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Health Care Providers Pharmaceutical Industry Disclosure Requirements

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

Gardner Law on

The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

White & Case LLP

2022 Drug Pricing Update: States Continue Legislative Push Even As Congress Passes Long Sought Changes

White & Case LLP on

States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more

Hogan Lovells

UK ABPI transfer of value disclosures: transitioning from consent to legitimate interests

Hogan Lovells on

UK pharmaceutical companies have historically relied upon consent as the lawful basis for the disclosure of healthcare professionals’ personal data relating to transfers of value. However, the low consent rates and the...more

King & Spalding

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

King & Spalding on

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

McDermott Will & Schulte

SAMHSA Proposed Rule Would Reduce Barriers to Care Coordination

SAMHSA has released a long-awaited proposed rule that would modify the federal regulations at 42 CFR Part 2 (Part 2) governing the confidentiality of substance use disorder (SUD) patient records created by federally assisted...more

Proskauer Rose LLP

HHS and SAMHSA Issue a Proposed Rule to Ease Coordination of Care for Patients with Substance Use Disorders

Proskauer Rose LLP on

On August 26, 2019, the U.S. Department of Health and Human Services ("HHS") and the Substance Abuse and Mental Health Services Administration ("SAMHSA") issued a proposed rule amending the regulations governing the...more

Mintz - Health Care Viewpoints

Part 2 Proposed Rule Brings Clarity and Reduces Regulatory Burdens for Substance Use Disorder Providers, but Challenges Remain

On August 22, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) announced a new proposed rule (the “Proposed Rule”) amending 42 CFR part 2 (“Part 2”), which is aimed at protecting patient records...more

Bass, Berry & Sims PLC

Proposed Changes Affect Privacy Protections of Patients Seeking Substance Use Disorder Treatment

On August 22, 2019, providers and other health industry participants involved in the provision of substance use disorder (SUD) services got some welcome news in the form of proposed regulatory changes. The U.S. Department of...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

This week’s “Capitol Hill Healthcare Update” includes the latest on a pending Senate vote on opioid legislation as Congress races to enact a response to the crisis before the November election; the Senate votes to expand...more

Smart & Biggar

Rx IP Update - December 2017

Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Burr & Forman

Office of Civil Rights Issues Guidance on HIPAA in Light of Opioid Crisis

Burr & Forman on

With an increased focus on opioid use and addiction, the Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) has issued guidance related to the Health Insurance Portability and Accountability Act of...more

Downs Rachlin Martin PLLC

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017 #3

Act 188 Plans On Hold as New Chemical Bill is Introduced - Nearly three years after the legislature passed a law to regulate children’s products containing chemicals of high concern, a web site intended to inform the...more

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