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

Tag Archives: Department of Health and Human Services

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

Monday Morning Regulatory Review – 6/2/14: Health & Food Regulations; Expected Electricity Carbon Rule; Waters of the United States; & Acid Rain Litigation

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

The short holiday workweek produced few hard regulatory events although soft indications continue of the federal government’s intent to regulate the minutiae of daily life.  The Department of Health and Human Services (HHS) published its final rule on long-term Obamacare exchange and insurance market standards and extended the comment period on several food labeling proposals. … Continue Reading

Monday Morning Regulatory Review – 4/28/14: Net Neutrality II; Coal Dust; Tier 3 Vehicle Emissions Standards; Beer & Grain Retreat; & Drones Won’t Fly

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

A crowded week of regulatory events means that some highlights must be left behind.  Highlights of the week in review (and the litigation to come) include the Federal Communications Commission (FCC) reboot of its vacated net neutrality rules, the Department of Labor (DOL) Federal Mine Safety and Health Administration (FMSHA) release of its new coal… Continue Reading

Monday Morning Regulatory Review: 4/14/14 – Syrian Sanctions Regulations Withdrawal; Medical Safety Codes Incorporated; & Official Seals Banned

Posted in Executive - OMB Review, Regulatory Process

With income tax filings due tomorrow, regulators appear glued to their computers, not preparing regulations, but entering numbers on their keypads, and, therefore, this week’s Monday Morning Regulatory Review focuses on three very different regulatory events:  The Department of the Treasury (DOTr)’s Office of Foreign Assets Control (OFAC) withdrew from public inspection a final rule… Continue Reading

Monday Morning Regulatory Review – 4/7/14: COOL First Amendment; Rearview Cameras; Electric Utility Safety Standards; & OMB Reviews

Posted in Constitutional Issues in Regulations, Executive - OMB Review, Judicial Review & Remedies

The United States Court of Appeals for the District of Columbia Circuit took a significant step toward giving agencies more definitive guidance on the whether and how information disclosure can be used as a regulatory mechanism by ordering, on its own initiative, en banc review of a panel decision issued only a week ago.  On… Continue Reading

Administrative Procedure Act Logical Outgrowth & Lack of Notice: D.C. Circuit Affirms Vacatur of HHS Hospital Reimbursement Rule

Posted in Judicial Review & Remedies

The United States Court of Appeals for the District of Columbia today affirmed the vacatur the portion of a Department of Health and Human Services (HHS) final rule setting hospital reimbursement rates because the final rule took a position diametrically opposed to the proposed rule without adequate notice that the final position was a possibility… Continue Reading

Monday Morning Regulatory Review – 3/31/14: Obamacare Extension; Waters of the United States; IRS Meets Bitcoin; & COOL Regulations Preliminary Injunction Denial Affirmed

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

Anthology of the highlights of the last week in regulatory practice is somewhat focuses on some large issues that drew immediate attention, even if the substantive resolutions are many years away.  Foremost (of course) is the latest adjustment in Obamacare in Bulletins from the Department of Health and Human Services (HHS) Centers for Medicare and… Continue Reading

Monday Morning Regulatory Review – 3/24/14: Debit Card Fees Revival; Contractors & Disability Data Analyses; Mathematics & Law; Food Safety Slip; & Obamacare Slide

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

This column changes each and every week as the moving parts of regulatory law shift.  Highlights from the past week illuminate significant government litigation victories in the revival of a regulation that set maximum fees between retailers and servicers of debit cards, summary judgment for the government in a challenge to a rule setting affirmative… Continue Reading

Monday Morning Regulatory Review I – 3/17/14: Obamacare Risks; Third-Party Payments; Medicare Drug Withdrawal; & Congressional Interventions

Posted in Legislation, Regulatory Process

Frenetic regulatory activity in the past week covered large swaths of substantive administrative law in the Administration and the Congress, and likely set the stage for more regulatory litigation, so much so that this Monday Morning Regulatory Review (MMRR) must be divided into two posts.  This post highlights the Department of Health and Human Services… Continue Reading

Monday Morning Regulatory Review – 3/10/14: Obamacare Delays & Exceptions; Regulatory Budget; & EPA Tier 3 Vehicle Emissions

Posted in Regulatory Process

Last week heard significant noise in the regulatory world with very little actual substantive movement.  The key events were a further delay in the Obamacare revision of insurance plans, while, at the same time, finality on some large employer insurance requirements.  Obamacare reporting reflected a larger sweep of regulatory budgeting – more funds swept (or… Continue Reading

Monday Morning Regulatory Review – 3/3/14: FDA Food Labeling; DOJ Guidelines on Journalist Subpoenas; & EPA Greenhouse Gas Data

Posted in Agency Authority, Regulatory Process

Odds and ends from the Federal Register last week  The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) proposed wholesale changes in food labeling, a White House priority.  The Department of Justice (DOJ) published a non-regulatory controversial final policy on how it will relate to news media in requesting information and… Continue Reading

Monday Morning Regulatory Review – 1/27/14: SCOTUS Enjoins Obamacare Preventive Contraception Rule; NLRB Rescinds Vacated Rule; OMB Economically Significant Reviews; and Social Cost of Carbon & Crystalline Silica Extensions

Posted in Judicial Review & Remedies, Regulatory Process

The United States Supreme Court (SCOTUS) last Friday enjoined enforcement of the Department of Health and Human Services (HHS) regulations on preventive contraception minimum regulations under Obamacare against several non-profit organizations in a procedural order that may be a guidepost for future litigation.  Regulatory activity of interest included the National Labor Relations Board (NLRB) best… Continue Reading

Monday Morning Regulatory Review – 1/13/14: Electric Generating Emissions; Demise of the NLRB Posting Rule; Obamacare Regulation by Blog Post; Aircraft Repair Stations Coordination; Unified Agendas & Regulatory Plans

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

The beginning of a new year raises several process questions for regulatory practitioners.  The Environmental Protection Agency (EPA) published a new proposed rule to limit emissions from new electric power generators – a rule EPA released several months ago, but only published last week.  The National Labor Relations Board (NLRB) threw in the towel on… Continue Reading

Monday Morning Regulatory Review – 1/6/14: Obamacare @ SCOTUS; Mortgage Disclosure Relief; Wood Burning Stoves; and Firearms & Mental Health

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

The end of 2013 was hardly quiet, with five notable events worth highlighting.  While this blog has foresworn further coverage of the crenelated litigation in the United States District Courts over the Obamacare contraceptive coverage requirements, one case has moved to an unusual posture before the United States Supreme Court (SCOTUS) though it may not… Continue Reading

Monday Morning Regulatory Review – 12/23/13: Obamacare Guidance, not Rules, & More Exceptions; Carbon Capture & Sequestration; OMB Reviews; Contracts, Dogs & Cats

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

As the end of year holidays and the health insurance deadline nears, the patchwork of Obamacare fixes and court decisions creating exceptions grows geometrically, making Obamacare less and less universal: at least two core policy changes and three new court decisions highlight the week.  The Environmental Protection Agency (EPA) released a final rule that may… Continue Reading

Monday Morning Regulatory Review – 12/16/13: Obamacare Deadlines; Labor Elections Rule; Swaps Litigation; Vacating Empty Rules; & the Volcker Rule

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

Regulatory highlights from the past week include the Administration pushing back the deadline for applying for Obamacare and then begging insurance companies for even more time and leniency.  Two independent agencies – the Commodities Futures Trading Commission (CFTC) and the National Labor Relations Board (NLRB) threw in the towel on litigation and proposed new rules… Continue Reading

Monday Morning Regulatory Review – 12/2/13: Obamacare, Tax Exempt Organizations, Social Cost of Carbon, and Litigation Management

Posted in Judicial Review & Remedies, Regulatory Process

The Administration made major and often unheralded moves last week on several different issues that deserve highlighting.  The success or failure of the Obamacare website may have dominated the general and political news media, but lurking behind that behemoth political risk the Administration moved with haste to finalize and publish massive new Obamacare / Medicare… Continue Reading

SCOTUS Grants Review of Obamacare Contraceptive Rule & Religious Freedom Rights

Posted in Constitutional Issues in Regulations, Judicial Review & Remedies

The United States Supreme Court (SCOTUS) announced today that it will hear two cases raising questions of whether the Administration has adequately respected a business owner’s freedom of religion in the Obamacare (Patient Protection and Affordable Care Act or PPACA) regulations when it required that employers provide no cost preventive contraceptive care in employee health… Continue Reading