7/27/2019 ACS memo

1/5

MEMORANDUM

Sharen Muraoka,American Cancer Society, California DivisionPublic Issues DirectorFROM: John G. Narkin

TO:

Re:DATE:

Genetic Information Legislative OverviewJanuary 6,1997

I. CURRENT AND PROPOSED LEGISLATIVE PROTECTIONThanks to the legislative initiatives of State Senator Patrick Johnston, California residents

now possess significant protection against misuse of information derived from genetic testing byhealth care plans, employee welfare benefit plans and certain life and disability insurers(collectively the Regulated Parties ). In addition, legislation authored by Senator Johnstonprohibits the Regulated Parties from seeking, using or maintaining information regardinggenetic characteristics for any nontheraputic purpose. The legislation also prohibits theRegulated Parties from discriminating in enrollment, rates, renewal or other terms andconditions of any policy they issue.

On the Federal level, in August 1996, Congress passed, and President Clinton signed intolaw, the Health Insarance Portability and Accountability Act of 1996 (also known as theKennedy-Kassebaum Bill'), P.L.104-191. Among other things, the Kennedy-Kassebaum Billprohibits group health plans and heatth insurance issuers from establishing rules conditioningeligibilitv or continued eligibility on the basis of individuals' (or their dependents') geneticinformation. More specific guidance interpreting this provision awaits the promulgation ofregulations by the U.S. Department of Health and Human Services.

Apart from the Kennedy-Kassebaum Bill, several other relevant bills were introduced inthe l04th session of Congress. A summary of the most significant proposed Federal legislation isattached to this memorandum as Exhibit A. In general, Congressional initiatives have attempted tocontrol the disclosure and confidential use of genetic information -- not merely the results ofgenetic testing. The distinction is critical. As Kathy L. Hudson, the Assistant Director of PolicyCoordination at the National Center for Human Genone Research, National Institutes of Health,observed, it is important to expand the scope of protection beyond genetic testing to restrictimproper use of genetic information generated by family history, physical examinationor...medical record[s]. This is because:

fi]imiting the scope of protection to results ofgenetic tests means that insurers are only prohibitedfrom using the results of a chemical test of DNA' orin some cases, the protein product of a gene. Butinsurers can use other phenotypic indicators, patterns

7/27/2019 ACS memo

2/5

Genetic Information Legislative OvervrewJanuara 6. L997Page Two

of inheritance of genetic characteristics or evenrequests -for genetic testing as the basis o_f discrimination.Meaningful protection against genetic discriminationrequires that insurers be prohibited from using a//information about genes. gene products or inheritedcharacteristics to denv or limit insurance coveraset

(emphasis supplied)In addition, the need to circumscribe use of genetic information is not limited to insurance

companies or employee welfare benefit plans. As Representative Jim McDermott said in supportof the Medical Privacy in the Age af New Technologres Acl, Genetic health information is anespecially sensitive part of a patient's medical record....One recent study documented 200 cases ofhealthy people being denied jobs, insurance, the right to adopt, and educational opportunitiesbecause they either had or were suspected to have a genetic predisposition for a disease, eventhough they did not actually have the disease.

For that reason, at least one proposed Federal bill, 5.1898 (the Genetic Confidentialityand Nondiscriminstion Act of 1996), would affirmatively prohibit employers or potentialemployers from seeking to obtain, obtaining or using genetic information in connection withemployment decisions. See also, Proposed Legislation Summary, Exhibit A. This legislativeprotection would complement an administrative guideline established by the U.S. EqualEmployment Opportunity Commission on March 15, 1995, which expands the definition ofdisability in the Americans with Disabilities Act of 1990 to include persons having a geneticpredisposition to illness.

II. DESIRABILITY OF ADDITIONAL LEGISLATTVf, PROTECTIONTaken as a whole, the proposed Federal legislation identified in Exhibit A' reflects a

strong sensitivity to the issue of genetic information in Congress. It is therefore reasonable toexpect that several of these bills will be reintroduced during the new Congressional session andthit important Federal legislation may be passed into law within the next 24 months. There is, ofcourse, no assurance that such legislation will actually be forthcoming or enacted.

' S4 Hudson et al. Genetic Discrimination and Health Insurance; An Urgent Need for Reforz (Science .october 1995). a cop.v of which is appended to this memorandum at Exhibit B.' See Congressional Record at E829 (May 16. 1996).3 It is signrficant to note that Senator Dianne Feinstein is the sponsor of S. 1600. the Genetic Fairness Actof 1996, and that Representative Nancv Pelosi is a co-sponsor of H.R. 3482, the Medical Privaclt in the Age of l'lewTechnologies Act.

7/27/2019 ACS memo

3/5

Genetic Information Legislative OverviewJanuara 6,1997Page Three

Whatever may or may not happen in Congress, it is appropriate that California,capitalizing on the leadership provided by Senator Johnston, should avail itself of the opportunityto enhance the level of protection currently available to residents of this state. Certiinlv, tneAmerican Cancer Society should consider the advantages ofjoining with other interested groups(such as the National Action Plan on Breast Cancer) in forming a strategic alliance designed toeliminate a// discrinunatory uses of genetic information in California. While this issue requiresmore exhaustive research and in-depth consultation with responsible national authorities, thefollowing supplementary protections appear desirable:

' Strict limitations on disclosure of genetic informationa by all entities that maintain,transmit or exchange medical information as a regular part of their business. By carefully limitingdisclosure of genetic information in the first instance, the possibilitv that such information canlater be put to discriminatory use is effectively minimized;' Explicit provisions prohibiting discriminatory use of genetic information by allentities that may have an economic incentive to discriminate against persons possessing geneticcharacteristics suggesting a predisposition to disease. Such parties may include employers,lenders, educational institutions, adoption agencies and similar lvpes of organizations;o Enhanced monetary penalties for improper use of genetic information. Underexisting California law, the penalties -eoverning Regulated Parties' misuse of genetic testinginformation may be too modest to provide an effective deterrent to willful or negligent violationsof the law. (Compare sanctions authorized by California Senate Bill 1740 with comparableprovisions of Federal Senate Bill 1898, described in Exhibit A);r For purposes of cohesion, clarity andcodify all genetic information protections inCode.

simplicity of reference, it might be beneficial toone new omnibus section of the CaliforniaDue to Senator Johnston's efforts, Californians now have protection against geneticdiscrimination in the area of health, life and disability insurance coverage. While current state andFederal law represents a promising beginning, the legislative task is not complete as long asCalifornians remain subject to any kind of discriminatory action based upon their inalterablegenetic make-up.

o For purposes of these limitatrons. the term genetic information should embrace more than genetic testresults, See supra at L-2. ln addrtion. the term genetic charactenstics as currentl-v defined under Cahforma lawseems too restrictive insofar as the definition. even after recent amendment. still emphasizes scientifically ormedrcally identifiable gene[s] and chromosome[s] that are l

7/27/2019 ACS memo

4/5

''EXHIBIT A''Sisnificant Proposed Federal Genetic Information Legislation

I. Senate BillsA. Genetic Conjidentiality and Nondiscrimination Act of 1996, ^S.18g8Introduced on June 24,1996 by Senator Pete Domenici, this bill provides that no person who, inthe ordinary course ofbusiness, practice ofa profession, or rendering ofa service, creares, srores,receives or furnishes genetic information may disclose such information without express writtenauthorization or except under narrowly defined circumstances (such as under a court order). TheBill also prohibits employers from seeking to obtain, obtaining or using genetic information and itbans employers from requirin-q employees and prospective employees to submit to genetic testing.A private right of action for violations of the Act is authorized in both Federal and State Court,with strict penalties provided: the greater of actual damages or $50,000 for negligent violations(subject to trebling in cases where monetary gain can be established) and the greater of actualdamages or $100,000 (and possible punitive damages) for wilful violations, not including costsand attorneys'fees. Other provisions of the bill proscribe discrimination by insurers.B. Genetic Information Nondiscrimination in Health Insurance Act of 1996, 5.1694(Identical to H.R 2748)Introduced on April 23,1996, this bill provides that insurance providers may not deny or cancelhealth coverage, or vary the premiums, terms or conditions for health coverage (a) on the basisof genetic information [defined broadly as information about genes, gene products, or inheritedcharacteristics ] or (b) on the basis that an individual or family member requested or receivedgenetic services [defined as services to obtain, assess, and interpret genetic information fordiagnostic and therapeutic purposes, and for genetic education and counselling ].C. Genetic Fairness Act of 1996, S. 1600Introduced by Senator Dianne Feinstein on March 7, 1996, this bill would prohibit insurers,HMOs, and employee welfare benefit plan providers from making coverage determinations orchanging policy teffns and conditions on the basis of any genetic information concerning anindMdual or family member or on the basis of an individual's or family member's request for orreceipt of genetic services. The definitions of genetic information and genetic services arevirtually identical to those set forth in S. 1694.D. Genertc Privacy and Nondiscrimination Act of 1995, S. 1416(Identical to H.R 2690)Introduced by Senator Mark Hatfield on November 15, 1995, this bill would, with few carefullydelineated exceptions, prohibit all entities from disclosing genetic information without expresswritten authorization, Like S, 1898, the bill would bar employers from seeking, obtaining orusing genetic information of employees and prospective employees and it would likewise preventemployers from requiring genetic tests. Private enforcement action is authorized under the Civil

7/27/2019 ACS memo

5/5

EXHIBIT A (Continued)Significant Proposed FederalGenetic Information LegislationI. Senate Bills (Continued)Rights Act of 1964, The bill also prohibits discrimination by insurers offering health insurance,,,but it would permit requests for genetic testing in connection with applications for other kinds ofinsurance when (a) the use of the results of such test is disclosedib the applicant and (b) theapplicant provides specifi c written authorization.II. Ilouse BillsA, Medical Privacy in the Age of New Technologies Act, H.R 3492Introduced on May 16, 1996 by Representative Jim McDermott (and co-sponsored byRepresentative Nancy Pelosi), this bill would provide an elaborate -- and comprehensive --scheme establishing safeguards and restricting the use and disclosure of personal healthinformation by health information trustees, a term which encompasses any person or entitythat creates, receives, obtains, maintains, uses, or transmits protected personal healtirinformation...and any employee, agent or contractor of such a person. Although the provisions ofthis bill are highly detailed (and quite beyond the more limited issue of genetic information), thisbill contains several provisions which might be usefully incorporated in California state legislation.B. Proposed Amendment to the Fair Labor standards Act of 1938, H.R 3477Introduced by Representative Joseph Kennedy on May 16, 1996, this bill would prohibitemployers from obtaining from any source genetic information about an employee or prospectiveemployee unless such employee or applicant provides written authorization after receiving fromthe employer a written statement of the uses which the employer intends for the information.C. Genaic Information Health Insurance Nondiscrimination Act of 1996, H.R 4008Incorporating the same definition of genetic information described above, this bill would alsoprohibit insurers and group health plans from making coverage or policy decisions (a) on thebasis of genetic information or (b) on the basis of [a] request for, or receipt of, geneticinformation or a genetic test. The bill further prohibits insurers and group health plans fromrequesting genetic information and/or tests from applicants, beneficiaries or plan participants andit prohibits dissemination of genetic information by insurers and group health plans except undernarrowly circumscribed circumstances.D. Women's Health Equity Aci of 1996, H.R 317EWould mandate virtually the same protections set forth in the Genetic Information HealthInsurance Nondiscrimination Act of 1996