Final Rules

News & Analysis as of

CMS Finalizes Bundled Payment Program for Hip and Knee Replacements

On November 16, 2015, CMS finalized the Comprehensive Care for Joint Replacement (CJR) model. Starting April 1, 2016, certain hospitals will receive retrospective bundled payments for lower extremity joint replacement (LEJR)...more

CMS Finalizes Mandatory Bundled Payment Model for Lower Extremity Joint Replacements

On November 16, 2015, the Centers for Medicare & Medicaid Services (CMS) released final regulations implementing the Comprehensive Care for Joint Replacement Model, its five-year mandatory bundled payment program for hip and...more

Final Stark Law Regulations Published by CMS

As previously discussed here and on our Health Industry Washington Watch blog here the Centers for Medicare & Medicaid Services (CMS) has released final regulations under the physician self-referral law known as the Stark...more

CMS Finalizes Revisions to Stark to Ease Burden on Providers, Refines “Incident to” Requirements

In its calendar year 2016 Physician Fee Schedule Final Rule published in the Federal Register on November 16, 2015 (Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized amendments to the federal...more

CMS Finalizes Major Changes and Clarification to the Stark Law Regulations

Introduction - Since the passage of the Physician Self-Referral Act, also known as the “Stark Law,” health care providers have had to learn to work within and adjust to certain statutory and regulatory exceptions in...more

Final Rule Issued: Stark Law Modifications Designed to Ease the Burden of Compliance

On October 30, 2015, the Centers for Medicare and Medicaid (“CMS”) issued a final regulation that includes modifications to the Stark Law (the “Final Rule”). Among other things, the Final Rule adds two new exceptions to the...more

Prudential Regulators Adopt Final Rule for Margin on Non-cleared Swaps and Non-cleared Security-Based Swaps

On October 22, 2015, the Board of Directors of the Federal Deposit Insurance Corporation, the Office of the Comptroller of the Currency, the Board of Governors of the Federal Reserve System, the Farm Credit Administration and...more

Manatt on Health Reform: Weekly Highlights - November 2015 #3

Kansas legislators supportive of Medicaid expansion are pulled from committee; Montana’s Medicaid expansion is off to a strong start; and New Mexico sees declines in uncompensated care since ACA implementation....more

Five Years Later, Final Rules on Grandfathered Plan Status, Etc.

Today, the ACA enforcement agencies (DOL, HHS, IRS) jointly published final rules, effective January 1, 2017, on grandfathered plan status, pre-existing condition exclusions, lifetime and annual limits, rescissions, dependent...more

CMS Issues Final Payment Rules for Physicians and Hospitals

On October 30, 2015, the U.S. Department of Health and Human Services (HHS) released several final rules related to physician and hospital Medicare payments for 2016. Specifically, HHS’s Centers for Medicare and Medicaid...more

CMS Finalizes Stark Law Changes in CY 2016 Medicare Physician Fee Schedule Final Rule

This past July, on the heels of a decision in which a judge for the U.S. Court of Appeals for the Fourth Circuit characterized the federal physician self-referral prohibition commonly known as the “Stark Law” as, “even for...more

CMS and OIG Issue Final Rule on Fraud and Abuse Waivers for ACOs

On October 29, 2015, the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) of the Department of Health and Human Services published a final rule related to fraud and abuse law...more

DOE Adds New Export Control Contract Clauses, Creating Additional Risk for Contractors

Effective November 23, 2015, all solicitations and contracts issued by the Department of Energy will require compliance with applicable export control requirements....more

CMS Publishes Final Rule on Medicaid Fee-For-Service Ratesetting for Assuring Access to Covered Medicaid Services

On November 2, 2015, CMS published a final rule with comment period that is intended to provide a transparent, data-driven process for states to follow when they set Medicaid provider payment rates, effective January 4, 2016....more

CMS Finalizes “Comprehensive Care for Joint Replacement” Model

On November 16, 2015, CMS released its final rule to establish a Medicare Comprehensive Care for Joint Replacement (CJR) model that will test whether bundled payments to acute care hospitals for lower extremity joint...more

The Push for Pay Transparency and Equity

On September 10, 2015, the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) published its final rule on pay transparency, setting a trend for states to enact legislation aimed at strengthening...more

CMS Finalizes Medicare Physician Fee Schedule Rates, Policies for 2016

On November 17, 2015, the Centers for Medicare & Medicaid Services (CMS) published the final rule to update the Medicare physician fee schedule (MPFS) for calendar year (CY) 2016. Despite the Medicare Access and CHIP...more

UPDATE: When Will The Exemption Changes Occur?

Since our recent post on this topic, U.S. Solicitor of Labor M. Patricia Smith has appeared at the annual conference of the American Bar Association's Labor & Employment Law Section. Some of her remarks indicate that the U.S....more

Three More FSMA Rules Finalized As the Year Comes to a Close

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the...more

EPA Updates UST Rules

EPA has issued a final rule applicable to new and existing underground storage tanks (“USTs”). The rule is the first significant amendment to EPA’s 1988 UST regulations. Here are some of the highlights....more

EPA Tightens Wastewater Discharge Limits for Power Plants

EPA recently issued a final rule setting new Effluent Limitation Guidelines and Standards for the Steam Electric Power Generating Point Source Category. According to EPA, while the electric power industry has made...more

Attention Food Importers: New FDA Final Rule on Foreign Supplier Verification Programs

On November 13, 2015, the FDA finalized its rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. The rule is scheduled to be published in the Federal Register on November...more

FINALLY… SEC Finalizes Crowdfunding Rules

On October 30, 2015, the U.S. Securities Exchange Commission ("SEC") adopted final rules which will allow companies to offer and sell equity and securities through a crowdfunding exemption in the Jumpstart Our Businesses Act...more

New Ozone Standard: Better Than it Could Have Been, But Creates Uncertainty for Industry

EPA has issued a final rule tightening the primary ozone national ambient air quality standard (“NAAQS”) down to 70 ppb from the 75 ppb limit established in 2008. The new NAAQS takes effect on December 28, 2015 (despite the...more

Two Years and Essentially As Proposed: SEC Adopts Final Crowdfunding Rules

What is “Crowdfunding”? - Crowdfunding is a term often used to describe an evolving method of raising money from individuals through the Internet. The term is often applied to any number of different activities that are...more

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