justicedao/ipfs_state_laws huggingface dataset:
836-200-0315 Disclosures; Form and Contents (1) The disclosures required by Oregon Laws 2011, chapter 499, section 2(4) shall be in 12-point font or larger, on the first content page of marketing materials, including websites, and in the first content page of contracts with retainer medical patients, including the retainer medical agreement. (2) In addition to the disclosures required by Oregon Laws 2011, chapter 499, section 2(4), a retainer medical practice shall make the following written information available to retainer medical patients and prospective retainer medical patients by prominently disclosing, in 12-point font or larger, in all marketing materials, including websites and in the medical retainer agreement: (a) “The Department of Consumer and Business Services issued a certification to this practice. You can contact consumer advocates at the Division of Financial Regulation at (888) 877-4894, DFR.InsuranceHelp.dcbs.oregon.gov, or dfr.oregon.gov.”; (b) A statement explaining the retainer medical practice’s cancellation and refund policy; (c) A statement explaining how fees are charged by the retainer medical practice; and (d) A list of services included for the fees charged. Statutory/Other Authority: ORS 731.244 & Or Laws 2011, ch 499, sec 2-3 Statutes/Other Implemented: ORS 731.244 & Or Laws 2011, ch 499, sec 2-3 History: ID 35-2024, minor correction filed 09/19/2024, effective 09/19/2024 ID 19-2011, f. 11-29-11, cert. ef. 1-1-12
836-200-0401 Statement of Purpose; Authority; Applicability Under the authority of Oregon Laws 2013, chapter 570, section 1, ORS 735.530 to 735.552 shall be administered and enforced in accordance with the Insurance Code. The rules promulgated under ORS 735.530 to 735.552 are authorized and reasonably necessary for, or as an aid to, the effectuation of the Insurance Code. Statutory/Other Authority: ORS 731.244 & 735.532 Statutes/Other Implemented: ORS 735.530 - 735.552 History: ID 6-2025, amend filed 07/29/2025, effective 08/01/2025 ID 42-2024, temporary amend filed 12/23/2024, effective 01/01/2025 through 06/29/2025 ID 16-2017, amend filed 12/28/2017, effective 01/01/2018 ID 12-2014, f. & cert. ef. 7-21-14
836-200-0406 Application Requirements for Pharmacy Benefit Manager (1) Each pharmacy benefit manager conducting business in Oregon must obtain a license to transact business as a pharmacy benefit manager from the Department of Consumer and Business Services. To obtain a license under this rule, an applicant must submit a Pharmacy Benefit Manager Application, in form as posted on the department’s Division of Financial Regulation website. (2) An application for licensure as a pharmacy benefit manager shall include: (a) The name, address and FEIN of the pharmacy benefit manager; (b) The names, business addresses and job titles of the principal officers of the pharmacy benefit manager; (c) The name, business address, business telephone number, business e-mail address and job title of the officer or employee who should be contacted regarding any pharmacy benefit manager regulatory compliance concerns; (d) The business telephone number and business e-mail address where pharmacy benefit manager personnel directly responsible for the processing of appeals may be contacted; and (e) Information relevant to a determination of the circumstances listed in ORS 735.533(1). (3) A pharmacy benefit manager shall provide the department with written notification of any change to its licensure information not later than 30 days after the date of change. (4) The application for licensure as a pharmacy benefit manager must include a fee of $1100. Statutory/Other Authority: ORS 731.244 & 735.532 Statutes/Other Implemented: ORS 735.530, 735.532 & OL 2024, ch 87 History: ID 6-2025, amend filed 07/29/2025, effective 08/01/2025 ID 42-2024, temporary amend filed 12/23/2024, effective 01/01/2025 through 06/29/2025 ID 16-2017, amend filed 12/28/2017, effective 01/01/2018 ID 12-2014, f. & cert. ef. 7-21-14
836-200-0411 Renewal of Pharmacy Benefit License (1) All pharmacy benefit manager licenses expire annually on September 1 unless renewed on or before that date. A pharmacy benefit manager must apply for renewal of the license by submitting a renewal application, in form as posted on the department’s Division of Financial Regulation website, to the director of the Department of Consumer and Business Services. The application to renew a license to transact business as a pharmacy benefit manager must include a renewal fee of $1100. (2) A pharmacy benefit manager shall provide the department with written notification of any change to its licensure information not later than 30 days after the date of change. Statutory/Other Authority: ORS 731.244 & 735.532 Statutes/Other Implemented: ORS 735.530, 735.532 & OL 2024, ch 87 History: ID 6-2025, amend filed 07/29/2025, effective 08/01/2025 ID 42-2024, temporary amend filed 12/23/2024, effective 01/01/2025 through 06/29/2025 ID 16-2017, amend filed 12/28/2017, effective 01/01/2018 ID 12-2014, f. & cert. ef. 7-21-14
836-200-0416 Licensure Requirements Not Exclusive Compliance with pharmacy benefit manager licensure requirements is additional to and not in lieu of filing and other requirements established by law for the purpose of doing business in this state, including but not limited to licensure as a third-party administrator under ORS 744.700 et seq and compliance with registration requirements of the Secretary of State applicable to assumed business names and applicable to the business structure of an applicant. Statutory/Other Authority: ORS 731.244 & 735.532 Statutes/Other Implemented: ORS 735.530, 735.532 & OL 2024, ch 87 History: ID 6-2025, amend filed 07/29/2025, effective 08/01/2025 ID 42-2024, temporary amend filed 12/23/2024, effective 01/01/2025 through 06/29/2025 ID 16-2017, amend filed 12/28/2017, effective 01/01/2018 ID 12-2014, f. & cert. ef. 7-21-14
836-200-0421 Service on Licensee The director of the Department of Consumer and Business Services may direct notices and inquiries to, and make service on a pharmacy benefit manager at, the address shown on the current license of the pharmacy benefit manager on file with the director, in the manner provided in ORS Chapter 183. Statutory/Other Authority: ORS 731.244 & 735.532 Statutes/Other Implemented: ORS 735.530 - 735.552, 731.296, 731.236 & OL 2024, ch 87 History: ID 6-2025, amend filed 07/29/2025, effective 08/01/2025 ID 42-2024, temporary amend filed 12/23/2024, effective 01/01/2025 through 06/29/2025 ID 16-2017, amend filed 12/28/2017, effective 01/01/2018 ID 12-2014, f. & cert. ef. 7-21-14
836-200-0436 Submission of Complaints (1) Any complaint filed with the Department of Consumer and Business Services by a pharmacy, or by an entity acting on behalf of a pharmacy, alleging a violation of ORS 735.530 to 735.552, shall be in form as posted on the department’s Division of Financial Regulation website. (2) A complaint shall include documentation of the alleged violation and of all efforts made to resolve the alleged violation prior to filing of the complaint. Statutory/Other Authority: ORS 731.244 & 735.532 Statutes/Other Implemented: ORS 735.530 - 735.552 History: ID 6-2025, amend filed 07/29/2025, effective 08/01/2025 ID 42-2024, temporary amend filed 12/23/2024, effective 01/01/2025 through 06/29/2025 ID 16-2017, adopt filed 12/28/2017, effective 01/01/2018
836-200-0500 Purpose and Statutory Authority The purpose of OAR 836-200-0500 to 836-200-0560 is to administer the Oregon Prescription Drug Price Transparency Program established in the Department of Consumer and Business Services for the purposes of providing notice and disclosure of information relating to the cost and pricing of prescription drugs in order to provide accountability for prescription drug pricing. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 & 646A.692 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0510 Account Generation Requirement (1) Beginning in 2020 and for any subsequent year, reporting manufacturers must create an online account with the department no later than 30 days after becoming a reporting manufacturer or 10 days prior to a required reporting deadline, whichever is earlier. (2) Reporting manufacturers are responsible for ensuring that they designate at least one contact person, with a valid email address, mailing address, and phone number, in the department’s reporting system for purposes of communications and notices by the department. At least one contact person must be a reporting manufacturer employee who manages access to the account and receipt of trade secret determinations. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0515 Temporary rule language in effect until 08/11/2026. Threshold for Reporting Drug Price Increase (1) No later than July 1, 2019, a reporting manufacturer must report the information described in OAR 836-200-0530(2) to the department regarding each prescription drug for which: (a) The price at any point in 2018 was $100 or more for a one-month supply; and (b) There was a net yearly increase of 10 percent or more in the price of the prescription drug described in subsection (a) of this section during 2018. (2) Beginning March 15, 2020, no later than March 15 annually, a reporting manufacturer must report to the department the information described in OAR 836-200-0530(2) regarding each prescription drug for which: (a) The price at any point during the previous year was $100 or more for a one-month supply; and (b) There was a net yearly increase of 10 percent or more in the price of the prescription drug described in subsection (a) of this section over the course of the previous calendar year. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 1-2026, temporary amend filed 02/12/2026, effective 02/13/2026 through 08/11/2026 ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0520 Threshold for Reporting New Prescription Drug (1) For new prescription drugs introduced on or after March 15, 2019, with a price for a one-month supply that exceeds the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program, the manufacturer must report to the department the information described in OAR 836-200-0531. (2) For new prescription drugs introduced on or after January 1, 2025, the threshold is $950, which is the dollar amount specified for minimum Medicare Part D specialty tier eligibility in the 2024 Final Call Letter from the Centers for Medicare and Medicaid Services. (3) For new prescription drugs introduced prior to January 1, 2025, the threshold is $670, which is the dollar amount specified for minimum Medicare Part D specialty tier eligibility in the 2018 Final Call Letter from the Centers for Medicare and Medicaid Services. (4) The date of introduction is the FDA start marketing date or the date the product is first available for purchase in the United States, whichever is later. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0525 Expectations of Reporting Manufacturers (1) Reporting manufacturers must act in good faith to include all of the information required in a report or a response to a request for additional information under OAR 836-200-0530 to 836-200-0535, and conduct a reasonable investigation to ensure the accuracy and completeness of their reports. (2) If any of the information required in a report or a response to a request for additional information under OAR 836-200-0530 to 836-200-0535 is not available to the reporting manufacturer at the time of the filing due to circumstances outside the manufacturer’s control, the manufacturer must provide any available portion of the required information and a thorough explanation. The explanation must include a description of the missing information and the circumstances contributing to the manufacturer’s inability to meet the requirement. (3) If the information required in a report or a response to a request for additional information under OAR 836-200-0530 to 836-200-0535 is not currently available to the manufacturer but is expected to be available in the future, the manufacturer must provide an explanation and a timeline for providing the required information to the department. (4) When providing information required by ORS 646A.689(2) to (7), reporting manufacturers must act in good faith to limit information provided to the department to information that is necessary for the director’s review and analysis of drug prices. (5) A reporting manufacturer’s failure to comply with sections (1) to (4) of this rule may subject the manufacturer to a civil penalty under OAR 836-200-0560. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 & 646A.692 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0531 Prescription Drug Reporting – New Prescription Drug For new prescription drugs meeting the conditions specified in OAR 836-200-0520, the report furnished to the department must include the following information: (1) The full trade name of the drug (proprietary), full chemical name or biologic product name of the drug (nonproprietary), recognized industry standard drug identification information for the drug as specified on the department’s website, drug strength, drug package size, the date the drug was initially approved by the United States Food and Drug Administration, and the date the drug was introduced in the United States market. (2) The price and dosage of the drug the reporting manufacturer used to determine that the price of the drug for a one-month supply exceeds the threshold defined in OAR 836-200-0520. (3) A description of the marketing used in the introduction of the drug, including the types of marketing, target audience, and associated spending for the four quarters prior to launch and planned costs for the four quarters following launch, with any associated explanation: (a) Types of marketing includes digital (e.g., consumer or industry websites, social media), TV or audio, and other types of promotion; (b) Target audience includes consumers, health care professionals, pharmacy benefit managers, insurance carriers, and other entities in the pharmaceutical supply chain. (4) The methodology used to establish the price of the new prescription drug, including all factors, with any associated impact or explanation, that influenced the decision to set the price of the drug at the level it was first set by the reporting manufacturer following its approval for marketing by the United States Food and Drug Administration. Factors may include, but are not limited to: (a) Other prescription drugs including the drug name, labeler name, and price; (b) Estimated manufacturing costs for the prescription drug; (c) Estimated marketing costs for the prescription drug; (d) Estimated distribution costs for the prescription drug; (e) Estimated costs of ongoing safety and effectiveness research associated with the prescription drug; (f) Other costs for the prescription drug; and, (g) Other costs not specifically associated with the prescription drug. (5) Whether the United States Food and Drug Administration granted the new prescription drug a breakthrough therapy designation or a priority review; (6) If the new prescription drug was not developed by the manufacturer, the date of and the price paid for acquisition of the new prescription drug by the manufacturer; (7) The manufacturer’s estimate of the average number of patients in the United States who will be prescribed the new prescription drug each month; and (8) The research and development costs associated with the new prescription drug that were paid using public funds, including all available information about the sources and uses of these public funds. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, adopt filed 03/26/2025, effective 04/01/2025
836-200-0532 Prescription Drug Reporting – Patient Assistance Programs (1) If a reporting manufacturer offers one or more patient assistance programs to consumers residing in Oregon to reduce consumer out-of-pocket costs for a drug meeting the conditions specified in OAR 836-200-0515, the report furnished to the department under OAR 836-200-0530(2) must have an appendix that includes at least the following information for each patient assistance program relevant to the drug that is the subject of the report: (a) The number of consumers residing in Oregon who participated in the patient assistance program over the previous calendar year; (b) The total dollar value of the coupons, discounts, copayment assistance or other reduction in costs provided to consumers residing in Oregon who participated in the patient assistance program over the previous calendar year; (c) For each drug, the number of refills that qualify for the program, if applicable; (d) If the program expires after a specified period of time, the period of time that the program is available to each consumer; and (e) The eligibility criteria for the program and how eligibility is verified for accuracy. (2) If a reporting manufacturer provides funding for an independent patient assistance program that reduces consumer out-of-pocket costs for a drug meeting the conditions specified in OAR 836-200-0515, the report furnished to the department under OAR 836-200-0530(2) must have an appendix that provides the name of the independent program and includes all of the information specified in section (1) that is available to the manufacturer at the time of the report. If the independent program provides services in addition to reducing consumer out-of-pocket costs for the drug that is the subject of the report, the manufacturer may limit the information provided to the information applicable to the drug that is the subject of the report. Reporting manufacturers that provide funding for independent patient assistance programs must act in good faith to secure this information. (3) Reporting manufacturers that provide funding for a bona fide Independent Charity Patient Assistance Program operating in full compliance with the guidance provided in the Department of Health and Human Services Office of the Inspector General’s Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Notices) are not required to include information about the bona fide Independent Charity Patient Assistance Program in any appendix required by this rule. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, adopt filed 03/26/2025, effective 04/01/2025
836-200-0535 Additional Information Requests (1) Within 60 calendar days of receiving a report from a prescription drug manufacturer in accordance with OAR 836-200-0515 to 836-200-0532, the director or director's designee may submit one or more written requests for supporting documentation or additional information to the manufacturer. (2) The department’s request shall be limited to information necessary to clarify or substantiate the material previously reported, or to enable the department to conduct an analysis of factors affecting drug prices for the purposes of providing recommendations to the Legislature as provided by ORS 646A.689. (3) Within 60 calendar days of receiving the department’s request for supporting documentation or additional information following a report provided in accordance with OAR 836-200-0515 to 836-200-0532, a prescription drug manufacturer must provide a full and complete written response, including any requested documentation. Supporting documentation or additional information submitted will be part of the report published to the department’s website. If the manufacturer asserts that any of the requested information is conditionally exempt from disclosure as a trade secret, the manufacturer must clearly identify the information claimed as trade secret and provide an explanation, as specified under OAR 836-200-0540, for each piece of information that is claimed to be exempt from disclosure. (4) If additional time is needed, within 15 calendar days of receiving the department’s request for supporting documentation or additional information following a report provided in accordance with ORS 646A.689 and OAR 836-200-0515 to 836-200-0532, a prescription drug manufacturer must submit a notice to the department for up to 30 additional days to prepare and submit a response. A drug manufacturer’s request for additional time must be in writing, and must explain the grounds for the request and the need for additional time to prepare a response. The department will automatically grant requests submitted in accordance with this section. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0545 Public Disclosure of Prescription Drug Manufacturer Filings (1) As soon as practicable after receiving a filing from a prescription drug manufacturer under OAR 836-200-0530 to 836-200-0532, the department shall post to its website the name of the manufacturer and the prescription drug that is the subject of the filing. (2) Notwithstanding section (1), if a manufacturer has made a trade secret claim, the information that is the subject of the trade secret claim will not be posted to the department's website until a determination has been made by the department or, in the case of a manufacturer's appeal, the director, as specified by OAR 836-200-0540. (3) No information determined by the department or the director to be exempt from disclosure under OAR 836-200-0540 shall be included in the information posted to the department's website. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 1-2020, amend filed 01/29/2020, effective 02/01/2020 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019
836-200-0550 Consumer Notices to the Department (1) The department shall make available a telephone line and an online mechanism to receive notices from members of the public about increases in the cost of prescription drugs. The department shall prominently display the telephone and online contact information on its website. (2) The department shall include a summary of the notices received in its annual report to the Legislature for that calendar year under ORS 646A.689. Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019