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Federal Regulations Advisor Insight and Commentary on U.S. Government Regulatory Affairs

Tag Archives: HHS

Monday Morning Regulatory Review – 2/8/16: Petitions for Clean Power Stay; Rural Hospitals Shifts; Superfund Insurance; Size Matters More & Pay Disclosure

Posted in Judicial Process, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory Process

Regulatory practice litigation highlights over the past two weeks include the latest round of applications to stay the Administration’s Clean Power Plan, another problematic rework of Medicare rules for hospitals, and a consent decree to propose superfund insurance 30 years after authorization. On the rulemaking front, the Small Business Administration (SBA) completed critical size standards… Continue Reading

Monday Morning Regulatory Review – 1/11/16: Firearms Executive Action; IRS Withdrawal & Petition Petition Jurisdiction

Posted in Agency Authority, Judicial Process, Regulatory Process

The President of the United States (POTUS) dominated regulatory affairs last week by announcing firearms executive actions and the devil, as always, is in the details. Two other actions at least deserve a mention – the appropriate withdrawal of a contentious proposed rule that simply did not work and the dismissal of a complaint in… Continue Reading

Monday Morning Regulatory Review – 12/28/15: A Regulatory Appropriation

Posted in Agency Authority, Legislation

This last column of the year takes a different approach to regulatory practice – a survey of some of the realities of Congressional “review” in the omnibus Consolidated Appropriations Act, 2016 (CAA16), signed into law December 18, 2015. This massive appropriation includes many different styles of Congressional oversight and intervention – from outright prohibition, to… Continue Reading

Monday Morning Regulatory Review – 11/9/15: Obamacare Contraceptive Non-Profit Sequel; Crowdfunding Uncrowded; & Electric Water Effluents

Posted in Judicial Process, Judicial Review & Remedies, Regulatory Flexibility & Small Business

The United States Supreme Court (SCOTUS) granted certiorari in seven Obamacare contraceptive coverage cases signaling the return of an agency regulatory compliance issue, not a constitutional or “rights” issue. Still noteworthy, however, are two other recent actions: the Securities and Exchange Commission (SEC) adoption of crowdfunding rules and the Environmental Protection Agency (EPA) publication of… Continue Reading

Monday Morning Regulatory Review – 10/19/15: WOTUS Unconsolidated; Orphan Drug Misinterpretation; Optional Practical Training Proposed Extension-Extension; & OMB Benefit / Cost Report

Posted in Judicial Process, Judicial Review & Remedies, Regulatory Process

Some regulatory litigation settled slightly last week as the multitude of district court cases challenging the Waters of the United States (WOTUS) rule will remain where they were filed. Administrative agencies continue to amend regulations in responses to litigation with varying success, including skirting the issues that lead to a prior regulatory vacatur and a… Continue Reading

Monday Morning Regulatory Review 9/28/15: Two Midnight Rule Remand; Final Rules Respond & Proposed Rules Review

Posted in Executive - OMB Review, Judicial Process, Judicial Review & Remedies

Judicial vacaturs and remands, and agency responses to them, dominated the past week in regulatory practice. In a new case, a court found that the balancing of equities warranted only a remand for notice and comment rulemaking. Two final rules respond to a prior vacatur and impact present litigation. In addition, two agencies respond to… Continue Reading

Monday Morning Regulatory Review – 9/21/15: Contraceptive Percolation; FLSA Home Care Delay & Behavioral Science

Posted in Judicial Process, Regulatory Process

Obamacare (Patient Protection and Affordable Care Act or PPACA) percolated back to the forefront of regulatory practice last week with a new conceptual intercircuit conflict. A notice relating to the even longer running issue of labor standards applicable to home health care aids raises questions of how an agency should reset effective and compliance dates… Continue Reading

Monday Morning Regulatory Review – 9/14/15: Human Research; Food Safety Rules; Extraordinary Writs Declined; Finality Petition & Obamacare Coverage Regulation Enjoined

Posted in Judicial Process, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory Process

New food safety rules and a proposed common rule on protection of human subjects in research deserve attention in the regulatory process. An unsurprising denial of an extraordinary writ and an unsurprising petition for certiorari deserve as much attention as a surprising injunction against an insurance coverage regulation in the judicial process.

Monday Morning Regulatory Review – 7/20/15: More WOTUS Litigation; Contraceptive Coverage Uncovered & Employee / Independent Contractor Guidance

Posted in Agency Authority, Constitutional Issues in Regulations, Judicial Review & Remedies, Regulatory Process

As Washington swelters, the regulatory docket remains relatively cool. Among last week’s highlights, litigants further challenged the regulatory jurisdictional definition of “Waters of the United States” and the current, now published final iteration of Obamacare contraceptive coverage rules generate more issues for potential litigation. On a less-than-regulatory front, new guidance on the distinction between employees… Continue Reading

Monday Morning Regulatory Review – 7/13/15: Nutrition Labeling Extended; Housing Grants; Contraceptive Mandate Update; Truck Emissions & Immigration Executive Action Again

Posted in Judicial Review & Remedies, Regulatory Process

Summer in Washington and the regulatory agenda is not on vacation, but small sauntering through large items. For example, one agency has extended by a year the compliance date for a major rule, another agency created a public relations controversy while releasing a much narrower rule, a third agency released only a fact sheet on… Continue Reading

Monday Morning Regulatory Review – 6/22/15: Truck Emissions Standards & Orphan Drugs Revisited

Posted in Agency Authority, Regulatory Process

While we await the major decisions of the year by the United States Supreme Court (SCOTUS), the regulatory process was relatively quiet last week. The most significant activity focused on proposed emission standards for heavy duty trucks and a proposed rethinking of the orphan drug program, both of which deserve critical review for regulatory process… Continue Reading

Monday Morning Regulatory Review – 6/15/15: Final Rules, not Proposed; Open Internet Unstayed & Effective; Complete Agency Rulemaking Records; Aircraft Engine Endangerment; & Food Safety Returns

Posted in Agency Authority, Judicial Process, Regulatory Process

Federal courts reminded by agencies and litigators of lessons they should have previously learned last week, while agencies banked more fuel for future regulatory fires. The United States Court of Appeals for the District of Columbia Circuit reiterated that only final rules, not proposed rules, are subject to judicial review, and it also denied a… Continue Reading

Monday Morning Regulatory Review – 4/20/15: Retirement Fiduciary Definition; H-2B Authority Redux; Open Neutral Utility Internet Review; & Contraceptive Mandate

Posted in Agency Authority, Executive - OMB Review, Judicial Process

A hodgepodge of highlights from regulatory practice in the past week. The Department of Labor (DOL) today publishes its long-awaited and controversial proposed fiduciary duties rule for public comment. Slightly further down a different rocky road, DOL last week submitted two final rules to the Office of Management and Budget (OMB) that may represent an… Continue Reading

Monday Morning Regulatory Review – 1/5/15: Ozone Standards Authority; Toxic Spent Munitions; FLSA Home Care Regulations; Medicaid Hospital Limits FAQ; & Immigration Executive Action

Posted in Agency Authority, Judicial Process, Judicial Review & Remedies

Welcome to 2015, the fourth year of the Federal Regulations Advisor.  Two short holiday workweeks are compiled today in one loaded post.  The agencies may have been (largely) quiet, but the courts provided grist for the mill.  The United States Court of Appeals for the District of Columbia Circuit vacated parts of the Environmental Protection… Continue Reading

Monday Morning Regulatory Review – 11/17/14: Obamacare Subsidies Docket; Obamacare 2nd Contraceptives Accommodation & SCOTUS Criminal / Administrative Deference Invitation

Posted in Judicial Process, Judicial Review & Remedies, Regulatory Process

Last week focused on appellate practice, notably cases related to but not necessarily before, the United States Supreme Court (SCOTUS).  The United States Court of Appeals for the District of Columbia Circuit delayed further consideration of the issue of whether the Internal Revenue Service (IRS) could interpret the Obamacare (Patient Protection and Affordable Care Act… Continue Reading

Monday Morning Regulatory Review II – 11/3/14: Gainful Employment; WOTUS Science; and OMB Reviews

Posted in Executive - OMB Review, Regulatory Process

The agencies began to get busy in the two weeks running up to tomorrow’s mid-term elections.  Among key events, the Department of Education (ED) published yet another chapter in the gainful employment saga.  The Environmental Protection Agency (EPA) released the results of a scientific advisory board opining on the Waters of the United States.  The… Continue Reading

Monday Morning Regulatory Review I – 11/3/14: Notice and Logical Outgrowth; Standing Fall Down; Revised Contraceptive Rule Preliminary Injunction; SCOTUS Watch; and Shepherds’ Wages Rule

Posted in Agency Authority, Judicial Process, Judicial Review & Remedies

Catching up on the last two weeks presents a challenge:  many small actions vie for attention with a small lesson.  The United States Court of Appeals for the District of Columbia Circuit focused on the Administrative Procedure Act (APA)’s notice / logical outgrowth problem and organizational standing in two recent cases.  Two district courts issued… Continue Reading

Monday Morning Regulatory Review – 10/13/14: Hobby Lobby Implementation; Jumping the Gun on a Final Rule; Extended Waters of the United States; and EPA Rules to Watch

Posted in Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory Process

Two highly technical cases from the past week illustrate the complexity of invoking federal jurisdiction to challenge administrative action:  one, a failure to sufficiently allege that the harm was imposed by the governmental action and is redressable by the court, and the other an attempt to enforce an interpretation of potentially conflicting statues that would… Continue Reading

Monday Morning Regulatory Review – 10/6/14: Failing Grades Episode 4; Oklahoma & Obamacare Intercircuit Conflict; and Contractor Minimum Wage

Posted in Agency Authority, Judicial Review & Remedies, Regulatory Process

Two district court decisions from last week warrant some comment while agencies added more fodder for the judicial review of rules.  The United States District Court for the District of Columbia again revisited the Administration’s failing grades in regulating for-profit colleges, and their scores have not improved, but the court failed to incentivize compliance with… Continue Reading

Monday Morning Regulatory Review – 9/22/14: CFTC Extraterritorial Application; Food Safety Rules; & OMB Reviews

Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Process

Summer is clearly over and the regulatory machinery is back up to full speed.  The United States District Court for the District of Columbia remanded without vacatur more than half a dozen Commodities Futures Trading Commission (CFTC) rules for failure to adequately explain the costs and benefits of extraterritorial application of those rules.  Within the… Continue Reading

Obamacare Contraceptive Mandate Regulations Respond to Hobby Lobby and Wheaton College: A Preliminary Review

Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory Process

The Administration released new and expected revisions and proposals to Obamacare (Patient Protection and Affordable Care Act or PPACA) regulations to address exemption from the contraceptives mandate for non-profit and for-profit organizations in light of recent adverse United States Supreme Court (SCOTUS) decisions.  One interim final rule (IFR) addresses non-profits related to religious institutions, while… Continue Reading

Monday Morning Regulatory Review – 7/28/14: Contraception Regulations Revision; Advisory Committee Appointments; Orphan Drugs; and Oil & Ethanol Rail Cars

Posted in Agency Authority, Executive - OMB Review, Judicial Review & Remedies, Regulatory Process

A number of volatile issues made ripples in regulatory practice last week that will not be found in the general media.  The saga of the religious exemption from the contraceptives mandate in Obamacare (Patient Protection and Affordable Care Act or PPACA) added an introduction to a new chapter last week when the Department of Justice… Continue Reading

Monday Morning Regulatory Review – 7/21/14: IRS Tax Preparer Suits; Hobby Lobby FAQ; Obamacare in the Territories; Drone Dismissal; and an Upgrade

Posted in Agency Authority, Judicial Review & Remedies, Regulatory Process

Among its woes, the Internal Revenue Service (IRS) lost another regulatory case for exceeding its statutory authority last week, and was sued yet again.  In other fallout, the Department of Health and Human Services (HHS), Department of Labor (DOL), and Department of the Treasury (DOTr) released a FAQ in light of the United States Supreme… Continue Reading

SCOTUS: Obamacare Contraceptive Rule Failed to Accommodate Corporate Owner’s Religious Rights

Posted in Judicial Review & Remedies, Regulatory Process

The United States Supreme Court (SCOTUS) today required the Obama Administration to implement Obamacare (Patient Protection and Affordable Care Act or PPACA) and it’s regulations to permit closely held corporations to decline to purchase preventative or contraceptive health care coverage that would violate their owners’ religious beliefs in Burwell v. Hobby Lobby.  SCOTUS found that… Continue Reading