Second Regular Session Seventy-third General Assembly STATE OF COLORADO REVISED This Version Includes All Amendments Adopted on Second Reading in the Second House LLS NO. 22-0786.01 Christy Chase x2008 HOUSE BILL 22-1264 House Committees Senate Committees Agriculture, Livestock, & Water Health & Human Services A BILL FOR AN ACT C ONCERNING UPDATING REFERENCE S TO THE FEDERAL FOOD AND101 DRUG ADMINISTRATION IN TH E HEALTH INSURANCE LAW .102 Bill Summary (Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov/ .) Statutory Revision Committee. The bill strikes references to the federal food and drug administration in the health insurance code and replaces the references with the term "FDA", which is defined for the entire code to mean the federal food and drug administration. SENATE 2nd Reading Unamended April 6, 2022 HOUSE 3rd Reading Unamended March 17, 2022 HOUSE 2nd Reading Unamended March 16, 2022 HOUSE SPONSORSHIP Valdez D. and Woodrow, Lynch, Pico, Boesenecker, Esgar, Exum, Jodeh, Snyder SENATE SPONSORSHIP Moreno and Woodward, Kirkmeyer, Zenzinger Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. Capital letters or bold & italic numbers indicate new material to be added to existing statute. Dashes through the words indicate deletions from existing statute. Be it enacted by the General Assembly of the State of Colorado:1 SECTION 1. In Colorado Revised Statutes, 10-16-104, amend2 (5.5)(a)(III)(B) and (21)(a) as follows:3 10-16-104. Mandatory coverage provisions - definitions -4 rules. (5.5) Behavioral, mental health, and substance use disorders5 - rules. (a) (III) (B) A health benefit plan subject to this subsection (5.5)6 must provide coverage without prior authorization for a five-day supply7 of at least one of the federal food and drug administration-approved8 FDA- APPROVED drugs for the treatment of opioid dependence; except that9 this requirement is limited to a first request within a twelve-month period.10 (21) Oral anticancer medication. (a) Any health benefit plan11 that provides coverage for cancer chemotherapy treatment shall provide12 coverage for prescribed, orally administered anticancer medication that13 has been approved by the federal food and drug administration FDA and14 is used to kill or slow the growth of cancerous cells. The orally15 administered medication shall be provided at a cost to the covered person16 not to exceed the coinsurance percentage or the copayment amount as is17 applied to an intravenously administered or an injected cancer medication18 prescribed for the same purpose. A medication provided pursuant to this19 subsection (21) shall be prescribed only upon a finding that it is medically20 necessary by the treating physician for the purpose of killing or slowing21 the growth of cancerous cells in a manner that is in accordance with22 nationally accepted standards of medical practice, clinically appropriate23 in terms of type, frequency, extent site, and duration, and not primarily for24 the convenience of the patient, physician, or other health-care provider.25 This subsection (21) does not require the use of orally administered26 medications as a replacement for other cancer medications. Nothing in27 1264 -2- this subsection (21) prohibits coverage for oral generic medications in a1 health benefit plan. Nothing in this subsection (21) prohibits a carrier2 from applying an appropriate formulary or other clinical management to3 any medication described in this subsection (21). For the purposes of this4 subsection (21), the treating physician for a patient covered under a health5 maintenance organization's health benefit plan shall be a physician who6 is designated by and affiliated with the health maintenance organization.7 SECTION 2. In Colorado Revised Statutes, 10-16-104.6, amend8 (1) introductory portion as follows:9 10-16-104.6. Off-label use of cancer drugs. (1) A health benefit10 plan that provides coverage for prescription drugs shall not limit or11 exclude coverage for any drug approved by the United States food and12 drug administration FDA for use in the treatment of cancer on the basis13 that the drug has not been approved by the United States food and drug14 administration FDA for the treatment of the specific type of cancer for15 which the drug is prescribed if:16 SECTION 3. In Colorado Revised Statutes, 10-16-112.5, amend17 (7)(c)(I) as follows:18 10-16-112.5. Prior authorization for health-care services -19 disclosures and notice - determination deadlines - criteria - limits and20 exceptions - definitions - rules. (7) Definitions. As used in this section:21 (c) "Medical necessity" means a determination by the carrier that22 a prudent provider would provide a particular covered health-care service23 to a patient for the purpose of preventing, diagnosing, or treating an24 illness, injury, disease, or symptom in a manner that is:25 (I) In accordance with generally accepted standards of medical26 practice and approved by the federal food and drug administration FDA27 1264 -3- or other required agency;1 SECTION 4. In Colorado Revised Statutes, 10-16-124.7, amend2 (3)(a) as follows:3 10-16-124.7. Opioid analgesics with abuse-deterrent4 properties - study - definitions. (3) As used in this section:5 (a) "Abuse-deterrent opioid analgesic drug product" means a6 brand or generic opioid analgesic drug product approved by the United7 States food and drug administration FDA with abuse-deterrence labeling8 claims that indicate that the drug product is expected to result in a9 meaningful reduction in abuse.10 SECTION 5. In Colorado Revised Statutes, 10-16-148, repeal (2)11 as follows:12 10-16-148. Medication-assisted treatment - limitations on13 carriers - rules. (2) As used in this section, "FDA" means the food and14 drug administration in the United States department of health and human15 services.16 SECTION 6. Act subject to petition - effective date. This act17 takes effect at 12:01 a.m. on the day following the expiration of the18 ninety-day period after final adjournment of the general assembly; except19 that, if a referendum petition is filed pursuant to section 1 (3) of article V20 of the state constitution against this act or an item, section, or part of this21 act within such period, then the act, item, section, or part will not take22 effect unless approved by the people at the general election to be held in23 November 2022 and, in such case, will take effect on the date of the24 official declaration of the vote thereon by the governor.25 1264 -4-