Upload
hamien
View
215
Download
0
Embed Size (px)
Citation preview
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
®
3
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
4
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
5
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
6
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
7
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
8
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
12
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
14
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
16
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
18
Were You Paying Attention?
TRUE OR FALSE?
19
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?
20
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?
21
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
240-632-5312
Contact Information
22