Steve Zielinski Regional Director SUNRx, LLC April 16, 2010

Transcription

1 Steve Zielinski Regional Director SUNRx, LLC April 16, 2010 Mississippi Primary Care Association

2 340B Program Overview Contracted Pharmacy Model New Multiple Contract Pharmacy Elements Maintaining 340B Integrity Contractual Responsibilities & Obligations

3 Section 340B of the Public Health Service (PHS) Act 1992 Provides discounts on outpatient drugs to certain safety net ft t organizations/entities titi Covered drugs are only for patients of covered entity Mfrs that participate in Medicaid must also participate in the 340B program

4 340B Program Intent Financial stability of the entity Savings for taxpayers Access to affordable meds by uninsured Average savings of 25 50% (AWP 51%) Savings may be used to: Reduce price of drugs for patients Expand drug formularies Expand services offered to patients

5 340B Participation Statistics - January 2010 Number of Active Registered Covered Entity Sites 14,457 Number of Active Contract Pharmacy Records 2,559 Number of Active Manufacturers Records 849 Total Number of Active Registered DSH sites 2,611 Urban* 2,203 Rural* 408 Number of factive Registered DSH organizations i 941 Urban* 690 Rural* 251 Total Number of Active Registered Community Health sites 3,971 Number of Active Reg. Community Health organizations 1,012 National Association of State Legislatures

6 340B Participation Statistics - January 2010 FQHC 3971 FQHC LA 210 Certain Disproportionate share Hospitals (DSH) 2611 Aids Clinics and drug purchasing programs (Ryan White Title I-IV) 581 Black Lung Clinics 14 Hemophilia Treatment Centers 99 Urban Indian Clinics 24 Tribal Centers 148 Family Planning Clinics 4087 STD Clinics 1468 TB Clinics 1194 Native Hawaiian Health Center 11 Office of Pharmacy Affairs (OPA)

7 Lack of Space in entity Staffing Costs Startup Costs (Inventory, Software, Hardware) Prescription volume Lack of 340B expertise Technology allows Virtual Inventory to be used Pharmacist value is available to patients Contract Pharmacy is billing agent/dispensing agent for health entity Inventory is replenished (ship to bill to) Pharmacist receives negotiated dispensing fee

8 Contract Pharmacies in 340B

9 Covered Entities need to: Understand the marketplace Seek to align entity needs with programs Recognize opportunities for noncompliance Be Pro active in collaborations Will increase because of technology & Regulation Opportunity for increased program efficiency and revenue capture April 5, 2010 Multiple Contract Pharmacy Regulation p, p y g

10 3000 Growth in 340B Contract Pharmacy Arrangements

11 Old, Single-Pharmacy Rules

12 New Multi-Pharmacy Rules

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14 Effective April 5, 2010 NEW Opportunity No Change to basic requirement CE is purchaser, owner and responsible for all 340B drug purchases Provides opportunity for 340B Participants to contract with multiple pharmacies Prior rule 1:1 relationship or AMDP Diversion was rationale for 1:1 existence

15 Purpose Further increase access to affordable drugs to vulnerable population lti Increase revenue opportunity for safety net organizations Increase positive health outcomes thru an increased access comprehensive pharmacy services

16 Optional participation Contractual Responsibilities and Reporting Single 340B entity with multiple 340B eligible sites Updated Contracts Pharmacy Identification & agreements Network Arrangements

17 Written Contract Must existdirectlybetween y covered entity & specified pharmacy Registration of CE & contracted pharmacy Addendum A & B Single 340B entity with multiple 340B eligible sites M h i di id l f h li ibl i i l d May have individual contracts for each eligible site or include multiple sites in a single Pharmacy Services Agreement (PSA)

18 Record Keeping as long as required under federal, state and local law federal antifraudlaws are 10 years! Previous guidelines did not state record keeping timeframe Number of pharmacies HRSA has not capped the number of pharmacies per entity Contract pharmacy required to verify that customer is a current covered entity patient U d t C t t Update Contract A covered entity with existing contract with a pharmacy may need to revise it

19 Pharmacy Identification & agreements Covered entity is required to submit it s name and 340B identification number together with pharmacy name(s) to HRSA s Office of Pharmacy Affairs A single covered entity may enter into a single agreement with a chain pharmacy each chain location must be listed on the contract and meet terms of agreement Network Arrangements g AMDP process required if more than one 340B covered entity form a distribution system

20 Covered entity responsible for pharmacy s compliance expected to be done through independent audits. Noncompliance findings to be documented and HRSA informedofcorrective of actions Informing 340B Eligible Patients Patients have his/her freedom of choice in choosing a pharmacy. If a patient obtains a drug from a pharmacy outside ofthe entity s 340B pharmacies, the manufacturer does not have to offer the 340B price.

21 Required Provisions Prevent Diversion Prevent Duplicate Discounts Covered entities responsibilities

22 Responsible for administration & oversight Strategies: integrity, access and value Mission: Promote access to clinically and cost effective pharmacy services Maximize the value of participation in 340B Developinnovative pharmacy servicesmodels Serve as a Federal resource for pharmacy practice Provide technical assistance

23 Ship to Bill to Procedure Covered entity is purchaser of the drugs and maintains ownership. The manufacturer, via wholesalers, will bill the covered entity and ship to contract pharmacy. Pharmacy & Covered Entity Tracking System The contract pharmacy, ALONG with the covered entity, must create and maintain a tracking system to prevent diversion to non qualified individuals.

24 Must indicate responsible party for services: Dispensing Recordkeeping Drug Utilization Reviews Formulary maintenance Patient profile and counseling Medication therapy management (MTM) Covered entity responsibility Specify which arrangement, if any, is in place p y g, y, p Names of Pharmacy providing services Report pharmacy violations immediately upon discovery

25 Patient Eligibility The covered entity and the contract pharmacy must develop a system to verify patient eligibility Audits All parties to agreement are subject to audits related to drug purchases and distribution by HRSA and/or Manufacturers HRSA expects the covered entity to perform annual audits, the exact method isleftup to the entity

26 Reports The contract pharmacy (s) will provide the covered entity with reports consistent with customary business practices and applicable to 340B rules and regulations. Duplicate Discounts If a party wants to dispense Medicaid prescriptions under 340B, the contract pharmacy, covered entity and state Medicaid agency must have a system to prevent duplication of discounts.

27 Certification of Pharmacy Compliance The covered entity must submit certification to OPA that an agreementexists exists and the contract pharmacy(s) willcomply with the 340B program integrity requirements Self reporting If a covered entity determines drug diversion or duplicate discounts has occurred, OPA is to be notified to obtain guidance on remedial actions. Recertification New recertification requirement suggests annual submission of data to certify CE s compliance with 340B requirements

28 Entities submitting annual recertification will be listed on OPA website bi Covered entities (CE) with contract pharmacies required to verify : All info listed in OPA database is complete, accurate, correct That the CE met the 340B eligibility bl requirements throughout h the prior year and continues to do so; CE obtains sufficient info from contract pharmacy to ensure compliance; and The methodology (independent audit or other mechanism) used to ensure pharmacy s compliance

29 Safety Net Hospitals for Pharmaceutical Access (SNHPA) Office of Pharmacy Affairs (OPA) Pharmacy Services Support Center (PSSC) Apexus 340B Prime Vendor Program SUNRx, LLC

30 Steve Zielinski RPh Tess Morgan SUNRx Southeast Regional Director