Testimony for the 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 Suzanne Gelber, Ph.D.  I am the Managing Partner of The Avisa Group, a boutique research and consulting firm with offices in Berkeley, CA and Atlanta, GA. We specialize in evaluation, planning and policy analysis in substance abuse, mental health and chronic disease management...  The Avisa Group works extensively with key stakeholders involved in policy and service delivery in substance abuse and mental health.  Our clients include states, Federal agencies, counties, public and private payers, professional associations, foundations, consumer organizations, large private sector employers, specialty pharmaceutical firms, and even investment banks.  We and our clients are vitally interested in improving the accessibility, quality, policies and services paid for with public and private dollars and delivered by providers and provider systems to individuals with substance abuse, mental illnesses and other stigmatized chronic illnesses.

 Over the last decade, Avisa has been closely involved in issues such as improving the quality and accountability of public and private managed care initiatives, accreditation and technology initiatives for mental health and substance abuse, and especially in evidence-based quality improvement innovations such as medication-assisted treatment in substance abuse and mental health. This last interest has led to extensive work over the last 3 years on a major ongoing change in the field of substance abuse treatment:  the policy, organizational and financing issues related to the integration of medical, technological and pharmaceutical approaches such as buprenorphine treatment into substance abuse treatment and into the fabric of the therapies and supportive services that enhance recovery for individuals who are addicted and/or mentally ill. Because of our clients and our own interests, we have become quite familiar with e-prescribing and even in e-pharmacy and e-therapy, focusing on the opportunities and challenges they present in the quickly evolving fields of alcohol, substance abuse and mental health treatment.  

As others have said or will say, the opportunities and challenges of e-prescribing in substance abuse treatment are both unique and complex because of the stigma unfortunately associated with this chronic illness and the special need for confidentiality, privacy and security that the effects of that stigma create.  As do others in this field, we contend that substance abuse treatment concerns regarding e-prescribing truly require special attention and possibly a special hearing from this subcommittee due to the unique privacy and confidentiality concerns and related criminal justice issues for those treated in drug court or similar programs.  My major point is that the alcohol and substance abuse treatment and screening fields have many unusual legal, consumer, infrastructure, business process and technological issues that make e-prescribing a special case for you to consider.

 This subcommittee may not have had a chance yet to discover that the field of alcohol and substance abuse treatment is undergoing a quiet revolution. But it is.  This revolution involves increasing research on and adoption of evidence-based treatments and client supports, which include but are certainly not limited to the clinically appropriate use of medication-assisted treatments that require prescriptions and/or medical supervision of medications for chronic alcohol and substance treatment and detoxification. The medications being used today to treat substance dependence are effective and evidence-based, although not perfect. Some are available by prescription; others are available only in Federally regulated drug treatment clinics or via approved clinical research programs.  Many of these medications were developed by NIDA’s Division of Treatment Research, often in conjunction with private pharmaceutical firms and research institutes. The fruit of that public-private investment is the emergence of medication-assisted treatment, for which SAMHSA is the public sector lead, along with its other Federal partners.  For example, field training and careful dissemination of buprenorphine, are being launched by SAMHSA, cooperating with the DEA, the FDA, numerous medical, osteopathic and other clinical professional societies and private manufacturers.  Because of this trend, e-prescribing is going to affect physicians and other practitioners, clients, policymakers, researchers, payers and many other substance abuse stakeholders.  But, needless to say, the advent of e-prescribing was not foreseen during the last ten years in which many of the medications were developed. 

A brief list of medications offered by treatment programs (and in certain cases in physicians’ offices) currently approved by the FDA for use in treating chronic alcohol and substance abuse includes acamprosate, naltrexone, methadone, buprenorphine, LAAM, naloxone, and antabuse. These and other medications are being used in treatment along with verbal therapies and supportive services. Some are used in detoxification as well.  Ongoing public sector and private clinical trials, both for alcohol and other substance dependence and for withdrawal medications are at various stages of completion, including trials for medications that, along with therapy and supports, may effectively address prescription drug, cocaine, club drug and methamphetamine/stimulant dependence.

  It is also very important to note that some of the medications mentioned just now, including methadone and buprenorphine, are themselves controlled substances, subject to special DEA requirements and audits that may conflict with HIPAA/CHI and other information standards you may recommend and with the technologies proposed. For example, certain controlled substances (Schedules I and II - chiefly methadone) cannot currently be made available via electronically transmitted prescriptions, although the DEA is working on a new policy and electronic standard for controlled, it is not clear when it will be completed or that it will be the same as the standards you are considering because of the parallel development processes. Currently, the client in a pilot program for prescribing methadone must have an original, signed paper prescription, even if a prescription is also recorded electronically.    

Substance abuse treatment is moving rapidly in the direction of all types of evidence-based therapies, including controlled substance and other medications, just at the time that CMS and other major payers and technology developers are focusing on the emergence of e-prescribing but substance abuse has a unique set of stakeholders compared to other chronic disease.  The emergence of e-prescribing and your focus on it as a major health policy issue is critically important for the field of substance abuse treatment; as more and more  treatment medications emerge, e-prescribing will become even more important. E-prescribing carries with it not only the possibility of quality improvement but for substance abuse in particular also serious challenges to maintaining the mandated confidentiality, security and privacy protections necessitated by the intense stigma and criminal justice status surrounding substance abuse. My Legal Action Center Colleagues and the consumers who are also testifying here can best address these issues.

In addition to these key legal and personal privacy, security and confidentiality concerns, there are a number of related significant and unique business process and practical challenges possibly posed by the advent of e-prescribing that may affect key substance abuse stakeholders, including  physician and other treatment providers, payers and policymakers.  The NCVHS letter to Secretary Thompson does not, and of course could not, address these special issues. I would like to address some of these issues, raised by key stakeholders in the field, very briefly, in order to give you a further sense of some of the practical hurdles e-prescribing could represent in the substance abuse treatment field.

Business Process and Practical Challenges Posed by E-Prescribing in Substance Abuse Treatment

These challenges include the following:

1. Physicians in office-based or clinic-based substance abuse treatment programs who write prescriptions and perform medical supervision often suffer from the lack of fiscal and clinical infrastructure that is typical of substance abuse treatment entities, but less common in other medical/clinical services.  E-prescribing often involves the use of  costly mobile or medical record-linked PDA’s with built-in programs that advise the physician on drug-drug, drug-allergy, formulary, benefit, clinical history, dosage levels and other key  information useful in quality client assessment and prescribing. Unfortunately, these systems and tools are not just expensive for substance abuse treatment prescribers.  They are not available in many of these physicians’ offices, especially in examination rooms, and especially in the many minimally funded public sector practices and programs that still dominate the substance abuse field.  In fact, in many underserved areas of this country and in many public clinics, the computers are tabletop models that are out-of-date and sometimes there are no computers, much less up-to-date PDA’s loaded with e-prescribing software to help avoid medical errors.
2. Nurses or other physician practice personnel will also need to be able to communicate physician-approved prescription and refill information to pharmacies with appropriate privacy protections around the substance abuse diagnosis.  Today this is done telephonically; many physicians feel it would be difficult to maintain privacy, security and confidentiality of electronic transmissions of such prescription transactions, not to mention the  currently prohibited without consent but likely redisclosure of such information electronically to PBM’s, health insurers, utilization management firms, health plans and other players who weigh in on the administration of prescriptions.  E-prescribing and transmission may be prohibited activities currently for some substances.  Forcing physicians to move to e-prescribing could require doctors and their staff assistants to substantially change office work flows, to obtain legal and technological assistance and consulting, and to move to costly medical records systems that this relatively low-paid, low margin field makes unaffordable.  If unsubsidized costs rise substantially, patient access to treatment – a key public policy and criminal justice goal – could be impeded, just when new medications and evidence-based care are becoming available and when national policy is centered on prevention and increasing access to evidence-based treatment. .
3. The White House Office of National Drug Control Policy (ONDCP) has recently launched a campaign against prescription drug abuse.  Some of the new substance abuse medications, such as prescription buprenorphine, can be used to treat prescription opiate dependence, such as increasing abuse of the prescription painkiller Oxycontin®.   There is some concern amongst physician groups that e-prescribing of controlled substances such as buprenorphine needs to be carefully monitored by the physicians, the Federal agencies and law enforcement and also needs to be secure from patient and even rare unscrupulous provider security breaches, hacking and/or fraud that could enable further abuse of these medications or misuse of private, protected information. 
4. Some states have new or newly augmented prescription and controlled substance monitoring programs, encouraged by ONDCP and/or their own concerns regarding provider and patient abuses and rising Medicaid prescription drug costs.  They are trying to check for excessive writing of controlled substance prescriptions and other inappropriate prescribing patterns.  The states may not be able to adapt their earlier era monitoring systems to physician e-prescribing without substantial investment state financial circumstances often do not permit. 
5.  Many court-referred substance abuse clients being treated with medications to help them recover from alcohol and substance dependence. In many cases, drug court and other judges, probation or parole officers involved with diverted, incarcerated or paroled substance abusers who have outpatient, ambulatory prescriptions as part of their treatment must know if a client is regularly participating in treatment and is compliant with medication and other treatment plans. If such criminal justice clients are treated on an ambulatory basis, as many now are, e-prescribing, if approved under privacy, security and confidentiality regulations at all, would need to be disclosed regularly and over time to such professionals, who are legally responsible for their clients’ adherence to a treatment regimen, in lieu of incarceration or as a condition of post-incarceration release.  Yet, such disclosure would require documented client consent to these transactions and assumes that this type of communication would somehow be built into the e-prescribing system – a technological and fiscal challenge. E-prescribing systems and standards are certainly not being built with this very special potential requirement and the court-involved population in mind at this time.
6. E-prescribing of substance abuse treatment medications (which may also include medications prescribed by the treating physicians to address  the frequent co-occurring mental health and physical conditions that accompany much alcohol and substance dependence)  may require repeated (and currently forbidden without patient consent) redisclosure of  protected client information at several points in the prescribing process:

   Index event requiring exam
   Examination/Assessment
   Prescribing or Represcribing
   Eligibility
   Fulfillment
   Administration
   Renewals, refills or changes in prescription

7. Entities involved at these various stages will become aware of the substance abuse treatment plans and the confidentiality protected diagnoses of the patient unless e-prescribing is privacy-protected according the laws specific to substance abuse, which are not the same as HIPAA or CHI.  These entities may include law enforcement institutions, corrections, courts, other physician practices, PBM’s, health plans, insurers and public payers, pharmacies and pharmacists, disease management and utilization management companies, benefits administrators, and  even health plan sponsors.  Clients would have to sign release of information forms that permit such disclosures and these entities may have to receive the e-prescribing information – hardly communications that such software has thus far anticipated, as noted for criminal justice clients. 
8. Illegally or legally patients may be able to purchase substance abuse medications from legal or illegal domestic or international Internet pharmacies.  Physicians, including those who write substance abuse medication prescriptions, are already subject to AMA and other professional society recommendations, to state-specific licensure requirements and to FSMB requirements regarding e-prescribing.  The gist of these recommendations is to forbid prescribing unless it is preceded by an in-person medical examination.  This is especially true for physicians who are prescribing controlled substances for pain or for substance dependence, in which case an initial medical exam needs to be followed by frequent reassessment for relapse.  Allowing a substance abuse patient to forego a medical exam and to simply fill in a questionnaire on line before receiving an e-prescription from an Internet pharmacy is considered at best an unethical, if not illegal practice, even more so because that patient is being treated for substance dependence.

These are just a sample of the business process and privacy, security, confidentiality and clinical/practical challenges e-prescribing presents in the field of substance abuse.  As much as e-prescribing can be a positive step forward in avoidance of medical errors that can cost money and lives, it is a step that bears very careful and specialized consideration and probably will occasion specific legal, technological and clinical investments, policies and arrangements if it is to be utilized in the field of alcohol and substance abuse treatment to promote the safety and efficacy of treatment and the recovery of substance-dependent persons.   

Thank you for this opportunity to raise some of these challenging and unique issues.