Carrie Valiant, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was featured in an article titled "New HHS Fraud-Prevention Rules Could Cause New Barriers to Entry for Providers."
According to the article, the final rules that HHS issued on Jan. 24 to implement fraud-prevention provisions in the health reform law include some "very scary tools" the department will have that could wind up hurting honest providers.
Valiant said the rules make no distinction between those providers starting out and those already existing, "and I think there should be" a distinction. They also leave big questions, according to Valiant, such as how a "credible allegation" of fraud that triggers actions under the rules will be defined.
"I think these are some very scary tools that the OIG has at its disposal," Valiant said. "Suspension is the scariest aspect," she said, arguing that this puts much more power in the hands of "whistleblowers" making allegations and very little power in the hands of providers hoping for "due process" to challenge contentions.
Valiant maintained that the rules are "extremely broad" in defining credible allegations and could enable occurrences such as complaints filed with "hotlines" to be the basis for suspensions. Many False Claims Act cases, according to Valiant, are filed by "disgruntled former employees," and providers already are expending large amounts of resources to deal with them, even though many ultimately "go away" or are settled in a "much more minor way" than originally sought. Valiant said now, not only will the expense increase even if the allegations are unjustified, "but the government also can cut off your Medicare payments."
Valiant added: "'Credible' really is in the eye of the beholder." Furthermore, providers often don't have full information early in a case with which to defend themselves against allegations, especially since complaints may be kept under court seal for years, she said.
The screening for new entrants that the new rules provides is "understandable" for keeping out fraudulent providers, Valiant acknowledged. The impact, though, could be troublesome depending on how the powers are used, particularly since the reform law is encouraging formation of new entities, such as Medicare accountable care organizations, and "transactions." Many of the new features also will require new provider identifier numbers or expansion of existing entities into new locations, and all of those developments "implicate" the new screening aspects of the rules, Valiant asserted.
Valiant said that it already can take providers many months to "jump through hoops" when they have ownership changes or even a new location, and "the screening will only increase this time frame." The result of the rules' "overreaching" screening provision, in Valiant's view, will be "creating further barriers to entry" at a time when the reform law hopes to achieve broader participation.
Valiant also takes issue with the permanent-exclusion provisions regarding Medicaid and CHIP. A provider should be allowed to "do your time" and become "reformed," especially since exclusions can result from such "relatively innocuous things" as failing to file an address change, she said, citing a case she was involved in.
Since the rules are final, what can providers do about them? Valiant recommends that providers look for some kind of "accreditation" or "Good Housekeeping seal of approval" that OIG will accept in lieu of more extensive screening procedures. Other steps she suggests are standard compliance program components such as to make sure Medicare forms are up to date, do thorough investigations of allegations by potential whistleblowers, and "dig deep" to be able to respond quickly in the event of a possible suspension.
Still, Valiant said, "it's difficult to build a business plan" when "there are folks that could cut off your enrollment based on things unknown" to the providers involved.