On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more
7/28/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Drug Pricing ,
HOPPS ,
Hospitals ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Reimbursements ,
Reporting Requirements
The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of...more
There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota....more
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more
On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more
2/28/2025
/ Cost-Sharing ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Insurance Industry ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Regulatory Requirements ,
Reporting Requirements ,
State and Local Government
With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year....more
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now...more
11/22/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
HOPPS ,
Inflation Reduction Act (IRA) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Penalties ,
Physician Fee Schedule ,
Section 340B ,
Shareholders
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
7/18/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Reimbursements ,
Section 340B ,
Shareholders
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
6/27/2024
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
HRSA ,
Interstate Commerce ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
5/15/2024
/ Affordable Care Act ,
Conflicts of Interest ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Federal Rules of Civil Procedure ,
Federal Rules of Evidence ,
Final Rules ,
HRSA ,
Manufacturers ,
Office of Pharmacy Affairs (OPA) ,
Prescription Drugs ,
Section 340B
On April 25, the US Court of Appeals for the Third Circuit issued its precedential opinion in Mallinckrodt v. Sanofi-Aventis, Case No. 23-1111, reminding everyone that “creditors take on risks” when it ruled that the debtor...more
Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program.
The Oregon Drug Price Transparency Program was...more
The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more
12/27/2023
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inflation Adjustments ,
Inflation Reduction Act (IRA) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Rebates ,
Section 340B ,
Supply Chain ,
Supply Shortages
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
10/30/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Customs and Border Protection ,
DSCSA ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
MDRP ,
Medicaid ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry
The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...more
It is the annual summer pastime for the pharmaceutical community. Time to review the Centers for Medicare & Medicaid Services (CMS) release of the 2024 proposed Hospital Outpatient Prospective Payment System (HOPPS) and...more
On May 26, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule titled: “Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug...more
6/9/2023
/ Audits ,
Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Medicaid ,
Misclassification ,
OIG ,
Operational Requirements ,
Proposed Rules ,
Vaccinations
With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023.
End of the COVID-19 Public Health Emergency. After being in effect for more than...more
2/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Inflation Reduction Act (IRA) ,
No Surprises Act (NSA) ,
Popular ,
Proposed Rules ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Telehealth
The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of...more
The Centers for Medicare & Medicaid Services (CMS) has issued its annual final rules related to both the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for calendar year 2023 (the HOPPS...more
The Centers for Medicare & Medicaid Services (CMS) has released the first in what undoubtedly will be a series of guidance documents regarding the recently enacted Inflation Reduction Act (IRA).
ArentFox Schiff outlined...more
After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more
8/23/2022
/ Abbreviated New Drug Application (ANDA) ,
American Rescue Plan Act of 2021 ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Inflation Reduction Act (IRA) ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
New Legislation ,
Prescription Drugs ,
Section 340B