218-RICR-40-00-2
218-RICR-40-00-2. Rules, Regulations, and Standards Governing the Pharmaceutical Assistance to the Elderly Program (version Amendment, 01/01/2014 to 06/21/2017)
RULES, REGULATIONS AND STANDARDS GOVERNING
THE PHARMACEUTICAL ASSISTANCE TO THE
ELDERLY PROGRAM (RIPAE)
State of Rhode Island and Providence Plantations
Department of Human Services
Division of Elderly Affairs
As Amended:
January 2002 (re-filing in
accordance with the
provisions of section 42-34-
4.1 of the Rhode Island
general laws, as amended)
May 2007
January 2014
.
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Table of Contents
Sections
Page(s)
Part I: Overview and General Requirements .....................................................................1
Preface................................................................................................................................ 1
1.0 Program Authority...................................................................................................... 1
2.0 Nondiscrimination and Civil Rights Policy ............................................................... 1
3.0 Compliance with all Laws, Codes, Rules and Regulations........................................ 1
4.0 Divisions Duties under the Program .......................................................................... 2
5.0 Severability................................................................................................................. 2
Part II: Definitions............................................................................................................. 3
Part III: 6.0 Program Components ....................................................................................6
7.0 Allowances and Restrictions of the Program ............................................................. 6
8.0 Program Prohibitions.................................................................................................. 6
9.0 Consumer Eligibility .................................................................................................. 7
10.0 Program Benefits ......................................................................................................8
11.0 Financial Participation by Consumer ..................................................................... 10
12.0 Program Benefit in the Coverage Gap ...................................................................10
13.0 Application Form and Required Documentation ................................................... 11
14.0 Duration of Eligibility ............................................................................................ 15
15.0 Eligible Drugs ........................................................................................................ 15
16.0 Reporting Requirements......................................................................................... 16
Part IV: Appeals Procedures and Fraud and Abuse .........................................................17
17.0 Appeal Procedures.................................................................................................. 17
18.0 Fraud and Abuse..................................................................................................... 18
Part V: Pharmaceutical Manufacturer Rebates ...............................................................20
19.0 Pharmaceutical Manufacturer Drug Rebates.......................................................... 20
References .........................................................................................................................21
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PART I Overview and General Requirements
Preface
These rules, regulations and standards supersede any and all prior rules, regulations, and
standards relating to the creation and provision of pharmaceutical services to the elderly
promulgated pursuant to R.I.G.L. § 42-66.2 et.seq. They have been promulgated to ensure
that basic information about the nature of available services and eligibility to receive these
services is readily available to qualified service recipients and their families.
The intent of the Program is to be the payer of last resort and is limited to eligible persons
and eligible drugs.
Pursuant to the provisions of the Administrative Procedures Act, R.I.G.L. § 42-35-3, the
following were given consideration in arriving at the regulations: (a) alternative approaches
to the regulations; (b) duplication or overlap with other state regulations; and significant
economic impact. No alternative approach was identified; nor any duplication or overlap.
Section 1.0 Program Authority
1.1
The Rhode Island Pharmaceutical Assistance to the Elderly Program (RIPAE) is authorized
by, and these regulations are promulgated under, the authority of R.I.G.L. § 42-66.2 et .seq.,
“Rhode Island Pharmaceutical Assistance to the Elderly Program”, as amended.
Section 2.0 Non-discrimination and Civil Rights Policy
2.1
Each agency and individual involved in RIPAE shall be responsible for maintaining a policy
of nondiscrimination in the provision of services to participants and in the employment of
staff without regard to race, color, creed, national origin, sex, sexual orientation, age,
handicapping condition or degree of handicap, in accordance with Title VI of the Civil
Rights Act of 1964; the Rhode Island Executive Order No. 92-2, dated January 23, 1992 and
entitled “Compliance with the Americans with Disabilities Act”; the United States Executive
Order No. 11246 entitled “Equal Employment Opportunity”; United States Department of
Labor Regulations; Title V of the Rehabilitation Act of 1973, as amended; the 1990
Americans With Disabilities Act; R.I.G.L. § 42-87, which states that “Discrimination”
includes those acts prohibited on the basis of race by 42 U.S.C. #1981, 1983 and those on
the basis of handicap by 29 U.S.C. #794 and those on the basis of disability by 42 U.S.C.
#12100 et seq and those on the basis of disability by R.I.G.L. § 28-5; and the Rhode Island
Fair Employment Practices Act.
Section 3.0 Compliance with All Laws, Codes, Rules and Regulations
3.1
Each agency and individual that delivers RIPAE services shall be responsible for complying
with all local, state, and federal laws, codes, rules and regulations that apply to the Program.
Compliance with Pharmacy Laws, Codes, Rules and Regulations
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3.2
All pharmacy laws, codes, rules and regulations that apply to prescription medications shall
apply to the RIPAE Program. RIPAE enrollees shall be subject to these legal requirements.
Section 4.0 Division’s Duties under the Program
4.1
The Director shall enter into a contract with a contractor for the effective administrative
support of this program.
4.2
The contractor shall serve as the link between RIPAE and participating pharmacies. All
payments to pharmacies shall be made by the contractor. The and all participating
pharmacies shall be in compliance with all applicable sections of Chapter 42-66.2 of the
Rhode Island General Laws, as amended, and these rules and regulations.
Section 5.0 Severability
5.1
If any provision of the rules and regulations herein or the application thereof to any program
or circumstances shall be held invalid, such invalidity shall not affect the provision or
application of the rules and regulations which can be given effect, and to this end the
provisions of the rules and regulations are declared to be severable.
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PART II
Definitions
Section 6.0 Definitions
For the purpose of these rules and regulations, the following terms shall be construed as follows:
6.1
“The Act” means Chapter 42-66.2 of the Rhode Island General Laws, as amended.
6.2
“Additional drugs” means non-injectable drugs which require a physician’s prescription
according to federal law and which are contained in the American Hospital Formulary
Service pharmacologic-therapeutic classifications categories that have not been determined
by the federal “drug efficacy and safety implementation (DESI) commission” to lack
substantial evidence of effectiveness, which are not included in the definition of eligible
drugs listed below. However, “additional drugs” shall not include prescription drugs used
for cosmetic purposes.
6.3
“Approved documentation” means and includes a current explanation of benefits (EOB)
statement from a Medicare prescription drug plan (Part D) and a statement of current year-
to-date pharmacy medication expenses from a participating pharmacy.
6.4
“Consumer” means any full time resident of the State of Rhode Island who fulfills the
eligibility requirements set forth in Chapter 44-66.2 of the General Laws and section 9.0
herein.
6.5
“Contractor” means a third party or private vendor capable of administering a program of
reimbursement for prescription drugs, and drug program eligibility administrative support as
required by the Director. Such vendor shall be determined through a competitive bid
process.
6.6
“Coverage gap” means the out-of-pocket expenses for medications between the point where
an eligible person exceeds the Medicare Part D coverage limit under section 1860D-2(b)(3)
(42 U.S.C. 1395w-114a) of the Patient Protection and Affordable Care Act and below the
catastrophic amount specified in section 1860D2(b)(4)(B) of the Patient Protection and
Affordable Care Act for the year.
6.7
“Delegate agency” means any local community-based agency with which the Division
negotiates a contract for assistance with the implementation of the RIPAE Program.
6.8
“Department” means the Department of Human Services.
6.9
“Director” means the Director of the Division of Elderly Affairs
6.10
“Division” means the Department of Human Services, Division of Elderly Affairs.
6.11
“Eligible Drugs” means insulin and non-injectable drugs which:
6.11.1. Require a physician's (or other licensed practitioner authorized by state law to
prescribe) prescription according to federal law, and
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6.11.2. Are contained in the following American Hospital Formulary Service
pharmacologic therapeutic classifications categories that have not been
determined by the federal "drug efficacy and safety implementation (DESI)
commission" to lack substantial evidence of effectiveness.
6.11.3
“Classification categories” means:
1. anticoagulants
12. drugs for the treatment of arthritis
2. anti-diabetic agents
13. drugs for the treatment of asthma and other
chronic respiratory diseases
3. anti-infectives
14. drugs for the treatment of glaucoma
4. antilipemic drugs
15. drugs for the treatment of multiple sclerosis
(including injectables, $30,000 cap per fiscal year)
5. antidepressants
16. drugs for the treatment of osteoporosis
6. cardiac drugs
17. drugs for the treatment of Parkinson's disease
7. hypotensive drugs
18. drugs for the treatment of urinary incontinence
8.Vasodilators (cardiac indications only)
19. hemorrheologic agents
9.
drugs approved for the treatment of
cancer
10.
diuretics
20. insulin and disposible insulin syringes
21. oral antineoplastic drugs
11.
drugs approved for the treatment of
Alzheimer’s disease
22. prescription vitamin and mineral supplements for
renal patients.
23. neuraminidase inhibiting drugs indicated for the
treatment of influenza A and B.
6.12
“Full-time Resident” shall be determined consistent with the residency requirements set
forth in section 17-1-3.1 of the General Laws of Rhode Island, as amended, entitled,
"Residence for Voting Purposes".
6.13
“Income” means the sum of federal adjusted gross income as defined in the Internal
Revenue Code of the United States, and all non-taxable income including, but not limited to:
6.13.1 The amount of capital gains excluded from adjusted gross income;
6.13.2 Support money;
6.13.3 Alimony;
6.13.4 Non-taxable strike benefits;
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6.13.5
Cash public assistance and relief not including relief granted under the Act;
6.13.6
The gross amount of any pension or annuity (including Railroad Retirement
Act benefits, all payments received under the federal Social Security Act,
state unemployment insurance laws, and veterans disability pensions);
6.13.7
Non-taxable interest received from the federal government or any of its
instrumentalities;
6.13.8 Workers Compensation;
6.13.9 The gross amount of "loss of time" insurance.
“Income” shall not include:
6.13.10
Gifts from non-governmental sources;
6.13.11
Surplus foods;
6.13.12
Other relief in kind supplied by a public or private agency;
6.13.13
Sums of money expended for medical and pharmaceutical expenses that
exceed three percent (3%) of applicant's annual income or three percent (3%)
of applicant's preceding ninety (90) day income computed on an annual basis.
6.14
“Participating pharmacy” means any licensed pharmacy which has a written agreement
with the contractor agreeing to the conditions and requirements of participation in the
RIPAE Program.
6.15
“Pharmaceutical manufacturer” means any entity holding legal title to or possession of a
national drug code number issued by the federal Food and Drug Administration.
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PART III Program Components
Section 7.0 Allowances and Restrictions of the Program
7.1
The RIPAE Program shall include the following criteria:
7.1.1 Experimental drugs are excluded from the program.
7.1.2 A system of mail order delivery for prescriptions is allowed under the program.
7.1.3 Eligible and additional drugs must be dispensed within one (1) year of the original
prescription order.
7.1.4 Expenditures for multiple sclerosis drugs shall not exceed thirty thousand dollars
($30,000 per fiscal year).
7.1.5 Senior citizens participating in the program are required to maintain records of each
transaction, as specified by the Director in accordance with subsection 42-66.2-4(c)
of the Act and these regulations.
7.1.6 Prescription benefits for any single prescription may be dispensed in the amounts
authorized by the physician, and agreed to by the consumer, up to a maximum of a
one hundred (100) day supply or two hundred (200) doses, whichever is less; and/or
a one hundred (100) day supply or one quart of liquid, whichever is less; provided,
however, that disposable insulin syringes are dispersed in a quantity of one hundred
(100).
7.1.7 Generic drug substitution is mandatory when there is an available generic drug
equivalent.
Section 8.0
Program Prohibitions
8.1
Violation of any of the above criteria in section 7.1 herein shall constitute fraud and shall be
handled in accordance with Part IV herein.
Section 9.0 Consumer Eligibility
9.1
Eligibility shall be determined by the Division and its delegate agencies. In order to be
eligible to participate in RIPAE, consumers shall meet all of the following criteria:
9.1.1 Participants shall be 65 years of age or older at the time of application or between the
ages of 55-65 and receiving Social Security Disability benefits.
9.1.2 Participants shall be full time residents of the State of Rhode Island at the time of
application. Full time residence shall be determined consistent with section 17-1-3.1
of the General Laws of Rhode Island entitled, "Residence for Voting Purposes."
9.1.3 Participants shall be determined by the Division or its delegate agencies to meet the
following income criteria:
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a) Unmarried or married living separate and apart -Income for the calendar year
immediately preceding the year in which assistance is sought. Eligibility may also be
determined by using income data for the (90) ninety days prior to application for
benefits and projecting that income on an annual basis.
b) Married - Income for the calendar year immediately preceding the year, in which
assistance is sought, when combined with any income of such person's spouse in the
same year.
c) Eligibility may also be determined by using income data for the ninety (90) days prior
to application for benefits and projecting that income on an annual basis.
d) Except that, on July first of each year the maximum amount of allowable income for
both unmarried and married residents shall be increased by a percentage equal to the
percentage of the cost of living adjustment provided for Social Security recipients.
9.2
However, the fact that some of a person's prescription drug expenses are paid or
reimbursable either in whole or in part, under the provisions of Medicare Part D shall not
disqualify said person, if he or she is otherwise eligible to receive assistance under the Act,
provided that if the federal share equals or exceeds sixty percent (60%) of the cost, the state
shall make no payment.
Medicare Part D
9.3
All consumers shall demonstrate proof of enrollment in a Medicare prescription drug
program (“Medicare Part D”) in order to receive benefits under RIPAE.
Section 10.0 Program Benefits
10.1
The RIPAE Program shall pay the appropriate percentage of the cost of eligible drugs for
eligible consumers, 55 years or older, that are dispensed within one (1) year of the original
prescription order.
10.2
The percentage of cost RIPAE pays shall be based on the annual income of the eligible,
consumer as stipulated in section 10.3 below, less the amount of any other health insurance
payment and/or federal discounts, including those under the federal Patient Protection and
Affordable Care Act (PPACA), that have been paid on the claim at the pharmacy.
10.3
State and consumer co-payment shares for consumers shall be determined as follows:
10.3.1 For unmarried persons or married persons living separate and apart whose income
for the calendar year immediately preceding the year in which assistance is sought
is:
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(i) Less than nineteen thousand three hundred forty-one dollars ($19,341) the state
shall provide reimbursement such that the consumer shall pay no more than forty
percent (40%) of the cost of the prescriptions.
(ii) More than nineteen thousand three hundred forty-one dollars ($19,341) and less
than, twenty-four thousand two hundred and eighty dollars ($24,280) the state
shall provide reimbursement such that the consumer shall pay no more than
seventy percent (70%) of the cost of the prescriptions; and
(iii) More than twenty-four thousand two hundred and eighty dollars ($24,280) and
less than forty-two thousand four hundred and ninety-three dollars ($42,493), the
state shall provide reimbursement such that the consumer shall pay no more than
eighty-five percent (85%) of the cost of prescriptions.
10.3.2 For married persons whose income for the calendar year immediately preceding the
year in which assistance is sought hereunder when combined with any income of the
person's spouse in the same year is:
(i) Twenty-four thousand one hundred and seventy-nine dollars ($24,179) or less, the
state shall provide reimbursement such that the consumer shall pay no more than
forty percent (40%) of the cost of the prescriptions;
(ii) More than twenty-four thousand one hundred and seventy-nine dollars ($24,179)
and less than thirty thousand three hundred and fifty-two dollars ($30,352), the
state shall provide reimbursement such that the consumer shall pay no more than
seventy percent (70%) of the cost of prescriptions; and
(iii) More than thirty thousand three hundred and fifty-two dollars ($30,352) and less
than forty-eight thousand five hundred and sixty-three dollars ($48,563), the
state shall provide reimbursement such that the consumer shall pay no more
than eighty-five percent (85%) of the cost of prescriptions.
10.3.3 For persons on Social Security Disability benefits who are:
(i) unmarried or married and living separate and apart with income for the calendar
year immediately preceding the year in which assistance is sought that is less than
forty-two thousand four hundred and ninety-three dollars ($42,493); or
(ii) married with income that is less than forty-eight thousand five hundred and sixty-
three dollars ($48,563) the state shall provide reimbursement such that the
consumer shall pay no more than eighty five percent (85%) of the cost.
Section 11.0 Financial Participation by Consumer
11.1
RIPAE participants, 65 years old or older, shall pay up to 40%, 70% or 85%, as determined
by their income, of the cost of eligible drugs (after applicable senior citizen discounts,
coupons and any other health insurance payment and/or federal discounts, including those
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provided under the federal Patient Protection and Affordable Care Act (PPACA) have been
applied.
11.2
RIPAE consumers 65 years old or older shall pay 100% of the RIPAE discount price for
additional drugs as defined herein.
11.3
RIPAE consumers between 55-64 years of age and receiving Social Security Disability
benefits (SSDI) shall pay 100 % of the RIPAE discount price for both eligible and additional
drugs, as defined herein.
Section 12.0 Program Benefit in the Coverage Gap
12.1
The state shall reimburse the consumer up to the percentage rate of the maximum allowable
amount per prescription as set forth in section 10.3 herein as of the date of the purchase of
the drug, in accordance with the income eligibility and co-payment shares set forth in
section 42-66.2-5 of the Act and these regulations.
12.2
The rebates generated pursuant to section 42-66.2-10 of the Act shall be used to offset the
state’s payment under this section.
12.3
Reimbursement payments shall be made to consumers no less than quarterly.
12.4
After an eligible consumer reaches the coverage gap, he/she shall submit to the Division, or
its delegate agencies, a copy of approved documentation for the purchase of eligible drugs.
12.5
The Division shall verify the expenses, determine the reimbursement payment amount, and
authorize payment(s) to the eligible consumer, as applicable.
12.5.1 Delegate agencies shall not be authorized to determine the reimbursement payment
amount for the eligible consumer.
12.5.2 Claims for reimbursement for the purchase of eligible drugs shall be submitted
within one hundred eighty (180) days of the date of purchase of the drug.
Section 13.0 Application Form and Required Documentation
13.1
The Division shall utilize an application form, which shall serve as the primary vehicle for
determination of Program eligibility. This form may include but shall not be limited to:
a)
pertinent demographic information;
b)
residence;
c)
date of birth;
d)
annual income for the previous calendar year, including amount and source of
income (such income documentation shall be supplied for applicant and spouse when
applicant is married);
e)
Social Security number;
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f)
all other data essential for the determination of eligibility and maintenance of client
statistics;
g)
certification through signature of the applicant that permission is granted to the
Division to verify any and all information supplied on the application form as well as
certification through signature that the applicant will supply to the Division upon
request, written documentation of all information included on the application form.
13.2 Such application form shall be made available at the Division and its delegate agencies.
13.3 The Division may verify eligibility information in one or more of the following ways:
a)
Review and certification of eligibility by trained staff for each application file with
the Division or its delegate agencies;
b)
Perform computer cross checks with available data banks to verify eligibility;
c)
Conduct personal interviews to review documentation for age, residence and
previous year's annual income or income for ninety (90) days prior to application.
13.4 Notification shall be made to each applicant of eligibility/ineligibility within thirty (30) days
of receipt of application by the Division or its delegate agencies
13.5
Notification of ineligibility shall be in writing and shall detail the reason the application was
denied, and the process for appeal of this decision (refer to section 17.0 herein - Appeals
Procedures).
13.6
Names and pertinent information for each eligible consumer shall be supplied to the
contractor.
13.7
Benefits shall be paid only to those persons determined eligible by the Division as provided
herein.
13.8
The following documentation shall be accepted as verification of age/residence/income
under RIPAE:
13.8.1 Any one of the following documents shall be acceptable to document age:
a
RI Driver's License;
b)
Birth Certificate;
c)
RIPTA Senior bus pass;
d)
Pharmacy printout with date-of-birth imprint.
13.8.2 Any one of the following documents shall be acceptable to document residency:
a)
Address furnished to the Registry of Motor Vehicles for the applicant’s license;
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b)
Address at which the applicant's motor vehicle is registered;
c)
Address furnished to the companies from which the applicant has obtained retail
credit cards;
d)
Address furnished to the financial institutions where the applicant maintains
accounts;
e)
Address furnished to the tax collector and/or assessor in those communities where
the applicant owns taxable real or personal property;
f)
Address furnished to the insurance companies with which the applicant maintains
policies;
g)
Address furnished to the applicant's employer;
h)
Address furnished by the applicant to any business, professional, union, or fraternal
organizations of which he/she is a member;
i)
Address furnished to governmental agencies with which the applicant has contact;
j)
Address of a hospital, convalescent home, or like facility at which the applicant has
been a patient or resident for the preceding thirty (30) days or longer.
k)
Address at which the applicant filed his last federal and/or state income tax form.
13.8.3
A combination of the following documents shall be sufficient to document all income:
a)
For previous calendar year: federal income tax return and Social Security income
document;
b)
Employment Income: W-2 Form, pay stubs with year to date total, letter from
employer indicating length of employment and wages for previous calendar year;
c)
TDI/Worker's Compensation: an award letter or copies of checks;
d)
Unemployment benefits: a stamped unemployment book or copy of check;
e)
Alimony or support: a court decree or other documentation;
f)
Pension benefits: (Social Security, Veterans Benefits, SSI, etc.) a current or previous
year’s award letter or, a copy of most recent check, written verification from income
source, current statement from bank showing pension or Social Security income
direct deposit;
g)
TANF (Temporary Aid to Needy Families) /GPA (General Public Assistance): a
letter from the Department of Human Services detailing income from the previous
calendar year or a listing of such supplied by DHS;
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h)
Interest income: savings statements, passbook, letter from savings institution, W-
1099 or W-9 interest form;
i)
Rental income: rent receipts, lease agreements;
j)
Self-employment income: all receipts, bills, invoices and other documents
establishing income and expenses of operations;
k)
any listing or verification from an agency or organization for one of the above shall
constitute acceptable documentation of income.
Income Disregards
13.9
The following shall be excluded for purposes of income determination as provided in section
9.0 herein:
a)
Gifts from non-governmental sources;
b)
Value of surplus foods;
c)
Benefits excluded from income by federal or state law (i.e., stipends received by
Senior Companions under the Domestic Volunteer Services Act of 1973, as
amended);
d)
Benefits received under the Low Income Energy Assistance Program;
e)
Other relief in-kind supplied by a public or private agency;
f)
Sums of money expended for medical and pharmaceutical expenses that exceed three
percent (3%) of applicant's annual income or, if ninety (90) days income data is used
for eligibility purposes, three percent (3%) of applicant's preceding ninety (90) day
income computed on annual basis.
13.10 All income and/or medical expense documentation provided to the Division for purposes of
determining income shall have been earned (income) or incurred (expenses) during the
current or immediately preceding calendar year.
Section 14.0 Duration of Eligibility
14.1
Consumers whose eligibility has been established as described in section 9.0 above shall
remain eligible for a period determined by the Division or until the following, whichever
occurs first:
14.1.1 The consumer moves out of Rhode Island and is no longer a full-time resident;
14.1.2 The Division conducts a recertification of consumer eligibility and determines the
consumer to be ineligible.
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14.1.3 The consumer becomes eligible for Medical Assistance (Medicaid).
14.1.4 The consumer discontinues participation in a Medicare Part D plan.
Section 15.0 Eligible Drugs
15.1
The contractor shall supply to all participating pharmacies and to the Division a periodically
updated list of eligible drugs.
15.2
The contractor shall supply to all participating pharmacies and to the Division a periodically
updated list of additional drugs.
15.3
No payment shall be made under this Program to a participating pharmacy for any drug not
included on the contractor’s list of eligible drugs.
Section 16.0 Reporting Requirements
16.1
The Director shall submit an annual report to the following:
a)
The Governor;
b)
The Budget Officer;
c)
The Chairperson of the House Finance Committee;
d)
The Chairperson of the Senate Finance Committee;
e)
The Chairperson of the Board of Pharmacy as established by section 5-19-2 of the
Rhode Island General Laws, as amended.
16.2
This report shall contain at least the following:
a)
Number of consumers eligible for the RIPAE Program;
b)
Number of consumers utilizing the program;
c)
Number of appeals;
d)
An outline of problems encountered in the administration of the Program, suggested
solutions to same, and any recommendations to enhance the program.
16.3
The contractor shall submit an annual report to the following:
a)
Director of the Division;
b)
Governor;
c)
Budget Officer;
d)
Chairperson of the House Finance Committee;
e)
Chairperson of the Senate Finance Committee;
f)
Chairperson of the Board of Pharmacy as established by section 5-19-2 of the Rhode
Island General Laws, as amended.
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16.4
This report shall contain at least the following:
a)
Financial and utilization statistics as to drug use by therapeutic category, actuarial
projections;
b)
An outline of problems encountered in the administration of the Program, suggested
solutions to same, and any recommendations to enhance the Program.
PART IV Appeals Procedure and Fraud and Abuse
Section 17.0 Filing an Appeal
17.1
Any person whose application for assistance under RIPAE is denied shall have the right to
appeal such a decision. Such appeals shall follow the procedures listed below:
.
Notice of Denial
17.1.1 Applicants shall receive written notice that their applications for RIPAE have been
denied.
17.1.2 Such notice shall be provided by the Division on a standard denial form developed
by the Division. This notice shall be provided as soon as possible after receipt of the
application, but not more than thirty (30) days after receipt of the application.
17.1.3 This notice shall include:
a) The reason(s) for denial; and
b) The procedure for appeal.
Procedure for Appeal
17.2
Applicants shall contact the Division to request an appeal.
17.3
A hearing shall be scheduled to take place as soon as possible but not longer than fourteen
(14) days after the request for the hearing.
17.4
The applicant shall contact the Division within ninety (90) days of the date of the denial
letter from the Division. No hearing shall be granted upon a request more than ninety (90)
days from the date of the denial letter. However, an applicant may apply or reapply at any
time.
17.5
Written notice of the hearing shall be supplied to the applicant and shall include:
a) A statement of the time, place, and nature of the hearing;
b) A statement of the legal authority and jurisdiction under which the hearing is to be held;
c) A reference to the particular sections of the statutes and rules involved; and
d) A short and plain statement of the issues involved.
17.6
The Division Hearing Officer shall conduct the hearing.
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17.7
The applicant shall have the right to bring with him/her any person or any documentation
pertinent to the issues involved. The applicant shall supply documentation at the time of
the hearing for age, residence, and income, as outlined in section 13.0 above.
17.8
The Division Hearing Officer shall maintain a record of the hearing including the
following:
a) Evidence received or considered;
b) Statement of matters officially noted;
c) Questions and offers of proof and rulings;
d) Findings and exceptions;
e) The decision by the Division Hearing Officer; and
f) All memoranda or data submitted to the Division Hearing Officer presiding at the
hearing.
17.9
A complete record of the proceedings shall be recorded on audiotape or electronic device,
or at the discretion of the Hearing Officer, by stenographic record. In the event the
Hearing Officer orders a stenographic record, the Hearing Officer shall declare which
party or parties shall bear the cost thereof. Any party to the proceedings may on his, her or
its own initiative order a stenographic record made of the proceedings. The requesting
party shall incur all costs associated therewith. The Hearing Officer shall be provided, at
no cost, with a copy of the stenographic record and the Division’s legal counsel shall be
provided a copy at no cost. Any party to the proceedings may request a copy of the
audiotape record of the proceedings. The requesting party shall bear the cost thereof.
17.10
Findings of fact shall be exclusively on the evidence and matters officially noted.
Appeal of Hearing Officer Decision
17.11 Any person or individual acting on behalf of a person who elects to appeal an adverse
decision of the Hearing Officer shall have thirty (30) days after the mailing of the notice of
the final decision to request judicial review. The procedures outlined in R.I.G.L. § 42-35- 15
shall be followed.
17.12 If a party chooses to appeal a final Division’s decision to Superior Court and the Superior
Court requires a transcript of the hearing, said party shall be responsible for having the
transcript prepared by an independent person or company at his/ her expense within twenty
(20) days of filing the appeal.
17.13 If any administrative penalty is assessed at the conclusion of an administrative hearing, the
administrative penalty shall be final upon the expiration of thirty (30) days if no action for
judicial review of the decision is commenced.
Section 18.0 Fraud and Abuse
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18.1
The Division shall declare ineligible any consumer who abuses or misuses RIPAE. The
Division is empowered to investigate cases of suspected provider or consumer fraud.
18.2
Delegate agencies and participating pharmacies shall report to the Division any suspected
incident of fraud or abuse. Such reports shall be made to the Director or designee.
18.3
Fraud and abuse shall include but not be limited to:
18.3.1 Falsification of information on the application for assistance;
18.3.2 Use or attempted use of an eligibility card by an unauthorized individual;
18.3.3 Falsification of information by a participating pharmacy;
18.3.4 Consumer or provider claims for duplicative benefits;
18.3.5
Any violation or attempt to violate the provisions of Chapter 42-66.2 § of the
Rhode Island General Laws, as amended or these rules and regulations.
18.4
Individuals attempting fraud or abuse and individuals who aid or abet another in attempting
fraud or abuse shall be subject to imprisonment for a term of not more than one (1) year or a
fine of not less than five hundred dollars ($500) or both. The Division shall investigate all
reports of fraud and abuse, and shall refer all pertinent findings to the Office of the Attorney
General.
18.5
Any provider or consumer found guilty of intentionally violating the provisions of these
rules and regulations shall be subject to immediate termination from this program for a
period of no less than one (1) year. Notice of such termination shall be in writing and shall
not carry with it the right to appeal.
18.6
Any provider or consumer who is found guilty under the Act and these regulations shall be
subject to repay three (3) times the value of the material gain he or she received.
PART V Pharmaceutical Manufacturer Rebates
Section 19.0 Rebates
19.1
The Director shall enter into prescription drug rebate agreements with individual
pharmaceutical manufacturers under which the Division shall receive a rebate from the
pharmaceutical manufacturer equal to the basic rebate supplied by the manufacturer under
section 1927 of Title XIX of the Social Security Act for every prescription drug dispensed
under the Program.
19.2
Each such agreement shall provide that the pharmaceutical manufactures shall make
quarterly rebate payments to the Division equal to the basic rebate supplied by the
manufacturer under section 1927 of Title XIX of the Social Security Act for the total
number of dosage units of each form and strength of a prescription drug which the Division
reports as reimbursed to providers of prescription drugs, provided such payments shall not
be due until thirty (30) days following the manufacturer's receipt of utilization data from the
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Division including the number of dosage units reimbursed to providers of prescription drugs
during the quarter for which payment is due.
19.3
Upon receipt of such data from the Division, the pharmaceutical manufacturer shall
calculate the quarterly payment. The Division may, at its expense, hire a mutually agreed
upon independent auditor to verify the calculation and payment. In the event that a
discrepancy is discovered between the pharmaceutical manufacturer's calculation and the
independent auditor's calculation, the pharmaceutical manufacturer shall justify its
calculations or make payment to the Division for any additional amount due.
19.4
The pharmaceutical manufacturer may, at its expense, hire a mutually agreed upon
independent auditor to verify the accuracy of the utilization data provided by the Division.
In the event that a discrepancy is discovered, the Division shall justify its data or refund any
excess payment to the pharmaceutical manufacturer. The Division may, at its expense,
establish a grievance adjudication procedure which provides for independent review of
manufacturer documentation substantiating the basic rebate amount per unit delivered under
section 1927 of Title XIX of the Social Security Act. In the event that a discrepancy is
discovered, the Division shall justify its data or refund any excess payment to the
pharmaceutical manufacturer.
19.5
All prescription drugs of a pharmaceutical manufacturer that enters into an agreement
pursuant to of these rules and regulations shall be immediately available and the cost of such
drugs shall be reimbursed and not subject to any restrictions or prior authorization
requirements. Any prescription drug of a manufacturer that does not enter into such an
agreement shall not be reimbursable, unless the Division determines the eligible prescription
drug is essential to program participants.
19.6
All rebates collected by the Division from the rebate payments made for drugs for persons
eligible under the provisions of § 42-66.2-5(a) shall be deposited in a restricted receipt
account, hereby created within the agency and known as Pharmaceutical Rebates, to pay
costs in accordance with the provisions of § 42-66.2-4 of the Rhode Island General Laws, as
amended.
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REFERENCES
1.
“Pharmaceutical Assistance to the Elderly Act”, Chapter 42-66.2 of the Rhode Island
General Laws, as amended. Available online:
http://www.rilin.state.ri.us/Statutes/TITLE42/42-66.2/INDEX.HTM
2.
“Administrative Procedures”, Chapter 42-35 of the Rhode Island General Laws, as
amended. Available online:
http://www.rilin.state.ri.us/Statutes/TITLE42/42-35/INDEX.HTM
3.
“Patient Protection and Affordable Care Act”, Public Law 111-148, enacted March 23, 2010.
Available online:
http://frwebgate.access.gpo.gov/cgi-
bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h3590enr.txt.pdf