February 14, 2020

The Trump administration has made plenty of high-profile health care moves in recent years, generating waves of headlines and buzz in the industry. But after the initial hubbub faded, some of these proposals stumbled on the road to implementation.

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What's behind the delays? To find out, let's dig into several recent proposals—and discover why they haven't yet come to fruition.

Proposal #1: Revamp kidney care

The most recent example involves the Trump administration's efforts to reform and improve kidney care.

HHS last July unveiled five new payment models related to end-stage renal disease (ESRD) and kidney care, including a proposed mandatory payment model. Under the proposed mandatory ESRD Treatment Choice model, CMS would assess participating providers based on their rates of kidney and kidney-pancreas transplant and home dialysis. The agency said it planned to randomly select participants from across the country that manage about 50% of the U.S. adult ESRD beneficiaries, and it planned to launch the program in 2020.

The administration's efforts received praise from some stakeholders, with some providers saying they were eager to work with the administration to improve kidney care and advocates calling it a "win" for patients. Trump even touted the initiative earlier this month during his State of the Union Address.

But the proposal also faced powerful opposition. As the Washington Post's Christopher Rowland reported last week, "[A]mid resistance from kidney doctors and large dialysis companies," the Trump administration has delayed the mandatory payment model. According to Rowland, providers and dialysis companies are urging the administration to lower or eliminate proposed financial penalties under the model—which had been scheduled to take effect Jan. 1. "[N]ow the timetable is unclear," Rowland writes, and some advocates have raised concerns, saying change is needed to bolster care for kidney patients. Providers also face uncertainty about when or whether the payment model will take effect, as well as how it will be structured.

Joseph Grogan, director of the White House Domestic Policy Council, told the Rowland that the administration delayed the new payment model for no "other reason than to get it right."

Proposal #2: Disclose Rx drug prices in TV ads

Opposition from industry stakeholders also played a role in delaying some of the Trump administration's proposals related to prescription drug prices, Rowland reports.

Take, for example, the administration's final rule to require drugmakers to disclose their products' prices in television advertisements. HHS released the final rule last May, and it was scheduled to take effect in July 2019. The rule would require drugmakers to include list prices in television ads for Medicare- and Medicaid-covered drugs if the price for a typical course of treatment or a 30-day supply is greater than $35. HHS under the rule also would maintain and publish a list of pharmaceutical companies that do not comply with the new requirements, and those companies could be subject to litigation.

Some industry stakeholders lauded the rule. The American Medical Association said it would "give consumers a data point that is currently unavailable," and Matt Eyles, president and CEO of America's Health Insurance Plans, "commend[ed] the administration for taking such bold action to lower prices for patients."

But Pharmaceutical Research and Manufacturers of America President Steve Ubl said requiring drugmakers to disclose medications' list prices in advertisements would be "very confusing, misleading, lac[k] appropriate context, and isn't what patients want or need." Ubl also expressed concerns about whether the federal government legally can require drugmakers to include list prices in advertisements.

In June 2019, a few drugmakers and the Association of National Advertisers filed a lawsuit challenging the final rule, arguing that the rule exceeds HHS' statutory authority and violates the First Amendment. So far, that lawsuit has kept the rule from taking effect. Judge Amit Mehta of the U.S. District Court for the District of Columbia last August ruled that HHS doesn't have the authority to require manufacturers to disclose their drugs' list prices in TV advertisements and blocked the final rule.

HHS has appealed that ruling. 

Proposal #3: Shift more primary care to value-based payment models

While health care lobbies have driven some of the administration's policy delays, in other instances, the initiatives have simply taken more time to implement than expected.

For example, CMS last April announced five new voluntary payment models intended to shift primary care providers and other eligible professionals from fee-for-service payments to value-based payments. CMS divided the payment models into two paths under the agency's Primary Cares initiative: the Direct Contracting path and the Primary Care First (PCF) path. The agency began accepting applications to participate in the PCF payment models in spring 2019 and had planned to launch the payment models in 26 regions throughout the United States beginning in 2020.

Many stakeholders had applauded the new payment models. For instance, Don Crane, president and CEO of America's Physician Groups, said, "We're very excited to see the start of this new model and commend CMMI for their work in helping advance the value movement."

But last October, CMS announced that the PCF models will not start until 2021. While the agency initially didn't provide a reason for the delay, a spokesperson later said CMS wanted to give providers more time to consider participating in the models. The spokesperson also said CMS intended to use the additional time to evaluate and incorporate stakeholders' feedback—meaning final details on how the models will be structured could change down the road.

What could the delays mean for Trump?

If there's a theme behind these delays, it's that health care reform is very, very hard—sometimes harder than even the White House expects.

After all, many proposals create "winners" and "losers" in the industry, and the "losers" have plenty of ways to fight back, including through PR campaigns, Congress, and the judicial system. And even if a proposal is popular with most or all industry stakeholders, it still takes time to shift the course of America's multi-trillion-dollar health care industry.

But it's possible time is running out for the Trump administration. Some observers argue the delays that have mired the administration's proposals also could affect Trump's re-election chances. Health care is at the top of voters' minds as we near the presidential election. And it's notable that, while some of Trump's now-delayed proposals were well-received by the public, some of his less-popular health policy ideas—such as Medicaid work requirements in some states—already have taken effect.

Only time will tell whether Trump's health care record influences voters' decisions—and, as such, whether the administration will be able to bring these proposals to fruition. In the meantime, we'll be watching the initiatives that matter most for providers and tracking where they stand.

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