Independent Charitable Patient Assistance Program (IPAP) Code of Ethics

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1 Independent Charitable Patient Assistance Prgram (IPAP) Cde f Ethics Independent charitable patient assistance prgrams (IPAPs) fcus n the needs f patients wh are insured, meet certain financial limitatin threshlds, and as a result are heavily burdened by cst sharing bligatins. Adequate access t treatments and therapies is ften critical t a patient s fight against chrnic, debilitating r life-threatening diseases. Althugh underinsured patients turn t varius surces fr financial assistance with cinsurance, cpayments, health insurance premiums and/r deductibles, many such prgrams are nt available t all patients, especially federal health care prgram beneficiaries. Cnsequently, charitable assistance is crucial fr this ppulatin f patients. IPAPs prvide a necessary and essential service t patients in need and are held t a high standard f integrity. Certain aspects f IPAP activities may implicate the federal Anti-Kickback Statue and the Beneficiary Inducement Civil Mnetary Penalty Law enfrced by the Department f Health and Human Services (HHS) and varius Internal Revenue Service (IRS) regulatins. This Cde f Ethics (the Cde) is intended t set frth ethical guidelines fr IPAP peratins. The Cde has been develped by a grup f independent charitable rganizatins ffering patient assistance prgrams cmmitted t reducing the financial barriers t access t treatment and therapies that many patients face. The Cde articulates the principles that IPAPs embrace when they prvide financial assistance and addresses the gvernance bligatins incumbent upn all well-run charitable rganizatins. By cmmitting t and cmplying with the fllwing Cde principles, participating IPAPs hpe t enhance an awareness f their effrts t help patients and their families cpe with the financial challenges f their illnesses and carry ut thse effrts in a manner that exemplifies cmpliance, ethical business practices and service t patients. Operate under the auspices f and in nging cmpliance with an rganizatinspecific HHS Office f Inspectr General (OIG) Advisry Opinin Having an rganizatin-specific Advisry Opinin assures that IPAPs are accuntable fr maintaining cmpliant nging peratins. Hld a favrable OIG Advisry Opinin(s) r have an applicatin fr an Advisry Opinin pending and be actively engaged and cmmitted t wrking in gd faith with the OIG t gain apprval Remain in nging cmpliance with its Advisry Opinin(s), any applicable Mdificatin(s) theret and any updated OIG guidance applicable t patient assistance prgrams Pst n its website its OIG Advisry Opinin(s) and any Mdificatin(s) theret that have nt been withdrawn r superseded 1

2 Maintain public charity status under 501(c)(3) f the Internal Revenue Cde Public charities receive funding frm diverse surces. Ensuring public charity status in accrdance with applicable IRS regulatins facilitates public assessment f the integrity f an rganizatin. Diverse funding als is a critical cmpnent f IPAP cmpliance. In additin t maintaining 501(c)(3) status as a public charity, each rganizatin adpting the IPAP Cde must: Pst the full public inspectin cpy f its Frm 990s n its website Pst its mst current cmplete audited financial statement n its website Operate a cmpliance prgram that incrprates rutine financial and prgram audits t ensure the integrity f the rganizatin s finances and its peratinal cmpliance with the Cde, internal plicies and prcedures, including its cnflict f interest plicy, and the requirements f its OIG Advisry Opinin(s), Mdificatin(s) theret and any updated OIG guidance applicable t patient assistance prgrams Cmpliance prgrams and the assciated third-party audits and assessments are designed t encurage early detectin and crrectin f financial and cmpliance issues. Adpt a Bard-apprved cmpliance prgram addressing, at a minimum: This Cde Requirements f its OIG Advisry Opinin(s), Mdificatin(s) theret and any updated OIG guidance applicable t patient assistance prgrams Financial reprting and disclsure requirements under Generally Accepted Accunting Principles and IRS regulatins Cnflicts f interest Designate an individual(s) t be respnsible fr the day-t-day management and versight f the cmpliance prgram and any assciated audits r assessments Adpt internal plicies and prcedures t guide the cmpliance prgram and IPAP peratins, including plicies and prcedures t implement a Bard- apprved mechanism fr establishing new disease funds Ensure the cmpliance prgram incrprates clear standards that can be audited and mnitred t assess cmpliance with this Cde and applicable regulatins Establish Bard-apprved financial and prgram audit plans Engage an independent certified public accuntant t cnduct annual financial audits Engage an independent third-party t assess cmpliance with the Cde, internal plicies and prcedures and the rganizatin s OIG Advisry Opinin(s), 2

3 Mdificatin(s) theret and any updated OIG guidance applicable t patient assistance prgrams Establish direct reprting t the Bard regarding audit and assessment results, findings and recmmendatins Reslve any material weaknesses identified thrugh the audit and assessment prcesses in a timely and cmplete manner Implement and clsely mnitr cmpliance with a strng cnflict f interest plicy A strng cnflict f interest plicy that reaches beynd dnr relatinships and als addresses, at a minimum, self-dealing by an rganizatin s Bard, executive leadership team, and ther emplyees in decisin-making psitins is central t ensuring public trust in the legitimacy f a IPAP s cmmitment t a patient-centric missin. Any such prgram must ensure the disclsure f ptential cnflicts f interest and that prcedures fr effectively reslving all disclsed cnflicts are rutinely implemented. Develp and rutinely fllw a cnflict f interest plicy that details a defined prcess and an implementatin strategy fr identifying, evaluating and reslving ptential cnflicts f interest Subject cmpliance with its cnflict f interest plicy, including thse prvisins fcused n the reslutin f cnflicts, t the cmpliance prgram assessment prcess Operate independently, free frm the influence f dnrs Cmpliance with this Cde and with the requirements f an rganizatin s OIG Advisry Opinin(s), any Mdificatin(s) theret and updated OIG guidance applicable t patient assistance prgram are key, but nt exclusive, hallmarks f independence. Because peratin in a manner that is free frm the direct r indirect influence r cntrl f dnrs ver the rganizatin s missin and prgram peratins is essential, each rganizatin adpting the IPAP Cde must: Designate disease-state funds in a manner cnsistent with OIG guidance and independent f dnr input Define a prescribed Bard-apprved mechanism fr establishing new disease funds Design funds in a manner that prvides a range f financial supprt t patients based n their prescribed medical treatment regimen Determine patient eligibility fr assistance withut input frm dnrs accrding t reasnable, verifiable, and unifrm measures f financial need that are applied in a cnsistent manner t each applicant t a given disease-state fund Abstain frm using the cst f a particular drug r its assciated ut-f-pcket cst as a stand-alne factr in determining patient eligibility 3

4 Prvide infrmatin abut its disease-state fund fferings t the general public withut bias based upn dnr, manufacturer, treatment r therapy, methd f therapy administratin, r site f service Nt participate, endrse, r encurage any effrt n the part f a dnr t advertise the availability f the IPAP s disease-state fund(s) t which it dnates Nt disclse the identity f any dnr t any particular disease-state fund t avid prviding any incidental benefit t it r its prducts Refrain frm prviding dnrs r ther entities with infrmatin that culd permit the crrelatin f the amunt r frequency f dnatins with the number f patients assisted by the IPAP wh use a dnr s prducts r services r the vlume f thse prducts supprted by the IPAP Ensure that its cnflict f interest plicy addresses prhibited relatinships with dnrs Permit dnrs t earmark dnatins t a particular disease-state fund but prhibit them frm impsing further restrictins n the use f their dnatin within the designed fund Participate in agreed upn accuntability prcedures The accuntability requirements assciated with the Cde are designed t give all IPAPs that cmmit t the Cde assurances that their peers have each adpted cmpliance prcesses and prcedures capable f achieving sme baseline level f cmpliance effectiveness. They als are intended t give each participating IPAP cnfidence that ther Cde signatries are living up t their cmmitments. D s thrugh a frmal reslutin f the gverning bdy respnsible fr versight f the IPAP s activities (the Bard) and pst the Cde alng with a statement addressing its cmmitment t the Cde n its website Agree t train the members f its Bard in the requirements f the Cde and their respnsibility fr ensuring nging cmpliance with thse requirements. At a minimum, such training must address: Requirements f the IPAP s then-current OIG Advisry Opinin, the federal Anti-Kickback Statute, the federal Beneficiary Inducement Civil Mnetary Penalty Law and available OIG guidance n issues relevant t IPAP peratins IRS requirements applicable t IPAPs The IPAP s bligatins under the Cde The nature, scpe and peratinal aspects f the IPAP s cmpliance prgram and the Bard s bligatins t versee all cmpliance activities, prvide fr 4

5 annual cmpliance prgram audits, and ensure the reslutin, in a timely and cmplete manner, f any material weaknesses identified thrugh the day-tday peratin f the cmpliance prgram r thrugh the annual financial r cmpliance audits The nature and scpe f the IPAP s cnflict f interest plicy with an emphasis n apprpriate appraches t the effective reslutin f cnflicts The Bard s rle in ensuring the IPAP perates in an independent matter free frm dnr influence, especially with respect t the establishment f the IPAP s disease-state funds and its patient eligibility standards Apprpriately dcument Brad training thrugh a signed affirmatin frm each Bard member attesting t his/her participatin in the training within 6 mnths f the IPAP cmmitting t the Cde and at least annually thereafter within 3 mnths f the clse f the IPAP s fiscal year Annually, beginning n earlier than 12 mnths but n later than 18 mnths after a IPAP cmmits t the Cde, pst an attestatin, adpted by Bard reslutin, n the IPAP s website certifying that: The Bard has executed all duties required f it t ensure the IPAP s cmpliance with the terms f its OIG Advisry Opinin and the requirements f the Cde The IPAP s Cmpliance Officer has had direct access t the Bard n an as needed basis thrughut the year and has presented an annual (r mre frequent) cmpliance reprt t the Bard The IPAP has taken crrective actin t address any material weaknesses identified thrugh either the day-t-day peratin f its cmpliance prgram r thrugh its annual financial r cmpliance audits 5

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