Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
12/3/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Competitive Bidding ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
International Trade ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a press release announcing the voluntary “GENErating cost Reductions for U.S. Medicaid (GENEROUS)” payment model, which will implement most...more
11/19/2025
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Press Releases ,
Section 340B
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
11/4/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Final Rules ,
Healthcare Reform ,
HRSA ,
Inflation Reduction Act (IRA) ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
10/20/2025
/ Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Section 340B ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
10/7/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Drug Pricing ,
Executive Orders ,
Final Guidance ,
Inflation Reduction Act (IRA) ,
Medicaid Drug Rebate Program ,
Most-Favored Nations ,
Proposed Rules ,
Reporting Requirements ,
SCOTUS ,
Section 340B ,
Sunshine Act ,
Tariffs ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
9/22/2025
/ Advertising ,
Audits ,
CBO Report ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
GAO ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
9/8/2025
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Pharmaceutical Industry ,
Regulatory Reform ,
Section 340B ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
8/26/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Healthcare Reform ,
HRSA ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Section 340B ,
State and Local Government ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
8/12/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Healthcare Reform ,
HRSA ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicaid Drug Rebate Program ,
Medicare Advantage ,
Pharmaceutical Industry ,
Section 340B ,
Trump Administration
The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
7/29/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Federal Register ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pending Litigation ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Rules ,
Section 340B ,
Vouchers
On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more
7/15/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
HRSA ,
Inflation Reduction Act (IRA) ,
Medicare ,
Orphan Drugs ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
7/1/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Federal Grants ,
Health Care Providers ,
HRSA ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B
Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more
6/18/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
5/20/2025
/ Comment Period ,
Department of Health and Human Services (HHS) ,
Deregulation ,
Drug Pricing ,
Executive Orders ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B ,
Supply Chain
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
5/6/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Drug Pricing ,
Executive Orders ,
Federal Budget ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Information Reports ,
Medicaid ,
Medicare ,
Most-Favored Nations ,
Pending Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Trump Administration
On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more
4/22/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform ,
Tariffs ,
Trump Administration
On April 2, 2025, the Supreme Court unanimously held that the US Food and Drug Administration (FDA) lawfully denied marketing authorization for certain flavored e-liquids used in electronic nicotine delivery systems (ENDS),...more
The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
4/8/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Government Agencies ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Tariffs ,
Trump Administration
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
1/16/2025
/ Compliance ,
Data-Sharing ,
Enforcement ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Regulatory Requirements ,
Risk Management ,
Safe Harbors
FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited.
On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more
9/10/2024
/ Administrative Procedure Act ,
Chevron Deference ,
E-Cigarettes ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Authority ,
Statutory Interpretation ,
Tobacco ,
Tobacco Regulations
The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties.
On August 31, 2023, the US Food and Drug Administration (FDA or...more
The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders.
On September 22, 2023, the US...more
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others.
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
1/16/2023
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biosimilars ,
Cosmetics ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Inspections ,
Interchangeability ,
Manufacturing Facilities ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform
The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers.
Key Points:
..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more