The Public Voice in Health Care Reform: The Rulemaking Process July 14, 2010 1:00 2:00 Department of Health & Human Services Centers for Medicare & Medicaid Services and Office on Disability 1
Regulations Overview A regulation is a general statement issued by an agency, board, or commission that has the force and effect of law. Congress often grants agencies the authority to issue regulations. Many laws passed by Congress give Federal agencies some flexibility in deciding how best to implement those laws. Federal regulations specify the details and requirements necessary to implement and to enforce legislation enacted by Congress. 2
Regulations Overview (cont.) Federal regulations are created through a process known as "rulemaking," which is governed by the Administrative Procedure Act (APA) (5 U.S.C. Chapter 5). Once an agency decides that a regulatory action is necessary or appropriate, it develops and typically publishes a proposed rule in the Federal Register, soliciting comments from the public on the regulatory proposal. After the agency considers this public feedback and makes changes where appropriate, it then publishes a final rule in the Federal Register with a specific date upon which the rule becomes effective and enforceable. In issuing a final rule, the agency must describe and respond to the public comments it received. 3
Federal Register The Federal Register is the official daily publication for agency rules, proposed rules, and notices of Federal agencies and organizations, as well as for Executive Orders and other presidential documents. The Federal Register is published by the Office of the Federal Register within the National Archives and Records Administration (NARA). To learn more, visit the Federal Register website at: http://www.gpoaccess.gov/fr/. 4
Rulemaking: Step 1 Initiating Events Agency Initiatives Agency initiatives for rulemaking originate from such things as: Agency priorities and plans New scientific data New technologies Accidents Required Reviews Statutory Mandates Recommendations from Other Agencies/External Groups/States/Federal Advisory Committees Lawsuits Petitions OMB Prompt Letters 5
Rulemaking: Step 2 Determination Whether a Rule Is Needed Administrative Procedure Act Provisions Under the Administrative Procedure Act provisions that are included as part of the Freedom of Information Act at 5 U.S.C. 552, agencies are required to publish in the Federal Register: Substantive rules of general applicability Interpretive rules Statements of general policy Rules of procedure Information about forms Information concerning agency organization and methods of operation 6
Rulemaking: Step 3 Preparation of Proposed Rule Proposed Rule A notice of proposed rulemaking proposes to add, change, or delete regulatory text and contains a request for public comments. Advance Notice of Proposed Rulemaking An advance notice of proposed rulemaking requests information needed for developing a proposed rule. Negotiated Rulemaking (rare) Negotiated rulemaking is a mechanism under the Negotiated Rulemaking Act (5 U.S.C. 561-570) for bringing together representatives of an agency and the various interests to negotiate the text of a proposed rule. 7
Rulemaking: Step 3 (cont.) Preparation of Proposed Rule Rule making agencies may seek subject matter expertise in developing rules such as: Listening sessions Open door forums Informal discussions Meetings with stakeholders Etc. 8
Rulemaking: Step 4 Office of Management and Budget Review of Proposed Rule OMB Review Under Executive Order 12866 OMB reviews only those rulemaking actions determined to be "significant." Independent agencies are exempt from OMB review. Significant regulatory actions are defined in the Executive Order as those that: Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or Raise novel legal or policy issues arising out of legal mandates, the President s priorities, or the principles set forth in this Executive order. 9
Rulemaking: Step 5 Publication of Proposed Rule Proposed rules are published in the Federal Register http://www.gpoaccess.gov/fr/index.html 10
Rulemaking: Step 6 Public Comments Under the Administrative Procedure Act provisions of 5 U.S.C. 553, an agency must provide the public the opportunity to submit written comments for consideration by the agency. (see http://www.regulations.gov/search/regs/home.html#home). As required by Public Law No. 107-347, agencies must provide for submission of comments by electronic means and must make available online the comments and other materials included in the rulemaking docket under 5 U.S.C. 553 (c). Executive Order 12866 established 60 days as the standard for the comment period. The holding of a public hearing is discretionary unless required by statute or agency policy. 11
Rulemaking: Step 6 (cont.) Public Comments It is imperative that consumers and advocacy groups submit comments Comments can be based on any issue that are relevant to the commenter and the rule. Comments can be based on direct experience with the issue, anticipated consequences of the proposed rule, and would ideally suggest more effective solutions. All public comments must be addressed by the rulemaking agency in the next iteration of the rule. 12
Rulemaking: Step 7 Preparation of Final Rule, Interim Final Rule, or Direct Final Rule Final Rule A final rule adds, changes, deletes, or affirms regulatory text. Special Types of Final Rules Interim Final Rule An interim final rule adds, changes, or deletes regulatory text and contains a request for comments. The subsequent final rule may make changes to the text of the interim final rule. Direct Final Rule A direct final rule adds, changes, or deletes regulatory text at a specified future time, with a duty to withdraw the rule if the agency receives adverse comments within the period specified by the agency. 13
Rulemaking: Step 8 OMB Review of Final Rule, Interim Final Rule, or Direct Final Rule OMB Review Under Executive Order 12866 OMB reviews only those rulemaking actions determined to be "significant. Independent agencies are exempt from OMB review. It is unclear how many or which regulations of the Patient Protection and Affordable Care Act will require OMB review 14
Rulemaking: Step 9 Publication of Final Rule, Interim Final Rule, or Direct Final Rule Final rules are published in the Code of Federal Regulations Congressional Review Act (5 U.S.C. 801-808) An agency must submit most final rules, interim final rules, and direct final rules, along with supporting information, to both houses of Congress and the General Accounting Office before they can take effect. Major rules are subject to a delayed effective date (with certain exceptions). Action by Congress and the President could have an impact on the rule. 15
Agendas for Rules Under Development of Review Unified Regulatory Agenda: The Unified Regulatory Agenda provides information concerning agency rules under development or review. The Unified Regulatory Agenda is published in the Federal Register in the spring and fall of each year. Regulatory Plan: The Regulatory Plan provides information concerning the most important significant regulatory actions that the agency is planning to take. The Regulatory Plan is published in the Unified Regulatory Agenda in the fall of each year. Regulatory Flexibility Agenda: The Regulatory Flexibility Agenda provides information concerning any rule that an agency expects to prepare or promulgate that is likely to have a significant economic impact on a substantial number of small entities. Agency regulatory flexibility agendas are published as part of the Unified Regulatory Agenda in the spring and fall of each year. 16
Questions Send Questions to the following email address community.living@hhs.gov 17
Resources Office of Regulation and Regulatory Affairs: http://www.reginfo.gov/public/jsp/utilities/index.jsp Regulations.gov http://www.regulations.gov/search/regs/home.html#home Unified Agenda: http://www.reginfo.gov/public/do/eagendamain Reg Map: Graphic Depiction of Regulation Development Process http://www.reginfo.gov/public/reginfo/regmap/index.jsp Federal Register: http://www.gpoaccess.gov/fr/index.html CMS Quarterly Prover Updates https://www.cms.gov/quarterlyproviderupdates/ 18