Medicaid Drug Rebate Program claims level data requests

Jeremy Docken filed this request with the Division of Finance and Rate Setting of New York.
Status
Awaiting Acknowledgement

Communications

From: Jeremy Docken

To Whom It May Concern:

Pursuant to the New York Freedom of Information Law, I hereby request the following records:

Pharmaceutical manufacturers engage Kalderos to assist them with performing "audits" of Medicaid claims data used by states such as New York for determining Medicaid Drug Rebate Program rebates due to the state. This "audit" right is granted to drug manufacturers as part of the Medicaid Drug Rebate Program statute [See https://www.law.cornell.edu/uscode/text/42/1396r-8] as well as under the rebate agreement entered into with the HHS Secretary [see https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/samplerebateagreement.pdf]

Kalderos has been granted authority by its clients (pharmaceutical manufacturers) to obtain claims level data on their behalf. As such, we respectively request New York Medicaid claims data to enable us to perform validation tests on behalf of our clients. We will provide letters granting us such authority upon request.

Our clients desire that we focus on looking for suspected 340B duplicate discounts. To enable us to perform 340B duplicate discount validation tests, we must receive the following fields without encryption: Pharmacy ID, Date of Service, Prescriber ID, and Rx ID. We understand that these fields are often considered Protected Health Information "PHI"). However, HHS guidance makes clear that providing even PHI necessary for performing claims validations is allowable [See https://www.hhs.gov/hipaa/for-professionals/faq/456/does-hipaa-permit-state-medicaid-agencies-to-disclose-information-to-pharmaceutical-manufacturers/index.html?language=es]

We respectively request that these data be provided electronically.

The time period we request claims data is for rebate quarters 2014Q1 to 2016Q3. Please note that our request for data will be ongoing on a quarterly basis, and we desire to work out an arrangement with the state for providing data in a systematic and recurring basis.

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 5 business days, as the statute requires.

Sincerely,

Jeremy Docken

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