SRDP Settlement: Improper EHR Donation Arrangement Among Violations

August 8, 2013 By

Last month CMS settled several violations of the self-referral statute (aka Stark Law) with an Ohio hospital, including a failure to appropriately structure a donation arrangement for electronic health records (EHR) .  The hospital disclosed under the Self-Referral Disclosure Protocol that it may have violated the Stark Law with regard to several arrangements with certain physicians, including arrangements for EKG interpretations, medical director services, Vice-Chief of Staff services, and hospital services (no specifics provided in CMS release).  The settlement was for $265,565.  The SRDP, which was included in the ACA, was created as a mechanism for providers to self-report potential Stark law violations.

The EHR donation arrangement to the Stark and Anti-Kickback laws permits hospitals to enter into certain arrangements with physicians for the donation of EHR related software and services.  The donation arrangement exception is scheduled to expire on December 31, 2013, however CMS has proposed extending the exception through 2016.  If CMS does not extend the exception, existing donation arrangements will have to convert to fair market value for shared technology and services.

If you have questions regarding the SRDP or structuring a EHR donation arrangement please contact Elana Zana.

Filed Under: Anti-Kickback/Stark, EHR, Hospitals, SRDP Tagged With: , ,

OIG Issues Updated Self-Disclosure Protocol

April 17, 2013 By

The OIG recently issued an update to its self-disclosure protocols to supply providers with additional guidance for self-disclosure.  In touting the benefits of self-disclosure, the OIG update notes that it now rarely requires integrity agreements in conjunction with self-disclosure settlement, it’s damage multiplier may be as low as 1.5, and the self-disclosure may stop the sixty (60) day clock running on potential False Claims Act liability.

The updated protocols emphasize that not every billing error is eligible for or should be reported under these protocols.  Reporting is limited to matters that may potentially violate federal laws for which civil monetary penalties are authorized.  Thus, for example, if you should discover that you may not have met all the criteria for provider based billing in an off campus clinic, you may have billing errors, but properly and promptly addressed, these do not invoke civil monetary penalties.

Recognizing that conduct for which civil monetary penalties are authorized also may be conduct that violates the Stark law, the updated protocols have a separate section providing guidance for disclosing arrangements that potentially violate both anti- kickback and Stark laws.  Arrangements that potentially violate both anti-kickback and Stark laws should be disclosed under the OIG protocol and not under the CMS stark self-disclosure protocol.  Of note in comparison to the CMS self-disclosure protocol for potential Stark violations, the updated OIG protocol is very clear that the self-disclosure submittal  must clearly acknowledge that the disclosed arrangement constitutes a potential violation of the anti-kickback and Stark laws.

As part of its on-going quarterly lunch time webinar series, the Ogden Murphy Wallace Healthcare Practice Group will provide a presentation on self-disclosure options and avoidance of state and federal false claims act liability in its June 2013 webinar (to register click here).  If you have questions regarding these updated protocols or self-disclosure and overpayments in general please contact Greg Montgomery.

 

Filed Under: Compliance, OIG, SRDP, Stark

CMS Proposed Rule on Overpayments – A 10 Year Burden

February 21, 2012 By

CMS recently published its proposed rules on reporting and returning overpayments.  These rules are intended to implement the 60 day overpayment reporting requirement pursuant to the Affordable Care Act (the “ACA”).  The ACA created a new section 1128J(d) of the Social Security Act requiring a person who receives an overpayment to return and report the overpayment to HHS, the State, a carrier or a contractor and notify the recipient of the reason for the overpayment.  The statute requires that all  overpayments be refunded within 60 days after the date the overpayment was identified or the date of any corresponding cost report (as applicable), whichever is later.

The proposed regulations only relate to Medicare Parts A and B.  Medicaid, Medicare Advantage, Part D, and managed care organizations are not covered by the proposed rules; however, the 60 day shot clock noted in the statute still applies.

Reporting Overpayments

The proposed rules rename the current voluntary refund process the “self-reported overpayment refund process” (described more fully in the Medicare Financial Management Manual).  Providers will use voluntary refund forms currently on the websites of their Medicare contractors.  Reports of overpayments will require the inclusion of the following information:

1)      Name;

2)      TIN;

3)      How the error was discovered;

4)      The reason for the overpayment;

5)      The health insurance claim number, as appropriate;

6)      Date of service;

7)      Medicare claim control number, as appropriate;

8)      NPI;

9)      Description of the corrective action plan to ensure the error does not occur again;

10)   Whether the person has a corporate integrity plan with the OIG or is under the OIG Self-Disclosure Protocol;

11)   The timeframe and the total amount of the refund for the period during which the problem existed that caused the refund;

12)   If a statistical sample was used to determine the overpayment amount, a description of the statistically valid methodology used to determine the overpayment; and

13)   A refund in the amount of the overpayment.

Under the proposed rules, providers are required to report the overpayment within 60 days of identification and refund the overpayment within the same 60 day period.  Providers may request a refund extension through the extended repayment schedule.  A person has “identified” an overpayment if that person has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the existence of the overpayment.  Providers who retain an overpayment after the 60 day deadline for reporting and returning the overpayment are liable under the False Claims Act.  Additionally, any person who knows of an overpayment and does not report and return the overpayment may be found liable for Civil Monetary Penalties and excluded from participation in federal health care programs.

Significantly, the proposed rules also set a lookback period of 10 years, meaning that if a provider identifies an overpayment within 10 years of the date the overpayment is received it will have to report and refund such overpayment.

SRDP and OIG Self-Disclosure Protocol

CMS attempts to reconcile these proposed regulations with the OIG Self-Disclosure Protocol and the new CMS Self-Referral Disclosure Protocol (“SRDP”) (which allows reports of Stark Law violations).  The reconciliation falls flat and creates confusion which will hopefully be remedied in the final rule.

The 60 day deadline for returning overpayments will be suspended if the OIG acknowledges receipt of submission to the OIG Self-Disclosure Protocol.  This suspension will last until a settlement agreement is entered, the person withdraws from the OIG Self-Disclosure Protocol, or the person is removed from the OIG Self-Disclosure Protocol.  Additionally, a person satisfies the reporting requirements listed above by making a disclosure under the OIG Self-Disclosure Protocol which results in a settlement agreement.

Similarly, the 60 day deadline for returning overpayments is suspended if CMS acknowledges receipt of a submission to the SRDP until such time as a settlement agreement is entered, a person withdraws from the SRDP, or the person is removed from the SRDP.  However, the reporting requirement described above is not tolled by submission to the SRDP.

Conclusion

Regardless of these proposed rules, providers must currently report and refund overpayments within 60 days per the ACA.  CMS has opened public comment on these proposed rules through April 16, 2012.  If you would like assistance on drafting comments or assistance with reporting an overpayment please contact Don Black or Elana Zana.

Filed Under: Anti-Kickback/Stark, Health Reform, Medicare, OIG, SRDP, Stark