OIG Invitation To Comment On Possible Changes To Provider Self-Disclosure Protocol Invaluable Opportunity To Provide Feedback

Health care providers and other interested persons have until to submit recommendations and other input in response to the Solicitation of Information and Recommendations for Revising OIG’s Provider Self-Disclosure Protocol (“RFR”) published by the Department of Health & Human Services (HHS) Office of Inspector General (OIG) on June 20, 2012 here.  Prompt response to this invitation by the August 17, 2012 deadline established by OIG provides a valuable opportunity for health care providers and others who have concerns or other perspectives about the current Protocol as used by the OIG in connection with its enforcement of federal health care fraud laws. 

Protocol Intended To Be Tool To Resolve Civil Monetary Penalty & Other Health Care Fraud Exposures

While OIG touts the Protocol as a valuable tool to providers for resolving certain health care fraud exposures through self-disclosure, physicians, hospitals and other health care providers often are critical of the Protocol and its application by the OIG for deterring self-disclosure by providers by being unduly punitive to providers using the protocol to self-report and self-correct potential violations.

Originally published by OIG in 1998, the Protocol as later supplemented by a series of letters to providers currently defines the opportunity that OIG offers to health care providers to disclose potential fraud to resolve Civil Monetary Penalty and federal health care fraud exposures under Federal law through self-disclosure.  

The potential liability exposures for health care providers accused of running afoul of these federal health care fraud laws are substantial and growing.   Under the Civil Monetary Penalties Law (“CMPL”), 42 U.S.C. § 1320a-7a, and other provisions of the Social Security Act, health care providers face significant criminal and civil risk for violation of federal health care fraud laws.  Among other things, risk the assessment of CMPs, exclusion from participation in all Federal health care programs or both if they knowingly and willfully:  

  • Offer or pay remuneration to induce the referral of or solicit or receive remuneration in return for the referral of Federal health care program business in violation of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b));
  • Present or cause to be presented a claim that the person knows or should know is for a service for which payment may not be made under 42 U.S.C. § 1395nn, the physician self-referral or “Stark” law. 42 U.S.C. § 1395nn(g)(3); or
  • Engage in certain other prohibited activities under federal healthcare fraud laws.

For an Anti-Kickback violation, the OIG may seek a penalty of up to $50,000 for each improper act and damages of up to three times the amount of remuneration at issue (regardless of whether some of the remuneration was for a lawful purpose). 42 U.S.C. § 1320a-7a(a).   With the federal government expanding fraud enforcement and tightening federal anti-fraud laws as part of its broader effort to control federal health care spending, OIG and other federal regulators are stepping up enforcement of these and other federal health care laws.  OIG touts the Protocol as offering a valuable opportunity for health care providers to resolve potential health care fraud liabilities by self-disclosing under the Protocol.

The Protocol provides guidance on how to investigate this conduct, quantify damages, and report the conduct to OIG to resolve the provider’s liability exposure under OIG’s civil money penalty (CMP) authorities.  Since its original publication in 2009, OIG has supplemented its guidance by issuing three Open Letters to Health Care Providers to supplement and clarify the Protocol and its application, including:

  • In 2006 announcing an initiative to encourage disclosure of conduct creating liability under OIG’s ant kickback and physician self-referral law CMP authorities.
  • In 2008, issuing additional guidance and requirements for Protocol submissions to increase the efficiency of the Protocol, including new requirements for the initial submission and specific time commitments from the provider, as well as announcing he presumption of not requiring a compliance agreement as part of settling a cooperative and complete disclosure.
  • In 2009, announcing it would no longer accept disclosure of a matter into the Protocol that involved only liability under the physician self-referral law in the absence of a colorable anti-kickback violation and announcing a minimum $50,000 settlement amount for kickback-related submissions.

You can review this guidance governing the Protocol here and see examples of past settlements under the Protocol here.

Many Providers, Industry Leaders Express Concerns About Protocol

OIG characterizes the Protocol as offering health care providers “specific steps, including a detailed audit methodology, that may be undertaken if they wish to work openly and cooperatively with the OIG to efficiently quantify a particular problem and, ultimately promomote a higher level of ethical and lawful conduct throughout the health care industry.  In the RFR, OIG credited the Protocol with allowing OIG to resolve over 800 disclosures resulting in recovering over $280 million to the Federal health care programs over the past 14 years.  In the RFR, OIG reports that it believes this experience reflects the Protocol to be a highly valuable tool, which added and refined guidance would strengthen to the benefit of the provider community and the efficient resolution of Protocol matters. OIG now is announcing plans to further revise the Protocol to provide additional guidance.  Accordingly, OIG is soliciting comments, recommendations, and other suggestions from concerned parties and organizations on how best to revise the Protocol to address relevant issues and to provide useful guidance to the health care industry. 

For providers with concerns about the Protocol and its value to providers as a tool for resolving health care fraud, the invitation should provide a welcome opportunity for feedback.  While OIG perceives the Protocol with these later refinements as a valuable tool to OIG and providers in identifying and resolving known or suspected health care fraud, stiff penalties and restrictions on the Protocol have engendered widespread criticism of the Protocol by many providers and health industry advisors.   See, e.g. Voluntary Disclosure-Look before You Leap; HHS Office of Inspector General Sweetens Its Self-Disclosure Protocol.  For these and other reasons, many health care providers and health industry advisors view the Protocol as now configured and applied as counterproductive to its stated goals.  Critics often argue that the punishment of self-reporting providers discourages self-reporting and self-correction by providing too little reward and almost certain punishment to providers who chose the self-correction path.

Although OIG’s expectations about the Protocol and opportunities for improvement and those of many providers may be widely disparate, all parties with concerns or other opinions are urged to share their input in response to the RFR.  The RFR invitation provides an invaluable opportunity both to share feedback with OIG, as well as to create a record of concerns that would be available to share with members of Congress and other leaders to the extent the OIG fails to adequately address these concerns.

For More Information Or Assistance

For help in responding to the RFR; reviewing and updating your Stark Law, Anti-Kickback Statute, or other health care compliance and risk management policies, practices or programs; assessing the strength of your organizations existing risk management and compliance controls under these laws or other healthcare laws and regulations; or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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©2012 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

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