CBI Pharmaceutical Compliance Congress Washington, D.C.

Transcription

1 Risks Associated with the Hub CBI Pharmaceutical Compliance Congress Washington, D.C. April 28, 2017

2 Disclaimer On behalf of this panel, please note that the views and opinions that will be expressed during this session are solely those of the presenters and do not reflect the official policy, position or views of their employers. Information has been gleaned from experiences in various settings as well as from open source data; thus, examples that may be discussed during this session are only examples and should not be attributed to any of their employers. 2

3 Agenda I. Session Objectives II. III. IV. The Hub Services Model Key Concerns Case Studies V. Q&A 3

4 Session Objectives The objectives of today s session are to discuss and evaluate: Hub Function / Arrangements Function/s of a Hub The difference between Specialty Pharmacies and Hubs Typical Hub arrangements Key Risks / Concerns Key risks/concerns associated with Hub functions The regulatory environment associated with Hub activities Mitigating Risks Various approaches to mitigate your risks Business scenarios to identify risks and mitigation approaches 4

5 The Hub Services Model The general objective of the Hub model is connecting patients with their prescribed therapies ( patient centered approach ) The Hub model is correlated with the rise/growth in high-cost and/or complex specialty drugs, which often results in certain reimbursement, patient access and continuity of care challenges Increasingly, Manufacturers use the Hub model for many of their non-specialty, lower cost products, particularly in connection with new product launches Hub providers are third party intermediaries, that mostly work on a fee-for-service basis, on behalf of Manufacturers 5

6 Hub Services The most common Hub services: Benefits investigations Reimbursement support (e.g., prior authorization and appeal support) Shipment services (e.g., welcome letters) Patient adherence support Patient education Data provision Copay card distribution Patient Assistance Program ( PAP ) administration Bridge program administration (i.e., free trial programs) 6

7 Key Concerns: Anti-kickback Statute Recent regulatory enforcement activity regarding Hub services primarily involved alleged violations of the Anti-kickback Statute where the Hub program focused on increasing utilization of the product rather than providing limited product-related support to patients after the product has been prescribed. Risk areas include: Manufacturer paying performance incentives to the Hub vendor based on patient adherence/ refill rates Assigning new patient enrollments to a specialty pharmacy as a reward for high adherence rates Hub coordinators providing services with substantial independent value to physicians by completing prior authorization forms, stewarding the prior authorization process between the HCP and payor, and coordinating the appeals process Failure to exclude government beneficiaries (e.g., Medicare, Medicaid, Tricare, VA, etc.) from certain product offerings, such as, copay card distribution, free product dissemination, financial assistance via Patient Assistance Programs ( PAPs ) 7

8 Key Concerns: False Claims Act Hubs, in the administration of services, uniquely position the Manufacturer within the patient, prescriber, insurer and pharmacist relationship. As a result, Manufacturers are in the position to potentially influence medical decisions. Risk areas include: Opportunities to discuss off-label information directly with patients, HCPs and payors or to support off-label use Hub coordinators pre-populating medical justifications or diagnosis codes on enrollment forms and/or prior authorization forms to increase the likelihood of favorable coverage determinations In addition, violations of the Anti-kickback Statute are a per se violation of the False Claims Act. 8

9 Key Concerns: Food, Drug, and Cosmetic Act Manufacturers are subject to FDA regulations that require fair balance in the promotion of products. Thus, Hubs that provide product information must ensure that the efficacy and safety information is adequately covered when providing services (e.g., specialty pharmacies ( SPs ) serve as the Hub and provide certain patient adherence services). Risk areas include: Hub coordinators answering patient product related questions with only efficacy information and omitting important safety information (i.e., lack of fair balance) Distribution of materials, such as welcome letters, prescription adherence reminders, and enrollment forms without a fair balance of safety risks and benefits of the product 9

10 Key Concerns: Privacy In connection with services administered by the Hub, Manufacturers may have the ability to access key patient data from the Hub vendor, in connection with those activities. Risk areas include: Patient enrollments forms do not include appropriate patient authorizations granting access for the Hub to share specific patient data with the Manufacturer for specific purposes and for a discreet period of time Case management systems utilized by Hub providers lack information security controls to safely encrypt, store and protect highly sensitive patient data (i.e., PHI) Calls are monitored and recorded without the patient s consent or authorization (in violation of certain state laws) Determining when and how to use a Business Associate Agreement ( BAA ) for HIPAA compliance purposes HITECH Act (2013) requirements for reasonable, cost-based fee to prepare and transmit medical records for patient adherence program activities Inappropriate access to PHI (through PA and other assistance) which could be perceived as aiding and abetting HCP HIPAA violations Prohibition on the sale of PHI 10

11 Key Concerns: Pharmacovigilance In connection with services administered by the Hub, Hub personnel may identify or be notified of Adverse Events ( AEs ) or Product Quality Complaints ( PQCs ) concerning the Manufacturer s product. Risk areas include: The Hub provider does not have sufficient processes or controls to identify or report adverse events per defined program business rules AEs may be ignored or improperly reported Communication of important safety information may be minimized when connecting with patients Pharmacovigilance System Master File ( PSMF ) non-compliance 11

12 Case Studies

13 Fact Pattern You are a newly hired Chief Compliance Officer of Millennial Therapeutics a prelaunch start up pharmaceutical manufacturer based in Brooklyn, New York Your company is preparing to launch an injectable Oncology product called OncoGen ; the expected PDUFA date is in nine (9) months The company estimates that the cost of therapy will be approximately $100,000 per year 13

14 Case Study 1: Seat at the Table A Director in the commercial team, Andrea, invites you to a meeting with her commercial team to discuss potential marketing and patient access strategies in connection with the OncoGen product launch. In particular, there is a concern that the new product may not be widely covered by payors due to less costly alternatives available in the market. During the meeting, the commercial team shares their preliminary plans to implement a specialty pharmacy network and patient support program to decrease OncoGen s access barriers at launch. Andrea turns to you and asks you to weigh in on the concept. 14

15 Case Study 1: Questions 1. What questions must you ask the commercial team immediately? 15

16 Case Study 1: Questions 1. What questions must you ask the commercial team immediately? 2. What should be your approach for assessing and mitigating risks for these programs going forward? 16

17 Case Study 1: Questions 1. What questions must you ask the commercial team immediately? 2. What should be your approach for assessing and mitigating risks for these programs going forward? 3. Were you informed of the plans to implement a Hub program during the appropriate time? 17

18 Case Study 2: The Water Cooler Through a casual water cooler conversation with Katie, a Vice President on the commercial team, you learn that the commercial team has entered into a contract with a network of specialty pharmacies and is about to sign a HUB services contract with a HUB vendor that has already been selected. The HUB vendor will administer certain patient support services in connection with the OncoGen launch. Specifically, the HUB vendor will provide reimbursement support, patient adherence support, copay program and a bridge (free trial) program. Katie shares that she aims to have the program fully implemented a month prior to the OncoGen launch. She further shares that she received full support from the company s senior leadership team during the program design process and HUB vendor selection process. Katie walks back to her office; she does not ask you for advice, offer any more details, or request a follow up meeting. 18

19 Case Study 2: Questions 1. What are your immediate concerns? 19

20 Case Study 2: Questions 1. What are your immediate concerns? 2. What are your next steps? 20

21 Case Study 3: Reviewing Business Rules Same as Scenario B, but assume you diligently (and appropriately) inserted compliance into the process immediately upon learning of commercial s plans to launch HUB services in connection with the OncoGen launch. You are fully aware of the plans and your input has been carefully considered and implemented. Before program launch, the Hub vendor has provided your company with draft program business rules, which have been routed to you for your review and approval: 21

22 Case Study 3: Questions What potential risks can you identify from the following scenarios? Upon your review of the benefits investigation business rules, you notice that HUB Patient Coordinators are required to refer to themselves as calling on behalf of the HCP when calling payors to obtain a patient s benefits information. 22

23 Case Study 3: Questions What potential risks can you identify from the following scenarios? Upon your review of the benefits investigation business rules, you notice that HUB Patient Coordinators are required to refer to themselves as calling on behalf of the HCP when calling payors to obtain a patient s benefits information. Upon your review of the benefits investigation business rules, you notice that government beneficiaries are only identified by matching the patient s BIN/PCN numbers against the posted CMS list of government beneficiaries. 23

24 Case Study 3: Questions What potential risks can you identify from the following scenarios? Upon your review of the benefits investigation business rules, you notice that HUB Patient Coordinators are required to refer to themselves as calling on behalf of the HCP when calling payors to obtain a patient s benefits information. Upon your review of the benefits investigation business rules, you notice that government beneficiaries are only identified by matching the patient s BIN/PCN numbers against the posted CMS list of government beneficiaries. Upon your review of the patient intake business rules, you notice that it provides a detailed call script for the HUB Patient Coordinator to follow up with prescribers when they provide an ineligible diagnosis code on an enrollment form. 24

25 Case Study 3: Questions What potential risks can you identify from the following scenarios? Upon your review of the benefits investigation business rules, you notice that HUB Patient Coordinators are required to refer to themselves as calling on behalf of the HCP when calling payors to obtain a patient s benefits information. Upon your review of the benefits investigation business rules, you notice that government beneficiaries are only identified by matching the patient s BIN/PCN numbers against the posted CMS list of government beneficiaries. Upon your review of the patient intake business rules, you notice that it provides a detailed call script for the HUB Patient Coordinator to follow up with prescribers when they provide an ineligible diagnosis code on an enrollment form. Upon review of the bridge program (free trial program) business rules, you notice that it does not include call scripts or call guidance for pharmacists to conduct shipment coordination calls with patients to schedule free product shipments. 25

26 Thank you Richard Liner Bayer HealthCare Senior Counsel, Compliance & Investigations (862) Jane H. Yoon Paul Hastings LLP Of Counsel, Litigation Department (212) Regina Gore Cavaliere KPMG LLP Principal, Life Sciences Advisory (973) Evan Bartell KPMG LLP Director, Life Sciences Advisory (212) No part of this presentation may be circulated, quoted, or reproduced for distribution without written authorization from KPMG LLP, Bayer HealthCare or Paul Hastings LLP. This document was used to facilitate a panel discussion at the CBI Pharmaceutical Compliance Congress on April 28, This document, without a transcript of the corresponding live presentation, is an incomplete record of the event.