Why?

1. HIPAA and 42 CFR Part 2: Walking Through the MazeA Presentation to the Law and Community Health SectionJoan M. Wilson Assistant Attorney General Joan.Wilson@alaska.gov

2. Why? • Growing body of medical research • High prevalence of individuals with co-occurring substance abuse and mental health disorders • Difficulty in accessing appropriate treatment in separate mental health and substance abuse systems • Challenges to recovery when undiagnosed disorders

3. Why? • To remedy, the Substance Abuse and Mental Health Services Administration (SAMSHA) created the Co-Occurring State Incentive Grant Program • Alaska Department of Health and Social Services is a recipient • One of seven initial states

4. Why? • Requirements of Grant– Infrastructure Development in following areas • Standardized Screening and Assessment • Complementary Licensure and Credentialing Requirements • Service Coordination and Network Building • Financial Planning • Information Sharing

5. Why? • Alaska Department of Health and Social Services, Division of Behavioral Health • DBH Grantees to Provide Integrated Care for Coexisting Substance Abuse and Mental Health Disorders • Present Approach • Substance abuse treatment facilities screen for mental illness, • Mental health facilities screen for substance abuse • No wrong door policy • Eventual treatment for both disorders in all locations

6. Mental Health Facilities • Does Screening Alone Subject Entities to the Substance Abuse Treatment Regulations for the first time?

7. 42 CFR PART 2

8. 42 CFR Part 2 • Except under certain conditions, there is a prohibition on disclosure of information concerning a “patient” in a “federally assisted” program • Federal assistance • Program • Patient

9. 42 CFR Part 2 • Federal assistance • Includes federal block grants or other funds channeled through state or local governments • Medicaid • COSIG Grant • Includes certification for Medicare reimbursement

10. 42 C.F.R. Part 2 • Program • Individual or entity that holds itself out as providing and does provide alcohol or drug abuse diagnosis, treatment, counseling, or referral for treatment • Note does not say “referral for diagnosis” • Could stand in the place of a program if State law, regulation, or licensing requirement binds the individual or entity to the standards of 42 C.F.R. Part 2

11. 42 CFR Part 2 • Program, includes • Individual or entity other than a general medical care facility • Identified Unit within a general medical facility • Medical staff in a general medical facility whose primary function is diagnosis, treatment, or referral

12. 42 CFR Part 2 • Patient • An individual who has applied for or been given diagnosis or treatment for alcohol or drug abuse at a federally assisted program

13. 42 CFR Part 2 • General Rule: Information that identifies an individual as a patient of a program may not be used or disclosed absent patient authorization, unless an exception for the use or disclosure applies

14. HIPAA Use and Disclosure Rule • General rule: A covered entity and its workforce, may not use or disclose PHI, except — • For TPO • With individual permission • To the individual • As otherwise permitted or required by HIPAA

15. Mental Health Programs • Utilize screening tool • Raises possible of substance abuse problem • Refers to another organization for diagnosis • Is it subject to the Substance Abuse Treatment regulations?

16. From SAMSHA Information gathered by a program for purposes other than a diagnosis, treatment, or referral for treatment is not subject to the 42 C.F.R. Part 2 restrictions covered Screen or pre-screen procedures Identifying an Individual as possibly having a substance abuse problem by use of a screening or prescreening procedure that is not conducted as part of diagnosis or treatment is not subject to the 42 CFR Part 2 restrictions SAMSHA Technical Assistance Publication Series 24, “Welfare Reform and Abuse Treatment Confidentiality: General Guidance for Reconciling Need to Know and Privacy” Screening vs. Diagnosis

17. Key Benchmark for 42 CFR Part 2 • Diagnosis and treatment • The act or process of deciding the nature of a diseased condition by examination of the symptoms • A careful analysis of the facts meant to explain something • A decision based on such an examination or analysis

18. Not there yet, But

19. HIPAA and 42 CFR Part 2

20. Uses and Disclosures Under Both Regulations

21. HIPAA and 42 CFR Part 2 • HIPPA • Providers who electronically transmit any health information in a HIPAA covered standard transaction • 42 CFR Part 2 • Individual or entity that holds itself out as providing and does provide alcohol or drug abuse diagnosis, treatment, counseling, or referral for treatment

22. Standard for Uses And Disclosures • Apply the more restrictive standard • Standards that provide greater privacy protections • Exceptions • Disclosures to the individual whose health information is at issue • Disclosures to federal Department of Health and Human Services for HIPAA compliance determinations

23. The Answer: 42 CFR Part 2 • General Rule: Information that identifies an individual as a patient of a program may not be used or disclosed absent patient authorization, unless an exception for the use or disclosure applies

24. With AuthorizationMake consistent with both regulations • Elements Patient Name Meaningful and specific description of information Specific name or general description of Persons authorized to disclose Name of individual or organization to receive Purpose of disclosure Expiration date/ event (no longer than reasonably necessary for purpose • Required statements: • Right to revoke • Whether authorization is a condition of treatment • 42 CFR Part 2 re-disclosure statement • Obtain appropriate signature or signatures copy to individual

25. Patient Authorization/Consent • Statement to accompany disclosure • This information has been disclosed to you from records protected by Federal confidentiality rules (42 CFR Part 2). The Federal rules prohibit you from making any further disclosure of this information unless further disclosure is expressly permitted by the written consent of the person to whom it pertains or is otherwise permitted by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. The Federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.

26. Patient Authorization/Consent • Disclosures to the referring criminal justice patient • Patient has signed a written consent • Disclosure only to individuals with a need to monitor progress • Reasonable duration of consent • Expiration of consent may be no later than final disposition • Re-disclosure is permissible to carry out duties with regard to conditional release

28. As required by other laws Public health activities Victims of abuse, etc. Health oversight activities Workers’ compensation Law enforcement purposes Decedents - coroners and medical examiners Organ procurement Research purposes, under limited circumstances Imminent threat to health or safety (to the individual or the public) Specialized government function Judicial and administrative proceedings HIPAA Permitted Disclosures Government and Other Purposes

29. Internal Communications and Use of TPO • Communications of patient identifying information among personnel with a need to know within a program or with an entity having direct administrative control over the program • Determine what uses or disclosures this will cover • Do you need to disclose patient-identifying information? • Disclosure must be permissible under this or another section

30. No Patient Identifying Information • Disclosure does not impliedly or expressly indicate individual is or was a substance abuse patient • Disclosure does not impliedly or expressly indicate an individual has applied for or received substance abuse diagnosis, treatment, counseling, or referral for treatment

31. No Patient Identifying Information • Guidance from SAMSHA on “No Patient Identifying Information” • If a program can disclose a patient’s identifying information without indicating “patient” status, 42 CFR Part 2 is not violated • Disclosures possible primarily when a program is part of a larger entity and can use the larger entity’s name when making the disclosure • Program physician with separate office • Anonymous disclosures (e.g. vulnerable adult abuse reporting, duty to warn) Technical Assistance Publication Series 18, “Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance”

32. No Patient Identifying Information • Key – Does the Disclosure identify an individual who has applied for or been given diagnosis or treatment for alcohol or drug abuse at a federally assisted program • Can you give information without identifying self as substance abuse treatment provider • If so, Permitted Disclosures Under HIPAA can operate • Required by Law Disclosures • Public Health Activities • Duty to Warn • If not, consider anonymous disclosures • Especially for duty to warn/threat of imminent harm

33. Medical Emergency • Disclosure to medical personnel • Treating a condition posing immediate threat to health of individual • Immediate intervention required • Documentation required

34. Court Orders • HIPAA’s More Permissive Provisions will not Operate • Subpoena alone not sufficient • Court Order, including search warrant, alone not sufficient • Satisfactory Assurances? • Inoperable

35. Court Orders -- Civil • Motion for Release of Records filed in court • Fictitious name or • Sealed proceeding • Notice to patient and provider • Opportunity to respond

36. Court Orders – Civil • Hearing • Criteria for order • Other ways of obtaining information not available or effective • Public interest and need for disclosure outweigh injury to patient, physician-patient, and treatment

37. Court Orders – Civil • Confidential communications • Necessary to protect against an existing threat, including child abuse • Necessary to prosecute a serious crime, or • Door opened

38. Court Orders - Civil • Content of Order • Limit disclosure to essential • Limit recipients • Order alone is not sufficient • Subpoena is required

39. Court orders -- Criminal • Motion, Notice, and Hearing like civil • Criteria • Extremely serious crime • Reasonable likelihood of substantial value • Other ways not effective • Public interest weighing • Independent representation for record holder • Same criteria for confidential communications

40. Court Orders -- Criminal • Content of order • Limit disclosure to essential • Limit recipients • Order alone is not sufficient • Subpoena is required

41. Court Orders – Criminal • Additional criteria for investigation of a program or use of undercover agents • 42 C.F.R. 2.66 and 2.67

42. Crime on Premises • From program to law enforcement • Crime or threat of crime on premises • Limited to circumstances, but can disclose • Patient name • Patient status • Address or last known location

43. Emergencies and Crimes • Medical Emergencies • HIPAA Treatment Exception • Crimes on Premises • HIPAA Law Enforcement Exception

44. Mandated Reporting • Child Abuse and Neglect • Report according to state law • Does not cover release of records • Other Disclosures? • Vulnerable Adult Abuse • Gunshot wound or burn • Birth of child • Public Health Crisis • Attended or unattended death

45. Child Abuse and Other Required Reporting • Child Abuse • May Identify Patient Status • Other Required Reports • Remember required reports under state law only permissive under HIPAA • May Not Identify Patient Status • If Cannot Report without identifying patient • Consider anonymous reporting • HIPAA Required Reports • HIPAA preemption provisions specific to state law • But, required report to HHS for HIPAA compliance likely necessity (audit and evaluation) • Access – same likely result

46. Audit and Evaluation Activities • Disclosure is permissible if recipients agree in writing on redisclosure restrictions • Person who conducts an audit or evaluation on behalf of federal, state, or local agencies providing financial assistance to the program or authorized by law to regulate the program’s activities • Third party payer • Peer review organization • Otherwise qualified to conduct audit/evaluation activities (on premises only) • Special rules for Medicaid/Medicare audits (42 C.F.R. 2.53(c))

47. Audit, Evaluation, and Oversight • Key Factors for 42 CFR compliance • Get statement in writing on re-disclosure restriction operations • Feds and state should provide in request for disclosure • Some organizations may rise to level of BA (e.g., accreditation organizations) • Third party payer disclosures could fall in here • Do you need to identify patient status?

48. Qualified Service Organization • Person that provides services to a program that has entered into a written agreement acknowledging it is bound by 42 CFR Part 2 and will resist judicial disclosure (other than as permitted) • Examples (operational services to organization, not program to program for substance abuse treatment) • Data processing • Bill collecting • Dosage preparation • Laboratory Analysis • Professional services (legal, medical, accounting) • Services to prevent, treat child abuse, including training on nutrition and child care or individual and group counseling

49. QSO’s and Business Associates • Identify QSO status • Identify Business Associate status • e.g., laboratory analysis would fall under treatment • Written Agreement • Bound by 42 CFR Part 2 disclosure and judicial resistance provisions • Other Business Associate provisions

50. 42 CFR Part 2 • Minors • If a minor has legal capacity to consent under State law, no other consent is required • If parental consent is required, need both consents • In states requiring parental consent • Minor must consent to disclosure to parent or • Provider must decide minor lacks capacity to make rational choice