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Since its inception in 1992, the 340B Drug Pricing Program (340B Program) has provided eligible health care providers (covered entities) access to significant discounts on the cost of outpatient pharmaceuticals from participating manufacturers.
Over the past 15 years, the 340B Program’s size and scope has expanded due to actions by Congress and the federal Health Resources and Services Administration (HRSA). This article provides an overview of the program's current state.
Resource Details
Interest Area:
Health Law
Region:
United States
7 pages
This sample policy covers medical providers giving financial assistance to eligible patients for costs not covered by insurance.
Resource Details
Interest Area:
Health Law
Region:
United States
This article provides recommendations on how to minimize regulatory risks associated with patient assistance programs in the United States.
Resource Details
Interest Area:
Compliance and Ethics,
Health Law
Region:
United States
2 pages
This article discuses the Federal Trade Commission (FTC) finalized amendments to the Negative Option Rule, now retitled the “Rule Concerning Recurring Subscriptions and Other Negative Option Program.“
The rule represents a significant overhaul of the regulatory framework governing how companies handle subscription services and automatic renewals.
Resource Details
Interest Area:
Commercial and Contracts,
Information Governance,
Health Law,
Technology, Privacy, and eCommerce
Region:
United States
4 pages
This article discusses the Center for Medicare & Medicaid Services (CMS) final regulation interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage (MA) and the Prescription Drug Plans).
Resource Details
Interest Area:
Health Law
Region:
United States
This resource covers how to create and enforce effective document retention policies, especially for organizations in the health-care industry.
Resource Details
Interest Area:
Litigation and Dispute Resolution,
Compliance and Ethics,
Health Law,
Technology, Privacy, and eCommerce
Region:
Global
In February 2024, the U.S. Department of Health and Human Services (HHS) issued the much anticipated final rule to update the Confidentiality of Substance Abuse Disorder Patient Records regulations at 42 CFR Part 2 (Part 2).
This article discusses the amendments to Part 2 and its most impactful revisions, including the amendments to loosen patient consent requirements, regulate SUD counseling notes, and create new patient rights and breach notification requirements.
Resource Details
Interest Area:
Health Law,
Technology, Privacy, and eCommerce
Region:
United States