OIG Regulatory Guidance Standards
OIG Regulatory Guidance from the Office of the Inspector General for U.S. Department of Health and Human Services

OIG Regulatory Guidance Standards

What is OIG Regulatory Guidance in Healthcare?

OIG Regulatory Guidance has seven elements and is divided by the healthcare industry sector.

The U.S. HHS Office of the Inspector General (OIG) developed a series of voluntary compliance program guidance documents. The documents are directed at various segments of the health care industry, such as hospitals, nursing homes, third-party billers, and durable medical equipment

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suppliers. They are intended to encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements.

It is not new news that the Medicare system has challenges dealing with fraud and abuse.  In 1992 the General Accounting Office (GAO identified Medicare claims to be at high risk for fraud and abuse.  (See GAO / HR-93-6, December 1992).  Subsequently, in 1996 OIG initiated an audit of the Healthcare Finance Administration (later renamed CMS) for Medicare claims.  This resulted in an estimated $23 billion in improper payments.

Healthcare billing and reimbursement compliance is not the only type of OIG Regulatory Guidance.   HIPAA, which has fraud and abuse provisions, also has mandatory privacy and security compliance programs that are overseen by the Office of Civil Rights (OCR) and the U.S. Department of Health and Human Services (HHS).

Two of the latest compliance initiatives can be found in the Patient Protection and Affordable Care Act of 2010 (PACA) as amended seven days later by the Healthcare and Education Reconciliation Act of 2010 and the HITECH Act of 2009.

The challenge has been the detection of actual fraud and the use of methodologies that incorporate generally accepted Standards.  In the alternative, some organizations may be accused of fraud or abuse, but the data to support such allegations does not exist, or if it exists it has not been properly analyzed and produced to prove a claim of fraud or abuse.

The OIG Regulatory Guidance twenty program guidance documents are listed below:

Seven Elements to Effective OIG Compliance

The Inspector-General of OIG Stated that there were seven elements to an effective compliance program:

IG Remarks and Program Objectives

The guidance includes seven fundamental elements to an effective compliance program:

1. Implementing written policies, procedures, and standards of conduct;

2. Designating a compliance officer and compliance committee;

3. Conducting effective training and education;

4. Developing effective lines of communication;

5. Enforcing standards through well-publicized disciplinary guidelines;

6. Conducting internal monitoring and auditing; and

7. Responding promptly to detected offenses and developing corrective action initiatives.

OIG Regulatory Guidance by Healthcare Industry Sector

Ambulance OIG Regulatory Guidance Standards

Compliance Program Guidance for Ambulance Suppliers (68 Fed. Reg. 14245; March 24, 2003)

Third-Party Medical Billing Company OIG Regulatory Guidance Standards

Compliance Program Guidance for Third-Party Medical Billing Companies (63 Fed. Reg. 70138; December 18, 1998)

Hospital OIG Regulatory Guidance Standards

Supplemental Compliance Program Guidance for Hospitals (70 Fed. Reg. 4858; January 31, 2005)

Compliance Program Guidance for Hospitals (63 Fed. Reg. 8987; February 23, 1998)

Supplemental Compliance Program Guidance for Hospitals (70 Fed. Reg. 4858; January 31, 2005)

Small-Group Physician Practices OIG Regulatory Guidance Standards

Compliance Program Guidance for Individual and Small Group Physician Practices (65 Fed. Reg. 59434; October 5, 2000)

Clinical Laboratories OIG Regulatory Guidance Standards

Compliance Program Guidance for Clinical Laboratories (63 Fed. Reg. 45076; August 24, 1998)

Nursing Facility OIG Regulatory Guidance Standards

Supplemental Compliance Program Guidance for Nursing Facilities (73 Fed. Reg. 56832; September 30, 2008)

Compliance Program Guidance for Nursing Facilities (65 Fed. Reg. 14289; March 16, 2000)

Home Health Agency OIG Regulatory Guidance Standards

Compliance Program Guidance for Home Health Agencies (63 Fed. Reg. 42410; August 7, 1998)

Hospice Facility OIG Regulatory Guidance Standards

Compliance Program Guidance for Hospices (64 Fed. Reg. 54031; October 5, 1999)

Medicare Advantage (fka Medicare+Choice) OIG Regulatory Guidance Standards

Compliance Program Guidance for Medicare+Choice Organizations (64 Fed. Reg. 61893; November 15, 1999) President Clinton signed Medicare+Choice into law in 1997. The program was re-named Medicare Advantage in 2003.

Research Grants and Awards OIG Regulatory Guidance Standards

Draft Compliance Program Guidance for Recipients of PHS Research Awards (70 Fed. Reg. 71312; November 28, 2005)

NSTC Launches Government-Wide Initiative Based on OIG Draft Guidance for HHS Research Grants (June 7, 2006)

Pharmaceutical Manufacturers OIG Regulatory Guidance Standards

Compliance Program Guidance for Pharmaceutical Manufacturers (68 Fed. Reg. 23731; May 5, 2003)

Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DME POS) OIG Industry Guidance Standards

Compliance Program Guidance for the Durable Medical Equipment, Prosthetics, Orthotics, and Supply Industry (64 Fed. Reg. 36368; July 6, 1999)

 

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Michael F. Arrigo

Michael is Managing Partner & CEO of No World Borders, a leading healthcare management and IT consulting firm. He serves as an expert witness in Federal and State Court and was recently ruled as an expert by a 9th Circuit Federal Judge. He serves as a patent expert witness on intellectual property disputes, both as a Technical Expert and a Damages expert. He leads a team that provides Cybersecurity best practices for healthcare clients, ICD-10 Consulting, Meaningful Use of Electronic Health Records. He advises legal teams as an expert witness in HIPAA Privacy and Security, medical coding and billing and usual and customary cost of care, the Affordable Care Act and benefits enrollment, white collar crime, False Claims Act, Anti-Kickback, Stark Law, Insurance Fraud, payor-provider disputes, and consults to venture capital and private equity firms on mHealth, Cloud Computing in Healthcare, and Software as a Service. He advises self-insured employers on cost of care and regulations. Arrigo was recently retained by the U.S. Department of Justice (DOJ) regarding a significant false claims act investigation. He has provided opinions on over $1 billion in health care claims and due diligence on over $8 billion in healthcare mergers and acquisitions. Education: UC Irvine - Economics and Computer Science, University of Southern California - Business, studies at Stanford Medical School - Biomedical Informatics, studies at Harvard Medical School - Bioethics. Trained in over 10 medical specialties in medical billing and coding. Trained by U.S. Patent and Trademark Office (USPTO) and PTAB Judges on patent statutes, rules and case law (as a non-attorney to better advise clients on Technical and Damages aspects of patent construction and claims). Mr. Arrigo has been quoted in the Wall Street Journal, New York Times, and National Public Radio.

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