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.

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.

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.

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.

America's Essential Hospitals expressed deep concern with the agency's ill-timed launch of the 340B Drug Pricing Program acquisition cost survey during this public health emergency.

America's Essential Hospitals calls on the Health Resources and Services Administration to allow newly eligible entities and sites to immediately register and begin purchasing 340B drugs, suspend program audits, and disregard DSH payment adjustment percentage changes during the COVID-19 emergency.

The survey will run April 24 to May 15 and requests drug acquisition costs from all hospitals participating in the 340B Drug Pricing Program, except critical access hospitals. CMS might use data collected through the survey to determine Medicare Part B drug reimbursement rates.

Congress should increase emergency funding for hospitals on the front lines of the COVID-19 epidemic, target hospitals in greatest need, adjust Medicaid to help essential hospitals, and provide other financial and regulatory relief.

The March 20 letter details additional action needed to support essential hospitals as they respond to the pandemic. The letter also explains how essential hospitals face significant financial challenges as they work on the front lines of public health threats.

The Health Resources and Services Administration (HRSA) has created a webpage with COVID-19 resources for providers participating in the 340B Drug Pricing Program. HRSA acknowledges 340B covered entities will need additional flexibility pertaining to program compliance during the COVID-19 crisis.

America's Essential Hospitals expressed concern that a proposed drug acquisition cost survey exceeds CMS authority under Medicare statute and would impose excessive burden on hospitals in the 340B Drug Pricing Program.

Current and future threats to the 340B Drug Pricing Program jeopardize the ability of essential hospitals to tailor services and programs to their community’s unique challenges.

Comments on a proposed acquisition cost survey to inform Outpatient Prospective Payment System payment rates for 340B drugs are due March 9.

The proposal calls for $920 billion in cuts to Medicaid funding, including a call to finalize the Medicaid Fiscal Accountability Regulation.

GAO found that state Medicaid programs did not always have written procedures to identify 340B drugs and prevent duplicate discounts. Even when states have written policies and procedures, GAO found they were not always adequate to prevent duplicate discounts.

America's Essential Hospitals this week is closely following congressional health care committee efforts to develop a robust legislative package to stop impending cuts to Medicaid disproportionate share hospital funding and extend funding for several expiring health care programs.

The recommendations come after a GAO review of more than 250 nongovernmental hospitals found several issues with how the Health Resources and Services Administrative oversees 340B program compliance.

In an informational bulletin to state Medicaid agencies, CMS provides best practices to avoid duplicate discounts on drugs purchased through the 340B Drug Pricing Program.

America’s Essential Hospitals expressed concern that a proposed drug acquisition cost survey would impose excessive burden on hospitals and raise many operational challenges.

The final rules for Medicare’s Outpatient Prospective Payment System and Physician Fee Schedule for calendar year 2020 also expand access to opioid use disorder treatment and establish a prior authorization process for certain services.

In a separate, forthcoming final rule, the Centers for Medicare & Medicaid Services will summarize and respond to the more than 1,400 public comments it received about proposed requirements for hospitals to make public their standard charges.

Essential hospitals tackle social determinants of health while operating with limited means. Congress must act to preserve the federal support essential hospitals rely on to fulfill their mission of care for all and keep communities healthy.

Unlawful cuts to Medicare Part B reimbursement at 340B hospitals and other harmful policy changes threaten the program, a key part of the patchwork of federal support essential hospitals rely on to meet their mission.

The association urged the Centers for Medicare & Medicaid Services to reverse policies that will result in significant funding cuts to essential hospitals and hinder access to care.

The agency seeks comments until Nov. 29 on a proposal to collect acquisition cost data from hospitals participating in the 340B Drug Pricing Program.

Covered entities that fail to complete recertification will be removed from the 340B program for a minimum of one quarter.

America's Essential Hospitals details key provisions of the proposed rules for the Medicare Outpatient Prospective Payment System and Physician Fee Schedule for calendar year 2020.

The agency now will require hospitals to submit documents supporting the hospital classification they select during 340B Drug Pricing Program registration.

The Medicare Outpatient Prospective Payment System proposed rule for calendar year 2020 would continue cuts to hospitals in the 340B Drug Pricing Program and to off-campus provider-based departments and introduce new transparency requirements.

Covered entities can access the webinar online or via phone on Aug. 14 from 1–2 pm ET.

The final judgement, in favor of America's Essential Hospitals, does not indicate how the Department of Health and Human Services should remedy unlawful payment reductions to hospitals in the 340B Drug Pricing Program in 2018 and 2019.

Hospitals must complete recertification through the Office of Pharmacy Affairs Information System by Sept. 16 to remain in the 340B Drug Pricing Program.

America's Essential Hospitals and its association partners have created a detailed update on recent court activity in their lawsuit to reverse Medicare outpatient payment cuts to hospitals in the 340B Drug Pricing Program.

A bipartisan group of 300 House lawmakers sent a letter to leadership calling for a two-year delay of Medicaid disproportionate share hospital cuts. The House will vote on a legislative package to expedite the availability of generic drugs and protect parts of the Affordable Care Act.

A federal judge found the Department of Health and Human Services’ Medicare outpatient payment cuts in 2019 to hospitals in the 340B Drug Pricing Program were unlawful, extending a similar decision regarding 2018 cuts. The case was sent back to the agency to determine the appropriate remedy.

America’s Essential Hospitals and industry partners have officially closed the book on their successful lawsuit to force the Department of Health and Human Services to implement long-delayed rules on pharmaceutical manufacturer accountability in the 340B Drug Pricing Program.

The agency on April 1 launched a long-awaited website that outlines pharmaceutical manufacturers' ceiling prices under the 340B Drug Pricing Program. A recent webinar outlines how covered entities can view this data and report 340B pricing issues.

The recent webinar reviewed publication of 340B Drug Pricing Program ceiling prices and the process by which covered entities can report 340B pricing issues.

The budget plan proposes to overhaul the Medicaid program, as well as significantly change the 340B Drug Pricing Program and expand site-neutral payment policies in hospital outpatient departments.

For more than 25 years 340B has been a shield against soaring drug prices. We ask Congress to leave the 340B program out of the drug pricing debate.

As initially planned, any pharmacy participating in the 340B Drug Pricing Program could have been denied rebates provided through the pharmacy benefit manager, resulting in significant cuts to 340B hospitals.

America’s Essential Hospitals and other plaintiffs have asked the U.S. District Court for the District of Columbia to order the federal government to restore losses caused by Medicare outpatient payment cuts to 340B hospitals.

The association urged the agency to consider the interplay of new policies with existing government programs, such as the 340B Drug Pricing Program.

Recent policy changes have drained vital funding and threaten a financial crisis at essential hospitals. Without action by Congress, communities nationwide will lose access to care and vital support services.

The final rule and advanced effective date represent a significant victory for essential hospitals.

America’s Essential Hospitals urged the agency to promptly finalize its proposal to move up to Jan. 1, 2019, the effective and implementation date for a final rule on the calculation of ceiling prices for drugs purchased through the 340B Drug Pricing Program.

The Outpatient Prospective Payment System and Physician Fee Schedule final rules for calendar year 2019 expand damaging site-neutral payment policies and continue Medicare Part B drug payment cuts to hospitals in the 340B Drug Pricing Program.

Next steps for both parties include choosing leadership for the next Congress and, for Republicans, accomplishing remaining legislative priorities while they still control all levers of the federal government.

The long-delayed final rule on the calculation of ceiling prices in the 340B Drug Pricing Program, as well as civil monetary penalties on manufactures who knowingly overcharge, will go into effect Jan. 1, 2019.

The Medicare Outpatient Prospective Payment System final rule for calendar year 2019 broadens the scope of cuts to hospitals in the 340B Drug Pricing Program and to off-campus provider-based departments; in a statement, the association strongly objected to these additional payment cuts.

The five-year demonstration, beginning in 2020, would be open to hospitals and physicians in selected geographic areas representing 50 percent of Medicare Part B spending on separately payable drugs.

America’s Essential Hospitals urged the Centers for Medicare & Medicaid Services to reverse policies that will result in significant funding cuts to essential hospitals and hinder access to care.

Covered entities that fail to complete recertification by the deadline will be removed from the 340B Drug Pricing Program for a minimum of one quarter.

Leaders of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions expressed concern that the Health Resources and Services Administration is not using its existing authority to ensure proper management of the 340B Drug Pricing Program.

Congress is expected to consider legislation to combat the opioid epidemic, fund the Department of Health and Human Services, and enable federal response to pandemic threats.

The Centers for Medicare & Medicaid Services has released Outpatient Prospective Payment System and Physician Fee Schedule proposed rules for calendar year 2019 that would expand site-neutral payment policies and continue Medicare Part B drug payment cuts to 304B hospitals.

A new proposed rule for Medicare’s Outpatient Prospective Payment System would broaden the scope of cuts to hospitals in the 340B Drug Pricing Program and to off-campus provider-based departments; it also contains provisions related to quality reporting and transparency.

America’s Essential Hospitals and the other plaintiffs are coordinating next steps and plan to promptly refile the case in district court.

Hospitals will have until Sept. 12 to complete the recertification process through the Office of Pharmacy Affairs Information System.

A Government Accountability Office witness and several 340B Drug Pricing Program stakeholders testified last week at a House committee hearing; another House committee marked up several consumer-driven health care bills.

The July 11 hearing will focus on contract pharmacies and a slate of 15 bills and discussion drafts related to the program; two essential hospital leaders will testify.

A new bill by Rep. Chris Collins (R-NY) would impose a user fee for hospitals participating in the 340B Drug Pricing Program; a House subcommittee marked up hospital preparedness and graduate medical education bills.

Modeled on a program developed at essential hospital St. Joseph's Regional Medical Center, in Paterson, N.J., the Alternatives to Opioids bill is one of 25 opioid-related bills the House passed last week.

The House aims to complete voting by the July Fourth recess, but Senate work on opioid legislation likely will continue into August amid a shortened recess.

This is the latest of several delays of a rule that provides guidance on the calculation of ceiling prices and imposes civil monetary penalties on manufacturers who knowingly exceed them.

Senate Democrats sharply questioned the repeated delays of a final rule on drug ceiling prices and manufacturer civil monetary penalties; The House continues to focus on passing an opioid package.

The association urged the Health Resources and Services Administration to immediately implement a final rule establishing the calculation of ceiling prices and imposing manufacturer civil monetary penalties.

House leadership remains focused on passing a bipartisan opioid-related legislative package by Memorial Day, but recently indicated a June vote might be more likely.

The plan cites and builds on proposed changes to the 340B Drug Pricing Program in the president’s fiscal year 2019 budget, as well as damaging cuts implemented through the calendar year 2018 Outpatient Prospective Payment System final rule.

The proposal would delay by an additional year implementation of a final rule on ceiling prices and manufacturer civil monetary penalties in the 340B Drug Pricing Program.

Four House hearings this week examine the opioid crisis, as lawmakers work to craft bipartisan legislation; A Senate hearing focuses on oversight reports on the 340B Drug Pricing Program.

On May 4, America’s Essential Hospitals and fellow plaintiffs will make oral arguments in a legal battle to reverse damaging Medicare cuts to hospitals in the 340B Drug Pricing Program; The public can watch via livestream.

The Centers for Medicare & Medicaid Services offers details on how Medicare Advantage plans might be affected by reimbursement reductions in the calendar year 2018 Outpatient Prospective Payment System final rule.

House Republicans this week hope to bring to the floor a bill to fund the government through the remainder of the fiscal year; America's Essential Hospitals CEO asked to testify during Senate committee hearing on 340B Drug Pricing Program.

Even with its long record of success, the 340B program still faces undue scrutiny, distorted and misleading claims, and demands for onerous new reporting.

The budget plan for fiscal years 2018 and 2019 proposes changes to the distribution of 340B Drug Pricing Program savings and increased funding to fight the opioid crisis.

Congress returns from recess to focus on long-term solutions after passing a short-term bill to fund the government through Jan. 19; lawmakers push for delay of 340B Drug Pricing Program cuts.

The new document details the use of two Medicare outpatient, claims-based modifiers hospitals will be required to report, starting Jan. 1, for drugs purchased through the 340B Drug Pricing Program.

Republican leaders hope to introduce the final tax reform bill early next week; a bill to stop cuts to the 340B Drug Pricing Program has 130 cosponsors.

Tax reform legislation heads to a House-Senate conference committee. Meanwhile, a bill to delay Medicaid disproportionate share hospital payment cuts could be included in year-end legislation.

The legislative priorities include a health care extenders package, tax reform, and a long-term funding bill. Also, bipartisan House legislation to halt 340B payment cuts now has more than 50 cosponsors.

Hospitals that contract with or are owned by state or local government must now identify a government official to attest to the hospital's classification.

America’s Essential Hospitals is closely reviewing the final rules and pursuing strategies to protect our members from these devastating cuts. Key aspects of the recently released final rules are summarized in this Action Update.

Due to technical difficulties, the new 340B recertification period will run through Dec. 6; hospitals that already started the process must restart.

The rule cuts 340B Drug Pricing Program payments by $1.6 billion and requires hospitals to use modifiers to identify 340B drugs in Medicare claims.

Hospitals will have until Nov. 21 to complete the recertification process through the new Office of Pharmacy Affairs Information System.

The harmful payment reduction was included in the 2018 Outpatient Prospective Payment System proposed rule, expected to be finalized this fall.

The most recent delay to July 2018 comes after the Health Resources and Services Administration issued a proposed rule seeking feedback from stakeholders.

Providers can register a new entity or contract pharmacy through the 340B Office of Pharmacy Affairs Information System through Oct. 16.

The component enables manufacturers and covered entities to register for the 340B Drug Pricing Program, participate in annual recertification, and communicate with the Office of Pharmacy Affairs on pending tasks.

The meeting came a day after the association submitted comments to the agency in response to the proposed annual update of the Hospital Outpatient Prospective Payment System.

Congress aims to pass legislation by Sept. 30 to stabilize the Affordable Care Act (ACA) insurance markets and reauthorize several health care programs; three senators plan to unveil new ACA repeal legislation.

The Sept. 13 webinar for covered entities will focus on the registration component of the new Office of Pharmacy Affairs Information System.

By cutting reimbursement rates for Part B drugs to 340B hospitals, the Centers for Medicare & Medicaid Services would harm essential hospitals, which care for the nation’s poorest, most complex, and costliest patients.

The Health Resources and Services Administration is seeking comments on whether to further delay implementation of a final rule on ceiling prices and civil monetary penalties in the 340B Drug Pricing Program by nine months.

The system will be unavailable from Aug. 15 until mid-September; hospitals are urged to verify contact information for authorizing officials and primary contacts in the system before Aug. 14.

The delay allows for implementation of a new online tool that will allow providers to register and recertify 340B sites and contract pharmacies.

The proposed rule would increase outpatient payment rates by 1.75 percent and drastically reduce Medicare Part B reimbursement for drugs purchased through the 340B Drug Pricing Program.

A group of Republican and Democratic governors sent a letter to Senate leadership encouraging a bipartisan approach to repealing the Affordable Care Act.

The committee’s intentions remain unclear; we recommend essential hospitals prepare to publicly describe what auditors found and corrective actions taken.

The final rule on drug ceiling prices and manufacturer civil monetary penalties under the 340B Drug Pricing Program now will go into effect on Oct. 1.

HRSA has delayed until March 21 the effective date of a final rule on drug ceiling prices and manufacturer civil monetary penalties in the 340B program.

The Feb. 7 letter offers recommendations on proposed executive orders, regulations, and legislation that could affect essential hospitals, patients.

A memo instructs all executive departments and agencies to temporarily halt pending regulations until incoming department or agency heads can review them.

The regulation makes "penny pricing" final and sets fines of up to $5,000 per instance of a manufacturer overcharging providers for covered medications in the 340B Drug Pricing Program.

Under the rule, CMS would increase the OPPS payment rate by 1.65 percent and provide flexibility in the meaningful use of EHRs, among other things.

CMS provides more flexibility than previously proposed, ensuring non-grandfathered, off-campus hospital outpatient departments will be reimbursed in 2017.

Hospitals eligible for the essential community providers list are participants in the 340B and DSH programs, critical access hospitals, and others.

Hospitals must complete recertification of their compliance with all requirements of the 340B program. Failure to do so results in removal from the program.

HRSA is proposing that a decision-making body within the Department of Health and Human Services be responsible for reviewing claims and resolving deputes.

This week, the Senate votes on the Comprehensive Addiction and Recovery Act. Last week, the House passed a mental health bill in a bipartisan vote.

The proposed rule would implement Section 603 of the Bipartisan Budget Act, which reduced payments for new, off-campus hospital outpatient departments.

The event, from 1 - 2 pm ET, will include important information on the annual recertification process and best practices.

Senate appropriators pass HHS spending bill that includes 340B Drug Pricing Program user fee and instructions to HRSA to consider stakeholder input in final mega-guidance.

The decision follows the pharmaceutical company's recent recalculation of 340B ceiling prices for 25 products for the third quarter of 2012 through the second quarter of 2013.

In new Modern Healthcare commentary, America's Essential Hospitals president and CEO says proposed guidance conflicts with HHS goals for readmissions, access, and care coordination.

A 2015 budget law that creates site-neutral payment for off-campus hospital outpatient departments does not directly affect 340B Drug Pricing Program eligibility, but changes to how hospitals report Medicare costs does raise concerns.

Final rule and implementation as described in the guidance could significantly reduce Medicaid payments for 340B-covered outpatient drugs in some states.

Webcasts, co-hosted by HRSA OPA and pharmacist association, will focus on helping covered entities identify steps needed to develop and maintain comprehensive 340B policies and procedures in an auditable manner.

Covered entities are no longer required to post a public letter to the HRSA website if 340B audit findings result in potential repayment. Instead, HRSA will publish notices with covered entity contact information.

Agency seeks comment on its proposal to collect information on the burden associated with guidelines for manufacturer audits of covered entities; comments are due to HRSA by Feb. 22.

Member leaders attend more than 100 meetings with lawmakers and congressional staff as part of fall Policy Assembly. Event also included insights from policymakers and a Capitol Hill reception honoring 2015 Gage Award recipients.

In comments to HRSA, the association says the proposal would harm care for the vulnerable by restricting the definition of a patient, adding requirements for hospital outpatient facility eligibility, and narrowing which drugs qualify for discounts.

U.S. District Court says 2014 HRSA interpretive rule is contrary to plain language of ACA provision that excludes certain hospitals from 340B discounts on orphan drugs.

Webinars help identify roles, responsibilities, and other elements of 340B risk management. OPA and APhA also accepting leading practice site applications.

Zydus Pharmaceuticals Inc., charged incorrect rates on 340B drugs between January 2012 and December 2014. Refunds will be distributed via Apexus.