1. AUDITS….. MEANINGFUL USE AND HIPAA COMPLIANCE (OCR) MARK NORRIS MEDICAL RECORDS SERVICES 1.21.16

2. MEANINGFUL USE AUDITS….NOT IF BUT WHEN FIGLIOZZI AND ASSOCIATES OR OIG Prepayment or not……. Post payment 2-6 years later…Need to be organized Figliozzi and Associates – one year at a time, one provider at a time OIG – One provider at a time, over multiple years.

3. YOUR “ BOOK OF EVIDENCE ” CMS published guidance resources about MU audits, with limited details:. Given the lack of specificity, providers are challenged to determine an appropriate audit strategy. Creating a robust set of documentation to support attestation is a significant undertaking and should be completed prior to attestation. This audit checklist, while not exhaustive, serves as starting point for organizations to develop their own book of evidence. We encourage organizations to add documents or substitute the suggestions with more appropriate evidence to reflect their MU environment.

6. THE AUDIT PROCESS When a provider is selected for an audit, it receives an initial request letter from Figliozzi and Company via e-mail. The notice is accompanied by an information request list that, according to the CMS, “may not be all inclusive” and may require the submission of additional information in order to complete the audit. Providers have 14 days after receiving the request to supply the requested information.

8. MU 2 AUDIT DOCUMENT REQUEST See attachment

9. MU 1 AUDIT RESPONSE LETTER See Attachment

10. LIKE MU, ITS CONSTANTLY CHANGING

11. RED FLAGS

12. REASONS FOR FAILURE Fraud Insufficient Documentation SRA incomplete (60% of all audit failures) Incorrect Values reported

14. According to CMS, there is no all-inclusive list of supporting documents, as the level of the audit review may depend on a number of factors. However, CMS clearly states that the primary documentation that will be requested in all reviews is the source document(s) that the provider used when completing the attestation.

15. Audit Appeals CMS is now accepting appeals for eligible professionals and eligible hospitals that have not passed the Meaningful Use EHR Audit. For general questions and for information on how to file an appeal, please visit the EHR Incentive Programs Appeals page on the CMS Website. EHR Incentive Programs Appeals page

16. Details of the Audits  There are numerous pre-payment edit checks built into the EHR Incentive Programs' systems to detect inaccuracies in eligibility, reporting and payment.  Post-payment audits will also be completed during the course of the EHR Incentive Programs.  If, based on an audit, a provider is found to not be eligible for an EHR incentive payment, the payment will be recouped.  CMS has an appeals process for eligible professionals, eligible hospitals and critical access hospitals that participate in the Medicare EHR Incentive Program.  States will implement appeals processes for the Medicaid EHR Incentive Program. For more information about these appeals, please contact your State Medicaid Agency.

17. Meaningful Use Audit Preparation Checklist Tool Provider Name: __________________________________________________________________ National Provider Identifier (NPI) ______________________________________________________ CMS EHR Certification ID: ____________________________________________________________ Reporting Period Start Date: __________________________________________________________ Reporting Period End Date: ___________________________________________________________ ☐ Documentation is attached demonstrating that at least 50% of patient encounters during the EHR reporting period occurred at a practice(s)/location(s) equipped with certified EHR technology. Core Measures 1. CPOE for Medications: ☐ Exclusion Claimed. Reason: ☐ Audit Documentation: Report used to obtain the numerator and denominator OR to document reason for exclusion ☐ EP reported using ALL patient records ☐ EP reported using only patient records maintained in the certified EHR 2. Drug Interaction Check: ☐ Audit Documentation: Screenshot from EHR of settings showing active drug-drug and drug-allergy checking, for the entire reporting period, if possible, or an interaction alert audit report. 3. Maintain Problem List: ☐ Audit Documentation: Report used to obtain numerator and denominator 4. e-Prescribing (eRx): ☐ Exclusion Claimed. Reason: ☐ Audit Documentation: Report used to obtain the numerator and denominator OR to document reason for exclusion ☐ EP reported using ALL patient records ☐ EP reported using only patient records maintained in the certified EHR

18. 5. Active Medication List: ☐ Audit Documentation: Report used to obtain numerator and denominator 6. Medication Allergy List: ☐ Audit Documentation: Report used to obtain numerator and denominator 7. Demographics: ☐ Audit Documentation: Report used to obtain numerator and denominator 8. Vital Signs: ☐ Exclusion Claimed. Reason: ☐ Audit Documentation: Report used to obtain the numerator and denominator OR to document reason for exclusion ☐ EP reported using ALL patient records ☐ EP reported using only patient records maintained in the certified EHR ☐ EP reported using ALL patient records ☐ EP reported using only patient records maintained in the certified EHR 9. Smoking Status: ☐ Exclusion Claimed. Reason: ☐ Audit Documentation: Report used to obtain the numerator and denominator OR to document reason for exclusion ☐ EP reported using ALL patient records ☐ EP reported using only patient records maintained in the certified EHR 10. Clinical Quality Measure (CQMs): ☐ Attach list of core or alternate core CQMs submitted ☐ Attach list of three additional CQMs selected ☐ Audit Documentation: Report used to obtain the numerator and denominator for each CQM 11. Clinical Decision Support Rule: ☐ Audit Documentation: Screenshot of the EHR showing use of a clinical decision support rule along with any and all documentation that the CDS has been in place and uninterrupted for the entire reporting period. You may have to contact your vendor for this documentation.

19. 12. Electronic Copy of Health Information: ☐ Exclusion Claimed. Reason: ☐ Audit Documentation: Report used to obtain the numerator and denominator OR to document reason for exclusion ☐ EP reported using ALL patient records ☐ EP reported using only patient records maintained in the certified EHR 13. Clinical Summaries: ☐ Exclusion Claimed. Reason: ☐ Audit Documentation: Report used to obtain the numerator and denominator OR to document reason for exclusion ☐ Copy of a clinical summary showing that all required components are included. ☐ EP reported using ALL patient records ☐ EP reported using only patient records maintained in the certified EHR 14. Electronic Exchange of Clinical Information: ☐ Audit Documentation: screenshot documenting test of sending electronic health information plus documentation that the test was or was not successful/received. 15. Protect Electronic Health Information: ☐ Audit Documentation: In the event of an audit, the EP must be able to provide a copy of the security risk analysis. Keeping a copy of the security risk analysis in the EP audit file can be security vulnerability for an organization. As a compromise, consider placing a letter in the EP audit file similar to the following template:

30. OCR AUDITS HIPAA COMPLIANCE

31. OCR ASKED THE COVERED ENTITY TO SUPPLY THE FOLLOWING INFORMATION WITHIN 20 DAYS OF THE RECEIPT OF THE OCR AUDIT LETTER 1 Please submit a response to the allegations made in the complaint. Please describe the circumstances leading to the alleged incident to include the date of the incident and the date of discovery of the incident. Please list in detail the protected health information (PHI) that was made available to unauthorized individuals. 2. Copies of any notes, documents and reports relating to any internal investigation including of any forensic analysis, conducted by the covered entity, or its designated contractor or agent, of the alleged incident. Please detail any corrective measures taken as a result of this alleged incident.

32. 3. Please indicate whether you conducted a breach risk assessment for the alleged incident. If so, please provide a copy of the breach risk assessment. If you determined that a breach of patients’ PHI occurred as a result of this incident, please indicate, as applicable, whether you notified the affected individuals, the media, and the HHS Secretary. If you notified the affected individuals, the media, and the HHS Secretary, please provide OCR with documentation of said notifications.

33. 4, A copy of the covered entity’s policies and procedures with respect to uses and disclosures of PHI and safeguarding PHI developed pursuant to HIPAA. 5. Please provide a copy of the covered entity’s business associate agreement with the vendor that was in effect at the time of this incident.

34. 6. A copy of any risk analysis performed pursuant to 45 C.F.R 164.308(a)(1)(ii) prior to the date of the incident and any risk management plans developed as a result of the risk analysis. Any revisions or updates made to the risk analysis to include malware infection or hacking attacks as a risk item. Evidence of all implemented security measures to reduce the risk of malware infection or hacking (e.g. screenshots, configuration settings).

35. 7. Evidence of information system activity reviews (e.g. user access, user activity, network security, etc.). 8. Evidence of any network scans or penetration tests performed before and/or after the incident. 9. A copy of the covered entity’s approved access management policy pursuant to 45 C.F.R. 164.308(a)(4). 10. A copy of the covered entity’s security awareness and training materials prior to the incident. Please include evidence of workforce attendance to the training

36. 11. Evidence of malicious software protection (antivirus system) installed at the time of the incident. Please also include evidence of patching on the affected systems. 12,. A copy of the covered entity’s approved data backup procedures. Please include evidence of data backup mechanism/process. 13. Evidence of technical access controls that the covered entity implemented. Please include a copy of the covered entity’s approved password management policy and procedure.

37. 14. Evidence of implemented network security devices such as firewalls, intrusion detection systems, etc. Please include evidence of any network scans performed on the network/computer before and/or after the incident. 15. Details of network security monitoring to identify network related threats and vulnerabilities. For each data request item listed above, specify the name and title of each individual who furnished information in response to the request. We ask that the information requested above be provided within 20 days of the receipt of this letter.

38. TAKEAWAYS Again it is important to remember that the breach was not caused by the covered entity but by one of their business associates. Regardless of who caused the breach, OCR was looking directly at the covered entity. The sum of the information requested is clearly looking to see if the covered entity was complying with HIPAA regulations and more specifically the HIPAA Security Rule. 20 days is not a lot of time to produce all of this information. If the covered entity did not already have the information it would be very difficult to create and compile the information in the requested timeframe.

39. OCR WAS LOOKING FOR THE FOLLOWING: Evidence the covered entity (CE) performed a Risk Assessment prior to the incident. In addition OCR is looking for evidence of a Risk Management plan or in other words that the CE performed a Risk Assessment and put together a work plan to implement additional security safeguards. Just performing a Risk Assessment and not implementing additional safeguards is not acceptable.performed a Risk Assessment Evidence of HIPAA policies and procedures on safeguarding PHI.policies and procedures Evidence of employee training.employee training. Evidence of breach procedures including a breach risk assessment and breach notification procedures.

40. WHAT ARE THEY LOOKING FOR? Evidence of network vulnerability and penetration scans along with evidence of anti- virus/anti-malware software. Evidence of system activity review – who accessed PHI, what PHI was accessed and when was the PHI accessed.

41. IT WONT HAPPEN TO ME…….. Many covered entities don’t feel the risk of an audit is real. They point to the lack of HIPAA enforcement and have a false sense of security. This case shows that CEs and BAs need to not focus on random audits but understand that they can be audited if one of their subcontractors (in the case of a CE or BA) or one of their clients (in the case of BA) have a security breach. And not being able to produce the above requested items by OCR may lead to OCR finding the organization in willful neglect of HIPAA regulations.willful neglect of HIPAA regulations Be Careful with that, you might be next……….are you ready?