News & Analysis as of

Section 340B

Proposed Legislation Aimed to Block 340B Drug Discount Program Cuts

by King & Spalding on

On November 15, 2017, a bipartisan bill was introduced in the U.S. House of Representatives aimed at preventing CMS from reducing reimbursement by nearly 30 percent for Medicare Part B drugs purchased by certain hospitals...more

The 340B Drug Pricing Program: New CMS Final Rule Draws a Motion for Preliminary Injunction from Hospital Groups

On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more

CMS Releases Final 2018 Medicare Payment Regulations

by Baker Donelson on

On November 1 and 2, the Centers for Medicare and Medicaid Services (CMS) released the final 2018 Medicare Payment Regulations for the Physician Fee Schedule, Hospital Outpatient Prospective Payment System and Ambulatory...more

340B Hospitals File Suit in Wake of Hospital Outpatient Cuts

by Foley Hoag LLP on

On November 13, 2017, a group of hospital trade associations (the American Hospital Association, the Association of American Medical Colleges, and America’s Essential Hospitals), along with two health system providers, filed...more

K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

by K&L Gates LLP on

In this episode, Richard Church and Ryan Severson discuss the recent decision by the Centers for Medicare and Medicaid Services (CMS) to substantially decrease reimbursement under the Outpatient Prospective Payment System...more

CMS Finalizes Reimbursement Cuts for 340B Hospitals

by Foley & Lardner LLP on

In a striking blow to 340B hospitals, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) released a final Medicare Outpatient Prospective Payment System (OPPS) rule adopting its...more

CMS Issues Final OPPS Rule, Slashing Reimbursement for 340B Drugs

by King & Spalding on

On November 1, 2017, CMS issued the 2018 Hospital Outpatient Prospective Payment System (OPPS) final rule in which it finalized steep cuts to reimbursement for drugs purchased through the 340B Drug Pricing Program, among...more

340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

by K&L Gates LLP on

On November 1, 2017, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule updating the Medicare hospital Outpatient Prospective Payment System (“OPPS”) for the calendar year 2018. As part of this update,...more

CMS Releases 2018 OPPS/ASC Payment Systems Final Rule

The Centers for Medicare and Medicaid Services (CMS) issued the 2018 Medicare: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Final Rule with comment...more

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

by Polsinelli on

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

CMS Finalizes Medicare Part B Reimbursement Cut for 340B – What Does it Mean?

On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the...more

CMS Cuts Payments for Most 340B Drugs

by McDermott Will & Emery on

On November 1, 2017, the US Department of Health and Human Services released a Final Rule implementing a payment reduction for most covered outpatient drugs billed to Medicare by 340B-participating hospitals from the current...more

CMS moves forward with controversial reductions in Medicare reimbursement for 340B drugs

by Dentons on

On November 1, 2017, the Centers for Medicare & Medicaid Services (CMS) posted a display copy of its final rule regarding the Medicare outpatient prospective payment system (OPPS) for Calendar Year (CY) 2018. (The final rule...more

Reportedly Leaked White House Policy “Wish-List” Lists “Serious 340B Reform,” Demonstration of Value-Based Payments for Drugs and...

by King & Spalding on

A While House policy “wish-list,” reportedly leaked on October 19 (Policy Document), identifies what appear to be the Trump Administration’s policy goals for various government programs, including Medicaid, the 340B Drug...more

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more

Congressional Health Policy Hearings

by Reed Smith on

Recent Congressional hearings focusing on health policy issues include the following: House Energy and Commerce Committee hearings on how covered entities use the 340B drug pricing program, ways to address the opioid...more

House Energy and Commerce Committee Holds Second Hearing on the 340B Drug Pricing Program

by King & Spalding on

On October 11, 2017, the House Energy & Commerce’s Oversight and Investigations Subcommittee held a hearing entitled “Examining How Covered Entities Utilize the 340B Drug Pricing Program.” This was the Subcommittee’s second...more

Capitol Hill Healthcare Update

by BakerHostetler on

President Trump’s announcement Friday that he would stop cost-sharing payments to insurance companies triggered a firestorm on Capitol Hill, with lawmakers in both parties calling on Congress to restore the funding...more

HRSA Delays Final 340B Penalty Rule until July 1, 2018; Additional Rulemaking in the Works

by Reed Smith on

The Health Resources and Services Administration (HRSA) has adopted its proposal to delay the effective date of its final rule revising the calculation of the 340B “ceiling price” that may be charged to covered entities and...more

Drug Pricing, Drug Costs, and the Opioid Crisis are the Focus of Upcoming Congressional Hearings

by Reed Smith on

The Energy and Commerce Subcommittee on Health has scheduled an October 11, 2017 hearing to discuss how covered entities use the 340B drug pricing program. A second Subcommittee hearing on October 11 will consider proposals...more

HRSA delays 340B CMP and Ceiling Price Rule to July 1, 2018 and intends to reopen rulemaking

by Hogan Lovells on

Last week, the Health Resources and Services Administration (HRSA) issued a Final Rule delaying the effective date and the enforcement date of the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties Rule (the...more

Capitol Hill Healthcare Update

by BakerHostetler on

The chairman of a Senate healthcare committee outlined a key test for stabilizing the Affordable Care Act’s (ACA) shaky individual marketplace: Both Republicans and Democrats will have to give a little. That formula has...more

HRSA Proposes Delaying 340B Drug Pricing Program Reforms until July 1, 2018

by Reed Smith on

The Trump Administration is proposing to once again push back the effective date of a January 2017 final rule making changes to the calculation of the 340B “ceiling price” that may be charged to covered entities and related...more

CMS Outpatient Advisory Panel Speaks Out Against Planned 340B Cuts

by King & Spalding on

On August 21, 2017, a CMS advisory panel consisting of provider representatives recommended that CMS not finalize its proposed rule to reduce payments for outpatient drugs to hospitals under the 340B Drug Pricing Program....more

340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again

by K&L Gates LLP on

On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more

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