News & Analysis as of

Final Rules

The 340B Drug Pricing Program: New CMS Final Rule Draws a Motion for Preliminary Injunction from Hospital Groups

On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more

Status of State Plan Implementation of OSHA’s E-Recordkeeping Data Submission Rule – Updated

by Conn Maciel Carey LLP on

OSHA’s Final Rule to “Improve Tracking of Workplace Injuries and Illnesses” (aka the E-Recordkeeping Rule) requires employers of certain sizes that fall into certain categories to proactively submit electronic injury and...more

The Obama Administration’s Overtime Final Rule: Unlawful and Revisited

by Benesch on

On October 30, 2017, the Department of Labor (the “Department”) filed a notice to appeal a decision by Judge Amos Mazzant of the Eastern District of Texas, holding that the Overtime Final Rule (“Final Rule”) was unlawful. The...more

Final Home Health Rule Drops Controversial Proposed Payment Model

by Bass, Berry & Sims PLC on

Last week, home health agencies welcomed the Centers for Medicare & Medicaid Services' (CMS) decision to drop a controversial proposed payment model and leave largely unchanged the current payment system. Responding to...more

Top Takeaways for Medicare Physician and Hospital Payments in 2018

by Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more

Deadline Approaching for Refiling Designated Agent Information Under Digital Millennium Copyright Act

by Perkins Coie on

Last November, the U.S. Copyright Office issued its Final Rule regarding designating copyright agents under the Digital Millennium Copyright Act (DMCA) and announced a new electronic system for filing such designations....more

CMS Releases 2018 OPPS/ASC Payment Systems Final Rule

The Centers for Medicare and Medicaid Services (CMS) issued the 2018 Medicare: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Final Rule with comment...more

Halloween Ushers In Potential Resurrection Of Proposed Overtime Rule

You thought it was dead – but the United States Department of Labor (DOL) announced on October 30 that it plans to appeal a Texas district court’s August ruling which invalidated the Obama administration’s overtime rule. The...more

Buckle Up for 2018: New Overtime Regulations Manufacturing Confusion

Readers of this blog may recognize I have spilled a good deal of ink over the last two years discussing the impact of the Obama Administration’s efforts to increase the minimum salary for certain employees to be considered...more

Newly-Announced 340B Payment Rule Presents Financial & Operational Challenges to All Covered Entities

by Polsinelli on

In its 2018 Outpatient Prospective Payment System final rule (Final Rule) issued Nov. 1, Centers for Medicare and Medicaid Services (CMS) implemented a significant Medicare Part B payment reduction for separately payable,...more

CMS Finalizes Medicare Part B Reimbursement Cut for 340B – What Does it Mean?

On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the...more

CMS moves forward with controversial reductions in Medicare reimbursement for 340B drugs

by Dentons on

On November 1, 2017, the Centers for Medicare & Medicaid Services (CMS) posted a display copy of its final rule regarding the Medicare outpatient prospective payment system (OPPS) for Calendar Year (CY) 2018. (The final rule...more

The Obama Administration’s Overtime Final Rule: Unlawful and Revisited

by Benesch on

On October 30, 2017, the Department of Labor (the “Department”) filed a notice to appeal a decision by Judge Amos Mazzant of the Eastern District of Texas, holding that the Overtime Final Rule (“Final Rule”) was unlawful. The...more

Red Notice Newsletter - October 2017

ANTICORRUPTION DEVELOPMENTS – Global Compliance Overhaul for SAP as DOJ and SEC Investigate Payments Allegedly Related to South African Government Contracts – On October 26, 2017, German software company SAP SE...more

NESHAP/Clean Air Act: U.S. Environmental Protection Agency Final Rule Addressing Publicly Owned Treatment Works/Residual Risk and...

The United States Environmental Protection Agency (“EPA”) issued a final rule addressing the Clean Air Act National Emission Standards for Hazardous Air Pollutants (“NESHAP”) for Publicly Owned Treatment Works...more

A Deeper Dive: The CFPB Short-Term Small- Dollar Lending Rule

Introduction - By now you’ve likely heard that the Consumer Financial Protection Bureau (CFPB) has released a final small-dollar lending rule. The hallmark of the rule is the requirement That lenders make a reasonable...more

Washington State’s Paid Sick and Safe Leave Update: The Administrative Regulations Are Finally Final

Washington’s Department of Labor and Industries has now concluded its process for drafting and finalizing the regulations for implementing Washington’s paid sick leave law, which becomes effective on January 1, 2018. Now...more

Department of Labor's Fiduciary Rule

by Ropes & Gray LLP on

David Tittsworth, Ropes & Gray investment management counsel, analyzes the possible fate of the Department of Labor’s Fiduciary Rule. ____ In April 2016, the Department of Labor issued a final rule that amends the...more

If Pain, Yes Gain — Part XXXVIII: Washington Releases Final Paid Sick Leave Rules

by Seyfarth Shaw LLP on

Seyfarth Synopsis: On October 20, 2017, the Washington Department of Labor & Industries released the state’s final paid sick leave rules. Among other things, the final rules impose a number of additional burdens on covered...more

CFPB’s Effort to Axe Class Waivers Gets Axed by the Senate

By the hair of its chinny chin chin, the Senate voted on Tuesday to nullify the CFPB’s previously announced final rule that would have prohibited banks, credit card companies, and other financial service entities from...more

U.S. Court of Appeals for the District of Columbia Circuit Issues Decision on Definition of Solid Waste

by Blank Rome LLP on

In American Petroleum Institute (“API”) v. Environmental Protection Agency (“EPA”), the D.C. Circuit upheld, severed, and vacated portions of a 2015 EPA final rule, Definition of SolidWaste (the “Final Rule”). As explained...more

Clinical trials Part I: The upcoming clinical trials reporting rule

by Thompson Coburn LLP on

In 2007, Congress passed the “Food and Drug Administration Amendments Act of 2007,” the purpose of which was, in part, to update the FDA’s rules surrounding clinical trials. The FDA took nearly a decade to review the law,...more

Department of Labor and Industries Issued Final Paid Sick Leave Rules

On Friday, October 20, 2017, the Department of Labor and Industries issued its final paid sick leave rules addressing employer requirements and employee rights under Initiative 1433. Beginning on January 1, 2018, all...more

Weekly Update Newsletter - October 2017 #2

by PilieroMazza PLLC on

GOVERNMENT CONTRACTS - “Conferees Will Determine Fate of Defense Bill Provision to Deter Frivolous Contractor Bid Protest” Government Executive, October 13, 2017. Retrieved from govexec.com Senators, as they have in...more

EEOC Issues Final Rule To Modify FOIA Regulations

Changes Will Affect Certain FOIA Procedures, Federal Agency Says - WASHINGTON -- The U.S. Equal Employment Opportunity Commission (EEOC) has finalized an update of its Freedom of Information Act (FOIA) procedures by...more

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