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Health Reform Implementation

Explore the implementation of over 540 federal laws effecting Health Reform since 2010, highlighting agency rulemaking procedures and oversight mechanisms such as Congressional review and Judicial intervention.

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Health Reform Implementation

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  1. Health Reform Implementation Katherine Hayes The George Washington University, SPHHS Department of Health Policy July 9, 2010

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. Other Agency Tools • Executive Orders • Letters • Letters to Governors • State Medicaid Directors • Manuals • Medicare provider manuals • Medicaid manuals • Policy statements • Other guidance

  9. Congressional Oversight • Hearings • Letters to Executive and Agency Heads • Investigations – GAO • Legislation • Authorizing legislation • Appropriations – “No funds shall be used…”

  10. 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?

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