CPAP Foundation Overview

CBI Coupon and Copay Conference

September 2017

There Will Be a Test at the End, But First Some History

• 2003 – Medicare Part D Expansion – OK for manufacturers to offer

financial assistance to commercially-insured patients

• However, offering direct assistance to Medicare patients would violate the

Anti-Kickback Statute

• OIG issued its first Special Advisory Bulletin on Patient Assistance Programs

for Medicare Part D Enrollees in November 2005 in order to identify

potentially abusive patient assistance program structures as well as methods

of providing assistance that mitigate/vitiate the potential for fraud and abuse

• That original Bulletin gave independent, bona fide Charitable PAPs a

lawful avenue for pharmaceutical manufacturers and others to provide

financial assistance to Part D beneficiaries to obtain medically necessary

drugs without running the risk of violating the Anti-Kickback Statute

• There have been subsequent periodic OIG advisory supplemental bulletins

The HealthWell Foundation

An independent, 501(c)(3) national

organization based in Germantown,

Maryland

Established in 2003 to improve patient

access to life-changing medical treatments

Offered assistance across 60 disease areas

since launching first fund in 2004

Currently have over 58,000 active patient

grants

Only Foundation that has a written OIG

opinion to operate funds open only to

Medicare patients – currently 83% of our

grantees are Medicare patients

®

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Benefits of Donating to Independent PAP Charities

1. Helping underinsured patients who have difficulty affording vital medical treatments

2. Aiding governmentally-insured (Medicare) patients in general; those patients are not able to be assisted by manufacturer PAP’s

3. Providing commitment to those stakeholders (patients, physicians, pharmacies, etc.) in the space

4. Donations to 501(c)(3) organizations are tax deductible

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5. You will go straight to heaven

What to Look for in a Compliant, Efficient Foundation

• Independent, non-conflicted Board of Directors

• Verified charitable status (Form 509)

• Transparency

• OIG Opinions

• Complete 990’s with all schedules

• Staff and Board salaries commensurate with industry standard range

• Program overhead rate in the acceptable range

• Target under 10%

• Preferable under 5%

• Donations should go entirely to patient grants or to programming

• Should not go toward administrative salaries and expenses

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What to Look for in a Compliant, Efficient Foundation

• Broadly defined funds with inclusive product lists

• Minimal descriptive adjectives in the fund title/definition

• Medicare Covered Products For Specific Disease Area

• FDA Approved

• Compendia Listed

• Cannot discriminate for or against products for any reason (including price, brand vs. generic, manufacturer, etc.)

• Set consistent eligibility criteria across all funds with hotline and online application access

• Patient or advocates (with patient’s permission) may apply

• Physicians/Providers

• Pharmacies

• Family Members

• Manufacturer PAPs

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What to Look for in a Compliant, Efficient Foundation

• Similar grant management for all funds and all patients

• Patient income verification and full document review processes (generally limited to patient households that are 400-500% above the Federal Poverty Line, adjusted for household size and geographic location)

• Consistent reimbursement parameters and processes across all funds

• First come, first served policy on grant applicants: No favoritism to any referral source, product, income status, etc.

• Maintaining anonymity of donors

• Foundations should provide only aggregate fund data to donors

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How Do Foundations Help Patients?

Generally provide assistance for:

• Copays, deductibles and coinsurances

• Premium costs – can often be more burdensome than the copay

• Ancillary costs

• There is also the possibility to provide assistance for travel, companion diagnostics, vitamins, supplements, etc. in stand alone or combined funds

• Medicare patients

• HealthWell happens to be the only Foundation to have written OIG opinion to establish funds dedicated to Medicare patients only

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The Grant Process

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The Grant Process (cont.)

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The Grant Process (cont.)

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Treatment Community

Bulk of referrals from providers,

advocates, Hubs & pharmacies

Disseminate news releases and patient

resource materials to provider offices,

pharmacies and patient advocacy groups

Provider31%

Pharmacy16%

Hub14%

Advocate13%

Other CPAP

9%

Financial Counselor

5%

Private Payer3%

Advocacy 3%

Website2% All Others

4%

Finding HealthWell

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HealthWell Funds

Autoimmune

ANCA – Associated Vasculitis, Wegeners and

Granulomatosis with Polyangiitis

Ankylosing Spondylitis

Giant Cell Arteritis/Temporal Arteritis

Psoriasis

Psoriatic Arthritis

Rheumatoid Arthritis

Systemic Lupus Erythematosus

Urticaria

Blood Disorders

Idiopathic Thrombocytopenic Purpura

Iron Overload as a Result of Blood Transfusions

Endocrine Disorders

Growth Hormone Deficiency

Eye Diseases

Macular Degeneration

Gastrointestinal Diseases

Inflammatory Bowel Disease

Infectious Diseases

Cytomegalovirus – Prevention and Treatment

Diabetic Foot Ulcers

Fungal Infections – Aspergillosis and Candidiasis

Hepatitis C

HIV/AIDS-Related Wasting Syndrome or

Anorexia

Oncology

Bladder and Urothelial Cancers

Bone Metastases

Breakthrough Cancer Pain

Breast Cancer

Carcinoid Tumors & Associated Symptoms

Chemotherapy Induced Anemia

Chemotherapy Induced Nausea or Vomiting

Chemotherapy Induced Neutropenia

Chronic Myeloid Leukemia

Colorectal Carcinoma

Cutaneous T-Cell Lymphoma

Glioblastoma Multiforme/Anaplastic Astro.

Head and Neck Cancer

Hodgkin's Lymphoma

Melanoma

Multiple Myeloma

Myelodysplastic Syndromes

Non-Hodgkin's Lymphoma

Non-Small Cell Lung Cancer

Ovarian Cancer

Renal Cell Carcinoma

Wilms' Tumor

Inherited Metabolic DisordersHomocystinuriaPorphyriasUrea Cycle Disorders

Kidney Diseases

Anemia Associated with Chronic Renal Insufficiency/Failure

Secondary Hyperparathyroidism

Musculoskeletal Conditions

Dupuytren’s Disease

Gout

Gout Travel Assistance

Post Menopausal Osteoporosis

Neurologic Disorders

ALS

Multiple Sclerosis

Movement Disorders

Pulmonary Diseases

Asthma

Cystic Fibrosis

Pulmonary Fibrosis

Specialty

Pediatric Assistance

Transplant

Immunosuppressive Treatment for Solid Organ

Transplant Recipients

Urologic Disorders

Peyronie’s Disease

Online Tools

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Reporting

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Planning Ahead

• Proactive, pre-defined fund definitions and listings

• Continued disallowing of batch enrollment

• Shifted existing and all new funds over to pharmacy card-capability

• Second grant options in some funds

• Donor infoCenter reporting tool

• Business as usual with regard to first come, first served grantee queue, fund definition policy, reimbursable product list, etc.

• Expedited solutions for unused grants

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Website Update

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How Do Organizations Donate to Foundations

• No one set methodology

• The contacts within a donor organization are usually located in the charitable assistance, legal/compliance, patient advocacy, or market access divisions within corporations – not within the marketing group!

• Sometimes foundations are required to formally request funds via:

• Online processes

• RFP’s

• Letters of Requests

• Donation timing varies throughout companies, but generally fall into 3 categories:

• Quarterly

• Just in time funding (as the individual funds are nearing closure)

• Annual/semi-annual

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Were You Paying Attention?

TRUE OR FALSE?

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You should try to influence an independent charity’s management of their funds

False

An example of an appropriate fund name is:

“12th Line Therapies for Female Multiple Myeloma Patients Born on February 29”

False

All Pharmaceutical companies with marketed products should donate to

copay assistance foundations via a consistent internal process

True

Who is This?

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D. Someone who should have better involved legal/compliance in charitable

giving and pricing decisions

C. President Trump’s new Director of Price Controls at CMS

A. Clean shaven unabomber

B. Long lost member of the Beastie Boys

Today’s Take Home Message Is?

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A. Foundational Giving should be a part of all manufacturer’s programming

B. For the good of your organization, foundations should be selected on the

basis of their compliance with OIG Regulations and efficiency of funds

C. Manufacturer foundation giving decisions and processes ideally should be

firewalled from marketing decisions

D. Foundations are the most efficient and most compliant method of

financially assisting Medicare patients with copays and premiums

E. Covfefe would be an excellent name for a new gastroenteritis drug

F. All of the Above

G. A through D above

Alan Klein

Chief Development Officer

alan.klein@healthwellfoundation.org

240-632-5312

Contact Information

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