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

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 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.

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

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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

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