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Recent Developments in Health Law

The OIG Means Business This Time: The Increasing Use of Strict Liability in Excluding Pharmaceutical Executives from Federal Health Care Programs

Published online by Cambridge University Press:  01 January 2021

Extract

In the past several years, the Office of Inspector General (OIG), the branch of the Department of Health and Human Services that combats fraud and abuse, has begun enforcing a little-used provision that allows the government to exclude owners and managers of sanctioned entities based on their position in the company. The OIG's exclusion authority under 42 USC § 1320a-7(b)(15) is not unique in applying strict liability to individual executives as a tool to halt corporate misconduct, but it represents a startling change for health care executives who could now face exclusion for their company's misdeeds. While the OIG has expanded its use of this statute, it has indicated some hesitancy in exercising the full scope of its statutory power.

Pursuant to §1128 and §1156 of the Social Security Act, the OIG can exclude individuals and entities from participating in federal healthcare programs. The OIG has both mandatory and permissive exclusion power, based on the circumstances of the offense.

Type
JLME Column
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

U.S. Department of Health and Human Services, Office of Inspector General, “Exclusions Program,” available at <http://oig.hhs.gov/exclusions/index.asp> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
Id. The OIG has permissive exclusion authority over: “misdemeanor convictions related to healthcare fraud other than Medicare or a State health program, fraud in a program (other than a healthcare program) funded by any Federal, State or local government agency; misdemeanor convictions relating to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances; suspension, revocation, or surrender of a license to provide healthcare for reasons bearing on professional competence, professional performance, or financial integrity; provision of unnecessary or substandard services; submission of false or fraudulent claims to a Federal healthcare program; engaging in unlawful kickback arrangements; and defaulting on health education loan or scholarship obligations; and controlling a sanctioned entity as an owner, officer, or managing employee.” Office of Inspector General, Exclusions Program, available at <http://oig.hhs.gov/exclusions/index.asp> (February 2, 2012).+(February+2,+2012).>Google Scholar
U.S. Department of Health and Human Services, Office of Inspector General, The Effect of Exclusion From Participation in Federal Health Care Programs, September 1999, available at <http://oig.hhs.gov/exclusions/effects_of_exclusion.asp> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
U.S. Department of Health and Human Services, Office of Inspector General, Exclusions Program, available at <http://oig.hhs.gov/exclusions/index.asp> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
See U.S. Department of Health and Human Services, supra note 4.Google Scholar
42 USC § 1320a-7(b)(15).Google Scholar
Managing employee is defined in this section as “an individual, including a general manager, business manager, administrator, and director, who exercises operational or managerial control over the entity, or who directly or indirectly conducts the day-to-day operations of the entity.” 42 USCS § 1320a-5(b).Google Scholar
42 USC § 1320a-7(b)(15).Google Scholar
42 USC § 1320a-7(b)(15).Google Scholar
United States v. Park, 421 U.S. 658, 670.Google Scholar
United States v. Park, 421 U.S. 658, 670.Google Scholar
Id., at 671.Google Scholar
Id., at 672.Google Scholar
Id., at 668, citing United States v. Dotterweich, 320 U.S. 277, 280.Google Scholar
See Lawrence, supra note 3.Google Scholar
Gibson, Dunn, & Crutcher LLP, “‘Clawbacks’ of Executive Compensation,” July 9, 2008, at <http://www.gibsondunn.com/publications/Pages/ClawbacksOfExecutiveCompensation.aspx>..>Google Scholar
Mundy, A., “U.S. Effort to Remove Drug CEO Jolts Firms,” Wall Street Journal, April 26, 2011, available at <http://online.wsj.com/article/SB10001424052748704123204576283283851626952.html> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
Testimony of Lewis Morris, House Committee on Ways and Means, Subcommittee on Oversight, March 2, 2011, available at <http://oig.hhs.gov/testimony/docs/2011/morris_testimony_03022011.pdf> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
See Mundy, , supra note 19.Google Scholar
See Testimony of Lewis Morris, supra note 20.Google Scholar
Armstrong, W., “Crackdown on the C-Suite,” Pharmaceutical Executive, June 1, 2010, available at <http://pharmexec.findpharma.com/pharmexec/Strategy/Crackdown-on-the-C-Suite/ArticleStandard/Article/detail/676059> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
See Testimony of Lewis Morris, supra note 20.Google Scholar
However, the executives at Purdue Pharmaceuticals have challenged the lack of judicial or administrative review after they were convicted of fraud under the responsible corporate officers doctrine. See Heisey, C. Gucciardo, D. C., “Guidance on Permissive Exclusion Authority,” September 2011, available at <http://www.hunton.com/files/Publication/568e6b8c-3318-44a2-a88a-17835b01d6b9/Presentation/PublicationAttachment/be33e72c-a78f-4929-b03d-1f72e10539f7/FDAWatch_ContractPharma_September_2011.pdf> (last visited February 2, 2012). While they were not excluded under (b)(15), other bases for exclusion are similarly unreviewable, and the Purdue executives are challenging the OIG's general power to exclude people without oversight.+(last+visited+February+2,+2012).+While+they+were+not+excluded+under+(b)(15),+other+bases+for+exclusion+are+similarly+unreviewable,+and+the+Purdue+executives+are+challenging+the+OIG's+general+power+to+exclude+people+without+oversight.>Google Scholar
“Strengthening Medicare Anti-Fraud Measures Act of 2011,” available at <http://www.stark.house.gov/images/stories/112/press/fraudlegislation.pdf> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
U.S. House of Representatives (California).Google Scholar
“Herger, Stark Reintroduce Bipartisan Bill to Fight Medicare Fraud,” February 2, 2011, available at <http://herger.house.gov/index.php?option=com_content&task=view&id=778&Itemid=112> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
Thomas, Library of Congress, Bill Summary & Status, available at <http://thomas.loc.gov/cgi-bin/bdquery/z?d112:h.r.00675:> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
U.S. Department of Health and Human Services, Office of Inspector General, “Exclusion Types,” available at <http://exclusions.oig.hhs.gov/ExclusionType-Counts.aspx> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
In 2008, the OIG excluded 3 former executives of Purdue Frederick, based on their status as responsible corporate officers, for their convictions resulting from the pharmaceutical company's misbranding of the painkiller Oxycontin. See Morris testimony. The executives have appealed their exclusion (which was under §1320(a)(7) (b)(1) and (b)(3)). See Heisey, Gucciardo, , supra note 27. These convictions (under 42 U.S.C. § 1128(b)(1) and 42 U.S.C. § 1128(b)(3)) were upheld by the US District Court for the District of Columbia in Friedman, et al., v. Sebelius, Civil Action No. 09–2028 (D.C. Dec. 13, 2010).Google Scholar
“Trio of Insurers File Largest No-Fault Lawsuit in N.Y. History,” Insurance Journal, December 4, 2003, available at <http://www.insurancejournal.com/news/east/2003/12/04/34694.htm> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
“PTs Charged with Medicare/Medicaid Fraud,” Advance, May 13, 2002, available at <http://physical-therapy.advanceweb.com/Article/PTs-Charged-With-MedicareMedicaid-Fraud.aspx> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
Michael A. Cox, ex rel People of the State of Michigan v. Rhea A. Zagerman and Zagerman Enterprise, Inc., Settlement Agreement, 2004, available at <http://www.michigan.gov/documents/ag/rhea.2002092391_276284_7.pdf> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
Testimony of Lewis Morris, House Committee on Ways and Means, Subcommittee on Oversight, March 2, 2011, available at <http://oig.hhs.gov/testimony/docs/2011/morris_testimony_03022011.pdf> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
Whittington, J. Harris, A., “Ex- KV Pharmaceutical CEO Hermelin Pleads Guilty to Drug Label Law Breach,” Bloomberg, March 10, 2011, available at <http://www.bloomberg.com/news/2011-03-10/ex-kv-pharmaceutical-ceo-hermelin-pleads-guilty-to-drug-label-law-breach.html> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
“Forest Firing,” The Economist, May 5, 2011, available at <http://www.economist.com/node/18651821?story_id=18651821> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
See Lawrence, , supra note 3.Google Scholar
United States Securities & Exchange Commission, Schedule 14A, August 5, 2011, available at <http://www.sec.gov/Archives/edgar/data/38074/000095012311073903/y92213kdefa14a.htm> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
See Armstrong, , supra note 24.Google Scholar
Mundy, A., “U.S. Drops Effort to Oust Forest Labs CEO,” Wall Street Journal, August 6, 2011, available at <http://online.wsj.com/article/SB10001424053111903885604576490631294926432.html> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
“Kathleen Spitzer,” Wall Street Journal, May 2, 2011, available at <http://online.wsj.com/article/SB10001424052748703655404576293232066996982.html?mod=WSJ_newsreel_opinion> (last visited February 2, 2012).+(last+visited+February+2,+2012).>Google Scholar
See “Forest Firing,” supra note 46.Google Scholar