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This article provides an in-depth look into the implementation of the Affordable Care Act in the United States between its enactment and September 1, 2019. It covers over 540 provisions coming into effect, primary implementing agencies, agency rulemaking processes, Congressional oversight, and judicial review procedures. The text explores formal and informal rulemaking, negotiated rulemaking, and various agency tools such as executive orders, letters, and policy statements. It also delves into Congressional oversight methods like hearings, investigations, and legislation, as well as the judicial review of agency actions, with a focus on the Chevron v. NRDC case from 1984.
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Health Reform Implementation Katherine Hayes The George Washington University, SPHHS Department of Health Policy July 9, 2010
Affordable Care Act • Between date of enactment and September 1, 2019, more than 540 provisions of federal law go into effect. • Three primary implementing agencies: HHS, Labor and Treasury • About 40 instances in which Secretary is required to promulgate rules • Tremendous discretion given to the respective agencies • Subject to Congressional oversight and judicial review
Agency Rulemaking • Administrative Procedure Act 1946 (5 USC 550 et. seq.) • Formal rulemaking • Informal or “notice and comment” rulemaking • Negotiated Rulemaking • General Policy statements – Manuals, directives, communications, letters, etc. • Subject to • Congressional Oversight • Judicial Review
Formal Rulemaking (almost extinct) • Agency employee or ALJ presides over “on-the-record” hearing • Witnesses under oath • Agency may issue subpoenas • Rule on evidence • Takes depositions • Official records and preparations of transcripts • Decision must be based on the record (limit ex parte communications)
Informal Rulemaking - Notice • Notice - published in Federal Register must include: • Time, place, nature • Legal authority • Description of subject or issue • Exceptions • interpretive rules • general statements of policy, • agency organization • “good cause” *Exception for military, foreign affairs, agency administration
Informal Rulemaking - Comment • Comment – interested persons must have opportunity submit written data, views or arguments. • Incorporate general statement of rules and purpose • Publication made not less than 30 days prior to effective date • Exceptions: • Substantive rule which grants exemption or relieves a restriction • Interpretive rules or statements of policy • “good cause” – must be published within the rule • Right to petition for issuance, amendment or repeal
Negotiated Rulemaking • Notice and Comment on Committee Formation • Application, nomination and appointment of members • Agency administrative support • Committee report – consensus (all), unless otherwise agreed • Public Record
Other Agency Tools • Executive Orders • Letters • Letters to Governors • State Medicaid Directors • Manuals • Medicare provider manuals • Medicaid manuals • Policy statements • Other guidance
Congressional Oversight • Hearings • Letters to Executive and Agency Heads • Investigations – GAO • Legislation • Authorizing legislation • Appropriations – “No funds shall be used…”
Judicial Review of Agency Action • Difficult to overturn agency decision, but not impossible • Chevron v. NRDC, 467 US 837 (1984) • Is there a clear answer provided by law? If so, the agency must follow. • If no clear answer, was agency delegated the authority to make the decision? Generally yes, if the agency has particular expertise. • Is the agency’s interpretation reasonable?
