Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more
1/14/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
GAO ,
Hospitals ,
HRSA ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B
A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more
12/6/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Local Coverage Determination (LCD) ,
Medicare ,
Medicare Part C ,
New Guidance ,
Notice and Comment ,
OGC ,
Overpayment ,
Provider Payments ,
Rulemaking Process ,
SCOTUS ,
Social Security Act
On October 31, 2018, the Health Resources and Services Administration (HRSA) at the US Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to move up the effective date of a final rule that...more
On September 11, 2018, the American Hospital Association (AHA) and several other hospital system and hospital association stakeholders1; (Plaintiffs) filed a lawsuit (Complaint) against the U.S. Department of Health and Human...more
In late December 2017, Republican Rep. Larry Bucshon (with bi-partisan support) introduced the “340B Protecting Access for the Underserved and Safety-net Entities Act” (340B PAUSE Act), legislation that would implement a...more
On November 1, 2017, the US Department of Health and Human Services released a Final Rule implementing a payment reduction for most covered outpatient drugs billed to Medicare by 340B-participating hospitals from the current...more
As part of the CY 2018 proposed updates to the Medicare Hospital OPPS, the US Department of Health and Human Services has proposed to decrease Medicare Part B payments to hospitals for 340B drugs by almost 30 percent. The cut...more
With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more
As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB)...more
The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more
On December 19, 2016, the US Department of Health and Human Services Office of Inspector General (OIG) posted a report examining the Centers for Medicare & Medicaid Services’ (CMS’s) “2-Midnight Rule.” The OIG concluded that...more
On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more
8/17/2016
/ Administrative Proceedings ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Affordable Care Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Government Claims ,
HRSA ,
Manufacturers ,
Prescription Drug Coverage ,
Prescription Drugs ,
Proposed Rules ,
Section 340B ,
Statute of Limitations
In Depth -
On June 16, 2016, the US Department of Health and Human Services Office of Inspector General (OIG) posted a report examining the Centers for Medicare & Medicaid Services’ (CMS’s) oversight of billing by...more
On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more
10/21/2015
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Hospitals ,
HRSA ,
Judicial Review ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B
In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more
9/1/2015
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
DSH Adjustments ,
GPOs ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
MCOs ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Recordkeeping Requirements ,
Recovery Audit Contractors (RACs) ,
Section 340B
On June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program...more
The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more
On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more
On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more
On February 4, 2014, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) issued a memorandum report regarding contract pharmacy arrangements in the 340B Program. In its report, OIG found...more
On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more