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
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
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
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
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2023 (the HOPPS Proposed Rule) on...more
8/3/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
HOPPS ,
Manufacturers ,
Payment Systems ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
SCOTUS ,
Supply Chain
The Centers for Medicare & Medicaid Services (CMS) calendar year 2023 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more
7/20/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Federal Register ,
HCPCS ,
Infrastructure Investment and Jobs Act (IIJA) ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Social Security Act
The Centers for Medicare & Medicaid Services (CMS) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on...more
1/27/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Fees ,
Medical Loss Ratio ,
Medicare ,
Medicare Advantage ,
Medicare Modernization Act ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Rebates ,
Social Security Act
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule finalizing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Final Rule) was published on November 19, 2021....more
The Centers for Medicare & Medicaid Services (CMS) has released a proposed rule (the Proposed Rule) which, if finalized and adopted, would rescind the Trump Administration’s attempt to align reimbursement under Medicare Part...more
The Centers for Medicare & Medicaid Services (CMS) has issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (HOPPS) (the Proposed Rule)....more
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
...more
3/3/2021
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Bonuses ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Commercially Reasonable Efforts ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Profit Sharing ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed.
The Centers for Medicare & Medicaid Services (CMS) released an advance copy of an interim final rule with a comment period announcing...more
The White House released a new Executive Order on September 13, 2020, related to drug prices titled “Lowering Drug Prices by Putting America First” the September Order), whose stated purpose is to address reimbursement for...more
9/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Medicare Part B ,
Medicare Part D ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Mitigation ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
In a move with far reaching implications for the health care industry, the Department of Health and Human Services (HHS) recently released a proposed rule that would codify into regulation specific requirements that it and...more
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted.
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
8/24/2020
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCPCS ,
HOPPS ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medical Devices ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Pharmacist ,
Physician Fee Schedule ,
Proposed Rules ,
Public Health Emergency ,
Social Security Act
The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more