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A look ahead at digital health and health policy under President Trump

Jan 29, 2017

Healthcare wasn’t exactly priority number one in President Donald Trump’s inaugural address this morning. In fact, despite the apparently looming repeal of the Affordable Care Act, the only reference to healthcare in the whole speech was a vague promise, buried with two or three other vague promises, to “to free the Earth from the miseries of disease”. Whether this is a veiled promise to increase federal investment in medical research remains to be seen, but it doesn’t seem consistent with Trump’s stated goals of slashing the federal budget.

On the day of Trump’s inauguration as 45th president of the United States, we’re looking back at the question we tried to answer when Trump won back in November: What will a Trump presidency mean for digital health? Now we know more than we did then, but there is still a lot of uncertainty. Read on below for a summary of what we know now about the future of healthcare, interspersed with quotes from those in the know in the world of digital health.

The Affordable Care Act

The biggest, most obvious change to the healthcare landscape under the new regime is the Republican majority’s plan to “repeal and replace” the Affordable Care Act, President Obama’s landmark healthcare law that’s often colloquially referred to as Obamacare. The ACA is a broad piece of legislation best known for its insurance reforms, which set up government exchanges, mandate that individuals have health insurance, and prohibit insurers from discriminating on the basis of pre-existing conditions.

While Republicans have a majority in the House and Senate, they don’t have a filibuster-proof supermajority, which limits what they can do in repealing and replacing Obamacare. They are poised to use the budget reconciliation process, a special set of rules that allows laws that have to do with spending, revenue, and debt to be passed with a simple majority.

While using budget reconciliation will allow the Republicans to dodge a filibuster, it does limit what provisions of Obamacare they can repeal, since they can’t touch certain provisions that don’t require government spending, like the prohibition on pre-existing condition discrimination. Senate rules also limit the use of budget reconciliation to once per year for each category (spending, revenue, and debt). This means that if the Republicans repeal Obamacare without a replacement in place, they will need bipartisan support to craft the replacement unless they wait a whole year to push it though.

It looks like that’s what is going to happen, as the House and Senate have already had the first votes on a budget measure that would repeal much of the law (in fact, a the House and Senate passed a bill to that effect last year, but it was vetoed by President Obama).

The exact nature and the timing of the “replace” half of repeal-and-replace remains unclear. There are Republican plans that have floated around for some time, including one from 2015 by Rep. Tom Price, Trump’s pick for HHS Secretary. That plan, detailed here, relies on a combination of Health Savings Accounts and high-risk pools to keep people insured.

Earlier this week, the Congressional Budget Office came out with a report stating that, if the ACA budget provisions are repealed without either a replacement or a plan to delay the enactment of the bill until a replacement existed, 18 million people could lose their health insurance. Republicans responded to the report by saying that it was irrelevant as it didn’t take their as-yet-unannounced replacement into consideration.

Jodi Daniel, who was the founding director of the Office of Policy at the Office of the National Coordinator and now works as the lead digital health partner at DC law firm Crowell & Moring, said its still too early to really tell.

“What [repeal] looks like is still very murky,” Daniel said at a panel during JP Morgan in San Francisco last week. “I don’t think, quite frankly, that they have figured it out. It’s really hard to both keep the consumer protections in place and not have a way of paying for it.”

Daniel did say that she expects the shift towards value-based care to continue, despite changes in the administration, and that digital health could have a big role to play in the coming years.

“What I’ve been hearing from Republicans on the Hill is that value-based payment is still a very important approach to figuring out this equation, and I think technology is going to be an important component of that,” she said. “Any products that help support population health management and help support patient behavior management and things like that are still going to be very, very important and very much aligned with healthcare policy that comes out of Washington.”

Daniel even suggested it might not be as haphazard as some fear, given the experience of some people guiding the transition.

“As we are talking about the Trump transition, the folks who are leading the healthcare transition are former HHS Bush appointees who I worked with,” she said. “They understand bureaucracy, they understand the challenges of working in government, they came in in 2001 saying they were going to change all the regulations and they didn’t. They tweaked them. And it’s a lot of the same folks who are coming back.”

Adam Brickman, Director of Strategic Communication and Public Policy for digital diabetes management company Omada Health, said it’s important to understand what is meant by value-based initiatives when considering what aspects of the ACA should remain.

“I’m actually a little more bullish on the move towards value,” Brickman told MobiHealthNews in an interview. “If you really want to break down the ACA, I think there are two large buckets where you can put a lot of separate initiatives – there’s coverage expansion, individual exchanges, etc. Then there are program delivery reforms. My view on it is that you sort of have to separate out those two buckets.”

Brickman, who previously told MobiHealthNews that Omada would not exist without the ACA, emphasized the need for discernment when evaluating the impact of the ACA.

“A lot of the way people talk about ACA and Obamacare, especially if they are negative on it, focuses on coverage expansion elements, especially with the individual mandate,” he said. “But I think that where we are, and what has enabled us as a company to really thrive, are those program delivery reforms.”

Echoing that, fellow panelist Glenn Tullman, the CEO of Livongo Health, said he expected certain aspects of the current healthcare law to stay in place.

“First of all, I don’t think it’s repeal and replace. I think what we are talking about is rename and kind of re-face this. Trump has already said the primary provisions he wants to keep. I think that’s true in Congress,” he said. “ I think value-based payments in Congress have very strong support across the board. And it’s starting to work. They are starting to get companies that are actually delivering measurable results. And that’s what the future is going to be about. Remember, the government controls a substantial portion – half – but there’s another half. Employers have said it’s unsustainable to keep healthcare costs growing. So they are going to do whatever they need to do almost independently of the government. My advice is don’t get distracted by tweets. Let’s focus on really important stuff.”

Medicare and Medicaid

What will happen to Medicare and Medicaid under President Trump is another unanswered question. Trump promised during his campaign not to make cuts to Medicaid or Social Security, but there are multiple reasons to think he might not keep that promise. One is that Price has slashed both programs in budget proposals he’s recently made to the house, and refused to rule out slashing Medicaid during his confirmation hearing. Another is that Trump’s plans to cut the federal budget by $10 trillion over 10 years are based on a blueprint from the heritage foundation, and that blueprint cuts Medicare and Medicaid both by more than 40 percent to get to its numbers. It also takes a $4 billion bite out of military healthcare spending.

In the digital health world, the question is what will become of the CMS Innovation Center, which supports ACOs and other value-based care reforms. While technically a full repeal of the ACA would destroy the center, a piece in Modern Healthcare quotes a number of policy experts who believe that both sides of the aisle support the Innovation Center and the work it’s doing, so it could be safe. The piece also notes that the Medicare Access and CHIP Reauthorization Act, or MACRA, is a bipartisan piece of legislation.

Brickman, too, pointed out the significance of MACRA and said it is among the reasons he is “cautiously optimistic” about the future of healthcare under the Trump administration. “The last thing is people aren’t focusing on as much are the reforms with MACRA,” he said. “I can’t think of the last time there was a wholly bipartisan piece of healthcare legislation that made it through both the House and the Senate that was signed by the president. And MACRA did.”

Telemedicine

While most of the biggest policy changes in telemedicine are on a state level, the new administration will still impact the sector as the question of reimbursement is still not clear, particularly if Medicare and Medicaid budgets change.

“From a Washington standpoint, we are heading for a heavy focus on managed care, and heavy focus on controlling costs. Telehealth will do well on both of those fronts,” Gary Capistrant, chief policy officer for the American Telemedicine Association told MobiHealthNews in an interview. “There are lot of opportunities, but I think it will important where our new president and new Congress stand; whether they want to deal with that level of detail, or outsource to Medicare and managed care.”

Capistrant said the ACA is just one piece for the telehealth sector to think about, as the greatest consequences to reimbursement will come from decisions on Medicare and Medicaid.

“Under the Trump administration, there will be a heavy focus on Medicare Advantage plans. And while there is a lot of focus on what Donald Trump wants to do, it’s very important what Paul Ryan wants and Orrin Hatch wants and all the others involved. The realities of governing are settling in,” he said. “There are a lot of Republicans that just want to cut government – whether that is CMS and a lot of the work they do on a thousand different levels, or a lot of the insurance management methods that could be cut.”

The FDA

When we looked at the future of the FDA under Trump in November, FDA expert Bradley Merrill Thompson, a partner at Epstein Becker Green, told us digital health folks had room for optimism about Trump’s approach to the agency.

“From everything I’ve heard, Trump is very supportive of technology development, and very concerned about regulatory red tape. So I think we can feel confident that Trump will certainly not increase the regulation of digital health,” he told us at the time. “The bottom line is, while the two men seem to disagree on just about everything, it would appear that the two men might actually agree on the need to support the development of digital health, and we can expect a continuation of those policies under the Trump administration.”

There have been a few names floated for FDA Commissioner under Trump: Jim O’Neill, managing director at Peter Thiel’s Mithril Capital Management, and Balaji Srinivasan, founder of genomics company Counsyl. Both men are pretty strongly anti-regulation. O’Neill has said that he would like to see the FDA shed its efficacy-evaluating functions and focus only on safety. Srinivasan, in a now-deleted tweet, argued that “a Yelp! for drugs” would be more helpful to consumers than the FDA.

As scary as these sentiments might be for some patients, they could spell positive change for digital health if they led to significant relaxations of FDA clearance requirements. We could see a blossoming of innovations and formerly stalled products rushing quickly to market. Conversely, we could also see a rise in dangerous or irresponsible health devices and apps.

21st Century Cures

While the future of healthcare under Trump is unclear, there do exist opportunities in health innovation on a federal level.

“21st Century Cures Act passed in the lame duck session just a few weeks ago,” said Daniel. “So everyone is focused on ACA reform, but there is this huge other agenda, 995 pages of new legislation that just passed, bipartisan, led by Republicans, lots of money for research, changes in the way FDA oversees the review process for technologies and there’s also doubling down of interoperability from the health IT space and mental health. … If folks are sort of looking in this ring over here at what’s happening in ACA reform, we have certainty of a lot of other issues that just passed. A lot of people at HHS are going to be spending a lot of time with their heads down trying to figure out how to implement how that law was just passed. If you want to look at where changes are going to come about – research, data analytics, Cancer Moonshot, big data – you can look at things that have already gotten support from Congress and see things that are safe investments.”