Executive Orders Issued by the Trump Administration Regarding the Inappropriateness of Guidance Documents
Two Executive Orders: 84 FR 55235 and 84 FR 55239
Following SCOTUS’ ruling in Azar v. Allina Health Services reported by us here, in which the Court invalidated CMS’ Part C policy for failure to comply with notice and comment rulemaking before applying the policy, the executive orders issued by the Trump Administration on October 9, 2019 “Promoting the Rule of Law Through Improved Agency Guidance Documents” and “Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication” are both aimed at transparency in the regulatory process and to curtail guidance documents from being improperly used by agencies in lieu of following public notice-and-comment mandates of the Administrative Procedure Act.
"Promoting the Rule of Law Through Improved Agency Guidance Documents,” found here at 84 FR 55235, has sweeping implications for agencies that “sometimes used this authority inappropriately in attempts to regulate the public without following the rulemaking procedures of the APA.” This executive order puts in place certain requirements that agencies must follow such as providing the opportunity for public comment before finalizing significant guidance, amend existing regulations as necessary, and implement processes and procedures for issuing guidance documents that includes procedures for the public to petition for withdrawal or modification of a particular guidance document, and establish or maintain on its website a “single, searchable, indexed database that contains or links to all guidance documents in effect from such agency or component” with a disclaimer noting “that guidance documents lack the force and effect of law, except as authorized by law or as incorporated into a contract.”
Specifically, the order states an agency cannot treat failure to comply with a standard of conduct announced solely in a guidance document as itself a violation of applicable statutes or regulations. The guidance document cannot be used as a prohibition of conduct but instead only to articulate the agency's understanding of how a statute or regulation applies to particular circumstances. In sum, the executive order provides additional protection for the public and providers by ensuring a fair and transparent regulatory process.
The “Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication” executive order, found here at 84 FR 55239, is intended to safeguard against guidance documents being used to impose new standards of conduct except as expressly authorized by law or as expressly incorporated into a contract and to avoid unexpected penalties.
Star Rating Update: Last month, CMS released premium and cost-sharing data for Medicare Advantage and Part D prescription drug plans for the 2020 calendar year, found here. Earlier this month, the Trump Administration issued the executive order, “Protecting and Improving Medicare for Our Nation’s Seniors” that authorizes the Department of Health & Human Services to expand Medicare Advantage, reduce fee-for-service, and level the playing field between MA plans and Medicare, found here. Then weeks later, CMS released its star ratings for 2020 Medicare Advantage and prescription drug plans, found here. Of all 210 MA-PD plans, fifty-two percent received four stars or above for 2020. CMS found that 81 percent of MA-PD plan enrollees will be in a plan rated four stars or more based on 2019 enrollment. This is 12 percentage points higher than it was in 2017. We will continue to update you as growing attention surrounds Medicare Advantage plans.
The list above does not include every proposed or adopted legislation, litigation or guidance document that may impact the health care industry. Instead, it includes only a select few chosen by the authors, and any information in this Update is not intended to provide legal advice. If you are concerned that a proposed or adopted legislation, litigation or guidance document may impact your practice, then you should seek legal advice. We send these Updates to our clients and friends to share our insights on new developments in the law. Nothing in this Update should be relied upon as legal advice in any particular matter. © 2019 Riker Danzig Scherer Hyland & Perretti LLP.