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Newly-Announced 340B Payment Rule Presents Financial & Operational Challenges to All Covered Entities

In its 2018 Outpatient Prospective Payment System final rule (Final Rule) issued Nov. 1, Centers for Medicare and Medicaid Services (CMS) implemented a significant Medicare Part B payment reduction for separately payable,...more

Hospital Medicare Certification at Risk? CMS Clarifies Inpatient Volume Expectations

Hospitals with dangerously low inpatient volume and micro hospitals focused primarily on the delivery of outpatient and/or emergency room services instead of inpatient services beware: CMS (Centers for Medicare and Medicaid...more

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

New 340B Dispute Resolution Process: Will It Level the Playing Field?

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more

CMS Proposes Amendments to Payments Furnished from Provider-Based Departments

As part of the CY 2017 proposed Hospital Outpatient Prospective Payment System rules (OPPS) the Centers for Medicare and Medicaid Services (CMS) released the long awaited proposed payment changes for items and services...more

Provider-Based Update: Congress Offers Encouraging Step to Reduce Scope of BBA Reimbursement Reductions

On Wednesday, members of the House Ways and Means Health Subcommittee introduced bipartisan legislation that would provide some welcome relief to hospitals who had already invested resources to develop new provider-based...more

MedPAC Report Recommends Reduction in Medicare Part B Payments to 340B Hospitals

On March 15, 2016, the Medicare Payment Advisory Commission (MedPAC) released its latest report to Congress that included 340B Implications for Medicare Part B Drugs along with a quick fact sheet regarding the report. Key...more

Congress, CMS Seek Input on Provider-Based Reimbursement Reductions

Late last year, Congress made sweeping changes to Medicare provider-based reimbursement that virtually shut down any future off-campus, provider-based site developments. Section 603 of the Bipartisan Budget Act of 2015 (BBA)...more

Provider-Based Status: A Quiet Casualty of the Bipartisan Budget Act

Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many...more

Orphan Drug Ruling Disrupts the 340B Program

On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more

Summary of Key 340B Omnibus Guidance Proposals

As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more

Breaking News: Proposed 340B Omnibus Guidance Released

The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the...more

340B Program Change on the Horizon? OMB Completes Review of the 340B Omnibus Guidance

Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more

Special Update: OPA Sends 340B Program Omnibus Guidelines to Office of Management and Budget

On Wednesday, May 6, the Health Resources and Services Administration, Office of Pharmacy Affairs (“OPA”) forwarded a draft copy of its 340B Program Omnibus Guidelines (“Guidelines”) to the Office of Management and Budget for...more

RESCHEDULED: 340B in the Spotlight: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

The House Energy & Commerce Health Subcommittee on Health hearing entitled, “Examining the 340B Drug Pricing Program”, originally scheduled for Thursday, March 5th has been RESCHEDULED for March 24, 2015 at 10:00 a.m. EST. ...more

340B in the Spotlight This Thursday: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

Thursday, March 5th at 10:00 a.m. EST, the House Energy & Commerce Health Subcommittee on Health will hold a hearing entitled, “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the...more

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

Breaking 340B News: HRSA Withdrew its Much-Anticipated 340B Mega-Reg

On Thursday, HRSA formally withdrew its much-anticipated 340B Mega-Reg from the rulemaking process, effectively abandoning its effort to overhaul existing 340B program guidance through new regulations. Commander Krista...more

11/18/2014  /  HRSA , Rulemaking Process , Section 340B
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