Federal Regulations

ASCs are highly regulated healthcare facilities. Each ASC must comply with a host of statutes and regulations at both the federal and state levels. These laws cover all aspects of ASCs from their day-to-day operations to how they are paid.

Most ASCs provide care to Medicare beneficiaries and, thus, must demonstrate continual compliance with Medicare standards. There are additional federal laws all ASCs must comply with, such as the Health Insurance Portability and Accountability Act (HIPAA). In addition, ASCs must meet specific requirements and obtain a state license in virtually every state. Visit ASCA’s State Law Database for more information on state requirements.

Medicare Certification

To be paid by Medicare, ASCs must enter into an agreement with Medicare and meet its certification requirements, known as the Conditions for Coverage (CFC). Additionally, some states and private payers require that ASCs meet Medicare’s Conditions for Coverage. These requirements are comprehensive and cover every aspect of an ASC, from facility design to patient care.

CMS also produces a State Operations Manual which includes guidance for surveyors, often referred to as the Interpretive Guidelines. The guidance specific to ASCs can be found in Appendix L: Interpretive Guidelines for ASCs. In addition to reiterating the text of the Conditions for Coverage, this document provides guidance on the meaning of the rules and further advice on how ASCs should comply.

It is important to note, however, that two other appendices also apply to ASCs. ASCs are required to comply with Appendix I: Survey Procedures and Interpretive Guidelines for Life Safety Code Surveys, which addresses the Life Safety Code, and Appendix Q: Guidelines for Determining Immediate Jeopardy.

Medicare Payment Resources

In 2008, CMS implemented a significantly revised payment methodology based on the Ambulatory Payment Classification systems used in HOPDs. See ASCA’s Medicare payment resources to understand the impact of CMS’ payment changes and ensure that your ASC is being paid correctly. Resources include ASCA’s Medicare Rate Calculator, which shows the national and local payment rates, a chart comparing the ASC rates with the HOPD rates for the same surgical procedures and more.

Medicare’s Quality Reporting

CMS requires ASCs to report data on quality measures. ASCs that fail to report will face reductions in their Medicare payment rates in future years. ASCA members can learn more about the current requirements and access resources to help them comply on the Quality Reporting page.

Emergency Preparedness

CMS requires ASCs to develop and maintain an emergency preparedness plan. This regulation was updated in a final rule released in September 2016, and ASCs are being surveyed on the new requirements as of November 15, 2017. ASCs are required to perform a risk assessment, develop policies, procedures and a communication plan, and complete trainings and testing of their final plan. For more information, please review the Interpretive Guidelines in Appendix Z of the State Operations Manual as well as the resources on this site. ASCA members can view a custom tool that lists the surveyor tags specific to ASCs.

Other Federal Regulation Information

Affordable Care Act, Section 1557 Resources

While there is no substitute for receiving a legal opinion regarding the specific facts in a particular case from qualified counsel that practice in this specialized area of law, the Federal Regulations section of ASCA’s website provides a starting point for understanding the federal rules impacting ASCs. For questions or more information, contact Kara Newbury.

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