News & Analysis as of

Hospitals Draft Guidance

Manatt, Phelps & Phillips, LLP

Achieving Diversity in Clinical Trials - Expanding Hospital Capacity to Offer Clinical Trials in the Community

Executive Summary - The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that end has been limited. When the Covid-19 pandemic threw into stark relief...more

Stevens & Lee

Draft Merger Guidelines: Rebutting a Claim of Substantial Lessening of Competition

Stevens & Lee on

In a recent post, we discussed the 13 guidelines set forth in the recently issued proposed Hospital Merger Guidelines (“Draft Guidelines”) issued by the Federal Trade Commission and the Department of Justice (the “Agencies”)....more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 11

McGuireWoods LLP on

A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve...more

BakerHostetler

FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

BakerHostetler on

On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more

Holland & Knight LLP

Healthcare Law Update: October 2021

Holland & Knight LLP on

Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more

Smart & Biggar

Rx IP Update - July 2019

Smart & Biggar on

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

Cozen O'Connor

CMS Guidance On “Shared Space” – Comment Period Closing July 2, 2019

Cozen O'Connor on

CMS recently issued long-awaited draft guidance on hospital co-location with other hospitals or healthcare facilities, providing some potential insight on the otherwise ambiguous prohibition on “shared space.” This...more

Epstein Becker & Green

CMS Releases Draft Guidance on Shared Space Arrangements

Epstein Becker & Green on

The Centers for Medicare & Medicaid Services (“CMS”) recently released draft guidance for state survey agencies regarding shared space and co-location arrangements between hospitals and other hospitals or health care...more

Holland & Hart - Health Law Blog

CMS Issues DRAFT Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities

Earlier this month, the Centers for Medicare & Medicaid Services (“CMS”) issued draft “Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities” (the “Draft Guidance”) intended to change earlier CMS...more

Hogan Lovells

CMS proposes long-awaited draft guidance on co-located hospitals

Hogan Lovells on

On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft manual guidance for surveyors evaluating whether hospitals that are co-located with other hospitals (or with other health care entities) meet the...more

Saul Ewing LLP

CMS Issues DRAFT Guidance for Hospital Co-Location Initiatives; Industry is Invited to Submit Comments

Saul Ewing LLP on

As the health care delivery system continues to evolve, on May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a draft guidance document to state survey agency directors entitled, “Guidance for Hospital...more

K&L Gates LLP

CMS Issues Long-Awaited Draft Guidance on Hospital Co-Location and Space Sharing

K&L Gates LLP on

Summary - On May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued long-awaited draft guidance addressing compliance with the hospital Conditions of Participation (“CoPs”) and survey procedures in regard...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Long-Awaited Draft Guidance for Hospital Co-Location with Other Hospitals or Healthcare Facilities

On May 3, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released long-awaited draft guidance (the “Guidance”), proposing to allow hospitals to co-locate with other hospitals or healthcare facilities in certain...more

McGuireWoods LLP

CMS Issues Long-Awaited Guidance on Hospital Co-Location Policy

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On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance formalizing the agency’s policy on hospital co-location with other hospitals and healthcare entities. CMS’ new policy walks back its...more

Dorsey & Whitney LLP

At Long Last, CMS Issues Proposed Guidance on Hospital Co-Locations

Dorsey & Whitney LLP on

For years, CMS has informally applied restrictions for hospitals which share space, equipment, staff or services in the same physical location (i.e., “co-locate”) with other hospitals or health care entities. Although these...more

Baker Donelson

CMS Issues Draft Guidance on Shared Space Arrangements

Baker Donelson on

On May 3, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a draft of long-awaited guidance for hospitals on how they can share space, services and staff with other co-located hospitals and health care...more

McDermott Will & Emery

CMS Releases Long-Awaited Guidance on Hospital Co-Location Arrangements

The Centers for Medicare and Medicaid Services has issued long-awaited draft guidance addressing the use of shared space and contracted services. Though aiming to increase transparency into the scope and interpretation of its...more

Katten Muchin Rosenman LLP

CMS Issues Draft Guidance for Hospital Co-Location

On May 3, CMS issued a draft letter to State Survey Agency Directors regarding "Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities" ("Guidance") that is intended to provide clarity on how...more

Holland & Knight LLP

Hospitals Sharing Space – CMS Draft Guidance for Co-Location

Holland & Knight LLP on

As new healthcare delivery models evolve, we may see an increase in hospitals that share space with other hospitals or healthcare entities. On May 3, 2019, Centers for Medicare and Medicaid Services (CMS) issued draft...more

King & Spalding

FDA Issues Three Draft Guidance Documents For Drug Compounders

King & Spalding on

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing... - FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

King & Spalding on

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...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

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