IP Library Granted Patent US 12,640,242
Granted Patent B1
US 12,640,242 · App. 17/675,885 · Granted May 26, 2026

Member-specific formulary data interface overlay

Inventors: Rob Todd (Doylestown, PA); Jerry Wrobel (Aurora, OH); John Pigott (Slyvania, OH); Cassandra Talafous (North Lawrence, OH)
Assignee: Xact Laboratories, LLC
G16H10/60G16H15/00G16H20/10G16H40/67
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Quick Facts
Patent No.
US 12,640,242
App. No.
17/675,885
Granted
May 26, 2026
Kind
B1
Abstract

An electronic data interface overlay for modifying existing formulary data is provided along with systems and methods for the same. The overlay comprises member-specific clinical data and causes automatic generation of code(s) indicating coverage denial upon querying of treatments of the existing formulary data associated with certain of the member-specific clinical data, such as pharmacogenetic (“PGx”) test results, of the data interface overlay. The formulary data includes alternative treatments which may be suggested and approved upon denial based on PGx test results. An electronic health record is automatically updated with the alternative treatment.

Claims (78)

1 . A method for automatically alerting, at the point of prescribing or prescription fulfilment, using interoperable, standardized messaging, to wholly or partially ineffective medications for a member based on the member's relevant genetic makeup and updating electronic medical records data comprising patient data stored at an electronic health record (“EHR”) system for the member, said method comprising the steps of, electronically and automatically:

causing, by way of a laboratory information system (“LIS”) associated with a laboratory and exerting operative control over one or more genetic sequencing machines, genetic testing to be carried out;

receiving, from the one or more genetic sequencing machines, genetic testing results data at the LIS;

generating a data interface overlay, by way of the LIS, including the genetic testing results data and configured to create member-specific modifications to existing data of a formulary upon application thereto;

transmitting, by way of the LIS, the data interface overlay to one or more non-transitory electronic storage devices comprising the formulary for integration therewith, thereby creating, following receipt, the member-specific modifications to existing data of the formulary such that a pharmacy benefits manager (“PBM”) system is configured to cause automatic generation of a standardized code upon subsequent querying in responses to receiving standardized requests for coverage information for members and medications indicated in the modified data as being known to be partially or wholly ineffective in persons having a same relevant genetic makeup as the members according to the genetic testing results data (“genetic contraindication code”);

generating, by way of the LIS, a second data interface overlay including available but unperformed, genetic testing for medications;

transmitting, by way of the LIS, the second da a interface overlay to the one or more non-transitory electronic storage devices comprising, the formulary, thereby creating, following receipt, further member-specific modifications to the existing data of the formulary such that the PBM system is configured to cause automatic generation of a standardized code indicating denial of coverage due to available and unperformed genetic testing (“genetic testing availability code”) for the queried medication upon subsequent querying, in responses to receiving further ones of the standardized requests for coverage information, the formulary for the billing information for the medications indicated in the modified data as being available for yet unperformed genetic testing for the members;

receiving, at the PBM system from a pharmacy system or the EHR system, the standardized requests for coverage information, said standardized request each including a standardized code identifying a respective one of the medications;

querying, by way of the PBM system, for each of, based on, and in response to receipt of, the standardized requests, the one or more non-transitory electronic storage devices comprising the formulary associated with the PBM system for billing information for the medications and the members, said formulary comprising data regarding prescription drugs covered by a prescription drug plan or plans for the members, associated billing information, and the member-specific modifications to the data indicating certain of the prescription drugs contraindicated for at least certain of the members, including e-member, based member specific genetic testing results data for such members; and

for at least one standardized requests:

receiving, at the pharmacy system by way of the PBM system and in response to querying the formulary associated with the PBM system based on and in response to the standardized request, a standardized communication including the genetic contraindication code indicating that dispensing of the medication for the member as indicted in the standardized request is not authorized for the member based on the genetic testing results data for the member indicating that the medication is wholly or partially ineffective for the member;

in response to receiving the genetic contraindication code, further querying an alternative treatment database for an alternative medication for the medication;

in response to receiving the alternative medication, transmitting, by way of a modification platform interposed between, separate from, and in electronic communication with the PBM system and the EHR system for the member, a standardized change request to the EHR system for the member for approval by a healthcare provider for the member requesting change from the medication to the alternative medication, including a standardized code identifying the alternative medication; and

receiving, in response to receiving the change request, a standardized communication indicating approval of the change request at the modification platform from the EHR system for the member at the medication platform, and in response, causing the patient data at the EHR system for the member to be updated to reflect prescription of the alternative medication instead of the medication, and transmitting a standardized communication to the PBM system including the standardized code for the alternative medication indicating approved prescription of the alternative medication in substitution for the medication.

2 . The method of claim 1 further comprising the steps of:

initiating, at a health plan system associated with the PBM, an electronic review of the modified data to identify a subset of the members for which the genetic testing availability code would be generated;

electronically generating and transmitting a standardized communication to the identified subset of members requesting electronic consent for the genetic testing (“consent communication”);

in response to receiving the consent for testing from consenting ones of the identified subset of members (“consenting members”) in response to the consent communication, providing a standardized testing request communication to the LIS including requested genetic testing and mailing information for the consenting members;

in response to receiving the standardized testing request communication, and by way of one or more robots under operative control of the LIS, generating a testing kit for each of the consenting members comprising a genetic material gathering device, instructions, and a return label; and

performing genetic testing on received specimens at the one or more genetic sequencing machines from returned ones of the genetic material gathering devices in accordance with the ordered genetic testing.

3 . The method of claim 1 further comprising:

generating, by way of the PBM system and in response to receiving the genetic contraindication code, standardized report data for the medication comprising a PGx contraindication indicator; and

transmit, by way of the PBM system, the standardized report data to an originating one of the pharmacy system and the EHR system for the standardized request for coverage.

4 . The method of claim 3 wherein:

the standardized report data, upon access for display at an electronic display of the originating one of the pharmacy system and the EHR system, is configured to generate a table comprising a medication name column, a therapeutic class column, a dose/strength column, a status information column comprising the billing information, and a notes and restrictions column; and

the PGx contraindication indicator comprises an icon or graphic provided at the notes and restrictions column.

5 . The method of claim 1 wherein:

each of the standardized codes comprises a National Council for Prescription Drug Programs (“NCPDP”) accepted code.

6 . The method of claim 1 wherein:

at least the standardized request for coverage information, the standardized communication including the genetic contraindication code, the standardized change request, and the standardized communication indicating approval of the change request comprise HL7 communications.

7 . One or more non-transitory electronic storage devices comprising software instructions, which when executed, configure one or more processors to:

carry out the method of claim 1 .

8 . A system for alerting, at the point of prescribing or prescription fulfillment, using interoperable, standardized messaging, to wholly or partially ineffective medications for a member based on the member's relevant genetic makeup and updating electronic medical records data comprising patient data stored at an electronic health record (“EHR”) system for the member, said system comprising:

the EHR system associated with a healthcare provider for the member and comprising the patient data for the member, including prescribed medications and diagnosed diseases;

a modification platform, separate from and in electronic communication with, the EHR system and a pharmacy benefits manager (“PBM”) system;

a pharmacy system configured to receive electronic prescription requests from the healthcare provider by way of the EHR system; and

the PBM system associated with a health plan and in electronic communication with the pharmacy system comprising or associated with one or more processors and one or more non-transitory electronic storage devices comprising a formulary comprising data regarding prescription drugs covered by a prescription drug plan or plans for members, including the member, associated billing information, and associated clinical information including member-specific modifications to the data indicating certain of the prescription drugs contraindicated for the respective member based genetic testing results data for the respective member and alternative treatment options, said one or more non-transitory electronic storage devices comprising executable software instructions, which when executed, configure said one or more processors to, electronically and automatically:

receive, from the pharmacy system or the EHR system, a standardized request for coverage information regarding a medication for the member prescribed by the healthcare provider by way of the EHR system, said standardized request including a first standardized code identifying the medication;

query, based on and in response to receipt of the standardized request, the formulary for the billing information associated with the medication and the member;

where the query indicates that the medication is genetically contraindicated for the member, generate a second standardized code indicating that dispensing of the medication is not authorized for the member based on the genetic testing results data for the member indicating that the medication is wholly or partially ineffective for the member (“genetic contraindication code”); and

where the genetic contraindication code is generated, further query the alternative treatment options for an alternative medication for the medication, transmit, by way of the modification platform, a standardized change request to the EHR system for the member for approval by the healthcare provider comprising the second standardized code and a third standardized code identifying the alternative medication, and where approval of the change request is received from the EHR system by way of the modification platform, cause the EHR system to be automatically updated to reflect prescription of the alternative medication instead of the medication within the member data; and

a laboratory information system (“LIS”) associated with a laboratory and one or more genetic sequencing machines, said LIS having operative control over said one more genetic sequencing machines and comprising one or more processors and one or more non-transitory electronic storage devices comprising executable software instructions, which when executed, configure said one or more processors to, automatically and electronically:

cause the one or more genetic sequencing machines to carry out genetic testing;

receive the genetic testing results data from the one or more genetic sequencing machines;

automatically generating a data interface overlay reflecting the genetic test results data configured to create the member-specific modification to existing data of the formulary upon application thereto;

transmit the data interface overlay to the one or more non-transitory electronic storage devices comprising the formulary for integration therewith, thereby causing, following receipt, the member-specific modifications to the existing data of the formulary such that such that the PBM system is configured to cause automatic generation of the second standardized code upon subsequent querying in re es to receiving further ones of the standardized request for coverage information for members and medications indicated in the modified data as being known to be partially or wholly ineffective in persons having a same relevant genetic makeup as the members according to the genetic testing results data;

generate a second data interface overlay including available, but unperformed, genetic testing for medications, including the medication; and

transmit the second data interface overlay to the one or more non-transitory electronic storage devices comprising the formulary, thereby creating, following receipt, further member-specific modifications to the existing data of the formulary such that the PBM system is configured to cause automatic generation of a fourth, standardized code indicating denial of coverage due to available and unperformed genetic testing for the medication upon subsequent querying in responses to receiving further ones of the standardized request for coverage information for medications and members indicated in the modified data as being available for yet unperformed genetic testing.

9 . The system of claim 8 further comprising:

a health plan system for the member and other members in electronic communication with the PBM system and comprising a review module and a notification module, wherein said review module is configured to, automatically and electronically, review the formulary for said member and said other members to identify a subset of members for which genetic testing is available in accordance with the modified data and one or more criteria defined by a health plan, and wherein said notification module is configured to generate and transmit a standardized communication to each of the identified members requesting electronic consent for the genetic testing, and transmit, in response to receipt of indication of electronic consent for the genetic testing from one or more of the contacted members (“consenting members”), requested genetic testing and mailing information regarding the consenting members to the LIS.

10 . The system of claim 9 further comprising:

a test kit assembly subsystem comprising associated with the laboratory and under operative control of the LIS, said test kit assembly subsystem configured to generate test kits the consenting members in an at least partially automated fashion, wherein said test kits comprise genetic material gathering devices, instructions, and labels printed with the mailing information for the consenting members.

11 . The system of claim 10 further comprising:

an automated testing subsystem associated with the laboratory and under operative control of the LIS and comprising the one or more genetic sequencing machines, said automated testing subsystem configured to:

assemble testing devices for PGx testing for each specimen returned to the laboratory from the genetic material gathering devices from the test kits in an at least partially automated fashion;

perform PGx testing on the specimens at the one or more genetic sequencing machines in an at least partially automated fashion; and

electronically report the genetic testing results data from the one or more genetic sequencing machines to the LIS.

12 . The system of claim 11 wherein:

said test kit assembly subsystem and said automated test subsystem comprise one or more controllers, handling robots, conveyor systems, and printers under operative control of the LIS.

13 . The system of claim 8 wherein:

the one or more non-transitory electronic storage devices of the PBM system comprise additional executable software instructions, which when executed, configure said one or more processors of the PBM system to, electronically and automatically:

generating, in response to receiving the second standardized code, standardized report data for the medication comprising a PGx contraindication indicator; and

transmit, by way of the PBM system, the standardized report data to the pharmacy system, wherein the standardized report data, upon access for display at an electronic display of the originating one of the pharmacy system and the EHR system, is configured to generate a table comprising a medication brand name column, a therapeutic class column, a dose/strength column, a status information column comprising the billing information, and a notes and restrictions column, where the PGx contraindication indicator comprises an icon or graphic provided at the notes and restrictions column.

14 . The system of claim 8 wherein:

at least the standardized request for coverage information and the standardized change request comprise HL7 communications.

15 . The system of claim 8 wherein:

each of the first, second, third, standardized codes comprises a respective National Council for Prescription Drug Programs (“NCPDP”) accepted code.

16 . A method for automatically alerting, at the point of prescribing or prescription fulfilment, using interoperable, standardized messaging, to wholly or partially ineffective medications for a member based on the member's relevant genetic makeup, said method comprising the steps of, electronically and automatically:

causing performance of genetic testing on genetic material samples by one or more genetic sequencing machines for one or more individuals to generate genetic testing results data;

generating a data interface overlay including the genetic testing results data and configured to create member-specific modifications to existing data of a formulary upon application thereto, said formulary comprising data regarding prescription drugs covered by a prescription drug plan or plans for members and associated billing information;

applying the data interface overlay to one or more non-transitory electronic storage devices comprising the formulary for integration therewith, thereby creating, following receipt, the member-specific modifications to existing data of the formulary such that standardized codes are automatically generated upon subsequent query of the formulary for the billing information in responses to receiving standardized requests for coverage information for members and medications indicated in the modified data as being known to be partially or wholly ineffective in persons having a same relevant genetic makeup as the members according to the genetic testing results data (“genetic contraindication code”);

generating a second data interface overlay including available, but unperformed, genetic testing for medications; and

applying the second data interface overlay to the one or more non-transitory electronic storage devices comprising the formulary, thereby creating, following receipt, further member-specific modifications to the existing data of the formulary such that a standardized code indicating denial of coverage due to available and unperformed genetic testing (“genetic testing availability code”) is automatically generated upon subsequent querying of the formulary for the billing information in responses to receiving further ones of the standardized requests for coverage information, for the members, for any medications indicated in the modified data as being available for yet unperformed genetic testing for the members.

17 . The method of claim 16 further comprising:

receiving, at a pharmacy benefits manager (“PBM”) system, the standardized requests for coverage information regarding medications prescribed by healthcare providers for the members;

querying, by way of the PBM system and based on and in response to receipt of the respective standardized requests, the one or more non-transitory electronic storage devices comprising the formulary associated with the PBM system for the billing information for the medications and the members, said formulary comprising the member-specific modifications to the data from the data interface overlay and the second data interface overlay;

receiving, in response to querying the formulary based on and in response to at least one of the standardized requests, a standardized communication including the genetic contraindication code; and

receiving, in response to querying the formulary based on and in response to at least other one of the standardized requests, a second standardized communication including the genetic testing availability code.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2026
From: PIGOTT, JOHN; TODD, ROB; WROBEL, JERRY; TALAFOUS, CASSANDRA
To: XACT LABORATORIES, LLC
Reel/Frame 074483/0730 →
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