On May 6, 2019, a federal district court held that the Department of Health and Human Services’ (HHS) 2018 and 2019 rate reductions for 340B Program participants, including safety net On May 6, 2019, a federal district court...more
5/22/2019
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Hospitals ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Remand ,
Section 340B
On November 2, 2018, CMS released an on-line display copy of its Outpatient Prospective Payment System (OPPS) Final Rule implementing payment changes effective January 1, 2019. The official Federal Issuance is expected on...more
On Tuesday, July 17, 2018, the United States Court of Appeals for the District of Columbia ended a challenge brought by hospitals and hospital associations to the nearly 28 percent reimbursement cuts for 340B hospitals under...more
On Friday, December 29, 2017, the U.S. District Court for the District of Columbia dealt a blow to hospitals participating in the 340B Drug Pricing Program. By participating in the 340B program, eligible public and...more
1/4/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
OPPS ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six...more
Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule...more
Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the...more
8/4/2016
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Hospitals ,
HRSA ,
Managed Care Contracts ,
Medicaid ,
Off-Campus Departments ,
OIG ,
Outpatient Services ,
Prescription Drugs ,
Section 340B
CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more
7/13/2016
/ Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Grandfathered Status ,
Health Care Providers ,
Hospitals ,
Medicare ,
MPFS ,
Off-Campus Departments ,
OPPS ,
Proposed Legislation ,
Proposed Regulation ,
Section 340B
The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating...more
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
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
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