New administration pledges zealous enforcement of FCA may reset the clock on privacy regs
New administration pledges zealous enforcement of FCA may reset the clock on privacy regs
Health care providers’ pleas for relaxation of Stark II and HIPAA privacy rules may go unanswered
Health care providers hoping for a reprieve in the enforcement of the False Claims Act (FCA) under the Bush administration shouldn’t hold their breath. In fact, newly appointed U.S. Attorney General John Ashcroft already has pledged vigorous FCA protection at the same time that as many as a dozen states are now testing their own recently passed FCA statutes.
Former Department of Justice (DOJ) attorney and FCA expert John Boese of Fried, Frank in Washington, DC, says that what effect the incoming Bush administration would have on FCA enforcement efforts may already have been answered.
In a Jan. 31 letter, Ashcroft told Sen. Charles Grassley (R-IA), author of the 1986 amendments that resurrected the Act, that he plans not only vigorous enforcement of the FCA, but active defense of its constitutionality and opposition to any efforts to weaken it.
Under the Clinton administration, DOJ became an avid and vocal advocate of qui tam constitutionality, notes Boese. In fact, Assistant U.S. Attorney General David Ogden personally argued in the Fifth Circuit on the constitutionality of the statute.
Health care attorney William Saraille of the Washington, DC-based Arent Fox agrees that the DOJ is by and large extremely supportive of whistle-blowers and the whistle-blower provisions simply because they bring cases. "More and more, we are seeing the health care agenda set not so much by DOJ, but by the whistle-blowers that come to DOJ," he asserts. "That is a fundamental change in the landscape over the last two years."
On the brighter side, Saraille says that at least certain elements of the Bush administration may be somewhat more sympathetic to claims by providers that they have been misled by incorrect or missing guidance either by the Health Care Financing Administration (HCFA) or its contractors.
In fact, Saraille predicts that both the Bush administration and Congress will take a hard look at HCFA’s management of both Medicare and Medicaid. "That criticism could draw attention to the administrative handling of certain issues that may give either OIG or DOJ some pause," he predicts. While that will not mean a sea of change in terms of the overall level of enforcement activity, it could have an impact in discreet areas where there are well-publicized complaints, he adds.
But the good news may stop there. Saraille says the Bush administration’s recent 60-day freeze on new regulations issued under the Clinton administration is not likely to translate into further revisions of the final Stark II regulations released last month. In fact, he predicts only marginal changes, if any.
"HCFA saw the writing on the wall and decided to do itself what it would have been forced to do if it failed to take action," asserts Saraille. He says that silenced the outcry that marked the response to the proposed rules and probably avoided a reform bill from Congress. "That means that compensation arrangements will stay in the Stark law," he predicts.
The Health Care Portability and Accountability Act (HIPAA) of 1996 may be a different story, however. The American Hospital Associations executive vice president Rick Pollack urged the Department of Health and Human Services Secretary Tommy Thompson to reopen for comment certain portions of the new privacy rules that are scheduled to go into effect Feb. 26. "The cost and scheduled implementation date for the new privacy rules are overwhelming," Pollack asserted Jan. 31. "Adherence to that compliance schedule will be unattainable for many hospitals given the extensive changes in overall operations the new privacy rules will require and their high cost."
There is some question about whether or not the 60-day pause affects the HIPAA regulations because those regulations were passed pursuant to a congressional deadline. "Whether or not the 60-day hold applies in that context is an open question," says Saraille.
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