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
/ Distributors ,
Government Agencies ,
Healthcare ,
Imports ,
Licenses ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
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
/ Alabama ,
Government Agencies ,
Healthcare ,
Penalties ,
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
/ Alabama ,
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
/ Arbitration ,
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
/ Drug Pricing ,
FQHC ,
Health Care Providers ,
Healthcare ,
HRSA ,
Life Sciences ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more
10/30/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
HRSA ,
Life Sciences ,
Medicare ,
Office of Pharmacy Affairs Information System (OPAIS) ,
Outpatient Services ,
Patients ,
Pharmaceutical Industry ,
Registration Requirement ,
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
The Centers for Medicare & Medicaid Services ("CMS") recently announced its proposal to make a one-time lump sum payment of roughly $9 billion to 340B-covered entity hospitals that were impacted by the agency's unlawful...more
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
As detailed further in our article on the current state of the 340B Program and what to expect in 2023, a growing list of manufacturers have taken the step of significantly restricting 340B pricing for fills completed by...more
The Arkansas House of Representatives proposed a bill that would amend the Pharmacy Practice Act to restrict pharmacy ownership to certain individuals and entities. The bill would require an applicant for a pharmacy permit to...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
/ Anti-Discrimination Policies ,
Healthcare ,
HRSA ,
Insurance Industry ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B
At a special called meeting on January 4, 2023, the Kentucky Board of Pharmacy (“Board”) was set to address public comment on new regulation, 201 KAR 2:460, and proposed amendments to 201 KAR 2:030. The amendments to 201 KAR...more
As the extensively covered Genesis Healthcare, Inc. v. Azar case continues to proceed, 340B covered entities expect to soon receive much-anticipated clarification on what can reasonably constitute a 340B eligible patient. In...more
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
During its August 31, 2022 meeting, the Kentucky Board of Pharmacy (“Board”) voted to move forward with the rule promulgation process for proposed amendments to 201 KAR 2:030. The proposed amendment will create a new...more
While the vast majority of states require non-resident wholesale distributors and manufacturers that ship prescription drugs into their states to obtain a non-resident license, Puerto Rico had been one of the few that did not...more
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
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
/ Becerra Secretary Of Health And Human Services v Empire Health Foundation For Valley Hospital Medical Center ,
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
The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk...more