HHS OIG Release of New “General Compliance Program Guidance” Provides Valuable Insight on Prevention of Health Care Fraud, Waste, and Abuse

By Michelle E. Missigman, J.D.
On November 6, 2023, the U.S. Department of Health and Human Services (HHS), Office of the Inspector General (OIG), released 91 pages of “General Compliance Program Guidance” (GCPG) on its website.  This is the first compliance program guidance the OIG has released since 2008.  The GCPG provides general compliance guidance, tools, and references for use by federal health care program providers.
This new guidance brings together many resources and links, making it a valuable and easy-to-read tool to keep on hand for any professional working within the healthcare industry.
The GCPG covers the following topics:
I.  Introduction
The GCPG  provides a thorough introduction to the OIG’s history and commitment to preventing health care fraud an abuse.  It provides a roadmap for how the OIG intends to modernize and improve its publicly available resources.  The OIG’s goal is to continue producing these resources, deliver information to the public in a user-friendly approach using modern technology, and produce informative and useful resources to help advance the health care industry’s compliance efforts in preventing fraud, waste, and abuse.
II.  Health Care Fraud Enforcement
The GCPG provides a broad overview of federal healthcare fraud enforcement standards and laws,  such as: the anti-kickback statute, physician self-referral law, false claims act, civil monetary penalties, exclusions from federal programs, criminal health care fraud statute, HIPAA privacy and security rules.
III.  Seven Elements of a Successful Compliance Program
The largest section of the GCPG reinforces and provides a thorough explanation of the seven elements of an effective compliance program:
1.  Written Policies and Procedures
2.  Compliance Leadership and Oversight
3.  Training and Education
4.  Effective Lines of Communication with the Compliance Officer and Disclosure Programs
5.  Enforcing Standards: Consequences and Incentives
6.  Risk Assessment, Auditing, and Monitoring
7.Responding to Detected Offenses and Developing Corrective Action Initiatives
Much of the guidance in this section reflects the OIG’s prior guidance in monitoring Corporate Integrity Agreements (CIAs).  Check out this article on CIAs.
IV.  Compliance Program Adaptations for Small and Large Entities
Maintaining an effective compliance program can be burdensome for smaller entities that have limited resources.  The OIG acknowledges this and provides guidance on how smaller entities can still implement a compliance program that meets the above seven elements of a compliance program.
For larger entities with more resources, the GCPG goes into detail about the compliance officer’s role within the organization.  The compliance officer should have the authority to oversee and direct the organization’s compliance function and lead the compliance department. The organization’s board of directors and compliance office should meet periodically to evaluate the compliance department and determine whether it meets the needs of the organization.
V.  Other Compliance Considerations
The GCPG considers other areas to assist entities in developing policies and procedures to reduce or eliminate potential fraud and abuse risks.  Some other areas they have considered are: quality and patient safety, new entrants in the health care industry (e.g. technology companies, new investors, and non-traditional services in health care such as social services, food delivery, and care coordination services), financial incentives, and financial arrangements.
VI.  Additional OIG Resources and Tools

Lastly, the CPCG lists links all of the resources available on the OIG website, including previous compliance program guidance, advisory opinions, special fraud alerts, safe harbor regulations, compliance toolkits, OIG reports and publications, corporate integrity agreements, self-disclosure information and access to OIG’s hotline. The OIG has even implemented a FAQ process to provide informal feedback to the health care community.
Contact Health Law Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.
The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).
To contact The Health Law Firm, please call (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.
About the Author: Michelle E. Missigman, is a health attorney practicing with The Health Law Firm.  The firm has a national practice.  Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.
Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: [email protected] or fax them to (407) 331-3030.
“Criteria for Implementing Section 1128(b)(7) Exclusion Authority.” U.S. Department of Health and Human Services Office of Inspector General. (2016). Web.
Dani Kass. “HHS Watchdog Lays Out New Grounds For Exclusion List.” Law360. (2016). Web.
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One in Four Florida Healthcare Providers Skipped Required Opioid Prescribing Class

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On February 5, 2019, state officials announced that about one in four Florida health care providers failed to take a required two-hour continuing education (CE) course on prescribing controlled substances.  The deadline for the mandated course was January 31, 2019. The Florida Department of Health (DOH) is now preparing to send non-compliance letters advising the providers that they have 15 days to take the mandated course or face disciplinary action, said DOH agency spokesman Brad Dalton.

“If the department does not receive a response within 15 days from receipt of the notice, a formal complaint will be initiated,” he said.

New Standards for Prescribing Controlled Substances.

A law in 2018 required all health care providers registered with the DEA and authorized to prescribe controlled substances to take a CE course.  The course covers the current standards for prescribing controlled substances, particularly opiates.

Click here to read our prior blog and learn more about House Bill 21, the Controlled Substances Bill.

In in the of Florida, nurses, dentists physicians, podiatrists, physician assistants and advanced practice registered nurses practitioners (APRNs) can prescribe controlled substances for pain. Prior to the passage of this law in 2018, only physician assistants and APRNs were required to take CE courses on controlled substances as part of licensure requirements.

The new mandate impacts an estimated 114,000 Florida healthcare providers including all dentists, according to the DOH.

Click here to read one of our prior blogs on the importance of health care compliance for all health care providers.

We have seen firsthand the kinds of problems that can arise when licensed health professionals do not follow up on continuing education requirements.  Click here to read one of my prior blogs and learn more.

How a Disciplinary Action May Affect Your Healthcare License.

It is important that health care providers understand how this could impact your professional license and professional reputation. Failing to obtain the required CE during the time period set forth by state and board regulation can result in disciplinary action being taken against a licensee. Disciplinary action in one state can lead to disciplinary action commenced against a license held in another state, if the licensee holds multiple licenses.

Often consulting an experienced health law attorney on such matters can save a great deal of turmoil, mental anguish, cost and damage. Click here to read one of our prior blogs and learn more.

Contact Health Law Attorneys Experienced with Department of Health Investigations of Pharmacists, Pharmacies and Other Healthcare Professionals.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.
To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


“A Quarter Of Florida Docs, Dentists Skip Required Opioid Training.” Health New Florida. (February 5, 2019). Web.

Sexton, Christine. “Thousands of Florida doctors, dentists skip required opioid training.” Orlando Sentinel. (Web.)

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

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