Nicole N. Crase Pharmacy Manager/340B Peer to Peer Mentor Five Rivers Health Centers

Nicole N. Crase Pharmacy Manager/340B Peer to Peer Mentor Five Rivers Health Centers

Statement of Conflict of Interest Nicole Crase has no actual or potential conflict of interest in relation to this presentation

Today s Agenda Review the elements of a compliant 340B program List areas of focus for an audit Discuss the audit process and preparation

Five Rivers Health Centers Background Five Rivers Health Centers (FRHC) is an Federally Qualified Health Center (FQHC) located in Dayton, Ohio Urban area In 2014, we served 18,000 patients with 51,000 visits In 2011, we took three (3) former residency clinics of Good Samaritan and Miami Valley Hospital and spun off from the hospitals with the purpose of creating a FQHC Medical Surgical Health Center Family Health Center Center for Women s Health

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Five Rivers Health Centers Background Unlike most FQHCs, our providers are primarily residents or fellows Family Medicine Internal Medicine OB/GYN General Surgery, Orthopedic, and Hand Surgery Hematology/Oncology, Infectious Diseases, and Gastroenterology Fellows In total we have 200 residents, 5 Certified Nurse Midwives, and 90 precepting physicians

Five Rivers Health Centers Background In house pharmacy opened September 3, 2013 340B only physical inventory All patients must fit the definition of a patient in order to utilize our pharmacy (prevents drug diversion) Carve in Medicaid Contract pharmacy arrangement with a network pharmacy Leading practice site for the Peer to Peer Program

340B Program Then and Now Have seen a transition of the 340B program over my past 10 years of involvement 340B Then Focus on increasing awareness of the 340B program Era of access 340B Now Focus on compliance and oversight of the program auditing Era of integrity Participation in the 340B program is a great benefit but not without risk

Key Elements of 340B Compliance Self Audit internal monitoring and auditing Oversight of Contract Pharmacy Staff Education/Training Designating 340B accountable individuals Involve C Suite Effective communication amongst all staff continued 340B education Enforce culture of compliance Contact with State Medicaid Agency document conversations! Policies and Procedures Implement them/follow them/update them Be Proactive Responding quickly to noncompliance Establish a Corrective Action Plan Determine who should staff contact if they have a 340B issue or concern

340B Compliance Assessment at Operational Site Visits OSV s after October 1, 2014 will include a brief assessment of compliance with 340B requirements. OSV review teams will assess 340B compliance using a set of standard questions and will report responses directly to OPA. OSV reviewers will not actually test compliance but instead will flag health centers that may be out of compliance with 340B.

340B Compliance Assessment at Operational Site Visits If there is a NO response to any of the questions, the OSV review team with share the information with OPA. The report to OPA could trigger a more extensive 340B audit.

The Five Questions 1. Does the health center participate in the 340B drug pricing program? 2. If yes, does the health center have written 340B policies and procedures? 3. If yes, do the policies and procedures account for how the health center will prevent duplicate discounts and diversion? 4. If the health center uses contract pharmacies, do they have appropriate contracts in place with clauses to prohibit duplicate discounts and diversion? 5. Does the health center attest that it provides oversight (e.g. annual audit or other mechanism) of the 340B drugs dispensed by the contract pharmacy?

NO Response If there is a NO response HRSA Sanctions Prospective corrective action After notice and hearing, repayment of the amount of the discount to the manufacturer payment of interest on the discount for knowing and intentional diversion, and/or removal from the 340B Program and disqualification for a reasonable period of time if the violation was systemic and egregious Collateral Sanctions False Claims OIG and related penalties

Information Provided to the Auditors Answers to the five questions Copies of all policies and procedures specifically emphasized policies and procedures which focused on the 340B program. Copy of contract for the contract pharmacy arrangement Description on how we handle referrals Also was asked to provide most recent copies of selfauditing done for our 340B program (including in house and contract pharmacy)

Audit Focus Elements 340B policies and procedures Preventing diversion Preventing duplicate discounts Eligibility Contract pharmacy

Self Audit Concrete methodologies for routine self auditing and processes for internal corrective action Self audit tool on the Prime Vendor website 340B Compliance Self Assessment: Self Audit Process Tool Review your self audits and have a corrective action plan Following slides will provide detailed information to review in self audits

340B Policies and Procedures Implement them/follow them/update them Are staff knowledgeable about them? Enforcing culture of compliance? Sample 340B P&P manual on Apexus website Patient definition Preventing duplicate discounts Scope of practice Contract pharmacy include your oversight New policy Self Reporting Policy Tool on Apexus website Establish a threshold for a material breach (% of drug purchases/rx volume) and how you will evaluate the data Corrective Action Plan

Preventing Diversion Listing of all facilities where 340B drugs are used Listing of 340B drugs available Documentation of most recent reconciliation of physical inventory P&P that detail procurement, inventory management, and dispensing of 340B drugs

Preventing Duplicate Discounts OPA Medicaid Exclusion File status is correct Communication with State Medicaid Agency Document these conversations Apexus has contact information Policies and Procedures Define your Medicaid billing status Define your state Medicaid billing requirement Define mechanism to prevent duplicate discount (make sure you include contract pharmacy in this)

Eligibility Covered entity eligibility Accuracy of the OPA database (including contract pharmacies) may want to include screen shot in your P&P manual Records of facilities using 340B drugs Documentation in place to demonstrate entity s eligibility Patient eligibility Encounter within scope of practice Qualified provider Documentation of referral close the loop

Contract Pharmacy Must be properly registered Must have a copy of the agreement/contract on file Locations Dates of eligibility 340B policies which address monitoring expectation of oversight and independent, external audit When was monitoring last documented? Mechanism in place to prevent duplicate discounts State in P&P s We state in our contract that we will exclude Medicaid (includes Medicaid MCO s in Ohio block BIN/PCN s)

Staying Updated on Auditing Expectations HRSA policy releases FAQ s on the PVP website HRSA webinars Peer to Peer webinars 340B University (slides online) 340B Coalition

Audit Ready. Every Day. To Do List Create a 340B Team Have 340B policies and procedures implement them/follow them/update them Check your OPA Database updated/correct including Medicaid exclusion file, Authorizing Official Self audit, self audit, self audit use Apexus tool to cover all 340B components Staff/C Suite 340B education continued training and emphasis on compliance Conversation with State Medicaid Office document it! Contract pharmacy oversight and get that independent, external, annual audit completed! Be proactive! Respond to noncompliance and have a Corrective Action Plan In case you missed it above self audit, self audit, self audit!!

Additional Questions? Nicole N. Crase Pharmacy Manager/340B Peer to Peer Mentor Five Rivers Health Centers 725 S. Ludlow Street Dayton, Ohio 45402 Phone: 937.208.8850 Fax: 937.208.8855 ncrase@premierhealth.com