Data Extraction Requirements for Pharmacy Audits

1. Data Extraction Requirements for Pharmacy Audits Mark R. Jacobs RPh, Senior Audit Analyst PAAS National, Inc. Pharmacy Audit Assistance Service Intro History of PAAS National and my experience with Pharmacy Audits Started by Ed Heckman RPh Mark will explain the requirements for electronic signatures, fax-back forms, prescription record retention requirements for third-party audits, and the like. This is more complicated than meets the eye.Intro History of PAAS National and my experience with Pharmacy Audits Started by Ed Heckman RPh Mark will explain the requirements for electronic signatures, fax-back forms, prescription record retention requirements for third-party audits, and the like. This is more complicated than meets the eye.

2. Standards for E-Prescribing Medication History Formulary and Benefits Fill Status Notification (RxFill) NPI as a standard for identifying health care providers E-Prescribing has great potential to finally bring us into the 21st Century with regard to medical and prescription records Standards adopted thus far will be required by April 1, 2009. E-Prescribing itself is not required, but when implemented, must follow adopted E-Rx rules April 1, 2008 Some discussion to require E-Rx by 2011 Discuss adopted standards Discuss briefly, non-adopted standardsE-Prescribing has great potential to finally bring us into the 21st Century with regard to medical and prescription records Standards adopted thus far will be required by April 1, 2009. E-Prescribing itself is not required, but when implemented, must follow adopted E-Rx rules April 1, 2008 Some discussion to require E-Rx by 2011 Discuss adopted standards Discuss briefly, non-adopted standards

3. Electronic Signatures Proof of Delivery (why) E-Signature Privacy Acknowledgement Eligible for benefits, received the medication, release of information to the payor, authorizes payment to pharmacy, pharmacy will abide by HIPAA, false claims under state and federal programs may be prosecuted by law, worker�s compensation, privacy acknowledgement, receipt of NOPP, how your medical information may be used and how you may gain access to it, and does not acknowledge any restrictions you may place on it. Prescriptions require proof of receipt for services provided Paper records have been used for many years Goes beyond just getting a signature HIPAA requirements Who may sign How they can sign Special Concerns Drive through pick-up Multiple Rx�s Nursing Home Home or other deliveries Prescriptions require proof of receipt for services provided Paper records have been used for many years Goes beyond just getting a signature HIPAA requirements Who may sign How they can sign Special Concerns Drive through pick-up Multiple Rx�s Nursing Home Home or other deliveries

4. Prescription requirements are complicated YOUR SIGNATURE certifies that the information contained hereon is correct and that the person for whom the prescription was written is eligible for the benefits. You also certify that you have received the medication and authorize release of all the information contained on this log and prescription to which it corresponds, to the plan administrator, the underwriter, the sponsor, the policyholder, the Workman�s Compensation Commission (if applicable), and the employer. You hereby assign to this provider pharmacy any payment due pursuant to this transaction and authorize payment directly to this provider pharmacy. You agree to allow this pharmacy or its designee to mail to you prescription refill reminders and information about alternative and companion medications and products. The pharmacy may be reimbursed to provide appropriate dispensing information to other entities. Pharmacy will comply with all applicable patient confidentiality laws. In addition: You understand that if payment for this service or item will be from Federal and State funds and that any false claims, statements or documents, or concealment of material facts may be prosecuted under applicable Federal and State Laws. Furthermore, as required by State Laws you acknowledge receipt of an OFFER TO COUNSEL and have accepted or refused counseling as indicated. WORKERS COMPENSATION ONLY: Your signature certifies that this medication is for the treatment of an on-the-job injury. ALL OTHER THIRD PARTY PROGRAMS: Your signature certifies that this medication is not for treatment of an on-the-job injury. PRIVACY ACKNOWLEDGEMENT Your signature acknowledges your receipt of our Notice of Privacy Practices (This Notice Describes How Medical Information About You May Be Used and Disclosed and How You Can Get Access to This Information) and does not acknowledge your Agreement or any restrictions you may request regarding your Protected Health Information. YOUR SIGNATURE certifies that the information contained hereon is correct eligible received the medication authorize release of all the information to- the plan administrator, the underwriter, the sponsor, the policyholder, the Workman�s Compensation Commission (if applicable), and the employer. assign and authorize payment directly to this provider pharmacy. You agree to allow this pharmacy or its designee to mail you stuff The pharmacy may get paid to provide appropriate dispensing information Pharmacy will follow patient confidentiality laws. In addition: if payment for this service is from Federal and State funds false claims may be prosecuted under applicable Federal and State Laws. Furthermore, as required by State Laws you acknowledge receipt of an OFFER TO COUNSEL and have accepted or refused counseling as indicated. WORKERS COMPENSATION ONLY: Your signature certifies that this medication is for the treatment of an on-the-job injury. ALL OTHER THIRD PARTY PROGRAMS: Your signature certifies that this medication is not for treatment of an on-the-job injury. PRIVACY ACKNOWLEDGEMENT Your signature acknowledges your receipt of our Notice of Privacy Practices (This Notice Describes How Medical Information About You May Be Used and Disclosed and How You Can Get Access to This Information) and does not acknowledge your Agreement or any restrictions you may request regarding your Protected Health Information. YOUR SIGNATURE certifies that the information contained hereon is correct eligible received the medication authorize release of all the information to- the plan administrator, the underwriter, the sponsor, the policyholder, the Workman�s Compensation Commission (if applicable), and the employer. assign and authorize payment directly to this provider pharmacy. You agree to allow this pharmacy or its designee to mail you stuff The pharmacy may get paid to provide appropriate dispensing information Pharmacy will follow patient confidentiality laws. In addition: if payment for this service is from Federal and State funds false claims may be prosecuted under applicable Federal and State Laws. Furthermore, as required by State Laws you acknowledge receipt of an OFFER TO COUNSEL and have accepted or refused counseling as indicated. WORKERS COMPENSATION ONLY: Your signature certifies that this medication is for the treatment of an on-the-job injury. ALL OTHER THIRD PARTY PROGRAMS: Your signature certifies that this medication is not for treatment of an on-the-job injury. PRIVACY ACKNOWLEDGEMENT Your signature acknowledges your receipt of our Notice of Privacy Practices (This Notice Describes How Medical Information About You May Be Used and Disclosed and How You Can Get Access to This Information) and does not acknowledge your Agreement or any restrictions you may request regarding your Protected Health Information.

5. What is E-Prescribe? Computer to Computer transmission of prescription information through a secure data encrypted network. E-RX must originate from a CPOE device And, be transmitted through a secure data encrypted network E-Rx will revolutionize the way we provide prescription services Back in the 1960�s most prescriptions were compounded according to a physician�s recipe Nursing home orders originated from MAR�s Third Party insurance for Rx�s was essentially non-existent Pharmacies operated a cash business, and charged a reasonable fee for their service Around the 1980�s PBM�s became prominent as did computers (in pharmacy), and the physician orders became a subject to question in relation to payment E-RX must originate from a CPOE device And, be transmitted through a secure data encrypted network E-Rx will revolutionize the way we provide prescription services Back in the 1960�s most prescriptions were compounded according to a physician�s recipe Nursing home orders originated from MAR�s Third Party insurance for Rx�s was essentially non-existent Pharmacies operated a cash business, and charged a reasonable fee for their service Around the 1980�s PBM�s became prominent as did computers (in pharmacy), and the physician orders became a subject to question in relation to payment

6. E-Prescribing Can an e-prescription be sent directly from a prescriber�s computer to a pharmacy computer? No It must be sent through a secure data encrypted networkCan an e-prescription be sent directly from a prescriber�s computer to a pharmacy computer? No It must be sent through a secure data encrypted network

7. What may not be E-Rx? Computer to Fax How do we know? What can you do about it? PBM Contract vs state law A prescription order that originates from a prescriber�s CPOE device, but is transmitted via phone line, may not be acceptable according to some state pharmacy rules. Therefore, a faxed Rx may need to meet fax rule requirements that include a prescriber signature. Faxes may not be �electronically signed� SKIP BACK AND FORTH TO NEXT SLIDE OF FAX Iowa said as long as there is reasonable assurance that a prescription originated from a prescriber, that they will allow an electronic signature, but when challenged by a RPh in our office, How do you know for sure?, they could not provide a response So� what can you do about it? We need to consider state rules on faxed prescriptions and whether a prescriber signature or graphic representation of such is allowed A prescription order that originates from a prescriber�s CPOE device, but is transmitted via phone line, may not be acceptable according to some state pharmacy rules. Therefore, a faxed Rx may need to meet fax rule requirements that include a prescriber signature. Faxes may not be �electronically signed� SKIP BACK AND FORTH TO NEXT SLIDE OF FAX Iowa said as long as there is reasonable assurance that a prescription originated from a prescriber, that they will allow an electronic signature, but when challenged by a RPh in our office, How do you know for sure?, they could not provide a response So� what can you do about it? We need to consider state rules on faxed prescriptions and whether a prescriber signature or graphic representation of such is allowed

8. Faxed Prescription Faxed Rx�s travel through the telephone lines Telephone lines are not secure Faxed Rx�s can be designed to look like they are real, so the only way to distinguish (or enhance validity of the order) is to require a prescriber signature. Bottom line is: A state may not recognize an electronically signed Rx order if it arrives via fax.Faxed Rx�s travel through the telephone lines Telephone lines are not secure Faxed Rx�s can be designed to look like they are real, so the only way to distinguish (or enhance validity of the order) is to require a prescriber signature. Bottom line is: A state may not recognize an electronically signed Rx order if it arrives via fax.

9. Discuss DiagramDiscuss Diagram

10. Data Retention Requirements Record requirements vary based on: Contract - TPA State Law Federal Law HIPAA DME Requirements for Part B Part D Requirements Another area we are concerned with in Pharmacy is data retention requirements. It used to be that we only had to worry about the first three. Another area we are concerned with in Pharmacy is data retention requirements. It used to be that we only had to worry about the first three.

11. Data Retention Requirements State and Federal Law Contract Requirement HIPAA Medicare Part B Medicare Part D � 10 years plus the life of the contract! State and Federal Law commonly 3-5 years Contracts commonly 4-6 years HIPAA 6 years Part B 7 years Part D � 10 years plus the life of the contract State and Federal Law commonly 3-5 years Contracts commonly 4-6 years HIPAA 6 years Part B 7 years Part D � 10 years plus the life of the contract

12. Data Retention Requirements The bottom line, is retain records according to maximum requirement. �Part D� Physical copy of Rx for 3 years Scanned image o.k. after 3 years * With the 10 year requirement, Pharmacy may become interested in data storage software that will allow the computerized storage of Rx records* With the 10 year requirement, Pharmacy may become interested in data storage software that will allow the computerized storage of Rx records

13. Pharmacy Audits Pharmacists are asked to present relevant data to justify a Rx Order Desk Audit Central Review On-Site Audit

14. Software Extraction Capabilities Date Range BIN # (Third Party Insurance) Rx # Range Override field usage

15. Software Extraction Capabilities PA Field Populated Quantity Field Changed DEA Number Abnormalities NPI # Abnormalities

16. Software Extraction Capabilities Compounds Diabetes Items or Specified Class Controlled Substances

17. Pharmacy Audit Concerns Software Capabilities E-Prescribe Fax Rx�s and Fax-back Rx�s Walk-in or Phone-in Rx�s

18. How Technology Can Help Design Software to calculate Days Supply. Soft Sigs: Directions that are not mathematically usable. Provide an alert to physicians and pharmacies when days supply may need to be justified Within the patient�s plan limits Require the Doctor to enter a days supply field that is mathematically justifiedWithin the patient�s plan limits Require the Doctor to enter a days supply field that is mathematically justified

19. How Technology Can Help Allow only one prescriber and corresponding ID on the Rx Require all data fields entered Re-Design current fax-back Rx requests (Rx renewals) PA-C�s and NP�s Problems with LTC Rx�s PA-C�s and NP�s Problems with LTC Rx�s

22. How do we re-design a fax-back Rx renewal request? Two Ways 1) Assist pharmacies by developing data formats that clearly distinguish a new current order from the previous (expired) order

23. 1) Re-Designing the �Fax-Back Rx� Eliminate unnecessary information Truncate old data from the new data Write clear instructions for completing the new order. For example, �Prescriber Must fill out this Section�. Date, Refills, Signature Eliminate DAW traps??? * May need to add a statement, �I authorize XYZ Pharmacy to create a valid telephone prescription order based on the following information. * May need to add a statement, �I authorize XYZ Pharmacy to create a valid telephone prescription order based on the following information.

24. 2) Route request directly to CPOE Device Advantages Eliminates confusion over state law requirements for fax Requires prescriber to write the order By sending through a secure data encrypted network� * Pharmacy�s capability to route the request directly to the prescriber through a secure data encrypted network, is the first step in eliminating questionable fax orders. * The second step is for the response to that order to follow the reverse path (through a secure data encrypted network) back to the pharmacy.* Pharmacy�s capability to route the request directly to the prescriber through a secure data encrypted network, is the first step in eliminating questionable fax orders. * The second step is for the response to that order to follow the reverse path (through a secure data encrypted network) back to the pharmacy.

25. We essentially eliminate the faxand replace with E-Prescribe Whether or not CMS requires E-Rx by 2011 or sometime in the future is still to be determined. It is still important that we focus on using technology to improve efficiency in pharmacy in healthcare delivery. Current State Medicaid hard copy Rx requirements dictate that by October 1, 2008, all hand written Rx�s contain three tamper proof features. One that prevents erasure, Two that copying, and Three that prevents counterfeiting The question becomes not, �if� E-Rx will be a CMS requirement, but rather �when� it will be required As I stated before, this is a great time in history for the modernizing of health records. I encourage everyone to work with pharmacy leaders and the pharmacy audit assistance service in contributing to the success and acceptability by payors of prescription services.Whether or not CMS requires E-Rx by 2011 or sometime in the future is still to be determined. It is still important that we focus on using technology to improve efficiency in pharmacy in healthcare delivery. Current State Medicaid hard copy Rx requirements dictate that by October 1, 2008, all hand written Rx�s contain three tamper proof features. One that prevents erasure, Two that copying, and Three that prevents counterfeiting The question becomes not, �if� E-Rx will be a CMS requirement, but rather �when� it will be required As I stated before, this is a great time in history for the modernizing of health records. I encourage everyone to work with pharmacy leaders and the pharmacy audit assistance service in contributing to the success and acceptability by payors of prescription services.