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FEATURE


published. Agencies that are consid- ering “significant” rules, or rules that raise important policy issues or have considerable economic effects, may be required to submit their proposed rules to OIRA before they can be released. For significant rules, an agency must estimate costs, benefits and the paper- work burden on the public. This step aligns the proposed rule with the presi- dent’s priorities and goals. OIRA often reviews final rules in a similar fashion. An agency also may reach out to


Setting the Rules


How the regulatory requirements that apply to your ASC are created and changed BY STEVEN SELDE


J


ust as there is a legislative pro- cess that all bills must go through


to become law [see page 10], there is a regulatory, or rulemaking, process that determines the rules that will be adopted to enforce new laws. Most laws contain language that helps to identify which federal agency will set those rules. Often, the laws also identify specific areas that the rules should address. The rules that guide the federal


regulatory, or rule-making, process are part of the Administrative Proce- dure Act (APA), which was adopted in 1946. Under the APA, an agency charged with developing the regula- tions needed to enforce a law typically begins the process by issuing a pro- posed rule that contains all of the regu- lations the agency is planning to put in place. All proposed rules are published in the Federal Register, a legal news-


14 ASC FOCUS FEBRUARY 2016


paper of sorts, that the federal govern- ment issues daily to make all federal agency rules, public notices, executive orders and other presidential docu- ments available to the public. Once the proposed rule is published,


the agency then accepts comments from the public, considers those comments, makes any changes in the proposed rule that it believes are warranted and issues a final rule. That final rule then con- tains all of the regulatory policies that individuals, and individual entities like ASCs, need to follow to be considered “in compliance” with the new law.


Prior to a Proposed Rule In many cases, the Office of Informa- tion and Regulatory Affairs (OIRA), which is housed in the President’s Office of Management and Budget (OMB), gets involved with new regu- lations before a proposed rule is even


the public for input prior to publishing a proposed rule by issuing a Request for Information (RFI) or Advance Notice of Proposed Rulemaking in the Federal Register. RFIs and Advance Notices of Proposed Rulemaking are formal invitations for the public to participate in shaping the proposed rule and begin the notice-and-com- ment process. Last fall, for example, the Centers for Medicare & Medicaid Services (CMS) issued an RFI seeking comments regarding the regulations it is preparing to issue to implement the Medicare Access and Children’s Health Insurance Program Reauthori- zation Act of 2015 (MACRA).


Proposed Rules Congress may grant broad authority to an agency that is preparing the regula- tions needed to enforce a new law by providing only general guidance regard- ing what the new rules should con- tain. This technique can be seen in the Patient Protection and Affordable Care Act (PPACA), which contains a num- ber of provisions giving federal agen- cies discretion to issue “such regula- tions as may be necessary.” Conversely, Congress may delineate exactly what, when and how agencies can regulate. For example, Congress was specific in requiring that the Secretary of the US Department of Health and Human Services (HHS) “review not less often than annually and revise” the Hospi- tal Outpatient Prospective Payment and Ambulatory Surgical Center Payment


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