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
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
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
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 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 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
On Friday, December 29, 2017, the U.S. District Court for the District of Columbia dealt a blow to hospitals participating in the 340B Drug Pricing Program. By participating in the 340B program, eligible public and...more
1/4/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
OPPS ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
In a striking blow to 340B hospitals, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) released a final Medicare Outpatient Prospective Payment System (OPPS) rule adopting its...more
The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the...more
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more
10/20/2015
/ Abuse of Discretion ,
Administrative Procedure Act ,
Arbitrary and Capricious ,
Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
HRSA ,
Interpretive Rule ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B ,
Vacated
The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more
9/1/2015
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Guidance Update ,
Healthcare Facilities ,
Hospitals ,
MCOs ,
Medicaid ,
Medicare ,
New Guidance ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Recordkeeping Requirements ,
Section 340B
The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more
On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more
A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more
On February 5, 2014, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) published a report (OIG Report) describing the results of a survey it had conducted of the use of contract...more