340B

News & Analysis as of

Two Recent 340B Developments: New Hospital Registration Guidance and Proposed Rules Under Review at OMB

Earlier this week, the much-anticipated 340B Drug Pricing Program (340B Program) proposed rule arrived at the Office of Management and Budget for review. Publication of this proposed rule is expected in June and will likely...more

HHS OIG Reports Findings on 340B Contract Pharmacy Program

Program often fails to pass through savings to uninsured patients and creates risk of diversion and duplicate discounts. As a condition of payment for covered outpatient drugs by Medicaid, manufacturers must enter into...more

OIG Reveals Pervasive Problems in Federal Drug Discounting Program

The 340B drug pricing program was created by Congress in 1992 to make prescription medicines more available to low-income and indigent patient populations. The program has been, and likely will continue to be, fertile ground...more

OIG Publishes Report Identifying Issues With 340B Contract Pharmacy Arrangements

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

OIG Reports on Contract Pharmacy Arrangements in the 340B Program

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

Congress Also Provides for Ramped-Up 340B Enforcement With Allocation of Additional Funding

The FY 2014 spending bill also allocates $6 million to “implement a new program integrity effort within the 340B Drug Pricing Program.” The Joint Explanatory Statement directs the Director of the 340B Program to brief the...more

340B Drug Pricing Program Developments in the New Year

On January 9, 2014, the Health Resources and Services Administration (HRSA) posted an update on its current and anticipated 340B drug pricing program (340B) program integrity efforts.1 The update includes a discussion of...more

Grassley Turns His 340B Microscope on Manufacturers

For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers. As we previously wrote, Senator Grassley has been among the most vocal of critics in...more

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

HRSA Issues Final 340B Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance...

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more

HRSA Clarifies 340B Orphan Drug Exception But 340B Audit Enforcement Remains Murky

Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more

HRSA Publishes Orphan Drug Rule for 340B Program

Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

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

Hospitals Fight Back to Defend 340B Program Operations

Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting...more

US District Court Prohibits Enforcement of California 340B Medicaid Mandatory Carve-In Law

The 340B program permits eligible hospitals and other “safety-net” providers (340B Covered Entities) to purchase outpatient drugs from pharmaceutical manufacturers at significant discounts. To address its fiscal woes,...more

340B Drug Pricing Program: Recent Developments

The 340B Drug Pricing Program (340B Program) continues to undergo a period of intense scrutiny and debate over how compliance with program rules is enforced. As previously reported in the May 30, 2012 edition of Foley’s Legal...more

340B Program GPO Prohibition Compliance Extension

Hospitals subject to the 340B Drug Pricing Program (340B Program) Group Purchasing Organization (GPO) prohibition now have an additional four months, until August 7, 2013, to comply with 340B Program guidance issued February...more

Grassley Questions Hospital 340B Program Profits

In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more

340B Drug Pricing Program Notices on Group Purchasing Organizations and Medicaid Exclusion File

Following the recent release of new Program Notices regarding the Group Purchase Organization (GPO) prohibition and Medicaid Exclusion File, 340B participating entities should review their 340B program policies and procedures...more

Big Changes Are Happening With the 340B Drug Program

Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more

21 Results
|
View per page
Page: of 1