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
The Drug Enforcement Administration (DEA) recently issued a new regulation codifying provisions of the Veterinary Medicine Mobility Act of 2014 (VMMA). The VMMA, which was signed into law in 2014, allows a veterinarian to...more
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
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
This week, Governor Holcomb signed House Enrolled Act 1461 ("the Act") into law. The Act significantly reforms the long-term care landscape in Indiana, with many of the changes directed towards improving oversight of...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
In late February 2023, the University of Pittsburgh Medical Center (UPMC) and one of its surgeons agreed to pay the federal government $8.5 million to resolve claims that the surgeon violated Medicare and Medicaid rules by...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
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
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