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 ID: 330333
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Slide1
PATIENT SERVICES, INC.“Overcoming New Challenges to Patient Assistance”
Presentation to RDLA
Thursday, October 16, 2014Slide2
Background Leading to May 21, 2014 Special Advisory Bulletin (OIG)One NPO exceeded the OIG guidelinesBarron’s Oct 18, 2013/ Oct 22, 2013 Seeking Alpha publicationsSingle 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 Slide3
Compliance is a High Priority(New Office of Inspector General Special Advisory Bulletin, May 21, 2014)1. 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 generics”.
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)
Slide4
Compliance is a High Priority(New Office of Inspector General Special Advisory Bulletin, May 21, 2014)2. No single-drug funds… a. Providing copayment for only one drug or only one manufacturer.
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
.
Slide5
Compliance is a High Priority(New Office of Inspector General Special Advisory Bulletin, May 21, 2014)3. 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.)
4.
Reporting
must be OIG compliant and not correlate donation amount with patient usage
Slide6
Consequences to Manufacturers and PatientsManufacturers Add more drugs to the “fund” including generics –supporting other drugsAdd 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
Patients
No access to rare and orphan drugs
Barrier to assistance: adverse health; life/death
Most vulnerable populations (Medicare beneficiaries); establishes a class medical society
Slide7
PSI Legislative ResponseDevelop partnership with patient communitiesDeveloped bipartisan letter CongressWorking 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)Slide8
What Can Your Organization Do to Help? Sign Organizational Support Letter to Congressman Leonard Lance (R-NJ).Work with PSI to activate patient advocates to send letters to Members of Congress.