Updated Self-Disclosure Protocol

I am Tony Maida with the Office of Inspector
General and I am going to give you information on an important issue for healthcare providers
-- what to do when you discover conduct that may violate the federal fraud and abuse laws. OIG has created a way for you to disclose
that conduct to us, it's called the Provider Self-Disclosure Protocol. I am going to explain
when self-disclosure can be the right decision for your organization and what to expect when
you enter the Protocol. OIG has long believed that timely corrective
action, including self-disclosure, is a key element of an effective compliance program.

We recognize that disclosing issues to the
Government is not an easy decision. But, when you disclose a problem in good faith, you
are demonstrating that your organization has embraced a culture of compliance and is committed
to dealing with the Federal health care programs with integrity. In a disclosure, you get to
work collaboratively with the Government towards a resolution. It may sound odd to say providers
disclosing fraud are able to work collaboratively with the Government, but it can happen when
a provider self-discloses.

That provider is in a very different position than one who
is under investigation because of a whistleblower complaint or other leads. Also, keeping Federal health care program
payments that you should not have can create additional liability under the False Claims
Act and the Civil Monetary Penalties Law. What should you do when you find a problem?
Here are three things to do: First, clarify the issue and confirm that
it is a potential fraud issue. Issues that are only overpayments or innocent mistakes
can be reported to your Medicare contractor through the normal refund process.

Second, consult with a health care attorney
who has experience dealing with the federal health care programs. They will be helpful
in confirming that you in fact have a problem and what your options are for reporting it. Third, decide where to disclose the conduct.
Disclosure to your local US Attorneys' Office may be appropriate depending on the conduct.
Also, CMS has created a disclosure process specifically for Stark Law violations. And
OIG has its Protocol.

Here's how to self-disclose to the OIG: OIG's website has instructions on how to submit
a disclosure. Since we created the Protocol in 1998, many providers have used it. We revised
the Protocol in 2013 to give more guidance on how to properly make a submission. To date,
monetary recoveries have exceeded $280 million dollars.

The most common issues providers disclose
include billing for items or services furnished by excluded individuals, evaluation & management
services and DRG upcoding, duplicate billing, alteration or falsification of records, and
kickbacks & Stark Law violations. How can you make your Protocol resolution
process go smoothly? Here are three pieces of advice: First, think carefully about the timing of
a disclosure to avoid disclosing prematurely. Your internal investigation and damages calculation
either needs to be finished or you need to commit to being done within three months of
your submission. Second, we ask for a lot of specific information
in the submission, including a full description of the conduct.

Please provide it all. Incomplete
submissions may be rejected and may otherwise delay our review process. And third, please respond promptly to requests
for more information. We need, and expect, your cooperation in reaching a resolution
efficiently.

The plan is for all disclosures to end in
a settlement agreement, either a False Claims Act settlement with the Department Of Justice
and OIG, or a Civil Monetary Penalties settlement with OIG. In recognition of coming forward and disclosing
conduct, OIG gives two important incentives. First, providers generally are permitted to
pay a lower settlement amount as compared to providers who do not self-disclose. Second,
the OIG does not require a Corporate Integrity Agreement as long as the provider has fully
cooperated with the disclosure process.

Disclosing a problem and working with the
Government to resolve it in a cooperative way shows that your compliance program is
alive and well in your organization. The saying "actions speak louder than words" rings especially
true here. That is why we have created these two valuable incentives: a lower settlement
amount and presumption against having a CIA, to recognize providers who do the right thing
and have fully embraced a culture of compliance. OIG is committed to working collaboratively
with providers to resolve disclosed conduct.

When we work together, we can strengthen the
integrity of the federal health care programs..

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