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Health Care Providers Biologics

Alston & Bird

Health Care Week in Review: CMS Finalizes the TCET Pathway for Breakthrough Technologies; HRSA Awards Health Centers Funding for...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week In Review: House Held Oversight Hearing on the 340B Program and HHS Expanded Certified Community Behavioral...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: House Passes Appropriations Bill and Senate Expected to Vote Shortly, CMS Unveils the ACO Primary Care...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: Congress Passed a New Continuing Resolution for FY 2024 to Avert a Government Shutdown; Biden...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: HRSA Issues Requests For Proposals As Part Of Initiative To Reform The Organ Transplant System;...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Foley & Lardner LLP

Decentralized Clinical Trials: Diversity in Clinical Trials

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) has demonstrated a commitment to expanding diversity in clinical trials. Decentralized Clinical Trials ( DCTs) contribute to this effort by enhancing convenience for trial...more

Hogan Lovells

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

Hogan Lovells on

Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more

Alston & Bird

Health Care Week In Review: HHS Selects the First 10 Drugs for Medicare Drug Price Negotiation

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

K&L Gates LLP

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

K&L Gates LLP on

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more

Alston & Bird

Health Care Week In Review: COVID-19 PHE Expires, DEA Issues Final Rule

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Hogan Lovells

When being a little bit square is a good thing: CMS AppliedVR decision shows how innovative technology can secure a payment...

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While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when an item or service does not fall within one...more

Manatt, Phelps & Phillips, LLP

[Webinar] A Fireside Chat With FDA Leadership - April 29th, 12:00 pm - 1:00 pm ET

We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more

Manatt, Phelps & Phillips, LLP

Delivering Breakthrough Treatments Affordably

Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more

Bricker Graydon LLP

2022 Medicare OPPS/ASC Proposed Rule includes updated reimbursement rates, new policies, and reversals of recent policy changes

Bricker Graydon LLP on

On July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2022 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (Proposed Rule). In...more

Smart & Biggar

Quebec initiating a shift to use of biosimilar drugs

Smart & Biggar on

As previously reported, British Columbia, Alberta, and New Brunswick have all launched biosimilar initiatives which require that patients switch from certain reference biologics to biosimilars for certain indications. On May...more

Alston & Bird

Alston & Bird Health Care Week in Review - July 2021 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Proskauer - Life Sciences

“Advancing Education on Biosimilars”: Game Changer or More of the Same?

The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

Health Care Compliance Association (HCCA)

CMS Hikes Payment for COVID-19 Inpatients Treated With New Drugs, Links it to 20% Bonus

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Smart & Biggar

New reports on utilization of biologics and biosimilars for chronic inflammatory diseases in Ontario

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The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a report titled Utilization of Innovator Biologics and Biosimilars for Chronic Inflammatory Diseases in Canada: A Provincial Perspective. The...more

Katten Muchin Rosenman LLP

FDA Reduces Regulatory Uncertainty with New Finalized Rule Defining "Biological Product" under BPCIA to Include Insulin and Other...

Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more

Mintz - Health Care Viewpoints

Recap of Our Health Law and Policy Year-in-Review Posts for 2019

Over the past month or so, our Health Care Team has published a number of posts examining important developments and trends in health law and policy during 2019, as well as providing some thoughts on what we expect to see in...more

Epstein Becker & Green

7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 2020

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more

Hogan Lovells

What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing...

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FDA authority to crack down on illegally marketed stem cell treatments confirmed - On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more

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