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.

Background


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

On March 17, 2014, the Centers for Medicare and Medicaid Services (CMS) issued for public inspection a proposed rule regarding the Exchange and Insurance Market Standards for 2015 and later years. The proposed rule addresses requirements under the Affordable Care Act (ACA) applicable to insurance issuers, exchanges, and other entities.
Continue Reading CMS Issues Proposed Rule Regarding Exchange and Insurance Market Standards for 2015 and Beyond

In a March 10, 2014 letter to Congress, CMS Administrator Marilyn Tavenner indicated that—based on concerns from Congress and the public—CMS shall not finalize the Proposed Rules’ proposals that would have:

  • Removed the protected class definition for immunosuppressant drugs used in transplant patients, antidepressants, and antipsychotic medicines used to treat schizophrenia and certain related disorders

On January 27, 2014, the Internal Revenue Service (IRS) issued proposed regulations (“Proposed Regulations”, available here) clarifying the penalties imposed on nonexempt persons who fail to maintain minimum essential coverage as required by Internal Revenue Code (Code) Section 5000A. Very generally, Code Section 5000A requires nonexempt persons to either (1) maintain minimum essential coverage, or (2) make a shared responsibility payment. The Proposed Regulations:

  1. explain which government-sponsored programs do not qualify as “government-sponsored minimum essential coverage”;
  2. clarify that “minimum essential coverage” excludes health plans and programs that consist solely of “excepted benefits”;
  3. clarify—for purposes of the “lack of affordable coverage” exemption—the required contribution for individuals eligible to enroll in an eligible employer-sponsored plan that provides employer contributions to health reimbursement arrangements (HRAs) or wellness program incentives;
  4. expand the definition of hardship exemptions that may be claimed on a federal income tax return and provide additional guidance; and
  5. clarify the computation of the monthly “shared responsibility payment” penalty amount.

Comments with respect to the Proposed Regulations are due by April 28, 2014, and a public hearing is scheduled for May 21, 2014.


Continue Reading IRS Promulgates Clarifying Regulations Regarding Abstainer Penalties Under the ACA

On November 25, 2013, the Department of Health and Human Services (HHS) released a Proposed Notice of Benefit and Payment Parameters for 2015 regarding the Affordable Care Act’s Transitional Reinsurance Program (TRP) fee.

The Proposed Notice includes the previously announced carve-outs from the TRP fee for the 2015 and 2016 years for certain self-insured, “self-administered”

On September 25, 2013, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule to establish the Basic Health Program pursuant to Section 1331 of the Affordable Care Act (ACA). The Basic Health Program aims at assisting individuals whose incomes exceed the threshold for Medicaid and similar programs, but who cannot afford to purchase coverage in the ACA’s Health Insurance Marketplaces (i.e., .individuals who have income levels between 133 to 200 percent of the federal poverty level). States that establish a Basic Health Program will receive federal funding equal to 95 percent of the amount of the premium tax credits and the cost sharing reductions that would have otherwise been provided to (or on behalf of) eligible individuals if these individuals enrolled in Qualified Health Plans through the Marketplaces.
Continue Reading CMS Publishes Proposed Rule on Basic Health Program

On September 19, 2013, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding financial integrity and oversight standards with respect to Affordable Care Act Insurance Exchanges.

As of January 1, 2014, Affordable Insurance Exchanges (“Exchanges”) can make available private health insurance coverage for qualified individuals and employers. This proposed rule outlines

On August 7, 2013, the Office of Personnel Management (OPM) released a proposed rule on federal employee health benefits for members of Congress and congressional staff. The Affordable Care Act (ACA) contains a provision requiring Congress and their staff to obtain health insurance coverage via an Affordable Insurance Exchange or a health plan created by