After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to...more
As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more
4/15/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Involuntary Reduction in Force ,
Layoffs ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform
Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...more
The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more
On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more
1/24/2025
/ Competition ,
Cost-Sharing ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Health Insurance ,
Life Sciences ,
Mergers ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Reimbursements
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
9/13/2021
/ Biden Administration ,
Biosimilars Action Plan (BAP) ,
BPCIA ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Pharmaceutical Industry ,
Prescription Drugs
On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more
7/20/2021
/ Antitrust Provisions ,
Biden Administration ,
Biosimilars ,
Competition ,
CREATE Act ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Pharmaceutical Industry ,
USPTO
With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic...more
Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription...more
5/29/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Electronic Prescribing ,
Final Rules ,
Gag Clauses ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more
10/17/2018
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Disclosure Requirements ,
First Amendment ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Television Commercials
States may be starting to take aim at prescription automatic refill programs. Automatic refill programs have been proven to increase patient adherence, especially among patients with chronic conditions. However, these...more
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more
3/16/2017
/ ACOs ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medicare Shared Savings Program ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Safe Harbors ,
Stark Law ,
Value-Based Care
The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move...more
In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of...more
In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more
12/9/2015
/ AstraZeneca ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
FDA Approval ,
HRSA ,
Kickbacks ,
Kmart ,
Novartis ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Value-Based Purchasing
We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more
10/8/2015
/ Comment Period ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Interpretive Rule ,
MCOs ,
Medicaid ,
Medicare ,
Omnibus Guidance ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Regulation ,
Section 340B ,
State Medicaid Programs
Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological...more