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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 – 8/22/16: Tobacco Products Guidance Vacatur; Waters Abeyance; Swaps Remand Response & Medium and Heavy Duty Emissions

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

A hodgepodge of actions occurred in regulatory practice last week, including a district court decision vacating part of an agency guidance and a court of appeals decision to hold in abeyance litigation on regulatory efficacy to avoid possible conflicts with a sister circuit.  One agency published a final response to a remand that raises old… Continue Reading

Monday Morning Regulatory Review – 7/25/16: Immigration Rule or Non-Rule Rehearing; Contraceptives Information Request & Zubik Review; Distance Learning Accreditation & Payday Loans

Posted in Judicial Review & Remedies, Regulatory Process

Inter-convention, highlights from regulatory practice might be sparse, but both litigation and regulation provide some spice.  The Administration filed a petition for rehearing in the immigration policy case and a further response to the remand of a dozen decisions on the Administration’s contraceptive mandate application to religious organizations.  Two rules with regulatory process implications were… Continue Reading

Monday Morning Regulatory Review – 7/4/16: Agency Exceeds Authority in Limiting Obamacare Exceptions; Second Persuader Challenge Persuaded; Conviction Guidance as Final Agency Action & Regulatory Deck-Clearing

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

Independence Day – a day to celebrate the right to choose between praising or criticizing the administrative state – or both.  Several courts took exception from Administration regulatory actions in the past week, including a regulation that exceeded the agency’s authority, a regulation that likely failed to comport with a number of superior requirements, and… Continue Reading

Monday Morning Regulatory Review – 6/6/16: Warning Letter Finality; Untrusted Fiduciary Rule Tested; Great Lakes Pilotage Foundering; Oyster Illness Hazard Petition Grounding & Payday Loans Proposal Interest

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

The United States Supreme Court (SCOTUS) decision in United States Army Corps of Engineers v. Hawkes Co. last Monday reverberated on Friday in United States Court of Appeals for the District of Columbia Circuit in dynamic Fair Labor Standards Act (FLSA) litigation.  In two different district courts, expected litigation challenged another Department of Labor (DOL)… Continue Reading

Monday Morning Regulatory Review – 5/23/16: Clean Power En Banc; FLSA Overtime & Exemptions; Food Labeling; E-Cigarettes Baggage & Unified Agenda

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

More surprises after Spokeo and Zubik leavened last week’s regulatory practice, including an order by the United States Court of Appeals for the District of Columbia Circuit to hold en banc oral argument on the many challenges to the Administration’s environmental signature Clean Power Plan.  Major economically significant final rules to hit the street last… Continue Reading

SCOTUS Remands Contraceptives Regulation Cases to Uncertain Future

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

The United States Supreme Court (SCOTUS) on Monday remanded to the lower courts its docket of cases raising the question of whether the Department of Health and Human Services (HHS) sufficiently accommodated religiously affiliated non-profits in its exception from the contraceptives mandate.  The SCOTUS orders in Zubik v. Burwell and its dozen fellow travelers make… Continue Reading

Monday Morning Regulatory Review – 5/16/16: Deeming Rule & Litigation; Safety and Health Electronic Recordkeeping; Reconstructed or Modified Methane; Transgender Accommodations Guidance; & Conflicting Disability Compliance

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

Highlights with no surprises in regulatory practice last week focused on the rush to complete regulatory actions.  The Administration issued the controversial tobacco “deeming rule” and a vaping manufacturer immediately sued.  A new electronic reporting requirement must be challenged in affirmative pre-enforcement litigation because the underlying statute may bar challenges to the regulations in defensive… Continue Reading

Monday Morning Regulatory Review – 5/9/16: Consumer Class Non-Arbitration; Citizenship and Immigration Fees, Mental Competency for Firearms & Health COOP Exceptionalism

Posted in Agency Authority, Regulatory Process

Four highlights from last week’s regulatory practice include unsurprisingly swings in money issues and engagement in one of the most emotional topics for any regulatory.  The Consumer Financial Protection Bureau (CFPB) took steps to rein in arbitration clauses in consumer financial services contracts.  The Department of Homeland Security (DHS) proposed substantial increases in citizenship and… Continue Reading

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