On August 20, 2020 the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (85 Fed. Reg. 51397) on good practices for the release and maintenance of agency guidance documents. Comments must be posted by 11:59 pm on September 16, 2020.

As instructed in the October 9, 2019 Executive Order 13891 (EO), titled ‘‘Promoting the Rule of Law Through Improved Agency Guidance Documents (84 FR 55235 (Oct. 15, 2019)), HHS proposes to issue regulations to ensure (i) there is proper notice of any new guidance, and (ii) that the guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations.

This proposed rule appears to follow the Office of Management and Budget, “Final Bulletin for Agency Good Guidance Practices,” issued on January 25, 2007 (72 Fed. Reg. 3432) with respect to the significant guidance document that may, for example “adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities” or “materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof” and generally requires a 30 day notice and comment period.

BackgroundContinue Reading HHS Proposes a New Rule to Govern Release and Maintenance of Agency’s Guidance Documents

On August 9, 2013, the Centers for Medicare and Medicaid Services (CMS) released guidance on State Alternative Applications for Health Coverage through the Small Business Health Options Program (SHOP). Beginning October 1, 2013, the new SHOP marketplaces will use applications to determining eligibility for participation in SHOP and enrollment in qualified health plans through the SHOP. In May 2013, CMS released model applications for shop coverage, but state-based SHOPs may also use an alternative SHOP application as approved by CMS. This guidance provides background on the development process, review, and approval of alternative SHOP applications.

States may submit SHOP applications for approval, and the alternative applications must meet the general principles of the model applications by adhering to regulations implementing the Affordable Care Act. Some aspects of the application will require formal approval. But there are also a number of ways a state can adopt the model applications without formal approval as an alternative application. For example, states can add state SHOP program names and contact information to the application, change the visuals of the application for proper branding, add language to the privacy statement, or remove questions about text messaging. Moreover, no approval is required for some modifications that minimize consumer burden.Continue Reading CMS Issues Guidance on Alternative SHOP Applications

On July 10, 2013, the Center for Medicare and Medicaid Services (CMS) released a “Frequently Asked Question” response regarding CCIIO assessment fees. The question asked “Can States collect assessment fees in their first year of Exchange operations for use in the second year of operations?” The response explained that States can decide to collect assessment

On April 10th, 2013, the U.S. Office of Personnel Management (OPM) Director of Healthcare and Insurance released an FEHB Program Carrier Letter outlining the ACA MLR procedures for FEHB insurance carriers and related entities. The Carrier Letter may be found here.

Under the ACA, all health insurance issuers—including FEHBP carriers—must submit MLR calculations to