Disclosures to the Government:

Transcription

1 Disclosures to the Government: Whether, Where, When, Why and What to Expect Dallas Bar Association Health Law Section January 16, 2019 Frank Sheeder, Partner Alston & Bird LLP What We Will Cover Legal and strategic considerations Federal and Texas disclosure options Practical approaches Alston & Bird LLP

2 Alston & Bird LLP Practical Reasons to Disclose Preserve organization s reputation Avoid potential whistleblower litigation Mitigate risk Minimize business disruptions Alston & Bird LLP

3 Statutory Reasons to Disclose FERA (2009) expands FCA reverse false claims provision: knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government. obligation is an established duty, whether or not fixed, arising from the retention of any overpayment. ACA (2010) adds 60-day report and return obligation: Recipients of Medicare and Medicaid funds who have received an overpayment must report and return overpayments. UnitedHealthcareIns. Co. v. Azar Other potential consequences Civil Monetary Penalties Exclusion Alston & Bird LLP The Morass of When to Disclose FCA reverse false claim provision applies to all government-funded programs 60-day report and repay obligation is in ACA and CMS regulations Trigger: when provider has determined and quantified provider after reasonable diligence Reasonable diligence: includes proactive compliance and timely investigations CMS guidance allows up to 6 months to investigate potential Medicare Part A and B overpayments How to address reimbursements from these payors, and how long do you have? Medicaid Managed Medicaid Medicare Advantage Part D TriCare/CHAMPUS, VA FEHBP Alston & Bird LLP

4 Common Examples of What to Disclose Billing standards not met Services provided by excluded or unlicensed provider Falsification of records Anti-Kickback Statute violation (in some circumstances) Stark violations Anything else for which a release might be needed Other regulatory non-compliance Alston & Bird LLP Where to Disclose Department of Health and Human Services Office of Inspector General (HHS-OIG) Violation of federal law with CMP liability But not pure Stark Law violations Centers for Medicare and Medicaid Services (CMS) Stark Law violations Texas Medicaid Inspector General Others? Medicare contractor (no release) Medicaid MCO Department of Justice Corporate integrity agreement monitor Alston & Bird LLP

5 HHS-OIG Self-Disclosure Protocol Factual summary Specifically identify statutes or rules that were violated Estimate damages Explain corrective actions Identify individual who can enter into settlement Certification No repayment pending investigation Alston & Bird LLP HHS-OIG Self-Disclosure Protocol What to disclose Stops 60-day clock Liability Lower damages multiplier (1.5x) Limits reverse false claims liability But OIG may report and DOJ can still prosecute Presumption against CIA Must fully disclose and cooperate in process Burdensome process Alston & Bird LLP

6 CMS Self-Referral Disclosure Protocol Use CMS forms Factual summary Specifically identify statutes or rules that were violated Estimate damages Explain corrective actions Certification 6-year lookback Alston & Bird LLP CMS Self-Referral Disclosure Protocol Report violations of Stark law only Stops 60-day clock Liability Limits reverse false claims liability CMS will consider lower damages multiplier But OIG may report and DOJ can still prosecute Failure to cooperate may increase penalties Burdensome process Alston & Bird LLP

7 Disclosure to Texas Medicaid Inspector General The IG endeavors to have a provider-friendly approach May avoid or mitigate enhanced damages, fines, etc. Relationships matter Reputation matters Must be candid and fully cooperative The IG is willing to resolve amounts owing to Medicaid MCOs There are some uncertainties with this approach May not get comprehensive releases Alston & Bird LLP Disclosure to Other Agencies Department of Justice Has authority to settle most claims (FCA, CMP) But no defined process for self-reporting Medicaid: many states have their own reporting requirements Medicaid MCOs Medicare contractors (for honest mistakes) Corporate monitor (for CIA violations) Alston & Bird LLP

8 Practical Considerations Benefits of disclosure Risks of disclosure Timing issues When did you identify an overpayment (notice and reasonable inquiry) How long to investigate Alston & Bird LLP Practical Considerations Deciding to report Building internal consensus with stakeholders Develop publicity and internal communications strategies Who do you report to HHS-OIG CMS State agency/medicaid Others Problems that arise after reporting Protracted investigation Internal complaints New matters Alston & Bird LLP

9 Practical Considerations Scoping issues What payors to review What providers review Do you investigate related issues Lookback period What documentation, coding, and reimbursement standards apply Who to involve Compliance In-house counsel Outside counsel External auditors Financial/billing experts Alston & Bird LLP Practical Considerations Documenting your investigation Establish a work plan at outset of investigation Document what you did and what you chose not to investigate (and why) Privilege and work product Benefits and drawbacks of conducting an investigation under privilege When to waive privilege Scope of privilege waiver Alston & Bird LLP

10 Closing Thoughts Disclosures are at an all time high Have a plan before you start Anticipate the end game Know internal factors and stakeholders Know your external audience Partner with people who have been through it before Alston & Bird LLP Connecting Alston & Bird LLP

11 Disclosures to the Government: Whether, Where, When, Why and What to Expect Frank Sheeder, Partner Alston & Bird LLP