{"id":66,"date":"2016-05-12T15:24:35","date_gmt":"2016-05-12T15:24:35","guid":{"rendered":"http:\/\/blogs.luc.edu\/compliance\/?p=66"},"modified":"2016-05-12T15:24:35","modified_gmt":"2016-05-12T15:24:35","slug":"a-new-role-for-compliance-programs-in-hhs-oig-resolutions-of-non-compliant-conduct","status":"publish","type":"post","link":"https:\/\/blogs.luc.edu\/compliance\/?p=66","title":{"rendered":"A New Role for Compliance Programs in HHS-OIG Resolutions of Non-compliant Conduct"},"content":{"rendered":"

Ryan Meade<\/em>
\nEditor-in-Chief<\/em>
\n Director of Regulatory Compliance Studies at Loyola University Chicago School of Law<\/em>
\n<\/strong><\/p>\n

 <\/p>\n

A recent commentary from the U.S. Department of Health & Human Services\u2019 Office of Inspector General (HHS-OIG) indicates it will not consider the existence of an effective compliance program as a positive factor in resolving civil non-compliance but it will count the absence<\/em> of an effective compliance program as a negative factor in the resolution.\u00a0\u00a0http:\/\/www.oig.hhs.gov\/exclusions\/files\/1128b7exclusion-criteria.pdf<\/a>\u00a0 HHS-OIG has gone beyond making compliance programs mandatory through its settlement power.\u00a0 It has sent a clear signal to the health care industry that compliance programs are expected to be as much a part of day to day business as treating employees fairly or making sure elevators work. \u00a0This is a subtle but important new twist on HHS-OIG\u2019s position on compliance programs and surprisingly pivots away from the incentives offered under the Federal Sentencing Guidelines for having effective compliance programs.\u00a0 Under the Federal Sentencing Guidelines (Chapter 8), having an effective compliance program lowers a convicted organization\u2019s culpability score, thereby decreasing criminal penalties.\u00a0 HHS-OIG appears no longer willing to parallel these incentives in their resolutions.<\/p>\n

HHS-OIG has long used its authority to exclude individuals and entities from participation in federal health care programs as leverage to get organizations to adopt compliance programs even when the law does not require them.\u00a0 HHS-OIG\u2019s most frequent approach in resolving serious instances of non-compliance is to ask the organization to adopt a \u201cCorporate Integrity Agreement\u201d (CIA) in exchange for HHS-OIG foregoing the option of excluding the organization from participation in the Medicare and Medicaid programs. \u00a0\u00a0CIAs usually require re-designs in the organization\u2019s compliance programs (or adoption of a compliance program if there isn\u2019t one), stepped up education and auditing, and mandatory outside reviews and monitoring.\u00a0 Since exclusion from federal health care programs effectively closes down a health care provider, HHS-OIG has been hugely successful in getting health care organizations to adopt compliance programs proactively, if for no other reason than to avoid CIAs if there is need to resolve serious non-compliance.<\/p>\n

Not everyone resolving a regulatory matter with HHS-OIG received an offer that allowed them to escape exclusion.\u00a0 Several thousand individuals and organizations have been excluded from participation in federal health care programs since the mid-90s in instances when HHS-OIG thought that their continued participation in federal health care programs posed a high risk to federal funds or federal beneficiaries.\u00a0 Although it has been mostly a guessing game as to whether HHS-OIG would require a CIA, exclude the individual or entity, or give a release with no CIA, clear trends emerged over the years and there were helpful (but non-binding) criteria published in 1997 (See, 62 Fed. Reg. 67,392 (December 24, 1997)) along with a variety of Open Letters from the Inspector General.\u00a0 One trend which seemed to hold was that organizations that demonstrated a strong and effective compliance program were given valuable resolution credit for their efforts at being good corporate citizens.\u00a0 (See for example, HHS-OIG \u201cAn Open Letter to Health Care Providers,\u201d March 9, 2000: \u201cWhen False Claims Act liability results from such a disclosure, the OIG can be more flexible in considering the terms of a CIA in light of the demonstrated effectiveness of the provider’s compliance program.\u201d)<\/p>\n

On April 18, 2016, HHS-OIG rescinded and replaced its 1997 non-binding criteria with a new set of criteria, aptly and plainly named, \u201cCriteria for implementing section 1128(b)(7) exclusion authority.\u201d\u00a0 The statutory reference is to Section 1128 of the Social Security Act (42 U.S.C. 1320a\u20137), which grants the Secretary of HHS permissive authority to exclude individuals and entities for a laundry list of non-compliant conduct.\u00a0 The 2016 criteria set out considerations for how HHS-OIG will assess the level of risk the organization poses to federal health care programs.\u00a0 The level of risk impacts the severity of the resolution.\u00a0 There are four categories of considerations: (1) nature and circumstances of the conduct; (2) conduct during the government\u2019s investigation; (3) significant ameliorative effects; and, (4) history of compliance.\u00a0 It\u2019s the last category\u2019s commentary on compliance programs that has left some people in the compliance industry wondering if this is a turning point moment in health care compliance and the law.<\/p>\n

Important to this discussion is that the 2016 criteria generally identify three ways the various considerations will be used in the government\u2019s risk assessment: (1) indicating less risk to federal health care programs; (2) indicating higher risk to federal health care programs; or, (3) not factoring into the risk assessment.\u00a0 The last category is on the order of \u201cit doesn\u2019t help you or hurt you,\u201d in that even good facts under that consideration are not going to help an organization get a better resolution.\u00a0 Although some considerations in the various criteria are silent as to which of the three impacts the factor will have on the government\u2019s risk assessment of the organization, most of the considerations are grouped into one of these three.<\/p>\n

In the context of the government\u2019s risk calculation, the 2016 criteria address compliance programs under the \u201chistory of compliance\u201d category.\u00a0 HHS-OIG sets out two distinct bullet points about compliance programs on the very last page of the document:<\/p>\n

    \n
  1. \u201cThe existence<\/u> of a compliance program that incorporates the U.S. Sentencing Commission Guidelines Manual\u2019s seven elements of an effective compliance program does not affect the risk assessment<\/u>.\u201d (emphasis added)<\/li>\n
  2. \u201cThe absence<\/u> of a compliance program that incorporates the U.S. Sentencing Commission Guidelines Manual\u2019s seven elements of an effective compliance program indicates higher risk<\/u>.\u201d (emphasis added)<\/li>\n<\/ol>\n

    These two bullets need to be read together.\u00a0 Having an effective compliance program will no longer get a health care provider credit or a lighter resolution (\u201cthe existence\u2026does not affect the risk assessment\u201d), but not having an effective compliance program will count against an organization and suggest a tougher resolution (\u201cthe absence\u2026indicates higher risk\u201d).\u00a0 What HHS-OIG appears to be saying is that compliance programs are now of such a high degree of expectation from the government that having one doesn\u2019t help an organization in negotiating fines, penalties, and releases.\u00a0 In other words, you will not get credit for something you are already expected to be doing.\u00a0 This is not only reinforcing compliance programs as mandatory in the sense of \u201cit must be done,\u201d but also emphasizing that compliance programs are expected to be so common place that having a robust compliance program is not something the government sees as being extraordinary.\u00a0 This is perhaps not an unexpected move in that it is matching industry expectations for compliance programs as being a permanent part of administration, but it is an important shift in thinking from HHS-OIG’s previous view on giving credit for an effective compliance program.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law   A recent commentary from the U.S. Department of Health & Human Services\u2019 Office of Inspector General (HHS-OIG) indicates it will not consider the existence of an effective compliance program as a positive factor in resolving civil non-compliance but it …
    Read more<\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[468,473,522,1030,1470],"class_list":["post-66","post","type-post","status-publish","format-standard","hentry","category-compliance-the-law","tag-compliance","tag-compliance-program","tag-corporate-integrity-agreement","tag-hhs","tag-oig"],"_links":{"self":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/66","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=66"}],"version-history":[{"count":0,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/66\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=66"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=66"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=66"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}