Compliance is a High Priority (Office of Inspector General Bulletin

“Overcoming New Challenges to
Patient Assistance”
Presentation to RDLA
Thursday, October 16, 2014
Background Leading to May 21, 2014
Special Advisory Bulletin (OIG)
• One NPO exceeded the OIG guidelines
• Barron’s Oct 18, 2013/ Oct 22, 2013 Seeking
Alpha publications
• Single Rx program increased donors quarterly
cash dividends by 20%. Acthar for MS
• Created alleged fraud and abuse
• Report reached Dept. of Justice, DOJ inquired of
OIG who granted opinion
Compliance is a High Priority
(New Office of Inspector General Special Advisory Bulletin, May 21,
Disease Funds will…
a. Be legitimately defined in accordance with “widely
recognized clinical standards” (e.g. FDA, CMS???)
b. Be defined “in a manner that covers within each fund a
broad spectrum of products wherever possible including
c. “Not be defined by reference of specific symptoms,
severity of symptoms, method of administration,
stages of particular disease, type of drug treatment,
or any other way of narrowing”
d. Not be defined as “high cost or specialty drug funds”
and must consider other financial variables beyond
income (e.g. costs of living, debt)
Compliance is a High Priority
(New Office of Inspector General Special Advisory Bulletin, May 21,
No single-drug funds…
a. Providing copayment for only one drug or only one
b. Unless fund is legitimately defined, includes combining
two or more related disease funds, covers any drugs
needed by patient, covers all copayments for items
and services needed by patients and is submitted for
consideration to OIG on a case by case basis.
Compliance is a High Priority
(New Office of Inspector General Special Advisory Bulletin, May 21,
Diluting Funds May Be Acceptable…
a. According to legal counsel discussions with OIG,
OIG may consider single drug funds if they
are “diluted”.
(1). Dilution means: Premium , Copayment, Travel
Expenses, and Ancillary Expenses (Nursing, labs,
diagnostic test, physician copays, infusion costs, etc.)
Reporting must be OIG compliant and not correlate
donation amount with patient usage
Consequences to Manufacturers and Patients
• Add more drugs to the “fund” including generics –supporting
other drugs
• Add premium assistance if a “copayment” program
• Provide “copayment” assistance for only private patients
• If single donor program; dilute with copay, premium, travel
expense, ancillary services
• No access to rare and orphan drugs
• Barrier to assistance: adverse health; life/death
• Most vulnerable populations (Medicare beneficiaries);
establishes a class medical society
PSI Legislative Response
• Develop partnership with patient
• Developed bipartisan letter Congress
– Working with Caucus Co-Chair Leonard Lance
& Congresswoman Matsui to anchor letter
• Met with Congressional Offices regarding
issue including House Majority Whip, Steve
Scaliece (R-LA)
What Can Your Organization Do to
• Sign Organizational Support
Letter to Congressman Leonard
Lance (R-NJ).
• Work with PSI to activate patient
advocates to send letters to
Members of Congress.

similar documents