Tag Archives: 340B

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

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 related civil money penalties.  As previously reported, while implementation of the January 5, 2017 rule was already delayed until … Continue Reading

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

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 from House members on ways to address the opioid crisis. On October 17, the Senate Health, Education, Labor, and Pensions … Continue Reading

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

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 civil money penalties. As previously reported, while implementation of this rule has already been delayed until October … Continue Reading

CMS Proposes Medicare OPPS, ASC Update for CY 2018

CMS has published its proposed rule to update Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system rates and policies for calendar year (CY) 2018. In addition to proposing rate updates for the two payment systems, CMS solicits comments on a wide range of topics, including, among others:  deep OPPS … Continue Reading

House Committees Examine Health Care Policy Issues

Recent House of Representatives committee hearings have focused on a variety of health care policy issues, including the following: Energy and Commerce Committee hearings on: the growth and oversight of the 340B drug discount program; drug and device company communications, including clinical/economic data; state efforts to address the opioid crisis; and extension of safety net … Continue Reading

HRSA Pushes Back 340B Rule Implementation Until October 1, 2017

Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017 under a rule published by the Health Resources and Services Administration (HRSA) on May 19, 2017.  The rule initially was scheduled to go into effect … Continue Reading

340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”

The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the 340B drug pricing program until May 22, 2017 – with a longer delay being contemplated.  The January 5, 2017 final rule … Continue Reading

HRSA Publishes Final Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties

The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under the Affordable Care Act.  In particular, the final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; … Continue Reading

President Trump’s Regulatory Review to Impact Recent Health Rules

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff … Continue Reading

OIG Faults State Efforts to Identify 340B Drug Claims; Cites Risk of Duplicate Discounts, Forgone Rebates

The OIG recently examined how states that pay for drugs through Medicaid managed care organizations (MCOs) identify and exclude 340B drug claims when collecting Medicaid rebates, since states are prohibited from collecting “duplicate discounts” (i.e., when manufacturers pay Medicaid rebates on drugs sold at the discounted 340B price).  The OIG also reviewed potential vulnerabilities that … Continue Reading

HRSA Reopens Comment Period on 340B CMP Proposed Rule

On April 19, 2016, the Health Resources and Services Administration (HRSA) is publishing a notice reopening for 30 days the comment period on its June 17, 2015 proposed rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.”  While comments may be submitted on any aspect of the proposed rule, feedback … Continue Reading

MedPAC Releases Annual Recommendations to Congress on Medicare Policy

The Medicare Payment Advisory Commission (MedPAC) has released its annual recommendations to Congress on Medicare policies, including Medicare fee-for-service (FFS) payment updates and a status report on the Medicare Advantage and Medicare Part D programs.  The following are highlights of the recommendations for 2017 (some of which were recommended previously):… Continue Reading

HHS Posts Fall 2015 Regulatory Agenda Listing Rules in Pipeline

The Obama Administration has released its latest regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda includes numerous pending HHS proposed and final rules affecting a wide range of policy areas, including Medicare payment rules, fraud and abuse authorities, the 340B drug pricing program, and … Continue Reading

OIG Examines Medicare Part B Payments for 340B Purchased Drugs

A new OIG report reviews Medicare Part B spending on drugs purchased by eligible health care providers through the 340B drug discount program.  The OIG describes the report as “an independent analysis to inform the ongoing discussion” among policymakers about the nature of 340B discounts and whether statutory changes should be made to enable Medicare … Continue Reading

340B Drug Pricing Program Omnibus Guidance Notice Published by HRSA

On August 28, 2015, the Health Services Resources Administration (HRSA) published long-awaited 340B Drug Pricing Program Omnibus Guidance.  Although many aspects of the notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program, particularly because of its potential to narrow the scope of permissible … Continue Reading

GAO Report Examines Hospital Financial Incentives to Prescribe 340B Drugs to Medicare Beneficiaries

The Government Accountability Office (GAO) has issued a report examining financial and other characteristics of hospitals that participate in the 340B Drug Pricing Program, focusing on disproportionate share hospitals (DSH) that account for the majority of 340B Program discount drug purchases.  Based on a review of Health Resources and Services Administration (HRSA) data for 2008 … Continue Reading

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the Affordable Care Act (ACA). The proposed rule addresses three primary issues: (i) the calculation of the 340B “ceiling price” … Continue Reading

OMB Reviewing New HRSA 340B Omnibus Guidelines

Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by … Continue Reading

HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on … Continue Reading

Congressional Health Policy Hearings

Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program. Also on March 24, the House Ways and Means Subcommittee on Oversight examined CMS’s use of the Fraud Prevention System (FPS) to identify and stop … Continue Reading

March Congressional Health Policy Hearings

On March 10, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on “Continuing America’s Leadership in Medical Innovation for Patients,” featuring testimony from NIH Director Francis Collins, MD, PhD, and FDA Commissioner Margaret Hamburg, MD.   On March 17, the HELP Committee has scheduled a hearing on “America’s Health IT Transformation: … Continue Reading

President Signs Government Funding Bill with Health Spending/Policy Provisions

On December 16, 2014, President Obama signed a $1.1 trillion spending bill that funds most government agencies through the end of the fiscal year on September 30, 2015 (funding for the Department of Homeland Security is funded through February 27, 2015). With regard to HHS funding, the bill, among other things: holds CMS funding at FY … Continue Reading

HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking

The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in 2015 … Continue Reading
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