Title 14 — Subtitle 01. Prescription Drug Affordability Board

Based on credible scientific evidence published in peer reviewed medical literature generally recognized by the relevant medical community;

Consistent with physician specialty society recommendations; or

Consistent with the views of physicians practicing in the relevant clinical areas.

The day of the act, event, or default after which the designated period of time begins to run is not included;

If the period of time allowed is more than 7 days, intermediate Saturdays, Sundays, and legal holidays are counted;

If the period of time allowed is 7 days or less, intermediate Saturdays, Sundays, and legal holidays are not counted; and

The last day of the computed period is included unless it is a Saturday, Sunday, or legal holiday, in which event the period runs until the end of the next day that is a work day.

In determining the latest day for performing an act that is required to be performed a prescribed number of days before a certain day, act, or event, all days preceding that day, including intervening Saturdays, Sundays, and legal holidays, are counted in the number of days so prescribed; and

The latest day is included in the determination unless it is a Saturday, Sunday, or legal holiday, in which event the latest day is the first preceding day that is a work day.

The Board expressly invites public testimony, questions, comments, or other forms of public participation; or

Public participation is otherwise authorized by law or regulation.

Order an individual who persists in conduct prohibited by §C(1) of this regulation, or who has violated any other regulation concerning the conduct of the open session, to be removed or disconnected from the session, and may request police assistance to restore order; and

Recess the session while order is restored.

A person submitting information, including data and records, for the Board’s consideration under this subtitle and Health-General Article, Title 21, Subtitle 2C, Annotated Code of Maryland, shall:

The Board may also determine that information it has received is confidential, trade-secret, or proprietary.

The Board may seek additional information regarding whether the information is confidential, trade-secret, proprietary, or not otherwise publicly available from:

Considered to be a trade secret and confidential and proprietary information; and

Is not subject to inspection or disclosure under the Public Information Act.

Confidential, trade-secret, or proprietary information obtained by the Board under this subtitle and Health-General Article, Title 21, Subtitle 2C, Annotated Code of Maryland, may be accessed only by:

A person with access to confidential, trade-secret, or proprietary information shall maintain the confidentiality of the information in accordance with State Government Article, §10-617, and Health-General Article, §21-2C-10, Annotated Code of Maryland.

The Board may discuss confidential, trade-secret, and proprietary information in a closed session.

The Board may not disclose confidential, trade-secret, or proprietary information in an open meeting, its public meeting materials, or its summary report of a cost review study.

Submitting a written notice that:

Submitting the written notice to the Board at least 2 work days before the scheduled meeting.

Unless expressly exempted, these provisions apply to all written public comments.

Except as provided in §B(5) of this regulation, a member of the public may submit written comments to the Board by email, courier, or postal service.

An individual submitting comments on behalf of an organization, agency, employer, or other entity shall:

Written comments received by the date prescribed by regulation or set by the Board will be:

Board staff shall redact sociological information prior to posting the written comments on the Board website.

A member of the public may submit written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures in §B(1) and (5) of this regulation.

Written comments received more than 2 work days before the scheduled Board meeting will be shared with the Board prior to the Board meeting.

Written comments received less than 2 work days before the scheduled Board meeting will be shared with the Board and posted on the Board’s website after the scheduled meeting.

Written comments received less than 2 work days before the scheduled Board meeting may be considered at the next Board meeting if the issue, matter, or decision is still pending.

A member of the public that wishes to submit written comments or attachments to written comments that contain confidential, trade-secret, and proprietary information shall:

The Board and Board staff shall use, protect, and manage written comments and attachments containing confidential, trade-secret, and proprietary information in compliance with Regulation .04 of this chapter and Health-General Article, §§21-2C-03 and 21-2C-10, Annotated Code of Maryland.

To gather information from the general public before making recommendations or taking action with respect to a policy; or

For the purpose of receiving technical input, technical information or expert testimony before making recommendations or taking action with respect to a policy.

The public;

A person with a specific interest in the issue including a stakeholder; or

A person with specific knowledge, skills, expertise or technical information or input.

The Board shall publish a notice of the hearing on the Board’s website.

The Board shall include in the notice of the hearing:

A hearing held under this regulation is quasi-legislative and may be conducted or presided over by:

The Chair or designee shall determine the conduct of the hearing, including:

The Chair or designee may:

For hearings held under this regulation the following does not apply:

If an exhibit is offered and is relevant to the hearing, the Chair or designee shall receive and mark the exhibit offered in testimony.

Unless the Chair or designee believes that an oath provides some assurance of veracity, formality, or decorum to the hearing, the Chair or designee may dispense with the formality of an oath.

The Chair or designee has discretion to:

The Board may, through Board staff, convene informational hearings to receive input, information, and opinions from the public and stakeholders to inform the consideration and development of a recommendation, policy, regulation or action.

The Board shall provide public notice of the hearing in accordance with §B of this regulation.

In advance of the scheduled hearing, the Board may identify and publish questions, topics or matters about which the Board would like to receive information.

A person who wishes to provide input, information and opinions by testifying shall:

The Chair or designee shall give all persons who register to speak an opportunity to do so but may limit repetitious testimony.

The Chair or designee may:

Following an informational hearing, Board staff may provide the Board with summaries of the information received and staff’s recommendations.

The Board may convene a hearing for the purpose of receiving technical input, technical information or expert testimony from persons with specific knowledge, skills or expertise.

The Board shall provide public notice of the hearing in accordance with §B of this regulation.

The Board shall identify and invite a person to testify at a technical hearing to provide technical input, technical information or expert testimony on an issue the Board wishes to explore.

The Board may request that a person invited to testify submit a written statement to the Board two business days before the scheduled hearing.

The Chair may:

Following a technical hearing, Board staff may provide the Board with summaries of the information received and staff’s recommendations.

The Board shall arrange for the court reporter service to retain the recording for 1 year following the final decision or action; and

A person who desires a copy of the transcript may purchase a copy from the court reporter service.

The Board shall keep the recording with the original of the record; and

A person who desires a copy of the transcript may purchase a copy from the Board for a reasonable cost in accordance with COMAR 14.01.03, if a transcript has been prepared.

Exhibits and documents entered into the record;

Documents concerning the hearing such as a proposed regulation, the purpose of the hearing and public notice of the hearing;

Relevant supporting and opposing documentation obtained before, during, and subsequent to the hearing;

The register of persons who attended the hearing including name, address, and any affiliation relevant to the hearing;

In accordance with §E of this regulation, any:

Board staff’s summaries of the information received and staff’s recommendations, if any.

The entity is not a qualifying entity as defined in COMAR 14.01.01 and Health-General Article, §21-2C-11(b)(1), Annotated Code of Maryland;

The entity no longer does business in Maryland; or

The entity is not subject to assessment for another reason with an explanation of that reason.

The entity shall provide an executed certificate of business record (available on the Board’s website) authenticating any business record the entity submits in support of the request for exemption.

For carriers, supporting documentation may include but is not limited to NAIC “Annual Statement” including the cover page (signature page/jurat), Maryland State page, and Schedule T, acknowledgment from Maryland Insurance Administration of merger/change in subsidiary status, and SEC 10-K (any applicable exhibits).

For manufacturers, distributors, and PBMs, supporting documentation may include but is not limited to discharge in bankruptcy, documentation of merger/change in corporate structure/subsidiary status (for example, SEC 10-K and any applicable exhibits), acknowledgment from Board of Pharmacy of expiration of license/registration, expired license/registration, documentation that manufacturer/distributor provides only non-covered products (for example, provides gases only, product or inventory lists), and documentation that the entity does not do business in Maryland.

If the entity is unable to provide any documentation supporting the claimed exemption, the entity shall provide an affidavit (form on Board’s website) from the chief operating officer, chief financial officer, or other authorized official attesting to the factual basis of the claimed exemption.

A request for reconsideration on the form provided; and

Additional information or documentation in support of the claimed exemption.

Review the list, but staff shall review the list on at least an annual basis;

Add additional entities reported by or obtained from other agencies or identified by staff; and

Remove entities if the entity:

The Act or any other law may prevent the disclosure of the public record to the applicant; or

A written request will materially assist the Board in responding.

Immediately; or

Within a reasonable time period, not to exceed 30 days after the date of the request, if that period is needed to retrieve the public record and conduct any necessary review.

The amount of time that the custodian anticipates it will take to produce the public record;

An estimate of the range of fees that may be charged to comply with the request for public records; and

The reason why it will take more than 10 working days to produce the records.

Why the denial is necessary, that is, why disclosure of the public record would be contrary to the public interest; and

An explanation of why redacting information would not address the reasons for the denial;

The name of the custodian of the public record; and

The location or possible location of the public record.

Search for requested public records;

Review requested public records for potential disclosure; and

Prepare public records for inspection and copying.

The applicant requests a waiver; and

Either:

The 100 prescription drug products with the highest total gross spending in the most recent available calendar year;

The 100 prescription drug products with the highest total gross spending per patient in the most recent available calendar year;

The 100 prescription drug products with the highest percent change increase in WAC over the most recent available calendar year;

The 100 prescription drug products with the highest percent change increase in WAC over the most recent available 5-year period;

The 100 prescription drug products with the highest dollar increase in WAC per year or course of treatment over the most recent available calendar year;

The 100 prescription drug products with the highest dollar increase in WAC over the most recent available 5-year period; and

The 100 prescription drug products with the highest percent change increase in total gross spending;

The 100 prescription drug products with the highest total patient out-of-pocket costs in the most recent available calendar year;

The 100 prescription drug products with the highest average patient total out-of-pocket costs in the most recent available calendar year;

The 100 prescription drug products ranked at the 50th percentile for patient total out-of-pocket costs in the most recent available calendar year; and

The 100 prescription drug products ranked at the 90th percentile for patient total out-of-pocket costs; and

The date the FDA first approved the prescription drug product;

If applicable, the date the last patent expired or will expire;

Whether the prescription drug product was approved through an FDA accelerated approval pathway; and

Whether the prescription drug product is designated by the Secretary of the FDA, under 21 U.S.C. §360bb, as a drug for a rare disease or condition;

The class of the prescription drug product as identified in a recognized classification system;

Whether the prescription drug product is the only prescription drug product in its class;

Any therapeutic equivalent prescription drug product identified by examination of the FDA Orange Book, FDA Purple Book, or other therapeutic equivalence databases; and

The availability and number of therapeutic equivalents for sale in the State;

The patient count for the prescription drug product in the most recent available calendar year;

The total gross spending for the prescription drug product in the most recent available calendar year;

The total gross spending per patient for the prescription drug product in the most recent available calendar year;

The WAC on January 1 of the current calendar year, on January 1 of the previous calendar year, and at launch of the product;

The percent increase in WAC of the prescription drug product over the most recent available calendar year;

The percent increase in WAC of the prescription drug product over the most recent available 5-year period;

The dollar increase in WAC over the most recent available calendar year;

The dollar increase in WAC over the most recent available 5-year period;

The dollar increase in WAC per year or course of treatment over the most recent available calendar year;

The percent increase in overall total gross spending for the prescription drug product in the most recent available calendar year;

The estimated percentage of manufacturer national net sales to gross sales of a prescription drug product for the most recently reported year;

The average payor cost per patient for the prescription drug product in the most recent available calendar year; and

The average cost share for the prescription drug product;

The total patient out-of-pocket cost for the prescription drug product in the most recent available calendar year;

The average total out-of-pocket costs in the most recent available calendar year;

Patient total out-of-pocket costs ranked at the 50th percentile in the most recent available calendar year; and

Patient total out-of-pocket costs ranked at the 90th percentile in the most recent available calendar year;

Consider the prescription drug products identified on the Board’s agenda and any eligible drug proposed for consideration by a Board member at the meeting; and

Select one or more prescription drug products by NDC to refer to the Stakeholder Council to receive input from the Stakeholder Council on the selection of prescription drug products for cost review.

The information set forth in §B of this regulation;

Whether the prescription drug product was reported by an individual member of the public; and

Whether the prescription drug product was added by the Board for consideration under Regulation .02 of this chapter.

Review the information provided for each referred prescription drug product; and

Discuss the referred prescription drug products at an open meeting.

Complying with the procedures in COMAR 14.01.01.05B(3); and

Submitting the written comments to the Board within 30 calendar days of the date the list is posted on the Board’s website.

The prescription drug products referred to the Stakeholder Council from the prescription drug products identified under the statutory metrics and regulatory criteria in Regulation .02 of this chapter and the information provided under §B of this regulation;

The average cost share of the prescription drug product, the average patient total out-of-pocket cost, the average total payor cost, and publicly available data on direct-to-consumer advertising spending for the prescription drug product;

Input from the Stakeholder Council provided under §G of this regulation; and

Input from the public provided under COMAR 14.01.01.05.

NDC;

ANDA, NDA, or BLA, as applicable; and

Active moiety or active ingredient.

Documents and research explaining the relationship between the pricing of the prescription drug product and the cost of development, the relationship between the pricing of the prescription drug product and the therapeutic benefit, and information that is otherwise pertinent to the manufacturer’s pricing decision such as:

The total amount of the price concessions, discounts, and rebates provided to each payor type operating in the State;

The total amount of the price concessions, discounts, and rebates the manufacturer is expected to provide to each payor type;

The net price received by manufacturers for the drug product in the State accounting for all price concessions, discounts, and rebates;

The units of the prescription drug product sold in the State;

The units of the prescription drug product sold nationally;

The total dollar amount of sales of the prescription drug product into the State;

The total dollar amount of sales of the prescription drug product nationally;

The invoice price per unit for the prescription drug product charged to purchasers in the United Kingdom, Germany, France, and Canada, reported in U.S. dollars;

Prices charged to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers;

The average profit margin of the prescription drug product over the prior 5-year period and the projected profit margin anticipated for the current year for the prescription drug product;

Maryland and national gross and net manufacturer revenues for the prescription drug product under review for the most recent tax year;

Information concerning all authorized generics as defined by 42 CFR §447.502 for the prescription drug product;

Information concerning all other ANDAs, BLAs, and NDAs that pertain to the same active moiety and the same manufacturer;

The manufacturer’s research and development costs, as indicated on the manufacturer’s federal tax filing or information filed with the Federal Securities and Exchange Commission for the most recent tax year;

The portion of direct-to-consumer marketing costs eligible for favorable federal tax treatment in the most recent tax year that are specific to the prescription drug product under review; and

Any additional factors or information the manufacturer proposes that the Board consider.

The total amount of the price concessions, discounts, and rebates the manufacturer provides to each health plan operating in the State, expressed as a percent of the WAC;

The average price concession, discount, and rebate provided in the State for therapeutic alternatives;

Placement in each formulary offered or administered in the State and the number of covered lives for each formulary;

Benefit design around the prescription drug product, including copayment and coinsurance amounts in the State;

The net cost incurred by the insurance carrier for the prescription drug product in the State; and

Any additional factors or information the health insurance carrier, HMO, or MCO proposes that the Board consider.

The therapeutic alternatives for the prescription drug product(s) under review identified by each formulary administered by the PBM;

The total amount of the price concessions, discounts, and rebates the manufacturer provides to each PBM operating in the State, expressed as a percent of the WAC;

The average price concession, discount, and rebate provided in the State for therapeutic alternatives;

Placement in each formulary offered or administered in the State and the number of covered lives for each formulary;

Benefit design around the prescription drug product, including copayment and coinsurance amounts;

Maryland and national gross and net PBM revenues for the prescription drug product under review for the most recent tax year; and

Any additional factors or information the PBM proposes that the Board consider.

Prices charged to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers;

The total amount of price concessions and discounts provided by the wholesale distributor to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers;

Units of the prescription drug product sold in the State; and

Any additional factors or information the wholesale distributor proposes that the Board consider.

Completing the data form developed by the Board; and

Providing supporting documentation.

In paper form using a tracked common carrier, courier, or postal service; or

Electronically using secure file transfer.

Affordability challenges to the State health care system; or

High out-of-pocket costs for patients;

The labeling approved by the FDA; or

Standard medical practice; and

Derived from published peer-reviewed literature;

Derived from published public sources such as the FDA Orange Book, the FDA Purple Book, and other sources;

Reported by or derived from manufacturers, health insurance plans, HMOs, MCOs, PBMs, and wholesale distributors;

Produced by Board staff through analysis;

Derived from external analyses and modeling studies;

Derived from the MCDB, any claims set of the MCDB, and any other databases containing relevant information;

Derived from reports generated by U.S. governmental entities, State governmental entities, foreign governmental and quasi-governmental agencies, and U.S. and foreign non-profit organizations; or

Derived from quantitative and qualitative data collected by Board staff.

Drug Pricing for Drug Product Under Review:

Price Concessions, Discounts, and Rebates:

Therapeutic Alternatives:

Patient Access:

Cost and Comparative Effectiveness Analyses:

Cost Sharing:

Additional Board Factors:

Within 60 days of the date the drug’s selection for cost review study is posted on the Board’s website; and

In accordance with the procedures in COMAR 14.01.01.05B(3).

Use of the prescription drug product, identified by NDC, has led or will lead to:

Whether the use that has led to affordability challenges or high out-of-pocket costs is consistent with:

Federal support for the research and development of the prescription drug product; and

Pricing data from other countries for the prescription drug product.

Board staff shall prepare a draft of the preliminary determination cost review report that summarizes the information considered by the Board in conducting the cost review study, the Board’s deliberations, the circumstances or indicia reflecting the affordability challenge, and the Board’s preliminary determination.

The public may comment on the draft of the preliminary determination cost review report.

Informational hearings;

Stakeholder Council input;

Expert testimony hearings;

Board staff research and analysis; and

Eligible governmental entities’ information;

Policy actions other than UPLs; and

Policy action in the form of a UPL and the process for setting upper payment limits; and

Adoption of the final cost review report;

Adoption of non-UPL policy recommendations; and

Adoption of proposed regulations setting a UPL amount.

The Board may, through Board staff, convene a hearing to receive input, information, and opinions from the public and stakeholders to inform the consideration and development of policy options including upper payment limits to redress an affordability challenge.

The public informational hearing shall be conducted in accordance with COMAR 14.01.01.06.

The Board may request input from the Stakeholder Council. This input can be a request for general input and ideas on policies or more specific requests for specific information.

Board staff may provide the Board with summaries of input from the Stakeholder Council.

The Board may convene a hearing for the purpose of receiving technical input, technical information or expert testimony.

The technical hearing shall be conducted in accordance with COMAR 14.01.01.06.

Board staff may provide the Board with policy research and analyses related to the drivers of the potential affordability and potential options.

Research may include a literature review of available literature and original quantitative or qualitative research conducted by staff.

Board staff may collect information concerning the prescription drug product and therapeutic alternatives from eligible governmental entities.

The information collected may include utilization, spending, costs, benefit design, formulary placement, rebates, discounts, price concessions and other relevant information.

Drivers of the affordability challenge;

How the policy addresses a driver;

Strengths and weaknesses of the policy;

Possible implementation of the policy through legislation, regulation, or enforcement; and

Potential impacts of the policy.

Adopt none of the non-UPL policy recommendations;

Adopt one or more policy recommendations; or

Adopt and modify one or more policy recommendations.

Made a final affordability challenge determination; and

Adopted the final cost review study report under COMAR 14.01.04.05G.

The drivers and market conditions causing the affordability challenge phenomena;

Ability of a UPL to address these issues;

Strengths and weaknesses of the UPL policy;

Potential impacts of the UPL policy;

Possible implementation of the policy through legislation, regulation or enforcement;

Relevant regulatory criteria under Regulation .02 of this chapter; and

Use of the drug by eligible governmental entities.

An assessment of the drivers of the affordability challenge; and

The extent to which a UPL may address the drivers.

Post staff’s recommendations on the Board’s website in advance of the Board meeting; and

Request public comment.

Under this framework, a maximum UPL value may be set by:

When providing a UPL amount developed using this framework, Board staff shall identify the health outcome, threshold, and relevant underlying assumptions used in the analysis.

Under this framework, a UPL value may be set using the lowest net price or net cost among competitor products in the same therapeutic class.

The Board may limit the prescription drug products used for analysis to a subset of drugs in the same therapeutic class.

When determining whether to use a product in the same therapeutic class as a reference product, the Board may consider:

Under this framework, a UPL value may be set based on the initial price at which the drug was first marketed (launch price) adjusted for inflation.

The Board shall adjust the launch price using the CPI-U.

Under the same molecule reference UPL framework, a UPL value may be set by comparing prices of certain reference drugs:

When using this framework Board staff may consider:

Under the domestic reference UPL framework, a UPL value may be set using the estimated net cost of a prescription drug product to other purchasers and payors for the same prescription drug product within the United States or the net price received by the manufacturer.

Under this framework, the UPL may be set using the cost of the lowest estimated net-cost purchaser or payor, excluding Medicaid.

The Board may consider information for all other payors, including information on the Medicare Maximum Fair Price.

Under the international reference UPL framework, a UPL value may be set by comparing drug prices in other countries.

Under this framework, the Board may consider the lowest price received by manufacturers for sales in the United Kingdom, Germany, France, and Canada, converted to U.S. dollars.

Under the budget impact-based UPL framework, a UPL value may be set so that spending on the drug does not exceed a certain percentage of a budget as specified by the Board or have a disproportionate impact on that budget.

The Board may consider current spending, projected spending, and potential offsets in developing a UPL value.

When setting the percentage, the Board may consider the number of patients impacted, the disease burden, the current and projected future spending on other treatments and management of the disease.

Under this framework, Board staff may recommend potential UPL values derived from:

When providing a blended UPL amount developed using this framework, Board staff shall identify how the potential blended UPL value was generated.

State health plan;

County, bicounty, and municipal health plans;

Direct government purchases; and

Medicaid;

State health plan;

County, bicounty, and municipal health plans; and

Medicaid;

State health plan;

County, bicounty, and municipal health plans; and

Medicaid;

State health plan;

County, bicounty, and municipal health plans; and

Medicaid;

Number of prescriptions paid;

Number of patients who received the prescription drug product; and

Total amount paid for the prescription drug product;

Select one or more of the frameworks and contextual information identified in §§B and C of this regulation;

Identify another framework;

Prioritize the selected and identified frameworks and contextual information; and

Direct staff to use the selected and identified frameworks and contextual information to perform analyses and calculations to obtain UPL values.

Reflects all discounts, rebates and price concessions;

Excludes dispensing and administration fees and direct and indirect renumeration to pharmacies; and

Includes patient out-of-pocket costs other than costs attributable to dispensing fees under §D(3)(b) of this regulation.

The UPL values developed through analysis;

Staff’s recommendation for a proposed UPL amount with a description of the calculation and analyses and relevant underlying assumptions used in the analysis such as health outcome or threshold; and

A request for public written comment on the Board’s website.

Make a final determination of whether the prescription drug has or will create an affordability challenge; and

Adopt as final a cost review study report under COMAR 14.01.04.05G.

Non-UPL policy recommendations in accordance with Regulation .05 of this chapter;

Proposed regulations setting the UPL at the specified amount in accordance with Regulation .08 of this chapter; or

Both.

Shall be performed sequentially; and

May be taken at the same Board meeting.

Take no action and allow the UPL to stand;

Modify the UPL amount and propose amendment of the UPL regulation setting the new modified UPL amount;

Suspend the UPL for a specified period and propose amendment of the regulation to proscribe the suspension; and

Repeal the UPL and propose repealing the regulation setting the UPL amount.

Board staff shall post notice of the reconsideration of the UPL on the Board’s website.

The Board may solicit patient and stakeholder feedback through written comments submitted in accordance with COMAR 14.01.01.05B(4) and informational hearings held under COMAR 14.01.01.06C.

The Board may use the information gathering process under Regulation .04 of this chapter to obtain information for the reconsideration process.

Board staff shall present to the Board:

The Board may take any action specified under §A(4) of this regulation.

If Board staff recommends further study to support modification of the UPL, the Board shall use the procedures in Regulations .06D-F and .07B(1)(b) of this chapter to develop a new UPL amount and receive public comment.

The Board may modify the UPL amount and propose amendment of the UPL regulation setting the modified UPL amount under § A(4)(b) of this regulation.

Select the prescription drug product for cost review study if the drug product meets the eligibility requirements set forth in COMAR 14.01.04.02;

Conduct a cost review study in accordance with COMAR 14.01.04.05; and

Make a preliminary determination in accordance with COMAR 14.01.04.05.

Consider any element or analysis from the original cost review study report;

If available, consider information from the UPL monitoring program;

Consider information obtained through the reconsideration process under §B of this regulation; and

Set a UPL or make other policy recommendations in accordance with Regulations .07—.08 of this chapter.