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Nursing Homes Face Steep Hurdles to Reopening Under New CMS Recommendations

With statistics indicating that deaths from COVID-19 among nursing home residents represent an alarming percentage of total COVID-19 deaths in a number of states, a cautious approach to reopening nursing homes is no doubt...more

CMS Issues New or Revised COVID-19 Blanket Waivers for Health Care Providers

Although many states are beginning to relax stay-at-home and other restrictions in response to the novel coronavirus pandemic, the Centers for Medicare and Medicaid Services (CMS) continues to issue or revise COVID-19...more

CDC Issues COVID-19 Guidance with Focus on Memory Care Residents in Long-Term Care

After nearly a month without new or updated guidance for nursing homes and assisted living facilities (collectively, “LTCFs”), the Centers for Disease Control and Prevention (“CDC”), on May 14, released new guidance focused...more

CMS Details Enforcement of COVID-19 Nursing Home Reporting and Notification Requirements but Troubling Ambiguities Remain

Two days before official publication in the Federal Register of an Interim Final Rule with Comment Period that, inter alia, establishes new reporting and notification requirements applicable to nursing homes, the Centers for...more

AGG Food & Drug Newsletter - April 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

Hazardous Waste Pharmaceuticals Management Standard Effective in Georgia, Other States

While health care providers, including long-term care providers, rightly have been consumed the past several months with preparing for and responding to the novel coronavirus pandemic, regulatory agencies across the United...more

CMS Announces Temporary Freeze on Inspection Domain on Nursing Home Compare, Other Changes

The Quality, Safety & Oversight Group (QSOG) within the Centers for Medicare and Medicaid Services (CMS), issued a memorandum on April 24, 2020, which outlines temporary changes to the Nursing Home Compare website and Five...more

Status of USP Chapter 800 Becomes More (and Less) Clear Following USP Appeals Panel Decision

On March 12, 2020, an Appeals Panel of the United States Pharmacopeial Convention (“USP”) granted appeals to revisions of two compounding standards—General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparation...more

HUD Updates and Clarifies Assistance Animal Guidance

The United States Department of Housing and Urban Development (HUD), on Jan. 28, issued new guidance on requests for reasonable accommodation under the Fair Housing Act (FHA) relative to “assistance animals” in various...more

AGG Food & Drug Newsletter - December 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

OIG Report Scrutinizes RN Supervisory Visits in Hospice

A report by the U.S. Department of Health and Human Services, Office of Inspector General (OIG) finds that hospices did not always comply with the portion of the “hospice aide and homemaker services” condition of...more

Understanding USP 800: A Resource for Long-Term Care Providers

Introduction - When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous...more

USP 800 to Present Significant Compliance Challenges for Long-Term Care Providers

When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous pharmaceuticals rule (“EPA...more

CMS to Include Warning Icon on Nursing Home Compare for Facilities Cited for Abuse

As part of its five-part approach to ensuring safety and quality in nursing homes, the Centers for Medicare and Medicaid Services (CMS) announced that as of October. 23, 2019, it would begin displaying a consumer alert icon...more

CMS Proposes Changes to Stark Law Advisory Opinion Process

As part of its proposed rule pertaining to CY 2020 changes to the physician fee schedule published in the Federal Register on August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) also proposes significant...more

CMS Finalizes Hospice Payment, Reporting, and Other Changes

In a final rule published in the Federal Register on August 6, the Centers for Medicare and Medicaid Services (CMS), implemented several important changes in the hospice payment framework and FY 2020 rates, as well as...more

CMS Proposes a Host of Changes to Nursing Home Requirements for Participation - Part Two

The Centers for Medicare and Medicaid Services (CMS) proposes a host of changes to the revised Medicare Requirements for Participation (“Requirements for Participation”) that it promulgated in 2016 and an extension of the...more

CMS Proposes a Host of Changes to Nursing Home Requirements for Participation - Part One

More than a year after soliciting feedback from stakeholders and the public on areas for reducing the regulatory burden on nursing facilities, the Centers for Medicare and Medicare Services (CMS) on July 18 released...more

OIG Details Hospice Quality of Care Issues and Recommends Tougher Enforcement Measures

Earlier this month, the U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued two companion reports that, together, called for increased regulatory scrutiny of hospices, greater transparency...more

OIG Urges Increased Regulatory Scrutiny and Expanded Enforcement Options for Hospice

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) earlier this month issued two companion reports that called for increased regulatory scrutiny of hospices, greater transparency for...more

[Webinar] Are You Ready? The Clock is Ticking to Comply with New EPA Hazardous Waste Pharmaceuticals Rule - May 2nd, 12:00pm ET

On February 22, 2019, the Environmental Protection Agency (EPA) published its final rule revising management standards for hazardous waste pharmaceuticals, which will take effect August 2019. Healthcare facilities that...more

New Hazardous Waste Pharmaceuticals Rule: Significant Changes Coming for Health Care Facilities, Particularly Long-Term Care...

Health care facilities that provide a host of health care-related services or distribute, sell, or dispense pharmaceuticals will need to learn a whole new set of regulations thanks to a finalized new rule promulgated by the...more

OSHA Rescinds Mandate for Large Employers to Submit Forms 300 and 301 Data Electronically

Despite the partial shutdown, some Federal agencies were still hard at work. Count the Occupational Safety and Health Administration (OSHA) among them. ...more

Seventh Circuit Upholds Citation and Penalty Against Nursing Facility Relating to Sexual Activity Among Residents

The United States Court of Appeals for the Seventh Circuit (“Seventh Circuit”) rejected an Illinois nursing facility’s challenges to an Immediate Jeopardy (“IJ”) citation and resultant $83,800 civil monetary penalty (“CMP”)...more

CMS Extends Designation of “Extraordinary Circumstance” for Hospice Nurse Staffing Purposes

Citing findings from the Bureau of Labor Statistics which indicate a shortage of nurses through 2024, the Centers for Medicare and Medicaid Services (CMS) issued a Memorandum - extended its designation of the nursing shortage...more

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