2013 -- H 6237

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LC02740

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2013

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A N A C T

RELATING TO INSURANCE -- HEALTH INSURANCE

     Introduced By: Representatives McNamara, Malik, Corvese, and Azzinaro

     Date Introduced: June 13, 2013

     Referred To: House Health, Education & Welfare

It is enacted by the General Assembly as follows:

1-1

     SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness

1-2

Insurance Policies" is hereby amended by adding thereto the following section:

1-3

     27-18-79. Utilization of opioid mediations with tamper-resistance formulations. -- (a)

1-4

All individual or group health insurance plans or policies delivered, issued for delivery or review

1-5

in this state on or after January 1, 2014, shall provide coverage for the utilization of opioid

1-6

medications with tamper-resistance formulations in accordance with this section.

1-7

     (b) "Tamper-resistant opioid formulation" means an opioid, that is prescribed to treat

1-8

moderate to severe pain, addiction or other conditions, that incorporates tamper-resistant

1-9

technology; approved by the United States Food and Drug Administration from an application

1-10

that includes at least:

1-11

     (1) One human tampering or abuse potential study; or

1-12

     (2) A drug or a drug formulation that satisfies at least two (2) of the following qualities:

1-13

     (i) Physical/chemical barriers that can prevent chewing, crushing, cutting, grating, or

1-14

grinding designed to enhance euphoric effect.

1-15

     (ii) Agonist/antagonist combinations that seek to interfere with, reduce, or defeat the

1-16

euphoria associated with abuse.

1-17

     (iii) Aversion that can produce an unpleasant effect if the dosage form is altered.

1-18

     (iv) Delivery systems that offer resistance to abuse including, but not limited to, depot

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injections.

2-20

     (v) Pro-drug techniques that limit opioid effect until digested in the gastrointestinal

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system.

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     (c) As used in this section, "prior authorization form" means a form developed by the

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department of health, with input from interested parties, designed for prescribers to document a

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patient's history or risk of abusing or diverting prescription medications.

2-25

     (d) If, in the prescriber's reasonable professional judgment, tamper-resistant opioid

2-26

formulation(s) are warranted in the treatment and support of a patient's recovery, a prior

2-27

authorization form shall be available for submission to the plan/payer.

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     (1) The form shall be available to prescribers electronically, by the department of health

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and by the health plan/payer.

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     (2) The completed form or its data elements may be submitted electronically from the

2-31

prescribing healthcare provider to the health plan/payer.

2-32

     (3) The department of health shall promulgate procedures that enable plans/payers to

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incorporate the contents of the prior authorization form into a plan's existing form for a specific

2-34

medication.

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     (4) The health plan/payer shall notify a healthcare provider of or make available to a

2-36

healthcare provider a receipt of the request for prior authorization and any needed missing

2-37

information within twenty-four (24) hours of receipt.

2-38

     (5) Prior authorization requests for tamper-resistant opioid formulations shall be

2-39

administered by the plan/payers in the same fashion and time frames as are all other prior

2-40

authorization requests accepted by the plan/payer.

2-41

     (e) Every plan/payer shall accept a prior authorization form from prescribers

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recommending tamper-resistant opioids for patients with a documented history of prescription

2-43

drug abuse and/or diversion or a patient at high risk of relapsing into abuse of drugs.

2-44

     (f) It shall remain at the discretion of the plan/payer to approve or deny the prior

2-45

authorization recommendation of the physician.

2-46

     (g) If the prior authorization is approved, it shall remain at the discretion of the

2-47

plan/payer as to the appropriate tamper-resistant opioid to be therapeutically substituted.

2-48

     (h) Plan/payer denials remain subject to all existing patient utilization review due process

2-49

rights.

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     (i) The board of pharmacy shall promulgate and make available to prescribers a list of

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tamper-resistant opioid formulations, based on the study described in this section.

2-52

     SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service

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Corporations" is hereby amended by adding thereto the following section:

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     27-19-70. Utilization of opioid mediations with tamper-resistance formulations. -- (a)

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All individual or group health insurance plans or policies delivered, issued for delivery or review

3-56

in this state on or after January 1, 2014, shall provide coverage for the utilization of opioid

3-57

medications with tamper-resistance formulations in accordance with this section.

3-58

     (b) "Tamper-resistant opioid formulation" means an opioid, that is prescribed to treat

3-59

moderate to severe pain, addiction or other conditions, that incorporates tamper-resistant

3-60

technology; approved by the United States Food and Drug Administration from an application

3-61

that includes at least:

3-62

     (1) One human tampering or abuse potential study; or

3-63

     (2) A drug or a drug formulation that satisfies at least two (2) of the following qualities:

3-64

     (i) Physical/chemical barriers that can prevent chewing, crushing, cutting, grating, or

3-65

grinding designed to enhance euphoric effect.

3-66

     (ii) Agonist/antagonist combinations that seek to interfere with, reduce, or defeat the

3-67

euphoria associated with abuse.

3-68

     (iii) Aversion that can produce an unpleasant effect if the dosage form is altered.

3-69

     (iv) Delivery systems that offer resistance to abuse including, but not limited to, depot

3-70

injections.

3-71

     (v) Pro-drug techniques that limit opioid effect until digested in the gastrointestinal

3-72

system.

3-73

     (c) As used in this section, "prior authorization form" means a form developed by the

3-74

department of health, with input from interested parties, designed for prescribers to document a

3-75

patient's history or risk of abusing or diverting prescription medications.

3-76

     (d) If, in the prescriber's reasonable professional judgment, tamper-resistant opioid

3-77

formulation(s) are warranted in the treatment and support of a patient's recovery, a prior

3-78

authorization form shall be available for submission to the plan/payer.

3-79

     (1) The form shall be available to prescribers electronically, by the department of health

3-80

and by the health plan/payer.

3-81

     (2) The completed form or its data elements may be submitted electronically from the

3-82

prescribing healthcare provider to the health plan/payer.

3-83

     (3) The department of health shall promulgate procedures that enable plans/payers to

3-84

incorporate the contents of the prior authorization form into a plan's existing form for a specific

3-85

medication.

3-86

     (4) The health plan/payer shall notify a healthcare provider of or make available to a

3-87

healthcare provider a receipt of the request for prior authorization and any needed missing

3-88

information within twenty-four (24) hours of receipt.

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     (5) Prior authorization requests for tamper-resistant opioid formulations shall be

4-2

administered by the plan/payers in the same fashion and time frames as are all other prior

4-3

authorization requests accepted by the plan/payer.

4-4

     (e) Every plan/payer shall accept a prior authorization form from prescribers

4-5

recommending tamper-resistant opioids for patients with a documented history of prescription

4-6

drug abuse and/or diversion or a patient at high risk of relapsing into abuse of drugs.

4-7

     (f) It shall remain at the discretion of the plan/payer to approve or deny the prior

4-8

authorization recommendation of the physician.

4-9

     (g) If the prior authorization is approved, it shall remain at the discretion of the

4-10

plan/payer as to the appropriate tamper-resistant opioid to be therapeutically substituted.

4-11

     (h) Plan/payer denials remain subject to all existing patient utilization review due process

4-12

rights.

4-13

     (i) The board of pharmacy shall promulgate and make available to prescribers a list of

4-14

tamper-resistant opioid formulations, based on the study described in this section.

4-15

     SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service

4-16

Corporations" is hereby amended by adding thereto the following section:

4-17

     27-20-66. Utilization of opioid mediations with tamper-resistance formulations. -- (a)

4-18

All individual or group health insurance plans or policies delivered, issued for delivery or review

4-19

in this state on or after January 1, 2014, shall provide coverage for the utilization of opioid

4-20

medications with tamper-resistance formulations in accordance with this section.

4-21

     (b) "Tamper-resistant opioid formulation" means an opioid, that is prescribed to treat

4-22

moderate to severe pain, addiction or other conditions, that incorporates tamper-resistant

4-23

technology; approved by the United States Food and Drug Administration from an application

4-24

that includes at least:

4-25

     (1) One human tampering or abuse potential study; or

4-26

     (2) A drug or a drug formulation that satisfies at least two (2) of the following qualities:

4-27

     (i) Physical/chemical barriers that can prevent chewing, crushing, cutting, grating, or

4-28

grinding designed to enhance euphoric effect.

4-29

     (ii) Agonist/antagonist combinations that seek to interfere with, reduce, or defeat the

4-30

euphoria associated with abuse.

4-31

     (iii) Aversion that can produce an unpleasant effect if the dosage form is altered.

4-32

     (iv) Delivery systems that offer resistance to abuse including, but not limited to, depot

4-33

injections.

5-34

     (v) Pro-drug techniques that limit opioid effect until digested in the gastrointestinal

5-35

system.

5-36

     (c) As used in this section, "prior authorization form" means a form developed by the

5-37

department of health, with input from interested parties, designed for prescribers to document a

5-38

patient's history or risk of abusing or diverting prescription medications.

5-39

     (d) If, in the prescriber's reasonable professional judgment, tamper-resistant opioid

5-40

formulation(s) are warranted in the treatment and support of a patient's recovery, a prior

5-41

authorization form shall be available for submission to the plan/payer.

5-42

     (1) The form shall be available to prescribers electronically, by the department of health

5-43

and by the health plan/payer.

5-44

     (2) The completed form or its data elements may be submitted electronically from the

5-45

prescribing healthcare provider to the health plan/payer.

5-46

     (3) The department of health shall promulgate procedures that enable plans/payers to

5-47

incorporate the contents of the prior authorization form into a plan's existing form for a specific

5-48

medication.

5-49

     (4) The health plan/payer shall notify a healthcare provider of or make available to a

5-50

healthcare provider a receipt of the request for prior authorization and any needed missing

5-51

information within twenty-four (24) hours of receipt.

5-52

     (5) Prior authorization requests for tamper-resistant opioid formulations shall be

5-53

administered by the plan/payers in the same fashion and time frames as are all other prior

5-54

authorization requests accepted by the plan/payer.

5-55

     (e) Every plan/payer shall accept a prior authorization form from prescribers

5-56

recommending tamper-resistant opioids for patients with a documented history of prescription

5-57

drug abuse and/or diversion or a patient at high risk of relapsing into abuse of drugs.

5-58

     (f) It shall remain at the discretion of the plan/payer to approve or deny the prior

5-59

authorization recommendation of the physician.

5-60

     (g) If the prior authorization is approved, it shall remain at the discretion of the

5-61

plan/payer as to the appropriate tamper-resistant opioid to be therapeutically substituted.

5-62

     (h) Plan/payer denials remain subject to all existing patient utilization review due process

5-63

rights.

5-64

     (i) The board of pharmacy shall promulgate and make available to prescribers a list of

5-65

tamper-resistant opioid formulations, based on the study described in this section.

5-66

     SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance

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Organizations" is hereby amended by adding thereto the following section:

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     27-41-83. Utilization of opioid mediations with tamper-resistance formulations. -- (a)

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All individual or group health insurance plans or policies delivered, issued for delivery or review

6-70

in this state on or after January 1, 2014, shall provide coverage for the utilization of opioid

6-71

medications with tamper-resistance formulations in accordance with this section.

6-72

     (b) "Tamper-resistant opioid formulation" means an opioid, that is prescribed to treat

6-73

moderate to severe pain, addiction or other conditions, that incorporates tamper-resistant

6-74

technology; approved by the United States Food and Drug Administration from an application

6-75

that includes at least:

6-76

     (1) One human tampering or abuse potential study; or

6-77

     (2) A drug or a drug formulation that satisfies at least two (2) of the following qualities:

6-78

     (i) Physical/chemical barriers that can prevent chewing, crushing, cutting, grating, or

6-79

grinding designed to enhance euphoric effect.

6-80

     (ii) Agonist/antagonist combinations that seek to interfere with, reduce, or defeat the

6-81

euphoria associated with abuse.

6-82

     (iii) Aversion that can produce an unpleasant effect if the dosage form is altered.

6-83

     (iv) Delivery systems that offer resistance to abuse including, but not limited to, depot

6-84

injections.

6-85

     (v) Pro-drug techniques that limit opioid effect until digested in the gastrointestinal

6-86

system.

6-87

     (c) As used in this section, "prior authorization form" means a form developed by the

6-88

department of health, with input from interested parties, designed for prescribers to document a

6-89

patient's history or risk of abusing or diverting prescription medications.

6-90

     (d) If, in the prescriber's reasonable professional judgment, tamper-resistant opioid

6-91

formulation(s) are warranted in the treatment and support of a patient's recovery, a prior

6-92

authorization form shall be available for submission to the plan/payer.

6-93

     (1) The form shall be available to prescribers electronically, by the department of health

6-94

and by the health plan/payer.

6-95

     (2) The completed form or its data elements may be submitted electronically from the

6-96

prescribing healthcare provider to the health plan/payer.

6-97

     (3) The department of health shall promulgate procedures that enable plans/payers to

6-98

incorporate the contents of the prior authorization form into a plan's existing form for a specific

6-99

medication.

6-100

     (4) The health plan/payer shall notify a healthcare provider of or make available to a

6-101

healthcare provider a receipt of the request for prior authorization and any needed missing

6-102

information within twenty-four (24) hours of receipt.

7-1

     (5) Prior authorization requests for tamper-resistant opioid formulations shall be

7-2

administered by the plan/payers in the same fashion and time frames as are all other prior

7-3

authorization requests accepted by the plan/payer.

7-4

     (e) Every plan/payer shall accept a prior authorization form from prescribers

7-5

recommending tamper-resistant opioids for patients with a documented history of prescription

7-6

drug abuse and/or diversion or a patient at high risk of relapsing into abuse of drugs.

7-7

     (f) It shall remain at the discretion of the plan/payer to approve or deny the prior

7-8

authorization recommendation of the physician.

7-9

     (g) If the prior authorization is approved, it shall remain at the discretion of the

7-10

plan/payer as to the appropriate tamper-resistant opioid to be therapeutically substituted.

7-11

     (h) Plan/payer denials remain subject to all existing patient utilization review due process

7-12

rights.

7-13

     (i) The board of pharmacy shall promulgate and make available to prescribers a list of

7-14

tamper-resistant opioid formulations, based on the study described in this section.

7-15

     SECTION 5. This act shall take effect on October 1, 2013.

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LC02740

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N A C T

RELATING TO INSURANCE -- HEALTH INSURANCE

***

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     This act would give the prescribers of medication the discretion to request a prior

8-2

authorization for a tamper-resistant opioid medication for patients with a history of

8-3

abuse/diversion or at risk of abusing drugs.

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     This act would take effect on October 1, 2013.

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LC02740

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