On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more
On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more
On May 21, the U.S. Court of Appeals for the District of Columbia Circuit upheld the right of pharmaceutical manufacturers to place at least some restrictions on the shipment of 340B drugs to contract pharmacies of 340B...more
Prenatal vaccines provide important protection for pregnant women and newborns against communicable diseases such as whooping cough and influenza. However, fewer than one out of four pregnant women receives all federally...more
5/18/2023
/ Children's Health Insurance Program (CHIP) ,
Continuing Legal Education ,
Denial of Insurance Coverage ,
Fee-for-Service ,
Health Care Providers ,
Health Insurance ,
Infectious Diseases ,
MCOs ,
Medicaid ,
Payment Rates ,
Pharmaceutical Industry ,
Pharmacist ,
Physicians ,
Pregnancy ,
Reimbursements ,
Vaccinations ,
Webinars
On January 31, the U.S. Court of Appeals for the Third Circuit found in favor of pharmaceutical manufacturers in the ongoing dispute over whether manufacturers may restrict the shipment of reduced-price drugs to contract...more
Editor’s Note: In a new survey, Manatt examines 340B anti-discrimination legislation in all 50 states. Highlights are below. For more information on accessing the full survey—available on its own or through a subscription to...more
Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy -
The 340B discount program—which requires manufacturers to provide outpatient drugs to...more
10/12/2022
/ Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Reimbursements ,
Section 340B ,
Webinars
The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more
9/7/2022
/ Biosimilars ,
Continuing Legal Education ,
Drug Pricing ,
Generic Drugs ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Beneficiaries ,
Medicare Part D ,
New Regulations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B ,
Webinars
On August 16, President Joe Biden signed into law H.R. 5376 , the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
On August 16, President Joe Biden signed into law H.R. 5376 , the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
On August 16, President Joe Biden signed into law H.R. 5376, the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
The last two weeks of June saw several key developments affecting the 340B Drug Pricing Program—a federal government program created in 1992 that requires pharmaceutical manufacturers to provide outpatient drugs to eligible...more
7/7/2021
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
HRSA ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Regulatory Agenda ,
Section 340B
In the courts, in the Administration and in drug maker initiatives, action on the Section 340B prescription drug discount program has heated up this summer. The program, known by its section number of the federal Public...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
8/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
FQHC ,
HRSA ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regulatory Agenda ,
Rulemaking Process ,
Section 340B ,
Trump Administration
The 340B Program’s Growing Scope -
The 340B program has grown significantly in scope. According to the Health Resources and Services Administration (HRSA), as of January 1, 2018, the 340B program included 12,823 providers...more
Editor’s Note: In a recent webinar, Manatt explained the complexities of the 340B program, which requires drug manufacturers to provide outpatient drugs to eligible healthcare entities at sharply reduced prices. The webinar...more
Editor’s Note: To help provide clarity on the interplay between Medicaid and 340B, Manatt Health has developed a 50-state survey on 340B, analyzing how state Medicaid programs reimburse 340B-covered entities and contract...more
Manatt, Phelps & Phillips, LLP, a multidisciplinary, integrated professional services firm, announced today the release of its Comprehensive 50-State Survey: State Medicaid Programs and 340B. Conducted by Manatt Health, the...more
On November 2, 2018, the federal Health Resources and Services Administration (HRSA) issued a proposed rule that would advance the implementation date for the oft-postponed 340B Ceiling Price and Civil Monetary Penalties...more
Hospitals and Health Systems Prepare for a Value-Based Future -
Editor’s Note: Hospitals and health systems are actively working to service their communities in numerous ways, including through the adoption of initiatives...more
2/22/2018
/ Antitrust Division ,
Cost-Sharing ,
False Claims Act (FCA) ,
Hospitals ,
Information Sharing ,
Medicare ,
Medicare Part D ,
No-Poaching ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Substance Abuse ,
Universal Health Services Inc v United States ex rel Escobar
Part 1: Megatrends Reinventing How Patients Think -
Editor’s Note: In a recent webinar for PharmaVOICE, Manatt Health revealed the megatrends reinventing the life sciences industry—and how they relate to new thinking by...more
Next Steps on Healthcare Reform -
Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...more
8/8/2017
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Cost-Sharing ,
DSH ,
Health Insurance ,
Healthcare Reform ,
HOPPS ,
Pharmaceutical Industry ,
Repeal ,
Section 340B ,
Tax Reform ,
Waivers