How you can negotiate a manageable CIA
When the Health and Human Services (HHS) Office of Inspector General (OIG) investigates a provider, it always asks three questions, says Joe Russo, president of HP3 Healthcare Concepts in Bethlehem, PA:
1. Is there a compliance plan in place?
2. Is that plan effective?
3. Was that plan in place when the alleged wrongdoing occurred?
If you can answer "yes" to each of those questions, you will have dramatically improved your chances of negotiating a manageable corporate integrity agreement (CIA), Russo argues.
"A CIA is not a boilerplate document to be presented to you for your execution," asserts Michael Kline of Fox Rothschild in Lawrenceville, NJ. He says getting outside counsel involved early is an important part of the process that can take a variety of forms. That is because outside counsel may or may not initially have a good sense of a provider’s operations, depending on how long they have served and how they have historically interacted with the compliance department or in-house counsel on reimbursement issues.
Early involvement allows the outside counsel to work with the provider and its compliance officer to identify important operational and other issues for the negotiation process.
"If you do things right, you can also retain a potential scintilla of attorney/client privilege," adds Kline. He points out that audits and other information required under a CIA lack attorney/client privilege with respect to the OIG because the agreement stipulates that everything will be disclosed.
But the fact that information must be disclosed to the OIG does not mean providers are prohibited from asserting under the Freedom of Information Act (FOIA) that certain proprietary, financial, or other exclusionary material cannot be obtained from the OIG.
In other words, just because providers must make complete disclosure to the OIG does not mean they are required to disclose the same information to competitors and third-party payers. For example, some insurance companies now routinely seek FOIA disclosures following OIG settlements to determine whether copayments and deductibles should be returned to them.
An effective response asserting attorney-client privilege and other proprietary rights of a provider usually can thwart or slow those attempts, he maintains.
Gil Stone, chief compliance officer at The Medical Center at Princeton (NJ), says that one of the mistakes made by his facility, which now is operating under a five-year CIA, was not heeding the advice of Horizon Blue Cross’s Medicare bulletin regarding outpatient billing regulations. "We put a lot of reliance in our relationship with Horizon, as our fiscal intermediary, believing they would act as a monitor for us if we had any Medicare billing overpayments," he explains. Instead, Horizon passed certain information to the OIG.
Stone says Princeton, which lacked a compliance plan at the time, realized its error and immediately settled with the government. That helped to avoid treble damages. But when it came to negotiating the CIA, Princeton was not in a hurry. Those negotiations started off without outside counsel and took more than a year to complete, he reports.
Princeton started with the standard CIA but then successfully negotiated with the OIG to have its own internal review group. It also added the option of having an independent review organization (IRO) review the results of its compliance and billing practices. "I would not have done it without having an IRO available," says Stone. While most providers will have a difficult time understanding the OIG’s sampling and auditing procedures, known as RAT-STATS, IROs are experts in that area, he points out.
In addition, when the CIA implementation report was ready to be submitted, "the IRO’s independent review of our compliance program proved helpful," Stone reports. As a result, Princeton received no exceptions in the implementation report of its compliance program.
Russo says that ongoing internal monitoring and external nonstatistical random reviews are critical for providers, even those not under a CIA. He says that should include education in the health information management field.
While the medical record function is critical to the financial viability of the organization as well as False Claims Act exposure, many providers are reluctant to spend money on credentialed certified expert coders. "That’s a mistake," he says.
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