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Welcome to : Understanding the SAMHSA FAQs: Part 2
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Welcome to : Understanding the SAMHSA FAQs: Part 2

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  1. TO HEAR this webinar, you must dial thenumber emailed to you in your registration confirmation and use the access code also provided in the same email. The audio pin is on the panel to the right of this screen. The webinar will begin at 3:00 p.m.EDT Thank you for your patience. Welcome to: Understanding the SAMHSA FAQs: Part 2 Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  2. Can’t hear the presentation? Using your telephone, dial thenumber emailed to you in your registration. When prompted, use the access code also provided in the same email. The audio pin is on the panel to the right of this screen. Having trouble with the phone number? Call 212-243-1313. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  3. Four-Part Webinar Series on… Confidentiality, Substance Use Treatment, and Health Information Technology (HIT) First 3 Webinars Presented by the Legal Action Center. Today’s presenter is Anita Marton, Esq. 4th Webinar Presented by SAMHSA Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  4. Who is the Legal Action Center? • National law & policy non-profit organization • Policy and legal work on anti-discrimination & privacy issues affecting people with • Substance Use Disorders • Criminal records or • HIV/AIDS Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  5. Have a Question During this Presentation? • Use the “Question(s)” feature on the upper right-hand corner of your screens to type in your question(s). • Will stop for Q&A about every 20 minutes. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  6. Today’s Materials • This PowerPoint presentation • FAQs by SAMHSA & ONC: Applying the Substance Abuse Confidentiality Regulations to Health Information Exchange (HIE) (2010) http://www.samhsa.gov/healthPrivacy/docs/EHR-FAQs.pdf • Applying the Substance Abuse Confidentiality Regulations 42 C.F.R. Part 2 (REVISED) 12.14.11http://www.samhsa.gov/about/laws/SAMHSA_42CFRPART2FAQII_Revised.pdf • 42 C.F.R. Part 2 – the regulations Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  7. Today’s Materials • Download them on: • www.lac.org – click on “Free Webinars” • www.pfr.samhsa.gov Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  8. Recording of this webinar will be available soon at www.lac.org and www.pfr.samhsa.gov Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  9. Who’s today’s audience? This training is for . . . • State Government agencies overseeing/providing treatment for substance use and mental health disorders • SAMHSA representatives who oversee drug/alcohol treatment and mental health programs • Providers treating people with substance use/mental health disorders Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  10. This series is about . . . • How to apply the Federal alcohol/drug confidentiality regulations – 42 C.F.R. Part 2 – to Health Information Technology (HIT) • Understanding the 2 sets of FAQs issued by SAMSHA Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  11. This series is about . . . Why now? • Use of HIT is growing rapidly across U.S. – due to technological advances, incentives through the Health Information Technology for Economic and Clinical Health Act (HITECH) enacted as part of American Recovery and Reinvestment Act of 2009. • In 2010 and 2011, SAMHSA released 2 sets of FAQs addressing how alcohol/drug treatment records can be incorporated into HIT environment without violating federal alcohol/drug confidentiality regulations. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  12. This series is about . . . Why now? (cont.) • Even after the release of the FAQs, many have questions about how to integrate alcohol/drug treatment records into HIT systems. • Goal of these webinars is to advance understanding of how to do this. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  13. Summary of Webinar #1 • Provided general overview of HIPAA • Provided general overview of 42 C.F.R. Part 2, with a focus on the provisions of Part 2 that are most relevant to an e-health environment, including: • which programs are covered by Part 2; • what patient information is protected; and • provisions that allow for the disclosure of patient identifying information. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  14. Summary of Webinar #2 • Discussed SAMHSA FAQs Relating To: • Patient choice models • Consent issues, including: • consent forms; • redisclosure issues; and • minors and consent Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  15. Today’s Presentation • Will Discuss SAMHSA FAQs Relating To: • Qualified Service Organization Agreements (“QSOAs”); • Medical emergencies; • Immediate threats to health or safety of an individual or the public; and • Screening, Brief Intervention and Referral to Treatment (“SBIRT”) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  16. Save the Date! Upcoming Webinar: • SAMHSA’s Investment to Support of HIT Adoption – May 25, 2012 Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  17. Let’s Get Started Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  18. Useful Terms & Definitions • 42 C.F.R. Part 2 (“Part 2”): federal regulations protecting the confidentiality of drug/alcohol patient information • Health Information Exchange (“HIE”): various methods & mechanisms through which information can be exchanged electronically via a computer network between health care providers and other health care stakeholders • Health Information Organization (“HIO”): an organization that oversees and governs the exchange of health-related information among organizations • HIO Affiliated Members: Entities that participate in a HIO network, including but not limited to participating health care providers Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  19. PART ONE QUALIFIED SERVICE ORGANIZATION AGREEMENTS (“QSOAs”) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  20. QSOAs: Definition of QSOA • A Qualified Services Organization Agreement (“QSOA”) isa written agreement between a Part 2 program and a Qualified Service Organization (“QSO”), allowing two-way communication between the two parties. FAQ I(6) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  21. QSOAs: Definition of QSOA • A QSOA is similar to a Business Associate agreement under HIPAA. As a practical matter, Part 2 programs will have to enter into QSO/BA agreements to meet both the Part 2 and HIPAA requirements. • The FAQs only address Part 2 requirements. • As covered in Webinar #1, QSO/BA agreements will have to meet Part 2’s stricter requirement. Thus, this Webinar focuses on QSOAs under Part 2’s requirements. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  22. QSOAs: Definition of QSO Under Part 2, a QSO is defined as a person or organization that: • Provides services to a Part 2 program (e.g., data processing, bill collecting, dosage preparation, laboratory analyses, medical, etc.) • In the HIE context, the services a HIO could provide to a Part 2 program could include: “holding and storing patient data, receiving and reviewing requests for disclosures to third parties, and facilitating the electronic exchange of patients’ information through the HIO network.” AND more… Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  23. QSOAs: Definition of QSO • Has entered into a written agreement with a Part 2 program in which the QSO: • acknowledges that in receiving, storing, processing or otherwise dealing with any patient records from the programs it is fully bound by the Part 2 regulations AND • will resist in judicial proceedings any efforts to obtain access to patient records unless otherwise permitted by Part 2. FAQ I(5) and FAQ II(6) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  24. QSOAs: No Patient Consent Needed • Can a Part 2 program give patient information to an entity that provides services to the Part 2 program (e.g., a laboratory) pursuant to a QSOA without a patient’s consent? Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  25. QSOAs: No Patient Consent Needed YES, but only when a Part 2 program has entered into a QSOA with the entity providing such services. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  26. QSOAs: HIOs • Is a Part 2 program allowed to enter into a QSOA with a HIO without the patient’s written consent? Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  27. QSOAs: HIOs YES, if: • the HIO provides covered services to the Part 2 program, such as holding and storing patient data, etc.; • the Part 2 program and the HIO enter into a two-way written QSOA; AND • the Part 2 patient information made available to the HIO is restricted to the information needed by the HIO to provide services to the Part 2 program. FAQ I(6), (7) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  28. QSOAs: HIOs • The scope of a QSOA is limited. • As discussed in previous slides, a QSOA is a two-way agreement between a Part 2 Program and the QSO. • The QSOA only authorizes communications between the Part 2 program and the QSO. Information can flow back and forth between the parties. • This is true even when the QSO is a HIO. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  29. QSOAs: HIOs Case Study/Poll: Part 2 Program ABC has a written QSOA with a HIO. Pursuant to the QSOA, may the Part 2 Program upload (electronically transmit) information about its patients without the written consent of its patients? Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  30. QSOAs: HIOs Possible answers: • YES. No, not even with a QSOA in place, a program cannot upload information about its patients without consent. • NO. Patient consent is always needed when patient-identifying information is disclosed by a Part 2 program. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  31. QSOAs: HIOs Answer: #1 - YES, if: • a QSOA is in place; AND • the HIO’s choice model (discussed in Webinar 2) does not require patient consent before information can be disclosed to the HIO. For example, if the HIO uses an “Opt-In” choice model, a QSOA cannot be used because patient consent is required before a Part 2 program can disclose patient information to the HIO. FAQ I(6 and 7) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  32. QSOAs: HIO Disclosures to Third Parties • Generally, a HIO that is holding or storing Part 2 patient data through a QSOA IS NOT ALLOWED to redisclose data from a Part 2 program to a third party without a patient’s written consent. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  33. QSOAs: HIO Disclosures to Third Parties However, a HIO IS PERMITTED to: • Disclose Part 2 information to a contract agent of the HIO when: • a HIO needs to do so to provide the services described in the QSOA; AND • as long as the agent only discloses the information back to the HIO or the originating Part 2 program more… Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  34. QSOAs: HIO Disclosures to Third Parties • Redisclose Part 2 information in a medical emergency situation. • We will address medical emergencies later on in this presentation. FAQ I(10) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  35. QSOAs: HIO Disclosures to Third Parties Case Study/Poll: Part 2 Program ABC has a QSOA with a HIO and has uploaded information about Patient Nellie without her written consent. General Hospital XYZ is affiliated with that HIO network. Can the HIO redisclose Patient Nellie’s Part 2 information to General Hospital XYZ without her consent? Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  36. QSOAs: HIO Disclosures to Third Parties Possible Answers: • Yes, because a QSOA is in place, and General Hospital XYZ is providing medical services to Nellie, a Part 2 program ABC’s patient. • No, because a QSOA is a 2-way agreement between the HIO and Part 2 program ABC, and since General Hospital XYZ is not an agent of the HIO, the HIO cannot disclose information about Nellie without consent unless there is a medical emergency. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  37. QSOAs: HIO Disclosures to Third Parties Answer: #2- NO, unless there is a medical emergency. • A HIO may only disclose Part 2 information that it has received from a Part 2 program to HIO affiliated members (in this case General Hospital XYZ) if the patient signs a Part 2-compliant consent form allowing the disclosure. HIO FAQ I(8); FAQ II(15) Affiliated member HIO Part 2 program HIO affiliated member Part 2 information redisclosed by consent QSOA Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  38. QSOAs: QSOAs with Two Service Providers Case Study/Poll: Patient Nora is a patient at Part 2 Program ABC. Part 2 Program ABC has a written QSOA with a laboratory and a separate QSOA with a HIO. Part 2 Program ABC discloses Part 2 information about Patient Nora to the laboratory without her consent. Given that Part 2 Program ABC has a QSOA with the HIO, can the laboratory disclose the Part 2 information it received from the program about Patient Nora to the HIO? Part 2 program HIO affiliated member HIO QSOA QSOA LAB Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  39. QSOAs: QSOAs with Two Service Providers Possible Answers: • Yes, because the Part 2 program has QSOAs with both the lab and HIO. • No, not without Patient Nora’s written consent, because a QSOA is a two-way agreement between a Part 2 program and a service provider. Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  40. QSOAs: QSOAs with Two Service Providers ANSWER: #2 NO, not without Patient Nora’s written consent. As we learned in Webinar #2, one consent form could authorize: • Part 2 Program ABC to disclose information about Patient Nora to the lab; AND • the lab to redisclose Part 2 information to the HIO. more… FAQ II(14) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  41. QSOAs: QSOAs with Two Service Providers Assuming Patient Nora signed such a consent form and the lab was authorized to disclose Nora’s lab results to the HIO, could the HIO redisclose that information back to Part 2 program via the QSOA that is in place? YES. Pursuant to the consent form the lab could send the lab results to the HIO. Once the HIO received the results, it could (through the QSOA it has with Part 2 Program ABC), send those lab results to Program ABC, if that was a service described in the QSOA. FAQ II(14) Part 2 program HIO affiliated member HIO QSOA Consent to redisclose Consent LAB Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  42. QSOAs: Providers of “On-Call Coverage” • A Part 2 program can have a QSOA with a provider of “on-call” coverage (a physician on-call to provide medical services to the program’s patients with emergency or urgent medical needs.) • A Part 2 program can also have a QSOA with a HIO. • If a HIO receives Part 2 patient information from a Part 2 program via a QSOA , the HIO CANNOT redisclosethe patient information to a provider of “on-call coverage” without a patient’s written consent. FAQ II(3) HIO QSOA Part 2 program HIO affiliated member On –call provider QSOA Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  43. QSOAs: Providers of “On-Call Coverage” • As previously mentioned, a QSOA between a Part 2 program and a HIO is a two-way agreement between those parties. Generally, a HIO cannot redisclose Part 2 information that it receives from a Part 2 program to a third party unless there is a medical emergency or the third party is a contract agent of the HIO. Therefore, a HIO is not allowed to redisclose Part 2 information to a provider of “on-call coverage” without a patient’s written consent. FAQ II(3) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  44. QSOAs: Providers of “On-Call Coverage” • HOWEVER, patient consent IS NOT needed for a HIO to redisclose patient information to providers “on-call coverage” when: • the providers are part of the Part 2 program; or • the providers are part of an entity that has direct administrative control over the program Note: In both circumstances, the on-call providers must need the information in connection with their duties that arise out of the provision of diagnosis, treatment or referral for treatment services. FAQ II(3) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  45. HAVE QUESTIONS? Now for your questions... Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  46. PART TWO MEDICAL EMERGENCY ISSUES Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  47. Medical Emergency: Definition The Part 2 medical emergency provision states: “Patient identifying information may be disclosed to medical personnel who have a need for information about a patient for the purpose of treating a condition which poses an immediate threat to the health of any individual and which requires immediate medical intervention.” 42 C.F.R. § 2.51(a) FAQ I(24); FAQ II(5) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  48. Medical Emergency: Definition • A medical emergency includes both physical and mental health emergencies under Part 2. FAQ I(29) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  49. Medical Emergency: Exception to Consent • When a medical emergency exists, patient consent IS NOT required under Part 2 in order to disclose Part 2 patient information to medical personnel treating the emergency. FAQ II(5) Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA

  50. Medical Emergency: The Determination Case Study/Poll: Does a Part 2 program have to make the decision that a medical emergency exists? Prepared by the Legal Action Center with support from Partners for Recovery Initiative and SAMHSA