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Recordkeeping Requirements Department of Health and Human Services (HHS)

Whiteford

New CMS EMTALA Portal Signals CMS Continued Focus on Enforcement Fight Against State Abortion Bans

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On May 21, the Centers for Medicare and Medicaid Services (CMS) announced a new option on CMS.gov to allow individuals to more easily file an Emergency Medical Treatment and Labor Act (EMTALA) complaint. Before launching the...more

McCarter & English, LLP

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

Snell & Wilmer

2023 End-of-Year Plan Sponsor “To Do” Lists (Part 1) Health and Welfare

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We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more

Foley & Lardner LLP

DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends

Foley & Lardner LLP on

On February 24, 2023, the Drug Enforcement Agency announced proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The proposed rules are open for public...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

DirectEmployers Association

OFCCP Week In Review: January 2022

The DE OFCCP Week in Review (WIR) is a simple, fast and direct summary of relevant happenings in the OFCCP regulatory environment, authored by experts John C. Fox, Candee Chambers and Jennifer Polcer. In today’s edition, they...more

Baker Donelson

Coronavirus: Implications of an Emergency Declaration

Baker Donelson on

As the situation continues to unfold, the outbreak of the coronavirus (COVID-19) in the United States is prompting increased federal and state action. There is much confusion regarding the implications of an emergency...more

Holland & Knight LLP

A New HIPAA Accounting Rule on the Horizon?

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Under HIPAA, patients have a right to information about certain disclosures, referred to as an accounting. Under the current iteration of the regulations, covered entities and business associates need not account for...more

McDermott Will & Emery

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

McDermott Will & Emery

HHS Proposes Clarifications for Market Reform Regulations and New Exchange-Related Obligations But Leaves Key Questions Unanswered

McDermott Will & Emery on

The proposed rule imposes new requirements on health insurance issuers offering Qualified Health Plans through Health Insurance Exchanges and clarifies other obligations for various market reforms and the Premium...more

NAVEX

Enterprise Risk Management: The benefits of online policy and procedure management systems

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ABSTRACT - Operational inefficiencies, sub-optimal patient care, financial losses and missing or ineffective sanctions for non-compliance are all potential outcomes that can stem from passive policy and procedure management....more

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