The Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics was convened on Monday and Tuesday, February 3 and 4, in the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Robert M. Gellman, J.D., Chair
Richard Harding, M.D.
M.
Elizabeth Ward
Don E. Detmer, M.D., NCVHS Chair
Simon Cohn, M.D.
Marjorie Greenberg, Acting Executive Secretary, National Center for
Health Statistics (NCHS)
Lynnette Araki, NCHS
Harvey Schwartz,
Ph.D., Agency for Health Care Policy and Research liaison
James
Scanlon, HHS Executive Staff Director
Jackie Adler, NCHS
Deanna Mool, IL Department of Public Health
Kelly Vogel, Pharmaceutical Care Management Assn.
Bill
Blumenthal, The Duberstein Group
Carrie Moser, ACLU
Don Haines,
ACLU
Robert Beck, MultiState Associates
Lyndalee Korn, TRW SIG
Kristin Steward, AAHP
Michael Romansky, McDermott, Will &
Emery
David Larsen, IHC Health Plan
Kristin Bass, American Assn.
of Health Plans
Reid Cushman, Yale University
David Chung, NCQA
Gary Friend, IMS America
Sheri Alpert, IRS Privacy Advocate
Elizabeth Hadley, National Assn. of Insurance Commissioners
Cynthia
Haney, AMA
Samantha Silva, Healthcare Leadership Council
Pat
O'Connor, American College of Occupational and Environmental Med.
Ellen
McCleskey, BNA
Richard Grier, M. Valentine
William Applegate,
American Society of Clinical Pathology
Henry Heffernan, EDPNS
Laura
Fogt, NACDS
Rita Russell, Revco D.S. Inc.
Robert Thompson, Revco
D.S. Inc.
Reid Cushman, Yale University
Christie Lyman,
Georgetown Legislation Clinic
Kelly Vogel, Pharmaceutical Case
Management Assn.
Marion Torchia, PhRMA
Mark Lador, The Pine
Sheet
Sara Froelich, Glaxo Wellcome
David Chung, NCQA
P.J.
Keating, Lisboa
S.P. Tomlinson, BIO
Gary Friend, IMS America
D.T. Boswell, Hogan & Hartson
David Foster, Genzyme
Roy
Bussewitz, NACDS
J. Peter Melrose, Consultant
Kathleen Fyffe,
HIAA
Nellie Bristol, Health News Daily
Janis Steward, ACLU
Lynnette
Araki
Mark Uncapher, Subcommittee on Government Management
William
Blandin, Georgetown University Law Center
Alexandria Calcaguo,
Massachusetts Medical Society
Geoffrey Funk, SSA Office of Disability
Madeleine Golde, National Assn. of Social Workers
Elizabeth
DuMez, National Assn. of Social Workers
Danna Chung, DHHS
Hossein
Faris, DHHS
John McManus, Eli Lilly
Donna Slighft, HIMA
Chris
Moriarty, NCHS
Larri Short, American Assn. of Occupational Health
Nurses
Megan Sexauer, NHGRI
Gwen Campbell, Congressional
Consultants
Robert Burleigh, Brandywine Healthcare Services
Diedra
Abbott, College of American Pathologists
David Miller, Glaxo Wellcome
David Gencarelli, law office
Gary Persinger, Pharmaceutical
Research & Mfrs. of America
On February 3 and 4, the Subcommittee on Privacy and Confidentiality held the second of three two-day hearings to hear testimony from and discuss issues with the members of five panels.
The panelists were Richard Kowalski, General Motors; Kathleen Fyffe, Health Insurance Association of America; and David Larson, Intermountain Health Care and American Association of Health Plans.
Mr. Kowalski stressed the need to protect occupational health workers from pressure by employers to reveal confidential information about patients/employees. The other members of this panel urged that privacy/confidentiality provisions not impede the move toward administrative simplification. They also noted the importance of accommodating the needs of integrated systems.
One theme of the discussion with Subcommittee members was the tension between companies and their health departments, and by extension between health care providers and employers, around access to information. The group also discussed what amount of information it is appropriate to ask for in connection with a claim, with agreement that it should be the minimum, as determined by both parties (the requestor and provider of the information).
The theme of education arose both in the context of informed consent -- educating patients about what they are consenting to -- and the notion of health information trusteeship -- educating companies about the principle of protecting patient confidentiality. It was noted that the latter may be an especially difficult concept for self-insuring employers. The panelists made clear that it is meaningless for patients to impose special restrictions on consent forms, because the forms do not travel with the medical records.
Profiling emerged as one of the uses of medical records for which insurers and plans feel they need access to the records. Mr. Larson asserted that additional patient consent requirements would undercut quality control efforts.
Employee Assistance Programs (EAPs) were identified as a difficult area for regulation, partly because those who work in this area are not recognized as a profession.
The panelists were Robert Burleigh, International Billing Association; Jeanne Schulte Scott, Association for Electronic Health Care Transactions; and Tom Gilligan, Executive Director, AFEHCT.
Mr. Burleigh stressed the tension between privacy and confidentiality protections and administrative simplification.
Ms. Scott pointed out that consideration of this issue should not be allowed to become adversarial. AFEHCT promotes the idea of protecting confidentiality and privacy through tight security and strong penalties for violations, rather than by impeding information flow and reducing the benefits of EDI. Mr. Gilligan described the complex communications web, or "connectivity," involved in electronic claims processing. He and others explained that this web makes it infeasible to require patient consents for every link in the communications chain.
Attention focused on value-added services, which not only process claims but analyze the data for payers. Legislation is needed to prevent potential abuses in this area, such as the sale of lists of patients with a given condition to a pharmaceutical company. In this and other contexts, the differences among billers, clearinghouses and value added services became more clear to the Subcommittee.
The panelists said they liked the Condit bill's approach to patient consent, which assumes disclosures for payment and treatment and only involves patients in consent issues when there is a special issue.
A general conclusion from the discussions was that this is a very dynamic industry, and privacy/confidentiality legislation must be flexible enough not to impede its development. It was agreed that claims processing needs to be defined as a separate activity.
All of the panelists favored standardization in general, and uniform privacy/confidentiality laws in particular.
The panelists were Robert Thompson, R.Ph,, Revco Drug Stores and National Association of Chain Drug Stores; Richard Kent, M.D., Pharmaceutical Research and Manufacturers of America and Glaxo-Wellcome; and Alan Goldhammer, Ph.D., Biotechnology Industry Organizations.
Dr. Thompson described the contemporary pharmacist's use of electronic information to take part in a therapeutic partnership with physicians and patients about patient care. He argued for strong national confidentiality laws that supersede state laws. Dr. Kent discussed the role of pharmaceutical research in advancing medical care, and argued for the need for access to patient records for this purpose. He and Dr. Goldhammer stressed that genetic information should not be treated differently from other forms of medical information. Dr. Kent explained that the existing protections on information used in clinical trials are adequate, and he described some of his profession's objections to proposed new provisions. Dr. Goldhammer stressed the important distinctions between identifiable and non-identifiable data, and he made a strong case for federal preemption.
In regard to genetic testing, the group agreed that discrimination is a troubling byproduct that deserves attention but that is not within the scope of the current legislation.
There was lengthy discussion of panelists' concern about allowing patients to request information in the midst of clinical trials, with Mr. Gellman expressing some doubt that this is as great a threat to research as was suggested. Registries were another major focus of discussion.
Subcommittee members were interested in the reported activities of some plans and pharmacies that mail information to patients about specific drugs. Those in control of the patient records control these mailings. (Mr. Larson had described a similar practice by his plan, done to help finance some of its profiling.) The group discussed patients' sometimes inadvertent entry into promotional databases, either through their pharmacies or by responding to surveys or other outreach. Questions were raised about the possibility of a pharmacy's being purchased by a company with no appreciation for the principle of patient confidentiality -- e.g. a hypothetical "Junk Mail, Inc."
The group then discussed what might be realistic regulations for disclosure to next of kin.
All panelists expressed support for national uniformity in privacy and confidentiality laws.
As he did with some other panels, Mr. Gellman urged this group to participate in the country's policy discussions about privacy and confidentiality legislation, and to make an effort to educate the nation about the social value of their activities.
The panelists were Stephen Joseph, M.D., M.P.H., Department of Defense, and Charles De Coste, Department of Veterans Affairs.
Dr. Joseph stressed that some aspects of the disclosure authorities included in the Privacy Act need to be preserved, to allow the DOD to use medical records for purposes critical to national defense and mission effectiveness. Stronger protection is needed than that afforded by the Privacy Act in respect to the rights of dependents and in respect to its DNA specimen repositories.
Much of Mr. Gellman's questioning of the panelists concerned their experience with the Privacy Act, about which they had uniformly positive things to say. This applied, among other things, to their experience with the patient right to correct records and with provisions for clinical research similar to those proposed under Senate bill 1360. Mr. Gellman and Dr. Joseph explored the similarities and differences between a military physician and one employed by a company, with the former more constrained by the chain of command. It was agreed that the new legislation and the debate leading up to it should recognize evidentiary privilege as a substantive issue.
Mr. Gellman observed that new privacy legislation will operate alongside the existing Privacy Act, raising questions about how to avoid conflicting and overlapping requirements. He suggested that the federal agencies take a close look at this question and convey their thoughts to the people on the Hill drafting the legislation.
The panelists were Elizabeth Du Mez, National Association of Social Workers, and Jeffrey Funk, Social Security Administration.
Ms. Du Mez stressed the wide variety of conditions in which social workers practice, and the fact that many, but not all, of them should be considered health care providers. She and NASW were encouraged by Mr. Gellman to clarify the conditions under which social workers are health care providers, and to determine whether it is in those social workers' interest to be covered under national privacy and confidentiality legislation. She noted the ways in which the need to give access to clients' records militates against keeping comprehensive records, and she pointed out that social workers and other professionals keep separate progress notes for their own use. She also recommended an integrated privacy and confidentiality law that would apply to the education, health and social service sectors.
The Social Security Administration uses medical records only to determine eligibility for disability benefits, and it does this with patient consent.
In addition to the topics noted above, much of the discussion with Ms. Du Mez centered on disclosures. The issues were diverse, but not qualitatively different from those faced by other health care providers.
In this meeting, the Subcommittee neither took any actions nor identified any future actions in this meeting. Several panelists were asked or offered to provide follow-up information to the Subcommittee; these promised actions are indicated in the minutes.
Mr. Gellman called the meeting to order, saying that it is the second of three two-day hearings designed to help the Subcommittee advise the Secretary on her August recommendations to Congress on health privacy. In these hearings, the Subcommittee is emphasizing in-depth discussion with panelists.
Richard Kowalski, General Motors (GM)
Mr. Kowalski is an occupational health nurse and General Supervisor of GM's medical departments. He began by noting that employers have legitimate needs for health information about their employees, to protect their health and safety. However, identifiable information must be protected in terms of the access to it and its uses. In his view, none of the bills proposed thus far adequately protects employees' privacy rights because they fail to limit employer disclosure of personally identifiable health information. State laws are either deficient or non-existent in this regard. He described GM's stringent policy on confidentiality, which requires health professionals not to disclose to the employer patients' diagnoses or other personal health information. The policy protects employees' privacy while maintaining a productive work force and limiting the company's exposure to discrimination claims. He encouraged the Subcommittee to include in its recommendations specific provisions to protect health information obtained at the work site.
Kathleen Fyffe, Health Insurance Association of America (HIAA)
Typical company policies on confidentiality for those controlling health information for payment purposes involve the signing of confidentiality statements by employees. They expressly forbid them from disclosing confidential data, and include stiff consequences such as firing in the case of violation.
HIAA asks the Subcommittee to consider these points:
· to make its recommendations consistent with the goals of administrative simplification
· to avoid placing onerous administrative burdens on providers and payers
· to make privacy recommendations flexible
· to have procedures for correcting or amending protected health information go through the physician or other provider
· to have federal law supersede state law in this area
· to allow for coordinated patient care services in network-based health care plans
David Larson, Intermountain Health Care (IHC) and American Association of Health Plans (AAHP)
Testifying on behalf of AAHP, Mr. Larson stressed that the Subcommittee's recommendations should recognize the needs of integrated delivery systems. Many of these systems' activities require the use of individually identifiable information or the linkage of non- identifiable information back to the patient, to develop more effective treatment protocols or identify health risks. He described the care process models being developed by IHC, which must share information among corporate entities, physicians, hospitals and health plans to manage and improve the health of the people it insures. The company has invested efforts in ensuring security and confidentiality of the information.
Mr. Gellman pointed out that panelists were not expected to make binding statements on behalf of their organizations during this discussion. He first discussed with Mr. Larson the putative benefits of uniform protection of health records through federal law.
Mr. Kowalski said many members of the American Association of Occupational Health Nurses and of the American College of Occupational Physicians are the only medical person in their place of employment. Many complain of being intimidated and threatened with losing their jobs if they don't release health information on employees to personnel people. Clear federal mandates in this area would help.
Ms. Fyffe said her organization prefers federal legislation over regulation.
Mr. Gellman raised the question of the quantity of information requested and the problem with determining what amount is appropriate for a given request. Ms. Fyffe said it is often easier for the information specialists to send entire records, rather than specific pieces of information. She added that many requests for information are for the purpose of managing the cost of care. Mr. Larson said ICC imposes a charge for the entire chart, creating a disincentive for asking for it. Mr. Kowalski said his experience is that everything is asked for, which becomes a burden. The panelists agreed on the merits of requiring that all disclosures be limited to the minimum amount of information necessary. They agreed that this still requires a judgment call, which should be shared by the requestor and the person in charge of the record. Some panelists liked the idea of having requests indicate the purpose to which the information will be put, although Mr. Larson said that would be onerous.
Dr. Harding asked for more comments on the tension between companies and their health departments, and Mr. Kowalski said that although employers should trust the professional judgment of their medical staff, they often want information to verify why an employee is off work. Nurses have sometimes been fired for refusing to give information about a diagnosis, and this is "the number one issue for occupational health nurses." Dr. Harding noted the parallel with an MCO's being asked for specific information on an employee by an employer paying for its services. Mr. Fanning noted that MCOs are being criticized for requiring too much information on their enrollees from physicians; psychiatric care, infectious disease and OB/GYN issues were cited. Mr. Larson said ICC has instituted a special process for mental health records. In response to a request from Mr. Scanlon, he described how his company handles medical records. When it gets requests from employers for information on a specific patient, it states that they do not provide confidential information.
Dr. Harding raised the issue of correcting medical records, and Mr. Gellman explained that about half of the states have patient access laws. These laws do not allow patients to write in any changes they want, but provide a remedy by allowing patients to include a statement of disagreement. None of the bills requires that the information be removed from the record, even if the patient is correct.
The group then discussed informed consent for release of information. Mr. Larson said his company is working toward a single consent form for its entire integrated system, hoping that members will progressively understand it better if the same form is always used. Dr. Harding noted that the question is how to educate patients to understand what they are signing. Ms. Fyffe called attention to the two types of consents for the use of medical records: those for payment purposes, and those for treatment. In response to a question from Dr. Detmer, Mr. Larson said a law that limited the use of data to the purpose for which it was obtained would be too constraining. He agreed with Dr. Detmer that a number of uses could be specified at once in the consent form. It was noted that regardless of the amount of information specified, the underlying principle remains that of asking for the minimum amount of information necessary. The question remains who gets to define the purpose.
In response to a question, Mr. Larson described the health profiling uses to which ICC puts patient information -- for example, comparing clinical practice guidelines for asthma treatment against profiles of physicians' practices. Encrypted information is used for the patient profiles, and patients at risk are called to their doctors' attention. Mr. Gellman noted that this activity "fuzzes the line" between paying for and providing care, although in a positive way, and it makes the drafting of legislation more difficult.
Returning to patient consent for disclosure, he noted the widespread view that the consent is not really voluntary if care can be denied if it is not given. He asked if it were realistic to allow patients to impose constraints on the uses of their information when they sign forms, and was told that such restrictions would not be communicated, especially with the electronic transmission of information. Consent forms stay in the physician's office. Mr. Gellman said the Condit Bill proposes to do away with informed consent for disclosures for treatment and payment. A procedure is available if patients have problems. Statutory rules would govern how information can and cannot be used. The panelists said they liked this approach, provided patients are educated about the process and also provided that patients' rights are truly protected. Regarding the length of time that an authorization would be in effect, Ms. Fyffe said one year is standard. Mr. Larson said it would be difficult for his company to have enrollees re-sign annually. Mr. Gellman concluded from the panelists' comments that getting too specific about the requirements for authorization would present problems for companies.
In response to another question, Mr. Larson said if patients had to give their consent for his company's profiling activities, quality improvement activities would be seriously curtailed. He stressed that the key here is establishing confidence in the patient's mind that his/her interests are being taken care of in the uses of information. Asked how a company can establish that level of trust and knowledge, he described Harvard Community Health Plan's efforts in that area, which include producing a video. Mr. Larson and Ms. Fyffe described their organizations' employee training on confidentiality and privacy protection.
Ms. Ward raised the question of penalties, and Mr. Larson said having stronger ones is less important than enforcing current ones. He suggested increasing voluntary compliance through accreditation, such as with NCQA, which could do more on-site inspection to make sure confidentiality policies are being followed. A member hotline is also a possibility, to signal abuses. He said he does not favor more state oversight or regulation. Mr. Gellman said all the proposed legislation imposes serious criminal penalties for willful misuse of information.
The group discussed a variety of external uses of information. Ms. Fyffe commented on insurers' anti-fraud uses of claims information. The normal procedure is for suspect cases to be referred to a special investigative unit that would then have access to the information. Mr. Larson noted the uses of claims data to profile patterns of care. Asked about disclosure outside the company, he said researchers sometimes ask for access to the data. ICC has strict policies on this and is establishing an IRB-type process for the rare instances when it would give out identifiable information. Information given to public health authorities does not have patient identifiers, but can be linked back by ICC. Ms. Fyffe said that for public health disclosure, it makes more sense for the information to come from the originating source, the provider, rather than from the insurer. Other uses of information outside the organization are for accreditation bodies such as NCQA, and in response to subpoenas. Fraud investigators have no direct access to the computer systems of these organizations.
Mr. Scanlon then raised the issue of self-insuring employers. Mr. Larson said ICC has not had a problem with employers' insisting on access to the data, but the data do belong to them and if they insisted ICC would have to comply. He suggested that employer groups should have safeguards within their own organizations against such invasions. Mr. Gellman noted that comprehensive federal legislation would do that. Asked to comment on this question, Mr. Kowalski reiterated his comments about the pressure employers exert on health professionals in their employ. He advocated stiff criminal penalties to enforce protections.
Dr. Harding asked about redisclosure, and Mr. Larson described "partnerships" between his company and pharmaceutical companies in which ICC does mailings to its patients on pharmaceutical products and the pharmaceutical companies fund ICC projects such as the asthma project.
Returning to the issue of employer access to insurance records, Mr. Gellman raised the specter of insurance companies that are forced by employers to give up identifiable patient information. Ms. Fyffe agreed that this could be part of a contractual relationship.
Mr. Gellman noted that writing legislation is complicated by the overlaps and variety among players' roles. In response to a question, Ms. Fyffe speculated that many processes could be carried out using non-identifiable information. Mr. Gellman noted that the flow of identifiable information back to employers is an issue that has not been addressed in any of the bills. Ms. Fyffe raised the subject of employee assistance programs, where there is even less law and precedent. Mr. Gellman said one proposal would prohibit employers from processing health claims, and Ms. Fyffe said it was unusual for employees to process their own claims. Mr. Larson recommended requiring separate processes to differentiate claims processing from normal business operations.
Asked about GM's practices and policies, Mr. Kowalski said that in its EAP, all case files are confidential by company policy, as stipulated in union contracts since the 1970s. He noted that in smaller companies, in contrast, the same occupational nurse is responsible for safety, workman's comp and EAP, and "they are getting killed out there." Mr. Gellman observed that one problem that makes it harder to regulate EAPs is that their workers are not universally recognized as a licensed profession. He asked Mr. Kowalski how his program handles a situation where a patient has a condition that is a threat to others, and was told that they write restrictions saying they cannot do certain things (e.g., operate an overhead crane), but without revealing the diagnosis (e.g., epilepsy). AIDS does not present special problems because universal precautions are observed.
Mr. Fanning asked about situations in which outside organizations have identifiable patient information, and Mr. Larson said ICC only sends patient information to primary care physicians on contract. Claims are transmitted by paper or electronically. Ms. Fyffe noted that there is "a vast patchwork quilt of intermediary processors" between providers and payers.
Dr. Harding noted that Senate bill 1360 identifies an entity called a health information trustee, and employers would be such an entity. Mr. Kowalski said it will require a good deal of education to change company attitudes and culture, as they now believe that records belong to them. However, he noted that attitudes and practices have changed since the inception of OSHA reporting.
Mr. Gellman asked about the feasibility of creating subfiles of patient information with special restrictions, and Mr. Larson said this would create tremendous administrative problems. He favors treating all information with the same safeguards. Ms. Fyffe added that patients may not be qualified to decide what information should have restricted access.
Mention was made of the different practices and laws overseas, which can affect insurance companies with international operations. There are also challenges with organizations headquartered in other countries that send medical information here.
Mr. Gellman asked for comments on the patient identifier. Mr. Larson said ICC is creating a master member index of its own. Ms. Fyffe said most insurance companies use the Social Security number, and changing from those systems would be very expensive. In any case, she added the problem is not the number itself, but the security surrounding its use; there could be the same problems with another set of numbers.
Robert Burleigh, International Billing Association (IBA)
IBA strongly supports the goal of protecting confidentiality, but has several objections to the Bennett and Condit goals, which it believes defeat the goal of administrative streamlining. Billing companies' services and the way they conduct business vary widely, and there are many hybrid arrangements. Mr. Burleigh outlined some of IBA's objections to proposed legislation, notably IBS's contention that billing companies should not be considered health information trustees and that this function should rest with the originating provider. IBA is also concerned that proposed disclosure requirements could create lengthy delays in processing claims.
Mr. Gellman said that some of the concerns expressed are already reflected in the Condit bill.
Jeanne Schulte Scott, Association for Electronic Health Care Transactions (AFEHCT)
Ms. Scott works for CIS, a subsidiary of National Data Company. It is a member of AFEHCT, whose members are investing hundreds of billions of dollars to build the electronic highway. EDI is already bringing huge savings in health care, with much more to come. These organizations support the development of national, consistent and workable medical record privacy standards, thus giving the industry needed tools. The important thing is to balance the advantages offered by EDI with the costs to individual privacy.
Ms. Scott stressed that the developmental process must not be allowed to become adversarial, but rather the parties must work together for optimization, with the needs of society in mind. She noted that anyone who violates the law and violates privacy should be severely punished; this and optimum security and protection should be the emphasis rather than imposing barriers to the flow of information. The latter approach is based on the fallacy or myth that computerized systems are "some sort of big brother and the potential villain," when in reality the "horror stories" of privacy violation have arisen in a paper environment.
AFEHCT suggests the following measures: a clearly expressed national policy, uniform standards, limits on the uses of information, and appropriate punishments.
Tom Gilligan, Executive Director, AFEHCT
Mr. Gilligan focused on the flow of data within this industry, noting that "there is all sorts of connectivity there." For example, as many as three clearinghouses may be involved in a single transaction. The reason for calling attention to this is to show why the proposed disclosure provisions are unworkable. Having to get the proposed number of authorizations would send the health field back to a paper operation and a system "that takes days instead of seconds and dollars instead of pennies." He recommended that the legislation instead provide for authorization that applies to the entire communication chain between provider and payer.
In response to a question, both Mr. Burleigh and Ms. Scott said their organizations support confidentiality legislation in principle. Ms. Scott added that they want to know where it is headed, because billions of dollars are at stake. The panelists were asked to explain why patients cannot control the flow of their information through the payment system. Mr. Gilligan challenged the notion that the patient should have to know the entire chain within a transaction. He noted that such a consent form would have to be many pages long; moreover, the path of information is unpredictable because of the nature of telecommunications. Ms. Scott added that an insistence on a specific path would place impediments in the design of the system. The alternative of setting overall standards for the way people behave is preferable.
Mr. Burleigh added that complicating this process might have the outcome of a decision by providers not to accept insurance, and instead to operate on a cash basis as in the past.
Dr. Harding asked about the likelihood of having information side-tracked or broken into for malicious purposes in the electronic system, and Ms. Scott acknowledged that "a determined hacker can probably break into even the most secure system." However, the greater risk is from those with legitimate access to the data, using it for a purpose other than it was intended for. She cautioned against "trying to solve one problem by creating another."
To another question, she explained that "pure clearinghouse applications" involve simply reformatting and standardization; however, other services are increasingly being provided, generally in response to requests from managed care. The competition among information companies is in the area of these value-added services. One potential abuse is the selling to pharmaceutical companies of the names of people with a given disease; this is the type of abuse that federal legislation should protect against. Mr. Gilligan said he would provide the Subcommittee with a slide presentation outlining the kinds of services provided by billing agents, clearinghouses and value-added networks.
Asked about voluntary policies and controls within the industry, Ms. Scott referred to EHNAC, the Electronic Health Network Accreditation Commission, which has a section on security and privacy in its accreditation standards as well as a code of ethics. In addition, many standard trading partner agreements spell out relationships and constraints. Mr. Burleigh said there is no accreditation process for billing companies. IBA has begun developing training programs to accredit people who work for companies; it has a code of ethics and advocates a written contract between the customers of a billing service and the company, including a confidentiality statement that applies to all company employees. Asked about preventing or punishing abuses, he said there is no way to enforce guidelines within the organization, which is voluntary.
Dr. Schwartz asked about education programs within the industry, and Ms. Scott described such practices in her company. Its training program covers the fact that anyone misusing data will be immediately terminated. Mr. Burleigh said the billing industry does not currently have such training.
The panelists were asked to explain the AFEHCT view that its members should not be regarded as information trustees. They said they could assure protection of confidentiality, but could not deal with provisions to permit patients to correct information; such corrections should only be made at the request of the provider.
Mr. Burleigh noted that in contrast with other segments of the industry, billing organizations deal with the public daily in regard to incomplete information and other problems. In this context, it would be appropriate for a provider to limit the information a billing company reveals to a patient.
Mr. Gellman returned to the point that the overlaps and ambiguities among various entities' roles make it difficult to design legislation -- for example, identifying who is an independent information trustee and who is an agent of those trustees. He explained the Condit bill's distinction between an affiliated person (an agent) and a trustee, with the latter given responsibility for determining the responsibilities of the former. Ms. Scott said this is the kind of flexible, broad principle AFEHCT favors. Mr. Burleigh said he likes the concept, although there is concern that the affiliated person language could be read to extend obligations to that person directly rather than by delegation.
Mr. Gilligan commented that the affiliated person concept connotes a relationship between the provider/trustee and a contractor once removed, when in reality in his business there are relationships with several entities. Mr. Gellman characterized this as "affiliated persons having affiliated persons," and he acknowledged that it is a level of detail not apparent to the drafters of the bill. He also noted that billing people and processors cannot be put in a single category, nor lumped under "affiliated person." Mr. Burleigh said he describes the relationships as a triangle involving a doctor, a patient and an insurer. The biller is hired by the doctor to interact with the patient and the insurer. In contrast with clearinghouses, which can work with payers or providers or both, billing companies are only paid by providers.
Mr. Gellman asked the panelists to comment on the Condit Bill's idea of assuming disclosures for payment and treatment and only involving patients in consent issues when there is a special issue. Mr. Burleigh said this is a more practical approach, and Ms. Scott added that it is what is already happening in practice. Both panelists said their organizations hold that the provider is responsible for having the consent of the patients involved.
At Mr. Gellman's request, the panelists described their organizations' operations. Mr. Burleigh noted that billers use especially complex information systems. Mr. Gilligan added that practice management system companies analyze claims for physicians to help them improve management. They use identifiable, but not patient-specific, records for this. Ms. Scott said there are tailored search engines for these tasks, to compile aggregate data in areas of interest. This is a growth area for the industry. She pointed out that telemedicine, which sends personally identifiable information through a network, adds to the need for confidentiality protections.
In response to an inquiry, Mr. Gilligan said there are no entry requirements in the claims processing industry; anyone can set up shop. The size of these operations varies widely.
Mr. Burleigh said people going into the billing business have traditionally been practice employees. There has been extensive consolidation in that industry in the last five years, and the size of its companies also varies widely.
Following up on another question about how information travels "up and down the food chain," Mr. Burleigh described some of the difficulty the industry has had with attachments, with which it has wrestled for years. Mr. Gellman asked if it was possible to compile a "shadow medical record" from the information going back and forth among the players, and Mr. Gilligan said that would be virtually impossible in his sector, because the value-added networks store no data.
Mr. Burleigh said that in the billing sector, someone with the motivation could put together a patient's medical history. He added that another major source of vulnerability is coding, which billers are increasingly asked to do because of providers' fears about making a mistake and getting investigated. Doing this requires a copy of the original record, which is generally stored for long periods of time.
Mr. Gellman asked about uses of data provided back to the source by processors for purposes other than claims payment. Mr. Gilligan said this is unusual, although practice management organizations are capable of using data for profiling. Mr. Burleigh said the service industry does provide such data to managed care companies, for improving cost effectiveness. Another use of data is for fraud investigation.
Mr. Gellman observed that this industry is dynamic, and the legislation needs to anticipate this dynamism and allow enough flexibility. He asked for predictions about how the industry will develop. Mr. Burleigh stressed the fact that individual information is "sacred" and only belongs to the patient. Companies have a legal right to use aggregate information, but it must not be patient specific. Whatever happens must take this basic principle into consideration. Mr. Gilligan said his industry is shrinking in numbers through consolidation while growing exponentially in the services it offers. He added that it looks forward to the privacy bill. He agreed with Mr. Gellman that claims processing somehow needs to be defined as a separate activity.
Mr. Burleigh discussed his association's term "originating provider," indicating the author of the medical record. He noted that medical transcription companies are another player, and an industry that is going through consolidation. They often work at great distance from their clients, and maintain all the information they have transcribed on patients and can profile them in the aggregate. Some of these companies do coding as well. In response to a request from Mr. Burleigh, he said his organization would submit a proposed definition in the near future.
Dr. Harding asked about interstate transmissions; Mr. Gilligan said the industry will have problems with this if the bill does not contain a strong state preemption clause, because states are starting to develop their own privacy laws. Ms. Ward said the states are waiting to see if a federal law offers a national solution. Mr. Burleigh said the issues of his group's members have to do with different payer requirements rather than state privacy laws; however, he still favors a federal law over multiple state laws. The panelists said different state laws in respect to AIDS have not been a problem. As for other countries, Mr. Burleigh noted that companies will probably start moving their transcription business overseas.
Asked to comment on liability issues, Mr. Gilligan recommended paying attention to what constitutes a violation in regard to civil penalties, as small errors in computer processing could yield big fines. A cap also might be set on penalties, to avoid driving people out of business. Mr. Gellman agreed, noting that in the Condit bill, people are entitled to actual damages and only entitled to minimum statutory damages in the event of a knowing violation.
Responding to a question about reporting to public health officials, Mr. Burleigh said his industry would only do this under assignment by a provider. As for giving information to health researchers, Mr. Gilligan said this might happen in the future, if so instructed by the client, especially given a definition of research that includes what practice management systems do for doctors.
Mr. Burleigh observed that in contrast with the EDI industry, which keeps information in its pipeline only briefly, his sector's members retain information for a long time. Asked if members might detect patterns of abuse, he said this was highly unlikely given their way of processing data, unless they were given the authority or required to do so. Mr. Gilligan noted that state Medicaid programs do this routinely, as required by the MMIS system. Law enforcement agencies normally go to providers rather than to these organizations.
Ms. Ward asked if standardization would be beneficial in terms of privacy and security, and Mr. Burleigh said it is "everyone's dream" to have one data set. Mr. Gilligan said his industry "loves" the idea of standards, which should help in the manipulation of data and improve security. Mr. Burleigh added that the trend is currently "flowing backwards" because new managed care companies are slow to go to electronic claims.
Asked about self-policing and how his organization deals with "rogues," Mr. Burleigh said enforcement has been a matter of controversy in the organization. Mr. Gilligan said AFEHCT set up an accreditation program.
Finally, Mr. Gellman asked about health identifiers, and Mr. Gilligan noted that the convention is the Social Security number and it might be preferable not to have to change systems. On a national provider ID, the panelists said it would help, assuming certain technical issues are worked out.
Mr. Gellman thanked the panelists for their presentations, despite their having "made everything more complicated" for the Subcommittee.
There being no public witnesses, he recessed the meeting until the following day.
Robert Thompson, R.Ph, Revco Drug Stores and National Association of Chain Drug Stores (NACDS)
Dr. Thompson noted that having access to accurate and complete patient records is essential to delivering quality pharmaceutical care. Revco pharmacy systems' integration into the electronic prescription infrastructure is advantageous to both the patients and its business operations. Today's pharmacist spends time discussing patients' treatment with them, their caregivers, and the prescribing provider, and this role is dependent on electronic capability in a coordinated care system. The security of these records is a top priority for Revco, which never sells or gives away patient-specific identifiable information for commercial gain.
Patients' records are protected through secure technology and limited access, combined with strong penalties for abusers in the form of immediate termination. Dr. Thompson noted that the system is still vulnerable, however, and state laws are not strong or comprehensive enough. Thus, his company hopes for national legislation to ensure the confidentiality of identifiable patient information.
NACDS has developed principles that it believes will result in effective federal confidentiality legislation, as follows:
· minimal interference in the provision of care
· comprehensive scope so that state confidentiality laws are unnecessary
· strong criminal and civil fines and penalties
· sufficient time to implement new uniform standards, including employee training
Richard Kent, M.D., Pharmaceutical Research and Manufacturers of America (PhRMA), Glaxo-Wellcome
Dr. Kent began by noting the tension between patients' rights to the privacy of their information and to having answers to their unmet medical needs through research and new treatments. Thus, federal policy must accomplish the twin objectives of protecting the privacy of individual patients and protecting the continued viability of research. This can best be met through uniform national requirements for handling medical information, defined to include genetic information.
The requirements should include the continuation of existing FDA protections for clinical trial information, and any new legislation or regulations should preserve researchers' access to the full range of potentially useful epidemiological information. Encrypted data sources should be freely available to researchers. Dr. Kent described the strict controls regulating FDA-monitored clinical trials, and expressed concern that the proposed new legislation may impair the ability to conduct clinical trials. He enumerated some of the troubling restrictions being considered, such as a requirement to obtain a patient's informed consent for each use of his/her information.
Alan Goldhammer, Ph.D., Biotechnology Industry Organizations (BIO)
The companies in BIO do genetic research on the causes of disease and on new diagnostics and therapies. They support a strong federal role to protect individual information and to preserve the ability to continue medical and biotechnology research. Specifically, BIO encourages the inclusion of genetic information with other kinds of information in consideration of privacy issues, and it supports the preemption of state law. It also supports the creation of federal standards to protect the confidentiality of the result of genetic testing, and it urges that genetic privacy issue not be addressed in isolation because this would inappropriately stigmatize genetic information in the public's mind and risk failing to address larger issues of medical privacy.
It is recommended that legislation include the following principles: encouragement of medical research, use of informed consent, clear delineation between identifiable and non- identifiable samples and records, and a national scope. Dr. Goldhammer called attention to the crucial need for distinctions between identifiable and anonymous data, and recommended that the bill's provisions for informed consent only apply to personally identifiable samples. If there is an appropriate firewall between the data in the identifiers, the use of the data for research should not breach confidentiality. He also elaborated on the strong case for federal preemption, given the multistate nature of much research and the inconsistencies among state approaches.
Mr. Gellman elicited from the panelists their agreement that medical records need better legal protection at the federal level, and that a bill is preferable to regulation.
He asked Dr. Goldhammer if his arguments for not isolating genetic information extended to other classes of information such as on AIDS, mental health, and substance abuse. Dr. Goldhammer said his organization's views were confined to its own area of expertise. He explained that a problem with singling out genetic information is that it is often difficult to draw the line between it and medical information in general. Dr. Kent agreed, noting that genetic information is only singled out now because it is relatively new.
In response to a follow-up question, Dr. Goldhammer said his organization has been studying the issue of genetic discrimination. A key issue regarding the use of genetic samples is whether or not they are identifiable. He and Dr. Kent stressed that patient privacy can be protected through adequate firewalls and encryption of data, and these protections make possible clinical research in sensitive areas.
Mr. Gellman asked how a genetic sample could be non-identified, and Dr. Kent explained that genetic research typically analyzes a specific gene and has no reason to do genetic fingerprinting. Dr. Goldhammer added that tests are generally done for specific purposes, such as to see if a child has a particular genetic disease. He added that the National Bioethics Advisory Committee is exploring the issue of samples. The larger issue is to what use, if any, the samples should be put once the original purpose is fulfilled.
Dr. Harding observed that the population is concerned about how information can be protected so that genetic testing helps rather than harms the person being tested. Dr. Goldhammer agreed that this is the critical issue, and the reason why stronger privacy protections and informed consents are needed. Dr. Harding noted the specter of the denial of care once certain information is known. Dr. Kent observed that the issue of discrimination is an important one, but separate from confidentiality issues. His organization hopes to be able to continue its research while the appropriate laws and regulations protect people from abuses.
Turning to clinical trials, Mr. Gellman asked what problems might result from the application of formal federal privacy standards to clinical trials. As an example, Dr. Kent said that the ability of patients to get access to their clinical trial data in the middle of a trial could put the entire trial in jeopardy by unblinding the data and undermining randomization. He noted that privacy protections already exist through the FDA, the sponsor, the patient and the IRB. Imposing extra burdens to enforce privacy on the IRB would be problematic. Dr. Goldhammer agreed, and added that problems would be caused by giving patients the right to require the destruction of all samples following a trial.
Mr. Gellman noted that there is strong public support for patient access, and no legislative proposal makes an exception for clinical trials, nor does any European law. He asked whether the problems envisioned by the panelists are in fact "a real problem." Dr. Kent explained that patients already are told whether they were on an active drug or a placebo at the end of their trials; moreover, if they have adverse reactions to a drug during the trial they are pulled out of the trial. Giving them information before the study is complete would jeopardize the integrity of the study. In response to a follow-up question, he said he was not aware of an instance in his 14 years in this field in which a patient asked for access to data in the middle of a trial. To another question, he said his company does not avoid conducting trials in states with patient access laws. Mr. Gellman concluded discussion on this topic by explaining that he is trying to determine whether this is a serious enough problem to warrant special statutory provision. Dr. Kent said if the practices discussed became widespread, they could damage clinical research.
The next subject was registries, and Mr. Gellman asked a series of questions about their use by pharmaceutical manufacturers and researchers. Dr. Kent said his company maintains several of them -- for example, to follow use of a drug that causes birth defects. For that one, physicians send details about their patients' pregnancies, but without identifying them. If a patient moves to another doctor, the company loses track of them. Registries with identified patients are created with informed consent, typically for orphan diseases. Dr. Goldhammer said his industry uses a registry for gene therapy, and the Public Health Service is proposing one for xenotransplantation -- i.e., the receipt of cells, tissue or an organ from a foreign source. There, the critical issue is infectious diseases from "outside the human sphere." The genetic therapy registries are maintained with patient consent. The panelists agreed that registries should only be opened with informed consent.
Mr. Gellman asked about drug distribution activities for which manufacturers need to know the names of patients, and Dr. Kent said the industry is required to report adverse reactions on marketed products to the FDA, but this is done without personally identifiable information. Dr. Goldhammer said his industry has the same practice.
In response to a question about use of patient lists for marketing, Dr. Thompson said his company considers its patient information proprietary, and if a manufacturer wants to contact a group of patients it will send the information to the patients. Dr. Kent said it is common for a company to put out an advertisement inviting the public to request information on a given condition, and the responses then form a marketing database. Mr. Gellman noted that this is the voluntary disclosure of information, although patients often reveal information through opportunities such as this without anticipating the ramifications of doing so. While troubling, this area is beyond the scope of the privacy bills.
Mr. Gellman noted that all centralized, nationwide files of personal information he knows of have been abused because there are always scoundrels; he asked what kinds of protections exist in the panelists' computer files, how they limit access, and how they guard against abuses. Dr. Thompson said Revco's computer system is used only to process and dispense prescriptions and for no other activities. The company uses dedicated phone lines, and pharmacists have to log on and off the system, creating an audit trail.
Noting that all the bills propose audit trails for disclosures, Mr. Gellman expressed his doubts about whether they are feasible given the volume of transactions the system would have to support and store.
To a later question, Dr. Thompson said patients do not give consent to be in Revco's basic prescription database; this happens automatically when their prescriptions are filled. He said that mailings to remind patients to take their medication or information about new medications are financed by manufacturers, but are only done if Revco thinks the communication is of merit. When patients first become customers, they are asked if they want to receive mailings; he acknowledged that if they decline, they still may be contacted, but Revco is trying to improve its performance in this regard.
Responding to a question from Dr. Schwartz, Dr. Thompson said his company is estimating the cost of implementing new federal legislation. He offered to supply its findings to the Subcommittee.
Dr. Detmer asked about unique patient identifiers, and Dr. Thompson said most of his company's business is now paid by managed care and increasingly prescriptions are paid by third party payers. Therefore, they use the identifiers assigned by the plan or payer. Revco has built a system that accommodates this variety of numbers, but would prefer a uniform system of identifiers.
Mr. Gellman returned to the subject of manufacturers' use of patient information, noting that some manufacturers own pharmacies and it will be important to know how information flows in those cases. Another troubling scenario would be if a pharmacy or hospital were purchased by "Junk Mail, Inc." He asked Dr. Thompson to elaborate on the practice of sending reminders to patients, and he explained the practice of disease state management in which the pharmacist helps the physician manage the patient's proper use of pharmacotherapy. Both manufacturers and managed care companies have an interest in better patient compliance in this area. To another question, Dr. Thompson said his company would not share patient information with researchers.
Turning to the subject of disclosures, Mr. Gellman noted that all of the bills deal with issue of disclosure to next of kin. He asked about the practices and policies of the panelists' organizations. Dr. Thompson said state pharmacy practice laws generally set the standards, which are often developed in the context of ethical education in colleges of pharmacy. In general, Revco's policies rely on professional judgment on a case by case basis; there are no formal guidelines. The pharmacist assesses the motivation for gaining the information. Asked if the procedures required for disclosure in the proposed bills would present practical problems, he said they would present a lot of them. He expressed support for the flexibility provided in the Bennett bill and the Condit bill's limiting of next-of-kin disclosures to oral disclosure, as well as other provisions of the Condit bill, praising those provisions that are consistent with current practice. Mr. Gellman noted that if a privacy bill excessively limits the flow of information, it will not work and will become a laughingstock.
Ms. Ward asked if the issue of disclosure to next of kin is worthy of the attention it is being given in the bills, and Mr. Gellman replied that a comprehensive scheme regulating disclosure has to address the issue. He said the Subcommittee would revisit the matter when it talks with providers.
On a related issue, he asked about sharing research information with other researchers. Dr. Kent said his associates share identifiable information only with the IRB where the study is taking place and with the FDA. Any other information sharing would be done without identifying individuals. Dr. Goldhammer said the same applied to his field.
Dr. Kent said he knew of no reason why disclosures would be made to public health authorities. Asked about disclosures to employers, Dr. Thompson said Revco does not and would not give information directly to employers, but the latter might obtain such information from their benefits management organization or insurer. To a follow up question about these entities, he said the use of information in these context is a large, complex issue with managed care organizations. Typically, pharmacies supply benefits management organizations with a patient number, a drug number and a charge. Some pharmacy benefit managers can maintain lists of the medications a patient is taking. Regarding commercial services that collect information on prescriptions, Dr. Thompson said no identifiable information is shared with such bodies, which perform marketing functions.
Next, the group discussed the issue of uniformity, with Mr. Gellman asking how much of it is necessary. Dr. Goldhammer noted the tremendous inconsistency among state approaches, which make a federal approach necessary. Moreover, state laws are often not well thought out and sometimes contain contradictory sections. He agreed with Dr. Detmer that there is sufficient wisdom today to write and defend a national standard and model. Dr. Kent expressed strong agreement, saying that his industry wants a uniform way to do things. It was later noted that this kind of uniformity would result in cost savings.
Mr. Gellman asked about possible problems of meshing a federal confidentiality standard with state rules regulating pharmacies, and Dr. Thompson said he, too, favors uniform standards. He noted that the proposed legislation moves across the health care continuum, and should supersede state regulations without negating the right of state boards of pharmacy to regulate practicing pharmacists in their states. States should have to meet federal guidelines to protect patient confidentiality. To another question, he said a situation in which states are competing to have more stringent regulations --a possible outcome of allowing more protective state laws to stay in place -- should be avoided. He described some of the difficulties of having to deal with conflicting state laws.
Asked about requests from police and fraud investigators, Dr. Thompson said this happens routinely. For a standard police investigation, they require a court order or subpoena, but state board of pharmacy inspectors and DEA inspectors have privilege to inspect and investigate. Most of the requests for information come from the latter two sources.
Asked about patient access in order to correct records, Dr. Thompson said patients have a right to seek corrections of their Revco records. On another topic, he and Dr. Kent said they regarded civil liability and criminal penalties as appropriate remedies for abuses.
Mr. Gellman raised the subject of the international flow of information. Dr. Thompson said Revco operates only in the U.S.. Dr. Kent said that for clinical trials, patient information flows quite freely among nations, as many studies are multinational. Also, they are required to notify investigators if serious adverse events occur during the studies, and data are often compiled in London. In these instances, however, identifiable information is not used. Dr. Goldhammer said the same applied to his field: when most of the clinical research is done overseas, the data travel but the identifiers do not. To another question, Dr. Kent said they have not yet encountered problems with European privacy regulations. His company is currently studying a new EU directive on patient data privacy, and Mr. Gellman asked him to share any interesting conclusions.
Dr. Kent said that his industry's clinical studies are done irrespective of geography, based on where the best centers and specific patient populations are located. It would be disastrous to have to take geography into account, within or beyond the U.S., because it would affect the generalizability and quality of the data.
Bringing the discussion to a close, Mr. Gellman commented on the tendency of industries to know they are doing a good job and to fail to realize they have to make others aware of their importance. He urged the panelists and their industries to be aware of the need to connect their activities to social benefits and to "sell themselves to the population at large." Dr. Detmer noted the critical importance in research of sample sizes and cell sets to get valid and reliable data, and the need to help the public understand this. Mr. Gellman thanked the panelists for their participation.
Stephen Joseph, M.D., M.P.H., Department of Defense (DOD)
Dr. Joseph said DOD policy is to safeguard personal information, including medical records. DOD's medical records are exempted from public disclosure under the Freedom of Information Act. It stems from the Privacy Act, which allows disclosure for specific purposes related to official duties. DOD welcomes many of the changes contemplated under HIPAA, but stresses that some aspects of the disclosure authorities included in the Privacy Act need to be preserved, to allow the DOD to use medical records for purposes critical to national defense and mission effectiveness. He outlined some examples of circumstances in which line commanders must have critical medical information to make safe and protective decisions.
The Privacy Act's protections by themselves are insufficient in two areas, he said. The first has to do with physician-patient privilege in the military setting but applying to nonactive duty members. DOD maintains that the records of military psychotherapist sessions with a spouse or child of a military member should not be subject to disclosure under the same rules as those that apply to active duty members. The second area is the use of DNA-related information in the military. DOD has a specimen repository to help identify military fatalities, and it has imposed restrictions on disclosure that are much stricter than those allowed under the Privacy Act.
Charles De Coste, Department of Veterans Affairs (VA)
Mr. De Coste introduced General Counsel Jeff Corzatt and Privacy Act Officer Celia Winter. He began with an overview of the VA and its major components using health information. The present VA population, estimated at 26.2 million, is served by a multifaceted health care system. Like other presenters, he noted the need for balance between trust, frank communication and confidentiality, on the one hand, and efficient electronic exchange of information, on the other. He stressed the VA's commitment to maintaining patient rights, as well as its routine interaction with the VBA and the DOD in the provision of health services.
Mr. Gellman noted that both agencies operate under the Privacy Act, an implementation of the Code of Fair Information Practices, and that the legislation mandated under HIPAA for health records will be the same. He asked the panelists about their experience with patients' right of access to their records, and both said they were not aware of problems. Moreover, patient access has not been costly to implement. Mr. Gellman asked about patient access to their records in clinical trials, referring to the discussion with earlier panelists about this issue. Again, both panelists said they were not aware of problems. Mr. Gellman asked them to inform the Subcommittee if they become aware of any.
Regarding patients' right to seek correction of their records, Mr. De Coste said the VA handles this at the local level, and generally to the satisfaction of patients and physicians.
Mr. Gellman concluded from these comments that it may be possible to reassure the rest of the medical community that the proposed requirements of access and correction are not as difficult and costly as some may fear. He asked if the Privacy Act's requirement of a record of the date, nature and identity of each recipient of information for each external disclosure has been a problem. Dr. Joseph said it does not come to him as a problem; Mr. De Coste said there is an associated cost, but VA has an effective system for responding to these requests.
Mr. Gellman noted the parallel between the disclosure issues in a military context and those in occupational medicine. Dr. Joseph pointed out, however, that in the military the patient is bound to the command authority in a way that limits his/her privacy rights compared to those of the employee outside the military. He said there are circumstances, as in an ordinary employment situation, where limitations will be imposed without an explanation, to protect the individual. However, the military health care provider has a different relationship with the line commander than the occupational physician does to the company owner. A military physician might balance external demands with the need for confidentiality by releasing only partial information. Mr. Gellman observed that some legislative proposals do not address military use, probably because the military has not come forward to make its case. He urged the panelists to participate in this process more fully in the future, and to speak up for their needs and interests. Dr. Joseph responded that it would be useful if the debate leading up to the legislation, as well as the legislation, recognized evidentiary privilege as an issue of substance.
Mr. Gellman noted that the Condit bill says that the restrictions on use and disclosure of information do not apply to exchanges within the Department of Veterans' Affairs. Mr. Corzatt said what is needed, as well, is recognition of the unique nature of the federal government and its relationship with the congressional and other branches. He added that veterans' service organizations represent veterans in claims for benefits and use a long-lasting power of attorney to do so. This relationship also needs to be recognized.
On request, Mr. De Coste described the flow of records between the VA and DOD, and agreed that it is not generically different from the flow between any other medical facilities. Mr. Gellman noted the preference in the legislation to treat everyone the same way to the extent possible. Dr. Joseph noted that the difference is that everyone leaving the DOD system is automatically in the VA system. He explained that records are not automatically transferred; rather they go to a repository until the veteran presents for care in the VA system, at which time another consent would be signed authorizing them to obtain the military medical records.
Dr. Detmer praised Dr. Joseph's statement that the confidentiality rights of dependents in the military need to be "shored up." He asked if the panelists would support a recommendation of omnibus coverage to bring the federal side in line with the rest of the country. Dr. Joseph said he believed that would be helpful. Mr. De Coste said that if such a bill were to come to pass, he would hope for ample time for a transition to a new system.
Regarding access to information, Dr. Joseph suggested as the schematic that for active duty, disclosure is the rule and exceptions need to be made, while for non-active duty and dependents, non-disclosure should be the rule. The group discussed these principles further.
Dr. Detmer asked for comments on unique identifiers. Mr. De Coste said VA has historically used the Social Security number, and continues to analyze and evaluate it.
Asked about researcher access to VA records, Ms. Winter said that a lot of research, mostly clinical, is done using VA records. Research outside the federal sector must be approved by the medical center's R&D committee and must meet all Privacy Act provisions. She reviews all request from within the agency. Dr. Joseph said the DOD provides its records to internal or external researchers using the usual informed consent and human subjects protection criteria. He noted that the DOD's repositories of serum and DNA are of great interest to researchers, but it has taken the position that they are not available without individual informed consent. As a result of this policy, no research has been done on the DNA samples. He said he would let the Subcommittee know about research on the serum repository.
Mr. Gellman asked if there were special problems finding third party payers and getting them the right kind of information, and both panelists said the consent issues have not presented problems.
Mr. Gellman asked a series of questions about disease registries. Ms. Winter said the VA has cancer registries, and cooperates with the registries maintained by others. A complex procedure by the medical center chief of staff, his staff, the oncology staff, and the affiliated university medical school is used to determine the legitimacy of a registry. Dr. Detmer asked both panelists to share with the Subcommittee their procedures for determining the worth of a registry, and they said they would. Dr. Joseph suggested also talking to the Armed Forces Institute of Pathology.
Mr. Gellman observed that new privacy legislation will operate alongside the existing Privacy Act, raising questions about how to avoid conflicting and overlapping requirements. He suggested that federal agencies take a close look at this question, and he invited them to convey their thoughts to the people on the Hill drafting the legislation. He thanked the panelists for meeting with the Subcommittee, and Mr. Fanning encouraged them to contact him about the administration's position.
Elizabeth Du Mez, National Association of Social Workers (NASW)
Ms. Du Mez began with an overview of NASW, whose 155,000 members work in a broad array of systems and as private practitioners. In these capacities, they enjoy privileged communication with professionals that is protected by law from compelled disclosure. NASW has just implemented a new code of ethics, which broadly covers the subjects of privacy and confidentiality. She read seven relevant principles, which include soliciting private information only as essential, requiring informed and purposeful consent for disclosure, making exceptions to confidentiality to prevent harm to the client or others or to comply with mandatory reporting laws, and informing clients of the limits of confidentiality.
Ms. Du Mez speculated that social workers often "cleanse or redact" their records in an effort to protect clients whose records are going to be reviewed. She noted that this operates against comprehensive and coherent recordkeeping. Other problems include the occasional use of open-ended consent forms that may not be well understood, and the existence within or among systems of contradictory requirements (e.g., regarding the confidentiality of information about minors' drug dependency or sexually transmitted diseases.) Many questions are also raised in the areas of elder care and mental health service for domestic abuse victims. She also noted that overburdened practitioners can find burdensome the requirements for retention and access to records. Another problem is the inconsistency of state and federal laws. In view of the national trend to integrate services, she recommended that a national law extend across health, education and social service systems.
Jeffrey Funk, Social Security Administration (SSA)
Mr. Funk is in the SSA's Office of Disability, which uses medical records to support disability determinations. The agency has agreements with every state government to establish an agency to make eligibility determinations for the federal Social Security program. Only active claims are kept in SSA's central repository of information. If a claim is denied or for some other reason retired, the record is retired to a national archives site. When a person files a claim, he/she signs a disclosure statement allowing SSA to obtain records.
The agency has strict confidentiality policies and tightly limits redisclosure. It is required to refer people to state vocational rehabilitation agencies, in which cases it sends the person's medical records. No additional consent is needed for this, because the original consent "for program purposes" covers this use.
Asked about SSA's needs regarding the duration of an authorization, Mr. Funk said SSA goes back to the person with a new consent when it does its periodic re-reviews. He explained that the person is required to submit evidence in support of their disability claim, and the agency does not go after other evidence without their consent. If an individual has been declared incompetent, SSA would take the application from the guardian.
Mr. Gellman asked if SSA encountered problems living under the Privacy Act, and Mr. Funk said it merely necessitated new policy allowing client access to records when it was enacted. If there is nothing in the record that would interfere with the person's medical management, they are allowed access; if this is not the case, the person is asked to designate a representative to have access. He added that people seldom request access.
Mr. Gellman thanked Mr. Funk, and turned his questions to Ms. Du Mez. He noted that until recently, the problems of social workers were not considered in health care privacy legislation. The key issue in this context is defining who is a health care provider, and he asked whether social workers are health care providers. She replied that they are, inasmuch as they provide more mental health services than any other profession and also work in hospital and nursing care settings. As far as distinguishing between the activities that are health care and those that are not, she said there are indeed clear distinctions, except for "a small middle" that would need definition. To another question, she said all states have some kind of registration, certification or licensing, but it is not uniform. The licenses do not correspond to definitions of health care providers. However, she pointed out that all social workers are held to the same confidentiality provisions.
Following further discussion of school social work as an example of the middle, or grey, areas to which Ms. Du Mez referred, Mr. Gellman explained that the question here is whether social workers would be better served by excluding or including them from health care privacy legislation. Ms. Du Mez said she would consult NASW staff members with subject matter expertise on this matter. Subcommittee members encouraged NASW to think through the question of what aspects of social work qualify as health care provision, and to get back to them.
Ms. Du Mez made the general statement that there is a lot of variability in the way social workers keep records, probably to a greater extent than is true of physicians' records.
Dr. Schwartz asked how informed consents are handled in group counseling, and Ms. Du Mez said the consent would include the purpose for which the information would be shared, with whom it will be shared, and the duration of the consent. She noted that it is important in advance to enlighten clients as to the limits of confidentiality, so they have the choice to withhold information. Mr. Gellman noted that there are many problems with group therapy.
To a question, Ms. Du Mez said that in general, social workers get access to the records of health care providers with the consent of patients. In hospital settings, standardized consent forms are used that apply to social workers and others. Mr. Gellman asked if there were instances in which social workers would require non-consensual access to records, and Ms. Du Mez said this would generally not be the case, except perhaps in the forensic criminal justice system.
To another question on disclosure, she said social workers do not normally disclose medical information to public health authorities. They do disclose suspected cases of child abuse and abuse of other vulnerable populations such as the elderly. Disclosures to researchers are only in aggregate form. Asked about how social workers relate to oversight activities in terms of making records available, Ms. Du Mez said social workers are struggling with this. If it is part of their contractual arrangement, they are required to make records available; but in that instance, they would inform clients of this limit on confidentiality. Social workers also have an obligation to try and change policies that are detrimental to their clients, and many social workers are engaged in advocacy around these issues.
Regarding information flow to insurers, Ms. Du Mez said social workers face the same kind of struggles as other health care providers with payers' demands for more information to justify claims.
Social workers provide services to people on the fringe of society, and as a result sometimes are subpoenaed to appear in court and even to testify against their clients. They are sometimes contacted by police about fugitives. In such cases, they have to exercise professional judgment about the competing demands of client and society.
Next of kin disclosure issues generally pertain to minors, and are often governed by state laws. One arena where the issues arise is custody battles. Ms. Du Mez said social workers would conduct themselves in a variety of ways in these situations. She agreed with Mr. Fanning that social workers work closely with relatives of clients, for example in nursing home settings, and they encounter disclosure issues in this context. In response to a question about legislative proposals on next of kin disclosures, she said she favors giving discretion to the professional practitioner rather than establishing a formal notice process to which the patient may object. She noted that social workers are carefully trained in an ethical problem solving model.
Noting that some might view as paternalistic NASW's code allowing the withholding of records if disclosure would harm the client, Mr. Gellman asked for comments on patient access to their own records. Ms. Du Mez replied that clients can and should have access to their records. She added that many social workers keep progress notes for their own guidance, to which clients do not have access. This is not unlike the practice of other service providers, who need private records to protect them in malpractice suits and complaints.
Finally, Mr. Gellman pointed out that social work needs to think about the impending legislation, paying particular attention to the definitional issues, and needs to figure out how it wants to fit under the bill. He added that there is a price to be paid for the protections it affords. Social workers may not need the range of authority to disclose records for other purposes that the legislation affords. Ms. Du Mez said she would seek input from NASW's practice specialists.
There being no public witnesses, Mr. Gellman then adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ Don E. Detmer, M.D. April 8, 1998
______________________________________
NCVHS Chair Date