Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more
Illinois passed S.B. 1913, which requires Medicaid FFS and Medicaid managed care plans to provide coverage of mental health services, substance use disorder treatment, and ‘behavioral telehealth services’. Requires Medicaid...more
H.R. 4189 / S. 2016: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act ....more
As announced by the White House on January 30, 2023, the public health emergency (PHE) is set to end on May 11, 2023. The end of the PHE also brings an end to several flexibilities that were implemented that impact telehealth...more
Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more
On July 24 2020, President Trump signed three Executive Orders targeting prescription drug prices and proposed a fourth. The Orders represent the Trump Administration's latest effort to implement previously outlined...more
US President Donald Trump signed four executive orders implementing policies on drug pricing on July 24. One of the orders directs the secretary of the US Department of Health and Human Services (HHS) to condition future...more
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more
The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more
In prior articles regarding the OIG's Work Plan (July 2017 and November 2017) and its recent telehealth claim audit, we have noted how telehealth is clearly on the OIG's radar. Now, the first advisory opinion addressing...more
On Feb. 9, 2018, Congress passed and President Donald Trump signed into law the Bipartisan Budget Act of 2018 (BBA). This wide-reaching legislation enacts major changes for telehealth policy in Medicare by incorporating...more
Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more
In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...more
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
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published the proposed 340B Drug Pricing Program Omnibus Guidance (“Omnibus Guidance”) which is intended to clarify for covered entities, such as...more
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more
On June 29 and 30, 2015, the Connecticut General Assembly conducted a special legislative session following the close of the 2015 regular session. Among other things, the General Assembly passed a bill to implement the state...more