On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers....more
4/22/2024
/ Claim Procedures ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Healthcare ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022. CMS discussed a...more
It has certainly been a year of ups and downs for 340B hospitals. While litigation continues in the manufacturer 340B price restriction space, and 340B hospitals continue to experience financial, legal and operational...more
On Friday, July 15th, CMS published its CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule) and gave 340B covered entities a glimpse into how the agency intends to react to...more
7/19/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Remedies ,
Section 340B
Wednesday, the United States Supreme Court handed down a highly anticipated, unanimous opinion, AHA v. Becerra, confirming that CMS exceeded its statutory authority when it implemented a discriminatory reimbursement structure...more
6/17/2022
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Lack of Authority ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
SCOTUS ,
Section 340B ,
Statutory Authority
The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like...more
2/22/2022
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inpatient Prospective Payment System (IPPS) ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
Medicare Advantage ,
Outpatient Prospective Payment System (OPPS) ,
Payor Contracts ,
Physician Fee Schedule ,
Section 340B ,
Surprise Medical Bills ,
Telehealth
Recently, HRSA verbally confirmed that it has assigned Administrative Dispute Resolution (ADR) panelists, a key development to move a handful of pending ADR complaints forward. Those complaints contain allegations that drug...more
On July 1, 2021, the Departments of Health and Human Services (“HHS”), Treasury, and Labor, along with the Office of Personnel Management (collectively the “Departments”), issued the first tranche of regulations implementing...more
9/30/2021
/ Biden Administration ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Interim Final Rules (IFR) ,
Legislative Agendas ,
Medical Reimbursement ,
Out of Network Provider ,
Price Transparency ,
Provider Relief Fund ,
Regulatory Agenda ,
Surprise Medical Bills ,
Value-Based Care
On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more
7/22/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drug Coverage ,
Prescription Drugs ,
Reimbursements ,
Section 340B
The U.S. Department of Health & Human Services (HHS) released its highly anticipated Provider Relief Fund (PRF) reporting guidance on June 11, 2021, which outlines deadlines for providers to use the funding received and when...more