NY Opioid Annual Assessment Technical Report and File Specifications

This technical document is to be used by manufacturers/distributers of opioids to report the total morphine milligram equivalent amount and other required data elements for opioids sold/distributed in New York State for a given calendar year.

For additional clarification on the required reporting data elements, refer to the document, 'New York State Opioid Annual Assessment Reporting Guidance' at: https://apps.health.ny.gov/pub/ctrldocs/bne/nyosareportingguidance.pdf

File 'nyosareportsample.xml' is a sample NY Opioid Assessment Report XML file. This is available at https://apps.health.ny.gov/pub/ctrldocs/bne/nyosareportsample.xml

File 'nyosareportsample.html' is an HTML presentation of the values in nyosareportsample.xml. This is available at https://apps.health.ny.gov/pub/ctrldocs/bne/nyosareportsample.html

File 'NyOpioidAssessmentReport.xsd' is a schema file giving technical details used by the reporting organization to validate NY Opioid Assessment XML reports. This XSD file is available at "https://apps.health.ny.gov/pub/ctrldocs/bne/NyOpioidAssessmentReport.xsd"

Definitions of terms used in this schema

MME
- Morphine Milligram Equivalent
NY
- New York State
Reporter
- The manufacturer/distributer selling or distributing opioids to or within NYS. A reporter is uniquely identified by its DEA registration number and its NY Controlled Substance License number
SFS
- NY State Statewide Financial System
NDC
- National Drug Code
Reportable
- All sale-distribution transactions of opioids by the reporter as detailed in the ‘New York State Opioid Annual Assessment Reporting Guidance’ document.
Assessable
- All reportable opioid transactions whose total MME's will be used to determine the reporter's ratable share of the Opioid Stewardship Fund. This includes all reportable opioid transactions except those exempted by NY State Public Health Law, Article 33, Title 2A and other exemptions as detailed in the ‘New York State Opioid Annual Assessment Reporting Guidance’ document.

All information in this report is limited to sales and distributions of opioids to or within NY by the reporter for the transaction year being reported.

Table of Contents

Elements

Complex Types

Simple Types

Element: NyOpioidAssessmentReport

Attributes
Attribute: transactionYear
 transactionYearType required

The calendar year in which an opioid sale or distribution occurred. For information due by June 1, 2022 the vaild year is 2018.

Attribute: reporterDeaNumber
 repDeaNumberType required

DEA registration number of the NYS DOH Controlled Substance licensee authorized to sell or distribute controlled substances to or within NYS. The NYS DOH Controlled Substance licensee must submit a separate report for each DEA number under which a transaction was made during the transaction year.

Attribute: reporterNyControlledSubstanceLicense
 nyRepCsLicType required

NYS DOH Controlled Substance license number for the entity authorized by NYS to sell or distribute controlled substances to or within NYS.

Attribute: nyGrossOpioidReceipts
 mmeMoneyType required

The total overall sales in dollars and cents for all opioids sold or distributed to or within NYS, minus opioid returns to the reporter, during the Transaction Year being reported. Do not include any sales from NYS to outside of NYS.

Attribute: nyGrossAssessableOpioidReceipts
 mmeMoneyType required

This shall only apply to the initial transaction in the distribution chain when opioids are sold or distributed to or within NYS. This is the total NY Gross Opioid Receipts (defined above) for all assessable opioid transactions (defined under assessable above and in the 'New York State Opioid Annual Assessment Reporting Guidance' document).

Attribute: nyTotalMme
 mmeNumberType required

The sum of morphine milligram equivalents for all opioid sales or distributions to or within NYS minus opioid returns to the reporter. Determination of MMEs will be pursuant to the formulation issued by DOH.

Attribute: nyTotalAssessableMme
 mmeNumberType required

This shall only apply to the initial transaction in the distribution chain when opioids are sold or distributed to or within NYS. This is the total NY MMEs (defined above) for assessable transactions (defined under assessable above and in the 'New York State Opioid Annual Assessment Reporting Guidance' document).

Attribute: billingContactName
 addressNameType required

First and last name of individual to be contacted for questions related to invoice.

Attribute: billingContactPhone
 phoneNumberType required

Phone number for 'billingContactName'

Attribute: billingContactEmail
 emailType required

Email for 'billingContactName'

Attribute: reportingContactName
 addressNameType required

First and last name of individual to be contacted for questions related to the NY Opioid Assessment data reported.

Attribute: reportingContactPhone
 phoneNumberType required

Phone number for 'reportingContactName'

Attribute: reportingContactEmail
 emailType required

Email for 'reportingContactName'

Attribute: sfsCustomerId
 xsd:string optional

If known, the Customer ID assigned by DOH for invoicing purposes in the Statewide Financial System.

Elements
Element: ReporterAddress
 addressType exactly 1

Reporter name and address.

Element: BillingAddress
 addressType exactly 1

Name and address for invoicing purposes.

Element: NyTotalDistributedOpioidDrugList
 contains: NyDistributedOpioidDrug optional non-repeatable

List of all reportable opioids sold/distributed to or within NYS, by NDC number.

Total yearly quantity and MME’s for an opioid as identified by it’s NDC number.

Element: NyDistributedOpioidDrug
 mmeByNdcType 1 or more

Total yearly quantity and MME’s for an opioid as identified by it’s NDC number.

Element: NyExemptOpioidDrugList
 contains: NyExemptOpioidDrug optional non-repeatable

A list of each drug by NDC number, sold ordistributed in NY, that is exempt from the assessment. The exempt drug names are listed in the New York State Opioid Annual Assessment Reporting Guidance.

Element: NyExemptOpioidDrug
 exemptNdcType 1 or more
Element: NyReceiver-AssociateDeaList
 contains: NyReceiver-AssociateDea optional non-repeatable

a list of each receiver/associate DEA Number to which opioids were sold/distributed, their NYS Controlled Substance License Number, if applicable, and the exemption status of that receiver.

Element: NyReceiver-AssociateDea
 receivingOrgType 1 or more
Element: Comments
 mmeCommentType optional non-repeatable

Additional comments or clarification. Limited to 4,000 chars. You must wrap value in CDATA tags. CDATA start tag: <![CDATA[ , CDATA end tag: ]]>

Content Model

exemptNdcType

Attributes
Attribute: ndcNumber
 ndcNumberType required

The 11 digit NDC code identifying the exempt drug. Format does not include dashes.

mmeByNdcType

Attributes
Attribute: ndcNumber
 ndcNumberType required

The NDC number of each opioid sold or distributed to or within NYS. 11 digit code identifying the drug. Format does not include dashes

Attribute: packageSize
 mmeNumberType required

The NDC package size (not package code) associated with the NDC number reported. It identifies the quantity of drugs in the package sold. Ex. A package code of ‘02’ for a particular labeler’s NDC number could = a bottle of 100 tablets. In this example, indicate ‘100’ for the Package Size.

Attribute: nyTotalPackages
 mmeNumberType required

The total number of packages sold or distributed to or within NYS for that particular NDC number.

Attribute: nyTotalNdcMme
 mmeNumberType required

Total number of morphine milligram equivalents (MMEs) sold or distributed to or within NYS for that particular NDC number.

Attribute: nyTotalAssessablePackages
 mmeNumberType required

The total number of packages sold or distributed to or within NYS for that particular NDC number minus those packages that are exempt as stated in description of NY Total Assessable MMEs

Attribute: nyTotalAssessableNdcMme
 mmeNumberType required

Total MMEs for the assessable packages for the associated NDC number.

addressType

Attributes
Attribute: name
 addressNameType required
Attribute: address1
 addressLineType required
Attribute: address2
 addressLineType optional
Attribute: city
 addressCityType required
Attribute: state
 addressStateType required
Attribute: zip5
 zip5Type required
Attribute: zip4
 zip4Type optional
Attribute: nyCounty
 nyCountyType required

The NY county. If not a NY state address, then use "Not NY" for nyCounty.

receivingOrgType

Attributes
Attribute: receiverDeaNumber
 deaNumberType required

DEA number of the entity who received opioids from the reporter.

Attribute: receiverNyControlledSubstanceLicense
 nyCsLicType optional

NY Controlled Substance License of the entity who received opioids from the reporter.

Attribute: receiverStatus
 receiverStatusType required

Assessable status of entity who received opioids from the reporter.

receiverStatusType

Enumeration:

nyCountyType

Enumeration:

transactionYearType

Enumeration:

ndcNumberType

Pattern: [^\-]{11}

mmeCommentType

Maximum Length: 4000

repDeaNumberType

Pattern: [PR][A-Z9][0-9]{7}

deaNumberType

Pattern: [ABFGMPR][A-Z9][0-9]{7}

emailType

Pattern: [^@]+@[^@]+

Maximum Length: 49

phoneNumberType

Pattern: [0-9]{3}\-?[0-9]{3}\-?[0-9]{4}.{0,13}

nyCsLicType

Pattern: (010|01A|020|02A|02B|030|03A|03B|03C|03D|03E|040|04A|050|060|06A|06B|070|080|090|09A|100|10A|110)[0-9]{4}

nyRepCsLicType

Pattern: (010|01A|020|02A|02B|090)[0-9]{4}

addressLineType

Maximum Length: 60

addressNameType

Maximum Length: 255

addressCityType

Maximum Length: 45

addressStateType

Maximum Length: 2

zip5Type

Pattern: [0-9]{5}

zip4Type

Pattern: [0-9]{4}

mmeNumberType

Total Digits: 38

Fraction Digits: 4

mmeMoneyType

Total Digits: 20

Fraction Digits: 2