Upon registration, a covered entity should contact its wholesaler to set up its B account. The covered entity can also request a price list for B drugs from its wholesaler. Until , covered entities had to rely on wholesalers and manufacturers to obtain pricing information on B drugs. However, on April 1, , HRSA launched a secure website that lists B ceiling prices for covered entities interested in validating the prices they pay for B drugs.
In , Congress mandated the creation of a binding administrative dispute resolution ADR process to settle claims by covered entities that drug companies have overcharged them for B drugs and claims by drug companies that audited entities have violated the prohibitions on diversion or duplicate discounts, which are explained below.
The final regulation establishing the ADR process took effect in January , although it is unclear when the process will be fully implemented. Adding further uncertainty to the future of the ADR process, drug manufacturers have filed lawsuits challenging the legality of the ADR final rule. Apexus has served as the Prime Vendor since A covered entity does not have to join the PVP to participate in B and may negotiate sub-ceiling discounts on its own.
However, because the PVP can negotiate prices on behalf of many B purchasers, it has been able to negotiate favorable prices and develop a national distribution system that may not be possible for some covered entities to obtain individually. The patient definition guidelines establish a test that individuals must meet to be eligible to receive B-priced drugs.
Under the guidelines, an individual is not considered a patient of the covered entity if the only health care service received by the individual from the entity is the dispensing of a drug for subsequent self-administration or administration in the home setting. Federal law protects manufacturers from giving a B discount and Medicaid fee-for-service FFS rebate on the same drug. The rules for carving in for Medicaid FFS patients differ depending on whether a contract pharmacy is used.
For drugs dispensed by a contract pharmacy, a covered entity may not carve in Medicaid FFS unless the entity, state Medicaid program, and contract pharmacy have established an arrangement to prevent duplicate discounts and notified OPA of the arrangement. To carve in drugs dispensed or administered at a hospital location or an entity-owned pharmacy, an entity must inform OPA of its decision to carve in and ensure that all numbers it uses to bill B drugs to Medicaid FFS i.
This allows state Medicaid agencies to exclude claims billed under those numbers from their rebate requests. Some states impose additional notification requirements, such as requiring the use of a modifier on B claims. Manufacturers that offer B ceiling prices as of the quarter beginning January 1, must comply with the requirements of the final regulation. Which manufacturers and drugs are subject to B pricing, and can participating manufacturers offer only a subset of the drugs they manufacturer at B prices?
Manufacturers who participate in Medicaid are required to participate in the B Program and provide a B ceiling price for all covered outpatients drugs.
A B participating manufacturer must provide a B price on all the covered outpatient drugs that meet the definition in section k of the Social Security Act. The B ceiling price is calculated using six decimal places and HRSA publishes the price rounded to two decimal places. Who is tasked with imposing civil monetary penalties against manufacturers who knowingly and intentionally overcharge a covered entity?
If a manufacturer determines it overcharged a covered entity for a covered outpatient drug, how soon must the manufacturer refund the affected covered entity? HRSA requires manufacturers to refund covered entities on all drug overcharges and should work with the covered entities in good faith to make repayments.
Specifically for new drugs and as outlined in the CMP final rule, manufacturers are required to calculate the actual B ceiling price and offer to refund or credit the covered entity the difference between the estimated B ceiling price and the actual B ceiling price within days of the determination by the manufacturer that an overcharge occurred. The B ceiling price is the maximum statutory price a manufacturer can charge a covered entity for the purchase of a covered outpatient drug and is equal to the average manufacturer price AMP from the preceding calendar quarter for the smallest unit of measure minus the unit rebate amount URA.
HRSA publishes the package adjusted price as a courtesy to assist manufacturers and covered entities in evaluating the B ceiling price. The package adjusted price is calculated using the B ceiling price, the package size PS , and the case pack size CSP for a covered outpatient drug, and represents the price that the covered entity actually pays for the drug. The PS is the quantity of a unit of measure contained in one package sold by a manufacturer under a particular 11 digit NDC.
The CSP is the number of salable units in the shipping container. In these cases, the B ceiling price rounded to two decimal places will be multiplied by the package size and case pack size to equal the package adjusted price. This is consistent with the Final Rule. Educational Resources. Program Requirements. Duplicate Discount Prohibition. Orphan Drugs. Manufacturer Notices to Covered Entities. Manufacturer Resources. Skip to main content. Learn more ». FAQs General May a manufacturer require only B entities to purchase covered outpatient drugs through specialty distribution channels?
View Answer Consistent with section B a 1 of the Public Health Service Act, manufacturers are expected to provide the same opportunity for B covered entities and nonB purchasers to purchase covered outpatient drugs when such drugs are sold through limited distributors or specialty pharmacies.
View Answer No. The PVP is a voluntary program for B covered entities and serves its participants in three primary roles: Negotiating subB pricing on pharmaceuticals; Establishing distribution solutions and networks that improve access to affordable medications; and Providing other value-added products and services.
View Answer Covered entities should always ensure they are adhering to all federal, state, and local laws. View Answer HRSA is now requesting documentation to support the hospital classification selected at the time of registration to further verify eligibility of parent hospital registrations.
View Answer A hospital that is private, non-profit with a contract with a state or local government to provide health care services to low income individuals who are not entitled to benefits under Medicare or eligible for State Medicaid, is eligible for the B Program.
View Answer An entity receiving in-kind contributions through section or may qualify for the B Drug Pricing Program provided all the remaining B requirements are met. View Answer The They are defined in the Section d 5 F i II of the Social Security Act as "a hospital that serves a significantly disproportionate number of low income patients and is located in an urban area, has or more beds, and can demonstrate that its net inpatient care revenues excluding any of such revenues attributable to this title or State plans approved under title XIX during the cost reporting period in which the discharges occur, for indigent care from state and local government sources exceed 30 percent of its total of such net inpatient care revenues during the period.
The outpatient facility guidelines can be found at 59 Fed. View Answer Off-site outpatient facilities are eligible child sites of a B hospital in the following circumstances: 1. Clinics at an offsite location from the registered parent must separately register on the B database, even if they are located within the four walls of that child site.
Every eligible clinic which will purchase or use B drugs within such a hospital must register separately as a child site. View Answer HRSA does not require a child site hospital location to register inpatient locations with observation beds.
View Answer Pharmacies are not eligible B covered entities and therefore, should not be listed as a child site with a B ID in the database. View Answer The B Program is an outpatient drug program. The hospital must develop appropriate tracking systems to ensure that covered outpatient drugs purchased through the B Program are not used for hospital inpatients. It is the responsibility of the hospital to ensure appropriate safeguards are in place to protect against diversion. If a hospital is unable to implement an effective tracking system, it should not use the B Program in that setting.
Additionally, covered entities and manufacturers receive e-mail notifications of pending tasks. Enhanced security features such as two-part authentication for covered entities and manufacturers.
View Answer 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.
If your email address has not been previously associated with a covered entity or manufacturer, enter your name, title, organization name employer , phone number, and extension in the spaces provided before proceeding. All fields are required except phone extension. Type your password and then type it again to confirm. Type your email address and password in the spaces provided.
Type your email address. Click the URL in the email message. Enter and confirm your new password. When reset is complete, you may proceed to log in as usual. View Answer 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.
View Answer Except for new account creation, only a covered entity or a manufacturer AO or PC can submit an online change request. Our extensive experience in healthcare technology and the B Program enables us to provide clients with the most advanced solutions in the industry. Utilizing a superior B platform is only one piece of the puzzle. Customer support should be viewed as an integral part of services being provided. Security and your TPA. Supports expanding the program to reach additional vulnerable communities, including investor-owned hospitals that provide care for underserved populations.
Supports voluntary program integrity efforts already underway to ensure this vital program remains available to safetynet providers. View the entire Fact Sheet under Key Resources.
Action Alert. Congress is back in Washington, D.
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