On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Such privacy laws and regulations as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule can have a significant impact on the development of health care data analytics in cases where those analytics...more
The Centers for Medicare & Medicaid Services (CMS) has just released the final 60-day overpayment rule (the Rule) on February 11, 2016, in what the agency describes as a continuing move targeted at rooting out fraudulent...more
In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more
10/27/2015
/ Administrative Authority ,
Administrative Procedure Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Discount Pricing ,
HRSA ,
Interpretive Rule ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B ,
Vacated
The United States Government Accountability Office (GAO) recently released a report entitled “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals” (“the...more
7/14/2015
/ Beneficiaries ,
GAO ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Part B ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Section 340B