Final Rules

News & Analysis as of

Final Regulations Released Regarding PFIC Ownership Determination and Annual Reporting Requirements

On December 27, 2016, the Treasury Department (Treasury) and Internal Revenue Service (IRS) released final regulations regarding the determination of ownership of a passive foreign investment company ("PFIC") and regarding...more

U.S. Department of Labor Issues More Stringent Regulations for the Review of Disability Benefit Claims

The Department of Labor (DOL) published the Final Rule on December 19, 2016, revising the regulations addressing claims procedures for ERISA plans providing disability benefits. These claims procedures were developed pursuant...more

Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects

On January 19, 2017, the U.S. Environmental Protection Agency (EPA), together with a host of other federal agencies, announced revisions via a final rule to modernize, strengthen, and make more effective the Federal Policy...more

CMS Finalizes Revamped Home Health Agency Conditions of Participation

CMS recently issued revamped home health agency (HHA) conditions of participation (CoPs), strengthening patient confidentiality, patient rights, quality assessment, care and performance standards. The final rule was published...more

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

In Depth - On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.”...more

The Final Rule: DOL Releases Additional FAQs Related to New Fiduciary Rule

The Department of Labor (DOL) has released two additional sets of FAQs providing guidance related to its final rule expanding the definition of fiduciary “investment advice” (the Final Rule) for purposes of the Employee...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

USCIS Finalizes International Entrepreneur Rule

On January 17, 2017, the U.S. Citizenship and Immigration Services (USCIS) finalized the International Entrepreneur Rule. This rule was proposed last summer by the Obama Administration, after Congress failed to pass any...more

U.S. Department of Education Issues Final Regulations Regarding Teacher Preparation Programs

On October 31, 2016, the U.S. Department of Education (ED) published final regulations regarding teacher preparation programs, implementing the accountability provisions of Title II of the Higher Education Act (HEA) and...more

Clean Water Act Nationwide Permits Reissued: Permit Streamlining Remains Intact

The U.S. Army Corps of Engineers (Corps) on Jan. 6, 2017, published a final rule reissuing its Clean Water Act Nationwide Permits (NWPs) with some modifications (88 Fed. Reg. 1860). The NWP program authorizes streamlined...more

Retailers Seek to Improve Website Accessibility Following Surge of ADA Claims

Retailers have faced a wave of demand letters and lawsuits recently alleging that their websites are inaccessible in violation of the Americans With Disabilities Act of 1990 (the “ADA”), despite the fact that the ADA and its...more

OSHA Issues Final Rule Clarifying Ongoing Recordkeeping Obligations

OSHA is scheduled to publish a final rule January 19, 2017 in the Federal Register, clarifying an employer’s ongoing duty to correct records of injuries and illnesses. The rule, which modifies 29 CFR Part 1904, will become...more

The MACRA Final Rule: In Search of the “Goldilocks” Model

The Medicare Access and CHIP Reauthorization Act (“MACRA”) Final Rule published late last year implements CMS’ new payment approach for physicians and other Medicare Part B eligible clinicians under the Merit-Based Incentive...more

UPDATE: SBA Clarifies Profit Percentages for Joint Ventures under the Small Business Mentor-Protégé Program

As previously reported, on July 22, 2016, the Small Business Administration (SBA) issued a final rule establishing a government-wide mentor-protégé program encompassing all small business concerns....more

States Argue That Texas Court Properly Blocked Overtime Rule

In a legal brief filed on January 17, 2017, the 21 states that obtained a nationwide preliminary injunction that blocks the U.S. Department of Labor (DOL) from implementing its revisions to overtime rules under the Fair Labor...more

State Plaintiffs Urge Fifth Circuit to Affirm Nationwide Injunction Blocking DOL Overtime Rule

In the latest round in the litigation between 21 States, led by the State of Nevada, and the Department of Labor regarding the Final Rule, the State Plaintiffs filed their appeal brief today with the Fifth Circuit, urging the...more

HHS Finalizes Major Changes to the Common Rule

On January 18, 2017, the U.S. Department of Health and Human Services (HHS), together with fifteen other federal Departments and Agencies, issued a final rule intended to revise and modernize the federal Policy for the...more

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

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