While President Trump made good on a campaign promise Monday morning when he signed an executive order that requires the repeal of two regulations for each new one that is put in place, the vagueness of the order has many in the healthcare field wondering what the effects will be in their highly regulated sector.
For starters, the 21st Century Cures Act, which aims to quicken the introduction of new medical treatments by speeding up FDA approval processes and boosting federal funding, could face hurdles, experts said.
"We are still trying to understand the full implications for the health IT community, but the executive order signed today adds a layer of complexity to the regulatory process for healthcare and health IT this year, particularly with the number of expected regulations needed to implement the 21st Century Cures Act," said Tom Leary, vice president of government relations for HIMSS. "We anticipate that the Trump Administration will try to ease the regulatory burden on providers in the course of identifying regulations to eliminate, in order to add the necessary structure for implementing 21st Century Cures requirements and other healthcare-related programs."
Also among those programs is the Medicare Access and CHIP Reauthorization Act, known as MACRA. The 2,400-page rule has saddled providers with a host of new rules and regulations that govern how clinicians who treat Medicare beneficiaries will be paid under its value-based Quality Payment Program. How this program will be treated under the new executive order remains to be seen, including how many existing regulations will be axed under the order.
Referred to as the "one in, two out" executive order, Trump said the rule is intended to help small businesses who are struggling with regulatory burdens. And making room for new regulations is supposed to be a budget-neutral endeavor, with Trump stating the fiscal costs of new rules will be "no greater than zero." According to him, any new costs will be offset by the elimination of other rules.
"The impact of this executive order is difficult to predict without more information as to how the Trump administration will operationalize it. This adds to the uncertainty that healthcare providers are facing," said Eric Cragun, senior director of health policy at Advisory Board.
Yet, some healthcare industry pros see the order as a step in the right direction. One of the major complaints about MACRA was the fact that providers are already besieged by regulations and reporting burden, causing burnout and frustration industry-wide that in turn affects patient care quality. The American Hospital Association said reducing the administrative complexity of healthcare would allow providers to spend more time on patients, not paperwork, and pointed out that in the past year alone, the federal government added 23,531 pages to the stack of existing regulations affecting hospitals and health systems. This order, they said, starts to address the concerns of clinicians who are tired of being buried under rules and paperwork.
"The regulatory burden that is imposed on hospitals and health systems is substantial and unsustainable and has grown in recent years. We are encouraged by the executive order signed by President Trump today that will help reduce red tape," said Rick Pollack, AHA president and CEO. "Excessive red tape not only stands as a barrier to care but as a key driver of cost. Reducing the burden would not only provide relief, but would also provide an opportunity to make care more patient-centered than ever before."
AAFP President, John Meigs, Jr. also said the order is a positive start towards decreasing regulation, but they are reserving final judgment on it.
"Health care is one of the most highly complex and regulated industries in our economy, and family physicians are no strangers to the negative impacts of excessive regulation. To the extent that President Trump's executive order may reduce the administrative burden and the cost of doing business for family physicians, this would be a welcome step. However, we will need more information and specifics before we can formally react or respond."
What is clear now is that regulators will be spending as much time figuring out what rules to eliminate as they will crafting new ones to benefit the industry.
"It's a tough balancing act for HHS, but they have lots of experience writing regulations and implementing programmatic requirements that attempt to mitigate any excessive regulatory burden on the provider or vendor communities," Leary said.