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More Questions Than Answers Remain on Trump Administration's Focus on Health Care
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Results of a Reuters/Ipsos poll taken during Nov. 9-14, 2016 indicated 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 Healio Rheumatology reached out to members of the clinical community for commentary on what could realistically be accomplished, there were more questions than answers.
“The answers you are going to get are pretty much going to be the same from everybody, which is: we don’t know yet,” Michael C. Schweitz, MD, chief of the Division of Rheumatology at Good Samaritan Medical Center in West Palm Beach Fla., and past president and national advocacy chair of the Coalition of State Rheumatology Organizations, said in an interview with Healio Rheumatology. “I can give you some generalizations, but the fact of the matter is we don’t know what is going to happen. We can make guesses based on his campaign and based on a general Republican platform. But we think Trump doesn’t know what to do when it comes to health care.”
Schweitz added whatever the administration attempts to accomplish will take time.
“I am hopeful that the administration will be able to come up with policy that is fair to everyone,” he said. “They have suggested that they would like to maintain or improve coverage for patients. In addition to this, I would like to see programs that ensure reasonable reimbursement for providers, programs that hopefully will address the onerous regulatory system that is now in place for providing medical care. The last thing I hope is that the system of drug pricing is addressed and understood better so more patients have access to the medications they need.”
Others were somewhat more measured in their opinions, including Steven J. Ubl, president and CEO of PhRMA. “We look forward to working with the new administration, as well as members of Congress on both sides of the aisle, to advance pragmatic solutions that enhance the private market, improve patient access to care and foster the development of innovative medicines,” he said in a statement to Healio.com.
Affordable Care Act
Angus B. Worthing, MD, FACP, FACR, clinical assistant professor of Medicine at Georgetown University Medical Center and chair of the American College of Rheumatology Government Affairs Committee, expressed cautious optimism about improving components of the Affordable Care Act (ACA) that may not be functioning optimally.
“There are a lot of potential opportunities for health care in the United States to be reformed under unified government, but there are also some potential risks,” he said in an interview with Healio.com. “I don’t anticipate that in a Republican-led administration and Congress that innovative regulatory pathways, such as biosimilar drug approval, 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.”
Schweitz said the new administration is in line with the Republican position, which has been to dismantle the ACA altogether.
“The question is how much dismantling is feasible administratively and how much is feasible politically,” he said. “You have 20 million people with some sort of insurance that may or may not be adequate for their needs. The administration is going to have to look at the nuts and bolts of the Act to see how much they can change.”
The regulatory aspects may not be easy to repeal as other parts of the ACA, 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 Schweitz, who is also a member of Healio Rheumatology’s Peer Perspective Board.
“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.”
Schweitz said 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
Although many clinicians and researchers have strong opinions on the FDA approval process, the sources who spoke to Healio Rheumatology were 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,” Ubl said. “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.”
Worthing noted the Republican appreciation for market-based solutions to problems.
“I am anticipating that we may see some action on this, perhaps with more support of the FDA in their guidance and approval process, so the 60-plus biosimilar drugs in the pipeline can come out and reach the marketplace in a safe and effective way,” he said.
Medicare
Trump has chosen Rep. Tom Price, MD, (R-Ga.) as secretary of HHS. In 2016, Price introduced the Empowering Patients First Act (H.R. 2300). The bill would fully repeal the ACA and focus on the “principles of affordability, accessibility, quality, innovation, choices and responsiveness,” Price said in a press release.
“Congressman Tom Price and Speaker 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,” he said.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) will be “way down on the list of priorities to address and was passed with bipartisan support,” according to Schweitz. However, he suggested the Part B Demonstration Project may meet its end.
“This was the Obama administration’s final attempt to reduce costs,” he said. “It was poorly designed and too over-reaching in scope.”
Rep. Nancy Pelosi and Rep. Chuck Schumer wrote a letter to stop Part B, according to Schweitz. “This was applauded by physicians everywhere,” he said.
Schweitz added that re-evaluation 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.
Biosimilars and drug pricing
Of particular interest to rheumatologists is what may happen with biosimilar therapies.
“We definitely are seeing that the era of biosimilars, from the creation of the pathway in 2010 until now, is costing the system money instead of saving the system money,” Worthing said. He noted the price of infliximab (Remicade, Janssen), increased about 70% during that 6-year period, whereas biosimilar infliximab (Inflectra, Pfizer) will come out at a 15% discount.
“From that perspective, the system is costing us money. It may require multiple biosimilars for each original reference drug to create enough competition so that we can net a cost savings,” he said.
There are a number of concerns with the way biologic therapies are tiered and prescribed, Schweitz said, adding that non-medical switching has become a real problem and needs to be addressed at either the state or federal level.
“We hope to be able to educate the new administration about these issues,” Schewitz said.
It is for this reason despite uncertainty, Schweitz remains optimistic about the ability of the clinical community to impact policy.
“We are working to establish sustainable relationships with people in the new administration,” he said. “Eventually, we hope they will hear the message and come on board. We need to remember that it can take a long time to make change.” — by Rob Volansky
Reference:
www.reuters.com/article/us-usa-trump-poll-idUSKBN13C2HM
Disclosures: Schweitz reports no relevant financial disclosures. Ubl reports he is president and CEO of PhRMA . Worthing reports he receives less than $5,000 in consultation fees from AbbVie in 2016.