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Feds aim to streamline gene therapy oversight
“As the NIH, the FDA, and research entities have moved to strengthen their individual oversight efforts, some overlaps have occurred,” Dr. Collins and Dr. Gottlieb wrote Aug. 15 in the New England Journal of Medicine. “Substantial duplication has arisen in the submission of initial protocols, annual reports, amendments, and reports of serious adverse events. Originally, these overlaps – which affect no other field in biomedical research – were viewed as harmonized reporting that enabled FDA to conduct regulatory oversight while maintaining confidentiality with sponsors and allowed NIH to provide transparency with regard to the research.”
With three approved treatments – two CAR T therapies and a treatment for a genetic retinal dystrophy – and more than 700 active investigational new drug applications in front of the FDA, “it seems reasonable to envision a day when gene therapy will be a mainstay of treatment for many diseases,” according to the editorial.
To remedy the situation, NIH officials Aug. 16 posted a proposed update to NIH guidance that seeks “to reduce the duplicative oversight burden by further limiting the role of NIH and RAC [Recombinant DNA Advisory Committee] in assessing gene therapy protocols and reviewing their safety information,” Dr. Collins and Dr. Gottlieb wrote. “Specifically, these proposals will eliminate RAC review and reporting requirements to the NIH for human gene therapy protocols. They will also revise the responsibility of institutional Biosafety Committees, which have local oversight for this research, making their review of human gene therapy protocols consistent with review of other research subject to the NIH Guidelines. Such streamlining will also appropriately place the focus of the NIH Guidelines squarely back on laboratory biosafety.”
RAC was originally established in 1974 to advise the NIH director on research involving manipulation of nucleic acids, but was later expanded to review and discuss protocols for gene therapy in humans.
The proposed structure provides an opportunity “to return the RAC to the spirit in which it was founded. ... The NIH envisions using the RAC as an advisory board on today’s emerging technologies, such as gene editing, synthetic biology, and neurotechnology, while harnessing the attributes that have long ensured its transparency,” they wrote.
This latest proposal follows a suite of FDA draft guidances on gene therapies issued in July that proposed new guidance on manufacturing issues, long-term follow-up, and pathways for clinical development in certain areas.
The guidance is scheduled for publication in the Federal Register on Aug. 17.
SOURCE: Collins FS and Gottlieb S. N Engl J Med. doi: 10.1056/NEJMp1810628.
“As the NIH, the FDA, and research entities have moved to strengthen their individual oversight efforts, some overlaps have occurred,” Dr. Collins and Dr. Gottlieb wrote Aug. 15 in the New England Journal of Medicine. “Substantial duplication has arisen in the submission of initial protocols, annual reports, amendments, and reports of serious adverse events. Originally, these overlaps – which affect no other field in biomedical research – were viewed as harmonized reporting that enabled FDA to conduct regulatory oversight while maintaining confidentiality with sponsors and allowed NIH to provide transparency with regard to the research.”
With three approved treatments – two CAR T therapies and a treatment for a genetic retinal dystrophy – and more than 700 active investigational new drug applications in front of the FDA, “it seems reasonable to envision a day when gene therapy will be a mainstay of treatment for many diseases,” according to the editorial.
To remedy the situation, NIH officials Aug. 16 posted a proposed update to NIH guidance that seeks “to reduce the duplicative oversight burden by further limiting the role of NIH and RAC [Recombinant DNA Advisory Committee] in assessing gene therapy protocols and reviewing their safety information,” Dr. Collins and Dr. Gottlieb wrote. “Specifically, these proposals will eliminate RAC review and reporting requirements to the NIH for human gene therapy protocols. They will also revise the responsibility of institutional Biosafety Committees, which have local oversight for this research, making their review of human gene therapy protocols consistent with review of other research subject to the NIH Guidelines. Such streamlining will also appropriately place the focus of the NIH Guidelines squarely back on laboratory biosafety.”
RAC was originally established in 1974 to advise the NIH director on research involving manipulation of nucleic acids, but was later expanded to review and discuss protocols for gene therapy in humans.
The proposed structure provides an opportunity “to return the RAC to the spirit in which it was founded. ... The NIH envisions using the RAC as an advisory board on today’s emerging technologies, such as gene editing, synthetic biology, and neurotechnology, while harnessing the attributes that have long ensured its transparency,” they wrote.
This latest proposal follows a suite of FDA draft guidances on gene therapies issued in July that proposed new guidance on manufacturing issues, long-term follow-up, and pathways for clinical development in certain areas.
The guidance is scheduled for publication in the Federal Register on Aug. 17.
SOURCE: Collins FS and Gottlieb S. N Engl J Med. doi: 10.1056/NEJMp1810628.
“As the NIH, the FDA, and research entities have moved to strengthen their individual oversight efforts, some overlaps have occurred,” Dr. Collins and Dr. Gottlieb wrote Aug. 15 in the New England Journal of Medicine. “Substantial duplication has arisen in the submission of initial protocols, annual reports, amendments, and reports of serious adverse events. Originally, these overlaps – which affect no other field in biomedical research – were viewed as harmonized reporting that enabled FDA to conduct regulatory oversight while maintaining confidentiality with sponsors and allowed NIH to provide transparency with regard to the research.”
With three approved treatments – two CAR T therapies and a treatment for a genetic retinal dystrophy – and more than 700 active investigational new drug applications in front of the FDA, “it seems reasonable to envision a day when gene therapy will be a mainstay of treatment for many diseases,” according to the editorial.
To remedy the situation, NIH officials Aug. 16 posted a proposed update to NIH guidance that seeks “to reduce the duplicative oversight burden by further limiting the role of NIH and RAC [Recombinant DNA Advisory Committee] in assessing gene therapy protocols and reviewing their safety information,” Dr. Collins and Dr. Gottlieb wrote. “Specifically, these proposals will eliminate RAC review and reporting requirements to the NIH for human gene therapy protocols. They will also revise the responsibility of institutional Biosafety Committees, which have local oversight for this research, making their review of human gene therapy protocols consistent with review of other research subject to the NIH Guidelines. Such streamlining will also appropriately place the focus of the NIH Guidelines squarely back on laboratory biosafety.”
RAC was originally established in 1974 to advise the NIH director on research involving manipulation of nucleic acids, but was later expanded to review and discuss protocols for gene therapy in humans.
The proposed structure provides an opportunity “to return the RAC to the spirit in which it was founded. ... The NIH envisions using the RAC as an advisory board on today’s emerging technologies, such as gene editing, synthetic biology, and neurotechnology, while harnessing the attributes that have long ensured its transparency,” they wrote.
This latest proposal follows a suite of FDA draft guidances on gene therapies issued in July that proposed new guidance on manufacturing issues, long-term follow-up, and pathways for clinical development in certain areas.
The guidance is scheduled for publication in the Federal Register on Aug. 17.
SOURCE: Collins FS and Gottlieb S. N Engl J Med. doi: 10.1056/NEJMp1810628.
Key clinical point: NIH and FDA are looking to streamline gene therapy development oversight.
Major finding: The proposal would return the function of the Recombinant DNA Advisory Committee (RAC) to a function more in line with its original mission.
Study details: Full proposal details are to be published in the Federal Register on Aug. 17.
Disclosures: The agency leaders reported no relevant disclosures in the production of the proposal.
Source: Collins FS and Gottlieb S. N Engl J Med. doi: 10.1056/NEJMp1810628.
Having prescription drug coverage is associated with improved myeloma outcomes
Medicare beneficiaries with myeloma who have prescription drug coverage have shown both decreased used of classic cytotoxic chemotherapy and better survival, according to new research.
The findings suggested that prescription drug coverage brings better access to all existing treatment options.
“In this analysis of Medicare beneficiaries with myeloma, the receipt of therapy and survival differed according to prescription drug coverage status,” Adam Olszewski, MD, of the Lifespan Cancer Institute at Rhode Island Hospital in Providence, R.I., and his colleagues noted in the study. “Patients with PDP [prescription drug plan coverage through Medicare Part D] or OCC [other credible prescription drug coverage] more often received active myeloma care, compared to those without coverage,” they wrote in Journal of Clinical Oncology.
The researchers looked at 9,755 patients diagnosed with myeloma during 2006-2011 and examined what was used to treat the myeloma as a first line treatment. The cohort included 1,460 patients with no prescription drug coverage, 3,283 with PDP coverage, 3,607 with OCC, and 1,405 dual eligibility for Medicare and Medicaid coverage.
The study found that, compared with beneficiaries with no coverage, Medicare beneficiaries with PDP coverage “were 14% less likely to be treated with parenteral chemotherapy and 38% less likely to receive classic cytotoxic agents.” Additionally, among the cohort of beneficiaries that were without drug coverage prior to the diagnosis of myeloma, 41% actively obtained coverage, but even then, their survival was “significantly worse, compared with the beneficiaries who had coverage at diagnosis.”
Beneficiaries classified as having other credible coverage were 3% more likely to receive active myeloma care than were those without coverage, but the use of parenteral regimens did not differ between those groups.
Researchers noted that overall survival was 10% higher at 1 year and 6% higher at 3 years for beneficiaries with PDP coverage or OCC than it was for those without coverage, but they added that the analysis required cautious interpretation “as it is confounded by multiple baseline factors and mediated by the quality of cancer treatment. ... We could not discern whether worse survival in the group without coverage was a result of not receiving therapy at all, an inability to access IMiDs [immunomodulatory drugs], or poor control of other medical issues.”
However, a comparison with the control group “strongly suggest[s] that patients with myeloma without prescription drug coverage may not have received the most effective first-line therapy,” Dr. Olszewski and his colleagues added. “Survival for PDP and OCC groups remained identical, which supports the notion that having any prescription drug coverage contributed to optimal treatment and outcomes.”
The study was limited by the fact that unobserved clinical differences between beneficiaries with or without prescription drug coverage could have accounted for differences in mortality and that the comparison of treatments was restricted to parenteral regimens because IMiDs were observed to have been administered only for PDP enrollees.
Dr. Olszewski and study coauthor Amy Davidoff, PhD, of Yale University, New Haven, Conn., disclosed acting in consulting or advisory roles and receiving research funding from several pharmaceutical companies that develop cancer treatments.
SOURCE: Olszewski A et al. J Clin Oncol. 2018 Aug 16. doi: 10.1200/JCO.2018.77.8894.
Medicare beneficiaries with myeloma who have prescription drug coverage have shown both decreased used of classic cytotoxic chemotherapy and better survival, according to new research.
The findings suggested that prescription drug coverage brings better access to all existing treatment options.
“In this analysis of Medicare beneficiaries with myeloma, the receipt of therapy and survival differed according to prescription drug coverage status,” Adam Olszewski, MD, of the Lifespan Cancer Institute at Rhode Island Hospital in Providence, R.I., and his colleagues noted in the study. “Patients with PDP [prescription drug plan coverage through Medicare Part D] or OCC [other credible prescription drug coverage] more often received active myeloma care, compared to those without coverage,” they wrote in Journal of Clinical Oncology.
The researchers looked at 9,755 patients diagnosed with myeloma during 2006-2011 and examined what was used to treat the myeloma as a first line treatment. The cohort included 1,460 patients with no prescription drug coverage, 3,283 with PDP coverage, 3,607 with OCC, and 1,405 dual eligibility for Medicare and Medicaid coverage.
The study found that, compared with beneficiaries with no coverage, Medicare beneficiaries with PDP coverage “were 14% less likely to be treated with parenteral chemotherapy and 38% less likely to receive classic cytotoxic agents.” Additionally, among the cohort of beneficiaries that were without drug coverage prior to the diagnosis of myeloma, 41% actively obtained coverage, but even then, their survival was “significantly worse, compared with the beneficiaries who had coverage at diagnosis.”
Beneficiaries classified as having other credible coverage were 3% more likely to receive active myeloma care than were those without coverage, but the use of parenteral regimens did not differ between those groups.
Researchers noted that overall survival was 10% higher at 1 year and 6% higher at 3 years for beneficiaries with PDP coverage or OCC than it was for those without coverage, but they added that the analysis required cautious interpretation “as it is confounded by multiple baseline factors and mediated by the quality of cancer treatment. ... We could not discern whether worse survival in the group without coverage was a result of not receiving therapy at all, an inability to access IMiDs [immunomodulatory drugs], or poor control of other medical issues.”
However, a comparison with the control group “strongly suggest[s] that patients with myeloma without prescription drug coverage may not have received the most effective first-line therapy,” Dr. Olszewski and his colleagues added. “Survival for PDP and OCC groups remained identical, which supports the notion that having any prescription drug coverage contributed to optimal treatment and outcomes.”
The study was limited by the fact that unobserved clinical differences between beneficiaries with or without prescription drug coverage could have accounted for differences in mortality and that the comparison of treatments was restricted to parenteral regimens because IMiDs were observed to have been administered only for PDP enrollees.
Dr. Olszewski and study coauthor Amy Davidoff, PhD, of Yale University, New Haven, Conn., disclosed acting in consulting or advisory roles and receiving research funding from several pharmaceutical companies that develop cancer treatments.
SOURCE: Olszewski A et al. J Clin Oncol. 2018 Aug 16. doi: 10.1200/JCO.2018.77.8894.
Medicare beneficiaries with myeloma who have prescription drug coverage have shown both decreased used of classic cytotoxic chemotherapy and better survival, according to new research.
The findings suggested that prescription drug coverage brings better access to all existing treatment options.
“In this analysis of Medicare beneficiaries with myeloma, the receipt of therapy and survival differed according to prescription drug coverage status,” Adam Olszewski, MD, of the Lifespan Cancer Institute at Rhode Island Hospital in Providence, R.I., and his colleagues noted in the study. “Patients with PDP [prescription drug plan coverage through Medicare Part D] or OCC [other credible prescription drug coverage] more often received active myeloma care, compared to those without coverage,” they wrote in Journal of Clinical Oncology.
The researchers looked at 9,755 patients diagnosed with myeloma during 2006-2011 and examined what was used to treat the myeloma as a first line treatment. The cohort included 1,460 patients with no prescription drug coverage, 3,283 with PDP coverage, 3,607 with OCC, and 1,405 dual eligibility for Medicare and Medicaid coverage.
The study found that, compared with beneficiaries with no coverage, Medicare beneficiaries with PDP coverage “were 14% less likely to be treated with parenteral chemotherapy and 38% less likely to receive classic cytotoxic agents.” Additionally, among the cohort of beneficiaries that were without drug coverage prior to the diagnosis of myeloma, 41% actively obtained coverage, but even then, their survival was “significantly worse, compared with the beneficiaries who had coverage at diagnosis.”
Beneficiaries classified as having other credible coverage were 3% more likely to receive active myeloma care than were those without coverage, but the use of parenteral regimens did not differ between those groups.
Researchers noted that overall survival was 10% higher at 1 year and 6% higher at 3 years for beneficiaries with PDP coverage or OCC than it was for those without coverage, but they added that the analysis required cautious interpretation “as it is confounded by multiple baseline factors and mediated by the quality of cancer treatment. ... We could not discern whether worse survival in the group without coverage was a result of not receiving therapy at all, an inability to access IMiDs [immunomodulatory drugs], or poor control of other medical issues.”
However, a comparison with the control group “strongly suggest[s] that patients with myeloma without prescription drug coverage may not have received the most effective first-line therapy,” Dr. Olszewski and his colleagues added. “Survival for PDP and OCC groups remained identical, which supports the notion that having any prescription drug coverage contributed to optimal treatment and outcomes.”
The study was limited by the fact that unobserved clinical differences between beneficiaries with or without prescription drug coverage could have accounted for differences in mortality and that the comparison of treatments was restricted to parenteral regimens because IMiDs were observed to have been administered only for PDP enrollees.
Dr. Olszewski and study coauthor Amy Davidoff, PhD, of Yale University, New Haven, Conn., disclosed acting in consulting or advisory roles and receiving research funding from several pharmaceutical companies that develop cancer treatments.
SOURCE: Olszewski A et al. J Clin Oncol. 2018 Aug 16. doi: 10.1200/JCO.2018.77.8894.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Prescription drug coverage is related to better outcomes for Medicare patients with myeloma.
Major finding: Compared with patients without coverage, patients with prescription drug plan coverage through Medicare Part D were 14% less likely to receive parenteral chemotherapy and 38% less likely to receive classic cytotoxic agents.
Study details: Observational study using SEER-Medicare data for 9,755 beneficiaries diagnosed with myeloma during 2006-2011.
Disclosures: The study was supported by scholar awards from the American Cancer Society and the American Society of Hematology and by a grant from the National Institute of General Medical Sciences. Report authors Dr. Olszewski and one coauthor disclosed receiving research funding and other financial compensation from several pharmaceutical companies that develop cancer treatments.
Source: Olszewski A et al. J Clin Oncol. 2018 Aug 16. doi: 10.1200/JCO.2018.77.8894
Docs push back on step therapy in Medicare Advantage
A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.
The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement. Step therapy, as described by the announcement “is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.”
Doctors aren’t having it.
“Put simply, this policy change is a gross affront to America’s sickest Medicare patients – individuals living with diseases like inflammatory arthritis and cancer – who depend on timely access to safe, affordable, and high-quality treatments,” American College of Rheumatology President David Daikh, MD, PhD, said in a statement.
“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” Dr. Daikh continued. “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time.”
The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.
By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.
Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”
The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.
CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.
The American Society of Clinical Oncology also voiced its objection.
“ASCO strongly opposes the Centers for Medicare & Medicaid Services decision to allow Medicare Advantage plans to employ step therapy,” ASCO President Monica Bertagnolli, MD, said in a statement. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medications before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, [but it also] potentially leads to irreversible disease progression and other significant patient health risks.”
Further, the American Gastroenterology Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement.
Barbara L. McAneny, MD, president of the American Medical Association, said that physicians “are concerned with patients getting the most effective treatment, and step therapy requirements frequently get in the way. ... Physicians have no easy access to patient benefit and formulary information at the point of prescribing, so they will not be able to readily determine which drugs are preferred by their patients’ [Medicare Advantage] plans. This results in treatment delays and unnecessary red tape for physicians and patients.”
The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.
The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement. Step therapy, as described by the announcement “is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.”
Doctors aren’t having it.
“Put simply, this policy change is a gross affront to America’s sickest Medicare patients – individuals living with diseases like inflammatory arthritis and cancer – who depend on timely access to safe, affordable, and high-quality treatments,” American College of Rheumatology President David Daikh, MD, PhD, said in a statement.
“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” Dr. Daikh continued. “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time.”
The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.
By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.
Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”
The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.
CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.
The American Society of Clinical Oncology also voiced its objection.
“ASCO strongly opposes the Centers for Medicare & Medicaid Services decision to allow Medicare Advantage plans to employ step therapy,” ASCO President Monica Bertagnolli, MD, said in a statement. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medications before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, [but it also] potentially leads to irreversible disease progression and other significant patient health risks.”
Further, the American Gastroenterology Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement.
Barbara L. McAneny, MD, president of the American Medical Association, said that physicians “are concerned with patients getting the most effective treatment, and step therapy requirements frequently get in the way. ... Physicians have no easy access to patient benefit and formulary information at the point of prescribing, so they will not be able to readily determine which drugs are preferred by their patients’ [Medicare Advantage] plans. This results in treatment delays and unnecessary red tape for physicians and patients.”
The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
A new policy that allows Medicare Advantage plans to use step therapy to control spending on prescription drug administered in the office is not going over well with doctors.
The Centers for Medicare & Medicaid Services announced the policy change Aug. 7, which will give Medicare Advantage plan sponsors the “choice of implementing step therapy to manage Part B drugs, beginning Jan. 1, 2019,” the agency said in a statement. Step therapy, as described by the announcement “is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.”
Doctors aren’t having it.
“Put simply, this policy change is a gross affront to America’s sickest Medicare patients – individuals living with diseases like inflammatory arthritis and cancer – who depend on timely access to safe, affordable, and high-quality treatments,” American College of Rheumatology President David Daikh, MD, PhD, said in a statement.
“Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage,” Dr. Daikh continued. “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will makes it much more difficult for patients to get this treatment in time.”
The action is part of the broader Trump administration initiative to lower the prices and out-of-pocket costs of prescription drugs as outlined in the American Patients First blueprint.
By “implementing step therapy along with care coordination and drug adherence programs in [Medicare Advantage], it will lower costs and improve the quality of care for Medicare beneficiaries,” CMS officials said in a statement. The move to allow step therapy will give Medicare Advantage plan sponsors the ability to negotiate the designation of a preferred drug, something the agency believes could result in lower prices for these drugs, which in turn will lower the copays for Medicare beneficiaries.
Plan sponsors will be required to pass savings onto beneficiaries through some sort of rewards program, according to a memo detailing the policy change, which also notes that plan rewards “cannot be offered in the form of cash or monetary rebate, but may be offered as gift cards or other items value to all eligible enrollees.”
The value of the rewards must be more than half of the savings generated from implementing the step therapy program, according to the memo.
CMS officials noted that there will be a process that beneficiaries can follow if they believe they need direct access to a drug that would otherwise be available only after failing on another drug.
The American Society of Clinical Oncology also voiced its objection.
“ASCO strongly opposes the Centers for Medicare & Medicaid Services decision to allow Medicare Advantage plans to employ step therapy,” ASCO President Monica Bertagnolli, MD, said in a statement. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medications before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, [but it also] potentially leads to irreversible disease progression and other significant patient health risks.”
Further, the American Gastroenterology Association “is concerned that the proposal could limit access for current and future beneficiaries and could add to the growing regulatory burden that physicians already face,” according to a statement.
Barbara L. McAneny, MD, president of the American Medical Association, said that physicians “are concerned with patients getting the most effective treatment, and step therapy requirements frequently get in the way. ... Physicians have no easy access to patient benefit and formulary information at the point of prescribing, so they will not be able to readily determine which drugs are preferred by their patients’ [Medicare Advantage] plans. This results in treatment delays and unnecessary red tape for physicians and patients.”
The new policy applies to only new prescriptions or administrations of Part B drugs. Patients will not have current treatments disrupted if that drug is not the first drug on the step therapy ladder. Additionally, patients will have the opportunity to make a one-time change in plans during the first quarter annually if they are finding the plan is not working for them. Plan sponsors must disclose that Part B drugs may be subject to step therapy.
Key clinical point: Medicare Advantage plans will now be able to implement step therapy on Part B drugs.
Major finding: Only new prescriptions will be eligible for step therapy; existing treatments will not be disrupted.
Study details: CMS made the decision to reverse previously existing policy on step therapy as part of an ongoing effort to help lower the cost of prescription drugs.
Disclosures: There were no relevant disclosures.
Source: Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage;
CMS pushes ACOs to take on more risk
Accountable care organizations (ACOs) are playing it too safe, according to the Centers for Medicare & Medicaid Services, which wants to change the rules and push more ACOs into taking on more financial risk – with a little flexibility added in.
“ACOs were designed to move Medicare away from fee for service by encouraging providers to find efficiencies and innovative ways to deliver high-quality care to their patients while reducing costs, giving them the flexibility they need to focus on health outcomes over process,” CMS Administrator Seema Verma said during an Aug. 9 press conference.
That’s not what is happening now, Ms. Verma said. Under the current program, physicians and other health care professionals can participate in an ACO that takes on upside risk only – that is, to share in any of the savings it is able to generate – for up to 6 years before having to take on downside risk to return payment to the government if the ACO fails to hit spending targets.
“This environment has created a perverse incentive leading to the shocking present day reality that, after 6 years, over 82% of shared saving program ACOs are in an upside-only track, meaning that these ACOs have no incentive at all to reduce health care cost while improving outcomes as they were intended,” she said. “The program has not lived up to the accountability part of their name.”
In the aggregate, ACOs that only take on upside risk generally are spending more money and not generating the savings that ACOs in a two-sided risk arrangement are, she added.
To get more health care professionals into two-sided risk arrangements, the CMS released a proposed rule Aug. 9 that caps ACO participation in an upside risk–only arrangement for 2 years before having to migrate to a two-sided risk arrangement. To sweeten the pot, the CMS proposes to allow more flexibility for innovation and encouraging patients to maintain their health.
“On top of [antikickback law] waivers they already receive, we are proposing to allow ACOs that are taking risk to give incentive payments in order to reward patients for taking steps to achieve good health, such as gift cards for patients who receive necessary primary and preventive care,” she said, adding that ACOs who take on downside risk also will be eligible to receive payments for providing telehealth services.
ACOs also will need to adopt the 2015 edition of certified EHR technology and the CMS also will be looking to streamline quality measures, according to the proposal.
The CMS is extending current ACO contracts for 6 months, with the new rules, if finalized, going into effect in the middle of 2019.
The proposal also simplifies the ACO program by offering two tracks, as detailed in a blog post penned by Administrator Verma that appeared Aug. 9 in Health Affairs.
The Basic track “would feature a glide path for taking risk,” she wrote. “It would begin with up to 2 years of upside-only risk and then gradually transition in years 3, 4, and 5 to increasing levels of performance risk, concluding in year 5 at a level of risk that meets the standard to qualify as an advanced alternative payment model [APM]” under the Quality Payment Program. Those entering the enhanced track, taking on two-sided risk immediately, would need to meet the standard of an APM immediately.
The proposal also calls for more transparency and would require providers to alert Medicare beneficiaries that services are being provided in the context of an ACO and to explain what that means for their care.
Spending benchmarks would continue to be calculated using both regional and national spending trends. Program integrity also will be enhanced “by holding ACOs in two-sided models accountable for losses even if they exit midway through a performance year, and by authorizing termination of ACOs with multiple years of poor financial performance,” Ms. Verma wrote.
The Pathways to Success proposed rule was slated to be published in the Federal Register on Aug. 17. Comments are being accepted at regulations.gov until Oct. 16.
Accountable care organizations (ACOs) are playing it too safe, according to the Centers for Medicare & Medicaid Services, which wants to change the rules and push more ACOs into taking on more financial risk – with a little flexibility added in.
“ACOs were designed to move Medicare away from fee for service by encouraging providers to find efficiencies and innovative ways to deliver high-quality care to their patients while reducing costs, giving them the flexibility they need to focus on health outcomes over process,” CMS Administrator Seema Verma said during an Aug. 9 press conference.
That’s not what is happening now, Ms. Verma said. Under the current program, physicians and other health care professionals can participate in an ACO that takes on upside risk only – that is, to share in any of the savings it is able to generate – for up to 6 years before having to take on downside risk to return payment to the government if the ACO fails to hit spending targets.
“This environment has created a perverse incentive leading to the shocking present day reality that, after 6 years, over 82% of shared saving program ACOs are in an upside-only track, meaning that these ACOs have no incentive at all to reduce health care cost while improving outcomes as they were intended,” she said. “The program has not lived up to the accountability part of their name.”
In the aggregate, ACOs that only take on upside risk generally are spending more money and not generating the savings that ACOs in a two-sided risk arrangement are, she added.
To get more health care professionals into two-sided risk arrangements, the CMS released a proposed rule Aug. 9 that caps ACO participation in an upside risk–only arrangement for 2 years before having to migrate to a two-sided risk arrangement. To sweeten the pot, the CMS proposes to allow more flexibility for innovation and encouraging patients to maintain their health.
“On top of [antikickback law] waivers they already receive, we are proposing to allow ACOs that are taking risk to give incentive payments in order to reward patients for taking steps to achieve good health, such as gift cards for patients who receive necessary primary and preventive care,” she said, adding that ACOs who take on downside risk also will be eligible to receive payments for providing telehealth services.
ACOs also will need to adopt the 2015 edition of certified EHR technology and the CMS also will be looking to streamline quality measures, according to the proposal.
The CMS is extending current ACO contracts for 6 months, with the new rules, if finalized, going into effect in the middle of 2019.
The proposal also simplifies the ACO program by offering two tracks, as detailed in a blog post penned by Administrator Verma that appeared Aug. 9 in Health Affairs.
The Basic track “would feature a glide path for taking risk,” she wrote. “It would begin with up to 2 years of upside-only risk and then gradually transition in years 3, 4, and 5 to increasing levels of performance risk, concluding in year 5 at a level of risk that meets the standard to qualify as an advanced alternative payment model [APM]” under the Quality Payment Program. Those entering the enhanced track, taking on two-sided risk immediately, would need to meet the standard of an APM immediately.
The proposal also calls for more transparency and would require providers to alert Medicare beneficiaries that services are being provided in the context of an ACO and to explain what that means for their care.
Spending benchmarks would continue to be calculated using both regional and national spending trends. Program integrity also will be enhanced “by holding ACOs in two-sided models accountable for losses even if they exit midway through a performance year, and by authorizing termination of ACOs with multiple years of poor financial performance,” Ms. Verma wrote.
The Pathways to Success proposed rule was slated to be published in the Federal Register on Aug. 17. Comments are being accepted at regulations.gov until Oct. 16.
Accountable care organizations (ACOs) are playing it too safe, according to the Centers for Medicare & Medicaid Services, which wants to change the rules and push more ACOs into taking on more financial risk – with a little flexibility added in.
“ACOs were designed to move Medicare away from fee for service by encouraging providers to find efficiencies and innovative ways to deliver high-quality care to their patients while reducing costs, giving them the flexibility they need to focus on health outcomes over process,” CMS Administrator Seema Verma said during an Aug. 9 press conference.
That’s not what is happening now, Ms. Verma said. Under the current program, physicians and other health care professionals can participate in an ACO that takes on upside risk only – that is, to share in any of the savings it is able to generate – for up to 6 years before having to take on downside risk to return payment to the government if the ACO fails to hit spending targets.
“This environment has created a perverse incentive leading to the shocking present day reality that, after 6 years, over 82% of shared saving program ACOs are in an upside-only track, meaning that these ACOs have no incentive at all to reduce health care cost while improving outcomes as they were intended,” she said. “The program has not lived up to the accountability part of their name.”
In the aggregate, ACOs that only take on upside risk generally are spending more money and not generating the savings that ACOs in a two-sided risk arrangement are, she added.
To get more health care professionals into two-sided risk arrangements, the CMS released a proposed rule Aug. 9 that caps ACO participation in an upside risk–only arrangement for 2 years before having to migrate to a two-sided risk arrangement. To sweeten the pot, the CMS proposes to allow more flexibility for innovation and encouraging patients to maintain their health.
“On top of [antikickback law] waivers they already receive, we are proposing to allow ACOs that are taking risk to give incentive payments in order to reward patients for taking steps to achieve good health, such as gift cards for patients who receive necessary primary and preventive care,” she said, adding that ACOs who take on downside risk also will be eligible to receive payments for providing telehealth services.
ACOs also will need to adopt the 2015 edition of certified EHR technology and the CMS also will be looking to streamline quality measures, according to the proposal.
The CMS is extending current ACO contracts for 6 months, with the new rules, if finalized, going into effect in the middle of 2019.
The proposal also simplifies the ACO program by offering two tracks, as detailed in a blog post penned by Administrator Verma that appeared Aug. 9 in Health Affairs.
The Basic track “would feature a glide path for taking risk,” she wrote. “It would begin with up to 2 years of upside-only risk and then gradually transition in years 3, 4, and 5 to increasing levels of performance risk, concluding in year 5 at a level of risk that meets the standard to qualify as an advanced alternative payment model [APM]” under the Quality Payment Program. Those entering the enhanced track, taking on two-sided risk immediately, would need to meet the standard of an APM immediately.
The proposal also calls for more transparency and would require providers to alert Medicare beneficiaries that services are being provided in the context of an ACO and to explain what that means for their care.
Spending benchmarks would continue to be calculated using both regional and national spending trends. Program integrity also will be enhanced “by holding ACOs in two-sided models accountable for losses even if they exit midway through a performance year, and by authorizing termination of ACOs with multiple years of poor financial performance,” Ms. Verma wrote.
The Pathways to Success proposed rule was slated to be published in the Federal Register on Aug. 17. Comments are being accepted at regulations.gov until Oct. 16.
Doctors decry inaction on physician-focused APMs
Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).
As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.
The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.
So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.
“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”
Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.
The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”
The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.
AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”
The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”
Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.
The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.
The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”
Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”
Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).
As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.
The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.
So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.
“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”
Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.
The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”
The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.
AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”
The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”
Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.
The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.
The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”
Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”
Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).
As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.
The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.
So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.
“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”
Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.
The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”
The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.
AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”
The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”
Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.
The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.
The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”
Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”
FDA proposes broader outcomes for OUD treatment drug approvals
Manufacturers developing the next generation of drugs to help combat opioid use disorder could have a broader set of outcome measures to target when bringing their products before the Food and Drug Administration for approval.
Traditionally, the FDA has used a reduction in drug-taking behavior as the endpoint for approving a medication-assisted treatment to combat opioid use disorder. But a draft guidance issued Aug. 6 could change that.
The guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” proposes numerous clinical endpoints, including reduction in adverse outcomes of opioid use disorder, (for example, mortality, the need for emergency medical interventions, or hepatitis C seroconversion); change in the disease status using diagnostic criteria for opioid use disorder; development of patient-reported outcome measures; or changes in drug use patterns other than the commonly used endpoint of abstinence.
, such as the ability to resume work or school.
“The evidence is clear. Medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country,” Department of Health and Human Services Secretary Alex Azar said in a statement. He added that the new guidance has “the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better change at recovery.”
FDA Commissioner Scott Gottlieb, MD, added in the statement: “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission. Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder.”
Guidance comments are due Oct. 9 and can be submitted online here.
Manufacturers developing the next generation of drugs to help combat opioid use disorder could have a broader set of outcome measures to target when bringing their products before the Food and Drug Administration for approval.
Traditionally, the FDA has used a reduction in drug-taking behavior as the endpoint for approving a medication-assisted treatment to combat opioid use disorder. But a draft guidance issued Aug. 6 could change that.
The guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” proposes numerous clinical endpoints, including reduction in adverse outcomes of opioid use disorder, (for example, mortality, the need for emergency medical interventions, or hepatitis C seroconversion); change in the disease status using diagnostic criteria for opioid use disorder; development of patient-reported outcome measures; or changes in drug use patterns other than the commonly used endpoint of abstinence.
, such as the ability to resume work or school.
“The evidence is clear. Medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country,” Department of Health and Human Services Secretary Alex Azar said in a statement. He added that the new guidance has “the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better change at recovery.”
FDA Commissioner Scott Gottlieb, MD, added in the statement: “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission. Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder.”
Guidance comments are due Oct. 9 and can be submitted online here.
Manufacturers developing the next generation of drugs to help combat opioid use disorder could have a broader set of outcome measures to target when bringing their products before the Food and Drug Administration for approval.
Traditionally, the FDA has used a reduction in drug-taking behavior as the endpoint for approving a medication-assisted treatment to combat opioid use disorder. But a draft guidance issued Aug. 6 could change that.
The guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” proposes numerous clinical endpoints, including reduction in adverse outcomes of opioid use disorder, (for example, mortality, the need for emergency medical interventions, or hepatitis C seroconversion); change in the disease status using diagnostic criteria for opioid use disorder; development of patient-reported outcome measures; or changes in drug use patterns other than the commonly used endpoint of abstinence.
, such as the ability to resume work or school.
“The evidence is clear. Medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country,” Department of Health and Human Services Secretary Alex Azar said in a statement. He added that the new guidance has “the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better change at recovery.”
FDA Commissioner Scott Gottlieb, MD, added in the statement: “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission. Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder.”
Guidance comments are due Oct. 9 and can be submitted online here.
CMS proposal to level E/M payments raises concerns
Citing the need to reduce paperwork hassles, officials at the Centers for Medicare & Medicaid Services are proposing to flatten the payment for evaluation and management (E/M) visits coded at levels 2-5.
The CMS outlined how the proposal would affect payment using 2018 rates to model the change. The proposal would set the payment rate for level 1 E/M office visits for new patients at $44, down from the $45 using the current methodology. Levels 2-5 would receive $135. Currently, payments for level 2 visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.
For office visits with established patients, the proposed rate would be $24, up from the current payment of $22 for a level 1 visit. Levels 2-5 would receive $93. Under the current methodology, payments for level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.
The change also comes with a reduced documentation burden, so the same documentation is needed regardless of which level between 2 and 5 the office visit is, a move that is expected to save some time each day.
The CMS outlined its vision for changes to the E/M payment in the proposed update to the 2019 Medicare physician fee schedule. Comments on the proposal are due Sept. 10, 2018.
The agency estimated that for most specialties, there would be minimal effect on this proposed change. However, for 10 specialties, payment reductions could result from this change.
Specialties identified as potentially losing less than 3% of their overall payment include allergy/immunology, audiologists, hematology/oncology, neurology, otolaryngology, pulmonary disease, and radiation oncology and radiation therapy centers.
Rheumatologists are expected to lose 3% of their pay from the proposal, while dermatologists and podiatrists are expected to lose 4%.
On the flip side, obstetricians/gynecologists are expected to see a 4% bump because of this proposal, while nurse practitioners could see a 3% increase. Specialties expected to see an increase of less than 3% include hand surgery, interventional pain management, optometry, physician assistants, psychiatry, and urology.
The proposal is raising concerns, particularly from those who stand to see their pay reduced by the proposal.
CMS "has proposed a disastrous plan that would force most neurologists not just to abandon Medicare participation, but also to refuse treatment to Medicare patients," Marc Raphaelson, MD, chair of the American Academy of Neurology's Coding Subcommittee and the Academy's representative to the Relative Value Scale Update Committee, wrote in a report. "The AAN is responding vigorously that one size does not fit all. One visit type does not fit our patients or our practices. Neurologists could not sustain our practices at the proposed payment rates."
Dr. Raphaelson noted that the AAN applauds the agency's "willingness to abandon medically irrelevant charting that contributes to our frustration and burnout. CMS has brought payment and documentation reform into a bright light. In return, it is up to the AAN, and our collegial medical societies, to propose a fair and transparent way to pay doctors for the work we really do."
The AAN recently joined the Americal College of Rheumatology (ACR) on Capitol Hill to raise awareness of the proposed cuts.
“Rheumatologists are pretty concerned about this,” Angus B. Worthing, MD, chair of the ACR’s Committee on Government Affairs, said in an interview. “Being a cognitive specialty ... we see patients who have complex or multiple issues and we focus more in the clinic on cognitive services, instead of procedural services.” He noted that rheumatologists bill across the E/M levels so it would be difficult to suggest a flat fee that would keep them from losing money.
Dr. Worthing, whose practice is in the Washington, D.C., metro area, said that about 70% of the Medicare payment covers overhead for the practice, leaving 30% to go toward the rheumatologist’s salary. To illustrate the impact of the proposed 3% cut, Dr. Worthing used the hypothetical of a current $100 payment turning into a $97 payment under the proposal. The overhead doesn’t change, so the physician’s portion that goes toward his salary drops 10% when it decreases from $30 to $27.
The Community Oncology Alliance made a similar observation.
“CMS is proposing to drastically cut payment for the critical evaluation and management of more complex cancer cases from $172 to $135 (a 22% payment cut) for a new patient and from $148 to $93 (a 37% payment cut) for an existing patient. Although CMS is proposing to streamline the reporting of these cases, the proposal severely undervalues the thorough and critical evaluation and management of seniors with cancer, especially life-threatening complex cases,” the organization said in a statement.
Dr. Worthing said the proposal has implications for recruiting medical trainees into rheumatology and for physicians in practice who may be considering whether to stop seeing Medicare patients. “Since we already have a shortage of rheumatologists in the U.S. that, per the ACR’s recent study, appears to be worsening, we are pretty concerned that if this proposal is finalized, we could be facing a situation with longer wait times to see a rheumatologist,” he said.
But Dr. Worthing praised the proposed reduction of documentation and said that it could save physicians some time. “If this proposal were finalized, I might be able to spend a minute or two less typing or documenting in a typical patient visit,” he said. “That might add up over time to seeing more patients.”
CMS officials estimate the proposal would save a lot more time. CMS Administrator Seema Verma said that the documentation change would result in an additional 51 hours for patient care per clinician per year.
However, Dr. Worthing said he was doubtful that any increase in volume would offset the losses from the proposed flat payment across levels 2-5 E/M visits, especially if the pay decrease results in access issues. “If doctors were seeing less and having a harder time covering their business expenses seeing Medicare patients, they might be incentivized to see more commercially insured patients and maintain their practice’s viability that way and not participate in Medicare anymore,” he said.
***This story was updated 8/8/2018.
SOURCE: CMS proposed rule, CMS-1693-P.
Citing the need to reduce paperwork hassles, officials at the Centers for Medicare & Medicaid Services are proposing to flatten the payment for evaluation and management (E/M) visits coded at levels 2-5.
The CMS outlined how the proposal would affect payment using 2018 rates to model the change. The proposal would set the payment rate for level 1 E/M office visits for new patients at $44, down from the $45 using the current methodology. Levels 2-5 would receive $135. Currently, payments for level 2 visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.
For office visits with established patients, the proposed rate would be $24, up from the current payment of $22 for a level 1 visit. Levels 2-5 would receive $93. Under the current methodology, payments for level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.
The change also comes with a reduced documentation burden, so the same documentation is needed regardless of which level between 2 and 5 the office visit is, a move that is expected to save some time each day.
The CMS outlined its vision for changes to the E/M payment in the proposed update to the 2019 Medicare physician fee schedule. Comments on the proposal are due Sept. 10, 2018.
The agency estimated that for most specialties, there would be minimal effect on this proposed change. However, for 10 specialties, payment reductions could result from this change.
Specialties identified as potentially losing less than 3% of their overall payment include allergy/immunology, audiologists, hematology/oncology, neurology, otolaryngology, pulmonary disease, and radiation oncology and radiation therapy centers.
Rheumatologists are expected to lose 3% of their pay from the proposal, while dermatologists and podiatrists are expected to lose 4%.
On the flip side, obstetricians/gynecologists are expected to see a 4% bump because of this proposal, while nurse practitioners could see a 3% increase. Specialties expected to see an increase of less than 3% include hand surgery, interventional pain management, optometry, physician assistants, psychiatry, and urology.
The proposal is raising concerns, particularly from those who stand to see their pay reduced by the proposal.
CMS "has proposed a disastrous plan that would force most neurologists not just to abandon Medicare participation, but also to refuse treatment to Medicare patients," Marc Raphaelson, MD, chair of the American Academy of Neurology's Coding Subcommittee and the Academy's representative to the Relative Value Scale Update Committee, wrote in a report. "The AAN is responding vigorously that one size does not fit all. One visit type does not fit our patients or our practices. Neurologists could not sustain our practices at the proposed payment rates."
Dr. Raphaelson noted that the AAN applauds the agency's "willingness to abandon medically irrelevant charting that contributes to our frustration and burnout. CMS has brought payment and documentation reform into a bright light. In return, it is up to the AAN, and our collegial medical societies, to propose a fair and transparent way to pay doctors for the work we really do."
The AAN recently joined the Americal College of Rheumatology (ACR) on Capitol Hill to raise awareness of the proposed cuts.
“Rheumatologists are pretty concerned about this,” Angus B. Worthing, MD, chair of the ACR’s Committee on Government Affairs, said in an interview. “Being a cognitive specialty ... we see patients who have complex or multiple issues and we focus more in the clinic on cognitive services, instead of procedural services.” He noted that rheumatologists bill across the E/M levels so it would be difficult to suggest a flat fee that would keep them from losing money.
Dr. Worthing, whose practice is in the Washington, D.C., metro area, said that about 70% of the Medicare payment covers overhead for the practice, leaving 30% to go toward the rheumatologist’s salary. To illustrate the impact of the proposed 3% cut, Dr. Worthing used the hypothetical of a current $100 payment turning into a $97 payment under the proposal. The overhead doesn’t change, so the physician’s portion that goes toward his salary drops 10% when it decreases from $30 to $27.
The Community Oncology Alliance made a similar observation.
“CMS is proposing to drastically cut payment for the critical evaluation and management of more complex cancer cases from $172 to $135 (a 22% payment cut) for a new patient and from $148 to $93 (a 37% payment cut) for an existing patient. Although CMS is proposing to streamline the reporting of these cases, the proposal severely undervalues the thorough and critical evaluation and management of seniors with cancer, especially life-threatening complex cases,” the organization said in a statement.
Dr. Worthing said the proposal has implications for recruiting medical trainees into rheumatology and for physicians in practice who may be considering whether to stop seeing Medicare patients. “Since we already have a shortage of rheumatologists in the U.S. that, per the ACR’s recent study, appears to be worsening, we are pretty concerned that if this proposal is finalized, we could be facing a situation with longer wait times to see a rheumatologist,” he said.
But Dr. Worthing praised the proposed reduction of documentation and said that it could save physicians some time. “If this proposal were finalized, I might be able to spend a minute or two less typing or documenting in a typical patient visit,” he said. “That might add up over time to seeing more patients.”
CMS officials estimate the proposal would save a lot more time. CMS Administrator Seema Verma said that the documentation change would result in an additional 51 hours for patient care per clinician per year.
However, Dr. Worthing said he was doubtful that any increase in volume would offset the losses from the proposed flat payment across levels 2-5 E/M visits, especially if the pay decrease results in access issues. “If doctors were seeing less and having a harder time covering their business expenses seeing Medicare patients, they might be incentivized to see more commercially insured patients and maintain their practice’s viability that way and not participate in Medicare anymore,” he said.
***This story was updated 8/8/2018.
SOURCE: CMS proposed rule, CMS-1693-P.
Citing the need to reduce paperwork hassles, officials at the Centers for Medicare & Medicaid Services are proposing to flatten the payment for evaluation and management (E/M) visits coded at levels 2-5.
The CMS outlined how the proposal would affect payment using 2018 rates to model the change. The proposal would set the payment rate for level 1 E/M office visits for new patients at $44, down from the $45 using the current methodology. Levels 2-5 would receive $135. Currently, payments for level 2 visits are set at $76, level 3 at $110, level 4 at $167, and level 5 at $211.
For office visits with established patients, the proposed rate would be $24, up from the current payment of $22 for a level 1 visit. Levels 2-5 would receive $93. Under the current methodology, payments for level 2 visits are set at $45, level 3 at $74, level 4 at $109, and level 5 at $148.
The change also comes with a reduced documentation burden, so the same documentation is needed regardless of which level between 2 and 5 the office visit is, a move that is expected to save some time each day.
The CMS outlined its vision for changes to the E/M payment in the proposed update to the 2019 Medicare physician fee schedule. Comments on the proposal are due Sept. 10, 2018.
The agency estimated that for most specialties, there would be minimal effect on this proposed change. However, for 10 specialties, payment reductions could result from this change.
Specialties identified as potentially losing less than 3% of their overall payment include allergy/immunology, audiologists, hematology/oncology, neurology, otolaryngology, pulmonary disease, and radiation oncology and radiation therapy centers.
Rheumatologists are expected to lose 3% of their pay from the proposal, while dermatologists and podiatrists are expected to lose 4%.
On the flip side, obstetricians/gynecologists are expected to see a 4% bump because of this proposal, while nurse practitioners could see a 3% increase. Specialties expected to see an increase of less than 3% include hand surgery, interventional pain management, optometry, physician assistants, psychiatry, and urology.
The proposal is raising concerns, particularly from those who stand to see their pay reduced by the proposal.
CMS "has proposed a disastrous plan that would force most neurologists not just to abandon Medicare participation, but also to refuse treatment to Medicare patients," Marc Raphaelson, MD, chair of the American Academy of Neurology's Coding Subcommittee and the Academy's representative to the Relative Value Scale Update Committee, wrote in a report. "The AAN is responding vigorously that one size does not fit all. One visit type does not fit our patients or our practices. Neurologists could not sustain our practices at the proposed payment rates."
Dr. Raphaelson noted that the AAN applauds the agency's "willingness to abandon medically irrelevant charting that contributes to our frustration and burnout. CMS has brought payment and documentation reform into a bright light. In return, it is up to the AAN, and our collegial medical societies, to propose a fair and transparent way to pay doctors for the work we really do."
The AAN recently joined the Americal College of Rheumatology (ACR) on Capitol Hill to raise awareness of the proposed cuts.
“Rheumatologists are pretty concerned about this,” Angus B. Worthing, MD, chair of the ACR’s Committee on Government Affairs, said in an interview. “Being a cognitive specialty ... we see patients who have complex or multiple issues and we focus more in the clinic on cognitive services, instead of procedural services.” He noted that rheumatologists bill across the E/M levels so it would be difficult to suggest a flat fee that would keep them from losing money.
Dr. Worthing, whose practice is in the Washington, D.C., metro area, said that about 70% of the Medicare payment covers overhead for the practice, leaving 30% to go toward the rheumatologist’s salary. To illustrate the impact of the proposed 3% cut, Dr. Worthing used the hypothetical of a current $100 payment turning into a $97 payment under the proposal. The overhead doesn’t change, so the physician’s portion that goes toward his salary drops 10% when it decreases from $30 to $27.
The Community Oncology Alliance made a similar observation.
“CMS is proposing to drastically cut payment for the critical evaluation and management of more complex cancer cases from $172 to $135 (a 22% payment cut) for a new patient and from $148 to $93 (a 37% payment cut) for an existing patient. Although CMS is proposing to streamline the reporting of these cases, the proposal severely undervalues the thorough and critical evaluation and management of seniors with cancer, especially life-threatening complex cases,” the organization said in a statement.
Dr. Worthing said the proposal has implications for recruiting medical trainees into rheumatology and for physicians in practice who may be considering whether to stop seeing Medicare patients. “Since we already have a shortage of rheumatologists in the U.S. that, per the ACR’s recent study, appears to be worsening, we are pretty concerned that if this proposal is finalized, we could be facing a situation with longer wait times to see a rheumatologist,” he said.
But Dr. Worthing praised the proposed reduction of documentation and said that it could save physicians some time. “If this proposal were finalized, I might be able to spend a minute or two less typing or documenting in a typical patient visit,” he said. “That might add up over time to seeing more patients.”
CMS officials estimate the proposal would save a lot more time. CMS Administrator Seema Verma said that the documentation change would result in an additional 51 hours for patient care per clinician per year.
However, Dr. Worthing said he was doubtful that any increase in volume would offset the losses from the proposed flat payment across levels 2-5 E/M visits, especially if the pay decrease results in access issues. “If doctors were seeing less and having a harder time covering their business expenses seeing Medicare patients, they might be incentivized to see more commercially insured patients and maintain their practice’s viability that way and not participate in Medicare anymore,” he said.
***This story was updated 8/8/2018.
SOURCE: CMS proposed rule, CMS-1693-P.
Key clinical point: Some specialties would be paid less under proposed payment changes for 2019.
Major finding: New patient visits (levels 2-5) would be paid at $135 and established patient visits (levels 2-5) would be paid at $93.
Study details: The physician fee schedule proposal would pay level 2-5 E/M visits at the same rate, and reduce some documentation requirements.
Disclosures: No relevant financial disclosures were reported.
Source: CMS proposed rule, CMS-1693-P.
CMS targets Part B drug policy in 2019 regulatory updates
Doctors could see changes in how they are paid by the Centers for Medicare & Medicaid Services for the drugs they administer in their office, depending on the outcome of two recent regulatory actions proposed by the agency.
The more immediate action could see an alteration to payment rates for newly launched drugs. The more long-term action could be the relaunch of the Competitive Acquisition Program, although there is much more uncertainty surrounding that change.
CMS is seeking to lower the Part B add-on payment for drugs that are new to market and do not yet have an average sales price (ASP) established. The proposal calls for these drugs to be reimbursed at the wholesale acquisition cost (WAC) plus 3%, rather than the current rate of WAC plus 6%. The change is part of the proposed physician fee schedule for 2019.
The add-on payment has no statutory definition as to what it is intended to cover, but CMS noted in the proposed rule that it “is widely believed to include services associated with drug acquisition that are not separately paid for, such as handling and storage, as well as additional mark-ups in drug distribution channels.”
Agency officials said that the add-on payment has raised concerns in recent years “because more revenue can be generated from percentage-based add-on payments for expensive drugs, and an opportunity to generate more revenue may create an incentive for the use of more expensive drugs.”
CMS also noted that once an ASP has been established – generally after a drug has been available for several months – the price for that drug is generally lower than the WAC price and, citing a 2014 HHS Office of Inspector General report, noted that “WACs often do not reflect the actual market price for drugs.”
The move to lower payments to WAC plus 3% for new drugs is consistent with a recent recommendation from the Medicare Payment Advisory Commission (MedPAC).
CMS added that the reduction would reduce beneficiary out-of-pocket costs, since copayments are a percentage of the total cost of the drug, including the add-on payment amount.
“The proposed approach would help Medicare beneficiaries afford to pay for new drugs by reducing out-of-pocket expenses and would help counteract the effects of increasing launch prices for newly approved drugs and biologicals,” CMS said in the proposed regulation.
But the American College of Rheumatology raised concerns about the proposal. Specifically, ACR is concerned that plans to cut add-on payments for new drugs “could slow market uptake of biosimilars and thwart the Administration’s efforts to reduce drug prices,” the group said in a statement.
The Community Oncology Alliance (COA) also took issue with the proposal. “This is a payment cut from the current rate of Wholesale Acquisition Cost (WAC) plus 6%, or what is really plus 4.3% when factoring in the sequester,” the COA said in a statement. “COA believes that this payment cut for new cancer therapies will result in drug manufacturers actually increasing WAC list prices so that their new products will not be at a competitive disadvantage to existing products, which are reimbursed at average sales price (ASP) plus 6%.”
The second proposal, which could take longer to materialize, revolves around the potential relaunch of the failed competitive acquisition program (CAP) for Part B drugs. CMS is currently requesting information, with questions on what a revamped program could look like if the agency were to move forward with it. The request for information is part of the proposed rule updating the Outpatient Prospective Payment System for 2019.
Under the original CAP, physicians who participated in the program would order drugs from an approved vendor, who would then bill Medicare and collect cost-sharing payments from the beneficiary. The original program was in operation for 18 months, ending on Dec. 31, 2008, after it had little participation and faced other concerns.
More recently, MedPAC recommended a revised version of the program, which they dubbed the Part B Drug Value Program (DVP). Under this construct, private vendors would acquire drugs at lower prices using various negotiation tools, and physicians would be encouraged to make more value-based use decisions based on opportunities for shared savings though their Medicare billing for the use of Part B drugs.
CMS is asking for feedback on a wide range of questions on how the revamped CAP program should be designed, including program design, which suppliers and drugs to include, how to incentivize participation, how to structure outcomes-based arrangements, and whether indication-based pricing should be used.
Doctors could see changes in how they are paid by the Centers for Medicare & Medicaid Services for the drugs they administer in their office, depending on the outcome of two recent regulatory actions proposed by the agency.
The more immediate action could see an alteration to payment rates for newly launched drugs. The more long-term action could be the relaunch of the Competitive Acquisition Program, although there is much more uncertainty surrounding that change.
CMS is seeking to lower the Part B add-on payment for drugs that are new to market and do not yet have an average sales price (ASP) established. The proposal calls for these drugs to be reimbursed at the wholesale acquisition cost (WAC) plus 3%, rather than the current rate of WAC plus 6%. The change is part of the proposed physician fee schedule for 2019.
The add-on payment has no statutory definition as to what it is intended to cover, but CMS noted in the proposed rule that it “is widely believed to include services associated with drug acquisition that are not separately paid for, such as handling and storage, as well as additional mark-ups in drug distribution channels.”
Agency officials said that the add-on payment has raised concerns in recent years “because more revenue can be generated from percentage-based add-on payments for expensive drugs, and an opportunity to generate more revenue may create an incentive for the use of more expensive drugs.”
CMS also noted that once an ASP has been established – generally after a drug has been available for several months – the price for that drug is generally lower than the WAC price and, citing a 2014 HHS Office of Inspector General report, noted that “WACs often do not reflect the actual market price for drugs.”
The move to lower payments to WAC plus 3% for new drugs is consistent with a recent recommendation from the Medicare Payment Advisory Commission (MedPAC).
CMS added that the reduction would reduce beneficiary out-of-pocket costs, since copayments are a percentage of the total cost of the drug, including the add-on payment amount.
“The proposed approach would help Medicare beneficiaries afford to pay for new drugs by reducing out-of-pocket expenses and would help counteract the effects of increasing launch prices for newly approved drugs and biologicals,” CMS said in the proposed regulation.
But the American College of Rheumatology raised concerns about the proposal. Specifically, ACR is concerned that plans to cut add-on payments for new drugs “could slow market uptake of biosimilars and thwart the Administration’s efforts to reduce drug prices,” the group said in a statement.
The Community Oncology Alliance (COA) also took issue with the proposal. “This is a payment cut from the current rate of Wholesale Acquisition Cost (WAC) plus 6%, or what is really plus 4.3% when factoring in the sequester,” the COA said in a statement. “COA believes that this payment cut for new cancer therapies will result in drug manufacturers actually increasing WAC list prices so that their new products will not be at a competitive disadvantage to existing products, which are reimbursed at average sales price (ASP) plus 6%.”
The second proposal, which could take longer to materialize, revolves around the potential relaunch of the failed competitive acquisition program (CAP) for Part B drugs. CMS is currently requesting information, with questions on what a revamped program could look like if the agency were to move forward with it. The request for information is part of the proposed rule updating the Outpatient Prospective Payment System for 2019.
Under the original CAP, physicians who participated in the program would order drugs from an approved vendor, who would then bill Medicare and collect cost-sharing payments from the beneficiary. The original program was in operation for 18 months, ending on Dec. 31, 2008, after it had little participation and faced other concerns.
More recently, MedPAC recommended a revised version of the program, which they dubbed the Part B Drug Value Program (DVP). Under this construct, private vendors would acquire drugs at lower prices using various negotiation tools, and physicians would be encouraged to make more value-based use decisions based on opportunities for shared savings though their Medicare billing for the use of Part B drugs.
CMS is asking for feedback on a wide range of questions on how the revamped CAP program should be designed, including program design, which suppliers and drugs to include, how to incentivize participation, how to structure outcomes-based arrangements, and whether indication-based pricing should be used.
Doctors could see changes in how they are paid by the Centers for Medicare & Medicaid Services for the drugs they administer in their office, depending on the outcome of two recent regulatory actions proposed by the agency.
The more immediate action could see an alteration to payment rates for newly launched drugs. The more long-term action could be the relaunch of the Competitive Acquisition Program, although there is much more uncertainty surrounding that change.
CMS is seeking to lower the Part B add-on payment for drugs that are new to market and do not yet have an average sales price (ASP) established. The proposal calls for these drugs to be reimbursed at the wholesale acquisition cost (WAC) plus 3%, rather than the current rate of WAC plus 6%. The change is part of the proposed physician fee schedule for 2019.
The add-on payment has no statutory definition as to what it is intended to cover, but CMS noted in the proposed rule that it “is widely believed to include services associated with drug acquisition that are not separately paid for, such as handling and storage, as well as additional mark-ups in drug distribution channels.”
Agency officials said that the add-on payment has raised concerns in recent years “because more revenue can be generated from percentage-based add-on payments for expensive drugs, and an opportunity to generate more revenue may create an incentive for the use of more expensive drugs.”
CMS also noted that once an ASP has been established – generally after a drug has been available for several months – the price for that drug is generally lower than the WAC price and, citing a 2014 HHS Office of Inspector General report, noted that “WACs often do not reflect the actual market price for drugs.”
The move to lower payments to WAC plus 3% for new drugs is consistent with a recent recommendation from the Medicare Payment Advisory Commission (MedPAC).
CMS added that the reduction would reduce beneficiary out-of-pocket costs, since copayments are a percentage of the total cost of the drug, including the add-on payment amount.
“The proposed approach would help Medicare beneficiaries afford to pay for new drugs by reducing out-of-pocket expenses and would help counteract the effects of increasing launch prices for newly approved drugs and biologicals,” CMS said in the proposed regulation.
But the American College of Rheumatology raised concerns about the proposal. Specifically, ACR is concerned that plans to cut add-on payments for new drugs “could slow market uptake of biosimilars and thwart the Administration’s efforts to reduce drug prices,” the group said in a statement.
The Community Oncology Alliance (COA) also took issue with the proposal. “This is a payment cut from the current rate of Wholesale Acquisition Cost (WAC) plus 6%, or what is really plus 4.3% when factoring in the sequester,” the COA said in a statement. “COA believes that this payment cut for new cancer therapies will result in drug manufacturers actually increasing WAC list prices so that their new products will not be at a competitive disadvantage to existing products, which are reimbursed at average sales price (ASP) plus 6%.”
The second proposal, which could take longer to materialize, revolves around the potential relaunch of the failed competitive acquisition program (CAP) for Part B drugs. CMS is currently requesting information, with questions on what a revamped program could look like if the agency were to move forward with it. The request for information is part of the proposed rule updating the Outpatient Prospective Payment System for 2019.
Under the original CAP, physicians who participated in the program would order drugs from an approved vendor, who would then bill Medicare and collect cost-sharing payments from the beneficiary. The original program was in operation for 18 months, ending on Dec. 31, 2008, after it had little participation and faced other concerns.
More recently, MedPAC recommended a revised version of the program, which they dubbed the Part B Drug Value Program (DVP). Under this construct, private vendors would acquire drugs at lower prices using various negotiation tools, and physicians would be encouraged to make more value-based use decisions based on opportunities for shared savings though their Medicare billing for the use of Part B drugs.
CMS is asking for feedback on a wide range of questions on how the revamped CAP program should be designed, including program design, which suppliers and drugs to include, how to incentivize participation, how to structure outcomes-based arrangements, and whether indication-based pricing should be used.
CMS to resume risk adjustment payments for 2017
The Centers for Medicare & Medicaid Services has resumed the risk adjustment payment program from calendar year 2017 and is taking steps to ensure the program’s operation for 2018 and beyond.
CMS posted a final rule on July 24 that reissues, with additional explanation, the risk adjustment methodology that was used to calculate payments made to insurers for 2017.
The risk adjustment payment program uses statewide average premiums to draw money from health insurance plans within a state that have low levels of high-need patients and funnels that money to plans in that state with high amounts of high-need patients as a way to minimize adverse selection and to spread risk.
CMS halted the risk adjustment program earlier in the month following legal action. In January 2018, the U.S. District Court for the District of Massachusetts ruled that the CMS was acting within its authority in promulgating its methodology based on statewide average premiums. A month later, the U.S. District Court for the District of New Mexico ruled that the methodology was invalid and barred the CMS from collecting or making payments, which prompted the agency to temporarily halt the program.
“This final rule will restore operation of the risk adjustment program and mitigate some of the uncertainty caused by the New Mexico litigation,” CMS Administrator Seema Verma said in a statement. “Issuers that had expressed concern about having to withdraw from markets or becoming insolvent should be assured by our actions today.”
CMS said the final rule provides a fuller explanation to support the 2017 risk adjustment methodology. The agency dispensed with the normal notice and comment period before issuing the final rule to help ensure timely payments are made by the program while working to resolve the legal questions. A motion to reconsider was filed in New Mexico on June 21, but a ruling on that is not expected until early September, which prompted the unusual move to issue a final rule without any notice or comment period.
CMS added that there will be a notice of proposed rule making with the normal comment period related to the risk adjustment payments for the 2018 calendar year. The existing rule was also vacated by the New Mexico court. The risk adjustment methodology for 2019 and beyond was finalized in a rule issued on April 17.
The Centers for Medicare & Medicaid Services has resumed the risk adjustment payment program from calendar year 2017 and is taking steps to ensure the program’s operation for 2018 and beyond.
CMS posted a final rule on July 24 that reissues, with additional explanation, the risk adjustment methodology that was used to calculate payments made to insurers for 2017.
The risk adjustment payment program uses statewide average premiums to draw money from health insurance plans within a state that have low levels of high-need patients and funnels that money to plans in that state with high amounts of high-need patients as a way to minimize adverse selection and to spread risk.
CMS halted the risk adjustment program earlier in the month following legal action. In January 2018, the U.S. District Court for the District of Massachusetts ruled that the CMS was acting within its authority in promulgating its methodology based on statewide average premiums. A month later, the U.S. District Court for the District of New Mexico ruled that the methodology was invalid and barred the CMS from collecting or making payments, which prompted the agency to temporarily halt the program.
“This final rule will restore operation of the risk adjustment program and mitigate some of the uncertainty caused by the New Mexico litigation,” CMS Administrator Seema Verma said in a statement. “Issuers that had expressed concern about having to withdraw from markets or becoming insolvent should be assured by our actions today.”
CMS said the final rule provides a fuller explanation to support the 2017 risk adjustment methodology. The agency dispensed with the normal notice and comment period before issuing the final rule to help ensure timely payments are made by the program while working to resolve the legal questions. A motion to reconsider was filed in New Mexico on June 21, but a ruling on that is not expected until early September, which prompted the unusual move to issue a final rule without any notice or comment period.
CMS added that there will be a notice of proposed rule making with the normal comment period related to the risk adjustment payments for the 2018 calendar year. The existing rule was also vacated by the New Mexico court. The risk adjustment methodology for 2019 and beyond was finalized in a rule issued on April 17.
The Centers for Medicare & Medicaid Services has resumed the risk adjustment payment program from calendar year 2017 and is taking steps to ensure the program’s operation for 2018 and beyond.
CMS posted a final rule on July 24 that reissues, with additional explanation, the risk adjustment methodology that was used to calculate payments made to insurers for 2017.
The risk adjustment payment program uses statewide average premiums to draw money from health insurance plans within a state that have low levels of high-need patients and funnels that money to plans in that state with high amounts of high-need patients as a way to minimize adverse selection and to spread risk.
CMS halted the risk adjustment program earlier in the month following legal action. In January 2018, the U.S. District Court for the District of Massachusetts ruled that the CMS was acting within its authority in promulgating its methodology based on statewide average premiums. A month later, the U.S. District Court for the District of New Mexico ruled that the methodology was invalid and barred the CMS from collecting or making payments, which prompted the agency to temporarily halt the program.
“This final rule will restore operation of the risk adjustment program and mitigate some of the uncertainty caused by the New Mexico litigation,” CMS Administrator Seema Verma said in a statement. “Issuers that had expressed concern about having to withdraw from markets or becoming insolvent should be assured by our actions today.”
CMS said the final rule provides a fuller explanation to support the 2017 risk adjustment methodology. The agency dispensed with the normal notice and comment period before issuing the final rule to help ensure timely payments are made by the program while working to resolve the legal questions. A motion to reconsider was filed in New Mexico on June 21, but a ruling on that is not expected until early September, which prompted the unusual move to issue a final rule without any notice or comment period.
CMS added that there will be a notice of proposed rule making with the normal comment period related to the risk adjustment payments for the 2018 calendar year. The existing rule was also vacated by the New Mexico court. The risk adjustment methodology for 2019 and beyond was finalized in a rule issued on April 17.
CMS proposes site-neutral payments for hospital outpatient setting
In the proposed update to the Outpatient Prospective Payment System (OPPS) for 2019, released July 27 and scheduled to be published July 31 in the Federal Register, the CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under the OPPS.
“The clinic visit is the most common service billed under the OPPS and is often furnished in the physician office setting,” the CMS said in a fact sheet detailing its proposal.
According to the CMS, the average current clinical visit paid by the CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.
“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.
The American Hospital Association already is pushing back on this proposal.
“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”
However, Farzad Mostashari, MD, founder of the health care technology company Aledade and National Coordinator for Health IT under President Obama, suggested that this could actually be a good thing for hospitals.
“The truth is that this proposal could help hospitals be more competitive in value-based contracts/alternative-payment models, and they should embrace the changes,” he said in a tweet.
The OPPS update also includes proposals to expand the list of covered surgical procedures that can be performed in an ambulatory surgical center, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”
“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.
The CMS also will review all procedures added to the covered procedure list in the past 3 years to determine whether such procedures should continue to be covered.
In addition, the OPPS is seeking feedback on a number of topics.
One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.
The CMS also is seeking information about relaunching a revamped competitive acquisition program that would have private vendors administer payment arrangements for Part B drugs. The agency is soliciting feedback on ways to design a model for testing.
Finally, the agency is seeking more information on solutions to better promote interoperability.
In the proposed update to the Outpatient Prospective Payment System (OPPS) for 2019, released July 27 and scheduled to be published July 31 in the Federal Register, the CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under the OPPS.
“The clinic visit is the most common service billed under the OPPS and is often furnished in the physician office setting,” the CMS said in a fact sheet detailing its proposal.
According to the CMS, the average current clinical visit paid by the CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.
“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.
The American Hospital Association already is pushing back on this proposal.
“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”
However, Farzad Mostashari, MD, founder of the health care technology company Aledade and National Coordinator for Health IT under President Obama, suggested that this could actually be a good thing for hospitals.
“The truth is that this proposal could help hospitals be more competitive in value-based contracts/alternative-payment models, and they should embrace the changes,” he said in a tweet.
The OPPS update also includes proposals to expand the list of covered surgical procedures that can be performed in an ambulatory surgical center, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”
“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.
The CMS also will review all procedures added to the covered procedure list in the past 3 years to determine whether such procedures should continue to be covered.
In addition, the OPPS is seeking feedback on a number of topics.
One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.
The CMS also is seeking information about relaunching a revamped competitive acquisition program that would have private vendors administer payment arrangements for Part B drugs. The agency is soliciting feedback on ways to design a model for testing.
Finally, the agency is seeking more information on solutions to better promote interoperability.
In the proposed update to the Outpatient Prospective Payment System (OPPS) for 2019, released July 27 and scheduled to be published July 31 in the Federal Register, the CMS is proposing to apply a physician fee schedule–equivalent for the clinic visit service when provided at an off-campus, provider-based department that is paid under the OPPS.
“The clinic visit is the most common service billed under the OPPS and is often furnished in the physician office setting,” the CMS said in a fact sheet detailing its proposal.
According to the CMS, the average current clinical visit paid by the CMS is $116 with $23 being the average copay by the patient. If the proposal is finalized, the payment would drop to about $46 with an average patient copay of $9.
“This is intended to address concerns about recent consolidations in the market that reduce competition,” CMS Administrator Seema Verma said during a July 25 press conference.
The American Hospital Association already is pushing back on this proposal.
“With today’s proposed rule, CMS has once again showed a lack of understanding about the reality in which hospitals and health systems operate daily to serve the needs of their communities,” AHA Executive Vice President Tom Nickels said in a statement. “In 2015, Congress clearly intended to provide current off-campus hospital clinics with the existing outpatient payment rate in recognition of the critical role they play in their communities. But CMS’s proposal runs counter to this and will instead impede access to care for the most vulnerable patients.”
However, Farzad Mostashari, MD, founder of the health care technology company Aledade and National Coordinator for Health IT under President Obama, suggested that this could actually be a good thing for hospitals.
“The truth is that this proposal could help hospitals be more competitive in value-based contracts/alternative-payment models, and they should embrace the changes,” he said in a tweet.
The OPPS update also includes proposals to expand the list of covered surgical procedures that can be performed in an ambulatory surgical center, a move that Ms. Verma said would “provide patients with more choices and options for lower-priced care.”
“For CY 2019, CMS is proposing to allow certain CPT codes outside of the surgical code range that directly crosswalk or are clinically similar to procedures within the CPT surgical code range to be included on the [covered procedure list] and is proposing to add certain cardiovascular codes to the ASC [covered procedure list] as a result,” the CMS fact sheet notes.
The CMS also will review all procedures added to the covered procedure list in the past 3 years to determine whether such procedures should continue to be covered.
In addition, the OPPS is seeking feedback on a number of topics.
One is related to price transparency. The agency is asking “whether providers and suppliers can and should be required to inform patients about charges and payment information for healthcare services and out-of-pocket costs, what data elements the public would find most useful, and what other charges are needed to empower patients,” according to the fact sheet.
The CMS also is seeking information about relaunching a revamped competitive acquisition program that would have private vendors administer payment arrangements for Part B drugs. The agency is soliciting feedback on ways to design a model for testing.
Finally, the agency is seeking more information on solutions to better promote interoperability.