Proposed

(3) Reporting entities must comply with the authority's processes for submitting data as outlined in the authority's data submission guides as published on the authority's website.

To clarify in rule the function of the data submission guides.

Adopted

(3) Reporting entities must comply with the authority's processes for submitting data as outlined in the authority's data submission guides as published on the authority's website.The authority publishes a data submission guide to the authority's website, detailing the data elements to report as required by chapter 43.71C RCW, and how to submit the data.

Proposed

N/A

To clarify what the health care authority (HCA) means by this term as it is used in this chapter.

Because of this addition, the subsequent subsections were renumbered.

Adopted

(3) "Calendar year" means the period from January 1 to December 31 of each year.

(4) "Covered drug" means …

Proposed

(3)(a) A covered manufacturer intends to introduce to the market at a wholesale acquisition cost of ten thousand dollars or more for a course of treatment lasting less than one month or a thirty-day supply, whichever period is longer; or

To clarify that the introduction to market is in Washington state.

Adopted

(3)(4)(a) A covered manufacturer intends to introduce to the market in Washington state at a wholesale acquisition cost of ten thousand dollars or more for a course of treatment lasting less than one month or a thirty-day supply, whichever period is longer; or

Proposed

(3)(b) Meets all of the following:

(i) Is currently on the market;

To clarify that the introduction to market is in Washington state.

Adopted

(3)(4)(b) Meets all of the following:

(i) Is currently on the market in Washington state;

Proposed

(3)(b)(iii) Has a wholesale acquisition cost of more than one hundred dollars for a course of treatment lasting less than one month or a thirty-day supply, and, taking into account only price increases that take effect after July 28, 2019, the manufacturer increases the wholesale acquisition cost at least:

(A) Twenty percent, including the proposed increase and the cumulative increase over one calendar year before the date of the proposed increase; or

(B) Fifty percent, including the proposed increase and the cumulative increase over three calendar years before the date of the proposed increase.

To more clearly define what HCA means by "covered drug" in regards to its new wholesale acquisition cost.

Adopted

(3)(4)(b)(iii) Has a wholesale acquisition cost of more than one hundred dollars for a course of treatment lasting less than one month or a thirty-day supply, and, taking into account only price increases that take effect after July 28, 2019, the manufacturer increases the wholesale acquisition cost at leastsuch that:

(A) The new wholesale acquisition cost is twenty percent, including the proposed increase and the cumulative increase over one calendar yearhigher than the wholesale acquisition cost on the same day of the month, twelve months before the date of the proposed increase; or

(B) The new wholesale acquisition cost isFfifty percent, including the proposed increase and the cumulative increase over three calendar yearshigher than the wholesale acquisition cost on the same day of the month, thirty-six months before the date of the proposed increase.

Proposed

(7) "Data submission guide" means the document that contains the required data, required format, and instructions on submitting the data to be reported to the authority for each submitter type.

To more clearly define the data submission guides as instructional documents that only provide guidance to reporting entities.

Adopted

(7)(8) "Data submission guide" means the document that contains the required data, required format, and instructions on submitting the data to be reported to the authority for each submitter typeidentifies the data required under chapter 43.71C RCW, and provides instructions for submitting this data to the authority, including guidance on required format for reporting, for each reporting entity.

Proposed

(10) "Introduced to market" means made available for purchase in Washington state.

To remove the implication that "introduced to market" means available for purchase.

Adopted

(10)(11) "Introduced to market" means made available for purchasemarketed in Washington state.

Proposed

(11) "New drug" means a drug for which a manufacturer is seeking initial approval under an original new drug application under 21 U.S.C. Sec. 355(b), under an abbreviated new drug application under 21 U.S.C. Sec. 355(j), or under a biologics license application under 42 U.S.C. Sec. 262. Each product listed on the application must be considered a new drug for purposes of reporting according to RCW 43.71C.060.

HCA removed the definition of "new drug" and replaced it with a definition of "pipeline drug" to better align with statute. The subsection was moved to maintain alphabetical order.

Adopted

Proposed

(14) "Prescription drug" means a drug regulated under chapter 69.41 or 69.50 RCW, including generic, brand name, specialty drugs, and biological products that are prescribed for outpatient use and distributed in a retail setting.

To improve clarity, HCA moved the clause "that are prescribed for outpatient use and distributed in a retail setting."

Adopted

(14)(15) "Prescription drug" means a drug regulated under chapter 69.41 or 69.50 RCW that is prescribed for outpatient use and distributed in a retail setting, including generic, brand name, specialty drugs, and biological products that are prescribed for outpatient use and distributed in a retail setting.

Proposed

(17) "Rebate" means negotiated price concessions, discounts, refunds or revenue, however characterized, that accrue directly or indirectly to a reporting entity in connection with utilization of prescription drugs by reporting entity members including, but not limited to, rebates, administrative fees, market share rebates, price protection rebates, performance-based price concessions, volume-related rebates or refunds, other credits, and any other negotiated price concessions or discounts that are reasonably anticipated to be passed through to a reporting entity during a coverage year, and any other form of price concession prearranged with a covered manufacturer, dispensing pharmacy, pharmacy benefit manager, rebate aggregator, group purchasing organization, or other party which are paid to a reporting entity and are directly attributable to the utilization of certain drugs by reporting entity members.

To remove any association between rebates and refunds or revenue from the definition.

Adopted

(17)(18) "Rebate" means negotiated price concessions, discounts, refunds or revenue, however characterized, that accrue directly or indirectly to a reporting entity in connection with utilization of prescription drugs by reporting entity members including, but not limited to, rebates, administrative fees, market share rebates, price protection rebates, performance-based price concessions, volume-related rebates or refunds, other credits, and any other negotiated price concessions or discounts that are reasonably anticipated to be passed through to a reporting entity during a coverage year, and any other form of price concession prearranged with a covered manufacturer, dispensing pharmacy, pharmacy benefit manager, rebate aggregator, group purchasing organization, or other party which are paid to a reporting entity and are directly attributable to the utilization of certain drugs by reporting entity members.

Proposed

(3) Failure to register and provide or maintain accurate contact information with the authority may result in a reporting entity's inability to submit required data in compliance with this chapter and may result in fines as described in WAC 182-51-1100.

To remove reference to punitive action being taken for failing to maintain accurate contact information.

Adopted

(3) Failure to register and provide or maintain accurate contact information with the authority may result in a reporting entity's inability to submit required data in compliance with this chapter and may result in fines as described in WAC 182-51-1100.

Proposed

(1) No later than October 1st of each year, a health carrier must submit to the authority the prescription drug cost and utilization data for one or more previous calendar years for each health plan it offered in the state in the required format in accordance with the authority's applicable data submission guide.

To clarify the time periods reporting entities are required to submit data and to clarify that the data submission guides are only guidelines for submitting data.

Adopted

(1) No later than October 1st of each year16, 2020, a health carrier must submit to the authority the prescription drug cost and utilization data for one or more previous calendar yearscalendar years 2018 and 2019, for each health plan it offered in theWashington state in calendar years 2018 and 2019, following the guidelines set inthe required format in accordance with the authority's applicable data submission guide.

Proposed

N/A

To clarify reporting deadlines for reporting entities.

The subsections were renumbered to compensate for the new subsection.

Adopted

(2) Beginning October 1, 2021, and no later than October 1st annually thereafter, a health carrier must submit to the authority the prescription drug cost and utilization data for the previous calendar year for each health plan it offered in Washington state, following the guidelines set in the authority's applicable data submission guide.

(3) A carrier may voluntarily submit …

Proposed

(3) The authority may assess fines for not complying with the requirements in this section. See WAC 182-51-1000.

To fix an erroneous cross-reference.

Adopted

(3)(4) The authority may assess fines for not complying with the requirements in this section. See WAC 182-51-10001100.

Proposed

(1) No later than March 1st of each year, a pharmacy benefit manager must submit to the authority all data specified in RCW 43.71C.030 in the required format in accordance with the authority's applicable data submission guide.

To clarify that the data submission guides are only guidelines for submitting data.

Adopted

(1) No later than March 1st of each year, a pharmacy benefit manager must submit to the authority all data specified in RCW 43.71C.030 in the required format in accordance with, following the guidelines set in the authority's applicable data submission guide.

Proposed

N/A

To clarify that the information submitted according to this section is not subject to public disclosure. The proposed subsection (4) was renumbered to subsection (5) to compensate for the new subsection. HCA also corrected an erroneous cross-reference in newly numbered subsection (5).

Adopted

(4) The information submitted according to this section is not subject to public disclosure under chapter 42.56 RCW.

(5) The agency may assess fines for not complying with the requirements in this section. See WAC 182-51-10001100.

Proposed

(1) On or before October 1, 2020, a covered manufacturer must submit to the authority all data specified in RCW 43.71C.050 and 43.71C.070 in accordance with the applicable data submission guide for each covered drug as the drug existed between July 28, 2019, and December 31, 2020.

To change reporting deadlines for reporting entities and to clarify that the data submission guides are only guidelines for submitting data.

Adopted

(1) On or before October 1December 31, 2020, a covered manufacturer must submit to the authority all data specified in RCW 43.71C.050 and 43.71C.070 in accordance with, following the guidelines set in the authority's applicable data submission guide for each covered drug as the drug existed between and including July 28, 2019, and December 31August 17, 2020.

Proposed

(2) Beginning October 1, 2020, and monthly thereafter, a covered manufacturer must submit to the authority all data specified in RCW 43.71C.050 and 43.71C.070 in accordance with the applicable data submission guide, for each covered drug as follows:

(a) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between January 1st and January 31st, inclusive, is due by November 30th of the prior year;

(b) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between February 1st and February 28th, or in a leap year February 29th, inclusive, is due by December 31st of the prior year;

To clarify reporting deadlines for reporting entities, specifically for reporting new covered drugs and qualifying price increases for covered drugs. HCA also clarified that the data submission guides are only guidelines for submitting data.

 

(c) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between March 1st and March 31st, inclusive, is due by January 31st of the same year;

(d) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between April 1st and April 30th, inclusive, is due by February 28th, or in a leap year February 29th, of the same year;

(e) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between May 1st and May 31st, inclusive, is due by March 31st of the same year;

 

 

(f) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between June 1st and June 30th, inclusive, is due by April 30th of the same year;

(g) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between July 1st and July 31st, inclusive, is due by May 31st of the same year;

(h) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between August 1st and August 31st, inclusive, is due by June 30th of the same year;

 

 

(i) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between September 1st and September 30th, inclusive, is due by July 31st of the same year;

(j) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between October 1st and October 31st, inclusive, is due by August 31st of the same year;

(k) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between November 1st and November 30th, inclusive, is due by September 30th of the same year; and

(l) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between December 1st and December 31st, inclusive, is due by October 31st of the same year.

 

Adopted

(2) Beginning October 16, 2020, and monthly thereafter, a covered manufacturer must submit to the authority all data specified in RCW 43.71C.050 and 43.71C.070 in accordance with, following the guidelines set in the authority's applicable data submission guide, for each covered drug as follows:

(a) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between January 1st and January 31st, inclusive, is due by November 30th of the prior yearSixty days in advance of a qualifying prices increase for a covered drug marketed in Washington state; or;

 

 

(b) Each report related to a covered drug introduced to market or a qualifying price increase with an effective date between February 1st and February 28th, or in a leap year February 29th, inclusive, is due by December 31st of the prior year;Thirty days in advance of a new covered drug's introduction to market in Washington state.

 

 

 

 

 

Proposed

N/A

To allow for the possibility that reporting entities may not be able to report the information required in this section and to give guidelines surrounding that possibility.

The proposed subsection (3) was renumbered to subsection (4) to compensate for the new subsection.

Adopted

(3) For any drug approved under section 505(j) of the federal Food, Drug, and Cosmetic Act as it existed on August 18, 2020, or a biosimilar approved under section 351(k) of the federal public health service act as it existed on August 18, 2020, if submitting data in accordance with subsection 2(a) of this section is not possible sixty days before the price increase; or if submitting data in accordance with subsection 2(b) of this section is not possible thirty days before the introduction to market, that submission must be made as soon as known but no later than the date of the price increase or introduction to market.

(4) The information submitted….

Proposed

(4) The authority may assess fines for not complying with the requirements in this section. See WAC 182-51-1000.

To correct an erroneous cross-reference.

Adopted

(4)(5) The authority may assess fines for not complying with the requirements in this section. See WAC 182-51-10001100.

Proposed

WAC 182-51-0700 Manufacturers—Notice of new drug applications. (1) On or before October 1, 2020, a manufacturer must submit to the authority all data specified in RCW 43.71C.060(1) in accordance with the applicable data submission guide for all new drug applications or biologic license applications submitted on or after October 1, 2019, through September 30, 2020, for which the manufacturer has received an FDA approval date.

To change reporting deadlines for reporting entities and to clarify that the data submission guides are only guidelines for submitting data. HCA also clarified that this section pertains to biologic license applications.

Adopted

WAC 182-51-0700 Manufacturers—Notice of new drug applications and biologic license applications. (1) On or before October 1December 31, 2020, a manufacturer must submit to the authority all data specified in RCW 43.71C.060(1) in accordance with, following the guidelines set in the authority's applicable data submission guide for all new drug applications or biologic license applications for pipeline drugs submitted on or after October 1, 2019, through September 30October 15, 2020, for which the manufacturer has received an FDA approval date.

Proposed

(2) Beginning October 1, 2020, a manufacturer must submit to the authority all data specified in RCW 43.71C.060(1) in accordance with the applicable data submission guide for all new drug applications or biologic license applications submitted on or after October 1, 2020, within sixty calendar days of the manufacturer receiving the FDA approval date as follows:

(a) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between January 1st and January 31st, inclusive, is due by November 30th of the prior year;

To clarify reporting deadlines for reporting entities and to clarify that the data submission guides are only guidelines for submitting data.

 

(b) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between February 1st and February 28th, or in a leap year February 29th, inclusive, is due by December 31st of the prior year;

(c) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between March 1st and March 31st, inclusive, is due by January 31st of the same year;

(d) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between April 1st and April 30th, inclusive, is due by February 28th, or in a leap year February 29th, of the same year;

(e) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between May 1st and May 31st, inclusive, is due by March 31st of the same year;

 

 

(f) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between June 1st and June 30th, inclusive, is due by April 30th of the same year;

(g) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between July 1st and July 31st, inclusive, is due by May 31st of the same year;

(h) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between August 1st and August 31st, inclusive, is due by June 30th of the same year;

 

 

(i) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between September 1st and September 30th, inclusive, is due by July 31st of the same year;

(j) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between October 1st and October 31st, inclusive, is due by August 31st of the same year;

(k) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between November 1st and November 30th, inclusive, is due by September 30th of the same year; and

(l) All new drug applications or biologic license applications for which the manufacturer has received an FDA approval date between December 1st and December 31st, inclusive, is due by October 31st of the same year.

 

Adopted

(2) Beginning October 16, 2020, a manufacturer must submit to the authority all data specified in RCW 43.71C.060(1) in accordance with, following the guidelines set in the authority's applicable data submission guide for all new drug applications or biologic license applications for pipeline drugs submitted on or after October 16, 2020, within sixty calendar days of the manufacturer receiving the FDA approval date. as follows:

 

 

 

 

 

 

 

Proposed

N/A

To clarify in rule how HCA determines when a new drug has the potential to have a significant impact on state expenditures.

The proposed subsection (4) was renumbered to subsection (5) to compensate for the new subsection.

Adopted

(3) The authority considers fifty thousand dollars per biennium to be a significant impact on state expenditures. Reporting entities may anticipate a request for additional information per RCW 43.71C.060(3) from the authority for products expected to exceed fifty thousand dollars per biennium. To improve efficiency in reporting, manufacturers who submit a new drug application or a biologics license application for a pipeline drug or a biologics license application for a biological product that is expected to cost the state more than fifty thousand dollars per biennium may submit the data elements in RCW 43.71C.060(3) at the same time they submit the notice of the new drug application.

(4) A manufacturer may limit …

Proposed

(4) The agency may assess fines for not complying with the requirements in this section. See WAC 182-51-1000.

To correct an erroneous cross-reference.

Adopted

(4)(5) The agency may assess fines for not complying with the requirements in this section. See WAC 182-51-10001100.

Proposed

(1) No later than October 1st of each year, a pharmacy services administrative organization representing a pharmacy or pharmacy chain in the state must submit to the authority the data specified in RCW 43.71C.080 following the guidelines set in the authority's applicable data submission guide.

To clarify reporting deadlines for reporting entities.

Adopted

(1) No later than October 16, 2020, and October 1st of each year thereafter, a pharmacy services administrative organization representing a pharmacy or pharmacy chain in theWashington state must submit to the authority the data specified in RCW 43.71C.080 following the guidelines set in the authority's applicable data submission guide.

Proposed

(2) Any pharmacy services administrative organization whose revenue is generated from flat service fees not connected to drug prices or volume, and paid by the pharmacy, is exempt from reporting, subject to audit by the authority. These organizations must petition the authority for exemption from the reporting requirements according to the frequency listed and the format required in the authority's applicable data submission guide.

To clarify that the data submission guides are only guidelines for submitting data.

Adopted

(2) Any pharmacy services administrative organization whose revenue is generated from flat service fees not connected to drug prices or volume, and paid by the pharmacy, is exempt from reporting, subject to audit by the authority. These organizations must petition the authority for exemption from the reporting requirements according to the frequency listed and the format requiredformatting guidelines in the authority's applicable data submission guide.

Proposed

(3) The authority may assess fines for not complying with the requirements in this section. See WAC 182-51-1000.

To correct an erroneous cross-reference.

Adopted

(3) The authority may assess fines for not complying with the requirements in this section. See WAC 182-51-10001100.

Proposed

(2) The authority develops data submission guides and has final approval authority over them.

To provide the opportunity for reporting entities to comment on changes HCA makes to the data submission guides.

Adopted

(2) The authority develops data submission guides and has final approval authority over them. The authority provides reporting entities the opportunity to comment on changes to data requirements in the applicable data submission guide, at least thirty days before the effective date of the change.

Proposed

(1) RCW 43.71C.090 allows the authority to assess a fine of up to one thousand dollars per day for failure to comply with the requirements of RCW 43.71C.020 through 43.71C.080 and the requirements of this chapter.

To improve usability.

Adopted

(1) RCW 43.71C.090 allows the authority to assess a fine of up to one thousand dollars per day for failure to comply with the requirements of RCW 43.71C.020 through 43.71C.080 and the requirements of this chapter. See WAC 182-51-1300 for fines for failing to comply with reporting requirements and WAC 182-51-1400 for the amount of fines based on culpability.

Proposed

(2) The authority may, at its sole discretion, grant an extension of time to a reporting requirement deadline under WAC 182-51-1200.

To remove redundant language.

Adopted

(2) The authority may, at its sole discretion, grant an extension of time to a reporting requirement deadline under WAC 182-51-1200.

Proposed

(1) The authority may, at its sole discretion, grant:

To remove redundant language.

Adopted

(1) The authority may, at its sole discretion, grant:

Proposed

(b) The request for an extension must be for no more than one reporting period and must contain a detailed explanation as to the reason the reporting entity is unable to meet the reporting requirements for that period.

To remove a restriction on how long reporting entities may ask for an extension.

Adopted

(b) The request for an extension must be for no more than one reporting period and must contain a detailed explanation as to the reason the reporting entity is unable to meet the reporting requirements for that period.

Proposed

(d) The authority may approve a request for extenuating circumstances. The authority provides written notification of the approval or denial to the requestor within fifteen calendar days from when the authority receives the request from the reporting entity. If the authority does not approve a request for an extension, the written notification includes the reason for the denial.

To clarify what extensions are for.

Adopted

(d) The authority may approve a request for an extension for a period of time based on the specific circumstances or other extenuating circumstances. The authority provides written notification of the approval or denial to the requestor within fifteen calendar days from when the authority receives the request from the reporting entity. If the authority does not approve a request for an extension, the written notification includes the reason for the denial.

Proposed

(2) Unless the authority has approved an extension, the authority may assess a fine for failure to comply with general reporting requirements contained in chapter 43.71C RCW and this chapter including, but not limited to, the following:

To clarify that HCA will also not assess a fine if HCA has received a request to correct previously submitted data.

Adopted

(2) Unless the authority has approved an extension or has received a request to correct previously submitted data, the authority may assess a fine for failure to comply with general reporting requirements contained in chapter 43.71C RCW and this chapter including, but not limited to, the following:

Proposed

(3) Unless the authority has approved an extension, the authority may assess fines for failure to comply with data file requirements outlined in the applicable data submission guide in effect for the required reporting period including, but not limited to, the following:

To clarify that HCA will also not assess a fine if HCA has received a request to correct previously submitted data.

Adopted

(3) Unless the authority has approved an extension or has received a request to correct previously submitted data, the authority may assess fines for failure to comply with data file requirements outlined in the applicable data submission guide in effect for the required reporting period including, but not limited to, the following:

Proposed

(4) Upon failing to comply with a reporting requirement in this chapter, the authority first issues a warning notice to a reporting entity. The authority sends the warning notice to the reporting entity's last known email or physical address. The warning notice describes the failure to comply with the requirements of this chapter and gives the reporting entity ten days to become compliant or request an extension of time to report the required data according to WAC 182-51-1200(2).

(5) A reporting entity that fails to comply with the same reporting requirement in this chapter for which it previously received a warning notice may be assessed a fine of up to one thousand dollars per day. Failure to comply with each reporting requirement for the reporting period is a different occurrence with a separate fine.

The [to] clarify the process HCA uses to work with reporting entities who fail to comply with reporting requirements laid out in this chapter, HCA moved this information to WAC 182-51-1500.

Due to this change, subsection (6) was renumbered to subsection (3).

Adopted

Proposed

N/A

To clarify how fines accrue.

Adopted

Proposed

To provide for a warning notice sent to reporting entities that gives reporting entities thirty days to become compliant or request an extension before a preliminary notice of violation and fine(s) is sent.

The proposed subsection (1) was renumbered to subsection (2) to compensate for the new subsection.

Adopted

WAC 182-51-1500 NPreliminary notice of violation and fine(s). (1) Upon failing to comply with a reporting requirement in this chapter, the authority first issues a warning notice to a reporting entity. The authority sends the warning notice to the reporting entity's last known email or physical address. The warning notice describes the failure to comply with the requirements of this chapter and gives the reporting entity thirty days to become compliant or request an extension of time to report the required data according to WAC 182-51-1200(2).

(1)(2) When a reporting entity fails …

Proposed

(1) When a reporting entity fails to comply with reporting requirement(s) after receiving a warning notice, the authority may assess a fine and notifies the reporting entity. The authority mails the notice of violation to the reporting entity's last known address by certified mail, return receipt requested.

To clarify the preliminary notice of violation and fine(s) process.

Adopted

(1)(2) When a reporting entity fails to comply with reporting requirement(s) after receiving a warning notice, the authority may assess a fine and notifies the reporting entity(s) as established in WAC 182-51-1400. The authority mails thea preliminary notice of violation and fine(s) to the reporting entity's last known address by certified mail, return receipt requested.

Proposed

(2) The notice of violation includes the following information:

(a) The specific reasons and criteria that support the imposition of the assessed fine(s);

(b) The legal authority that supports the imposition of a fine or fines;

(c) The amount of the fine(s);

(d) The date when the fine(s) and other actions imposed will take effect, if not appealed; and

(e) An explanation of the reporting entity's appeal rights.

To clarify what information is included in the preliminary notice of violation and fine(s).

Adopted

(2)(3) The preliminary notice of violation and fine(s) includes the following information:

(a) The specific reasons and criteria that support the imposition of the assessed fine(s);

(b) The legal authority that supports the imposition of a fine or fines;

(c) The amount of the fine(s) as of the date of the preliminary notice of violation and fine(s);

(d) The date when the fine(s) and other actions imposed will take effect, if not appealedNotice that fines will continue to accrue at the assessed daily rate, per WAC 182-51-1400, until the reporting entity either complies with the reporting requirements or settles through an informal dispute resolution conference; and

(e) An explanation of the reporting entity's appeal rightsto request an informal dispute resolution conference under WAC 182-51-1700.

Proposed

(1) Each reporting entity to whom the authority issues a notice of a violation and fine may request a hearing to be conducted in accordance with this chapter and chapter 182-526 WAC.

To clarify the difference between the preliminary notice of violation and fine(s) and the final notice of violation and fine(s) and to clarify the difference between the informal dispute resolution process under WAC 182-51-1700 and the formal administrative hearing process under WAC 182-51-1800.

Adopted

(1) Each reporting entity to whom the authority issues a preliminary notice of a violation and fine(s) may request a hearing to be conducted in accordance with this chapter and chapter 182-526 WACand informal dispute resolution conference under WAC 182-51-1700.

Proposed

(2) A reporting entity must submit a request for a hearing to the authority in writing, in a manner that provides proof of receipt, within twenty-eight calendar days after receipt of written notice provided under WAC 182-51-1500.

(3) The request for hearing must specify:

(a) The name of the reporting entity requesting the hearing and the reporting entity's, or representative's, mailing address, telephone number, and email address (if available);

(b) The items, facts, or conclusions in the notice of violation being contested; and

(c) The basis for contesting the authority's action, including any mitigating factors upon which the reporting entity relies and the outcome the reporting entity is seeking.

To clarify the process reporting entities may use to dispute or appeal notices of violation and fine(s). HCA added clarity surrounding the options reporting entities have and the timeliness requirements.

Adopted

(2) A reporting entity must submit a request for a hearing to the authority in writing, in a manner that provides proof of receipt, within twenty-eight calendar days after receipt of written notice provided under WAC 182-51-1500.

(c) The basis for contesting the authority's action, including any mitigating factors upon which the reporting entity relies and the outcome the reporting entity is seeking. If the reporting entity requests an informal dispute resolution conference under WAC 182-51-1700, the reporting entity must complete the informal dispute resolution process before requesting an administrative hearing.

 

 

(3) In lieu of an informal dispute resolution conference, the reporting entity may request a formal appeal under WAC 182-51-1800 in writing, in a manner that provides proof of receipt, within twenty-eight calendar days after receipt of the preliminary notice of violation and fine(s). Upon receipt for the reporting entity's request, the authority issues a final notice of violation and fine(s) with an explanation of the reporting entity's administrative hearing rights under WAC 182-51-1800.

(4) If the reporting entity does not request an informal dispute resolution conference or formal appeal within twenty-eight calendar days after receipt of the preliminary notice of violation and fine(s), the authority issues a final notice of violation with an explanation of the reporting entity's administrative hearing rights under WAC 182-51-1800.

 

Proposed

(1) A reporting entity may informally dispute the authority's determination of a violation under this chapter. Reporting entities must submit the request for dispute resolution in writing, and it must include the following:

(a) The supporting evidence for each assessed violation; and

(b) The relief sought for each disputed violation.

To clarify that this subsection is regarding the preliminary notice of violation and fine(s). HCA removed the final sentence in this subsection due to amending subsection (2) and adding a new subsection (3).

Adopted

(1) A reporting entity may informally dispute the authority's preliminary determination of a violation under this chapter. Reporting entities must submit the request for dispute resolution in writing, and it must include the following:

Proposed

(2) The dispute may include a request for a dispute resolution conference.

(a) If the agency grants the reporting entity's request for a dispute resolution conference, the conference occurs within sixty calendar days of the date the reporting entity received the authority's written acceptance of the request for a dispute resolution conference.

(b) The reporting entity must notify the authority of who will attend the dispute resolution conference on the reporting entity's behalf at least five business days before the conference.

To clarify how reporting entities may request an informal resolution conference and what information should be in the request.

Due to the additional subsections, proposed subsection (3) was renumbered to subsection (6).

Adopted

(2) The dispute may include a request for a dispute resolution conference.

(4) If the agency grants the reporting entity's request for a dispute resolution conference, the conference occurs within sixty calendar days of the date the reporting entity received the authority's written acceptance of the request for a dispute resolution conference.

(b)(5) The reporting entity must notify the authority of who will attend the dispute resolution conference on the reporting entity's behalf at least five business days before the conference.

Proposed

N/A

To clarify when HCA issues the final notice of violation and fine(s).

Due to the addition of this subsection, proposed subsection (4) was renumbered to subsection (8).

Adopted

Proposed

(1) A reporting entity has a right to an administrative hearing (formal appeal), and any resulting appeals process available under chapters 34.05 RCW and 182-526 WAC, if the authority assesses a fine against the reporting entity under any section of chapter 43.71C RCW and this chapter. To the extent that there may be a conflict between the general provisions contained in chapter 182-526 WAC and this chapter, the more specific provisions in this chapter apply.

To clarify that reporting entities have the right to a formal administrative hearing when they receive a final notice of violation and fine(s).

Adopted

(1) A reporting entity has a right to an administrative hearing (formal appeal), and any resulting appeals process available under chapters 34.05 RCW and 182-526 WAC, if the authority assesses a final notice of violation and fine(s) against the reporting entity under any section of chapter 43.71C RCW and this chapter. To the extent that there may be a conflict between the general provisions contained in chapter 182-526 WAC and this chapter, the more specific provisions in this chapter apply.

Proposed

(2) A reporting entity may appeal both the assessed violation(s) and the amount of the fine(s) assessed in the notice of violation and fine.

To clarify that this subsection is regarding the final notice of violation and fine(s).

Adopted

(2) A reporting entity may appeal both the assessed violation(s) and the amount of the fine(s) assessed in the final notice of violation and fine(s).

Proposed

N/A

To clarify how reporting entities may request a formal administrative hearing and what information should be in the request.

Because of this addition, the subsequent subsections were renumbered.

Adopted