Bill Text: IL HB4079 | 2015-2016 | 99th General Assembly | Introduced
Bill Title: Amends the Illinois Insurance Code. Provides a process to register with the Department of Insurance as a pharmacy benefits manager and what information must be included. Provides that the Director of Insurance may revoke, suspend, deny, or restrict a certificate of registration for violation of the Code or on other grounds as determined necessary or appropriate by the Director. Provides that the Department shall regulate the drug pricing process used by pharmacy benefits managers, and specifies the appeals process for such pricing. Provides that pharmacy benefits managers shall not mandate that a covered individual use a specific pharmacy or provide incentives to encourage the use of a specific pharmacy under specified circumstances. Provides criteria for entities to use in performing on-site audits of pharmacy records. Provides that health plans must permit their enrollees to receive benefits, which may include a 90-day supply of covered prescription drugs, at any of its network community pharmacies. Contains provisions concerning medication synchronization. Provides that dispensing fees shall be determined exclusively on the total number of prescriptions dispensed. Regulates how pharmacy benefits managers may utilize personally identifiable data. Provides that the Department can regulate other specified activities of pharmacy benefits managers. Makes other changes. Effective January 1, 2016.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2015-03-27 - Rule 19(a) / Re-referred to Rules Committee [HB4079 Detail]
Download: Illinois-2015-HB4079-Introduced.html
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1 | AN ACT concerning insurance.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The Illinois Insurance Code is amended by | ||||||||||||||||||||||||
5 | changing Sections 512-3, 512-4, 512-5, 512-6, 512-7, 512-8, | ||||||||||||||||||||||||
6 | 512-9, and 512-10 and by adding Sections 512-11, 512-12, | ||||||||||||||||||||||||
7 | 512-13, 512-14, 512-15, 512-16, 512-17, and 512-18 as follows:
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8 | (215 ILCS 5/512-3) (from Ch. 73, par. 1065.59-3)
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9 | Sec. 512-3. Definitions. For the purposes of this Article, | ||||||||||||||||||||||||
10 | unless the
context otherwise requires, the terms defined in | ||||||||||||||||||||||||
11 | this Article have the meanings
ascribed
to them herein:
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12 | "Compounding" has the meaning ascribed to it in the | ||||||||||||||||||||||||
13 | Pharmacy Practice Act. | ||||||||||||||||||||||||
14 | "Department" means the Department of Insurance. | ||||||||||||||||||||||||
15 | "Director" means the Director of Insurance. | ||||||||||||||||||||||||
16 | "Entity" means a managed care company, insurance company, | ||||||||||||||||||||||||
17 | third-party payor, a PBM, third-party prescription program, or | ||||||||||||||||||||||||
18 | any other organization that represents these companies, | ||||||||||||||||||||||||
19 | groups, or organizations. | ||||||||||||||||||||||||
20 | "Generic exclusivity period" means the period established | ||||||||||||||||||||||||
21 | in Section 355(j)(5)(B)(iv) of Title 21 of the United States | ||||||||||||||||||||||||
22 | Code. | ||||||||||||||||||||||||
23 | "Health plan" has the meaning ascribed to it in 45 CFR |
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1 | 160.103. | ||||||
2 | "Maximum allowable cost" or "MAC" means a maximum | ||||||
3 | reimbursement amount for a group of therapeutically and | ||||||
4 | pharmaceutically equivalent multiple source drugs that are | ||||||
5 | listed in the federal Food and Drug Administration's "Approved | ||||||
6 | Drug Products with Therapeutic Equivalence Evaluations" and | ||||||
7 | for which there are no fewer than 3 nationally available | ||||||
8 | equivalent drug products. | ||||||
9 | "Medical device" has the meaning ascribed to it in the | ||||||
10 | Pharmacy Practice Act. | ||||||
11 | "Medication synchronization" means the coordination of | ||||||
12 | medication refills for a patient taking 2 or more medications | ||||||
13 | for a chronic condition such that the patient's medications are | ||||||
14 | refilled on the same schedule for a given time period. | ||||||
15 | "Medication therapy management services" has the meaning | ||||||
16 | ascribed to it in the Pharmacy Practice Act. | ||||||
17 | "Multiple source drug" means a drug for which there are 3 | ||||||
18 | or more drug products that are: | ||||||
19 | (1) rated by the federal Food and Drug Administration | ||||||
20 | as therapeutically equivalent under the federal Food and | ||||||
21 | Drug Administration's most recent publication of Approved | ||||||
22 | Drug Products with Therapeutic Equivalence Evaluations; | ||||||
23 | (2) determined by the federal Food and Drug | ||||||
24 | Administration to be pharmaceutically equivalent or | ||||||
25 | bioequivalent; and | ||||||
26 | (3) separately sold or marketed in the United States |
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1 | during the same calendar quarter. | ||||||
2 | "Nationally available" means that such products are | ||||||
3 | available for purchase by pharmacies or chain-operated | ||||||
4 | warehouses in sufficient supply from national pharmaceutical | ||||||
5 | wholesalers and are not obsolete or temporarily unavailable. | ||||||
6 | Products must be available for purchase from a wholesale drug | ||||||
7 | distributor as defined and licensed according to the Wholesale | ||||||
8 | Drug Distribution Licensing Act. | ||||||
9 | "Obsolete" means that such products may be listed in the | ||||||
10 | national pricing compendia but are no longer actively marketed | ||||||
11 | by the manufacturer or labeler. | ||||||
12 | "Patient counseling" has the meaning ascribed to it in the | ||||||
13 | Pharmacy Practice Act. | ||||||
14 | "Pharmacist" has the meaning ascribed to it in the Pharmacy | ||||||
15 | Practice Act. | ||||||
16 | "Pharmacist care" has the meaning ascribed to it in the | ||||||
17 | Pharmacy Practice Act and is considered to be a component of | ||||||
18 | pharmacist-provided care. | ||||||
19 | "Pharmacy" has the meaning ascribed to it in the Pharmacy | ||||||
20 | Practice Act. | ||||||
21 | "Pharmacy benefits manager" or "PBM" means an entity that | ||||||
22 | contracts with third-party pharmacies or pharmacists on behalf | ||||||
23 | of a health plan for the third-party pharmacy and pharmacists | ||||||
24 | to provide pharmacy services to such health plans. | ||||||
25 | "Practice of pharmacy" has the meaning ascribed to it in | ||||||
26 | the Pharmacy Practice Act. |
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1 | "Prescription" has the meaning ascribed to it in the | ||||||
2 | Pharmacy Practice Act. | ||||||
3 | "Standing Order" has the meaning ascribed to it in the | ||||||
4 | Pharmacy Practice Act. | ||||||
5 | "Temporarily unavailable" means that such products are | ||||||
6 | experiencing short-term supply interruptions for which only | ||||||
7 | inconsistent or intermittent supply is available in the current | ||||||
8 | marketplace. | ||||||
9 | "Unique Identifier" has the meaning ascribed to it in the | ||||||
10 | Pharmacy Practice Act. | ||||||
11 | (a) "Third party prescription program" or "program" means | ||||||
12 | any system of
providing for the reimbursement of pharmaceutical | ||||||
13 | services and prescription
drug products offered or operated in | ||||||
14 | this State under a contractual arrangement
or agreement between | ||||||
15 | a provider of such services and another party who is
not the | ||||||
16 | consumer of those services and products. Such programs may | ||||||
17 | include, but need not be limited to, employee benefit
plans | ||||||
18 | whereby a consumer receives prescription drugs or other | ||||||
19 | pharmaceutical
services and those services are paid for by
an | ||||||
20 | agent of the employer or others.
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21 | (b) "Third party program administrator" or "administrator" | ||||||
22 | means any person,
partnership or corporation who issues or | ||||||
23 | causes to be issued any payment
or reimbursement to a provider | ||||||
24 | for services rendered pursuant to a third
party prescription | ||||||
25 | program, but does not include the Director of Healthcare and | ||||||
26 | Family Services or any agent authorized by
the Director to |
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1 | reimburse a provider of services rendered pursuant to a
program | ||||||
2 | of which the Department of Healthcare and Family Services is | ||||||
3 | the third party.
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4 | (Source: P.A. 95-331, eff. 8-21-07.)
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5 | (215 ILCS 5/512-4) (from Ch. 73, par. 1065.59-4)
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6 | Sec. 512-4. Registration. | ||||||
7 | (a) All PBMs that provide services to residents of this | ||||||
8 | State shall apply for, obtain, and maintain a certificate of | ||||||
9 | registration to operate as a PBM from the Department. | ||||||
10 | (b) The PBM certificate of registration shall be renewed | ||||||
11 | annually. | ||||||
12 | (c) The Director shall establish the fees and shall have | ||||||
13 | the authority to assess fees to cover the annual expenses and | ||||||
14 | costs of administering this Article. | ||||||
15 | (d) The application for a certificate of registration to | ||||||
16 | operate in this State as a PBM shall be in a form prescribed by | ||||||
17 | the Director and shall be verified by an officer or authorized | ||||||
18 | representative of the PBM. | ||||||
19 | (e) The application shall include, but is not limited to, | ||||||
20 | the following: | ||||||
21 | (1) All organizational documents, including, but not | ||||||
22 | limited to, articles of incorporation, bylaws, and other | ||||||
23 | similar documents and any amendments. | ||||||
24 | (2) The names, addresses, titles, and qualifications | ||||||
25 | of the members and officers of the board of directors, |
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1 | board of trustees, or other governing body or committee, or | ||||||
2 | the partners or owners in case of a partnership or other | ||||||
3 | entity or association. | ||||||
4 | (3) A detailed description of the claims processing | ||||||
5 | services, pharmacy services, insurance services, other | ||||||
6 | prescription drug or device services, or other | ||||||
7 | administrative services provided. | ||||||
8 | (4) The name and address of the agent for service of | ||||||
9 | process in the State. | ||||||
10 | (5) Financial statements for the current and the | ||||||
11 | preceding year, showing the assets, liabilities, direct or | ||||||
12 | indirect income, and any other sources of financial support | ||||||
13 | as deemed sufficient by the Director to show financial | ||||||
14 | stability and viability to meet its full obligations to | ||||||
15 | participants and participating pharmacies. The Director | ||||||
16 | may allow a recent financial statement prepared by an | ||||||
17 | independent certified public accountant to meet this | ||||||
18 | requirement. | ||||||
19 | (6) Such other information as the Director may require. | ||||||
20 | (f) The Director may revoke, suspend, deny, or restrict a | ||||||
21 | certificate of registration of a PBM for violation of this | ||||||
22 | Article or on other grounds or violations of State or federal | ||||||
23 | laws, rules, or regulations as determined necessary or | ||||||
24 | appropriate by the Director. In the event that a certificate is | ||||||
25 | revoked, suspended, or denied, the Director may permit such | ||||||
26 | further operation of the PBM for a limited time, not to exceed |
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1 | 60 days, under conditions and restrictions as determined by the | ||||||
2 | Director as necessary for the beneficial interests of the | ||||||
3 | participants and pharmacy and pharmacist providers. | ||||||
4 | (g) The Director may renew the certificate of any PBM, | ||||||
5 | subject to any restrictions considered necessary or | ||||||
6 | appropriate by the Director. | ||||||
7 | (h) The Director shall provide written notice to the PBM of | ||||||
8 | any revocation, denial, suspension, or restriction, including | ||||||
9 | the specific reasons. The PBM shall have the same rights to | ||||||
10 | notice, hearings, and other provisions as provided to insurers | ||||||
11 | or third party administrators, respectively, under State law. | ||||||
12 | (i) The Director shall, upon request, provide the | ||||||
13 | Department of Financial and Professional Regulation with | ||||||
14 | copies of applications, correspondence, and any other | ||||||
15 | documents provided by the PBM to the Director, and with | ||||||
16 | notices, findings, determinations, and other documents | ||||||
17 | provided by the Director to the PBM. | ||||||
18 | All third party prescription programs and
administrators doing | ||||||
19 | business in the State shall register with the Director
of | ||||||
20 | Insurance. The Director shall promulgate regulations | ||||||
21 | establishing criteria
for registration in accordance with the | ||||||
22 | terms of this Article. The Director
may by rule establish an | ||||||
23 | annual registration fee for each third party administrator.
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24 | (Source: P.A. 82-1005.)
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25 | (215 ILCS 5/512-5) (from Ch. 73, par. 1065.59-5)
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1 | Sec. 512-5. Fiduciary and Bonding Requirements. An entity | ||||||
2 | A third party prescription program administrator shall (1) | ||||||
3 | establish and
maintain a fiduciary account, separate and apart | ||||||
4 | from any and all other
accounts, for the receipt and | ||||||
5 | disbursement of funds for reimbursement of
providers of | ||||||
6 | services under the entity's program, or (2) post,
or cause to | ||||||
7 | be posted, a bond of indemnity in an amount equal to not less
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8 | than 10% of the total estimated annual reimbursements under the | ||||||
9 | entity's program.
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10 | The establishment of such fiduciary accounts and bonds | ||||||
11 | shall be consistent
with applicable State law.
If a bond of | ||||||
12 | indemnity is posted, it shall be held by the Director of | ||||||
13 | Insurance
for the benefit and indemnification of the providers | ||||||
14 | of services under the entity
third party prescription program .
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15 | An entity administrator who operates more than one third | ||||||
16 | party prescription program
may establish and maintain a | ||||||
17 | separate fiduciary account or bond of indemnity
for each such | ||||||
18 | program, or may operate and maintain a consolidated fiduciary
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19 | account or bond of indemnity for all such programs.
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20 | The requirements of this Section do not apply to any third | ||||||
21 | party prescription
program administered by or on behalf of any | ||||||
22 | insurance company, Health Care
Service Plan Corporation or | ||||||
23 | Pharmaceutical Service Plan Corporation authorized
to do | ||||||
24 | business in the State of Illinois.
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25 | (Source: P.A. 82-1005.)
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1 | (215 ILCS 5/512-6) (from Ch. 73, par. 1065.59-6)
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2 | Sec. 512-6. Notice. Notice of any change in the terms of a | ||||||
3 | PBM third party prescription program ,
including but not limited | ||||||
4 | to drugs covered, pharmacist-provided services, reimbursement | ||||||
5 | rates, co-payments,
and dosage quantity, shall be given to each | ||||||
6 | enrolled pharmacy at least 30
days prior to the time it becomes | ||||||
7 | effective.
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8 | (Source: P.A. 82-1005.)
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9 | (215 ILCS 5/512-7) (from Ch. 73, par. 1065.59-7)
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10 | Sec. 512-7. Contractual provisions.
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11 | (a) Any agreement or contract entered into in this State | ||||||
12 | between the PBM
administrator of a program and a pharmacy or | ||||||
13 | pharmacist shall include a statement of the
method and amount | ||||||
14 | of reimbursement to the pharmacy or pharmacist for services | ||||||
15 | rendered to
persons enrolled in the program, the frequency of | ||||||
16 | payment by the PBM program
administrator to the pharmacy or | ||||||
17 | pharmacist for those services, and a method for the
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18 | adjudication of complaints and the settlement of disputes | ||||||
19 | between the
contracting parties.
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20 | (b)(1) A program shall provide an annual period of at least | ||||||
21 | 30 days
during which any pharmacy licensed under the | ||||||
22 | Pharmacy Practice Act
may elect to participate in the | ||||||
23 | program under the program terms for at
least one year.
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24 | (2) If compliance with the requirements of this | ||||||
25 | subsection (b) would
impair any provision of a contract |
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1 | between a program and any other person,
and if the contract | ||||||
2 | provision was in existence before January 1, 1990,
then | ||||||
3 | immediately after the expiration of those contract | ||||||
4 | provisions the program shall comply with the requirements | ||||||
5 | of this subsection (b).
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6 | (3) This subsection (b) does not apply if:
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7 | (A) the program administrator is a licensed health | ||||||
8 | maintenance
organization that owns or controls a | ||||||
9 | pharmacy and that enters into an
agreement or contract | ||||||
10 | with that pharmacy in accordance with subsection (a); | ||||||
11 | or
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12 | (B) the program administrator is a licensed health | ||||||
13 | maintenance
organization that is owned or controlled | ||||||
14 | by another entity that also owns
or controls a | ||||||
15 | pharmacy, and the administrator enters into an | ||||||
16 | agreement or
contract with that pharmacy in accordance | ||||||
17 | with subsection (a).
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18 | (4) This subsection (b) shall be inoperative after | ||||||
19 | October 31,
1992.
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20 | (c) The PBM program administrator shall cause to be issued | ||||||
21 | an identification
card to each person enrolled in the program. | ||||||
22 | The identification card
shall include:
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23 | (1) the name of the individual enrolled in the program; | ||||||
24 | and
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25 | (2) an expiration date if required under the | ||||||
26 | contractual arrangement or
agreement between a provider of |
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1 | pharmaceutical services and prescription
drug products and | ||||||
2 | the PBM third party prescription program administrator .
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3 | (Source: P.A. 95-689, eff. 10-29-07.)
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4 | (215 ILCS 5/512-8) (from Ch. 73, par. 1065.59-8)
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5 | Sec. 512-8. Cancellation procedures. | ||||||
6 | (a) The PBM administrator of a program
shall notify all | ||||||
7 | pharmacies and pharmacists enrolled in the program of any | ||||||
8 | cancellation
of the coverage of benefits of any group enrolled | ||||||
9 | in the program at least
30 days prior to the effective date of | ||||||
10 | such cancellation.
However, if the PBM administrator of a | ||||||
11 | program is not notified at least 45
days prior to the effective | ||||||
12 | date of such cancellation, the PBM administrator
shall notify | ||||||
13 | all pharmacies and pharmacists enrolled in the program of the | ||||||
14 | cancellation
as soon as practicable after having received | ||||||
15 | notice.
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16 | (b) When a program is terminated, all persons enrolled | ||||||
17 | therein shall be
so notified, and the employer or plan sponsor | ||||||
18 | shall make every reasonable effort to gain
possession of any | ||||||
19 | plan identification cards in such persons' possession.
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20 | (c) Any person who intentionally uses a program | ||||||
21 | identification card to
obtain services from a pharmacy or | ||||||
22 | pharmacist after having received notice of the cancellation
of | ||||||
23 | his benefits shall be guilty of a Class C misdemeanor. Persons | ||||||
24 | shall
be liable to the PBM program administrator for all monies | ||||||
25 | paid by the PBM program
administrator for any services received |
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1 | pursuant to any improper use of
the identification card.
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2 | (Source: P.A. 82-1005.)
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3 | (215 ILCS 5/512-9) (from Ch. 73, par. 1065.59-9)
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4 | Sec. 512-9. Denial of Payment. | ||||||
5 | (a) No PBM administrator shall deny payment
to any pharmacy | ||||||
6 | or pharmacist for covered pharmaceutical services , | ||||||
7 | pharmacist-provided services, or prescription drug
products | ||||||
8 | rendered as a result of the misuse, fraudulent or illegal use | ||||||
9 | of
an identification card unless such identification card had | ||||||
10 | expired, been
noticeably altered, or the pharmacy or pharmacist | ||||||
11 | was notified of the cancellation of
such card. In lieu of | ||||||
12 | notifying pharmacies which have a common ownership,
the PBM | ||||||
13 | administrator may notify a party designated by the pharmacy or | ||||||
14 | pharmacist to receive
such notice, in which case, notification | ||||||
15 | shall not become effective until
5 calendar days after the | ||||||
16 | designee receives notification.
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17 | (b) No PBM program administrator may withhold any payment | ||||||
18 | to any pharmacy or pharmacist
for covered pharmaceutical | ||||||
19 | services , pharmacist-provided services, or prescription drug | ||||||
20 | products beyond
the time period specified in the payment | ||||||
21 | schedule provisions of the agreement,
except for individual | ||||||
22 | claims for payment which have been returned to the pharmacy
as | ||||||
23 | incomplete or illegible. Such returned claims shall be paid if | ||||||
24 | resubmitted
by the pharmacy to the PBM program administrator | ||||||
25 | with the appropriate corrections made.
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1 | (Source: P.A. 82-1005.)
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2 | (215 ILCS 5/512-10) (from Ch. 73, par. 1065.59-10)
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3 | Sec. 512-10. Failure to Register. Any entity third party | ||||||
4 | prescription program
or administrator which operates without a | ||||||
5 | certificate of registration or
fails to register with the | ||||||
6 | Director and pay the fee prescribed by this Article
shall be | ||||||
7 | construed to be an unauthorized insurer as defined in Article | ||||||
8 | VII
of this Code and shall be subject to all penalties | ||||||
9 | contained therein.
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10 | The provisions of the Article shall apply to all new | ||||||
11 | programs established
on or after January 1, 1983. Existing | ||||||
12 | programs shall comply with the provisions
of this Article on | ||||||
13 | the anniversary date of the programs that occurs on or
after | ||||||
14 | January 1, 1983.
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15 | (Source: P.A. 82-1005.)
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16 | (215 ILCS 5/512-11 new) | ||||||
17 | Sec. 512-11. Pricing. | ||||||
18 | (a) A MAC shall be: | ||||||
19 | (1) established for any drug with at least 3 or more | ||||||
20 | A-rated therapeutically equivalent multiple source drugs, | ||||||
21 | as defined by the federal Food and Drug Administration or | ||||||
22 | when only 2 products are available during a generic | ||||||
23 | exclusivity period; and | ||||||
24 | (2) determined using comparable drug prices obtained |
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1 | from multiple nationally recognized comprehensive data | ||||||
2 | sources, including wholesalers, drug file vendors, and | ||||||
3 | pharmaceutical manufacturers for drugs that are nationally | ||||||
4 | available and available for purchase locally by multiple | ||||||
5 | pharmacies in the State. A MAC shall be established for a | ||||||
6 | product using only equivalent drugs as determined by the | ||||||
7 | federal Food and Drug Administration. | ||||||
8 | (b) For those drugs in which a MAC applies, the PBM shall | ||||||
9 | include in contracts with pharmacies information regarding | ||||||
10 | which of the national compendia is used to obtain pricing data | ||||||
11 | used in the calculation of MAC pricing and shall make MAC price | ||||||
12 | adjustments at least twice a month and provide pharmacies with | ||||||
13 | prompt notification of any changes or additions made to the MAC | ||||||
14 | price list and MAC rates at that time, except when a price for | ||||||
15 | a drug changes by more than 100%; in such cases, the MAC price | ||||||
16 | adjustment for that drug shall be made within 3 business days | ||||||
17 | of the change in price. | ||||||
18 | The PBM shall provide a process to allow providers to | ||||||
19 | submit 200 claims per MAC appeal, in an Excel file, containing | ||||||
20 | all National Drug Codes within the Generic Product Identifier, | ||||||
21 | and shall allow pharmacy providers to comment on, contest, or | ||||||
22 | appeal the MAC rates and MAC list. The right to contest shall | ||||||
23 | be limited in duration and provide for retroactive payment in | ||||||
24 | the event it is determined that MAC pricing has been applied | ||||||
25 | incorrectly. All inquiries to the PBM concerning MAC lists, MAC | ||||||
26 | rates, and pricing shall be acted upon and responded to within |
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1 | 5 business days. | ||||||
2 | If the challenge is successful, the PBM shall make an | ||||||
3 | adjustment in the drug price to the date of the original | ||||||
4 | challenge and make the adjustment applicable to all similarly | ||||||
5 | situated network pharmacy providers, as determined by the | ||||||
6 | managed care organization or PBM, as appropriate. | ||||||
7 | If the challenge is successful, a network pharmacy retains | ||||||
8 | the right to collect or not collect additional appropriate | ||||||
9 | co-payments from a patient after adjustments in the drug price. | ||||||
10 | The PBM shall make all applicable MAC lists, including all | ||||||
11 | changes in the price of drugs, available to network pharmacies | ||||||
12 | upon request in a readily accessible and usable format that | ||||||
13 | contains a complete list of the drug name, National Drug Code, | ||||||
14 | package size, per unit price, strength of drug, Generic Price | ||||||
15 | Identifier, and Generic Code Number. In the event there are | ||||||
16 | multiple MAC lists under the same contract, the contract shall | ||||||
17 | identify which MAC lists are appropriately applicable. | ||||||
18 | (c) A PBM shall also include in contracts with pharmacies a | ||||||
19 | process for no less than once a week updates to pharmacy | ||||||
20 | product pricing files used to calculate prescription prices | ||||||
21 | that will be used to reimburse pharmacies. | ||||||
22 | (d) A PBM shall provide a contractual commitment to deliver | ||||||
23 | a particular average reimbursement rate for generic drugs. The | ||||||
24 | average reimbursement rate for generic drugs shall be | ||||||
25 | calculated using the actual amount paid to the pharmacy, | ||||||
26 | including patient co-pays and reimbursements from PBMs but |
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1 | excluding the dispensing fee. The average reimbursement rate | ||||||
2 | for generic drugs shall not be calculated solely according to | ||||||
3 | the amount allowed by the plan and shall include all generics | ||||||
4 | dispensed, regardless of whether they are subject to MAC | ||||||
5 | pricing. The PBM shall disclose to the network pharmacy the | ||||||
6 | methodology used in determining the average reimbursement rate | ||||||
7 | for generic drugs. | ||||||
8 | (e) A PBM may not charge a transaction fee for claims | ||||||
9 | submissions provided in an electronic format by a health care | ||||||
10 | provider. | ||||||
11 | (f) The Director may require a pharmacy benefits manager to | ||||||
12 | submit information to the Department related to the pharmacy | ||||||
13 | benefits manager's pricing methodology for MAC prices.
| ||||||
14 | (215 ILCS 5/512-12 new) | ||||||
15 | Sec. 512-12. PBM networks. | ||||||
16 | (a) A PBM shall not mandate that a covered individual use a | ||||||
17 | specific community pharmacy, mail order pharmacy, specialty | ||||||
18 | pharmacy, or other pharmacy or entity. Nor can the PBM provide | ||||||
19 | incentives to beneficiaries or plan sponsors to encourage the | ||||||
20 | use of a specific pharmacy if only applicable to a PBM | ||||||
21 | pharmacy. | ||||||
22 | (b) A PBM may not require that a pharmacist or pharmacy | ||||||
23 | participate in a network managed by the PBM as a condition for | ||||||
24 | the pharmacy to participate in another network managed by the | ||||||
25 | same PBM. |
| |||||||
| |||||||
1 | (c) A PBM may not exclude an otherwise qualified pharmacist | ||||||
2 | or pharmacy from participation in a particular network provided | ||||||
3 | that the pharmacist or pharmacy accepts the terms, conditions, | ||||||
4 | and reimbursement rates of the PBM, meets all applicable | ||||||
5 | federal and State licensure and permit requirements, and has | ||||||
6 | not been excluded from participation in any federal or State | ||||||
7 | program. | ||||||
8 | (d) A PBM or entity shall not automatically enroll or | ||||||
9 | disenroll a pharmacy in a contract or modify an existing | ||||||
10 | agreement without written agreement of the pharmacist or | ||||||
11 | pharmacy. | ||||||
12 | (e) If a PBM establishes a discount card network, the PBM | ||||||
13 | shall not require participation in the discount card network by | ||||||
14 | a pharmacy in exchange for participation in the broader retail | ||||||
15 | network. The PBM shall allow a pharmacy to opt out of the | ||||||
16 | discount card network and choose to only participate in the | ||||||
17 | PBM's funded retail network. | ||||||
18 | (f) A PBM must have a contracted pharmacy network | ||||||
19 | consisting of retail pharmacies sufficient to ensure that the | ||||||
20 | following requirements are satisfied: | ||||||
21 | (1) At least 90% of health plan beneficiaries, on | ||||||
22 | average, in urban areas served by the PBM live within 2 | ||||||
23 | miles of a network pharmacy that is a community pharmacy. | ||||||
24 | (2) At least 90% of health plan beneficiaries, on | ||||||
25 | average, in suburban areas served by the PBM live within 5 | ||||||
26 | miles of a network pharmacy that is a community pharmacy. |
| |||||||
| |||||||
1 | (3) At least 70% of health plan beneficiaries, on | ||||||
2 | average, in rural areas served by the PBM live within 15 | ||||||
3 | miles of a network pharmacy that is a community pharmacy.
| ||||||
4 | (215 ILCS 5/512-13 new) | ||||||
5 | Sec. 512-13. Audit of pharmacy records. | ||||||
6 | (a) Notwithstanding any other law, when an on-site audit of | ||||||
7 | the records of a pharmacy is conducted by an entity, the audit | ||||||
8 | shall be conducted in accordance with the following criteria: | ||||||
9 | (1) The entity conducting the initial on-site audit | ||||||
10 | shall give the pharmacy and the pharmacy's corporate office | ||||||
11 | written notice at least 30 days before conducting the | ||||||
12 | initial on-site audit for each audit cycle and shall | ||||||
13 | disclose the specific prescriptions to be included in the | ||||||
14 | audit. | ||||||
15 | (2) Unless otherwise consented to by the pharmacy, an | ||||||
16 | audit shall not be initiated or scheduled during the first | ||||||
17 | 5 calendar days of any month or the day before or after a | ||||||
18 | federal holiday due to the high volume of prescriptions | ||||||
19 | filled during that time. | ||||||
20 | (3) The entity conducting the on-site audit shall not | ||||||
21 | interfere with the delivery of pharmacist services to a | ||||||
22 | patient and shall utilize every effort to minimize | ||||||
23 | inconvenience and disruption to pharmacy operations during | ||||||
24 | the audit process. The on-site audit shall not exceed 4 | ||||||
25 | hours in duration and shall review no more than 100 unique |
| |||||||
| |||||||
1 | prescription numbers during an initial audit. | ||||||
2 | (4) No entity shall conduct an on-site audit at a | ||||||
3 | particular pharmacy more than one time annually. However, | ||||||
4 | this paragraph (4) shall not apply when an entity must | ||||||
5 | return to a pharmacy to complete an audit already in | ||||||
6 | progress. | ||||||
7 | (5) The period covered by an audit shall not exceed 2 | ||||||
8 | years from the date the initial prescription claim was | ||||||
9 | submitted to or adjudicated by an entity. | ||||||
10 | (6) Each pharmacy shall be audited under the same | ||||||
11 | standards and parameters as other similarly situated | ||||||
12 | pharmacies audited by the entity. Any documentation and | ||||||
13 | records required by an auditor during an audit shall be of | ||||||
14 | the same type as the documentation and records required for | ||||||
15 | other similarly situated pharmacies. | ||||||
16 | (7) Any audit that involves clinical or professional | ||||||
17 | judgment shall be conducted by or in consultation with a | ||||||
18 | pharmacist. | ||||||
19 | (8) Each audit shall be conducted by a field agent who | ||||||
20 | possesses the requisite expertise in pharmacy practice. | ||||||
21 | (9) Any unintentional clerical or record-keeping | ||||||
22 | error, such as a typographical error, scrivener's error, or | ||||||
23 | computer error, regarding a required document or record | ||||||
24 | shall not necessarily constitute fraud. These claims may be | ||||||
25 | subject to recoupment, but shall not subject a pharmacy to | ||||||
26 | criminal penalties without proof of intent to commit fraud. |
| |||||||
| |||||||
1 | In the case of errors which have no financial harm to the | ||||||
2 | patient or plan, the entity must not assess any | ||||||
3 | chargebacks. | ||||||
4 | (10) All audits shall be conducted in accordance with | ||||||
5 | generally accepted accounting principles, standards, and | ||||||
6 | procedures; and auditing principles, standards, and | ||||||
7 | procedures; and using standards and parameters established | ||||||
8 | by rule that are identical for all audits conducted. | ||||||
9 | (11) Prescriptions are considered valid prescriptions | ||||||
10 | if they are compliant with the Pharmacy Practice Act and | ||||||
11 | Illinois Controlled Substances Act and have been | ||||||
12 | positively adjudicated upon claim submission by the | ||||||
13 | entity. Plan restrictions should be addressed during the | ||||||
14 | claims adjudication process either through the rejection | ||||||
15 | of the claim or a rejection of the claim with direction to | ||||||
16 | obtain a prior authorization and may not be the basis for a | ||||||
17 | retrospective recoupment of a paid claim. | ||||||
18 | (12) A finding of an overpayment or underpayment must | ||||||
19 | be based on the actual overpayment or underpayment and may | ||||||
20 | not be a projection based on the number of patients served | ||||||
21 | having a similar diagnosis or on the number of similar | ||||||
22 | orders or refills for similar drugs. | ||||||
23 | (13) With the exception of overpayments, if a PBM | ||||||
24 | approves a claim through adjudication, the PBM may not | ||||||
25 | retroactively deny or modify reimbursement based on | ||||||
26 | information accompanying the original claim or information |
| |||||||
| |||||||
1 | available to the PBM at the time of adjudication, unless | ||||||
2 | the claim was fraudulent, the pharmacy or pharmacist had | ||||||
3 | been reimbursed for the claim previously, or the services | ||||||
4 | reimbursed were not rendered by the pharmacy or pharmacist. | ||||||
5 | (14) A PBM may not require more information to be | ||||||
6 | written on a prescription than is required by State or | ||||||
7 | federal law. Nor may a PBM require more stringent records | ||||||
8 | to validate a prescription order than is required by State | ||||||
9 | or federal law. | ||||||
10 | (15) Electronic records, including electronic | ||||||
11 | beneficiary signature logs, electronic tracking of | ||||||
12 | prescriptions, electronic prescriber prescription | ||||||
13 | transmissions and imagery of hard copy prescriptions, | ||||||
14 | electronically scanned store, patient records maintained | ||||||
15 | at or accessible to the offices of an audited pharmacy's | ||||||
16 | central operations, and any other reasonably clear and | ||||||
17 | accurate electronic documentation shall be acceptable for | ||||||
18 | auditing under the same terms and conditions and for the | ||||||
19 | same purposes as their paper analogs. | ||||||
20 | If paper logs are used, auditors must look at least 14 | ||||||
21 | days past the dispense date to check for patient pickup. | ||||||
22 | Point of sale electronic register data shall qualify as | ||||||
23 | proof of delivery to the patient. | ||||||
24 | (16) A pharmacy may use the records of a hospital, | ||||||
25 | physician, or other authorized practitioner of the healing | ||||||
26 | arts for drugs or medicinal supplies written or transmitted |
| |||||||
| |||||||
1 | by any means of communication for purposes of validating | ||||||
2 | the pharmacy record with respect to orders or refills of a | ||||||
3 | legend drug or other controlled substance. | ||||||
4 | (17) Validation of appropriate day's supply and drug | ||||||
5 | dosing must be based on manufacturer guidelines and | ||||||
6 | definitions or, in the case of topical products or titrated | ||||||
7 | products, the professional judgment of the pharmacist | ||||||
8 | based upon communication with the patient or prescriber. | ||||||
9 | (18) A pharmacy's usual and customary price for | ||||||
10 | compounded medications is considered the reimbursable cost | ||||||
11 | unless an alternate price is published in the provider | ||||||
12 | contract and signed by both parties. | ||||||
13 | (19) A PBM may not require a pharmacy to agree to | ||||||
14 | recoupments deducted against future remittances and shall | ||||||
15 | invoice the pharmacy for payment if the pharmacy elects. | ||||||
16 | Recoupment may be deducted against future remittances | ||||||
17 | without mutual consent when the pharmacy is considered | ||||||
18 | delinquent in payment of the invoice per the contractual | ||||||
19 | arrangement. | ||||||
20 | (20) Interest shall not accrue during the audit period. | ||||||
21 | (21) Notwithstanding any other provision in this | ||||||
22 | subsection (a), the entity conducting the audit shall not | ||||||
23 | use the accounting practice of extrapolation in | ||||||
24 | calculating recoupments or penalties for audits. A finding | ||||||
25 | of overpayment or underpayment must be based on the actual | ||||||
26 | overpayment or underpayment and not on a projection based |
| |||||||
| |||||||
1 | on the number of patients served having a similar diagnosis | ||||||
2 | or on the number of similar orders or refills for similar | ||||||
3 | drugs. | ||||||
4 | (22) A finding of an overpayment shall not include the | ||||||
5 | dispensing fee amount. | ||||||
6 | (23) The preliminary audit report shall be delivered to | ||||||
7 | the pharmacy and pharmacy corporate office within 30 days, | ||||||
8 | with reasonable extensions allowed, after conclusion of | ||||||
9 | the audit and shall contain claim level information for any | ||||||
10 | discrepancy found and total dollar amount of claims subject | ||||||
11 | to recovery. | ||||||
12 | (24) A pharmacy shall be allowed at least 30 days | ||||||
13 | following receipt of the preliminary audit report in which | ||||||
14 | to produce documentation to address any discrepancy found | ||||||
15 | during an audit or to file an appeal. | ||||||
16 | (25) A final audit report containing claim level | ||||||
17 | information for any discrepancy found and total dollar | ||||||
18 | amount of claims subject to recovery shall be delivered to | ||||||
19 | the pharmacy and pharmacy corporate office within 45 days | ||||||
20 | after the audited pharmacy's receipt of the preliminary | ||||||
21 | audit report if the audited pharmacy does not file an | ||||||
22 | appeal or offers no documentation to address a discrepancy | ||||||
23 | found during an audit, or within 60 days after the auditing | ||||||
24 | entity receives the audited pharmacy's appeal or | ||||||
25 | documentation to address a discrepancy. The final audit | ||||||
26 | results shall be reflected in the remittance advice at the |
| |||||||
| |||||||
1 | claim level. | ||||||
2 | (26) The entity shall establish an appeals process that | ||||||
3 | meets the following requirements: | ||||||
4 | (A) The National Council for Prescription Drug | ||||||
5 | Programs or any other recognized national industry | ||||||
6 | standard shall be used to evaluate claims submission | ||||||
7 | and product size disputes. | ||||||
8 | (B) Each entity conducting an audit shall | ||||||
9 | establish a written appeals process under which a | ||||||
10 | pharmacy may appeal an unfavorable preliminary audit | ||||||
11 | report to the entity. | ||||||
12 | (C) If, following the appeal, the entity finds that | ||||||
13 | an unfavorable audit report or any portion thereof is | ||||||
14 | unsubstantiated, the entity shall dismiss the audit | ||||||
15 | report or said portion without the necessity of any | ||||||
16 | further action. | ||||||
17 | (27) A PBM may not recover payment of claims from the | ||||||
18 | pharmacy which is identified through the audit process to | ||||||
19 | be the responsibility of another payer. The PBM must | ||||||
20 | reconcile directly with the other payer for any monies owed | ||||||
21 | without requiring the pharmacy to reverse and rebill the | ||||||
22 | original claim in the retail setting. | ||||||
23 | (28) Each entity conducting an audit shall provide a | ||||||
24 | copy of the final audit report, after completion of any | ||||||
25 | review process, to the plan sponsor. | ||||||
26 | (29) The full amount of any recoupment on an audit |
| |||||||
| |||||||
1 | shall be refunded to the plan sponsor. | ||||||
2 | (30) Neither the agency conducting the audit nor its | ||||||
3 | agents shall receive payment based on a percentage of the | ||||||
4 | amount recovered. This Section does not prevent the entity | ||||||
5 | conducting the audit from charging or assessing the | ||||||
6 | responsible party, directly or indirectly, based on | ||||||
7 | amounts recouped if both of the following conditions are | ||||||
8 | met: | ||||||
9 | (A) the plan sponsor and the entity conducting the | ||||||
10 | audit have a contract that explicitly states the | ||||||
11 | percentage charge or assessment to the plan sponsor; | ||||||
12 | and | ||||||
13 | (B) a commission to an agent or employee of the | ||||||
14 | entity conducting the audit is not based, directly or | ||||||
15 | indirectly, on amounts recouped. | ||||||
16 | (31) The entity conducting the audit shall not base | ||||||
17 | compensation of any employees of the entity involved with | ||||||
18 | the audit process on a percentage of the amount recovered | ||||||
19 | or audit findings. | ||||||
20 | (b) Recoupments of any disputed funds shall occur after | ||||||
21 | final internal disposition of the audit, including the appeals | ||||||
22 | process as set forth in subsection (c) of this Section. | ||||||
23 | (c) Notwithstanding any other law, each entity conducting | ||||||
24 | an audit shall establish an appeals process under which a | ||||||
25 | pharmacy may appeal a preliminary audit report to the entity. | ||||||
26 | (d) This Section does not apply to any audit, review, or |
| |||||||
| |||||||
1 | investigation that involves allegations of fraud, willful | ||||||
2 | misrepresentation, or abuse.
| ||||||
3 | (215 ILCS 5/512-14 new) | ||||||
4 | Sec. 512-14. 90-day supplies at community pharmacies. A | ||||||
5 | health plan must permit its enrollees to receive benefits, | ||||||
6 | which may include a 90-day supply of covered prescription | ||||||
7 | drugs, at any of its network community pharmacies. A health | ||||||
8 | insurance policy or government program providing benefits for | ||||||
9 | prescriptions may not impose on a covered individual utilizing | ||||||
10 | a community pharmacy a copayment, deductible, fee, limitation | ||||||
11 | on benefits, or other condition or requirement not otherwise | ||||||
12 | imposed on the covered individual when using a mail order | ||||||
13 | pharmacy. | ||||||
14 | Nothing in this Section shall prohibit a pharmacist who is | ||||||
15 | exercising his or her professional judgment from dispensing | ||||||
16 | additional quantities of medication up to the total number of | ||||||
17 | dosage units authorized by the prescriber on the original | ||||||
18 | prescription and any refills.
| ||||||
19 | (215 ILCS 5/512-15 new) | ||||||
20 | Sec. 512-15. Medication synchronization. All entities | ||||||
21 | providing prescription drug coverage shall permit and apply a | ||||||
22 | prorated daily cost-sharing rate to prescriptions that are | ||||||
23 | dispensed by a pharmacy for less than a 30-day supply if the | ||||||
24 | prescriber or pharmacist indicates the fill or refill could be |
| |||||||
| |||||||
1 | in the best interest of the patient or is for the purpose of | ||||||
2 | synchronizing the patient's chronic medications. | ||||||
3 | No entity providing prescription drug coverage shall deny | ||||||
4 | coverage for the dispensing of any drug prescribed for the | ||||||
5 | treatment of a chronic illness that is made in accordance with | ||||||
6 | a plan among the insured, the prescriber, and a pharmacist to | ||||||
7 | synchronize the refilling of multiple prescriptions for the | ||||||
8 | insured. | ||||||
9 | No entity providing prescription drug coverage shall use | ||||||
10 | payment structures incorporating prorated dispensing fees | ||||||
11 | determined by calculation of the days' supply of medication | ||||||
12 | dispensed. Dispensing fees shall be determined exclusively on | ||||||
13 | the total number of prescriptions dispensed. | ||||||
14 | The provisions of this Section shall not apply to a | ||||||
15 | supplemental insurance policy, including a life care contract, | ||||||
16 | accident-only policy, specified-disease policy, hospital | ||||||
17 | policy providing a fixed daily benefit only, Medicare | ||||||
18 | supplement policy, long-term care policy, or short-term major | ||||||
19 | medical policy of 6 months or less in duration or any other | ||||||
20 | supplemental policy.
| ||||||
21 | (215 ILCS 5/512-16 new) | ||||||
22 | Sec. 512-16. Treatment of data. A PBM must adhere to the | ||||||
23 | following criteria when handling personally identifiable | ||||||
24 | utilization and claims data or other sensitive patient data: | ||||||
25 | (1) A PBM shall notify the health plan sponsor if it |
| |||||||
| |||||||
1 | intends to sell utilization or claims data that the PBM | ||||||
2 | possesses. | ||||||
3 | (2) A PBM shall notify the health plan sponsor 30 days | ||||||
4 | before selling, leasing, or renting claims data, along with | ||||||
5 | the name of the potential purchaser of the data and the | ||||||
6 | expected use. | ||||||
7 | (3) A PBM may not sell, lease, or rent utilization or | ||||||
8 | claims data without written approval from the health plan | ||||||
9 | sponsor. The PBM must also allow each individual covered | ||||||
10 | the option to opt out. | ||||||
11 | (4) A PBM may not use a pharmacy's usual and customary | ||||||
12 | claims information for purposes other than determining | ||||||
13 | reimbursement and may not sell, lease, or rent a pharmacy's | ||||||
14 | usual and customary information without the pharmacy's | ||||||
15 | express written consent. | ||||||
16 | (5) A PBM may not contact covered individuals without | ||||||
17 | express written permission of the health plan sponsor and | ||||||
18 | the covered individual. | ||||||
19 | (6) A PBM may not transmit any personally identifiable | ||||||
20 | utilization or claims data to a pharmacy owned by a PBM if | ||||||
21 | the patient has not voluntarily elected in writing to fill | ||||||
22 | that particular prescription at the PBM-owned pharmacy.
| ||||||
23 | (215 ILCS 5/512-17 new) | ||||||
24 | Sec. 512-17. Regulated activities. The Department may | ||||||
25 | adopt rules to regulate the following activities of PBMs: |
| |||||||
| |||||||
1 | (1) claims processing; | ||||||
2 | (2) pharmacy network management; | ||||||
3 | (3) pharmacy discount card, employer sponsored plan, | ||||||
4 | managed care Medicaid, and workers compensation | ||||||
5 | management; | ||||||
6 | (4) payment of claims to pharmacies for prescription | ||||||
7 | drugs, medical devices, and durable medical equipment | ||||||
8 | dispensed to covered individuals; | ||||||
9 | (5) payment of claims to pharmacists for | ||||||
10 | pharmacist-provided services to covered individuals, | ||||||
11 | including, but not limited to, medication therapy | ||||||
12 | management services; | ||||||
13 | (6) clinical formulary development and management | ||||||
14 | services, including, but not limited to, utilization | ||||||
15 | management and quality assurance programs; | ||||||
16 | (7) rebate contracting and administration; | ||||||
17 | (8) conducting audits of contracted pharmacies; | ||||||
18 | (9) setting pharmacy reimbursement pricing and | ||||||
19 | methodologies, including MAC, and determining single | ||||||
20 | source and multiple source drugs; and | ||||||
21 | (10) retention of any differential between what is | ||||||
22 | received from health plans as reimbursement for | ||||||
23 | prescription drugs or services and what is paid to | ||||||
24 | pharmacies or pharmacists by the PBM for such drugs.
| ||||||
25 | (215 ILCS 5/512-18 new) |
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
1 | Sec. 512-18. Enforcement. | |||||||||||||||||||||||||
2 | (a) Enforcement of this Act shall be the responsibility of | |||||||||||||||||||||||||
3 | the Department and the Director. | |||||||||||||||||||||||||
4 | (b) The Director shall have the authority to adopt any | |||||||||||||||||||||||||
5 | rules necessary for the implementation and administration of | |||||||||||||||||||||||||
6 | this Article. | |||||||||||||||||||||||||
7 | (c) The Director shall take action or impose penalties to | |||||||||||||||||||||||||
8 | bring non-complying entities into full compliance with this | |||||||||||||||||||||||||
9 | Article.
| |||||||||||||||||||||||||
10 | Section 99. Effective date. This Act takes effect January | |||||||||||||||||||||||||
11 | 1, 2016.
| |||||||||||||||||||||||||
|