1. The practical guide to the U.S. Physician office laboratory (POL) Part four: Regulatory requirements and considerations Laboratory Informatics Institute May 2014

2. Clinical laboratory improvement amendments (CLIA) Health insurance portability and accountability act (HIPAA) Patient protection and affordable care act (PPACA) Note: This is not a substitute for performing due diligence for compliance with current regulatory environment. 3. CLIA CLIA-1988 Regulation with most relevance to the laboratory. Federal regulation. Requires laboratories to register and obtain a certificate, even those that perform waived testing. 4. Waived tests have the lowest risk for an incorrect result. This category includes tests that have been approved by the food and drug administration (FDA) for home use. Waiver laboratories must register and get a certificate, but are not inspected routinely and do not require proficiency testing. Laboratories wishing to switch from waived to some other complexity, must meet the compliance requirements for the new level of complexity 5. HIPAA HIPAA-1996 Portability of health insurance Better guidance on privacy and security of data. Improved accountability for violators. Requires laboratories to implement measures to prevent the unauthorized access and disclosure of laboratory data. 6. Prior to February 2014, laboratories were exempted from the requirement to provide patients with protected health information. Requires laboratories to comply with this requirement as of February 2014. Compliance with new requirement estimated to cost $59 million over the first 5 years. Laboratories such as Quest, support this rule as it allows for the patient to receive lab results, without requiring approval of the patient's provider. 7. Laboratory testing informs 70% of clinician medical decision making process. Comprises less than 2% of Medicare spending. PPACA: Passed in 2010. Also known as ACA. Does not negate obligations under CLIA and HIPAA. 8. PPACA PPACA cuts the laboratory fee schedule by 1.75% every year for 5 years as of 2011. This 9% cut is the largest cut for all Medicare Part B providers. Productivity adjustment cuts and additional 11% over the next 10 years. These cuts result in approximately 20% cuts to the fee schedule over the next 10 years. Additional 2% cut per year as a result of sequestration beginning in January 2013. 9. Accountable care organization (ACO) business model may challenge laboratories. Under the ACO model redundant and unnecessary testing is discouraged. Resulting in decrease of testing volume. Could be good for the POL as waived testing can be performed in house. May be a problem as physicians will need to recalculate the economic sense of opening a POL. 10. For more information Link to white paper with references: http://tinyurl.com/oqorxvu Contact the institute via our website: http://tinyurl.com/o5o23fp