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
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
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
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
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
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
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 blocking...more
The promise of academic medicine is to create new knowledge, train the next generation of practitioners and advance standards of patient care. The funding is the oil that lubricates this powerful innovation engine. In...more
As the old model of patient care silos—where behavioral health providers treat patients separately from the rest of the healthcare system—breaks down, participants from across healthcare are attempting to access...more
The Vulnerability of Healthcare Information -
According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more
7/28/2016
/ Abortion ,
Affordable Care Act ,
Anti-Steering Rules ,
Antitrust Violations ,
Attorney's Fees ,
Bad Faith ,
Brandt Fees ,
Children's Health Insurance Program (CHIP) ,
Compensatory Damages ,
Contraceptive Coverage Mandate ,
Cybersecurity ,
Data Protection ,
Denial of Benefits ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
Employee Retirement Income Security Act (ERISA) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Gobeille v Liberty Mutual Insurance Com. ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Justice Scalia ,
Market Power ,
Materiality ,
Medicaid ,
Medical Devices ,
Medicare ,
Nurses ,
OCR ,
Patient Privacy Rights ,
PHI ,
Preemption ,
Punitive Damages ,
Religious Institutions ,
Right to Privacy ,
SCOTUS ,
Undue Burden ,
Universal Health Services Inc v United States ex rel Escobar ,
Wearable Technology ,
Whole Woman's Health v Hellerstedt ,
Zubik v Burwell
“Healthcare-Related” Calls: Ambiguity at the Intersection of HIPAA and TCPA -
Editor’s Note: The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer...more
11/21/2014
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Electronic Medical Records ,
FCC ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Hospitals ,
PHI ,
Physicians ,
Standard of Care ,
TCPA ,
Text Messages ,
Voicemail
The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer Protection Act (TCPA) for health care messages regulated under the Health Insurance Portability and...more