November 7, 2012—The Office of Pharmacy Affairs (OPA) significantly revised its 340B “flexibilities during disasters” policy yesterday just four days after activating it in New York and New Jersey in the wake of Hurricane Sandy.
Under the revised policy, it is no longer clear whether OPA will give hospitals, health centers, and other providers affected by the storm flexibility about dispensing 340B-purchased drugs to displaced persons who might not meet the 340B definition of a patient.[ms-protect-content id=”2799″] OPA’s original notice, posted on Nov. 2, said the office would grant such leniency and described specific scenarios in which it would do so.
The Health Resources and Services Administration (HRSA) has not yet responded to a request for comment on why it made the change and the status of the withdrawn guidance. (UPDATE: A HRSA spokesperson said: “It was brought to our attention that information given for previous emergency situations was posted within our message regarding the recent emergency. We have updated the web site to include only the information relevant to the current emergency. We will continue to provide any updates regarding the emergency on our web site.”)
OPA announced that it had implemented its 340B regulatory flexibility policy on Nov. 2 following Secretary of Health and Human Services Kathleen Sebelius’s Oct. 31 and Nov. 1 declarations of public health emergencies in the two states.
In a public notice that remained on its Web site from Nov. 2 through at least the early afternoon of Nov. 5, OPA explained that it was acting “in accordance with limited flexibilities the 340B drug pricing program has during emergencies and disasters to make it easier to provide needed care.”
Under its flexibilities during disasters policy, OPA continued, “eligible organizations/covered entities already enrolled in the 340B program may dispense pharmaceuticals to displaced patients who may not meet the 340B definition of a patient.”
In addition, “eligible organizations/covered entities not yet enrolled can have their registration process expedited so they can begin buying drugs at 340B prices immediately upon approval,” OPA said.
The Nov. 2 notice included a question-and-answer section addressing whether a 340B covered entity in a disaster zone could dispense 340B-purchased drugs to an individual from another state with a prescription from another state, and whether an entity could refill a prescription for a disaster victim unknown to them without medical staff intervention. The notice also included a section entitled “Health Record” describing what type of documentation would be adequate during an emergency to satisfy the 340B program’s patient definition.
The Nov. 2 notice also explained that, under the flexibilities during disasters policy, OPA can admit covered entities and contract pharmacies to 340B on a rolling basis, rather than on its normal quarterly basis, “to get temporary (or permanent) address changes on the [OPA covered entity] database as soon as we get the information.”
The replacement notice that appeared on the OPA website on Nov. 6 removed all references to flexibility in meeting the 340B patient definition. It now states only that OPA has begun rolling admissions for covered entities and contract pharmacies affected by the hurricane.
“Affected covered entities in New York and New Jersey may register at any point throughout the duration of the emergency; entities may begin participating on the start date reflected in the 340B program database,” the new notice says. “Entities in the two states that were previously approved for 1/1/2013 start dates may begin utilizing the program as soon as their records have been updated in the program database. In addition, change requests from New York and New Jersey entities will be prioritized to ensure continued access to 340B pricing.”
A significant coastal storm is likely to affect New York and New Jersey beginning today and lasting overnight. While this second storm is not expected to be as severe as the hurricane, it could compound the region’s problems.[/ms-protect-content]