CDC and FDA recommend pausing Janssen COVID-19 vaccine administration after six U.S. reports of blood clots; HHS expands the Health Center Vaccine Program.

The new guidance and deadline apply to all provider relief fund allocations to date except the Health Resources and Services Administration uninsured program, nursing home infection control distribution, and rural health clinic testing distribution.

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.

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.

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.

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.

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.

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.

Hospitals can now register as participating providers to receive reimbursement for COVID-19 testing and treatment services furnished to uninsured patients on or after Feb. 4. Participating providers can begin submitting claims May 6.

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.

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.

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

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

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

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.

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 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.

This funding supports initiatives under the agency's Five-Point Opioid Strategy and was distributed in conjunction with Prescription Opioid and Heroin Epidemic Awareness Week.

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.

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

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.

The interagency effort targets obstacles to health care, including a fragmented delivery system and lack of specialty service access, faced by many rural communities.

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.

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.

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

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

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 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.

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.

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

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

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.

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.

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.

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

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.

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.

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.

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.

Bill would fund the government through fiscal year 2014

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

Failure to complete recertification could result in dismissal from program

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

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

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

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

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