Hearing on Privacy and Confidentiality Issues in E-Prescribing

Subcommittee on Privacy and Confidentiality of the

National Committee on Vital and Health Statistics (NCVHS)

November 18, 2004

Presented by

Anita R. Marton
Vice President and Senior Attorney

Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics (NCVHS)

Hearing on Privacy and Confidentiality Issues in E-Prescribing

My name is Anita Marton. I am Vice President and Senior Attorney at the Legal Action Center. The Legal Action Center is a non-profit public interest organization that specializes in legal and policy issues concerning alcohol and drug addiction, HIV/AIDS and criminal justice. Thank you for this opportunity to testify on these most important issues.

One of the Legal Action Center’s areas of expertise is in the laws and regulations governing the confidentiality of alcohol and drug patient records. We first published a book on this topic in 1988, and the current and 6th edition of the book is entitled Confidentiality and Communication: A Guide to the Federal Drug and Alcohol Confidentiality Law and HIPAA. Over the past two decades LAC staff attorneys have conducted training seminars on confidentiality of alcohol and drug patient records for alcohol and drug programs, law enforcement and child welfare agencies, and many others in all 50 States, the District of Columbia, and most of the territories.

We strongly concur with the viewpoint expressed by others in the alcohol and drug field that when it comes to e-prescribing, as with other aspects of care, treatment of people for alcohol and drug misuse and addiction raises a host of specific and sometimes difficult issues that warrant special attention. This is particularly true when it comes to the confidentiality issues to which I will devote my testimony today.

While records pertaining to alcohol and drug treatment are covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as are all other types of medical records, they are also covered by a much earlier and sometimes stricter law and implementing regulations devoted exclusively to protecting the confidentiality of those types of records. That law and regulations, codified at 42 U.S.C. section 290dd-2 and 42 C.F.R. Part 2, was first passed in the early 1970’s in order to afford sufficient privacy protections so that persons in need of alcohol and drug treatment would feel comfortable enough to come forward for care without fear of being arrested or losing their jobs or other necessities of life. Sadly that stigma and risk of discrimination continues to compel the need for the strong privacy protections embodied in the federal requirements, as does the desire of patients to be confident that highly personal information of this type will not be freely available to the public.

While we support the development of new technologies, such as e-prescribing, which have the potential to improve the delivery of medical care, we strongly caution that great forethought must be given to the confidentiality implications – and how best to address them – before this new technology is put into place. In doing so we urge the Department of Health and Human Services to take into account the special confidentiality requirements set forth in federal law and ensure that any system established to implement e-prescribing complies with those requirements.

Specifically, while HIPAA allows most if not all of the disclosures necessary to implement e-prescribing to be made without written consent of the patient since the disclosures are for the purposes of providing medical treatments and payment, the federal confidentiality law and regulations governing confidentiality of alcohol and drug treatment records require written patient consent before these disclosures can be made. Before a treating professional who is covered under the federal alcohol and drug confidentiality rules can make a disclosure to a pharmacy – by e-mail or otherwise – the patient must sign a consent form, utilizing the specific and detailed consent form required by 42 C.F.R. Part 2, section 2.31. After a patient has signed such a consent, the treating professional can then make the disclosure but must also transmit the notice prohibiting redisclosure required by section 2.32 of the regulations. Any redisclosures made by the pharmacy or others who receive confidential information pursuant to this consent form, such as to a payer, must also be authorized by a signed consent form. (Initial disclosures and subsequent redisclosures can be authorized by the same consent form as long as all the required elements authorizing each disclosure are contained in the signed form.)

These rules apply not just to disclosures relating to the transmission of an e-prescription, but also to any other disclosures that may be necessary, such as discussion of medical history or other factors pertinent to the prescription.

Given the importance of these requirements, and the fact that they apply only to treating professionals providing alcohol and drug care who are covered by the federal law and regulations concerning alcohol and drug patient records, policies and practices involving e-prescribing must pay them special attention. We recommend that this include the development of model implementation policies and forms, including model consent forms that authorize the necessary disclosures. The software and other technology for e-prescribing must provide for the consent forms, notices prohibiting disclosure, and redisclosure limitations in the absence of written consent required by the federal confidentiality rules.

These steps are critically important and must be taken to ensure that e-prescribing is done in ways that honor and comply with confidentiality requirements. At the same time, while it will take time and concerted effort to ensure that occurs, it is not impossible. Confidentiality is a very valuable right and must be protected, but it need not be an insurmountable barrier to providing e-prescribing and other new technologies which will improve the care of patients receiving alcohol and drug treatment.

We would be happy to provide any assistance to the Subcommittee as you move forward in your deliberations on this most important topic. Thank you again for the opportunity to testify.