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MIPS: Nearly all eligible clinicians got a bonus for 2018
Nearly all clinicians who are eligible to participate in the Merit-Based Incentive Payment System (MIPS) track of the Quality Payment Program did so in 2018; most scored above the performance threshold and got a bonus.
According to the most recent data released this month by the Centers for Medicare & Medicaid Services, 98.37% of MIPS-eligible clinicians participated in the program. In the small/solo practice space, 89.20% of MIPS-eligible clinicians participated.
But more importantly, the clinicians are performing better one year later with the program, even though fewer are participating.
In 2018, 97.63% of clinicians scored above the performance threshold, up from 93.12% in 2017. There also were fewer clinicians performing at the threshold (0.42% in 2018, down from 2.01% in the previous year) and fewer clinicians scoring below the threshold (1.95%, down from 4.87%).
Exceeding the performance threshold resulted in a bonus to fee schedule payments in 2018, although the agency did not disclose how much money was paid out in performance bonuses.
MIPS scored “improved across performance categories, with the biggest gain in the Quality performance category, which highlights the program’s effectiveness in measuring outcomes for beneficiaries,” CMS Administrator Seema Verma wrote in a blog post.
The total number of eligible clinicians decreased in 2018 to 916,058, down from 1,057,824 in 2017 because CMS broadened the low-volume threshold to exempt providers from participation requirements.
Participants in a MIPS alternative payment model saw even more success in 2018. Participation increased from 341,220 clinicians in 2017 to 356,828 clinicians in 2018, while virtually all performed above the performance threshold (100% in 2017 and 99.99% in 2018). The 0.01% that was not above the threshold still met it, while no clinicians in either year that participated in a MIPS alternative payment model performed below the threshold.
Participation in the advanced alternative payment model track increased as well, going from 99,026 in 2017 to 183,306 in 2018.
Nearly all clinicians who are eligible to participate in the Merit-Based Incentive Payment System (MIPS) track of the Quality Payment Program did so in 2018; most scored above the performance threshold and got a bonus.
According to the most recent data released this month by the Centers for Medicare & Medicaid Services, 98.37% of MIPS-eligible clinicians participated in the program. In the small/solo practice space, 89.20% of MIPS-eligible clinicians participated.
But more importantly, the clinicians are performing better one year later with the program, even though fewer are participating.
In 2018, 97.63% of clinicians scored above the performance threshold, up from 93.12% in 2017. There also were fewer clinicians performing at the threshold (0.42% in 2018, down from 2.01% in the previous year) and fewer clinicians scoring below the threshold (1.95%, down from 4.87%).
Exceeding the performance threshold resulted in a bonus to fee schedule payments in 2018, although the agency did not disclose how much money was paid out in performance bonuses.
MIPS scored “improved across performance categories, with the biggest gain in the Quality performance category, which highlights the program’s effectiveness in measuring outcomes for beneficiaries,” CMS Administrator Seema Verma wrote in a blog post.
The total number of eligible clinicians decreased in 2018 to 916,058, down from 1,057,824 in 2017 because CMS broadened the low-volume threshold to exempt providers from participation requirements.
Participants in a MIPS alternative payment model saw even more success in 2018. Participation increased from 341,220 clinicians in 2017 to 356,828 clinicians in 2018, while virtually all performed above the performance threshold (100% in 2017 and 99.99% in 2018). The 0.01% that was not above the threshold still met it, while no clinicians in either year that participated in a MIPS alternative payment model performed below the threshold.
Participation in the advanced alternative payment model track increased as well, going from 99,026 in 2017 to 183,306 in 2018.
Nearly all clinicians who are eligible to participate in the Merit-Based Incentive Payment System (MIPS) track of the Quality Payment Program did so in 2018; most scored above the performance threshold and got a bonus.
According to the most recent data released this month by the Centers for Medicare & Medicaid Services, 98.37% of MIPS-eligible clinicians participated in the program. In the small/solo practice space, 89.20% of MIPS-eligible clinicians participated.
But more importantly, the clinicians are performing better one year later with the program, even though fewer are participating.
In 2018, 97.63% of clinicians scored above the performance threshold, up from 93.12% in 2017. There also were fewer clinicians performing at the threshold (0.42% in 2018, down from 2.01% in the previous year) and fewer clinicians scoring below the threshold (1.95%, down from 4.87%).
Exceeding the performance threshold resulted in a bonus to fee schedule payments in 2018, although the agency did not disclose how much money was paid out in performance bonuses.
MIPS scored “improved across performance categories, with the biggest gain in the Quality performance category, which highlights the program’s effectiveness in measuring outcomes for beneficiaries,” CMS Administrator Seema Verma wrote in a blog post.
The total number of eligible clinicians decreased in 2018 to 916,058, down from 1,057,824 in 2017 because CMS broadened the low-volume threshold to exempt providers from participation requirements.
Participants in a MIPS alternative payment model saw even more success in 2018. Participation increased from 341,220 clinicians in 2017 to 356,828 clinicians in 2018, while virtually all performed above the performance threshold (100% in 2017 and 99.99% in 2018). The 0.01% that was not above the threshold still met it, while no clinicians in either year that participated in a MIPS alternative payment model performed below the threshold.
Participation in the advanced alternative payment model track increased as well, going from 99,026 in 2017 to 183,306 in 2018.
Surprise medical billing legislation advances to the House floor
Legislation to end surprise medical billing cleared the House Energy and Commerce Committee and is headed to the House floor, but it contains a somewhat controversial arbitration mechanism that allows physicians and hospitals to seek higher payments within 30 days.
The bill, which was tacked on to H.R. 2328, passed the committee by voice vote on July 17. The amendment on arbitration also passed the committee via voice vote.
“Our most important task today is to protect patients from the unreasonable and unacceptable practice of surprise billing,” Rep. Frank Pallone (D-N.J.), chairman of the Energy and Commerce Committee, said just prior to the votes being taken by the committee. “Under the [legislation], providers would no longer be able to balance bill patients for out-of-network emergency services or for scheduled services from providers the patient was not aware would be in their treatment.”
Out-of-network providers would receive a benchmark payment for the services they provided under the legislation.
Rep. Pallone described the legislation as taking patients out of the middle of disputes between payers and providers.
He went on to describe the arbitration amendment, introduced by Rep. Raul Ruiz, MD, (D.-Calif.) and Rep. Larry Bucshon, MD, (R-Ind.), as creating an independent dispute resolution process for physicians and hospitals to file a claim in the event that they don’t think they were adequately paid for their services.
“The amendment would allow providers to have 30 days within which to file an appeal of the benchmark payment with the insurer,” Rep. Pallone said. “The insurer would then have 30 days to adjudicate the appeal, after which the provider could initiate independent dispute resolution.”
The amendment limits appeals to extenuating circumstances so that only complex cases would qualify, and it limits the variables that can be considered during arbitration to the quality of care that was provided to the patient, according to Rep. Pallone.
“Most importantly to me, it bars arbitrators from considering billed charges, which are unilaterally set by providers,” Rep. Pallone said. “Provider charges are often double or triple Medicare rates, and in some cases for some large physician staffing companies, it is around 500% of Medicare rates. If Congress sends this signal to arbiters that provider charges are to be considered, we would be creating a significantly higher standard for payment, decreasing incentives for providers to be in network and putting upward pressure on health care premiums.”
Rep. Michael Burgess, MD, (R-Texas) praised the inclusion of the arbitration amendment and said the surprise billing legislation would not be able to be passed without its inclusion.
Rep. Janice Schakowsky (D-Ill.) offered a dissenting voice to the amendment. “Arbitration, in my view, which is used as the backstop, will not lower the health care costs,” she said. “Arbitration actually comes with additional administrative costs and complexities, which could then be passed on to consumers in the form of higher premiums. Even as a backstop, I think that binding arbitration leaves a public interest, public health decision, up to an unaccountable private decision maker, and I don’t think that is a very progressive way to be dealing with the issue of pricing.”
The American Medical Association praised the inclusion of an appeals process for resolving out-of-network payment disputes. “This addition represents progress,” Patrice Harris, MD, president of the AMA, said in a statement. “While we continue to have concerns with elements of the legislation, we remain committed to working with all committee members to secure further improvements to protect patients, preserve access, and foster fair payments for out-of-network services.”
America’s Health Insurance Plans, which represents health insurers, voiced its opposition to the arbitration provision. “We strongly oppose the inclusion of arbitration because it does not solve the problem of surprise medical bills,” AHIP President and CEO Matt Eyles said in a statement. “It increases the financial burden on everyone with coverage, increasing patient premiums and driving up the cost of health care. The arbitration proposal allows private-equity firms and certain providers to price gouge patients and then shifts the final decision to a ‘third party.’ This process introduces new bureaucracy and red tape into the system, with costs to hardworking taxpayers exceeding $1 billion.”
Benedic Ippolito, research fellow in economic policy studies at the American Economic Institute, further criticized the use of arbitration in this process.
“This concept that arbitration is a backstop doesn’t really make a lot of sense,” he said during a July 17 panel discussion hosted by the Bipartisan Policy Center on surprise billing. “The arbiter has to do the same thing any sort of rate setter has to do.” He noted that if they are doing “baseball-style” arbitration, they have to choose between two offers placed in front of the arbiter, based on what the arbiter believes to be closer to whatever the reasonable rate is.
This process will eventually lead to either a system that favors the payer, the provider, or ends up being exactly what the benchmark is that has been set. “If it is better for one or the other, somebody is going to have an incentive to just trigger this thing the whole time,” Mr. Ippolito said.
Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, said during the panel discussion that “there is no policy reason to have arbitration. There is nothing it adds for policy value.”
Mr. Adler called the arbitration amendment “a provider giveaway bill,” adding that if there has to be an arbitration option, it should have a very high threshold to be triggered.
Legislation to end surprise medical billing cleared the House Energy and Commerce Committee and is headed to the House floor, but it contains a somewhat controversial arbitration mechanism that allows physicians and hospitals to seek higher payments within 30 days.
The bill, which was tacked on to H.R. 2328, passed the committee by voice vote on July 17. The amendment on arbitration also passed the committee via voice vote.
“Our most important task today is to protect patients from the unreasonable and unacceptable practice of surprise billing,” Rep. Frank Pallone (D-N.J.), chairman of the Energy and Commerce Committee, said just prior to the votes being taken by the committee. “Under the [legislation], providers would no longer be able to balance bill patients for out-of-network emergency services or for scheduled services from providers the patient was not aware would be in their treatment.”
Out-of-network providers would receive a benchmark payment for the services they provided under the legislation.
Rep. Pallone described the legislation as taking patients out of the middle of disputes between payers and providers.
He went on to describe the arbitration amendment, introduced by Rep. Raul Ruiz, MD, (D.-Calif.) and Rep. Larry Bucshon, MD, (R-Ind.), as creating an independent dispute resolution process for physicians and hospitals to file a claim in the event that they don’t think they were adequately paid for their services.
“The amendment would allow providers to have 30 days within which to file an appeal of the benchmark payment with the insurer,” Rep. Pallone said. “The insurer would then have 30 days to adjudicate the appeal, after which the provider could initiate independent dispute resolution.”
The amendment limits appeals to extenuating circumstances so that only complex cases would qualify, and it limits the variables that can be considered during arbitration to the quality of care that was provided to the patient, according to Rep. Pallone.
“Most importantly to me, it bars arbitrators from considering billed charges, which are unilaterally set by providers,” Rep. Pallone said. “Provider charges are often double or triple Medicare rates, and in some cases for some large physician staffing companies, it is around 500% of Medicare rates. If Congress sends this signal to arbiters that provider charges are to be considered, we would be creating a significantly higher standard for payment, decreasing incentives for providers to be in network and putting upward pressure on health care premiums.”
Rep. Michael Burgess, MD, (R-Texas) praised the inclusion of the arbitration amendment and said the surprise billing legislation would not be able to be passed without its inclusion.
Rep. Janice Schakowsky (D-Ill.) offered a dissenting voice to the amendment. “Arbitration, in my view, which is used as the backstop, will not lower the health care costs,” she said. “Arbitration actually comes with additional administrative costs and complexities, which could then be passed on to consumers in the form of higher premiums. Even as a backstop, I think that binding arbitration leaves a public interest, public health decision, up to an unaccountable private decision maker, and I don’t think that is a very progressive way to be dealing with the issue of pricing.”
The American Medical Association praised the inclusion of an appeals process for resolving out-of-network payment disputes. “This addition represents progress,” Patrice Harris, MD, president of the AMA, said in a statement. “While we continue to have concerns with elements of the legislation, we remain committed to working with all committee members to secure further improvements to protect patients, preserve access, and foster fair payments for out-of-network services.”
America’s Health Insurance Plans, which represents health insurers, voiced its opposition to the arbitration provision. “We strongly oppose the inclusion of arbitration because it does not solve the problem of surprise medical bills,” AHIP President and CEO Matt Eyles said in a statement. “It increases the financial burden on everyone with coverage, increasing patient premiums and driving up the cost of health care. The arbitration proposal allows private-equity firms and certain providers to price gouge patients and then shifts the final decision to a ‘third party.’ This process introduces new bureaucracy and red tape into the system, with costs to hardworking taxpayers exceeding $1 billion.”
Benedic Ippolito, research fellow in economic policy studies at the American Economic Institute, further criticized the use of arbitration in this process.
“This concept that arbitration is a backstop doesn’t really make a lot of sense,” he said during a July 17 panel discussion hosted by the Bipartisan Policy Center on surprise billing. “The arbiter has to do the same thing any sort of rate setter has to do.” He noted that if they are doing “baseball-style” arbitration, they have to choose between two offers placed in front of the arbiter, based on what the arbiter believes to be closer to whatever the reasonable rate is.
This process will eventually lead to either a system that favors the payer, the provider, or ends up being exactly what the benchmark is that has been set. “If it is better for one or the other, somebody is going to have an incentive to just trigger this thing the whole time,” Mr. Ippolito said.
Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, said during the panel discussion that “there is no policy reason to have arbitration. There is nothing it adds for policy value.”
Mr. Adler called the arbitration amendment “a provider giveaway bill,” adding that if there has to be an arbitration option, it should have a very high threshold to be triggered.
Legislation to end surprise medical billing cleared the House Energy and Commerce Committee and is headed to the House floor, but it contains a somewhat controversial arbitration mechanism that allows physicians and hospitals to seek higher payments within 30 days.
The bill, which was tacked on to H.R. 2328, passed the committee by voice vote on July 17. The amendment on arbitration also passed the committee via voice vote.
“Our most important task today is to protect patients from the unreasonable and unacceptable practice of surprise billing,” Rep. Frank Pallone (D-N.J.), chairman of the Energy and Commerce Committee, said just prior to the votes being taken by the committee. “Under the [legislation], providers would no longer be able to balance bill patients for out-of-network emergency services or for scheduled services from providers the patient was not aware would be in their treatment.”
Out-of-network providers would receive a benchmark payment for the services they provided under the legislation.
Rep. Pallone described the legislation as taking patients out of the middle of disputes between payers and providers.
He went on to describe the arbitration amendment, introduced by Rep. Raul Ruiz, MD, (D.-Calif.) and Rep. Larry Bucshon, MD, (R-Ind.), as creating an independent dispute resolution process for physicians and hospitals to file a claim in the event that they don’t think they were adequately paid for their services.
“The amendment would allow providers to have 30 days within which to file an appeal of the benchmark payment with the insurer,” Rep. Pallone said. “The insurer would then have 30 days to adjudicate the appeal, after which the provider could initiate independent dispute resolution.”
The amendment limits appeals to extenuating circumstances so that only complex cases would qualify, and it limits the variables that can be considered during arbitration to the quality of care that was provided to the patient, according to Rep. Pallone.
“Most importantly to me, it bars arbitrators from considering billed charges, which are unilaterally set by providers,” Rep. Pallone said. “Provider charges are often double or triple Medicare rates, and in some cases for some large physician staffing companies, it is around 500% of Medicare rates. If Congress sends this signal to arbiters that provider charges are to be considered, we would be creating a significantly higher standard for payment, decreasing incentives for providers to be in network and putting upward pressure on health care premiums.”
Rep. Michael Burgess, MD, (R-Texas) praised the inclusion of the arbitration amendment and said the surprise billing legislation would not be able to be passed without its inclusion.
Rep. Janice Schakowsky (D-Ill.) offered a dissenting voice to the amendment. “Arbitration, in my view, which is used as the backstop, will not lower the health care costs,” she said. “Arbitration actually comes with additional administrative costs and complexities, which could then be passed on to consumers in the form of higher premiums. Even as a backstop, I think that binding arbitration leaves a public interest, public health decision, up to an unaccountable private decision maker, and I don’t think that is a very progressive way to be dealing with the issue of pricing.”
The American Medical Association praised the inclusion of an appeals process for resolving out-of-network payment disputes. “This addition represents progress,” Patrice Harris, MD, president of the AMA, said in a statement. “While we continue to have concerns with elements of the legislation, we remain committed to working with all committee members to secure further improvements to protect patients, preserve access, and foster fair payments for out-of-network services.”
America’s Health Insurance Plans, which represents health insurers, voiced its opposition to the arbitration provision. “We strongly oppose the inclusion of arbitration because it does not solve the problem of surprise medical bills,” AHIP President and CEO Matt Eyles said in a statement. “It increases the financial burden on everyone with coverage, increasing patient premiums and driving up the cost of health care. The arbitration proposal allows private-equity firms and certain providers to price gouge patients and then shifts the final decision to a ‘third party.’ This process introduces new bureaucracy and red tape into the system, with costs to hardworking taxpayers exceeding $1 billion.”
Benedic Ippolito, research fellow in economic policy studies at the American Economic Institute, further criticized the use of arbitration in this process.
“This concept that arbitration is a backstop doesn’t really make a lot of sense,” he said during a July 17 panel discussion hosted by the Bipartisan Policy Center on surprise billing. “The arbiter has to do the same thing any sort of rate setter has to do.” He noted that if they are doing “baseball-style” arbitration, they have to choose between two offers placed in front of the arbiter, based on what the arbiter believes to be closer to whatever the reasonable rate is.
This process will eventually lead to either a system that favors the payer, the provider, or ends up being exactly what the benchmark is that has been set. “If it is better for one or the other, somebody is going to have an incentive to just trigger this thing the whole time,” Mr. Ippolito said.
Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, said during the panel discussion that “there is no policy reason to have arbitration. There is nothing it adds for policy value.”
Mr. Adler called the arbitration amendment “a provider giveaway bill,” adding that if there has to be an arbitration option, it should have a very high threshold to be triggered.
First take on radiation oncology APM mixed
Radiation oncologists are applauding the Centers for Medicare & Medicaid Services’ introduction of a test radiation oncology alternative payment model (APM) to help encourage the move to value-based care, but concerns, particularly about its mandatory participation, have been raised.
The proposed radiation oncology APM, posted online as part of a larger notice of proposed rulemaking on July 10 and scheduled for publication in the Federal Register on July 18, will be tested over a 5-year period to determine if a prospective, site-neutral, episode-based payment for radiation therapy will improve the quality of care and lower costs for Medicare. Comments on the proposal are due 60 days from Federal Register publication.
According to the CMS website, the agency would make “prospective, episode-based (i.e. bundled) payments, based on a patient’s cancer diagnosis, that would cover radiotherapy services furnished in a 90-day episode for the 17 cancer types meeting the included cancer type criteria.”
The site-neutral payments would be based on a “common, adjusted national base payment amount” and would contain two components (professional and technical) “to allow for use of current claims systems for PFS [physician fee schedule] and OPPS [outpatient prospective payment system] to be used to adjudicate RO (radiation oncology) Model claims and be consistent with existing business relationships.”
Payments would be linked to quality “using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to participants.” The radiation oncology model qualifies as an advanced alternative payment model under the Quality Payment Program.
In addition to measuring whether the model improves quality and lowers costs, CMS will be studying whether it results in shorter courses of radiation therapy, more efficient care delivery, and higher-value care for Medicare beneficiaries.
The biggest detail about this proposed alternative payment model that is raising some red flags within the community is that it has a mandatory participation requirement, with participation determined by a random selection of providers in selected geographic areas.
The Community Oncology Alliance said in a statement that it has “deep reservations and fundamental opposition to a proposed mandatory or ‘required’ Center for Medicare & Medicaid Innovation model. Radiation therapy is a powerful, complex part of cancer care for patients. While the proposed CMMI model does include a much-needed policy proposal to implement site-neutral payments, COA absolutely does not support mandatory CMMI models,” adding that if models are “reasonable and would advance value-based care, then voluntary provider participation would be robust.”
Dave Adler, vice president of advocacy at the American Society for Radiation Oncology, also expressed concern regarding the requirement for participation.
“At least at the outset, having a voluntary model is the right way to start,” he said in an interview. “This is something that has not been tested before. I think it’s really important to its long-term success that we understand its impact on providers and patients before it’s required for anybody.”
He offered a little flexibility on that stance, noting that if CMS would not budge on the mandatory aspect, he suggested that it lower the amount of participation that will be required from the proposed 40% of radiation oncologists to something smaller, coupled with a mechanism for voluntary participation, which does not exist in the current proposal.
Outside of that immediate concern, Mr. Adler said it was really too early to tell whether the proposal is in fact adequate to meet the needs of practicing radiation oncologists, including the payment rates, and the patients they treat. He said ASTRO will be doing a deeper analysis in the coming weeks and will provide the necessary feedback to CMS on the proposal.
Another thing that stood out as concerning was the start date, which CMS suggested could be as early as January 2020, but it also suggested that could be pushed back to April 2020. Practices won’t know if they are selected as required to participate until the final rule is issued, likely in November.
“We are pleased that CMS seems to be open to considering an April 1 start date,” he said. “That’s probably the earliest that it could start,” adding that ASTRO might look to see if there is an opportunity to encourage CMS to implement a rolling start date.
He also noted that CMS did not include any sort of hardship exemption for practices that have a rationale for not wanting to or being able to participate.
That, and including a voluntary participation option, “can be done without compromising the evaluation of the model.”
That being said, Mr. Adler spoke positively in general.
“We are moving in the right direction here with the model,” he said. “We are very much committed to working with CMS and our champions in Congress constructively to improve upon what has been proposed here.”
One thing he liked was the prospective payment aspect of the model.
“Radiation oncology practices, given the expense of the equipment, the staff, and the delivery of the sophisticated treatment requires a huge up-front expense,” he noted. “The ability to have this up-front payment prospectively is something we recommended, and it is very good to see that in there.”
He also spoke positively of the quality measures that are part of the proposed model.
“They really seemed to have zeroed in on meaningful measures for radiation oncology practices ... things that are really connected to guidelines that are known to support patients,” he said. “We didn’t see anything in the list of quality measures that are off base. That was a real positive [and] consistent with things that we have recommended that CMS should consider on the quality front.”
He also said the structure of the model will drive more guideline-concordant care, and incentives are there that will make treatments more convenient for patients.
“There are some positive aspects here that we can really build on,” Mr. Adler said.
Radiation oncologists are applauding the Centers for Medicare & Medicaid Services’ introduction of a test radiation oncology alternative payment model (APM) to help encourage the move to value-based care, but concerns, particularly about its mandatory participation, have been raised.
The proposed radiation oncology APM, posted online as part of a larger notice of proposed rulemaking on July 10 and scheduled for publication in the Federal Register on July 18, will be tested over a 5-year period to determine if a prospective, site-neutral, episode-based payment for radiation therapy will improve the quality of care and lower costs for Medicare. Comments on the proposal are due 60 days from Federal Register publication.
According to the CMS website, the agency would make “prospective, episode-based (i.e. bundled) payments, based on a patient’s cancer diagnosis, that would cover radiotherapy services furnished in a 90-day episode for the 17 cancer types meeting the included cancer type criteria.”
The site-neutral payments would be based on a “common, adjusted national base payment amount” and would contain two components (professional and technical) “to allow for use of current claims systems for PFS [physician fee schedule] and OPPS [outpatient prospective payment system] to be used to adjudicate RO (radiation oncology) Model claims and be consistent with existing business relationships.”
Payments would be linked to quality “using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to participants.” The radiation oncology model qualifies as an advanced alternative payment model under the Quality Payment Program.
In addition to measuring whether the model improves quality and lowers costs, CMS will be studying whether it results in shorter courses of radiation therapy, more efficient care delivery, and higher-value care for Medicare beneficiaries.
The biggest detail about this proposed alternative payment model that is raising some red flags within the community is that it has a mandatory participation requirement, with participation determined by a random selection of providers in selected geographic areas.
The Community Oncology Alliance said in a statement that it has “deep reservations and fundamental opposition to a proposed mandatory or ‘required’ Center for Medicare & Medicaid Innovation model. Radiation therapy is a powerful, complex part of cancer care for patients. While the proposed CMMI model does include a much-needed policy proposal to implement site-neutral payments, COA absolutely does not support mandatory CMMI models,” adding that if models are “reasonable and would advance value-based care, then voluntary provider participation would be robust.”
Dave Adler, vice president of advocacy at the American Society for Radiation Oncology, also expressed concern regarding the requirement for participation.
“At least at the outset, having a voluntary model is the right way to start,” he said in an interview. “This is something that has not been tested before. I think it’s really important to its long-term success that we understand its impact on providers and patients before it’s required for anybody.”
He offered a little flexibility on that stance, noting that if CMS would not budge on the mandatory aspect, he suggested that it lower the amount of participation that will be required from the proposed 40% of radiation oncologists to something smaller, coupled with a mechanism for voluntary participation, which does not exist in the current proposal.
Outside of that immediate concern, Mr. Adler said it was really too early to tell whether the proposal is in fact adequate to meet the needs of practicing radiation oncologists, including the payment rates, and the patients they treat. He said ASTRO will be doing a deeper analysis in the coming weeks and will provide the necessary feedback to CMS on the proposal.
Another thing that stood out as concerning was the start date, which CMS suggested could be as early as January 2020, but it also suggested that could be pushed back to April 2020. Practices won’t know if they are selected as required to participate until the final rule is issued, likely in November.
“We are pleased that CMS seems to be open to considering an April 1 start date,” he said. “That’s probably the earliest that it could start,” adding that ASTRO might look to see if there is an opportunity to encourage CMS to implement a rolling start date.
He also noted that CMS did not include any sort of hardship exemption for practices that have a rationale for not wanting to or being able to participate.
That, and including a voluntary participation option, “can be done without compromising the evaluation of the model.”
That being said, Mr. Adler spoke positively in general.
“We are moving in the right direction here with the model,” he said. “We are very much committed to working with CMS and our champions in Congress constructively to improve upon what has been proposed here.”
One thing he liked was the prospective payment aspect of the model.
“Radiation oncology practices, given the expense of the equipment, the staff, and the delivery of the sophisticated treatment requires a huge up-front expense,” he noted. “The ability to have this up-front payment prospectively is something we recommended, and it is very good to see that in there.”
He also spoke positively of the quality measures that are part of the proposed model.
“They really seemed to have zeroed in on meaningful measures for radiation oncology practices ... things that are really connected to guidelines that are known to support patients,” he said. “We didn’t see anything in the list of quality measures that are off base. That was a real positive [and] consistent with things that we have recommended that CMS should consider on the quality front.”
He also said the structure of the model will drive more guideline-concordant care, and incentives are there that will make treatments more convenient for patients.
“There are some positive aspects here that we can really build on,” Mr. Adler said.
Radiation oncologists are applauding the Centers for Medicare & Medicaid Services’ introduction of a test radiation oncology alternative payment model (APM) to help encourage the move to value-based care, but concerns, particularly about its mandatory participation, have been raised.
The proposed radiation oncology APM, posted online as part of a larger notice of proposed rulemaking on July 10 and scheduled for publication in the Federal Register on July 18, will be tested over a 5-year period to determine if a prospective, site-neutral, episode-based payment for radiation therapy will improve the quality of care and lower costs for Medicare. Comments on the proposal are due 60 days from Federal Register publication.
According to the CMS website, the agency would make “prospective, episode-based (i.e. bundled) payments, based on a patient’s cancer diagnosis, that would cover radiotherapy services furnished in a 90-day episode for the 17 cancer types meeting the included cancer type criteria.”
The site-neutral payments would be based on a “common, adjusted national base payment amount” and would contain two components (professional and technical) “to allow for use of current claims systems for PFS [physician fee schedule] and OPPS [outpatient prospective payment system] to be used to adjudicate RO (radiation oncology) Model claims and be consistent with existing business relationships.”
Payments would be linked to quality “using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to participants.” The radiation oncology model qualifies as an advanced alternative payment model under the Quality Payment Program.
In addition to measuring whether the model improves quality and lowers costs, CMS will be studying whether it results in shorter courses of radiation therapy, more efficient care delivery, and higher-value care for Medicare beneficiaries.
The biggest detail about this proposed alternative payment model that is raising some red flags within the community is that it has a mandatory participation requirement, with participation determined by a random selection of providers in selected geographic areas.
The Community Oncology Alliance said in a statement that it has “deep reservations and fundamental opposition to a proposed mandatory or ‘required’ Center for Medicare & Medicaid Innovation model. Radiation therapy is a powerful, complex part of cancer care for patients. While the proposed CMMI model does include a much-needed policy proposal to implement site-neutral payments, COA absolutely does not support mandatory CMMI models,” adding that if models are “reasonable and would advance value-based care, then voluntary provider participation would be robust.”
Dave Adler, vice president of advocacy at the American Society for Radiation Oncology, also expressed concern regarding the requirement for participation.
“At least at the outset, having a voluntary model is the right way to start,” he said in an interview. “This is something that has not been tested before. I think it’s really important to its long-term success that we understand its impact on providers and patients before it’s required for anybody.”
He offered a little flexibility on that stance, noting that if CMS would not budge on the mandatory aspect, he suggested that it lower the amount of participation that will be required from the proposed 40% of radiation oncologists to something smaller, coupled with a mechanism for voluntary participation, which does not exist in the current proposal.
Outside of that immediate concern, Mr. Adler said it was really too early to tell whether the proposal is in fact adequate to meet the needs of practicing radiation oncologists, including the payment rates, and the patients they treat. He said ASTRO will be doing a deeper analysis in the coming weeks and will provide the necessary feedback to CMS on the proposal.
Another thing that stood out as concerning was the start date, which CMS suggested could be as early as January 2020, but it also suggested that could be pushed back to April 2020. Practices won’t know if they are selected as required to participate until the final rule is issued, likely in November.
“We are pleased that CMS seems to be open to considering an April 1 start date,” he said. “That’s probably the earliest that it could start,” adding that ASTRO might look to see if there is an opportunity to encourage CMS to implement a rolling start date.
He also noted that CMS did not include any sort of hardship exemption for practices that have a rationale for not wanting to or being able to participate.
That, and including a voluntary participation option, “can be done without compromising the evaluation of the model.”
That being said, Mr. Adler spoke positively in general.
“We are moving in the right direction here with the model,” he said. “We are very much committed to working with CMS and our champions in Congress constructively to improve upon what has been proposed here.”
One thing he liked was the prospective payment aspect of the model.
“Radiation oncology practices, given the expense of the equipment, the staff, and the delivery of the sophisticated treatment requires a huge up-front expense,” he noted. “The ability to have this up-front payment prospectively is something we recommended, and it is very good to see that in there.”
He also spoke positively of the quality measures that are part of the proposed model.
“They really seemed to have zeroed in on meaningful measures for radiation oncology practices ... things that are really connected to guidelines that are known to support patients,” he said. “We didn’t see anything in the list of quality measures that are off base. That was a real positive [and] consistent with things that we have recommended that CMS should consider on the quality front.”
He also said the structure of the model will drive more guideline-concordant care, and incentives are there that will make treatments more convenient for patients.
“There are some positive aspects here that we can really build on,” Mr. Adler said.
Value-based metrics gain ground in physician employment contracts
Physician employment contracts increasingly include value- and quality-based metrics as bases for production bonuses, according to an analysis of recruitment searches from April 1, 2018, to March 31, 2019.
Metrics such as physician satisfaction rates, proper use of EHRs, following treatment protocols, and others that don’t directly measure volume are becoming more commonplace in employment contracts, though volume measures still are included, according to Phil Miller, vice president of communications at health care recruiting firm Merritt Hawkins and author of the company’s 2019 report on physician and advanced practitioner recruiting incentives, released July 8.
Of 70% of searches that offered a production bonus, 56% featured a bonus based at least in part on quality metrics, up from 43% in 2018. The finding represents the highest percent of contracts offering a quality-based bonus that the company has tracked, according to the report.
Merritt Hawkins’ review is based on a sample of the 3,131 permanent physician and advanced practitioner search assignments that Merritt Hawkins and its sister physician staffing companies at AMN Healthcare have ongoing or were engaged to conduct from April 1, 2018 to March 31, 2019.
Other common value-based metrics include reduction in hospital readmissions, cost containment, and proper coding.
While value-based incentives are on the rise, “facilities that employ physicians want to ensure they stay productive, and ‘productivity’ still is measured in part by what are essentially fee-for-service metrics, including relative value units [RVUs], net collections, and number of patients seen.”
RVUs were used in 70% of production formulas tracked in the 2019 review, up from 50% in the previous year and also a record high.
Mr. Miller noted that employers are seeking the “Goldilocks’ zone,” a balance point between traditional productivity measures and value-based metrics, very much a work in progress right now.
A possible corollary to the increase in production bonuses is a flattening of signing bonuses. During the current review period, 71% of contracts came with a signing bonus, up slightly from 70% in the previous year’s report and down from 76% 2 years ago.
Signing bonuses in the review period for the 2019 report averaged $32,692, down from $33,707 during the 2018 report’s review period.
Overall, family practice physicians remain the highest in demand for job searches, but specialty practice is gaining ground.
For the 2018-2019 review, family medicine was the most requested search by specialty, with 457 searches requested. While the ranking remains No. 1, as it has for the past 13 years, the number of searches has been on a steady decline. Last year, there were 497 searches, which was down from 607 2 years ago and 734 4 years ago.
Mr. Miller said there were a few reasons for the lower number of searches. “One is just the momentum shifts that are kind of inherent to recruiting. People put all of their resources into one area, typically, and in this case it was primary care and they realized, ‘Hey wait a minute, we need some specialists for these doctors to refer to, so now we have to put some of our chips in the specialty basket.’ ”
The Baby Boomers also is having an effect – as they age and are experiencing more health issues, more specialists are needed.
“[Older patients] visit the doctor twice or three times the rate of a younger person and they also generate a much higher percentage of inpatient procedures and tests and diagnoses,” he said.
On the opposite end of the spectrum, “younger people are less likely to have a primary care doctor who coordinates their care,” Mr. Miller said. “What they typically do is go to an urgent care center, a retail clinic, maybe even [use] telemedicine so they are not accessing the system in the same way or necessarily through the same provider.”
Demand for psychiatrists remained strong for the fourth year in a row, but the number of searches has declined for the last several years. For the current review period, there were 199 searches, down from 243 the previous year, 256 2 years ago, and 250 3 years ago.
There is “pretty much a crisis in behavioral health care now because there are so few psychiatrists and the demand has increased,” Mr. Miller noted.
Physician employment contracts increasingly include value- and quality-based metrics as bases for production bonuses, according to an analysis of recruitment searches from April 1, 2018, to March 31, 2019.
Metrics such as physician satisfaction rates, proper use of EHRs, following treatment protocols, and others that don’t directly measure volume are becoming more commonplace in employment contracts, though volume measures still are included, according to Phil Miller, vice president of communications at health care recruiting firm Merritt Hawkins and author of the company’s 2019 report on physician and advanced practitioner recruiting incentives, released July 8.
Of 70% of searches that offered a production bonus, 56% featured a bonus based at least in part on quality metrics, up from 43% in 2018. The finding represents the highest percent of contracts offering a quality-based bonus that the company has tracked, according to the report.
Merritt Hawkins’ review is based on a sample of the 3,131 permanent physician and advanced practitioner search assignments that Merritt Hawkins and its sister physician staffing companies at AMN Healthcare have ongoing or were engaged to conduct from April 1, 2018 to March 31, 2019.
Other common value-based metrics include reduction in hospital readmissions, cost containment, and proper coding.
While value-based incentives are on the rise, “facilities that employ physicians want to ensure they stay productive, and ‘productivity’ still is measured in part by what are essentially fee-for-service metrics, including relative value units [RVUs], net collections, and number of patients seen.”
RVUs were used in 70% of production formulas tracked in the 2019 review, up from 50% in the previous year and also a record high.
Mr. Miller noted that employers are seeking the “Goldilocks’ zone,” a balance point between traditional productivity measures and value-based metrics, very much a work in progress right now.
A possible corollary to the increase in production bonuses is a flattening of signing bonuses. During the current review period, 71% of contracts came with a signing bonus, up slightly from 70% in the previous year’s report and down from 76% 2 years ago.
Signing bonuses in the review period for the 2019 report averaged $32,692, down from $33,707 during the 2018 report’s review period.
Overall, family practice physicians remain the highest in demand for job searches, but specialty practice is gaining ground.
For the 2018-2019 review, family medicine was the most requested search by specialty, with 457 searches requested. While the ranking remains No. 1, as it has for the past 13 years, the number of searches has been on a steady decline. Last year, there were 497 searches, which was down from 607 2 years ago and 734 4 years ago.
Mr. Miller said there were a few reasons for the lower number of searches. “One is just the momentum shifts that are kind of inherent to recruiting. People put all of their resources into one area, typically, and in this case it was primary care and they realized, ‘Hey wait a minute, we need some specialists for these doctors to refer to, so now we have to put some of our chips in the specialty basket.’ ”
The Baby Boomers also is having an effect – as they age and are experiencing more health issues, more specialists are needed.
“[Older patients] visit the doctor twice or three times the rate of a younger person and they also generate a much higher percentage of inpatient procedures and tests and diagnoses,” he said.
On the opposite end of the spectrum, “younger people are less likely to have a primary care doctor who coordinates their care,” Mr. Miller said. “What they typically do is go to an urgent care center, a retail clinic, maybe even [use] telemedicine so they are not accessing the system in the same way or necessarily through the same provider.”
Demand for psychiatrists remained strong for the fourth year in a row, but the number of searches has declined for the last several years. For the current review period, there were 199 searches, down from 243 the previous year, 256 2 years ago, and 250 3 years ago.
There is “pretty much a crisis in behavioral health care now because there are so few psychiatrists and the demand has increased,” Mr. Miller noted.
Physician employment contracts increasingly include value- and quality-based metrics as bases for production bonuses, according to an analysis of recruitment searches from April 1, 2018, to March 31, 2019.
Metrics such as physician satisfaction rates, proper use of EHRs, following treatment protocols, and others that don’t directly measure volume are becoming more commonplace in employment contracts, though volume measures still are included, according to Phil Miller, vice president of communications at health care recruiting firm Merritt Hawkins and author of the company’s 2019 report on physician and advanced practitioner recruiting incentives, released July 8.
Of 70% of searches that offered a production bonus, 56% featured a bonus based at least in part on quality metrics, up from 43% in 2018. The finding represents the highest percent of contracts offering a quality-based bonus that the company has tracked, according to the report.
Merritt Hawkins’ review is based on a sample of the 3,131 permanent physician and advanced practitioner search assignments that Merritt Hawkins and its sister physician staffing companies at AMN Healthcare have ongoing or were engaged to conduct from April 1, 2018 to March 31, 2019.
Other common value-based metrics include reduction in hospital readmissions, cost containment, and proper coding.
While value-based incentives are on the rise, “facilities that employ physicians want to ensure they stay productive, and ‘productivity’ still is measured in part by what are essentially fee-for-service metrics, including relative value units [RVUs], net collections, and number of patients seen.”
RVUs were used in 70% of production formulas tracked in the 2019 review, up from 50% in the previous year and also a record high.
Mr. Miller noted that employers are seeking the “Goldilocks’ zone,” a balance point between traditional productivity measures and value-based metrics, very much a work in progress right now.
A possible corollary to the increase in production bonuses is a flattening of signing bonuses. During the current review period, 71% of contracts came with a signing bonus, up slightly from 70% in the previous year’s report and down from 76% 2 years ago.
Signing bonuses in the review period for the 2019 report averaged $32,692, down from $33,707 during the 2018 report’s review period.
Overall, family practice physicians remain the highest in demand for job searches, but specialty practice is gaining ground.
For the 2018-2019 review, family medicine was the most requested search by specialty, with 457 searches requested. While the ranking remains No. 1, as it has for the past 13 years, the number of searches has been on a steady decline. Last year, there were 497 searches, which was down from 607 2 years ago and 734 4 years ago.
Mr. Miller said there were a few reasons for the lower number of searches. “One is just the momentum shifts that are kind of inherent to recruiting. People put all of their resources into one area, typically, and in this case it was primary care and they realized, ‘Hey wait a minute, we need some specialists for these doctors to refer to, so now we have to put some of our chips in the specialty basket.’ ”
The Baby Boomers also is having an effect – as they age and are experiencing more health issues, more specialists are needed.
“[Older patients] visit the doctor twice or three times the rate of a younger person and they also generate a much higher percentage of inpatient procedures and tests and diagnoses,” he said.
On the opposite end of the spectrum, “younger people are less likely to have a primary care doctor who coordinates their care,” Mr. Miller said. “What they typically do is go to an urgent care center, a retail clinic, maybe even [use] telemedicine so they are not accessing the system in the same way or necessarily through the same provider.”
Demand for psychiatrists remained strong for the fourth year in a row, but the number of searches has declined for the last several years. For the current review period, there were 199 searches, down from 243 the previous year, 256 2 years ago, and 250 3 years ago.
There is “pretty much a crisis in behavioral health care now because there are so few psychiatrists and the demand has increased,” Mr. Miller noted.
FDA pushes for more diversity in clinical trials in draft guidance
Officials at the Food and Drug Administration have issued draft guidance aimed at increasing the diversity of clinical trial populations, including adding children and adolescents earlier in drug development and making trial participation less burdensome for patients.
Despite efforts to enroll clinical trial participants who better reflect a real-world population, “challenges to participation in clinical trials remain, and certain groups continue to be unnecessarily underrepresented in many clinical trials,” the FDA noted in the document’s introduction.
The FDA noted that these challenges could have a significant impact on trial outcomes.
For example, the failure to include complex patients in a clinical trial “may lead to a failure to discover important safety information about the use of the investigational drug in patients who will take the drug after approval.”
In its draft recommendations, the FDA calls on trial sponsors to conduct a closer examination of exclusion criteria and to make it as narrow as possible; consider whether criteria from phase 2 studies, which are restrictive but often transferred to phase 3 protocols, can be eliminated or modified; and consider including children and adolescents when appropriate.
Recommendations related to trial design include characterizing early on the drug metabolism and clearance across populations that may metabolize or clear the drug differently, such as elderly or patients with liver or kidney dysfunction. The agency also called on trial sponsors to use “adaptive clinical trials,” which allow for prespecified trial design changes during the trial, and an early pediatric development program.
Another set of draft recommendations relates to ensuring trial participation is less burdensome for patients by reducing the frequency of study visits and making participants more aware of reimbursement for travel and lodging associated with the trial.
Additionally, the agency is recommending that trial sponsors adopt enrollment and retention practices that enhance inclusiveness, such as ensuring that trial sites include geographic locations with a higher concentration of racial and ethnic minority patients, and holding recruitment events on nights and weekends and in nonclinical locations.
Finally, the FDA issued a set of recommendations to trial sponsors aimed at broadening eligibility criteria when evaluating drugs intended for the treatment of rare diseases. In those trials, the FDA recommended reenrolling participants from early-phase trials in later-phase trials if it can be done safely.
“Because rare diseases often affect small, geographically dispersed patient populations with disease-related travel limitations, special efforts may be necessary to enroll and retain these participants to ensure that a broad spectrum of the patient population is represented,” the agency stated.
At first blush, the draft recommendations are being greeted with a positive response.
“We certainly need more diversity in clinical trial populations, so I think anything that FDA can say that will help encourage that is a good thing,” Richard Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology, said in an interview, noting that this new guidance builds off the work that ASCO and Friends of Cancer Research did with the FDA on previous efforts to expand clinical trial populations.
“I think that this new guidance, as best as I can tell, builds off of that, generalizes it across all therapeutic areas and goes a little bit beyond eligibility criteria to other features of clinical trials that may be impediments to patient participation and thereby limit the diversity of the populations in the studies,” he added.
That said, Dr. Schilsky said he welcomed the draft document as a step toward getting broader participation from patients who are more representative of the ultimate users of these treatments.
“All people who could potentially benefit from the trial should have the opportunity to participate as long as it’s safe for them to do so, and they should not be excluded based upon some of these arbitrary structural things,” he said.
“More importantly, we need data on how these new interventions perform in the patients who are seen and treated by doctors every day. We don’t want data just on patients who have no comorbid illnesses, patients who are otherwise perfectly well, patients who could run a marathon before they go to the doctor’s office. Those are generally not the patients that most doctors are seeing. If they are not represented in the trial population, then we are left with having to extrapolate from the trial data to a population for whom there is no information on how to use the treatment,” he added.
Public comments on the draft document are due on Aug. 6.
Officials at the Food and Drug Administration have issued draft guidance aimed at increasing the diversity of clinical trial populations, including adding children and adolescents earlier in drug development and making trial participation less burdensome for patients.
Despite efforts to enroll clinical trial participants who better reflect a real-world population, “challenges to participation in clinical trials remain, and certain groups continue to be unnecessarily underrepresented in many clinical trials,” the FDA noted in the document’s introduction.
The FDA noted that these challenges could have a significant impact on trial outcomes.
For example, the failure to include complex patients in a clinical trial “may lead to a failure to discover important safety information about the use of the investigational drug in patients who will take the drug after approval.”
In its draft recommendations, the FDA calls on trial sponsors to conduct a closer examination of exclusion criteria and to make it as narrow as possible; consider whether criteria from phase 2 studies, which are restrictive but often transferred to phase 3 protocols, can be eliminated or modified; and consider including children and adolescents when appropriate.
Recommendations related to trial design include characterizing early on the drug metabolism and clearance across populations that may metabolize or clear the drug differently, such as elderly or patients with liver or kidney dysfunction. The agency also called on trial sponsors to use “adaptive clinical trials,” which allow for prespecified trial design changes during the trial, and an early pediatric development program.
Another set of draft recommendations relates to ensuring trial participation is less burdensome for patients by reducing the frequency of study visits and making participants more aware of reimbursement for travel and lodging associated with the trial.
Additionally, the agency is recommending that trial sponsors adopt enrollment and retention practices that enhance inclusiveness, such as ensuring that trial sites include geographic locations with a higher concentration of racial and ethnic minority patients, and holding recruitment events on nights and weekends and in nonclinical locations.
Finally, the FDA issued a set of recommendations to trial sponsors aimed at broadening eligibility criteria when evaluating drugs intended for the treatment of rare diseases. In those trials, the FDA recommended reenrolling participants from early-phase trials in later-phase trials if it can be done safely.
“Because rare diseases often affect small, geographically dispersed patient populations with disease-related travel limitations, special efforts may be necessary to enroll and retain these participants to ensure that a broad spectrum of the patient population is represented,” the agency stated.
At first blush, the draft recommendations are being greeted with a positive response.
“We certainly need more diversity in clinical trial populations, so I think anything that FDA can say that will help encourage that is a good thing,” Richard Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology, said in an interview, noting that this new guidance builds off the work that ASCO and Friends of Cancer Research did with the FDA on previous efforts to expand clinical trial populations.
“I think that this new guidance, as best as I can tell, builds off of that, generalizes it across all therapeutic areas and goes a little bit beyond eligibility criteria to other features of clinical trials that may be impediments to patient participation and thereby limit the diversity of the populations in the studies,” he added.
That said, Dr. Schilsky said he welcomed the draft document as a step toward getting broader participation from patients who are more representative of the ultimate users of these treatments.
“All people who could potentially benefit from the trial should have the opportunity to participate as long as it’s safe for them to do so, and they should not be excluded based upon some of these arbitrary structural things,” he said.
“More importantly, we need data on how these new interventions perform in the patients who are seen and treated by doctors every day. We don’t want data just on patients who have no comorbid illnesses, patients who are otherwise perfectly well, patients who could run a marathon before they go to the doctor’s office. Those are generally not the patients that most doctors are seeing. If they are not represented in the trial population, then we are left with having to extrapolate from the trial data to a population for whom there is no information on how to use the treatment,” he added.
Public comments on the draft document are due on Aug. 6.
Officials at the Food and Drug Administration have issued draft guidance aimed at increasing the diversity of clinical trial populations, including adding children and adolescents earlier in drug development and making trial participation less burdensome for patients.
Despite efforts to enroll clinical trial participants who better reflect a real-world population, “challenges to participation in clinical trials remain, and certain groups continue to be unnecessarily underrepresented in many clinical trials,” the FDA noted in the document’s introduction.
The FDA noted that these challenges could have a significant impact on trial outcomes.
For example, the failure to include complex patients in a clinical trial “may lead to a failure to discover important safety information about the use of the investigational drug in patients who will take the drug after approval.”
In its draft recommendations, the FDA calls on trial sponsors to conduct a closer examination of exclusion criteria and to make it as narrow as possible; consider whether criteria from phase 2 studies, which are restrictive but often transferred to phase 3 protocols, can be eliminated or modified; and consider including children and adolescents when appropriate.
Recommendations related to trial design include characterizing early on the drug metabolism and clearance across populations that may metabolize or clear the drug differently, such as elderly or patients with liver or kidney dysfunction. The agency also called on trial sponsors to use “adaptive clinical trials,” which allow for prespecified trial design changes during the trial, and an early pediatric development program.
Another set of draft recommendations relates to ensuring trial participation is less burdensome for patients by reducing the frequency of study visits and making participants more aware of reimbursement for travel and lodging associated with the trial.
Additionally, the agency is recommending that trial sponsors adopt enrollment and retention practices that enhance inclusiveness, such as ensuring that trial sites include geographic locations with a higher concentration of racial and ethnic minority patients, and holding recruitment events on nights and weekends and in nonclinical locations.
Finally, the FDA issued a set of recommendations to trial sponsors aimed at broadening eligibility criteria when evaluating drugs intended for the treatment of rare diseases. In those trials, the FDA recommended reenrolling participants from early-phase trials in later-phase trials if it can be done safely.
“Because rare diseases often affect small, geographically dispersed patient populations with disease-related travel limitations, special efforts may be necessary to enroll and retain these participants to ensure that a broad spectrum of the patient population is represented,” the agency stated.
At first blush, the draft recommendations are being greeted with a positive response.
“We certainly need more diversity in clinical trial populations, so I think anything that FDA can say that will help encourage that is a good thing,” Richard Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology, said in an interview, noting that this new guidance builds off the work that ASCO and Friends of Cancer Research did with the FDA on previous efforts to expand clinical trial populations.
“I think that this new guidance, as best as I can tell, builds off of that, generalizes it across all therapeutic areas and goes a little bit beyond eligibility criteria to other features of clinical trials that may be impediments to patient participation and thereby limit the diversity of the populations in the studies,” he added.
That said, Dr. Schilsky said he welcomed the draft document as a step toward getting broader participation from patients who are more representative of the ultimate users of these treatments.
“All people who could potentially benefit from the trial should have the opportunity to participate as long as it’s safe for them to do so, and they should not be excluded based upon some of these arbitrary structural things,” he said.
“More importantly, we need data on how these new interventions perform in the patients who are seen and treated by doctors every day. We don’t want data just on patients who have no comorbid illnesses, patients who are otherwise perfectly well, patients who could run a marathon before they go to the doctor’s office. Those are generally not the patients that most doctors are seeing. If they are not represented in the trial population, then we are left with having to extrapolate from the trial data to a population for whom there is no information on how to use the treatment,” he added.
Public comments on the draft document are due on Aug. 6.
Louisiana HCV program cuts costs – and hassles
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
Visit the AGA GI Patient Center for information to share with your patients about hepatitis C at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
Visit the AGA GI Patient Center for information to share with your patients about hepatitis C at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
Visit the AGA GI Patient Center for information to share with your patients about hepatitis C at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv
Court halts rule requiring drug list pricing in advertising
The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.
“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.
“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.
The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”
In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.
“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”
The American Medical Association expressed disappointment that the final rule is not moving forward.
“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”
Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”
Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”
Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”
The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.
“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.
“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.
The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”
In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.
“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”
The American Medical Association expressed disappointment that the final rule is not moving forward.
“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”
Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”
Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”
Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”
The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.
“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.
“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.
The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”
In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.
“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”
The American Medical Association expressed disappointment that the final rule is not moving forward.
“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”
Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”
Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”
Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”
Louisiana HCV program cuts costs – and hassles
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
MedPAC to Congress: End “incident-to” billing
Incident-to billing occurs when an advanced practicing registered nurse (APRN) or a physician assistant (PA) performs a service but bills Medicare under the physician’s national provider number and receives full physician fee schedule payment, as opposed to 85% of the fee under their own number.
“Medicare beneficiaries increasingly use APRNs and PAs for both primary and specialty care,” according to MedPAC’s June report. “APRNs are furnishing a larger share and a greater variety of services for Medicare beneficiaries than they did in the past. Despite this growing reliance, Medicare does not have a full accounting of the services delivered and beneficiaries treated.”
Currently, identical coding requirements obscure whether the physician or the APRN/PA is providing the service, making it difficult to track volume and quality.
MedPAC estimated that, in 2016, 17% of all nurse practitioners billed all their services as incident to, as that was the number of nurse practitioners who never appeared in the performing provider field for reimbursement but ordered services/drugs or at least one Medicare fee-for-service beneficiary.
Another 34% billed some of their services as incident to as their name appeared at least once in the performing provider they ordered services/drugs for, but ordered more services/drugs for patients where they were not listed as the performing provider.
That leaves just about half (49%) who did not billing their services as incident to.
Requiring APRNs and PAs to bill directly for all of their services provided would update Medicare’s payment policies to better reflect current clinical practice, according to the MedPAC report. “In addition to improving policy makers’ foundational knowledge of who provides care for Medicare beneficiaries, direct billing could create substantial benefits for the Medicare program, beneficiaries, clinicians, and researchers that range from improving the accuracy of the physician fee schedule, reducing expenditures, enhancing program integrity, and allowing for better comparisons between cost and quality of care provided by physicians and APRNs/PAs.”
At their October 2018 meeting, MedPAC commissioners discussed how to appropriately compensate APRNs and PAs, should incident-to billing be eliminated; they ultimately recommended maintaining the 85% rate.
The American Academy of Family Practitioners spoke out against the idea of eliminating incident-to billing.
However, lowering all APRN/PA payments to 85% of what physicians make would impact doctors in a negative way, according to AAFP President Michael Munger, MD.
Dr. Munger described primary care as a team sport, and “this is certainly going to be felt in terms of the overall mission of delivering quality care.”
Access to care also could be reduced along with the reduced payment level.
“You have to make business decisions at the end of the day,” he said in an interview. “You need to make sure that you can have adequate revenue to offset expenses, and if you are going to take a 15% cut in your revenue in, you have to look at where your expenses are, and obviously salary is your No. 1 expense. If you are not able to count on this revenue and you can’t afford to have NPs and PAs as part of the team, it is going to become an access issue for patients.”
The MedPAC commissioner saw it differently.
“Most of these clinicians are already paid at this lower rate, and yet the supply of these clinicians has increased dramatically over the last several years,” the report states, adding that the salary differential between these clinicians and physicians “is large enough that employing them likely would remain attractive even if all of their services were paid at 85% of physician fee schedule rates.”
MedPAC, as an advisory body to Congress, makes no disclosures.
Incident-to billing occurs when an advanced practicing registered nurse (APRN) or a physician assistant (PA) performs a service but bills Medicare under the physician’s national provider number and receives full physician fee schedule payment, as opposed to 85% of the fee under their own number.
“Medicare beneficiaries increasingly use APRNs and PAs for both primary and specialty care,” according to MedPAC’s June report. “APRNs are furnishing a larger share and a greater variety of services for Medicare beneficiaries than they did in the past. Despite this growing reliance, Medicare does not have a full accounting of the services delivered and beneficiaries treated.”
Currently, identical coding requirements obscure whether the physician or the APRN/PA is providing the service, making it difficult to track volume and quality.
MedPAC estimated that, in 2016, 17% of all nurse practitioners billed all their services as incident to, as that was the number of nurse practitioners who never appeared in the performing provider field for reimbursement but ordered services/drugs or at least one Medicare fee-for-service beneficiary.
Another 34% billed some of their services as incident to as their name appeared at least once in the performing provider they ordered services/drugs for, but ordered more services/drugs for patients where they were not listed as the performing provider.
That leaves just about half (49%) who did not billing their services as incident to.
Requiring APRNs and PAs to bill directly for all of their services provided would update Medicare’s payment policies to better reflect current clinical practice, according to the MedPAC report. “In addition to improving policy makers’ foundational knowledge of who provides care for Medicare beneficiaries, direct billing could create substantial benefits for the Medicare program, beneficiaries, clinicians, and researchers that range from improving the accuracy of the physician fee schedule, reducing expenditures, enhancing program integrity, and allowing for better comparisons between cost and quality of care provided by physicians and APRNs/PAs.”
At their October 2018 meeting, MedPAC commissioners discussed how to appropriately compensate APRNs and PAs, should incident-to billing be eliminated; they ultimately recommended maintaining the 85% rate.
The American Academy of Family Practitioners spoke out against the idea of eliminating incident-to billing.
However, lowering all APRN/PA payments to 85% of what physicians make would impact doctors in a negative way, according to AAFP President Michael Munger, MD.
Dr. Munger described primary care as a team sport, and “this is certainly going to be felt in terms of the overall mission of delivering quality care.”
Access to care also could be reduced along with the reduced payment level.
“You have to make business decisions at the end of the day,” he said in an interview. “You need to make sure that you can have adequate revenue to offset expenses, and if you are going to take a 15% cut in your revenue in, you have to look at where your expenses are, and obviously salary is your No. 1 expense. If you are not able to count on this revenue and you can’t afford to have NPs and PAs as part of the team, it is going to become an access issue for patients.”
The MedPAC commissioner saw it differently.
“Most of these clinicians are already paid at this lower rate, and yet the supply of these clinicians has increased dramatically over the last several years,” the report states, adding that the salary differential between these clinicians and physicians “is large enough that employing them likely would remain attractive even if all of their services were paid at 85% of physician fee schedule rates.”
MedPAC, as an advisory body to Congress, makes no disclosures.
Incident-to billing occurs when an advanced practicing registered nurse (APRN) or a physician assistant (PA) performs a service but bills Medicare under the physician’s national provider number and receives full physician fee schedule payment, as opposed to 85% of the fee under their own number.
“Medicare beneficiaries increasingly use APRNs and PAs for both primary and specialty care,” according to MedPAC’s June report. “APRNs are furnishing a larger share and a greater variety of services for Medicare beneficiaries than they did in the past. Despite this growing reliance, Medicare does not have a full accounting of the services delivered and beneficiaries treated.”
Currently, identical coding requirements obscure whether the physician or the APRN/PA is providing the service, making it difficult to track volume and quality.
MedPAC estimated that, in 2016, 17% of all nurse practitioners billed all their services as incident to, as that was the number of nurse practitioners who never appeared in the performing provider field for reimbursement but ordered services/drugs or at least one Medicare fee-for-service beneficiary.
Another 34% billed some of their services as incident to as their name appeared at least once in the performing provider they ordered services/drugs for, but ordered more services/drugs for patients where they were not listed as the performing provider.
That leaves just about half (49%) who did not billing their services as incident to.
Requiring APRNs and PAs to bill directly for all of their services provided would update Medicare’s payment policies to better reflect current clinical practice, according to the MedPAC report. “In addition to improving policy makers’ foundational knowledge of who provides care for Medicare beneficiaries, direct billing could create substantial benefits for the Medicare program, beneficiaries, clinicians, and researchers that range from improving the accuracy of the physician fee schedule, reducing expenditures, enhancing program integrity, and allowing for better comparisons between cost and quality of care provided by physicians and APRNs/PAs.”
At their October 2018 meeting, MedPAC commissioners discussed how to appropriately compensate APRNs and PAs, should incident-to billing be eliminated; they ultimately recommended maintaining the 85% rate.
The American Academy of Family Practitioners spoke out against the idea of eliminating incident-to billing.
However, lowering all APRN/PA payments to 85% of what physicians make would impact doctors in a negative way, according to AAFP President Michael Munger, MD.
Dr. Munger described primary care as a team sport, and “this is certainly going to be felt in terms of the overall mission of delivering quality care.”
Access to care also could be reduced along with the reduced payment level.
“You have to make business decisions at the end of the day,” he said in an interview. “You need to make sure that you can have adequate revenue to offset expenses, and if you are going to take a 15% cut in your revenue in, you have to look at where your expenses are, and obviously salary is your No. 1 expense. If you are not able to count on this revenue and you can’t afford to have NPs and PAs as part of the team, it is going to become an access issue for patients.”
The MedPAC commissioner saw it differently.
“Most of these clinicians are already paid at this lower rate, and yet the supply of these clinicians has increased dramatically over the last several years,” the report states, adding that the salary differential between these clinicians and physicians “is large enough that employing them likely would remain attractive even if all of their services were paid at 85% of physician fee schedule rates.”
MedPAC, as an advisory body to Congress, makes no disclosures.
Medicare may best Medicare Advantage at reducing readmissions
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
FROM ANNALS OF INTERNAL MEDICINE