Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...more
Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more
On July 25, 2023, the Centers for Medicare & Medicaid Services (CMS) republished its Drug Price Negotiation Process Information Collection Request (Negotiation Process ICR). The Negotiation Process ICR, which was originally...more
PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more
Congress - House - Representatives Propose a Permanent Extension of CHIP Funding - The House Energy and Commerce Committee is looking at ways to strengthen the Affordable Care Act (ACA) and expand Medicaid coverage. A...more
On February 7, 2020, the Centers for Medicare and Medicaid Service (CMS) published a notice signaling that it has submitted its previously published September 2019 proposed survey of hospital 340B drug costs for Office of...more
This week in Washington: The House and Senate are in recess. Congress House Senate Administration Proposed Regulations/Guidance Final Rules/Guidance Reports House Bipartisan Legislation Introduced on Accurate Provider...more
Congress - Hearings/Markups - Senate Finance Committee: "Drug Pricing in America: A Prescription for Change, Part III" - Tuesday, April 9, 2019: The Senate Finance Committee continued its drug pricing series by...more
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
Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “TBA Hearing on Drug Pricing” - The second hearing in a series on drug pricing in the Senate Finance Committee will include the testimonies of...more
Last week concluded the Senate’s time in Washington prior to the lame duck session. With both the House and the Senate back home and focused on campaigning, we turn our attention to action from the Administration. As of...more
Outlook for This Week in the Nation's Capital - Appropriations. The Senate is expected to begin work this week on its next minibus appropriations bill- a package that would contain the Defense and Labor-HHS spending bills....more
The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...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
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and...more
Congress Slowly Works on Budget Reconciliation; ACA Reform Proposals Still Up in the Air - The FY 2016 budget resolution, which was agreed to by Congress this past April, included broad reconciliation instructions...more
CMS Publishes Corrected Comment Deadline for FY 2016 IPPS and LTCH Proposed Rule; Comments Due by June 16, 2015 – On May 5, 2015, CMS published in the Federal Register a corrected comment period for the FY 2016 Medicare IPPS...more