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

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 2

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 3

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) 4

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 5 *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 6

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 7

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

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

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 agencys interpretation reasonable? 10