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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.
| ||||||
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.
| ||||||
4 | (Source: P.A. 95-331, eff. 8-21-07.)
| ||||||
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.)
| ||||||
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
| ||||||
8 | than 10% of the total estimated annual reimbursements under the | ||||||
9 | entity's program.
| ||||||
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.
| ||||||
8 | (Source: P.A. 82-1005.)
| ||||||
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:
| ||||||
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
| ||||||
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:
| ||||||
23 | (1) the name of the individual enrolled in the program; | ||||||
24 | and
| ||||||
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 .
| ||||||
3 | (Source: P.A. 95-689, eff. 10-29-07.)
| ||||||
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.
| ||||||
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.
| ||||||
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.)
| ||||||
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.
| ||||||
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.)
| ||||||
2 | (215 ILCS 5/512-10) (from Ch. 73, par. 1065.59-10)
| ||||||
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.
| ||||||
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.
| ||||||
15 | (Source: P.A. 82-1005.)
| ||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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) |
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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.
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10 | Section 99. Effective date. This Act takes effect January | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
11 | 1, 2016.
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