On 2 July 2021, the Supreme Court announced that it has accepted the American Hospital Association’s (AHA) petition for certiorari in American Hospital Association v. Becerra. At issue is the Centers for Medicare and Medicaid...more
Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the...more
On 23 December 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order,...more
The U.S. Supreme Court recently issued a unanimous decision in Rutledge v. Pharmaceutical Care Management Ass’n, which supports the validity of state statutes that regulate reimbursement rates pharmacy benefit managers (PBMs)...more
12/23/2020
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
On Thursday, 10 December 2020, the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) issued a pre-publication copy of the long-awaited 340B Drug Pricing Program Alternative...more
On November 20, the Centers for Medicare & Medicaid Services (CMS) issued the Most Favored Nation (MFN) Model interim final rule (MFN Rule), implementing President Trump’s proposal to align drug prices in the United States...more
In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more
12/3/2020
/ Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Health Care Providers ,
HRSA ,
Manufacturers ,
Medicaid ,
OMB ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Covered entities participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers’ actions to limit contract pharmacy access to 340B pricing....more
In recent weeks, several drug manufacturers have taken actions that impact covered entities participating in the 340B Drug Pricing Program (340B Program) and their contract pharmacies....more
In this episode of Triage, Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association, including its potential impact on nearly...more
On July 24, 2020, President Trump issued four executive orders aimed at lowering drug prices. The executive orders direct the Secretary of the Department of Health and Human Services (HHS) to: Increase access to insulin and...more
In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...more
7/23/2020
/ Covered Entities ,
Drug Pricing ,
Eli Lilly ,
Eligibility ,
Health Care Providers ,
Hospitals ,
HRSA ,
Merck ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Reporting Requirements ,
Section 340B
In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more
4/9/2020
/ Coronavirus/COVID-19 ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
DSH ,
DSH Adjustments ,
Eligibility Determination ,
Emergency Response ,
Group Purchasing Organizations (GPO) ,
Health Care Providers ,
Hospitals ,
HRSA ,
Medicaid ,
Medical Records ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B ,
Social Security ,
Telehealth
On February 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a notice relating to the agency’s intention to survey hospitals about their acquisition costs for specified covered outpatient drugs (“SCODs”)...more
In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more
1/30/2020
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Discounts ,
Drug Pricing ,
Fee-for-Service ,
Health Care Providers ,
MCOs ,
Medicaid ,
Medicaid Drug Rebate Program ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more
12/20/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Executive Orders ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Prescription Drugs ,
Proposed Legislation ,
Reimbursements ,
Section 340B