6 | | - | ONCERNING UPDATING REFERENCES TO THE FEDERAL FOOD AND DRUG |
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7 | | - | ADMINISTRATION IN THE HEALTH INSURANCE LAW |
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8 | | - | . |
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9 | | - | |
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10 | | - | Be it enacted by the General Assembly of the State of Colorado: |
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11 | | - | SECTION 1. In Colorado Revised Statutes, 10-16-104, amend |
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12 | | - | (5.5)(a)(III)(B) and (21)(a) as follows: |
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13 | | - | 10-16-104. Mandatory coverage provisions - definitions - rules. |
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14 | | - | (5.5) Behavioral, mental health, and substance use disorders - rules. |
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15 | | - | (a) (III) (B) A health benefit plan subject to this subsection (5.5) must |
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16 | | - | provide coverage without prior authorization for a five-day supply of at |
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17 | | - | least one of the federal food and drug administration-approved |
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18 | | - | FDA-APPROVED drugs for the treatment of opioid dependence; except that |
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19 | | - | this requirement is limited to a first request within a twelve-month period. |
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20 | | - | (21) Oral anticancer medication. (a) Any health benefit plan that |
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21 | | - | provides coverage for cancer chemotherapy treatment shall provide |
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22 | | - | NOTE: This bill has been prepared for the signatures of the appropriate legislative |
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23 | | - | officers and the Governor. To determine whether the Governor has signed the bill |
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24 | | - | or taken other action on it, please consult the legislative status sheet, the legislative |
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25 | | - | history, or the Session Laws. |
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26 | | - | ________ |
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27 | | - | Capital letters or bold & italic numbers indicate new material added to existing law; dashes |
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28 | | - | through words or numbers indicate deletions from existing law and such material is not part of |
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29 | | - | the act. coverage for prescribed, orally administered anticancer medication that has |
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30 | | - | been approved by the federal food and drug administration FDA and is used |
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31 | | - | to kill or slow the growth of cancerous cells. The orally administered |
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32 | | - | medication shall be provided at a cost to the covered person not to exceed |
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33 | | - | the coinsurance percentage or the copayment amount as is applied to an |
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34 | | - | intravenously administered or an injected cancer medication prescribed for |
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35 | | - | the same purpose. A medication provided pursuant to this subsection (21) |
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36 | | - | shall be prescribed only upon a finding that it is medically necessary by the |
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37 | | - | treating physician for the purpose of killing or slowing the growth of |
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38 | | - | cancerous cells in a manner that is in accordance with nationally accepted |
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39 | | - | standards of medical practice, clinically appropriate in terms of type, |
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40 | | - | frequency, extent site, and duration, and not primarily for the convenience |
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41 | | - | of the patient, physician, or other health-care provider. This subsection (21) |
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42 | | - | does not require the use of orally administered medications as a replacement |
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43 | | - | for other cancer medications. Nothing in this subsection (21) prohibits |
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44 | | - | coverage for oral generic medications in a health benefit plan. Nothing in |
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45 | | - | this subsection (21) prohibits a carrier from applying an appropriate |
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46 | | - | formulary or other clinical management to any medication described in this |
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47 | | - | subsection (21). For the purposes of this subsection (21), the treating |
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48 | | - | physician for a patient covered under a health maintenance organization's |
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49 | | - | health benefit plan shall be a physician who is designated by and affiliated |
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50 | | - | with the health maintenance organization. |
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51 | | - | SECTION 2. In Colorado Revised Statutes, 10-16-104.6, amend |
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52 | | - | (1) introductory portion as follows: |
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53 | | - | 10-16-104.6. Off-label use of cancer drugs. (1) A health benefit |
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54 | | - | plan that provides coverage for prescription drugs shall not limit or exclude |
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55 | | - | coverage for any drug approved by the United States food and drug |
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56 | | - | administration FDA for use in the treatment of cancer on the basis that the |
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57 | | - | drug has not been approved by the United States food and drug |
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58 | | - | administration FDA for the treatment of the specific type of cancer for |
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59 | | - | which the drug is prescribed if: |
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60 | | - | SECTION 3. In Colorado Revised Statutes, 10-16-112.5, amend |
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61 | | - | (7)(c)(I) as follows: |
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62 | | - | 10-16-112.5. Prior authorization for health-care services - |
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63 | | - | disclosures and notice - determination deadlines - criteria - limits and |
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64 | | - | exceptions - definitions - rules. (7) Definitions. As used in this section: |
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65 | | - | PAGE 2-HOUSE BILL 22-1264 (c) "Medical necessity" means a determination by the carrier that a |
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66 | | - | prudent provider would provide a particular covered health-care service to |
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67 | | - | a patient for the purpose of preventing, diagnosing, or treating an illness, |
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68 | | - | injury, disease, or symptom in a manner that is: |
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69 | | - | (I) In accordance with generally accepted standards of medical |
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70 | | - | practice and approved by the federal food and drug administration |
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71 | | - | FDA or |
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72 | | - | other required agency; |
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73 | | - | SECTION 4. In Colorado Revised Statutes, 10-16-124.7, amend |
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74 | | - | (3)(a) as follows: |
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75 | | - | 10-16-124.7. Opioid analgesics with abuse-deterrent properties |
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76 | | - | - study - definitions. (3) As used in this section: |
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77 | | - | (a) "Abuse-deterrent opioid analgesic drug product" means a brand |
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78 | | - | or generic opioid analgesic drug product approved by the United States food |
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79 | | - | and drug administration FDA with abuse-deterrence labeling claims that |
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80 | | - | indicate that the drug product is expected to result in a meaningful reduction |
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81 | | - | in abuse. |
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82 | | - | SECTION 5. In Colorado Revised Statutes, 10-16-148, repeal (2) |
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83 | | - | as follows: |
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84 | | - | 10-16-148. Medication-assisted treatment - limitations on |
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85 | | - | carriers - rules. (2) As used in this section, "FDA" means the food and |
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86 | | - | drug administration in the United States department of health and human |
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87 | | - | services. |
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88 | | - | SECTION 6. Act subject to petition - effective date. This act |
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89 | | - | takes effect at 12:01 a.m. on the day following the expiration of the |
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90 | | - | ninety-day period after final adjournment of the general assembly; except |
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91 | | - | that, if a referendum petition is filed pursuant to section 1 (3) of article V |
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92 | | - | of the state constitution against this act or an item, section, or part of this act |
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93 | | - | within such period, then the act, item, section, or part will not take effect |
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94 | | - | unless approved by the people at the general election to be held in |
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95 | | - | PAGE 3-HOUSE BILL 22-1264 November 2022 and, in such case, will take effect on the date of the official |
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96 | | - | declaration of the vote thereon by the governor. |
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97 | | - | ____________________________ ____________________________ |
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98 | | - | Alec Garnett Steve Fenberg |
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99 | | - | SPEAKER OF THE HOUSE PRESIDENT OF |
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100 | | - | OF REPRESENTATIVES THE SENATE |
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101 | | - | ____________________________ ____________________________ |
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102 | | - | Robin Jones Cindi L. Markwell |
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103 | | - | CHIEF CLERK OF THE HOUSE SECRETARY OF |
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104 | | - | OF REPRESENTATIVES THE SENATE |
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105 | | - | APPROVED________________________________________ |
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106 | | - | (Date and Time) |
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107 | | - | _________________________________________ |
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108 | | - | Jared S. Polis |
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109 | | - | GOVERNOR OF THE STATE OF COLORADO |
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110 | | - | PAGE 4-HOUSE BILL 22-1264 |
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| 13 | + | ONCERNING UPDATING REFERENCE S TO THE FEDERAL FOOD AND101 |
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| 14 | + | DRUG ADMINISTRATION IN TH E HEALTH INSURANCE LAW .102 |
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| 15 | + | Bill Summary |
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| 16 | + | (Note: This summary applies to this bill as introduced and does |
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| 17 | + | not reflect any amendments that may be subsequently adopted. If this bill |
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| 18 | + | passes third reading in the house of introduction, a bill summary that |
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| 19 | + | applies to the reengrossed version of this bill will be available at |
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| 20 | + | http://leg.colorado.gov/ |
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| 21 | + | .) |
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| 22 | + | Statutory Revision Committee. The bill strikes references to the |
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| 23 | + | federal food and drug administration in the health insurance code and |
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| 24 | + | replaces the references with the term "FDA", which is defined for the |
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| 25 | + | entire code to mean the federal food and drug administration. |
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| 26 | + | SENATE |
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| 27 | + | 3rd Reading Unamended |
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| 28 | + | April 7, 2022 |
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| 29 | + | SENATE |
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| 30 | + | 2nd Reading Unamended |
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| 31 | + | April 6, 2022 |
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| 32 | + | HOUSE |
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| 33 | + | 3rd Reading Unamended |
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| 34 | + | March 17, 2022 |
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| 35 | + | HOUSE |
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| 36 | + | 2nd Reading Unamended |
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| 37 | + | March 16, 2022 |
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| 38 | + | HOUSE SPONSORSHIP |
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| 39 | + | Valdez D. and Woodrow, Lynch, Pico, Boesenecker, Esgar, Exum, Jodeh, Snyder |
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| 40 | + | SENATE SPONSORSHIP |
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| 41 | + | Moreno and Woodward, Kirkmeyer, Zenzinger, Priola |
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| 42 | + | Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. |
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| 43 | + | Capital letters or bold & italic numbers indicate new material to be added to existing statute. |
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| 44 | + | Dashes through the words indicate deletions from existing statute. Be it enacted by the General Assembly of the State of Colorado:1 |
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| 45 | + | SECTION 1. In Colorado Revised Statutes, 10-16-104, amend2 |
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| 46 | + | (5.5)(a)(III)(B) and (21)(a) as follows:3 |
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| 47 | + | 10-16-104. Mandatory coverage provisions - definitions -4 |
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| 48 | + | rules. (5.5) Behavioral, mental health, and substance use disorders5 |
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| 49 | + | - rules. (a) (III) (B) A health benefit plan subject to this subsection (5.5)6 |
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| 50 | + | must provide coverage without prior authorization for a five-day supply7 |
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| 51 | + | of at least one of the federal food and drug administration-approved8 |
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| 52 | + | FDA- |
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| 53 | + | APPROVED drugs for the treatment of opioid dependence; except that9 |
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| 54 | + | this requirement is limited to a first request within a twelve-month period.10 |
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| 55 | + | (21) Oral anticancer medication. (a) Any health benefit plan11 |
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| 56 | + | that provides coverage for cancer chemotherapy treatment shall provide12 |
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| 57 | + | coverage for prescribed, orally administered anticancer medication that13 |
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| 58 | + | has been approved by the federal food and drug administration |
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| 59 | + | FDA and14 |
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| 60 | + | is used to kill or slow the growth of cancerous cells. The orally15 |
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| 61 | + | administered medication shall be provided at a cost to the covered person16 |
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| 62 | + | not to exceed the coinsurance percentage or the copayment amount as is17 |
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| 63 | + | applied to an intravenously administered or an injected cancer medication18 |
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| 64 | + | prescribed for the same purpose. A medication provided pursuant to this19 |
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| 65 | + | subsection (21) shall be prescribed only upon a finding that it is medically20 |
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| 66 | + | necessary by the treating physician for the purpose of killing or slowing21 |
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| 67 | + | the growth of cancerous cells in a manner that is in accordance with22 |
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| 68 | + | nationally accepted standards of medical practice, clinically appropriate23 |
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| 69 | + | in terms of type, frequency, extent site, and duration, and not primarily for24 |
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| 70 | + | the convenience of the patient, physician, or other health-care provider.25 |
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| 71 | + | This subsection (21) does not require the use of orally administered26 |
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| 72 | + | medications as a replacement for other cancer medications. Nothing in27 |
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| 73 | + | 1264 |
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| 74 | + | -2- this subsection (21) prohibits coverage for oral generic medications in a1 |
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| 75 | + | health benefit plan. Nothing in this subsection (21) prohibits a carrier2 |
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| 76 | + | from applying an appropriate formulary or other clinical management to3 |
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| 77 | + | any medication described in this subsection (21). For the purposes of this4 |
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| 78 | + | subsection (21), the treating physician for a patient covered under a health5 |
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| 79 | + | maintenance organization's health benefit plan shall be a physician who6 |
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| 80 | + | is designated by and affiliated with the health maintenance organization.7 |
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| 81 | + | SECTION 2. In Colorado Revised Statutes, 10-16-104.6, amend8 |
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| 82 | + | (1) introductory portion as follows:9 |
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| 83 | + | 10-16-104.6. Off-label use of cancer drugs. (1) A health benefit10 |
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| 84 | + | plan that provides coverage for prescription drugs shall not limit or11 |
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| 85 | + | exclude coverage for any drug approved by the United States food and12 |
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| 86 | + | drug administration FDA for use in the treatment of cancer on the basis13 |
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| 87 | + | that the drug has not been approved by the United States food and drug14 |
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| 88 | + | administration FDA for the treatment of the specific type of cancer for15 |
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| 89 | + | which the drug is prescribed if:16 |
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| 90 | + | SECTION 3. In Colorado Revised Statutes, 10-16-112.5, amend17 |
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| 91 | + | (7)(c)(I) as follows:18 |
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| 92 | + | 10-16-112.5. Prior authorization for health-care services -19 |
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| 93 | + | disclosures and notice - determination deadlines - criteria - limits and20 |
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| 94 | + | exceptions - definitions - rules. (7) Definitions. As used in this section:21 |
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| 95 | + | (c) "Medical necessity" means a determination by the carrier that22 |
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| 96 | + | a prudent provider would provide a particular covered health-care service23 |
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| 97 | + | to a patient for the purpose of preventing, diagnosing, or treating an24 |
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| 98 | + | illness, injury, disease, or symptom in a manner that is:25 |
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| 99 | + | (I) In accordance with generally accepted standards of medical26 |
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| 100 | + | practice and approved by the federal food and drug administration FDA27 |
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| 101 | + | 1264 |
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| 102 | + | -3- or other required agency;1 |
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| 103 | + | SECTION 4. In Colorado Revised Statutes, 10-16-124.7, amend2 |
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| 104 | + | (3)(a) as follows:3 |
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| 105 | + | 10-16-124.7. Opioid analgesics with abuse-deterrent4 |
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| 106 | + | properties - study - definitions. (3) As used in this section:5 |
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| 107 | + | (a) "Abuse-deterrent opioid analgesic drug product" means a6 |
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| 108 | + | brand or generic opioid analgesic drug product approved by the United7 |
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| 109 | + | States food and drug administration FDA with abuse-deterrence labeling8 |
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| 110 | + | claims that indicate that the drug product is expected to result in a9 |
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| 111 | + | meaningful reduction in abuse.10 |
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| 112 | + | SECTION 5. In Colorado Revised Statutes, 10-16-148, repeal (2)11 |
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| 113 | + | as follows:12 |
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| 114 | + | 10-16-148. Medication-assisted treatment - limitations on13 |
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| 115 | + | carriers - rules. (2) As used in this section, "FDA" means the food and14 |
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| 116 | + | drug administration in the United States department of health and human15 |
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| 117 | + | services.16 |
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| 118 | + | SECTION 6. Act subject to petition - effective date. This act17 |
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| 119 | + | takes effect at 12:01 a.m. on the day following the expiration of the18 |
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| 120 | + | ninety-day period after final adjournment of the general assembly; except19 |
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| 121 | + | that, if a referendum petition is filed pursuant to section 1 (3) of article V20 |
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| 122 | + | of the state constitution against this act or an item, section, or part of this21 |
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| 123 | + | act within such period, then the act, item, section, or part will not take22 |
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| 124 | + | effect unless approved by the people at the general election to be held in23 |
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| 125 | + | November 2022 and, in such case, will take effect on the date of the24 |
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| 126 | + | official declaration of the vote thereon by the governor.25 |
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| 127 | + | 1264 |
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| 128 | + | -4- |
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