90-590-570 Me. Code R. § 2

Current through 2024-51, December 18, 2024

Section 590-570-2 - Registration and Submission Requirements

Reporting entities shall submit to the MHDO or its designee complete prescription drug price data sets in accordance with the requirements of this section. Data may be submitted by corporate entities or their subsidiaries. Reporting entities that engage subcontractors or other third parties to submit information on their behalf warrant the completeness and accuracy of all data submitted.

A.Registration. Each entity required to report shall complete an online registration form, or update an existing one, via the MHDO Prescription Drug Price Data Portal web interface (https://mhdo.maine.gov/pharma_portal/) by January 30^th of each year. It is the responsibility of the reporting entity to complete, as needed, all company and contact information.

B.Public Notice of Substantial Drug Price Change or Introduction. No later than January 30th of each year, the MHDO shall produce and post on its publicly accessible website a list of prescription drugs for which the manufacturer has during the prior calendar year:

1) Increased the wholesale acquisition cost of a brand-name drug by more than 20% per pricing unit;

2) Increased the wholesale acquisition cost of a generic drug that costs at least $10 per pricing unit by more than 20% per pricing unit; or

3) Introduced a new prescription drug for distribution in this State when the wholesale acquisition cost is greater than the amount that would cause the drug to be considered a specialty drug under the Medicare Part D program (hereinafter "new drug"). For the purposes of this paragraph, "Medicare Part D" has the same meaning as in 22 M.R.S. §254-D(1)(F).

C.Disclosures by manufacturers, wholesale drug distributors and pharmacy benefits managers. The following disclosures apply to manufacturers, wholesale drug distributors and pharmacy benefits managers.

1) On or before February 15th of each year, the MHDO shall produce and post on its publicly accessible website a list of drug product families for which it intends to request pricing component data from manufacturers, wholesale drug distributors and pharmacy benefits managers. The MHDO will base its inclusion of drug product families on any information the MHDO determines is relevant to providing greater consumer awareness of the factors contributing to the cost of prescription drugs in the State, and the MHDO will consider drug product families of prescription drugs:

a) Included in the public notice of substantial drug price change or introduction under subsection 2(B); and;

b) For which the MHDO is required to produce an annual report pursuant to 22 M.R.S. §8712(5), including, but not limited to, the 25 costliest drugs (determined by the total amount spent in the State), the 25 most frequently prescribed drugs in the State, and the 25 drugs with the highest year-over-year cost increases (determined by the total amount spent in the State).

2) Not sooner than 30 days after publicly posting the list of drug product families pursuant to subsection C(1), the MHDO will notify, via e-mail:

a) manufacturers that are required to report pricing component data as detailed in section 2(J)(1);

b) wholesale drug distributors that are required to report pricing component data as detailed in section 2(J)(2); and

c) pharmacy benefits managers that are required to report pricing component data as detailed in section 2(J)(3).

3) Each reporting entity receiving such a notification shall submit their pricing component data to the MHDO for each NDC in each drug product family included in the notice in accordance with the requirements below.

D.Submission Method. Data files must be submitted via the MHDO Prescription Drug Price Data Portal web interface (https://mhdo.maine.gov/pharma_portal/). E-mail attachments shall not be accepted.

E.File Format. The file format will be an MHDO-provided Excel template for each dataset submitted via a secure web upload interface. Submitters must use the current version of the appropriate template. The file format will contain the data elements found in the Reporting Specifications described in subsection 2(J). File naming conventions will be specified in the instructions included with each template.

F.Codes. Unless otherwise specified, only the code sources listed and described in the templated reports are to be utilized. Specific or unique coding systems shall not be permitted.

G.Submission Deadline. Prescription drug manufacturers, wholesale drug distributors and pharmacy benefits managers shall report no later than 60 days after notification from the MHDO, as described in subsection 2(C)(2).

H.Rejection of Submissions. Failure to conform to the requirements of subsections D, E or F of this Section shall result in the rejection of the data file(s). All rejected files must be corrected and resubmitted to the MHDO or its designee within 30 days.

I.Replacement of Data Files. A reporting entity may replace data submitted to the MHDO with updated data within 90 days of the updated information becoming available. Any replacements after this period must be approved by the MHDO.

J.Reporting Specifications. For each drug product NDC indicated in the MHDO notice, the reporting entity must report the following data. Data related to sales volume, acquisition volume, revenue, acquisition amount, and rebates should be provided net of returns.

K.

1)Manufacturer Report

Data Element Name	Description/Codes/Sources
NDC	The national drug code maintained by the FDA for the drug product that includes the labeler code, product code, and package code. A drug's NDC is typically expressed using 11 digits in a 5-4-2 format (xxxxx-yyyy-zz). The first five digits identify the manufacturer, the second four digits identify the product and strength, and the last two digits identify the package size and type. Do not leave blank.
Drug Indicator	1 = Brand Name; 2 = Generic
Estimated Number of Patients	Estimated annual patient volume in the United States for this drug product during the current calendar year.
Baseline WAC Amount	The wholesale acquisition cost of the drug product on the later of the day prior to the first day of the prior calendar year, the introduced to market date, or the acquisition date.
Total WAC Change Amount	The total amount of wholesale acquisition cost change for the drug product during the last calendar year. Indicate $0 if no change.
WAC After Change	The wholesale acquisition cost resulting from the reported wholesale acquisition cost change for the drug product. That is, the wholesale acquisition cost on the last day of the calendar year. If no change, this amount should be the same as the Baseline WAC Amount.
Unit Sales Volume in US	The number of units of the drug product sold in the United States during the prior calendar year.
Revenue in US	Gross revenue from sales in the United States for this drug product during the prior calendar year.
Total Rebate Payable Amount in US	Total rebate payable amount accrued for the drug product in the United States during the prior calendar year.
Cost Change Factors	Reasons for WAC change 0 - No change/not applicable 1 - Change in administrative expenses 2 - Scheduled price change 3 - Change in ingredient costs 4 - Change in manufacturing 5 - Change in marketing & advertising costs 6 - Change in financial assistance 7 - Change in R&D costs 8 - Change in rebates to PBMs/wholesalers 9 - Other rebate change 10 - Change in supply (shortage or surplus) 11 - Change in sales costs 12 - Change in state and federal taxes 13 - Change in profit targets 14 - Change in supplier price (repackaged NDC) 15 - Other/Specify
Acquisition Date	If the drug product was acquired by the manufacturer within the previous five years, the date of acquisition. If not, leave blank.
Company Acquired from Name	If the drug product was acquired by the manufacturer within the previous five years, the name of the company from which the drug was acquired. If not, leave blank.
Company Acquired from Tax ID Number	If the drug product was acquired by the manufacturer within the previous five years, the TIN of the company from which the drug was acquired. If not, leave blank.
Acquisition Price	If the drug product was acquired by the manufacturer within the previous five years, the purchase price of acquisition. If not, leave blank.
WAC at Acquisition	If the drug product was acquired by the manufacturer within the previous five years, and the acquisition date falls after the introduced to market date, the wholesale acquisition cost of the drug product at the time of acquisition. If not, leave blank.
WAC One Year Prior to Acquisition	If the drug product was acquired by the manufacturer within the previous five years, and the acquisition date falls more than 365 days after the introduced to market date, the wholesale acquisition cost of the drug product one year prior to the date of acquisition. If not, leave blank.
Introduced to Market Date	If the drug product was introduced to market within the previous calendar year or acquired by the manufacturer within the previous five years, the date the drug product was introduced to market. If not, leave blank.
WAC at Market Introduction	If the drug product was introduced to market within the previous calendar year or acquired by the manufacturer within the previous five years, the wholesale acquisition cost of the drug product when it was introduced to market. If not, leave blank.
Acquisition Comments	Additional information related to the acquisition information provided, if applicable.
General Comments	Additional information related to the data submitted for this drug product, if applicable.

2)Wholesale Drug Distributor Report

Data Element Name	Description/Codes/Sources
NDC	The national drug code maintained by the FDA for the drug product that includes the labeler code, product code, and package code. A drug's NDC is typically expressed using 11 digits in a 5-4-2 format (xxxxx-yyyy-zz). The first five digits identify the manufacturer, the second four digits identify the product and strength, and the last two digits identify the package size and type. Do not leave blank.
Unit Acquisition Volume in US	The number of units of the drug product acquired in the United States by the wholesale drug distributor during the prior calendar year.
Total Acquisition Amount in US	Total spent before rebates by the wholesale drug distributor to acquire the drug product in the United States during the prior calendar year.
Total Rebate Receivable Amount in US	Total rebate receivable amount accrued by the wholesale drug distributor for the drug product in the United States during the prior calendar year.
Unit Sales Volume in US	Number of units of the drug product sold by the wholesale drug distributor in the United States during the prior calendar year.
Revenue in US	Gross revenue from sales in the United States generated by the wholesale drug distributor for this drug product during the prior calendar year.
Total Rebate Payable Amount in US	Total rebate payable amount accrued by the wholesale drug distributor for the drug product in the United States during the prior calendar year.
General Comments	Additional information related to the data submitted for this drug product, if applicable.

3)Pharmacy Benefits Manager Report

Data Element Name	Description/Codes/Sources
NDC	The national drug code maintained by the FDA for the drug product that includes the labeler code, product code, and package code. A drug's NDC is typically expressed using 11 digits in a 5-4-2 format (xxxxx-yyyy-zz). The first five digits identify the manufacturer, the second four digits identify the product and strength, and the last two digits identify the package size and type. Do not leave blank.
Pricing Units Administered in Maine	The number of pricing units of the drug product filled in Maine for which the PBM administered claims during the prior calendar year.
Total Pharmacy Reimbursement in Maine	Total reimbursement amount accrued and payable to pharmacies for pricing units of the drug product filled in Maine for which the PBM administered claims during the prior calendar year.
Total Payment Received in Maine	Total reimbursement and/or administrative fee amount accrued and receivable from payers for pricing units of the drug product filled in Maine for which the PBM administered claims during the prior calendar year.
Total Rebate Receivable Amount in Maine	Total rebate receivable amount accrued by the PBM for the drug product in Maine during the prior calendar year.
Total Rebate Payable Amount in Maine	Total rebate payable amount accrued by the PBM for the drug product in Maine during the prior calendar year.
General Comments	Additional information related to the data submitted for this drug product, if applicable.

90-590 C.M.R. ch. 570, § 2