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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

The guidance no longer recommends routine testing of women unless there was ongoing potential exposure; the Health Resources and Services Administration awarded $7 million to fight Zika in U.S. territories.

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

Several leadership posts — including FDA commissioner, National Coordinator for Health IT, AHRQ director, and HRSA administrator — have been filled.

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Health Resources and Services Administration (HRSA)

Health care professionals who provide chronic care management services often are not aware they are eligible for separate payments under Medicare Part B.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

In this webinar we looked back at the 2016 advocacy landscape, discussed the progress we have made on key issues affecting essential hospitals, reviewed our interaction with the Trump transition team, and looked forward to 2017. Webinar Recording

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

The grants will be used to expand telehealth use, help providers make quality improvement efforts, and support policy-focused research.

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

The database could help determine a rural hospital's classification as a teaching hospital and, in turn, its eligibility for Medicare funding of a new residency program.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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.

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

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

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Health Resources and Services Administration (HRSA)

Heritage Pharmaceuticals Inc., charged 340B covered entities incorrect rates between April 18, 2008 and Dec. 31, 2014. Refunds are available for products purchased directly from Heritage or through a wholesale distributor.

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Health Resources and Services Administration (HRSA)

Proposed changes could significantly narrow the scope of patients for whom 340B pricing may be utilized and reduce potential savings from program

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Health Resources and Services Administration (HRSA)

Omnibus guidance proposes an expanded list of six requirements for an individual to be considered a patient of a 340B covered entity.

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Health Resources and Services Administration (HRSA)

Participants learned about HRSA's guidance on the 340B Drug Pricing Program and how it will affect their hospital.

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Health Resources and Services Administration (HRSA)

Failure to recertify will result in removal from the 340B program. Authorizing officials from all hospitals should have already received an email with information needed to recertify from the Office of Pharmacy Affairs.

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Health Resources and Services Administration (HRSA)

The 2015 recertification period will be from Aug. 5 to Sept. 9. Failure to recertify will result in removal from the program.

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Health Resources and Services Administration (HRSA)

Proposed rule also calls for increased transparency in ceiling price calculation. Separate guidance to replace mega reg.

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Health Resources and Services Administration (HRSA)

Previously, HRSA submitted a comprehensive proposed rule to OMB on 340B issues, but a subsequent court ruling called into question the agency's authority to issue a rule.

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Health Resources and Services Administration (HRSA)

America's Essential Hospitals condemns drug makers' attempts to gut a federal rule that allows hospitals to purchase expensive orphan drugs at a discount to serve low-income and other vulnerable patients

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Health Resources and Services Administration (HRSA)

OPA webinar will cover recent changes to 340B audit process. The office is also working to standardize the process for self-disclosing a 340B requirement breach and notes successful recertification process.

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Health Resources and Services Administration (HRSA)

OPA notify hospitals via email of the need to recertify for eligibility for the 340B program. Hospitals must recertify annually to show compliance with all parts of the 340 program.

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Health Resources and Services Administration (HRSA)

New interpretive rule will address the 340B orphan drug exclusion.

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Health Resources and Services Administration (HRSA)

HRSA announced that it plans to stand by its interpretation of the 340B orphan drug rule and will continue to publish updated orphan drug designation lists to assist organizations with compliance with the policy.

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Health Resources and Services Administration (HRSA)

Congress continues its two-week recess. Five Senate Democrats sent a letter to OMB and HRSA supporting the 340B program. The 340B mega reg set to be released in June is currently at OMB. House and Senate appropriations committees begin their markup processes, although nothing has been announced regarding HHS and related agencies.

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Health Resources and Services Administration (HRSA)

The new guidance is now the primary source of guidance on governance issues, consolidating information previously provided through multiple Policy Information Notices. The guidance continues to permit public entities to share governance authorities with a community-based FQHC governing board.

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Health Resources and Services Administration (HRSA)

The Office of the Inspector General (OIG) released Feb. 4 a report on the use of contract pharmacies in the 340B Drug Pricing Program. The OIG gathered information from a sample of covered entities—15 disproportionate share hospitals and 15 community health centers—to learn about their contract pharmacy arrangements.

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Health Resources and Services Administration (HRSA)
Health Resources and Services Administration (HRSA)

Association, two other national organizations file amicus brief in support of HRSA interpretation of law

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Health Resources and Services Administration (HRSA)

Failure to complete recertification could result in dismissal from program

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Health Resources and Services Administration (HRSA)

All 340B authorizing officials expected to receive access to complete process by email

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Health Resources and Services Administration (HRSA)

Certain providers may receive drug discounts for uses outside indication associated with orphan designation

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Health Resources and Services Administration (HRSA)

Money to 32 centers nationwide will be used to train more than 300 primary care residents

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Health Resources and Services Administration (HRSA)

Hospitals urged to review language on certification of compliance with group purchasing organization guidance

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Health Resources and Services Administration (HRSA)

Deadline extended after significant pressure from America's Essential Hospitals and association members

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Health Resources and Services Administration (HRSA)

About America’s Essential Hospitals

America’s Essential Hospitals is the leading association and champion for hospitals and health systems dedicated to high-quality care for all, including the most vulnerable. Since 1981, America’s Essential Hospitals has initiated, advanced, and preserved programs and policies that help these hospitals ensure access to care. We support members with advocacy, policy development, research, and education.