Product Reimbursement Services and Patient Assistance Programs KATHY CHAURETTE ALESSANDRO MARTUSCELLI

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1 Product Reimbursement Services and Patient Assistance Programs KATHY CHAURETTE ALESSANDRO MARTUSCELLI

2 Overview of Legal Framework OIG Guidance Pharmaceutical manufacturers may provide certain support services in connection with the sale of their products Standing alone, services that have no substantial independent value may not implicate the anti-kickback statute.

3 What are the type of services that manufacturers provide? Benefits investigation Prior Authorizations and Appeals Financial Assistance Co-payment assistance Patient Assistance Programs Free drug program Quick start program Bridge / Gap program Educational programs related to use of product

4 There Are Considerations Beyond The Anti-Kickback Statute When do the reimbursement services amount to a kickback? Are you providing something of value to HCPs? Are there other legal implications? Handling and maintenance of patient information (Privacy & HIPAA) Discussing efficacy / safety of product (Adv/Promotion) Interfering with the HCP/patient relationship (Product liability / tort) Handling of product complaints and adverse events (Safety reporting)

5 Challenges Associated with Patient Assistance Programs (PAPs) FREE DRUG PROGRAMS

6 Free Drug for the Uninsured and Functionally Uninsured Free drug for the uninsured and functionally uninsured is usually known as PAP drug Uninsured patients do not have any insurance coverage for drugs Functionally uninsured patients have insurance coverage for drugs, but it does not cover the particular drug at issue for this patient Step edit; denied prior auth; excluded from formulary

7 Free Drug for the Uninsured and Functionally Uninsured PAPs operated in the U.S. typically include the following eligibility criteria: U.S. licensed prescriber Patient is resident in the U.S. Undocumented Income limit Documentation of income or soft credit inquiry Uninsured or functionally uninsured

8 Free Drug for the Uninsured and Functionally Uninsured Re-apply annually (rolling 12 months) If insurance status changes mid-year and patient now has coverage for the drug, patient moves to commercial drug Drug added to formulary Prior auth approved

9 Patients with Medicare Coverage Special considerations apply to patients who have coverage for their prescription through Medicare, but cannot afford their medication These patients do not meet the definition of uninsured or functionally uninsured These patients tend to have a high prescription medication out-ofpocket burden (many Rx and/or expensive drug with high copay/coinsurance) Cannot participate in manufacturer copayment assistance programs

10 Patients with Medicare Coverage Several OIG Advisory Opinions covering Part D e.g., 06-03, 06-14, OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees (issued in 2005)

11 Patients with Medicare Coverage Free drug can be provided to patients having coverage for their medication through their Part D Plan, but it must be provided for the remainder of the calendar year Eligibility based solely on financial need, without regard to patient s choice of Part D plan, benefit design, or place on the Part D spectrum Avoids gaming of coverage gap/donut hole and catastrophic coverage phase Part D patients are insured during the coverage gap: they are neither uninsured nor functionally uninsured while in the coverage gap

12 Patients with Medicare Coverage Other eligibility criteria same or similar to PAP for the uninsured/functionally uninsured: U.S. licensed prescriber Patient is resident in the U.S. Income limit Documentation of income or soft credit inquiry Part D Plan is notified Re-apply each calendar year

13 Patients with Medicare Coverage The Advisory Opinions approve but do not require, a patient spend down Example: patient must spend 3% of projected annual income out-ofpocket on prescription medications before becoming eligible for free drug Example: patient must spend $700 out-of-pocket on prescription medications during the calendar year before becoming eligible for free drug

14 Patients with Medicare Coverage The Advisory Opinions and Special Bulletin are specific to Part D Should they be applied to Part B drugs? Important distinctions: no coverage gap, no TrOOP, no catastrophic coverage phase

15 Interim Access Programs Interim Access Programs provide free drug to Newly prescribed patients awaiting insurance coverage final determination (QuickStart) Patients on therapy who are experiencing a temporary gap in insurance coverage (Bridge) Job change Extended Travel Delay in obtaining continuing prior authorization

16 Interim Access Programs: New to Therapy Patients QuickStart provides drug free of charge for a limited period of time while benefits are being verified Move to commercial drug when coverage is confirmed If coverage is denied or benefits remain undetermined when program time limit approaches, assess whether patient meets free drug eligibility criteria applicable to the functionally uninsured

17 Interim Access Programs: New to Therapy Patients What about patients who received Quick Start, coverage is denied or time limit met, and do not meet functionally uninsured free drug criteria? Have HCP affirmatively select QuickStart If not selected, then patient does not receive QuickStart drug Separate Rx for QuickStart

18 Interim Access Programs: New to Therapy Patients Special considerations for Medicare patients Advisory Opinion Product is a substantial clinical improvement over other therapies in the class Notify Part D Plan 60 day limit Free drug may be provided only after: (a) payor delay of greater than 5 days after submission of all required information, or (b) initial denial received and pursuing appeal

19 Interim Access Programs: New to Therapy Patients Advisory Opinion (continued) Pharmacy does not also handle commercial drug No barrier to switching to another drug On-label No active marketing to patients No advertising in any outlet commonly accessed/seen/read/heard by patients No DTC Website may include information about the program and field force may had out approved materials to HCPs Notice to patient that free drug does not count towards TrOOP and that patient may not seek reimbursement

20 Interim Access Programs: New to Therapy Patients Advisory Opinion relates to a QuickStart program in the Part D context Consider how it can apply to a Part B drug Most of the criteria can be applied in the Part B context

21 Interim Access Programs: Bridge Drug Bridge is for patients already on therapy and experiencing a temporary lapse in insurance coverage Definitely not for Part D patients in the coverage gap/donut hole Very narrow circumstances in which Medicare patients may receive bridge Medicaid patients would qualify for PAP Potential health consequences of temporarily halting ongoing therapy during the gap Might not be eligible for functionally uninsured free drug (e.g., over income limit) Documented expectation that this is a temporary situation (e.g., known job change; extended travel)

22 Interim Access Programs: Bridge Drug Program criteria should be clearly defined Acceptable reasons narrowly defined Time limit Advisory Opinion does not apply Eligibility of Medicare patients Part A length of stay?

23 Donations to 501(c)(3) Organizations Providing Patient Assistance NON-MANUFACTURER PATIENT ASSISTANCE PROGRAMS

24 Late 2015 Present: Donations To 501(c)(3) Organizations Are Under Intense Scrutiny

25 Several Small, Mid-Size and Large Manufacturers Receive Subpoenas

26 What Has Been The Impact? Have manufacturers continued / discontinued donations? Are patients receiving the type of care and access to the drugs they need? Will OIG step in and provide additional guidance? How can manufacturers continue to donate to these organizations without running afoul of the OIG guidance?

27 What s The Theory? Manufacturers are using 501(c)(3)s as improper conduits to provide a subsidy to patients using their drugs that they cannot provide directly This can encourage manufacturers to increase prices at a cost to Federal healthcare programs OIG: The AKS could be violated AKS: If a donation is made to a 501(c)(3) to induce the PAP to recommend or arrange for the purchase of the donor s federally reimbursable items If a PAP s grant of financial assistance to a patient is made to influence the patient to purchase or induce the patient s physician's to prescribe certain items Government must show that something of value (e.g., remuneration) was offered to induce orders or a physician to prescribe defendant s drugs that are paid in whole or in part by the Federal healthcare programs. Government must show that the inducement was knowing and willful.

28 What is the Government Concerned About? Influencing beneficiaries drug choices Encouraging overutilization or inappropriate utilization of drugs Increase costs to federal healthcare programs

29 What Does The OIG Guidance Tell Us? Manufacturers can effectively contribute by making cash donations to independent, bona fide charitable assistance programs. Guidance sets forth factors that OIG believes are fundamental to a properly structured Independent Charity PAP Factors (1) neither the donor nor any affiliate should exert any direct or indirect influence or control over the PAP; (2) the PAP should award assistance in a truly independent manner that severs any link between the donor s funding and the beneficiary; (3) the PAP should award assistance without regard to the manufacturer s interests or the patient s choice of product or physician (4) the PAP should provide assistance based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner; and (5) the manufacturer should not solicit or receive data that would allow it to link its donations to the number of subsidized prescriptions for its products.

30 Independence Is KEY Do not exert any influence whatsoever, directly or indirectly, into how the organization implements its programs Eligibility criteria Identification of disease fund or how to define the disease reference to certain symptoms, severity of symptoms, method of administration of drug, stage of disease,

31 Implement Policy and SOP Independent Review Committee Composition of the Review Committee Comprehensive documentation from 501(c)(3) organizations Communication of approval of donations to other functions

32 What Type of Information is the 501(c)(3) Providing Back To Manufacturer? Patient Services Do not receive any information from organization that will permit manufacturer to correlate donation to amount of subsidized product Review reports roll up your sleeves and review the data Ensure Patient Services and/or Hub Services are appropriately triaging patients to 501(c)(3)s on a rotational or round robin basis Finance No ROI analyses