CMS Small Entity Compliance Guides

CMS Small Entity Compliance Guides

The programs CMS administers, including original Medicare, Medicare Advantage, Medicare Part D, Medicaid, the Children's Health Insurance Program, the Healthcare.gov exchanges, and delegated functions under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), directly or indirectly affect more than one million health care providers and suppliers. The great majority of these entities are technically small within the established Small Business Administration (SBA) revenue size guidelines, or because they are non-profit, or both. CMS generally treats all providers and suppliers affected by a rule as small entities.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA, Pub. L. 104-121, as amended by Pub. L. 110-28, May 25, 2007 and Pub. L. 117-188, Oct 22, 2022) requires the issuance of small entity compliance guides for each rule for which CMS is required to prepare a final regulatory flexibility analysis under 5 U.S.C. 604 and 605(b). The compliance guides explain to small entities, in plain language, what CMS requires of them with respect to complying with new rules. The head of each agency must also submit an annual report to Congress describing the status of its compliance with this requirement.

It is long-standing CMS policy to minimize the burden of its rules on all affected entities, whether technically small or not. As a result, many CMS rules do not create a significant impact on a substantial number of small entities and hence do not require either a regulatory flexibility analysis or a compliance guide. However, when a rule creates new compliance requirements with a significant economic impact, CMS provides a small entity compliance guide for each regulation. These small entity compliance guides are included at the bottom of this page. 

In addition, CMS uses several mechanisms to minimize the burdens of its proposed regulations before publication and before issuance as final rules. CMS has developed the www.cms.hhs.gov website to serve the needs of providers, suppliers, and others for compliance-related information. CMS has consciously designed this website to provide a comprehensive, thorough, and useful guide to compliance with every CMS rule by every type of provider or supplier. 

As a primary informational tool for providers and suppliers, CMS sponsors a “Medicare Learning Network” (MLN) that provides educational compliance information for Medicare fee-for-service providers. The MLN provides a variety of training and educational materials that break down Medicare policy into plain language with actionable tips to use in day-to-day work. 

As another informational assistance tool, CMS created a comprehensive manual system that presents compliance information on virtually all CMS regulations. The manual chapters pull together all the issuances on particular topics (whether or not any particular issuance resulted from a rule with significant impacts) and provide integrated and cohesive statements of operational policy. 

CMS also provides Open Door Forums on almost all major regulatory issues, with particular emphasis on those that impact providers in new or burdensome ways. Providers and other stakeholders can attend virtually from anywhere in the United States. These forums provide small entities an opportunity to obtain information, ask questions, and express their views to senior CMS officials. They focus strongly on ideas to reduce unnecessary burden or costs.