Feature

HCV Experts Discuss Impact of Trump Administration

Results of a Reuters/Ipsos poll taken during Nov. 9-14, 2016 indicated that more than 20% of Americans wanted President-elect Donald J. Trump to focus on health care in his first 100 days in office. However, when HCV Next reached out to a cross-section of experts for commentary on exactly what Trump could realistically expect to accomplish in health care, and how he would accomplish it, there were more questions than answers. Of note, some experts declined to comment.

“It’s a little bit soon because I can’t read this guy,” Michael S. Saag, MD, professor of medicine, Jim Straley Chair in AIDS Research and director of the Center for AIDS Research at the University of Alabama at Birmingham and co-chief medical editor of HCV Next, said in an interview. “I can imagine some worst-case scenarios. Certainly, if [Sec. Hillary Clinton] were there, I would have great confidence, but I don’t have a lot of confidence at the moment.”

Michael S. Saag, MD

Michael S. Saag

Steven Echard, IOM, CAE, CEO of the AASLD, is also taking a wait-and-see approach. “It is too soon for us to speculate how the Trump administration will address health care,” he said. “Our policy agenda remains focused on funding for hepatology research and training and access to care for patients with liver disease.”

Murray Penner, executive director of the National Alliance of State & Territorial AIDS Directors (NASTAD), remains optimistic about moving forward in HCV care. “Our top priority is for people at risk or living with HCV, and other health conditions, to have access to high quality and affordable medical care,” he said. “During the campaign, president-elect Trump expressed his commitment to ensuring that people would not lose health insurance. As we work with the president-elect and the new Congress to strengthen the health system, we’re hopeful that insurers will be prohibited from discriminating against policyholders based on pre-existing conditions and that low-income Americans will continue to have access to affordable insurance — including through Medicaid and subsidies. We’re hopeful that the Administration and Congress will also act to address insurance restrictions which, due to high drug prices and discriminatory practices, limit who is eligible for HCV treatment.”

HCV Next will attempt to gain a handle on expectations from the new administration for the Affordable Care Act, Medicare and the FDA approval process in addition to HCV-specific issues such as drug pricing for DAA therapies and the opioid epidemic.

Targeting HCV

Penner spoke directly to the continuum of HCV care. “We look forward to the release of a national hepatitis elimination strategy from the National Academies of Medicine in the Spring of 2017,” he said. “With strong HCV testing recommendations, effective prevention interventions, and curative HCV therapies — we are well positioned to make the elimination of HCV in the U.S. a reality. This will take bold leadership from the administration and Congress. We believe that the elimination of hepatitis is an achievable goal and something that the Trump administration should be excited about and could be an important part of his administration’s legacy.”

Before these specifics can be accomplished, a close examination of some of the root causes of HCV must be undertaken, including opioid abuse. “For nearly a decade, NASTAD, health departments and community advocates have been sounding the alarm regarding the growing hepatitis epidemic in rural America,” Penner said. “This epidemic, tied to the opioid epidemic, is impacting Americans in every state and community. With president-elect Trump and Congress’s messaging about the challenges faced by many Americans, we are hopeful that the infectious disease consequences of the opioid epidemic will rise in priority and urgency in 2017.”

On the ACA

Angus B. Worthing, MD, clinical assistant professor of Medicine at Georgetown University Medical Center, is hopeful that some aspects of the ACA that may not be functioning optimally will be improved. “There are a lot of potential opportunities for health care in the U.S. to be reformed under unified government, but there are also some potential risks,” he said. “I don’t anticipate that in a Republican-led administration and Congress that innovative regulatory pathways would be taken away. This component of the ACA is meant to save a fair amount of money and of course do so by spurring competition, and I think Republicans will be friendly to that.”

The regulatory aspects may not be easy to repeal as other parts of the Act, according to Worthing. “The easiest pieces to repeal are associated with taxes and can be done under reconciliation, or a single majority vote,” he said. “I don’t anticipate that that would change.”

Dealing with subsidies is another component of the plan that will impact the budget but may come with consequences, according to Michael Schweitz, MD, a rheumatologist affiliated with Good Samaritan Medical Center and JFK Medical Center in West Palm Beach, Fla. “If you get rid of the subsidies and the mandate, it totally disrupts the ACA,” he said. “I don’t know how they can do that politically.”

That said, Schweitz believes that addressing the issue of pools across state lines is a good idea. “It makes more sense from a premium standpoint to widen the pools,” he said. “Whether they can or will do that or not, I don’t know. They are going to be addressing some parts of the ACA that make sense economically and politically for them, but we still don’t know what those parts are.”

FDA approval

Many clinicians have strong opinions about the FDA approval process in general. “The dropping of regulations in some ways theoretically should help, but it could aggravate the pricing,” Saag said. “We need to move in a direction of the government having more of a role in pricing, not less, but that doesn’t seem to be philosophically in line with what Trump is about.”

Others were more measured in their opinions on the matter.

“We are in a new era of medicine with treatments and cures that are completely transforming the fight against debilitating diseases,” Steven J. Ubl, president and CEO of PhRMA, said in an interview. “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. In addition, we strive to empower consumers with information to make more informed health care decisions.”

Medicare

Schweitz commented on the politics of Medicare. “Congressman Tom Price [R-Ga.] and [Speaker of the House] Paul Ryan are interested in ways to bend the spending curve on Medicare,” he said, and suggested that higher cost sharing from higher income seniors may be one way to accomplish this. “A bill from Congressman Price calls for individual contracts between physicians and Medicare patients. This could shift some of the cost away from Medicare and allow physicians not to be bound by Medicare costs.”

Echard was positive about the potential relationship between the AASLD and the new administration. “We are confident our work with government agencies such as NIH, CDC, CMS and AHRQ will continue and that liver disease will be an important part of the health care conversation over the next 4 years,” he said.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) will be “way down on the list” of priorities, according to Schweitz. However, he suggested that the Part B Demonstration Project may be finished. “This was the Obama administration’s final attempt to reduce costs,” he said. “It was poorly designed and too over-reaching in scope.”

Congresswoman Nancy Pelosi (D-Calif.) and Senator Chuck Schumer (D-NY) wrote a letter to stop Part B, according to Schweitz. “This was applauded by physicians everywhere,” he said.

Schweitz added that a reassessment of the Center for Medicare Innovations, which was involved in designing Part B, is more likely to be on the agenda of the new administration.

DAA therapies drug pricing

Hepatologists and gastroenterologists everywhere are curious, if not anxious, about how the new administration will deal with the high cost of DAA therapies.

“As part of efforts to strengthen the health system for all Americans, there must be a serious examination of the cost of prescription drugs and their impact on overall health costs,” Penner said. “On an individual level, high drug prices have resulted in insurance practices that have restricted access to the HCV cure for many people living with HCV. We look forward to partnering with the Administration and Congress to lower the cost of prescription drugs, especially for those who need them the most.”

Saag offered a practical solution. “There should be a two-tiered approach for a new drug,” he said. “The first tier involves the usual safety and efficacy evaluations to gain approval. But once that happens, there should be a second review that sets a maximum price based on the price of development and other factors. That could occur in a closed hearing. The outcome of that would be a number. The payer would not be required to pay above that number.”

Another potential solution pertains to generic medications, according to Saag. “We also need to improve importing of generic products,” he said. “That might be something Trump could get behind. Then again, that would involve opening borders, so I’m not sure. I just don’t know what he will do.”

Schweitz spoke more broadly on the drug pricing process. “For starters, I think at some point it may come out that the pharmaceutical manufacturers are not as villainous as people think they are,” he said.  “But this is a function of the fact that more education has to happen for legislators, as well as physicians and the general public, to understand the drug pricing schema.” by Rob Volansky

References:

Kahn C. Americans want Trump to focus on healthcare first. http://www.reuters.com/article/us-usa-trump-poll-idUSKBN13C2HM. Published Nov. 18, 2016. Accessed Dec. 2, 2016.

Disclosures: Penner reports no relevant financial disclosures. Saag reports receiving grants to his institution from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck and ViiV. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Echard, Schweitz, Ubl and Worthing at the time of publication.

 

Results of a Reuters/Ipsos poll taken during Nov. 9-14, 2016 indicated that more than 20% of Americans wanted President-elect Donald J. Trump to focus on health care in his first 100 days in office. However, when HCV Next reached out to a cross-section of experts for commentary on exactly what Trump could realistically expect to accomplish in health care, and how he would accomplish it, there were more questions than answers. Of note, some experts declined to comment.

“It’s a little bit soon because I can’t read this guy,” Michael S. Saag, MD, professor of medicine, Jim Straley Chair in AIDS Research and director of the Center for AIDS Research at the University of Alabama at Birmingham and co-chief medical editor of HCV Next, said in an interview. “I can imagine some worst-case scenarios. Certainly, if [Sec. Hillary Clinton] were there, I would have great confidence, but I don’t have a lot of confidence at the moment.”

Michael S. Saag, MD

Michael S. Saag

Steven Echard, IOM, CAE, CEO of the AASLD, is also taking a wait-and-see approach. “It is too soon for us to speculate how the Trump administration will address health care,” he said. “Our policy agenda remains focused on funding for hepatology research and training and access to care for patients with liver disease.”

Murray Penner, executive director of the National Alliance of State & Territorial AIDS Directors (NASTAD), remains optimistic about moving forward in HCV care. “Our top priority is for people at risk or living with HCV, and other health conditions, to have access to high quality and affordable medical care,” he said. “During the campaign, president-elect Trump expressed his commitment to ensuring that people would not lose health insurance. As we work with the president-elect and the new Congress to strengthen the health system, we’re hopeful that insurers will be prohibited from discriminating against policyholders based on pre-existing conditions and that low-income Americans will continue to have access to affordable insurance — including through Medicaid and subsidies. We’re hopeful that the Administration and Congress will also act to address insurance restrictions which, due to high drug prices and discriminatory practices, limit who is eligible for HCV treatment.”

HCV Next will attempt to gain a handle on expectations from the new administration for the Affordable Care Act, Medicare and the FDA approval process in addition to HCV-specific issues such as drug pricing for DAA therapies and the opioid epidemic.

Targeting HCV

Penner spoke directly to the continuum of HCV care. “We look forward to the release of a national hepatitis elimination strategy from the National Academies of Medicine in the Spring of 2017,” he said. “With strong HCV testing recommendations, effective prevention interventions, and curative HCV therapies — we are well positioned to make the elimination of HCV in the U.S. a reality. This will take bold leadership from the administration and Congress. We believe that the elimination of hepatitis is an achievable goal and something that the Trump administration should be excited about and could be an important part of his administration’s legacy.”

Before these specifics can be accomplished, a close examination of some of the root causes of HCV must be undertaken, including opioid abuse. “For nearly a decade, NASTAD, health departments and community advocates have been sounding the alarm regarding the growing hepatitis epidemic in rural America,” Penner said. “This epidemic, tied to the opioid epidemic, is impacting Americans in every state and community. With president-elect Trump and Congress’s messaging about the challenges faced by many Americans, we are hopeful that the infectious disease consequences of the opioid epidemic will rise in priority and urgency in 2017.”

On the ACA

Angus B. Worthing, MD, clinical assistant professor of Medicine at Georgetown University Medical Center, is hopeful that some aspects of the ACA that may not be functioning optimally will be improved. “There are a lot of potential opportunities for health care in the U.S. to be reformed under unified government, but there are also some potential risks,” he said. “I don’t anticipate that in a Republican-led administration and Congress that innovative regulatory pathways would be taken away. This component of the ACA is meant to save a fair amount of money and of course do so by spurring competition, and I think Republicans will be friendly to that.”

The regulatory aspects may not be easy to repeal as other parts of the Act, according to Worthing. “The easiest pieces to repeal are associated with taxes and can be done under reconciliation, or a single majority vote,” he said. “I don’t anticipate that that would change.”

Dealing with subsidies is another component of the plan that will impact the budget but may come with consequences, according to Michael Schweitz, MD, a rheumatologist affiliated with Good Samaritan Medical Center and JFK Medical Center in West Palm Beach, Fla. “If you get rid of the subsidies and the mandate, it totally disrupts the ACA,” he said. “I don’t know how they can do that politically.”

That said, Schweitz believes that addressing the issue of pools across state lines is a good idea. “It makes more sense from a premium standpoint to widen the pools,” he said. “Whether they can or will do that or not, I don’t know. They are going to be addressing some parts of the ACA that make sense economically and politically for them, but we still don’t know what those parts are.”

FDA approval

Many clinicians have strong opinions about the FDA approval process in general. “The dropping of regulations in some ways theoretically should help, but it could aggravate the pricing,” Saag said. “We need to move in a direction of the government having more of a role in pricing, not less, but that doesn’t seem to be philosophically in line with what Trump is about.”

Others were more measured in their opinions on the matter.

“We are in a new era of medicine with treatments and cures that are completely transforming the fight against debilitating diseases,” Steven J. Ubl, president and CEO of PhRMA, said in an interview. “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. In addition, we strive to empower consumers with information to make more informed health care decisions.”

Medicare

Schweitz commented on the politics of Medicare. “Congressman Tom Price [R-Ga.] and [Speaker of the House] Paul Ryan are interested in ways to bend the spending curve on Medicare,” he said, and suggested that higher cost sharing from higher income seniors may be one way to accomplish this. “A bill from Congressman Price calls for individual contracts between physicians and Medicare patients. This could shift some of the cost away from Medicare and allow physicians not to be bound by Medicare costs.”

Echard was positive about the potential relationship between the AASLD and the new administration. “We are confident our work with government agencies such as NIH, CDC, CMS and AHRQ will continue and that liver disease will be an important part of the health care conversation over the next 4 years,” he said.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) will be “way down on the list” of priorities, according to Schweitz. However, he suggested that the Part B Demonstration Project may be finished. “This was the Obama administration’s final attempt to reduce costs,” he said. “It was poorly designed and too over-reaching in scope.”

Congresswoman Nancy Pelosi (D-Calif.) and Senator Chuck Schumer (D-NY) wrote a letter to stop Part B, according to Schweitz. “This was applauded by physicians everywhere,” he said.

Schweitz added that a reassessment of the Center for Medicare Innovations, which was involved in designing Part B, is more likely to be on the agenda of the new administration.

DAA therapies drug pricing

Hepatologists and gastroenterologists everywhere are curious, if not anxious, about how the new administration will deal with the high cost of DAA therapies.

“As part of efforts to strengthen the health system for all Americans, there must be a serious examination of the cost of prescription drugs and their impact on overall health costs,” Penner said. “On an individual level, high drug prices have resulted in insurance practices that have restricted access to the HCV cure for many people living with HCV. We look forward to partnering with the Administration and Congress to lower the cost of prescription drugs, especially for those who need them the most.”

Saag offered a practical solution. “There should be a two-tiered approach for a new drug,” he said. “The first tier involves the usual safety and efficacy evaluations to gain approval. But once that happens, there should be a second review that sets a maximum price based on the price of development and other factors. That could occur in a closed hearing. The outcome of that would be a number. The payer would not be required to pay above that number.”

Another potential solution pertains to generic medications, according to Saag. “We also need to improve importing of generic products,” he said. “That might be something Trump could get behind. Then again, that would involve opening borders, so I’m not sure. I just don’t know what he will do.”

Schweitz spoke more broadly on the drug pricing process. “For starters, I think at some point it may come out that the pharmaceutical manufacturers are not as villainous as people think they are,” he said.  “But this is a function of the fact that more education has to happen for legislators, as well as physicians and the general public, to understand the drug pricing schema.” by Rob Volansky

References:

Kahn C. Americans want Trump to focus on healthcare first. http://www.reuters.com/article/us-usa-trump-poll-idUSKBN13C2HM. Published Nov. 18, 2016. Accessed Dec. 2, 2016.

Disclosures: Penner reports no relevant financial disclosures. Saag reports receiving grants to his institution from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck and ViiV. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Echard, Schweitz, Ubl and Worthing at the time of publication.