90-590 MAINE HEALTH DATA ORGANIZATION
- Chapter 340: UNIFORM REPORTING SYSTEM FOR REPORTING 340B DRUG PROGRAM DATA SETS
SUMMARY: This Chapter contains the provisions for filing 340B Drug Program data sets from participating Maine hospitals.
The provisions include:
Identification of the organizations required to register and report;
Establishment of requirements for the content, format, method, and time frame for filing 340B Drug Program data;
Establishment of standards for the data reported; and Compliance provisions.
Definitions
- Unless the context indicates otherwise, the following words and phrases shall have the following meanings:
- 340B Acquisition Cost. “340B Acquisition Cost” means the cost to the hospital and, where applicable, its 340B Contract Pharmacies and 340B Third Party Administrators, to purchase a prescription drug product with a unique NDC under the 340B Drug Program.
- 340B Child Facilities. “340B Child Facilities” means outpatient facilities under the 340B program based on their inclusion in a hospital’s Medicare cost report and registration with the 340B Office of Pharmacy Affairs (OPA). These facilities can participate in the 340B program and purchase/provide discounted drugs to their patients, provided they meet specific eligibility criteria.
- 340B Contract Pharmacy. “340B Contract Pharmacy” means a pharmacy contracted by a Hospital to dispense 340B drugs to patients, that is registered for the 340B Drug Program, and listed as active on the 340B Office of Pharmacy Affairs Information System (OPAIS), whether or not such pharmacy is located in the State.
- 340B Drug. “340B Drug” means a drug that is purchased or eligible for purchase under Section 340B of the federal public Service Act, 42 United States Code, Section 256b(a)(3).
- 340B Drug Program. “340B Drug Program” means Section 340B of the Public Health Service Act that requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients. These organizations include federal grantee organizations and several types of hospitals, including critical access hospitals (CAHs), sole community hospitals (SCHs), rural referral centers (RRCs), and public and nonprofit disproportionate share hospitals (DSHs) that serve low-income and indigent populations.
- 340B Entity. “340B Entity” means an entity participating or authorized to participate in the federal 340B drug discount program, as described in 42 United States Code, Section 256b, including its pharmacy, or any pharmacy contracted with the participating entity to dispense drugs purchased through the federal 340B drug discount program.
- 340B Rebate Model Pilot Program. “340B Rebate Model Pilot Program” means a rebate program introduced by the Health Resources and Services Administration (HRSA) under which 340B Entities purchase specific 340B Drugs through their current 340B wholesaler account based on the WAC price provided by the manufacturer and are later provided a manufacturer rebate after the drug is dispensed or administered to an eligible 340B patient.
- 340B Third Party Administrator. “340B Third Party Administrator” means an entity contracted by a Hospital to administer tasks related to purchasing, inventory management, reporting, billing, or other administration for its 340B Drug Program.
- Hospital. “Hospital” means (i) an acute care institution licensed and operating in this State as a hospital under section 1811 or the parent of such institution; or a (ii) hospital subsidiary or hospital affiliate in the State that provides medical services or medically related diagnostic and laboratory services or engages in ancillary activities supporting those services
- MHDO. "MHDO" means the Maine Health Data Organization
- M.R.S. “M.R.S.” means Maine Revised Statutes.
- National Drug Code (NDC). “National Drug Code” means the three-segment code maintained by the federal Food and Drug Administration that includes a labeler code, a product code, and a package code for a drug product and that has been converted to an 11-digit format consisting of five digits in the first segment, four digits in the second segment, and two digits in the third segment. A three-segment code shall be considered converted to an 11-digit format when, as necessary, at least one “0” has been added to the front of each segment containing less than the specified number of digits such that each segment contains the specified number of digits.
- Payable. “Payable” means a payment amount accrued to be paid to another party.
- Pricing Unit. “Pricing Unit” means the smallest dispensable amount of a prescription drug that can be dispensed or administered.
- Receivable. “Receivable” means a payment amount accrued to be received from another party.
Registration and Submission Requirements
- Hospitals participating in the 340B Drug Program shall submit to the MHDO or its designee complete 340B Drug Program data sets in accordance with the requirements of this section.
- Registration. Each Hospital participating in the 340B Drug Program shall complete an online registration form, or update an existing one, via the MHDO Rx Data Portal web interface by December 1st of each year. It is the responsibility of the reporting entity to update, as needed, all company and contact information.
- Submission Method. Each Hospital participating in the 340B Drug Program shall annually submit data to the MHDO using the MHDO Rx Data Portal by entering each required data field directly into the data portal.
- Data that is required to be reported by payor type and/or NDC may also be submitted by unloading an MHDO provided Excel (xlsx) template that includes all required information in the format specified below, as applicable. Blank templates should be downloaded from the data portal. E-mail attachments shall not be accepted.
- Submission Deadline. The annual submission of 340B data shall cover the previous fiscal year and shall be due no later than six months after its most recent fiscal year end in accordance with the following schedule:
Fiscal Year End Date | Filing Deadline |
January 31 | July 31 |
February 28 | August 31 |
March 31 | September 30 |
April 30 | October 31 |
May 31 | November 30 |
June 30 | December 31 |
July 31 | January 31 |
August 31 | February 28 |
September 30 | March 31 |
October 31 | April 30 |
November 30 | May 31 |
December 31 | June 30 |
- Rejection of Submissions. Failure to conform to the requirements of subsections B of this Section shall result in the rejection of the data submissions. All rejected data must be corrected and resubmitted in the MHDO Rx Data Portal within 30 days of the rejection.
- Replacement of Data Files. A Hospital may replace data submitted to the MHDO with updated data within 90 days of the updated information becoming available if that date does not occur more than 18 months after the hospital’s fiscal year end.
- Reporting Specifications. Each Hospital must report the following data.
- Part 1
- For the top three drugs with a unique NDC having the highest acquisition costs and the top three drugs that were dispensed most often, and acquired by the Hospital (or its 340B Contract Pharmacies and 340B Third Party Administrators) under the 340B Drug Program during the fiscal year, the following data elements:
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. |
Drug Name | A description of the drug including the product name, dosage form, strength, and package size. |
Total 340B Drug Acquisition Cost (NDC) | The cost in whole dollars to the hospital and, where applicable, its 340B Contract Pharmacies and 340B Third Party Administrators, to purchase the drug under the 340B Drug Program. |
340B Estimated Savings | The cost that would have otherwise been paid to acquire the drug had a 340B discount not been applied (based on the average actual acquisition cost paid for the same drug outside the 340B Drug Program on a per unit basis), reduced by the 340B Acquisition Cost. |
- For all drugs acquired by the hospital (or its 340B Contract Pharmacies and 340B Third Party Administrators) participating in the 340B Drug Program during the fiscal year, the aggregated total across all drugs for the following data elements:
Data Element Name | Description/Codes/Sources |
Total 340B Drug Acquisition Cost (All 340B Drugs) | The sum total in whole dollars of all drugs under the 340B Drug Program, purchased by a Hospital, and where applicable, its 340B Contract Pharmacies and 340B Third Party Administrators. |
Total Drug Expenditures (All Drugs) | The sum total in whole dollars of all drugs purchased by a Hospital, and where applicable, its 340B Contract Pharmacies and 340B Third Party Administrators. |
Total 340B Drug Program Estimated Savings (All 340B Drugs) | The cost that would have otherwise been paid to acquire drugs purchased under the 340B Drug Program had a 340B discount not been applied (based on the average acquisition cost paid for the same drugs outside the 340B program on a per unit basis), reduced by: - the 340B Acquisition Cost; and
- the total amount of payments made to 340B Contract Pharmacies, including any share of 340B savings retained by 340 B Contract Pharmacies, for dispensing drugs obtained under the 340B program; and
- the total amount of payments made to 340B Third Party Administrators, including any share of 340B savings retained by 340B Third Party Administrators, for 340B program administration tasks; and
- any additional administrative costs associated with the 340B program.
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Program or Service Name / Category | The name of any program or service which is funded in whole or in part from Estimated Savings from the 340B Drug Program and provide community benefits. |
Description of Program or Service | A description of any program or service which is funded in whole or in part from Estimated Savings from the 340B Drug Program and provide community benefits. |
Hospital Internal Review and Oversight | A description of the Hospital's internal review and oversight of the 340B Drug Program, which meets the federal DHHS, HRSA's program rules and guidance for compliance. |
Part 2
This section is separated into seven defined reporting categories, identified as a.-g. Data submitted for each of the sections below must include prescription drugs dispensed or administered by the hospitals outpatient facilities that are identified as child facilities under the 340B Drug Program based on their inclusion in the Hospital’s Medicare cost report.
- Hospital Totals: Data elements the Hospital must manually enter to report on totals for the entire Hospital.
Data Element Name | Description/Codes/Sources |
Total 340B Acquisition Cost | The aggregated 340B Acquisition Cost for all prescription drugs obtained by, or on behalf of, the Hospital under the 340B Drug Program during the previous fiscal year. |
Total 340B Contract Pharmacy Claims | The aggregated number of claims for prescriptions filled by 340B Contract Pharmacies during the previous fiscal year for drugs obtained under the 340B Drug Program. |
Total 340B Contract Pharmacy Cost | The aggregated payments made to 340B Contract Pharmacies to dispense drugs during the previous fiscal year for drugs obtained under the 340B Drug Program. |
Total 340B Outside Entity Cost | The aggregated payments made to any other entity that is not the Hospital, and is not a 340B Contract Pharmacy, for managing any aspect of the Hospital’s 340B Drug Program during the previous fiscal year. |
Total Other 340B Expenses | The aggregated payments made for all other expenses related to administering the 340B Drug Program during the previous fiscal year, including any contract fees, staffing, operational, and administrative expenses. |
Total 340B Rebate Receivable Amount | The aggregated rebate receivable amount accrued by the Hospital during the previous fiscal year related to the dispensing or administration of 340B drugs. |
Total 340B Rebate Payable Amount | The aggregated rebate payable amount accrued by the Hospital during the previous fiscal year related to the dispensing or administration of 340B drugs. |
- Hospital Totals by Primary Payor Type: Data elements the Hospital must manually enter or provide by uploading an MHDO provided Excel (.xlsx) template to report on totals for the Hospital by primary payor type.
Data Element Name | Description/Codes/Sources |
Payor Type | When using an MHDO provided Excel Template, enter value: 1 – Commercial 2 – Medicare 3 – MaineCare 4 – Medical Assistance 5 – Other/Specify in General Comments |
Total 340B Pricing Units – Dispensed Drugs | The total number of Pricing Units dispensed to patients during the previous fiscal year for all drugs obtained under the 340B Drug Program. |
Total 340B Payment Received – Dispensed Drugs | The aggregated payment receivable amount accrued for all drugs obtained under the 340B Drug Program and dispensed to patients during the previous fiscal year. |
Total 340B Pricing Units – Administered Drugs | The total number of Pricing Units administered to patients during the previous fiscal year for all drugs obtained under the 340B Drug Program. |
Total 340B Payment Received – Administered Drugs | The aggregated payment receivable amount accrued for all drugs obtained under the 340B Drug Program and administered to patients during the previous fiscal year. |
- Hospital Top 50 Dispensed Drugs: Data elements the Hospital must manually enter or provide by uploading an MHDO provided Excel (.xlsx) template to report on totals for the Hospital’s top 50 drugs with a unique NDC that were dispensed most often, and acquired by, or on behalf of, the Hospital under the 340B Drug Program during the fiscal year.
Data Element Name | Description/Codes/Sources |
NDC | The NDC of the drug. |
Drug Name | A description of the drug including the product name, dosage form, strength, and package size. |
Total 340B Acquisition Cost | The aggregated 340B Acquisition Cost for the NDC obtained by, or on behalf of, the Hospital under the 340B Drug Program during the previous fiscal year. |
Total 340B Rebate Receivable Amount | The aggregated rebate receivable amount accrued by the Hospital during the previous fiscal year related to the dispensing of the NDC under the 340B drug program. |
Total 340B Rebate Payable Amount | The aggregated rebate payable amount accrued by the Hospital during the previous fiscal year related to the dispensing of the NDC under the 340B drug program. |
- Hospital top 50 Dispensed Drugs by Primary Payor Type: Data elements the Hospital must manually enter or provide by uploading an MHDO provided Excel (.xlsx) template to report on totals for the Hospital’s top 50 drugs with a unique NDC that were dispensed most often, and acquired by, or on behalf of, the Hospital under the 340B Drug Program during the fiscal year by primary payor type.
Data Element Name | Description/Codes/Sources |
NDC | The NDC of the drug. |
Drug Name | A description of the drug including the product name, dosage form, strength, and package size. |
Payor Type | When using an MHDO provided Excel Template, enter value: 1 – Commercial 2 – Medicare 3 – MaineCare 4 – Medical Assistance 5 – Other/Specify in General Comments |
Total 340B Pricing Units – Dispensed Drugs | The total number of Pricing Units dispensed to patients during the previous fiscal year for all drugs obtained under the 340B Drug Program. |
Total 340B Payment Received – Dispensed Drugs | The aggregated payment receivable amount accrued for all drugs obtained under the 340B Drug Program and dispensed to patients during the previous fiscal year. |
- Hospital Top 50 Administered Drugs: Data elements the Hospital must manually enter or provide by uploading an MHDO provided Excel (.xlsx) template to report on totals for the Hospital’s top 50 drugs with a unique NDC that were administered most often, and acquired by, or on behalf of, the Hospital under the 340B Drug Program during the fiscal year.
Data Element Name | Description/Codes/Sources |
NDC | The NDC of the drug. |
Drug Name | A description of the drug including the product name, dosage form, strength, and package size. |
Total 340B Acquisition Cost | The aggregated 340B Acquisition Cost for the NDC obtained by, or on behalf of, the Hospital under the 340B Drug Program during the previous fiscal year. |
Total 340B Rebate Receivable Amount | The aggregated rebate receivable amount accrued by the Hospital during the previous fiscal year related to the administering of the NDC under the 340B drug program. |
Total 340B Rebate Payable Amount | The aggregated rebate payable amount accrued by the Hospital during the previous fiscal year related to the administering of the NDC under the 340B drug program. |
- Hospital Top 50 Administered Drugs by Primary Payor Type: Data elements the Hospital must manually enter or provide by uploading an MHDO provided Excel (.xlsx) template to report on totals for the Hospital’s top 50 drugs with a unique NDC that were administered most often, and acquired by, or on behalf of, the Hospital under the 340B Drug Program during the fiscal year by primary payor type.
Data Element Name | Description/Codes/Sources |
NDC | The NDC of the drug. |
Drug Name | A description of the drug including the product name, dosage form, strength, and package size. |
Payor Type | When using an MHDO provided Excel Template, enter value: 1 – Commercial 2 – Medicare 3 – MaineCare 4 – Medical Assistance 5 – Other/Specify in General Comments |
Total 340B Pricing Units – Administered Drugs | The total number of Pricing Units administered to patients during the previous fiscal year for all drugs obtained under the 340B Drug Program. |
Total 340B Payment Received – Administered Drugs | The aggregated payment receivable amount accrued for all drugs obtained under the 340B Drug Program and administered to patients during the previous fiscal year. |
- Hospital Community Benefits: Data elements the Hospital must manually enter to report on Hospital programs or services that provide community benefits and are funded in whole or in part from 340B drug program savings.
Data Element Name | Description/Codes/Sources |
Program or Service Name / Category | The name of any program or service which is funded in whole or in part from estimated savings from the 340B Drug Program and provide community benefits. |
Description of Program or Service | A description of any program or service which is funded in whole or in part from estimated savings from the 340B Drug Program and provide community benefits. |
Evaluation; Notification; Response
- A. Evaluation. The MHDO or its vendor shall evaluate each file in accordance with the following standards:
- When applicable, only an eligible code value for a specified data element shall be accepted;
- Coding values indicating “data not available”, “data unknown”, or the equivalent shall not be used for individual data elements unless specified as an eligible value for the element.
- B. Notification. Upon completion of the data evaluation, the MHDO or its designee will promptly notify each Hospital whose data submissions do not satisfy the standards for any filing period. This notification will identify the specific file and the data elements within them that do not satisfy the standards.
- C. Response. Each Hospital notified under subsection 3(B) will respond within 30 days of the notification by making and reporting the changes necessary to satisfy the standards.
Compliance
Certification of accuracy. Hospitals will be required to attest to the accuracy of their data submissions through the MHDO Rx Data Portal web interface.
Enforcement. The failure to file, report, or correct 340B Drug Program data sets when required in accordance with the provisions of this Chapter may be considered a civil violation under 22 M.R.S. § 8705-A and Code of Maine Rules 90-590, Chapter 100: Enforcement Procedures.
Extensions to Data Submission Requirements
- If a Hospital, due to circumstances beyond its control, is temporarily unable to meet the terms and conditions of this Chapter, a written request must be made to the Compliance Officer of the MHDO as soon as it is practicable after the reporting entity has determined that an extension is required.
- Annual Report Requirement
- Information provided to the MHDO as required by this rule shall be used by the MHDO to:
- Produce and post on MHDO’s publicly accessible website, a report that includes a summary of the aggregate information received from Hospitals required to report under 22 M.R.S. § 1728 subsection 2, and
- Submit the reports required by this subsection to the Office of Affordable Health Care, as established in Title 5, section 3122, the Maine Prescription Drug Affordability Board, as established in Title 5, section 12004-G, subsection 14-I, and the joint standing committee of the Legislature having jurisdiction over health data reporting and prescription drug matters.
STATUTORY AUTHORITY: 22 M.R.S. §§ 1728, 8703(1), and 8704(1) & (4)
EFFECTIVE (NEW): September 17, 2024
APAO ACCESSIBILITY CHECK (Word):
March 3, 2026
AMENDED:
March 8, 2026 – filing 2026-058