Gregory Twachtman

The Centers for Medicare & Medicaid Services may be able to reduce spending through the Medicare Shared Savings Program (MSSP) without asking for health care professionals and organizations to take on penalties or so-called downside risk, according to a study published in Sept. 5 in the New England Journal of Medicine.

TheaDesign/Thinkstock

Researchers, using fee-for-service claims from 2009 through 2015 and performing difference-in-difference analyses to compare changes in Medicare spending, found that Accountable Care Organizations (ACOs) formed from physician practices were able to save money while hospital-based ACOs were not.

“Our results also suggest that shared-savings contracts that do not impose a downside risk of financial losses for spending above benchmarks – which may appeal to smaller organizations without sufficient reserves to withstand potential losses – may be effective in lowering Medicare spending,” J. Michael McWilliams, MD, PhD, of Harvard Medical School, Boston, and his colleagues wrote.

Researchers found that by 2015, groups participating in MSSP, as compared with those who did not participate, were “associated with a mean differential reduction of $302 in total Medicare spending per beneficiary in the 2012 entry of cohorts of ACOs,” without accounting for bonus payments.

“Accounting for shared-savings bonus payments, we determined that the differential spending reductions in the entry cohorts of physician-group ACOs from 2012 through 2014 constituted a net savings to Medicare of $256.4 million in 2015,” Dr. McWilliams and his colleagues wrote. “For hospital-integrated ACOs, bonus payments more than offset annual spending reductions.”

Dr. McWilliams and his colleagues noted that their findings were limited by a narrow focus on organizational structure (financial independence from hospitals), so other factors could have held to differences in savings; changes in coding practices for ACOs coming in as of 2013; lack of data on costs to ACOs or efforts to lower spending or improve quality; and the inability to assess the effects of the MSSP on many aspects of quality of care because of the nature of using claims-based measures.

“Our results probably underestimate savings to Medicare because they do not account for spillover effects of ACO efforts on nonattributed patients or effects of lower fee-for-service Medicare spending on payments to Medicare Advantage plans,” the researchers added.

The study was funded by a grant from the National Institute on Aging. Dr. McWilliams and Michael Chernew, PhD, also of Harvard Medical School, both have received consulting fees related to ACO research.

gtwachtman@mdedge.com

SOURCE: McWilliams JM et al. N Engl J Med. 2018 Sep 5. doi: 10.1056/NEJMsa1803388.

The Centers for Medicare & Medicaid Services may be able to reduce spending through the Medicare Shared Savings Program (MSSP) without asking for health care professionals and organizations to take on penalties or so-called downside risk, according to a study published in Sept. 5 in the New England Journal of Medicine.

TheaDesign/Thinkstock

Researchers, using fee-for-service claims from 2009 through 2015 and performing difference-in-difference analyses to compare changes in Medicare spending, found that Accountable Care Organizations (ACOs) formed from physician practices were able to save money while hospital-based ACOs were not.

“Our results also suggest that shared-savings contracts that do not impose a downside risk of financial losses for spending above benchmarks – which may appeal to smaller organizations without sufficient reserves to withstand potential losses – may be effective in lowering Medicare spending,” J. Michael McWilliams, MD, PhD, of Harvard Medical School, Boston, and his colleagues wrote.

Researchers found that by 2015, groups participating in MSSP, as compared with those who did not participate, were “associated with a mean differential reduction of $302 in total Medicare spending per beneficiary in the 2012 entry of cohorts of ACOs,” without accounting for bonus payments.

“Accounting for shared-savings bonus payments, we determined that the differential spending reductions in the entry cohorts of physician-group ACOs from 2012 through 2014 constituted a net savings to Medicare of $256.4 million in 2015,” Dr. McWilliams and his colleagues wrote. “For hospital-integrated ACOs, bonus payments more than offset annual spending reductions.”

Dr. McWilliams and his colleagues noted that their findings were limited by a narrow focus on organizational structure (financial independence from hospitals), so other factors could have held to differences in savings; changes in coding practices for ACOs coming in as of 2013; lack of data on costs to ACOs or efforts to lower spending or improve quality; and the inability to assess the effects of the MSSP on many aspects of quality of care because of the nature of using claims-based measures.

“Our results probably underestimate savings to Medicare because they do not account for spillover effects of ACO efforts on nonattributed patients or effects of lower fee-for-service Medicare spending on payments to Medicare Advantage plans,” the researchers added.

The study was funded by a grant from the National Institute on Aging. Dr. McWilliams and Michael Chernew, PhD, also of Harvard Medical School, both have received consulting fees related to ACO research.

gtwachtman@mdedge.com

SOURCE: McWilliams JM et al. N Engl J Med. 2018 Sep 5. doi: 10.1056/NEJMsa1803388.

The Centers for Medicare & Medicaid Services may be able to reduce spending through the Medicare Shared Savings Program (MSSP) without asking for health care professionals and organizations to take on penalties or so-called downside risk, according to a study published in Sept. 5 in the New England Journal of Medicine.

TheaDesign/Thinkstock

Researchers, using fee-for-service claims from 2009 through 2015 and performing difference-in-difference analyses to compare changes in Medicare spending, found that Accountable Care Organizations (ACOs) formed from physician practices were able to save money while hospital-based ACOs were not.

“Our results also suggest that shared-savings contracts that do not impose a downside risk of financial losses for spending above benchmarks – which may appeal to smaller organizations without sufficient reserves to withstand potential losses – may be effective in lowering Medicare spending,” J. Michael McWilliams, MD, PhD, of Harvard Medical School, Boston, and his colleagues wrote.

Researchers found that by 2015, groups participating in MSSP, as compared with those who did not participate, were “associated with a mean differential reduction of $302 in total Medicare spending per beneficiary in the 2012 entry of cohorts of ACOs,” without accounting for bonus payments.

“Accounting for shared-savings bonus payments, we determined that the differential spending reductions in the entry cohorts of physician-group ACOs from 2012 through 2014 constituted a net savings to Medicare of $256.4 million in 2015,” Dr. McWilliams and his colleagues wrote. “For hospital-integrated ACOs, bonus payments more than offset annual spending reductions.”

Dr. McWilliams and his colleagues noted that their findings were limited by a narrow focus on organizational structure (financial independence from hospitals), so other factors could have held to differences in savings; changes in coding practices for ACOs coming in as of 2013; lack of data on costs to ACOs or efforts to lower spending or improve quality; and the inability to assess the effects of the MSSP on many aspects of quality of care because of the nature of using claims-based measures.

“Our results probably underestimate savings to Medicare because they do not account for spillover effects of ACO efforts on nonattributed patients or effects of lower fee-for-service Medicare spending on payments to Medicare Advantage plans,” the researchers added.

The study was funded by a grant from the National Institute on Aging. Dr. McWilliams and Michael Chernew, PhD, also of Harvard Medical School, both have received consulting fees related to ACO research.

gtwachtman@mdedge.com

SOURCE: McWilliams JM et al. N Engl J Med. 2018 Sep 5. doi: 10.1056/NEJMsa1803388.

More than 170 physician groups are calling on the Centers for Medicare & Medicaid Services to withdraw a provision in the proposed 2019 physician fee schedule that would flatten evaluation and management payments.

TheaDesign/Thinkstock

The controversial proposal would set the payment rate for a level 1 evaluation and management (E/M) office visit for a new patient at $44, down from the $45 using the current methodology. Payment for levels 2-5 would be $135. Currently, payments for level 2 new patient visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For E/M office visits with established patients, the proposed rate would be $24 for level 1, up from the current payment of $22. Payment for levels 2-5 would be $93. Under the current methodology, payments for established patient level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

In an Aug. 28 letter to the CMS, led by the American College of Rheumatology, physician groups applauded CMS recognition of the problems with the current E/M documentation guidelines and codes, but urged them to reconsider plans to “cut and consolidate evaluation and management services.” Doing so would “severely reduce Medicare patients’ access to care by cutting payments for complex office visits, adversely affecting the care and treatment of patients with complex conditions, and potentially exacerbate physician workforce shortages.”

A separate letter, led by the American Medical Association, made similar assertions that the current proposal has the potential to “hurt physicians and other health care professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care.”

The American Gastroenterological Association sigend on to both letters.

AGA, along with the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy, sent out a member alert, asking their members to tell CMS not to move forward with the proposed change because all three societies believe that such a payment system undervalues care provided to their sickest and most vulnerable seniors and other Medicare beneficiaries.

Another concern related to the implementation of this proposal is the financial impact on physicians.

Implementation of the CMS proposal, as currently written, “would be amazingly expensive for private practice [doctors] and really for anyone else because we would have to change our EMRs,” Barbara Levy, MD, cochair of the CPT/RUC Work Group at the AMA.

“We would have to reprogram our billing software. All of that comes with a significant cost,” said Dr. Levy, who also serves as vice president of health policy at the American College of Obstetricians and Gynecologists.

Part of the selling point of the CMS proposal is the reduction in documentation that accompanies the E/M payment changes. The goal, according to the CMS, is to reduce time spent on paperwork and free up physicians to devote more time to patient care. But some physicians are skeptical it would work out that way.

"CMS has clearly heard from physicians about the need to reduce administrative burdens for physicians, and AGA appreciates that they're listening," said Peter S. Margolis, MD, AGAF, AGA Practice Councillor, University Gastroenterology, Providence, Rhode Island. "However, CMS' proposal drastically undervalues the care gastroenterologists and hepatologists provide to complex patients, including but not limited to those with inflammatory bowel disease, motility disorders, and chronic liver disease. Additionally, our experience shows that utilization management methods, such as prior authorization and step therapy appeals, are far more burdensome to physicians and physician practices than current E/M documentation requirements." 

Another element of the proposal that is raising concerns among physician groups is a proposed payment reduction when a visit involves more than one service. For example, when a single office visit includes both an E/M code and a procedure code, the proposal calls for the E/M code to be cut in half.

“From the patients’ perspective, the potential threat is that doctors could be incentivized to spend less time with patients or potentially bring patients back for subsequent visits to handle multiple problems,” Angus Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said in an interview.

Comments on the proposed update to the 2019 Medicare physician fee schedule are due Sept. 10.

gtwachtman@mdedge.com

More than 170 physician groups are calling on the Centers for Medicare & Medicaid Services to withdraw a provision in the proposed 2019 physician fee schedule that would flatten evaluation and management payments.

TheaDesign/Thinkstock

The controversial proposal would set the payment rate for a level 1 evaluation and management (E/M) office visit for a new patient at $44, down from the $45 using the current methodology. Payment for levels 2-5 would be $135. Currently, payments for level 2 new patient visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For E/M office visits with established patients, the proposed rate would be $24 for level 1, up from the current payment of $22. Payment for levels 2-5 would be $93. Under the current methodology, payments for established patient level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

In an Aug. 28 letter to the CMS, led by the American College of Rheumatology, physician groups applauded CMS recognition of the problems with the current E/M documentation guidelines and codes, but urged them to reconsider plans to “cut and consolidate evaluation and management services.” Doing so would “severely reduce Medicare patients’ access to care by cutting payments for complex office visits, adversely affecting the care and treatment of patients with complex conditions, and potentially exacerbate physician workforce shortages.”

A separate letter, led by the American Medical Association, made similar assertions that the current proposal has the potential to “hurt physicians and other health care professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care.”

The American Gastroenterological Association sigend on to both letters.

AGA, along with the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy, sent out a member alert, asking their members to tell CMS not to move forward with the proposed change because all three societies believe that such a payment system undervalues care provided to their sickest and most vulnerable seniors and other Medicare beneficiaries.

Another concern related to the implementation of this proposal is the financial impact on physicians.

Implementation of the CMS proposal, as currently written, “would be amazingly expensive for private practice [doctors] and really for anyone else because we would have to change our EMRs,” Barbara Levy, MD, cochair of the CPT/RUC Work Group at the AMA.

“We would have to reprogram our billing software. All of that comes with a significant cost,” said Dr. Levy, who also serves as vice president of health policy at the American College of Obstetricians and Gynecologists.

Part of the selling point of the CMS proposal is the reduction in documentation that accompanies the E/M payment changes. The goal, according to the CMS, is to reduce time spent on paperwork and free up physicians to devote more time to patient care. But some physicians are skeptical it would work out that way.

"CMS has clearly heard from physicians about the need to reduce administrative burdens for physicians, and AGA appreciates that they're listening," said Peter S. Margolis, MD, AGAF, AGA Practice Councillor, University Gastroenterology, Providence, Rhode Island. "However, CMS' proposal drastically undervalues the care gastroenterologists and hepatologists provide to complex patients, including but not limited to those with inflammatory bowel disease, motility disorders, and chronic liver disease. Additionally, our experience shows that utilization management methods, such as prior authorization and step therapy appeals, are far more burdensome to physicians and physician practices than current E/M documentation requirements." 

Another element of the proposal that is raising concerns among physician groups is a proposed payment reduction when a visit involves more than one service. For example, when a single office visit includes both an E/M code and a procedure code, the proposal calls for the E/M code to be cut in half.

“From the patients’ perspective, the potential threat is that doctors could be incentivized to spend less time with patients or potentially bring patients back for subsequent visits to handle multiple problems,” Angus Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said in an interview.

Comments on the proposed update to the 2019 Medicare physician fee schedule are due Sept. 10.

gtwachtman@mdedge.com

More than 170 physician groups are calling on the Centers for Medicare & Medicaid Services to withdraw a provision in the proposed 2019 physician fee schedule that would flatten evaluation and management payments.

TheaDesign/Thinkstock

The controversial proposal would set the payment rate for a level 1 evaluation and management (E/M) office visit for a new patient at $44, down from the $45 using the current methodology. Payment for levels 2-5 would be $135. Currently, payments for level 2 new patient visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For E/M office visits with established patients, the proposed rate would be $24 for level 1, up from the current payment of $22. Payment for levels 2-5 would be $93. Under the current methodology, payments for established patient level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

In an Aug. 28 letter to the CMS, led by the American College of Rheumatology, physician groups applauded CMS recognition of the problems with the current E/M documentation guidelines and codes, but urged them to reconsider plans to “cut and consolidate evaluation and management services.” Doing so would “severely reduce Medicare patients’ access to care by cutting payments for complex office visits, adversely affecting the care and treatment of patients with complex conditions, and potentially exacerbate physician workforce shortages.”

A separate letter, led by the American Medical Association, made similar assertions that the current proposal has the potential to “hurt physicians and other health care professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care.”

The American Gastroenterological Association sigend on to both letters.

AGA, along with the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy, sent out a member alert, asking their members to tell CMS not to move forward with the proposed change because all three societies believe that such a payment system undervalues care provided to their sickest and most vulnerable seniors and other Medicare beneficiaries.

Another concern related to the implementation of this proposal is the financial impact on physicians.

Implementation of the CMS proposal, as currently written, “would be amazingly expensive for private practice [doctors] and really for anyone else because we would have to change our EMRs,” Barbara Levy, MD, cochair of the CPT/RUC Work Group at the AMA.

“We would have to reprogram our billing software. All of that comes with a significant cost,” said Dr. Levy, who also serves as vice president of health policy at the American College of Obstetricians and Gynecologists.

Part of the selling point of the CMS proposal is the reduction in documentation that accompanies the E/M payment changes. The goal, according to the CMS, is to reduce time spent on paperwork and free up physicians to devote more time to patient care. But some physicians are skeptical it would work out that way.

"CMS has clearly heard from physicians about the need to reduce administrative burdens for physicians, and AGA appreciates that they're listening," said Peter S. Margolis, MD, AGAF, AGA Practice Councillor, University Gastroenterology, Providence, Rhode Island. "However, CMS' proposal drastically undervalues the care gastroenterologists and hepatologists provide to complex patients, including but not limited to those with inflammatory bowel disease, motility disorders, and chronic liver disease. Additionally, our experience shows that utilization management methods, such as prior authorization and step therapy appeals, are far more burdensome to physicians and physician practices than current E/M documentation requirements." 

Another element of the proposal that is raising concerns among physician groups is a proposed payment reduction when a visit involves more than one service. For example, when a single office visit includes both an E/M code and a procedure code, the proposal calls for the E/M code to be cut in half.

“From the patients’ perspective, the potential threat is that doctors could be incentivized to spend less time with patients or potentially bring patients back for subsequent visits to handle multiple problems,” Angus Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said in an interview.

Comments on the proposed update to the 2019 Medicare physician fee schedule are due Sept. 10.

gtwachtman@mdedge.com

More than 170 physician groups are calling on the Centers for Medicare & Medicaid Services to withdraw a provision in the proposed 2019 physician fee schedule that would flatten evaluation and management payments.

TheaDesign/Thinkstock

The controversial proposal would set the payment rate for a level 1 evaluation and management (E/M) office visit for a new patient at $44, down from the $45 using the current methodology. Payment for levels 2-5 would be $135. Currently, payments for level 2 new patient visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For E/M office visits with established patients, the proposed rate would be $24 for level 1, up from the current payment of $22. Payment for levels 2-5 would be $93. Under the current methodology, payments for established patient level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

In an Aug. 28 letter to the CMS, led by the American College of Rheumatology, physician groups applauded CMS recognition of the problems with the current E/M documentation guidelines and codes, but urged them to reconsider plans to “cut and consolidate evaluation and management services.” Doing so would “severely reduce Medicare patients’ access to care by cutting payments for complex office visits, adversely effecting the care and treatment of patients with complex conditions, and potentially exacerbate physician workforce shortages.”

A separate letter, led by the American Medical Association, made similar assertions that the current proposal has the potential to “hurt physicians and other health care professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care.”

Daniel P. McQuillen, MD, of Lahey Hospital and Medical Center, Burlington, Mass. and member of the Infectious Diseases Society of America, said that IDSA is “worried that the implementation is being pushed ahead too fast without really considering whether it’s the right way of doing it and whether there might be some alternative ways of doing it that make more sense.”

Another concern related to the implementation of this proposal is the financial impact on physicians.

Implementation of the CMS proposal, as currently written, “would be amazingly expensive for private practice [doctors] and really for anyone else because we would have to change our EMRs,” Barbara Levy, MD, cochair of the CPT/RUC Work Group at the AMA.

“We would have to reprogram our billing software. All of that comes with a significant cost,” said Dr. Levy, who also serves as vice president of health policy at the American College of Obstetricians and Gynecologists.

Part of the selling point of the CMS proposal is the reduction in documentation that accompanies the E/M payment changes. The goal, according to the CMS, is to reduce time spent on paperwork and free up physicians to devote more time to patient care. But some physicians are skeptical it would work out that way.

“I don’t think it is going to change my documentation burden very much,” Jeffery Ward, MD, chair of the American Society of Clinical Oncology Government Relations Committee, said in an interview. “Their assumption is that I write my notes in order to meet a billing requirement and if I don’t have that billing requirement, I won’t have to write nearly as detailed notes. My notes are written so that if someone else needs to take care of my patient when I am not there, they can step in, read my notes, know what’s going on, and follow the patient.”

Dr. Ward suggested that the real purpose of the proposal is to shift more money to primary care, and raised the concern that the CMS is using this proposal “as a vehicle to take money away from specialists who take care of very complicated patients in order to give it to other people, particularly to primary care.”

ASCO and the Community Oncology Alliance both anticipate a 7%-8% reduction in payments to cancer specialists if this provision takes effect, Dr. Ward said.

Another element of the proposal that is raising concerns among physician groups is a proposed payment reduction when a visit involves more than one service. For example, when a single office visit includes both an E/M code and a procedure code, the proposal calls for the E/M code to be cut in half.

“From the patients’ perspective, the potential threat is that doctors could be incentivized to spend less time with patients or potentially bring patients back for subsequent visits to handle multiple problems,” Angus Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said in an interview.

Comments on the proposed update to the 2019 Medicare physician fee schedule are due Sept. 10.

gtwachtman@mdedge.com

More than 170 physician groups are calling on the Centers for Medicare & Medicaid Services to withdraw a provision in the proposed 2019 physician fee schedule that would flatten evaluation and management payments.

TheaDesign/Thinkstock

The controversial proposal would set the payment rate for a level 1 evaluation and management (E/M) office visit for a new patient at $44, down from the $45 using the current methodology. Payment for levels 2-5 would be $135. Currently, payments for level 2 new patient visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For E/M office visits with established patients, the proposed rate would be $24 for level 1, up from the current payment of $22. Payment for levels 2-5 would be $93. Under the current methodology, payments for established patient level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

In an Aug. 28 letter to the CMS, led by the American College of Rheumatology, physician groups applauded CMS recognition of the problems with the current E/M documentation guidelines and codes, but urged them to reconsider plans to “cut and consolidate evaluation and management services.” Doing so would “severely reduce Medicare patients’ access to care by cutting payments for complex office visits, adversely effecting the care and treatment of patients with complex conditions, and potentially exacerbate physician workforce shortages.”

A separate letter, led by the American Medical Association, made similar assertions that the current proposal has the potential to “hurt physicians and other health care professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care.”

Daniel P. McQuillen, MD, of Lahey Hospital and Medical Center, Burlington, Mass. and member of the Infectious Diseases Society of America, said that IDSA is “worried that the implementation is being pushed ahead too fast without really considering whether it’s the right way of doing it and whether there might be some alternative ways of doing it that make more sense.”

Another concern related to the implementation of this proposal is the financial impact on physicians.

Implementation of the CMS proposal, as currently written, “would be amazingly expensive for private practice [doctors] and really for anyone else because we would have to change our EMRs,” Barbara Levy, MD, cochair of the CPT/RUC Work Group at the AMA.

“We would have to reprogram our billing software. All of that comes with a significant cost,” said Dr. Levy, who also serves as vice president of health policy at the American College of Obstetricians and Gynecologists.

Part of the selling point of the CMS proposal is the reduction in documentation that accompanies the E/M payment changes. The goal, according to the CMS, is to reduce time spent on paperwork and free up physicians to devote more time to patient care. But some physicians are skeptical it would work out that way.

“I don’t think it is going to change my documentation burden very much,” Jeffery Ward, MD, chair of the American Society of Clinical Oncology Government Relations Committee, said in an interview. “Their assumption is that I write my notes in order to meet a billing requirement and if I don’t have that billing requirement, I won’t have to write nearly as detailed notes. My notes are written so that if someone else needs to take care of my patient when I am not there, they can step in, read my notes, know what’s going on, and follow the patient.”

Dr. Ward suggested that the real purpose of the proposal is to shift more money to primary care, and raised the concern that the CMS is using this proposal “as a vehicle to take money away from specialists who take care of very complicated patients in order to give it to other people, particularly to primary care.”

ASCO and the Community Oncology Alliance both anticipate a 7%-8% reduction in payments to cancer specialists if this provision takes effect, Dr. Ward said.

Another element of the proposal that is raising concerns among physician groups is a proposed payment reduction when a visit involves more than one service. For example, when a single office visit includes both an E/M code and a procedure code, the proposal calls for the E/M code to be cut in half.

“From the patients’ perspective, the potential threat is that doctors could be incentivized to spend less time with patients or potentially bring patients back for subsequent visits to handle multiple problems,” Angus Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said in an interview.

Comments on the proposed update to the 2019 Medicare physician fee schedule are due Sept. 10.

gtwachtman@mdedge.com

More than 170 physician groups are calling on the Centers for Medicare & Medicaid Services to withdraw a provision in the proposed 2019 physician fee schedule that would flatten evaluation and management payments.

TheaDesign/Thinkstock

The controversial proposal would set the payment rate for a level 1 evaluation and management (E/M) office visit for a new patient at $44, down from the $45 using the current methodology. Payment for levels 2-5 would be $135. Currently, payments for level 2 new patient visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For E/M office visits with established patients, the proposed rate would be $24 for level 1, up from the current payment of $22. Payment for levels 2-5 would be $93. Under the current methodology, payments for established patient level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

In an Aug. 28 letter to the CMS, led by the American College of Rheumatology, physician groups applauded CMS recognition of the problems with the current E/M documentation guidelines and codes, but urged them to reconsider plans to “cut and consolidate evaluation and management services.” Doing so would “severely reduce Medicare patients’ access to care by cutting payments for complex office visits, adversely effecting the care and treatment of patients with complex conditions, and potentially exacerbate physician workforce shortages.”

A separate letter, led by the American Medical Association, made similar assertions that the current proposal has the potential to “hurt physicians and other health care professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care.”

Daniel P. McQuillen, MD, of Lahey Hospital and Medical Center, Burlington, Mass. and member of the Infectious Diseases Society of America, said that IDSA is “worried that the implementation is being pushed ahead too fast without really considering whether it’s the right way of doing it and whether there might be some alternative ways of doing it that make more sense.”

Another concern related to the implementation of this proposal is the financial impact on physicians.

Implementation of the CMS proposal, as currently written, “would be amazingly expensive for private practice [doctors] and really for anyone else because we would have to change our EMRs,” Barbara Levy, MD, cochair of the CPT/RUC Work Group at the AMA.

“We would have to reprogram our billing software. All of that comes with a significant cost,” said Dr. Levy, who also serves as vice president of health policy at the American College of Obstetricians and Gynecologists.

Part of the selling point of the CMS proposal is the reduction in documentation that accompanies the E/M payment changes. The goal, according to the CMS, is to reduce time spent on paperwork and free up physicians to devote more time to patient care. But some physicians are skeptical it would work out that way.

“I don’t think it is going to change my documentation burden very much,” Jeffery Ward, MD, chair of the American Society of Clinical Oncology Government Relations Committee, said in an interview. “Their assumption is that I write my notes in order to meet a billing requirement and if I don’t have that billing requirement, I won’t have to write nearly as detailed notes. My notes are written so that if someone else needs to take care of my patient when I am not there, they can step in, read my notes, know what’s going on, and follow the patient.”

Dr. Ward suggested that the real purpose of the proposal is to shift more money to primary care, and raised the concern that the CMS is using this proposal “as a vehicle to take money away from specialists who take care of very complicated patients in order to give it to other people, particularly to primary care.”

ASCO and the Community Oncology Alliance both anticipate a 7%-8% reduction in payments to cancer specialists if this provision takes effect, Dr. Ward said.

Another element of the proposal that is raising concerns among physician groups is a proposed payment reduction when a visit involves more than one service. For example, when a single office visit includes both an E/M code and a procedure code, the proposal calls for the E/M code to be cut in half.

“From the patients’ perspective, the potential threat is that doctors could be incentivized to spend less time with patients or potentially bring patients back for subsequent visits to handle multiple problems,” Angus Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said in an interview.

Comments on the proposed update to the 2019 Medicare physician fee schedule are due Sept. 10.

gtwachtman@mdedge.com

Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.

Kenishirotie/Thinkstock

The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.

According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”

Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.

The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”

Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.

“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.

However, physician groups see this more as something that could create access issues for patients.

The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”

The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.

The American Medical Association agreed.

“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”

Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.

“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”

She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.

gtwachtman@mdedge.com

Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.

Kenishirotie/Thinkstock

The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.

According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”

Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.

The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”

Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.

“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.

However, physician groups see this more as something that could create access issues for patients.

The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”

The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.

The American Medical Association agreed.

“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”

Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.

“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”

She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.

gtwachtman@mdedge.com

Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.

Kenishirotie/Thinkstock

The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.

According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”

Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.

The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”

Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.

“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.

However, physician groups see this more as something that could create access issues for patients.

The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”

The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.

The American Medical Association agreed.

“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”

Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.

“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”

She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.

gtwachtman@mdedge.com

Drugmakers and physician groups expressed concern about connecting patient reported outcomes (PRO) to coverage decisions for chimeric antigen receptor T-cell therapy (CAR T) at a recent Medicare meeting.

copyright roobcio/Thinkstock

Despite these objections, members of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) generally expressed confidence in the use of PROs in a series of votes about PRO instruments’ use in cancer care trials.

MEDCAC opened a national coverage analysis in May 2018 at the request of UnitedHealthcare. The insurer had asked the Centers for Medicare & Medicaid Services to clarify the circumstances for coverage of the new CAR T therapies.

In presentations at an Aug. 22 MEDCAC meeting, representatives from the two manufacturers that have approved CAR T treatments on the market cautioned against using PROs in the context of coverage decisions, even though both companies used PRO data in their clinical trials and are collecting it in the postmarketing period.

“While Kite recognizes the importance of PROs in ... clinical trials, the PRO CAR T science, where these instruments are most appropriate for CAR T, remains a still to be determined and still is evolving and still quite early in the developments,” said William Go, MD, PhD, vice president of clinical development at Kite Pharmaceuticals, a Gilead company.

Despite PROs playing an active role in the ongoing development and clinical trials that Kite is running, in the context of CAR T, “we feel PROs are not quite ready for real-world coverage decisions at this time,” Dr. Go said.

A representative from Novartis agreed. “It is important to clearly define research objectives when considering whether to collect patient reported outcomes data, particularly given the burden associated with advanced disease experienced by the patients that are likely to receive this therapy,” Ilia Ferrusi, PhD, associate director, HEOR (CAR T Therapy), U.S. Oncology, Novartis, told the panel.

She noted that Novartis experienced challenges collecting PRO data, which resulted in risks to data quality and interpretation. “This could very well be amplified in larger trials or in real-world practice.”

The presenters’ comments were echoed by written comments submitted to the CMS prior to the MEDCAC meeting.

The American Society for Blood and Marrow Transplantation (ASBMT), despite supporting the collection of patient-reported outcomes, particularly in oncology, “strongly objects to any mechanism that would tie patient access or provider reimbursement to the reporting of PROs, especially in the case of CAR T therapy,” the organization said in a letter to the CMS.

Optimal PRO instruments and time points “are currently unknown” as the PROs used today were developed around chemotherapy use.

“Mandating the use of a current instrument or set of outcomes through NCD [national coverage determination] or CED [coverage with evidence development] will set a course of collecting data that is very likely to be inaccurate and inadequate,” they said.

The ASBMT also noted there is significant heterogeneity in the CAR T constructs and associated disease indications. “Products will utilize different scientific constructs and the time frames for clinical response and/or potential onset of toxicities may differ for each construct, which will challenge the establishment of set time points for data collection.”

And while presentations and comments focused on PROs in the context of CAR T, conversation and voting on the use of PROs was in the broader context of oncology clinical trials, not specific to CAR T, changing the nature of the debate and calling into question the point of the meeting and how it will inform the national coverage determination on CAR T specifically.

The June 15 meeting announcement published in the Federal Register stated that the advisory committee “will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient’s cancer.”

However, the committee was asked to evaluate evidence on a number of potential PRO instruments in the broader context of oncology clinical trials without a cancer-specific or treatment-specific context, leading to a debate over how different types of cancer will have different kinds of PRO assessments related to them.

The CMS is expected to make a national coverage decision on CAR T-cell therapy by Feb. 16, 2019.

gtwachtman@mdedge.com

Drugmakers and physician groups expressed concern about connecting patient reported outcomes (PRO) to coverage decisions for chimeric antigen receptor T-cell therapy (CAR T) at a recent Medicare meeting.

copyright roobcio/Thinkstock

Despite these objections, members of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) generally expressed confidence in the use of PROs in a series of votes about PRO instruments’ use in cancer care trials.

MEDCAC opened a national coverage analysis in May 2018 at the request of UnitedHealthcare. The insurer had asked the Centers for Medicare & Medicaid Services to clarify the circumstances for coverage of the new CAR T therapies.

In presentations at an Aug. 22 MEDCAC meeting, representatives from the two manufacturers that have approved CAR T treatments on the market cautioned against using PROs in the context of coverage decisions, even though both companies used PRO data in their clinical trials and are collecting it in the postmarketing period.

“While Kite recognizes the importance of PROs in ... clinical trials, the PRO CAR T science, where these instruments are most appropriate for CAR T, remains a still to be determined and still is evolving and still quite early in the developments,” said William Go, MD, PhD, vice president of clinical development at Kite Pharmaceuticals, a Gilead company.

Despite PROs playing an active role in the ongoing development and clinical trials that Kite is running, in the context of CAR T, “we feel PROs are not quite ready for real-world coverage decisions at this time,” Dr. Go said.

A representative from Novartis agreed. “It is important to clearly define research objectives when considering whether to collect patient reported outcomes data, particularly given the burden associated with advanced disease experienced by the patients that are likely to receive this therapy,” Ilia Ferrusi, PhD, associate director, HEOR (CAR T Therapy), U.S. Oncology, Novartis, told the panel.

She noted that Novartis experienced challenges collecting PRO data, which resulted in risks to data quality and interpretation. “This could very well be amplified in larger trials or in real-world practice.”

The presenters’ comments were echoed by written comments submitted to the CMS prior to the MEDCAC meeting.

The American Society for Blood and Marrow Transplantation (ASBMT), despite supporting the collection of patient-reported outcomes, particularly in oncology, “strongly objects to any mechanism that would tie patient access or provider reimbursement to the reporting of PROs, especially in the case of CAR T therapy,” the organization said in a letter to the CMS.

Optimal PRO instruments and time points “are currently unknown” as the PROs used today were developed around chemotherapy use.

“Mandating the use of a current instrument or set of outcomes through NCD [national coverage determination] or CED [coverage with evidence development] will set a course of collecting data that is very likely to be inaccurate and inadequate,” they said.

The ASBMT also noted there is significant heterogeneity in the CAR T constructs and associated disease indications. “Products will utilize different scientific constructs and the time frames for clinical response and/or potential onset of toxicities may differ for each construct, which will challenge the establishment of set time points for data collection.”

And while presentations and comments focused on PROs in the context of CAR T, conversation and voting on the use of PROs was in the broader context of oncology clinical trials, not specific to CAR T, changing the nature of the debate and calling into question the point of the meeting and how it will inform the national coverage determination on CAR T specifically.

The June 15 meeting announcement published in the Federal Register stated that the advisory committee “will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient’s cancer.”

However, the committee was asked to evaluate evidence on a number of potential PRO instruments in the broader context of oncology clinical trials without a cancer-specific or treatment-specific context, leading to a debate over how different types of cancer will have different kinds of PRO assessments related to them.

The CMS is expected to make a national coverage decision on CAR T-cell therapy by Feb. 16, 2019.

gtwachtman@mdedge.com

Drugmakers and physician groups expressed concern about connecting patient reported outcomes (PRO) to coverage decisions for chimeric antigen receptor T-cell therapy (CAR T) at a recent Medicare meeting.

copyright roobcio/Thinkstock

Despite these objections, members of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) generally expressed confidence in the use of PROs in a series of votes about PRO instruments’ use in cancer care trials.

MEDCAC opened a national coverage analysis in May 2018 at the request of UnitedHealthcare. The insurer had asked the Centers for Medicare & Medicaid Services to clarify the circumstances for coverage of the new CAR T therapies.

In presentations at an Aug. 22 MEDCAC meeting, representatives from the two manufacturers that have approved CAR T treatments on the market cautioned against using PROs in the context of coverage decisions, even though both companies used PRO data in their clinical trials and are collecting it in the postmarketing period.

“While Kite recognizes the importance of PROs in ... clinical trials, the PRO CAR T science, where these instruments are most appropriate for CAR T, remains a still to be determined and still is evolving and still quite early in the developments,” said William Go, MD, PhD, vice president of clinical development at Kite Pharmaceuticals, a Gilead company.

Despite PROs playing an active role in the ongoing development and clinical trials that Kite is running, in the context of CAR T, “we feel PROs are not quite ready for real-world coverage decisions at this time,” Dr. Go said.

A representative from Novartis agreed. “It is important to clearly define research objectives when considering whether to collect patient reported outcomes data, particularly given the burden associated with advanced disease experienced by the patients that are likely to receive this therapy,” Ilia Ferrusi, PhD, associate director, HEOR (CAR T Therapy), U.S. Oncology, Novartis, told the panel.

She noted that Novartis experienced challenges collecting PRO data, which resulted in risks to data quality and interpretation. “This could very well be amplified in larger trials or in real-world practice.”

The presenters’ comments were echoed by written comments submitted to the CMS prior to the MEDCAC meeting.

The American Society for Blood and Marrow Transplantation (ASBMT), despite supporting the collection of patient-reported outcomes, particularly in oncology, “strongly objects to any mechanism that would tie patient access or provider reimbursement to the reporting of PROs, especially in the case of CAR T therapy,” the organization said in a letter to the CMS.

Optimal PRO instruments and time points “are currently unknown” as the PROs used today were developed around chemotherapy use.

“Mandating the use of a current instrument or set of outcomes through NCD [national coverage determination] or CED [coverage with evidence development] will set a course of collecting data that is very likely to be inaccurate and inadequate,” they said.

The ASBMT also noted there is significant heterogeneity in the CAR T constructs and associated disease indications. “Products will utilize different scientific constructs and the time frames for clinical response and/or potential onset of toxicities may differ for each construct, which will challenge the establishment of set time points for data collection.”

And while presentations and comments focused on PROs in the context of CAR T, conversation and voting on the use of PROs was in the broader context of oncology clinical trials, not specific to CAR T, changing the nature of the debate and calling into question the point of the meeting and how it will inform the national coverage determination on CAR T specifically.

The June 15 meeting announcement published in the Federal Register stated that the advisory committee “will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient’s cancer.”

However, the committee was asked to evaluate evidence on a number of potential PRO instruments in the broader context of oncology clinical trials without a cancer-specific or treatment-specific context, leading to a debate over how different types of cancer will have different kinds of PRO assessments related to them.

The CMS is expected to make a national coverage decision on CAR T-cell therapy by Feb. 16, 2019.

gtwachtman@mdedge.com

A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.

The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement.

The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.

By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.

Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”

The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.

CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.

The American Gastroenterological Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement. AGA stated that “any change in policy must ensure that patients have access to the appropriate therapies to manage their diseases and not contribute to additional administrative burdens for physician practices.” In addition to responding to CMS, AGA continues to advocate to Congress for patient protections for those subject to step therapy protocols in employer-­sponsored health plans; learn more at http:/ow.ly/kp8l30lnDmp.

The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
 

gtwachtman@mdedge.com

A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.

The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement.

The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.

By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.

Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”

The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.

CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.

The American Gastroenterological Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement. AGA stated that “any change in policy must ensure that patients have access to the appropriate therapies to manage their diseases and not contribute to additional administrative burdens for physician practices.” In addition to responding to CMS, AGA continues to advocate to Congress for patient protections for those subject to step therapy protocols in employer-­sponsored health plans; learn more at http:/ow.ly/kp8l30lnDmp.

The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
 

gtwachtman@mdedge.com

A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.

The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement.

The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.

By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.

Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”

The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.

CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.

The American Gastroenterological Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement. AGA stated that “any change in policy must ensure that patients have access to the appropriate therapies to manage their diseases and not contribute to additional administrative burdens for physician practices.” In addition to responding to CMS, AGA continues to advocate to Congress for patient protections for those subject to step therapy protocols in employer-­sponsored health plans; learn more at http:/ow.ly/kp8l30lnDmp.

The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
 

gtwachtman@mdedge.com

Certain procedures conducted in the hospital outpatient setting could see a reimbursement cut under the physician fee schedule if a proposal introduced by the Centers for Medicare & Medicaid Services is finalized.

In the proposed update to the Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for 2019, CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under OPPS.

According to CMS, the average current clinical visit paid by CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.

“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.

The American Hospital Association already is pushing back on this proposal.

“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”

The OPPS/ASC update also includes proposals to expand the list of covered surgical procedures that can be performed in an ASC, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”

“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.

Another change proposed by CMS relates to how ASC reimbursement rates are updated. They have been based on the consumer price index-­urban, which has resulted in a decline in ASC payments relative to hospitals for the same service. For 2019-2023, CMS proposes to use the hospital market basket instead, which will help promote site neutrality between hospitals and ASCs. The AGA applauds this proposal, and has been working for it with the ACG and ASGE for nearly a decade.

In addition, the OPPS is seeking feedback on a number of topics.

One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.

Finally, the agency is seeking more information on solutions to better promote interoperability.
 

gtwachtman@mdedge.com

Certain procedures conducted in the hospital outpatient setting could see a reimbursement cut under the physician fee schedule if a proposal introduced by the Centers for Medicare & Medicaid Services is finalized.

In the proposed update to the Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for 2019, CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under OPPS.

According to CMS, the average current clinical visit paid by CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.

“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.

The American Hospital Association already is pushing back on this proposal.

“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”

The OPPS/ASC update also includes proposals to expand the list of covered surgical procedures that can be performed in an ASC, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”

“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.

Another change proposed by CMS relates to how ASC reimbursement rates are updated. They have been based on the consumer price index-­urban, which has resulted in a decline in ASC payments relative to hospitals for the same service. For 2019-2023, CMS proposes to use the hospital market basket instead, which will help promote site neutrality between hospitals and ASCs. The AGA applauds this proposal, and has been working for it with the ACG and ASGE for nearly a decade.

In addition, the OPPS is seeking feedback on a number of topics.

One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.

Finally, the agency is seeking more information on solutions to better promote interoperability.
 

gtwachtman@mdedge.com

Certain procedures conducted in the hospital outpatient setting could see a reimbursement cut under the physician fee schedule if a proposal introduced by the Centers for Medicare & Medicaid Services is finalized.

In the proposed update to the Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for 2019, CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under OPPS.

According to CMS, the average current clinical visit paid by CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.

“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.

The American Hospital Association already is pushing back on this proposal.

“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”

The OPPS/ASC update also includes proposals to expand the list of covered surgical procedures that can be performed in an ASC, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”

“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.

Another change proposed by CMS relates to how ASC reimbursement rates are updated. They have been based on the consumer price index-­urban, which has resulted in a decline in ASC payments relative to hospitals for the same service. For 2019-2023, CMS proposes to use the hospital market basket instead, which will help promote site neutrality between hospitals and ASCs. The AGA applauds this proposal, and has been working for it with the ACG and ASGE for nearly a decade.

In addition, the OPPS is seeking feedback on a number of topics.

One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.

Finally, the agency is seeking more information on solutions to better promote interoperability.
 

gtwachtman@mdedge.com

Citing the need to reduce paperwork hassles, officials at the Centers for Medicare & Medicaid Services are proposing to flatten the payment for evaluation and management (E/M) visits coded at levels 2-5.

The CMS outlined how the proposal would affect payment using 2018 rates to model the change. The proposal would set the payment rate for level 1 E/M office visits for new patients at $44, down from the $45 using the current methodology. Levels 2-5 would receive $135. Currently, payments for level 2 visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For office visits with established patients, the proposed rate would be $24, up from the current payment of $22 for a level 1 visit. Levels 2-5 would receive $93. Under the current methodology, payments for level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

The change also comes with a reduced documentation burden, so the same documentation is needed regardless of which level between 2 and 5 the office visit is, a move that is expected to save time.

The CMS outlined its vision for changes to the E/M payment in the proposed update to the 2019 Medicare physician fee schedule. Comments on the proposal are due Sept. 10, 2018.

The agency estimated that for most specialties, there would be minimal effect on this proposed change. However, for 10 specialties, payment reductions could result from this change. The proposal is raising concerns, particularly from those who stand to see their pay reduced.

CMS officials estimate the proposal would save time. CMS Administrator Seema Verma said that the documentation change would result in an additional 51 hours for patient care per clinician per year.

“The agency has clearly heard from physicians about the need to reduce administrative burdens for physicians,” stated Lisa Gangarosa, MD, AGAF, chair, AGA Government Affairs Committee. “In that regard, CMS should be commended. Unfortunately, in their efforts to reduce burden, CMS has proposed changes that drastically undervalue the care gastroenterologists and hepatologists provide to patients with inflammatory bowel disease, motility disorders, chronic liver disease and other complex gastrointestinal diseases.”

Angus B. Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said he was doubtful that any increase in volume would offset the losses from the proposed flat payment across levels 2-5 E/M visits, especially if the pay decrease results in access issues.

gtwachtman@mdedge.com

SOURCE: CMS proposed rule, CMS-1693-P.

Citing the need to reduce paperwork hassles, officials at the Centers for Medicare & Medicaid Services are proposing to flatten the payment for evaluation and management (E/M) visits coded at levels 2-5.

The CMS outlined how the proposal would affect payment using 2018 rates to model the change. The proposal would set the payment rate for level 1 E/M office visits for new patients at $44, down from the $45 using the current methodology. Levels 2-5 would receive $135. Currently, payments for level 2 visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For office visits with established patients, the proposed rate would be $24, up from the current payment of $22 for a level 1 visit. Levels 2-5 would receive $93. Under the current methodology, payments for level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

The change also comes with a reduced documentation burden, so the same documentation is needed regardless of which level between 2 and 5 the office visit is, a move that is expected to save time.

The CMS outlined its vision for changes to the E/M payment in the proposed update to the 2019 Medicare physician fee schedule. Comments on the proposal are due Sept. 10, 2018.

The agency estimated that for most specialties, there would be minimal effect on this proposed change. However, for 10 specialties, payment reductions could result from this change. The proposal is raising concerns, particularly from those who stand to see their pay reduced.

CMS officials estimate the proposal would save time. CMS Administrator Seema Verma said that the documentation change would result in an additional 51 hours for patient care per clinician per year.

“The agency has clearly heard from physicians about the need to reduce administrative burdens for physicians,” stated Lisa Gangarosa, MD, AGAF, chair, AGA Government Affairs Committee. “In that regard, CMS should be commended. Unfortunately, in their efforts to reduce burden, CMS has proposed changes that drastically undervalue the care gastroenterologists and hepatologists provide to patients with inflammatory bowel disease, motility disorders, chronic liver disease and other complex gastrointestinal diseases.”

Angus B. Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said he was doubtful that any increase in volume would offset the losses from the proposed flat payment across levels 2-5 E/M visits, especially if the pay decrease results in access issues.

gtwachtman@mdedge.com

SOURCE: CMS proposed rule, CMS-1693-P.

Citing the need to reduce paperwork hassles, officials at the Centers for Medicare & Medicaid Services are proposing to flatten the payment for evaluation and management (E/M) visits coded at levels 2-5.

The CMS outlined how the proposal would affect payment using 2018 rates to model the change. The proposal would set the payment rate for level 1 E/M office visits for new patients at $44, down from the $45 using the current methodology. Levels 2-5 would receive $135. Currently, payments for level 2 visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.

For office visits with established patients, the proposed rate would be $24, up from the current payment of $22 for a level 1 visit. Levels 2-5 would receive $93. Under the current methodology, payments for level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.

The change also comes with a reduced documentation burden, so the same documentation is needed regardless of which level between 2 and 5 the office visit is, a move that is expected to save time.

The CMS outlined its vision for changes to the E/M payment in the proposed update to the 2019 Medicare physician fee schedule. Comments on the proposal are due Sept. 10, 2018.

The agency estimated that for most specialties, there would be minimal effect on this proposed change. However, for 10 specialties, payment reductions could result from this change. The proposal is raising concerns, particularly from those who stand to see their pay reduced.

CMS officials estimate the proposal would save time. CMS Administrator Seema Verma said that the documentation change would result in an additional 51 hours for patient care per clinician per year.

“The agency has clearly heard from physicians about the need to reduce administrative burdens for physicians,” stated Lisa Gangarosa, MD, AGAF, chair, AGA Government Affairs Committee. “In that regard, CMS should be commended. Unfortunately, in their efforts to reduce burden, CMS has proposed changes that drastically undervalue the care gastroenterologists and hepatologists provide to patients with inflammatory bowel disease, motility disorders, chronic liver disease and other complex gastrointestinal diseases.”

Angus B. Worthing, MD, chair of the American College of Rheumatology’s Committee on Government Affairs, said he was doubtful that any increase in volume would offset the losses from the proposed flat payment across levels 2-5 E/M visits, especially if the pay decrease results in access issues.

gtwachtman@mdedge.com

SOURCE: CMS proposed rule, CMS-1693-P.

Children are more at risk for drug-drug interactions (DDI) as a growing number are taking more than one medication at a time.

IPGGutenbergUKLtd/thinkstockphotos.com

“During 2013-2014, one-fifth of children and adolescents used at least one prescription medication and [about] 1 in 10 concurrently used two [or more] prescription medications,” Dima M. Qato, PharmD, MPH, PhD, of the University of Illinois at Chicago, and her colleagues wrote in Pediatrics. “Among children and adolescents concurrently using two [or more] prescription medications, 1 in 12 was at risk for a major DDI.”

The researchers used data from the six most recent cycles of the National Health and Nutrition Examination Survey conducted by the National Center for Health Statistics, beginning with the 2003-2004 cycle through the 2013-2014 cycle, yielding a sample of 23,152 participants aged 0-19 years across the 10-year period. The survey differentiated between prescriptions for acute use (used for 30 days or less) or for chronic use. Concurrent use was defined as using two or more prescription drugs within the 30 days prior to taking the survey. The Micromedex was used to determine the possibility of having a DDI.

The investigators noted a “notable” decrease in the use of acute drug treatments from 11% at the beginning to 7% at the end of the 10-year cycle (P less than .01). This was “driven largely by a decrease in the use of antibiotics.”

They identified the most commonly used prescription drugs, including respiratory agents, especially bronchodilators (the most common type was albuterol); psychotherapeutic agents, especially CNS stimulants (most commonly methylphenidate); and antidepressants (most commonly fluoxetine).

“Among concurrent users of prescription medications, combinations that involved respiratory agents, such as bronchodilators and leukotriene modifiers, and psychotropic medications, including antidepressants, atypical antipsychotics, and CNS stimulants, were the most prevalent,” Dr. Qato and her colleagues wrote. Of the 301 concurrent users in the 2013-2014 survey cycle, 156 unique drugs were used.

Of the children and adolescents who were concurrently using prescription medications, 8% were at risk for major DDIs, the researchers noted. “Nearly half of interacting regimens used involved psychotropic agents, primarily antidepressants, the most common adverse interaction effect being QT prolongation.” About 68% of these regimens included use of at least one acute medication.

They also found that “prescription medications associated with an increased risk of suicidality are commonly used in children and adolescents and are often used together. For example, more than half of adolescent girls taking antidepressants concurrently use at least two additional psychotropic medications or hormonal contraceptives. Although there is some evidence that the combined use of these drugs may increase the onset and severity of suicidal thoughts and behavior, we found no cases of DDIs associated with suicidality.”

Dr. Qato and her colleagues noted some limitations to their study, including using the potential for DDI rather than actual adverse events, survey data being limited to prescription medications and not over-the-counter treatments, and the possible misclassification of chronic medications as acute medications depending on when treatments were initiated.

That being said, the investigators concluded that treatment “and prevention efforts to reduce the burden of adverse drug events in younger populations should be used to consider the role of interacting drug combinations, especially among these individuals.”

Funding for the study was provided by the Robert Woods Johnson Foundation. No relevant financial disclosures were reported.

gtwachtman@mdedge.com

SOURCE: Qato DM et al. Pediatrics. 2018 Aug 27. doi: 10.1542/peds.2018-1042.

Children are more at risk for drug-drug interactions (DDI) as a growing number are taking more than one medication at a time.

IPGGutenbergUKLtd/thinkstockphotos.com

“During 2013-2014, one-fifth of children and adolescents used at least one prescription medication and [about] 1 in 10 concurrently used two [or more] prescription medications,” Dima M. Qato, PharmD, MPH, PhD, of the University of Illinois at Chicago, and her colleagues wrote in Pediatrics. “Among children and adolescents concurrently using two [or more] prescription medications, 1 in 12 was at risk for a major DDI.”

The researchers used data from the six most recent cycles of the National Health and Nutrition Examination Survey conducted by the National Center for Health Statistics, beginning with the 2003-2004 cycle through the 2013-2014 cycle, yielding a sample of 23,152 participants aged 0-19 years across the 10-year period. The survey differentiated between prescriptions for acute use (used for 30 days or less) or for chronic use. Concurrent use was defined as using two or more prescription drugs within the 30 days prior to taking the survey. The Micromedex was used to determine the possibility of having a DDI.

The investigators noted a “notable” decrease in the use of acute drug treatments from 11% at the beginning to 7% at the end of the 10-year cycle (P less than .01). This was “driven largely by a decrease in the use of antibiotics.”

They identified the most commonly used prescription drugs, including respiratory agents, especially bronchodilators (the most common type was albuterol); psychotherapeutic agents, especially CNS stimulants (most commonly methylphenidate); and antidepressants (most commonly fluoxetine).

“Among concurrent users of prescription medications, combinations that involved respiratory agents, such as bronchodilators and leukotriene modifiers, and psychotropic medications, including antidepressants, atypical antipsychotics, and CNS stimulants, were the most prevalent,” Dr. Qato and her colleagues wrote. Of the 301 concurrent users in the 2013-2014 survey cycle, 156 unique drugs were used.

Of the children and adolescents who were concurrently using prescription medications, 8% were at risk for major DDIs, the researchers noted. “Nearly half of interacting regimens used involved psychotropic agents, primarily antidepressants, the most common adverse interaction effect being QT prolongation.” About 68% of these regimens included use of at least one acute medication.

They also found that “prescription medications associated with an increased risk of suicidality are commonly used in children and adolescents and are often used together. For example, more than half of adolescent girls taking antidepressants concurrently use at least two additional psychotropic medications or hormonal contraceptives. Although there is some evidence that the combined use of these drugs may increase the onset and severity of suicidal thoughts and behavior, we found no cases of DDIs associated with suicidality.”

Dr. Qato and her colleagues noted some limitations to their study, including using the potential for DDI rather than actual adverse events, survey data being limited to prescription medications and not over-the-counter treatments, and the possible misclassification of chronic medications as acute medications depending on when treatments were initiated.

That being said, the investigators concluded that treatment “and prevention efforts to reduce the burden of adverse drug events in younger populations should be used to consider the role of interacting drug combinations, especially among these individuals.”

Funding for the study was provided by the Robert Woods Johnson Foundation. No relevant financial disclosures were reported.

gtwachtman@mdedge.com

SOURCE: Qato DM et al. Pediatrics. 2018 Aug 27. doi: 10.1542/peds.2018-1042.

Children are more at risk for drug-drug interactions (DDI) as a growing number are taking more than one medication at a time.

IPGGutenbergUKLtd/thinkstockphotos.com

“During 2013-2014, one-fifth of children and adolescents used at least one prescription medication and [about] 1 in 10 concurrently used two [or more] prescription medications,” Dima M. Qato, PharmD, MPH, PhD, of the University of Illinois at Chicago, and her colleagues wrote in Pediatrics. “Among children and adolescents concurrently using two [or more] prescription medications, 1 in 12 was at risk for a major DDI.”

The researchers used data from the six most recent cycles of the National Health and Nutrition Examination Survey conducted by the National Center for Health Statistics, beginning with the 2003-2004 cycle through the 2013-2014 cycle, yielding a sample of 23,152 participants aged 0-19 years across the 10-year period. The survey differentiated between prescriptions for acute use (used for 30 days or less) or for chronic use. Concurrent use was defined as using two or more prescription drugs within the 30 days prior to taking the survey. The Micromedex was used to determine the possibility of having a DDI.

The investigators noted a “notable” decrease in the use of acute drug treatments from 11% at the beginning to 7% at the end of the 10-year cycle (P less than .01). This was “driven largely by a decrease in the use of antibiotics.”

They identified the most commonly used prescription drugs, including respiratory agents, especially bronchodilators (the most common type was albuterol); psychotherapeutic agents, especially CNS stimulants (most commonly methylphenidate); and antidepressants (most commonly fluoxetine).

“Among concurrent users of prescription medications, combinations that involved respiratory agents, such as bronchodilators and leukotriene modifiers, and psychotropic medications, including antidepressants, atypical antipsychotics, and CNS stimulants, were the most prevalent,” Dr. Qato and her colleagues wrote. Of the 301 concurrent users in the 2013-2014 survey cycle, 156 unique drugs were used.

Of the children and adolescents who were concurrently using prescription medications, 8% were at risk for major DDIs, the researchers noted. “Nearly half of interacting regimens used involved psychotropic agents, primarily antidepressants, the most common adverse interaction effect being QT prolongation.” About 68% of these regimens included use of at least one acute medication.

They also found that “prescription medications associated with an increased risk of suicidality are commonly used in children and adolescents and are often used together. For example, more than half of adolescent girls taking antidepressants concurrently use at least two additional psychotropic medications or hormonal contraceptives. Although there is some evidence that the combined use of these drugs may increase the onset and severity of suicidal thoughts and behavior, we found no cases of DDIs associated with suicidality.”

Dr. Qato and her colleagues noted some limitations to their study, including using the potential for DDI rather than actual adverse events, survey data being limited to prescription medications and not over-the-counter treatments, and the possible misclassification of chronic medications as acute medications depending on when treatments were initiated.

That being said, the investigators concluded that treatment “and prevention efforts to reduce the burden of adverse drug events in younger populations should be used to consider the role of interacting drug combinations, especially among these individuals.”

Funding for the study was provided by the Robert Woods Johnson Foundation. No relevant financial disclosures were reported.

gtwachtman@mdedge.com

SOURCE: Qato DM et al. Pediatrics. 2018 Aug 27. doi: 10.1542/peds.2018-1042.

Photo by Bill Branson

Prescription drug coverage at diagnosis is associated with outcomes among Medicare beneficiaries with myeloma, according to new research.

Patients enrolled in a Medicare Part D plan (PDP) and those with other creditable prescription drug coverage (OCC) at the time of myeloma diagnosis were more likely to receive active care and had better overall survival (OS) than Medicare beneficiaries with no drug coverage.

Adam Olszewski, MD, of Rhode Island Hospital in Providence, and his colleagues reported these findings in the Journal of Clinical Oncology.

The researchers looked at 9755 patients diagnosed with myeloma from 2006 to 2011, assessing the patients’ first-line treatment and OS.

The team classified patients according to the prescription drug coverage they had at myeloma diagnosis. There were 1460 patients with no prescription drug coverage, 3283 with PDP, 3607 with OCC, and 1405 with dual eligibility for Medicare and Medicaid coverage.

Treatment

In a multivariate analysis, PDP beneficiaries were 6% more likely than beneficiaries with no drug coverage to receive active care for myeloma.

However, PDP beneficiaries were 14% less likely to receive parenteral chemotherapy and 38% less likely to receive classic cytotoxic agents. The use of bortezomib-based regimens was similar between PDP patients and those with no drug coverage.

Beneficiaries with OCC were 3% more likely than those with no drug coverage to receive active myeloma care. The use of parenteral chemotherapy, classic cytotoxic agents, and bortezomib-based regimens was similar between the OCC group and the group without drug coverage.

Medicare/Medicaid dual enrollees were about as likely as beneficiaries with no drug coverage to receive active myeloma care. However, the dual enrollees were less likely to receive parenteral chemotherapy, classic cytotoxic agents, and bortezomib-based regimens.

Survival

The median follow-up was 4.9 years. The median survival for all myeloma patients was 2.3 years, and the 3-year OS was 43.1%.

The researchers noted that, among the beneficiaries without drug coverage at diagnosis, 41% had obtained PDP or OCC by the following January. Even so, their OS was significantly worse than beneficiaries who had PDP or OCC at diagnosis.

In a multivariate analysis, OS was 16% longer in both the PDP group and the OCC group than in the group without drug coverage at diagnosis. OS was 8% longer for dual enrollees than for patients without drug coverage.

Dr Olszewski and his colleagues noted that survival differences were largest during the first year and decreased over time as more patients without drug coverage obtained coverage.

The researchers said they couldn’t determine whether the worse OS in the group without drug coverage was the result of not receiving therapy, lack of access to immunomodulatory drugs, or other medical issues.

The team also said their findings should be interpreted with caution because the survival results are “confounded by multiple baseline factors and mediated by the quality of cancer treatment.”

Still, the results “strongly suggest that patients with myeloma without prescription drug coverage may not have received the most effective first-line therapy,” Dr Olszewski and his colleagues wrote.

“Survival for PDP and OCC groups remained identical, which supports the notion that having any prescription drug coverage contributed to optimal treatment and outcomes.”

Photo by Bill Branson

Prescription drug coverage at diagnosis is associated with outcomes among Medicare beneficiaries with myeloma, according to new research.

Patients enrolled in a Medicare Part D plan (PDP) and those with other creditable prescription drug coverage (OCC) at the time of myeloma diagnosis were more likely to receive active care and had better overall survival (OS) than Medicare beneficiaries with no drug coverage.

Adam Olszewski, MD, of Rhode Island Hospital in Providence, and his colleagues reported these findings in the Journal of Clinical Oncology.

The researchers looked at 9755 patients diagnosed with myeloma from 2006 to 2011, assessing the patients’ first-line treatment and OS.

The team classified patients according to the prescription drug coverage they had at myeloma diagnosis. There were 1460 patients with no prescription drug coverage, 3283 with PDP, 3607 with OCC, and 1405 with dual eligibility for Medicare and Medicaid coverage.

Treatment

In a multivariate analysis, PDP beneficiaries were 6% more likely than beneficiaries with no drug coverage to receive active care for myeloma.

However, PDP beneficiaries were 14% less likely to receive parenteral chemotherapy and 38% less likely to receive classic cytotoxic agents. The use of bortezomib-based regimens was similar between PDP patients and those with no drug coverage.

Beneficiaries with OCC were 3% more likely than those with no drug coverage to receive active myeloma care. The use of parenteral chemotherapy, classic cytotoxic agents, and bortezomib-based regimens was similar between the OCC group and the group without drug coverage.

Medicare/Medicaid dual enrollees were about as likely as beneficiaries with no drug coverage to receive active myeloma care. However, the dual enrollees were less likely to receive parenteral chemotherapy, classic cytotoxic agents, and bortezomib-based regimens.

Survival

The median follow-up was 4.9 years. The median survival for all myeloma patients was 2.3 years, and the 3-year OS was 43.1%.

The researchers noted that, among the beneficiaries without drug coverage at diagnosis, 41% had obtained PDP or OCC by the following January. Even so, their OS was significantly worse than beneficiaries who had PDP or OCC at diagnosis.

In a multivariate analysis, OS was 16% longer in both the PDP group and the OCC group than in the group without drug coverage at diagnosis. OS was 8% longer for dual enrollees than for patients without drug coverage.

Dr Olszewski and his colleagues noted that survival differences were largest during the first year and decreased over time as more patients without drug coverage obtained coverage.

The researchers said they couldn’t determine whether the worse OS in the group without drug coverage was the result of not receiving therapy, lack of access to immunomodulatory drugs, or other medical issues.

The team also said their findings should be interpreted with caution because the survival results are “confounded by multiple baseline factors and mediated by the quality of cancer treatment.”

Still, the results “strongly suggest that patients with myeloma without prescription drug coverage may not have received the most effective first-line therapy,” Dr Olszewski and his colleagues wrote.

“Survival for PDP and OCC groups remained identical, which supports the notion that having any prescription drug coverage contributed to optimal treatment and outcomes.”

Photo by Bill Branson

Prescription drug coverage at diagnosis is associated with outcomes among Medicare beneficiaries with myeloma, according to new research.

Patients enrolled in a Medicare Part D plan (PDP) and those with other creditable prescription drug coverage (OCC) at the time of myeloma diagnosis were more likely to receive active care and had better overall survival (OS) than Medicare beneficiaries with no drug coverage.

Adam Olszewski, MD, of Rhode Island Hospital in Providence, and his colleagues reported these findings in the Journal of Clinical Oncology.

The researchers looked at 9755 patients diagnosed with myeloma from 2006 to 2011, assessing the patients’ first-line treatment and OS.

The team classified patients according to the prescription drug coverage they had at myeloma diagnosis. There were 1460 patients with no prescription drug coverage, 3283 with PDP, 3607 with OCC, and 1405 with dual eligibility for Medicare and Medicaid coverage.

Treatment

In a multivariate analysis, PDP beneficiaries were 6% more likely than beneficiaries with no drug coverage to receive active care for myeloma.

However, PDP beneficiaries were 14% less likely to receive parenteral chemotherapy and 38% less likely to receive classic cytotoxic agents. The use of bortezomib-based regimens was similar between PDP patients and those with no drug coverage.

Beneficiaries with OCC were 3% more likely than those with no drug coverage to receive active myeloma care. The use of parenteral chemotherapy, classic cytotoxic agents, and bortezomib-based regimens was similar between the OCC group and the group without drug coverage.

Medicare/Medicaid dual enrollees were about as likely as beneficiaries with no drug coverage to receive active myeloma care. However, the dual enrollees were less likely to receive parenteral chemotherapy, classic cytotoxic agents, and bortezomib-based regimens.

Survival

The median follow-up was 4.9 years. The median survival for all myeloma patients was 2.3 years, and the 3-year OS was 43.1%.

The researchers noted that, among the beneficiaries without drug coverage at diagnosis, 41% had obtained PDP or OCC by the following January. Even so, their OS was significantly worse than beneficiaries who had PDP or OCC at diagnosis.

In a multivariate analysis, OS was 16% longer in both the PDP group and the OCC group than in the group without drug coverage at diagnosis. OS was 8% longer for dual enrollees than for patients without drug coverage.

Dr Olszewski and his colleagues noted that survival differences were largest during the first year and decreased over time as more patients without drug coverage obtained coverage.

The researchers said they couldn’t determine whether the worse OS in the group without drug coverage was the result of not receiving therapy, lack of access to immunomodulatory drugs, or other medical issues.

The team also said their findings should be interpreted with caution because the survival results are “confounded by multiple baseline factors and mediated by the quality of cancer treatment.”

Still, the results “strongly suggest that patients with myeloma without prescription drug coverage may not have received the most effective first-line therapy,” Dr Olszewski and his colleagues wrote.

“Survival for PDP and OCC groups remained identical, which supports the notion that having any prescription drug coverage contributed to optimal treatment and outcomes.”