Clinicians to President-elect Trump: Embrace compromise, collaboration and the value proposition

As Inauguration Day nears, the uncertainty about the impact of Donald J. Trump’s presidency on the fields of hematology and oncology — and the medical community at large — continues to intensify.

On the campaign trail, Trump vowed to repeal and replace the Affordable Care Act, reform the FDA, reduce drug prices, and preserve Medicare and Medicaid.

Since the election, he has softened his stance on health care reform but provided few specifics about how he intends to deliver on his other promises.

“The biggest concern I have is, it is very difficult to predict what this administration will do,” Derek Raghavan, MD, PhD,HemOnc Today’s Chief Medical Editor for Oncology, said in an interview. “This has been a recurring theme on many fronts. Even Saturday Night Live skits relate to the lack of precision of the promissory note.”

Affordable Care Act

Trump — whose transition team did not respond to a request for comment for this article — made his pledge to repeal and replace the Affordable Care Act a central tenet of his campaign.

Soon after the election, however, he expressed support for two key provisions in President Barack Obama’s signature health care law: one that guarantees coverage for individuals with pre-existing conditions and another that allows children to stay on their parents’ health care plans until age 26 years.

Derek Raghavan

“It’s hard to know exactly where the pendulum will finish swinging,” Raghavan said. “However, we do know from 2008 that — when the world economy tanked — the death rate from cancer went up as a function of people losing their jobs and either giving up health care or delaying health care. If there is a sudden removal of insurance for 20 million-plus people, you cannot predict that it will make health care better for those patients.”

Sara Rosenbaum, JD, professor of health law and policy at George Washington University, described any effort to repeal the Affordable Care Act without a clearly defined alternative as “not rational.”

“I think the hope was that you could ram the repeal through and then there would be time to think about a replacement,” Rosenbaum said. “More and more, it has become evident ... that maybe a standalone repeal measure is not doable. It doesn’t mean it’s not going to happen, but people are realizing that it is not rational.”

Attempts to change the health care law most likely will be gradual, according to Richard O. Dolinar, MD, senior fellow in health care policy at The Heartland Institute, a conservative and libertarian public policy think tank.

Use of health savings accounts likely will increase dramatically, and a provision that allows insurance companies to sell plans across state lines could lower rates, Dolinar said.

The key will be for the administration not to take action that triggers retrogression, Alan E. Lichtin, MD, staff physician in the department of hematology and medical oncology at Cleveland Clinic and outgoing chair of ASH’s committee on government affairs, told HemOnc Today.

“We clearly support initiatives that would continue to ensure patient access and make the quality of care better,” Lichtin said. “We hope whatever changes occur do not take away any of the preventive care promotion that has occurred, and we hope the other improvements that already have been made will be sustained.”

Alan E. Lichtin

The lack of integration between the federal and state governments in the implementation of the Affordable Care Act adds another layer of complexity, Raghavan said.

“It’s quite clear nobody wants to pay for health care, and each side has tried to push it in the other’s direction,” he said. “This is a national financial crisis. I would like to see the administration take advantage of the level of mandate that it has to come up with bipartisan solutions that link the function of state and federal governments to provide appropriate care.”

NIH funding, drug pricing

Funding for cancer research has been the subject of annual protracted battles between members of the scientific community and federal lawmakers.

In fiscal year 2017, ASCO asked for $34.5 billion for the NIH and $5.9 billion for NCI. ASH hopes for $34.1 billion for NIH.

It remains unclear if — or how — the Trump administration will prioritize public funding for scientific investigations.

“If our new president is as good of a businessman as he appears to be, he will realize the amount of investment that government has made in NIH funding over the years has led to a tremendous return,” Lichtin said.

In an interview published Dec. 7 in Time, Trump said he intends “to bring down drug prices.” Although he did not specify how he would do so, the news sent pharmaceutical and biotech stocks tumbling.

Richard O. Dolinar

Stephen J. Ubl — president and CEO of PhRMA, which represents the country’s leading biopharmaceutical research companies — told HemOnc Today the association looks forward to working with the Trump administration and members of Congress “to advance pragmatic solutions that enhance the private market, improve patient access to care and foster the development of innovative medicines.”

Ubl touted “a new era of medicine,” noting that treatments are transforming the fight against debilitating diseases.

“To ensure this innovation continues, we need to modernize the [FDA] to keep pace with scientific advances, remove regulatory barriers that make it harder to move to a value-driven health care system and focus on making better use of the medicines we have today,” Ubl said. “In addition, we strive to empower consumers with information to make more informed health care decisions.”

FDA authority

Trump’s health care plan calls for reforming the FDA “to put greater focus on the need of patients for new and innovative medical products.”

Proponents suggest this effort may encourage innovation and accelerate the process by which new medicines are made available in the clinic. Others caution that this may dramatically erode the safeguards established to protect patients from ineffective — or potentially harmful — therapies.

Lichtin called on the administration to provide the FDA with the resources necessary to adequately review therapies while addressing safety and shortage concerns.

“If there is deregulation, and then a drug comes in and is not up to the same standards that would have been in place had the FDA been funded at a certain level, there is going to be a bipartisan outcry to get the FDA to do a better job,” he said. “I don’t think an attempt to deregulate the drug approval process — with the potentially negative results — would be fruitful.”

FDA spokesman Jason Young told HemOnc Today that the agency was not able to speculate whether this means Trump will pursue deregulation and had no comment on his election as president.

Advocacy and the value proposition

Regardless of how the Trump administration’s policies impact health care, members of the hematology and oncology communities must continue to advocate for their patients and their profession, Lichtin said.

“It is also important to remember that — despite what may be said during a campaign — sometimes after people go through the transition and actually have the mantle of the administration on their shoulders, they understand the problems better and have a greater amount of wisdom than they had before,” he said.

“I really hope the new administration hears the voices of compromise,” Lichtin added. “We need to find a way to embrace each other’s differences and hear each other across the aisle.”

Raghavan called for leaders of government, the pharmaceutical industry and the health care profession to collaborate in the quest for true value in health care.

“We can contain costs dramatically if we really focus on the value proposition,” he said. “It makes little sense to me that we spend so much more money in the United States on our health care industry without having concomitantly better results than countries that pay a lot less.

“If you go back to the Oregon [Health Insurance] Experiment, one side was in favor of rationalizing health care, and the other side immediately accused them of rationing,” Raghavan added. “Having a rational approach to health care is not about rationing. It is about using treatments that work, not using treatments that don’t work and having the willingness to think about alternative approaches.” – by Mark Leiser

Disclosure: Dolinar, Lichtin, Raghavan, Rosenbaum and Ubl report no relevant financial disclosures.

As Inauguration Day nears, the uncertainty about the impact of Donald J. Trump’s presidency on the fields of hematology and oncology — and the medical community at large — continues to intensify.

On the campaign trail, Trump vowed to repeal and replace the Affordable Care Act, reform the FDA, reduce drug prices, and preserve Medicare and Medicaid.

Since the election, he has softened his stance on health care reform but provided few specifics about how he intends to deliver on his other promises.

“The biggest concern I have is, it is very difficult to predict what this administration will do,” Derek Raghavan, MD, PhD,HemOnc Today’s Chief Medical Editor for Oncology, said in an interview. “This has been a recurring theme on many fronts. Even Saturday Night Live skits relate to the lack of precision of the promissory note.”

Affordable Care Act

Trump — whose transition team did not respond to a request for comment for this article — made his pledge to repeal and replace the Affordable Care Act a central tenet of his campaign.

Soon after the election, however, he expressed support for two key provisions in President Barack Obama’s signature health care law: one that guarantees coverage for individuals with pre-existing conditions and another that allows children to stay on their parents’ health care plans until age 26 years.

Derek Raghavan

“It’s hard to know exactly where the pendulum will finish swinging,” Raghavan said. “However, we do know from 2008 that — when the world economy tanked — the death rate from cancer went up as a function of people losing their jobs and either giving up health care or delaying health care. If there is a sudden removal of insurance for 20 million-plus people, you cannot predict that it will make health care better for those patients.”

Sara Rosenbaum, JD, professor of health law and policy at George Washington University, described any effort to repeal the Affordable Care Act without a clearly defined alternative as “not rational.”

“I think the hope was that you could ram the repeal through and then there would be time to think about a replacement,” Rosenbaum said. “More and more, it has become evident ... that maybe a standalone repeal measure is not doable. It doesn’t mean it’s not going to happen, but people are realizing that it is not rational.”

Attempts to change the health care law most likely will be gradual, according to Richard O. Dolinar, MD, senior fellow in health care policy at The Heartland Institute, a conservative and libertarian public policy think tank.

Use of health savings accounts likely will increase dramatically, and a provision that allows insurance companies to sell plans across state lines could lower rates, Dolinar said.

The key will be for the administration not to take action that triggers retrogression, Alan E. Lichtin, MD, staff physician in the department of hematology and medical oncology at Cleveland Clinic and outgoing chair of ASH’s committee on government affairs, told HemOnc Today.

“We clearly support initiatives that would continue to ensure patient access and make the quality of care better,” Lichtin said. “We hope whatever changes occur do not take away any of the preventive care promotion that has occurred, and we hope the other improvements that already have been made will be sustained.”

Alan E. Lichtin

The lack of integration between the federal and state governments in the implementation of the Affordable Care Act adds another layer of complexity, Raghavan said.

“It’s quite clear nobody wants to pay for health care, and each side has tried to push it in the other’s direction,” he said. “This is a national financial crisis. I would like to see the administration take advantage of the level of mandate that it has to come up with bipartisan solutions that link the function of state and federal governments to provide appropriate care.”

PAGE BREAK

NIH funding, drug pricing

Funding for cancer research has been the subject of annual protracted battles between members of the scientific community and federal lawmakers.

In fiscal year 2017, ASCO asked for $34.5 billion for the NIH and $5.9 billion for NCI. ASH hopes for $34.1 billion for NIH.

It remains unclear if — or how — the Trump administration will prioritize public funding for scientific investigations.

“If our new president is as good of a businessman as he appears to be, he will realize the amount of investment that government has made in NIH funding over the years has led to a tremendous return,” Lichtin said.

In an interview published Dec. 7 in Time, Trump said he intends “to bring down drug prices.” Although he did not specify how he would do so, the news sent pharmaceutical and biotech stocks tumbling.

Richard O. Dolinar

Stephen J. Ubl — president and CEO of PhRMA, which represents the country’s leading biopharmaceutical research companies — told HemOnc Today the association looks forward to working with the Trump administration and members of Congress “to advance pragmatic solutions that enhance the private market, improve patient access to care and foster the development of innovative medicines.”

Ubl touted “a new era of medicine,” noting that treatments are transforming the fight against debilitating diseases.

“To ensure this innovation continues, we need to modernize the [FDA] to keep pace with scientific advances, remove regulatory barriers that make it harder to move to a value-driven health care system and focus on making better use of the medicines we have today,” Ubl said. “In addition, we strive to empower consumers with information to make more informed health care decisions.”

FDA authority

Trump’s health care plan calls for reforming the FDA “to put greater focus on the need of patients for new and innovative medical products.”

Proponents suggest this effort may encourage innovation and accelerate the process by which new medicines are made available in the clinic. Others caution that this may dramatically erode the safeguards established to protect patients from ineffective — or potentially harmful — therapies.

Lichtin called on the administration to provide the FDA with the resources necessary to adequately review therapies while addressing safety and shortage concerns.

“If there is deregulation, and then a drug comes in and is not up to the same standards that would have been in place had the FDA been funded at a certain level, there is going to be a bipartisan outcry to get the FDA to do a better job,” he said. “I don’t think an attempt to deregulate the drug approval process — with the potentially negative results — would be fruitful.”

FDA spokesman Jason Young told HemOnc Today that the agency was not able to speculate whether this means Trump will pursue deregulation and had no comment on his election as president.

Advocacy and the value proposition

Regardless of how the Trump administration’s policies impact health care, members of the hematology and oncology communities must continue to advocate for their patients and their profession, Lichtin said.

“It is also important to remember that — despite what may be said during a campaign — sometimes after people go through the transition and actually have the mantle of the administration on their shoulders, they understand the problems better and have a greater amount of wisdom than they had before,” he said.

“I really hope the new administration hears the voices of compromise,” Lichtin added. “We need to find a way to embrace each other’s differences and hear each other across the aisle.”

Raghavan called for leaders of government, the pharmaceutical industry and the health care profession to collaborate in the quest for true value in health care.

“We can contain costs dramatically if we really focus on the value proposition,” he said. “It makes little sense to me that we spend so much more money in the United States on our health care industry without having concomitantly better results than countries that pay a lot less.

“If you go back to the Oregon [Health Insurance] Experiment, one side was in favor of rationalizing health care, and the other side immediately accused them of rationing,” Raghavan added. “Having a rational approach to health care is not about rationing. It is about using treatments that work, not using treatments that don’t work and having the willingness to think about alternative approaches.” – by Mark Leiser

Disclosure: Dolinar, Lichtin, Raghavan, Rosenbaum and Ubl report no relevant financial disclosures.

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