The Health Resources and Services Administration (HRSA) has created a webpage with COVID-19 resources for providers participating in the 340B Drug Pricing Program.
On the resource page, HRSA acknowledges that 340B covered entities will need additional flexibility pertaining to program compliance as they respond to the COVID-19 crisis and encourages providers to contact the 340B Prime Vendor Program (Apexus) directly if they have questions about compliance or eligibility (1.888.340.2787 or firstname.lastname@example.org).
HRSA reminds providers to have policies and procedures on the dispensing of 340B drugs to patients, as well as auditable records. The agency notes that while responding to the crisis, abbreviated health records documenting patient information will be sufficient. Further, as covered entities enlist volunteer health professionals in their response efforts, HRSA reminds covered entities to document the relationship between these volunteers and the covered entity.
Regarding the intersection of the 340B program and telehealth services, HRSA notes that the use of technology to deliver health care is critical and that “telemedicine is merely a mode by which the health care service is delivered.” Covered entities should describe the use of telehealth in their policies and procedures and continue to keep auditable records of eligible patients.
On a question-and-answer portion of the site, HRSA addresses other issues, including:
- Covered entity audits — while HRSA is not suspending audits, it will perform audits remotely over the next few months;
- Patient definition — HRSA cannot waive the statutory prohibition on diversion, but says covered entities should reference the content on the resource page regarding record keeping flexibility;
- Group purchasing organization (GPO) prohibition — HRSA cannot waive statutory requirements that prohibit 340B hospitals from purchasing covered outpatient drugs through a GPO. If a hospital is unable to purchase a drug at the 340B price or wholesale acquisition cost, it can purchase the drug using a GPO if it notifies the Office of Pharmacy Affairs of the situation by emailing 340Bpricing@hrsa.gov;
- Registration — New providers, child sites, and contract pharmacies must register for the 340B program during the first 15 days of any calendar quarter and can begin participating in the program the following quarter. HRSA does not make any blanket exemptions to this process in its guidance but notes that covered entities should contact Apexus about any concerns about the eligibility of a new site.
HRSA encourages covered entities to check the webpage regularly for any additional 340B guidance on flexibility during the pandemic.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.