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
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)
Related Topics:
Medicare Fraud Damages Expert Witness
Medical Billing Expert Witness
