1. National Cancer Institute Cancer Therapy Evaluation Program (CTEP) presents: How to Obtain Protected Health Information (PHI) from an Outside Healthcare Facility or Provider

2. NCI /Cancer Therapy Evaluation Program (CTEP) 2 Objectives To understand:  The importance of sending requested patient information in a timely manner.  The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.  How the HIPAA document can help clinical sites obtain PHI from an outside health care facility or provider.

3. NCI /Cancer Therapy Evaluation Program (CTEP) 3 Objectives To learn:  The process for obtaining PHI from an outside health care facility or provider.  How to obtain PHI from an outside health care facility or provider when the patient is deceased.

4. NCI /Cancer Therapy Evaluation Program (CTEP) 4 Why must clinical sites send requested information to the Cancer Therapy Evaluation Program (CTEP) in a timely manner? Timelines

5. NCI /Cancer Therapy Evaluation Program (CTEP) 5 CTEP is required to meet FDA established guidelines when reporting adverse events from CTEP-sponsored trials. Timelines

6. NCI /Cancer Therapy Evaluation Program (CTEP) 6 In order to meet FDA guidelines, CTEP relies on the clinical sites to submit patient information as within a day of the electronic adverse event submission. Timelines

7. NCI /Cancer Therapy Evaluation Program (CTEP) 7 Clinical sites have reported difficulty obtaining necessary patient medical records when the patient is seen and/or treated in an outside facility. NOTE:These delays impact CTEP’s ability to meet the FDA’s timelines for submission. Timelines

8. NCI /Cancer Therapy Evaluation Program (CTEP) 8 The HIPAA Privacy Rule:  Is not intended to impede public health activities.  Permits certain disclosures of PHI for public health activities and research without a patient’s authorization.  Permits disclosures to clinical research facilities/clinical investigators in NCI-sponsored clinical studies, as long as the reason for the requests fit within the Privacy Rule’s relevant exception(s).

9. NCI /Cancer Therapy Evaluation Program (CTEP) 9 The HIPAA Privacy Rule:  The disclosure of PHI is permitted under section 45 CFR Part 164.512 (b) (1), which states: “If an entity qualifies as a public health authority, a covered entity may disclose PHI to the public health authority if the law authorizes the public health authority to collect or receive such information for the purposes set forth in section 45 CFR Part 164.512 (b) (1).”

10. NCI /Cancer Therapy Evaluation Program (CTEP) 10  CTEP has designed a document that can be sent to outside health care facilities and providers to obtain medical documents without a patient’s consent. NOTE:This document has been reviewed and approved by the attorneys of the National Cancer Institute. HIPAA Document

11. NCI /Cancer Therapy Evaluation Program (CTEP) 11 For More Information http://www.cdc.gov/mmwr/preview/mmwrhtml/ su5201a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/ su5201a1.htm  For additional guidance on disclosures of PHI for public health purposes to a government agency that also conducts research, see: HIPAA privacy rule and public health: guidance from CDC and the U.S. Department of health and human services located at: http://www.cdc.gov/mmwr/preview/mmwrhtml/ su5201a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/ su5201a1.htm

12. NCI /Cancer Therapy Evaluation Program (CTEP) 12 How to Use the “Request for Information on Patient Participating in NCI Clinical Research Study” Document STEP 1: Complete the ‘Request for Information on Patient Participating in NCI Clinical Research Study’ document (page 2) by filling out the following information:

13. NCI /Cancer Therapy Evaluation Program (CTEP) 13 Include:  Your name and phone number as the requestor.  Patient’s ID or MR #.  ER visit/hospitalization dates.  Specific information required (provided in email document from CTEP to clinical site).  Due date for information to be faxed/mailed to reporter. How to Use the “Request for Information on Patient Participating in NCI Clinical Research Study” Document

14. NCI /Cancer Therapy Evaluation Program (CTEP) 14 STEP 2: Forward the form, along with the document on the following page (page 3) entitled ‘Obtaining Medical Information from Outside Health Care Facilities for Patients on Clinical Protocols When Authorization for PHI is not required,’ to the facility or provider. How to Use the “Request for Information on Patient Participating in NCI Clinical Research Study” Document

15. NCI /Cancer Therapy Evaluation Program (CTEP) 15 STEP 3: After receiving the requested information from the medical records department and/or outside facility/provider, you must remove the patient name and identifiers. How to Use the “Request for Information on Patient Participating in NCI Clinical Research Study” Document

16. NCI /Cancer Therapy Evaluation Program (CTEP) 16 The following identifiers must be removed from all medical documents that are faxed to CTEP:  Patient’s:  Name  Postal address information, including:  Street address  City  County  Precinct  ZIP code, and their equivalent geocodes How to Use the “Request for Information on Patient Participating in NCI Clinical Research Study” Document

17. NCI /Cancer Therapy Evaluation Program (CTEP) 17 The following identifiers must be removed from all medical documents that are faxed to CTEP (continued):  Patient’s:  Telephone Number(s)  Social Security Number  Medical Record Numbers  Health Plan Beneficiary Numbers  Account Numbers (FIN)  Full-face photographic images and any comparable images How to Use the “Request for Information on Patient Participating in NCI Clinical Research Study” Document

18. NCI /Cancer Therapy Evaluation Program (CTEP) 18 STEP 4:  After all patient identifiers have been removed, include the patient ID, protocol number, and electronic adverse event ticket number on each page being forwarded to CTEP. STEP 5:  Fax the requested information to CTEP at: (301) 230-0159 How to Use the “Request for Information on Patient Participating in NCI Clinical Research Study” Document

19. NCI /Cancer Therapy Evaluation Program (CTEP) 19 How to Obtain PHI from an Outside Facility/Provider When the Patient is Deceased  Section 164.512 of the CFR/ICH GCP Reference Guide states that: “A covered entity may disclose PHI of a deceased person to a clinical investigator, without the authorization of the decease person’s estate, if the clinical investigator provides the covered entity certain assurances.”

20. NCI /Cancer Therapy Evaluation Program (CTEP) 20 The clinical investigator must provide documentation that the person is deceased and submit a request to the outside medical facility stating that:  The use/disclosure of the PHI is needed for research purposes only.  The person is deceased. How to Obtain PHI from an Outside Facility/Provider When the Patient is Deceased

21. NCI /Cancer Therapy Evaluation Program (CTEP) 21 For more information contact the AESMD Help Desk:  Email: AEMD@tech-res.comAEMD@tech-res.com  Phone: 301-897-7497