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ADDITIONAL VIEWS

Although the Committee has made important improvements to H.R. 493, the `Genetic Information Non-Discrimination Act' (GINA), we believe it is imperative that all parties continue to work to improve this legislation and address the issues we raise in these additional views. We believe there are significant technical problems with the legislation in its current form. We respect the changes and the work of the Committee in the short period of time from the hearing to full committee markup. We note the inclusion of information on embryos, fetuses, and adopted children; a clear statement that Title II does not apply to group health plans and insurers; a clear statement that nothing affects claims processing and related items; and, an exemption from the unworkable Title II mandates for entities already subject to regulations governing personally identifiable health information. Among other things we believe these changes should be consistent with group health plans and health insurance issuers providing information to providers or individuals about genetic tests for coverage and benefits, treatment alternatives, disease management, case management, patient care management, care coordination and prevention programs. These programs are today improving the quality of health care and nothing in this bill should undermine such efforts. These are solid steps in the right direction,

The primary author of the House bill, Ms. Slaughter, has stated:

GINA prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to develop a disease in the future. Furthermore, it bars employers from using an individual's genetic information when making hiring, firing, job placement or promotion decisions.

We want to focus the legislation on these objectives and not go beyond them. The drafting simply does not match, or at least is not tailored to, the statement of the primary sponsor. The legislation, in its current form, will needlessly disrupt and hinder positive activities and policies for employers, insurers and health care. These are not easy issues. The protagonists of GINA have delved into some sweeping and difficult arenas: the ability to define and segregate `genetic information' from other medical information, new permutations of civil rights laws, new restrictions on health information, occupational safety issues, and Federal-State relations are among them. We think the suggestions we make below could be very helpful.

THE NEW REGULATORY REGIME IN TITLE II FOR THE DELIVERY OF HEALTH CARE AND RELATED SERVICES THAT MAY BE OFFERED BY OR SPONSORED BY EMPLOYERS IS INAPPROPRIATE

CONCERNS REGARDING DELIVERY OF HEALTH CARE

Title III of GINA would launch a new health information regulatory scheme that would be administered out of the Equal Employment Opportunities Commission. Our understanding is this scheme would cover, in part, the communications of certain health care providers or companies providing electronic health record services. Specifically, if an employer is providing a health service or electronic record service, the provisions of Title II of GINA attach. Providing a service includes both in-house employees and contracts with other entities.

We fail to see why covering the delivery of health care and health services in Title II has anything to do with hiring, firing, job placement or promotion decisions. People delivering health care and health services are not hiring or firing people. Health information, including genetic information is critical to the delivery of care. If a company is providing a personal health record service it is technically problematic and detrimental to the patient to sanitize information like family medical history or other genetic information.

Here are the potential problems:

1. GINA provides that the medical decisions of certain health care providers in using genetic information can be a basis for a civil rights violation. That means the practice of medicine may be subject to claims of discrimination, even though they have nothing to do with hiring, firing, job placement or promotion.

2. Under section 202(b), 202(c) and 206(b) the communications in the process of health services are restricted well above what is appropriate under the extensive privacy regulations governed by the Department of Health and Human Services.

3. These restrictions will inhibit the coordination of care among health providers, slow down processing and care because of the need to evaluate each document to sanitize or specially handle information, and increase medical errors.

4. These restrictions will essentially make employer participation in electronic health record services and personal health record services extremely burdensome. Indeed, contracting with a company to provide such services for employees is covered under the information restrictions of Title II.

5. This health information regulatory regime would be inconsistent with the regime run by the Department of Health and Human Services.

We should not penalize the good that employers can do for their employees by providing health care services or electronic health record services. Sponsorship of the delivery of health care by an employer is not hiring, firing, job placement or promotion. And genetic information is important to the delivery of health care. We believe nothing in Title II should apply to the actions or communication respecting the delivery, administration, or operation of health care including any health services, pharmacies, health records services, health counseling, or health education. We also believe that nothing in either title should regulate actions or communications respecting the practice of medicine including but not limited to diagnosis, treatment, counseling and education. These activities clearly fall outside the scope of the author of GINA's stated intent. We would like to work with all parties and craft language that makes these points clear.

We are pleased at the amendments in Full Committee that would exempt covered entities within the meaning of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule from the unworkable mandates of Title II. This helps with respect to the concerns we raise in a number of instances, but not in others.

We have heard specific concerns regarding the application of sections 202(b) and 206(b) and the broad definitions and prohibitions as they might restrict or delay further adoption of electronic health records and personal health records.

We note that the exclusion for HIPAA covered entities is helpful but will not fully address the issues. We fear these points are just the tip of the iceberg. We see no reason that the delivery of health care should be regulated or restricted by Title II. These issues have nothing to do with Ms. Slaughter's stated purpose concerning making hiring, firing, job placement or promotion decisions. However, the current bill could drastically impede a much shared goal to transform our health care system through utilization of electronic health records.

THE INFORMATION REGULATIONS IN TITLE II ARE OVERLY BROAD AND UNWORKABLE

A SWEEPING NEW REGULATORY SCHEME

Title II has sweeping breadth. It covers employers from the FBI to NASA to laboratories, to State and local governments, to nuclear power plants, to hospitals, and many more. Title II restricts information flow in numerous settings from employers involved in responses to pandemic flu outbreaks, to employers involved in judicial proceedings, to health and safety monitoring, and to employers administering or sponsoring benefits. We cannot today easily imagine all of the circumstances. The HIPAA Privacy Rule gives us a clue to this complexity. It is a complex series of extensively debated exceptions to prohibited uses and disclosures of information. The proposed rule received over 50,000 comments and the next proposed set of modifications received over 11,000 comments. Among other things, this draft document will point out below how section 202(b) and 206 and other provisions of GINA fail to include the numerous exclusions for use and disclosure that HHS had to address in the Privacy Rule. The Americans with Disabilities Act also has information regulations with respect to disability related inquiries and medical examinations. Rather than use the knowledge from either of these two models, GINA strikes out on a third, unworkable scheme. The biggest problem is that subsections like 202(b), 203(b), 204(b) and 206(b) start with sweeping prohibitions on either acquisition or disclosure of information. These subsections then follow with exactly five specific exemptions. Note that these exemptions are not even coextensive between subsections 202(b) and 206(b).

Based on this statutory structure, it may be impossible for the Equal Employment Opportunities Commission to argue that it could add to the list of statutory exemptions. Accordingly, the authors of GINA must assume Congress has contemplated all reasonable circumstances for acquisition and disclosure by employers or sponsored activities and set them out in the exemptions. Although the Privacy Rule starts out with

bans on use and disclosure, there are dozens of important exceptions. For example, if you were to work with a contract organization to manage records, that would fall under the business associate provisions of the rule. Even disclosures for civil and criminal litigation, law enforcement, to heirs of decedents, for serious threats to health and safety, essential government functions, incidental uses, workers compensation, treatment, payment, health care operations all have specific exceptions. These exceptions are not in GINA. We are not saying all of the Privacy Rule map perfectly to the employer context. (We are saying that for delivery of health care). However, many of the Privacy Rule's permitted uses and disclosures include normal and routine uses and disclosures, including those important for the public good. These would seem to make sense and be necessary within the context of GINA.

EXAMPLES IN THE LAW ENFORCEMENT AND JUDICIAL SETTINGS

Moreover, even where GINA has exemptions they are not always logical. Consider this concern voiced in technical assistance from the FBI:

Section 206, subpart (b)(3), permits an employer to provide genetic information concerning an employee or a request by the employee for genetic services in response to a court order ONLY after providing notice to the employee of the court order and permitting the employee to challenge the order. It doesn't distinguish between civil cases and criminal cases, or those situations in which the court order may require that the recipient not disclose the order. The section also does not describe how the recipient employer is supposed to handle notice if the employee no longer works for their company, or has moved from their last address known to the employer, or has died.

These are valid considerations. In fact, we are wondering why GINA would in any way suggest anything other than full compliance with a court order. And why would GINA impose a duty of notice concerning such an order to an employer. Notice to the employee to challenge any order should come through the court.

In fact, when compared with GINA, the HIPAA Privacy Rule permits disclosures pursuant to warrants, subpoenas and administrative orders. GINA does not. Is GINA forbidding response to such orders? The Privacy Rule would allow a covered entity to respond to the request of law enforcement officials for blood type information. As discussed below, blood typing seems to `detect a genotype' within the meaning of the GINA definitions. Why should GINA be more restrictive with respect to law enforcement and judicial proceedings that the current HIPAA regulations?

Some employers use DNA identification tests, which appear to be covered by the GINA definitions. For example, labs and some policy enforcement organizations may take DNA samples to help unravel contamination issues at labs or crime scenes. Some employers provide for medical monitoring programs to protect against injuries to employees. We received the following technical assistance from FBI:

Section 201. Recommend narrowing the definition of `genetic test' to the following, and to strike the subsection on Exceptions:

The term `genetic test' means--the analysis of human DNA, RNA, chromosomes, proteins, or certain metabolites in order to detect disease-related genotypes or related phenotypes. The term does not apply to any such testing which is conducted for the exclusive purposes of identification, where no information regarding the sample is to be provided to any entity for the purposes of determining any health related information regarding either the individual or members of the individual's family.

We received this point as technical assistance from staff in the Bureau of Alcohol, Tobacco, and Firearms (ATF):

`. . . . Please let me know if there is anything we in the forensic DNA community can do to aid in the modification of this bill so it will not have the unintentional effects that it may have as written. I have outlined my concerns below. . . .

Forensic DNA technology has progressed to the point that it is possible to obtain a DNA profile from handled objects or even a fingerprint. Because of this, most forensic DNA labs have created a staff DNA index. Any DNA profiles developed from evidence are then compared to the staff index. This accomplishes two things. First, if the DNA profile developed from the evidence is actually from an investigator or laboratory person and not the true perpetrator, a false exclusion might be made. Second, unknown profiles developed from evidence are typically uploaded to the Combined DNA Index System (CODIS). If the investigator's profile or laboratory scientist's profile is not caught through the use of a staff index, the profile would be uploaded to CODIS. If it happens again, two unrelated crimes could subsequently linked that are not truly linked.'

We received this point as technical assistance from the staff of the Veterans Administration:

This section does not authorize disclosure in administrative or court proceedings in which the employee has either placed the genetic condition at issue or raised a claim for which the information is clearly relevant. It would appear that VA, as an employer, could not provide the records to an administrative entity upon its request or order without first obtaining a Federal court order to produce the information.

EXAMPLES FOR HEALTH AND SAFETY MONITORING ISSUES

Beyond these judicial and law enforcement issues are safety issues:

Mr. Deal asked the witness from the EEOC the following question:

We want your interpretation of section 202(b)(5)(B). Assume that genetic monitoring is not required by Federal or state law. The business nonetheless feels that safety requires such monitoring. If the employee says he does not want to be subject to such monitoring, does the employer still have the right to reassign him away from the position that needed the monitoring? Or must the employer allow the employee to continue without the monitoring?

Our understanding is the EEOC witness stated that reassigning an employee who refuses to provide information for monitoring described above would be subject to a claim of an illegal employer practice under GINA. This is a problem. Why would we take away from employers the ability to demand monitoring for worker safety?

We further note that the definition of acceptable genetic monitoring is only in the context of exposure at the work place. If an employer is monitoring for infectious diseases to protect public safety, such monitoring does not seem to have an exception to allow consideration of genetic information in that context.

WAYS TO REDUCE THE PROBLEMS

All of the above pieces of technical assistance, letters, or testimony identify unexpected problems with the prohibitions on acquisition and disclosure. We believe these are just the tip of the iceberg. The EEOC has provided some technical assistance that might provide for regulatory authority to create additional exemptions. In addition, employer stakeholders have been asking Congress to not use language like that in subsections 202(b) or 206(b). Employers note the model under the Americans with Disabilities Act is familiar to them and more workable. It seems entirely possible to use language similar to that under the ADA provisions to make this law consistent. Until there are changes to these sections, GINA poses many counterproductive results. We would like to work with all parties to eliminate these counterproductive results.

GINA CONTAINS INCONSISTENT, OVERLY BROAD AND UNWORKABLE DEFINITIONS OF GENETIC TEST AND GENETIC INFORMATION

The terms genetic test and genetic information are overly broad in GINA. The definitions are inconsistent between titles and not matched to the policy purpose. Forty-three states have definitions. None of the state definitions are as broad or as unworkable as the definitions in GINA. GINA simply includes information well beyond tests intended to find a predictive genetic marker for a genetic disease. Title II of GINA covers blood typing, tissue typing, cancer tumor typing, DNA forensic information, genotypic information useful to reduce adverse reactions to treatments and therapies, and more. The definition of genetic information includes `the occurrence of a disease in a family member'--even when not used for predictive purposes.

Apparently, if we were to ask one of our staff how one of their children were doing with the flu or other disease, we would be requesting genetic information within the meaning of GINA. Apparently, if an employer is testing for drugs but that test also detects the blood type AB in an employee, that test detected a genotype and would be

subject to the sanctions of this bill.

It is not alright to subject employers to vague and unworkable standards and levy the threat of sanctions for civil rights violations against them. The current language of this bill could have serious negative consequences to both the individual and public health by saddling health and safety monitoring, electronic health information systems, health care providers, emergency preparedness efforts, claims processing for workers compensation and many other items with the burden of separating legitimate medical information into two file folders.

As Dr. Francis Collins testified, genetic information is basically medical information. To treat it under a separate regulatory regime for items such as medical monitoring for employee safety or employee sponsored health services will remove vital information for vital purposes. This will create medical errors and needless bureaucracy.

PROBLEMS WITH THE SWEEP OF INCLUDING THE OCCURRENCE OF A DISEASE OR DISORDER IN FAMILY MEMBERS WITHOUT FURTHER LIMITATION OR CLARIFICATION

On the point concerning `the occurrence of a disease or disorder in a family member', under subsection 202(b) an employer may not request or require such information, unless pursuant to a specific exception. We realize that the occurrence of a disease or disorder could be part of a scheme to forecast a genetic disease in an employee. It is also useful information for many other purposes. We believe that the basic intent of the authors is to regulate a predictive assessment concerning an individual's propensity to get an inheritable genetic disease or disorder based on the occurrence of an inheritable genetic disease or disorder in the family member. After all, if an employer or insurer is not trying to make such a predictive assessment, they really are not within the scope of the policy purpose of the bill. By using the broader universe of information concerning `a disease or disorder in a family member' GINA opens up an incredible range of workability problems. Note that `a disease or disorder' does not have to be a genetic disease or disorder. It could just be a cold or a disease that came from poisoning.

If an employer sponsors a benefit for an employee to raise money for the employee's child's illness that employer seems to have violated both subsection 202(b) and 206(b). What if an employer wants information from an employee as back up for a worker absence that is not pursuant to the Family Medical Leave Act? What happens if an employer employs several family members. Does the `occurrence of a disease or disorder' language apply to each employee? If so, would record keeping on employee absences not be acceptable.

What if there are issues about infectious diseases? Under the National Pandemic Flu Preparedness Plan, employers would play a key role in information dissemination and assessment of the spread of the disease. There are no exceptions for such emergencies under GINA.

All of these problems would be unnecessary if the language were restricted to a predictive assessment concerning an individual's propensity to get an inheritable genetic disease or disorder based on the occurrence of an inheritable genetic disease or disorder in the family member.

NUMEROUS INCONSISTENCIES WITHIN THE BILL

On the definition of genetic test, we point out that the definitions are, for no apparent reason, different in Title I and Title II. In conjunction with this we note the treatment of manifested diseases and how they affect regulation are also different in Title I and Title II for no apparent reason. We further note that the treatment of tests which identify genotype, mutation, or chromosomal changes, based on protein or metabolite analysis in the context of manifested diseases are excluded under Title I. Yet a test which identifies the same things based on DNA or chromosome analyses are not excluded for purposes of Title I. There is no manifested disease exclusion in the definitions in Title II. This means some tests that can type a cancer tumor fall into one regulatory category and others do not. And this is all just in one bill. Please understand this bill will partially override 43 State definitions of genetic tests and genetic information creating maximum confusion.

FAILURE TO LIMIT DEFINITION TO GENETIC MARKERS FOR GENETIC DISEASES

Under GINA, the term `genetic test' means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. Francis Collins, head of the National Human Genome Research Institute said the GINA reference to detecting a genotype covered, among other things, tests to look at genetic profiles to select safer drugs, forensic DNA identification tests, tissue typing for organ donation; and paternity tests. He stated that the fact that someone has an O or AB blood type also detects that person has the O or AB genotype. He also made clear that certain DNA tests for tumor typing of cancer are covered by the definition. He further stated that the phrase `occurrence of a disease or disorder in family members of the individual' was not limited to inheritable genetic disease and that this might include infectious or contagious diseases of family members. We have tried to review definitions of genetic information or test under state laws. None of them have the breadth of the GINA definitions.

As confirmed by Committee Counsel during the markup we do not read any requirement that the detection of `genotypes' within this paragraph is limited to genotypes related to genetic diseases, disorders or pathological conditions. Our further concern is that more and more clinical diagnostics will `detect a genotype' in at least one part of the analysis. This may be true even if it is not the purpose of the test to look for genetic markers for disease. It may also be true if the basic purpose of the test is not to look for a blood type. Yet if the test detects a blood type, it would appear to be covered by the GINA definitions. This means a tremendous level of basic information is not defined as a genetic test or genetic information well beyond the core purposes of the bill.

We remain unclear on how tests for the effects of viruses or pathogens might fit in to GINA. Some types of viruses actually physically insert their genes into the host's genome (it is the defining feature of retroviruses, the family of viruses that includes HIV, the virus that causes AIDS). This incorporates the genes of that virus among the genes of the host cell for the life span of that cell. Beyond this some viruses, such as the Hepatitis C virus, also add material to human chromosomes or DNA.

We believe there may be analyses of human DNA, RNA, chromosomes, proteins, or metabolites that provide direct evidence of retroviruses or other viruses. These analyses may be construed to detect a human chromosomal change or mutation. We recognize the insertion into the human chromosome or mutation to DNA is, in part, an insertion of viral DNA. There nonetheless appears to be a change in the sequence of the human DNA, genotype or chromosome. We want to know whether the phrase `detects a genotype, mutation, chromosomal change' could refer to such mutations and chromosomal changes in humans caused by such viruses. If it can we have further concerns about the effect of this legislation with respect to health and safety monitoring and employer precautions.

Again, Ms. Slaughter's stated concern was discrimination `based solely on a genetic predisposition to develop a disease in the future.' This would be consistent with the language in Executive Order 13145 which was limited to tests done `in order to detect disease-related genotypes or mutations.' In the 108th Congress, Ms. Slaughter's bill exempted from the definition of protected genetic information any `information about physical exams of the individual and other information that indicates the current health status of the individual.' This is a very useful exception. It's just not in GINA. We keep asking, what do DNA forensic evidence, blood typing, tissue typing, cancer tumor typing, or pharmacogenomics have to do with predicting a genetic disease?

The downsides of the inconsistent and overly broad definitions are many. Employers and employer sponsored benefit programs will have several information regimes for medical information. GINA force separation of such information which will be a bureaucratic nightmare, lead to medical errors, create inconsistencies in communications with providers, limit medical monitoring, create confusion in law enforcement and judicial functions. If important information related to viruses or contagious diseases are also covered, we may be compromising the ability of an employer to help in public safety efforts or to protect the public's health and safety. We would not want to see medical monitoring for infectious diseases precluded from an employers tool box for instances where public health and safety is at stake.

The discouraging part of this is that the 43 states that have definitions do not have these problems. They all limit regulations to genetic markers that predispose toward a future disease. Many specifically refer to inherited genetic material. Many have specific exceptions for items like HIV testing or drug and alcohol tests. Despite these problems we have been met with a seeming unwillingness from the protagonists to address any of these issues. We hope that is not the case.

GINA WILL CREATE CONFUSION FOR THE 43 STATES THAT CURRENTLY HAVE LAWS PROHIBITING DISCRIMINATION BASED ON GENETIC INFORMATION

We have not done a complete survey but understand that 43 States already have programs and definitions. We would then want to ask Members if they find the programs in their state inadequate. If you were to superimpose the GINA requirements on those states it will involve a lot of confusion. Many exemptions and clear statements regarding HIV testing, drug testing, and other issues would appear to be wiped out. Even more frustrating for the regulatory community the operative Federal-state relationship rule is whatever part of a state law is more stringent survives. This means pieces of state law will apply while other pieces will be preempted. This would all have to be sorted out by the courts. We think there are better approaches. The worst approach is this partial preemption approach. For some programs there is across the board preemption. In other cases, a state is allowed to submit its program for evaluation as a whole. If such programs are adequate or substantially promoting the policy, they would stay intact. We believe our States are substantially meeting the policy and do not see the need for disruption. In any event, some Federal agency should at least sort out what law applies in advance so that the regulated community is not held hostage to more lawyers and uncertainty.
Joe Barton.
Nathan Deal.
Michael Burgess.
Steve Buyer.
Barbara Cubin.
Mike Rogers.
John Shadegg.
Cliff Stearns.
Lee Terry.
Heather Wilson.
Tim Murphy.

Congress makes the following findings:

(1) Deciphering the sequence of the human genome and other advances in genetics open major new opportunities for medical progress. New knowledge about the genetic basis of illness will allow for earlier detection of illnesses, often before symptoms have begun. Genetic testing can allow individuals to take steps to reduce the likelihood that they will contract a particular disorder. New knowledge about genetics may allow for the development of better therapies that are more effective against disease or have fewer side effects than current treatments. These advances give rise to the potential misuse of genetic information to discriminate in health insurance and employment.

(2) The early science of genetics became the basis of State laws that provided for the sterilization of persons having presumed genetic `defects' such as mental retardation, mental disease, epilepsy, blindness, and hearing loss, among other conditions. The first sterilization law was enacted in the State of Indiana in 1907. By 1981, a majority of States adopted sterilization laws to `correct' apparent genetic traits or tendencies. Many of these State laws have since been repealed, and many have been modified to include essential constitutional requirements of due process and equal protection. However, the current explosion in the science of genetics, and the history of sterilization laws by the States based on early genetic science, compels Congressional action in this area.

(3) Although genes are facially neutral markers, many genetic conditions and disorders are associated with particular racial and ethnic groups and gender. Because some genetic traits are most prevalent in particular groups, members of a particular group may be stigmatized or discriminated against as a result of that genetic information. This form of discrimination was evident in the 1970s, which saw the advent of programs to screen and identify carriers of sickle cell anemia, a disease which afflicts African-Americans. Once again, State legislatures began to enact discriminatory laws in the area, and in the early 1970s began mandating genetic screening of all African Americans for sickle cell anemia, leading to discrimination and unnecessary fear. To alleviate some of this stigma, Congress in 1972 passed the National Sickle Cell Anemia Control Act, which withholds Federal funding from States unless sickle cell testing is voluntary.

(4) Congress has been informed of examples of genetic discrimination in the workplace. These include the use of pre-employment genetic screening at Lawrence Berkeley Laboratory, which led to a court decision in favor of the employees in that case Norman-Bloodsaw v. Lawrence Berkeley Laboratory (135 F.3d 1260, 1269 (9th Cir. 1998)). Congress clearly has a compelling public interest in relieving the fear of discrimination and in prohibiting its actual practice in employment and health insurance.

(5) Federal law addressing genetic discrimination in health insurance and employment is incomplete in both the scope and depth of its protections. Moreover, while many States have enacted some type of genetic non-discrimination law, these laws vary widely with respect to their approach, application, and level of protection. Congress has collected substantial evidence that the American public and the medical community find the existing patchwork of State and Federal laws to be confusing and inadequate to protect them from discrimination. Therefore Federal legislation establishing a national and uniform basic standard is necessary to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.

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