Pharmaceuticals, HIPAA top year 2002 enforcement agenda
Pharmaceuticals, HIPAA top year 2002 enforcement agenda
Compliance executives see Office of Inspector General playing an increasingly central role
"Drugs, drugs, and pharmaceuticals," are the top three issues that compliance officers and others should look for in 2002, says qui tam attorney Marc Raspanti of Miller Alfonso in Philadelphia. "That is where you are going to see all the cases."
Bill Sarraille, a health care attorney with Washington, DC-based Arent Fox, says other health care providers should pay attention to the scope of these investigations because the heightened scrutiny on pharmaceutical companies will focus attention on all entities that have a relationship with these companies.
Physicians, academic institutions, and others will be forced to re-evaluate "standard practices" and initiate a wave of compliance efforts, he predicts.
Raspanti says kickback cases will remain prominent. "They are still very big and getting bigger," he reports.
Again, Raspanti says the key ingredient is pharmaceuticals. "The reason they are going to get bigger is that you can’t put together a pharmaceutical case without having a kickback issue come up, because you can’t move drugs without physicians," he explains.
According to Raspanti, the recently settled TAP Pharmaceuticals case is only the tip of the iceberg. "Look at the TAP case as the paradigm of what lies ahead," he says (See Compliance Hotline, September 10, 2001.)
Sarraille says the other major issue compliance officers should watch is the Health Care Portability and Accountability Act (HIPAA). "HIPAA will move from being a hypothetical concern to a very immediate and real concern in the next year," he warns. "That is true, notwithstanding the delay that some people will have from an administrative simplification perspective," he says.
Dan Roach, vice president and corporate compliance officer at San Francisco-based Catholic Healthcare West, agrees that compliance officers should not take any false hope from the delay. "Even though the electronic data interchange portion of it has been delayed, that does not mean that we can postpone our preparation for a year," he warns.
"It does give people more time to prepare," he adds. "The flip side is that people tend to work better under pressure. Many of the organizations I know are simply moving ahead with the plans they already have in place."
In addition to coding, cost-report issues, and other compliance mainstays, Roach says the government will look at research and compliance with federal research requirements for those institutions that receive money for federally-funded research.
Former Inspector General Richard Kusserow says it is quite clear that the preponderance of the Health and Human Services’ Office of Inspector General’s (OIG) latest Workplan is on Centers for Medicare & Medicaid Services projects that focus on compliance-related issues. "That is pretty consistent," he says. "That has not really changed at all."
Kusserow, now president of Strategic Management Systems in Alexandria, VA, says it also is significant that roughly half of the initiatives included in the Workplan are carryovers from last year. That means compliance officers should expect many of these reports to be issued early in the year, he says.
According to Kusserow, another area to which hospitals should pay attention is appropriate screening.
"The question is increasingly being asked if hospitals are screening their physicians, medical staff, and vendors, as is called for by the OIG in their various compliance guidance documents," he explains. "They don’t know the extent to which this is being done. I think this is the first step in looking under the sheets."
With the continuing focus of the FBI on terrorism-related issues, Sarraille adds that he expects to see a clear increase in the importance of OIG-initiated and involved investigations.
Mary Grealy, president of the Healthcare Leadership Council based in Washington, DC, says while major cuts in Medicare funding in order to balance the budget are not likely, attempts to save money by closing loopholes.
"I would go back and look at every OIG and General Accounting Office report and various recommendations that they have made," she says. Many of the OIG’s recommendations
talk about efficiency in addition to fraud, she notes.
The first job of compliance officers is to make sure there is a system in place to combat fraud, says Grealy. But the other is to ensure that they are complying with complex rules and regulations and keeping pace with new program changes.
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