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Michigan becomes first state to ban flavored e-cigarettes
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
Videos help chemo patients better understand their treatments
Showing cancer patients receiving chemotherapy short videos about their treatments has the potential to improve their understanding about the treatments they are receiving, new research in Cancer has shown.
Researchers showed 50 patients at an underserved hospital six 1-minute videos focused on important terms related to their chemotherapy treatments and found that the videos helped them better understand what those key terms mean. Before viewing the videos, 15 of 20 terms were misunderstood by more than one third of patients, with 98% unable to define “maintenance,” 74% unable to define “cancer,” and 58% unable to define “chemotherapy.” Six pilot educational videos describing a narrowed down list of six terms were created, and patient understanding of all six terms improved by at least 20% after watching the videos. The six terms defined in the videos were “palliative chemotherapy,” “curative,” “cancer,” “blood count,” “risk of infection,” and “chemotherapy.”
“Although a current concern is that precision medicines will not be understood due to genetic illiteracy and misunderstandings about the immune system, it is important to remember that the terminology used to describe chemotherapy, the backbone of many cancer treatments, may also be incomprehensible to some patients,” Rebecca Pentz, PhD, of Emory University, Atlanta, and colleagues wrote.
“Our video pilot suggests that multimedia can help patients understand chemotherapy terminology,” Dr. Pentz and colleagues said. “For each term, there was at least a 20% increase in patient understanding after watching the video. None of the patients could define palliative chemotherapy before watching the video, but 72% were able to provide a definition afterward.”
Researchers noted that the term most understood after the video was curative treatment (patients being able to define the phrase grew from 34% to 88%).
“Our study establishes that basic chemotherapy terminology is widely misunderstood by an underserved population, but that video-based education can significantly increase patient understanding,” the investigators concluded, but noted the research was limited by the small number of videos as well as the single underserved hospital, which may limit the generalizablility of the study.
Dr. Pentz and colleagues added that “education of physicians about the severe patient lack of understanding of basic cancer terminology and methods to improve understanding would be most helpful.”
SOURCE: Pentz R et al. Cancer. 2019 Aug 16. doi: 10.1002/cncr.32421.
Research conducted by Pentz et al. on how much the core vocabulary is misunderstood is deeply troubling, suggesting that we as oncologists are not meeting the informational needs of patients who are consenting to undergo chemotherapy.
With patients showing better understanding after the videos on the terminology, it revives the notion that informed consent is a process that may require multiple interactions to ensure that patients truly understand what they are getting into with chemotherapy treatment, counter to the current treatment environment where there is a rush to get consent, treat the patient, and move onto the next one.
Whether the results of the study improve informed consent policy is something that remains to be seen.
Kerry Kilbridge, MD , of the Dana-Farber Cancer Institute in Boston made these comments in an Aug. 16 accompanying editorial published in Cancer (doi: 10.1002/cncr.32418).
Research conducted by Pentz et al. on how much the core vocabulary is misunderstood is deeply troubling, suggesting that we as oncologists are not meeting the informational needs of patients who are consenting to undergo chemotherapy.
With patients showing better understanding after the videos on the terminology, it revives the notion that informed consent is a process that may require multiple interactions to ensure that patients truly understand what they are getting into with chemotherapy treatment, counter to the current treatment environment where there is a rush to get consent, treat the patient, and move onto the next one.
Whether the results of the study improve informed consent policy is something that remains to be seen.
Kerry Kilbridge, MD , of the Dana-Farber Cancer Institute in Boston made these comments in an Aug. 16 accompanying editorial published in Cancer (doi: 10.1002/cncr.32418).
Research conducted by Pentz et al. on how much the core vocabulary is misunderstood is deeply troubling, suggesting that we as oncologists are not meeting the informational needs of patients who are consenting to undergo chemotherapy.
With patients showing better understanding after the videos on the terminology, it revives the notion that informed consent is a process that may require multiple interactions to ensure that patients truly understand what they are getting into with chemotherapy treatment, counter to the current treatment environment where there is a rush to get consent, treat the patient, and move onto the next one.
Whether the results of the study improve informed consent policy is something that remains to be seen.
Kerry Kilbridge, MD , of the Dana-Farber Cancer Institute in Boston made these comments in an Aug. 16 accompanying editorial published in Cancer (doi: 10.1002/cncr.32418).
Showing cancer patients receiving chemotherapy short videos about their treatments has the potential to improve their understanding about the treatments they are receiving, new research in Cancer has shown.
Researchers showed 50 patients at an underserved hospital six 1-minute videos focused on important terms related to their chemotherapy treatments and found that the videos helped them better understand what those key terms mean. Before viewing the videos, 15 of 20 terms were misunderstood by more than one third of patients, with 98% unable to define “maintenance,” 74% unable to define “cancer,” and 58% unable to define “chemotherapy.” Six pilot educational videos describing a narrowed down list of six terms were created, and patient understanding of all six terms improved by at least 20% after watching the videos. The six terms defined in the videos were “palliative chemotherapy,” “curative,” “cancer,” “blood count,” “risk of infection,” and “chemotherapy.”
“Although a current concern is that precision medicines will not be understood due to genetic illiteracy and misunderstandings about the immune system, it is important to remember that the terminology used to describe chemotherapy, the backbone of many cancer treatments, may also be incomprehensible to some patients,” Rebecca Pentz, PhD, of Emory University, Atlanta, and colleagues wrote.
“Our video pilot suggests that multimedia can help patients understand chemotherapy terminology,” Dr. Pentz and colleagues said. “For each term, there was at least a 20% increase in patient understanding after watching the video. None of the patients could define palliative chemotherapy before watching the video, but 72% were able to provide a definition afterward.”
Researchers noted that the term most understood after the video was curative treatment (patients being able to define the phrase grew from 34% to 88%).
“Our study establishes that basic chemotherapy terminology is widely misunderstood by an underserved population, but that video-based education can significantly increase patient understanding,” the investigators concluded, but noted the research was limited by the small number of videos as well as the single underserved hospital, which may limit the generalizablility of the study.
Dr. Pentz and colleagues added that “education of physicians about the severe patient lack of understanding of basic cancer terminology and methods to improve understanding would be most helpful.”
SOURCE: Pentz R et al. Cancer. 2019 Aug 16. doi: 10.1002/cncr.32421.
Showing cancer patients receiving chemotherapy short videos about their treatments has the potential to improve their understanding about the treatments they are receiving, new research in Cancer has shown.
Researchers showed 50 patients at an underserved hospital six 1-minute videos focused on important terms related to their chemotherapy treatments and found that the videos helped them better understand what those key terms mean. Before viewing the videos, 15 of 20 terms were misunderstood by more than one third of patients, with 98% unable to define “maintenance,” 74% unable to define “cancer,” and 58% unable to define “chemotherapy.” Six pilot educational videos describing a narrowed down list of six terms were created, and patient understanding of all six terms improved by at least 20% after watching the videos. The six terms defined in the videos were “palliative chemotherapy,” “curative,” “cancer,” “blood count,” “risk of infection,” and “chemotherapy.”
“Although a current concern is that precision medicines will not be understood due to genetic illiteracy and misunderstandings about the immune system, it is important to remember that the terminology used to describe chemotherapy, the backbone of many cancer treatments, may also be incomprehensible to some patients,” Rebecca Pentz, PhD, of Emory University, Atlanta, and colleagues wrote.
“Our video pilot suggests that multimedia can help patients understand chemotherapy terminology,” Dr. Pentz and colleagues said. “For each term, there was at least a 20% increase in patient understanding after watching the video. None of the patients could define palliative chemotherapy before watching the video, but 72% were able to provide a definition afterward.”
Researchers noted that the term most understood after the video was curative treatment (patients being able to define the phrase grew from 34% to 88%).
“Our study establishes that basic chemotherapy terminology is widely misunderstood by an underserved population, but that video-based education can significantly increase patient understanding,” the investigators concluded, but noted the research was limited by the small number of videos as well as the single underserved hospital, which may limit the generalizablility of the study.
Dr. Pentz and colleagues added that “education of physicians about the severe patient lack of understanding of basic cancer terminology and methods to improve understanding would be most helpful.”
SOURCE: Pentz R et al. Cancer. 2019 Aug 16. doi: 10.1002/cncr.32421.
FROM CANCER
Key clinical point: Short videos on chemotherapy terms improved patient understanding of concepts.
Major finding: Patient understanding of the six terms chosen as part of the study improved by at least 20%.
Study details: 50 patients were asked to define six terms related to cancer treatment before and after seeing a 1-minute video on each term.
Disclosures: The research was sponsored by the Winship Cancer Institute and the National Cancer Institute. Research authors reported no conflicts of interest.
Source: Pentz R et al. Cancer. 2019 Aug 16. doi: 10.1002/cncr.32421.
Medicare’s CAR T-cell coverage decision draws praise, but cost issues linger
Physicians are praising the decision by officials at the Centers for Medicare & Medicaid Services to provide coverage of chimeric antigen receptor T-cell therapy, though they say the planned payment structure will still leave hospitals in the red when treatment is administered.
On Aug. 7, 2019, the agency issued a national coverage determination that outlines Medicare coverage of chimeric antigen receptor (CAR) T-cell therapies when they are provided in health care facilities enrolled in the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies program. Medicare will cover treatments for both FDA-approved indications and off-label uses that are recommended in CMS-approved compendia.
“What you’ve seen in both the [Medicare Inpatient Prospective Payment System] rule, as well as this coverage determination, is recognition by CMS that, with CAR T cells, we are dealing with something different and something extraordinary,” Joseph Alvarnas, MD, vice president of government affairs at City of Hope, Duarte, Calif., said in an interview. “For a lot of patients who suffer with non-Hodgkin’s lymphoma, the consequences of being refractory to standard therapies mean that many patients have few great prospects for moving forward with curative treatments. CAR T cells represent a really innovative set of treatments for patients.”
A proposed national coverage determination, issued in February 2019, would have put in place a coverage with evidence development (CED) requirement for CAR T-cell therapy, covering treatment nationwide if it was offered through CMS-approved registries or clinical studies in which patients were monitored for 2 or more years following treatment.
Physicians applauded the decision not to restrict access by imposing the CED requirement.
“I think what CMS has put out is a good thing,” said Navneet Majhail, MD, director of the Cleveland Clinic’s blood and marrow transplant program, and president of the American Society for Transplantation and Cellular Therapy.
“Both at the Cleveland Clinic level and the society level, we have been asking CMS for something similar and we are really glad and excited that CMS did do this. The concern was that CMS might do this in the context of some other regulatory requirements like CED that they sometimes do. I am glad that CMS decided not to put that mechanism into place for the CAR T-cell therapies,” Dr. Majhail said.
Dr. Alvarnas, who also serves as chair of the American Society of Hematology Committee on Practice, agreed. “I see good. I don’t see bad. I have read through this and it strikes me as being written with fairly great clarity.”
Dr. Alvarnas added that he had been worried about potential restrictions, such as CED. “Once you put something under that whole rubric of coverage with evidence development, then what you do is you create a bottleneck around access to therapy because you have to have an accruing clinical trial for patients to, in fact, be able to participate in that form of therapy.”
By not imposing a CED requirement, it opens the door to better understanding the role CAR T cells play in treatment, Dr. Alvarnas noted.
“Over time, the number of patients for whom these therapeutics work, based upon real medical evidence, will escalate and grow at a pace that can far exceed the restrictions placed under a CED model,” he said, adding that the national coverage determination “gives us the license to deliver therapeutics to the right patients based upon medical evidence as it evolves, provided that these things get listed as part of the compendia. I think that is a fantastic recognition that new roles for drugs, agents, therapeutics ... are going to evolve at a pace far faster than what CMS can write rules about.”
While Medicare’s coverage determination garnered positive reviews, the agency’s Inpatient Prospective Payment System final rule – which outlines reimbursement for CAR T-cell therapy and other new technologies – got a more tepid response.
In the final rule, CMS raised the payment it makes to hospitals for administering CAR T-cell therapies through its new technology add-on payment. Payments will rise from 50% of the technology to 65%, an increase from $186,500 to $242,450 for CAR T-cell therapies, beginning on Oct. 1, 2019.
But even the bump up to 65% may not be enough.
“I see the move to 65% as a new technology add-on payment as an incremental step in the correct direction, but what we’ve done to some extent is that we’ve delayed getting to some sort of more wholly conceived system,” Dr. Alvarnas said, noting that a new system will be needed as the new technology add-on payment goes away in 2021.
Abhinav Deol, MD, of the Karmanos Cancer Institute in Detroit said it’s a challenge to cover costs for the treatment. “If you just look at the simple math, it is still going to be an economic challenge. The cells that are approved for lymphoma patients that will probably fall into the Medicare category, the list price of those cells is $373,000. Even with the 65% coverage, it’s about $235,000-$240,000 in reimbursement,” he said. “For a facility to be able to provide the care for patients, you have that delta that is still not covered. It is still going to be an economic challenge for many of the facilities to provide this care.”
Thomas LeBlanc, MD, an associate professor of medicine at Duke University, Durham, N.C., said that, while the coverage determination is a positive step, it’s not clear that it will provide meaningful access to CAR T-cell therapy because of the cost.
“These products are incredibly expensive, and the total cost of providing them is woefully underestimated in only focusing on the sticker price of the product,” he said. “Doing so ignores the significant hospital care, sometimes even critical care, as well as specialized knowledge and high touch supportive care, all of which is required to safely get patients through this revolutionary yet often risky treatment. So when CMS offers to pay just 65% of the sticker price, I suspect that many institutions will still lose six figures for each patient treated.”
Dr. LeBlanc predicted that many centers will decline to provide CAR T-cell therapy despite the increase in the new technology add-on payment, though he added that “I’d love to be wrong about this.”
Dr. Majhail agreed, noting that, even with the bump in the add-on payment, hospitals “won’t be whole in terms of providing care for these patients.”
“The reimbursement piece continues to be a challenge,” he said. “It is better than what it was, but there is still more work to be done. That is something we will have to keep working with the agency on.”
Physicians are praising the decision by officials at the Centers for Medicare & Medicaid Services to provide coverage of chimeric antigen receptor T-cell therapy, though they say the planned payment structure will still leave hospitals in the red when treatment is administered.
On Aug. 7, 2019, the agency issued a national coverage determination that outlines Medicare coverage of chimeric antigen receptor (CAR) T-cell therapies when they are provided in health care facilities enrolled in the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies program. Medicare will cover treatments for both FDA-approved indications and off-label uses that are recommended in CMS-approved compendia.
“What you’ve seen in both the [Medicare Inpatient Prospective Payment System] rule, as well as this coverage determination, is recognition by CMS that, with CAR T cells, we are dealing with something different and something extraordinary,” Joseph Alvarnas, MD, vice president of government affairs at City of Hope, Duarte, Calif., said in an interview. “For a lot of patients who suffer with non-Hodgkin’s lymphoma, the consequences of being refractory to standard therapies mean that many patients have few great prospects for moving forward with curative treatments. CAR T cells represent a really innovative set of treatments for patients.”
A proposed national coverage determination, issued in February 2019, would have put in place a coverage with evidence development (CED) requirement for CAR T-cell therapy, covering treatment nationwide if it was offered through CMS-approved registries or clinical studies in which patients were monitored for 2 or more years following treatment.
Physicians applauded the decision not to restrict access by imposing the CED requirement.
“I think what CMS has put out is a good thing,” said Navneet Majhail, MD, director of the Cleveland Clinic’s blood and marrow transplant program, and president of the American Society for Transplantation and Cellular Therapy.
“Both at the Cleveland Clinic level and the society level, we have been asking CMS for something similar and we are really glad and excited that CMS did do this. The concern was that CMS might do this in the context of some other regulatory requirements like CED that they sometimes do. I am glad that CMS decided not to put that mechanism into place for the CAR T-cell therapies,” Dr. Majhail said.
Dr. Alvarnas, who also serves as chair of the American Society of Hematology Committee on Practice, agreed. “I see good. I don’t see bad. I have read through this and it strikes me as being written with fairly great clarity.”
Dr. Alvarnas added that he had been worried about potential restrictions, such as CED. “Once you put something under that whole rubric of coverage with evidence development, then what you do is you create a bottleneck around access to therapy because you have to have an accruing clinical trial for patients to, in fact, be able to participate in that form of therapy.”
By not imposing a CED requirement, it opens the door to better understanding the role CAR T cells play in treatment, Dr. Alvarnas noted.
“Over time, the number of patients for whom these therapeutics work, based upon real medical evidence, will escalate and grow at a pace that can far exceed the restrictions placed under a CED model,” he said, adding that the national coverage determination “gives us the license to deliver therapeutics to the right patients based upon medical evidence as it evolves, provided that these things get listed as part of the compendia. I think that is a fantastic recognition that new roles for drugs, agents, therapeutics ... are going to evolve at a pace far faster than what CMS can write rules about.”
While Medicare’s coverage determination garnered positive reviews, the agency’s Inpatient Prospective Payment System final rule – which outlines reimbursement for CAR T-cell therapy and other new technologies – got a more tepid response.
In the final rule, CMS raised the payment it makes to hospitals for administering CAR T-cell therapies through its new technology add-on payment. Payments will rise from 50% of the technology to 65%, an increase from $186,500 to $242,450 for CAR T-cell therapies, beginning on Oct. 1, 2019.
But even the bump up to 65% may not be enough.
“I see the move to 65% as a new technology add-on payment as an incremental step in the correct direction, but what we’ve done to some extent is that we’ve delayed getting to some sort of more wholly conceived system,” Dr. Alvarnas said, noting that a new system will be needed as the new technology add-on payment goes away in 2021.
Abhinav Deol, MD, of the Karmanos Cancer Institute in Detroit said it’s a challenge to cover costs for the treatment. “If you just look at the simple math, it is still going to be an economic challenge. The cells that are approved for lymphoma patients that will probably fall into the Medicare category, the list price of those cells is $373,000. Even with the 65% coverage, it’s about $235,000-$240,000 in reimbursement,” he said. “For a facility to be able to provide the care for patients, you have that delta that is still not covered. It is still going to be an economic challenge for many of the facilities to provide this care.”
Thomas LeBlanc, MD, an associate professor of medicine at Duke University, Durham, N.C., said that, while the coverage determination is a positive step, it’s not clear that it will provide meaningful access to CAR T-cell therapy because of the cost.
“These products are incredibly expensive, and the total cost of providing them is woefully underestimated in only focusing on the sticker price of the product,” he said. “Doing so ignores the significant hospital care, sometimes even critical care, as well as specialized knowledge and high touch supportive care, all of which is required to safely get patients through this revolutionary yet often risky treatment. So when CMS offers to pay just 65% of the sticker price, I suspect that many institutions will still lose six figures for each patient treated.”
Dr. LeBlanc predicted that many centers will decline to provide CAR T-cell therapy despite the increase in the new technology add-on payment, though he added that “I’d love to be wrong about this.”
Dr. Majhail agreed, noting that, even with the bump in the add-on payment, hospitals “won’t be whole in terms of providing care for these patients.”
“The reimbursement piece continues to be a challenge,” he said. “It is better than what it was, but there is still more work to be done. That is something we will have to keep working with the agency on.”
Physicians are praising the decision by officials at the Centers for Medicare & Medicaid Services to provide coverage of chimeric antigen receptor T-cell therapy, though they say the planned payment structure will still leave hospitals in the red when treatment is administered.
On Aug. 7, 2019, the agency issued a national coverage determination that outlines Medicare coverage of chimeric antigen receptor (CAR) T-cell therapies when they are provided in health care facilities enrolled in the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies program. Medicare will cover treatments for both FDA-approved indications and off-label uses that are recommended in CMS-approved compendia.
“What you’ve seen in both the [Medicare Inpatient Prospective Payment System] rule, as well as this coverage determination, is recognition by CMS that, with CAR T cells, we are dealing with something different and something extraordinary,” Joseph Alvarnas, MD, vice president of government affairs at City of Hope, Duarte, Calif., said in an interview. “For a lot of patients who suffer with non-Hodgkin’s lymphoma, the consequences of being refractory to standard therapies mean that many patients have few great prospects for moving forward with curative treatments. CAR T cells represent a really innovative set of treatments for patients.”
A proposed national coverage determination, issued in February 2019, would have put in place a coverage with evidence development (CED) requirement for CAR T-cell therapy, covering treatment nationwide if it was offered through CMS-approved registries or clinical studies in which patients were monitored for 2 or more years following treatment.
Physicians applauded the decision not to restrict access by imposing the CED requirement.
“I think what CMS has put out is a good thing,” said Navneet Majhail, MD, director of the Cleveland Clinic’s blood and marrow transplant program, and president of the American Society for Transplantation and Cellular Therapy.
“Both at the Cleveland Clinic level and the society level, we have been asking CMS for something similar and we are really glad and excited that CMS did do this. The concern was that CMS might do this in the context of some other regulatory requirements like CED that they sometimes do. I am glad that CMS decided not to put that mechanism into place for the CAR T-cell therapies,” Dr. Majhail said.
Dr. Alvarnas, who also serves as chair of the American Society of Hematology Committee on Practice, agreed. “I see good. I don’t see bad. I have read through this and it strikes me as being written with fairly great clarity.”
Dr. Alvarnas added that he had been worried about potential restrictions, such as CED. “Once you put something under that whole rubric of coverage with evidence development, then what you do is you create a bottleneck around access to therapy because you have to have an accruing clinical trial for patients to, in fact, be able to participate in that form of therapy.”
By not imposing a CED requirement, it opens the door to better understanding the role CAR T cells play in treatment, Dr. Alvarnas noted.
“Over time, the number of patients for whom these therapeutics work, based upon real medical evidence, will escalate and grow at a pace that can far exceed the restrictions placed under a CED model,” he said, adding that the national coverage determination “gives us the license to deliver therapeutics to the right patients based upon medical evidence as it evolves, provided that these things get listed as part of the compendia. I think that is a fantastic recognition that new roles for drugs, agents, therapeutics ... are going to evolve at a pace far faster than what CMS can write rules about.”
While Medicare’s coverage determination garnered positive reviews, the agency’s Inpatient Prospective Payment System final rule – which outlines reimbursement for CAR T-cell therapy and other new technologies – got a more tepid response.
In the final rule, CMS raised the payment it makes to hospitals for administering CAR T-cell therapies through its new technology add-on payment. Payments will rise from 50% of the technology to 65%, an increase from $186,500 to $242,450 for CAR T-cell therapies, beginning on Oct. 1, 2019.
But even the bump up to 65% may not be enough.
“I see the move to 65% as a new technology add-on payment as an incremental step in the correct direction, but what we’ve done to some extent is that we’ve delayed getting to some sort of more wholly conceived system,” Dr. Alvarnas said, noting that a new system will be needed as the new technology add-on payment goes away in 2021.
Abhinav Deol, MD, of the Karmanos Cancer Institute in Detroit said it’s a challenge to cover costs for the treatment. “If you just look at the simple math, it is still going to be an economic challenge. The cells that are approved for lymphoma patients that will probably fall into the Medicare category, the list price of those cells is $373,000. Even with the 65% coverage, it’s about $235,000-$240,000 in reimbursement,” he said. “For a facility to be able to provide the care for patients, you have that delta that is still not covered. It is still going to be an economic challenge for many of the facilities to provide this care.”
Thomas LeBlanc, MD, an associate professor of medicine at Duke University, Durham, N.C., said that, while the coverage determination is a positive step, it’s not clear that it will provide meaningful access to CAR T-cell therapy because of the cost.
“These products are incredibly expensive, and the total cost of providing them is woefully underestimated in only focusing on the sticker price of the product,” he said. “Doing so ignores the significant hospital care, sometimes even critical care, as well as specialized knowledge and high touch supportive care, all of which is required to safely get patients through this revolutionary yet often risky treatment. So when CMS offers to pay just 65% of the sticker price, I suspect that many institutions will still lose six figures for each patient treated.”
Dr. LeBlanc predicted that many centers will decline to provide CAR T-cell therapy despite the increase in the new technology add-on payment, though he added that “I’d love to be wrong about this.”
Dr. Majhail agreed, noting that, even with the bump in the add-on payment, hospitals “won’t be whole in terms of providing care for these patients.”
“The reimbursement piece continues to be a challenge,” he said. “It is better than what it was, but there is still more work to be done. That is something we will have to keep working with the agency on.”
Critics say hospital price transparency proposal ‘misses the mark’
A proposal by the Centers for Medicare & Medicaid Services to require full price transparency, including the disclosure of both list prices and payer-negotiated prices, is already receiving pushback.
Rick Pollack, president and CEO of the American Hospital Association, said in a statement that “mandating disclosure of negotiated rates between insurers and hospitals is the wrong approach,” adding that it “could seriously limit the choices available to patients in the private market and fuel anticompetitive behavior among commercial health insurers in an already highly concentrated insurance industry.”
The requirement for hospital price transparency was posted online July 29 as part of the proposed annual update to the hospital outpatient prospective payment system (OPPS) for 2020. It is scheduled for publication in the Federal Register on Aug. 9.
CMS is proposing, beginning in calendar year 2020, that hospitals make publicly available their “standard charges,” defined as the gross – or list – price of for all services provided by the hospital, as well as payer-specific negotiated prices. To allow for price comparisons, prices would be posted on the Internet in a machine-readable file that includes common billing or accounting codes and a description of the item of service being delivered.
Additionally, hospitals must make payer-specific negotiated prices for “shoppable” services, defined as services that can be scheduled in advance – such as x-rays, outpatient visits, imaging and laboratory tests, or bundled services like a cesarean delivery with pre- and postdelivery care – in a consumer-friendly manner.
“As deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” CMS Administrator Seema Verma said during a July 29 press conference. “In fact, a recent poll showed that the majority of Americans have tried to get pricing information before getting care, but have found it challenging to find that information.”
She noted that patients may see prices that range from 150% of Medicare rates to more than 400% for the same service.
Hospitals will need to display at least 300 shoppable services, including 70 that are CMS selected and 230 that are hospital selected, according to a fact sheet outlining this and other proposed OPPS updates for 2020.
“If a hospital does not provide one or more of the 70 CMS selected shoppable services, the hospital must select additional shoppable services such that the total number of shoppable services is at least 300,” the fact sheet states.
Information on pricing will be required to be updated at least annually.
CMS is including enforcement tools as part of the proposal, including fines to hospitals for noncompliance.
“Price transparency creates a marketplace where providers compete on the basis of cost and quality that will lower cost,” Ms. Verma said.
However, that notion has been challenged by America’s Health Insurance Plans (AHIP).
Matt Eyles, president and CEO of AHIP said in a statement that “multiple experts, including the Federal Trade Commission, agree that disclosing privately negotiated rates will make it harder to bargain for lower rates, creating a floor, not a ceiling, for the prices that hospitals would be willing to accept. Publicly disclosing competitively negotiated, proprietary rates will push prices and premiums higher, not lower, for consumers, patients, and taxpayers.”
Mr. Pollack of the American Hospital Association agreed. “While we support transparency, [this] proposal misses the mark, exceeds the Administration’s legal authority, and should be abandoned.”
Ms. Verma said she believed the agency had legal authority to impose this requirement and is not worried about possible lawsuits that could challenge this provision.
“This administration is not afraid of those things,” she said. “We are not about protecting the status quo when it doesn’t work for patients.”
A proposal by the Centers for Medicare & Medicaid Services to require full price transparency, including the disclosure of both list prices and payer-negotiated prices, is already receiving pushback.
Rick Pollack, president and CEO of the American Hospital Association, said in a statement that “mandating disclosure of negotiated rates between insurers and hospitals is the wrong approach,” adding that it “could seriously limit the choices available to patients in the private market and fuel anticompetitive behavior among commercial health insurers in an already highly concentrated insurance industry.”
The requirement for hospital price transparency was posted online July 29 as part of the proposed annual update to the hospital outpatient prospective payment system (OPPS) for 2020. It is scheduled for publication in the Federal Register on Aug. 9.
CMS is proposing, beginning in calendar year 2020, that hospitals make publicly available their “standard charges,” defined as the gross – or list – price of for all services provided by the hospital, as well as payer-specific negotiated prices. To allow for price comparisons, prices would be posted on the Internet in a machine-readable file that includes common billing or accounting codes and a description of the item of service being delivered.
Additionally, hospitals must make payer-specific negotiated prices for “shoppable” services, defined as services that can be scheduled in advance – such as x-rays, outpatient visits, imaging and laboratory tests, or bundled services like a cesarean delivery with pre- and postdelivery care – in a consumer-friendly manner.
“As deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” CMS Administrator Seema Verma said during a July 29 press conference. “In fact, a recent poll showed that the majority of Americans have tried to get pricing information before getting care, but have found it challenging to find that information.”
She noted that patients may see prices that range from 150% of Medicare rates to more than 400% for the same service.
Hospitals will need to display at least 300 shoppable services, including 70 that are CMS selected and 230 that are hospital selected, according to a fact sheet outlining this and other proposed OPPS updates for 2020.
“If a hospital does not provide one or more of the 70 CMS selected shoppable services, the hospital must select additional shoppable services such that the total number of shoppable services is at least 300,” the fact sheet states.
Information on pricing will be required to be updated at least annually.
CMS is including enforcement tools as part of the proposal, including fines to hospitals for noncompliance.
“Price transparency creates a marketplace where providers compete on the basis of cost and quality that will lower cost,” Ms. Verma said.
However, that notion has been challenged by America’s Health Insurance Plans (AHIP).
Matt Eyles, president and CEO of AHIP said in a statement that “multiple experts, including the Federal Trade Commission, agree that disclosing privately negotiated rates will make it harder to bargain for lower rates, creating a floor, not a ceiling, for the prices that hospitals would be willing to accept. Publicly disclosing competitively negotiated, proprietary rates will push prices and premiums higher, not lower, for consumers, patients, and taxpayers.”
Mr. Pollack of the American Hospital Association agreed. “While we support transparency, [this] proposal misses the mark, exceeds the Administration’s legal authority, and should be abandoned.”
Ms. Verma said she believed the agency had legal authority to impose this requirement and is not worried about possible lawsuits that could challenge this provision.
“This administration is not afraid of those things,” she said. “We are not about protecting the status quo when it doesn’t work for patients.”
A proposal by the Centers for Medicare & Medicaid Services to require full price transparency, including the disclosure of both list prices and payer-negotiated prices, is already receiving pushback.
Rick Pollack, president and CEO of the American Hospital Association, said in a statement that “mandating disclosure of negotiated rates between insurers and hospitals is the wrong approach,” adding that it “could seriously limit the choices available to patients in the private market and fuel anticompetitive behavior among commercial health insurers in an already highly concentrated insurance industry.”
The requirement for hospital price transparency was posted online July 29 as part of the proposed annual update to the hospital outpatient prospective payment system (OPPS) for 2020. It is scheduled for publication in the Federal Register on Aug. 9.
CMS is proposing, beginning in calendar year 2020, that hospitals make publicly available their “standard charges,” defined as the gross – or list – price of for all services provided by the hospital, as well as payer-specific negotiated prices. To allow for price comparisons, prices would be posted on the Internet in a machine-readable file that includes common billing or accounting codes and a description of the item of service being delivered.
Additionally, hospitals must make payer-specific negotiated prices for “shoppable” services, defined as services that can be scheduled in advance – such as x-rays, outpatient visits, imaging and laboratory tests, or bundled services like a cesarean delivery with pre- and postdelivery care – in a consumer-friendly manner.
“As deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” CMS Administrator Seema Verma said during a July 29 press conference. “In fact, a recent poll showed that the majority of Americans have tried to get pricing information before getting care, but have found it challenging to find that information.”
She noted that patients may see prices that range from 150% of Medicare rates to more than 400% for the same service.
Hospitals will need to display at least 300 shoppable services, including 70 that are CMS selected and 230 that are hospital selected, according to a fact sheet outlining this and other proposed OPPS updates for 2020.
“If a hospital does not provide one or more of the 70 CMS selected shoppable services, the hospital must select additional shoppable services such that the total number of shoppable services is at least 300,” the fact sheet states.
Information on pricing will be required to be updated at least annually.
CMS is including enforcement tools as part of the proposal, including fines to hospitals for noncompliance.
“Price transparency creates a marketplace where providers compete on the basis of cost and quality that will lower cost,” Ms. Verma said.
However, that notion has been challenged by America’s Health Insurance Plans (AHIP).
Matt Eyles, president and CEO of AHIP said in a statement that “multiple experts, including the Federal Trade Commission, agree that disclosing privately negotiated rates will make it harder to bargain for lower rates, creating a floor, not a ceiling, for the prices that hospitals would be willing to accept. Publicly disclosing competitively negotiated, proprietary rates will push prices and premiums higher, not lower, for consumers, patients, and taxpayers.”
Mr. Pollack of the American Hospital Association agreed. “While we support transparency, [this] proposal misses the mark, exceeds the Administration’s legal authority, and should be abandoned.”
Ms. Verma said she believed the agency had legal authority to impose this requirement and is not worried about possible lawsuits that could challenge this provision.
“This administration is not afraid of those things,” she said. “We are not about protecting the status quo when it doesn’t work for patients.”
Key clinical point: CMS proposes complete transparency in hospital prices.
Major finding: Hospitals would be required to make public the list prices, as well as all payer-negotiated prices.
Study details: CMS asserts that the disclosure of pricing data will lead to reduced prices through market competition.
Disclosures: CMS, as issuer of the proposed rule, makes no disclosures.
Source: Proposed rule updating the hospital outpatient prospective payment system for 2020.
CMS plans to give MIPS an overhaul
Changes are coming to the Merit-based Incentive Payment System track of the Quality Payment Program and officials at the Centers for Medicare & Medicaid Services say these revisions are aimed at making the transition to value-based care easier for physicians.
The new framework for the Merit-based Incentive Payment System (MIPS) program was included as part of a proposed rule that updated both the physician fee schedule and the Quality Payment Program (QPP) for 2020. The proposed rule was posted online July 29, 2019, and is scheduled for publication in the Federal Register on Aug. 14. Comments on the rule are due on Sept. 27.
“We are overhauling the Merit-based Incentive Payment System to reduce reporting burden, making sure the measures relevant to clinicians as they move toward value-based care,” CMS Administrator Seema Verma said during a July 29 press conference. “Clinicians will now report on fewer, more meaningful measures that are aligned to their specialty or practice area, making it easier to participate in MIPS. We are looking for the public’s input on this new framework so that we can build a better program together.”
CMS is proposing a new conceptual framework called MIPS Value Pathways (MVPs), which would apply to future proposals beginning in the 2021 performance year.
“The goal is to move away from siloed activities and measures and more towards an aligned set of measure options more relevant to a clinician’s scope of practice that is meaningful to patient care,” the CMS said in a fact sheet highlighting the changes.
The framework would align and connect measures across the four performance categories (quality, cost, promoting interoperability, and improvement activities) and there would be MVP measures for different specialties.
“A clinician or group would be in one MVP associated with their specialty or with a condition, reporting on the same measures and activities as other clinicians and groups in that MVP,” according to the fact sheet.
As part of the proposed framework, the CMS aims to provide “enhanced data and feedback to clinicians.”
In the meantime, the agency is proposing other updates to the program, including adjustments to the weighting of the performance category in 2020. The quality category would drop from 45% to 40%, while the cost category would rise from 15% to 20%. No changes in the weighting of the interoperability (25%) and improvement activities (15%) are proposed.
A number of measures are altered in each of the performance categories, such as increasing the data completeness requirement in the quality category from reporting on 60% of Medicare Part B patients to 70%, changes to patient-centered medical home criteria in the improvement activities performance category, and requiring a yes/no response to the query of the Prescription Drug Monitoring Program measure in the promoting interoperability category.
The range of adjustment, by statute for the 2020 performance year, will go up to 9% (plus or minus) depending on the MIPS scoring, expanding from the 7% (plus or minus) range in the 2019 performance year.
A number of provisions of the Quality Payment Program program are proposed to have no change, including the low-volume threshold and opt-in policy, the MIPS performance period, and EHR certification requirements. No quality measures were changed based on changes to clinical guidelines.
The American Medical Association voiced support for the proposal.
“The AMA commends CMS for requesting input on a simplified option that would give physicians the choice to focus on episodes of care rather than following the current, more fragmented approach,” AMA President Patrice Harris, MD, said in a statement. “Making MIPS more clinically relevant and less burdensome is a top priority for the AMA and we believe CMS is taking an important step toward this goal.”
However, AMGA had a different take, expressing concern that MIPS is not becoming a pathway to value-based care.
The group, which represents multispecialty medical groups and integrated health systems, noted that, while the statutory range for bonus payments may be expanding, CMS is estimating that overall payment adjustment will be only 1.4%.
“In light of this significantly reduced adjustment, AMGA is concerned that MIPS is no longer a transition tool to value-based care, but instead represents a regulatory burden that does not support physician group practices and integrated systems of care that are investing in delivery models based on care coordination and improving population health,” AMGA said in a statement. “In addition, this adjustment undermines the intent of Congress to use MACRA [Medicare Access and CHIP Reauthorization Act] to move the health care system to value-based payment.”
Changes are coming to the Merit-based Incentive Payment System track of the Quality Payment Program and officials at the Centers for Medicare & Medicaid Services say these revisions are aimed at making the transition to value-based care easier for physicians.
The new framework for the Merit-based Incentive Payment System (MIPS) program was included as part of a proposed rule that updated both the physician fee schedule and the Quality Payment Program (QPP) for 2020. The proposed rule was posted online July 29, 2019, and is scheduled for publication in the Federal Register on Aug. 14. Comments on the rule are due on Sept. 27.
“We are overhauling the Merit-based Incentive Payment System to reduce reporting burden, making sure the measures relevant to clinicians as they move toward value-based care,” CMS Administrator Seema Verma said during a July 29 press conference. “Clinicians will now report on fewer, more meaningful measures that are aligned to their specialty or practice area, making it easier to participate in MIPS. We are looking for the public’s input on this new framework so that we can build a better program together.”
CMS is proposing a new conceptual framework called MIPS Value Pathways (MVPs), which would apply to future proposals beginning in the 2021 performance year.
“The goal is to move away from siloed activities and measures and more towards an aligned set of measure options more relevant to a clinician’s scope of practice that is meaningful to patient care,” the CMS said in a fact sheet highlighting the changes.
The framework would align and connect measures across the four performance categories (quality, cost, promoting interoperability, and improvement activities) and there would be MVP measures for different specialties.
“A clinician or group would be in one MVP associated with their specialty or with a condition, reporting on the same measures and activities as other clinicians and groups in that MVP,” according to the fact sheet.
As part of the proposed framework, the CMS aims to provide “enhanced data and feedback to clinicians.”
In the meantime, the agency is proposing other updates to the program, including adjustments to the weighting of the performance category in 2020. The quality category would drop from 45% to 40%, while the cost category would rise from 15% to 20%. No changes in the weighting of the interoperability (25%) and improvement activities (15%) are proposed.
A number of measures are altered in each of the performance categories, such as increasing the data completeness requirement in the quality category from reporting on 60% of Medicare Part B patients to 70%, changes to patient-centered medical home criteria in the improvement activities performance category, and requiring a yes/no response to the query of the Prescription Drug Monitoring Program measure in the promoting interoperability category.
The range of adjustment, by statute for the 2020 performance year, will go up to 9% (plus or minus) depending on the MIPS scoring, expanding from the 7% (plus or minus) range in the 2019 performance year.
A number of provisions of the Quality Payment Program program are proposed to have no change, including the low-volume threshold and opt-in policy, the MIPS performance period, and EHR certification requirements. No quality measures were changed based on changes to clinical guidelines.
The American Medical Association voiced support for the proposal.
“The AMA commends CMS for requesting input on a simplified option that would give physicians the choice to focus on episodes of care rather than following the current, more fragmented approach,” AMA President Patrice Harris, MD, said in a statement. “Making MIPS more clinically relevant and less burdensome is a top priority for the AMA and we believe CMS is taking an important step toward this goal.”
However, AMGA had a different take, expressing concern that MIPS is not becoming a pathway to value-based care.
The group, which represents multispecialty medical groups and integrated health systems, noted that, while the statutory range for bonus payments may be expanding, CMS is estimating that overall payment adjustment will be only 1.4%.
“In light of this significantly reduced adjustment, AMGA is concerned that MIPS is no longer a transition tool to value-based care, but instead represents a regulatory burden that does not support physician group practices and integrated systems of care that are investing in delivery models based on care coordination and improving population health,” AMGA said in a statement. “In addition, this adjustment undermines the intent of Congress to use MACRA [Medicare Access and CHIP Reauthorization Act] to move the health care system to value-based payment.”
Changes are coming to the Merit-based Incentive Payment System track of the Quality Payment Program and officials at the Centers for Medicare & Medicaid Services say these revisions are aimed at making the transition to value-based care easier for physicians.
The new framework for the Merit-based Incentive Payment System (MIPS) program was included as part of a proposed rule that updated both the physician fee schedule and the Quality Payment Program (QPP) for 2020. The proposed rule was posted online July 29, 2019, and is scheduled for publication in the Federal Register on Aug. 14. Comments on the rule are due on Sept. 27.
“We are overhauling the Merit-based Incentive Payment System to reduce reporting burden, making sure the measures relevant to clinicians as they move toward value-based care,” CMS Administrator Seema Verma said during a July 29 press conference. “Clinicians will now report on fewer, more meaningful measures that are aligned to their specialty or practice area, making it easier to participate in MIPS. We are looking for the public’s input on this new framework so that we can build a better program together.”
CMS is proposing a new conceptual framework called MIPS Value Pathways (MVPs), which would apply to future proposals beginning in the 2021 performance year.
“The goal is to move away from siloed activities and measures and more towards an aligned set of measure options more relevant to a clinician’s scope of practice that is meaningful to patient care,” the CMS said in a fact sheet highlighting the changes.
The framework would align and connect measures across the four performance categories (quality, cost, promoting interoperability, and improvement activities) and there would be MVP measures for different specialties.
“A clinician or group would be in one MVP associated with their specialty or with a condition, reporting on the same measures and activities as other clinicians and groups in that MVP,” according to the fact sheet.
As part of the proposed framework, the CMS aims to provide “enhanced data and feedback to clinicians.”
In the meantime, the agency is proposing other updates to the program, including adjustments to the weighting of the performance category in 2020. The quality category would drop from 45% to 40%, while the cost category would rise from 15% to 20%. No changes in the weighting of the interoperability (25%) and improvement activities (15%) are proposed.
A number of measures are altered in each of the performance categories, such as increasing the data completeness requirement in the quality category from reporting on 60% of Medicare Part B patients to 70%, changes to patient-centered medical home criteria in the improvement activities performance category, and requiring a yes/no response to the query of the Prescription Drug Monitoring Program measure in the promoting interoperability category.
The range of adjustment, by statute for the 2020 performance year, will go up to 9% (plus or minus) depending on the MIPS scoring, expanding from the 7% (plus or minus) range in the 2019 performance year.
A number of provisions of the Quality Payment Program program are proposed to have no change, including the low-volume threshold and opt-in policy, the MIPS performance period, and EHR certification requirements. No quality measures were changed based on changes to clinical guidelines.
The American Medical Association voiced support for the proposal.
“The AMA commends CMS for requesting input on a simplified option that would give physicians the choice to focus on episodes of care rather than following the current, more fragmented approach,” AMA President Patrice Harris, MD, said in a statement. “Making MIPS more clinically relevant and less burdensome is a top priority for the AMA and we believe CMS is taking an important step toward this goal.”
However, AMGA had a different take, expressing concern that MIPS is not becoming a pathway to value-based care.
The group, which represents multispecialty medical groups and integrated health systems, noted that, while the statutory range for bonus payments may be expanding, CMS is estimating that overall payment adjustment will be only 1.4%.
“In light of this significantly reduced adjustment, AMGA is concerned that MIPS is no longer a transition tool to value-based care, but instead represents a regulatory burden that does not support physician group practices and integrated systems of care that are investing in delivery models based on care coordination and improving population health,” AMGA said in a statement. “In addition, this adjustment undermines the intent of Congress to use MACRA [Medicare Access and CHIP Reauthorization Act] to move the health care system to value-based payment.”
Key clinical point: The Centers for Medicare & Medicaid Services proposes an overhaul to the Merit-based Incentive Payment System track of the Quality Payment Program.
Major finding: The move is intended to make measures more meaningful to clinicians.
Study details: Measures would be more focused to specialties through Merit-based Incentive Payment System Value Pathways, with all those reporting on a specialty or condition reporting on more streamlined measures.
Disclosures: CMS, as the issuer of the rules, makes no disclosures.
CMS is proposing higher payments for E/M visits
Physicians could be getting more money for evaluation and management (E/M) visits under a new proposal from the Centers for Medicare & Medicaid Services.
The increased funding is part of a proposed rule that provides the annual update to the Medicare physician fee schedule for 2020, as well as updates for the Quality Payment Program. The proposed rule was posted online July 29 and is scheduled to be published in the Federal Register on Aug. 14. Comments are due to CMS on Sept. 27.
CMS officials are seeking to increase Medicare payments to physicians starting in 2021 for E/M visits, based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be “rewarding the time that doctors spend with patients,” CMS Administrator Seema Verma said during a July 29 teleconference with reporters.
A fact sheet highlighting changes in the proposed physician fee schedule update for 2020 notes that the agency also is looking to add a new CPT code for prolonged services time, also to commence in 2021.
“The RUC recommendations reflect a robust survey approach by the AMA, including surveying over 50 specialty types [that] demonstrate that office/outpatient E/M visits are generally more complex and require additional resources for most clinicians,” the fact sheet states.
Physicians would also get paid for care management services related to patients with a single chronic condition, rather than only patients with multiple chronic conditions, as current regulations state. There’s also a proposal to increase payments for transitional care management services provided after a Medicare patient is discharged from an inpatient stay or certain outpatient stays.
The proposed update to the physician fee schedule also puts into regulation a new benefit for opioid use disorder treatment that was authorized under the SUPPORT (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities) Act. To meet the requirements of the law, CMS has included in the proposal definitions for opioid treatment programs and opioid use disorder treatment services; enrollment policies for programs; bundled payment rates for treatment programs, with adjusters for geography and annual updates; flexibility for telehealth services; and zero beneficiary copays for a time-limited duration.
The American Medical Association praised proposed changes to documentation requirements that are included in the rule.
Patrice Harris, MD, the AMA president, said in a statement that the proposed rule “will streamline reporting requirements, reduce note bloat, improve workflow, and contribute to a better environment for health care professionals and their Medicare patients.”
The proposal also includes a modification to the physician supervision requirements for physician assistants that would give PAs “greater flexibility to practice more broadly in the current health system in accordance with state law and state scope of practice,” the fact sheet notes.
Overall, Dr. Harris appeared to have a good first impression of the proposed update, noting that the AMA is “pleased to see important policy revisions that will bring us closer to a more patient-centered health care system that promotes the key principles of affordability, accessibility, quality, and innovation.”
Physicians could be getting more money for evaluation and management (E/M) visits under a new proposal from the Centers for Medicare & Medicaid Services.
The increased funding is part of a proposed rule that provides the annual update to the Medicare physician fee schedule for 2020, as well as updates for the Quality Payment Program. The proposed rule was posted online July 29 and is scheduled to be published in the Federal Register on Aug. 14. Comments are due to CMS on Sept. 27.
CMS officials are seeking to increase Medicare payments to physicians starting in 2021 for E/M visits, based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be “rewarding the time that doctors spend with patients,” CMS Administrator Seema Verma said during a July 29 teleconference with reporters.
A fact sheet highlighting changes in the proposed physician fee schedule update for 2020 notes that the agency also is looking to add a new CPT code for prolonged services time, also to commence in 2021.
“The RUC recommendations reflect a robust survey approach by the AMA, including surveying over 50 specialty types [that] demonstrate that office/outpatient E/M visits are generally more complex and require additional resources for most clinicians,” the fact sheet states.
Physicians would also get paid for care management services related to patients with a single chronic condition, rather than only patients with multiple chronic conditions, as current regulations state. There’s also a proposal to increase payments for transitional care management services provided after a Medicare patient is discharged from an inpatient stay or certain outpatient stays.
The proposed update to the physician fee schedule also puts into regulation a new benefit for opioid use disorder treatment that was authorized under the SUPPORT (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities) Act. To meet the requirements of the law, CMS has included in the proposal definitions for opioid treatment programs and opioid use disorder treatment services; enrollment policies for programs; bundled payment rates for treatment programs, with adjusters for geography and annual updates; flexibility for telehealth services; and zero beneficiary copays for a time-limited duration.
The American Medical Association praised proposed changes to documentation requirements that are included in the rule.
Patrice Harris, MD, the AMA president, said in a statement that the proposed rule “will streamline reporting requirements, reduce note bloat, improve workflow, and contribute to a better environment for health care professionals and their Medicare patients.”
The proposal also includes a modification to the physician supervision requirements for physician assistants that would give PAs “greater flexibility to practice more broadly in the current health system in accordance with state law and state scope of practice,” the fact sheet notes.
Overall, Dr. Harris appeared to have a good first impression of the proposed update, noting that the AMA is “pleased to see important policy revisions that will bring us closer to a more patient-centered health care system that promotes the key principles of affordability, accessibility, quality, and innovation.”
Physicians could be getting more money for evaluation and management (E/M) visits under a new proposal from the Centers for Medicare & Medicaid Services.
The increased funding is part of a proposed rule that provides the annual update to the Medicare physician fee schedule for 2020, as well as updates for the Quality Payment Program. The proposed rule was posted online July 29 and is scheduled to be published in the Federal Register on Aug. 14. Comments are due to CMS on Sept. 27.
CMS officials are seeking to increase Medicare payments to physicians starting in 2021 for E/M visits, based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be “rewarding the time that doctors spend with patients,” CMS Administrator Seema Verma said during a July 29 teleconference with reporters.
A fact sheet highlighting changes in the proposed physician fee schedule update for 2020 notes that the agency also is looking to add a new CPT code for prolonged services time, also to commence in 2021.
“The RUC recommendations reflect a robust survey approach by the AMA, including surveying over 50 specialty types [that] demonstrate that office/outpatient E/M visits are generally more complex and require additional resources for most clinicians,” the fact sheet states.
Physicians would also get paid for care management services related to patients with a single chronic condition, rather than only patients with multiple chronic conditions, as current regulations state. There’s also a proposal to increase payments for transitional care management services provided after a Medicare patient is discharged from an inpatient stay or certain outpatient stays.
The proposed update to the physician fee schedule also puts into regulation a new benefit for opioid use disorder treatment that was authorized under the SUPPORT (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities) Act. To meet the requirements of the law, CMS has included in the proposal definitions for opioid treatment programs and opioid use disorder treatment services; enrollment policies for programs; bundled payment rates for treatment programs, with adjusters for geography and annual updates; flexibility for telehealth services; and zero beneficiary copays for a time-limited duration.
The American Medical Association praised proposed changes to documentation requirements that are included in the rule.
Patrice Harris, MD, the AMA president, said in a statement that the proposed rule “will streamline reporting requirements, reduce note bloat, improve workflow, and contribute to a better environment for health care professionals and their Medicare patients.”
The proposal also includes a modification to the physician supervision requirements for physician assistants that would give PAs “greater flexibility to practice more broadly in the current health system in accordance with state law and state scope of practice,” the fact sheet notes.
Overall, Dr. Harris appeared to have a good first impression of the proposed update, noting that the AMA is “pleased to see important policy revisions that will bring us closer to a more patient-centered health care system that promotes the key principles of affordability, accessibility, quality, and innovation.”
CMS proposes improved E/M payments, additional price transparency for hospitals
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states "that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format" which would allow them to be included in price transparency tools and electronic health records.
"Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers," CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As "deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal," she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be "rewarding the time that doctors spend with patients," Administrator Verma said.
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
"For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care," she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, "making it easier to participate in MIPS."
Look for in depth analysis of both proposals shortly on this website.
gtwachtman@mdedge.com
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states "that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format" which would allow them to be included in price transparency tools and electronic health records.
"Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers," CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As "deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal," she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be "rewarding the time that doctors spend with patients," Administrator Verma said.
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
"For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care," she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, "making it easier to participate in MIPS."
Look for in depth analysis of both proposals shortly on this website.
gtwachtman@mdedge.com
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states "that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format" which would allow them to be included in price transparency tools and electronic health records.
"Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers," CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As "deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal," she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA-RUC).
With this update, the agency will be "rewarding the time that doctors spend with patients," Administrator Verma said.
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
"For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care," she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, "making it easier to participate in MIPS."
Look for in depth analysis of both proposals shortly on this website.
gtwachtman@mdedge.com
CMS proposes improved E/M payments, additional price transparency for hospitals
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states “that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format” which would allow them to be included in price transparency tools and electronic health records.
“Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers,” CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As “deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC). In fact, CMS is walking back the recently proposed plans to collapse E/M levels. The CPT code changes recommended by the AMA allow clinicians to choose the E/M visit level based on either medical decision making or time.
With this update, the agency will be “rewarding the time that doctors spend with patients,” Administrator Verma said.
In a joint statement, the American Gastroenterological Association, the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy welcomed the news as the GI societies opposed CMS’ proposal when it was announced last year. “We worked with the AMA and a coalition of specialty societies in an effort to get CMS to rethink collapsing payment for E/M code levels, and subsequently decided to support the AMA’s proposed E/M changes as they moved through the CPT and RUC processes. In the rule, CMS abandons its proposal and adopts the AMA CPT changes and RUC valuation.”
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
“For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care,” she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, “making it easier to participate in MIPS.” CMS proposed removal of 2 colonoscopy measures from MIPS performance year 2022 because they do not align with MIPS scoring methodology.
The American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy are currently reviewing the details of the proposed rules and will be providing joint comments. CMS will accept comments until Sept. 27, 2019.
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states “that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format” which would allow them to be included in price transparency tools and electronic health records.
“Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers,” CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As “deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC). In fact, CMS is walking back the recently proposed plans to collapse E/M levels. The CPT code changes recommended by the AMA allow clinicians to choose the E/M visit level based on either medical decision making or time.
With this update, the agency will be “rewarding the time that doctors spend with patients,” Administrator Verma said.
In a joint statement, the American Gastroenterological Association, the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy welcomed the news as the GI societies opposed CMS’ proposal when it was announced last year. “We worked with the AMA and a coalition of specialty societies in an effort to get CMS to rethink collapsing payment for E/M code levels, and subsequently decided to support the AMA’s proposed E/M changes as they moved through the CPT and RUC processes. In the rule, CMS abandons its proposal and adopts the AMA CPT changes and RUC valuation.”
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
“For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care,” she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, “making it easier to participate in MIPS.” CMS proposed removal of 2 colonoscopy measures from MIPS performance year 2022 because they do not align with MIPS scoring methodology.
The American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy are currently reviewing the details of the proposed rules and will be providing joint comments. CMS will accept comments until Sept. 27, 2019.
The Centers for Medicare & Medicaid Services is proposing improvements to physician payments and an overhaul of the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.
In a separate proposal also released on July 29, the agency proposed that hospitals be required to make more pricing information publicly available.
The Medicare Outpatient Prospective Payment System proposed rule for the 2020 annual update would require hospitals to not only publish their gross charges, but also the negotiated price by specific payer for select services that can be scheduled by a patient in advance.
The proposal states “that hospitals make public their standard changes (both gross charges and payer-specific negotiated charges) for all items and services online in a machine-readable format” which would allow them to be included in price transparency tools and electronic health records.
“Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers,” CMS Administrator Seema Verma said during a July 29 conference call with reporters.
As “deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” she said.
The rule also comes with new enforcement tools so that CMS can ensure hospitals are complying with the rule, should it be finalized.
Hospitals would need to start publishing list prices and payer-specific negotiated prices beginning Jan. 1, 2020.
In a separate proposal to update the physician fee schedule for 2020, CMS is looking to increase Medicare payments in 2021 for evaluation and management (E/M) visits based on recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC). In fact, CMS is walking back the recently proposed plans to collapse E/M levels. The CPT code changes recommended by the AMA allow clinicians to choose the E/M visit level based on either medical decision making or time.
With this update, the agency will be “rewarding the time that doctors spend with patients,” Administrator Verma said.
In a joint statement, the American Gastroenterological Association, the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy welcomed the news as the GI societies opposed CMS’ proposal when it was announced last year. “We worked with the AMA and a coalition of specialty societies in an effort to get CMS to rethink collapsing payment for E/M code levels, and subsequently decided to support the AMA’s proposed E/M changes as they moved through the CPT and RUC processes. In the rule, CMS abandons its proposal and adopts the AMA CPT changes and RUC valuation.”
The fact sheet on the proposed update to the physician fee schedule also highlights improvements to case management payments, allowing physicians to get paid for case management services if the patient only has one high-risk condition.
“For 2021, we are overhauling the Merit-based Incentive Payment System, or MIPS, to reduce reporting burden, making sure the measures are relevant to clinicians as they move toward value-based care,” she said, noting that clinicians would be reporting on fewer, more meaningful measures that are aligned to their specialty or practice area, “making it easier to participate in MIPS.” CMS proposed removal of 2 colonoscopy measures from MIPS performance year 2022 because they do not align with MIPS scoring methodology.
The American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy are currently reviewing the details of the proposed rules and will be providing joint comments. CMS will accept comments until Sept. 27, 2019.
A personal touch can be key to state-level advocacy
WASHINGTON –
That was the message Matthew Lesser (D), deputy majority leader of the Connecticut state senate, told attendees at the National Comprehensive Cancer Network policy summit examining the impact of state policy on access to cancer care.
Mr. Lesser framed the advice around his own battle with cancer, a diagnosis that came with a need for immediate surgery within 36 hours. His diagnosis came with a recommendation for fertility preservation before he started treatment. And while the action for men is relatively inexpensive, he found after the fact that it could cost upwards of $15,000 for female cancer patients to undergo fertility preservation, and it was something insurance usually did not cover.
He made it a personal legislative priority to get a law on the books preventing insurance companies from restricting fertility coverage for those undergoing cancer treatment.
Mr. Lesser said he tried four times to get the bill passed but it failed to gain any traction. Then, in 2017, as he decided it would be his last attempt at getting a law passed, an advocate stepped up.
“This time something different happened,” he said. “We did the usual thing. We had a public hearing. Anybody can come up and speak. We don’t know in advance who that’s going to be.” A 32-year-old single mother battling advanced breast cancer, Melissa Thompson, “showed up at our public hearing and told her story.”
And it was her testimony, and persistent advocacy that followed, that won over the state legislators.
“Her story was incredibly powerful,” he recalled. “But for some of my more hard-nosed colleagues, stories aren’t enough. They want to see dollars and cents. They want to know the facts and the figures, and Melissa, a former Goldman Sachs analyst with an MBA from Columbia School of Business, was able to lay out dollars and cents argument much better than a lot of health professionals have been able to do.”
Her testimony was so powerful that Mr. Lesser said it was the only time he had seen a committee give an ovation to a witness.
Ms. Thompson followed up her appearance before a state committee with outreach to leadership on both sides of the aisle.
“Melissa changed the way we talked about the issue, and partly because this one person, this one Connecticut resident, reached out to every single member of the State senate,” he said. “She recorded a little video that she played to the 36 members of the state senate. She went and talked to Republican and Democratic leaders. She told her story. And she wouldn’t give up.”
And her work paid off, as H.B. 7124 passed with no dissenting votes in both chambers of the Connecticut state legislature, and was signed into law in 2017.
“This wasn’t something I did,” Mr. Lesser said. “It’s not something I could have done. I tried to do it and failed. But it does show the incredible power of individual advocates on the state level.”
The reason he thinks individual advocacy has a lot more impact on the state level is one of size and resources.
“Because state [governments] are so small, the power of individual advocates is enormous,” he stated. “Because we are so understaffed and so underresourced, compared to our colleagues on the federal level, that personal connection is magnified in importance.”
Mr. Lesser recalled other examples of how personal advocacy in Connecticut that have moved legislation in a bipartisan fashion in ways that would likely have otherwise failed without a voice outside the legislative body telling a personal story, including breast cancer imaging screening for women with dense breasts and raising the age for tobacco purchasing to 21.
WASHINGTON –
That was the message Matthew Lesser (D), deputy majority leader of the Connecticut state senate, told attendees at the National Comprehensive Cancer Network policy summit examining the impact of state policy on access to cancer care.
Mr. Lesser framed the advice around his own battle with cancer, a diagnosis that came with a need for immediate surgery within 36 hours. His diagnosis came with a recommendation for fertility preservation before he started treatment. And while the action for men is relatively inexpensive, he found after the fact that it could cost upwards of $15,000 for female cancer patients to undergo fertility preservation, and it was something insurance usually did not cover.
He made it a personal legislative priority to get a law on the books preventing insurance companies from restricting fertility coverage for those undergoing cancer treatment.
Mr. Lesser said he tried four times to get the bill passed but it failed to gain any traction. Then, in 2017, as he decided it would be his last attempt at getting a law passed, an advocate stepped up.
“This time something different happened,” he said. “We did the usual thing. We had a public hearing. Anybody can come up and speak. We don’t know in advance who that’s going to be.” A 32-year-old single mother battling advanced breast cancer, Melissa Thompson, “showed up at our public hearing and told her story.”
And it was her testimony, and persistent advocacy that followed, that won over the state legislators.
“Her story was incredibly powerful,” he recalled. “But for some of my more hard-nosed colleagues, stories aren’t enough. They want to see dollars and cents. They want to know the facts and the figures, and Melissa, a former Goldman Sachs analyst with an MBA from Columbia School of Business, was able to lay out dollars and cents argument much better than a lot of health professionals have been able to do.”
Her testimony was so powerful that Mr. Lesser said it was the only time he had seen a committee give an ovation to a witness.
Ms. Thompson followed up her appearance before a state committee with outreach to leadership on both sides of the aisle.
“Melissa changed the way we talked about the issue, and partly because this one person, this one Connecticut resident, reached out to every single member of the State senate,” he said. “She recorded a little video that she played to the 36 members of the state senate. She went and talked to Republican and Democratic leaders. She told her story. And she wouldn’t give up.”
And her work paid off, as H.B. 7124 passed with no dissenting votes in both chambers of the Connecticut state legislature, and was signed into law in 2017.
“This wasn’t something I did,” Mr. Lesser said. “It’s not something I could have done. I tried to do it and failed. But it does show the incredible power of individual advocates on the state level.”
The reason he thinks individual advocacy has a lot more impact on the state level is one of size and resources.
“Because state [governments] are so small, the power of individual advocates is enormous,” he stated. “Because we are so understaffed and so underresourced, compared to our colleagues on the federal level, that personal connection is magnified in importance.”
Mr. Lesser recalled other examples of how personal advocacy in Connecticut that have moved legislation in a bipartisan fashion in ways that would likely have otherwise failed without a voice outside the legislative body telling a personal story, including breast cancer imaging screening for women with dense breasts and raising the age for tobacco purchasing to 21.
WASHINGTON –
That was the message Matthew Lesser (D), deputy majority leader of the Connecticut state senate, told attendees at the National Comprehensive Cancer Network policy summit examining the impact of state policy on access to cancer care.
Mr. Lesser framed the advice around his own battle with cancer, a diagnosis that came with a need for immediate surgery within 36 hours. His diagnosis came with a recommendation for fertility preservation before he started treatment. And while the action for men is relatively inexpensive, he found after the fact that it could cost upwards of $15,000 for female cancer patients to undergo fertility preservation, and it was something insurance usually did not cover.
He made it a personal legislative priority to get a law on the books preventing insurance companies from restricting fertility coverage for those undergoing cancer treatment.
Mr. Lesser said he tried four times to get the bill passed but it failed to gain any traction. Then, in 2017, as he decided it would be his last attempt at getting a law passed, an advocate stepped up.
“This time something different happened,” he said. “We did the usual thing. We had a public hearing. Anybody can come up and speak. We don’t know in advance who that’s going to be.” A 32-year-old single mother battling advanced breast cancer, Melissa Thompson, “showed up at our public hearing and told her story.”
And it was her testimony, and persistent advocacy that followed, that won over the state legislators.
“Her story was incredibly powerful,” he recalled. “But for some of my more hard-nosed colleagues, stories aren’t enough. They want to see dollars and cents. They want to know the facts and the figures, and Melissa, a former Goldman Sachs analyst with an MBA from Columbia School of Business, was able to lay out dollars and cents argument much better than a lot of health professionals have been able to do.”
Her testimony was so powerful that Mr. Lesser said it was the only time he had seen a committee give an ovation to a witness.
Ms. Thompson followed up her appearance before a state committee with outreach to leadership on both sides of the aisle.
“Melissa changed the way we talked about the issue, and partly because this one person, this one Connecticut resident, reached out to every single member of the State senate,” he said. “She recorded a little video that she played to the 36 members of the state senate. She went and talked to Republican and Democratic leaders. She told her story. And she wouldn’t give up.”
And her work paid off, as H.B. 7124 passed with no dissenting votes in both chambers of the Connecticut state legislature, and was signed into law in 2017.
“This wasn’t something I did,” Mr. Lesser said. “It’s not something I could have done. I tried to do it and failed. But it does show the incredible power of individual advocates on the state level.”
The reason he thinks individual advocacy has a lot more impact on the state level is one of size and resources.
“Because state [governments] are so small, the power of individual advocates is enormous,” he stated. “Because we are so understaffed and so underresourced, compared to our colleagues on the federal level, that personal connection is magnified in importance.”
Mr. Lesser recalled other examples of how personal advocacy in Connecticut that have moved legislation in a bipartisan fashion in ways that would likely have otherwise failed without a voice outside the legislative body telling a personal story, including breast cancer imaging screening for women with dense breasts and raising the age for tobacco purchasing to 21.
REPORTING FROM THE NCCN POLICY SUMMIT
Private equity dermatology: Time for a moratorium?
Until there’s greater transparency – and greater understanding of the clinical and economic impact – it’s time for dermatologists to stop selling their practices to private equity firms.
That’s the opinion of Joshua Sharfstein, MD, and Jamar Slocum, MD, both of Johns Hopkins University, Baltimore, who published their views in an editorial in JAMA Dermatology.
“At current pace, by the time more is understood about the takeover of dermatology practices by private equity firms, it will be too late to change course,” Dr. Sharfstein, former principal deputy commissioner at the Food and Drug Administration, and Dr. Slocum wrote. “Efforts to protect the field of dermatology and the American public from the potential adverse consequences should begin now.”
Investment in dermatology practices has spiked in recent years.
Between May 1, 2012, and May 22, 2018, 17 private equity–backed dermatology management groups (DMG) acquired 184 practices, accounting for 381 dermatology clinics, according to a study by Sally Tan, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
The findings “likely underreported direct acquisitions of small physician-owned practices by small PE [private equity] firms,” Dr. Tan and colleagues wrote. “In addition, the data underestimated the number of clinics transitioning from physician to PE-backed ownership because the specific clinics associated with each DMG at the time of the DMG’s initial PE investment has not been disclosed.”
More than one-third of clinics associated with private equity–acquired practices are in Texas and Florida; however, clinics have been acquired in at least 30 states (JAMA Dermatol. doi: 10.1001/jamadermatol.2019.1634).
Physicians have raised concerns about the loss of autonomy and conflicts of interest from investors more concerned with a return on investment ahead of clinical concerns, Dr. Tan and colleagues noted.
From a clinical perspective, there are a number of things that have raised a red flag, Dr. Sharfstein noted.
There have been reports of inappropriate procedures being conducted, he said in an interview. “Another [concern] is unnecessary marketing of cosmetic procedures – the sale of various products that are not adding much of anything to health. So I think it is the unnecessary procedures on the one end and the huge focus on just driving up revenues without any real benefit.”
The flood of private equity money could, over the long term, create access to care and viability issues, he added.
“If you think of a doctor’s office as a revenue-generating machine, that could have pretty profound implications for the nature of treatment and the nature of access to care for different people,” he said. “There is reason to be worried about the viability of access to care in the ways that has been traditionally understood.”
To that end, Dr. Sharfstein and Dr. Slocum make recommendations on what to do in the near term.
First, they are calling for a moratorium on private equity investment either via a conscious decision by dermatologist to reject private equity investment or legislative/regulatory action preventing it.
“Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” they wrote in JAMA Dermatology. Exceptions could be made when “a practice can make a strong and public case to health officials that doing so is in the public interest.”
More transparency around these deals is needed as well.
They call on the American Academy of Dermatology to solicit, curate, and release data on the ownership of all dermatology practices, “as well as core measures related to their use of nonphysicians, access to essential and emergency care, the provision of uncompensated care, and revenue growth.”
Dr. Sharfstein and Dr. Slocum cautioned that “the basic approach and incentives of private equity are not aligned with health and value in dermatology. By focusing on short-term revenue opportunities, private equity acquisitions will likely add to the immense cost and stark inequality of our health care system, with the added risks of unnecessary treatments and significant disruptions in care.”
SOURCE: Tan S et al. JAMA Dermatol. 2019 Jul 24. doi: 10.1001/jamadermatol.2019.1634.
Until there’s greater transparency – and greater understanding of the clinical and economic impact – it’s time for dermatologists to stop selling their practices to private equity firms.
That’s the opinion of Joshua Sharfstein, MD, and Jamar Slocum, MD, both of Johns Hopkins University, Baltimore, who published their views in an editorial in JAMA Dermatology.
“At current pace, by the time more is understood about the takeover of dermatology practices by private equity firms, it will be too late to change course,” Dr. Sharfstein, former principal deputy commissioner at the Food and Drug Administration, and Dr. Slocum wrote. “Efforts to protect the field of dermatology and the American public from the potential adverse consequences should begin now.”
Investment in dermatology practices has spiked in recent years.
Between May 1, 2012, and May 22, 2018, 17 private equity–backed dermatology management groups (DMG) acquired 184 practices, accounting for 381 dermatology clinics, according to a study by Sally Tan, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
The findings “likely underreported direct acquisitions of small physician-owned practices by small PE [private equity] firms,” Dr. Tan and colleagues wrote. “In addition, the data underestimated the number of clinics transitioning from physician to PE-backed ownership because the specific clinics associated with each DMG at the time of the DMG’s initial PE investment has not been disclosed.”
More than one-third of clinics associated with private equity–acquired practices are in Texas and Florida; however, clinics have been acquired in at least 30 states (JAMA Dermatol. doi: 10.1001/jamadermatol.2019.1634).
Physicians have raised concerns about the loss of autonomy and conflicts of interest from investors more concerned with a return on investment ahead of clinical concerns, Dr. Tan and colleagues noted.
From a clinical perspective, there are a number of things that have raised a red flag, Dr. Sharfstein noted.
There have been reports of inappropriate procedures being conducted, he said in an interview. “Another [concern] is unnecessary marketing of cosmetic procedures – the sale of various products that are not adding much of anything to health. So I think it is the unnecessary procedures on the one end and the huge focus on just driving up revenues without any real benefit.”
The flood of private equity money could, over the long term, create access to care and viability issues, he added.
“If you think of a doctor’s office as a revenue-generating machine, that could have pretty profound implications for the nature of treatment and the nature of access to care for different people,” he said. “There is reason to be worried about the viability of access to care in the ways that has been traditionally understood.”
To that end, Dr. Sharfstein and Dr. Slocum make recommendations on what to do in the near term.
First, they are calling for a moratorium on private equity investment either via a conscious decision by dermatologist to reject private equity investment or legislative/regulatory action preventing it.
“Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” they wrote in JAMA Dermatology. Exceptions could be made when “a practice can make a strong and public case to health officials that doing so is in the public interest.”
More transparency around these deals is needed as well.
They call on the American Academy of Dermatology to solicit, curate, and release data on the ownership of all dermatology practices, “as well as core measures related to their use of nonphysicians, access to essential and emergency care, the provision of uncompensated care, and revenue growth.”
Dr. Sharfstein and Dr. Slocum cautioned that “the basic approach and incentives of private equity are not aligned with health and value in dermatology. By focusing on short-term revenue opportunities, private equity acquisitions will likely add to the immense cost and stark inequality of our health care system, with the added risks of unnecessary treatments and significant disruptions in care.”
SOURCE: Tan S et al. JAMA Dermatol. 2019 Jul 24. doi: 10.1001/jamadermatol.2019.1634.
Until there’s greater transparency – and greater understanding of the clinical and economic impact – it’s time for dermatologists to stop selling their practices to private equity firms.
That’s the opinion of Joshua Sharfstein, MD, and Jamar Slocum, MD, both of Johns Hopkins University, Baltimore, who published their views in an editorial in JAMA Dermatology.
“At current pace, by the time more is understood about the takeover of dermatology practices by private equity firms, it will be too late to change course,” Dr. Sharfstein, former principal deputy commissioner at the Food and Drug Administration, and Dr. Slocum wrote. “Efforts to protect the field of dermatology and the American public from the potential adverse consequences should begin now.”
Investment in dermatology practices has spiked in recent years.
Between May 1, 2012, and May 22, 2018, 17 private equity–backed dermatology management groups (DMG) acquired 184 practices, accounting for 381 dermatology clinics, according to a study by Sally Tan, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
The findings “likely underreported direct acquisitions of small physician-owned practices by small PE [private equity] firms,” Dr. Tan and colleagues wrote. “In addition, the data underestimated the number of clinics transitioning from physician to PE-backed ownership because the specific clinics associated with each DMG at the time of the DMG’s initial PE investment has not been disclosed.”
More than one-third of clinics associated with private equity–acquired practices are in Texas and Florida; however, clinics have been acquired in at least 30 states (JAMA Dermatol. doi: 10.1001/jamadermatol.2019.1634).
Physicians have raised concerns about the loss of autonomy and conflicts of interest from investors more concerned with a return on investment ahead of clinical concerns, Dr. Tan and colleagues noted.
From a clinical perspective, there are a number of things that have raised a red flag, Dr. Sharfstein noted.
There have been reports of inappropriate procedures being conducted, he said in an interview. “Another [concern] is unnecessary marketing of cosmetic procedures – the sale of various products that are not adding much of anything to health. So I think it is the unnecessary procedures on the one end and the huge focus on just driving up revenues without any real benefit.”
The flood of private equity money could, over the long term, create access to care and viability issues, he added.
“If you think of a doctor’s office as a revenue-generating machine, that could have pretty profound implications for the nature of treatment and the nature of access to care for different people,” he said. “There is reason to be worried about the viability of access to care in the ways that has been traditionally understood.”
To that end, Dr. Sharfstein and Dr. Slocum make recommendations on what to do in the near term.
First, they are calling for a moratorium on private equity investment either via a conscious decision by dermatologist to reject private equity investment or legislative/regulatory action preventing it.
“Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” they wrote in JAMA Dermatology. Exceptions could be made when “a practice can make a strong and public case to health officials that doing so is in the public interest.”
More transparency around these deals is needed as well.
They call on the American Academy of Dermatology to solicit, curate, and release data on the ownership of all dermatology practices, “as well as core measures related to their use of nonphysicians, access to essential and emergency care, the provision of uncompensated care, and revenue growth.”
Dr. Sharfstein and Dr. Slocum cautioned that “the basic approach and incentives of private equity are not aligned with health and value in dermatology. By focusing on short-term revenue opportunities, private equity acquisitions will likely add to the immense cost and stark inequality of our health care system, with the added risks of unnecessary treatments and significant disruptions in care.”
SOURCE: Tan S et al. JAMA Dermatol. 2019 Jul 24. doi: 10.1001/jamadermatol.2019.1634.
FROM JAMA DERMATOLOGY
Key clinical point: Investment by private equity firms in dermatology continues to rise.
Major finding: Seventeen private equity firms accounted for an estimated 381 dermatology clinics as of mid-2018.
Study details: A cross-sectional study of acquisitions of dermatology practices by private equity–backed dermatology management groups across the United States from May 1, 2012, through May 31, 2018.
Disclosures: The study was funded in part by the Department of Dermatology at Brigham and Women’s Hospital, Boston. Study authors made no relevant disclosures.
Source: Tan S et al. JAMA Dermatol. 2019 Jul 24. doi: 10.1001/jamadermatol.2019.1634.