The process of procuring a new PBM and perhaps adopting a new pharmacy program design can be excruciatingly long, full of anticipated and unanticipated pitfalls and – if not thoughtfully and meticulously planned – can result...more
On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more
In February 2024, a group representing (among others) the Johnson & Johnson Group Health Plan and its component plans (Plaintiffs) sued Johnson & Johnson and The Pension & Benefits Committee of Johnson and Johnson (J&J) over...more
12/3/2024
/ Benefit Plan Sponsors ,
Competition ,
Disclosure Requirements ,
Employee Retirement Income Security Act (ERISA) ,
Employer Group Health Plans ,
Fiduciary Duty ,
Healthcare ,
Johnson & Johnson ,
Pension Benefits ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drug Coverage
Anyone administering a pharmacy benefit program today knows that moving to a new model of service delivery seems all the rage. Deconstructing and reconstructing a system that is not providing the level of drug discounts,...more
Tensions between the Federal Trade Commission (FTC) and pharmacy benefit managers (PBMs) continue to mount, bringing PBM practices and calls for reform back into the spotlight. On September 17, 2024, one of the largest PBMs,...more
As many have now heard, on Thursday, August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the prices for the first 10 prescription drugs selected for negotiation with manufacturers (Selected Drugs)...more
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 Two Guidance on...more
Crafting a new pharmacy benefit manager (PBM) agreement may feel like an uphill battle when you do not have the time and resources to develop a highly customized contract. While it is often more beneficial to a health plan to...more
Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
5/15/2024
/ Administrative Dispute Resolution Act of 1996 ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
GAO ,
HRSA ,
Inflation Reduction Act (IRA) ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs
Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more
5/2/2024
/ Disclosure ,
Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Reimbursements ,
Remuneration ,
Reporting Requirements ,
Transparency
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
Health Care was a hot topic in the U.S. Senate on February 8, as two important Senate Committees – the Committee on Finance and the Committee on Health, Education, Labor, and Pensions (HELP) – held hearings, respectively, on...more
2/14/2024
/ Artificial Intelligence ,
Bias ,
Drug Pricing ,
Equity ,
Healthcare ,
HELP ,
Individual Accountability ,
Legislative Agendas ,
Pharmaceutical Industry ,
Prescription Drugs ,
Privacy Laws ,
Senate Finance Committee ,
Transparency
On Tuesday, August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) released the first ten prescription drugs selected for price negotiation with manufacturers (Selected Drugs) under the Inflation Reduction Act of...more
This month, the Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights sent letters warning about privacy and security risks related to online tracking technologies...more
7/31/2023
/ Data Privacy ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
NPRM ,
Technology ,
Telehealth ,
Tracking Systems ,
Web Tracking
On June 16, 2022, the Fair Trade Commission (FTC or Commission) unanimously voted to authorize its examination under Section 6(b) of the FTC Act of anti-competitive behavior of Pharmacy Benefit Managers and other...more
In part two, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander continue their discussion of the Most-Favored Nations (MFN) Rule and the Rebate Rule and look at the potential impacts of these Final...more
12/14/2020
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Managed Care Contracts ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Prescription Drugs ,
Rebates ,
Rulemaking Process
In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the...more
12/14/2020
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Managed Care Contracts ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Prescription Drugs ,
Rebates ,
Rulemaking Process