The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more
The Centers for Medicare & Medicaid Services (CMS) published two significant updates to its Medicaid regulations on May 10, 2024. The two Final Rules, a Medicaid Access Rule and a Medicaid Managed Care Rule, impose new...more
Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more
3/28/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicare ,
OIG ,
Payor Contracts ,
Reimbursements ,
Risk Mitigation ,
Stark Law
Along with its calendar year (CY) 2024 Medicare Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) have also published the long-awaited proposal to remediate the...more
7/27/2023
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare Administrative Contractors (MAC) ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Proposed Rules ,
SCOTUS ,
Section 340B
Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more
3/31/2023
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement ,
HRSA ,
Payment Systems ,
Pharmaceutical Industry ,
Pharmacies ,
Remedies ,
SCOTUS ,
Section 340B
This is the first article in a series addressing key changes to the California health care marketplace, focused on changes to California’s behavioral health delivery systems. Forthcoming articles in the series will address...more
In this episode, Foley partner Anil Shankar discusses California’s new Medicaid wavier called CalAIM, (California Advancing and Innovating Medi-Cal, the multiyear care delivery and payment reform initiative led by the...more
The Centers for Medicare and Medicaid Services (CMS) has announced that it “fully expects” to reverse Medicare Part B rate cuts for separately payable drugs acquired through the 340B Drug Pricing Program, resulting in an...more
The Supreme Court issued a long-awaited victory to 340B hospitals this week, when it held in American Hospital Association et al. v. Becerra et al. that the Department of Health and Human Services (HHS) had set unlawful...more
The COVID-19 vaccine mandate implemented by the Centers for Medicare and Medicaid Services (CMS) has affected investor interest in non-acute care providers and suppliers, including home care providers. As our colleagues...more
Since Spring 2020, the Department of Health and Human Services (HHS) has distributed more than $150 billion in Provider Relief Funds (PRF) to health care providers that can be used to reimburse their expenses attributable to...more
Medicaid providers cannot sue the state to seek payment from a Medicaid health plan, according to a July 9 Illinois federal district court decision. The court’s holding is likely to be a disappointment to providers...more
Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more
6/22/2021
/ Administrative Procedure Act ,
Advisory Opinions ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
HRSA ,
Manufacturers ,
Motion to Dismiss ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
The U.S. Department of Health and Human Services (HHS) has issued new guidance extending the timeline for health care providers that received more than $10,000 in payments from the Provider Relief Fund (PRF) to expend and...more
As part of the omnibus Federal appropriations bill enacted into law on December 27, 2020, Congress established new reporting requirements for states that make Medicaid supplemental payments. The new requirements follow on the...more
Congress’ recently-passed Federal Appropriations Act includes new provisions modifying the scope of the Provider Relief Fund payments overseen by the U.S. Department of Health and Human Services (HHS), granting providers new...more
On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing...more
On October 1, 2020, the Department of Health and Human Services (HHS) announced a new $20 billion Phase 3 of the Provider Relief Fund (PRF) General Distribution. Much like the Phase 2 funding, Phase 3 funding will be made...more
On September 19, 2020, the Department of Health and Human Services (HHS) released guidance establishing the reporting requirements for health care providers that received Provider Relief Fund (PRF) payments. These reporting...more
9/24/2020
/ Audits ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FEMA ,
Medical Expenses ,
New Guidance ,
Nursing Homes ,
Paycheck Protection Program (PPP) ,
Provider Relief Fund ,
Rural Health Care Providers ,
SBA ,
State and Local Government ,
Tribal Governments
The Department of Health & Human Services (DHHS) announced some Medicare providers who experienced challenges in the Phase 1 general distribution application period will get a second chance to apply for funds. This limited...more
On Wednesday April 22, 2020, the U. S. Department of Human Health and Services (HHS) unveiled its plan to disperse an additional $70 billion in COVID-19 funding authorized by the Coronavirus Aid Relief and Economic Security...more
On November 18, 2019, the Centers for Medicare & Medicaid Services (CMS) proposed changes to federal Medicaid rules that, if implemented, would affect billions of dollars of Medicaid payments nationwide, creating new...more
11/20/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Disproportionate Share Adjustments ,
Federal Funding ,
Fees ,
Funding ,
Health Care Providers ,
Hold Harmless ,
Medicaid ,
Proposed Amendments ,
Public Agencies ,
Public Entities ,
Reporting Requirements ,
Risk Retention ,
Rulemaking Process ,
State and Local Government ,
State Funding ,
State Taxes
On May 6, 2019, a federal district court held that the Department of Health and Human Services’ (HHS) 2018 and 2019 rate reductions for 340B Program participants, including safety net On May 6, 2019, a federal district court...more
5/22/2019
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Hospitals ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Remand ,
Section 340B
On November 2, 2018, CMS released an on-line display copy of its Outpatient Prospective Payment System (OPPS) Final Rule implementing payment changes effective January 1, 2019. The official Federal Issuance is expected on...more
On Tuesday, July 17, 2018, the United States Court of Appeals for the District of Columbia ended a challenge brought by hospitals and hospital associations to the nearly 28 percent reimbursement cuts for 340B hospitals under...more