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Confidentiality: 42 CFR Part 2 Final Rule Update 2018 for Alcohol and Drug Treatment

Discussion of Public Comments and Final Modifications to 42 CFR Part 2; Prohibition on Re-disclosure (section 2.32)

1. For what reason has SAMHSA adopted an abbreviated notice?

A. So that it fits in standard free-text space within health care electronic systems.

B. So that it is fast and easy for the health care provider to type out.

C. So that it is easy for the protected individuals to read.

D. All of the above.


Discussion of Public Comments and Final Modifications to 42 CFR Part 2; Disclosures Permitted with Written Consent (section 2.33)

2. SAMHSA adds language to the regulatory text in section 2.33(b) to clarify that disclosures to contractors, subcontractors, and legal representatives are not permitted for substance use disorder patient:

A. Diagnosis

B. Treatment

C. Referral for treatment

D. Any of the above


3. Because of its targeted populations, part 2 and its authorizing statute provides more stringent federal protections than other health privacy laws, including the HIPAA Rules, in order to encourage individuals with substance use disorders to seek treatment.

A. True

B. False


4. Which of the following would be a permissible activity under section 2.33(b) that SAMHSA considers to be a payment and health care operation activity?

A. Patient safety activities

B. Accreditation, certification, licensing, or credentialing activities

C. Third-party liability coverage

D. All of the above


5. Under section 2.33(c), SAMHSA is requiring that the contract specify the permitted uses of patient identifying information by the contractor, subcontractor, or legal representative.

A. True

B. False


6. SAMHSA is finalizing section 2.33(c) as proposed, but has revised the regulatory text to remove the reference to patient consent as it relates to the requirement to specify permitted uses of patient identifying information by the contractor, subcontractor, or legal representative.

A. True

B. False


7. If lawful holders choose not to re-disclose patient identifying information to contractors, subcontractors, or legal representative as specified under section 2.33(b), they do not have to comply with section 2.33(c).

A. True

B. False


8. A fundamental principle of 42 CFR part 2 is that patients should have as much control as possible over their patient identifying information.

A. True

B. False


9. Those utilizing contractors or subcontractors should inform those parties in their contracts that information governed by part 2 requires the contractor or subcontractor to:

A. Take reasonable steps to prevent unauthorized uses and disclosures.

B. Inform the lawful holder of any breaches and/or unauthorized uses.

C. Both (A) and (B).

D. None of the above.


10. With regard to the comments on Medicaid agencies and the managed care organization with which they contract, as well as those addressing administrative obstacles contractors may face in obtaining patient identifying information, the information can be disclosed directly to the contractor or subcontractor only if first disclosed to the lawful holder (i.e., recipient named on the consent form) before subsequently re-disclosing.

A. True

B. False


11. In the case where there is a legal representative who is required to represent the lawful holder by law, the requirement for a contract or comparable legal instrument in section 2.33(c):

A. Shall apply

B. Shall not apply

C. It is up to the lawful holder

D. It is up to the legal representative


12. SAMHSA eliminated the requirement that section 2.33(b) only applies to lawful holders that receive patient identifying information pursuant to a written consent.

A. True

B. False


Discussion of Public Comments and Final Modifications to 42 CFR Part 2; Requests for Public Comment

13. Section 2.53 provides that the audit and evaluation provisions do not authorize _____ to disclose or use patient identifying information obtained during the audit or evaluation for any purposes other than those necessary to complete the audit or evaluation.

A. The Part 2 program

B. The federal, state, or local government agency

C. Any individual or entity

D. All of the above


Rulemaking Analysis

14. In order to provide entities with maximum flexibility reflecting their unique contractual arrangements, contracts may include statements about required compliance with 42 CFR part 2, however, no specific language beyond this concept is required by the rule.

A. True

B. False


15. Because part 2 programs and other lawful holders can modify their contracts during the normal renegotiation of contracts as existing contracts expire or, if such contracts are not regularly updated, can make such changes up to _____ from this final rule’s effective date, new regulatory language required by section 2.33(c), as revised, should impose a minimal burden.

A. 6 months

B. 1 year

C. 2 years

D. 5 years


16. Entities not wishing to use the abbreviated notice may use the standard prohibition on re-disclosure notice.

A. True

B. False


17. The RFA generally defines a “small entity” as all of the following, except for:

A. A state

B. A proprietary firm meeting the size standards of the Small Business Administration

C. A nonprofit organization that is not dominant in its field

D. A small government jurisdiction with a population of less than 50,000


18. The rule, as defined by Executive Order 12866, triggers the Unfunded Mandates Reform Act because it results in expenditures of $100,000,000 or more by states or other government entities.

A. True

B. False


Provisions of Technical Amendments

19. Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule:

A. Only if they provide notice and an opportunity for public comment.

B. Without providing notice and an opportunity for public comment.

C. Notice and public comment depends on the rule at hand.

D. The agency must obtain written permission from HHS before applying the rule.


Conclusion

20. Contracts may not permit a contractor or subcontractor or voluntary legal representative to re-disclose information to a third party unless:

A. That third party is a contract agent of the contractor or subcontractor, helping them provide services described in the contract.

B. The agent only further discloses the information back to the contractor or lawful holder from which the information originated.

C. Both (A) and (B).

D. None of the above.


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