
340B and Drug Pricing
Sharply rising drug costs are unsustainable for patients, hospitals, and taxpayers, and underscore the urgent need for programs that protect patient access to lifesaving medications and treatment. The 30-year-old 340B Drug Pricing Program meets that need with nearly no cost to taxpayers.
Through manufacturer discounts rather than federal funding, the 340B program helps hospitals stretch scarce resources as they meet their commitment to care for vulnerable people. Consistent with the law and congressional intent, hospitals purchase pharmaceuticals at a discount and use the savings to deliver essential care services to the uninsured and other disadvantaged patients, both within the hospital and in the community. The 340B program is a key component of the nation’s health care safety net.
America’s Essential Hospitals, which supports transparency for and appropriate federal oversight of 340B, works to defend the program against attempts to scale back its use or limit how hospitals may use savings to benefit vulnerable patients.
The association has successfully turned back attempts by pharmaceutical manufacturers and others to reduce access to the program, including through proposed “mega-guidance” that would have dramatically narrowed eligibility for patients and hospitals. In January 2017, largely due to advocacy by essential hospitals since 2015, the Trump administration halted the mega-guidance.
The association remains wary of new attempts to restrict 340B and will remain vigilant and actively protect this program for essential hospitals and vulnerable patients.
Medicaid Drug Rebate Program Proposed Rule
May 31, 2023 ||The proposed rule targets drug misclassification, along with drug pricing and product data misreporting, by manufacturers.
view more »Association Urges HRSA to Clarify 340B Eligibility for Offsite Locations
May 11, 2023 ||The letter expressed concern with reports that HRSA no longer will allow hospitals to administer 340B drugs in offsite outpatient locations that have not yet appeared on a filed Medicare cost report.
view more »New Mexico Tackles 340B Discriminatory Payer Practices
April 11, 2023 ||A New Mexico law will prevent pharmacy benefit managers from discriminating against 340B Drug Pricing Program providers.
view more »On the Hill: 340B Legislation, Signs of Progress on Medicaid DSH
April 10, 2023 ||The bipartisan PROTECT 340B Act would prohibit discriminatory practices by insurers and pharmacy benefit managers against 340B Drug Pricing Program providers and their contract pharmacies.
view more »On the Hill: 340B, Transparency Discussed at Hearings
April 3, 2023 ||Amid ongoing hearings on the broader fiscal year (FY) 2024 federal budget, several committees of jurisdiction last week focused on health care programs and financing issues, including transparency and the 340B Drug Pricing Program. The House Committee on Energy and Commerce was characteristically busy. It held a Health Subcommittee hearing, “Lowering Unaffordable Costs: Examining Transparency
view more »Protect the Safety Net by Protecting 340B
Feb. 24, 2023 ||The 340B program continues to work as Congress intended. America’s Essential Hospitals urges Congress and the administration to protect the 340B program and ensure all stakeholders comply with the law.
view more »On the Hill: Biden Details Health Care Agenda in State of the Union
Feb. 13, 2023 ||The president vowed to veto attempts to roll back Inflation Reduction Act measures to reduce prescription drug prices. He also voiced his plan to make permanent pandemic-related increases to Affordable Care Act premium subsidies.
view more »District Court Orders HHS to Develop Remedy to Unlawful 340B Payment Cuts
Jan. 13, 2023 ||America’s Essential Hospitals and other plaintiffs had asked the judge to order an immediate repayment in full for five years of underpayments to 340B hospitals.
view more »HRSA Proposes Revised 340B Administrative Dispute Resolution Process
Dec. 7, 2022 ||Citing policy and operational challenges with implementing the administrative dispute resolution process as created in a 2020 final rule, HRSA proposes a less formal ADR process that it believes will be less burdensome for parties submitting claims.
view more »HRSA Proposes Revised 340B Dispute Resolution Process
Dec. 5, 2022 ||The proposed administrative dispute resolution process delegates the majority of decision-making authority to Office of Pharmacy Affairs staff and has no minimum monetary threshold for claims.
view more »CY 2023 OPPS Final Rule Includes 340B, Site-Neutral, and Quality Provisions
Nov. 14, 2022 ||The final rule reverses Medicare Part B drug payment cuts to hospitals in the 340B Drug Pricing Program, continues site-neutral payment policies, and revises the inpatient-only list, among other proposed changes.
view more »CMS to Pay 340B Hospitals at Full OPPS Rate for Remainder of 2022
Oct. 17, 2022 ||The decision to revert to the full payment rate is in compliance with a recent federal district court decision in favor of America’s Essential Hospitals.
view more »Essential Hospitals See New Win in Legal Challenge to 340B Payment Cuts
Sept. 29, 2022 ||A federal district court ruled that HHS must pay hospitals in the 340B Drug Pricing Program the full Medicare Part B drug payment rate for the remainder of calendar year 2022.
view more »Association Comments on CY 2023 OPPS Proposed Rule
Sept. 20, 2022 ||America’s Essential Hospitals urges CMS to swiftly restore full Medicare Part B drug payment rates for hospitals in the 340B Drug Pricing Program and define the select group of hospitals with a safety net mission.
view more »340B Recertification Open through Sept. 19
Aug. 26, 2022 ||The annual 340B Drug Pricing Program recertification period for hospitals began Aug. 24. Hospitals will have until Sept. 19 to complete the process.
view more »New York Sues CVS for Interfering with 340B Provider Discounts
Aug. 2, 2022 ||The lawsuit alleges that, since acquiring third party administrator Wellpartner in 2017, CVS required 340B covered entities to work with Wellpartner.
view more »HRSA Hosts 340B Recertification Webinar
July 25, 2022 ||The Aug. 22 webinar will complement other federal resources on the annual 340B Drug Pricing Program recertification period for hospitals, open from Aug. 24 to Sept. 19.
view more »CY 2023 OPPS Rule Includes 340B, Site-Neutral, and Quality Proposals
July 25, 2022 ||A proposed rule for Medicare’s Outpatient Prospective Payment System for calendar year 2023 would reverse Medicare Part B drug payment cuts to hospitals in the 340B Drug Pricing Program, continue site-neutral payment policies, and revise the inpatient-only list, among other proposed changes.
view more »340B State Policy: Combating Discriminatory Payer Practices
July 22, 2022 ||This State Policy Snapshot explores how legislatures are responding to the recent discriminatory actions by pharmacy benefit managers and other payers by enacting 340B-related nondiscrimination legislation.
view more »Protect and Strengthen Our Health Care Safety Net
March 15, 2022 ||Ensuring a reliable safety net, one ready to meet the moment in any crisis, means robustly protecting and bolstering the mechanisms and ideals that make the safety net function.
view more »House Passes Omnibus Spending Bill
March 10, 2022 ||The House-passed bill does not allocate additional COVID-19 relief for providers on the front lines of the pandemic. An initial version of the legislation included $15.6 billion in COVID-19 related spending — a scaled-back version of the $22.5 billion requested by the Biden administration.
view more »Michigan Enacts 340B Nondiscrimination Laws
March 8, 2022 ||The laws prohibit pharmacy benefit managers and insurance companies from discriminating against 340B Drug Pricing Program contract pharmacies and covered entities.
view more »State Policy Snapshot: Carving Out the Pharmacy Benefit from Medicaid Managed Care
Feb. 28, 2022 ||States argue shifting pharmacy benefits from managed care to Medicaid fee-for-service can lead to savings, but removing 340B Drug Pricing Program benefits for managed care drugs can jeopardize essential hospitals’ 340B savings — a critical source of support.
view more »On the Hill: Lawmakers Push for Nurse Staffing, 340B Protections
Jan. 25, 2022 ||In separate bipartisan letters, lawmakers called on the Biden administration to help mitigate dire hospital workforce shortages, particularly among nurses, and protect the 340B Drug Pricing Program from harmful drug manufacturer actions.
view more »New Rule Aims to Account for Rx Drug Costs in Health Care Spending
Nov. 18, 2021 ||The Department of Health and Human Services released a fourth interim final rule to implement the No Surprises Act. The agency aims to enhance transparency and provide insight into how prescription drugs contribute to the growth of health care spending and the cost of health coverage.
view more »HHS Releases Proposal to Lower Rx Drug Costs
Sept. 14, 2021 ||The comprehensive plan includes potential legislative and administrative actions that could be used to lower drug prices. The plan also notes the importance of the 340B Drug Pricing Program and its role in supporting the health care safety net.
view more »340B Recertification Ends Sept. 13
Sept. 9, 2021 ||Hospitals have until Sept. 13 to complete 340B Drug Pricing Program recertification through the Office of Pharmacy Affairs Information System.
view more »340B Recertification Begins Aug. 16
Aug. 9, 2021 ||The annual 340B Drug Pricing Program recertification period for hospitals will begin Aug. 16. Hospitals will have until Sept. 13 to complete the process.
view more »On the Hill: Infrastructure Legislation Released
Aug. 3, 2021 ||The Senate released much-anticipated legislative language for a $1.2 trillion bipartisan physical infrastructure package. While the legislation includes no major health care policies, it does list several health care changes to help pay for new spending.
view more »State 340B Policy: Mandating Carve-In, Carve-Out Policies
July 19, 2021 ||Recently, some states have started to direct providers on which carve-in or carve-out options they take so the state can claim its rebates without concern of duplicate discounts. This State Policy Snapshot examines the current landscape of state carve-in and carve-out policies.
view more »Executive Order Aims to Promote Economic Competition
July 13, 2021 ||Notable to essential hospitals, the Biden administration’s July 9 executive order includes health care items related to prescription drugs, price transparency, hospital consolidation, and health insurance.
view more »Supreme Court To Review Association’s Lawsuit on OPPS Cuts
July 6, 2021 ||The Supreme Court’s decision to review the case marks a significant step in the association’s efforts to overturn harmful Medicare Part B cuts to hospitals in the 340B Drug Pricing Program. The Supreme Court will hear oral arguments in the case in its next term, with a decision likely in 2022.
view more »Biden Administration Formally Proposes to Rescind FQHC Rule
June 21, 2021 ||The Biden administration proposes to rescind a Trump-era final rule requiring federally qualified health centers to charge certain low-income patients no more than the 340B Drug Pricing Program price for insulin and injectable epinephrine. Comments on the proposed rule are due July 16.
view more »On the Hill: Democrats Weigh Infrastructure Options; Budget Hearings
June 8, 2021 ||A bipartisan infrastructure plan is unlikely to pass the Senate by July. Democrats are likely to explore using budget reconciliation, but a recent parliamentarian ruling indicates they might be unable to attempt the process using the FY 2021 budget resolution.
view more »On the Hill: CMS Nominee Advances; Association Hosts Capitol Briefing
May 18, 2021 ||The Senate voted to advance the nomination of Chiquita Brooks-LaSure as Centers for Medicare & Medicaid Services administrator; a full Senate vote could take place this week. America’s Essential Hospitals hosted a virtual Capitol Hill briefing in recognition of the association’s 40th anniversary.
view more »HRSA Directs Manufacturers to Provide 340B Pricing through Contract Pharmacies
May 17, 2021 ||The Health Resources and Services Administration enforcement action marks a crucial victory for essential hospitals, which have seen their access to drugs with 340B discounts cut off by manufacturers since last summer.
view more »On the Hill: Republican Infrastructure Counteroffer; Rx Drug Pricing Bills
April 27, 2021 ||Senate Republicans release a $568 billion infrastructure framework to kickstart negotiations. House Democrats and Republicans reintroduce opposing prescription drug pricing bills. A CMS decision delays advancement of Chiquita Brooks-LaSure’s nomination for CMS administrator.
view more »On the Hill: House Votes to Avert Medicare Cuts; Becerra Confirmed
March 23, 2021 ||The House voted to extend the moratorium on a 2 percent Medicare sequester cut, but the bill lacks support from Senate Republicans. The Senate confirms Xavier Becerra. A reintroduced bipartisan bill would ensure 340B hospitals can maintain program eligibility while responding to COVID-19.
view more »HHS Proposes Further Delay of FQHC Rule
March 15, 2021 ||In accordance with the presidential regulatory freeze, HHS proposes to further delay until July 20 a final rule requiring federally qualified health centers to charge certain low-income patients no more than the 340B Drug Pricing Program price for insulin and injectable epinephrine.
view more »COVID-19 Protections and Support for Essential Hospitals
March 12, 2021 ||Essential hospitals lead the nation in the battle against COVID-19 but new challenges—including COVID variants, vaccination distribution management, and long-term hospitalizations—show more help is needed to ensure providers on the front lines can maintain access to care.
view more »Association Advocates for Priorities with Biden Administration
Feb. 16, 2021 ||America’s Essential Hospitals sent a letter to President Joe Biden and his administration detailing key priorities for essential hospitals, including issues related to structural racism, COVID-19, Medicaid, the 340B Drug Pricing Program, site-neutral payment policies, immigration, and other topics.
view more »On the Hill: House Committees Wrap Reconciliation Work; Trump Acquitted
Feb. 16, 2021 ||The House is expected to vote on a compiled reconciliation bill the week of Feb. 22. The Senate for the second time has acquitted former President Donald Trump of impeachment charges. House members are circulating a bipartisan letter calling for protections to the 340B Drug Pricing Program.
view more »Biden Administration Freezes Pending Regulations
Jan. 26, 2021 ||The regulatory freeze could affect rules directing health clinics to pass certain 340B discounts on to patients, establishing minimum standards in Medicaid state drug utilization review, and modifying Health Insurance Portability and Accountability Act privacy arrangements.
view more »HRSA Launches 340B Dispute Resolution Website
Jan. 15, 2021 ||The website contains FAQs on the administrative dispute resolution (ADR) panel and board, the monetary threshold for filing an ADR claim, the types of documentation stakeholders must provide as part of the ADR process, and other information.
view more »HRSA Finalizes Rule Requiring Health Centers to Share 340B Discounts
Jan. 7, 2021 ||The rule, currently on hold due to a regulatory freeze, requires federally qualified health centers to pass 340B Drug Pricing Program discounts on to certain low-income patients as a condition of receiving federal grant funding; it applies to insulin and injectable epinephrine.
view more »HRSA Finalizes 340B Dispute Resolution Process
Jan. 4, 2021 ||A new final rule from the Health Resources and Services Administration provides details on the long awaited administrative dispute resolution process, including the composition of a dispute resolution panel, types of claims covered entities and manufacturers can bring before the panel, and more.
view more »HHS General Counsel Confirms 340B Discounts for Contract Pharmacies
Dec. 31, 2020 ||The advisory opinion, favorable for essential hospitals, responds to actions by several drug manufacturers to restrict the ability of 340B Drug Pricing Program covered entities to receive program discounts on drugs dispensed at contract pharmacies.
view more »CY 2021 OPPS, PFS Rules Include 340B, Site-Neutral, and Star Rating Policies
Dec. 18, 2020 ||Final rules for Medicare’s Outpatient Prospective Payment System and Physician Fee Schedule for calendar year 2021 continue Medicare Part B drug payment cuts to hospitals in the 340B Drug Pricing Program and site-neutral payment policies.
view more »HRSA Finalizes 340B Dispute Resolution Process
Dec. 14, 2020 ||The Health Resources and Services Administration finalized a rule creating a 340B Drug Pricing Program administrative dispute resolution process for covered entities and drug manufacturers; the rule marks a long-delayed implementation of an Affordable Care Act requirement.
view more »CMS Finalizes Medicare Most Favored Nation Drug Model
Dec. 3, 2020 ||The rule builds on an International Pricing Index model CMS first outlined in an advance notice of proposed rulemaking in late 2018. The mandatory model will include most providers and suppliers who purchase and receive reimbursement for Medicare Part B drugs.
view more »Association Responds to Hill Request for 340B Feedback
Nov. 3, 2020 ||In a response to Republican leaders of House and Senate committees with jurisdiction over the 340B Drug Pricing Program, America’s Essential Hospitals said the program needs no fundamental reforms and continues to provide vital support to essential hospitals.
view more »Representatives Express Concerns about 340B Threats
Sept. 15, 2020 ||Nearly 250 members of Congress sent a bipartisan letter to Health and Human Services Secretary Alex Azar expressing concerns about recent actions by several drug manufacturers to impose policy changes that would undermine the 340B Drug Pricing Program.
view more »On the Hill: Final Work before Elections; House 340B Sign-On Letter
Sept. 8, 2020 ||The Senate reconvenes and is expected to consider a COVID-19 relief package. The Senate HELP Committee will hold a hearing on COVID-19 vaccines. A bipartisan group of House lawmakers circulates a letter to HHS expressing concern about drug manufacturer attacks on 340B contract pharmacies.
view more »Association Urges HHS to Prevent Harmful Drug Manufacturer Actions
Sept. 1, 2020 ||America’s Essential Hospitals urges HHS to prevent drug manufacturers from restricting access to life-saving drugs in the 340B Drug Pricing Program. Manufacturers recently notified covered entities that the companies will cease shipping 340B-priced drugs to some pharmacies; other manufacturers are requiring biweekly data on all contract pharmacy claims.
view more »Sept. 14 Deadline for 340B Recertification
Sept. 1, 2020 ||Hospitals have until Sept. 14 to complete the 340B Drug Pricing Program recertification process. Covered entities that fail to create OPAIS accounts and conduct recertification will be removed from the program.
view more »OPPS Proposed Rule Continues 340B, Site-Neutral Cuts
Aug. 4, 2020 ||The Medicare Outpatient Prospective Payment System proposed rule for calendar year 2021 would deepen cuts to hospitals in the 340B Drug Pricing Program, continue cuts to off-campus provider-based departments, and update the overall hospital star ratings methodology.
view more »HRSA Webinar on 340B Recertification
Aug. 4, 2020 ||The Health Resources and Services Administration Office of Pharmacy Affairs will hold an Aug. 12 webinar on the 2020 340B Drug Pricing Program recertification process. Hospitals must complete the recertification process by Sept. 14 to remain in the program.
view more »On the Hill: Negotiations on COVID-19 Package, New 340B Bill
Aug. 4, 2020 ||Republicans and Democrats have yet to make progress in negotiations on the next COVID-19 bill; the association shared essential hospital priorities with congressional leadership. A new House bill would ensure hospitals in the 340B Drug Pricing Program will not lose eligibility during the pandemic.
view more »White House Issues Executive Orders on Lowering Drug Prices
July 28, 2020 ||The executive orders aim to end retrospective rebates to Medicare Part D pharmacy benefit managers; allow patients of federally qualified health centers to purchase certain drugs at 340B discounted prices; and tie Medicare Part B payment to international drug prices, among other provisions.
view more »340B Recertification Begins Aug. 17
July 26, 2020 ||The annual 340B Drug Pricing Program recertification period for hospitals will run from Aug. 17 to Sept. 14. Covered entities that fail to recertify will be removed from the program.
view more »On the Hill: Planning Fourth COVID-19 Package, Support for 340B Hospitals
July 7, 2020 ||As Senate leaders consider a fourth COVID-19 aid package, the president signs legislation to extend the Paycheck Protection Program. A bipartisan bill would ensure 340B hospitals maintain eligibility amid COVID-19, regardless of payer mix changes.
view more »HRSA Issues Guidance on 340B Hospital Off-Site Locations
June 16, 2020 ||Hospitals in the 340B Drug Pricing Program may begin using 340B drugs for patients seen at off-site locations before the hospitals officially register these clinics in the Office of Pharmacy Affairs Information System. This guidance is intended to last beyond the COVID-19 public health emergency.
view more »Association Outlines Priorities for Future COVID-19 Legislation
June 16, 2020 ||In a letter to Senate leaders, America’s Essential Hospitals outlines key legislative priorities to assist essential hospitals in the ongoing response to the COVID-19 public health emergency as Congress considers another supplemental bill.
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