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The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a final rule implementing its statutory authority under the Affordable Care Act (ACA) to expand the exclusion regulations applicable to persons or entities receiving funds, directly or indirectly, from federal health care programs.

Specifically, the final rule expands OIG’s…

On January 12, 2017, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a final rule to expand the exclusion regulations applicable to persons or entities receiving funds, directly or indirectly, from federal health care programs (“Final Rule”).  The Final Rule, which implements Affordable Care Act authority, …

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff…

The HHS Office of Inspector General’s (OIG) latest Semiannual Report to Congress highlights top audits, investigations, and enforcement activities for the period of April 1 to September 30, 2016 and summarizes overall accomplishments for fiscal year (FY) 2016. Notably, the OIG reports:

  • Expected FY 2016 recoveries will exceed $5.66 billion, including nearly $1.2 billion in

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The OIG has issued its Spring 2016 Semiannual Report to Congress, which describes significant enforcement and investigative activities relating to HHS programs during the first half of FY 2016 (October 1, 2015 – March 31, 2016). The OIG reports expected recoveries of more than $2.77 billion ($554.7 million in audit receivables and about $2.22…

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued new, non-binding “Criteria for Implementing Section 1128(b)(7) Exclusion Authority” updating the factors OIG will consider in deciding whether to exclude persons “whose continued participation in the [federal health care programs] constitutes a risk to the programs and their beneficiaries.”  These are generally persons who have defrauded Medicare or another health care program in some way, such as being held liable under the False Claims Act.  OIG imposes a rebuttable presumption in favor of exclusion against persons who have committed health care fraud.  The new criteria, issued on April 18, 2016, describe the factors OIG will weigh in determining whether such a person falls on the high end of the compliance risk spectrum, thereby posing a continued risk to the federal health care programs and favoring exclusion, or on the low end of the spectrum, thereby making an alternative sanction more appropriate.
Continue Reading OIG Issues New Criteria for Implementing its Section 1128(b)(7) Exclusion Authority

On March 1, 2016, CMS is publishing a proposed rule that would make a variety of changes to the Medicare, Medicaid, and CHIP provider and supplier enrollment requirements.  CMS believes that the proposal would assist in ensuring that individuals and entities posing risks to federal health care programs are removed or temporarily/permanently barred from participation in such programs.  Comments regarding the proposed rule will be accepted for 60 days after publication.

Notably, the proposed rule would implement an Affordable Care Act (ACA) provision requiring certain providers and suppliers to disclose if they have any current or previous direct or indirect affiliations (as defined in the rule) with a provider or supplier that:  has uncollected debt; has been or is subject to a payment suspension under a federal health care program; has been excluded from Medicare, Medicaid or CHIP; or has had its Medicare, Medicaid or CHIP billing privileges denied or revoked.  Under the ACA, the Secretary is permitted to deny enrollment based on an affiliation that the Secretary determines poses an “undue risk” of fraud, waste or abuse.  The proposed rule enumerates the factors that would be considered in such a determination, such as the duration and extent of the affiliation and the nature of the affiliated party’s disclosable event.  CMS proposes a 5-year “look-back” period for determining previous affiliations (as of the date the enrollment application is submitted).

The proposed rule also would authorize the Secretary to: …
Continue Reading CMS Proposes Program Integrity Enhancements to the Provider/Supplier Enrollment Process, including New Affiliated Provider Disclosure Requirements

The OIG has released its Medicaid Fraud Control Units (MFCU) Fiscal Year 2014 Annual Report, which highlights statistical achievements of the 50 MFCUs nationwide, along with related OIG oversight activities. With regard to criminal cases, the report notes:

  • MFCUs reported 1,318 criminal convictions, most frequently involving home health care aides, certified nursing aides, and other medical

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The OIG published a notice today announcing that it is extending the public comment period on its July 11, 2014 notice soliciting recommendations for revising OIG’s non-binding criteria for implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act.  The OIG notes that due to a technical problem, the public may have been unable to…

The OIG published a notice July 11, 2014 announcing that it is considering revising its nonbinding criteria, established in 1997, outlining the circumstances under which the OIG may exercise its permissive authority under Section 1128(b)(7) of the Social Security Act to exclude an individual or entity from participation in the federal health care programs for…

The OIG has issued its spring Semiannual Report to Congress, which summarizes major OIG activities during the period of October 2013 through March 2014. The OIG highlights “ramped up” oversight of Affordable Care Act implementation efforts, particularly with regard to eligibility systems, payment accuracy, contractor oversight, and data security associated with the Health Insurance…

On the heels of its proposed rule to expand its health program exclusion authority, the Office of Inspector General (OIG) of the Department of Health and Human Services has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations. The rule would codify the OIG’s expanded statutory authority under the Affordable Care Act to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios, some of which could extend beyond what is currently permitted.

Reed Smith attorneys have prepared a Client Alert summarizing and analyzing the OIG’s proposed rule, including the various scenarios under which CMPs could be issued under the proposed regulations, such as: failure to report and return an overpayment; failure to grant OIG timely access to records upon request; ordering or prescribing items or services while excluded from a federal health care program, as well as arranging or contracting with an individual or entity who meets this criteria; making false statements or omitting or misrepresenting material facts in an application, bid, or contract; and failing to submit or certify drug-pricing and product information in a timely manner. In addition, the alert covers the changes in technical language proposed by OIG to clarify and more clearly define the scope of CMP regulations.
Continue Reading OIG Proposed Rule Would Expand Civil Monetary Penalty Authority