The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more
7/12/2021
/ Best Practices ,
Compliance ,
Continuing Legal Education ,
Covered Entities ,
DSH ,
Eligibility ,
Enforcement Actions ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medical Billing Codes ,
Medicare ,
Overpayment ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Prescription Drugs ,
Refunds ,
Regulatory Oversight ,
Section 340B ,
Webinars
This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow.
Our...more
3/16/2021
/ Biden Administration ,
Billing ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Health Care Providers ,
Legislative Agendas ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Section 340B ,
Webinars
On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more
2/5/2020
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
GAO ,
HRSA ,
Managed Care Contracts ,
Medicaid ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Section 340B
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
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 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 November 2015, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report (the Report) on the subject of Medicare Part B (Part B) payments made for covered outpatient drugs...more
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
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