Beginning on January 1, 2028, a health insurance carrier (carrier) of an individual or group health benefit plan in Colorado (plan) shall, when calculating a covered person's contribution to an out-of-pocket maximum or cost-sharing requirement under the plan, account for and credit to the covered person's contribution an out-of-pocket expense that the covered person incurs by purchasing a prescription drug directly from a pharmacy or direct-to-consumer platform (contribution credit). The carrier shall apply the contribution credit to the out-of-pocket maximum or cost-sharing requirement that is applicable in the plan year in which the out-of-pocket expense was incurred. To receive a contribution credit, a covered person must provide to the carrier proof of payment for a direct purchase of a prescription drug, such as an itemized receipt or pharmacy record, within 90 days after making the purchase (proof of payment). The carrier may request additional information or documentation if the proof of payment is insufficient or incomplete. The carrier shall not apply a contribution credit in the following circumstances:For an amount of a covered person's out-of-pocket expense incurred by the direct purchase of a prescription drug that is greater than the amount the covered person would have incurred if they had obtained the same prescription drug in the same plan year from an in-network pharmacy and pursuant to the terms of their plan;If the covered person does not provide proof of payment;If the covered person incurred the out-of-pocket expense by purchasing a prescription drug that is not covered under the formulary of the covered person's plan, unless the carrier grants an exception; orIf the covered person does not comply with the carrier's utilization management processes, including prior authorization and step therapy protocols required under the covered person's plan.(Note: This summary applies to this bill as enacted.)
The bill states that the Colorado prescription drug affordability review board has no authority to perform an affordability review of, or to establish an upper payment limit for, a prescription drug that is:Designated as a drug for a rare disease or condition by the food and drug administration (FDA) of the federal department of health and human services; orA licensed biological product that is derived from human whole blood or plasma as indicated on product labeling approved by the FDA.(Note: This summary applies to the reengrossed version of this bill as introduced in the second house.)
Section 2 of the act repeals a requirement that health-care profession regulators adopt rules that require each licensed health-care provider, as a condition of renewing, reactivating, or reinstating a license, to complete up to 4 credit hours of training per licensing cycle in order to demonstrate competency regarding topics related to prescribing drugs and treatment. Section 3 authorizes the Colorado dental board to adopt rules that require every dentist, dental therapist, and dental hygienist, as a condition of renewing, reactivating, or reinstating a license, to complete up to 4 credit hours of training per licensing cycle regarding topics related to prescribing drugs and treatment. Section 4 requires a licensed veterinarian to complete at least 1 hour of training per renewal period regarding topics related to prescribing drugs and treatment. Section 5 changes the frequency at which specific health-care facilities are required to apply for a license issued by the department of public health and environment from annually to every 2 years. Under current law, a health-care facility is required to screen each uninsured patient for eligibility for public health insurance programs and discounted care (screening) utilizing a single uniform application developed by the department of health care policy and financing (state department). Sections 6 through 11 change this requirement by:Changing the method used to conduct the screening from a uniform application to use of a third-party resource, such as a major credit bureau, or use of a uniform screening questionnaire (questionnaire) developed by the state department;Allowing a health-care facility the option of screening a patient for eligibility for the health-care facility's financial assistance program;Requiring a health-care facility to provide specified notifications upon completion of the screening;Creating an application for discounted care (application) for use by a health-care facility upon completion of the screening through which additional information is requested from a patient to determine whether the patient qualifies or is likely to qualify for public health-care coverage or discounted care;Requiring a health-care facility to provide specified notice and appeal rights to a patient upon completion and review of the application; andRequiring the state department to adopt rules regarding the questionnaire and application. Section 11 also narrows state department review requirements of health-care facilities' and licensed health-care professionals' billing for patients who are indigent. The act prohibits the state department from making changes to regulatory documents or imposing new requirements unless the changes or new requirements are adopted by rule by specified dates and are subject to stakeholder engagement. Section 12 requires the state department to establish by rule the content and format of the information each hospital must provide to the state department for a hospital transparency report at least 30 days prior to the hospital's fiscal year. The act changes the deadline for a hospital to submit to the state department an annual audited financial statement from 120 days to 150 days after the end of the hospital's fiscal year. Current law requires that each hospital has a minimum of 15 days to review the hospital transparency report; the act specifies that the review period is 15 business days and requires that a statewide hospital association must also have a minimum of 15 business days to review the report.(Note: This summary applies to this bill as enacted.)
If certain conditions are met, the act requires health benefit plans that provide hospital, surgical, or medical expense insurance to provide reimbursement for health-care services provided by a pharmacist that are within the pharmacist's scope of practice without entering into a collaborative pharmacy practice agreement. Similarly, under the medical assistance program (medicaid), the act authorizes reimbursement for services that are within a pharmacist's scope of practice and not duplicative of other pharmacist services or programs reimbursed by medicaid. Further, solely on the basis of the type of license or certification, a health benefit plan or health insurance company (carrier) shall not discriminate against a pharmacist who is acting within the scope of the pharmacist's license or certification under state law, with respect to participation, referral, reimbursement of covered services, or indemnification, or prohibit a pharmacist from membership in a provider network; except that, in selecting pharmacist providers, the act does not:Prohibit a health benefit plan or carrier from including providers in its provider network only to the extent necessary to meet the needs of the plan or from limiting referrals or establishing quality control measures;Require a health benefit plan or carrier to contract with any provider willing to abide by the terms and conditions for participation established by the health benefit plan or carrier; orRequire coverage for any health-care service that is not otherwise covered. The act makes changes to the definitions in the pharmacy practice statutes to include a definition for 'final product verification'. For drug, device, or product orders that are not for controlled substances, final product verification may be delegated by a supervising pharmacist to a certified pharmacy technician or pharmacy intern. A pharmacy or other outlet shall have a continuous quality assessment system in place to periodically verify the accuracy of the final drug, device, or product and must create a plan for final product verification, including how pharmacists' hours will be maintained to provide direct patient care. The state board of pharmacy is required to adopt rules relating to final product verification no later than December 31, 2026. Under current law, a pharmacist may administer certain tests to patients who are 12 years old or older for certain conditions and prescribe drugs to treat the tested conditions. The act adds to the definition of the 'practice of pharmacy' independent prescriptive authority for drugs that are not controlled substances, drug categories, or devices that are prescribed to patients who are 5 years old or older but under 12 years old for conditions that do not require a new diagnosis, that are minor and self-limiting, or that have a test that guides diagnosis and are not medications that may only be prescribed pursuant to a certified education program and a limited distribution network. If a pharmacist tests or treats any patient who is under 18 years old, the act requires a pharmacist to notify the patient's primary care provider consistent with health-care privacy laws or, if the patient does not have or disclose a primary care provider, refer the patient to a primary care provider for further care.(Note: This summary applies to this bill as enacted.)
The act requires an institution of higher education (institution) that operates a student health center to provide abortion medication to all students enrolled at the institution. The act requires an institution that has an on-site prescription drug outlet or other outlet to maintain a stock of and provide access to abortion medication to students enrolled at the institution. The act requires an institution that does not have an on-site prescription drug outlet or other outlet to either submit a prescription for abortion medication to an off-campus prescription drug outlet or other outlet or dispense abortion medication through the institution's student health center if permitted by the student health center's licensure. The act prohibits an institution from knowingly providing personally identifiable information contained in a student's patient records, billing records, or precise location data related to accessing abortion medication in response to a request from another state seeking to impose liability for accessing abortion medication. An institution is not required to provide access to or stock abortion medication if doing so would jeopardize an institution's federal grant participation, require the institution to deviate from generally accepted billing practices, modify the generally accepted standards of medical practice, or conflict with the institution's sincerely held religious beliefs or practices.(Note: This summary applies to this bill as enacted.)
The bill makes it an unfair or deceptive trade practice under the "Colorado Consumer Protection Act" for a facility or medical practice providing cosmetic, aesthetic, wellness, longevity, or lifestyle treatments involving the administration or use of prescription drugs, including injectable and sterile drug products (medical spa), to:Acquire or receive a prescription drug from a person not legally authorized to distribute or transfer the prescription drug;Fail to store, handle, prepare, or administer a prescription drug in accordance with manufacturer requirements, applicable federal and state law, or generally accepted standards of medical practice;Permit an individual to prescribe or administer prescription drugs outside the scope of the individual's state-issued credential;Fail to maintain reasonable safeguards to prevent contamination, diversion, theft, or misuse of prescription drugs;Represent that a prescription drug is safe or effective in a manner inconsistent with federal law or federal food and drug administration-approved labeling; has sponsorship, approval, characteristics, ingredients, uses, or benefits that it does not have; or is approved by the federal food and drug administration when it is not;Fail to designate a licensed health-care provider with prescriptive authority to provide clinical oversight of prescription drugs used at the medical spa; orFail to create, maintain, or produce to the attorney general or a district attorney records of serious adverse events involving patients.The attorney general or a district attorney may enforce a violation of a prohibited action specified in the bill. The attorney general may adopt rules to implement the bill.(Note: This summary applies to this bill as introduced.)
The act provides that, if the action is undertaken in accordance with applicable federal and state law:A licensed person may compound a drug or device in the state;A state-licensed pharmacy or a distribution facility registered with the federal food and drug administration (licensed 503B outsourcing facility) may supply a compounded drug or device to a licensed health-care provider, pharmacy, facility, or organization; andA licensed health-care provider, pharmacy, facility, or organization may obtain, dispense, or administer a compounded drug or device supplied by a state-licensed pharmacy or a licensed 503B outsourcing facility. In addition, the act prohibits the state board of pharmacy from adopting rules that are more restrictive than federal or state law regarding the compounding of drugs or devices by licensed 503B outsourcing facilities. Current law exempts drugs that are intended solely for investigational use by experts qualified by scientific training and experience and that are plainly labeled for investigational use only from the sales and delivery prohibition for new drugs. The act also exempts from the prohibition:Drugs that are reviewed by an institutional review board and plainly labeled for investigational use only; andCompounded drugs and devices if the compounding of the drug or device is undertaken in accordance with applicable federal and state law.(Note: This summary applies to this bill as enacted.)
The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medication, which custom-made medications that, is defined in the bill as a drug that is: Created by combining, mixing, or altering other drugs or drug substances; Intended to be used by humans for obesity or weight management and contains an active ingredient that is named in a drug approved by the federal food and drug administration (FDA); and A glucagon-like peptide-1 receptor agonist drug, known as a 'GLP-1' drug. Unlike mass-produced medications, a compound weight-loss medication is not subject to approval by the federal food and drug administration (FDA). A person may not sell, transfer, or distribute a compounded weight-loss medication unless the person confirms that the medication: FDA. Is made from bulk drug substances and drugs that are approved by the FDA when such approval is required; Was manufactured in compliance with FDA processes; Contains bulk drug substances that are pharmaceutical grade and are accompanied by a certificate of analysis containing information that is material to the safety and efficacy of the bulk drug substances; Was manufactured at a facility that is registered with the FDA and passed an FDA inspection within the previous 2 years; and Is verified for purity and accurate dosage. Labels for compounded weight-loss medications must list all active and inactive ingredients, the quantity of those ingredients, and the ingredients' country of origin. There must also be a warning on the label stating that the compounded weight-loss medication has not been FDA-approved, has inadequate evidence of safety or efficacy, and has known and unknown side effects. A person must also provide certain disclosures to a patient when prescribing compounded weight-loss medications. The bill prohibits the use of false or misleading claims, including unsubstantiated claims, when advertising or promoting compounded weight-loss medications. A person that sells, transfers, or distributes compounded weight-lost medication must keep records related to the compounded weight-loss medication for at least 2 years after the date of expiration of the compounded weight-loss medication and make those records available for inspection by the state board of pharmacy. The state board of pharmacy may issue fines of up to $1,000 per dose of compounded weight-loss medications that are sold or distributed in violation of the bill and may revoke a pharmacy or business license for violations. The attorney general has authority to enforce this bill as a deceptive trade practice under the 'Colorado Consumer Protection Act'. The bill establishes that a person engages in a deceptive trade practice when the person : Makes a false or misleading claim about a compounded weight-loss medication when advertising or promoting the medication; Distributes a compounded weight-loss medication when not legally authorized to distribute or transfer the drug used in the compounded weight-loss medication; Makes a materially false or misleading representation that the compounded weight-loss medication is approved by the FDA when the medication is not approved by the FDA; or Makes a materially false, misleading, or unverified claim regarding the efficacy, safety, performance, outcomes, or benefits of the compounded weight-loss medication. The attorney general has exclusive authority to enforce the bill as a deceptive trade practice under the 'Colorado Consumer Protection Act'. There is no private right of action for a violation of the bill, and the provisions of the bill may only be enforced by the attorney general. The bill does not apply to certain facilities or in certain circumstances, including: The administration of a compounded weight-loss medication by a practitioner at certain hospitals, clinics, and other health facilities licensed by the department of public health and environment; Long term care facilities; Assisted living residences; Home care agencies; The program of all-inclusive care for the elderly or PACE program; Adult day care facilities; or The compounding of drugs for animal use.(Note: Italicized words indicate new material added to the original summary; dashes through words indicate deletions from the original summary.)(Note: This summary applies to the reengrossed version of this bill as introduced in the second house.)
The act requires a health insurance carrier that provides prescription drug benefits to require that:The utilization review requirements, including prior authorization and step therapy, for a non-opioid drug prescribed and approved by the federal food and drug administration (FDA) for the treatment or management of chronic or acute pain (non-opioid pain management drug) are no more restrictive than the least restrictive utilization review requirements for opioid drugs prescribed for the treatment or management of chronic or acute pain; andThe cost-sharing, copayment, or deductible for a non-opioid pain management drug is not greater than the cost-sharing, copayment, or deductible for an opioid drug prescribed for the treatment or management of chronic or acute pain. The act requires each individual and small group health benefit plan issued or renewed on or after January 1, 2027, and each large employer health benefit plan issued or renewed on and after January 1, 2028, to ensure there is at least one non-opioid pain management drug available as a clinically appropriate alternative for an opioid pain management drug. If the division of insurance determines that coverage for a non-opioid pain management drug offered by individual and small group health benefit plans requires state defrayal of the cost of coverage, the requirement to make a non-opioid pain management drug available is inoperative. The state employee health benefit plan is excluded from the requirements of the act. The act appropriates $15,415 to the department of regulatory agencies for use by the division of insurance to implement the act.(Note: This summary applies to this bill as enacted.)
The bill creates the "Prescription Drug Optimized Sourcing Transparency and Integrity Act" to prohibit a pharmacy benefit manager (PBM) or a health-care consultant from knowingly making or disseminating false or misleading statements or claims to a self-insured employer or policyholder about the legality or safety of a lawful prescription drug optimized sourcing program established by a pharmacy stewardship program.Upon written request by a self-insured employer, a PBM or health-care consultant is required to provide certain cost information for each prescription drug dispensed under the health benefit plan.The prohibition and information-sharing provisions of the bill do not restrict or limit the rights of a self-insured employer to purchase prescription drugs through and contract for a lawful prescription drug optimized sourcing program. The bill also recognizes that a pharmacy stewardship program is an effective cost-containment tool and is authorized when implemented in compliance with federal law and with the bill.(Note: This summary applies to this bill as introduced.)
