Overpayment Rule Sets 6 Year Lookback

Nearly 6 years after the passage of the Affordable Care Act, CMS published the final 60 day rule for Medicare Parts A and B overpayments. The rule requires a person who has received an overpayment to report and return the overpayment to HHS, the State, an intermediary, a carrier or a contractor within 60 days after the date the overpayment was identified or the due date of any corresponding cost report, as applicable. The final rule is codified at 42 CFR 401.301 – 305; 401.607. Failure to properly identify and return overpayments may lead to liability under the False Claims Act.

The Final Rule sets a 6 year lookback period and clarifies what it means to identify an Overpayment. Prior to publication of the Final Rule, CMS previously published final rules for Medicare Parts C and D. As we previously reported, the New York District Court considered the “identification issue” in Kane v. Healthfirst, Inc. Unlike the Final Rule, the Court in Kane did not allow for quantification of an overpayment prior to commencement of the 60 day clock.

A. Ten Year Lookback Burden ‘Reduced’ to Six Years.

As we described in a February 2012, blog post, CMS initially proposed a ten year lookback period. The final rule eases this burden and requires that an overpayment be reported and returned within six years of receipt of the overpayment. In CMS’s view, “[c]reating this limitation for how far back a provider or supplier must look when identifying an overpayment is necessary in order to avoid imposing unreasonable additional burden or cost on providers and suppliers. Yes, 6 years is better than 10, but CMS declined to adopt a 4 year lookback as contained in the current reopening rules at 42 CFR 405.980. In reaching the 6 year rule, it appears that CMS contemplated burden, statutes of limitation in enforcement statutes, and state law record retention rules that require providers to retain records for 6 or 7 years.

B. Clarification of Meaning of ‘Identification’ of An Overpayment.

When does the 60 day clock start? The ACA provides that an overpayment must be reported and returned by the later of (i) the date which is 60 days after the date on which the overpayment was identified; or (ii) the date any corresponding cost report is due, if applicable. The Final Rule clarifies that “a person has identified an overpayment when the person has, or should have through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment.” 81 Fed. Reg. 7654. Conversely, the Final Rule provides that “a person should have determined that the person received an overpayment and quantified the overpayment if the person fails to exercise reasonable diligence and the person in fact received an overpayment.” 81 Fed. Reg. 7661, 7683. Moreover, it identifies specific examples of where an overpayment may be identified. 81 Fed. Reg. 7659.

1. Reasonable Diligence in Quantifying an Overpayment – The commentary to the Final Rule provides guidance on what constitutes reasonable diligence. In terms of quantifying an overpayment, reasonable diligence is demonstrated “through the timely, good faith investigation of credible information, which is at most 6 months from receipt of the credible information, except in extraordinary circumstances.” Extraordinary circumstances are fact specific but may include unusually complex matters. Reasonable diligence in the Final Rule replaced the concept of “all deliberate speed” in the proposed rule.

2. Reasonable Diligence Through Compliance Activities – Under the Final Rule, reasonable diligence includes both proactive compliance activities conducted in good faith by qualified individuals to monitor for the receipt of overpayments and investigations conducted in good faith in a timely manner by qualified individuals in response to obtaining credible information of a potential overpayment. The Final Rule admonishes the provider and supplier community to engage in meaningful compliance activities:

We believe that undertaking no or minimal compliance activities to monitor the accuracy and appropriateness of a provider or supplier’s Medicare claims would expose a provider or supplier to liability under the identified standard articulated in this rule based on the failure to exercise reasonable diligence if the provider or supplier received an overpayment.

81 Fed. Reg. 7661.

C. Reporting.

A person will satisfy the reporting obligations by making a disclosure under the OIG’s Self-Disclosure Protocol or the CMS Voluntary Self-Referral Disclosure Protocol. Otherwise, providers are required to use “an applicable claims adjustment, credit balance, self-reported refund, or other reporting process set forth by the Medicare contractor to report an overpayment.” Those SRDPs submitted prior to the effective date of the Final Rule will still be governed by the 4-year lookback period. Going forward the 6-year look back period will apply, though CMS still needs to modify this period with the OMB with regard to the financial analysis they are allowed to collect under the Paperwork Reduction Act. Therefore, at this point providers may voluntarily provide information for the 5th and 6th year. 81 Fed. Reg. 7673.

D. Conclusion.

In light of the Final Rule, providers should evaluate their compliance and auditing activities and evaluate the extent to which they could demonstrate “reasonable diligence.” In general, providers should work diligently to quantify and report overpayments by no later than 8 months (6 months to quantify, 2 months to report).

Adam Snyder is Chair of the Ogden Murphy Wallace Business Department and is a Part-time/Adjunct Faculty member of the University of Washington School of Law. For additional information regarding the Medicare 60 Day Overpayment Rule, Corporate Compliance, or internal investigations, please contact Adam Snyder.

CMS Issues Stark Law Changes

CMS issued last week its final rule modifying the Physician Self-Referral Law aka the Stark Law putting into place most of what it proposed to modify this summer. The majority of the new modifications become effective on January 1, 2016, though CMS indicates that many of the changes are just clarifications of existing application of the Stark Law.

Highlights of Some Proposed Revisions

The below list is not an all-inclusive list of the revisions to the Stark Law, but highlights some of the more substantial changes.

Temporary Noncompliance with Signature. Following the confusion between what was considered inadvertent and not inadvertent, CMS has modified this rule to allow the temporary noncompliance with the signature requirements for up to 90 days following the date of noncompliance regardless of the parties’ intention for not signing earlier.

Remuneration. The definition of remuneration has been revised to more clearly specify that certain items, devices, or supplies related to the collection, transportation, etc. of specimens are excluded from the definition of remuneration if used solely for one or more of such testing/specimen collection purposes.

Arrangement vs. Agreement. CMS clarifies in several of the exceptions (i.e personal services, leases, physician recruitment, etc.) that the requirement that the arrangement be set out in writing does not require a single formal contract but rather that several documents may establish sufficient documentation to satisfy the writing requirements. Examples of supplementary contemporaneous documents may include communications between the parties, check requests or invoices, time sheets, and call coverage schedules. Further examples are described within the final rule.

Holdover Provision. Prior to this final rule, the personal service arrangement, rental of office space and rental of equipment exceptions permitted a holdover arrangement for up to 6 months. CMS has modified these provisions to permit indefinite holdovers, provided that the arrangement continues on the same terms and conditions as the original arrangement.

Recruitment of Non-Physician Practitioners. CMS has added a new exception allowing a hospital (FQHC and RHC) to provide remuneration to a physician to compensate for non-physician practitioners if certain conditions are met (including cap of 50% of remuneration paid to non-physician practitioner and restriction on using the exception with the same referring physician only once every 3 years). Such non-physician practitioners include clinical psychologists and social workers, physician assistants, nurse practitioners, clinical nurse specialists and certified nurse midwives.

Timeshare Arrangements. CMS created a new exception for timeshare lease arrangements, which includes both space and equipment (supplies, items, services, etc.). The space/equipment must be predominately used for E/M services and remain on the same schedule. The equipment in the space must also be located in the same building as where the E/M services are furnished, not used to furnish DHS other than those incidental to E/M services furnished at the time of the patient’s visit and not include advanced imaging equipment, radiation therapy equipment or clinical & pathology lab equipment (other than CLIA waived tests).

The changes that relax some of the signature, holdover and writing requirements are consistent with CMS’ experience with SRDP submissions. Further the new exceptions recognize some of the changes in the delivery of patient care (such as non-physician providers and timeshare arrangements).  If you have questions about any of these modifications or the Stark Law in general please contact Elana Zana.

 

 

 

SRDP Settlement: Improper EHR Donation Arrangement Among Violations

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.

OIG Issues Updated Self-Disclosure Protocol

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.

 

CMS Proposed Rule on Overpayments – A 10 Year Burden

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.