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
The Centers for Medicare & Medicaid Services (CMS) updated its guidance on the Inflation Reduction Act of 2022’s (P.L. 117-169) (IRA) Medicare Prescription Payment Plan (M3P) with its release of the Final Part One Guidance on...more
Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...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
February 29 brings two annual deadlines for employers that sponsor a group health plan for their employees. Medicare Part D—Creditable Coverage Disclosure to CMS - An employer with a group health plan that provides...more
Employers, this is your annual reminder that the Centers for Medicare & Medicaid Services (CMS) requires sponsors of group health plans to notify eligible individuals whether the employer’s prescription drug coverage is...more
On April 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an Information Collection Request (ICR) addressing the “Drug Price Negotiation Process” for the Medicare Drug Price Negotiation Program, including...more
IRA Provision: The Medicare Prescription Drug Inflation Rebate Program - The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and a list of 27 Part B “rebatable drugs”...more
Over 12 million Americans are eligible for both Medicare and Medicaid, including roughly 7.5 million adults aged 65 and over and roughly 4.5 million people with disabilities under age 65. Many of these dual-eligible...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. This week's topics include ... ...more
In the second of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe, as well as David Chan, President and General Manager of...more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2022 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs...more
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires employers that offer prescription drug coverage to update the Centers for Medicare & Medicaid Services (CMS) regarding the creditable...more
On January 12, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs proposed rule,...more
On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more
In an effort to increase coverage transparency, for hospice elections beginning on or after October 1, 2020, the beneficiary, beneficiary’s representative, non-hospice providers, or Medicare contractors may request a written...more
Citing the high cost of insulin as a common barrier to proper diabetes treatment, CMS has announced a new model to allow beneficiaries additional Part D plan options with lower out-of-pocket costs for insulin. Under the Part...more
In an evening email that is sure to ruin the weekend for many, CMS announced on February 5, 2020, that it is proposing changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022. CMS will not issue a Call...more
On July 10, 2019, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted HHS’ request for a final judgment, clearing the way for the government to immediately appeal his earlier decision that...more
The U.S. government has appealed a federal district court decision issued in December 2018 that found the Department of Health & Human Services (HHS) exceeded its authority by reducing Part B drug reimbursement to certain...more
On January 18, 2019, CMS announced the Medicare Part D Payment Modernization Model, aimed at incentivizing Part D sponsors to reduce catastrophic phase federal reinsurance subsidy spending. The model, which will begin January...more
Dual Special Needs Plans - This part 6 of our 7 part series focuses on the provisions regarding dual special needs plans (“D-SNPs”) released by the Centers for Medicare and Medicaid Services (“CMS”) in the proposed rule...more
Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts - As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a...more
Quality Improvement Programs - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes two technical changes to 42 C.F.R. Part 422. The first change...more
Medicare Advantage and Part D Preclusion List - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more