The American Hospital Association has wasted no time asking President-elect Donald Trump for a slew of new laws and rules that would soften anti-kickback laws, reduce barriers to mergers and lower requirements for electronic health records.
The group, which represents 5,000 healthcare organizations and 43,000 individual members, sent a letter to Trump Wednesday asking that those wishes be prioritized. But experts say that might be unrealistic.
"The regulatory burden faced by hospitals is substantial and unsustainable,” the letter said, adding that reducing such burdens could save "billions of dollars annually."
The AHA says the cancellation of Stage 3 of the meaningful use program should be a top priority because hospitals are shouldering the expense of upgrading electronic health records solely for regulatory reasons.
The final stage of the health IT program requires providers to send electronic summaries for 50% of patients they refer to other providers, receive summaries for 40% of patients that are referred to them and reconcile past patient data with current reports for 80% of such patients.
Ending the last stage of meaningful use would require legislation and could cost money to offset any expected federal savings, according to Jeff Smith, vice president of public policy for the American Medical Informatics Association. So, a scale-back might be more easily accomplished through a new rule, he said.
The CMS could make it easier to comply, such as simply asking hospitals to prove they are using certified EHRs. The agency could also offer exemptions to those it deems worthy of one.
Any more lax regulations would likely carry little impact, since, Smith said, the program has reached a point of “diminishing returns.”
"I think MU has served its purpose and it's time to see if hospitals can ride their bike without the constraints of training wheels,” he said.
The AHA also asked the next administration do more, such as provide safe-harbor waivers and exemptions, to protect hospitals from inadvertently violating anti-kickback laws when providers collaborate on value-based pay initiatives. The relationships, in which one provider pays another, can be viewed as illegal.
The fear of penalties, felony conviction or exclusion from Medicaid and Medicare has dampened interest in alternative pay models.
“The current administration has been very generous historically with waivers, but more recently waivers have gotten more narrowly tailored and less helpful over time,” said Troy Barsky, a partner at the law firm Crowell & Moring. Barsky was previously the CMS director of the division of technical payment policy.
Congress would have to intervene to add more flexibility to anti-kickback laws.
HHS' Office of Inspector General and the CMS have found it hard to provide significant relief from anti-kickback safe harbors and Stark law exceptions, said Thomas S. Crane, an attorney at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo.
Sen. Orrin Hatch (R-Utah) has expressed interest in weakening current laws, saying he wanted to address concerns about the laws impeding the implementation of recently passed health reforms such as the Medicare Access and CHIP Reauthorization Act.
But, “If you soften the law too much it would allow physicians to make decisions based on cost versus what's best for the patient,” Barsky said.
Finally, the AHA seeks to standardize the federal merger review process between the Federal Trade Commission and the U.S. Justice Department to better support hospital transformation. The AHA has supported the Standard Merger and Acquisition Reviews Through Equal Rules (Smarter) Act which was introduced last year.
The FTC and Justice Department currently use different processes when challenging a merger or acquisition. The FTC must merely raise questions about the impact on competition, while the Justice Department must demonstrate actual harm to competition, according David A. Balto, a former antitrust lawyer at the Justice Department and the FTC.
Legal experts believe Trump might be friendlier to companies looking to merge, given his own business interests. That's now supported by Trump's pick to lead the transition for the Justice Department and FTC. Joshua Wright, formerly of the FTC, has historically supported large mergers, Balto said.
The Smarter Act was "very unpopular with the FTC," said Lisl Dunlop, a partner at the law firm Manatt, Phelps & Phillips in New York. “Under a Trump administration, the measure is likely to be passed. The AHA's letter will add to the support for the alignment.”