On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) finalized the rule Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the Calendar Years 2018–2022 to addresses how the...more
11/6/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
Medical Reimbursement ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 to address how...more
Although we are still awaiting final results of the November 8, 2022, midterm elections, the US House of Representatives appears likely to flip to Republican control, while the US Senate will remain in Democratic hands....more
The Centers for Medicare and Medicaid Services has released proposed updates to payment rates and regulations applicable to the Hospital Outpatient Prospective Payment System for Calendar Year 2020, including proposals...more
The US District Court for the District of Columbia recently held that the Centers for Medicare and Medicaid Services (CMS) exceeded its authority by reducing Medicare payment rates for 340B drugs, but, because of the...more
After an already active first half of 2018 for 340B Program developments, 340B Program stakeholders are not getting a summer respite. In just the past week, the US Government Accounting Office (GAO) released its...more
The Helping Ensure Low-income Patients have Access to Care and Treatment (HELP ACT) is the third 340B-related legislation to be introduced this month. The HELP ACT goes well beyond the 340B PAUSE Act in the scope of its...more
In late December 2017, Republican Rep. Larry Bucshon (with bi-partisan support) introduced the “340B Protecting Access for the Underserved and Safety-net Entities Act” (340B PAUSE Act), legislation that would implement a...more
As part of the CY 2018 proposed updates to the Medicare Hospital OPPS, the US Department of Health and Human Services has proposed to decrease Medicare Part B payments to hospitals for 340B drugs by almost 30 percent. The cut...more
As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB)...more
The Centers for Medicare & Medicaid Services released the calendar year 2017 final rule implementing changes to the Medicare hospital Outpatient Prospective Payment System, or OPPS, including provisions implementing Section...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 Depth -
Background -
On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) released the CY 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule, which includes proposed regulations to...more
7/12/2016
/ Ambulatory Surgery Centers ,
Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Hospitals ,
Medicare ,
MPFS ,
Off-Campus Departments ,
OIG ,
OPPS ,
Payment Systems ,
Physician Fee Schedule ,
Proposed Rules ,
Section 340B
On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more
10/30/2015
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Debt Ceiling ,
Federal Budget ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Medicaid ,
Medicare ,
Medicare Part B ,
OPPS ,
Pending Legislation ,
Physician Fee Schedule ,
Physicians ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Sequestration
The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more
On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more