reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0220 - License Requirement Not Exclusive

Current through Register Vol. 63, No. 7, July 1, 2024
Compliance with the licensing requirement of OAR 836-200-0200 is additional to and not in lieu of any other requirements established by law
				for the purpose of doing business in this state, including but not limited to
				compliance with filing requirements of the Secretary of State applicable to
				assumed business names and applicable to the business structure of an
				applicant.
Stat. Auth.: ORS
				  731.244
Stats. Implemented: ORS
				  742.426
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0250 - Purpose and Authority

Current through Register Vol. 63, No. 7, July 1, 2024
OAR 836-200-0255  is adopted to implement the provisions of
				Section 3, chapter 561, Oregon Laws 2011. OAR 836-014-0255 applies to a
				contracting entity as defined in Section 1, chapter 561, Oregon Laws 2011
				(Enrolled Senate Bill 634) other than an entity operating under a certificate
				of authority or license issued by the Department of Consumer and Business
				Services that enters into or renews a contract subject to Section 4, chapter
				561, Oregon Laws 2011 on or after January 1, 2012.
Stat. Auth.: ORS
				  731.244 & sec. 3, ch. 561,
				  OL 2011 (Enrolled SB 634)
Stat. Implemented.: Sec. 1 to 5, ch. 561, OL 2011 (Enrolled
				  SB 634))
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0255 - Registration of Contracting Entity

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A contracting entity, as defined in
			 Section 1, chapter 561, Oregon Laws 2011 (Enrolled Senate Bill 634), that is
			 not operating under a certificate of authority or license issued by the
			 Department of Consumer and Business Services shall register annually with the
			 Department of Consumer and Business Services by submitting the following
			 information to the department in the manner requested by the Director, along
			 with a $150 fee:
(a) The official name of the
			 entity and any secondary, alternative or substitute designations;
(b) The mailing address and telephone number
			 of the headquarters of the entity; and
(c) The name and phone number of a
			 representative of the entity who shall serve as the primary contact for the
			 department.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0300 - Statement of Purpose; Authority

Current through Register Vol. 63, No. 7, July 1, 2024
OAR 836-200-0300  to 836-200-0315  are adopted by the Director of
				the Department of Consumer and Business Services pursuant to sections 2 and 3,
				chapter 499, Oregon Laws 2011 (Enrolled Senate Bill 86). The purpose of OAR
				836-200-0300  to 836-200-0315  is to establish the requirements for initial
				certification, disclosure requirements and certification renewal, for a
				retainer medical practice.
Stat. Auth.: ORS
				  731.244 & sec. 2, 3, ch.
				  499, OL 2011 (Enrolled SB 86)
Stats. Implemented: sec. 2, 3, ch. 499, OL 2011 (Enrolled SB
				  86)
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0310 - Retainer Medical Practice Application for Renewal

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The director may renew a retainer medical
			 practice certification if the practice complies with all of the following:
(a) The retainer medical practice completes
			 and submits to the satisfaction of the director a retainer medical practice
			 renewal application as set forth on the website for the Division of Financial
			 Regulation of the Department of Consumer and Business Services at
			 dfr.oregon.gov. The renewal application must be submitted annually before
			 February 1 of each year in accordance with OAR 836-200-0305(2).
(b) The retainer medical practice acts in
			 accordance with the attestations required by OAR 836-200-0305(1).
(c) The retainer medical practice shall
			 provide with the renewal application, the following information for the prior
			 calendar year through December 31:
(A) The
			 total number of retainer medical patients under agreement with the retainer
			 medical practice;
(B) The total
			 number of retainer medical patients that voluntarily terminated the retainer
			 medical agreement;
(C) The total
			 number of patients with whom the retainer medical practice terminated an
			 agreement and the reasons for the terminations;
(D) The total number of applicants declined
			 by the retainer medical practice and the reasons for the declinations;
			 and
(E) Any changes to the
			 information submitted on the applicant's original application for
			 certification.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0315 - Disclosures; Form and Contents

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 The disclosures required by Section 2(4), chapter 499, Oregon Laws 2011 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 Section 2(4), chapter 499, Oregon Laws 2011, 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 Department of Consumer and
			 Business Services at (888) 977-4894, dcbs.insmail@state.or.us, or
			 www.insurance.oregon.gov [File Link Not Available].";
(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.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0401 - Statement of Purpose; Authority; Applicability

Current through Register Vol. 63, No. 7, July 1, 2024
Under the authority of section 1, chapter 570, Oregon Laws
				2013, 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,
				  Sec. 1, Ch. 570, OL 2013, Sec. 1-3, Ch. 73, OL 2017 & 2017 Or Laws ch 73,
				  §§ 1-3
Statutes/Other Implemented: ORS
				  735.530  to
				  735.552
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0406 - Application Requirements for Pharmacy Benefit Manager

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each pharmacy benefit manager conducting
			 business in Oregon must register with the Department of Consumer and Business
			 Services. To register as a pharmacy benefit manager, 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 registration 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 section
			 2(1), chapter 73, Oregon Laws 2017.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0411 - Renewal of Pharmacy Benefit Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(1) All pharmacy benefit manager
			 registrations expire annually on September 1 unless renewed on or before that
			 date. A pharmacy benefit manager must apply for renewal of the registration 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 registration 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 registration
			 information not later than 30 days after the date of change.
Statutory/Other Authority: ORS
				  731.244,
				  735.532,
				  Sec. 2-3, Ch. 73, OL 2017 & 2017 Or Laws ch 73, §§ 1-3
Statutes/Other Implemented: ORS
				  735.530,
				  735.532  & Sec. 2-5, Ch. 73, OL 2017
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0416 - Registration Requirements Not Exclusive

Current through Register Vol. 63, No. 7, July 1, 2024
Compliance with pharmacy benefit manager registration
				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 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,
				  Sec. 2-3, Ch. 73, OL 2017 & 2017 Or Laws ch 73, §§ 1-3
Statutes/Other Implemented: ORS
				  735.530,
				  735.532  & Sec. 2-5, Ch. 73, OL 2017
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0418 - Aggregated Rebate and Payment Reports

Current through Register Vol. 63, No. 7, July 1, 2024
(1) For the
			 purposes of this rule, "health benefit plan" has the meaning defined in ORS
			 743B.005(16).
(2) For the purposes of this rule, "pharmacy
			 benefit manager" has the meaning defined in ORS
			 735.530.
(3) No later than June 1 of each year, a
			 pharmacy benefit manager required to be registered with the Department of
			 Consumer and Business Services must file a report using the form and manner
			 prescribed by the department. The report must contain the following information
			 for the immediately preceding calendar year:
(a) The aggregated amount of rebates, fees,
			 price protection payments, and any other payments the pharmacy benefit manager
			 received from manufacturers related to managing the pharmacy benefits for
			 carriers issuing health benefit plans in this state.
(b) The aggregated amount of any payments, as
			 described in subsection (3)(a) of this rule, that were passed on to carriers
			 issuing health benefit plans in this state.
(c) The aggregated amount of any payments, as
			 described in subsection (3)(a) of this rule, that were passed on to enrollees
			 in a health benefit plan at the point of sale in this state.
(d) The aggregated amount of any payments, as
			 described in subsection (3)(a) of this rule, that were retained as revenue by
			 the pharmacy benefit manager.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0421 - Service on Registrant

Current through Register Vol. 63, No. 7, July 1, 2024
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 registration of the
				pharmacy benefit manager on file with the director, in the manner provided in
				ORS Chapter 183.
Statutory/Other Authority: 2017 Or Laws ch 73, §§
				  1-3, ORS
				  731.244,
				  735.532  & Sec. 2-3, Ch. 73, OL 2017
Statutes/Other Implemented: ORS
				  735.530  to
				  735.552,
				  ORS
				  731.236  & 731.296
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0436 - Submission of Complaints

Current through Register Vol. 63, No. 7, July 1, 2024
(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: 2017 Or Laws ch 73, §§
				  1-3, ORS
				  731.244,
				  735.532  & Sec. 2, Ch. 73, OL 2017
Statutes/Other Implemented: ORS
				  735.530  to
				  735.552
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0440 - Market Conduct Requirements for Pharmacy Benefit Managers

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A pharmacy
			 benefit manager shall allow a network pharmacy to mail, ship or deliver
			 prescription drugs to its patients as an ancillary service. A contract between
			 a pharmacy benefit manager and a network pharmacy may establish limits and
			 parameters on the pharmacy's mail, shipment and/or delivery of prescription
			 drugs on the request of enrollees based on the pharmacy's total prescription
			 volume. A pharmacy benefit manager is not required to reimburse a delivery fee
			 charged by a network pharmacy unless the fee is specified in the contract
			 between the pharmacy benefit manager and the pharmacy.
(2) Except as provided in subsection (6) of
			 this section, a pharmacy benefit manager may require a prescription for a
			 specialty drug to be filled or refilled at a specialty pharmacy as a condition
			 for the reimbursement of the cost of a drug.
(3) For the purposes of subsection (2) of
			 this section, the department will consider a prescription drug to meet the
			 definition of "specialty drug" under Oregon Laws 2019, chapter 526, section 4
			 if, to be properly dispensed according to standard industry practice, the drug:
(a) Requires specialized preparation,
			 administration, handling, storage, inventory, reporting or
			 distribution;
(b) Is associated
			 with difficult or unusual data collection or administrative requirements;
			 or
(c) Requires a pharmacist to
			 manage the patient's use of the drug by monitoring, provide disease or
			 therapeutic support systems, provide care coordination including collaboration
			 with patients or other health care providers to manage adherence, identify side
			 effects, monitor clinical parameters, assess responses to therapy, or document
			 outcomes.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0500 - Purpose and Statutory Authority

Current through Register Vol. 63, No. 7, July 1, 2024
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: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch
				  7
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0510 - Account Generation Requirement

Current through Register Vol. 63, No. 7, July 1, 2024
(1) No later than March 15, 2019, all
			 reporting manufacturers required to file a report by July 1, 2019, under OAR
			 836-200-0515(1)
 
			 must create an online account with the department.
(2) Beginning in 2020 and for any subsequent
			 year, reporting manufacturers without an online account with the department
			 that are required to file a report by March 15 of that year under OAR
			 836-200-0515(2)
 
			 must create an online account with the department no later than February 15 of
			 that same year.
(3) Reporting
			 manufacturers without an online account with the department that are required
			 to file a new specialty drug report under OAR
			 836-200-0520  must create an
			 online account with the department no later than 10 days prior to submitting
			 the report.
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0515 - Threshold for Reporting Drug Price Increase

Current through Register Vol. 63, No. 7, July 1, 2024
(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 or for a course of treatment lasting less than
			 one month; and
(b) There was a net
			 yearly increase of 10 percent or more in the price of the prescription drug
			 described in paragraph (a) of this subsection during 2018.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0520 - Threshold for Reporting New Specialty Drug

Current through Register Vol. 63, No. 7, July 1, 2024
Beginning March 15, 2019, 30 days or less after a manufacturer
				introduces a new prescription drug for sale in the United States at a price for
				a 30 day supply or for a course of treatment lasting less than one month 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
				836-200-0530(4).
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0525 - Expectations of Reporting Manufacturers

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Reporting manufacturers must make a
			 good-faith effort to include all of the information required in a report or a
			 response to a request for additional information under OAR
			 836-200-0530  and
			 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  and
			 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  and
			 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) Reporting manufacturers must make a
			 good-faith effort to limit information provided to the department to
			 information that is necessary for the director's review and analysis of drug
			 prices under 2018 Or Laws ch 7.
(5)
			 A reporting manufacturer's failure to comply with the expectations specified in
			 (1)-(4) of this section may subject the manufacturer to a civil penalty under
			 OAR 836-200-0560.
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0530 - Form and Manner Requirements for Drug Pricing Reporting

Current through Register Vol. 63, No. 7, July 1, 2024
(1) General requirements. All reports
			 submitted by drug manufacturers under this section must:
(a) Be provided in an electronic format
			 specified by the department;
(b) Be
			 provided via an electronic system specified by the department;
(c) Be machine readable;
(d) Be capable of being reduced to written
			 form;
(e) Clearly indicate the
			 information the manufacturer asserts to be conditionally exempt from disclosure
			 under ORS
			 192.345 as a trade secret in adherence with OAR
			 836-200-0540;
(f) Include a certification of compliance
			 document certifying that the filing complies with all applicable Oregon
			 statutes, rules, standards and filing requirements; and
(g) Adhere to the standards set forth on the
			 department's website.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0535 - Additional Information Requests

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Within 60 calendar days of receiving a report from a prescription drug
			 manufacturer in accordance with OAR
			 836-200-0515  to
			 836-200-0530, the director or
			 director's designee may submit a written request 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 2018 Or Laws ch 7.
(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
			 836-200-0530, a prescription
			 drug manufacturer must provide a full and complete written response, including
			 any requested documentation. If any of the requested information or
			 documentation is unavailable to a prescription drug manufacturer, the response
			 must include an explanation as specified by
			 836-200-0525. If the
			 manufacturer asserts that any of the requested information is conditionally
			 exempt from disclosure as a trade secret, the manufacturer must clearly
			 indicate that information and provide an explanation, as specified under
			 836-200-540, for each piece of information that is claimed to be exempt from
			 disclosure.
(4) Within 15 calendar
			 days of receiving the department's request for supporting documentation or
			 additional information following a report provided in accordance with 2018 Or
			 Laws ch 7 and OAR 836-200-0515  to
			 836-200-0530, a prescription
			 drug manufacturer may request 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.
(5) Within
			 15 days of receiving a manufacturer's request for additional time under
			 subsection (4), the director or director's designee shall respond to the
			 manufacturer in writing to specify that the director or director's designee
			 grants the request, denies the request, or grants an amount of additional time
			 less than requested, and explain the basis for the decision.
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0540 - Information Claimed to be Trade Secret

Current through Register Vol. 63, No. 7, July 1, 2024
(1) To request exemption from the disclosures
			 required under OAR 836-200-0545, reporting manufacturers must clearly indicate
			 any information provided to the department that they assert to be conditionally
			 exempt from disclosure under ORS
			 192.345 as a trade secret, in the following fashion:
(a) Each line and informational element in
			 every filed document that is claimed to be a trade secret must be clearly
			 marked by the manufacturer;
(b)
			 Each filing that contains information claimed as trade secret by the
			 manufacturer must include, in accordance with standards set forth on the
			 department's website and for each piece of information claimed as trade secret,
			 a succinct written explanation of why the information is exempt from disclosure
			 that demonstrates all of the following:
(A)
			 The information is not patented;
(B) The information is known only to certain
			 individuals within the manufacturer's organization and used in a business the
			 organization conducts;
(C) The
			 information has actual or potential commercial value;
(D) The information gives the manufacturer an
			 opportunity to obtain a business advantage over competitors who do not know or
			 use it; and
(E) The public interest
			 does not require disclosure of the information.
(c) If the manufacturer asserts that
			 disclosure of any information provided in a report is affirmatively prohibited
			 by state or federal law, the manufacturer must clearly indicate the relevant
			 information and explain the basis of this assertion, including citations of the
			 applicable state and federal laws.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0545 - Public Disclosure of Prescription Drug Manufacturer Filings

Current through Register Vol. 63, No. 7, July 1, 2024
(1) As soon as
			 practicable after receiving a filing from a prescription drug manufacturer
			 under OAR
			 836-200-0530,
			 the department shall post to it's website the name of the manufacturer and the
			 prescription drug that is the subject of the filing.
(2) No later than the applicable date as
			 specified in subsection (3) following the receipt of a filing from a
			 manufacturer under OAR
			 836-200-0530  or a response to a request for additional information from a manufacturer under
			 OAR
			 836-200-0535,
			 the department shall post to it's website the information provided by the
			 prescription drug manufacturer in the filing or response.
(3) Each year, the department shall post the
			 information specified in subsection (2) no later than:
(a) March 31, for filings or responses to
			 requests for additional information received between October 1 and December 31
			 of the previous calendar year;
(b)
			 June 30, for filings or responses to requests for additional information
			 received between January 1 and March 31;
(c) September 30, for filings or responses to
			 requests for additional information received between April 1 and June 30;
			 and
(d) December 31, for filings or
			 responses to requests for additional information received between July 1 and
			 September 30.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0550 - Consumer Notices to the Department

Current through Register Vol. 63, No. 7, July 1, 2024
(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 2018 Or Laws ch 7.
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0555 - Assessments Against Prescription Drug Manufacturers for 2023 and prior

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Once annually,
			 no later than October 1, all reporting manufacturers will pay an assessment of
			 $400. The director may by order reduce the fees assessed for any specific
			 year.
(2) Once annually, no later
			 than October 1, reporting manufacturers that have filed one or more reports
			 under OAR 836-200-0515  to
			 836-200-0530  between August 1 of
			 the previous year and July 31 of the current year must pay an additional
			 assessment for each report filed.
(3) For the purposes of subsection (2), the
			 director shall determine the amount of the assessment by subtracting the
			 revenue collected under subsection (1) from the amount of revenue needed to
			 cover the department's estimated expenses in administering Oregon Laws 2018,
			 chapter 7, section 2 and OAR
			 836-200-0500  to
			 836-200-0550
,
and
			 dividing the resulting amount by the total number of filings subject to
			 assessment between August 1 of the previous year and July 31 of the current
			 year. The director shall determine the amount of revenue needed by considering
			 the legislatively approved expenditures for administration of Oregon Laws 2018,
			 chapter 7, section 2 and OAR
			 836-200-0500  to 836-200-0555, as
			 well as the timing of cash revenues and expenditures.
(4) The revenue collected under subsections
			 (1) and (2) of this section must be used solely for expenses incurred in the
			 administration of Oregon Laws 2018, chapter 7, section 2 and OAR
			 836-200-0500  to
			 836-200-0555.
(5) A manufacturer
			 must pay each assessment imposed under this rule no later than 30 days after
			 the date of the assessment by the department. A manufacturer must pay interest
			 at nine percent per annum on any assessment that is not paid when
			 due.
Statutory/Other Authority: Or Laws 2018, ch 7
Statutes/Other Implemented: Or Laws 2018, ch
				  7
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0560 - Civil Penalties

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 director may impose civil penalties on reporting manufacturers for violations
			 of 2018 Or Laws ch 7 and OAR
			 836-200-0500  to 836-200-0560  including the following:
(a) Failing to
			 provide required information, or providing inaccurate or incomplete
			 information;
(b) Failing to respond
			 in a timely manner to a written request by the department for additional
			 information; or
(c) Failing to
			 submit required reports.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0600 - Purpose and Statutory Authority

Current through Register Vol. 63, No. 7, July 1, 2024
The purpose of OAR 836-200-0600  to 836-200-0670  is to
				administer the licensure of pharmaceutical representatives doing business in
				the state of Oregon pursuant to Oregon Laws 2021, chapter 593.
Statutory/Other Authority: ORS
				  731.244 & Or Laws 2021,
				  ch 593
Statutes/Other Implemented: Or Laws 2021, ch
				  593
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0605 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
For the purposes of OAR 836-200-0600  to 836-200-0670  the
				following definitions apply, unless the context requires otherwise:
(1) The "department" means the Oregon
			 Department of Consumer and Business Services.
(2) "Pharmaceutical product" means a
			 medication approved for human use by the federal Food and Drug Administration
			 that may be legally dispensed only with a valid prescription from a health care
			 provider.
(3) "Pharmaceutical
			 representative" means a person that markets or promotes pharmaceutical products
			 to health care providers.
(4)
			 "License" means a license issued to a pharmaceutical representative by the
			 department pursuant to OAR 836-200-0600  to 836-200-0670.
(5) "Licensee" means a person that holds a
			 valid and unexpired license issued under this section.
(6) "Calendar year" means each successive
			 period of 12 calendar months commencing on January 1 and ending on December
			 31.
(7) "Material change in a
			 licensee's business operations" means any change in the following information:
(a) A change in the business activity in
			 which the licensee engages;
(b)
			 Termination for cause from any employer or company that the licensee
			 represents;
(c) Any complaints made
			 to the licensee, the licensee's employer, or a company that the licensee
			 represents regarding the licensee's activities conducted under a license issued
			 under these rules.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0610 - License Required

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 pharmaceutical representative who does business with health care professionals
			 located within the state of Oregon must acquire a license from the department
			 prior to doing business in the state on 15 Or more days in a calendar
			 year.
(2) A license issued pursuant
			 to these rules is valid until the end of the calendar year in which the license
			 was issued.
(3) A license issued
			 pursuant to these rules is not transferable.
(4) A pharmaceutical representative must show
			 their license or an exact copy of it when a health care provider asks to see
			 it. An exact copy may include a legible reproduction, such as a photocopy or an
			 image saved or produced on an electronic device.
Statutory/Other Authority: ORS
				  731.244 & Or Laws 2021,
				  ch 593
Statutes/Other Implemented: Or Laws 2021, ch
				  593
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0615 - License Application and Renewal Application

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An applicant for a license to engage in
			 business as a pharmaceutical representative must submit the following
			 information in a form and manner specified by the department:
(a) The applicant's full name, Social
			 Security number, email address, residence address, personal telephone number,
			 business address, and business telephone number;
(b) A description of the business activities
			 in which the applicant will engage;
(c) Documentation that shows the applicant
			 has completed at least 10 hours of education as described in OAR
			 836-200-0635(1);
(d) The
			 application for licensure must be accompanied by a license fee of
			 $750.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0620 - Licensee Reporting Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must report to the department
			 in writing, in a form specified by the department, any changes to the
			 information submitted in an initial license application submitted pursuant to
			 OAR 836-200-0615(1)  or a renewal application submitted pursuant to OAR
			 836-200-0615(2), including any material changes made in the licensee's business
			 operations, as defined in OAR 836-200-0605(7).
(2) A licensee must report the information
			 regarding contacts specified in subsection (3) of this rule no later than April
			 1, 2023, and each year thereafter.
(3) The report described in subsection (2) of
			 this rule must contain the following information in a form specified by the
			 department:
(a) A list of health care
			 providers within this state that the licensee contacted during the preceding
			 calendar year;
(b) The number of
			 times the licensee contacted each health care provider during the preceding
			 calendar year;
(c) The location and
			 duration of the licensee's contact with each health care provider;
(d) Which pharmaceutical products the
			 licensee promoted;
(e) Whether the
			 licensee provided the health care provider with any product samples, materials
			 or gifts, and, if so, the monetary value of the samples, materials or gifts;
			 and
(f) Whether and how the
			 licensee otherwise compensated the health care provider for contact with the
			 licensee.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0625 - Prohibited Conduct for Licensees

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee may not:
(1) Engage in any deceptive or misleading
			 marketing of a pharmaceutical product, including knowingly concealing,
			 suppressing, omitting, misrepresenting, or misstating material facts concerning
			 or related to a pharmaceutical product;
(2) Use a title or designation that could
			 reasonably lead a health care provider or an employee of a health care provider
			 to believe that the licensee is a health care provider if the licensee is not
			 licensed as a health care provider or otherwise authorized to provide health
			 care services;
(3) Attend an
			 examination of a patient without the patient's consent; or
(4) Make or file, or cause to be made or
			 filed, to or with the director of the Department of Consumer and Business
			 Services, any statement, report or document which is known to be false in any
			 material respect or matter.
Statutory/Other Authority: ORS
				  731.244 & Or Laws 2021,
				  ch 593
Statutes/Other Implemented: Or Laws 2021, ch
				  593
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0630 - Civil Penalties and License Revocation

Current through Register Vol. 63, No. 7, July 1, 2024
The department may impose civil penalties on licensees, or to
				unlicensed pharmaceutical representatives under subsection (1)(c) of this rule,
				for violations of Oregon Laws 2021, chapter 593 and OAR 836-200-0600  to
				836-200-0670, including but not limited to the following:
(1) Engaging in any of the prohibited conduct
			 described in OAR 836-200-0625;
(2)
			 Failure to timely report any of the information described OAR
			 836-200-0620;
(3) Engaging in
			 business as a pharmaceutical representative in the state of Oregon for 15 Or
			 more days without first obtaining a license from the department.
Statutory/Other Authority: ORS
				  731.244 & Or Laws 2021,
				  ch 593
Statutes/Other Implemented: Or Laws 2021, ch
				  593
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0635 - Education Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
Education requirements for initial licensure.
In order to satisfy
			 the education requirement for an initial pharmaceutical representative license,
			 applicants must complete a course of education of at least 10 hours. The
			 education program must be approved by the department under OAR 836-200-0635  to
			 836-200-0670.The coursework must cover at least the following topics, and may
			 also include any of the topics described in subsection (2)(a) of this rule:
(a) The comparative clinical effectiveness of
			 pharmaceutical products, evidence based medicine, or basic
			 pharmacology;
(b) The comparative
			 cost effectiveness of pharmaceutical products, or pharmoeconomics;
			 and
(c) Legal and ethical issues
			 related to promoting pharmaceutical products to healthcare professionals, or
			 professional ethics generally.
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0640 - Education

Current through Register Vol. 63, No. 7, July 1, 2024
To demonstrate completion of a professional education course
				for the purpose of initial licensure as a pharmaceutical representative under
				these rules or renewal of licensure, documentation shall be submitted as
				follows:
(1) To the extent possible,
			 the education provider offering the course shall submit electronically a
			 transcript, certificate of completion or grade or course completion report,
			 whichever is issued by the education provider offering the course, or a copy
			 thereof. If it is not possible for the education provider offering the course
			 to submit a transcript, certificate of completion or grade or course completion
			 report, the pharmaceutical representative shall submit the transcript,
			 certificate of completion or grade or course completion report in accordance
			 with directions provided on the Department of Consumer and Business Services
			 website.
(2) The department may
			 accept evidence of completion of a course from education providers through
			 electronic means as specified by the department.
Statutory/Other Authority: ORS
				  731.244 & Or Laws 2021,
				  ch 593
Statutes/Other Implemented: Or Laws 2021, ch
				  593
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0645 - Education; Standards for Granting Credit Hours

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Subject to the subject matter
			 requirements of OAR 836-200-0635, a pharmaceutical representative may receive
			 credit for a course registered under OAR 836-200-0655:
(a) For not more than the credit hours
			 authorized by the director;
(b)
			 Only if an hour includes at least 50 minutes of instruction or study;
(c) For class hours in which a pharmaceutical
			 representative is an instructor of a course if the course meets the education
			 requirements of a pharmaceutical representative attending it. Credit may be
			 taken by pharmaceutical representative with respect to a course only once in
			 each renewal period in which the pharmaceutical representative instructs the
			 course;
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0650 - Education; Education Provider Registration

Current through Register Vol. 63, No. 7, July 1, 2024
A provider of education courses must register with the
				department in order to register courses under OAR 836-200-0655. An education
				provider must register electronically in the method required by the director.
				The registration of an education provider shall include the education
				provider's business name, business address, and the business telephone number.
				In addition, a direct contact name and telephone number employed by the
				provider.
(1) A provider shall notify
			 the department of any change in the address, telephone number, email address or
			 contact person of the education provider within 30 days after any such change
			 takes effect.
(2) Subject to
			 revocation of registration under OAR 836-200-0665, an education provider
			 registration expires on the second January 1 following the date of
			 registration.
Statutory/Other Authority: ORS
				  731.244 & Or Laws 2021,
				  ch 593
Statutes/Other Implemented: Or Laws 2021, ch
				  593
Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0655 - Education; Course Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 An education provider registered under OAR 836-200-0650  shall apply to the
			 department for registration of each course to be offered by the provider for
			 education credit. Application for registration shall be made electronically in
			 the method required by the department and shall include the name of the
			 provider, the education provider's registration number assigned by the
			 department, the course title and credit hours suggested by the education
			 provider for the course. The education provider shall include the course
			 outline with the registration application and shall submit any other
			 information requested by the department. The course outline must show
			 instruction in 50-minute periods. In order to ensure that a course is eligible
			 to be registered prior to the date of the first meeting of the course, a
			 registered education provider must apply for registration of the course not
			 later than the 60th day preceding the first date.
(2) The registration of a course expires on
			 the last day of the 24th month after the date the course is registered unless
			 the course is renewed prior to the date on which registration expires.
(3) Each course registration
			 application is subject to review by the department for the purpose of
			 evaluating and assigning credit hours and determining compliance with
			 requirements of course content under OAR 836-200-0635. The department may
			 reject a course for registration or terminate a course's registration if the
			 department determines that the course submitted fails to provide accurate,
			 sufficient, or germane information, or fails to show good faith with meeting
			 educational goals.
(4) A registered
			 education provider shall resubmit a registered course for review and approval
			 whenever the provider substantially changes the content of the course as
			 registered.
(5) All materials
			 required under this rule shall be submitted electronically in accordance with
			 directions of the department set forth on the division's website.
Statutory/Other Authority: ORS
				  731.244 & Or Laws 2021,
				  ch 593
Statutes/Other Implemented: Or Laws 2021, ch
				  593