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

Tag Archives: HHS

Monday Morning Regulatory Review – 4/25/16: Medicare Reimbursements; Medical Facility Fire Safety; Internet Neutrality Privacy; WOTUS on the Ohio River & Drone Review

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

This week’s highlights in regulatory practice seem to focus on periodic regulations from the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS).  CMS last week submitted an annual batch of Medicare financing regulations for publication this week, with at least one hidden response to a court.  Not far behind,… Continue Reading

Monday Morning Regulatory Review – 4/11/16: Corporate Inversions Ruled Out; Untrusted Fiduciary Rule; Sanitary Transport; Silica Suits & Agency Authority Constitutional Challenge

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

The Administration fully engaged in institutionalizing its policies through promulgated rules with the Employee Benefits Security Administration (EBSA), the Internal Revenue Service (IRS), and the Food and Drug Administration (FDA) all publishing economically significant final rules this week.  Petitions for review challenged the Occupational Safety and Health Administration (OSHA)’s crystalline silica rule as expected.  In… Continue Reading

Monday Morning Regulatory Review – 4/4/16: SCOTUS Seeks Contraceptive Alternatives; Religious Discrimination Regulations; Persuader Suits & Retirement Fiduciary Duties Debut

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

The United States Supreme Court (SCOTUS) rarely orders post-argument briefing, particularly on a discrete but lopsided question, but it did so last week on an issue of agency compliance with specific statutory freedom of religion requirements.  Several agencies, also last week, adopted “regulations” that further express grant administration policy for religiously affiliated non-profits.  Of the… Continue Reading

Monday Morning Regulatory Review – 3/21/16: SCOTUS Weighing Regulatory Accommodation; Another MATS Challenge; Overtime Laboring; Speculative Endangerment; & Removing Obsolescence

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

This week the United States Supreme Court (SCOTUS) will take up the latest edition of a significant statutory and regulatory conflict and SCOTUS may soon return to another substantial Administrative Procedure Act (APA) remand without vacatur case.  Far up the street, the Office of Management and Budget (OMB) began review of one of the more… Continue Reading

Monday Morning Regulatory Review – 2/15/16: Scalia Passing; Clean Power Plan Stayed; Mandamus, Compulsion, Deadlines, and Escalations; & Light Bulb and Computer Efficiency

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

No event in regulatory practice last week comes near in importance to the sudden passing of Justice Antonin Scalia. The United States Supreme Court (SCOTUS) did take the unusual step of granting a stay of the Administration’s signature environmental efforts pending resolution of litigation in the court of appeals and potentially before it. The United… Continue Reading

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