90-590-340 Me. Code R. § 2

Current through 2024-51, December 18, 2024

Section 590-340-2 - 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.

A.Registration. Each Hospital participating in the 340B Drug Program shall complete an online registration form, or update an existing one, via the MHDO Hospital Data Portal web interface (https://mhdo.maine.gov/hospital_portal/ by December 1^st of each year. It is the responsibility of the reporting entity to complete, as needed, all company and contact information.

B.Submission Method. Each Hospital participating in the 340B Drug Program shall annually complete a MHDO Standardized template as presented in Appendix A, that will be available in the MHDO Hospital Data Portal web interface (https://mhdo.maine.gov/hospital_portal/). E- mail attachments shall not be accepted.

C.Submission Deadline. The annual submission of 340B data shall cover the previous fiscal year and shall be due not 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

D.Rejection of Submissions. Failure to conform to the requirements of subsections B and C of this Section shall result in the rejection of the data submissions. All rejected data must be corrected and resubmitted in the MHDO Hospital Data Portal within 30 days of the rejection.

E.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 is no longer than 18 months after the hospital's fiscal year end.

F.Reporting Specifications. Each Hospital must report the following data.

For the top three drugs with a unique NDC having the highest acquisition costs and the top three drugs with a unique NDC that were dispensed most often, and acquired by the hospital (or its 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 total cost in whole dollars to the hospital and, where applicable, its Contract Pharmacies and 340B Third Party Administrators, to purchase the drug under the 340B Drug Program.
Total 340B Estimated Savings (NDC)	The total cost that would have otherwise been paid to acquire the drug had a 340B discount not been applied (based on the average acquisition cost paid for the same drug outside the 340B program on a per unit basis), reduced by the 340B Acquisition Cost.

For all drugs acquired by the hospital (or its Contract Pharmacies and 340B Third Party Administrators) under 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 Contract Pharmacies and 340B Third Party Administrators.
Total Drug Expenditures (All Drugs)	The sum in whole dollars of all drugs purchased by a hospital, and where applicable, its 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: 1. the 340B Acquisition Cost; and 2. the total amount of payments made to Contract Pharmacies, including any share of 340B savings retained by Contract Pharmacies, for dispensing drugs obtained under the 340B program; and 3. 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 4. any additional administrative costs associated with the 340B program.
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.

90-590 C.M.R. ch. 340, § 2