The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more
8/5/2025
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Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
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Johnson & Johnson ,
Manufacturers ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
New Guidance ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Pilot Programs ,
Prescription Drugs ,
Regulatory Agenda ,
Section 340B
In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
6/27/2025
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Government Agencies ,
Healthcare ,
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Licenses ,
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Manufacturers ,
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New Regulations ,
Non-Residents ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Puerto Rico ,
Regulatory Reform ,
Regulatory Requirements
As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more
4/11/2025
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Government Agencies ,
Healthcare ,
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Pending Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacist ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government
The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more
2/25/2025
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Fees ,
Healthcare ,
Healthcare Reform ,
Licenses ,
Pending Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government
The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in...more
12/31/2024
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Rebates ,
Section 340B
The Kentucky Attorney General published a formal opinion yesterday confirming that the Board of Pharmacy cannot require the licensure of pharmacists who reside outside of the Commonwealth of Kentucky. The proposed...more
11/13/2024
/ Dormant Commerce Clause ,
Healthcare ,
Interstate Commerce ,
Licensing Rules ,
Non-Residents ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
State Attorneys General ,
Statutory Authority ,
Statutory Interpretation
On April 15, 2024, the Kentucky Board of Pharmacy (“Board”) posted a suite of proposed non-resident pharmacist rules that will require any pharmacist working in another state and who provides services on a Kentucky citizen’s...more
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
4/25/2024
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Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Healthcare ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Section 340B
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
3/14/2024
/ Drug Distribution ,
Drug Pricing ,
Food & Drug Regulations ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Request For Information ,
Section 340B
In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more
11/7/2023
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FQHC ,
Health Care Providers ,
Healthcare ,
HRSA ,
Life Sciences ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more
9/20/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Suppliers ,
Supply Chain
On May 31, 2023, the Nevada Legislature enacted Assembly Bill 107, which reversed the Nevada Board of Pharmacy’s (the “Board”) interpretation that required Nevada pharmacist licensure for out-of-state pharmacists who dispense...more
2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration's (HRSA) underlying enforcement...more
2/9/2023
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Healthcare ,
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Insurance Industry ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B
Last week, the Supreme Court released a decision relating to how the Department of Health and Human Services (HHS) requires hospitals to calculate its disproportionate share percentage. While this percentage is primarily used...more
6/27/2022
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Disproportionate Share Adjustments ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reimbursements ,
SCOTUS ,
Section 340B
On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more
6/16/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Life Sciences ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Prescription Drugs ,
Reimbursements ,
SCOTUS ,
Section 340B
At the March 30, 2022 Kentucky Board of Pharmacy meeting, the Regulation Committee reported on its March 15 meeting where it discussed the new proposed non-resident pharmacy permit regulation. The Committee requested...more
In a move welcomed by the growing number of hospitals forced out of the 340B Program due to falling disproportionate share hospital (DSH) adjustment percentages, Congress has passed a measure offering a chance to rejoin....more
On March 15, 2022, the Regulation Committee for the Kentucky Board of Pharmacy reviewed potential amendments and proposed regulations governing non-resident pharmacy licensure in the state. Among the proposed changes is a...more