Katherine Hayes
The George Washington University, SPHHS
Department of Health Policy
July 9, 2010
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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
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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
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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)
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Informal Rulemaking - Notice
 Notice - published in Federal Register must include:
 Time, place, nature
 Legal authority
 Description of subject or issue
 Exceptions
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interpretive rules
general statements of policy,
agency organization
“good cause”
*Exception for military, foreign affairs, agency administration
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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:
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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
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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
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Other Agency Tools
 Executive Orders
 Letters
 Letters to Governors
 State Medicaid Directors
 Manuals
 Medicare provider manuals
 Medicaid manuals
 Policy statements
 Other guidance
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Congressional Oversight
 Hearings
 Letters to Executive and Agency Heads
 Investigations – GAO
 Legislation
 Authorizing legislation
 Appropriations – “No funds shall be used…”
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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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