340B Drug Pricing Program 'Mega Guidance'-- Key Takeaways
HRSA has released guidance on the 340B drug pricing program. The guidance will more than likely be issued in the Federal Register late summer. While the guidance addresses a range of issues, it will most likely focus on the definition of patient, contract pharmacy compliance requirements, hospital eligibility criteria and qualifications of off-site outpatient locations.
340B Drug Pricing Program Covered Entities
All off-site outpatient facilities and clinics not located at the same physical address as the parent hospital facility will be shown on the public 340B database. Off-site outpatient clinics are able to purchase and use 340B medications under the following two conditions:
Each clinic is listed on a line of the cost report that is reimbursable under Medicare
The care provided at the facility has associated outpatient Medicare costs and charges
Individuals who are not patients of a covered entity are not eligible to receive drugs bought through the pharmaceutical discount program. An individual must match the following criteria to be regarded as a 340B patient:
The individual receives a healthcare service at a facility enrolled and listed in the 340B Program.
A covered entity service provider can provide services to an individual when the provider is employed by the covered facility or is an independent contractor for the covered facility.
An individual receives a drug that is prescribed by the covered facility provider as a result of the services specified mentioned above.
The individual's healthcare must be consistent with the service or assortment of services designated in the federal grant, project, designation or contract.
Medications are purchased or prescribed pursuant to a healthcare service that is categorized as outpatient.
Patient records are managed by the covered entity and demonstrate that the covered entity is responsible for care.
Covered facilities removed from the system due to qualification guideline violations would be able to re-enroll during the next regular enrollment time after it had complied with all HHS statutory criteria and offered payment to affected manufacturers, if necessary.
We expect that HHS will define in its guidance the group purchasing organization prohibition for certain covered facilities. Off-site outpatient entities, which are not listed on the public 340B database will be able to access outpatient drugs through a GPO presuming the facility has a buying account separate from that of any 340B enrolled facility. Drugs acquired through GPO can never be supplied to outpatients of the hospital or other care locations enrolled in the program.
Hospitals may use GPO's when a drug can not be accessed at the 340B price or at wholesale acquisition cost to prevent disturbances in patient treatment. Certified hospitals that use a GPO for covered outpatient drugs in these circumstances must document the information surrounding the acquisition and provide records to HHS.
Routine maintenance of 340B Drug Discount Program Records
HHS is thinking about establishing a standard time interval for record retention. The Standard would attempt to balance the need for a covered facility to document compliance with program criteria with the effort and expense required to maintain records for any extensive period of time.
Statutory Requirements and Compliance
HHS is introducing compliance systems for covered entities that contract with pharmacies to dispense 340B priced drugs. Covered should take the opportunity to evaluate and reconcile pertinent 340B drug pricing program patient eligibility status through periodic audits and review of contracted pharmacy functions. We propose that Covered Facilities should compare prescribing records with the contracted pharmacy records every 3 months.
Referral for services for Specialty Services
The propositioned guidance indicates that this place of practice will be very minimal, if proposed language is adopted without considerable modifications. Entities should give careful consideration to future use of referrals and the related records of such services in the patient's medical record. In the current state, any referral should be recorded in the record as well as proof of the subsequent care plan or treatment plan. Additionally, the Entity should ensure the Primary care service provider accepts the report or plan and is assuming responsibility for any care given pursuant to the plan.
All 340B drug pricing program -qualified beneficiaries or other eligible facilities should be creating action plans to respond to the final presented guidance with a goal to achieve and maintain a compliant program.
Posted in 340B ProgramTagged with: 340b drug pricing, 340b program, hrsa, innova 340b solutions
