Many will be automatically re-enrolled in ACA plans

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WASHINGTON – Unless patients actively choose a new plan before Dec. 15, those who paid for a health insurance plan through the federal marketplace in 2014 will be automatically re-enrolled in the same plan for 2015, federal officials said.

The goal is to ensure there will be no gaps in coverage, Kevin Counihan, CEO of the federal health insurance marketplace, said at the Health Insurance Exchanges Forum held by America’s Health Insurance Plans.

Kevin Counihan

Mr. Counihan did not give an estimate on how many people might be automatically re-enrolled, but he did say that some 7.3 million Americans had selected and paid for a health plan through the federal marketplace.

Mr. Counihan was appointed in late August to oversee the operations of healthcare.gov, the web portal for the federal health insurance marketplace. He is also director of the Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight.

Open enrollment for health plans offered under the Affordable Care Act begins Nov. 15.

The CMS is starting to send notices to patients who either enrolled in a plan in 2014, or had been determined to be eligible but did not enroll, reminding them that they can start the renewal process on Nov. 15. The notices will arrive by mail or e-mail, depending on what the patient indicated as a preference.

At the same time, patients will receive notices from their current insurers, letting them know whether there are network or benefits changes, or if there is an increase or decrease in the premiums or other costs.

Patients have until Dec. 15 to enroll in a plan for coverage that starts on Jan. 1.

If they do not renew a current plan or elect a new plan by Dec. 15, they will be automatically re-enrolled in the existing plan, said Ben Walker, director of open enrollment for the federal marketplace at the CCIIO.

They will get the same amount of advance payment of the premium tax credit and same subsidies as in 2014. Those credits and cost-sharing reductions are subject to change, depending on a patient’s updated eligibility information.

Even if they’ve been auto-enrolled, they can eventually go back and select a different plan, as long as they do it by Feb. 15, when open season ends, Mr. Walker said at the meeting. The coverage in the new plan will start on the first day of the next or second month depending on when the patient enrolled.

The National Governors Association is somewhat concerned about the automatic re-enrollments, Esther Krofah, program director in the NGA’s health division, said at the meeting. “We have to make sure consumers are aware of their options and are taking the steps they need to protect themselves,” she said.

Rachel Klein, organizational strategy and enrollment program director for Families USA, said that patients could be confused, or potentially harmed, by the automatic re-enrollment. In some cases, they might want to stay with the plan, especially if they’ve developed a relationship with a physician in that plan’s network, she said.

But they may also have gotten a new diagnosis that requires them to see a particular doctor, who might not be in the plan, said Ms. Klein. For that reason, it will be especially important for patients to be able to “compare in much greater detail the plans available,” she said.

To help increase awareness of the re-enrollment process, the CMS on Oct. 15 launched the “Five Steps to Staying Covered” campaign, urging patients to review their current plans, and then, starting on Nov. 15, to update their income and other information, compare the current plan with other plans, choose a plan, and enroll.

The CMS has been testing the healthcare.gov website and is encouraged by what it has seen so far, Mr. Counihan told health plan representatives.

“We feel confident we’re going to have a successful 2015,” he said.

[email protected]

On Twitter @aliciaault

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WASHINGTON – Unless patients actively choose a new plan before Dec. 15, those who paid for a health insurance plan through the federal marketplace in 2014 will be automatically re-enrolled in the same plan for 2015, federal officials said.

The goal is to ensure there will be no gaps in coverage, Kevin Counihan, CEO of the federal health insurance marketplace, said at the Health Insurance Exchanges Forum held by America’s Health Insurance Plans.

Kevin Counihan

Mr. Counihan did not give an estimate on how many people might be automatically re-enrolled, but he did say that some 7.3 million Americans had selected and paid for a health plan through the federal marketplace.

Mr. Counihan was appointed in late August to oversee the operations of healthcare.gov, the web portal for the federal health insurance marketplace. He is also director of the Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight.

Open enrollment for health plans offered under the Affordable Care Act begins Nov. 15.

The CMS is starting to send notices to patients who either enrolled in a plan in 2014, or had been determined to be eligible but did not enroll, reminding them that they can start the renewal process on Nov. 15. The notices will arrive by mail or e-mail, depending on what the patient indicated as a preference.

At the same time, patients will receive notices from their current insurers, letting them know whether there are network or benefits changes, or if there is an increase or decrease in the premiums or other costs.

Patients have until Dec. 15 to enroll in a plan for coverage that starts on Jan. 1.

If they do not renew a current plan or elect a new plan by Dec. 15, they will be automatically re-enrolled in the existing plan, said Ben Walker, director of open enrollment for the federal marketplace at the CCIIO.

They will get the same amount of advance payment of the premium tax credit and same subsidies as in 2014. Those credits and cost-sharing reductions are subject to change, depending on a patient’s updated eligibility information.

Even if they’ve been auto-enrolled, they can eventually go back and select a different plan, as long as they do it by Feb. 15, when open season ends, Mr. Walker said at the meeting. The coverage in the new plan will start on the first day of the next or second month depending on when the patient enrolled.

The National Governors Association is somewhat concerned about the automatic re-enrollments, Esther Krofah, program director in the NGA’s health division, said at the meeting. “We have to make sure consumers are aware of their options and are taking the steps they need to protect themselves,” she said.

Rachel Klein, organizational strategy and enrollment program director for Families USA, said that patients could be confused, or potentially harmed, by the automatic re-enrollment. In some cases, they might want to stay with the plan, especially if they’ve developed a relationship with a physician in that plan’s network, she said.

But they may also have gotten a new diagnosis that requires them to see a particular doctor, who might not be in the plan, said Ms. Klein. For that reason, it will be especially important for patients to be able to “compare in much greater detail the plans available,” she said.

To help increase awareness of the re-enrollment process, the CMS on Oct. 15 launched the “Five Steps to Staying Covered” campaign, urging patients to review their current plans, and then, starting on Nov. 15, to update their income and other information, compare the current plan with other plans, choose a plan, and enroll.

The CMS has been testing the healthcare.gov website and is encouraged by what it has seen so far, Mr. Counihan told health plan representatives.

“We feel confident we’re going to have a successful 2015,” he said.

[email protected]

On Twitter @aliciaault

WASHINGTON – Unless patients actively choose a new plan before Dec. 15, those who paid for a health insurance plan through the federal marketplace in 2014 will be automatically re-enrolled in the same plan for 2015, federal officials said.

The goal is to ensure there will be no gaps in coverage, Kevin Counihan, CEO of the federal health insurance marketplace, said at the Health Insurance Exchanges Forum held by America’s Health Insurance Plans.

Kevin Counihan

Mr. Counihan did not give an estimate on how many people might be automatically re-enrolled, but he did say that some 7.3 million Americans had selected and paid for a health plan through the federal marketplace.

Mr. Counihan was appointed in late August to oversee the operations of healthcare.gov, the web portal for the federal health insurance marketplace. He is also director of the Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight.

Open enrollment for health plans offered under the Affordable Care Act begins Nov. 15.

The CMS is starting to send notices to patients who either enrolled in a plan in 2014, or had been determined to be eligible but did not enroll, reminding them that they can start the renewal process on Nov. 15. The notices will arrive by mail or e-mail, depending on what the patient indicated as a preference.

At the same time, patients will receive notices from their current insurers, letting them know whether there are network or benefits changes, or if there is an increase or decrease in the premiums or other costs.

Patients have until Dec. 15 to enroll in a plan for coverage that starts on Jan. 1.

If they do not renew a current plan or elect a new plan by Dec. 15, they will be automatically re-enrolled in the existing plan, said Ben Walker, director of open enrollment for the federal marketplace at the CCIIO.

They will get the same amount of advance payment of the premium tax credit and same subsidies as in 2014. Those credits and cost-sharing reductions are subject to change, depending on a patient’s updated eligibility information.

Even if they’ve been auto-enrolled, they can eventually go back and select a different plan, as long as they do it by Feb. 15, when open season ends, Mr. Walker said at the meeting. The coverage in the new plan will start on the first day of the next or second month depending on when the patient enrolled.

The National Governors Association is somewhat concerned about the automatic re-enrollments, Esther Krofah, program director in the NGA’s health division, said at the meeting. “We have to make sure consumers are aware of their options and are taking the steps they need to protect themselves,” she said.

Rachel Klein, organizational strategy and enrollment program director for Families USA, said that patients could be confused, or potentially harmed, by the automatic re-enrollment. In some cases, they might want to stay with the plan, especially if they’ve developed a relationship with a physician in that plan’s network, she said.

But they may also have gotten a new diagnosis that requires them to see a particular doctor, who might not be in the plan, said Ms. Klein. For that reason, it will be especially important for patients to be able to “compare in much greater detail the plans available,” she said.

To help increase awareness of the re-enrollment process, the CMS on Oct. 15 launched the “Five Steps to Staying Covered” campaign, urging patients to review their current plans, and then, starting on Nov. 15, to update their income and other information, compare the current plan with other plans, choose a plan, and enroll.

The CMS has been testing the healthcare.gov website and is encouraged by what it has seen so far, Mr. Counihan told health plan representatives.

“We feel confident we’re going to have a successful 2015,” he said.

[email protected]

On Twitter @aliciaault

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One-third of Medicaid programs will extend primary care pay bump

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WASHINGTON – One-third of the nation’s Medicaid programs say they will extend the primary care pay bump, whether or not the federal government continues to fund it, according to a survey conducted for the Kaiser Family Foundation and the National Association of State Medicaid Directors.

Medicaid programs from all 50 states and the District of Columbia responded to the survey.

©sndr/istockphoto.com
Fifteen states said that they will continue Medicaid pay parity after it expires in December, even if the federal government decides not to.

Programs in 15 states – Alaska, Alabama, Colorado, Connecticut, Delaware, Hawaii, Iowa, Maryland, Maine, Michigan, Mississippi, Nebraska, Nevada, New Mexico, and South Carolina – said they will continue Medicaid pay parity, the higher reimbursement rate that was established by the Affordable Care Act, but which expires at the end of December.

The ACA required state Medicaid plans to pay primary care physicians (internists, family physicians, and pediatricians) at the Medicare rate. The federal government has covered the cost.

Programs in 22 states said they would not extend the higher reimbursement rate beyond this year; the remaining 14 programs said they had not made a decision, in part because they wanted to see whether the pay bump had increased physician participation in Medicaid, but also because they were waiting to see whether Congress would continue the higher reimbursement rate.

Darin Gordon, director of TennCare, Tennesse’s Medicaid program, said that his state was too financially strapped to extend the pay bump. “We’re not in a situation where we can sustain that without the continuation of that funding,” Mr. Gordon said at a briefing held by the Kaiser Family Foundation.

Kate McEvoy, Connecticut’s Medicaid director, said that the pay raise has been a great success in her state.

The “primary care rate increase was a tremendous precipitator of increased participation” by physicians in the program, said Ms. McEvoy. She said it had been an “enormously effective” policy that helped widen provider networks and increase access to care in the state.

Before the temporary rate bump, 1,622 primary care providers participated in Medicaid in Connecticut; that number had risen to 3,458 by the end of July 2014.

The expanded network of providers was crucial because the state elected to expand eligibility under the ACA, Ms. McEvoy said. At the end of 2013, there were 626,519 enrollees; as of August, there were 745,145, according to state figures.

The Connecticut Medicaid program decided to continue the Medicaid pay raise – at a less-than-100% level – for 2 years; it will now expire on June 30, 2016, the end of the state’s fiscal year.

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On Twitter @aliciaault

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WASHINGTON – One-third of the nation’s Medicaid programs say they will extend the primary care pay bump, whether or not the federal government continues to fund it, according to a survey conducted for the Kaiser Family Foundation and the National Association of State Medicaid Directors.

Medicaid programs from all 50 states and the District of Columbia responded to the survey.

©sndr/istockphoto.com
Fifteen states said that they will continue Medicaid pay parity after it expires in December, even if the federal government decides not to.

Programs in 15 states – Alaska, Alabama, Colorado, Connecticut, Delaware, Hawaii, Iowa, Maryland, Maine, Michigan, Mississippi, Nebraska, Nevada, New Mexico, and South Carolina – said they will continue Medicaid pay parity, the higher reimbursement rate that was established by the Affordable Care Act, but which expires at the end of December.

The ACA required state Medicaid plans to pay primary care physicians (internists, family physicians, and pediatricians) at the Medicare rate. The federal government has covered the cost.

Programs in 22 states said they would not extend the higher reimbursement rate beyond this year; the remaining 14 programs said they had not made a decision, in part because they wanted to see whether the pay bump had increased physician participation in Medicaid, but also because they were waiting to see whether Congress would continue the higher reimbursement rate.

Darin Gordon, director of TennCare, Tennesse’s Medicaid program, said that his state was too financially strapped to extend the pay bump. “We’re not in a situation where we can sustain that without the continuation of that funding,” Mr. Gordon said at a briefing held by the Kaiser Family Foundation.

Kate McEvoy, Connecticut’s Medicaid director, said that the pay raise has been a great success in her state.

The “primary care rate increase was a tremendous precipitator of increased participation” by physicians in the program, said Ms. McEvoy. She said it had been an “enormously effective” policy that helped widen provider networks and increase access to care in the state.

Before the temporary rate bump, 1,622 primary care providers participated in Medicaid in Connecticut; that number had risen to 3,458 by the end of July 2014.

The expanded network of providers was crucial because the state elected to expand eligibility under the ACA, Ms. McEvoy said. At the end of 2013, there were 626,519 enrollees; as of August, there were 745,145, according to state figures.

The Connecticut Medicaid program decided to continue the Medicaid pay raise – at a less-than-100% level – for 2 years; it will now expire on June 30, 2016, the end of the state’s fiscal year.

[email protected]

On Twitter @aliciaault

WASHINGTON – One-third of the nation’s Medicaid programs say they will extend the primary care pay bump, whether or not the federal government continues to fund it, according to a survey conducted for the Kaiser Family Foundation and the National Association of State Medicaid Directors.

Medicaid programs from all 50 states and the District of Columbia responded to the survey.

©sndr/istockphoto.com
Fifteen states said that they will continue Medicaid pay parity after it expires in December, even if the federal government decides not to.

Programs in 15 states – Alaska, Alabama, Colorado, Connecticut, Delaware, Hawaii, Iowa, Maryland, Maine, Michigan, Mississippi, Nebraska, Nevada, New Mexico, and South Carolina – said they will continue Medicaid pay parity, the higher reimbursement rate that was established by the Affordable Care Act, but which expires at the end of December.

The ACA required state Medicaid plans to pay primary care physicians (internists, family physicians, and pediatricians) at the Medicare rate. The federal government has covered the cost.

Programs in 22 states said they would not extend the higher reimbursement rate beyond this year; the remaining 14 programs said they had not made a decision, in part because they wanted to see whether the pay bump had increased physician participation in Medicaid, but also because they were waiting to see whether Congress would continue the higher reimbursement rate.

Darin Gordon, director of TennCare, Tennesse’s Medicaid program, said that his state was too financially strapped to extend the pay bump. “We’re not in a situation where we can sustain that without the continuation of that funding,” Mr. Gordon said at a briefing held by the Kaiser Family Foundation.

Kate McEvoy, Connecticut’s Medicaid director, said that the pay raise has been a great success in her state.

The “primary care rate increase was a tremendous precipitator of increased participation” by physicians in the program, said Ms. McEvoy. She said it had been an “enormously effective” policy that helped widen provider networks and increase access to care in the state.

Before the temporary rate bump, 1,622 primary care providers participated in Medicaid in Connecticut; that number had risen to 3,458 by the end of July 2014.

The expanded network of providers was crucial because the state elected to expand eligibility under the ACA, Ms. McEvoy said. At the end of 2013, there were 626,519 enrollees; as of August, there were 745,145, according to state figures.

The Connecticut Medicaid program decided to continue the Medicaid pay raise – at a less-than-100% level – for 2 years; it will now expire on June 30, 2016, the end of the state’s fiscal year.

[email protected]

On Twitter @aliciaault

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Cancer community turns focus to ‘value’

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WASHINGTON – A coalition of cancer researchers, patient advocates, oncologists, and pharmaceutical companies has issued a 13-point call to action to create a path toward better value in cancer care.

The white paper was released at Turning the Tide Against Cancer on Oct. 9. The meeting was sponsored by the Personalized Medicine Coalition, the American Association for Cancer Research, and Feinstein Kean Healthcare, a consulting firm.

Dr. Richard L. Schilsky

Those organizations convened an initial “Turning the Tide” meeting in 2012. At that first gathering, participants discussed how the rapid-fire scientific developments in oncology could be incorporated into clinical care without bankrupting physicians, payers, or patients.

In the 2 years since, a task force met and created the new call to action, which focuses on how to foster a shift toward patient-centeredness in research and care, and how to address cost and value in ways that align with patient-centeredness and that do not hamper innovation.

Among the recommendations:

  • The government should encourage clinical trials that enable study of multiple drugs simultaneously.
  • The Food and Drug Administration should modernize its regulation of personalized medicine.
  • Congress should help fund the development of cancer quality and outcomes measures.
  • Federal and state marketplace plans should offer broad coverage of oncology drugs and services.
  • The government should do more to standardize clinical decision-making tools and make them available to the public in an easily-understood format.

“We must not only continue to support cutting-edge cancer research, but also engage patients as partners throughout the continuum of research and care because, by doing so, we can develop a better understanding of their individual needs and preferences and ensure that they receive the most effective treatment for their particular disease,” Dr. Margaret Foti, chief executive officer of the AACR, said in a statement.

The new report “demonstrates the value of shared commitment and collaboration,” John J. Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said at the Turning the Tide meeting.

The rising – and in some cases extremely high – cost of oncology chemotherapies and personalized medicine diagnostics has attracted growing attention as these treatments gain more widespread use.

Mr. Castellani sidestepped the expense issue, but other speakers took it on directly.

“I personally am very weary of drugs and biologics being the lightning rod in this discussion,” said Patricia J. Goldsmith, CEO of CancerCare, a patient support organization. “There’s a whole host of other cost drivers and factors in the delivery of oncology care that are not really being discussed,” she said at the meeting.

“All of us in the medical community have an important role to play in restraining costs and creating value for our patients,” said Dr. Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology. The high cost of therapies and increasing copays and deductibles play a role in rising cancer care costs, but “so do the practices that doctors follow,” as well as patient expectations, he said.

Patients need to be well-informed about what can and can’t be achieved, doctors need to practice evidence-based medicine, and reimbursement needs to be overhauled to focus on spending time with patients instead of just getting paid for a service, Dr. Schilsky said at the meeting.

He suggested that value can’t be a static concept, especially when it comes to chemotherapies. A newly introduced drug might provide value initially, but less so over time as other, better therapies become available.

ASCO has spent a year developing a framework for physicians and patients to discuss value, he said. The idea is to have a user-friendly way for patients to compare the value of various treatment approaches in consultation with the doctor. That project is close to completion, said Dr. Schilsky.

Dr. Michael Kolodziej, national medical director for oncology solutions at Aetna, agreed that the patient needed to be made more of the focus of cancer care, from drug development into the physician’s office. In clinical trials, “we are not recording what’s important to patients,” he said at the meeting.

But he also took drug makers to task for developing too many me-too products. “We do not need another [tyrosine-kinase inhibitor] for chronic myelogenous leukemia,” said Dr. Kolodziej. Manufacturers should be rewarded for innovation, but “we have dissociated true innovation from reimbursement,” he added.

Ms. Goldsmith, who was recently diagnosed with cancer, said that even with her background, the conversations with her surgeons and oncologists were difficult to navigate. “We have to do better by patients,” she said.

Dr. Schilsky agreed. “Doctors, like everybody else, have varying communications skills,” he said. “But the one thing doctors don’t have is time.”

 

 

He said that physicians should be equipped and encouraged to spend that time talking with patients.

[email protected]

On Twitter @aliciaault

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WASHINGTON – A coalition of cancer researchers, patient advocates, oncologists, and pharmaceutical companies has issued a 13-point call to action to create a path toward better value in cancer care.

The white paper was released at Turning the Tide Against Cancer on Oct. 9. The meeting was sponsored by the Personalized Medicine Coalition, the American Association for Cancer Research, and Feinstein Kean Healthcare, a consulting firm.

Dr. Richard L. Schilsky

Those organizations convened an initial “Turning the Tide” meeting in 2012. At that first gathering, participants discussed how the rapid-fire scientific developments in oncology could be incorporated into clinical care without bankrupting physicians, payers, or patients.

In the 2 years since, a task force met and created the new call to action, which focuses on how to foster a shift toward patient-centeredness in research and care, and how to address cost and value in ways that align with patient-centeredness and that do not hamper innovation.

Among the recommendations:

  • The government should encourage clinical trials that enable study of multiple drugs simultaneously.
  • The Food and Drug Administration should modernize its regulation of personalized medicine.
  • Congress should help fund the development of cancer quality and outcomes measures.
  • Federal and state marketplace plans should offer broad coverage of oncology drugs and services.
  • The government should do more to standardize clinical decision-making tools and make them available to the public in an easily-understood format.

“We must not only continue to support cutting-edge cancer research, but also engage patients as partners throughout the continuum of research and care because, by doing so, we can develop a better understanding of their individual needs and preferences and ensure that they receive the most effective treatment for their particular disease,” Dr. Margaret Foti, chief executive officer of the AACR, said in a statement.

The new report “demonstrates the value of shared commitment and collaboration,” John J. Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said at the Turning the Tide meeting.

The rising – and in some cases extremely high – cost of oncology chemotherapies and personalized medicine diagnostics has attracted growing attention as these treatments gain more widespread use.

Mr. Castellani sidestepped the expense issue, but other speakers took it on directly.

“I personally am very weary of drugs and biologics being the lightning rod in this discussion,” said Patricia J. Goldsmith, CEO of CancerCare, a patient support organization. “There’s a whole host of other cost drivers and factors in the delivery of oncology care that are not really being discussed,” she said at the meeting.

“All of us in the medical community have an important role to play in restraining costs and creating value for our patients,” said Dr. Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology. The high cost of therapies and increasing copays and deductibles play a role in rising cancer care costs, but “so do the practices that doctors follow,” as well as patient expectations, he said.

Patients need to be well-informed about what can and can’t be achieved, doctors need to practice evidence-based medicine, and reimbursement needs to be overhauled to focus on spending time with patients instead of just getting paid for a service, Dr. Schilsky said at the meeting.

He suggested that value can’t be a static concept, especially when it comes to chemotherapies. A newly introduced drug might provide value initially, but less so over time as other, better therapies become available.

ASCO has spent a year developing a framework for physicians and patients to discuss value, he said. The idea is to have a user-friendly way for patients to compare the value of various treatment approaches in consultation with the doctor. That project is close to completion, said Dr. Schilsky.

Dr. Michael Kolodziej, national medical director for oncology solutions at Aetna, agreed that the patient needed to be made more of the focus of cancer care, from drug development into the physician’s office. In clinical trials, “we are not recording what’s important to patients,” he said at the meeting.

But he also took drug makers to task for developing too many me-too products. “We do not need another [tyrosine-kinase inhibitor] for chronic myelogenous leukemia,” said Dr. Kolodziej. Manufacturers should be rewarded for innovation, but “we have dissociated true innovation from reimbursement,” he added.

Ms. Goldsmith, who was recently diagnosed with cancer, said that even with her background, the conversations with her surgeons and oncologists were difficult to navigate. “We have to do better by patients,” she said.

Dr. Schilsky agreed. “Doctors, like everybody else, have varying communications skills,” he said. “But the one thing doctors don’t have is time.”

 

 

He said that physicians should be equipped and encouraged to spend that time talking with patients.

[email protected]

On Twitter @aliciaault

WASHINGTON – A coalition of cancer researchers, patient advocates, oncologists, and pharmaceutical companies has issued a 13-point call to action to create a path toward better value in cancer care.

The white paper was released at Turning the Tide Against Cancer on Oct. 9. The meeting was sponsored by the Personalized Medicine Coalition, the American Association for Cancer Research, and Feinstein Kean Healthcare, a consulting firm.

Dr. Richard L. Schilsky

Those organizations convened an initial “Turning the Tide” meeting in 2012. At that first gathering, participants discussed how the rapid-fire scientific developments in oncology could be incorporated into clinical care without bankrupting physicians, payers, or patients.

In the 2 years since, a task force met and created the new call to action, which focuses on how to foster a shift toward patient-centeredness in research and care, and how to address cost and value in ways that align with patient-centeredness and that do not hamper innovation.

Among the recommendations:

  • The government should encourage clinical trials that enable study of multiple drugs simultaneously.
  • The Food and Drug Administration should modernize its regulation of personalized medicine.
  • Congress should help fund the development of cancer quality and outcomes measures.
  • Federal and state marketplace plans should offer broad coverage of oncology drugs and services.
  • The government should do more to standardize clinical decision-making tools and make them available to the public in an easily-understood format.

“We must not only continue to support cutting-edge cancer research, but also engage patients as partners throughout the continuum of research and care because, by doing so, we can develop a better understanding of their individual needs and preferences and ensure that they receive the most effective treatment for their particular disease,” Dr. Margaret Foti, chief executive officer of the AACR, said in a statement.

The new report “demonstrates the value of shared commitment and collaboration,” John J. Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said at the Turning the Tide meeting.

The rising – and in some cases extremely high – cost of oncology chemotherapies and personalized medicine diagnostics has attracted growing attention as these treatments gain more widespread use.

Mr. Castellani sidestepped the expense issue, but other speakers took it on directly.

“I personally am very weary of drugs and biologics being the lightning rod in this discussion,” said Patricia J. Goldsmith, CEO of CancerCare, a patient support organization. “There’s a whole host of other cost drivers and factors in the delivery of oncology care that are not really being discussed,” she said at the meeting.

“All of us in the medical community have an important role to play in restraining costs and creating value for our patients,” said Dr. Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology. The high cost of therapies and increasing copays and deductibles play a role in rising cancer care costs, but “so do the practices that doctors follow,” as well as patient expectations, he said.

Patients need to be well-informed about what can and can’t be achieved, doctors need to practice evidence-based medicine, and reimbursement needs to be overhauled to focus on spending time with patients instead of just getting paid for a service, Dr. Schilsky said at the meeting.

He suggested that value can’t be a static concept, especially when it comes to chemotherapies. A newly introduced drug might provide value initially, but less so over time as other, better therapies become available.

ASCO has spent a year developing a framework for physicians and patients to discuss value, he said. The idea is to have a user-friendly way for patients to compare the value of various treatment approaches in consultation with the doctor. That project is close to completion, said Dr. Schilsky.

Dr. Michael Kolodziej, national medical director for oncology solutions at Aetna, agreed that the patient needed to be made more of the focus of cancer care, from drug development into the physician’s office. In clinical trials, “we are not recording what’s important to patients,” he said at the meeting.

But he also took drug makers to task for developing too many me-too products. “We do not need another [tyrosine-kinase inhibitor] for chronic myelogenous leukemia,” said Dr. Kolodziej. Manufacturers should be rewarded for innovation, but “we have dissociated true innovation from reimbursement,” he added.

Ms. Goldsmith, who was recently diagnosed with cancer, said that even with her background, the conversations with her surgeons and oncologists were difficult to navigate. “We have to do better by patients,” she said.

Dr. Schilsky agreed. “Doctors, like everybody else, have varying communications skills,” he said. “But the one thing doctors don’t have is time.”

 

 

He said that physicians should be equipped and encouraged to spend that time talking with patients.

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Medicaid programs moving to alternative pay and delivery models

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WASHINGTON – Most Medicaid programs are embracing alternative delivery models that include patient-centered medical homes, shared risk, and value-based payment.

That conclusion is based on the results of a survey of the nation’s 51 Medicaid programs conducted for the Kaiser Family Foundation and the National Association of Medicaid Directors.

Not surprisingly, states that decided to expand Medicaid eligibility under the Affordable Care Act had higher enrollment growth and greater overall spending. The federal government is covering 100% of the cost of new Medicaid enrollees through 2016. Enrollment grew 18% in the 28 expansion states (which includes Washington), and spending rose 18%. Just 4% of the spending came out of state coffers. In nonexpansion states, enrollment grew 5%, while spending rose about 7%.

All states are looking for ways to contain costs and improve access and quality, said Vern Smith, who is a consultant with Health Management Associates and was involved in the survey.

In fiscal 2015 (which started in June 2014), 40 states have established some kind of payment or delivery system reform as compared to 30 in FY14, Mr. Smith said at a briefing held by Kaiser. “In some ways, this an even bigger story than the eligibility and enrollment changes.”

The models that states are using to align payment with outcomes and accountability include patient-centered medical homes, Medicaid health homes, and accountable care organizations. States are also increasingly integrating behavioral and physical health programs, Mr. Smith said.

Managed care is the main vehicle for achieving the new payment and delivery models; only three states – Alaska, Wyoming, and Connecticut – do not use managed care for their Medicaid recipients.

Overall, 24 states had a medical home in place in fiscal 2013, 17 were adding or expanding them in FY14, and 20 said they planned to do so in FY15, according to the Kaiser survey. Connecticut has a patient-centered medical home program that includes 1,273 providers and covers 254,000 of its 745,000 Medicaid recipients.

To spur new delivery and payment models, Tennessee launched an initiative in 2013 to focus on value as it pays for Medicaid services, Darin Gordon, director of TennCare, said at the briefing.

The goal over the next 5 years is “to get over 50% of our spend in some type of value-based payment,” he said.

The trend seems likely to stick, the survey authors said. “Whether a state elected to expand or not, Medicaid programs across the nation are being transformed with new enrollment procedures and outreach efforts combined with increased emphasis on delivery system reforms,” said Diane Rowland, executive vice president of the Kaiser Family Foundation.

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WASHINGTON – Most Medicaid programs are embracing alternative delivery models that include patient-centered medical homes, shared risk, and value-based payment.

That conclusion is based on the results of a survey of the nation’s 51 Medicaid programs conducted for the Kaiser Family Foundation and the National Association of Medicaid Directors.

Not surprisingly, states that decided to expand Medicaid eligibility under the Affordable Care Act had higher enrollment growth and greater overall spending. The federal government is covering 100% of the cost of new Medicaid enrollees through 2016. Enrollment grew 18% in the 28 expansion states (which includes Washington), and spending rose 18%. Just 4% of the spending came out of state coffers. In nonexpansion states, enrollment grew 5%, while spending rose about 7%.

All states are looking for ways to contain costs and improve access and quality, said Vern Smith, who is a consultant with Health Management Associates and was involved in the survey.

In fiscal 2015 (which started in June 2014), 40 states have established some kind of payment or delivery system reform as compared to 30 in FY14, Mr. Smith said at a briefing held by Kaiser. “In some ways, this an even bigger story than the eligibility and enrollment changes.”

The models that states are using to align payment with outcomes and accountability include patient-centered medical homes, Medicaid health homes, and accountable care organizations. States are also increasingly integrating behavioral and physical health programs, Mr. Smith said.

Managed care is the main vehicle for achieving the new payment and delivery models; only three states – Alaska, Wyoming, and Connecticut – do not use managed care for their Medicaid recipients.

Overall, 24 states had a medical home in place in fiscal 2013, 17 were adding or expanding them in FY14, and 20 said they planned to do so in FY15, according to the Kaiser survey. Connecticut has a patient-centered medical home program that includes 1,273 providers and covers 254,000 of its 745,000 Medicaid recipients.

To spur new delivery and payment models, Tennessee launched an initiative in 2013 to focus on value as it pays for Medicaid services, Darin Gordon, director of TennCare, said at the briefing.

The goal over the next 5 years is “to get over 50% of our spend in some type of value-based payment,” he said.

The trend seems likely to stick, the survey authors said. “Whether a state elected to expand or not, Medicaid programs across the nation are being transformed with new enrollment procedures and outreach efforts combined with increased emphasis on delivery system reforms,” said Diane Rowland, executive vice president of the Kaiser Family Foundation.

[email protected]

On Twitter @aliciaault

WASHINGTON – Most Medicaid programs are embracing alternative delivery models that include patient-centered medical homes, shared risk, and value-based payment.

That conclusion is based on the results of a survey of the nation’s 51 Medicaid programs conducted for the Kaiser Family Foundation and the National Association of Medicaid Directors.

Not surprisingly, states that decided to expand Medicaid eligibility under the Affordable Care Act had higher enrollment growth and greater overall spending. The federal government is covering 100% of the cost of new Medicaid enrollees through 2016. Enrollment grew 18% in the 28 expansion states (which includes Washington), and spending rose 18%. Just 4% of the spending came out of state coffers. In nonexpansion states, enrollment grew 5%, while spending rose about 7%.

All states are looking for ways to contain costs and improve access and quality, said Vern Smith, who is a consultant with Health Management Associates and was involved in the survey.

In fiscal 2015 (which started in June 2014), 40 states have established some kind of payment or delivery system reform as compared to 30 in FY14, Mr. Smith said at a briefing held by Kaiser. “In some ways, this an even bigger story than the eligibility and enrollment changes.”

The models that states are using to align payment with outcomes and accountability include patient-centered medical homes, Medicaid health homes, and accountable care organizations. States are also increasingly integrating behavioral and physical health programs, Mr. Smith said.

Managed care is the main vehicle for achieving the new payment and delivery models; only three states – Alaska, Wyoming, and Connecticut – do not use managed care for their Medicaid recipients.

Overall, 24 states had a medical home in place in fiscal 2013, 17 were adding or expanding them in FY14, and 20 said they planned to do so in FY15, according to the Kaiser survey. Connecticut has a patient-centered medical home program that includes 1,273 providers and covers 254,000 of its 745,000 Medicaid recipients.

To spur new delivery and payment models, Tennessee launched an initiative in 2013 to focus on value as it pays for Medicaid services, Darin Gordon, director of TennCare, said at the briefing.

The goal over the next 5 years is “to get over 50% of our spend in some type of value-based payment,” he said.

The trend seems likely to stick, the survey authors said. “Whether a state elected to expand or not, Medicaid programs across the nation are being transformed with new enrollment procedures and outreach efforts combined with increased emphasis on delivery system reforms,” said Diane Rowland, executive vice president of the Kaiser Family Foundation.

[email protected]

On Twitter @aliciaault

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Pioneer ACOs improve in second year

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WASHINGTON – The accountable care organizations that are participating in Medicare’s highest risk, highest reward program improved in both quality of care and controlling costs in the second year, according to new government figures.

Even so, groups continue to leave the Pioneer ACO program. In the first year, 2012, there were 32 ACOs agreeing to share a high proportion of savings – or take on a high proportion of losses – as part of the Pioneer ACO program; 23 participated in 2013. Currently, 19 ACOs are participating, according to the Centers for Medicare & Medicaid Services.

Alicia Ault/Frontline Medical News
Dr. Patrick Conway delivered results from the Pioneer ACO program.

Dr. Patrick Conway, CMS chief medical officer and deputy administrator for innovation and quality, said that drop outs were expected.

“We purposely set up the Pioneer program and our ACO program so that ACOs could migrate risk tracks,” Dr. Conway said at the meeting. “We actually predicted at this point we would have less Pioneer ACOs than we have now,” he said.

CMS would like to see every ACO stay in the Pioneer program, he said, adding, “but the reality is we set up the policy construct to allow flexibility of risk tracks.”

Dr. Conway noted that there are still some 600,000 Medicare beneficiaries who receive care through ACOs in the Pioneer program.

Overall, the 23 ACOs that participated in both 2012 and 2013 saved $90 million for 2013; they saved $128 million in 2012.

Not surprisingly, many hospitals that lost money in the first year did not participate in the second year, according to the CMS data. But some did, despite continued losses.

At least half of the Pioneers shared in savings, said Dr. Conway.

Beth Israel Deaconess Care Organization appeared to be a fairly big winner, generating $17.6 million in savings, and getting to keep some $10.6 million.

The San Francisco-based Brown & Toland Physicians’ ACO generated $4.5 million in savings, keeping almost $2.5 million. The Mount Auburn Cambridge Independent Practice Association, in the Boston area, kept $2.2 million of the $3.6 million it generated for Medicare.

Pioneers that created savings in the first 2 years are eligible to start receiving a per member per month prospective payment in 2014 if they are still participating.

The CMS has not yet released data on how many Pioneer ACOs are operating under that payment arrangement.

The Pioneer ACOs also improved quality of care, with mean performance scores for the group rising from 71% to 84%, said Dr. Conway. The Pioneers improved in 28 of the 33 goals measured.

He said he was particularly impressed with the overall improvement in six out of the seven measures of patient experience.

Patients reported on whether they received timely appointments, had good access to specialists, how well the physician communicated, and if there was shared decision making, among other measures.

Going forward, the CMS is considering removing some process measures and adding more outcome measures, said Dr. Conway.

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WASHINGTON – The accountable care organizations that are participating in Medicare’s highest risk, highest reward program improved in both quality of care and controlling costs in the second year, according to new government figures.

Even so, groups continue to leave the Pioneer ACO program. In the first year, 2012, there were 32 ACOs agreeing to share a high proportion of savings – or take on a high proportion of losses – as part of the Pioneer ACO program; 23 participated in 2013. Currently, 19 ACOs are participating, according to the Centers for Medicare & Medicaid Services.

Alicia Ault/Frontline Medical News
Dr. Patrick Conway delivered results from the Pioneer ACO program.

Dr. Patrick Conway, CMS chief medical officer and deputy administrator for innovation and quality, said that drop outs were expected.

“We purposely set up the Pioneer program and our ACO program so that ACOs could migrate risk tracks,” Dr. Conway said at the meeting. “We actually predicted at this point we would have less Pioneer ACOs than we have now,” he said.

CMS would like to see every ACO stay in the Pioneer program, he said, adding, “but the reality is we set up the policy construct to allow flexibility of risk tracks.”

Dr. Conway noted that there are still some 600,000 Medicare beneficiaries who receive care through ACOs in the Pioneer program.

Overall, the 23 ACOs that participated in both 2012 and 2013 saved $90 million for 2013; they saved $128 million in 2012.

Not surprisingly, many hospitals that lost money in the first year did not participate in the second year, according to the CMS data. But some did, despite continued losses.

At least half of the Pioneers shared in savings, said Dr. Conway.

Beth Israel Deaconess Care Organization appeared to be a fairly big winner, generating $17.6 million in savings, and getting to keep some $10.6 million.

The San Francisco-based Brown & Toland Physicians’ ACO generated $4.5 million in savings, keeping almost $2.5 million. The Mount Auburn Cambridge Independent Practice Association, in the Boston area, kept $2.2 million of the $3.6 million it generated for Medicare.

Pioneers that created savings in the first 2 years are eligible to start receiving a per member per month prospective payment in 2014 if they are still participating.

The CMS has not yet released data on how many Pioneer ACOs are operating under that payment arrangement.

The Pioneer ACOs also improved quality of care, with mean performance scores for the group rising from 71% to 84%, said Dr. Conway. The Pioneers improved in 28 of the 33 goals measured.

He said he was particularly impressed with the overall improvement in six out of the seven measures of patient experience.

Patients reported on whether they received timely appointments, had good access to specialists, how well the physician communicated, and if there was shared decision making, among other measures.

Going forward, the CMS is considering removing some process measures and adding more outcome measures, said Dr. Conway.

[email protected]

On Twitter @aliciaault   

WASHINGTON – The accountable care organizations that are participating in Medicare’s highest risk, highest reward program improved in both quality of care and controlling costs in the second year, according to new government figures.

Even so, groups continue to leave the Pioneer ACO program. In the first year, 2012, there were 32 ACOs agreeing to share a high proportion of savings – or take on a high proportion of losses – as part of the Pioneer ACO program; 23 participated in 2013. Currently, 19 ACOs are participating, according to the Centers for Medicare & Medicaid Services.

Alicia Ault/Frontline Medical News
Dr. Patrick Conway delivered results from the Pioneer ACO program.

Dr. Patrick Conway, CMS chief medical officer and deputy administrator for innovation and quality, said that drop outs were expected.

“We purposely set up the Pioneer program and our ACO program so that ACOs could migrate risk tracks,” Dr. Conway said at the meeting. “We actually predicted at this point we would have less Pioneer ACOs than we have now,” he said.

CMS would like to see every ACO stay in the Pioneer program, he said, adding, “but the reality is we set up the policy construct to allow flexibility of risk tracks.”

Dr. Conway noted that there are still some 600,000 Medicare beneficiaries who receive care through ACOs in the Pioneer program.

Overall, the 23 ACOs that participated in both 2012 and 2013 saved $90 million for 2013; they saved $128 million in 2012.

Not surprisingly, many hospitals that lost money in the first year did not participate in the second year, according to the CMS data. But some did, despite continued losses.

At least half of the Pioneers shared in savings, said Dr. Conway.

Beth Israel Deaconess Care Organization appeared to be a fairly big winner, generating $17.6 million in savings, and getting to keep some $10.6 million.

The San Francisco-based Brown & Toland Physicians’ ACO generated $4.5 million in savings, keeping almost $2.5 million. The Mount Auburn Cambridge Independent Practice Association, in the Boston area, kept $2.2 million of the $3.6 million it generated for Medicare.

Pioneers that created savings in the first 2 years are eligible to start receiving a per member per month prospective payment in 2014 if they are still participating.

The CMS has not yet released data on how many Pioneer ACOs are operating under that payment arrangement.

The Pioneer ACOs also improved quality of care, with mean performance scores for the group rising from 71% to 84%, said Dr. Conway. The Pioneers improved in 28 of the 33 goals measured.

He said he was particularly impressed with the overall improvement in six out of the seven measures of patient experience.

Patients reported on whether they received timely appointments, had good access to specialists, how well the physician communicated, and if there was shared decision making, among other measures.

Going forward, the CMS is considering removing some process measures and adding more outcome measures, said Dr. Conway.

[email protected]

On Twitter @aliciaault   

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Hydrocodone rescheduling takes effect Oct. 6

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Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.

After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.

Dr. Andrew Kolodny

That rule takes effect on Oct. 6.

After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.

Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.

The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.

In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.

The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.

Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.

He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.

Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.

Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.

“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.

He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.

The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.

Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.

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Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.

After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.

Dr. Andrew Kolodny

That rule takes effect on Oct. 6.

After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.

Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.

The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.

In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.

The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.

Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.

He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.

Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.

Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.

“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.

He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.

The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.

Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.

[email protected]

On Twitter @aliciaault

Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.

After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.

Dr. Andrew Kolodny

That rule takes effect on Oct. 6.

After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.

Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.

The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.

In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.

The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.

Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.

He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.

Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.

Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.

“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.

He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.

The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.

Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.

[email protected]

On Twitter @aliciaault

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Physicians should be paid for the time they spend counseling Medicare patients on end-of-life matters, according to several dozen members of Congress.

Rep. Earl Blumenauer (D-Ore.) and 33 other House members have written to the Centers for Medicare & Medicaid Services, urging the agency to adopt new CPT codes created by the American Medical Association’s Relative Value Update Committee. The codes – 99497 and 99498 – would reimburse physicians for discussing advance care planning.

Courtesy of Rep. Blumenauer
Rep. Earl Blumenauer

Code 99497 would be used for advance care planning, including the explanation and discussion of advance directives, such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional, and would cover the first 30 minutes, face to face with the patient, family member(s), and/or surrogate. Code 99498 would be employed for each additional 30 minutes of counseling.

The codes are included the 2015 CPT code set and can be used as of Jan. 1, if they are accepted and published in the Medicare physician fee schedule. The fee schedule is scheduled to be published by Nov. 1.

“Patients who wish to make clear their goals, values, and wishes through discussions with their trusted providers should have the opportunity to do so,” Rep. Blumenauer said in a statement. “In order to have these conversations, providers must have the adequate time, space, and reimbursement to conduct the complex and time-consuming discussions necessary to learn about the goals and values held by their patients and plan appropriately for their care.”

The Institute of Medicine also recently issued a report that called for reimbursement for physicians who talk to their patients about end-of-life issues.

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Physicians should be paid for the time they spend counseling Medicare patients on end-of-life matters, according to several dozen members of Congress.

Rep. Earl Blumenauer (D-Ore.) and 33 other House members have written to the Centers for Medicare & Medicaid Services, urging the agency to adopt new CPT codes created by the American Medical Association’s Relative Value Update Committee. The codes – 99497 and 99498 – would reimburse physicians for discussing advance care planning.

Courtesy of Rep. Blumenauer
Rep. Earl Blumenauer

Code 99497 would be used for advance care planning, including the explanation and discussion of advance directives, such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional, and would cover the first 30 minutes, face to face with the patient, family member(s), and/or surrogate. Code 99498 would be employed for each additional 30 minutes of counseling.

The codes are included the 2015 CPT code set and can be used as of Jan. 1, if they are accepted and published in the Medicare physician fee schedule. The fee schedule is scheduled to be published by Nov. 1.

“Patients who wish to make clear their goals, values, and wishes through discussions with their trusted providers should have the opportunity to do so,” Rep. Blumenauer said in a statement. “In order to have these conversations, providers must have the adequate time, space, and reimbursement to conduct the complex and time-consuming discussions necessary to learn about the goals and values held by their patients and plan appropriately for their care.”

The Institute of Medicine also recently issued a report that called for reimbursement for physicians who talk to their patients about end-of-life issues.

[email protected]

On Twitter @aliciaault

Physicians should be paid for the time they spend counseling Medicare patients on end-of-life matters, according to several dozen members of Congress.

Rep. Earl Blumenauer (D-Ore.) and 33 other House members have written to the Centers for Medicare & Medicaid Services, urging the agency to adopt new CPT codes created by the American Medical Association’s Relative Value Update Committee. The codes – 99497 and 99498 – would reimburse physicians for discussing advance care planning.

Courtesy of Rep. Blumenauer
Rep. Earl Blumenauer

Code 99497 would be used for advance care planning, including the explanation and discussion of advance directives, such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional, and would cover the first 30 minutes, face to face with the patient, family member(s), and/or surrogate. Code 99498 would be employed for each additional 30 minutes of counseling.

The codes are included the 2015 CPT code set and can be used as of Jan. 1, if they are accepted and published in the Medicare physician fee schedule. The fee schedule is scheduled to be published by Nov. 1.

“Patients who wish to make clear their goals, values, and wishes through discussions with their trusted providers should have the opportunity to do so,” Rep. Blumenauer said in a statement. “In order to have these conversations, providers must have the adequate time, space, and reimbursement to conduct the complex and time-consuming discussions necessary to learn about the goals and values held by their patients and plan appropriately for their care.”

The Institute of Medicine also recently issued a report that called for reimbursement for physicians who talk to their patients about end-of-life issues.

[email protected]

On Twitter @aliciaault

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It is tough to find a good fecal donor

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Finding healthy stool donors for fecal transplant may be a tough prospect.

That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.

Dr. Sudarshan Paramsothy

Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.

The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.

Overall, after screening, only 10% of recruits were considered eligible donors.

The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.

After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.

The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined immediately because of the 5-day-a-week donation requirement.

Twenty-seven had other issues, including medical comorbidities (13), risk factors for variant Cruetzfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.

Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.

While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, “we did not expect it in such a high proportion,” said Dr. Paramsothy. “Our screened donor population was not an at-risk group,” he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.

“Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review,” Dr. Paramsothy said.

There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, “are truly pathogenic or rather commensal organisms,” he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.

That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.

Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m2, 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.

At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.

The donor results “suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors,” Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.

Dr. Paramsothy reported no relevant financial conflicts.

[email protected]

References

Body

The AGA hosted the annual James W. Freston conference in Chicago this August, and this year’s topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.

The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.

It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.

Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.

The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.

Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago.

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Body

The AGA hosted the annual James W. Freston conference in Chicago this August, and this year’s topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.

The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.

It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.

Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.

The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.

Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago.

Body

The AGA hosted the annual James W. Freston conference in Chicago this August, and this year’s topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.

The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.

It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.

Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.

The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.

Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago.

Title
Therapeutic innovations in microbiome research
Therapeutic innovations in microbiome research

Finding healthy stool donors for fecal transplant may be a tough prospect.

That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.

Dr. Sudarshan Paramsothy

Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.

The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.

Overall, after screening, only 10% of recruits were considered eligible donors.

The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.

After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.

The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined immediately because of the 5-day-a-week donation requirement.

Twenty-seven had other issues, including medical comorbidities (13), risk factors for variant Cruetzfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.

Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.

While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, “we did not expect it in such a high proportion,” said Dr. Paramsothy. “Our screened donor population was not an at-risk group,” he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.

“Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review,” Dr. Paramsothy said.

There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, “are truly pathogenic or rather commensal organisms,” he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.

That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.

Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m2, 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.

At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.

The donor results “suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors,” Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.

Dr. Paramsothy reported no relevant financial conflicts.

[email protected]

Finding healthy stool donors for fecal transplant may be a tough prospect.

That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.

Dr. Sudarshan Paramsothy

Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.

The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.

Overall, after screening, only 10% of recruits were considered eligible donors.

The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.

After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.

The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined immediately because of the 5-day-a-week donation requirement.

Twenty-seven had other issues, including medical comorbidities (13), risk factors for variant Cruetzfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.

Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.

While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, “we did not expect it in such a high proportion,” said Dr. Paramsothy. “Our screened donor population was not an at-risk group,” he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.

“Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review,” Dr. Paramsothy said.

There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, “are truly pathogenic or rather commensal organisms,” he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.

That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.

Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m2, 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.

At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.

The donor results “suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors,” Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.

Dr. Paramsothy reported no relevant financial conflicts.

[email protected]

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FROM THE 2014 JAMES W. FRESTON CONFERENCE

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Inside the Article

Vitals

Key clinical point: Finding fecal transplant donors is not as simple as once thought.

Major finding: Only 10% of people recruited to be donors for a fecal microbiota transplant study were healthy enough to be eligible.

Data source: Donors recruited for the FOCUS study.

Disclosures: The study is sponsored by the University of New South Wales, Sydney. The investigators reported no relevant financial conflicts.

Canadian hospital’s Ebola scare exposes lack of readiness

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Canadian hospital’s Ebola scare exposes lack of readiness

WASHINGTON – While the U.S. waits for its first potential case of Ebola from a traveler, earlier this spring, officials at one hospital in Canada thought that they had a case and found themselves woefully unprepared.

In late March, a man who had returned from Liberia and had a fever of unknown origin, was admitted through the emergency department to the intensive care unit at St. Paul’s Hospital in Saskatoon, Sask. The clinicians suspected Ebola, but weren’t sure and late that night called the Saskatoon regional health department for a consultation.

Dr. Joseph Blondeau, interim head of pathology and laboratory medicine for the Saskatoon Health Region and the Royal University Hospital, took the call and set a process in motion that had been established for just such a moment, but later proved to have a variety of shortcomings, said Dr. Blondeau during a presentation at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Dr. Joseph Blondeau

Initially, the ICU clinicians treated the man empirically with a third-generation cephalosporin and vancomycin. There were still not enough details to make a definitive diagnosis, but by early the next morning there was a high level of suspicion. The patient was hemorrhaging from his eye, there was blood in his nasogastric tube, some rectal bleeding, and a diffuse and nonspecific rash.

Dr. Blondeau ordered all specimens from the man to be quarantined, and he activated the emergency response system for Canada. At that time, there were 27 cases in Liberia, with a 40% mortality rate.

Alarmingly, one of the patient’s cerebrospinal fluid specimens had leaked in transit from St. Paul’s Hospital to a biocontainment lab at the Royal University hospital. A technician at the lab attempted to clean the container and was potentially exposed.

Both St. Paul and Royal University hospitals decided they needed a communication strategy to help allay fear and anxiety among the staff. Many were questioning why the patient was not elevated to a high infection threat when admitted to the ICU, and why higher-level precautions had not been put into place earlier.

On his way to an emergency meeting at St. Paul’s to discuss these issues, Dr. Blondeau received a call from the director of one of Canada’s biosafety level 4 labs, the National Microbiology Lab in Winnipeg, Man., who said that it was likely the patient had Ebola.

“At that point in time all hell broke loose,” said Dr. Blondeau.

The patient’s specimens needed to be immediately transported for confirmation to that national lab, a 9-hour drive from Saskatoon. The regular couriers weren’t interested. Dr. Blondeau volunteered, initially thinking he would drive them.

The specimens were prepared and packaged for containment, but the government made the decision to transport them by jet instead.

Even so, Dr. Blondeau had to drive the specimens to the air ambulance that was waiting at the Saskatoon airport. He wondered whether that was the right decision. There were questions as to whether law enforcement should be informed of the transport – what if he had an accident? He put a sign in the windshield stating that he was transporting a potential Ebola specimen as a means of making it look official, and so that no one would mistake him for a terrorist. No one had worked out whether he should accompany the specimens to Winnipeg to maintain a chain of control. He did not go.

Simultaneously, the health authorities began trying to track down all of the patient’s contacts, from arrival in the country, through an urgent clinic visit, a busy emergency room, and staff and family visits after ICU admission.

Meanwhile, the patient was deteriorating and was already ventilated and required cardiovascular support. Dr. Blondeau began discussions to bring a more sophisticated mobile lab to Saskatoon so that the patient could be repeatedly tested on-site.

“I can say with certainty that there were not many people in the province of Saskatchewan who fully understood what was about to happen should this patient have tested positive for Ebola,” said Dr. Blondeau. “We were learning as we went.”

The plans were changing by the moment, he said.

And, he said, he still had many concerns about how the situation would be perceived by those inside and outside the hospital. There was a potential for public panic and for a breach of the patient’s and family’s privacy.

Among the staff, “there was tremendous fear and panic,” Dr. Blondeau said. The spouse of the lab technician who had a potential exposure wanted her to quit her job. Another technician was spreading incorrect information, he said.

 

 

While staff worried about their own exposure and whether they had exposed their families, the patient was still critically ill and needed care and acute testing.

Then, just 24 hours after the patient had been admitted, it was determined that he did not have Ebola or any other viral hemorrhagic fever.

But “we still didn’t have a diagnosis,” said Dr. Blondeau.

He ordered routine microbiology testing on all the specimens. A day later, it looked like the culprit was Staphylococcus aureus. Further testing confirmed that it was indeed S. aureus and that it was a methicillin-susceptible strain.

Officials and staff went back to routine care processes.

In retrospect, there was much to be concerned about, said Dr. Blondeau. Use of personal protective equipment was inconsistent, which could have led to exposures. There was uncertainty about how to keep the environment clean, including linens and uniforms. For instance, he noted, many health care staff wear uniforms to work or wear them home. “Is this a practice we should be endorsing?” he asked.

There were potential problems with the physical space; for instance, some patient room doors did not close tightly.

On the plus side, no staff refused to care for the patient or to do what was asked, said Dr. Blondeau.

The entire 96-hour experience “was exciting but it was terrifying,” he said.

The lack of preparedness and the lack of a more tightly-knit lab system in the U.S. and Canada are warning signs, he said.

“The reality is we’re only the next landing flight away from a potential infectious disease threat,” said Dr. Blondeau.

On Aug. 1, Saskatoon health authorities received an alert that a passenger on an inbound flight from Senegal had many of the symptoms of a viral hemorrhagic fever: vomiting, diarrhea, and headache. They put their response system in place, and “were much better prepared the second time around,” he said, adding, “but we aren’t where we need to be.”

Dr. Blondeau reported having no conflicts of interest.

[email protected]

On Twitter @aliciaault

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WASHINGTON – While the U.S. waits for its first potential case of Ebola from a traveler, earlier this spring, officials at one hospital in Canada thought that they had a case and found themselves woefully unprepared.

In late March, a man who had returned from Liberia and had a fever of unknown origin, was admitted through the emergency department to the intensive care unit at St. Paul’s Hospital in Saskatoon, Sask. The clinicians suspected Ebola, but weren’t sure and late that night called the Saskatoon regional health department for a consultation.

Dr. Joseph Blondeau, interim head of pathology and laboratory medicine for the Saskatoon Health Region and the Royal University Hospital, took the call and set a process in motion that had been established for just such a moment, but later proved to have a variety of shortcomings, said Dr. Blondeau during a presentation at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Dr. Joseph Blondeau

Initially, the ICU clinicians treated the man empirically with a third-generation cephalosporin and vancomycin. There were still not enough details to make a definitive diagnosis, but by early the next morning there was a high level of suspicion. The patient was hemorrhaging from his eye, there was blood in his nasogastric tube, some rectal bleeding, and a diffuse and nonspecific rash.

Dr. Blondeau ordered all specimens from the man to be quarantined, and he activated the emergency response system for Canada. At that time, there were 27 cases in Liberia, with a 40% mortality rate.

Alarmingly, one of the patient’s cerebrospinal fluid specimens had leaked in transit from St. Paul’s Hospital to a biocontainment lab at the Royal University hospital. A technician at the lab attempted to clean the container and was potentially exposed.

Both St. Paul and Royal University hospitals decided they needed a communication strategy to help allay fear and anxiety among the staff. Many were questioning why the patient was not elevated to a high infection threat when admitted to the ICU, and why higher-level precautions had not been put into place earlier.

On his way to an emergency meeting at St. Paul’s to discuss these issues, Dr. Blondeau received a call from the director of one of Canada’s biosafety level 4 labs, the National Microbiology Lab in Winnipeg, Man., who said that it was likely the patient had Ebola.

“At that point in time all hell broke loose,” said Dr. Blondeau.

The patient’s specimens needed to be immediately transported for confirmation to that national lab, a 9-hour drive from Saskatoon. The regular couriers weren’t interested. Dr. Blondeau volunteered, initially thinking he would drive them.

The specimens were prepared and packaged for containment, but the government made the decision to transport them by jet instead.

Even so, Dr. Blondeau had to drive the specimens to the air ambulance that was waiting at the Saskatoon airport. He wondered whether that was the right decision. There were questions as to whether law enforcement should be informed of the transport – what if he had an accident? He put a sign in the windshield stating that he was transporting a potential Ebola specimen as a means of making it look official, and so that no one would mistake him for a terrorist. No one had worked out whether he should accompany the specimens to Winnipeg to maintain a chain of control. He did not go.

Simultaneously, the health authorities began trying to track down all of the patient’s contacts, from arrival in the country, through an urgent clinic visit, a busy emergency room, and staff and family visits after ICU admission.

Meanwhile, the patient was deteriorating and was already ventilated and required cardiovascular support. Dr. Blondeau began discussions to bring a more sophisticated mobile lab to Saskatoon so that the patient could be repeatedly tested on-site.

“I can say with certainty that there were not many people in the province of Saskatchewan who fully understood what was about to happen should this patient have tested positive for Ebola,” said Dr. Blondeau. “We were learning as we went.”

The plans were changing by the moment, he said.

And, he said, he still had many concerns about how the situation would be perceived by those inside and outside the hospital. There was a potential for public panic and for a breach of the patient’s and family’s privacy.

Among the staff, “there was tremendous fear and panic,” Dr. Blondeau said. The spouse of the lab technician who had a potential exposure wanted her to quit her job. Another technician was spreading incorrect information, he said.

 

 

While staff worried about their own exposure and whether they had exposed their families, the patient was still critically ill and needed care and acute testing.

Then, just 24 hours after the patient had been admitted, it was determined that he did not have Ebola or any other viral hemorrhagic fever.

But “we still didn’t have a diagnosis,” said Dr. Blondeau.

He ordered routine microbiology testing on all the specimens. A day later, it looked like the culprit was Staphylococcus aureus. Further testing confirmed that it was indeed S. aureus and that it was a methicillin-susceptible strain.

Officials and staff went back to routine care processes.

In retrospect, there was much to be concerned about, said Dr. Blondeau. Use of personal protective equipment was inconsistent, which could have led to exposures. There was uncertainty about how to keep the environment clean, including linens and uniforms. For instance, he noted, many health care staff wear uniforms to work or wear them home. “Is this a practice we should be endorsing?” he asked.

There were potential problems with the physical space; for instance, some patient room doors did not close tightly.

On the plus side, no staff refused to care for the patient or to do what was asked, said Dr. Blondeau.

The entire 96-hour experience “was exciting but it was terrifying,” he said.

The lack of preparedness and the lack of a more tightly-knit lab system in the U.S. and Canada are warning signs, he said.

“The reality is we’re only the next landing flight away from a potential infectious disease threat,” said Dr. Blondeau.

On Aug. 1, Saskatoon health authorities received an alert that a passenger on an inbound flight from Senegal had many of the symptoms of a viral hemorrhagic fever: vomiting, diarrhea, and headache. They put their response system in place, and “were much better prepared the second time around,” he said, adding, “but we aren’t where we need to be.”

Dr. Blondeau reported having no conflicts of interest.

[email protected]

On Twitter @aliciaault

WASHINGTON – While the U.S. waits for its first potential case of Ebola from a traveler, earlier this spring, officials at one hospital in Canada thought that they had a case and found themselves woefully unprepared.

In late March, a man who had returned from Liberia and had a fever of unknown origin, was admitted through the emergency department to the intensive care unit at St. Paul’s Hospital in Saskatoon, Sask. The clinicians suspected Ebola, but weren’t sure and late that night called the Saskatoon regional health department for a consultation.

Dr. Joseph Blondeau, interim head of pathology and laboratory medicine for the Saskatoon Health Region and the Royal University Hospital, took the call and set a process in motion that had been established for just such a moment, but later proved to have a variety of shortcomings, said Dr. Blondeau during a presentation at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Dr. Joseph Blondeau

Initially, the ICU clinicians treated the man empirically with a third-generation cephalosporin and vancomycin. There were still not enough details to make a definitive diagnosis, but by early the next morning there was a high level of suspicion. The patient was hemorrhaging from his eye, there was blood in his nasogastric tube, some rectal bleeding, and a diffuse and nonspecific rash.

Dr. Blondeau ordered all specimens from the man to be quarantined, and he activated the emergency response system for Canada. At that time, there were 27 cases in Liberia, with a 40% mortality rate.

Alarmingly, one of the patient’s cerebrospinal fluid specimens had leaked in transit from St. Paul’s Hospital to a biocontainment lab at the Royal University hospital. A technician at the lab attempted to clean the container and was potentially exposed.

Both St. Paul and Royal University hospitals decided they needed a communication strategy to help allay fear and anxiety among the staff. Many were questioning why the patient was not elevated to a high infection threat when admitted to the ICU, and why higher-level precautions had not been put into place earlier.

On his way to an emergency meeting at St. Paul’s to discuss these issues, Dr. Blondeau received a call from the director of one of Canada’s biosafety level 4 labs, the National Microbiology Lab in Winnipeg, Man., who said that it was likely the patient had Ebola.

“At that point in time all hell broke loose,” said Dr. Blondeau.

The patient’s specimens needed to be immediately transported for confirmation to that national lab, a 9-hour drive from Saskatoon. The regular couriers weren’t interested. Dr. Blondeau volunteered, initially thinking he would drive them.

The specimens were prepared and packaged for containment, but the government made the decision to transport them by jet instead.

Even so, Dr. Blondeau had to drive the specimens to the air ambulance that was waiting at the Saskatoon airport. He wondered whether that was the right decision. There were questions as to whether law enforcement should be informed of the transport – what if he had an accident? He put a sign in the windshield stating that he was transporting a potential Ebola specimen as a means of making it look official, and so that no one would mistake him for a terrorist. No one had worked out whether he should accompany the specimens to Winnipeg to maintain a chain of control. He did not go.

Simultaneously, the health authorities began trying to track down all of the patient’s contacts, from arrival in the country, through an urgent clinic visit, a busy emergency room, and staff and family visits after ICU admission.

Meanwhile, the patient was deteriorating and was already ventilated and required cardiovascular support. Dr. Blondeau began discussions to bring a more sophisticated mobile lab to Saskatoon so that the patient could be repeatedly tested on-site.

“I can say with certainty that there were not many people in the province of Saskatchewan who fully understood what was about to happen should this patient have tested positive for Ebola,” said Dr. Blondeau. “We were learning as we went.”

The plans were changing by the moment, he said.

And, he said, he still had many concerns about how the situation would be perceived by those inside and outside the hospital. There was a potential for public panic and for a breach of the patient’s and family’s privacy.

Among the staff, “there was tremendous fear and panic,” Dr. Blondeau said. The spouse of the lab technician who had a potential exposure wanted her to quit her job. Another technician was spreading incorrect information, he said.

 

 

While staff worried about their own exposure and whether they had exposed their families, the patient was still critically ill and needed care and acute testing.

Then, just 24 hours after the patient had been admitted, it was determined that he did not have Ebola or any other viral hemorrhagic fever.

But “we still didn’t have a diagnosis,” said Dr. Blondeau.

He ordered routine microbiology testing on all the specimens. A day later, it looked like the culprit was Staphylococcus aureus. Further testing confirmed that it was indeed S. aureus and that it was a methicillin-susceptible strain.

Officials and staff went back to routine care processes.

In retrospect, there was much to be concerned about, said Dr. Blondeau. Use of personal protective equipment was inconsistent, which could have led to exposures. There was uncertainty about how to keep the environment clean, including linens and uniforms. For instance, he noted, many health care staff wear uniforms to work or wear them home. “Is this a practice we should be endorsing?” he asked.

There were potential problems with the physical space; for instance, some patient room doors did not close tightly.

On the plus side, no staff refused to care for the patient or to do what was asked, said Dr. Blondeau.

The entire 96-hour experience “was exciting but it was terrifying,” he said.

The lack of preparedness and the lack of a more tightly-knit lab system in the U.S. and Canada are warning signs, he said.

“The reality is we’re only the next landing flight away from a potential infectious disease threat,” said Dr. Blondeau.

On Aug. 1, Saskatoon health authorities received an alert that a passenger on an inbound flight from Senegal had many of the symptoms of a viral hemorrhagic fever: vomiting, diarrhea, and headache. They put their response system in place, and “were much better prepared the second time around,” he said, adding, “but we aren’t where we need to be.”

Dr. Blondeau reported having no conflicts of interest.

[email protected]

On Twitter @aliciaault

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CMS website snafu could lead to penalties for meaningful users

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First-time meaningful use participants who are using older technology, but who did not get a hardship exemption by July 1, will see their Medicare pay reduced 1% in 2015.

Because of a confluence of factors, a certain subset of physicians who engaged in meaningful use for the first time this year will not be able to attest to their participation by the Oct. 1 deadline set by the Centers for Medicare & Medicaid Services – and thus, will be penalized.

“Physicians are not only frustrated, but perhaps reaching despondency on the topic,” Dr. Steven J. Stack, president-elect of the American Medical Association, said in an interview.

Overall, about half of physicians had not participated in meaningful use as of the beginning of this year. Theoretically, all of them could face the 1% reduction in Medicare pay, though it’s likely that a smaller subset will, Dr. Stack said.

Those who did not meet meaningful use criteria in 2013 and who anticipated that they would not do so again in 2014 could have applied for a hardship exemption by July 1 to avoid a penalty in 2015. Physicians who were starting on the meaningful use process for the first time in 2014 also had until July 1 to apply for that exemption.

After determining that many vendors did not have 2014 software ready for physicians, CMS proposed in late May to give all meaningful users more flexibility. Physicians were told they could use either a 2011 version, a 2014 version, or some combination, and not be penalized in 2015. That proposal was made final in late August.

Applying for that flexibility will be done via the CMS website, which is slated to be ready a few weeks after Oct. 1.

But first-time meaningful use participants must make their attestation to the CMS by Oct. 1.

The bottom line is that first-time participants who are using older technology and did not get the exemption will be penalized.

A CMS spokesman said that they could still receive an incentive payment for 2014 – if they go online in mid-October and apply for the flexibility option.

But Dr. Stack called that little consolation. It is as if the CMS took away $100 of a $1,000 pot and said that there was still $900 left, he said.

“It doesn’t seem reasonable and certainly undermines the premise that they offered any kind of relief,” said Dr. Stack.

Thom Kuhn, a staff member at the American College of Physicians, also said that the CMS explanation was not good enough.

“Failure to have a system ready by the time a final rule is issued is a management failure,” said Mr. Kuhn, in an interview.

Meanwhile, two members of Congress - Rep. Renee Ellmers (R-N.C.) and Rep. Jim Matheson (D-Utah) - have called on the CMS to extend that Oct. 1 deadline. In a letter to the agency, they requested "an administrative delay" for those attempting to attest to meaningful use for the first time in 2014.*

[email protected]

On Twitter @aliciaault

*Correction, 9/24/2014: An earlier version of this article implied that the administrative delay was requested in legislation. It was requested in a letter.

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First-time meaningful use participants who are using older technology, but who did not get a hardship exemption by July 1, will see their Medicare pay reduced 1% in 2015.

Because of a confluence of factors, a certain subset of physicians who engaged in meaningful use for the first time this year will not be able to attest to their participation by the Oct. 1 deadline set by the Centers for Medicare & Medicaid Services – and thus, will be penalized.

“Physicians are not only frustrated, but perhaps reaching despondency on the topic,” Dr. Steven J. Stack, president-elect of the American Medical Association, said in an interview.

Overall, about half of physicians had not participated in meaningful use as of the beginning of this year. Theoretically, all of them could face the 1% reduction in Medicare pay, though it’s likely that a smaller subset will, Dr. Stack said.

Those who did not meet meaningful use criteria in 2013 and who anticipated that they would not do so again in 2014 could have applied for a hardship exemption by July 1 to avoid a penalty in 2015. Physicians who were starting on the meaningful use process for the first time in 2014 also had until July 1 to apply for that exemption.

After determining that many vendors did not have 2014 software ready for physicians, CMS proposed in late May to give all meaningful users more flexibility. Physicians were told they could use either a 2011 version, a 2014 version, or some combination, and not be penalized in 2015. That proposal was made final in late August.

Applying for that flexibility will be done via the CMS website, which is slated to be ready a few weeks after Oct. 1.

But first-time meaningful use participants must make their attestation to the CMS by Oct. 1.

The bottom line is that first-time participants who are using older technology and did not get the exemption will be penalized.

A CMS spokesman said that they could still receive an incentive payment for 2014 – if they go online in mid-October and apply for the flexibility option.

But Dr. Stack called that little consolation. It is as if the CMS took away $100 of a $1,000 pot and said that there was still $900 left, he said.

“It doesn’t seem reasonable and certainly undermines the premise that they offered any kind of relief,” said Dr. Stack.

Thom Kuhn, a staff member at the American College of Physicians, also said that the CMS explanation was not good enough.

“Failure to have a system ready by the time a final rule is issued is a management failure,” said Mr. Kuhn, in an interview.

Meanwhile, two members of Congress - Rep. Renee Ellmers (R-N.C.) and Rep. Jim Matheson (D-Utah) - have called on the CMS to extend that Oct. 1 deadline. In a letter to the agency, they requested "an administrative delay" for those attempting to attest to meaningful use for the first time in 2014.*

[email protected]

On Twitter @aliciaault

*Correction, 9/24/2014: An earlier version of this article implied that the administrative delay was requested in legislation. It was requested in a letter.

First-time meaningful use participants who are using older technology, but who did not get a hardship exemption by July 1, will see their Medicare pay reduced 1% in 2015.

Because of a confluence of factors, a certain subset of physicians who engaged in meaningful use for the first time this year will not be able to attest to their participation by the Oct. 1 deadline set by the Centers for Medicare & Medicaid Services – and thus, will be penalized.

“Physicians are not only frustrated, but perhaps reaching despondency on the topic,” Dr. Steven J. Stack, president-elect of the American Medical Association, said in an interview.

Overall, about half of physicians had not participated in meaningful use as of the beginning of this year. Theoretically, all of them could face the 1% reduction in Medicare pay, though it’s likely that a smaller subset will, Dr. Stack said.

Those who did not meet meaningful use criteria in 2013 and who anticipated that they would not do so again in 2014 could have applied for a hardship exemption by July 1 to avoid a penalty in 2015. Physicians who were starting on the meaningful use process for the first time in 2014 also had until July 1 to apply for that exemption.

After determining that many vendors did not have 2014 software ready for physicians, CMS proposed in late May to give all meaningful users more flexibility. Physicians were told they could use either a 2011 version, a 2014 version, or some combination, and not be penalized in 2015. That proposal was made final in late August.

Applying for that flexibility will be done via the CMS website, which is slated to be ready a few weeks after Oct. 1.

But first-time meaningful use participants must make their attestation to the CMS by Oct. 1.

The bottom line is that first-time participants who are using older technology and did not get the exemption will be penalized.

A CMS spokesman said that they could still receive an incentive payment for 2014 – if they go online in mid-October and apply for the flexibility option.

But Dr. Stack called that little consolation. It is as if the CMS took away $100 of a $1,000 pot and said that there was still $900 left, he said.

“It doesn’t seem reasonable and certainly undermines the premise that they offered any kind of relief,” said Dr. Stack.

Thom Kuhn, a staff member at the American College of Physicians, also said that the CMS explanation was not good enough.

“Failure to have a system ready by the time a final rule is issued is a management failure,” said Mr. Kuhn, in an interview.

Meanwhile, two members of Congress - Rep. Renee Ellmers (R-N.C.) and Rep. Jim Matheson (D-Utah) - have called on the CMS to extend that Oct. 1 deadline. In a letter to the agency, they requested "an administrative delay" for those attempting to attest to meaningful use for the first time in 2014.*

[email protected]

On Twitter @aliciaault

*Correction, 9/24/2014: An earlier version of this article implied that the administrative delay was requested in legislation. It was requested in a letter.

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