The CMS Interoperability and Prior Authorization Rules
Antitrust Considerations in Long-Term Care — Assisted Living and the Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 205: Novant Health’s Carolinas Expansion with Senior Vice President Jason Bernd
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 199: Bringing Awareness to Organ and Tissue Donation with Dave DeStefano of We Are Sharing Hope
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 193: Federally Qualified Health Centers and Rural Health with Dr. Jeniqua Duncan of CareSouth Carolina
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 192: Business Issues for Healthcare with Ira Bedenbaugh and Randi Branham of Elliott Davis
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 191: South Carolina Lowcountry Healthcare with Walter Bennet, MUSC Orangeburg CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 188: Healthcare Valuation with Darcy Devine, Founder of Buckhead FMV
Podcast - Conversions of Public Hospitals
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 187: South Carolina Hospitals and Healthcare Industry Trends with Thornton Kirby, SCHA President
Findings from Gibbins’ Annual Healthcare Bankruptcy Report
Hospital M&A Trends & Strategic Considerations for 2024
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 176: Tax Exempt Healthcare Entities with Jim Pool, Maynard Nexsen Health Care Attorney
Healthcare Practice Lease Negotiations: Avoid Missing Out on Potential Opportunities
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 173: Improving rural health care with Dr. Kevin Bennett, the Director of the Research Center for Transforming Health and the
La reforma del sistema de salud
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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