Understanding the 340b program a primer for health centers

Until , B discount drug pricing was only available from wholesalers. Drug manufacturers would calculate drug ceiling prices; wholesalers would add their service fee and generate a B drug price list to their contracted CEs.

This information is not available to the public as only B program participants can access the portal. For a complete list of B drugs and prices, CEs should request this information directly from the wholesaler. Only one of those patients has insurance.

The drug is purchased by the CAH at the same costs for both patients, but the income generated from the patient with insurance can now go towards helping the non-insured patient pay for their medication. In some cases, a drug manufacturer may encounter a drug price calculation that is negative or zero. Regardless of insurance type or lack of insurance coverage, covered entities can provide all of their patients with B drugs. It is often misunderstood that B pricing only applies to Medicare or Medicaid patients.

Orphan Drugs are a protected class of medications typically for rare conditions or diseases. Sometimes these same drugs also treat common conditions as well. Discounts on Orphan Drugs for rare diseases and conditions are at the discretion of the drug manufacturer for these CEs. Hospitals will not be retroactively repaid for B drug discounts. The courts acknowledge the role of HHS to control drug prices but warned against using that power to specifically undercut the purpose of the B program.

There continues to be concern amongst communities who currently benefit from the B program that more cuts could happen or regulatory burdens would increase. Duplicate Discount Prohibition. Orphan Drugs. Manufacturer Notices to Covered Entities.

Manufacturer Resources. The problem is compounded for Covered Entities employing multiple TPAs to gain access to pharmacies utilized by their patient population. However, we hold acccountable all TPAs serving our clients — ensuring they maintain the same standards for B compliance that we do. To learn more about how ProxsysRx optimizes B savings and revenue, visit this page of our website.

The Medicaid Drug Rebate Program interacts with other programs that receive manufacturer discounts on drugs. If a hospital uses B drugs for patients receiving healthcare in observations beds, the hospital must be able to explain how the covered entity is responsible for the use of the drugs on an outpatient basis and have auditable records and policies and procedures that demonstrate compliance with B Program requirements.

Policies and procedures should specifically address how the hospital defines inpatient and outpatient for purposes of the B Program, and how that relates to observation beds.

Which health care delivery sites must our B covered entity a non-hospital register on the B database? Clinics located off-site of the parent covered entity, regardless of whether those clinics are in the same building, must register with OPA as outpatient facilities of the parent B covered entity if the covered entity purchases or provides B drugs to patients of those facilities.

Hospital offsite outpatient facilities failing to the meet the registration eligibility requirements listed as reimbursable on the MCR with associated outpatient costs and charges become ineligible on the day the hospital files the MCR. If the hospital purchased while they were ineligible, the hospital should send the Office of Pharmacy Affairs OPA a self-disclosure to bselfdisclosure hrsa.

The hospital must submit a signed, dated, and electronically-stamped Worksheet S, along with other requested worksheets, as evidence the MCR was amended and filed with CMS. The hospital may be liable for any B purchases made during the period of ineligibility between when the original MCR was filed to when the amended MCR was filed, depending on the specific circumstances of the case.

HRSA does not authorize covered entities to reclassify a purchase as B eligible after the fact. Covered entities participating in the B Program are responsible for requesting B pricing at the time of the original purchase. If a covered entity wishes to reclassify a previous purchase as B, the covered entity should first notify manufacturers and ensure all processes are fully transparent with a clear audit trail that reflects the actual timing and facts underlying a transaction.

Whether a drug qualifies as outpatient and the individual meets the definition of patient depends upon the factual circumstances surrounding the care of that particular individual. If a covered entity uses B drugs, it should be able to explain why the covered entity is responsible for the use of the drugs on an outpatient basis and have auditable records that demonstrate compliance with B Program requirements.

May a hospital use B-priced drugs in "mixed-use" settings, such as a surgery department, where both inpatients and outpatients are treated? If so, what if the hospital cannot track which drugs are used for inpatients and which ones are used for outpatients?

Individuals from manufacturer or covered entity organizations listed as an Authorizing Official AO or Primary Contact PC of a manufacturer or covered entity record are required to create a secure user account. A B record is defined as an individual manufacturer labeler code or covered entity B ID.

Steps for creating a user account are determined by whether the user is currently listed with a B OPAIS record or are a first time user requesting to be associated with a manufacturer or covered entity record. The user will also receive a 6-digit authentication code via email, each time you attempt to login.

OPA Staff will review new user account requests and confirm or deny access to the B record. If the user is already registered in B OPAIS and the user no longer has access to the registered email address, the user will need to create a new account via the online change request process.

If you are using your current email address to access B OPAIS, but would like to change that email address, you will need to submit a change request via the online change request process. Except for new account creation, only a covered entity or a manufacturer AO or PC can submit an online change request.

Only an AO has the ability to approve on behalf of the covered entity or manufacturer and submit a change request. Manufacturers will no longer have a paper change request process and will follow the same online change request process as covered entities. What information will I be able to access if I do not have a login account?

Covered entity, manufacturer, and contract pharmacy profiles are still accessible for public viewing. All registration, recertification, change and termination requests for covered entities and manufacturers can perform these actions in B OPAIS and are only accessible by their respective AO and PC.

Will covered entities be able to register their contract pharmacies at the time of covered entity registration in B OPAIS? Only the AO is able to approve and submit the contract pharmacy registration. For covered entity hospitals and their outpatient facilities, as well as community health centers and their associated grant sites, each record has one AO and one PC per record. There is a requirement for hospital covered entity types that the AO be the same for all child sites, but the PC may be a separate person for each record.

For example, hospital A with three outpatient facilities has the same AO for all records, but may select a separate PC for each record. Manufacturers with multiple labeler codes may select different AOs and PCs for each labeler code. Prior to September , these covered entity types had a parent-child relationship. Manufacturers must submit B pricing information to HRSA, which will begin within a two week period starting on or about day 45 of the quarter. The pricing component of the B OPAIS will send an email alert to the registered authorizing official and primary contact of the manufacturer when the two-week window for reporting is open, as well as daily reminders that tasks are pending within the pricing component of the B OPAIS.

Once terminated, covered entities will no longer have the ability to log into the pricing system. Our hospital isn't subject to the GPO prohibition. The answer depends on how the HTC is registered with respect to the hospital. If the HTC is an off-site outpatient facility of a hospital subject to the GPO prohibition, but is not registered for the B Program as a child site of the hospital and meets all of the following, if may use a GPO for covered outpatient drugs: 1.

Is located at a different physical address than the parent; 2. Purchases drugs through a separate pharmacy wholesaler account than the B participating parent; and 4. The hospital maintains records demonstrating that any covered outpatient drugs purchased through the GPO at the HTC are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on the OPA B database.

When a covered entity is unable to purchase a covered outpatient drug at a B price, may the covered entity subject to the GPO prohibition buy via a GPO?

A covered entity that is subject to the GPO prohibition may not use a GPO for covered outpatient drugs at any point in time. However, if a covered entity is unable to purchase a covered outpatient drug at the B price, they should first try and work with the manufacturer to obtain the product at the B price.

If they are still unable to obtain the product at the B price, they should then try to obtain the product at WAC. In situations where a product is unavailable at B or WAC, and the covered entity can document that all other options have been exhausted, the covered entity should maintain auditable records demonstrating the circumstance, and show they attempted to purchase the product at B every time an order was made.

Covered entities may not use the fact that they were unable to obtain a product on one day, to then use a GPO for an extended period of time. If a product does not have a B price, does that mean it is not considered a covered outpatient drug for the purposes of the B Program?

The definition of covered outpatient drug is found in section k of the Social Security Act. The availability of a B price is not dispositive in determining whether that drug meets this definition of a covered outpatient drug. Can our B hospital, subject to the GPO prohibition, use a GPO for outpatient drugs at a non-reimbursable clinic within the four walls of the parent hospital?