News & Analysis as of

Hospitals Guidance Update

Husch Blackwell LLP

A Significant Departure: Unpacking What the New Antitrust Guidelines Mean for Healthcare Providers

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Join Husch Blackwell’s Meg Pekarske and Wendy Arends as they explore the new draft Merger Guidelines and what enforcement may look like in the future. Given the number of hospices looking to consolidate through mergers, joint...more

Health Care Compliance Association (HCCA)

A busy year for OIG

On April 24, at this year’s Compliance Institute, the U.S. Department of Health & Human Services (HHS) Inspector General (IG) Christi Grimm announced an important initiative, which was posted in the Federal Register the next...more

Venable LLP

DOJ Withdraws Past Guidance Including "Safety Zone" for Information Exchanges

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On February 3, 2023, the Antitrust Division of the Department of Justice (DOJ) withdrew its nearly 30-year-old guidance on information exchanges in the healthcare industry, including the "safety zone" for benchmarking that...more

King & Spalding

CMS Issues Revised Staff Vaccination Guidance

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On October 26, 2022, CMS issued revised guidance on COVID-19 vaccination requirements for staff working for Medicare-certified and Medicaid-certified providers and suppliers. While the revised guidance was issued in separate...more

Sheppard Mullin Richter & Hampton LLP

CMS Loosens Restrictions on Co-Located Healthcare Providers; Enforcement Interpretation Still to Be Determined

On November 12, 2021, the Centers for Medicare and Medicaid Services (“CMS”) revised and finalized draft guidance first issued on May 3, 2019, for co-location of hospitals with other hospitals or healthcare providers (the...more

McDermott Will & Emery

CMS Leaves Hospitals Guessing on Expectations for Compliant Co-Location Arrangements

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On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) released an updated version of its Quality, Safety and Oversight Group memorandum, QSO-19-13-Hospital, containing much-anticipated final guidance on...more

Husch Blackwell LLP

Post-Payment Notice Reporting Requirements Revised

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The Department of Health and Human Services (“HHS”) continues to modify guidance related to reporting requirements of the provider relief funds (“Relief Funds”) that were part of the Coronavirus Aid, Relief, and Economic...more

McDermott Will & Emery

Healthcare Enforcement Mid-Year Roundup: 2020

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In this installment of the Healthcare Enforcement Roundup we cover new and longstanding issues impacting the healthcare enforcement landscape. First, we explore the impact of the Coronavirus (COVID-19) on the healthcare...more

Jackson Walker

IRS Provides Updated Guidance on Provider Relief Funds

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Last week, the IRS clarified in a Frequently Asked Questions memo that for-profit healthcare providers who received grants through the COVID-19 Provider Relief Fund must include said payments as part of their gross income...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 25. News Briefs: July 2020

Report on Medicare Compliance 29, no. 25 (July 13, 2020)  -  Ophthalmic Consultants PA in Sarasota, Florida, agreed to pay $4.8 million to settle false claims allegations that it billed Medicare and other federal payers...more

Baker Donelson

Overview of HHS Provider Relief Fund Payments and Updated Guidance

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On May 1, 2020, the Department of Health and Human Services (HHS) announced additional payments under the COVID-19 Provider Relief Fund to reimburse providers for health care related expenses and revenue losses attributable...more

Seyfarth Shaw LLP

Texas State Agencies Weigh in on Governor’s Order on Non-Urgent Surgeries, But do They Provide Clarity?

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As previously reported, Texas Governor Greg Abbott issued Executive Order GA-15 extending the ban on surgeries and procedures with modifications regarding diagnostic procedures, timely (rather than immediate) need for...more

Seyfarth Shaw LLP

Guide For General Public: FDA Explains How Everyone Can “Make a Difference” During COVID-19 With Simple Infographic, Update

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The Food and Drug Administration has taken many steps to assist in the response to the COVID-19 health crisis, including easing regulations, expediting the availability of necessary medical equipment, and creating streamlined...more

Seyfarth Shaw LLP

Texas Allows More Elective Procedures, But Questions Remain

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On April 17, 2020, Texas Governor, Gregg Abbot signed Executive Order GA-15 which extended, with some modifications, Executive Order GA-09 which prohibits certain non-emergency surgeries and procedures and is set to expire on...more

Seyfarth Shaw LLP

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

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On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...more

Bass, Berry & Sims PLC

HHS OIG Releases Five Work Plan Updates Related to COVID-19

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On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic. The OIG Work Plan sets forth planned or ongoing agency evaluations,...more

McDermott Will & Emery

CMS Releases Updated Guidance on EMTALA Requirements and COVID-19 Implications

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In response to the spread of COVID-19 infections and questions from the provider community, the Centers for Medicare and Medicaid Services (CMS) Quality, Safety and Oversight Group (QSO) issued a series of three memoranda...more

Smart & Biggar

Rx IP Update - July 2019

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Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more

Baker Donelson

Medicare Two-Midnight Rule and Observation Status Updates

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What's new from Medicare in the areas of the Two-Midnight rule and observation services? CMS recently published updates to a Medicare manual reflecting clarifications to its Two-Midnight policy, a Medicare Quality Improvement...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

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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

Obermayer Rebmann Maxwell & Hippel LLP

Revised Guidance for Privacy and Security of Electronic Health Information Released by Government

The Office of the National Coordinator for Health Information Technology (“ONC”) has released a revised Guide to Privacy and Security of Electronic Health Information (the “Guide”), which is intended to be a resource for...more

Epstein Becker & Green

CMS Publishes Additional (but Limited) Guidance on the Coverage with Evidence Development Process

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On November 20, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published its latest round of guidance on its Coverage with Evidence Development (“CED”) policy for selected items and services under the Medicare...more

Miller & Martin PLLC

CDC Issues Additional Guidance to Healthcare Employers Regarding Protection of Workers from Ebola Virus

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Recently, Miller & Martin Workplace Safety Practice Group provided information regarding the U.S. Occupational Safety and Health Administration's (OSHA) launch of its new web page designed to assist employers with their...more

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