Understanding the 340B Drug Pricing Program
The 340B program allows safety-net providers to access discounted drugs to serve more eligible patients efficiently. Learn about eligibility, registration periods, recertification, and purchasing options under the 340B program.
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Demystifying 340B: Demystifying 340B: Frequently Asked Questions Frequently Asked Questions Mindy McGrath, MPH NFPRHA FEBRUARY 13, 2018
What is 340B? What is 340B? Allows safety-net providers to access discounted drugs in order to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services Administered by the Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) 2
Is Is My My S Site Eligible ite Eligible? ? All Title X-funded sites are eligible Safety Net Providers STD Program Funding (318) Ryan White FQHC Title X Some Hospitals 3
How How Do Certified Certified ? ? Do W We e G Get et https://340bopais.hrsa.gov/ 4
Key Information Key Information Four registration periods: January 1-15 April 1-15 June 1-15 October 1-15 Registration is effective at the beginning of the next calendar quarter 5
Annual Recertification Annual Recertification Must recertify annually, & attest to compliance during set recertification period Failure to recertify results in termination from the program 6
Title X & Title X & We receive Title X and 318 Title X and 318 STD need to be certified with both? STD funding. Do we We receive Title X funding and are a FQHC Title X funding and are a FQHC. Do we need to be certified with both? 7
How Can Providers How Can Providers Purchase 340B Drugs? Purchase 340B Drugs? Prime Vendor Program (Apexus) Directly from manufacturer Example: Liletta Wholesaler Group purchasing organization Example: Afaxys 8
Eligible Patient Eligible Patient 1. The patient must have an established relationship with the provider practice (i.e., have a medical record). established relationship 2. They must have received some clinical services from a provider that is employed by or contracted with a provider that is employed by or contracted with your organization your organization - either that day or previously. 3. The patient has to receive a health care service that is consistent with the grant consistent with the grant for which your entity is 340B certified. 9
Case Example #1 Case Example #1 In a 340B certified 340B under Title X: Mariam came in for a preventive health visit and decided to continue with Depo Provera last month. This month, if she comes in for a positive syphilis does she qualify for 340B-priced Bicillin L-A? (STD treatment, a service consistent with their Title X grant) If she comes in for a strep throat (a service outside the scope of the Title X grant), does she qualify to get 340B- priced penicillin? 10
Case Case Example #2 Example #2 At the Sunshine Title X Family Planning clinic, Sally was seen 3 months ago for an initial exam and is coming in for a nurse-only visit to get a repeat Depo. Can you provide her with a 340B priced Depo today if she has: Self-pay? Private insurance? Medicaid Fee-for-Service? Medicaid Managed Care? If the Depo Provera was purchased with Title X funds? 11
Billing for 340B Billing for 340B Insurance Self-Pay Can I use 340B? Yes, if patient meets eligibility criteria How do I bill for drugs? Use sliding fee scale and charge according to Title X requirements. Bill co-pay and insurance contracted rate. Private Yes, if patient meets eligibility criteria Medicaid FFS If carve in. Yes, if patient meets eligibility criteria Bill the state Medicaid agency as specified in state policy. Medicaid Managed Care If carve in. Yes, if patient meets eligibility criteria Bill the Medicaid MCO according to your state Medicaid agency s policy
Case Case Example #3 Example #3 If I provide a $20 340B priced medication to a privately insured patient. Do I bill the insurance company $20 or would I bill them the $35 that is in our contract with them for that medication? Is this different for a patient with Medicaid? 13
Billing Billing Questions Questions Can we use Title X funds to purchase 340B priced Can we use Title X funds to purchase 340B priced medications? medications? Can we use 340B medications for Expedited Can we use 340B medications for Expedited Partner Therapy? Partner Therapy? 2014 (FAQ ID 1375) : 340B drugs may be used for STD partner therapy in situations meeting the 340B Patient Definition 14
Who is Who is NOT Get Get 340B 340B Drugs NOT Eilgible Eilgible to Drugs? ? to Anyone in an inpatient setting (including immediate postpartum LARC) An individual receiving no service other than administration/dispensing of a drug. Return visit for repeat administration or refills such as a Depo Provera are ok. Employees of your organization who are not your patient (unless they separately meet patient definition) 15
Medicaid and 340B Medicaid and 340B 340B and Medicaid drug rebate program are tied together Use of 340B drugs with Medicaid patients is more complicated than for other patients Federal guidance only applies to fee-for- service/ straight Medicaid 16
Carve Carve- -in or Carve in or Carve- -out? out? Each covered entity makes a decision to either carve-in or carve-out and it is noted in the Medicaid Exclusion File (MEF) It is a decision made per entity, not per medication Carving in: Carving in: Using 340B drugs w/ Medicaid patients state should not collect rebate Carving out: Carving out: Not using 340B drugs w/ Medicaid patients state collects rebate 17
Making your carve Making your carve in/out decision in/out decision Some factors to consider when deciding to carve in or out: Size of Medicaid population Which drugs are most frequently dispensed The differences in available prices of 340B vs. non- 340B drugs Reimbursement rates and requirements for 340B vs. non-340B drugs Whether or not you dispense on site 18
What about Medicaid What about Medicaid Managed Care (MMC)? Managed Care (MMC)? Differs state by state To carve-in: consult state Medicaid agency s policies Duplicate discounts prohibited 19
Compliance Compliance Maintain auditable records of compliance with 340B Program requirements What are common 340B audit findings? Insufficient Policies and Procedures Inpatient Diversion Duplicate Discount 20
Case Case Example #4 Example #4 Title X-funded Big City Hospital has both 340B and non-340B priced medications. Do I have to store them separately? If we run out of inpatient supplies, can we use our 340B-priced drugs and just replace them? 21
Diversion Diversion Providing 340B drugs to someone who does not meet the patient definition. Transferring drugs from one covered entity to another Transferring from one covered entity to an uncovered entity Using 340B drugs in an inpatient setting Using 340B drugs with individuals who do not meet criteria for established patient relationship 22
Duplicate Discount Duplicate Discount Carving in Use 340B priced meds Medicaid agency does not collect rebates Carving out Do not use 340B meds for Medicaid Medicaid collects rebates Duplicate Discount Obtaining discounted drugs, when state Medicaid agency also receives rebate for drug 23
Compliance Best Compliance Best Practices Practices Check/update 340B database entry quarterly Conduct regular internal audits Conduct regular trainings for staff; include in new staff onboarding Have robust written policies and procedures 24
Policies and Procedures Policies and Procedures Robust policies and procedures should include: Definition of patient Inventory management Responsible staff Separation of services Medicaid carve in or out decision, billing procedures Oversight and management of vendors, providers, and contract pharmacies (if applicable) Internal audits 25
Questions or comments? Please use the chat! Thank you! Thank you! www.FPNTC.org www.FPNTC.org
Contact Contact: : The 340B Prime Vendor Program apexusanswers@340bpvp.com Family Planning National Training Center fpntc@jsi.com Mindy J. McGrath, NFPRHA mmcgrath@nfprha.org 27
