On September 8, 2015, the House of Representatives passed a bill intended to combat prescription drug abuse through the reauthorization of a program that provides federal grants to states for prescription drug monitoring...more
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more
9/11/2015
/ AIDS ,
Audits ,
Compliance ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
FQHC ,
GPOs ,
Healthcare ,
HRSA ,
Managed Care Contracts ,
MCOs ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more
On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more
7/21/2015
/ 21st Century Cures Initiative ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medicaid ,
Medicaid Reimbursements ,
Medical Devices ,
Medical Research ,
Medicare ,
National Institute of Health (NIH) ,
Physician Medicare Reimbursements ,
Prescription Drugs
The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more
On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) made available a dataset that provides detailed information on medications that physicians and other healthcare providers prescribed under the Medicare...more
Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance...more
In March 2014, CMS temporarily suspended the Recovery Audit Contractor (RAC) program until it secured new contracts. The contracts for the program expired in June 2014, and in August, CMS said that it would restart the...more
In response to a decision to deny coverage of approximately 1,000 active ingredients that are widely used by compounding pharmacies to create topical treatments, three compounding pharmacies have filed a lawsuit against the...more
In an attempt to clear the backlog of appeals of short inpatient stays, CMS recently announced a settlement offer for hospitals with claims currently pending in the appeals process. In exchange for withdrawal of their...more
The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee...more
The implementation of the ACA has afforded many with the opportunity to obtain insurance coverage. Despite the opportunity, a large number of individuals have either chosen not to enroll in a health plan or have been unable...more