 top-ranked academic institutions.
Disclosures: The study authors reported no conflicts of interest. The study was funded by the Jerry Isler Neuromuscular Fund.
Source: McDermott M et al. JAMA Neurol. 2018 Apr 2. doi: 10.1001/jamaneurol.2018.0275.
Value over volume
Kate Goodrich, MD, MHS, chief medical officer at the Centers for Medicare & Medicaid Services, opens HM18 on April 9 with a plenary talk focused on the rising cost of health care in the United States, and how hospitalists can be part of the solution.
“What I want people to understand is the evolution within our health care system from one where we pay for volume to paying for value, and the role that Medicare can play in that,” Dr. Goodrich said in an interview. “Medicare has traditionally been sort of a passive payer, if you will, a passive payer of claims without a great deal of emphasis on the cost of care and the quality of care. [Now there is] a groundswell of concern nationally, not just here at CMS but nationwide, around the rising cost of care, and our quality of care is not as good as it should be for the amount that we spend.”
Dr. Goodrich said she will discuss how “that came to be, and what CMS and other payers in the country are trying to do about it.” She said the U.S. is in a “truly transformative era in our health care system in changing how we pay for care, in service of better outcomes for patients and lower costs. I would like to give attendees the larger picture, of how we got here and what’s happening both at CMS and nationally to try and reverse some of those trends.”
As value-based purchasing programs – and the push to pay for value over volume in Medicare and the private sector – continue to become the norm, the expected trend of sicker, more complex patients entering the hospital already is happening, Dr. Goodrich said. She is experiencing it in her own clinical work, which continues in addition to her role at CMS.
“I can confirm from my own personal experience [that] I have absolutely encountered that exact trend,” she said. “I feel like every time I go in the hospital, my patients are sicker and more complex. That is the population of patients that hospitalists are dealing with. That’s why we are actually in that practice. We enjoy taking care of those types of patients and the challenges they bring, both on a clinical level, but I would say also even on a social and economic level.”
Dr. Goodrich said that trend will present one of the key challenges hospitalists face in the future, especially as paying for value entails more two-sided risk.
“In a value-based purchasing world, transitioning to payments based on quality and cost is harder, because by nature the sicker patients cost more and it is harder to improve their outcomes. They come to you already quite sick,” she said. “That’s a dilemma that a lot of hospitalists face, wondering ‘How is this going to affect me if I am already seeing the sickest of the sick?’”
Integration of data and technology innovation will be critical to better serving this sicker population, but physicians currently spend too much time entering data into computers and don’t get much useful information out of it.
“How do we make [health care IT] usable for the average front-line nurse or doctor who didn’t go to school to learn how to code and analyze data?” Dr. Goodrich asked. “How do we get platforms and analytics that are developed using human-centered design principles to make it very understandable and actionable to the front-end clinician, but also to patients and consumers? What is really needed to truly drive improvement is not just access to the data but usability.”
She said this problem is directly related to the usability of electronic health records. “That is a significant focus right now for the Office of the National Coordinator [of Health Information Technology] – to move away from just [adopting] EHRs, to promoting interoperability and also the usability aspects that exactly get to the problems we’ve identified.”
Kate Goodrich, MD, MHS, chief medical officer at the Centers for Medicare & Medicaid Services, opens HM18 on April 9 with a plenary talk focused on the rising cost of health care in the United States, and how hospitalists can be part of the solution.
“What I want people to understand is the evolution within our health care system from one where we pay for volume to paying for value, and the role that Medicare can play in that,” Dr. Goodrich said in an interview. “Medicare has traditionally been sort of a passive payer, if you will, a passive payer of claims without a great deal of emphasis on the cost of care and the quality of care. [Now there is] a groundswell of concern nationally, not just here at CMS but nationwide, around the rising cost of care, and our quality of care is not as good as it should be for the amount that we spend.”
Dr. Goodrich said she will discuss how “that came to be, and what CMS and other payers in the country are trying to do about it.” She said the U.S. is in a “truly transformative era in our health care system in changing how we pay for care, in service of better outcomes for patients and lower costs. I would like to give attendees the larger picture, of how we got here and what’s happening both at CMS and nationally to try and reverse some of those trends.”
As value-based purchasing programs – and the push to pay for value over volume in Medicare and the private sector – continue to become the norm, the expected trend of sicker, more complex patients entering the hospital already is happening, Dr. Goodrich said. She is experiencing it in her own clinical work, which continues in addition to her role at CMS.
“I can confirm from my own personal experience [that] I have absolutely encountered that exact trend,” she said. “I feel like every time I go in the hospital, my patients are sicker and more complex. That is the population of patients that hospitalists are dealing with. That’s why we are actually in that practice. We enjoy taking care of those types of patients and the challenges they bring, both on a clinical level, but I would say also even on a social and economic level.”
Dr. Goodrich said that trend will present one of the key challenges hospitalists face in the future, especially as paying for value entails more two-sided risk.
“In a value-based purchasing world, transitioning to payments based on quality and cost is harder, because by nature the sicker patients cost more and it is harder to improve their outcomes. They come to you already quite sick,” she said. “That’s a dilemma that a lot of hospitalists face, wondering ‘How is this going to affect me if I am already seeing the sickest of the sick?’”
Integration of data and technology innovation will be critical to better serving this sicker population, but physicians currently spend too much time entering data into computers and don’t get much useful information out of it.
“How do we make [health care IT] usable for the average front-line nurse or doctor who didn’t go to school to learn how to code and analyze data?” Dr. Goodrich asked. “How do we get platforms and analytics that are developed using human-centered design principles to make it very understandable and actionable to the front-end clinician, but also to patients and consumers? What is really needed to truly drive improvement is not just access to the data but usability.”
She said this problem is directly related to the usability of electronic health records. “That is a significant focus right now for the Office of the National Coordinator [of Health Information Technology] – to move away from just [adopting] EHRs, to promoting interoperability and also the usability aspects that exactly get to the problems we’ve identified.”
Kate Goodrich, MD, MHS, chief medical officer at the Centers for Medicare & Medicaid Services, opens HM18 on April 9 with a plenary talk focused on the rising cost of health care in the United States, and how hospitalists can be part of the solution.
“What I want people to understand is the evolution within our health care system from one where we pay for volume to paying for value, and the role that Medicare can play in that,” Dr. Goodrich said in an interview. “Medicare has traditionally been sort of a passive payer, if you will, a passive payer of claims without a great deal of emphasis on the cost of care and the quality of care. [Now there is] a groundswell of concern nationally, not just here at CMS but nationwide, around the rising cost of care, and our quality of care is not as good as it should be for the amount that we spend.”
Dr. Goodrich said she will discuss how “that came to be, and what CMS and other payers in the country are trying to do about it.” She said the U.S. is in a “truly transformative era in our health care system in changing how we pay for care, in service of better outcomes for patients and lower costs. I would like to give attendees the larger picture, of how we got here and what’s happening both at CMS and nationally to try and reverse some of those trends.”
As value-based purchasing programs – and the push to pay for value over volume in Medicare and the private sector – continue to become the norm, the expected trend of sicker, more complex patients entering the hospital already is happening, Dr. Goodrich said. She is experiencing it in her own clinical work, which continues in addition to her role at CMS.
“I can confirm from my own personal experience [that] I have absolutely encountered that exact trend,” she said. “I feel like every time I go in the hospital, my patients are sicker and more complex. That is the population of patients that hospitalists are dealing with. That’s why we are actually in that practice. We enjoy taking care of those types of patients and the challenges they bring, both on a clinical level, but I would say also even on a social and economic level.”
Dr. Goodrich said that trend will present one of the key challenges hospitalists face in the future, especially as paying for value entails more two-sided risk.
“In a value-based purchasing world, transitioning to payments based on quality and cost is harder, because by nature the sicker patients cost more and it is harder to improve their outcomes. They come to you already quite sick,” she said. “That’s a dilemma that a lot of hospitalists face, wondering ‘How is this going to affect me if I am already seeing the sickest of the sick?’”
Integration of data and technology innovation will be critical to better serving this sicker population, but physicians currently spend too much time entering data into computers and don’t get much useful information out of it.
“How do we make [health care IT] usable for the average front-line nurse or doctor who didn’t go to school to learn how to code and analyze data?” Dr. Goodrich asked. “How do we get platforms and analytics that are developed using human-centered design principles to make it very understandable and actionable to the front-end clinician, but also to patients and consumers? What is really needed to truly drive improvement is not just access to the data but usability.”
She said this problem is directly related to the usability of electronic health records. “That is a significant focus right now for the Office of the National Coordinator [of Health Information Technology] – to move away from just [adopting] EHRs, to promoting interoperability and also the usability aspects that exactly get to the problems we’ve identified.”
Drug pricing proposals raise red flags with specialists
White House proposals to help lower drug prices are being met with concerns by a group of specialists.
In a March 14 letter to Department of Health & Human Services Secretary Alex Azar, a group of nine specialty medical organizations highlighted four recent proposals that could have an unintended consequence of limiting access.
The specialty groups that signed onto the letter are the American Academy of Dermatology Association, American Academy of Neurology, American Academy of Ophthalmology, American Academy of Physical Medicine and Rehabilitation, American College of Gastroenterology, American College of Rheumatology, American Gastroenterological Association, American Urological Association, and the Infectious Diseases Society of America.
The groups focused on issues pertaining to four proposals highlighted in the White House’s proposed fiscal year 2019 budget and the February 2018 report from the Council of Economic Advisors titled, “Reforming Biopharmaceutical Pricing at Home and Abroad.”
The first proposal relates to changing the requirement that Medicare Part D prescription drug plans cover at least two drugs per category to covering only one as a way to provide more flexibility and potential negotiation power, while at the same time expanding the ability to use utilization management tools.
“We worry this could create access issues for patients on high cost biologic medications,” the groups said in the letter. “We believe Part D benefits should not limit patients’ access to the medical therapy judged by the treating physician to be the most efficacious choice.”
“We worry that moving Part B drugs into Part D may lead to access issues and force patients into higher cost sites of care,” the groups said.
Third, the White House is proposing to cut Part B drug reimbursement to physicians from the current average sales price plus 6% down to ASP+3% for new drugs.
The groups said that with the budget sequestration currently in place, “the existing Part B payment structure does not adequately cover the costs of obtaining and providing these complex therapies in an outpatient setting. If additional payment cuts or negative changes are implemented or activated through demonstration projects, many patients would be forced into more expensive, less convenient settings to receive their therapies – if an alternative setting is available at all in their areas.”
Finally, the groups mention a proposal that would introduce physician reimbursement that is not tied to drug pricing. But this option is not expanded upon in the Council of Economic Advisors report.
“We request more clarity on any potential policies that would affect physician reimbursement,” the groups said. “Physicians have no control over the cost of drugs or ancillary services, nor over the severity of illness and comorbidities that drive the need for such services.”
The groups did support a few of the recommendations from the two documents, including requiring Medicare Part D plans to apply a substantial portion of the rebate at point of sale, establishing a Part D out-of-pocket maximum in the catastrophic phase to better protect beneficiaries against high drug costs, decreasing the consolidation by pharmacy benefit managers and others in the supply chain, and providing the Centers for Medicare & Medicaid Services with guidance on how drug-related value-based contracts and price reporting would affect other price regulations.
“We appreciate HHS’ continued focus on transparency and patient-centered care,” the groups said. “Knowing that HHS is committed to transforming the health care delivery system and the Medicare program by putting a strong focus on patient-centered care, so providers can direct their time and resources to patients and improving outcomes, is reassuring to our providers.”
White House proposals to help lower drug prices are being met with concerns by a group of specialists.
In a March 14 letter to Department of Health & Human Services Secretary Alex Azar, a group of nine specialty medical organizations highlighted four recent proposals that could have an unintended consequence of limiting access.
The specialty groups that signed onto the letter are the American Academy of Dermatology Association, American Academy of Neurology, American Academy of Ophthalmology, American Academy of Physical Medicine and Rehabilitation, American College of Gastroenterology, American College of Rheumatology, American Gastroenterological Association, American Urological Association, and the Infectious Diseases Society of America.
The groups focused on issues pertaining to four proposals highlighted in the White House’s proposed fiscal year 2019 budget and the February 2018 report from the Council of Economic Advisors titled, “Reforming Biopharmaceutical Pricing at Home and Abroad.”
The first proposal relates to changing the requirement that Medicare Part D prescription drug plans cover at least two drugs per category to covering only one as a way to provide more flexibility and potential negotiation power, while at the same time expanding the ability to use utilization management tools.
“We worry this could create access issues for patients on high cost biologic medications,” the groups said in the letter. “We believe Part D benefits should not limit patients’ access to the medical therapy judged by the treating physician to be the most efficacious choice.”
“We worry that moving Part B drugs into Part D may lead to access issues and force patients into higher cost sites of care,” the groups said.
Third, the White House is proposing to cut Part B drug reimbursement to physicians from the current average sales price plus 6% down to ASP+3% for new drugs.
The groups said that with the budget sequestration currently in place, “the existing Part B payment structure does not adequately cover the costs of obtaining and providing these complex therapies in an outpatient setting. If additional payment cuts or negative changes are implemented or activated through demonstration projects, many patients would be forced into more expensive, less convenient settings to receive their therapies – if an alternative setting is available at all in their areas.”
Finally, the groups mention a proposal that would introduce physician reimbursement that is not tied to drug pricing. But this option is not expanded upon in the Council of Economic Advisors report.
“We request more clarity on any potential policies that would affect physician reimbursement,” the groups said. “Physicians have no control over the cost of drugs or ancillary services, nor over the severity of illness and comorbidities that drive the need for such services.”
The groups did support a few of the recommendations from the two documents, including requiring Medicare Part D plans to apply a substantial portion of the rebate at point of sale, establishing a Part D out-of-pocket maximum in the catastrophic phase to better protect beneficiaries against high drug costs, decreasing the consolidation by pharmacy benefit managers and others in the supply chain, and providing the Centers for Medicare & Medicaid Services with guidance on how drug-related value-based contracts and price reporting would affect other price regulations.
“We appreciate HHS’ continued focus on transparency and patient-centered care,” the groups said. “Knowing that HHS is committed to transforming the health care delivery system and the Medicare program by putting a strong focus on patient-centered care, so providers can direct their time and resources to patients and improving outcomes, is reassuring to our providers.”
White House proposals to help lower drug prices are being met with concerns by a group of specialists.
In a March 14 letter to Department of Health & Human Services Secretary Alex Azar, a group of nine specialty medical organizations highlighted four recent proposals that could have an unintended consequence of limiting access.
The specialty groups that signed onto the letter are the American Academy of Dermatology Association, American Academy of Neurology, American Academy of Ophthalmology, American Academy of Physical Medicine and Rehabilitation, American College of Gastroenterology, American College of Rheumatology, American Gastroenterological Association, American Urological Association, and the Infectious Diseases Society of America.
The groups focused on issues pertaining to four proposals highlighted in the White House’s proposed fiscal year 2019 budget and the February 2018 report from the Council of Economic Advisors titled, “Reforming Biopharmaceutical Pricing at Home and Abroad.”
The first proposal relates to changing the requirement that Medicare Part D prescription drug plans cover at least two drugs per category to covering only one as a way to provide more flexibility and potential negotiation power, while at the same time expanding the ability to use utilization management tools.
“We worry this could create access issues for patients on high cost biologic medications,” the groups said in the letter. “We believe Part D benefits should not limit patients’ access to the medical therapy judged by the treating physician to be the most efficacious choice.”
“We worry that moving Part B drugs into Part D may lead to access issues and force patients into higher cost sites of care,” the groups said.
Third, the White House is proposing to cut Part B drug reimbursement to physicians from the current average sales price plus 6% down to ASP+3% for new drugs.
The groups said that with the budget sequestration currently in place, “the existing Part B payment structure does not adequately cover the costs of obtaining and providing these complex therapies in an outpatient setting. If additional payment cuts or negative changes are implemented or activated through demonstration projects, many patients would be forced into more expensive, less convenient settings to receive their therapies – if an alternative setting is available at all in their areas.”
Finally, the groups mention a proposal that would introduce physician reimbursement that is not tied to drug pricing. But this option is not expanded upon in the Council of Economic Advisors report.
“We request more clarity on any potential policies that would affect physician reimbursement,” the groups said. “Physicians have no control over the cost of drugs or ancillary services, nor over the severity of illness and comorbidities that drive the need for such services.”
The groups did support a few of the recommendations from the two documents, including requiring Medicare Part D plans to apply a substantial portion of the rebate at point of sale, establishing a Part D out-of-pocket maximum in the catastrophic phase to better protect beneficiaries against high drug costs, decreasing the consolidation by pharmacy benefit managers and others in the supply chain, and providing the Centers for Medicare & Medicaid Services with guidance on how drug-related value-based contracts and price reporting would affect other price regulations.
“We appreciate HHS’ continued focus on transparency and patient-centered care,” the groups said. “Knowing that HHS is committed to transforming the health care delivery system and the Medicare program by putting a strong focus on patient-centered care, so providers can direct their time and resources to patients and improving outcomes, is reassuring to our providers.”
Rheumatologists push back on feds’ association health plan proposal
A proposed rule defining association health plans has raised red flags for the American College of Rheumatology.
In particular, ACR is concerned that, if enacted, the proposed rule published by the Department of Labor on Jan. 5 could create access issues.
“There is a marked lack of current data available related to the risk profile of existing and potential associations and how those intersect with the individual and small group markets,” ACR said in a March 6 comment letter to the Department of Labor.
The college also noted that, “we especially have concerns regarding patient access to care in rural and remote areas of the United States.”
The organization suggested that the Labor department write regulations to ensure network adequacy, particularly for specialty care, and address other reforms related to prior authorization.
Significantly, ACR expressed concerns that a kind of economic discrimination could occur under AHPs.
Discrimination could come from opting not to cover prescription drugs, extreme utilization management protocols, coverage caps, increased coinsurance for patients, and discriminatory tiering and other formulary designs for high-cost medications.
ACR “strongly opposes excessive patient cost sharing that results in untenable patient financial burden, thereby creating a de facto situation in which the patient does not have access to a medically necessary treatment,” the organization wrote. “For patients with complex conditions like rheumatoid arthritis, biologic medications are very expensive and excessive cost sharing can reduce adherence and patient access to treatment, leading to risk for irreversible damage, excess morbidity, and even mortality.”
“The ACR is concerned that loosening these consumer protections will reduce our patients’ access to care, either through weaker coverage or by driving up their premiums,” ACR President David Daikh, MD, said in a statement. “Our patients require continuous access to specialized care to manage pain and avoid long-term disability. Therefore it is imperative that the administration ensure that Americans living with rheumatic diseases be afforded adequate protections under these new rules.”
The comment period for the proposed rule closed in early March. At press time, the Labor department had not published a timeline for publishing a final rule.
A proposed rule defining association health plans has raised red flags for the American College of Rheumatology.
In particular, ACR is concerned that, if enacted, the proposed rule published by the Department of Labor on Jan. 5 could create access issues.
“There is a marked lack of current data available related to the risk profile of existing and potential associations and how those intersect with the individual and small group markets,” ACR said in a March 6 comment letter to the Department of Labor.
The college also noted that, “we especially have concerns regarding patient access to care in rural and remote areas of the United States.”
The organization suggested that the Labor department write regulations to ensure network adequacy, particularly for specialty care, and address other reforms related to prior authorization.
Significantly, ACR expressed concerns that a kind of economic discrimination could occur under AHPs.
Discrimination could come from opting not to cover prescription drugs, extreme utilization management protocols, coverage caps, increased coinsurance for patients, and discriminatory tiering and other formulary designs for high-cost medications.
ACR “strongly opposes excessive patient cost sharing that results in untenable patient financial burden, thereby creating a de facto situation in which the patient does not have access to a medically necessary treatment,” the organization wrote. “For patients with complex conditions like rheumatoid arthritis, biologic medications are very expensive and excessive cost sharing can reduce adherence and patient access to treatment, leading to risk for irreversible damage, excess morbidity, and even mortality.”
“The ACR is concerned that loosening these consumer protections will reduce our patients’ access to care, either through weaker coverage or by driving up their premiums,” ACR President David Daikh, MD, said in a statement. “Our patients require continuous access to specialized care to manage pain and avoid long-term disability. Therefore it is imperative that the administration ensure that Americans living with rheumatic diseases be afforded adequate protections under these new rules.”
The comment period for the proposed rule closed in early March. At press time, the Labor department had not published a timeline for publishing a final rule.
A proposed rule defining association health plans has raised red flags for the American College of Rheumatology.
In particular, ACR is concerned that, if enacted, the proposed rule published by the Department of Labor on Jan. 5 could create access issues.
“There is a marked lack of current data available related to the risk profile of existing and potential associations and how those intersect with the individual and small group markets,” ACR said in a March 6 comment letter to the Department of Labor.
The college also noted that, “we especially have concerns regarding patient access to care in rural and remote areas of the United States.”
The organization suggested that the Labor department write regulations to ensure network adequacy, particularly for specialty care, and address other reforms related to prior authorization.
Significantly, ACR expressed concerns that a kind of economic discrimination could occur under AHPs.
Discrimination could come from opting not to cover prescription drugs, extreme utilization management protocols, coverage caps, increased coinsurance for patients, and discriminatory tiering and other formulary designs for high-cost medications.
ACR “strongly opposes excessive patient cost sharing that results in untenable patient financial burden, thereby creating a de facto situation in which the patient does not have access to a medically necessary treatment,” the organization wrote. “For patients with complex conditions like rheumatoid arthritis, biologic medications are very expensive and excessive cost sharing can reduce adherence and patient access to treatment, leading to risk for irreversible damage, excess morbidity, and even mortality.”
“The ACR is concerned that loosening these consumer protections will reduce our patients’ access to care, either through weaker coverage or by driving up their premiums,” ACR President David Daikh, MD, said in a statement. “Our patients require continuous access to specialized care to manage pain and avoid long-term disability. Therefore it is imperative that the administration ensure that Americans living with rheumatic diseases be afforded adequate protections under these new rules.”
The comment period for the proposed rule closed in early March. At press time, the Labor department had not published a timeline for publishing a final rule.
Adapting consumer technology into GI practice
BOSTON – You can command Alexa to order pizza and spool up your favorite flick, but accessing digital health data remains a struggle. Michael Docktor, MD, wants to change that.
A pediatric gastroenterologist and the clinical director of innovation at Boston Children’s Hospital, Dr. Docktor believes that it’s just a matter of time before consumer-driven digital technology fundamentally changes the way physicians and patients interact. 
“In medicine, we are often in the habit of trying to recreate the wheel,” he said during the “Digital Health in GI Disease” session at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. “My hope and belief is that we can borrow from the best of the consumer technology world and apply that to our world in health care and GI specifically.”
Dr. Docktor shared some of the “tools and toys” that have come of his group’s program and also “exposed folks to things that they may not be thinking about traditionally in medicine.”
In particular, one area he focused on was how certain voice technologies are enhancing health care delivery, such as integration of Amazon’s Alexa. Consider Alexa a nurse on call.
he said. “We have placed a fairly large bet on voice in health care and built some skills for Alexa.”
He also highlighted a new virtual reality tool that was recently launched by Boston Children’s Hospital to help gastroenterologists better educate their patients.
HealthVoyager was developed in conjunction with Klick Health. The kid-friendly app lets children take a virtual ride through their GI tract. Clinicians draw in abnormal findings on a simplified template. The app then recreates those findings – lesions, polyps, or inflammatory changes – in the positions they actually occupy in the patient. It generates a QR code that’s given to the patient, allowing the child to access her imaging in a HIPAA-compliant manner.
It’s cool, sure, Dr. Docktor said. But does it bring any value to the physician-patient interaction?
“The challenge of digital health is to prove that there’s actual value, it’s not just a bunch of snazzy tech. Are patients really using it? Sharing it? Are they educating themselves and their family and their community? We want to study this clinically and validate whether or not it results in improved adherence and improved patient satisfaction.”
He covered other technologies, such as Chatbox and blockchain, and the roles they can play in health care.
In the not-too-distant future, Dr. Docktor envisions voice assistants integrated into daily medical practice. Amazon’s Alexa provides an aspirational goal, he said.
“We are seeing the rise of the voice assistant. By 2020, researchers predict that 50% of all Internet searches will happen just by voice. Voice interface, I believe, will be driving health care by interfacing with patients at home. I predict that over the next 5 years, most of us will have a medical encounter on a device like this. Technology is not a limiting factor in this scenario. It’s just red tape on the payer and provider side at this point.”
Dr. Docktor’s colleague, Carla E. Small, senior director of the Innovation & Digital Health Accelerator at Boston Children’s Hospital, provided another real-life example of his digital vision. The Innovation & Digital Health Accelerator is a division within the hospital devoted to identifying, nurturing, and implementing digital health care solutions.
“The world has moved to a technology-enabled health care environment, and we all have to be there along with it,” she said. “That also creates a great opportunity for those who have an interest in innovation. There is a lot of ground for changing the way we do things and really leveraging that creativity and innovation.”
One Accelerator product that’s up and running is Thermia. The online tool guides parents through the anxiety of managing a child’s fever.
Thermia quickly and easily allows concerned parents to interpret a child’s temperature and understand which steps they should consider taking. Parents enter their child’s age, temperature, weight, any associated symptoms like rash, sore throat, or GI upset, as well as comorbid medical conditions. An algorithm issues advice for treatment at home or, if the data suggest a risk or serious problem, suggests a visit to the pediatrician or the emergency room. Thermia also automatically calculates the dosage of over-the-counter antipyretic medications based on age and weight.
The Accelerator is investigating a host of other digital health products in different stages of concept, design, and execution. Health care simply has to embrace the digital trends that are changing the way people interact with their world.
The AGA Center for GI Innovation and Technology wants to hear the unique ways gastroenterologists are leveraging consumer technology in their practices. Send us an email at cgit@gastro.org.
gtwachtman@mdedge.com
msullivan@mdedge.com
BOSTON – You can command Alexa to order pizza and spool up your favorite flick, but accessing digital health data remains a struggle. Michael Docktor, MD, wants to change that.
A pediatric gastroenterologist and the clinical director of innovation at Boston Children’s Hospital, Dr. Docktor believes that it’s just a matter of time before consumer-driven digital technology fundamentally changes the way physicians and patients interact.
“In medicine, we are often in the habit of trying to recreate the wheel,” he said during the “Digital Health in GI Disease” session at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. “My hope and belief is that we can borrow from the best of the consumer technology world and apply that to our world in health care and GI specifically.”
Dr. Docktor shared some of the “tools and toys” that have come of his group’s program and also “exposed folks to things that they may not be thinking about traditionally in medicine.”
In particular, one area he focused on was how certain voice technologies are enhancing health care delivery, such as integration of Amazon’s Alexa. Consider Alexa a nurse on call.
he said. “We have placed a fairly large bet on voice in health care and built some skills for Alexa.”
He also highlighted a new virtual reality tool that was recently launched by Boston Children’s Hospital to help gastroenterologists better educate their patients.
HealthVoyager was developed in conjunction with Klick Health. The kid-friendly app lets children take a virtual ride through their GI tract. Clinicians draw in abnormal findings on a simplified template. The app then recreates those findings – lesions, polyps, or inflammatory changes – in the positions they actually occupy in the patient. It generates a QR code that’s given to the patient, allowing the child to access her imaging in a HIPAA-compliant manner.
It’s cool, sure, Dr. Docktor said. But does it bring any value to the physician-patient interaction?
“The challenge of digital health is to prove that there’s actual value, it’s not just a bunch of snazzy tech. Are patients really using it? Sharing it? Are they educating themselves and their family and their community? We want to study this clinically and validate whether or not it results in improved adherence and improved patient satisfaction.”
He covered other technologies, such as Chatbox and blockchain, and the roles they can play in health care.
In the not-too-distant future, Dr. Docktor envisions voice assistants integrated into daily medical practice. Amazon’s Alexa provides an aspirational goal, he said.
“We are seeing the rise of the voice assistant. By 2020, researchers predict that 50% of all Internet searches will happen just by voice. Voice interface, I believe, will be driving health care by interfacing with patients at home. I predict that over the next 5 years, most of us will have a medical encounter on a device like this. Technology is not a limiting factor in this scenario. It’s just red tape on the payer and provider side at this point.”
Dr. Docktor’s colleague, Carla E. Small, senior director of the Innovation & Digital Health Accelerator at Boston Children’s Hospital, provided another real-life example of his digital vision. The Innovation & Digital Health Accelerator is a division within the hospital devoted to identifying, nurturing, and implementing digital health care solutions.
“The world has moved to a technology-enabled health care environment, and we all have to be there along with it,” she said. “That also creates a great opportunity for those who have an interest in innovation. There is a lot of ground for changing the way we do things and really leveraging that creativity and innovation.”
One Accelerator product that’s up and running is Thermia. The online tool guides parents through the anxiety of managing a child’s fever.
Thermia quickly and easily allows concerned parents to interpret a child’s temperature and understand which steps they should consider taking. Parents enter their child’s age, temperature, weight, any associated symptoms like rash, sore throat, or GI upset, as well as comorbid medical conditions. An algorithm issues advice for treatment at home or, if the data suggest a risk or serious problem, suggests a visit to the pediatrician or the emergency room. Thermia also automatically calculates the dosage of over-the-counter antipyretic medications based on age and weight.
The Accelerator is investigating a host of other digital health products in different stages of concept, design, and execution. Health care simply has to embrace the digital trends that are changing the way people interact with their world.
The AGA Center for GI Innovation and Technology wants to hear the unique ways gastroenterologists are leveraging consumer technology in their practices. Send us an email at cgit@gastro.org.
gtwachtman@mdedge.com
msullivan@mdedge.com
BOSTON – You can command Alexa to order pizza and spool up your favorite flick, but accessing digital health data remains a struggle. Michael Docktor, MD, wants to change that.
A pediatric gastroenterologist and the clinical director of innovation at Boston Children’s Hospital, Dr. Docktor believes that it’s just a matter of time before consumer-driven digital technology fundamentally changes the way physicians and patients interact.
“In medicine, we are often in the habit of trying to recreate the wheel,” he said during the “Digital Health in GI Disease” session at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. “My hope and belief is that we can borrow from the best of the consumer technology world and apply that to our world in health care and GI specifically.”
Dr. Docktor shared some of the “tools and toys” that have come of his group’s program and also “exposed folks to things that they may not be thinking about traditionally in medicine.”
In particular, one area he focused on was how certain voice technologies are enhancing health care delivery, such as integration of Amazon’s Alexa. Consider Alexa a nurse on call.
he said. “We have placed a fairly large bet on voice in health care and built some skills for Alexa.”
He also highlighted a new virtual reality tool that was recently launched by Boston Children’s Hospital to help gastroenterologists better educate their patients.
HealthVoyager was developed in conjunction with Klick Health. The kid-friendly app lets children take a virtual ride through their GI tract. Clinicians draw in abnormal findings on a simplified template. The app then recreates those findings – lesions, polyps, or inflammatory changes – in the positions they actually occupy in the patient. It generates a QR code that’s given to the patient, allowing the child to access her imaging in a HIPAA-compliant manner.
It’s cool, sure, Dr. Docktor said. But does it bring any value to the physician-patient interaction?
“The challenge of digital health is to prove that there’s actual value, it’s not just a bunch of snazzy tech. Are patients really using it? Sharing it? Are they educating themselves and their family and their community? We want to study this clinically and validate whether or not it results in improved adherence and improved patient satisfaction.”
He covered other technologies, such as Chatbox and blockchain, and the roles they can play in health care.
In the not-too-distant future, Dr. Docktor envisions voice assistants integrated into daily medical practice. Amazon’s Alexa provides an aspirational goal, he said.
“We are seeing the rise of the voice assistant. By 2020, researchers predict that 50% of all Internet searches will happen just by voice. Voice interface, I believe, will be driving health care by interfacing with patients at home. I predict that over the next 5 years, most of us will have a medical encounter on a device like this. Technology is not a limiting factor in this scenario. It’s just red tape on the payer and provider side at this point.”
Dr. Docktor’s colleague, Carla E. Small, senior director of the Innovation & Digital Health Accelerator at Boston Children’s Hospital, provided another real-life example of his digital vision. The Innovation & Digital Health Accelerator is a division within the hospital devoted to identifying, nurturing, and implementing digital health care solutions.
“The world has moved to a technology-enabled health care environment, and we all have to be there along with it,” she said. “That also creates a great opportunity for those who have an interest in innovation. There is a lot of ground for changing the way we do things and really leveraging that creativity and innovation.”
One Accelerator product that’s up and running is Thermia. The online tool guides parents through the anxiety of managing a child’s fever.
Thermia quickly and easily allows concerned parents to interpret a child’s temperature and understand which steps they should consider taking. Parents enter their child’s age, temperature, weight, any associated symptoms like rash, sore throat, or GI upset, as well as comorbid medical conditions. An algorithm issues advice for treatment at home or, if the data suggest a risk or serious problem, suggests a visit to the pediatrician or the emergency room. Thermia also automatically calculates the dosage of over-the-counter antipyretic medications based on age and weight.
The Accelerator is investigating a host of other digital health products in different stages of concept, design, and execution. Health care simply has to embrace the digital trends that are changing the way people interact with their world.
The AGA Center for GI Innovation and Technology wants to hear the unique ways gastroenterologists are leveraging consumer technology in their practices. Send us an email at cgit@gastro.org.
gtwachtman@mdedge.com
msullivan@mdedge.com
REPORTING FROM THE 2018 AGA TECH SUMMIT
‘Right to try’ bill passes House
Terminal patients who have exhausted all approved drug options would be able to seek out investigational treatments – even if they do not qualify for clinical trials – under a bill passed in the U.S. House, despite opposition from more than 100 patient and physician groups.
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina 
For an unapproved drug to be made available to patients, it must have an active application that is not subject to any kind of clinical hold. Sponsors and manufacturers must notify the Food and Drug Administration when an unapproved drug is made available to the patient.
The bill also includes safeguards to prevent manufacturers from purposefully misbranding or mislabeling drugs.
H.R. 5247 provides liability protections to manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in providing experimental drugs to terminal patients through this new alternative pathway, although it does not shield them from liability stemming from reckless misconduct, gross negligence, or any other intentional violations. It requires sponsors and manufacturers to report all adverse events to the FDA.
It also provides certainty to manufacturers as to how the FDA will use patient outcomes from the use of treatments outside of clinical trials when it is evaluating the applications on these new drugs.
Rep. Michael Burgess (R-Tex.), the House Energy & Commerce Health Subcommittee chairman and a physician, spoke in support of the bill during a debate on the House floor.
“Mr. Speaker, as a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious, life-threatening conditions,” he said. “To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?”
Rep. Frank Pallone (D-N.J.), the top-ranking Democrat on the House Energy & Commerce Committee, responded by asking, “if this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it?”
In a March 19 letter to congressional leaders, a coalition of more than 100 physician and patient advocacy groups called the alternative pathway laid out in legislation “less safe” for patients than the FDA’s current expanded access process.
“This alternative pathway would allow for a 7-day lag between access to investigational therapies (as well as potential ensuing adverse effects) and FDA notification. FDA also is prohibited from halting access to these experimental therapies short of placing a clinical hold on all clinical research on the therapy in question, which is a blunt and disproportionate measure. The legislation would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program,” the groups wrote.
The groups that signed the letter included the American Society of Clinical Oncology, the Cystic Fibrosis Foundation, Friends of Cancer Research, the Leukemia & Lymphoma Society, the National Comprehensive Cancer Network, the National Organization for Rare Disorders, the Platelet Disorder Support Association, and Vietnam Veterans of America.
“The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials,” Rep. Burgess said. “But ‘right to try’ would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.”
But Rep. Pallone noted that a review by the Government Accountability Office found that the FDA approves 99% of the requests submitted to the agency. Of the nearly 1,700 requests the FDA received in 2017, just 9 were not approved. However, the agency also adjusted applications for 11% of the patients in order to improve patient safety protections and that type of review should be allowed to continue, he said.
Patient groups expressed disappointment following the House vote. “The House has voted for a proposal that would create a less-safe, redundant pathway for accessing investigational therapies outside of clinical trials,” the National Organization for Rare Disorders said in a statement. “We hope the Senate will recognize that patients deserve legislation that will genuinely increase access. For example, senators should focus on legislation that reduces the financial disincentives companies encounter in offering their therapy through expanded access.”
The Senate passed a version of “right to try” in 2017 through the unanimous consent process (S. 204). No schedule has been set yet to either combine the two bills in committee or for the Senate to take up the House bill. President Trump voiced support for “right to try” legislation during his 2018 State of the Union address.
Terminal patients who have exhausted all approved drug options would be able to seek out investigational treatments – even if they do not qualify for clinical trials – under a bill passed in the U.S. House, despite opposition from more than 100 patient and physician groups.
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina
For an unapproved drug to be made available to patients, it must have an active application that is not subject to any kind of clinical hold. Sponsors and manufacturers must notify the Food and Drug Administration when an unapproved drug is made available to the patient.
The bill also includes safeguards to prevent manufacturers from purposefully misbranding or mislabeling drugs.
H.R. 5247 provides liability protections to manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in providing experimental drugs to terminal patients through this new alternative pathway, although it does not shield them from liability stemming from reckless misconduct, gross negligence, or any other intentional violations. It requires sponsors and manufacturers to report all adverse events to the FDA.
It also provides certainty to manufacturers as to how the FDA will use patient outcomes from the use of treatments outside of clinical trials when it is evaluating the applications on these new drugs.
Rep. Michael Burgess (R-Tex.), the House Energy & Commerce Health Subcommittee chairman and a physician, spoke in support of the bill during a debate on the House floor.
“Mr. Speaker, as a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious, life-threatening conditions,” he said. “To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?”
Rep. Frank Pallone (D-N.J.), the top-ranking Democrat on the House Energy & Commerce Committee, responded by asking, “if this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it?”
In a March 19 letter to congressional leaders, a coalition of more than 100 physician and patient advocacy groups called the alternative pathway laid out in legislation “less safe” for patients than the FDA’s current expanded access process.
“This alternative pathway would allow for a 7-day lag between access to investigational therapies (as well as potential ensuing adverse effects) and FDA notification. FDA also is prohibited from halting access to these experimental therapies short of placing a clinical hold on all clinical research on the therapy in question, which is a blunt and disproportionate measure. The legislation would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program,” the groups wrote.
The groups that signed the letter included the American Society of Clinical Oncology, the Cystic Fibrosis Foundation, Friends of Cancer Research, the Leukemia & Lymphoma Society, the National Comprehensive Cancer Network, the National Organization for Rare Disorders, the Platelet Disorder Support Association, and Vietnam Veterans of America.
“The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials,” Rep. Burgess said. “But ‘right to try’ would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.”
But Rep. Pallone noted that a review by the Government Accountability Office found that the FDA approves 99% of the requests submitted to the agency. Of the nearly 1,700 requests the FDA received in 2017, just 9 were not approved. However, the agency also adjusted applications for 11% of the patients in order to improve patient safety protections and that type of review should be allowed to continue, he said.
Patient groups expressed disappointment following the House vote. “The House has voted for a proposal that would create a less-safe, redundant pathway for accessing investigational therapies outside of clinical trials,” the National Organization for Rare Disorders said in a statement. “We hope the Senate will recognize that patients deserve legislation that will genuinely increase access. For example, senators should focus on legislation that reduces the financial disincentives companies encounter in offering their therapy through expanded access.”
The Senate passed a version of “right to try” in 2017 through the unanimous consent process (S. 204). No schedule has been set yet to either combine the two bills in committee or for the Senate to take up the House bill. President Trump voiced support for “right to try” legislation during his 2018 State of the Union address.
Terminal patients who have exhausted all approved drug options would be able to seek out investigational treatments – even if they do not qualify for clinical trials – under a bill passed in the U.S. House, despite opposition from more than 100 patient and physician groups.
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina
For an unapproved drug to be made available to patients, it must have an active application that is not subject to any kind of clinical hold. Sponsors and manufacturers must notify the Food and Drug Administration when an unapproved drug is made available to the patient.
The bill also includes safeguards to prevent manufacturers from purposefully misbranding or mislabeling drugs.
H.R. 5247 provides liability protections to manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in providing experimental drugs to terminal patients through this new alternative pathway, although it does not shield them from liability stemming from reckless misconduct, gross negligence, or any other intentional violations. It requires sponsors and manufacturers to report all adverse events to the FDA.
It also provides certainty to manufacturers as to how the FDA will use patient outcomes from the use of treatments outside of clinical trials when it is evaluating the applications on these new drugs.
Rep. Michael Burgess (R-Tex.), the House Energy & Commerce Health Subcommittee chairman and a physician, spoke in support of the bill during a debate on the House floor.
“Mr. Speaker, as a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious, life-threatening conditions,” he said. “To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?”
Rep. Frank Pallone (D-N.J.), the top-ranking Democrat on the House Energy & Commerce Committee, responded by asking, “if this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it?”
In a March 19 letter to congressional leaders, a coalition of more than 100 physician and patient advocacy groups called the alternative pathway laid out in legislation “less safe” for patients than the FDA’s current expanded access process.
“This alternative pathway would allow for a 7-day lag between access to investigational therapies (as well as potential ensuing adverse effects) and FDA notification. FDA also is prohibited from halting access to these experimental therapies short of placing a clinical hold on all clinical research on the therapy in question, which is a blunt and disproportionate measure. The legislation would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program,” the groups wrote.
The groups that signed the letter included the American Society of Clinical Oncology, the Cystic Fibrosis Foundation, Friends of Cancer Research, the Leukemia & Lymphoma Society, the National Comprehensive Cancer Network, the National Organization for Rare Disorders, the Platelet Disorder Support Association, and Vietnam Veterans of America.
“The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials,” Rep. Burgess said. “But ‘right to try’ would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.”
But Rep. Pallone noted that a review by the Government Accountability Office found that the FDA approves 99% of the requests submitted to the agency. Of the nearly 1,700 requests the FDA received in 2017, just 9 were not approved. However, the agency also adjusted applications for 11% of the patients in order to improve patient safety protections and that type of review should be allowed to continue, he said.
Patient groups expressed disappointment following the House vote. “The House has voted for a proposal that would create a less-safe, redundant pathway for accessing investigational therapies outside of clinical trials,” the National Organization for Rare Disorders said in a statement. “We hope the Senate will recognize that patients deserve legislation that will genuinely increase access. For example, senators should focus on legislation that reduces the financial disincentives companies encounter in offering their therapy through expanded access.”
The Senate passed a version of “right to try” in 2017 through the unanimous consent process (S. 204). No schedule has been set yet to either combine the two bills in committee or for the Senate to take up the House bill. President Trump voiced support for “right to try” legislation during his 2018 State of the Union address.
FDA wants data on role of flavored tobacco products in youth initiation
The Food and Drug Administration is seeking data on the role that flavors, including menthol, in tobacco products play in the initiation, use, and cessation of tobacco products, with an emphasis on how flavoring impacts young people.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, MD, said in statement. It is important “that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain noncombustible forms of tobacco products.”
“Youth consistently report product flavoring as a leading reason for using tobacco products,” Dr. Gottlieb noted. “In fact, there is evidence indicating that youth tobacco users who reported their first tobacco was flavored had a higher prevalence of current tobacco product use, compared to youth whose product was not flavored.”
The advance notice calls for information across a number of areas, including the role of flavors other than tobacco in tobacco products; flavors and initiation and patterns of tobacco product use, particularly among youths and young adults; and flavors and cessation, dual-use, and relapse among current and former tobacco product users.
It also is seeking comment on whether standards should be set on tobacco flavoring, including whether there should a prohibition or restriction on flavors and to which types of products these standards should apply. The notice specifically asks about menthol and its role in cigarette initiation and whether limitations on menthol could lead to use of other tobacco products.
“Because almost 90% of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use,” Commissioner Gottlieb said.
The American Heart Association called the action “long overdue.”
“We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard,” CEO Nancy Brown said in a statement. “There is already clear evidence that flavored tobacco products, including menthol, harm the public health. To make it worse, fruit- and candy-flavored e-cigarettes, cigars, and other tobacco products are highly attractive to kids and make it more likely that they will take up this addiction.”
The action comes less than a week after FDA published an advance notice seeking information comments on reducing nicotine levels in cigarettes to help combat nicotine addiction.
The advance notice will be published March 21 in the Federal Register; comments will be accepted at www.regulations.gov for 90 days.
The Food and Drug Administration is seeking data on the role that flavors, including menthol, in tobacco products play in the initiation, use, and cessation of tobacco products, with an emphasis on how flavoring impacts young people.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, MD, said in statement. It is important “that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain noncombustible forms of tobacco products.”
“Youth consistently report product flavoring as a leading reason for using tobacco products,” Dr. Gottlieb noted. “In fact, there is evidence indicating that youth tobacco users who reported their first tobacco was flavored had a higher prevalence of current tobacco product use, compared to youth whose product was not flavored.”
The advance notice calls for information across a number of areas, including the role of flavors other than tobacco in tobacco products; flavors and initiation and patterns of tobacco product use, particularly among youths and young adults; and flavors and cessation, dual-use, and relapse among current and former tobacco product users.
It also is seeking comment on whether standards should be set on tobacco flavoring, including whether there should a prohibition or restriction on flavors and to which types of products these standards should apply. The notice specifically asks about menthol and its role in cigarette initiation and whether limitations on menthol could lead to use of other tobacco products.
“Because almost 90% of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use,” Commissioner Gottlieb said.
The American Heart Association called the action “long overdue.”
“We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard,” CEO Nancy Brown said in a statement. “There is already clear evidence that flavored tobacco products, including menthol, harm the public health. To make it worse, fruit- and candy-flavored e-cigarettes, cigars, and other tobacco products are highly attractive to kids and make it more likely that they will take up this addiction.”
The action comes less than a week after FDA published an advance notice seeking information comments on reducing nicotine levels in cigarettes to help combat nicotine addiction.
The advance notice will be published March 21 in the Federal Register; comments will be accepted at www.regulations.gov for 90 days.
The Food and Drug Administration is seeking data on the role that flavors, including menthol, in tobacco products play in the initiation, use, and cessation of tobacco products, with an emphasis on how flavoring impacts young people.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, MD, said in statement. It is important “that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain noncombustible forms of tobacco products.”
“Youth consistently report product flavoring as a leading reason for using tobacco products,” Dr. Gottlieb noted. “In fact, there is evidence indicating that youth tobacco users who reported their first tobacco was flavored had a higher prevalence of current tobacco product use, compared to youth whose product was not flavored.”
The advance notice calls for information across a number of areas, including the role of flavors other than tobacco in tobacco products; flavors and initiation and patterns of tobacco product use, particularly among youths and young adults; and flavors and cessation, dual-use, and relapse among current and former tobacco product users.
It also is seeking comment on whether standards should be set on tobacco flavoring, including whether there should a prohibition or restriction on flavors and to which types of products these standards should apply. The notice specifically asks about menthol and its role in cigarette initiation and whether limitations on menthol could lead to use of other tobacco products.
“Because almost 90% of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use,” Commissioner Gottlieb said.
The American Heart Association called the action “long overdue.”
“We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard,” CEO Nancy Brown said in a statement. “There is already clear evidence that flavored tobacco products, including menthol, harm the public health. To make it worse, fruit- and candy-flavored e-cigarettes, cigars, and other tobacco products are highly attractive to kids and make it more likely that they will take up this addiction.”
The action comes less than a week after FDA published an advance notice seeking information comments on reducing nicotine levels in cigarettes to help combat nicotine addiction.
The advance notice will be published March 21 in the Federal Register; comments will be accepted at www.regulations.gov for 90 days.
MedPAC to Congress: Eliminate MIPS
The Medicare Payment Advisory Commission has formally recommended to Congress that it repeal the Merit-based Incentive Payment System track of Medicare’s Quality Payment Program.
MedPAC “has concluded that ... the Merit-based Incentive Payment System (MIPS) will not fulfill its goals and therefore should be eliminated,” the commission said in its March 15 report to Congress. MedPAC added that the “basic design of MIPS is fundamentally incompatible with the goals of a beneficiary-focused approach to quality measurement.”
MedPAC adds that, by the Centers for Medicare & Medicaid Services’ own estimates, more than half of clinicians will be exempt from reporting on MIPS, based on the low-volume threshold that exempts providers who bill for $90,000 or less in Medicare claims or see 200 or fewer Medicare patients.
The advisory panel also highlighted other flaws. Those include MIPS’ onerous reporting burden; measures that do not allow for meaningful comparisons among clinicians; differing rules for clinicians depending on location, practice size, and other factors; and payment adjustments that could vary wildly from year to year, creating financial uncertainty for physicians.
The commission, which voted 14-2 in favor of eliminating MIPS, also recommended it be replaced with a “voluntary value program.” But it has offered Congress only a conceptual direction for that replacement program.
“This voluntary value program (VVP) is based on the premise that patient outcomes rely on the combined contributions of clinicians and emphasizes that quality improvement is a collective effort,” according to the report.
The VVP would measure all clinicians based on the same set of measures: clinical quality, patient experience, and value. And it would do so on a population level, rather than the individual patient level.
MedPAC sees the VVP not as an end goal in the transition to paying for value, but rather a stepping stone to get clinicians more comfortable with value-based payments en route to moving into the QPP’s advanced alternative payment model (A-APM) track.
“A VVP’s penalties and rewards might not be significant enough to meaningfully change clinician behavior,” the report stated. “However, the intent is to get clinicians comfortable with being measured in a manner similar to the way they would be in A-APMs. With that experience, clinicians would be poised to form or join robust A-APMs, under which the risk and reward are more meaningful, and the potential for true delivery system reform is within reach.”
There was a near unanimous consensus among MedPAC commissioners that MIPS is flawed, but not all commissioners were ready to give up on it – especially considering how much clinicians have already invested in the program.
MedPAC also heard from the American Medical Association, which voiced opposition to the idea of ending MIPS. In addition, the commission received written feedback from physicians against its proposal.
Other experts support preserving MIPS. Gail R. Wilensky, PhD, economist and senior fellow at Project Hope and a former top health aide to President George H.W. Bush, wrote in the New England Journal of Medicine that MIPS should be fixed rather than scrapped.
The Medicare Payment Advisory Commission has formally recommended to Congress that it repeal the Merit-based Incentive Payment System track of Medicare’s Quality Payment Program.
MedPAC “has concluded that ... the Merit-based Incentive Payment System (MIPS) will not fulfill its goals and therefore should be eliminated,” the commission said in its March 15 report to Congress. MedPAC added that the “basic design of MIPS is fundamentally incompatible with the goals of a beneficiary-focused approach to quality measurement.”
MedPAC adds that, by the Centers for Medicare & Medicaid Services’ own estimates, more than half of clinicians will be exempt from reporting on MIPS, based on the low-volume threshold that exempts providers who bill for $90,000 or less in Medicare claims or see 200 or fewer Medicare patients.
The advisory panel also highlighted other flaws. Those include MIPS’ onerous reporting burden; measures that do not allow for meaningful comparisons among clinicians; differing rules for clinicians depending on location, practice size, and other factors; and payment adjustments that could vary wildly from year to year, creating financial uncertainty for physicians.
The commission, which voted 14-2 in favor of eliminating MIPS, also recommended it be replaced with a “voluntary value program.” But it has offered Congress only a conceptual direction for that replacement program.
“This voluntary value program (VVP) is based on the premise that patient outcomes rely on the combined contributions of clinicians and emphasizes that quality improvement is a collective effort,” according to the report.
The VVP would measure all clinicians based on the same set of measures: clinical quality, patient experience, and value. And it would do so on a population level, rather than the individual patient level.
MedPAC sees the VVP not as an end goal in the transition to paying for value, but rather a stepping stone to get clinicians more comfortable with value-based payments en route to moving into the QPP’s advanced alternative payment model (A-APM) track.
“A VVP’s penalties and rewards might not be significant enough to meaningfully change clinician behavior,” the report stated. “However, the intent is to get clinicians comfortable with being measured in a manner similar to the way they would be in A-APMs. With that experience, clinicians would be poised to form or join robust A-APMs, under which the risk and reward are more meaningful, and the potential for true delivery system reform is within reach.”
There was a near unanimous consensus among MedPAC commissioners that MIPS is flawed, but not all commissioners were ready to give up on it – especially considering how much clinicians have already invested in the program.
MedPAC also heard from the American Medical Association, which voiced opposition to the idea of ending MIPS. In addition, the commission received written feedback from physicians against its proposal.
Other experts support preserving MIPS. Gail R. Wilensky, PhD, economist and senior fellow at Project Hope and a former top health aide to President George H.W. Bush, wrote in the New England Journal of Medicine that MIPS should be fixed rather than scrapped.
The Medicare Payment Advisory Commission has formally recommended to Congress that it repeal the Merit-based Incentive Payment System track of Medicare’s Quality Payment Program.
MedPAC “has concluded that ... the Merit-based Incentive Payment System (MIPS) will not fulfill its goals and therefore should be eliminated,” the commission said in its March 15 report to Congress. MedPAC added that the “basic design of MIPS is fundamentally incompatible with the goals of a beneficiary-focused approach to quality measurement.”
MedPAC adds that, by the Centers for Medicare & Medicaid Services’ own estimates, more than half of clinicians will be exempt from reporting on MIPS, based on the low-volume threshold that exempts providers who bill for $90,000 or less in Medicare claims or see 200 or fewer Medicare patients.
The advisory panel also highlighted other flaws. Those include MIPS’ onerous reporting burden; measures that do not allow for meaningful comparisons among clinicians; differing rules for clinicians depending on location, practice size, and other factors; and payment adjustments that could vary wildly from year to year, creating financial uncertainty for physicians.
The commission, which voted 14-2 in favor of eliminating MIPS, also recommended it be replaced with a “voluntary value program.” But it has offered Congress only a conceptual direction for that replacement program.
“This voluntary value program (VVP) is based on the premise that patient outcomes rely on the combined contributions of clinicians and emphasizes that quality improvement is a collective effort,” according to the report.
The VVP would measure all clinicians based on the same set of measures: clinical quality, patient experience, and value. And it would do so on a population level, rather than the individual patient level.
MedPAC sees the VVP not as an end goal in the transition to paying for value, but rather a stepping stone to get clinicians more comfortable with value-based payments en route to moving into the QPP’s advanced alternative payment model (A-APM) track.
“A VVP’s penalties and rewards might not be significant enough to meaningfully change clinician behavior,” the report stated. “However, the intent is to get clinicians comfortable with being measured in a manner similar to the way they would be in A-APMs. With that experience, clinicians would be poised to form or join robust A-APMs, under which the risk and reward are more meaningful, and the potential for true delivery system reform is within reach.”
There was a near unanimous consensus among MedPAC commissioners that MIPS is flawed, but not all commissioners were ready to give up on it – especially considering how much clinicians have already invested in the program.
MedPAC also heard from the American Medical Association, which voiced opposition to the idea of ending MIPS. In addition, the commission received written feedback from physicians against its proposal.
Other experts support preserving MIPS. Gail R. Wilensky, PhD, economist and senior fellow at Project Hope and a former top health aide to President George H.W. Bush, wrote in the New England Journal of Medicine that MIPS should be fixed rather than scrapped.