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
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 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
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
Contracting With Technology Vendors: Obligations and Compliance Strategies -
Editor’s Note: In a recent webinar, Manatt Health examined how to protect privacy when communicating in the digital age. The session revealed how...more
7/25/2017
/ Antitrust Division ,
Business Associates ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
Employee Retirement Income Security Act (ERISA) ,
Fair Credit Reporting Act (FCRA) ,
Federal Trade Commission (FTC) ,
Health Insurance ,
Medicare ,
Mergers ,
Physician Fee Schedule ,
Spokeo v Robins ,
Vendors
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
Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal -
Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more
12/22/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Contraceptive Coverage Mandate ,
Department of Health and Human Services (HHS) ,
Freedom of Religion ,
Hospital Mergers ,
IRS ,
Long-Term Care ,
Medicare ,
Medicare Part B ,
OIG ,
Prescription Drugs ,
Public Health Insurance Marketplace ,
SCOTUS ,
Section 340B ,
Split of Authority ,
Stark Law ,
Waivers
Avoiding the Regulatory Land Mines of Commercial ACOs -
While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more
7/23/2014
/ ACOs ,
EHR ,
Halifax Hospital ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medicare ,
Medicare Shared Savings Program ,
Regulatory Standards ,
Reporting Requirements ,
Social Networks ,
Stark Law
Removing Regulatory Barriers to Accelerate EHR Adoption -
Recognizing the potential long-term value of EHRs for improving care and reducing costs, many hospitals considered offering physicians financial support to...more
Assessing the Medicare Shared Savings Program: Diverse Participants, Diverse Results -
Rising healthcare costs and declining reimbursements have placed immense pressure on providers and health systems to manage the...more