News & Analysis as of

Medical Reimbursement Food and Drug Administration (FDA)

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - March 2024 #4

News Briefs - Lawmaker Introduces Health Care Cybersecurity Improvement Act - Senator Mark Warner (D-VA) has introduced the Health Care Cybersecurity Improvement Act of 2024, which would allow for advance and accelerated...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies : Insights on Coverage, Reimbursement and Emerging Models

Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021

Hogan Lovells on

In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - Part 3 - October 21st, 12:00 pm - 1:30 pm EDT

McDermott Will & Emery on

Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond. Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - Part 2 - October 14th, 12:00 pm - 1:30 pm EDT

McDermott Will & Emery on

Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond. Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - Part 1 - October 7th, 12:00 pm - 1:30 pm EDT

McDermott Will & Emery on

Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond. Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - October 29th, 10:00 am - 1:30 pm EDT

McDermott Will & Emery on

HPE New York brings together preeminent healthcare private equity executives and investment bankers and unmatched keynote speakers to your remote workspace in a cutting-edge format – unlike any other conference this fall. ...more

King & Spalding

EUROPE – Are Revisions of the Orphan Drug Regulation and Adoption of a Regulation on “Unmet Medical Needs” on the Horizon

King & Spalding on

The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

Baker Donelson on

In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Manatt, Phelps & Phillips, LLP

Evolving Pharmaceutical Benefit Trends and Medicaid Managed Care’s Role

Editor’s Note: State Medicaid programs continue to balance serving eligible beneficiaries and controlling costs. In an environment sharply focused on the cost of drugs, it is increasingly critical to understand the Medicaid...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Drug Pricing and Reimbursement

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Holland & Knight LLP

Left to Their Own Devices: Administration, FDA Turn to Medical Device Innovation

Holland & Knight LLP on

• Masked by the recent high-profile drug pricing debate has been the Trump Administration's discussions about the development, approval and reimbursement of medical devices. Recent comments by Administration leaders, as well...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

BakerHostetler

Never Fear Regulatory Violations – Focus on Conditions to Payment

BakerHostetler on

The U.S. Court of Appeals for the Fourth Circuit recently upheld the dismissal of a False Claims Act (FCA) suit against Omnicare, Inc., in which the relator alleged that certain drugs repackaged by Omnicare’s subsidiary were...more

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