Legislation being drafted as part of a budget deal between members of Congress and the White House includes language that will significantly alter the future of hospital-based outpatient care. The “discussion draft” of the...more
10/30/2015
/ Ambulatory Surgery Centers ,
Federal Budget ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Medicare ,
MedPAC ,
OIG ,
OPPS ,
Pending Legislation ,
Physician Fee Schedule ,
Reimbursements
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more
10/20/2015
/ Abuse of Discretion ,
Administrative Procedure Act ,
Arbitrary and Capricious ,
Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
HRSA ,
Interpretive Rule ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B ,
Vacated
The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more
9/1/2015
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Guidance Update ,
Healthcare Facilities ,
Hospitals ,
MCOs ,
Medicaid ,
Medicare ,
New Guidance ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Recordkeeping Requirements ,
Section 340B
The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more
6/19/2015
/ Affordable Care Act ,
Civil Monetary Penalty ,
Covered Entities ,
Drug Distribution ,
HRSA ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drug Coverage ,
Rulemaking Process ,
Section 340B
The Centers for Medicare and Medicaid Services (“CMS”) released, on May 26, 2015, the a far-ranging proposal for revising the Medicaid managed care regulations (“Proposed Rule”). The number of individuals enrolled in Medicaid...more
The Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule, on April 10, 2015, addressing the application of the Mental Health Parity and Addiction Equity Act of 2008 (“MHPAEA”) to the Medicaid and CHIP...more
The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more
A federal court entered a new order, on August 27, 2014, in an ongoing dispute between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Manufacturers of America (PhRMA) regarding HRSA’s issuance...more
On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more
A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more
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
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
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
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