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
Editor’s Note: In a new white paper funded by Pfizer, Inc., Manatt Health discusses the current landscape of Medicaid and Children’s Health Insurance Program (CHIP) coverage and reimbursement for prenatal vaccines, informed...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
Prenatal vaccines—those administered during a pregnancy—provide crucial protections to pregnant women and/or newborns against communicable diseases such as whooping cough and influenza. Additional prenatal vaccines are in...more
5/17/2023
/ Affordable Care Act ,
Children's Health Insurance Program (CHIP) ,
Fee-for-Service ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
MCOs ,
Medicaid ,
Medicare ,
Patient Access
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
In the wake of the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, the Department of Health and Human Services Office for Civil Rights (OCR) yesterday issued guidance addressing how the Health...more
6/30/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
First Amendment ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Human Rights ,
Medical Records ,
New Guidance ,
OCR ,
Patient Access ,
Patient Privacy Rights ,
PHI ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS
The Supreme Court yesterday issued a unanimous opinion striking down the federal government’s reduction in Medicare Part B reimbursement for 340B drugs for calendar years 2018 and 2019. As background, the Centers for Medicare...more
6/16/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Life Sciences ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Prescription Drugs ,
Reimbursements ,
SCOTUS ,
Section 340B
The Big Picture -
On November 2, the Centers for Medicare & Medicaid Services (CMS) released Medicare Program; CY 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies;...more
11/16/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
FQHC ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Medicare ,
Mental Health ,
Physician Fee Schedule ,
Physicians ,
Reimbursements ,
Rural Health Care Program ,
Telehealth ,
Telemedicine
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
The Big Picture -
Since the onset of the COVID-19 pandemic, Congress and the Centers for Medicare & Medicaid Services (CMS) have dramatically—but temporarily—expanded coverage and reimbursement for telehealth services....more
12/16/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Final Rules ,
Health Care Providers ,
Health Technology ,
Medicare ,
Physician Fee Schedule ,
Physicians ,
Public Health Emergency ,
Reimbursements ,
Telehealth ,
Telemedicine
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
Learn How Healthcare Entities Can Access the Federal Loans Available to Support Businesses Through the Financial Challenges of COVID-19—Including the Paycheck Protection Program, Main Street Lending Program and EIDL...more
4/15/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Economic Injury Disaster Loans ,
Health Care Providers ,
Healthcare ,
Independent Contractors ,
Lending Programs ,
Loan Forgiveness ,
Paycheck Protection Program (PPP) ,
Physicians ,
Relief Measures ,
Small Business ,
Webinars
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: Earlier this year, the federal Office of the National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services (HHS) issued proposed rules implementing the information...more
Editor’s Note: Earlier this year, the federal Office of the National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services (HHS) issued proposed rules implementing the information...more