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
Back in 2017, the state of Nevada passed a sweeping bill into law that addressed not only drug pricing transparency, but also reporting obligations applicable to pharmacy benefit managers and non-profit organizations and also...more
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
A handful of recent court decisions have brought a small degree of resolution and simultaneously a large degree of uncertainty to what we at Arent Fox affectionately refer to as the “340B Saga.”
It’s a dispute lasting...more
Proposed Rules Seek to Repeal Multiple Trump Era Regulations That Received Prior Industry Scrutiny -
The United States Department of Health and Human Services (HHS) – still within its first full year under the direction...more
The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals”...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
The United States Supreme Court has agreed to hear a case that has a direct impact on the 340B Drug Discount Program (the 340B Program) and how Medicare will reimburse hospitals for dispensing of 340B covered drugs, as well...more
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more
6/14/2021
/ Biden Administration ,
Canada ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Motion to Dismiss ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rulemaking Process ,
Secretary of HHS ,
Standing ,
Subject Matter Jurisdiction
Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers” -
The Governor of North Dakota signed House Bill 1032 into law on April 27,...more
Congress recently passed two bills that are designed to educate patients and prescribers about biosimilars and thereby encourage their use and to close a loophole in existing law that allows certain branded drugs to retain...more
Texas Health and Human Services announced that beginning April 1, 2021, drug manufacturers who wish for their products to be added to the Texas Drug Code Index (the Texas Medicaid formulary) must create an electronic account...more
US District Court for Southern District of Indiana granted plaintiffs Eli Lilly and Company and Lilly USA a preliminary injunction barring HRSA from implementing the final Administrative Dispute Resolution rule that was to...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