NOI to Enter into Negotiations for Rebates for On-body Bolus Insulin Delivery Device.docx

Due Diligence Posting of Notice of Intent to Enter into Negotiations for Rebates for On-body Bolus Insulin Delivery Device Document #: 23EHSPMRBTAGRMNTINSLN Issue Date: May 31, 2023 The Executive Office of Health and Human Services (EOHHS) of the Commonwealth of Massachusetts announces its intent to enter into negotiations for a rebate agreement for an on-body bolus insulin delivery device.

EOHHS is the single state agency responsible for administering the Commonwealth’s Medicaid program and its Children’s Health Insurance Program (together, MassHealth) in accordance with M.G.L. c. 6A, § 16, Titles XIX and XXI of the Social Security Act, M.G.L. c. 118E and other applicable federal and state laws, regulations, waivers and demonstration projects. EOHHS is also responsible for administering the Health Safety Net (HSN) pursuant to M.G.L. c. 118E and applicable regulations. EOHHS’s mission as a single state agency is to purchase high-quality health care for the financially needy that is affordable, promotes independence, and provides customer satisfaction.

Pending the results of this Notice of Intent (Notice), EOHHS intends to negotiate with CeQur (Known Manufacturer) to seek the largest rebate possible to EOHHS based on pharmacy fee-for-service claims for the manufacturer’s on-body bolus insulin delivery device submitted to EOHHS through the Pharmacy Online Processing System (POPS), including for MassHealth members enrolled in the MassHealth Primary Care Clinician Plan or a MassHealth Primary Care Accountable Care Organization; claims for HSN Patients submitted through POPS; and, at EOHHS’s option, claims that are paid through Participating MassHealth Managed Care Organizations and MassHealth Accountable Care Partnership Plans (collectively, Managed Care Entities (MCEs)).

Description EOHHS is seeking to enter rebate agreements with manufacturers on-body bolus insulin delivery devices. On-body bolus insulin delivery devices are wearable insulin patches designed to directly provide post prandial insulin to patients who require meal-time insulin. EOHHS is only seeking to enter rebate agreements covering meal-time insulin delivery devices approved by the FDA. EOHHS anticipates that negotiations would potentially lead to a rebate agreement lasting for a period of one or more years and could potentially result in one or more products being listed as a preferred product on the MassHealth Non-Drug Product List.

This Notice is seeking any qualified manufacturers who wish to negotiate rebate agreements with EOHHS for on-body bolus insulin delivery devices. Under rebate agreements, the manufacturer will pay rebates to EOHHS.

EOHHS is posting this Notice rather than conducting a full procurement because EOHHS believes that only one manufacturer offers on-body bolus insulin delivery device approved by the FDA and EOHHS wishes to seek rebates from this manufacturer. EOHHS is utilizing this Due Diligence Posting to ensure that the process is open, fair and competitive.

Determination of Other Interested Manufacturers EOHHS is posting to announce its intent to enter negotiations with the Known Manufacturer and to determine if there are any other interested and qualified manufacturers. Any such manufacturers must submit documentation that they can provide the product or service described in the Description.

Response Requirement and Deadline All interested manufacturers (other than the Known Manufacturer) interested in responding to this Notice, regardless of prior communications with EOHHS, must submit a Response to this posting with a signed cover letter that includes:

0. An expression of interest in negotiating rebate agreements with EOHHS;

0. A description regarding approvals received for the on-body bolus insulin delivery device from the FDA;

0. Any information the manufacturer wishes to share concerning its on-body bolus insulin delivery device’s clinical benefits; and

0. The name, title, address, phone number and e-mail address of the individual in the manufacturer’s organization who should be contacted regarding any aspect of the manufacturer’s response to this notice and any negotiations.

All required information must be submitted by email no later than 5:00 p.m. (prevailing Eastern Time) on June 14, 2023, to Massachusetts Executive Office of Health and Human Services One Ashburton Place, 11th floor Boston, MA 02108 Attn.: Shukri Osman, Procurement Coordinator Email: shukri.osman@mass.gov If, after the posting deadline has passed, interest is generated by this Notice, EOHHS will review all Responses and will determine whether it will: (i) withdraw the notice and not enter negotiations with the Known Manufacturer (and cancel the Notice of Intent); or (ii) enter into negotiations with Known Manufacturer to contract with EOHHS; or (iii) enter into negotiations with one or more other manufacturers; or (iv) enter into the negotiations with Known Manufacturer and one or more other manufacturers.

Additional Information

1. EOHHS anticipates that all claims for on-body bolus insulin delivery devices submitted to MassHealth or HSN on a fee-for-service basis through POPS, for which MassHealth or HSN is primary payer, will be eligible for rebate under any negotiated agreement.

1. At EOHHS’s option, MassHealth member utilization of on-body bolus insulin delivery devices through MassHealth MCEs may be included in a negotiated agreement.

1. EOHHS does not warrant or guarantee any particular volume of MassHealth member utilization of on-body bolus insulin delivery devices during the term of any rebate agreement entered into as a result of this notice.

1. In-person presentations will not be held.

1. Manufacturers may submit written questions regarding this Notice by e-mail to shukri.osman@mass.gov by June 7, 2023 by 5:00 PM. Questions must be submitted in non-tabular Word or .txt format. Questions submitted in any other formats will not be accepted.

EOHHS responses to questions of general interest that help to clarify the Due Diligence Posting will be posted shortly thereafter on COMMBUYS (available at https://www.commbuys.com), the Commonwealth’s electronic system and the official source of information for this Notice. No acknowledgement of receipt will be given.

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