Final Rules

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Blog: OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare...more

Weekly Update Newsletter - January 2017 #2

GOVERNMENT CONTRACTS - Federal Acquisition Regulation; Federal Acquisition Circular 2006-95 - This Federal Acquisition Circular provides a summary presentation of final rules issued by the Department of Defense...more

DOL’s Final Rule Modifies ERISA Disability Claim Regulations

Effective January 18, 2017, the Department of Labor issued a "final rule" modifying 29 CFR § 2560.503-1, governing claims procedures for disability benefits under ERISA plans. The new regulations apply to disability claims...more

Is There an Opening to Withdraw or Modify Electronic Logging Device Rule?

The Federal Motor Carrier Safety Administration (FMCSA) published its final electronic logging device (ELD) rule on Dec. 16, 2015, which the FMCSA claims, "is intended to help create a safer work environment for drivers, and...more

CMS Finalizes Testing of New Episode Payment Models and MSSP Track 1+ ACO

On January 3, 2017, CMS published a final rule addressing three care coordination models: - Cardiac care: CMS added two new cardiac care episode payment models (“EPMs”) for items and services furnished to patients...more

HHS OIG Finalizes New Exclusion Rules as Administration Exits

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

CFPB issues final rule to adjust civil penalties for inflation

The CFPB has published a final rule to adjust for inflation the civil penalties within its jurisdiction. The adjustments are required by the Federal Civil Penalties Inflation Adjustment Act of 1990 which, pursuant to a 2015...more

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

FERC Increases Maximum Civil Monetary Penalties

On January 9, 2017, the Federal Energy Regulatory Commission (FERC) issued a Final Rule—following an Interim Final Rule issued June 29, 2016, amending its regulations governing the maximum civil monetary penalties assessable...more

HRSA Releases Ceiling Price and CMP Final Rule

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

Injunction of the DOL’s Overtime Rule and Its Appeal

Is the Department of Labor (DOL) overtime rule now dead? Will the overtime rule be modified to a more modest version? Much uncertainty remains regarding the recently announced overtime rule in both the legal and the political...more

Final Rule for Penalties Relating to 340B Drug Pricing Program Nears Release

On December 23, 2016, the White House Office of Management and Budget (OMB) completed review of a final rule for penalties under the 340B Drug Pricing Program for drug manufacturers that intentionally charge a 340B covered...more

US Fish and Wildlife Service Finalizes Eagle Rule Revision

On December 14, 2016, the US Fish and Wildlife Service (FWS) finalized its proposed revisions to the Eagle Rule (Final Rule) and released its Record of Decision (ROD). The Final Rule allows companies and others to obtain...more

SBA Expands and Clarifies Ability of SBICs to Finance in Passive Businesses

New SBA rule affects the holding company and the blocker corporation exceptions for SBICs’ financing passive businesses. On December 28, the U.S. Small Business Administration (SBA) released a Final Rule modifying its...more

New Final Claims Regulations Regarding Disability-Related Claims Has Been Issued by DOL

On December 16, 2016, the U.S. Department of Labor (DOL) published a final rule altering the claims procedure regulations for ERISA plans providing disability benefits (the “Final Rule”). The regulations, which finalize...more

Federal Judge Blocks Transgender Protections

On Saturday, December 31, 2016, a federal judge in Texas entered a nationwide preliminary injunction barring the enforcement of antidiscrimination protections pertaining to transgender and abortion health services and...more

EEOC Rule on Affirmative Action for Individuals With Disabilities in Federal Employment

Seyfarth Synopsis: These new regulations require federal agencies to be “model employers” of individuals with disabilities. As such, they now must take specific steps that are “reasonably designed” to gradually increase the...more

OT Exemption Rules Lawsuit Will Proceed Despite Appeal

Judge Amos Mazzant of the U.S. District Court for the Eastern District of Texas has decided that he will not halt the lawsuit challenging the U.S. DOL’s new overtime exemption rules pending a ruling from the 5th Circuit Court...more

HHS OIG Expands Anti-Kickback Safe Harbors and Civil Monetary Penalties Law Exceptions; Issues Guidance on Gifts of Nominal Value

On December 7, 2016, the Office of Inspector General (the “OIG”) of the U.S. Department of Health and Human Services (“HHS”) issued a final rule modifying the safe harbors to the anti-kickback statute1 and the civi monetary...more

Portions of Section 1557 of the Affordable Care Act Enjoined by Texas Federal Court – Majority of Regulation Remains Intact.

In May 2016, the Office of Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“DHHS”) issued a Final Rule implementing Section 1557 of the Affordable Care Act (“ACA”). Section 1557 prohibits “covered...more

OFAC Expands Iran-Related Authorizations for Medicine, Medical Devices and Agricultural Commodities

On December 23, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued a Final Rule amending the Iranian Transactions and Sanctions Regulations, 31 C.F.R. Part 560 (ITSR) to expand the...more

U.S. EPA Chooses Flexible Approach to Stormwater General Permit for Small Communities

The U.S. Environmental Protection Agency (EPA) is issuing a final rule revising the regulations governing how small municipal separate storm sewer systems (MS4s) obtain coverage under National Pollutant Discharge Elimination...more

Court blocks DOL’s new overtime rule from taking effect

The Fair Labor Standards Act (FLSA) generally requires employers to pay employees at least the federal minimum wage (currently $7.25 per hour). The FLSA also requires employers to pay employees overtime compensation for all...more

CMS Finalizes Mandatory Cardiac Care Bundled Payment Model and More

On December 20, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (the Final Rule) which includes three new mandatory episode-based payment programs for cardiac care, as well as the expansion of the...more

TTB Publishes Final Rule to Streamline Importation and Exportation Procedures

On December 22, 2016, TTB published a Final Rule implementing the streamlined importation and exportation procedures established by the International Trade Data System (ITDS). See 91 Fed. Reg. 94186 (Dec. 22, 1016). ITDS is...more

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