2021 -- S 0592 | |
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LC001592 | |
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STATE OF RHODE ISLAND | |
IN GENERAL ASSEMBLY | |
JANUARY SESSION, A.D. 2021 | |
____________ | |
A N A C T | |
RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES--INSURANCE | |
| |
Introduced By: Senators Miller, Lawson, DiMario, Valverde, Archambault, and Bell | |
Date Introduced: March 11, 2021 | |
Referred To: Senate Health & Human Services | |
It is enacted by the General Assembly as follows: | |
1 | SECTION 1. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby amended |
2 | by adding thereto the following section: |
3 | 5-19.1-36. Maximum allowable cost lists. |
4 | (a) As used in this section: |
5 | (1) "Maximum allowable cost list" means a listing of drugs used by a pharmacy benefits |
6 | manager setting the maximum allowable cost on which reimbursement to a pharmacy or pharmacist |
7 | may be based; |
8 | (2) "Pharmaceutical wholesaler" means a person or entity that sells and distributes |
9 | prescription pharmaceutical products, including without limitation a full line of brand-name, |
10 | generic, and over-the-counter pharmaceuticals, and that offers regular and private delivery to a |
11 | pharmacy; |
12 | (3) "Pharmacist" means a licensed pharmacist as defined in § 5-19.1-2; |
13 | (4) "Pharmacist services" means products, goods, or services provided as a part of the |
14 | practice of pharmacy in Rhode Island; |
15 | (5) "Pharmacy" means that portion or part of a premise where prescriptions are |
16 | compounded and dispensed as defined in § 5-19.1-2; |
17 | (6) "Pharmacy acquisition cost" means the amount that a pharmaceutical wholesaler |
18 | charges for a pharmaceutical product as listed on the pharmacy's billing invoice; |
19 | (7) "Pharmacy benefits manager" means an entity that administers or manages a pharmacy |
| |
1 | benefits plan or program; |
2 | (8) "Pharmacy benefits manager affiliate" means a pharmacy or pharmacist that directly or |
3 | indirectly, through one or more intermediaries owns or controls, is owned or controlled by, or is |
4 | under common ownership or control with a pharmacy benefits manager; and |
5 | (9) "Pharmacy benefits plan or program" means a plan or program that pays for, |
6 | reimburses, covers the cost of, or otherwise provides for pharmacist services to individuals who |
7 | reside in or are employed in this state. |
8 | (b) Before a pharmacy benefits manager places or continues a particular drug on a |
9 | maximum allowable cost list, the drug shall: |
10 | (1) Be listed as therapeutically equivalent and pharmaceutically equivalent "A", "AB", or |
11 | "B" rated in the United States Food and Drug Administration’s most recent version of the "Orange |
12 | Book" or "Green Book" or has an NR or NA rating by Medi-spanTM, Gold Standard, or a similar |
13 | rating by a nationally recognized reference; |
14 | (2) Be available for purchase by each pharmacy in the state from national or regional |
15 | wholesalers operating in Rhode Island; and |
16 | (3) Not be obsolete. |
17 | (c) A pharmacy benefits manager shall: |
18 | (1) Provide access to its maximum allowable cost list to each pharmacy subject to the |
19 | maximum allowable cost list; |
20 | (2) Update its maximum allowable cost list on a timely basis, but in no event longer than |
21 | seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition |
22 | cost from sixty percent (60%) or more of the pharmaceutical wholesalers doing business in the |
23 | state, or a change in the methodology on which the maximum allowable cost list is based, or in the |
24 | value of a variable involved in the methodology; |
25 | (3) Provide a process for each pharmacy subject to the maximum allowable cost list to |
26 | receive prompt notification of an update to the maximum allowable cost list; and |
27 | (4)(i) Provide a reasonable administrative appeal procedure to allow pharmacies to |
28 | challenge maximum allowable costs and reimbursements made under a maximum allowable cost |
29 | for a specific drug or drugs as: |
30 | (A) Not meeting the requirements of this section; or |
31 | (B) Being below pharmacy acquisition cost. |
32 | (ii) The reasonable administrative appeal procedure shall include the following terms and |
33 | conditions: |
34 | (A) A dedicated telephone number and email address or website for the purpose of |
| LC001592 - Page 2 of 25 |
1 | submitting administrative appeals; |
2 | (B) The ability to submit an administrative appeal directly to the pharmacy benefits |
3 | manager regarding the pharmacy benefits plan or program or through a pharmacy service |
4 | administrative organization; and |
5 | (C) No less than seven (7) business days to file an administrative appeal. |
6 | (d) The pharmacy benefits manager shall respond to the challenge under subsection |
7 | (c)(4)(i) of this section within seven (7) business days after receipt of the challenge. |
8 | (e) If a challenge is under subsection (c)(4)(i) of this section, the pharmacy benefits |
9 | manager shall within seven (7) business days after receipt of the challenge either: |
10 | (1) If the appeal is upheld: |
11 | (i) Make the change in the maximum allowable cost; |
12 | (ii) Permit the challenging pharmacy or pharmacist to reverse and rebill the claim in |
13 | question; and |
14 | (iii) Provide the national drug code number that the increase or change is based on to the |
15 | pharmacy or pharmacist; and |
16 | (iv) Make the change under subsection (e)(1)(i) of this section effective for each similarly |
17 | situated pharmacy as defined by the payor subject to the maximum allowable cost list. |
18 | (2) If the appeal is denied, the pharmacy benefits manager shall provide the challenging |
19 | pharmacy or pharmacist the national drug code number and the name of the national or regional |
20 | pharmaceutical wholesalers operating in this state that have the drug currently in stock at a price |
21 | below the maximum allowable cost list; or |
22 | (3) If the national drug code number provided by the pharmacy benefits manager is not |
23 | available below the pharmacy acquisition cost from the pharmaceutical wholesaler from whom the |
24 | pharmacy or pharmacist purchases the majority of prescription drugs for resale, then the pharmacy |
25 | benefits manager shall adjust the maximum allowable cost list above the challenging pharmacy's |
26 | pharmacy acquisition cost and permit the pharmacy to reverse and rebill each claim affected by the |
27 | inability to procure the drug at a cost that is equal to or less than the previously challenged |
28 | maximum allowable cost. |
29 | (f)(1) A pharmacy benefits manager shall not reimburse a pharmacy or pharmacist in this |
30 | state an amount less than the amount that the pharmacy benefits manager reimburses a pharmacy |
31 | benefits manager affiliate for providing the same pharmacist services. |
32 | (2) The reimbursement amount shall be calculated on a per unit basis based on the same |
33 | generic product identifier or generic code number. |
34 | (g) A pharmacy or pharmacist may decline to provide the pharmacist services to a patient |
| LC001592 - Page 3 of 25 |
1 | or pharmacy benefits manager if, as a result of a maximum allowable cost list, a pharmacy or |
2 | pharmacist is to be paid less than the pharmacy acquisition cost of the pharmacy providing |
3 | pharmacist services. |
4 | (h) This section shall apply to a pharmacy benefits manager employed by the Rhode Island |
5 | Medicaid program and its contracted managed care entities. |
6 | (i) A violation of this section is a deceptive practice under § 6-13.1-2. |
7 | (j) The department of health may promulgate such rules and regulations as are necessary |
8 | and proper to effectuate the purpose and for the efficient administration and enforcement of this |
9 | chapter. |
10 | SECTION 2. Chapter 27-18 of the General Laws entitled "Accident and Sickness Insurance |
11 | Policies" is hereby amended by adding thereto the following section: |
12 | 27-18-33.3. Maximum allowable cost lists. |
13 | (a) As used in this section: |
14 | (1) "Maximum allowable cost list" means a listing of drugs used by a pharmacy benefits |
15 | manager setting the maximum allowable cost on which reimbursement to a pharmacy or pharmacist |
16 | may be based; |
17 | (2) "Pharmaceutical wholesaler" means a person or entity that sells and distributes |
18 | prescription pharmaceutical products, including without limitation a full line of brand-name, |
19 | generic, and over-the-counter pharmaceuticals, and that offers regular and private delivery to a |
20 | pharmacy; |
21 | (3) "Pharmacist" means a licensed pharmacist as defined in § 5-19.1-2; |
22 | (4) "Pharmacist services" means products, goods, or services provided as a part of the |
23 | practice of pharmacy in Rhode Island; |
24 | (5) "Pharmacy" means that portion or part of a premise where prescriptions are |
25 | compounded and dispensed as defined in § 5-19.1-2; |
26 | (6) "Pharmacy acquisition cost" means the amount that a pharmaceutical wholesaler |
27 | charges for a pharmaceutical product as listed on the pharmacy's billing invoice; |
28 | (7) "Pharmacy benefits manager" means an entity that administers or manages a pharmacy |
29 | benefits plan or program; |
30 | (8) "Pharmacy benefits manager affiliate" means a pharmacy or pharmacist that directly or |
31 | indirectly, through one or more intermediaries owns or controls, is owned or controlled by, or is |
32 | under common ownership or control with a pharmacy benefits manager; and |
33 | (9) "Pharmacy benefits plan or program" means a plan or program that pays for, |
34 | reimburses, covers the cost of, or otherwise provides for pharmacist services to individuals who |
| LC001592 - Page 4 of 25 |
1 | reside in or are employed in this state. |
2 | (b) Before a pharmacy benefits manager places or continues a particular drug on a |
3 | maximum allowable cost list, the drug shall: |
4 | (1) Be listed as therapeutically equivalent and pharmaceutically equivalent "A", "AB", or |
5 | "B" rated in the United States Food and Drug Administration’s most recent version of the "Orange |
6 | Book" or "Green Book" or has an NR or NA rating by Medi-spanTM, Gold Standard, or a similar |
7 | rating by a nationally recognized reference; |
8 | (2) Be available for purchase by each pharmacy in the state from national or regional |
9 | wholesalers operating in Rhode Island; and |
10 | (3) Not be obsolete. |
11 | (c) A pharmacy benefits manager shall: |
12 | (1) Provide access to its maximum allowable cost list to each pharmacy subject to the |
13 | maximum allowable cost list; |
14 | (2) Update its maximum allowable cost list on a timely basis, but in no event longer than |
15 | seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition |
16 | cost from sixty percent (60%) or more of the pharmaceutical wholesalers doing business in the |
17 | state, or a change in the methodology on which the maximum allowable cost list is based, or in the |
18 | value of a variable involved in the methodology; |
19 | (3) Provide a process for each pharmacy subject to the maximum allowable cost list to |
20 | receive prompt notification of an update to the maximum allowable cost list; and |
21 | (4)(i) Provide a reasonable administrative appeal procedure to allow pharmacies to |
22 | challenge maximum allowable costs and reimbursements made under a maximum allowable cost |
23 | for a specific drug or drugs as: |
24 | (A) Not meeting the requirements of this section; or |
25 | (B) Being below pharmacy acquisition cost. |
26 | (ii) The reasonable administrative appeal procedure shall include the following terms and |
27 | conditions: |
28 | (A) A dedicated telephone number and email address or website for the purpose of |
29 | submitting administrative appeals; |
30 | (B) The ability to submit an administrative appeal directly to the pharmacy benefits |
31 | manager regarding the pharmacy benefits plan or program or through a pharmacy service |
32 | administrative organization; and |
33 | (C) No less than seven (7) business days to file an administrative appeal. |
34 | (d) The pharmacy benefits manager shall respond to the challenge under subsection |
| LC001592 - Page 5 of 25 |
1 | (c)(4)(i) of this section within seven (7) business days after receipt of the challenge. |
2 | (e) If a challenge is under subsection (c)(4)(i) of this section, the pharmacy benefits |
3 | manager shall within seven (7) business days after receipt of the challenge either: |
4 | (1) If the appeal is upheld: |
5 | (i) Make the change in the maximum allowable cost; |
6 | (ii) Permit the challenging pharmacy or pharmacist to reverse and rebill the claim in |
7 | question; and |
8 | (iii) Provide the national drug code number that the increase or change is based on to the |
9 | pharmacy or pharmacist; and |
10 | (iv) Make the change under subsection (e)(1)(i) of this section effective for each similarly |
11 | situated pharmacy as defined by the payor subject to the maximum allowable cost list. |
12 | (2) If the appeal is denied, the pharmacy benefits manager shall provide the challenging |
13 | pharmacy or pharmacist the national drug code number and the name of the national or regional |
14 | pharmaceutical wholesalers operating in this state that have the drug currently in stock at a price |
15 | below the maximum allowable cost list; or |
16 | (3) If the national drug code number provided by the pharmacy benefits manager is not |
17 | available below the pharmacy acquisition cost from the pharmaceutical wholesaler from whom the |
18 | pharmacy or pharmacist purchases the majority of prescription drugs for resale, then the pharmacy |
19 | benefits manager shall adjust the maximum allowable cost list above the challenging pharmacy's |
20 | pharmacy acquisition cost and permit the pharmacy to reverse and rebill each claim affected by the |
21 | inability to procure the drug at a cost that is equal to or less than the previously challenged |
22 | maximum allowable cost. |
23 | (f)(1) A pharmacy benefits manager shall not reimburse a pharmacy or pharmacist in this |
24 | state an amount less than the amount that the pharmacy benefits manager reimburses a pharmacy |
25 | benefits manager affiliate for providing the same pharmacist services. |
26 | (2) The reimbursement amount shall be calculated on a per unit basis based on the same |
27 | generic product identifier or generic code number. |
28 | (g) A pharmacy or pharmacist may decline to provide the pharmacist services to a patient |
29 | or pharmacy benefits manager if, as a result of a maximum allowable cost list, a pharmacy or |
30 | pharmacist is to be paid less than the pharmacy acquisition cost of the pharmacy providing |
31 | pharmacist services. |
32 | (h) This section shall apply to a pharmacy benefits manager employed by the Rhode Island |
33 | Medicaid program and its contracted managed care entities. |
34 | (i) A violation of this section is a deceptive practice under § 6-13.1-2. |
| LC001592 - Page 6 of 25 |
1 | (j) The department of health may promulgate such rules and regulations as are necessary |
2 | and proper to effectuate the purpose and for the efficient administration and enforcement of this |
3 | chapter. |
4 | SECTION 3. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service |
5 | Corporations" is hereby amended by adding thereto the following section: |
6 | 27-19-26.3. Maximum allowable cost lists. |
7 | (a) As used in this section: |
8 | (1) "Maximum allowable cost list" means a listing of drugs used by a pharmacy benefits |
9 | manager setting the maximum allowable cost on which reimbursement to a pharmacy or pharmacist |
10 | may be based; |
11 | (2) "Pharmaceutical wholesaler" means a person or entity that sells and distributes |
12 | prescription pharmaceutical products, including without limitation a full line of brand-name, |
13 | generic, and over-the-counter pharmaceuticals, and that offers regular and private delivery to a |
14 | pharmacy; |
15 | (3) "Pharmacist" means a licensed pharmacist as defined in § 5-19.1-2; |
16 | (4) "Pharmacist services" means products, goods, or services provided as a part of the |
17 | practice of pharmacy in Rhode Island; |
18 | (5) "Pharmacy" means that portion or part of a premise where prescriptions are |
19 | compounded and dispensed as defined in § 5-19.1-2; |
20 | (6) "Pharmacy acquisition cost" means the amount that a pharmaceutical wholesaler |
21 | charges for a pharmaceutical product as listed on the pharmacy's billing invoice; |
22 | (7) "Pharmacy benefits manager" means an entity that administers or manages a pharmacy |
23 | benefits plan or program; |
24 | (8) "Pharmacy benefits manager affiliate" means a pharmacy or pharmacist that directly or |
25 | indirectly, through one or more intermediaries owns or controls, is owned or controlled by, or is |
26 | under common ownership or control with a pharmacy benefits manager; and |
27 | (9) "Pharmacy benefits plan or program" means a plan or program that pays for, |
28 | reimburses, covers the cost of, or otherwise provides for pharmacist services to individuals who |
29 | reside in or are employed in this state. |
30 | (b) Before a pharmacy benefits manager places or continues a particular drug on a |
31 | maximum allowable cost list, the drug shall: |
32 | (1) Be listed as therapeutically equivalent and pharmaceutically equivalent "A", "AB", or |
33 | "B" rated in the United States Food and Drug Administration’s most recent version of the "Orange |
34 | Book" or "Green Book" or has an NR or NA rating by Medi-spanTM, Gold Standard, or a similar |
| LC001592 - Page 7 of 25 |
1 | rating by a nationally recognized reference; |
2 | (2) Be available for purchase by each pharmacy in the state from national or regional |
3 | wholesalers operating in Rhode Island; and |
4 | (3) Not be obsolete. |
5 | (c) A pharmacy benefits manager shall: |
6 | (1) Provide access to its maximum allowable cost list to each pharmacy subject to the |
7 | maximum allowable cost list; |
8 | (2) Update its maximum allowable cost list on a timely basis, but in no event longer than |
9 | seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition |
10 | cost from sixty percent (60%) or more of the pharmaceutical wholesalers doing business in the |
11 | state, or a change in the methodology on which the maximum allowable cost list is based, or in the |
12 | value of a variable involved in the methodology; |
13 | (3) Provide a process for each pharmacy subject to the maximum allowable cost list to |
14 | receive prompt notification of an update to the maximum allowable cost list; and |
15 | (4)(i) Provide a reasonable administrative appeal procedure to allow pharmacies to |
16 | challenge maximum allowable costs and reimbursements made under a maximum allowable cost |
17 | for a specific drug or drugs as: |
18 | (A) Not meeting the requirements of this section; or |
19 | (B) Being below pharmacy acquisition cost. |
20 | (ii) The reasonable administrative appeal procedure shall include the following terms and |
21 | conditions: |
22 | (A) A dedicated telephone number and email address or website for the purpose of |
23 | submitting administrative appeals; |
24 | (B) The ability to submit an administrative appeal directly to the pharmacy benefits |
25 | manager regarding the pharmacy benefits plan or program or through a pharmacy service |
26 | administrative organization; and |
27 | (C) No less than seven (7) business days to file an administrative appeal. |
28 | (d) The pharmacy benefits manager shall respond to the challenge under subsection |
29 | (c)(4)(i) of this section within seven (7) business days after receipt of the challenge. |
30 | (e) If a challenge is under subsection (c)(4)(i) of this section, the pharmacy benefits |
31 | manager shall within seven (7) business days after receipt of the challenge either: |
32 | (1) If the appeal is upheld: |
33 | (i) Make the change in the maximum allowable cost; |
34 | (ii) Permit the challenging pharmacy or pharmacist to reverse and rebill the claim in |
| LC001592 - Page 8 of 25 |
1 | question; and |
2 | (iii) Provide the national drug code number that the increase or change is based on to the |
3 | pharmacy or pharmacist; and |
4 | (iv) Make the change under subsection (e)(1)(i) of this section effective for each similarly |
5 | situated pharmacy as defined by the payor subject to the maximum allowable cost list. |
6 | (2) If the appeal is denied, the pharmacy benefits manager shall provide the challenging |
7 | pharmacy or pharmacist the national drug code number and the name of the national or regional |
8 | pharmaceutical wholesalers operating in this state that have the drug currently in stock at a price |
9 | below the maximum allowable cost list; or |
10 | (3) If the national drug code number provided by the pharmacy benefits manager is not |
11 | available below the pharmacy acquisition cost from the pharmaceutical wholesaler from whom the |
12 | pharmacy or pharmacist purchases the majority of prescription drugs for resale, then the pharmacy |
13 | benefits manager shall adjust the maximum allowable cost list above the challenging pharmacy's |
14 | pharmacy acquisition cost and permit the pharmacy to reverse and rebill each claim affected by the |
15 | inability to procure the drug at a cost that is equal to or less than the previously challenged |
16 | maximum allowable cost. |
17 | (f)(1) A pharmacy benefits manager shall not reimburse a pharmacy or pharmacist in this |
18 | state an amount less than the amount that the pharmacy benefits manager reimburses a pharmacy |
19 | benefits manager affiliate for providing the same pharmacist services. |
20 | (2) The reimbursement amount shall be calculated on a per unit basis based on the same |
21 | generic product identifier or generic code number. |
22 | (g) A pharmacy or pharmacist may decline to provide the pharmacist services to a patient |
23 | or pharmacy benefits manager if, as a result of a maximum allowable cost list, a pharmacy or |
24 | pharmacist is to be paid less than the pharmacy acquisition cost of the pharmacy providing |
25 | pharmacist services. |
26 | (h) This section shall apply to a pharmacy benefits manager employed by the Rhode Island |
27 | Medicaid program and its contracted managed care entities. |
28 | (i) A violation of this section is a deceptive practice under § 6-13.1-2. |
29 | (j) The department of health may promulgate such rules and regulations as are necessary |
30 | and proper to effectuate the purpose and for the efficient administration and enforcement of this |
31 | chapter. |
32 | SECTION 4. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Services |
33 | Corporation" is hereby amended by adding thereto the following section: |
34 | 27-20-23.3. Maximum allowable cost lists. |
| LC001592 - Page 9 of 25 |
1 | (a) As used in this section: |
2 | (1) "Maximum allowable cost list" means a listing of drugs used by a pharmacy benefits |
3 | manager setting the maximum allowable cost on which reimbursement to a pharmacy or pharmacist |
4 | may be based; |
5 | (2) "Pharmaceutical wholesaler" means a person or entity that sells and distributes |
6 | prescription pharmaceutical products, including without limitation a full line of brand-name, |
7 | generic, and over-the-counter pharmaceuticals, and that offers regular and private delivery to a |
8 | pharmacy; |
9 | (3) "Pharmacist" means a licensed pharmacist as defined in § 5-19.1-2; |
10 | (4) "Pharmacist services" means products, goods, or services provided as a part of the |
11 | practice of pharmacy in Rhode Island; |
12 | (5) "Pharmacy" means that portion or part of a premise where prescriptions are |
13 | compounded and dispensed as defined in § 5-19.1-2; |
14 | (6) "Pharmacy acquisition cost" means the amount that a pharmaceutical wholesaler |
15 | charges for a pharmaceutical product as listed on the pharmacy's billing invoice; |
16 | (7) "Pharmacy benefits manager" means an entity that administers or manages a pharmacy |
17 | benefits plan or program; |
18 | (8) "Pharmacy benefits manager affiliate" means a pharmacy or pharmacist that directly or |
19 | indirectly, through one or more intermediaries owns or controls, is owned or controlled by, or is |
20 | under common ownership or control with a pharmacy benefits manager; and |
21 | (9) "Pharmacy benefits plan or program" means a plan or program that pays for, |
22 | reimburses, covers the cost of, or otherwise provides for pharmacist services to individuals who |
23 | reside in or are employed in this state. |
24 | (b) Before a pharmacy benefits manager places or continues a particular drug on a |
25 | maximum allowable cost list, the drug shall: |
26 | (1) Be listed as therapeutically equivalent and pharmaceutically equivalent "A", "AB", or |
27 | "B" rated in the United States Food and Drug Administration’s most recent version of the "Orange |
28 | Book" or "Green Book" or has an NR or NA rating by Medi-spanTM, Gold Standard, or a similar |
29 | rating by a nationally recognized reference; |
30 | (2) Be available for purchase by each pharmacy in the state from national or regional |
31 | wholesalers operating in Rhode Island; and |
32 | (3) Not be obsolete. |
33 | (c) A pharmacy benefits manager shall: |
34 | (1) Provide access to its maximum allowable cost list to each pharmacy subject to the |
| LC001592 - Page 10 of 25 |
1 | maximum allowable cost list; |
2 | (2) Update its maximum allowable cost list on a timely basis, but in no event longer than |
3 | seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition |
4 | cost from sixty percent (60%) or more of the pharmaceutical wholesalers doing business in the |
5 | state, or a change in the methodology on which the maximum allowable cost list is based, or in the |
6 | value of a variable involved in the methodology; |
7 | (3) Provide a process for each pharmacy subject to the maximum allowable cost list to |
8 | receive prompt notification of an update to the maximum allowable cost list; and |
9 | (4)(i) Provide a reasonable administrative appeal procedure to allow pharmacies to |
10 | challenge maximum allowable costs and reimbursements made under a maximum allowable cost |
11 | for a specific drug or drugs as: |
12 | (A) Not meeting the requirements of this section; or |
13 | (B) Being below pharmacy acquisition cost. |
14 | (ii) The reasonable administrative appeal procedure shall include the following terms and |
15 | conditions: |
16 | (A) A dedicated telephone number and email address or website for the purpose of |
17 | submitting administrative appeals; |
18 | (B) The ability to submit an administrative appeal directly to the pharmacy benefits |
19 | manager regarding the pharmacy benefits plan or program or through a pharmacy service |
20 | administrative organization; and |
21 | (C) No less than seven (7) business days to file an administrative appeal. |
22 | (d) The pharmacy benefits manager shall respond to the challenge under subsection |
23 | (c)(4)(i) of this section within seven (7) business days after receipt of the challenge. |
24 | (e) If a challenge is under subsection (c)(4)(i) of this section, the pharmacy benefits |
25 | manager shall within seven (7) business days after receipt of the challenge either: |
26 | (1) If the appeal is upheld: |
27 | (i) Make the change in the maximum allowable cost; |
28 | (ii) Permit the challenging pharmacy or pharmacist to reverse and rebill the claim in |
29 | question; and |
30 | (iii) Provide the national drug code number that the increase or change is based on to the |
31 | pharmacy or pharmacist; and |
32 | (iv) Make the change under subsection (e)(1)(i) of this section effective for each similarly |
33 | situated pharmacy as defined by the payor subject to the maximum allowable cost list. |
34 | (2) If the appeal is denied, the pharmacy benefits manager shall provide the challenging |
| LC001592 - Page 11 of 25 |
1 | pharmacy or pharmacist the national drug code number and the name of the national or regional |
2 | pharmaceutical wholesalers operating in this state that have the drug currently in stock at a price |
3 | below the maximum allowable cost list; or |
4 | (3) If the national drug code number provided by the pharmacy benefits manager is not |
5 | available below the pharmacy acquisition cost from the pharmaceutical wholesaler from whom the |
6 | pharmacy or pharmacist purchases the majority of prescription drugs for resale, then the pharmacy |
7 | benefits manager shall adjust the maximum allowable cost list above the challenging pharmacy's |
8 | pharmacy acquisition cost and permit the pharmacy to reverse and rebill each claim affected by the |
9 | inability to procure the drug at a cost that is equal to or less than the previously challenged |
10 | maximum allowable cost. |
11 | (f)(1) A pharmacy benefits manager shall not reimburse a pharmacy or pharmacist in this |
12 | state an amount less than the amount that the pharmacy benefits manager reimburses a pharmacy |
13 | benefits manager affiliate for providing the same pharmacist services. |
14 | (2) The reimbursement amount shall be calculated on a per unit basis based on the same |
15 | generic product identifier or generic code number. |
16 | (g) A pharmacy or pharmacist may decline to provide the pharmacist services to a patient |
17 | or pharmacy benefits manager if, as a result of a maximum allowable cost list, a pharmacy or |
18 | pharmacist is to be paid less than the pharmacy acquisition cost of the pharmacy providing |
19 | pharmacist services. |
20 | (h) This section shall apply to a pharmacy benefits manager employed by the Rhode Island |
21 | Medicaid program and its contracted managed care entities. |
22 | (i) A violation of this section is a deceptive practice under § 6-13.1-2. |
23 | (j) The department of health may promulgate such rules and regulations as are necessary |
24 | and proper to effectuate the purpose and for the efficient administration and enforcement of this |
25 | chapter. |
26 | SECTION 5. Chapter 27-20.1 of the General Laws entitled "Nonprofit Dental Service |
27 | Corporations" is hereby amended by adding thereto the following section: |
28 | 27-20.1-15.2. Maximum allowable cost limits. |
29 | (a) As used in this section: |
30 | (1) "Maximum allowable cost list" means a listing of drugs used by a pharmacy benefits |
31 | manager setting the maximum allowable cost on which reimbursement to a pharmacy or pharmacist |
32 | may be based; |
33 | (2) "Pharmaceutical wholesaler" means a person or entity that sells and distributes |
34 | prescription pharmaceutical products, including without limitation a full line of brand-name, |
| LC001592 - Page 12 of 25 |
1 | generic, and over-the-counter pharmaceuticals, and that offers regular and private delivery to a |
2 | pharmacy; |
3 | (3) "Pharmacist" means a licensed pharmacist as defined in § 5-19.1-2; |
4 | (4) "Pharmacist services" means products, goods, or services provided as a part of the |
5 | practice of pharmacy in Rhode Island; |
6 | (5) "Pharmacy" means that portion or part of a premise where prescriptions are |
7 | compounded and dispensed as defined in § 5-19.1-2; |
8 | (6) "Pharmacy acquisition cost" means the amount that a pharmaceutical wholesaler |
9 | charges for a pharmaceutical product as listed on the pharmacy's billing invoice; |
10 | (7) "Pharmacy benefits manager" means an entity that administers or manages a pharmacy |
11 | benefits plan or program; |
12 | (8) "Pharmacy benefits manager affiliate" means a pharmacy or pharmacist that directly or |
13 | indirectly, through one or more intermediaries owns or controls, is owned or controlled by, or is |
14 | under common ownership or control with a pharmacy benefits manager; and |
15 | (9) "Pharmacy benefits plan or program" means a plan or program that pays for, |
16 | reimburses, covers the cost of, or otherwise provides for pharmacist services to individuals who |
17 | reside in or are employed in this state. |
18 | (b) Before a pharmacy benefits manager places or continues a particular drug on a |
19 | maximum allowable cost list, the drug shall: |
20 | (1) Be listed as therapeutically equivalent and pharmaceutically equivalent "A", "AB", or |
21 | "B" rated in the United States Food and Drug Administration’s most recent version of the "Orange |
22 | Book" or "Green Book" or has an NR or NA rating by Medi-spanTM, Gold Standard, or a similar |
23 | rating by a nationally recognized reference; |
24 | (2) Be available for purchase by each pharmacy in the state from national or regional |
25 | wholesalers operating in Rhode Island; and |
26 | (3) Not be obsolete. |
27 | (c) A pharmacy benefits manager shall: |
28 | (1) Provide access to its maximum allowable cost list to each pharmacy subject to the |
29 | maximum allowable cost list; |
30 | (2) Update its maximum allowable cost list on a timely basis, but in no event longer than |
31 | seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition |
32 | cost from sixty percent (60%) or more of the pharmaceutical wholesalers doing business in the |
33 | state, or a change in the methodology on which the maximum allowable cost list is based, or in the |
34 | value of a variable involved in the methodology; |
| LC001592 - Page 13 of 25 |
1 | (3) Provide a process for each pharmacy subject to the maximum allowable cost list to |
2 | receive prompt notification of an update to the maximum allowable cost list; and |
3 | (4)(i) Provide a reasonable administrative appeal procedure to allow pharmacies to |
4 | challenge maximum allowable costs and reimbursements made under a maximum allowable cost |
5 | for a specific drug or drugs as: |
6 | (A) Not meeting the requirements of this section; or |
7 | (B) Being below pharmacy acquisition cost. |
8 | (ii) The reasonable administrative appeal procedure shall include the following terms and |
9 | conditions: |
10 | (A) A dedicated telephone number and email address or website for the purpose of |
11 | submitting administrative appeals; |
12 | (B) The ability to submit an administrative appeal directly to the pharmacy benefits |
13 | manager regarding the pharmacy benefits plan or program or through a pharmacy service |
14 | administrative organization; and |
15 | (C) No less than seven (7) business days to file an administrative appeal. |
16 | (d) The pharmacy benefits manager shall respond to the challenge under subsection |
17 | (c)(4)(i) of this section within seven (7) business days after receipt of the challenge. |
18 | (e) If a challenge is under subsection (c)(4)(i) of this section, the pharmacy benefits |
19 | manager shall within seven (7) business days after receipt of the challenge either: |
20 | (1) If the appeal is upheld: |
21 | (i) Make the change in the maximum allowable cost; |
22 | (ii) Permit the challenging pharmacy or pharmacist to reverse and rebill the claim in |
23 | question; and |
24 | (iii) Provide the national drug code number that the increase or change is based on to the |
25 | pharmacy or pharmacist; and |
26 | (iv) Make the change under subsection (e)(1)(i) of this section effective for each similarly |
27 | situated pharmacy as defined by the payor subject to the maximum allowable cost list. |
28 | (2) If the appeal is denied, the pharmacy benefits manager shall provide the challenging |
29 | pharmacy or pharmacist the national drug code number and the name of the national or regional |
30 | pharmaceutical wholesalers operating in this state that have the drug currently in stock at a price |
31 | below the maximum allowable cost list; or |
32 | (3) If the national drug code number provided by the pharmacy benefits manager is not |
33 | available below the pharmacy acquisition cost from the pharmaceutical wholesaler from whom the |
34 | pharmacy or pharmacist purchases the majority of prescription drugs for resale, then the pharmacy |
| LC001592 - Page 14 of 25 |
1 | benefits manager shall adjust the maximum allowable cost list above the challenging pharmacy's |
2 | pharmacy acquisition cost and permit the pharmacy to reverse and rebill each claim affected by the |
3 | inability to procure the drug at a cost that is equal to or less than the previously challenged |
4 | maximum allowable cost. |
5 | (f)(1) A pharmacy benefits manager shall not reimburse a pharmacy or pharmacist in this |
6 | state an amount less than the amount that the pharmacy benefits manager reimburses a pharmacy |
7 | benefits manager affiliate for providing the same pharmacist services. |
8 | (2) The reimbursement amount shall be calculated on a per unit basis based on the same |
9 | generic product identifier or generic code number. |
10 | (g) A pharmacy or pharmacist may decline to provide the pharmacist services to a patient |
11 | or pharmacy benefits manager if, as a result of a maximum allowable cost list, a pharmacy or |
12 | pharmacist is to be paid less than the pharmacy acquisition cost of the pharmacy providing |
13 | pharmacist services. |
14 | (h) This section shall apply to a pharmacy benefits manager employed by the Rhode Island |
15 | Medicaid program and its contracted managed care entities. |
16 | (i) A violation of this section is a deceptive practice under § 6-13.1-2. |
17 | (j) The department of health may promulgate such rules and regulations as are necessary |
18 | and proper to effectuate the purpose and for the efficient administration and enforcement of this |
19 | chapter. |
20 | SECTION 6. Chapter 27-41 of the General Laws entitled "Health Maintenance |
21 | Organizations" is hereby amended by adding thereto the following section: |
22 | 27-41-38.3. Maximum allowable cost limits. |
23 | (a) As used in this section: |
24 | (1) "Maximum allowable cost list" means a listing of drugs used by a pharmacy benefits |
25 | manager setting the maximum allowable cost on which reimbursement to a pharmacy or pharmacist |
26 | may be based; |
27 | (2) "Pharmaceutical wholesaler" means a person or entity that sells and distributes |
28 | prescription pharmaceutical products, including without limitation a full line of brand-name, |
29 | generic, and over-the-counter pharmaceuticals, and that offers regular and private delivery to a |
30 | pharmacy; |
31 | (3) "Pharmacist" means a licensed pharmacist as defined in § 5-19.1-2; |
32 | (4) "Pharmacist services" means products, goods, or services provided as a part of the |
33 | practice of pharmacy in Rhode Island; |
34 | (5) "Pharmacy" means that portion or part of a premise where prescriptions are |
| LC001592 - Page 15 of 25 |
1 | compounded and dispensed as defined in § 5-19.1-2; |
2 | (6) "Pharmacy acquisition cost" means the amount that a pharmaceutical wholesaler |
3 | charges for a pharmaceutical product as listed on the pharmacy's billing invoice; |
4 | (7) "Pharmacy benefits manager" means an entity that administers or manages a pharmacy |
5 | benefits plan or program; |
6 | (8) "Pharmacy benefits manager affiliate" means a pharmacy or pharmacist that directly or |
7 | indirectly, through one or more intermediaries owns or controls, is owned or controlled by, or is |
8 | under common ownership or control with a pharmacy benefits manager; and |
9 | (9) "Pharmacy benefits plan or program" means a plan or program that pays for, |
10 | reimburses, covers the cost of, or otherwise provides for pharmacist services to individuals who |
11 | reside in or are employed in this state. |
12 | (b) Before a pharmacy benefits manager places or continues a particular drug on a |
13 | maximum allowable cost list, the drug shall: |
14 | (1) Be listed as therapeutically equivalent and pharmaceutically equivalent "A", "AB", or |
15 | "B" rated in the United States Food and Drug Administration’s most recent version of the "Orange |
16 | Book" or "Green Book" or has an NR or NA rating by Medi-spanTM, Gold Standard, or a similar |
17 | rating by a nationally recognized reference; |
18 | (2) Be available for purchase by each pharmacy in the state from national or regional |
19 | wholesalers operating in Rhode Island; and |
20 | (3) Not be obsolete. |
21 | (c) A pharmacy benefits manager shall: |
22 | (1) Provide access to its maximum allowable cost list to each pharmacy subject to the |
23 | maximum allowable cost list; |
24 | (2) Update its maximum allowable cost list on a timely basis, but in no event longer than |
25 | seven (7) calendar days from an increase of ten percent (10%) or more in the pharmacy acquisition |
26 | cost from sixty percent (60%) or more of the pharmaceutical wholesalers doing business in the |
27 | state, or a change in the methodology on which the maximum allowable cost list is based, or in the |
28 | value of a variable involved in the methodology; |
29 | (3) Provide a process for each pharmacy subject to the maximum allowable cost list to |
30 | receive prompt notification of an update to the maximum allowable cost list; and |
31 | (4)(i) Provide a reasonable administrative appeal procedure to allow pharmacies to |
32 | challenge maximum allowable costs and reimbursements made under a maximum allowable cost |
33 | for a specific drug or drugs as: |
34 | (A) Not meeting the requirements of this section; or |
| LC001592 - Page 16 of 25 |
1 | (B) Being below pharmacy acquisition cost. |
2 | (ii) The reasonable administrative appeal procedure shall include the following terms and |
3 | conditions: |
4 | (A) A dedicated telephone number and email address or website for the purpose of |
5 | submitting administrative appeals; |
6 | (B) The ability to submit an administrative appeal directly to the pharmacy benefits |
7 | manager regarding the pharmacy benefits plan or program or through a pharmacy service |
8 | administrative organization; and |
9 | (C) No less than seven (7) business days to file an administrative appeal. |
10 | (d) The pharmacy benefits manager shall respond to the challenge under subsection |
11 | (c)(4)(i) of this section within seven (7) business days after receipt of the challenge. |
12 | (e) If a challenge is under subsection (c)(4)(i) of this section, the pharmacy benefits |
13 | manager shall within seven (7) business days after receipt of the challenge either: |
14 | (1) If the appeal is upheld: |
15 | (i) Make the change in the maximum allowable cost; |
16 | (ii) Permit the challenging pharmacy or pharmacist to reverse and rebill the claim in |
17 | question; and |
18 | (iii) Provide the national drug code number that the increase or change is based on to the |
19 | pharmacy or pharmacist; and |
20 | (iv) Make the change under subsection (e)(1)(i) of this section effective for each similarly |
21 | situated pharmacy as defined by the payor subject to the maximum allowable cost list. |
22 | (2) If the appeal is denied, the pharmacy benefits manager shall provide the challenging |
23 | pharmacy or pharmacist the national drug code number and the name of the national or regional |
24 | pharmaceutical wholesalers operating in this state that have the drug currently in stock at a price |
25 | below the maximum allowable cost list; or |
26 | (3) If the national drug code number provided by the pharmacy benefits manager is not |
27 | available below the pharmacy acquisition cost from the pharmaceutical wholesaler from whom the |
28 | pharmacy or pharmacist purchases the majority of prescription drugs for resale, then the pharmacy |
29 | benefits manager shall adjust the maximum allowable cost list above the challenging pharmacy's |
30 | pharmacy acquisition cost and permit the pharmacy to reverse and rebill each claim affected by the |
31 | inability to procure the drug at a cost that is equal to or less than the previously challenged |
32 | maximum allowable cost. |
33 | (f)(1) A pharmacy benefits manager shall not reimburse a pharmacy or pharmacist in this |
34 | state an amount less than the amount that the pharmacy benefits manager reimburses a pharmacy |
| LC001592 - Page 17 of 25 |
1 | benefits manager affiliate for providing the same pharmacist services. |
2 | (2) The reimbursement amount shall be calculated on a per unit basis based on the same |
3 | generic product identifier or generic code number. |
4 | (g) A pharmacy or pharmacist may decline to provide the pharmacist services to a patient |
5 | or pharmacy benefits manager if, as a result of a maximum allowable cost list, a pharmacy or |
6 | pharmacist is to be paid less than the pharmacy acquisition cost of the pharmacy providing |
7 | pharmacist services. |
8 | (h) This section shall apply to a pharmacy benefits manager employed by the Rhode Island |
9 | Medicaid program and its contracted managed care entities. |
10 | (i) A violation of this section is a deceptive practice under § 6-13.1-2. |
11 | (j) The department of health may promulgate such rules and regulations as are necessary |
12 | and proper to effectuate the purpose and for the efficient administration and enforcement of this |
13 | chapter. |
14 | SECTION 7. Section 27-18-33.2 of the General Laws in Chapter 27-18 entitled "Accident |
15 | and Sickness Insurance Policies" is hereby repealed. |
16 | 27-18-33.2. Pharmacy benefit manager requirements with respect to multi-source |
17 | generic pricing updates to pharmacies. |
18 | (a) Definitions. As used herein: |
19 | (1) "Maximum-allowable cost" or "MAC" means the maximum amount that a pharmacy |
20 | benefits manager will reimburse toward the cost of a drug; |
21 | (2) "Nationally available" means that there is an adequate supply available from regional |
22 | or national wholesalers and that the product is not obsolete or temporarily unavailable; |
23 | (3) "Pharmacy-benefit manager" or "PBM" means an entity doing business in this state that |
24 | contracts to administer or manage prescription-drug benefits on behalf of any carrier that provides |
25 | prescription-drug benefits to residents of this state. |
26 | (b) Upon each contract execution or renewal, a PBM shall, with respect to contracts |
27 | between a PBM and a pharmacy or, alternatively, a PBM and a pharmacy's contracting |
28 | representative or agent, such as a pharmacy services administrative organization (PSAO): |
29 | (1) Include in such contracts a requirement to update pricing information on the MAC list |
30 | at least every ten (10) calendar days; |
31 | (2) Maintain a procedure to eliminate products from the list of drugs subject to such pricing, |
32 | or modify MAC rates when such drugs do not meet the standards and requirements of this section |
33 | as set forth, in order to remain consistent with pricing changes in the marketplace. |
34 | (c) PBM requirements for inclusion of products on a list of drugs subject to MAC pricing. |
| LC001592 - Page 18 of 25 |
1 | In order to place a particular prescription drug on a MAC list, the PBM must, at a minimum, ensure |
2 | that: |
3 | (1) The product must be listed as "A," "AB," or "B" rated in the most recent version of the |
4 | United States Food and Drug Administration's approved drug products with therapeutic |
5 | equivalence evaluations, also known as the orange book, or has an "NR" or "NA" rating or similar |
6 | rating by a nationally recognized reference; and |
7 | (2) The product must be nationally available. |
8 | (d) Standards for pharmacy appeals. All contracts between a PBM, a contracted pharmacy |
9 | or, alternatively, a PBM and a pharmacy's contracting representative or agent, such as a pharmacy |
10 | services administrative organization (PSAO), shall include a process to appeal, investigate, and |
11 | resolve disputes regarding MAC pricing. The process shall include the following provisions: |
12 | (1) The right to appeal shall be limited to fifteen (15) days following the initial claim; |
13 | (2) The appeal shall be investigated and resolved within fifteen (15) days following receipt |
14 | of the appeal; |
15 | (3) A process by which a network pharmacy may contact the PBM regarding the appeals |
16 | process; |
17 | (4) If the appeal is denied, the PBM shall provide the reason for the denial and identify the |
18 | national drug code of a drug product that is available in adequate supply; |
19 | (5) If an appeal is upheld, the PBM shall make an adjustment to the list effective no later |
20 | than one day after the date of determination; and |
21 | (6) The department of health shall exercise oversight and enforcement of this section. |
22 | SECTION 8. Section 27-19-26.2 of the General Laws in Chapter 27-19 entitled "Nonprofit |
23 | Hospital Service Corporations" is hereby repealed. |
24 | 27-19-26.2. Pharmacy benefit manager requirements with respect to multi-source |
25 | generic pricing updates to pharmacies. |
26 | (a) Definitions. As used herein: |
27 | (1) "Maximum-allowable cost" or "MAC" means the maximum amount that a pharmacy |
28 | benefits manager will reimburse toward the cost of a drug; |
29 | (2) "Nationally available" means that there is an adequate supply available from regional |
30 | or national wholesalers and that the product is not obsolete or temporarily unavailable; |
31 | (3) "Pharmacy-benefit manager" or "PBM" means an entity doing business in this state that |
32 | contracts to administer or manage prescription-drug benefits on behalf of any carrier that provides |
33 | prescription-drug benefits to residents of this state. |
34 | (b) Upon each contract execution or renewal, a PBM shall, with respect to contracts |
| LC001592 - Page 19 of 25 |
1 | between a PBM and a pharmacy or, alternatively, a PBM and a pharmacy's contracting |
2 | representative or agent, such as a pharmacy services administrative organization (PSAO): |
3 | (1) Include in such contracts a requirement to update pricing information on the MAC list |
4 | at least every ten (10) calendar days; |
5 | (2) Maintain a procedure to eliminate products from the list of drugs subject to such pricing, |
6 | or modify MAC rates when such drugs do not meet the standards and requirements of this section |
7 | as set forth in order to remain consistent with pricing changes in the marketplace. |
8 | (c) PBM requirements for inclusion of products on a list of drugs subject to MAC pricing. |
9 | In order to place a particular prescription drug on a MAC list, the PBM must, at a minimum, ensure |
10 | that: |
11 | (1) The product must be listed as "A," "AB," or "B" rated in the most recent version of the |
12 | United States Food and Drug Administration's approved drug products with therapeutic |
13 | equivalence evaluations, also known as the orange book, or has an "NR" or "NA" rating or similar |
14 | rating by a nationally recognized reference; and |
15 | (2) The product must be nationally available. |
16 | (d) Standards for pharmacy appeals. All contracts between a PBM, a contracted pharmacy |
17 | or, alternatively, a PBM and a pharmacy's contracting representative or agent, such as a pharmacy |
18 | services administrative organization (PSAO), shall include a process to appeal, investigate, and |
19 | resolve disputes regarding MAC pricing. The process shall include the following provisions: |
20 | (1) The right to appeal shall be limited to fifteen (15) days following the initial claim; |
21 | (2) The appeal shall be investigated and resolved within fifteen (15) days following receipt |
22 | of the appeal; |
23 | (3) A process by which a network pharmacy may contact the PBM regarding the appeals |
24 | process; |
25 | (4) If the appeal is denied, the PBM shall provide the reason for the denial and identify the |
26 | national drug code of a drug product that is available in adequate supply; |
27 | (5) If an appeal is upheld, the PBM shall make an adjustment to the list effective no later |
28 | than one day after the date of determination; and |
29 | (6) The department of health shall exercise oversight and enforcement of this section. |
30 | SECTION 9. Section 27-20-23.2 of the General Laws in Chapter 27-20 entitled "Nonprofit |
31 | Medical Service Corporations" is hereby repealed. |
32 | 27-20-23.2. Pharmacy benefit manager requirements with respect to multi-source |
33 | generic pricing updates to pharmacies. |
34 | (a) Definitions. As used herein: |
| LC001592 - Page 20 of 25 |
1 | (1) "Maximum-allowable cost" or "MAC" means the maximum amount that a pharmacy |
2 | benefits manager will reimburse toward the cost of a drug; |
3 | (2) "Nationally available" means that there is an adequate supply available from regional |
4 | or national wholesalers and that the product is not obsolete or temporarily unavailable; |
5 | (3) "Pharmacy-benefit manager" or "PBM" means an entity doing business in this state that |
6 | contracts to administer or manage prescription-drug benefits on behalf of any carrier that provides |
7 | prescription-drug benefits to residents of this state. |
8 | (b) Upon each contract execution or renewal, a PBM shall, with respect to contracts |
9 | between a PBM and a pharmacy or, alternatively, a PBM and a pharmacy's contracting |
10 | representative or agent such as a pharmacy services administrative organization (PSAO): |
11 | (1) Include in such contracts a requirement to update pricing information on the MAC list |
12 | at least every ten (10) calendar days; |
13 | (2) Maintain a procedure to eliminate products from the list of drugs subject to such pricing, |
14 | or modify MAC rates when such drugs do not meet the standards and requirements of this section |
15 | as set forth in order to remain consistent with pricing changes in the marketplace. |
16 | (c) PBM requirements for inclusion of products on a list of drugs subject to MAC pricing. |
17 | In order to place a particular prescription drug on a MAC list, the PBM must, at a minimum, ensure |
18 | that: |
19 | (1) The product must be listed as "A," "AB," or "B" rated in the most recent version of the |
20 | United States Food and Drug Administration's approved drug products with therapeutic |
21 | equivalence evaluations, also known as the orange book, or has an "NR" or "NA" rating or similar |
22 | rating by a nationally recognized reference; and |
23 | (2) The product must be nationally available. |
24 | (d) Standards for pharmacy appeals. All contracts between a PBM, a contracted pharmacy |
25 | or, alternatively, a PBM and a pharmacy's contracting representative or agent, such as a pharmacy |
26 | services administrative organization (PSAO), shall include a process to appeal, investigate, and |
27 | resolve disputes regarding MAC pricing. The process shall include the following provisions: |
28 | (1) The right to appeal shall be limited to fifteen (15) days following the initial claim; |
29 | (2) The appeal shall be investigated and resolved within fifteen (15) days following receipt |
30 | of the appeal; |
31 | (3) A process by which a network pharmacy may contact the PBM regarding the appeals |
32 | process; |
33 | (4) If the appeal is denied, the PBM shall provide the reason for the denial and identify the |
34 | national drug code of a drug product that is available in adequate supply; |
| LC001592 - Page 21 of 25 |
1 | (5) If an appeal is upheld, the PBM shall make an adjustment to the list effective no later |
2 | than one day after the date of determination; and |
3 | (6) The department of health shall exercise oversight and enforcement of this section. |
4 | SECTION 10. Section 27-20.1-15.1 of the General Laws in Chapter 27-20.1 entitled |
5 | "Nonprofit Dental Service Corporations" is hereby repealed. |
6 | 27-20.1-15.1. Pharmacy benefit manager requirements with respect to multi-source |
7 | generic pricing updates to pharmacies. |
8 | (a) Definitions. As used herein: |
9 | (1) "Maximum-allowable cost" or "MAC" means the maximum amount that a pharmacy |
10 | benefits manager will reimburse toward the cost of a drug; |
11 | (2) "Nationally available" means that there is an adequate supply available from regional |
12 | or national wholesalers and that the product is not obsolete or temporarily unavailable; |
13 | (3) "Pharmacy-benefit manager" or "PBM" means an entity doing business in this state that |
14 | contracts to administer or manage prescription-drug benefits on behalf of any carrier that provides |
15 | prescription-drug benefits to residents of this state. |
16 | (b) Upon each contract execution or renewal, a PBM shall, with respect to contracts |
17 | between a PBM and a pharmacy or, alternatively, a PBM and a pharmacy's contracting |
18 | representative or agent, such as a pharmacy services administrative organization (PSAO): |
19 | (1) Include in such contracts a requirement to update pricing information on the MAC list |
20 | at least every ten (10) calendar days; |
21 | (2) Maintain a procedure to eliminate products from the list of drugs subject to such pricing, |
22 | or modify MAC rates when such drugs do not meet the standards and requirements of this section |
23 | as set forth in order to remain consistent with pricing changes in the marketplace. |
24 | (c) PBM requirements for inclusion of products on a list of drugs subject to MAC pricing. |
25 | In order to place a particular prescription drug on a MAC list, the PBM must, at a minimum, ensure |
26 | that: |
27 | (1) The product must be listed as "A," "AB," or "B" rated in the most recent version of the |
28 | United States Food and Drug Administration's approved drug products with therapeutic |
29 | equivalence evaluations, also known as the orange book, or has an "NR" or "NA" rating or similar |
30 | rating by a nationally recognized reference; and |
31 | (2) The product must be nationally available. |
32 | (d) Standards for pharmacy appeals. All contracts between a PBM, a contracted pharmacy |
33 | or, alternatively, a PBM and a pharmacy's contracting representative or agent, such as a pharmacy |
34 | services administrative organization (PSAO), shall include a process to appeal, investigate, and |
| LC001592 - Page 22 of 25 |
1 | resolve disputes regarding MAC pricing. The process shall include the following provisions: |
2 | (1) The right to appeal shall be limited to fifteen (15) days following the initial claim; |
3 | (2) The appeal shall be investigated and resolved within fifteen (15) days following receipt |
4 | of the appeal; |
5 | (3) A process by which a network pharmacy may contact the PBM regarding the appeals |
6 | process; |
7 | (4) If the appeal is denied, the PBM shall provide the reason for the denial and identify the |
8 | national drug code of a drug product that is available in adequate supply; |
9 | (5) If an appeal is upheld, the PBM shall make an adjustment to the list effective no later |
10 | than one day after the date of determination; and |
11 | (6) The department of health shall exercise oversight and enforcement of this section. |
12 | SECTION 11. Section 27-41-38.2 of the General Laws in Chapter 27-41 entitled "Health |
13 | Maintenance Organizations" is hereby repealed. |
14 | 27-41-38.2. Pharmacy benefit manager requirements with respect to multi-source |
15 | generic pricing updates to pharmacies. |
16 | (a) Definitions. As used herein: |
17 | (1) "Maximum-allowable cost" or "MAC" means the maximum amount that a pharmacy |
18 | benefits manager will reimburse toward the cost of a drug; |
19 | (2) "Nationally available" means that there is an adequate supply available from regional |
20 | or national wholesalers and that the product is not obsolete or temporarily unavailable; |
21 | (3) "Pharmacy-benefit manager" means an entity doing business in this state that contracts |
22 | to administer or manage prescription-drug benefits on behalf of any carrier that provides |
23 | prescription-drug benefits to residents of this state. |
24 | (b) Upon each contract execution or renewal, a PBM shall, with respect to contracts |
25 | between a PBM and a pharmacy or, alternatively, a PBM and a pharmacy's contracting |
26 | representative or agent, such as a pharmacy services administrative organization (PSAO): |
27 | (1) Include in such contracts a requirement to update pricing information on the MAC list |
28 | at least every ten (10) calendar days; |
29 | (2) Maintain a procedure to eliminate products from the list of drugs subject to such pricing, |
30 | or modify MAC rates when such drugs do not meet the standards and requirements of this section |
31 | as set forth in order to remain consistent with pricing changes in the marketplace. |
32 | (c) PBM requirements for inclusion of products on a list of drugs subject to MAC pricing. |
33 | In order to place a particular prescription drug on a MAC list, the PBM must, at a minimum, ensure |
34 | that: |
| LC001592 - Page 23 of 25 |
1 | (1) The product must be listed as "A," "AB," or "B" rated in the most recent version of the |
2 | United States Food and Drug Administration's approved drug products with therapeutic |
3 | equivalence evaluations, also known as the orange book, or has an "NR" or "NA" rating or similar |
4 | rating by a nationally recognized reference; and |
5 | (2) The product must be nationally available. |
6 | (d) Standards for pharmacy appeals. All contracts between a PBM, a contracted pharmacy |
7 | or, alternatively, a PBM and a pharmacy's contracting representative or agent, such as a pharmacy |
8 | services administrative organization (PSAO), shall include a process to appeal, investigate, and |
9 | resolve disputes regarding MAC pricing. The process shall include the following provisions: |
10 | (1) The right to appeal shall be limited to fifteen (15) days following the initial claim; |
11 | (2) The appeal shall be investigated and resolved within fifteen (15) days following receipt |
12 | of the appeal; |
13 | (3) A process by which a network pharmacy may contact the PBM regarding the appeals |
14 | process; |
15 | (4) If the appeal is denied, the PBM shall provide the reason for the denial and identify the |
16 | national drug code of a drug product that is available in adequate supply; |
17 | (5) If an appeal is upheld, the PBM shall make an adjustment to the list effective no later |
18 | than one day after the date of determination; and |
19 | (6) The department of health shall exercise oversight and enforcement of this section. |
20 | SECTION 12. This act shall take effect upon passage. |
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LC001592 | |
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| LC001592 - Page 24 of 25 |
EXPLANATION | |
BY THE LEGISLATIVE COUNCIL | |
OF | |
A N A C T | |
RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES--INSURANCE | |
*** | |
1 | This act would update and revise the current law on pharmacy benefit managers and |
2 | prescription drug pricing including establishing maximum allowable cost limits and providing for |
3 | amended administrative appeal procedures. |
4 | This act would take effect upon passage. |
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LC001592 | |
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| LC001592 - Page 25 of 25 |