News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) Prescription Drugs Pharmaceutical Industry

Troutman Pepper Locke

Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation...

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In this episode of Troutman Pepper Locke's Employee Benefits and Executive Compensation podcast, hosts Lydia Parker and Lynne Wakefield explore the complex legal landscape surrounding the coverage of GLP-1s prescribed for...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

McDermott+

McDermottPlus Check-Up: April 26, 2024

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A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

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As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more

McDermott Will & Schulte

[Webinar] 340B ESP AND HIPAA COMPLIANCE - December 6th, 12:00 pm - 1:00 pm EST

Many pharmaceutical manufacturers currently require 340B covered entities to provide de-identified pharmacy claims data for dispensed 340B drugs to a third party, 340B ESP, as a condition of receiving discounts under the 340B...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - July 2021

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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2020

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

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q4 2020

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more

McGuireWoods LLP

New HIPAA Change to Curb Opioid Abuse Requires Pharmacies to Note Partial-Fill Prescriptions

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The U.S. Department of Health and Human Services finalized a rule last week that will require pharmacies to track when prescriptions are partially filled. This rule is part of an ongoing effort by HHS to stem the tide of...more

King & Spalding

HHS Issues Final Rule Requiring Disclosure of Partial Refills of Prescriptions to Help Curb Opioid Abuse

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On January 23, 2020, HHS issued its final rule adopting a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D.0, National Council for Prescription Drug Programs...more

McGuireWoods Consulting

Washington Healthcare Update - January 2020 #4

This week in Washington: Both the House and Senate are back in session....more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

McGuireWoods Consulting

Washington Healthcare Update - October 2019 #3

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This week in Washington: House to hold a markup of five healthcare bills, as well as a hearing to seek clarity on the Trump administration's health care policy choices; Senate to discuss solutions to the substance misuse...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic & the Confidentiality of Substance Use Disorder Records: an Update on 42 CFR Part 2 - Part 1...

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This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more

McGuireWoods Consulting

Washington Healthcare Update April 2019 #2

Coming Week’s Highlights: Congress will continue to examine drug pricing; on Tuesday, the Senate Finance Committee will hold the third in a series of hearings, this one focused on pharmacy benefit managers (PBMs). The House...more

McGuireWoods Consulting

Washington Healthcare Update March 2019 #1

Upcoming Hearings - Tuesday, March 5, 2019 - Senate Committee on Health, Education, Labor and Pensions (HELP): “Vaccines Save Lives: What is Driving Preventable Disease Outbreaks?” - The Senate Committee on Health,...more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

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As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

Robinson+Cole Data Privacy + Security Insider

Physician Convicted of HIPAA Violation Receives Probation

According to reports, a Georgia-based physician who previously pleaded guilty to criminal violations of the Health Insurance Portability and Accountability Act (HIPAA) received six months of probation from a Massachusetts...more

McGuireWoods LLP

Online Pharmacies: Another Avenue to Monetize the Internet, but Buyer Beware

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Recent months have seen a rise in investors interested in acquiring physical, compounding and online pharmacies, as well as other traditional healthcare providers offering in-house pharmacy services to patients. The pharmacy...more

Dickinson Wright

HIPAA and the Opioid Crisis

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With the ever-growing opioid crisis and the President’s call to action to address that crisis, primary care, pain management and behavioral health providers in particular may be faced with privacy issues dealing with a...more

Foley & Lardner LLP

Health Care Policy Newsletter

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

K&L Gates LLP

K&L Gates Triage: Triage in 2018: Health Care Topics to Watch in the New Year

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We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...more

McGuireWoods LLP

Big Brother is a Pill: Digital Tracking Drugs

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Drug adherence programs have significantly evolved over the last few years with drug companies, health plans, and providers taking steps to monitor patient medication compliance. Drug adherence is the degree to which a...more

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