Dr. Price light on ACA replacement details at Senate hearing

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– Rep. Tom Price (R-Ga.) was light on specifics as to what he would favor in ACA replacement efforts, instead focused on broad goals for reform at a courtesy hearing Jan. 18 before the Senate Committee on Health, Education, Labor & Pensions.

Democratic senators on committee sought firm commitments on many issues – maintaining insurance coverage, women’s access to reproductive health care, coverage of mental health/substance use treatment, drug pricing, and reducing racial disparities – from Dr. Price, President-elect Trump’s nominee to lead the Health & Human Service department and a retired orthopedic surgeon. They also challenged Dr. Price on financial conflicts of interest related to legislation he supported.

Rep. Tom Price
For much of the courtesy hearing, Dr. Price reiterated his support for ensuring that Americans have access to their choice of health care coverage, without having that coverage dictated to them. Early in the hearing, however, when queried by Sen. Patty Murray (D-Wash.), the committee’s ranking member, regarding Mr. Trump’s recent statement that an ACA replacement plan would provide insurance for all, Dr. Price noted that has “always been my stated goal, it’s what we’ve worked on my entire public career.”

Dr. Price consistently avoided committing to specific policies, but insisted that “individuals [should] have the opportunity to gain access to the kind of coverage they desire.”

Senators specifically queried Dr. Price as to whether he would commit to maintaining copay-free insurance coverage of all 18 forms of birth control for women approved by the Food and Drug Administration, as mandated by the ACA.

“Every single American ought to have access to the coverage and care that they desire,” Dr. Price responded.

Similarly, regarding coverage of mental health and substance use disorders, Dr. Price called it an “absolutely an imperative” that “every single American” have access to the care for these health issues.

When pressed by Sen. Maggie Hassan (D-N.H.) to commit to ensuring that there would be no cuts to Medicaid funding for mental health care/substance use disorders, Dr. Price noted that “we will address that need.”

Senators also queried Dr. Price’s commitment to maintaining the HHS Office of Minority Health. Sen. Murray offered a number of statistics demonstrating how minority women in particular have benefited with coverage and access to health care under the ACA.

Dr. Price stopped well short of committing to keeping the office, but instead returned to his desire to pursue policies that ensure “every American has access to the care that they desire.”

Dr. Price did not commit to upholding Mr. Trump’s campaign promise that no dollars would be cut from Medicare; instead, he argued that money spent is the wrong metric to measure health care quality.

Regarding the Center for Medicare & Medicaid Innovation, Dr. Price said that the center has “great promise,” but he “opposed the mandatory nature” of some of its programs, highlighting the comprehensive joint replacement bundle, which he said limits how orthopedic surgeons practice.

Senators also paid special attention to Dr. Price’s potential conflicts of interest. Several pointed to medical industry stock purchases that occurred around the time he introduced legislation that could benefit these companies, including a device manufacturer that would potentially benefit from Dr. Price’s challenging of the comprehensive joint replacement bundle and of pharmaceutical companies that might see benefit from the drug provisions in the 21st Century Cures Act.

He vehemently denied any wrongdoing, noting that he regularly and consistently disclosed all security holdings as required by congressional ethics rules and said he did nothing different from what many people in Congress currently do.

Despite his assurances that his ethics have not been compromised, Sen. Murray called for an ethics probe to address any potential conflicts of interest before his confirmation vote.

In closing the hearing, Chairman Lamar Alexander (R-Tenn.) reiterated his plan for a phased timeline for ACA repeal and replacement, to be completed so that no one would lose coverage. He suggested that while legislative action could be swift, implementation could span years to minimize impact on insurance coverage and access to health care.

Dr. Price’s official confirmation hearing before the Senate Finance Committee is scheduled for Jan. 24.
 

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– Rep. Tom Price (R-Ga.) was light on specifics as to what he would favor in ACA replacement efforts, instead focused on broad goals for reform at a courtesy hearing Jan. 18 before the Senate Committee on Health, Education, Labor & Pensions.

Democratic senators on committee sought firm commitments on many issues – maintaining insurance coverage, women’s access to reproductive health care, coverage of mental health/substance use treatment, drug pricing, and reducing racial disparities – from Dr. Price, President-elect Trump’s nominee to lead the Health & Human Service department and a retired orthopedic surgeon. They also challenged Dr. Price on financial conflicts of interest related to legislation he supported.

Rep. Tom Price
For much of the courtesy hearing, Dr. Price reiterated his support for ensuring that Americans have access to their choice of health care coverage, without having that coverage dictated to them. Early in the hearing, however, when queried by Sen. Patty Murray (D-Wash.), the committee’s ranking member, regarding Mr. Trump’s recent statement that an ACA replacement plan would provide insurance for all, Dr. Price noted that has “always been my stated goal, it’s what we’ve worked on my entire public career.”

Dr. Price consistently avoided committing to specific policies, but insisted that “individuals [should] have the opportunity to gain access to the kind of coverage they desire.”

Senators specifically queried Dr. Price as to whether he would commit to maintaining copay-free insurance coverage of all 18 forms of birth control for women approved by the Food and Drug Administration, as mandated by the ACA.

“Every single American ought to have access to the coverage and care that they desire,” Dr. Price responded.

Similarly, regarding coverage of mental health and substance use disorders, Dr. Price called it an “absolutely an imperative” that “every single American” have access to the care for these health issues.

When pressed by Sen. Maggie Hassan (D-N.H.) to commit to ensuring that there would be no cuts to Medicaid funding for mental health care/substance use disorders, Dr. Price noted that “we will address that need.”

Senators also queried Dr. Price’s commitment to maintaining the HHS Office of Minority Health. Sen. Murray offered a number of statistics demonstrating how minority women in particular have benefited with coverage and access to health care under the ACA.

Dr. Price stopped well short of committing to keeping the office, but instead returned to his desire to pursue policies that ensure “every American has access to the care that they desire.”

Dr. Price did not commit to upholding Mr. Trump’s campaign promise that no dollars would be cut from Medicare; instead, he argued that money spent is the wrong metric to measure health care quality.

Regarding the Center for Medicare & Medicaid Innovation, Dr. Price said that the center has “great promise,” but he “opposed the mandatory nature” of some of its programs, highlighting the comprehensive joint replacement bundle, which he said limits how orthopedic surgeons practice.

Senators also paid special attention to Dr. Price’s potential conflicts of interest. Several pointed to medical industry stock purchases that occurred around the time he introduced legislation that could benefit these companies, including a device manufacturer that would potentially benefit from Dr. Price’s challenging of the comprehensive joint replacement bundle and of pharmaceutical companies that might see benefit from the drug provisions in the 21st Century Cures Act.

He vehemently denied any wrongdoing, noting that he regularly and consistently disclosed all security holdings as required by congressional ethics rules and said he did nothing different from what many people in Congress currently do.

Despite his assurances that his ethics have not been compromised, Sen. Murray called for an ethics probe to address any potential conflicts of interest before his confirmation vote.

In closing the hearing, Chairman Lamar Alexander (R-Tenn.) reiterated his plan for a phased timeline for ACA repeal and replacement, to be completed so that no one would lose coverage. He suggested that while legislative action could be swift, implementation could span years to minimize impact on insurance coverage and access to health care.

Dr. Price’s official confirmation hearing before the Senate Finance Committee is scheduled for Jan. 24.
 

 

– Rep. Tom Price (R-Ga.) was light on specifics as to what he would favor in ACA replacement efforts, instead focused on broad goals for reform at a courtesy hearing Jan. 18 before the Senate Committee on Health, Education, Labor & Pensions.

Democratic senators on committee sought firm commitments on many issues – maintaining insurance coverage, women’s access to reproductive health care, coverage of mental health/substance use treatment, drug pricing, and reducing racial disparities – from Dr. Price, President-elect Trump’s nominee to lead the Health & Human Service department and a retired orthopedic surgeon. They also challenged Dr. Price on financial conflicts of interest related to legislation he supported.

Rep. Tom Price
For much of the courtesy hearing, Dr. Price reiterated his support for ensuring that Americans have access to their choice of health care coverage, without having that coverage dictated to them. Early in the hearing, however, when queried by Sen. Patty Murray (D-Wash.), the committee’s ranking member, regarding Mr. Trump’s recent statement that an ACA replacement plan would provide insurance for all, Dr. Price noted that has “always been my stated goal, it’s what we’ve worked on my entire public career.”

Dr. Price consistently avoided committing to specific policies, but insisted that “individuals [should] have the opportunity to gain access to the kind of coverage they desire.”

Senators specifically queried Dr. Price as to whether he would commit to maintaining copay-free insurance coverage of all 18 forms of birth control for women approved by the Food and Drug Administration, as mandated by the ACA.

“Every single American ought to have access to the coverage and care that they desire,” Dr. Price responded.

Similarly, regarding coverage of mental health and substance use disorders, Dr. Price called it an “absolutely an imperative” that “every single American” have access to the care for these health issues.

When pressed by Sen. Maggie Hassan (D-N.H.) to commit to ensuring that there would be no cuts to Medicaid funding for mental health care/substance use disorders, Dr. Price noted that “we will address that need.”

Senators also queried Dr. Price’s commitment to maintaining the HHS Office of Minority Health. Sen. Murray offered a number of statistics demonstrating how minority women in particular have benefited with coverage and access to health care under the ACA.

Dr. Price stopped well short of committing to keeping the office, but instead returned to his desire to pursue policies that ensure “every American has access to the care that they desire.”

Dr. Price did not commit to upholding Mr. Trump’s campaign promise that no dollars would be cut from Medicare; instead, he argued that money spent is the wrong metric to measure health care quality.

Regarding the Center for Medicare & Medicaid Innovation, Dr. Price said that the center has “great promise,” but he “opposed the mandatory nature” of some of its programs, highlighting the comprehensive joint replacement bundle, which he said limits how orthopedic surgeons practice.

Senators also paid special attention to Dr. Price’s potential conflicts of interest. Several pointed to medical industry stock purchases that occurred around the time he introduced legislation that could benefit these companies, including a device manufacturer that would potentially benefit from Dr. Price’s challenging of the comprehensive joint replacement bundle and of pharmaceutical companies that might see benefit from the drug provisions in the 21st Century Cures Act.

He vehemently denied any wrongdoing, noting that he regularly and consistently disclosed all security holdings as required by congressional ethics rules and said he did nothing different from what many people in Congress currently do.

Despite his assurances that his ethics have not been compromised, Sen. Murray called for an ethics probe to address any potential conflicts of interest before his confirmation vote.

In closing the hearing, Chairman Lamar Alexander (R-Tenn.) reiterated his plan for a phased timeline for ACA repeal and replacement, to be completed so that no one would lose coverage. He suggested that while legislative action could be swift, implementation could span years to minimize impact on insurance coverage and access to health care.

Dr. Price’s official confirmation hearing before the Senate Finance Committee is scheduled for Jan. 24.
 

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Senate, House take first step toward repealing ACA

Comment by Dr. Michael Nelson
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With a Jan. 12 early morning procedural passed on party lines, the Senate has set the stage for the repeal of the revenue aspects of the Affordable Care Act. The House of Representatives passed similar legislation Jan. 13.*

Republicans will be using the budget reconciliation process, which will allow them to move forward with repealing certain provisions of the health care reform law without any Democratic support, although passage of any replacement will require some bipartisan support as Republicans do not have the required 60 votes to guarantee passage in the Senate.

The budget resolutions contain no details about what could be repealed or whether there will be a replacement, but it does direct the key committees to write draft legislation by Jan. 27.

Sen. Lamar Alexander (R-Tenn.)
However, in a floor speech Jan. 11, Sen. Lamar Alexander (R-Tenn.), chairman of the U.S. Senate Committee on Health, Education, Labor, and Pensions, offered some nuggets on how repeal-and-replace would proceed.

Senate Republicans “plan to rescue those trapped in a failing system, to replace that system with a functional market, or markets, and then repeal Obamacare for good,” he said.

Sen. Alexander said the process will come in three parts. The first will protect the 11 million people who have purchased health insurance through the exchanges so that they don’t lose coverage.

“Second, we will build better systems providing Americans with more choices that cost less,” he said. “Note I say systems, not one system. If anyone is expecting [Senate Majority Leader Mitch] McConnell [R-Ky.] to roll a wheelbarrow on the Senate floor with a comprehensive Republican health care plan, they’re going to be waiting a long time because we don’t believe in that. We don’t want to replace a failed Obamacare federal system with another failed federal system.”

The last part will be to repeal what remains of the law after the new plan is in place.

Sen. Alexander reiterated that any future bill will keep the ban on coverage denials for preexisting conditions and the allowance of coverage of children up to the age of 26 who are on their parents’ plans.

He stated that this reform effort will not address Medicare reform, which will be the subject of separate legislative action.

*This story was updated Jan. 13 at 4:30 pm.

Body

Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: Independent of whether one has a favorable opinion of the Affordable Care Act (ACA), as a health care provider one must favor providing some medical care to all. The Congressional Budget Office has estimated that approximately 18 million people will lose their health care insurance if the ACA is repealed. Certainly, the uncertainty generated by the absence of an alternative plan, despite the promises, has kept everyone associated with the health care system uneasy about the future. Now imagine if one were a patient without health care insurance. I would like to remind all of our politicians of the words of our 35th president, John Kennedy, “Let us not seek the Republican answer or the Democratic answer, but the right answer. Let us not seek to fix the blame for the past. Let us accept our own responsibility for the future.” I hope they are listening.

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Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: Independent of whether one has a favorable opinion of the Affordable Care Act (ACA), as a health care provider one must favor providing some medical care to all. The Congressional Budget Office has estimated that approximately 18 million people will lose their health care insurance if the ACA is repealed. Certainly, the uncertainty generated by the absence of an alternative plan, despite the promises, has kept everyone associated with the health care system uneasy about the future. Now imagine if one were a patient without health care insurance. I would like to remind all of our politicians of the words of our 35th president, John Kennedy, “Let us not seek the Republican answer or the Democratic answer, but the right answer. Let us not seek to fix the blame for the past. Let us accept our own responsibility for the future.” I hope they are listening.

Body

Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: Independent of whether one has a favorable opinion of the Affordable Care Act (ACA), as a health care provider one must favor providing some medical care to all. The Congressional Budget Office has estimated that approximately 18 million people will lose their health care insurance if the ACA is repealed. Certainly, the uncertainty generated by the absence of an alternative plan, despite the promises, has kept everyone associated with the health care system uneasy about the future. Now imagine if one were a patient without health care insurance. I would like to remind all of our politicians of the words of our 35th president, John Kennedy, “Let us not seek the Republican answer or the Democratic answer, but the right answer. Let us not seek to fix the blame for the past. Let us accept our own responsibility for the future.” I hope they are listening.

Title
Comment by Dr. Michael Nelson
Comment by Dr. Michael Nelson

With a Jan. 12 early morning procedural passed on party lines, the Senate has set the stage for the repeal of the revenue aspects of the Affordable Care Act. The House of Representatives passed similar legislation Jan. 13.*

Republicans will be using the budget reconciliation process, which will allow them to move forward with repealing certain provisions of the health care reform law without any Democratic support, although passage of any replacement will require some bipartisan support as Republicans do not have the required 60 votes to guarantee passage in the Senate.

The budget resolutions contain no details about what could be repealed or whether there will be a replacement, but it does direct the key committees to write draft legislation by Jan. 27.

Sen. Lamar Alexander (R-Tenn.)
However, in a floor speech Jan. 11, Sen. Lamar Alexander (R-Tenn.), chairman of the U.S. Senate Committee on Health, Education, Labor, and Pensions, offered some nuggets on how repeal-and-replace would proceed.

Senate Republicans “plan to rescue those trapped in a failing system, to replace that system with a functional market, or markets, and then repeal Obamacare for good,” he said.

Sen. Alexander said the process will come in three parts. The first will protect the 11 million people who have purchased health insurance through the exchanges so that they don’t lose coverage.

“Second, we will build better systems providing Americans with more choices that cost less,” he said. “Note I say systems, not one system. If anyone is expecting [Senate Majority Leader Mitch] McConnell [R-Ky.] to roll a wheelbarrow on the Senate floor with a comprehensive Republican health care plan, they’re going to be waiting a long time because we don’t believe in that. We don’t want to replace a failed Obamacare federal system with another failed federal system.”

The last part will be to repeal what remains of the law after the new plan is in place.

Sen. Alexander reiterated that any future bill will keep the ban on coverage denials for preexisting conditions and the allowance of coverage of children up to the age of 26 who are on their parents’ plans.

He stated that this reform effort will not address Medicare reform, which will be the subject of separate legislative action.

*This story was updated Jan. 13 at 4:30 pm.

With a Jan. 12 early morning procedural passed on party lines, the Senate has set the stage for the repeal of the revenue aspects of the Affordable Care Act. The House of Representatives passed similar legislation Jan. 13.*

Republicans will be using the budget reconciliation process, which will allow them to move forward with repealing certain provisions of the health care reform law without any Democratic support, although passage of any replacement will require some bipartisan support as Republicans do not have the required 60 votes to guarantee passage in the Senate.

The budget resolutions contain no details about what could be repealed or whether there will be a replacement, but it does direct the key committees to write draft legislation by Jan. 27.

Sen. Lamar Alexander (R-Tenn.)
However, in a floor speech Jan. 11, Sen. Lamar Alexander (R-Tenn.), chairman of the U.S. Senate Committee on Health, Education, Labor, and Pensions, offered some nuggets on how repeal-and-replace would proceed.

Senate Republicans “plan to rescue those trapped in a failing system, to replace that system with a functional market, or markets, and then repeal Obamacare for good,” he said.

Sen. Alexander said the process will come in three parts. The first will protect the 11 million people who have purchased health insurance through the exchanges so that they don’t lose coverage.

“Second, we will build better systems providing Americans with more choices that cost less,” he said. “Note I say systems, not one system. If anyone is expecting [Senate Majority Leader Mitch] McConnell [R-Ky.] to roll a wheelbarrow on the Senate floor with a comprehensive Republican health care plan, they’re going to be waiting a long time because we don’t believe in that. We don’t want to replace a failed Obamacare federal system with another failed federal system.”

The last part will be to repeal what remains of the law after the new plan is in place.

Sen. Alexander reiterated that any future bill will keep the ban on coverage denials for preexisting conditions and the allowance of coverage of children up to the age of 26 who are on their parents’ plans.

He stated that this reform effort will not address Medicare reform, which will be the subject of separate legislative action.

*This story was updated Jan. 13 at 4:30 pm.

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Study: Docs could see financial losses under partial ACA repeal

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An expected partial repeal of the Affordable Care Act would hit physicians’ bottom line, according to a new analysis from the Urban Institute.

Analysts using the vetoed January 2016 budget reconciliation bill as the basis for their projections estimate that the partial repeal could result in as many as 29.8 million Americans losing coverage through the elimination of the Medicaid expansion, the individual and employer mandates, and the insurance marketplace premium tax credits and cost-sharing reductions. In addition, there would be a surge in uncompensated care.
 

 

“The coverage losses would in turn decrease revenues for providers of all types,” the report states. “Providers’ variable costs would also decrease, but their fixed costs would not.”

The Urban Institute estimates that spending by insurers (public and private) and households on health care delivered to the nonelderly would decrease by $145.8 billion in 2019 and $1.7 trillion between 2019 and 2028.

copyright Karen Roach/Fotolia

The increase in the uninsured would cause a spike of $88 billion in uncompensated care ($26.4 billion in hospital care, $11.9 billion in physician office care, $33.6 billion in other services, and $18.0 billion in prescription drugs), reaching $1.1 trillion between 2019 and 2028. At the same time, federal funding for uncompensated care would increase no more than $3.2 billion in 2019 and no more than $35 billion from 2019 and 2028, analysts state.

“There is no clear source of funding for the remainder,” the report notes. “If federal, state, and local governments do not allocate more funding for this care, the financial burden would fall on health care providers. Large increases in unmet need for the uninsured are likely because the additional costs would require a fourfold increase in provider funding of uncompensated care from current levels.”

Congressional Republicans plan to use the budget reconciliation process to partially repeal the revenue generating aspects of the ACA, a process that allows the repeal to go through with a simple majority in the Senate. However, repeal of the health care reform law’s other parts would require at least 60 votes in the Senate, requiring at least eight Democrats to side with the Republican majority, assuming none in the majority go against the party.

The Trump administration has signaled that it plans to maintain certain aspects of the ACA, including the ability for parents to cover children up to age 26 and the ban on denial of coverage for preexisting conditions.

Research for the report was funded by the Robert Wood Johnson Foundation.

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An expected partial repeal of the Affordable Care Act would hit physicians’ bottom line, according to a new analysis from the Urban Institute.

Analysts using the vetoed January 2016 budget reconciliation bill as the basis for their projections estimate that the partial repeal could result in as many as 29.8 million Americans losing coverage through the elimination of the Medicaid expansion, the individual and employer mandates, and the insurance marketplace premium tax credits and cost-sharing reductions. In addition, there would be a surge in uncompensated care.
 

 

“The coverage losses would in turn decrease revenues for providers of all types,” the report states. “Providers’ variable costs would also decrease, but their fixed costs would not.”

The Urban Institute estimates that spending by insurers (public and private) and households on health care delivered to the nonelderly would decrease by $145.8 billion in 2019 and $1.7 trillion between 2019 and 2028.

copyright Karen Roach/Fotolia

The increase in the uninsured would cause a spike of $88 billion in uncompensated care ($26.4 billion in hospital care, $11.9 billion in physician office care, $33.6 billion in other services, and $18.0 billion in prescription drugs), reaching $1.1 trillion between 2019 and 2028. At the same time, federal funding for uncompensated care would increase no more than $3.2 billion in 2019 and no more than $35 billion from 2019 and 2028, analysts state.

“There is no clear source of funding for the remainder,” the report notes. “If federal, state, and local governments do not allocate more funding for this care, the financial burden would fall on health care providers. Large increases in unmet need for the uninsured are likely because the additional costs would require a fourfold increase in provider funding of uncompensated care from current levels.”

Congressional Republicans plan to use the budget reconciliation process to partially repeal the revenue generating aspects of the ACA, a process that allows the repeal to go through with a simple majority in the Senate. However, repeal of the health care reform law’s other parts would require at least 60 votes in the Senate, requiring at least eight Democrats to side with the Republican majority, assuming none in the majority go against the party.

The Trump administration has signaled that it plans to maintain certain aspects of the ACA, including the ability for parents to cover children up to age 26 and the ban on denial of coverage for preexisting conditions.

Research for the report was funded by the Robert Wood Johnson Foundation.


An expected partial repeal of the Affordable Care Act would hit physicians’ bottom line, according to a new analysis from the Urban Institute.

Analysts using the vetoed January 2016 budget reconciliation bill as the basis for their projections estimate that the partial repeal could result in as many as 29.8 million Americans losing coverage through the elimination of the Medicaid expansion, the individual and employer mandates, and the insurance marketplace premium tax credits and cost-sharing reductions. In addition, there would be a surge in uncompensated care.
 

 

“The coverage losses would in turn decrease revenues for providers of all types,” the report states. “Providers’ variable costs would also decrease, but their fixed costs would not.”

The Urban Institute estimates that spending by insurers (public and private) and households on health care delivered to the nonelderly would decrease by $145.8 billion in 2019 and $1.7 trillion between 2019 and 2028.

copyright Karen Roach/Fotolia

The increase in the uninsured would cause a spike of $88 billion in uncompensated care ($26.4 billion in hospital care, $11.9 billion in physician office care, $33.6 billion in other services, and $18.0 billion in prescription drugs), reaching $1.1 trillion between 2019 and 2028. At the same time, federal funding for uncompensated care would increase no more than $3.2 billion in 2019 and no more than $35 billion from 2019 and 2028, analysts state.

“There is no clear source of funding for the remainder,” the report notes. “If federal, state, and local governments do not allocate more funding for this care, the financial burden would fall on health care providers. Large increases in unmet need for the uninsured are likely because the additional costs would require a fourfold increase in provider funding of uncompensated care from current levels.”

Congressional Republicans plan to use the budget reconciliation process to partially repeal the revenue generating aspects of the ACA, a process that allows the repeal to go through with a simple majority in the Senate. However, repeal of the health care reform law’s other parts would require at least 60 votes in the Senate, requiring at least eight Democrats to side with the Republican majority, assuming none in the majority go against the party.

The Trump administration has signaled that it plans to maintain certain aspects of the ACA, including the ability for parents to cover children up to age 26 and the ban on denial of coverage for preexisting conditions.

Research for the report was funded by the Robert Wood Johnson Foundation.

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CMS finalizes cardiac pay bundles, but their future is unclear

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The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.

The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.

The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.

Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.

Dr. Patrick Conway
Dr. Patrick Conway
“One in three deaths are caused by heart attacks and strokes,” Patrick Conway, MD, CMS Acting Principal Deputy Administrator and Chief Medical Officer, said during a Dec. 20 press briefing. “In 2014, more than 200,000 Medicare beneficiaries were hospitalized for heart attack treatment or underwent bypass surgery, costing Medicare over $6 billion. But the cost to treat patients varied by 50% across hospitals and the share of patients readmitted to the hospital within 30 days also varied by 50%.”

CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.

Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.

“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”

The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.

These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”

During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.

The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.

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The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.

The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.

The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.

Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.

Dr. Patrick Conway
Dr. Patrick Conway
“One in three deaths are caused by heart attacks and strokes,” Patrick Conway, MD, CMS Acting Principal Deputy Administrator and Chief Medical Officer, said during a Dec. 20 press briefing. “In 2014, more than 200,000 Medicare beneficiaries were hospitalized for heart attack treatment or underwent bypass surgery, costing Medicare over $6 billion. But the cost to treat patients varied by 50% across hospitals and the share of patients readmitted to the hospital within 30 days also varied by 50%.”

CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.

Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.

“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”

The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.

These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”

During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.

The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.

 

The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.

The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.

The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.

Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.

Dr. Patrick Conway
Dr. Patrick Conway
“One in three deaths are caused by heart attacks and strokes,” Patrick Conway, MD, CMS Acting Principal Deputy Administrator and Chief Medical Officer, said during a Dec. 20 press briefing. “In 2014, more than 200,000 Medicare beneficiaries were hospitalized for heart attack treatment or underwent bypass surgery, costing Medicare over $6 billion. But the cost to treat patients varied by 50% across hospitals and the share of patients readmitted to the hospital within 30 days also varied by 50%.”

CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.

Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.

“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”

The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.

These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”

During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.

The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.

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CMS nixes Part B drug payment demonstration

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A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services.

The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.

anttohoho/Thinkstock
“After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this administration,” the agency said in a statement. “The proposal was intended to test whether alternative drug payment structures would improve the quality of patient care and the value of Medicare drug spending.”

The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”

The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.

Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.

One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.

“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”


An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
 

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A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services.

The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.

anttohoho/Thinkstock
“After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this administration,” the agency said in a statement. “The proposal was intended to test whether alternative drug payment structures would improve the quality of patient care and the value of Medicare drug spending.”

The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”

The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.

Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.

One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.

“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”


An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
 

 

A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services.

The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.

anttohoho/Thinkstock
“After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this administration,” the agency said in a statement. “The proposal was intended to test whether alternative drug payment structures would improve the quality of patient care and the value of Medicare drug spending.”

The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”

The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.

Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.

One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.

“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”


An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
 

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Rheumatology among specialties that continue to see strong Specialty Match Day

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Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Dr. Anne Bass
“There is something called the ‘scramble’ where any program that has empty slots that they want filled can match with applicants that have not matched,” Anne Bass, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, said. “Usually most, if not all, of those empty slots end up filling.”

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

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Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Dr. Anne Bass
“There is something called the ‘scramble’ where any program that has empty slots that they want filled can match with applicants that have not matched,” Anne Bass, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, said. “Usually most, if not all, of those empty slots end up filling.”

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

Rheumatology saw nearly 97% of its positions filled during the 2016 Specialty Match Day.

The specialty had 217 open slots and ended the Dec. 7 match day with only 7 positions unfilled. There were 312 applicants that selected rheumatology as their primary specialty, with 206 applicants being matched. Six were matched to different specialties and 100 who selected rheumatology as their primary specialty did not get matched to any program.

However, those seven unfilled slots will likely get matched.

Dr. Anne Bass
“There is something called the ‘scramble’ where any program that has empty slots that they want filled can match with applicants that have not matched,” Anne Bass, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, said. “Usually most, if not all, of those empty slots end up filling.”

Overall, Dr. Bass, who is the program director of the rheumatology fellowship program at the Hospital for Special Surgery, New York, said the numbers reflect strong interest in rheumatology.

“In 2012, there were 240 applicants to rheumatology, and this year there were 312,” she said. “It’s been a linear trend. ... The number of programs has actually gone up but it has not kept pace with demand. In 2012, 63 applicants didn’t match at any program, and this year, the number was 100.”

Dr. Bass said that this speaks to the attractiveness of rheumatology as a field and that there will be a need to create more fellowship slots.

To that end, the Rheumatology Research Foundation, the grant-giving philanthropic arm of ACR that funds research grants and fellowship training awards, is examining that very issue.

“I am leading a working group to try to figure out how to configure this award so that we try to direct them to fellowship programs that can expand or even [create] new fellowship programs,” Dr. Bass said. “The ACR and RRF will continue to fund fellowship programs because many programs have to scramble to fund the salary to support trainees and in particular to try to direct resources that will actually end up creating a new rheumatology fellow where one would not have existed before.”

The group is also looking at ways to encourage programs that have internal funding to increase their capacity if they are able to do so, she added.

Rheumatology was among a number of specialties that were able to fill at least 90% of their open slots, Other areas included allergy/immunology, cardiovascular disease, gastroenterology, hematology and oncology, pulmonary disease and pulmonary/critical care.

On the flip side, nephrology, infectious disease, and geriatric medicine had more positions available than there were applicants who prefer those specialties.

“The results this year mirror prior-year results, with slight improvement in a few specialties but no significant changes,” Mona Singer, president and CEO of the National Resident Match Program, said.

Overall, across all specialties, there were 4,731 slots, with 4,139 positions filled, accounting for about 75% of the 5,512 enrolled applicants.

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Gastros pleased with fee schedule update related to moderate sedation services

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Thu, 03/28/2019 - 14:59

Gastroenterologists will now have a separate billing code for the use of moderate sedation services under provisions finalized in the 2017 update to the physician fee schedule.

The change comes as a result of billing trends, with the Centers for Medicare & Medicaid Services noting in a statement announcing the final PFS update that anesthesia is “increasingly being separately reported for [certain endoscopic] procedures even though payment for sedation was built-in to the payment to the physician furnishing the primary procedure.”
 

 

As such, the agency finalized new billing codes for moderate sedation, along with a uniform methodology for valuating procedure codes that currently include moderate sedation as an inherent part of the procedure. Additionally, CMS finalized a separate endoscopy-specific moderate sedation code with valuations that reflect the differences in physician survey data between gastroenterology and other specialties.

Dr. Dawn L. Francis
“We are ultimately pleased that CMS acted in accordance with the member survey data provided by three societies,” Dawn Francis, MD, of the Mayo Clinic in Jacksonville, Fla., who is an AGA RUC Advisor, said in an interview, referring to the American Gastroenterological Association, the American Society of Gastrointestinal Endoscopy, and the American College of Gastroentrology. “Moderate sedation, when provided by the endoscopist for GI endoscopy, is different work than for other procedures, such as pain management.”

She acknowledged CMS’ goal of valuating moderate sedation was that, when it was used, “it could be billed with that service, but when it was not used it would not be reimbursed. This meant that, for gastroenterology procedures, there would be a reduction in the physician fee when billed with anesthesia services.” The three societies’ main goal was to be sure that “the valuation of moderate sedation services was accurate in the setting of GI procedures.”

Dr. Francis said that the change is not expected to have any meaningful impact on the performance of GI procedures regarding the location of where procedures are performed or the type of sedation that is used.

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Gastroenterologists will now have a separate billing code for the use of moderate sedation services under provisions finalized in the 2017 update to the physician fee schedule.

The change comes as a result of billing trends, with the Centers for Medicare & Medicaid Services noting in a statement announcing the final PFS update that anesthesia is “increasingly being separately reported for [certain endoscopic] procedures even though payment for sedation was built-in to the payment to the physician furnishing the primary procedure.”
 

 

As such, the agency finalized new billing codes for moderate sedation, along with a uniform methodology for valuating procedure codes that currently include moderate sedation as an inherent part of the procedure. Additionally, CMS finalized a separate endoscopy-specific moderate sedation code with valuations that reflect the differences in physician survey data between gastroenterology and other specialties.

Dr. Dawn L. Francis
“We are ultimately pleased that CMS acted in accordance with the member survey data provided by three societies,” Dawn Francis, MD, of the Mayo Clinic in Jacksonville, Fla., who is an AGA RUC Advisor, said in an interview, referring to the American Gastroenterological Association, the American Society of Gastrointestinal Endoscopy, and the American College of Gastroentrology. “Moderate sedation, when provided by the endoscopist for GI endoscopy, is different work than for other procedures, such as pain management.”

She acknowledged CMS’ goal of valuating moderate sedation was that, when it was used, “it could be billed with that service, but when it was not used it would not be reimbursed. This meant that, for gastroenterology procedures, there would be a reduction in the physician fee when billed with anesthesia services.” The three societies’ main goal was to be sure that “the valuation of moderate sedation services was accurate in the setting of GI procedures.”

Dr. Francis said that the change is not expected to have any meaningful impact on the performance of GI procedures regarding the location of where procedures are performed or the type of sedation that is used.

Gastroenterologists will now have a separate billing code for the use of moderate sedation services under provisions finalized in the 2017 update to the physician fee schedule.

The change comes as a result of billing trends, with the Centers for Medicare & Medicaid Services noting in a statement announcing the final PFS update that anesthesia is “increasingly being separately reported for [certain endoscopic] procedures even though payment for sedation was built-in to the payment to the physician furnishing the primary procedure.”
 

 

As such, the agency finalized new billing codes for moderate sedation, along with a uniform methodology for valuating procedure codes that currently include moderate sedation as an inherent part of the procedure. Additionally, CMS finalized a separate endoscopy-specific moderate sedation code with valuations that reflect the differences in physician survey data between gastroenterology and other specialties.

Dr. Dawn L. Francis
“We are ultimately pleased that CMS acted in accordance with the member survey data provided by three societies,” Dawn Francis, MD, of the Mayo Clinic in Jacksonville, Fla., who is an AGA RUC Advisor, said in an interview, referring to the American Gastroenterological Association, the American Society of Gastrointestinal Endoscopy, and the American College of Gastroentrology. “Moderate sedation, when provided by the endoscopist for GI endoscopy, is different work than for other procedures, such as pain management.”

She acknowledged CMS’ goal of valuating moderate sedation was that, when it was used, “it could be billed with that service, but when it was not used it would not be reimbursed. This meant that, for gastroenterology procedures, there would be a reduction in the physician fee when billed with anesthesia services.” The three societies’ main goal was to be sure that “the valuation of moderate sedation services was accurate in the setting of GI procedures.”

Dr. Francis said that the change is not expected to have any meaningful impact on the performance of GI procedures regarding the location of where procedures are performed or the type of sedation that is used.

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First addiction medicine certification exam slated for fall 2017

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Thu, 03/28/2019 - 14:59

 

The certification exam for the new subspecialty of addiction medicine will be held in fall 2017, the American Board of Preventive Medicine and the Addiction Medicine Foundation announced.

“We recognize the importance of providing certification in addiction medicine for physicians who have expertise and demonstrated knowledge in the prevention and treatment of substance use disorders,” ABPM President Marie Krousel-Wood, MD, said in a statement. “The advances in physician certification and training in addiction medicine set the stage to engage all of medicine as strong partners in addressing this critical public health issue.”

Katarzyna Bialasiewicz/ThinkStock
ABPM is finalizing the certification process but has released some details about what the program will entail. According to an FAQ on the organization’s website, there will be four components of eligibility. Applicants must:

1) Have an appropriate medical degree or its equivalent.

2) Have current certification by at least one American Board of Medical Specialties member board.

3) Complete specified education and training or experience in the subspecialty field through either the Practice Pathway or an Accreditation Council for Graduate Medical Education–accredited fellowship training pathway.

4) Have a current, unrestricted, and valid license to practice medicine.

During the first 5 years the exam is administered, physicians will use the Practice Pathway to meet certification eligibility requirements. The includes a minimum of 1,920 hours engaged in the practice of addiction medicine occurring over at least 24 of the previous 60 months prior to the application, though the 24 months need not be continuous. Credit for completing a non-ACGME–accredited fellowship may be substituted for the time in practice requirements.

Dates and updates to the application process will be posted on ABPM’s website as they become available.

The American Society of Addiction Medicine announced a review course scheduled for July 27-29, 2017, in Dallas, to help prepare physicians for the certification exam.
 

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The certification exam for the new subspecialty of addiction medicine will be held in fall 2017, the American Board of Preventive Medicine and the Addiction Medicine Foundation announced.

“We recognize the importance of providing certification in addiction medicine for physicians who have expertise and demonstrated knowledge in the prevention and treatment of substance use disorders,” ABPM President Marie Krousel-Wood, MD, said in a statement. “The advances in physician certification and training in addiction medicine set the stage to engage all of medicine as strong partners in addressing this critical public health issue.”

Katarzyna Bialasiewicz/ThinkStock
ABPM is finalizing the certification process but has released some details about what the program will entail. According to an FAQ on the organization’s website, there will be four components of eligibility. Applicants must:

1) Have an appropriate medical degree or its equivalent.

2) Have current certification by at least one American Board of Medical Specialties member board.

3) Complete specified education and training or experience in the subspecialty field through either the Practice Pathway or an Accreditation Council for Graduate Medical Education–accredited fellowship training pathway.

4) Have a current, unrestricted, and valid license to practice medicine.

During the first 5 years the exam is administered, physicians will use the Practice Pathway to meet certification eligibility requirements. The includes a minimum of 1,920 hours engaged in the practice of addiction medicine occurring over at least 24 of the previous 60 months prior to the application, though the 24 months need not be continuous. Credit for completing a non-ACGME–accredited fellowship may be substituted for the time in practice requirements.

Dates and updates to the application process will be posted on ABPM’s website as they become available.

The American Society of Addiction Medicine announced a review course scheduled for July 27-29, 2017, in Dallas, to help prepare physicians for the certification exam.
 

 

The certification exam for the new subspecialty of addiction medicine will be held in fall 2017, the American Board of Preventive Medicine and the Addiction Medicine Foundation announced.

“We recognize the importance of providing certification in addiction medicine for physicians who have expertise and demonstrated knowledge in the prevention and treatment of substance use disorders,” ABPM President Marie Krousel-Wood, MD, said in a statement. “The advances in physician certification and training in addiction medicine set the stage to engage all of medicine as strong partners in addressing this critical public health issue.”

Katarzyna Bialasiewicz/ThinkStock
ABPM is finalizing the certification process but has released some details about what the program will entail. According to an FAQ on the organization’s website, there will be four components of eligibility. Applicants must:

1) Have an appropriate medical degree or its equivalent.

2) Have current certification by at least one American Board of Medical Specialties member board.

3) Complete specified education and training or experience in the subspecialty field through either the Practice Pathway or an Accreditation Council for Graduate Medical Education–accredited fellowship training pathway.

4) Have a current, unrestricted, and valid license to practice medicine.

During the first 5 years the exam is administered, physicians will use the Practice Pathway to meet certification eligibility requirements. The includes a minimum of 1,920 hours engaged in the practice of addiction medicine occurring over at least 24 of the previous 60 months prior to the application, though the 24 months need not be continuous. Credit for completing a non-ACGME–accredited fellowship may be substituted for the time in practice requirements.

Dates and updates to the application process will be posted on ABPM’s website as they become available.

The American Society of Addiction Medicine announced a review course scheduled for July 27-29, 2017, in Dallas, to help prepare physicians for the certification exam.
 

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Trump administration to focus on ACA reform, tort reform

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Wed, 04/03/2019 - 10:29

Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.

Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.

President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.

 

Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.

Grace-Marie Turner
“I do think that [the new administration is] going to deliver on the repeal provision early on, but it is also likely to come with a bridge so that people are not thrown off their coverage,” Grace-Marie Turner, founder and president of the Galen Institute, said in an interview. She noted that one of the last ACA repeal efforts by congressional Republicans used the budget reconciliation process and included a 2-year transition period to spare 20 million people from losing their coverage while replacement legislation makes its way through Congress.

Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.

“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”

More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.


Gail Wilensky, PhD
“Honestly, I think it would be better if they delayed the repeal vote,” Gail Wilensky, PhD, senior fellow at Project HOPE, said in an interview. “It would be better in terms of the political dynamics of maybe being able to get possibly some Democratic support for the replacement legislation, which I think will be impossible to get if they do the repeal as a standalone.”

In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.

“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”

Sara R. Collins, PhD
ACA repeal without immediate replacement could wreak havoc in the health care insurance marketplace, according to Sara R. Collins, PhD, vice president of health care coverage and access at the Commonwealth Fund.

“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”

Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.

While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.

While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”

“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”

Thomas P. Miller
“The question is how much gain and pain is there in uprooting something that has its own built-in momentum, even though people in the midst of that will complain about aspects and want adjustments,” Thomas P. Miller, resident fellow at the American Enterprise Institute, said in an interview.

Mr. Trump also has called for Medicaid reform, with block grants to the states.

“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”

Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.

“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”

Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.

Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.

“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”

Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.

Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.

Timothy S. Jost

The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.

“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”

In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.

If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.

“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”

However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.

 

 

“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”

The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.

The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.

The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.

There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”

Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”

William W. Horton
Weaker enforcement of antitrust regulations in health care also could be on the horizon, said William W. Horton, a Birmingham, Ala.–based health law attorney and past chair of the American Bar Association Health Law Section.

“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”

The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.

Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”

Dennis A. Cardoza

Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.

Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.

“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”

Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.

Jamie Raskin
“The new justice is almost certain to swing the court in a conservative direction,” said Rep-elect Jamie Raskin (D-Md.), a constitutional law professor at American University in Washington. “The stakes are extremely high in the health care field as in every part of Supreme Court jurisprudence.”

Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.

“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”

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Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.

Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.

President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.

 

Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.

Grace-Marie Turner
“I do think that [the new administration is] going to deliver on the repeal provision early on, but it is also likely to come with a bridge so that people are not thrown off their coverage,” Grace-Marie Turner, founder and president of the Galen Institute, said in an interview. She noted that one of the last ACA repeal efforts by congressional Republicans used the budget reconciliation process and included a 2-year transition period to spare 20 million people from losing their coverage while replacement legislation makes its way through Congress.

Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.

“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”

More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.


Gail Wilensky, PhD
“Honestly, I think it would be better if they delayed the repeal vote,” Gail Wilensky, PhD, senior fellow at Project HOPE, said in an interview. “It would be better in terms of the political dynamics of maybe being able to get possibly some Democratic support for the replacement legislation, which I think will be impossible to get if they do the repeal as a standalone.”

In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.

“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”

Sara R. Collins, PhD
ACA repeal without immediate replacement could wreak havoc in the health care insurance marketplace, according to Sara R. Collins, PhD, vice president of health care coverage and access at the Commonwealth Fund.

“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”

Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.

While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.

While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”

“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”

Thomas P. Miller
“The question is how much gain and pain is there in uprooting something that has its own built-in momentum, even though people in the midst of that will complain about aspects and want adjustments,” Thomas P. Miller, resident fellow at the American Enterprise Institute, said in an interview.

Mr. Trump also has called for Medicaid reform, with block grants to the states.

“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”

Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.

“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”

Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.

Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.

“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”

Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.

Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.

Timothy S. Jost

The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.

“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”

In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.

If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.

“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”

However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.

 

 

“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”

The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.

The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.

The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.

There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”

Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”

William W. Horton
Weaker enforcement of antitrust regulations in health care also could be on the horizon, said William W. Horton, a Birmingham, Ala.–based health law attorney and past chair of the American Bar Association Health Law Section.

“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”

The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.

Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”

Dennis A. Cardoza

Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.

Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.

“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”

Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.

Jamie Raskin
“The new justice is almost certain to swing the court in a conservative direction,” said Rep-elect Jamie Raskin (D-Md.), a constitutional law professor at American University in Washington. “The stakes are extremely high in the health care field as in every part of Supreme Court jurisprudence.”

Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.

“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”

Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.

Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.

President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.

 

Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.

Grace-Marie Turner
“I do think that [the new administration is] going to deliver on the repeal provision early on, but it is also likely to come with a bridge so that people are not thrown off their coverage,” Grace-Marie Turner, founder and president of the Galen Institute, said in an interview. She noted that one of the last ACA repeal efforts by congressional Republicans used the budget reconciliation process and included a 2-year transition period to spare 20 million people from losing their coverage while replacement legislation makes its way through Congress.

Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.

“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”

More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.


Gail Wilensky, PhD
“Honestly, I think it would be better if they delayed the repeal vote,” Gail Wilensky, PhD, senior fellow at Project HOPE, said in an interview. “It would be better in terms of the political dynamics of maybe being able to get possibly some Democratic support for the replacement legislation, which I think will be impossible to get if they do the repeal as a standalone.”

In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.

“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”

Sara R. Collins, PhD
ACA repeal without immediate replacement could wreak havoc in the health care insurance marketplace, according to Sara R. Collins, PhD, vice president of health care coverage and access at the Commonwealth Fund.

“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”

Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.

While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.

While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”

“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”

Thomas P. Miller
“The question is how much gain and pain is there in uprooting something that has its own built-in momentum, even though people in the midst of that will complain about aspects and want adjustments,” Thomas P. Miller, resident fellow at the American Enterprise Institute, said in an interview.

Mr. Trump also has called for Medicaid reform, with block grants to the states.

“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”

Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.

“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”

Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.

Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.

“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”

Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.

Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.

Timothy S. Jost

The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.

“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”

In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.

If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.

“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”

However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.

 

 

“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”

The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.

The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.

The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.

There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”

Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”

William W. Horton
Weaker enforcement of antitrust regulations in health care also could be on the horizon, said William W. Horton, a Birmingham, Ala.–based health law attorney and past chair of the American Bar Association Health Law Section.

“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”

The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.

Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”

Dennis A. Cardoza

Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.

Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.

“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”

Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.

Jamie Raskin
“The new justice is almost certain to swing the court in a conservative direction,” said Rep-elect Jamie Raskin (D-Md.), a constitutional law professor at American University in Washington. “The stakes are extremely high in the health care field as in every part of Supreme Court jurisprudence.”

Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.

“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”

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House passes 21st Century Cures bill

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Wed, 04/03/2019 - 10:30

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News
The legislation also provides $1 billion in grants to states over a 2-year period to help supplement opioid abuse prevention and treatment activities.

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

 

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

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A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News
The legislation also provides $1 billion in grants to states over a 2-year period to help supplement opioid abuse prevention and treatment activities.

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

 

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News
The legislation also provides $1 billion in grants to states over a 2-year period to help supplement opioid abuse prevention and treatment activities.

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

 

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

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