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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 Arrigo brings four decades of experience in the software, financial services, and healthcare industries. In 2000, Mr. Arrigo founded No World Borders, a healthcare data, regulations, and economics firm with clients in the pharmaceutical, medical device, hospital, surgical center, physician group, diagnostic imaging, genetic testing, health IT, and health insurance markets. His expertise spans the federal health programs Medicare and Medicaid and private insurance. He advises Medicare Advantage Organizations who provide health insurance under Part C of the Medicare Act. Mr. Arrigo serves as an expert witness regarding medical coding and medical billing, fraud damages, as well as electronic health record software for the U.S. Department of Justice. He has valued well over $1 billion in medical billings in personal injury liens, medical malpractice, insurance fraud cases. The U.S. Court of Appeals considered Mr. Arrigo's opinion regarding loss amounts, vacating, and remanding sentencing in a fraud case. Mr. Arrigo provides expertise in the Medicare Secondary Payer Act, Medicare LCDs, anti-trust litigation, medical intellectual property and trade secrets, HIPAA privacy, health care electronic claim data Standards, physician compensation, Anti-Kickback Statute, Stark law, the Affordable Care Act, False Claims Act, and the ARRA HITECH Act. Arrigo advises investors on merger and acquisition (M&A) diligence in the healthcare industry on transactions cumulatively valued at over $1 billion. Mr. Arrigo spent over ten years in Silicon Valley software firms in roles from Product Manager to CEO. He was product manager for a leading-edge database technology joint venture that became commercialized as Microsoft SQL Server, Vice President of Marketing for a software company when it grew from under $2 million in revenue to a $50 million acquisition by a company now merged into Cincom Systems, hired by private equity investors to serve as Vice President of Marketing for a secure email software company until its acquisition and multi $million investor exit by a company now merged into Axway Software SA (Euronext: AXW.PA), and CEO of one of the first cloud-based billing software companies, licensing its technology to Citrix Systems (NASDAQ: CTXS). Later, before entering the healthcare industry, he joined Fortune 500 company Fidelity National Financial (NYSE: FNF) as a Vice President, overseeing eCommerce solutions for the mortgage banking industry. While serving as a Vice President at Fortune 500 company First American Financial (NYSE: FAF), he oversaw eCommerce and regulatory compliance technology initiatives for top ten mortgage banks and led the Sarbanes Oxley Act Section 302 internal controls IT audit for the company, supporting Section 404 of the Sarbanes Oxley Act. Mr. Arrigo earned his Bachelor of Science in Business Administration from the University of Southern California. Before that, he studied computer science, statistics, and economics at the University of California, Irvine. His post-graduate studies include biomedical ethics at Harvard Medical School, biomedical informatics at Stanford Medical School, blockchain and crypto economics at the Massachusetts Institute of Technology, and training as a Certified Professional Medical Auditor (CPMA). Mr. Arrigo is qualified to serve as a director due to his experience in healthcare data, regulations, and economics, his leadership roles in software and financial services public companies, and his healthcare M&A diligence and public company regulatory experience. Mr. Arrigo is quoted in The Wall Street Journal, Fortune Magazine, Kaiser Health News, Consumer Affairs, National Public Radio (NPR), NBC News Houston, USA Today / Milwaukee Journal Sentinel, Medical Economics, Capitol ForumThe Daily Beast, the Lund Report, Inside Higher Ed, New England Psychologist, and other press and media outlets. He authored a peer-reviewed article regarding clinical documentation quality to support accurate medical coding, billing, and good patient care, published by Healthcare Financial Management Association (HFMA) and is published in Healthcare IT News.

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