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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
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with regard to prohibition of conduct, but when it does so, HHS may only use the guidance document to articulate the Departments understanding of how a statute or regulation applies to particular circumstances. Except when referring to a guidance document for historical facts, the Department may reference a guidance document in a civil enforcement action only if it has notified the public of such document to convey that understanding in advance.
The Department must notify the public in advance of a guidance document through publication in the Departments guidance repository as described in 1.4 and available at hhs.gov/guidance.
D. Fairness and Notice in Civil Enforcement Actions and Administrative Inspections 45 CFR 1.7
This rule would require the Department to only apply standards or practices that have been publicly stated in a manner that would not cause unfair surprise when HHS takes a civil enforcement action or otherwise makes a determination based on an alleged violation of law that has legal consequence for a person or state, unless a statutory exception applies.
See, e.g., 42 U.S.C. 1395hhe. For purposes of this regulation, the Department would consider standards or practices to be publicly stated if available in paper publications or on the internet.
HHS avoids unfair surprise not only when it imposes penalties but also whenever it adjudges past conduct to have violated the law. For example, the Department generally cannot retroactively impose liability on a party for conduct that violates a new agency interpretation. But see 42 U.S.C.
1395hhe. The Department also may not alter its interpretation during an adjudicative proceeding if doing so would impose new liability on parties who have acted in good faith on the prior interpretation. SmithKline Beecham, 567 U.S. at 156 & n.15.
Section 7 of Executive Order 13892
requires that each agency that conducts civil administrative inspections must publish a rule of agency procedure governing such inspections, if such a rule does not already exist. The Department is adding a requirement at 45 CFR 1.7 that HHS shall only conduct civil administrative inspections according to published rules of agency procedure. While the Administrative Procedure Act exempts these subsequently issued rules of agency procedure themselves from notice-andcomment rulemaking, see 5 U.S.C.
553b3A, each agency must make the rules governing its civil administrative
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inspections, including audits, publicly available and readily accessible, such as by posting them on a website.
E. Fairness and Notice in Jurisdictional Determinations 45 CFR 1.8
The requirement for fairness and notice also extends to jurisdictional determinations. If the Department relies on a decision previously issued by an agency within the Department in an agency adjudication i.e., proceedings before and decided by the agency, administrative order, or agency document to assert a new or expanded claim of jurisdiction e.g., a claim to regulate a new subject matter or a new basis for liability, or a relinquishment of a claim of jurisdiction, the Department must give fair notice by publishing the initial decision in the Federal Register or the Departments guidance repository. See 45 CFR 1.4. The Department should not rely on the new claim of jurisdiction to take a civil enforcement action regarding conduct that occurred before such publication. A
claim of jurisdiction is not new or expanded simply because it involves a new or novel set of facts so long as it is based on an established principle of general applicability.
If the Department intends to rely on a document arising out of litigation other than a publicly published opinion of an adjudicator such as a brief, a consent decree, or a settlement agreement, to establish jurisdiction in future civil enforcement actions involving persons who were not parties to the litigation, the Department must also publish that document in the Federal Register or on the Departments guidance repository. Alongside publication of the document, the Department must also provide an explanation of the documents jurisdictional implications. Publication of a document discussed in this paragraph may either be in full or by citation, if the document is publicly available.
HHS is also proposing that if the Department seeks judicial deference to its interpretation of a document arising out of litigation other than a publicly published opinion of an adjudicator in order to establish a new or expanded claim of jurisdiction, HHS must, before seeking judicial deference, publish the document or a notice of availability in the Federal Register or on the Departments guidance repository, along with an explanation of the documents jurisdictional implications.

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F. Opportunity To Contest Agency Determinations 45 CFR 1.9
Providing regulated parties with the opportunity to be heard, including through informal oral or written communications, prior to the Department taking any civil enforcement action that has legal consequence is critical to ensuring that the Department operates with transparency and fairness. This rule will require that, before any component of the Department takes any civil enforcement action with respect to a particular entity that has legal consequence for that entityincluding by issuing to such a person a notice of noncompliance or other similar notice that has immediate regulatory consequence or the immediate effect of subjecting the person to potential liabilitythe Department must afford that person an opportunity to be heard, either orally or in writing, as deemed appropriate at the Departments election. The rule will require HHS to provide the person with its proposed legal and factual determinations and then give the person a reasonable amount of time to respond to those determinations. The specific timeframe shall be in the discretion of the agency but must be long enough to provide a meaningful opportunity to be heard.
Certain circumstances may warrant a time period of 30 days, while other circumstances may warrant a shorter period, such as 15 days or fewer, particularly where existing agency procedures already offer a shorter period in which to respond. Unless the Department withdraws the action, the Department must then respond in writing to the regulated party and articulate the final basis for the Departments action. This written response may be issued contemporaneous to the Department taking the action with legal consequence. We anticipate that generally, existing HHS procedures will already satisfy these standards, and where they do, those existing procedures will continue in effect unchanged. This rulemaking is not intended to preempt existing rules of agency procedure that are already consistent with this rule. Furthermore, where the Department takes an action based on a predicate finding that was reached following notice, an opportunity to be heard, and a written response, for example, where the Department revokes Medicare enrollment based on a prior exclusion or felony conviction, these procedural requirements are considered to have already been satisfied.

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