110TH CONGRESS 

2D SESSION H. R. 1424 

AN ACT 

To amend section 712 of the Employee Retirement Income 

Security Act of 1974, section 2705 of the Public Health 

Service Act, section 9812 of the Internal Revenue Code 

of 1986 to require equity in the provision of mental 

health and substance-related disorder benefits under 

group health plans, to prohibit discrimination on the 

basis of genetic information with respect to health insurance and employment, and for other purposes. 
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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. ORGANIZATION OF ACT INTO DIVISIONS; TABLE 

4 OF CONTENTS. 

5 (a) DIVISIONS.—This Act is organized into two divi6 sions as follows: 

7 (1) Division A—Paul Wellstone Mental Health 

8 and Addiction Equity Act of 2008. 

9 (2) Division B—Genetic Information Non10 discrimination Act of 2008. 

11 (b) TABLE OF CONTENTS.—The table of contents of 

12 this Act is as follows: 

Sec. 1. Organization of Act into divisions; table of contents. 

DIVISION A—PAUL WELLSTONE MENTAL HEALTH AND 

ADDICTION EQUITY ACT OF 2008 

Sec. 101. Short title. 

Sec. 102. Amendments to the Employee Retirement Income Security Act of 

1974. 

Sec. 103. Amendments to the Public Health Service Act relating to the group 

market. 

Sec. 104. Amendments to the Internal Revenue Code of 1986. 

Sec. 105. Medicaid drug rebate. 

Sec. 106. Limitation on Medicare exception to the prohibition on certain physician referrals for hospitals. 

Sec. 107. Studies and reports. 

DIVISION B—GENETIC INFORMATION NONDISCRIMINATION ACT 

OF 2008 

Sec. 100. Short title; findings. 

TITLE I—GENETIC NONDISCRIMINATION IN HEALTH INSURANCE 

Sec. 101. Amendments to Employee Retirement Income Security Act of 1974. 

Sec. 102. Amendments to the Public Health Service Act. 

Sec. 103. Amendments to the Internal Revenue Code of 1986. 

Sec. 104. Amendments to title XVIII of the Social Security Act relating to 

medigap. 

Sec. 105. Privacy and confidentiality. 

Sec. 106. Assuring coordination. 
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TITLE II—PROHIBITING EMPLOYMENT DISCRIMINATION ON THE 

BASIS OF GENETIC INFORMATION 

Sec. 201. Definitions. 

Sec. 202. Employer practices. 

Sec. 203. Employment agency practices. 

Sec. 204. Labor organization practices. 

Sec. 205. Training programs. 

Sec. 206. Confidentiality of genetic information. 

Sec. 207. Remedies and enforcement. 

Sec. 208. Disparate impact. 

Sec. 209. Construction. 

Sec. 210. Medical information that is not genetic information. 

Sec. 211. Regulations. 

Sec. 212. Authorization of appropriations. 

Sec. 213. Effective date. 

TITLE III—MISCELLANEOUS PROVISIONS 

Sec. 301. Guarantee agency collection retention. 

Sec. 302. Severability. 

1 DIVISION A—PAUL WELLSTONE 

2 MENTAL HEALTH AND ADDIC3 TION EQUITY ACT OF 2008 

4 SEC. 101. SHORT TITLE. 

5 This division may be cited as the ‘‘Paul Wellstone 

6 Mental Health and Addiction Equity Act of 2008’’. 

7 SEC. 102. AMENDMENTS TO THE EMPLOYEE RETIREMENT 

8 INCOME SECURITY ACT OF 1974. 

9 (a) EXTENSION OF PARITY TO TREATMENT LIMITS

10 AND BENEFICIARY FINANCIAL REQUIREMENTS.—Section 

11 712 of the Employee Retirement Income Security Act of 

12 1974 (29 U.S.C. 1185a) is amended— 

13 (1) in subsection (a), by adding at the end the 

14 following new paragraphs: 

15 ‘‘(3) TREATMENT LIMITS.—In the case of a 

16 group health plan that provides both medical and 
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1 surgical benefits and mental health or substance-re2 lated disorder benefits— 

3 ‘‘(A) NO TREATMENT LIMIT.—If the plan 

4 or coverage does not include a treatment limit 

5 (as defined in subparagraph (D)) on substan6 tially all medical and surgical benefits in any 

7 category of items or services, the plan or cov8 erage may not impose any treatment limit on 

9 mental health or substance-related disorder 

10 benefits that are classified in the same category 

11 of items or services. 

12 ‘‘(B) TREATMENT LIMIT.—If the plan or 

13 coverage includes a treatment limit on substan14 tially all medical and surgical benefits in any 

15 category of items or services, the plan or cov16 erage may not impose such a treatment limit on 

17 mental health or substance-related disorder 

18 benefits for items and services within such cat19 egory that is more restrictive than the predomi20 nant treatment limit that is applicable to med21 ical and surgical benefits for items and services 

22 within such category. 

23 ‘‘(C) CATEGORIES OF ITEMS AND SERV24 ICES FOR APPLICATION OF TREATMENT LIMITS

25 AND BENEFICIARY FINANCIAL REQUIRE-
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1 MENTS.—For purposes of this paragraph and 

2 paragraph (4), there shall be the following five 

3 categories of items and services for benefits, 

4 whether medical and surgical benefits or mental 

5 health and substance-related disorder benefits, 

6 and all medical and surgical benefits and all 

7 mental health and substance related benefits 

8 shall be classified into one of the following cat9 egories: 

10 ‘‘(i) INPATIENT, IN-NETWORK.—Items 

11 and services not described in clause (v) 

12 furnished on an inpatient basis and within 

13 a network of providers established or rec14 ognized under such plan or coverage. 

15 ‘‘(ii) INPATIENT, OUT-OF-NETWORK.— 

16 Items and services not described in clause 

17 (v) furnished on an inpatient basis and 

18 outside any network of providers estab19 lished or recognized under such plan or 

20 coverage. 

21 ‘‘(iii) OUTPATIENT, IN-NETWORK.— 

22 Items and services not described in clause 

23 (v) furnished on an outpatient basis and 

24 within a network of providers established 

25 or recognized under such plan or coverage. 
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1 ‘‘(iv) OUTPATIENT, OUT-OF-NET2 WORK.—Items and services not described 

3 in clause (v) furnished on an outpatient 

4 basis and outside any network of providers 

5 established or recognized under such plan 

6 or coverage. 

7 ‘‘(v) EMERGENCY CARE.—Items and 

8 services, whether furnished on an inpatient 

9 or outpatient basis or within or outside 

10 any network of providers, required for the 

11 treatment of an emergency medical condi12 tion (as defined in section 1867(e) of the 

13 Social Security Act, including an emer14 gency condition relating to mental health 

15 or substance-related disorders). 

16 ‘‘(D) TREATMENT LIMIT DEFINED.—For 

17 purposes of this paragraph, the term ‘treatment 

18 limit’ means, with respect to a plan or coverage, 

19 limitation on the frequency of treatment, num20 ber of visits or days of coverage, or other simi21 lar limit on the duration or scope of treatment 

22 under the plan or coverage. 

23 ‘‘(E) PREDOMINANCE.—For purposes of 

24 this subsection, a treatment limit or financial 

25 requirement with respect to a category of items 
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1 and services is considered to be predominant if 

2 it is the most common or frequent of such type 

3 of limit or requirement with respect to such cat4 egory of items and services. 

5 ‘‘(4) BENEFICIARY FINANCIAL REQUIRE6 MENTS.—In the case of a group health plan that 

7 provides both medical and surgical benefits and 

8 mental health or substance-related disorder bene9 fits— 

10 ‘‘(A) NO BENEFICIARY FINANCIAL RE11 QUIREMENT.—If the plan or coverage does not 

12 include a beneficiary financial requirement (as 

13 defined in subparagraph (C)) on substantially 

14 all medical and surgical benefits within a cat15 egory of items and services (specified under 

16 paragraph (3)(C)), the plan or coverage may 

17 not impose such a beneficiary financial require18 ment on mental health or substance-related dis19 order benefits for items and services within 

20 such category. 

21 ‘‘(B) BENEFICIARY FINANCIAL REQUIRE22 MENT.— 

23 ‘‘(i) TREATMENT OF DEDUCTIBLES, 

24 OUT-OF-POCKET LIMITS, AND SIMILAR FI25 NANCIAL REQUIREMENTS.—If the plan or 
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1 coverage includes a deductible, a limitation 

2 on out-of-pocket expenses, or similar bene3 ficiary financial requirement that does not 

4 apply separately to individual items and 

5 services on substantially all medical and 

6 surgical benefits within a category of items 

7 and services (as specified in paragraph 

8 (3)(C)), the plan or coverage shall apply 

9 such requirement (or, if there is more than 

10 one such requirement for such category of 

11 items and services, the predominant re12 quirement for such category) both to med13 ical and surgical benefits within such cat14 egory and to mental health and substance15 related disorder benefits within such cat16 egory and shall not distinguish in the ap17 plication of such requirement between such 

18 medical and surgical benefits and such 

19 mental health and substance-related dis20 order benefits. 

21 ‘‘(ii) OTHER FINANCIAL REQUIRE22 MENTS.—If the plan or coverage includes a 

23 beneficiary financial requirement not de24 scribed in clause (i) on substantially all 

25 medical and surgical benefits within a cat-
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1 egory of items and services, the plan or 

2 coverage may not impose such financial re3 quirement on mental health or substance4 related disorder benefits for items and 

5 services within such category in a way that 

6 results in greater out-of-pocket expenses to 

7 the participant or beneficiary than the pre8 dominant beneficiary financial requirement 

9 applicable to medical and surgical benefits 

10 for items and services within such cat11 egory. 

12 ‘‘(C) BENEFICIARY FINANCIAL REQUIRE13 MENT DEFINED.—For purposes of this para14 graph, the term ‘beneficiary financial require15 ment’ includes, with respect to a plan or cov16 erage, any deductible, coinsurance, co-payment, 

17 other cost sharing, and limitation on the total 

18 amount that may be paid by a participant or 

19 beneficiary with respect to benefits under the 

20 plan or coverage, but does not include the appli21 cation of any aggregate lifetime limit or annual 

22 limit.’’; and 

23 (2) in subsection (b)— 
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1 (A) by striking ‘‘construed—’’ and all that 

2 follows through ‘‘(1) as requiring’’ and insert3 ing ‘‘construed as requiring’’; 

4 (B) by striking ‘‘; or’’ and inserting a pe5 riod; and 

6 (C) by striking paragraph (2). 

7 (b) EXPANSION TO SUBSTANCE-RELATED DISORDER

8 BENEFITS AND REVISION OF DEFINITION.—Such section 

9 is further amended— 

10 (1) by striking ‘‘mental health benefits’’ each 

11 place it appears (other than in any provision amend12 ed by paragraph (2)) and inserting ‘‘mental health 

13 or substance-related disorder benefits’’, 

14 (2) by striking ‘‘mental health benefits’’ each 

15 place it appears in subsections (a)(1)(B)(i), 

16 (a)(1)(C), (a)(2)(B)(i), and (a)(2)(C) and inserting 

17 ‘‘mental health and substance-related disorder bene18 fits’’, and 

19 (3) in subsection (e), by striking paragraph (4) 

20 and inserting the following new paragraphs: 

21 ‘‘(4) MENTAL HEALTH BENEFITS.—The term 

22 ‘mental health benefits’ means benefits with respect 

23 to services for mental health conditions, as defined 

24 under the terms of the plan and in accordance with 
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1 applicable law, but does not include substance-re2 lated disorder benefits. 

3 ‘‘(5) SUBSTANCE-RELATED DISORDER BENE4 FITS.—The term ‘substance-related disorder bene5 fits’ means benefits with respect to services for sub6 stance-related disorders, as defined under the terms 

7 of the plan and in accordance with applicable law.’’. 

8 (c) AVAILABILITY OF PLAN INFORMATION ABOUT

9 CRITERIA FOR MEDICAL NECESSITY.—Subsection (a) of 

10 such section, as amended by subsection (a)(1), is further 

11 amended by adding at the end the following new para12 graph: 

13 ‘‘(5) AVAILABILITY OF PLAN INFORMATION.— 

14 The criteria for medical necessity determinations 

15 made under the plan with respect to mental health 

16 and substance-related disorder benefits (or the 

17 health insurance coverage offered in connection with 

18 the plan with respect to such benefits) shall be made 

19 available by the plan administrator (or the health in20 surance issuer offering such coverage) in accordance 

21 with regulations to any current or potential partici22 pant, beneficiary, or contracting provider upon re23 quest. The reason for any denial under the plan (or 

24 coverage) of reimbursement or payment for services 

25 with respect to mental health and substance-related 
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1 disorder benefits in the case of any participant or 

2 beneficiary shall, on request or as otherwise re3 quired, be made available by the plan administrator 

4 (or the health insurance issuer offering such cov5 erage) to the participant or beneficiary in accord6 ance with regulations.’’. 

7 (d) MINIMUM BENEFIT REQUIREMENTS.—Sub8 section (a) of such section is further amended by adding 

9 at the end the following new paragraph: 

10 ‘‘(6) MINIMUM SCOPE OF COVERAGE AND EQ11 UITY IN OUT-OF-NETWORK BENEFITS.— 

12 ‘‘(A) MINIMUM SCOPE OF MENTAL

13 HEALTH AND SUBSTANCE-RELATED DISORDER

14 BENEFITS.—In the case of a group health plan 

15 (or health insurance coverage offered in connec16 tion with such a plan) that provides any mental 

17 health or substance-related disorder benefits, 

18 the plan or coverage shall include benefits for 

19 any mental health condition or substance-re20 lated disorder included in the most recent edi21 tion of the Diagnostic and Statistical Manual of 

22 Mental Disorders published by the American 

23 Psychiatric Association. 

24 ‘‘(B) EQUITY IN COVERAGE OF OUT-OF25 NETWORK BENEFITS.— 
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1 ‘‘(i) IN GENERAL.—In the case of a 

2 plan or coverage that provides both med3 ical and surgical benefits and mental 

4 health or substance-related disorder bene5 fits, if medical and surgical benefits are 

6 provided for substantially all items and 

7 services in a category specified in clause 

8 (ii) furnished outside any network of pro9 viders established or recognized under such 

10 plan or coverage, the mental health and 

11 substance-related disorder benefits shall 

12 also be provided for items and services in 

13 such category furnished outside any net14 work of providers established or recognized 

15 under such plan or coverage in accordance 

16 with the requirements of this section. 

17 ‘‘(ii) CATEGORIES OF ITEMS AND

18 SERVICES.—For purposes of clause (i), 

19 there shall be the following three categories 

20 of items and services for benefits, whether 

21 medical and surgical benefits or mental 

22 health and substance-related disorder bene23 fits, and all medical and surgical benefits 

24 and all mental health and substance-re-
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1 lated disorder benefits shall be classified 

2 into one of the following categories: 

3 ‘‘(I) EMERGENCY.—Items and 

4 services, whether furnished on an in5 patient or outpatient basis, required 

6 for the treatment of an emergency 

7 medical condition (as defined in sec8 tion 1867(e) of the Social Security 

9 Act, including an emergency condition 

10 relating to mental health or sub11 stance-related disorders). 

12 ‘‘(II) INPATIENT.—Items and 

13 services not described in subclause (I) 

14 furnished on an inpatient basis. 

15 ‘‘(III) OUTPATIENT.—Items and 

16 services not described in subclause (I) 

17 furnished on an outpatient basis.’’. 

18 (e) REVISION OF INCREASED COST EXEMPTION.— 

19 Paragraph (2) of subsection (c) of such section is amended 

20 to read as follows: 

21 ‘‘(2) INCREASED COST EXEMPTION.— 

22 ‘‘(A) IN GENERAL.—With respect to a 

23 group health plan (or health insurance coverage 

24 offered in connection with such a plan), if the 

25 application of this section to such plan (or cov-
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1 erage) results in an increase for the plan year 

2 involved of the actual total costs of coverage 

3 with respect to medical and surgical benefits 

4 and mental health and substance-related dis5 order benefits under the plan (as determined 

6 and certified under subparagraph (C)) by an 

7 amount that exceeds the applicable percentage 

8 described in subparagraph (B) of the actual 

9 total plan costs, the provisions of this section 

10 shall not apply to such plan (or coverage) dur11 ing the following plan year, and such exemption 

12 shall apply to the plan (or coverage) for 1 plan 

13 year. 

14 ‘‘(B) APPLICABLE PERCENTAGE.—With re15 spect to a plan (or coverage), the applicable 

16 percentage described in this paragraph shall 

17 be— 

18 ‘‘(i) 2 percent in the case of the first 

19 plan year to which this paragraph applies; 

20 and 

21 ‘‘(ii) 1 percent in the case of each 

22 subsequent plan year. 

23 ‘‘(C) DETERMINATIONS BY ACTUARIES.— 

24 Determinations as to increases in actual costs 

25 under a plan (or coverage) for purposes of this 
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1 subsection shall be made in writing and pre2 pared and certified by a qualified and licensed 

3 actuary who is a member in good standing of 

4 the American Academy of Actuaries. Such de5 terminations shall be made available by the 

6 plan administrator (or health insurance issuer, 

7 as the case may be) to the general public. 

8 ‘‘(D) 6-MONTH DETERMINATIONS.—If a 

9 group health plan (or a health insurance issuer 

10 offering coverage in connection with such a 

11 plan) seeks an exemption under this paragraph, 

12 determinations under subparagraph (A) shall be 

13 made after such plan (or coverage) has com14 plied with this section for the first 6 months of 

15 the plan year involved. 

16 ‘‘(E) NOTIFICATION.—An election to mod17 ify coverage of mental health and substance-re18 lated disorder benefits as permitted under this 

19 paragraph shall be treated as a material modi20 fication in the terms of the plan as described in 

21 section 102(a) and notice of which shall be pro22 vided a reasonable period in advance of the 

23 change. 

24 ‘‘(F) NOTIFICATION OF APPROPRIATE

25 AGENCY.— 
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1 ‘‘(i) IN GENERAL.—A group health 

2 plan that, based on a certification de3 scribed under subparagraph (C), qualifies 

4 for an exemption under this paragraph, 

5 and elects to implement the exemption, 

6 shall notify the Department of Labor of 

7 such election. 

8 ‘‘(ii) REQUIREMENT.—A notification 

9 under clause (i) shall include— 

10 ‘‘(I) a description of the number 

11 of covered lives under the plan (or 

12 coverage) involved at the time of the 

13 notification, and as applicable, at the 

14 time of any prior election of the cost15 exemption under this paragraph by 

16 such plan (or coverage); 

17 ‘‘(II) for both the plan year upon 

18 which a cost exemption is sought and 

19 the year prior, a description of the ac20 tual total costs of coverage with re21 spect to medical and surgical benefits 

22 and mental health and substance-re23 lated disorder benefits under the plan; 

24 and 
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1 ‘‘(III) for both the plan year 

2 upon which a cost exemption is sought 

3 and the year prior, the actual total 

4 costs of coverage with respect to men5 tal health and substance-related dis6 order benefits under the plan. 

7 ‘‘(iii) CONFIDENTIALITY.—A notifica8 tion under clause (i) shall be confidential. 

9 The Department of Labor shall make 

10 available, upon request to the appropriate 

11 committees of Congress and on not more 

12 than an annual basis, an anonymous 

13 itemization of such notifications, that in14 cludes— 

15 ‘‘(I) a breakdown of States by 

16 the size and any type of employers 

17 submitting such notification; and 

18 ‘‘(II) a summary of the data re19 ceived under clause (ii). 

20 ‘‘(G) NO IMPACT ON APPLICATION OF

21 STATE LAW.—The fact that a plan or coverage 

22 is exempt from the provisions of this section 

23 under subparagraph (A) shall not affect the ap24 plication of State law to such plan or coverage. 
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1 ‘‘(H) CONSTRUCTION.—Nothing in this 

2 paragraph shall be construed as preventing a 

3 group health plan (or health insurance coverage 

4 offered in connection with such a plan) from 

5 complying with the provisions of this section 

6 notwithstanding that the plan or coverage is not 

7 required to comply with such provisions due to 

8 the application of subparagraph (A).’’. 

9 (f) CHANGE IN EXCLUSION FOR SMALLEST EMPLOY10 ERS.—Subsection (c)(1)(B) of such section is amended— 

11 (1) by inserting ‘‘(or 1 in the case of an em12 ployer residing in a State that permits small groups 

13 to include a single individual)’’ after ‘‘at least 2’’ the 

14 first place it appears; and 

15 (2) by striking ‘‘and who employs at least 2 em16 ployees on the first day of the plan year’’. 

17 (g) ELIMINATION OF SUNSET PROVISION.—Such sec18 tion is amended by striking subsection (f). 

19 (h) CLARIFICATION REGARDING PREEMPTION.— 

20 Such section is further amended by inserting after sub21 section (e) the following new subsection: 

22 ‘‘(f) PREEMPTION, RELATION TO STATE LAWS.— 

23 ‘‘(1) IN GENERAL.—This part shall not be con24 strued to supersede any provision of State law which 

25 establishes, implements, or continues in effect any 
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1 consumer protections, benefits, methods of access to 

2 benefits, rights, external review programs, or rem3 edies solely relating to health insurance issuers in 

4 connection with group health insurance coverage (in5 cluding benefit mandates or regulation of group 

6 health plans of 50 or fewer employees) except to the 

7 extent that such provision prevents the application 

8 of a requirement of this part. 

9 ‘‘(2) CONTINUED PREEMPTION WITH RESPECT

10 TO GROUP HEALTH PLANS.—Nothing in this section 

11 shall be construed to affect or modify the provisions 

12 of section 514 with respect to group health plans. 

13 ‘‘(3) OTHER STATE LAWS.—Nothing in this sec14 tion shall be construed to exempt or relieve any per15 son from any laws of any State not solely related to 

16 health insurance issuers in connection with group 

17 health coverage insofar as they may now or here18 after relate to insurance, health plans, or health cov19 erage.’’. 

20 (i) CONFORMING AMENDMENTS TO HEADING.— 

21 (1) IN GENERAL.—The heading of such section 

22 is amended to read as follows: 
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1 ‘‘SEC. 712. EQUITY IN MENTAL HEALTH AND SUBSTANCE2 RELATED DISORDER BENEFITS.’’. 

3 (2) CLERICAL AMENDMENT.—The table of con4 tents in section 1 of such Act is amended by striking 

5 the item relating to section 712 and inserting the 

6 following new item: 

‘‘Sec. 712. Equity in mental health and substance-related disorder benefits.’’. 

7 (j) EFFECTIVE DATE.— 

8 (1) IN GENERAL.—The amendments made by 

9 this section shall apply with respect to plan years be10 ginning on or after January 1, 2009. 

11 (2) SPECIAL RULE FOR COLLECTIVE BAR12 GAINING AGREEMENTS.—In the case of a group 

13 health plan maintained pursuant to one or more col14 lective bargaining agreements between employee rep15 resentatives and one or more employers ratified be16 fore the date of the enactment of this Act, the 

17 amendments made by this section shall not apply to 

18 plan years beginning before the later of— 

19 (A) the date on which the last of the col20 lective bargaining agreements relating to the 

21 plan terminates (determined without regard to 

22 any extension thereof agreed to after the date 

23 of the enactment of this Act), or 

24 (B) January 1, 2009. 
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1 For purposes of subparagraph (A), any plan amend2 ment made pursuant to a collective bargaining 

3 agreement relating to the plan which amends the 

4 plan solely to conform to any requirement added by 

5 this section shall not be treated as a termination of 

6 such collective bargaining agreement. 

7 (k) DOL ANNUAL SAMPLE COMPLIANCE.—The Sec8 retary of Labor shall annually sample and conduct random 

9 audits of group health plans (and health insurance cov10 erage offered in connection with such plans) in order to 

11 determine their compliance with the amendments made by 

12 this division and shall submit to the appropriate commit13 tees of Congress an annual report on such compliance with 

14 such amendments. The Secretary shall share the results 

15 of such audits with the Secretaries of Health and Human 

16 Services and of the Treasury. 

17 (l) ASSISTANCE TO PARTICIPANTS AND BENE18 FICIARIES.—The Secretary of Labor shall provide assist19 ance to participants and beneficiaries of group health 

20 plans with any questions or problems with compliance with 

21 the requirements of this division. The Secretary shall no22 tify participants and beneficiaries how they can obtain as23 sistance from State consumer and insurance agencies and 

24 the Secretary shall coordinate with State agencies to en-
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1 sure that participants and beneficiaries are protected and 

2 afforded the rights provided under this division. 

3 SEC. 103. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 

4 ACT RELATING TO THE GROUP MARKET. 

5 (a) EXTENSION OF PARITY TO TREATMENT LIMITS

6 AND BENEFICIARY FINANCIAL REQUIREMENTS.—Section 

7 2705 of the Public Health Service Act (42 U.S.C. 300gg– 

8 5) is amended— 

9 (1) in subsection (a), by adding at the end the 

10 following new paragraphs: 

11 ‘‘(3) TREATMENT LIMITS.—In the case of a 

12 group health plan that provides both medical and 

13 surgical benefits and mental health or substance-re14 lated disorder benefits— 

15 ‘‘(A) NO TREATMENT LIMIT.—If the plan 

16 or coverage does not include a treatment limit 

17 (as defined in subparagraph (D)) on substan18 tially all medical and surgical benefits in any 

19 category of items or services (specified in sub20 paragraph (C)), the plan or coverage may not 

21 impose any treatment limit on mental health or 

22 substance-related disorder benefits that are 

23 classified in the same category of items or serv24 ices. 
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1 ‘‘(B) TREATMENT LIMIT.—If the plan or 

2 coverage includes a treatment limit on substan3 tially all medical and surgical benefits in any 

4 category of items or services, the plan or cov5 erage may not impose such a treatment limit on 

6 mental health or substance-related disorder 

7 benefits for items and services within such cat8 egory that is more restrictive than the predomi9 nant treatment limit that is applicable to med10 ical and surgical benefits for items and services 

11 within such category. 

12 ‘‘(C) CATEGORIES OF ITEMS AND SERV13 ICES FOR APPLICATION OF TREATMENT LIMITS

14 AND BENEFICIARY FINANCIAL REQUIRE15 MENTS.—For purposes of this paragraph and 

16 paragraph (4), there shall be the following five 

17 categories of items and services for benefits, 

18 whether medical and surgical benefits or mental 

19 health and substance-related disorder benefits, 

20 and all medical and surgical benefits and all 

21 mental health and substance related benefits 

22 shall be classified into one of the following cat23 egories: 

24 ‘‘(i) INPATIENT, IN-NETWORK.—Items 

25 and services not described in clause (v) 
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1 furnished on an inpatient basis and within 

2 a network of providers established or rec3 ognized under such plan or coverage. 

4 ‘‘(ii) INPATIENT, OUT-OF-NETWORK.— 

5 Items and services not described in clause 

6 (v) furnished on an inpatient basis and 

7 outside any network of providers estab8 lished or recognized under such plan or 

9 coverage. 

10 ‘‘(iii) OUTPATIENT, IN-NETWORK.— 

11 Items and services not described in clause 

12 (v) furnished on an outpatient basis and 

13 within a network of providers established 

14 or recognized under such plan or coverage. 

15 ‘‘(iv) OUTPATIENT, OUT-OF-NET16 WORK.—Items and services not described 

17 in clause (v) furnished on an outpatient 

18 basis and outside any network of providers 

19 established or recognized under such plan 

20 or coverage. 

21 ‘‘(v) EMERGENCY CARE.—Items and 

22 services, whether furnished on an inpatient 

23 or outpatient basis or within or outside 

24 any network of providers, required for the 

25 treatment of an emergency medical condi-
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1 tion (as defined in section 1867(e) of the 

2 Social Security Act, including an emer3 gency condition relating to mental health 

4 or substance-related disorders). 

5 ‘‘(D) TREATMENT LIMIT DEFINED.—For 

6 purposes of this paragraph, the term ‘treatment 

7 limit’ means, with respect to a plan or coverage, 

8 limitation on the frequency of treatment, num9 ber of visits or days of coverage, or other simi10 lar limit on the duration or scope of treatment 

11 under the plan or coverage. 

12 ‘‘(E) PREDOMINANCE.—For purposes of 

13 this subsection, a treatment limit or financial 

14 requirement with respect to a category of items 

15 and services is considered to be predominant if 

16 it is the most common or frequent of such type 

17 of limit or requirement with respect to such cat18 egory of items and services. 

19 ‘‘(4) BENEFICIARY FINANCIAL REQUIRE20 MENTS.—In the case of a group health plan that 

21 provides both medical and surgical benefits and 

22 mental health or substance-related disorder bene23 fits— 

24 ‘‘(A) NO BENEFICIARY FINANCIAL RE25 QUIREMENT.—If the plan or coverage does not 
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1 include a beneficiary financial requirement (as 

2 defined in subparagraph (C)) on substantially 

3 all medical and surgical benefits within a cat4 egory of items and services (specified in para5 graph (3)(C)), the plan or coverage may not im6 pose such a beneficiary financial requirement on 

7 mental health or substance-related disorder 

8 benefits for items and services within such cat9 egory. 

10 ‘‘(B) BENEFICIARY FINANCIAL REQUIRE11 MENT.— 

12 ‘‘(i) TREATMENT OF DEDUCTIBLES, 

13 OUT-OF-POCKET LIMITS, AND SIMILAR FI14 NANCIAL REQUIREMENTS.—If the plan or 

15 coverage includes a deductible, a limitation 

16 on out-of-pocket expenses, or similar bene17 ficiary financial requirement that does not 

18 apply separately to individual items and 

19 services on substantially all medical and 

20 surgical benefits within a category of items 

21 and services, the plan or coverage shall 

22 apply such requirement (or, if there is 

23 more than one such requirement for such 

24 category of items and services, the pre25 dominant requirement for such category) 
28 

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1 both to medical and surgical benefits with2 in such category and to mental health and 

3 substance-related disorder benefits within 

4 such category and shall not distinguish in 

5 the application of such requirement be6 tween such medical and surgical benefits 

7 and such mental health and substance-re8 lated disorder benefits. 

9 ‘‘(ii) OTHER FINANCIAL REQUIRE10 MENTS.—If the plan or coverage includes a 

11 beneficiary financial requirement not de12 scribed in clause (i) on substantially all 

13 medical and surgical benefits within a cat14 egory of items and services, the plan or 

15 coverage may not impose such financial re16 quirement on mental health or substance17 related disorder benefits for items and 

18 services within such category in a way that 

19 results in greater out-of-pocket expenses to 

20 the participant or beneficiary than the pre21 dominant beneficiary financial requirement 

22 applicable to medical and surgical benefits 

23 for items and services within such cat24 egory. 
29 

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1 ‘‘(C) BENEFICIARY FINANCIAL REQUIRE2 MENT DEFINED.—For purposes of this para3 graph, the term ‘beneficiary financial require4 ment’ includes, with respect to a plan or cov5 erage, any deductible, coinsurance, co-payment, 

6 other cost sharing, and limitation on the total 

7 amount that may be paid by a participant or 

8 beneficiary with respect to benefits under the 

9 plan or coverage, but does not include the appli10 cation of any aggregate lifetime limit or annual 

11 limit.’’; and 

12 (2) in subsection (b)— 

13 (A) by striking ‘‘construed—’’ and all that 

14 follows through ‘‘(1) as requiring’’ and insert15 ing ‘‘construed as requiring’’; 

16 (B) by striking ‘‘; or’’ and inserting a pe17 riod; and 

18 (C) by striking paragraph (2). 

19 (b) EXPANSION TO SUBSTANCE-RELATED DISORDER

20 BENEFITS AND REVISION OF DEFINITION.—Such section 

21 is further amended— 

22 (1) by striking ‘‘mental health benefits’’ each 

23 place it appears (other than in any provision amend24 ed by paragraph (2)) and inserting ‘‘mental health 

25 or substance-related disorder benefits’’, 
30 

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1 (2) by striking ‘‘mental health benefits’’ each 

2 place it appears in subsections (a)(1)(B)(i), 

3 (a)(1)(C), (a)(2)(B)(i), and (a)(2)(C) and inserting 

4 ‘‘mental health and substance-related disorder bene5 fits’’, and 

6 (3) in subsection (e), by striking paragraph (4) 

7 and inserting the following new paragraphs: 

8 ‘‘(4) MENTAL HEALTH BENEFITS.—The term 

9 ‘mental health benefits’ means benefits with respect 

10 to services for mental health conditions, as defined 

11 under the terms of the plan and in accordance with 

12 applicable law, but does not include substance-re13 lated disorder benefits. 

14 ‘‘(5) SUBSTANCE-RELATED DISORDER BENE15 FITS.—The term ‘substance-related disorder bene16 fits’ means benefits with respect to services for sub17 stance-related disorders, as defined under the terms 

18 of the plan and in accordance with applicable law.’’. 

19 (c) AVAILABILITY OF PLAN INFORMATION ABOUT

20 CRITERIA FOR MEDICAL NECESSITY.—Subsection (a) of 

21 such section, as amended by subsection (a)(1), is further 

22 amended by adding at the end the following new para23 graph: 

24 ‘‘(5) AVAILABILITY OF PLAN INFORMATION.— 

25 The criteria for medical necessity determinations 
31 

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1 made under the plan with respect to mental health 

2 and substance-related disorder benefits (or the 

3 health insurance coverage offered in connection with 

4 the plan with respect to such benefits) shall be made 

5 available by the plan administrator (or the health in6 surance issuer offering such coverage) in accordance 

7 with regulations to any current or potential partici8 pant, beneficiary, or contracting provider upon re9 quest. The reason for any denial under the plan (or 

10 coverage) of reimbursement or payment for services 

11 with respect to mental health and substance-related 

12 disorder benefits in the case of any participant or 

13 beneficiary shall, on request or as otherwise re14 quired, be made available by the plan administrator 

15 (or the health insurance issuer offering such cov16 erage) to the participant or beneficiary in accord17 ance with regulations.’’. 

18 (d) MINIMUM BENEFIT REQUIREMENTS.—Sub19 section (a) of such section is further amended by adding 

20 at the end the following new paragraph: 

21 ‘‘(6) MINIMUM SCOPE OF COVERAGE AND EQ22 UITY IN OUT-OF-NETWORK BENEFITS.— 

23 ‘‘(A) MINIMUM SCOPE OF MENTAL

24 HEALTH AND SUBSTANCE-RELATED DISORDER

25 BENEFITS.—In the case of a group health plan 
32 

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1 (or health insurance coverage offered in connec2 tion with such a plan) that provides any mental 

3 health or substance-related disorder benefits, 

4 the plan or coverage shall include benefits for 

5 any mental health condition or substance-re6 lated disorder included in the most recent edi7 tion of the Diagnostic and Statistical Manual of 

8 Mental Disorders published by the American 

9 Psychiatric Association. 

10 ‘‘(B) EQUITY IN COVERAGE OF OUT-OF11 NETWORK BENEFITS.— 

12 ‘‘(i) IN GENERAL.—In the case of a 

13 group health plan (or health insurance cov14 erage offered in connection with such a 

15 plan) that provides both medical and sur16 gical benefits and mental health or sub17 stance-related disorder benefits, if medical 

18 and surgical benefits are provided for sub19 stantially all items and services in a cat20 egory specified in clause (ii) furnished out21 side any network of providers established 

22 or recognized under such plan or coverage, 

23 the mental health and substance-related 

24 disorder benefits shall also be provided for 

25 items and services in such category fur-
33 

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1 nished outside any network of providers es2 tablished or recognized under such plan or 

3 coverage in accordance with the require4 ments of this section. 

5 ‘‘(ii) CATEGORIES OF ITEMS AND

6 SERVICES.—For purposes of clause (i), 

7 there shall be the following three categories 

8 of items and services for benefits, whether 

9 medical and surgical benefits or mental 

10 health and substance-related disorder bene11 fits, and all medical and surgical benefits 

12 and all mental health and substance-re13 lated disorder benefits shall be classified 

14 into one of the following categories: 

15 ‘‘(I) EMERGENCY.—Items and 

16 services, whether furnished on an in17 patient or outpatient basis, required 

18 for the treatment of an emergency 

19 medical condition (as defined in sec20 tion 1867(e) of the Social Security 

21 Act, including an emergency condition 

22 relating to mental health or sub23 stance-related disorders). 
34 

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1 ‘‘(II) INPATIENT.—Items and 

2 services not described in subclause (I) 

3 furnished on an inpatient basis. 

4 ‘‘(III) OUTPATIENT.—Items and 

5 services not described in subclause (I) 

6 furnished on an outpatient basis.’’. 

7 (e) REVISION OF INCREASED COST EXEMPTION.— 

8 Paragraph (2) of subsection (c) of such section is amended 

9 to read as follows: 

10 ‘‘(2) INCREASED COST EXEMPTION.— 

11 ‘‘(A) IN GENERAL.—With respect to a 

12 group health plan (or health insurance coverage 

13 offered in connection with such a plan), if the 

14 application of this section to such plan (or cov15 erage) results in an increase for the plan year 

16 involved of the actual total costs of coverage 

17 with respect to medical and surgical benefits 

18 and mental health and substance-related dis19 order benefits under the plan (as determined 

20 and certified under subparagraph (C)) by an 

21 amount that exceeds the applicable percentage 

22 described in subparagraph (B) of the actual 

23 total plan costs, the provisions of this section 

24 shall not apply to such plan (or coverage) dur25 ing the following plan year, and such exemption 
35 

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1 shall apply to the plan (or coverage) for 1 plan 

2 year. 

3 ‘‘(B) APPLICABLE PERCENTAGE.—With re4 spect to a plan (or coverage), the applicable 

5 percentage described in this paragraph shall 

6 be— 

7 ‘‘(i) 2 percent in the case of the first 

8 plan year to which this paragraph applies; 

9 and 

10 ‘‘(ii) 1 percent in the case of each 

11 subsequent plan year. 

12 ‘‘(C) DETERMINATIONS BY ACTUARIES.— 

13 Determinations as to increases in actual costs 

14 under a plan (or coverage) for purposes of this 

15 subsection shall be made in writing and pre16 pared and certified by a qualified and licensed 

17 actuary who is a member in good standing of 

18 the American Academy of Actuaries. Such de19 terminations shall be made available by the 

20 plan administrator (or health insurance issuer, 

21 as the case may be) to the general public. 

22 ‘‘(D) 6-MONTH DETERMINATIONS.—If a 

23 group health plan (or a health insurance issuer 

24 offering coverage in connection with such a 

25 plan) seeks an exemption under this paragraph, 
36 

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1 determinations under subparagraph (A) shall be 

2 made after such plan (or coverage) has com3 plied with this section for the first 6 months of 

4 the plan year involved. 

5 ‘‘(E) NOTIFICATION.—A group health plan 

6 under this part shall comply with the notice re7 quirement under section 712(c)(2)(E) of the 

8 Employee Retirement Income Security Act of 

9 1974 with respect to a modification of mental 

10 health and substance-related disorder benefits 

11 as permitted under this paragraph as if such 

12 section applied to such plan. 

13 ‘‘(F) NOTIFICATION OF APPROPRIATE

14 AGENCY.— 

15 ‘‘(i) IN GENERAL.—A group health 

16 plan that, based on a certification de17 scribed under subparagraph (C), qualifies 

18 for an exemption under this paragraph, 

19 and elects to implement the exemption, 

20 shall notify the Secretary of Health and 

21 Human Services of such election. 

22 ‘‘(ii) REQUIREMENT.—A notification 

23 under clause (i) shall include— 

24 ‘‘(I) a description of the number 

25 of covered lives under the plan (or 
37 

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1 coverage) involved at the time of the 

2 notification, and as applicable, at the 

3 time of any prior election of the cost4 exemption under this paragraph by 

5 such plan (or coverage); 

6 ‘‘(II) for both the plan year upon 

7 which a cost exemption is sought and 

8 the year prior, a description of the ac9 tual total costs of coverage with re10 spect to medical and surgical benefits 

11 and mental health and substance-re12 lated disorder benefits under the plan; 

13 and 

14 ‘‘(III) for both the plan year 

15 upon which a cost exemption is sought 

16 and the year prior, the actual total 

17 costs of coverage with respect to men18 tal health and substance-related dis19 order benefits under the plan. 

20 ‘‘(iii) CONFIDENTIALITY.—A notifica21 tion under clause (i) shall be confidential. 

22 The Secretary of Health and Human Serv23 ices shall make available, upon request to 

24 the appropriate committees of Congress 

25 and on not more than an annual basis, an 
38 

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1 anonymous itemization of such notifica2 tions, that includes— 

3 ‘‘(I) a breakdown of States by 

4 the size and any type of employers 

5 submitting such notification; and 

6 ‘‘(II) a summary of the data re7 ceived under clause (ii). 

8 ‘‘(G) CONSTRUCTION.—Nothing in this 

9 paragraph shall be construed as preventing a 

10 group health plan (or health insurance coverage 

11 offered in connection with such a plan) from 

12 complying with the provisions of this section 

13 notwithstanding that the plan or coverage is not 

14 required to comply with such provisions due to 

15 the application of subparagraph (A).’’. 

16 (f) CHANGE IN EXCLUSION FOR SMALLEST EMPLOY17 ERS.—Subsection (c)(1)(B) of such section is amended— 

18 (1) by inserting ‘‘(or 1 in the case of an em19 ployer residing in a State that permits small groups 

20 to include a single individual)’’ after ‘‘at least 2’’ the 

21 first place it appears; and 

22 (2) by striking ‘‘and who employs at least 2 em23 ployees on the first day of the plan year’’. 

24 (g) ELIMINATION OF SUNSET PROVISION.—Such sec25 tion is amended by striking out subsection (f). 
39 

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1 (h) CLARIFICATION REGARDING PREEMPTION.— 

2 Such section is further amended by inserting after sub3 section (e) the following new subsection: 

4 ‘‘(f) PREEMPTION, RELATION TO STATE LAWS.— 

5 ‘‘(1) IN GENERAL.—Nothing in this section 

6 shall be construed to preempt any State law that 

7 provides greater consumer protections, benefits, 

8 methods of access to benefits, rights or remedies 

9 that are greater than the protections, benefits, meth10 ods of access to benefits, rights or remedies provided 

11 under this section. 

12 ‘‘(2) CONSTRUCTION.—Nothing in this section 

13 shall be construed to affect or modify the provisions 

14 of section 2723 with respect to group health plans.’’. 

15 (i) CONFORMING AMENDMENT TO HEADING.—The 

16 heading of such section is amended to read as follows: 

17 ‘‘SEC. 2705. EQUITY IN MENTAL HEALTH AND SUBSTANCE18 RELATED DISORDER BENEFITS.’’. 

19 (j) EFFECTIVE DATE.— 

20 (1) IN GENERAL.—Except as otherwise pro21 vided in this subsection, the amendments made by 

22 this section shall apply with respect to plan years be23 ginning on or after January 1, 2009. 
40 

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1 (2) ELIMINATION OF SUNSET.—The amend2 ment made by subsection (g) shall apply to benefits 

3 for services furnished after December 31, 2007. 

4 (3) SPECIAL RULE FOR COLLECTIVE BAR5 GAINING AGREEMENTS.—In the case of a group 

6 health plan maintained pursuant to one or more col7 lective bargaining agreements between employee rep8 resentatives and one or more employers ratified be9 fore the date of the enactment of this Act, the 

10 amendments made by this section shall not apply to 

11 plan years beginning before the later of— 

12 (A) the date on which the last of the col13 lective bargaining agreements relating to the 

14 plan terminates (determined without regard to 

15 any extension thereof agreed to after the date 

16 of the enactment of this Act), or 

17 (B) January 1, 2009. 

18 For purposes of subparagraph (A), any plan amend19 ment made pursuant to a collective bargaining 

20 agreement relating to the plan which amends the 

21 plan solely to conform to any requirement added by 

22 this section shall not be treated as a termination of 

23 such collective bargaining agreement. 
41 

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1 SEC. 104. AMENDMENTS TO THE INTERNAL REVENUE CODE 

2 OF 1986. 

3 (a) EXTENSION OF PARITY TO TREATMENT LIMITS

4 AND BENEFICIARY FINANCIAL REQUIREMENTS.—Section 

5 9812 of the Internal Revenue Code of 1986 is amended— 

6 (1) in subsection (a), by adding at the end the 

7 following new paragraphs: 

8 ‘‘(3) TREATMENT LIMITS.—In the case of a 

9 group health plan that provides both medical and 

10 surgical benefits and mental health or substance-re11 lated disorder benefits— 

12 ‘‘(A) NO TREATMENT LIMIT.—If the plan 

13 does not include a treatment limit (as defined 

14 in subparagraph (D)) on substantially all med15 ical and surgical benefits in any category of 

16 items or services (specified in subparagraph 

17 (C)), the plan may not impose any treatment 

18 limit on mental health or substance-related dis19 order benefits that are classified in the same 

20 category of items or services. 

21 ‘‘(B) TREATMENT LIMIT.—If the plan in22 cludes a treatment limit on substantially all 

23 medical and surgical benefits in any category of 

24 items or services, the plan may not impose such 

25 a treatment limit on mental health or sub26 stance-related disorder benefits for items and 
42 

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1 services within such category that is more re2 strictive than the predominant treatment limit 

3 that is applicable to medical and surgical bene4 fits for items and services within such category. 

5 ‘‘(C) CATEGORIES OF ITEMS AND SERV6 ICES FOR APPLICATION OF TREATMENT LIMITS

7 AND BENEFICIARY FINANCIAL REQUIRE8 MENTS.—For purposes of this paragraph and 

9 paragraph (4), there shall be the following five 

10 categories of items and services for benefits, 

11 whether medical and surgical benefits or mental 

12 health and substance-related disorder benefits, 

13 and all medical and surgical benefits and all 

14 mental health and substance related benefits 

15 shall be classified into one of the following cat16 egories: 

17 ‘‘(i) INPATIENT, IN-NETWORK.—Items 

18 and services not described in clause (v) 

19 furnished on an inpatient basis and within 

20 a network of providers established or rec21 ognized under such plan. 

22 ‘‘(ii) INPATIENT, OUT-OF-NETWORK.— 

23 Items and services not described in clause 

24 (v) furnished on an inpatient basis and 
43 

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1 outside any network of providers estab2 lished or recognized under such plan. 

3 ‘‘(iii) OUTPATIENT, IN-NETWORK.— 

4 Items and services not described in clause 

5 (v) furnished on an outpatient basis and 

6 within a network of providers established 

7 or recognized under such plan. 

8 ‘‘(iv) OUTPATIENT, OUT-OF-NET9 WORK.—Items and services not described 

10 in clause (v) furnished on an outpatient 

11 basis and outside any network of providers 

12 established or recognized under such plan. 

13 ‘‘(v) EMERGENCY CARE.—Items and 

14 services, whether furnished on an inpatient 

15 or outpatient basis or within or outside 

16 any network of providers, required for the 

17 treatment of an emergency medical condi18 tion (as defined in section 1867(e) of the 

19 Social Security Act, including an emer20 gency condition relating to mental health 

21 or substance-related disorders). 

22 ‘‘(D) TREATMENT LIMIT DEFINED.—For 

23 purposes of this paragraph, the term ‘treatment 

24 limit’ means, with respect to a plan, limitation 

25 on the frequency of treatment, number of visits 
44 

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1 or days of coverage, or other similar limit on 

2 the duration or scope of treatment under the 

3 plan. 

4 ‘‘(E) PREDOMINANCE.—For purposes of 

5 this subsection, a treatment limit or financial 

6 requirement with respect to a category of items 

7 and services is considered to be predominant if 

8 it is the most common or frequent of such type 

9 of limit or requirement with respect to such cat10 egory of items and services. 

11 ‘‘(4) BENEFICIARY FINANCIAL REQUIRE12 MENTS.—In the case of a group health plan that 

13 provides both medical and surgical benefits and 

14 mental health or substance-related disorder bene15 fits— 

16 ‘‘(A) NO BENEFICIARY FINANCIAL RE17 QUIREMENT.—If the plan does not include a 

18 beneficiary financial requirement (as defined in 

19 subparagraph (C)) on substantially all medical 

20 and surgical benefits within a category of items 

21 and services (specified in paragraph (3)(C)), 

22 the plan may not impose such a beneficiary fi23 nancial requirement on mental health or sub24 stance-related disorder benefits for items and 

25 services within such category. 
45 

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1 ‘‘(B) BENEFICIARY FINANCIAL REQUIRE2 MENT.— 

3 ‘‘(i) TREATMENT OF DEDUCTIBLES, 

4 OUT-OF-POCKET LIMITS, AND SIMILAR FI5 NANCIAL REQUIREMENTS.—If the plan in6 cludes a deductible, a limitation on out-of7 pocket expenses, or similar beneficiary fi8 nancial requirement that does not apply 

9 separately to individual items and services 

10 on substantially all medical and surgical 

11 benefits within a category of items and 

12 services, the plan shall apply such require13 ment (or, if there is more than one such 

14 requirement for such category of items and 

15 services, the predominant requirement for 

16 such category) both to medical and sur17 gical benefits within such category and to 

18 mental health and substance-related dis19 order benefits within such category and 

20 shall not distinguish in the application of 

21 such requirement between such medical 

22 and surgical benefits and such mental 

23 health and substance-related disorder bene24 fits. 
46 

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1 ‘‘(ii) OTHER FINANCIAL REQUIRE2 MENTS.—If the plan includes a beneficiary 

3 financial requirement not described in 

4 clause (i) on substantially all medical and 

5 surgical benefits within a category of items 

6 and services, the plan may not impose such 

7 financial requirement on mental health or 

8 substance-related disorder benefits for 

9 items and services within such category in 

10 a way that results in greater out-of-pocket 

11 expenses to the participant or beneficiary 

12 than the predominant beneficiary financial 

13 requirement applicable to medical and sur14 gical benefits for items and services within 

15 such category. 

16 ‘‘(C) BENEFICIARY FINANCIAL REQUIRE17 MENT DEFINED.—For purposes of this para18 graph, the term ‘beneficiary financial require19 ment’ includes, with respect to a plan, any de20 ductible, coinsurance, co-payment, other cost 

21 sharing, and limitation on the total amount 

22 that may be paid by a participant or beneficiary 

23 with respect to benefits under the plan, but 

24 does not include the application of any aggre25 gate lifetime limit or annual limit.’’, and 
47 

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1 (2) in subsection (b)— 

2 (A) by striking ‘‘construed—’’ and all that 

3 follows through ‘‘(1) as requiring’’ and insert4 ing ‘‘construed as requiring’’, 

5 (B) by striking ‘‘; or’’ and inserting a pe6 riod, and 

7 (C) by striking paragraph (2). 

8 (b) EXPANSION TO SUBSTANCE-RELATED DISORDER

9 BENEFITS AND REVISION OF DEFINITION.—Section 9812 

10 of such Code is further amended— 

11 (1) by striking ‘‘mental health benefits’’ each 

12 place it appears (other than in any provision amend13 ed by paragraph (2)) and inserting ‘‘mental health 

14 or substance-related disorder benefits’’, 

15 (2) by striking ‘‘mental health benefits’’ each 

16 place it appears in subsections (a)(1)(B)(i), 

17 (a)(1)(C), (a)(2)(B)(i), and (a)(2)(C) and inserting 

18 ‘‘mental health and substance-related disorder bene19 fits’’, and 

20 (3) in subsection (e), by striking paragraph (4) 

21 and inserting the following new paragraphs: 

22 ‘‘(4) MENTAL HEALTH BENEFITS.—The term 

23 ‘mental health benefits’ means benefits with respect 

24 to services for mental health conditions, as defined 

25 under the terms of the plan and in accordance with 
48 

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1 applicable law, but does not include substance-re2 lated disorder benefits. 

3 ‘‘(5) SUBSTANCE-RELATED DISORDER BENE4 FITS.—The term ‘substance-related disorder bene5 fits’ means benefits with respect to services for sub6 stance-related disorders, as defined under the terms 

7 of the plan and in accordance with applicable law.’’. 

8 (c) AVAILABILITY OF PLAN INFORMATION ABOUT

9 CRITERIA FOR MEDICAL NECESSITY.—Subsection (a) of 

10 section 9812 of such Code, as amended by subsection 

11 (a)(1), is further amended by adding at the end the fol12 lowing new paragraph: 

13 ‘‘(5) AVAILABILITY OF PLAN INFORMATION.— 

14 The criteria for medical necessity determinations 

15 made under the plan with respect to mental health 

16 and substance-related disorder benefits shall be 

17 made available by the plan administrator in accord18 ance with regulations to any current or potential 

19 participant, beneficiary, or contracting provider upon 

20 request. The reason for any denial under the plan of 

21 reimbursement or payment for services with respect 

22 to mental health and substance-related disorder ben23 efits in the case of any participant or beneficiary 

24 shall, on request or as otherwise required, be made 
49 

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1 available by the plan administrator to the partici2 pant or beneficiary in accordance with regulations.’’. 

3 (d) MINIMUM BENEFIT REQUIREMENTS.—Sub4 section (a) of section 9812 of such Code is further amend5 ed by adding at the end the following new paragraph: 

6 ‘‘(6) MINIMUM SCOPE OF COVERAGE AND EQ7 UITY IN OUT-OF-NETWORK BENEFITS.— 

8 ‘‘(A) MINIMUM SCOPE OF MENTAL

9 HEALTH AND SUBSTANCE-RELATED DISORDER

10 BENEFITS.—In the case of a group health plan 

11 that provides any mental health or substance12 related disorder benefits, the plan shall include 

13 benefits for any mental health condition or sub14 stance-related disorder included in the most re15 cent edition of the Diagnostic and Statistical 

16 Manual of Mental Disorders published by the 

17 American Psychiatric Association. 

18 ‘‘(B) EQUITY IN COVERAGE OF OUT-OF19 NETWORK BENEFITS.— 

20 ‘‘(i) IN GENERAL.—In the case of a 

21 group health plan that provides both med22 ical and surgical benefits and mental 

23 health or substance-related disorder bene24 fits, if medical and surgical benefits are 

25 provided for substantially all items and 
50 

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1 services in a category specified in clause 

2 (ii) furnished outside any network of pro3 viders established or recognized under such 

4 plan, the mental health and substance-re5 lated disorder benefits shall also be pro6 vided for items and services in such cat7 egory furnished outside any network of 

8 providers established or recognized under 

9 such plan in accordance with the require10 ments of this section. 

11 ‘‘(ii) CATEGORIES OF ITEMS AND

12 SERVICES.—For purposes of clause (i), 

13 there shall be the following three categories 

14 of items and services for benefits, whether 

15 medical and surgical benefits or mental 

16 health and substance-related disorder bene17 fits, and all medical and surgical benefits 

18 and all mental health and substance-re19 lated disorder benefits shall be classified 

20 into one of the following categories: 

21 ‘‘(I) EMERGENCY.—Items and 

22 services, whether furnished on an in23 patient or outpatient basis, required 

24 for the treatment of an emergency 

25 medical condition (as defined in sec-
51 

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1 tion 1867(e) of the Social Security 

2 Act, including an emergency condition 

3 relating to mental health or sub4 stance-related disorders). 

5 ‘‘(II) INPATIENT.—Items and 

6 services not described in subclause (I) 

7 furnished on an inpatient basis. 

8 ‘‘(III) OUTPATIENT.—Items and 

9 services not described in subclause (I) 

10 furnished on an outpatient basis.’’. 

11 (e) REVISION OF INCREASED COST EXEMPTION.— 

12 Paragraph (2) of section 9812(c) of such Code is amended 

13 to read as follows: 

14 ‘‘(2) INCREASED COST EXEMPTION.— 

15 ‘‘(A) IN GENERAL.—With respect to a 

16 group health plan, if the application of this sec17 tion to such plan results in an increase for the 

18 plan year involved of the actual total costs of 

19 coverage with respect to medical and surgical 

20 benefits and mental health and substance-re21 lated disorder benefits under the plan (as deter22 mined and certified under subparagraph (C)) by 

23 an amount that exceeds the applicable percent24 age described in subparagraph (B) of the actual 

25 total plan costs, the provisions of this section 
52 

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1 shall not apply to such plan during the fol2 lowing plan year, and such exemption shall 

3 apply to the plan for 1 plan year. 

4 ‘‘(B) APPLICABLE PERCENTAGE.—With re5 spect to a plan, the applicable percentage de6 scribed in this paragraph shall be— 

7 ‘‘(i) 2 percent in the case of the first 

8 plan year to which this paragraph applies, 

9 and 

10 ‘‘(ii) 1 percent in the case of each 

11 subsequent plan year. 

12 ‘‘(C) DETERMINATIONS BY ACTUARIES.— 

13 Determinations as to increases in actual costs 

14 under a plan for purposes of this subsection 

15 shall be made in writing and prepared and cer16 tified by a qualified and licensed actuary who is 

17 a member in good standing of the American 

18 Academy of Actuaries. Such determinations 

19 shall be made available by the plan adminis20 trator to the general public. 

21 ‘‘(D) 6-MONTH DETERMINATIONS.—If a 

22 group health plan seeks an exemption under 

23 this paragraph, determinations under subpara24 graph (A) shall be made after such plan has 
53 

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1 complied with this section for the first 6 

2 months of the plan year involved. 

3 ‘‘(E) NOTIFICATION OF APPROPRIATE

4 AGENCY.— 

5 ‘‘(i) IN GENERAL.—A group health 

6 plan that, based on a certification de7 scribed under subparagraph (C), qualifies 

8 for an exemption under this paragraph, 

9 and elects to implement the exemption, 

10 shall notify the Secretary of the Treasury 

11 of such election. 

12 ‘‘(ii) REQUIREMENT.—A notification 

13 under clause (i) shall include— 

14 ‘‘(I) a description of the number 

15 of covered lives under the plan (or 

16 coverage) involved at the time of the 

17 notification, and as applicable, at the 

18 time of any prior election of the cost19 exemption under this paragraph by 

20 such plan (or coverage); 

21 ‘‘(II) for both the plan year upon 

22 which a cost exemption is sought and 

23 the year prior, a description of the ac24 tual total costs of coverage with re25 spect to medical and surgical benefits 
54 

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1 and mental health and substance-re2 lated disorder benefits under the plan; 

3 and 

4 ‘‘(III) for both the plan year 

5 upon which a cost exemption is sought 

6 and the year prior, the actual total 

7 costs of coverage with respect to men8 tal health and substance-related dis9 order benefits under the plan. 

10 ‘‘(iii) CONFIDENTIALITY.—A notifica11 tion under clause (i) shall be confidential. 

12 The Secretary of the Treasury shall make 

13 available, upon request to the appropriate 

14 committees of Congress and on not more 

15 than an annual basis, an anonymous 

16 itemization of such notifications, that in17 cludes— 

18 ‘‘(I) a breakdown of States by 

19 the size and any type of employers 

20 submitting such notification; and 

21 ‘‘(II) a summary of the data re22 ceived under clause (ii). 

23 ‘‘(F) CONSTRUCTION.—Nothing in this 

24 paragraph shall be construed as preventing a 

25 group health plan from complying with the pro-
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1 visions of this section notwithstanding that the 

2 plan is not required to comply with such provi3 sions due to the application of subparagraph 

4 (A).’’. 

5 (f) CHANGE IN EXCLUSION FOR SMALLEST EMPLOY6 ERS.—Paragraph (1) of section 9812(c) of such Code is 

7 amended to read as follows: 

8 ‘‘(1) SMALL EMPLOYER EXEMPTION.— 

9 ‘‘(A) IN GENERAL.—This section shall not 

10 apply to any group health plan for any plan 

11 year of a small employer. 

12 ‘‘(B) SMALL EMPLOYER.—For purposes of 

13 subparagraph (A), the term ‘small employer’ 

14 means, with respect to a calendar year and a 

15 plan year, an employer who employed an aver16 age of at least 2 (or 1 in the case of an em17 ployer residing in a State that permits small 

18 groups to include a single individual) but not 

19 more than 50 employees on business days dur20 ing the preceding calendar year. For purposes 

21 of the preceding sentence, all persons treated as 

22 a single employer under subsection (b), (c), 

23 (m), or (o) of section 414 shall be treated as 1 

24 employer and rules similar to rules of subpara-
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1 graphs (B) and (C) of section 4980D(d)(2) 

2 shall apply.’’. 

3 (g) ELIMINATION OF SUNSET PROVISION.—Section 

4 9812 of such Code is amended by striking subsection (f). 

5 (h) CONFORMING AMENDMENTS TO HEADING.— 

6 (1) IN GENERAL.—The heading of section 9812 

7 of such Code is amended to read as follows: 

8 ‘‘SEC. 9812. EQUITY IN MENTAL HEALTH AND SUBSTANCE9 RELATED DISORDER BENEFITS.’’. 

10 (2) CLERICAL AMENDMENT.—The table of sec11 tions for subchapter B of chapter 100 of such Code 

12 is amended by striking the item relating to section 

13 9812 and inserting the following new item: 

‘‘Sec. 9812. Equity in mental health and substance-related disorder benefits.’’. 

14 (i) EFFECTIVE DATE.— 

15 (1) IN GENERAL.—Except as otherwise pro16 vided in this subsection, the amendments made by 

17 this section shall apply with respect to plan years be18 ginning on or after January 1, 2009. 

19 (2) ELIMINATION OF SUNSET.—The amend20 ment made by subsection (g) shall apply to benefits 

21 for services furnished after December 31, 2007. 

22 (3) SPECIAL RULE FOR COLLECTIVE BAR23 GAINING AGREEMENTS.—In the case of a group 

24 health plan maintained pursuant to one or more col25 lective bargaining agreements between employee rep-
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1 resentatives and one or more employers ratified be2 fore the date of the enactment of this Act, the 

3 amendments made by this section (other than sub4 section (g)) shall not apply to plan years beginning 

5 before the later of— 

6 (A) the date on which the last of the col7 lective bargaining agreements relating to the 

8 plan terminates (determined without regard to 

9 any extension thereof agreed to after the date 

10 of the enactment of this Act), or 

11 (B) January 1, 2009. 

12 For purposes of subparagraph (A), any plan amend13 ment made pursuant to a collective bargaining 

14 agreement relating to the plan which amends the 

15 plan solely to conform to any requirement added by 

16 this section shall not be treated as a termination of 

17 such collective bargaining agreement. 

18 SEC. 105. MEDICAID DRUG REBATE. 

19 Paragraph (1)(B)(i) of section 1927(c) of the Social 

20 Security Act (42 U.S.C. 1396r–8(c)) is amended— 

21 (1) by striking ‘‘and’’ at the end of subclause 

22 (IV); 

23 (2) in subclause (V)— 
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1 (A) by inserting ‘‘and before January 1, 

2 2009, and after December 31, 2014,’’ after 

3 ‘‘December 31, 1995,’’; and 

4 (B) by striking the period at the end and 

5 inserting ‘‘; and’’; and 

6 (3) by adding at the end the following new sub7 clause: 

8 ‘‘(VI) after December 31, 2008, 

9 and before January 1, 2015, is 20.1 

10 percent.’’. 

11 SEC. 106. LIMITATION ON MEDICARE EXCEPTION TO THE 

12 PROHIBITION ON CERTAIN PHYSICIAN RE13 FERRALS FOR HOSPITALS. 

14 (a) IN GENERAL.—Section 1877 of the Social Secu15 rity Act (42 U.S.C. 1395nn) is amended— 

16 (1) in subsection (d)(2)— 

17 (A) in subparagraph (A), by striking 

18 ‘‘and’’ at the end; 

19 (B) in subparagraph (B), by striking the 

20 period at the end and inserting ‘‘; and’’; and 

21 (C) by adding at the end the following new 

22 subparagraph: 

23 ‘‘(C) in the case where the entity is a hos24 pital, the hospital meets the requirements of 

25 paragraph (3)(D).’’; 
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1 (2) in subsection (d)(3)— 

2 (A) in subparagraph (B), by striking 

3 ‘‘and’’ at the end; 

4 (B) in subparagraph (C), by striking the 

5 period at the end and inserting ‘‘; and’’; and 

6 (C) by adding at the end the following new 

7 subparagraph: 

8 ‘‘(D) the hospital meets the requirements 

9 described in subsection (i)(1) not later than 18 

10 months after the date of the enactment of this 

11 subparagraph.’’; and 

12 (3) by adding at the end the following new sub13 section: 

14 ‘‘(i) REQUIREMENTS FOR HOSPITALS TO QUALIFY

15 FOR HOSPITAL EXCEPTION TO OWNERSHIP OR INVEST16 MENT PROHIBITION.— 

17 ‘‘(1) REQUIREMENTS DESCRIBED.—For pur18 poses of subsection (d)(3)(D), the requirements de19 scribed in this paragraph for a hospital are as fol20 lows: 

21 ‘‘(A) PROVIDER AGREEMENT.—The hos22 pital had— 

23 ‘‘(i) physician ownership on the date 

24 of enactment of this subsection; and 
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1 ‘‘(ii) a provider agreement under sec2 tion 1866 in effect on such date of enact3 ment. 

4 ‘‘(B) LIMITATION ON EXPANSION OF FA5 CILITY CAPACITY.—Except as provided in para6 graph (3), the number of operating rooms and 

7 beds of the hospital at any time on or after the 

8 date of the enactment of this subsection are no 

9 greater than the number of operating rooms 

10 and beds as of such date. 

11 ‘‘(C) PREVENTING CONFLICTS OF INTER12 EST.— 

13 ‘‘(i) The hospital submits to the Sec14 retary an annual report containing a de15 tailed description of— 

16 ‘‘(I) the identity of each physi17 cian owner and any other owners of 

18 the hospital; and 

19 ‘‘(II) the nature and extent of all 

20 ownership interests in the hospital. 

21 ‘‘(ii) The hospital has procedures in 

22 place to require that any referring physi23 cian owner discloses to the patient being 

24 referred, by a time that permits the pa25 tient to make a meaningful decision re-
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1 garding the receipt of care, as determined 

2 by the Secretary— 

3 ‘‘(I) the ownership interest of 

4 such referring physician in the hos5 pital; and 

6 ‘‘(II) if applicable, any such own7 ership interest of the treating physi8 cian. 

9 ‘‘(iii) The hospital does not condition 

10 any physician ownership interests either di11 rectly or indirectly on the physician owner 

12 making or influencing referrals to the hos13 pital or otherwise generating business for 

14 the hospital. 

15 ‘‘(iv) The hospital discloses the fact 

16 that the hospital is partially owned by phy17 sicians— 

18 ‘‘(I) on any public website for the 

19 hospital; and 

20 ‘‘(II) in any public advertising 

21 for the hospital. 

22 ‘‘(D) ENSURING BONA FIDE INVEST23 MENT.— 

24 ‘‘(i) Physician owners in the aggregate 

25 do not own more than 40 percent of the 
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1 total value of the investment interests held 

2 in the hospital or in an entity whose assets 

3 include the hospital. 

4 ‘‘(ii) The investment interest of any 

5 individual physician owner does not exceed 

6 2 percent of the total value of the invest7 ment interests held in the hospital or in an 

8 entity whose assets include the hospital. 

9 ‘‘(iii) Any ownership or investment in10 terests that the hospital offers to a physi11 cian owner are not offered on more favor12 able terms than the terms offered to a per13 son who is not a physician owner. 

14 ‘‘(iv) The hospital (or any investors in 

15 the hospital) does not directly or indirectly 

16 provide loans or financing for any physi17 cian owner investments in the hospital. 

18 ‘‘(v) The hospital (or any investors in 

19 the hospital) does not directly or indirectly 

20 guarantee a loan, make a payment toward 

21 a loan, or otherwise subsidize a loan, for 

22 any individual physician owner or group of 

23 physician owners that is related to acquir24 ing any ownership interest in the hospital. 
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1 ‘‘(vi) Investment returns are distrib2 uted to each investor in the hospital in an 

3 amount that is directly proportional to the 

4 investment of capital by such investor in 

5 the hospital. 

6 ‘‘(vii) Physician owners do not receive, 

7 directly or indirectly, any guaranteed re8 ceipt of or right to purchase other business 

9 interests related to the hospital, including 

10 the purchase or lease of any property 

11 under the control of other investors in the 

12 hospital or located near the premises of the 

13 hospital. 

14 ‘‘(viii) The hospital does not offer a 

15 physician owner the opportunity to pur16 chase or lease any property under the con17 trol of the hospital or any other investor in 

18 the hospital on more favorable terms than 

19 the terms offered to an individual who is 

20 not a physician owner. 

21 ‘‘(E) PATIENT SAFETY.— 

22 ‘‘(i) Insofar as the hospital admits a 

23 patient and does not have any physician 

24 available on the premises to provide serv25 ices during all hours in which the hospital 
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1 is providing services to such patient, before 

2 admitting the patient— 

3 ‘‘(I) the hospital discloses such 

4 fact to a patient; and 

5 ‘‘(II) following such disclosure, 

6 the hospital receives from the patient 

7 a signed acknowledgment that the pa8 tient understands such fact. 

9 ‘‘(ii) The hospital has the capacity 

10 to— 

11 ‘‘(I) provide assessment and ini12 tial treatment for patients; and 

13 ‘‘(II) refer and transfer patients 

14 to hospitals with the capability to 

15 treat the needs of the patient in16 volved. 

17 ‘‘(2) PUBLICATION OF INFORMATION RE18 PORTED.—The Secretary shall publish, and update 

19 on an annual basis, the information submitted by 

20 hospitals under paragraph (1)(C)(i) on the public 

21 Internet website of the Centers for Medicare & Med22 icaid Services. 

23 ‘‘(3) EXCEPTION TO PROHIBITION ON EXPAN24 SION OF FACILITY CAPACITY.— 

25 ‘‘(A) PROCESS.— 
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1 ‘‘(i) ESTABLISHMENT.—The Secretary 

2 shall establish and implement a process 

3 under which an applicable hospital (as de4 fined in subparagraph (E)) may apply for 

5 an exception from the requirement under 

6 paragraph (1)(B). 

7 ‘‘(ii) OPPORTUNITY FOR COMMUNITY

8 INPUT.—The process under clause (i) shall 

9 provide individuals and entities in the com10 munity that the applicable hospital apply11 ing for an exception is located with the op12 portunity to provide input with respect to 

13 the application. 

14 ‘‘(iii) TIMING FOR IMPLEMENTA15 TION.—The Secretary shall implement the 

16 process under clause (i) on the date that is 

17 18 months after the date of enactment of 

18 this subsection. 

19 ‘‘(iv) REGULATIONS.—Not later than 

20 the date that is 18 months after the date 

21 of enactment of this subsection, the Sec22 retary shall promulgate regulations to 

23 carry out the process under clause (i). 

24 ‘‘(B) FREQUENCY.—The process described 

25 in subparagraph (A) shall permit an applicable 
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1 hospital to apply for an exception up to once 

2 every 2 years. 

3 ‘‘(C) PERMITTED INCREASE.— 

4 ‘‘(i) IN GENERAL.—Subject to clause 

5 (ii) and subparagraph (D), an applicable 

6 hospital granted an exception under the 

7 process described in subparagraph (A) may 

8 increase the number of operating rooms 

9 and beds of the applicable hospital above 

10 the baseline number of operating rooms 

11 and beds of the applicable hospital (or, if 

12 the applicable hospital has been granted a 

13 previous exception under this paragraph, 

14 above the number of operating rooms and 

15 beds of the hospital after the application of 

16 the most recent increase under such an ex17 ception) by an amount determined appro18 priate by the Secretary. 

19 ‘‘(ii) LIFETIME 50 PERCENT INCREASE

20 LIMITATION.—The Secretary shall not per21 mit an increase in the number of operating 

22 rooms and beds of an applicable hospital 

23 under clause (i) to the extent such increase 

24 would result in the number of operating 

25 rooms and beds of the applicable hospital 
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1 exceeding 150 percent of the baseline num2 ber of operating rooms and beds of the ap3 plicable hospital. 

4 ‘‘(iii) BASELINE NUMBER OF OPER5 ATING ROOMS AND BEDS.—In this para6 graph, the term ‘baseline number of oper7 ating rooms and beds’ means the number 

8 of operating rooms and beds of the appli9 cable hospital as of the date of enactment 

10 of this subsection. 

11 ‘‘(D) INCREASE LIMITED TO FACILITIES

12 ON THE MAIN CAMPUS OF THE HOSPITAL.— 

13 Any increase in the number of operating rooms 

14 and beds of an applicable hospital pursuant to 

15 this paragraph may only occur in facilities on 

16 the main campus of the applicable hospital. 

17 ‘‘(E) APPLICABLE HOSPITAL.—In this 

18 paragraph, the term ‘applicable hospital’ means 

19 a hospital— 

20 ‘‘(i) that is located in a county in 

21 which the percentage increase in the popu22 lation during the most recent 5-year period 

23 (as of the date of the application under 

24 subparagraph (A)) is at least 200 percent 

25 of the percentage increase in the popu-
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1 lation growth of the United States during 

2 that period, as estimated by Bureau of the 

3 Census; 

4 ‘‘(ii) whose annual percent of total in5 patient admissions and outpatient visits 

6 that represent inpatient admissions and 

7 outpatient visits under the program under 

8 title XIX is equal to or greater than the 

9 average percent with respect to such ad10 missions and visits for all hospitals located 

11 in the State; 

12 ‘‘(iii) that does not discriminate 

13 against beneficiaries of Federal health care 

14 programs and does not permit physicians 

15 practicing at the hospital to discriminate 

16 against such beneficiaries; 

17 ‘‘(iv) that is located in a State in 

18 which the average bed capacity in the 

19 State is less than the national average bed 

20 capacity; and 

21 ‘‘(v) in the case of a hospital lo22 cated— 

23 ‘‘(I) in a core-based statistical 

24 area, that is located in such an area 

25 in which the average bed occupancy 
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1 rate in such area is greater than 80 

2 percent; or 

3 ‘‘(II) outside of a core-based sta4 tistical area, that is located in a State 

5 in which the average bed occupancy 

6 rate is greater than 80 percent. 

7 ‘‘(F) PUBLICATION OF FINAL DECI8 SIONS.—The Secretary shall publish final deci9 sions with respect to applications under this 

10 paragraph in the Federal Register. 

11 ‘‘(G) LIMITATION ON REVIEW.—There 

12 shall be no administrative or judicial review 

13 under section 1869, section 1878, or otherwise 

14 of the process under this paragraph (including 

15 the establishment of such process). 

16 ‘‘(4) COLLECTION OF OWNERSHIP AND INVEST17 MENT INFORMATION.—For purposes of clauses (i) 

18 and (ii) of paragraph (1)(D), the Secretary shall col19 lect physician ownership and investment information 

20 for each hospital as it existed on the date of the en21 actment of this subsection. 

22 ‘‘(5) PHYSICIAN OWNER DEFINED.—For pur23 poses of this subsection, the term ‘physician owner’ 

24 means a physician (or an immediate family member 
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1 of such physician) with a direct or an indirect own2 ership interest in the hospital.’’. 

3 (b) ENFORCEMENT.— 

4 (1) ENSURING COMPLIANCE.—The Secretary of 

5 Health and Human Services shall establish policies 

6 and procedures to ensure compliance with the re7 quirements described in subsection (i)(1) of section 

8 1877 of the Social Security Act, as added by sub9 section (a)(3), beginning on the date such require10 ments first apply. Such policies and procedures may 

11 include unannounced site reviews of hospitals. 

12 (2) AUDITS.—Beginning not later than 18 

13 months after the date of the enactment of this Act, 

14 the Secretary of Health and Human Services shall 

15 conduct audits to determine if hospitals violate the 

16 requirements referred to in paragraph (1). 

17 (c) ADJUSTMENT TO PAQI FUND.—Section 

18 1848(l)(2)(A)(i)(III) of the Social Security Act (42 U.S.C. 

19 1395w–4(l)(2)(A)(i)(III)), as amended by section 

20 101(a)(2) of the Medicare, Medicaid, and SCHIP Exten21 sion Act of 2007 (Public Law 110–173), is amended by 

22 striking ‘‘$4,960,000,000’’ and inserting 

23 ‘‘$5,120,000,000’’. 

24 SEC. 107. STUDIES AND REPORTS. 

25 (a) IMPLEMENTATION OF ACT.— 
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1 (1) GAO STUDY.—The Comptroller General of 

2 the United States shall conduct a study that evalu3 ates the effect of the implementation of the amend4 ments made by this division on— 

5 (A) the cost of health insurance coverage; 

6 (B) access to health insurance coverage 

7 (including the availability of in-network pro8 viders); 

9 (C) the quality of health care; 

10 (D) Medicare, Medicaid, and State and 

11 local mental health and substance abuse treat12 ment spending; 

13 (E) the number of individuals with private 

14 insurance who received publicly funded health 

15 care for mental health and substance-related 

16 disorders; 

17 (F) spending on public services, such as 

18 the criminal justice system, special education, 

19 and income assistance programs; 

20 (G) the use of medical management of 

21 mental health and substance-related disorder 

22 benefits and medical necessity determinations 

23 by group health plans (and health insurance 

24 issuers offering health insurance coverage in 

25 connection with such plans) and timely access 
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1 by participants and beneficiaries to clinically-in2 dicated care for mental health and substance3 use disorders; and 

4 (H) other matters as determined appro5 priate by the Comptroller General. 

6 (2) REPORT.—Not later than 2 years after the 

7 date of enactment of this Act, the Comptroller Gen8 eral shall prepare and submit to the appropriate 

9 committees of the Congress a report containing the 

10 results of the study conducted under paragraph (1). 

11 (b) GAO REPORT ON UNIFORM PATIENT PLACE12 MENT CRITERIA.—Not later than 18 months after the 

13 date of the enactment of this Act, the Comptroller General 

14 shall submit to each House of the Congress a report on 

15 availability of uniform patient placement criteria for men16 tal health and substance-related disorders that could be 

17 used by group health plans and health insurance issuers 

18 to guide determinations of medical necessity and the ex19 tent to which health plans utilize such criteria. If such 

20 criteria do not exist, the report shall include recommenda21 tions on a process for developing such criteria. 

22 (c) DOL BIANNUAL REPORT ON ANY OBSTACLES IN

23 OBTAINING COVERAGE.—Every 2 years, the Secretary of 

24 Labor, in consultation with the Secretaries of Health and 

25 Human Services and the Treasury, shall submit to the ap-
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1 propriate committees of each House of the Congress a re2 port on obstacles, if any, that individuals face in obtaining 

3 mental health and substance-related disorder care under 

4 their health plans. 

5 DIVISION B—GENETIC INFORMA6 TION NONDISCRIMINATION 

7 ACT OF 2008 

8 SEC. 100. SHORT TITLE; FINDINGS. 

9 (a) SHORT TITLE.—This division may be cited as the 

10 ‘‘Genetic Information Nondiscrimination Act of 2008’’. 

11 (b) FINDINGS.—Congress makes the following find12 ings: 

13 (1) Deciphering the sequence of the human ge14 nome and other advances in genetics open major 

15 new opportunities for medical progress. New knowl16 edge about the genetic basis of illness will allow for 

17 earlier detection of illnesses, often before symptoms 

18 have begun. Genetic testing can allow individuals to 

19 take steps to reduce the likelihood that they will con20 tract a particular disorder. New knowledge about ge21 netics may allow for the development of better thera22 pies that are more effective against disease or have 

23 fewer side effects than current treatments. These 

24 advances give rise to the potential misuse of genetic 
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1 information to discriminate in health insurance and 

2 employment. 

3 (2) The early science of genetics became the 

4 basis of State laws that provided for the sterilization 

5 of persons having presumed genetic ‘‘defects’’ such 

6 as mental retardation, mental disease, epilepsy, 

7 blindness, and hearing loss, among other conditions. 

8 The first sterilization law was enacted in the State 

9 of Indiana in 1907. By 1981, a majority of States 

10 adopted sterilization laws to ‘‘correct’’ apparent ge11 netic traits or tendencies. Many of these State laws 

12 have since been repealed, and many have been modi13 fied to include essential constitutional requirements 

14 of due process and equal protection. However, the 

15 current explosion in the science of genetics, and the 

16 history of sterilization laws by the States based on 

17 early genetic science, compels Congressional action 

18 in this area. 

19 (3) Although genes are facially neutral markers, 

20 many genetic conditions and disorders are associated 

21 with particular racial and ethnic groups and gender. 

22 Because some genetic traits are most prevalent in 

23 particular groups, members of a particular group 

24 may be stigmatized or discriminated against as a re25 sult of that genetic information. This form of dis-
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1 crimination was evident in the 1970s, which saw the 

2 advent of programs to screen and identify carriers of 

3 sickle cell anemia, a disease which afflicts African4 Americans. Once again, State legislatures began to 

5 enact discriminatory laws in the area, and in the 

6 early 1970s began mandating genetic screening of 

7 all African Americans for sickle cell anemia, leading 

8 to discrimination and unnecessary fear. To alleviate 

9 some of this stigma, Congress in 1972 passed the 

10 National Sickle Cell Anemia Control Act, which 

11 withholds Federal funding from States unless sickle 

12 cell testing is voluntary. 

13 (4) Congress has been informed of examples of 

14 genetic discrimination in the workplace. These in15 clude the use of pre-employment genetic screening at 

16 Lawrence Berkeley Laboratory, which led to a court 

17 decision in favor of the employees in that case Nor18 man-Bloodsaw v. Lawrence Berkeley Laboratory 

19 (135 F.3d 1260, 1269 (9th Cir. 1998)). Congress 

20 clearly has a compelling public interest in relieving 

21 the fear of discrimination and in prohibiting its ac22 tual practice in employment and health insurance. 

23 (5) Federal law addressing genetic discrimina24 tion in health insurance and employment is incom25 plete in both the scope and depth of its protections. 
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1 Moreover, while many States have enacted some type 

2 of genetic non-discrimination law, these laws vary 

3 widely with respect to their approach, application, 

4 and level of protection. Congress has collected sub5 stantial evidence that the American public and the 

6 medical community find the existing patchwork of 

7 State and Federal laws to be confusing and inad8 equate to protect them from discrimination. There9 fore Federal legislation establishing a national and 

10 uniform basic standard is necessary to fully protect 

11 the public from discrimination and allay their con12 cerns about the potential for discrimination, thereby 

13 allowing individuals to take advantage of genetic 

14 testing, technologies, research, and new therapies. 

15 TITLE I—GENETIC NON16 DISCRIMINATION IN HEALTH 

17 INSURANCE 

18 SEC. 101. AMENDMENTS TO EMPLOYEE RETIREMENT IN19 COME SECURITY ACT OF 1974. 

20 (a) NO DISCRIMINATION IN GROUP PREMIUMS

21 BASED ON GENETIC INFORMATION.—Section 702(b) of 

22 the Employee Retirement Income Security Act of 1974 

23 (29 U.S.C. 1182(b)) is amended— 
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1 (1) in paragraph (2)(A), by inserting before the 

2 semicolon the following: ‘‘except as provided in para3 graph (3)’’; and 

4 (2) by adding at the end the following: 

5 ‘‘(3) NO GROUP-BASED DISCRIMINATION ON

6 BASIS OF GENETIC INFORMATION.—For purposes of 

7 this section, a group health plan, and a health insur8 ance issuer offering group health insurance coverage 

9 in connection with a group health plan, may not ad10 just premium or contribution amounts for the group 

11 covered under such plan on the basis of genetic in12 formation.’’. 

13 (b) LIMITATIONS ON GENETIC TESTING; PROHIBI14 TION ON COLLECTION OF GENETIC INFORMATION; APPLI15 CATION TO ALL PLANS.—Section 702 of the Employee 

16 Retirement Income Security Act of 1974 (29 U.S.C. 1182) 

17 is amended by adding at the end the following: 

18 ‘‘(c) GENETIC TESTING.— 

19 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR20 ING GENETIC TESTING.—A group health plan, and a 

21 health insurance issuer offering health insurance 

22 coverage in connection with a group health plan, 

23 shall not request or require an individual or a family 

24 member of such individual to undergo a genetic test. 
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1 ‘‘(2) RULE OF CONSTRUCTION.—Paragraph (1) 

2 shall not be construed to limit the authority of a 

3 health care professional who is providing health care 

4 services to an individual to request that such indi5 vidual undergo a genetic test. 

6 ‘‘(3) RULE OF CONSTRUCTION REGARDING PAY7 MENT.— 

8 ‘‘(A) IN GENERAL.—Nothing in paragraph 

9 (1) shall be construed to preclude a group 

10 health plan, or a health insurance issuer offer11 ing health insurance coverage in connection 

12 with a group health plan, from obtaining and 

13 using the results of a genetic test in making a 

14 determination regarding payment (as such term 

15 is defined for the purposes of applying the regu16 lations promulgated by the Secretary of Health 

17 and Human Services under part C of title XI 

18 of the Social Security Act and section 264 of 

19 the Health Insurance Portability and Account20 ability Act of 1996, as may be revised from 

21 time to time) consistent with subsection (a). 

22 ‘‘(B) LIMITATION.—For purposes of sub23 paragraph (A), a group health plan, or a health 

24 insurance issuer offering health insurance cov25 erage in connection with a group health plan, 
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1 may request only the minimum amount of in2 formation necessary to accomplish the intended 

3 purpose. 

4 ‘‘(4) RESEARCH EXCEPTION.—Notwithstanding 

5 paragraph (1), a group health plan, or a health in6 surance issuer offering health insurance coverage in 

7 connection with a group health plan, may request, 

8 but not require, that a participant or beneficiary un9 dergo a genetic test if each of the following condi10 tions is met: 

11 ‘‘(A) The request is made, in writing, pur12 suant to research that complies with part 46 of 

13 title 45, Code of Federal Regulations, or equiv14 alent Federal regulations, and any applicable 

15 State or local law or regulations for the protec16 tion of human subjects in research. 

17 ‘‘(B) The plan or issuer clearly indicates to 

18 each participant or beneficiary, or in the case of 

19 a minor child, to the legal guardian of such 

20 beneficiary, to whom the request is made that— 

21 ‘‘(i) compliance with the request is 

22 voluntary; and 

23 ‘‘(ii) non-compliance will have no ef24 fect on enrollment status or premium or 

25 contribution amounts. 
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1 ‘‘(C) No genetic information collected or 

2 acquired under this paragraph shall be used for 

3 underwriting purposes. 

4 ‘‘(D) The plan or issuer notifies the Sec5 retary in writing that the plan or issuer is con6 ducting activities pursuant to the exception pro7 vided for under this paragraph, including a de8 scription of the activities conducted. 

9 ‘‘(E) The plan or issuer complies with such 

10 other conditions as the Secretary may by regu11 lation require for activities conducted under this 

12 paragraph. 

13 ‘‘(d) PROHIBITION ON COLLECTION OF GENETIC IN14 FORMATION.— 

15 ‘‘(1) IN GENERAL.—A group health plan, and a 

16 health insurance issuer offering health insurance 

17 coverage in connection with a group health plan, 

18 shall not request, require, or purchase genetic infor19 mation for underwriting purposes (as defined in sec20 tion 733). 

21 ‘‘(2) PROHIBITION ON COLLECTION OF GE22 NETIC INFORMATION PRIOR TO ENROLLMENT.—A 

23 group health plan, and a health insurance issuer of24 fering health insurance coverage in connection with 

25 a group health plan, shall not request, require, or 
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1 purchase genetic information with respect to any in2 dividual prior to such individual’s enrollment under 

3 the plan or coverage in connection with such enroll4 ment. 

5 ‘‘(3) INCIDENTAL COLLECTION.—If a group 

6 health plan, or a health insurance issuer offering 

7 health insurance coverage in connection with a group 

8 health plan, obtains genetic information incidental to 

9 the requesting, requiring, or purchasing of other in10 formation concerning any individual, such request, 

11 requirement, or purchase shall not be considered a 

12 violation of paragraph (2) if such request, require13 ment, or purchase is not in violation of paragraph 

14 (1). 

15 ‘‘(e) APPLICATION TO ALL PLANS.—The provisions 

16 of subsections (a)(1)(F), (b)(3), (c), and (d), and sub17 section (b)(1) and section 701 with respect to genetic in18 formation, shall apply to group health plans and health 

19 insurance issuers without regard to section 732(a).’’. 

20 (c) APPLICATION TO GENETIC INFORMATION OF A

21 FETUS OR EMBRYO.—Such section is further amended by 

22 adding at the end the following: 

23 ‘‘(f) GENETIC INFORMATION OF A FETUS OR EM24 BRYO.—Any reference in this part to genetic information 
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1 concerning an individual or family member of an indi2 vidual shall— 

3 ‘‘(1) with respect to such an individual or fam4 ily member of an individual who is a pregnant 

5 woman, include genetic information of any fetus car6 ried by such pregnant woman; and 

7 ‘‘(2) with respect to an individual or family 

8 member utilizing an assisted reproductive tech9 nology, include genetic information of any embryo le10 gally held by the individual or family member.’’. 

11 (d) DEFINITIONS.—Section 733(d) of the Employee 

12 Retirement Income Security Act of 1974 (29 U.S.C. 

13 1191b(d)) is amended by adding at the end the following: 

14 ‘‘(5) FAMILY MEMBER.—The term ‘family 

15 member’ means, with respect to an individual— 

16 ‘‘(A) a dependent (as such term is used for 

17 purposes of section 701(f)(2)) of such indi18 vidual, and 

19 ‘‘(B) any other individual who is a first-de20 gree, second-degree, third-degree, or fourth-de21 gree relative of such individual or of an indi22 vidual described in subparagraph (A). 

23 ‘‘(6) GENETIC INFORMATION.— 
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1 ‘‘(A) IN GENERAL.—The term ‘genetic in2 formation’ means, with respect to any indi3 vidual, information about— 

4 ‘‘(i) such individual’s genetic tests, 

5 ‘‘(ii) the genetic tests of family mem6 bers of such individual, and 

7 ‘‘(iii) subject to subparagraph (D), 

8 the manifestation of a disease or disorder 

9 in family members of such individual. 

10 ‘‘(B) INCLUSION OF GENETIC SERVICES.— 

11 Such term includes, with respect to any indi12 vidual, any request for, or receipt of, genetic 

13 services (including genetic services received pur14 suant to participation in clinical research) by 

15 such individual or any family member of such 

16 individual. 

17 ‘‘(C) EXCLUSIONS.—The term ‘genetic in18 formation’ shall not include information about 

19 the sex or age of any individual. 

20 ‘‘(D) APPLICATION TO FAMILY MEMBERS

21 COVERED UNDER SAME PLAN.—Information de22 scribed in clause (iii) of subparagraph (A) shall 

23 not be treated as genetic information to the ex24 tent that such information is taken into account 

25 only with respect to the individual in which 
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1 such disease or disorder is manifested and not 

2 as genetic information with respect to any other 

3 individual. 

4 ‘‘(7) GENETIC TEST.— 

5 ‘‘(A) IN GENERAL.—The term ‘genetic 

6 test’ means an analysis of human DNA, RNA, 

7 chromosomes, proteins, or metabolites, that de8 tects genotypes, mutations, or chromosomal 

9 changes. 

10 ‘‘(B) EXCEPTIONS.—The term ‘genetic 

11 test’ does not mean— 

12 ‘‘(i) an analysis of proteins or metabo13 lites that does not detect genotypes, 

14 mutations, or chromosomal changes; or 

15 ‘‘(ii) an analysis of proteins or me16 tabolites that is directly related to a mani17 fested disease, disorder, or pathological 

18 condition that could reasonably be detected 

19 by a health care professional with appro20 priate training and expertise in the field of 

21 medicine involved. 

22 ‘‘(8) GENETIC SERVICES.—The term ‘genetic 

23 services’ means— 

24 ‘‘(A) a genetic test; 
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1 ‘‘(B) genetic counseling (including obtain2 ing, interpreting, or assessing genetic informa3 tion); or 

4 ‘‘(C) genetic education. 

5 ‘‘(9) UNDERWRITING PURPOSES.—The term 

6 ‘underwriting purposes’ means, with respect to any 

7 group health plan, or health insurance coverage of8 fered in connection with a group health plan— 

9 ‘‘(A) rules for, or determination of, eligi10 bility (including enrollment and continued eligi11 bility) for benefits under the plan or coverage; 

12 ‘‘(B) the computation of premium or con13 tribution amounts under the plan or coverage; 

14 ‘‘(C) the application of any pre-existing 

15 condition exclusion under the plan or coverage; 

16 and 

17 ‘‘(D) other activities related to the cre18 ation, renewal, or replacement of a contract of 

19 health insurance or health benefits.’’. 

20 (e) ERISA ENFORCEMENT.—Section 502 of the Em21 ployee Retirement Income Security Act of 1974 (29 

22 U.S.C. 1132) is amended— 

23 (1) in subsection (a)(6), by striking ‘‘(7), or 

24 (8)’’ and inserting ‘‘(7), (8), or (9)’’; and 
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1 (2) in subsection (c), by redesignating para2 graph (9) as paragraph (10), and by inserting after 

3 paragraph (8) the following new paragraph: 

4 ‘‘(9) SECRETARIAL ENFORCEMENT AUTHORITY

5 RELATING TO USE OF GENETIC INFORMATION.— 

6 ‘‘(A) GENERAL RULE.—The Secretary may 

7 impose a penalty against any plan sponsor of a 

8 group health plan, or any health insurance 

9 issuer offering health insurance coverage in 

10 connection with the plan, for any failure by 

11 such sponsor or issuer to meet the requirements 

12 of subsection (a)(1)(F), (b)(3), (c), or (d) of 

13 section 702 or section 701 or 702(b)(1) with re14 spect to genetic information, in connection with 

15 the plan. 

16 ‘‘(B) AMOUNT.— 

17 ‘‘(i) IN GENERAL.—The amount of 

18 the penalty imposed by subparagraph (A) 

19 shall be $100 for each day in the non20 compliance period with respect to each par21 ticipant or beneficiary to whom such fail22 ure relates. 

23 ‘‘(ii) NONCOMPLIANCE PERIOD.—For 

24 purposes of this paragraph, the term ‘non-
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1 compliance period’ means, with respect to 

2 any failure, the period— 

3 ‘‘(I) beginning on the date such 

4 failure first occurs; and 

5 ‘‘(II) ending on the date the fail6 ure is corrected. 

7 ‘‘(C) MINIMUM PENALTIES WHERE FAIL8 URE DISCOVERED.—Notwithstanding clauses (i) 

9 and (ii) of subparagraph (D): 

10 ‘‘(i) IN GENERAL.—In the case of 1 or 

11 more failures with respect to a participant 

12 or beneficiary— 

13 ‘‘(I) which are not corrected be14 fore the date on which the plan re15 ceives a notice from the Secretary of 

16 such violation; and 

17 ‘‘(II) which occurred or continued 

18 during the period involved; 

19 the amount of penalty imposed by subpara20 graph (A) by reason of such failures with 

21 respect to such participant or beneficiary 

22 shall not be less than $2,500. 

23 ‘‘(ii) HIGHER MINIMUM PENALTY

24 WHERE VIOLATIONS ARE MORE THAN DE

25 MINIMIS.—To the extent violations for 
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1 which any person is liable under this para2 graph for any year are more than de mini3 mis, clause (i) shall be applied by sub4 stituting ‘$15,000’ for ‘$2,500’ with re5 spect to such person. 

6 ‘‘(D) LIMITATIONS.— 

7 ‘‘(i) PENALTY NOT TO APPLY WHERE

8 FAILURE NOT DISCOVERED EXERCISING

9 REASONABLE DILIGENCE.—No penalty 

10 shall be imposed by subparagraph (A) on 

11 any failure during any period for which it 

12 is established to the satisfaction of the 

13 Secretary that the person otherwise liable 

14 for such penalty did not know, and exer15 cising reasonable diligence would not have 

16 known, that such failure existed. 

17 ‘‘(ii) PENALTY NOT TO APPLY TO

18 FAILURES CORRECTED WITHIN CERTAIN

19 PERIODS.—No penalty shall be imposed by 

20 subparagraph (A) on any failure if— 

21 ‘‘(I) such failure was due to rea22 sonable cause and not to willful ne23 glect; and 

24 ‘‘(II) such failure is corrected 

25 during the 30-day period beginning on 
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1 the first date the person otherwise lia2 ble for such penalty knew, or exer3 cising reasonable diligence would have 

4 known, that such failure existed. 

5 ‘‘(iii) OVERALL LIMITATION FOR UN6 INTENTIONAL FAILURES.—In the case of 

7 failures which are due to reasonable cause 

8 and not to willful neglect, the penalty im9 posed by subparagraph (A) for failures 

10 shall not exceed the amount equal to the 

11 lesser of— 

12 ‘‘(I) 10 percent of the aggregate 

13 amount paid or incurred by the plan 

14 sponsor (or predecessor plan sponsor) 

15 during the preceding taxable year for 

16 group health plans; or 

17 ‘‘(II) $500,000. 

18 ‘‘(E) WAIVER BY SECRETARY.—In the case 

19 of a failure which is due to reasonable cause 

20 and not to willful neglect, the Secretary may 

21 waive part or all of the penalty imposed by sub22 paragraph (A) to the extent that the payment 

23 of such penalty would be excessive relative to 

24 the failure involved. 
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1 ‘‘(F) DEFINITIONS.—Terms used in this 

2 paragraph which are defined in section 733 

3 shall have the meanings provided such terms in 

4 such section.’’. 

5 (f) REGULATIONS AND EFFECTIVE DATE.— 

6 (1) REGULATIONS.—The Secretary of Labor 

7 shall issue final regulations not later than 1 year 

8 after the date of enactment of this Act to carry out 

9 the amendments made by this section. 

10 (2) EFFECTIVE DATE.—The amendments made 

11 by this section shall apply with respect to group 

12 health plans for plan years beginning after the date 

13 that is 18 months after the date of enactment of 

14 this Act. 

15 SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 

16 ACT. 

17 (a) AMENDMENTS RELATING TO THE GROUP MAR18 KET.— 

19 (1) NO DISCRIMINATION IN GROUP PREMIUMS

20 BASED ON GENETIC INFORMATION.—Section 

21 2702(b) of the Public Health Service Act (42 U.S.C. 

22 300gg–1(b)) is amended— 

23 (A) in paragraph (2)(A), by inserting be24 fore the semicolon the following: ‘‘except as pro25 vided in paragraph (3)’’; and 
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1 (B) by adding at the end the following: 

2 ‘‘(3) NO GROUP-BASED DISCRIMINATION ON

3 BASIS OF GENETIC INFORMATION.—For purposes of 

4 this section, a group health plan, and health insur5 ance issuer offering group health insurance coverage 

6 in connection with a group health plan, may not ad7 just premium or contribution amounts for the group 

8 covered under such plan on the basis of genetic in9 formation.’’. 

10 (2) LIMITATIONS ON GENETIC TESTING; PROHI11 BITION ON COLLECTION OF GENETIC INFORMATION; 

12 APPLICATION TO ALL PLANS.—Section 2702 of the 

13 Public Health Service Act (42 U.S.C. 300gg–1) is 

14 amended by adding at the end the following: 

15 ‘‘(c) GENETIC TESTING.— 

16 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR17 ING GENETIC TESTING.—A group health plan, and a 

18 health insurance issuer offering health insurance 

19 coverage in connection with a group health plan, 

20 shall not request or require an individual or a family 

21 member of such individual to undergo a genetic test. 

22 ‘‘(2) RULE OF CONSTRUCTION.—Paragraph (1) 

23 shall not be construed to limit the authority of a 

24 health care professional who is providing health care 
92 

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1 services to an individual to request that such indi2 vidual undergo a genetic test. 

3 ‘‘(3) RULE OF CONSTRUCTION REGARDING PAY4 MENT.— 

5 ‘‘(A) IN GENERAL.—Nothing in paragraph 

6 (1) shall be construed to preclude a group 

7 health plan, or a health insurance issuer offer8 ing health insurance coverage in connection 

9 with a group health plan, from obtaining and 

10 using the results of a genetic test in making a 

11 determination regarding payment (as such term 

12 is defined for the purposes of applying the regu13 lations promulgated by the Secretary under 

14 part C of title XI of the Social Security Act and 

15 section 264 of the Health Insurance Portability 

16 and Accountability Act of 1996, as may be re17 vised from time to time) consistent with sub18 section (a). 

19 ‘‘(B) LIMITATION.—For purposes of sub20 paragraph (A), a group health plan, or a health 

21 insurance issuer offering health insurance cov22 erage in connection with a group health plan, 

23 may request only the minimum amount of in24 formation necessary to accomplish the intended 

25 purpose. 
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1 ‘‘(4) RESEARCH EXCEPTION.—Notwithstanding 

2 paragraph (1), a group health plan, or a health in3 surance issuer offering health insurance coverage in 

4 connection with a group health plan, may request, 

5 but not require, that a participant or beneficiary un6 dergo a genetic test if each of the following condi7 tions is met: 

8 ‘‘(A) The request is made pursuant to re9 search that complies with part 46 of title 45, 

10 Code of Federal Regulations, or equivalent Fed11 eral regulations, and any applicable State or 

12 local law or regulations for the protection of 

13 human subjects in research. 

14 ‘‘(B) The plan or issuer clearly indicates to 

15 each participant or beneficiary, or in the case of 

16 a minor child, to the legal guardian of such 

17 beneficiary, to whom the request is made that— 

18 ‘‘(i) compliance with the request is 

19 voluntary; and 

20 ‘‘(ii) non-compliance will have no ef21 fect on enrollment status or premium or 

22 contribution amounts. 

23 ‘‘(C) No genetic information collected or 

24 acquired under this paragraph shall be used for 

25 underwriting purposes. 
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1 ‘‘(D) The plan or issuer notifies the Sec2 retary in writing that the plan or issuer is con3 ducting activities pursuant to the exception pro4 vided for under this paragraph, including a de5 scription of the activities conducted. 

6 ‘‘(E) The plan or issuer complies with such 

7 other conditions as the Secretary may by regu8 lation require for activities conducted under this 

9 paragraph. 

10 ‘‘(d) PROHIBITION ON COLLECTION OF GENETIC IN11 FORMATION.— 

12 ‘‘(1) IN GENERAL.—A group health plan, and a 

13 health insurance issuer offering health insurance 

14 coverage in connection with a group health plan, 

15 shall not request, require, or purchase genetic infor16 mation for underwriting purposes (as defined in sec17 tion 2791). 

18 ‘‘(2) PROHIBITION ON COLLECTION OF GE19 NETIC INFORMATION PRIOR TO ENROLLMENT.—A 

20 group health plan, and a health insurance issuer of21 fering health insurance coverage in connection with 

22 a group health plan, shall not request, require, or 

23 purchase genetic information with respect to any in24 dividual prior to such individual’s enrollment under 
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•HR 1424 EH

1 the plan or coverage in connection with such enroll2 ment. 

3 ‘‘(3) INCIDENTAL COLLECTION.—If a group 

4 health plan, or a health insurance issuer offering 

5 health insurance coverage in connection with a group 

6 health plan, obtains genetic information incidental to 

7 the requesting, requiring, or purchasing of other in8 formation concerning any individual, such request, 

9 requirement, or purchase shall not be considered a 

10 violation of paragraph (2) if such request, require11 ment, or purchase is not in violation of paragraph 

12 (1). 

13 ‘‘(e) APPLICATION TO ALL PLANS.—The provisions 

14 of subsections (a)(1)(F), (b)(3), (c) , and (d) and sub15 section (b)(1) and section 2701 with respect to genetic in16 formation, shall apply to group health plans and health 

17 insurance issuers without regard to section 2721(a).’’. 

18 (3) APPLICATION TO GENETIC INFORMATION OF

19 A FETUS OR EMBRYO.—Such section is further 

20 amended by adding at the end the following: 

21 ‘‘(f) GENETIC INFORMATION OF A FETUS OR EM22 BRYO.—Any reference in this part to genetic information 

23 concerning an individual or family member of an indi24 vidual shall— 
96 

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1 ‘‘(1) with respect to such an individual or fam2 ily member of an individual who is a pregnant 

3 woman, include genetic information of any fetus car4 ried by such pregnant woman; and 

5 ‘‘(2) with respect to an individual or family 

6 member utilizing an assisted reproductive tech7 nology, include genetic information of any embryo le8 gally held by the individual or family member.’’. 

9 (4) DEFINITIONS.—Section 2791(d) of the Pub10 lic Health Service Act (42 U.S.C. 300gg–91(d)) is 

11 amended by adding at the end the following: 

12 ‘‘(15) FAMILY MEMBER.—The term ‘family 

13 member’ means, with respect to any individual— 

14 ‘‘(A) a dependent (as such term is used for 

15 purposes of section 2701(f)(2)) of such indi16 vidual; and 

17 ‘‘(B) any other individual who is a first-de18 gree, second-degree, third-degree, or fourth-de19 gree relative of such individual or of an indi20 vidual described in subparagraph (A). 

21 ‘‘(16) GENETIC INFORMATION.— 

22 ‘‘(A) IN GENERAL.—The term ‘genetic in23 formation’ means, with respect to any indi24 vidual, information about— 

25 ‘‘(i) such individual’s genetic tests, 
97 

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1 ‘‘(ii) the genetic tests of family mem2 bers of such individual, and 

3 ‘‘(iii) subject to subparagraph (D), 

4 the manifestation of a disease or disorder 

5 in family members of such individual. 

6 ‘‘(B) INCLUSION OF GENETIC SERVICES.— 

7 Such term includes, with respect to any indi8 vidual, any request for, or receipt of, genetic 

9 services (including genetic services received pur10 suant to participation in clinical research) by 

11 such individual or any family member of such 

12 individual. 

13 ‘‘(C) EXCLUSIONS.—The term ‘genetic in14 formation’ shall not include information about 

15 the sex or age of any individual. 

16 ‘‘(D) APPLICATION TO FAMILY MEMBERS

17 COVERED UNDER SAME PLAN.—Information de18 scribed in clause (iii) of subparagraph (A) shall 

19 not be treated as genetic information to the ex20 tent that such information is taken into account 

21 only with respect to the individual in which 

22 such disease or disorder is manifested and not 

23 as genetic information with respect to any other 

24 individual. 

25 ‘‘(17) GENETIC TEST.— 
98 

•HR 1424 EH

1 ‘‘(A) IN GENERAL.—The term ‘genetic 

2 test’ means an analysis of human DNA, RNA, 

3 chromosomes, proteins, or metabolites, that de4 tects genotypes, mutations, or chromosomal 

5 changes. 

6 ‘‘(B) EXCEPTIONS.—The term ‘genetic 

7 test’ does not mean— 

8 ‘‘(i) an analysis of proteins or metabo9 lites that does not detect genotypes, 

10 mutations, or chromosomal changes; or 

11 ‘‘(ii) an analysis of proteins or me12 tabolites that is directly related to a mani13 fested disease, disorder, or pathological 

14 condition that could reasonably be detected 

15 by a health care professional with appro16 priate training and expertise in the field of 

17 medicine involved. 

18 ‘‘(18) GENETIC SERVICES.—The term ‘genetic 

19 services’ means— 

20 ‘‘(A) a genetic test; 

21 ‘‘(B) genetic counseling (including obtain22 ing, interpreting, or assessing genetic informa23 tion); or 

24 ‘‘(C) genetic education. 
99 

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1 ‘‘(19) UNDERWRITING PURPOSES.—The term 

2 ‘underwriting purposes’ means, with respect to any 

3 group health plan, or health insurance coverage of4 fered in connection with a group health plan— 

5 ‘‘(A) rules for, or determination of, eligi6 bility (including enrollment and continued eligi7 bility) for benefits under the plan or coverage; 

8 ‘‘(B) the computation of premium or con9 tribution amounts under the plan or coverage; 

10 ‘‘(C) the application of any pre-existing 

11 condition exclusion under the plan or coverage; 

12 and 

13 ‘‘(D) other activities related to the cre14 ation, renewal, or replacement of a contract of 

15 health insurance or health benefits.’’. 

16 (5) REMEDIES AND ENFORCEMENT.—Section 

17 2722(b) of the Public Health Service Act (42 U.S.C. 

18 300gg–22(b)) is amended by adding at the end the 

19 following: 

20 ‘‘(3) ENFORCEMENT AUTHORITY RELATING TO

21 GENETIC DISCRIMINATION.— 

22 ‘‘(A) GENERAL RULE.—In the cases de23 scribed in paragraph (1), notwithstanding the 

24 provisions of paragraph (2)(C), the succeeding 

25 subparagraphs of this paragraph shall apply 
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1 with respect to an action under this subsection 

2 by the Secretary with respect to any failure of 

3 a health insurance issuer in connection with a 

4 group health plan, to meet the requirements of 

5 subsection (a)(1)(F), (b)(3), (c), or (d) of sec6 tion 2702 or section 2701 or 2702(b)(1) with 

7 respect to genetic information in connection 

8 with the plan. 

9 ‘‘(B) AMOUNT.— 

10 ‘‘(i) IN GENERAL.—The amount of 

11 the penalty imposed under this paragraph 

12 shall be $100 for each day in the non13 compliance period with respect to each par14 ticipant or beneficiary to whom such fail15 ure relates. 

16 ‘‘(ii) NONCOMPLIANCE PERIOD.—For 

17 purposes of this paragraph, the term ‘non18 compliance period’ means, with respect to 

19 any failure, the period— 

20 ‘‘(I) beginning on the date such 

21 failure first occurs; and 

22 ‘‘(II) ending on the date the fail23 ure is corrected. 
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•HR 1424 EH

1 ‘‘(C) MINIMUM PENALTIES WHERE FAIL2 URE DISCOVERED.—Notwithstanding clauses (i) 

3 and (ii) of subparagraph (D): 

4 ‘‘(i) IN GENERAL.—In the case of 1 or 

5 more failures with respect to an indi6 vidual— 

7 ‘‘(I) which are not corrected be8 fore the date on which the plan re9 ceives a notice from the Secretary of 

10 such violation; and 

11 ‘‘(II) which occurred or continued 

12 during the period involved; 

13 the amount of penalty imposed by subpara14 graph (A) by reason of such failures with 

15 respect to such individual shall not be less 

16 than $2,500. 

17 ‘‘(ii) HIGHER MINIMUM PENALTY

18 WHERE VIOLATIONS ARE MORE THAN DE

19 MINIMIS.—To the extent violations for 

20 which any person is liable under this para21 graph for any year are more than de mini22 mis, clause (i) shall be applied by sub23 stituting ‘$15,000’ for ‘$2,500’ with re24 spect to such person. 

25 ‘‘(D) LIMITATIONS.— 
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1 ‘‘(i) PENALTY NOT TO APPLY WHERE

2 FAILURE NOT DISCOVERED EXERCISING

3 REASONABLE DILIGENCE.—No penalty 

4 shall be imposed by subparagraph (A) on 

5 any failure during any period for which it 

6 is established to the satisfaction of the 

7 Secretary that the person otherwise liable 

8 for such penalty did not know, and exer9 cising reasonable diligence would not have 

10 known, that such failure existed. 

11 ‘‘(ii) PENALTY NOT TO APPLY TO

12 FAILURES CORRECTED WITHIN CERTAIN

13 PERIODS.—No penalty shall be imposed by 

14 subparagraph (A) on any failure if— 

15 ‘‘(I) such failure was due to rea16 sonable cause and not to willful ne17 glect; and 

18 ‘‘(II) such failure is corrected 

19 during the 30-day period beginning on 

20 the first date the person otherwise lia21 ble for such penalty knew, or exer22 cising reasonable diligence would have 

23 known, that such failure existed. 

24 ‘‘(iii) OVERALL LIMITATION FOR UN25 INTENTIONAL FAILURES.—In the case of 
103 

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1 failures which are due to reasonable cause 

2 and not to willful neglect, the penalty im3 posed by subparagraph (A) for failures 

4 shall not exceed the amount equal to the 

5 lesser of— 

6 ‘‘(I) 10 percent of the aggregate 

7 amount paid or incurred by the em8 ployer (or predecessor employer) dur9 ing the preceding taxable year for 

10 group health plans; or 

11 ‘‘(II) $500,000. 

12 ‘‘(E) WAIVER BY SECRETARY.—In the case 

13 of a failure which is due to reasonable cause 

14 and not to willful neglect, the Secretary may 

15 waive part or all of the penalty imposed by sub16 paragraph (A) to the extent that the payment 

17 of such penalty would be excessive relative to 

18 the failure involved.’’. 

19 (b) AMENDMENT RELATING TO THE INDIVIDUAL

20 MARKET.— 

21 (1) IN GENERAL.—The first subpart 3 of part 

22 B of title XXVII of the Public Health Service Act 

23 (42 U.S.C. 300gg–51 et seq.) (relating to other re24 quirements) is amended— 
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1 (A) by redesignating such subpart as sub2 part 2; and 

3 (B) by adding at the end the following: 

4 ‘‘SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON 

5 THE BASIS OF GENETIC INFORMATION. 

6 ‘‘(a) PROHIBITION ON GENETIC INFORMATION AS A

7 CONDITION OF ELIGIBILITY.—A health insurance issuer 

8 offering health insurance coverage in the individual mar9 ket may not establish rules for the eligibility (including 

10 continued eligibility) of any individual to enroll in indi11 vidual health insurance coverage based on genetic infor12 mation. 

13 ‘‘(b) PROHIBITION ON GENETIC INFORMATION IN

14 SETTING PREMIUM RATES.—A health insurance issuer of15 fering health insurance coverage in the individual market 

16 shall not adjust premium or contribution amounts for an 

17 individual on the basis of genetic information concerning 

18 the individual or a family member of the individual. 

19 ‘‘(c) PROHIBITION ON GENETIC INFORMATION AS

20 PREEXISTING CONDITION.—A health insurance issuer of21 fering health insurance coverage in the individual market 

22 may not, on the basis of genetic information, impose any 

23 preexisting condition exclusion (as defined in section 

24 2701(b)(1)(A)) with respect to such coverage. 

25 ‘‘(d) GENETIC TESTING.— 
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•HR 1424 EH

1 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR2 ING GENETIC TESTING.—A health insurance issuer 

3 offering health insurance coverage in the individual 

4 market shall not request or require an individual or 

5 a family member of such individual to undergo a ge6 netic test. 

7 ‘‘(2) RULE OF CONSTRUCTION.—Paragraph (1) 

8 shall not be construed to limit the authority of a 

9 health care professional who is providing health care 

10 services to an individual to request that such indi11 vidual undergo a genetic test. 

12 ‘‘(3) RULE OF CONSTRUCTION REGARDING PAY13 MENT.— 

14 ‘‘(A) IN GENERAL.—Nothing in paragraph 

15 (1) shall be construed to preclude a health in16 surance issuer offering health insurance cov17 erage in the individual market from obtaining 

18 and using the results of a genetic test in mak19 ing a determination regarding payment (as such 

20 term is defined for the purposes of applying the 

21 regulations promulgated by the Secretary under 

22 part C of title XI of the Social Security Act and 

23 section 264 of the Health Insurance Portability 

24 and Accountability Act of 1996, as may be re-
106 

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1 vised from time to time) consistent with sub2 sections (a) and (c). 

3 ‘‘(B) LIMITATION.—For purposes of sub4 paragraph (A), a health insurance issuer offer5 ing health insurance coverage in the individual 

6 market may request only the minimum amount 

7 of information necessary to accomplish the in8 tended purpose. 

9 ‘‘(4) RESEARCH EXCEPTION.—Notwithstanding 

10 paragraph (1), a health insurance issuer offering 

11 health insurance coverage in the individual market 

12 may request, but not require, that an individual or 

13 a family member of such individual undergo a ge14 netic test if each of the following conditions is met: 

15 ‘‘(A) The request is made pursuant to re16 search that complies with part 46 of title 45, 

17 Code of Federal Regulations, or equivalent Fed18 eral regulations, and any applicable State or 

19 local law or regulations for the protection of 

20 human subjects in research. 

21 ‘‘(B) The issuer clearly indicates to each 

22 individual, or in the case of a minor child, to 

23 the legal guardian of such child, to whom the 

24 request is made that— 
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•HR 1424 EH

1 ‘‘(i) compliance with the request is 

2 voluntary; and 

3 ‘‘(ii) non-compliance will have no ef4 fect on enrollment status or premium or 

5 contribution amounts. 

6 ‘‘(C) No genetic information collected or 

7 acquired under this paragraph shall be used for 

8 underwriting purposes. 

9 ‘‘(D) The issuer notifies the Secretary in 

10 writing that the issuer is conducting activities 

11 pursuant to the exception provided for under 

12 this paragraph, including a description of the 

13 activities conducted. 

14 ‘‘(E) The issuer complies with such other 

15 conditions as the Secretary may by regulation 

16 require for activities conducted under this para17 graph. 

18 ‘‘(e) PROHIBITION ON COLLECTION OF GENETIC IN19 FORMATION.— 

20 ‘‘(1) IN GENERAL.—A health insurance issuer 

21 offering health insurance coverage in the individual 

22 market shall not request, require, or purchase ge23 netic information for underwriting purposes (as de24 fined in section 2791). 
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1 ‘‘(2) PROHIBITION ON COLLECTION OF GE2 NETIC INFORMATION PRIOR TO ENROLLMENT.—A 

3 health insurance issuer offering health insurance 

4 coverage in the individual market shall not request, 

5 require, or purchase genetic information with respect 

6 to any individual prior to such individual’s enroll7 ment under the plan in connection with such enroll8 ment. 

9 ‘‘(3) INCIDENTAL COLLECTION.—If a health in10 surance issuer offering health insurance coverage in 

11 the individual market obtains genetic information in12 cidental to the requesting, requiring, or purchasing 

13 of other information concerning any individual, such 

14 request, requirement, or purchase shall not be con15 sidered a violation of paragraph (2) if such request, 

16 requirement, or purchase is not in violation of para17 graph (1). 

18 ‘‘(f) GENETIC INFORMATION OF A FETUS OR EM19 BRYO.—Any reference in this part to genetic information 

20 concerning an individual or family member of an indi21 vidual shall— 

22 ‘‘(1) with respect to such an individual or fam23 ily member of an individual who is a pregnant 

24 woman, include genetic information of any fetus car25 ried by such pregnant woman; and 
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1 ‘‘(2) with respect to an individual or family 

2 member utilizing an assisted reproductive tech3 nology, include genetic information of any embryo le4 gally held by the individual or family member.’’. 

5 (2) REMEDIES AND ENFORCEMENT.—Section 

6 2761(b) of the Public Health Service Act (42 U.S.C. 

7 300gg–61(b)) is amended to read as follows: 

8 ‘‘(b) SECRETARIAL ENFORCEMENT AUTHORITY.— 

9 The Secretary shall have the same authority in relation 

10 to enforcement of the provisions of this part with respect 

11 to issuers of health insurance coverage in the individual 

12 market in a State as the Secretary has under section 

13 2722(b)(2), and section 2722(b)(3) with respect to viola14 tions of genetic nondiscrimination provisions, in relation 

15 to the enforcement of the provisions of part A with respect 

16 to issuers of health insurance coverage in the small group 

17 market in the State.’’. 

18 (c) ELIMINATION OF OPTION OF NON-FEDERAL

19 GOVERNMENTAL PLANS TO BE EXCEPTED FROM RE20 QUIREMENTS CONCERNING GENETIC INFORMATION.— 

21 Section 2721(b)(2) of the Public Health Service Act (42 

22 U.S.C. 300gg–21(b)(2)) is amended— 

23 (1) in subparagraph (A), by striking ‘‘If the 

24 plan sponsor’’ and inserting ‘‘Except as provided in 

25 subparagraph (D), if the plan sponsor’’; and 
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1 (2) by adding at the end the following: 

2 ‘‘(D) ELECTION NOT APPLICABLE TO RE3 QUIREMENTS CONCERNING GENETIC INFORMA4 TION.—The election described in subparagraph 

5 (A) shall not be available with respect to the 

6 provisions of subsections (a)(1)(F), (b)(3), (c), 

7 and (d) of section 2702 and the provisions of 

8 sections 2701 and 2702(b) to the extent that 

9 such provisions apply to genetic information.’’. 

10 (d) REGULATIONS AND EFFECTIVE DATE.— 

11 (1) REGULATIONS.—Not later than 1 year after 

12 the date of enactment of this Act, the Secretary of 

13 Health and Human Services shall issue final regula14 tions to carry out the amendments made by this sec15 tion. 

16 (2) EFFECTIVE DATE.—The amendments made 

17 by this section shall apply— 

18 (A) with respect to group health plans, and 

19 health insurance coverage offered in connection 

20 with group health plans, for plan years begin21 ning after the date that is 18 months after the 

22 date of enactment of this Act; and 

23 (B) with respect to health insurance cov24 erage offered, sold, issued, renewed, in effect, or 

25 operated in the individual market after the date 
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1 that is 18 months after the date of enactment 

2 of this Act. 

3 SEC. 103. AMENDMENTS TO THE INTERNAL REVENUE CODE 

4 OF 1986. 

5 (a) NO DISCRIMINATION IN GROUP PREMIUMS

6 BASED ON GENETIC INFORMATION.—Subsection (b) of 

7 section 9802 of the Internal Revenue Code of 1986 is 

8 amended— 

9 (1) in paragraph (2)(A), by inserting before the 

10 semicolon the following: ‘‘except as provided in para11 graph (3)’’; and 

12 (2) by adding at the end the following: 

13 ‘‘(3) NO GROUP-BASED DISCRIMINATION ON

14 BASIS OF GENETIC INFORMATION.—For purposes of 

15 this section, a group health plan may not adjust pre16 mium or contribution amounts for the group covered 

17 under such plan on the basis of genetic informa18 tion.’’. 

19 (b) LIMITATIONS ON GENETIC TESTING; PROHIBI20 TION ON COLLECTION OF GENETIC INFORMATION; APPLI21 CATION TO ALL PLANS.—Section 9802 of such Code is 

22 amended by redesignating subsection (c) as subsection (f) 

23 and by inserting after subsection (b) the following new 

24 subsections: 

25 ‘‘(c) GENETIC TESTING.— 
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1 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR2 ING GENETIC TESTING.—A group health plan may 

3 not request or require an individual or a family 

4 member of such individual to undergo a genetic test. 

5 ‘‘(2) RULE OF CONSTRUCTION.—Paragraph (1) 

6 shall not be construed to limit the authority of a 

7 health care professional who is providing health care 

8 services to an individual to request that such indi9 vidual undergo a genetic test. 

10 ‘‘(3) RULE OF CONSTRUCTION REGARDING PAY11 MENT.— 

12 ‘‘(A) IN GENERAL.—Nothing in paragraph 

13 (1) shall be construed to preclude a group 

14 health plan from obtaining and using the re15 sults of a genetic test in making a determina16 tion regarding payment (as such term is defined 

17 for the purposes of applying the regulations 

18 promulgated by the Secretary of Health and 

19 Human Services under part C of title XI of the 

20 Social Security Act and section 264 of the 

21 Health Insurance Portability and Accountability 

22 Act of 1996, as may be revised from time to 

23 time) consistent with subsection (a). 

24 ‘‘(B) LIMITATION.—For purposes of sub25 paragraph (A), a group health plan may re-
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1 quest only the minimum amount of information 

2 necessary to accomplish the intended purpose. 

3 ‘‘(4) RESEARCH EXCEPTION.—Notwithstanding 

4 paragraph (1), a group health plan may request, but 

5 not require, that a participant or beneficiary under6 go a genetic test if each of the following conditions 

7 is met: 

8 ‘‘(A) The request is made pursuant to re9 search that complies with part 46 of title 45, 

10 Code of Federal Regulations, or equivalent Fed11 eral regulations, and any applicable State or 

12 local law or regulations for the protection of 

13 human subjects in research. 

14 ‘‘(B) The plan clearly indicates to each 

15 participant or beneficiary, or in the case of a 

16 minor child, to the legal guardian of such bene17 ficiary, to whom the request is made that— 

18 ‘‘(i) compliance with the request is 

19 voluntary; and 

20 ‘‘(ii) non-compliance will have no ef21 fect on enrollment status or premium or 

22 contribution amounts. 

23 ‘‘(C) No genetic information collected or 

24 acquired under this paragraph shall be used for 

25 underwriting purposes. 
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1 ‘‘(D) The plan notifies the Secretary in 

2 writing that the plan is conducting activities 

3 pursuant to the exception provided for under 

4 this paragraph, including a description of the 

5 activities conducted. 

6 ‘‘(E) The plan complies with such other 

7 conditions as the Secretary may by regulation 

8 require for activities conducted under this para9 graph. 

10 ‘‘(d) PROHIBITION ON COLLECTION OF GENETIC IN11 FORMATION.— 

12 ‘‘(1) IN GENERAL.—A group health plan shall 

13 not request, require, or purchase genetic information 

14 for underwriting purposes (as defined in section 

15 9832). 

16 ‘‘(2) PROHIBITION ON COLLECTION OF GE17 NETIC INFORMATION PRIOR TO ENROLLMENT.—A 

18 group health plan shall not request, require, or pur19 chase genetic information with respect to any indi20 vidual prior to such individual’s enrollment under 

21 the plan or in connection with such enrollment. 

22 ‘‘(3) INCIDENTAL COLLECTION.—If a group 

23 health plan obtains genetic information incidental to 

24 the requesting, requiring, or purchasing of other in25 formation concerning any individual, such request, 
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1 requirement, or purchase shall not be considered a 

2 violation of paragraph (2) if such request, require3 ment, or purchase is not in violation of paragraph 

4 (1). 

5 ‘‘(e) APPLICATION TO ALL PLANS.—The provisions 

6 of subsections (a)(1)(F), (b)(3), (c), and (d) and sub7 section (b)(1) and section 9801 with respect to genetic in8 formation, shall apply to group health plans without re9 gard to section 9831(a)(2).’’. 

10 (c) APPLICATION TO GENETIC INFORMATION OF A

11 FETUS OR EMBRYO.—Such section is further amended by 

12 adding at the end the following: 

13 ‘‘(f) GENETIC INFORMATION OF A FETUS OR EM14 BRYO.—Any reference in this chapter to genetic informa15 tion concerning an individual or family member of an indi16 vidual shall— 

17 ‘‘(1) with respect to such an individual or fam18 ily member of an individual who is a pregnant 

19 woman, include genetic information of any fetus car20 ried by such pregnant woman; and 

21 ‘‘(2) with respect to an individual or family 

22 member utilizing an assisted reproductive tech23 nology, include genetic information of any embryo le24 gally held by the individual or family member.’’. 
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1 (d) DEFINITIONS.—Subsection (d) of section 9832 of 

2 such Code is amended by adding at the end the following: 

3 ‘‘(6) FAMILY MEMBER.—The term ‘family 

4 member’ means, with respect to any individual— 

5 ‘‘(A) a dependent (as such term is used for 

6 purposes of section 9801(f)(2)) of such indi7 vidual, and 

8 ‘‘(B) any other individual who is a first-de9 gree, second-degree, third-degree, or fourth-de10 gree relative of such individual or of an indi11 vidual described in subparagraph (A). 

12 ‘‘(7) GENETIC INFORMATION.— 

13 ‘‘(A) IN GENERAL.—The term ‘genetic in14 formation’ means, with respect to any indi15 vidual, information about— 

16 ‘‘(i) such individual’s genetic tests, 

17 ‘‘(ii) the genetic tests of family mem18 bers of such individual, and 

19 ‘‘(iii) subject to subparagraph (D), 

20 the manifestation of a disease or disorder 

21 in family members of such individual. 

22 ‘‘(B) INCLUSION OF GENETIC SERVICES.— 

23 Such term includes, with respect to any indi24 vidual, any request for, or receipt of, genetic 

25 services (including genetic services received pur-
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1 suant to participation in clinical research) by 

2 such individual or any family member of such 

3 individual. 

4 ‘‘(C) EXCLUSIONS.—The term ‘genetic in5 formation’ shall not include information about 

6 the sex or age of any individual. 

7 ‘‘(D) APPLICATION TO FAMILY MEMBERS

8 COVERED UNDER SAME PLAN.—Information de9 scribed in clause (iii) of subparagraph (A) shall 

10 not be treated as genetic information to the ex11 tent that such information is taken into account 

12 only with respect to the individual in which 

13 such disease or disorder is manifested and not 

14 as genetic information with respect to any other 

15 individual. 

16 ‘‘(8) GENETIC TEST.— 

17 ‘‘(A) IN GENERAL.—The term ‘genetic 

18 test’ means an analysis of human DNA, RNA, 

19 chromosomes, proteins, or metabolites, that de20 tects genotypes, mutations, or chromosomal 

21 changes. 

22 ‘‘(B) EXCEPTIONS.—The term ‘genetic 

23 test’ does not mean— 
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1 ‘‘(i) an analysis of proteins or metabo2 lites that does not detect genotypes, 

3 mutations, or chromosomal changes, or 

4 ‘‘(ii) an analysis of proteins or me5 tabolites that is directly related to a mani6 fested disease, disorder, or pathological 

7 condition that could reasonably be detected 

8 by a health care professional with appro9 priate training and expertise in the field of 

10 medicine involved. 

11 ‘‘(9) GENETIC SERVICES.—The term ‘genetic 

12 services’ means— 

13 ‘‘(A) a genetic test; 

14 ‘‘(B) genetic counseling (including obtain15 ing, interpreting, or assessing genetic informa16 tion); or 

17 ‘‘(C) genetic education. 

18 ‘‘(10) UNDERWRITING PURPOSES.—The term 

19 ‘underwriting purposes’ means, with respect to any 

20 group health plan ,or health insurance coverage of21 fered in connection with a group health plan— 

22 ‘‘(A) rules for, or determination of, eligi23 bility (including enrollment and continued eligi24 bility) for benefits under the plan or coverage; 
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1 ‘‘(B) the computation of premium or con2 tribution amounts under the plan or coverage; 

3 ‘‘(C) the application of any pre-existing 

4 condition exclusion under the plan or coverage; 

5 and 

6 ‘‘(D) other activities related to the cre7 ation, renewal, or replacement of a contract of 

8 health insurance or health benefits.’’. 

9 (e) ENFORCEMENT.— 

10 (1) IN GENERAL.—Subchapter C of chapter 

11 100 of the Internal Revenue Code of 1986 (relating 

12 to general provisions) is amended by adding at the 

13 end the following new section: 

14 ‘‘SEC. 9834. ENFORCEMENT. 

15 ‘‘For the imposition of tax on any failure of a group 

16 health plan to meet the requirements of this chapter, see 

17 section 4980D.’’. 

18 (2) CONFORMING AMENDMENT.—The table of 

19 sections for subchapter C of chapter 100 of such 

20 Code is amended by adding at the end the following 

21 new item: 

‘‘Sec. 9834. Enforcement.’’. 

22 (f) REGULATIONS AND EFFECTIVE DATE.— 

23 (1) REGULATIONS.—The Secretary of the 

24 Treasury shall issue final regulations or other guid25 ance not later than 1 year after the date of the en-
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1 actment of this Act to carry out the amendments 

2 made by this section. 

3 (2) EFFECTIVE DATE.—The amendments made 

4 by this section shall apply with respect to group 

5 health plans for plan years beginning after the date 

6 that is 18 months after the date of the enactment 

7 of this Act. 

8 SEC. 104. AMENDMENTS TO TITLE XVIII OF THE SOCIAL SE9 CURITY ACT RELATING TO MEDIGAP. 

10 (a) NONDISCRIMINATION.—Section 1882(s)(2) of the 

11 Social Security Act (42 U.S.C. 1395ss(s)(2)) is amended 

12 by adding at the end the following: 

13 ‘‘(E) An issuer of a medicare supplemental 

14 policy shall not deny or condition the issuance 

15 or effectiveness of the policy (including the im16 position of any exclusion of benefits under the 

17 policy based on a pre-existing condition) and 

18 shall not discriminate in the pricing of the pol19 icy (including the adjustment of premium rates) 

20 of an individual on the basis of the genetic in21 formation with respect to such individual.’’. 

22 (b) LIMITATIONS ON GENETIC TESTING AND GE23 NETIC INFORMATION.— 
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1 (1) IN GENERAL.—Section 1882 of the Social 

2 Security Act (42 U.S.C. 1395ss) is amended by add3 ing at the end the following: 

4 ‘‘(x) LIMITATIONS ON GENETIC TESTING AND IN5 FORMATION.— 

6 ‘‘(1) GENETIC TESTING.— 

7 ‘‘(A) LIMITATION ON REQUESTING OR RE8 QUIRING GENETIC TESTING.—An issuer of a 

9 medicare supplemental policy shall not request 

10 or require an individual or a family member of 

11 such individual to undergo a genetic test. 

12 ‘‘(B) RULE OF CONSTRUCTION.—Subpara13 graph (A) shall not be construed to limit the 

14 authority of a health care professional who is 

15 providing health care services to an individual 

16 to request that such individual undergo a ge17 netic test. 

18 ‘‘(C) RULE OF CONSTRUCTION REGARDING

19 PAYMENT.— 

20 ‘‘(i) IN GENERAL.—Nothing in sub21 paragraph (A) shall be construed to pre22 clude an issuer of a medicare supplemental 

23 policy from obtaining and using the results 

24 of a genetic test in making a determination 

25 regarding payment (as such term is de-
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1 fined for the purposes of applying the reg2 ulations promulgated by the Secretary 

3 under part C of title XI and section 264 

4 of the Health Insurance Portability and 

5 Accountability Act of 1996, as may be re6 vised from time to time) consistent with 

7 subsection (s)(2)(E). 

8 ‘‘(ii) LIMITATION.—For purposes of 

9 clause (i), an issuer of a medicare supple10 mental policy may request only the min11 imum amount of information necessary to 

12 accomplish the intended purpose. 

13 ‘‘(D) RESEARCH EXCEPTION.—Notwith14 standing subparagraph (A), an issuer of a 

15 medicare supplemental policy may request, but 

16 not require, that an individual or a family mem17 ber of such individual undergo a genetic test if 

18 each of the following conditions is met: 

19 ‘‘(i) The request is made pursuant to 

20 research that complies with part 46 of title 

21 45, Code of Federal Regulations, or equiv22 alent Federal regulations, and any applica23 ble State or local law or regulations for the 

24 protection of human subjects in research. 
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1 ‘‘(ii) The issuer clearly indicates to 

2 each individual, or in the case of a minor 

3 child, to the legal guardian of such child, 

4 to whom the request is made that— 

5 ‘‘(I) compliance with the request 

6 is voluntary; and 

7 ‘‘(II) non-compliance will have no 

8 effect on enrollment status or pre9 mium or contribution amounts. 

10 ‘‘(iii) No genetic information collected 

11 or acquired under this subparagraph shall 

12 be used for underwriting, determination of 

13 eligibility to enroll or maintain enrollment 

14 status, premium rating, or the creation, re15 newal, or replacement of a plan, contract, 

16 or coverage for health insurance or health 

17 benefits. 

18 ‘‘(iv) The issuer notifies the Secretary 

19 in writing that the issuer is conducting ac20 tivities pursuant to the exception provided 

21 for under this subparagraph, including a 

22 description of the activities conducted. 

23 ‘‘(v) The issuer complies with such 

24 other conditions as the Secretary may by 
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1 regulation require for activities conducted 

2 under this subparagraph. 

3 ‘‘(2) PROHIBITION ON COLLECTION OF GE4 NETIC INFORMATION.— 

5 ‘‘(A) IN GENERAL.—An issuer of a medi6 care supplemental policy shall not request, re7 quire, or purchase genetic information for un8 derwriting purposes (as defined in paragraph 

9 (3)). 

10 ‘‘(B) PROHIBITION ON COLLECTION OF

11 GENETIC INFORMATION PRIOR TO ENROLL12 MENT.—An issuer of a medicare supplemental 

13 policy shall not request, require, or purchase ge14 netic information with respect to any individual 

15 prior to such individual’s enrollment under the 

16 policy in connection with such enrollment. 

17 ‘‘(C) INCIDENTAL COLLECTION.—If an 

18 issuer of a medicare supplemental policy obtains 

19 genetic information incidental to the requesting, 

20 requiring, or purchasing of other information 

21 concerning any individual, such request, re22 quirement, or purchase shall not be considered 

23 a violation of subparagraph (B) if such request, 

24 requirement, or purchase is not in violation of 

25 subparagraph (A). 
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1 ‘‘(3) DEFINITIONS.—In this subsection: 

2 ‘‘(A) FAMILY MEMBER.—The term ‘family 

3 member’ means with respect to an individual, 

4 any other individual who is a first-degree, sec5 ond-degree, third-degree, or fourth-degree rel6 ative of such individual. 

7 ‘‘(B) GENETIC INFORMATION.— 

8 ‘‘(i) IN GENERAL.—The term ‘genetic 

9 information’ means, with respect to any in10 dividual, information about— 

11 ‘‘(I) such individual’s genetic 

12 tests, 

13 ‘‘(II) the genetic tests of family 

14 members of such individual, and 

15 ‘‘(III) subject to clause (iv), the 

16 manifestation of a disease or disorder 

17 in family members of such individual. 

18 ‘‘(ii) INCLUSION OF GENETIC SERV19 ICES.—Such term includes, with respect to 

20 any individual, any request for, or receipt 

21 of, genetic services (including genetic serv22 ices received pursuant to participation in 

23 clinical research) by such individual or any 

24 family member of such individual. 
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1 ‘‘(iii) EXCLUSIONS.—The term ‘ge2 netic information’ shall not include infor3 mation about the sex or age of any indi4 vidual. 

5 ‘‘(C) GENETIC TEST.— 

6 ‘‘(i) IN GENERAL.—The term ‘genetic 

7 test’ means an analysis of human DNA, 

8 RNA, chromosomes, proteins, or metabo9 lites, that detects genotypes, mutations, or 

10 chromosomal changes. 

11 ‘‘(ii) EXCEPTIONS.—The term ‘genetic 

12 test’ does not mean— 

13 ‘‘(I) an analysis of proteins or 

14 metabolites that does not detect 

15 genotypes, mutations, or chromosomal 

16 changes; or 

17 ‘‘(II) an analysis of proteins or 

18 metabolites that is directly related to 

19 a manifested disease, disorder, or 

20 pathological condition that could rea21 sonably be detected by a health care 

22 professional with appropriate training 

23 and expertise in the field of medicine 

24 involved. 
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1 ‘‘(D) GENETIC SERVICES.—The term ‘ge2 netic services’ means— 

3 ‘‘(i) a genetic test; 

4 ‘‘(ii) genetic counseling (including ob5 taining, interpreting, or assessing genetic 

6 information); or 

7 ‘‘(iii) genetic education. 

8 ‘‘(E) UNDERWRITING PURPOSES.—The 

9 term ‘underwriting purposes’ means, with re10 spect to a medicare supplemental policy— 

11 ‘‘(i) rules for, or determination of, eli12 gibility (including enrollment and contin13 ued eligibility) for benefits under the pol14 icy; 

15 ‘‘(ii) the computation of premium or 

16 contribution amounts under the policy; 

17 ‘‘(iii) the application of any pre-exist18 ing condition exclusion under the policy; 

19 and 

20 ‘‘(iv) other activities related to the 

21 creation, renewal, or replacement of a con22 tract of health insurance or health bene23 fits. 

24 ‘‘(F) ISSUER OF A MEDICARE SUPPLE25 MENTAL POLICY.—The term ‘issuer of a medi-
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1 care supplemental policy’ includes a third-party 

2 administrator or other person acting for or on 

3 behalf of such issuer.’’. 

4 (2) APPLICATION TO GENETIC INFORMATION OF

5 A FETUS OR EMBRYO.—Section 1882(x) of such Act, 

6 as added by paragraph (1), is further amended by 

7 adding at the end the following: 

8 ‘‘(4) GENETIC INFORMATION OF A FETUS OR

9 EMBRYO.—Any reference in this section to genetic 

10 information concerning an individual or family mem11 ber of an individual shall— 

12 ‘‘(A) with respect to such an individual or 

13 family member of an individual who is a preg14 nant woman, include genetic information of any 

15 fetus carried by such pregnant woman; and 

16 ‘‘(B) with respect to an individual or fam17 ily member utilizing an assisted reproductive 

18 technology, include genetic information of any 

19 embryo legally held by the individual or family 

20 member.’’. 

21 (3) CONFORMING AMENDMENT.—Section 

22 1882(o) of the Social Security Act (42 U.S.C. 

23 1395ss(o)) is amended by adding at the end the fol24 lowing: 
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1 ‘‘(4) The issuer of the medicare supplemental 

2 policy complies with subsection (s)(2)(E) and sub3 section (x).’’. 

4 (c) EFFECTIVE DATE.—The amendments made by 

5 this section shall apply with respect to an issuer of a medi6 care supplemental policy for policy years beginning on or 

7 after the date that is 18 months after the date of enact8 ment of this Act. 

9 (d) TRANSITION PROVISIONS.— 

10 (1) IN GENERAL.—If the Secretary of Health 

11 and Human Services identifies a State as requiring 

12 a change to its statutes or regulations to conform its 

13 regulatory program to the changes made by this sec14 tion, the State regulatory program shall not be con15 sidered to be out of compliance with the require16 ments of section 1882 of the Social Security Act due 

17 solely to failure to make such change until the date 

18 specified in paragraph (4). 

19 (2) NAIC STANDARDS.—If, not later than June 

20 30, 2008, the National Association of Insurance 

21 Commissioners (in this subsection referred to as the 

22 ‘‘NAIC’’) modifies its NAIC Model Regulation relat23 ing to section 1882 of the Social Security Act (re24 ferred to in such section as the 1991 NAIC Model 

25 Regulation, as subsequently modified) to conform to 
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1 the amendments made by this section, such revised 

2 regulation incorporating the modifications shall be 

3 considered to be the applicable NAIC model regula4 tion (including the revised NAIC model regulation 

5 and the 1991 NAIC Model Regulation) for the pur6 poses of such section. 

7 (3) SECRETARY STANDARDS.—If the NAIC 

8 does not make the modifications described in para9 graph (2) within the period specified in such para10 graph, the Secretary of Health and Human Services 

11 shall, not later than October 1, 2008, make the 

12 modifications described in such paragraph and such 

13 revised regulation incorporating the modifications 

14 shall be considered to be the appropriate regulation 

15 for the purposes of such section. 

16 (4) DATE SPECIFIED.— 

17 (A) IN GENERAL.—Subject to subpara18 graph (B), the date specified in this paragraph 

19 for a State is the earlier of— 

20 (i) the date the State changes its stat21 utes or regulations to conform its regu22 latory program to the changes made by 

23 this section, or 

24 (ii) October 1, 2008. 
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1 (B) ADDITIONAL LEGISLATIVE ACTION RE2 QUIRED.—In the case of a State which the Sec3 retary identifies as— 

4 (i) requiring State legislation (other 

5 than legislation appropriating funds) to 

6 conform its regulatory program to the 

7 changes made in this section, but 

8 (ii) having a legislature which is not 

9 scheduled to meet in 2008 in a legislative 

10 session in which such legislation may be 

11 considered, the date specified in this para12 graph is the first day of the first calendar 

13 quarter beginning after the close of the 

14 first legislative session of the State legisla15 ture that begins on or after July 1, 2008. 

16 For purposes of the previous sentence, in 

17 the case of a State that has a 2-year legis18 lative session, each year of such session 

19 shall be deemed to be a separate regular 

20 session of the State legislature. 

21 SEC. 105. PRIVACY AND CONFIDENTIALITY. 

22 (a) IN GENERAL.—Part C of title XI of the Social 

23 Security Act is amended by adding at the end the fol24 lowing new section: 
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1 ‘‘APPLICATION OF HIPAA REGULATIONS TO GENETIC

2 INFORMATION

3 ‘‘SEC. 1180. (a) IN GENERAL.—The Secretary shall 

4 revise the HIPAA privacy regulation (as defined in sub5 section (b)) so it is consistent with the following: 

6 ‘‘(1) Genetic information shall be treated as 

7 health information described in section 1171(4)(B). 

8 ‘‘(2) The use or disclosure by a covered entity 

9 that is a group health plan, health insurance issuer 

10 that issues health insurance coverage, or issuer of a 

11 medicare supplemental policy of protected health in12 formation that is genetic information about an indi13 vidual for underwriting purposes under the group 

14 health plan, health insurance coverage, or medicare 

15 supplemental policy shall not be a permitted use or 

16 disclosure. 

17 ‘‘(b) DEFINITIONS.—For purposes of this section: 

18 ‘‘(1) GENETIC INFORMATION; GENETIC TEST; 

19 FAMILY MEMBER.—The terms ‘genetic information’, 

20 ‘genetic test’, and ‘family member’ have the mean21 ings given such terms in section 2791 of the Public 

22 Health Service Act (42 U.S.C. 300gg–91), as 

23 amended by the Genetic Information Nondiscrimina24 tion Act of 2008. 
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1 ‘‘(2) GROUP HEALTH PLAN; HEALTH INSUR2 ANCE COVERAGE; MEDICARE SUPPLEMENTAL POL3 ICY.—The terms ‘group health plan’ and ‘health in4 surance coverage’ have the meanings given such 

5 terms under section 2791 of the Public Health Serv6 ice Act (42 U.S.C. 300gg–91), and the term ‘medi7 care supplemental policy’ has the meaning given 

8 such term in section 1882(g). 

9 ‘‘(3) HIPAA PRIVACY REGULATION.—The term 

10 ‘HIPAA privacy regulation’ means the regulations 

11 promulgated by the Secretary under this part and 

12 section 264 of the Health Insurance Portability and 

13 Accountability Act of 1996 (42 U.S.C. 1320d–2 

14 note). 

15 ‘‘(4) UNDERWRITING PURPOSES.—The term 

16 ‘underwriting purposes’ means, with respect to a 

17 group health plan, health insurance coverage, or a 

18 medicare supplemental policy— 

19 ‘‘(A) rules for eligibility (including enroll20 ment and continued eligibility) for, or deter21 mination of, benefits under the plan, coverage, 

22 or policy; 

23 ‘‘(B) the computation of premium or con24 tribution amounts under the plan, coverage, or 

25 policy; 
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1 ‘‘(C) the application of any pre-existing 

2 condition exclusion under the plan, coverage, or 

3 policy; and 

4 ‘‘(D) other activities related to the cre5 ation, renewal, or replacement of a contract of 

6 health insurance or health benefits. 

7 ‘‘(c) PROCEDURE.—The revisions under subsection 

8 (a) shall be made by notice in the Federal Register pub9 lished not later than 60 days after the date of the enact10 ment of this section and shall be effective upon publica11 tion, without opportunity for any prior public comment, 

12 but may be revised, consistent with this section, after op13 portunity for public comment. 

14 ‘‘(d) ENFORCEMENT.—In addition to any other sanc15 tions or remedies that may be available under law, a cov16 ered entity that is a group health plan, health insurance 

17 issuer, or issuer of a medicare supplemental policy and 

18 that violates the HIPAA privacy regulation (as revised 

19 under subsection (a) or otherwise) with respect to the use 

20 or disclosure of genetic information shall be subject to the 

21 penalties described in sections 1176 and 1177 in the same 

22 manner and to the same extent that such penalties apply 

23 to violations of this part.’’. 

24 (b) REGULATIONS; EFFECTIVE DATE.— 
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1 (1) REGULATIONS.—Not later than 1 year after 

2 the date of the enactment of this Act, the Secretary 

3 of Health and Human Services shall issue final reg4 ulations to carry out the revision required by section 

5 1180(a) of the Social Security Act, as added by sub6 section (a). The Secretary has the sole authority to 

7 promulgate such regulations, but shall promulgate 

8 such regulations in consultation with the Secretaries 

9 of Labor and the Treasury. 

10 (2) EFFECTIVE DATE.—The amendment made 

11 by subsection (a) shall take effect on the date that 

12 is 18 months after the date of the enactment of this 

13 Act. 

14 SEC. 106. ASSURING COORDINATION. 

15 Except as provided in section 105(b)(1), the Sec16 retary of Health and Human Services, the Secretary of 

17 Labor, and the Secretary of the Treasury shall ensure, 

18 through the execution of an interagency memorandum of 

19 understanding among such Secretaries, that— 

20 (1) regulations, rulings, and interpretations 

21 issued by such Secretaries relating to the same mat22 ter over which two or more such Secretaries have re23 sponsibility under this title (and the amendments 

24 made by this title) are administered so as to have 

25 the same effect at all times; and 
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1 (2) coordination of policies relating to enforcing 

2 the same requirements through such Secretaries in 

3 order to have a coordinated enforcement strategy 

4 that avoids duplication of enforcement efforts and 

5 assigns priorities in enforcement. 

6 TITLE II—PROHIBITING EM7 PLOYMENT DISCRIMINATION 

8 ON THE BASIS OF GENETIC 

9 INFORMATION 

10 SEC. 201. DEFINITIONS. 

11 In this title: 

12 (1) COMMISSION.—The term ‘‘Commission’’ 

13 means the Equal Employment Opportunity Commis14 sion as created by section 705 of the Civil Rights 

15 Act of 1964 (42 U.S.C. 2000e–4). 

16 (2) EMPLOYEE; EMPLOYER; EMPLOYMENT

17 AGENCY; LABOR ORGANIZATION; MEMBER.— 

18 (A) IN GENERAL.—The term ‘‘employee’’ 

19 means— 

20 (i) an employee (including an appli21 cant), as defined in section 701(f) of the 

22 Civil Rights Act of 1964 (42 U.S.C. 

23 2000e(f)); 

24 (ii) a State employee (including an ap25 plicant) described in section 304(a) of the 
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1 Government Employee Rights Act of 1991 

2 (42 U.S.C. 2000e–16c(a)); 

3 (iii) a covered employee (including an 

4 applicant), as defined in section 101 of the 

5 Congressional Accountability Act of 1995 

6 (2 U.S.C. 1301); 

7 (iv) a covered employee (including an 

8 applicant), as defined in section 411(c) of 

9 title 3, United States Code; or 

10 (v) an employee or applicant to which 

11 section 717(a) of the Civil Rights Act of 

12 1964 (42 U.S.C. 2000e–16(a)) applies. 

13 (B) EMPLOYER.—The term ‘‘employer’’ 

14 means— 

15 (i) an employer (as defined in section 

16 701(b) of the Civil Rights Act of 1964 (42 

17 U.S.C. 2000e(b))); 

18 (ii) an entity employing a State em19 ployee described in section 304(a) of the 

20 Government Employee Rights Act of 1991; 

21 (iii) an employing office, as defined in 

22 section 101 of the Congressional Account23 ability Act of 1995; 
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1 (iv) an employing office, as defined in 

2 section 411(c) of title 3, United States 

3 Code; or 

4 (v) an entity to which section 717(a) 

5 of the Civil Rights Act of 1964 applies. 

6 (C) EMPLOYMENT AGENCY; LABOR ORGA7 NIZATION.—The terms ‘‘employment agency’’ 

8 and ‘‘labor organization’’ have the meanings 

9 given the terms in section 701 of the Civil 

10 Rights Act of 1964 (42 U.S.C. 2000e). 

11 (D) MEMBER.—The term ‘‘member’’, with 

12 respect to a labor organization, includes an ap13 plicant for membership in a labor organization. 

14 (3) FAMILY MEMBER.—The term ‘‘family mem15 ber’’ means, with respect to an individual— 

16 (A) a dependent (as such term is used for 

17 purposes of section 701(f)(2) of the Employee 

18 Retirement Income Security Act of 1974) of 

19 such individual, and 

20 (B) any other individual who is a first-de21 gree, second-degree, third-degree, or fourth-de22 gree relative of such individual or of an indi23 vidual described in subparagraph (A). 

24 (4) GENETIC INFORMATION.— 
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1 (A) IN GENERAL.—The term ‘‘genetic in2 formation’’ means, with respect to any indi3 vidual, information about— 

4 (i) such individual’s genetic tests, 

5 (ii) the genetic tests of family mem6 bers of such individual, and 

7 (iii) subject to subparagraph (D), the 

8 manifestation of a disease or disorder in 

9 family members of such individual. 

10 (B) INCLUSION OF GENETIC SERVICES.— 

11 Such term includes, with respect to any indi12 vidual, any request for, or receipt of, genetic 

13 services (including genetic services received pur14 suant to participation in clinical research) by 

15 such individual or any family member of such 

16 individual. 

17 (C) EXCLUSIONS.—The term ‘‘genetic in18 formation’’ shall not include information about 

19 the sex or age of any individual. 

20 (5) GENETIC MONITORING.—The term ‘‘genetic 

21 monitoring’’ means the periodic examination of em22 ployees to evaluate acquired modifications to their 

23 genetic material, such as chromosomal damage or 

24 evidence of increased occurrence of mutations, that 

25 may have developed in the course of employment due 
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1 to exposure to toxic substances in the workplace, in 

2 order to identify, evaluate, and respond to the ef3 fects of or control adverse environmental exposures 

4 in the workplace. 

5 (6) GENETIC SERVICES.—The term ‘‘genetic 

6 services’’ means— 

7 (A) a genetic test; 

8 (B) genetic counseling (including obtain9 ing, interpreting, or assessing genetic informa10 tion); or 

11 (C) genetic education. 

12 (7) GENETIC TEST.— 

13 (A) IN GENERAL.—The term ‘‘genetic 

14 test’’ means an analysis of human DNA, RNA, 

15 chromosomes, proteins, or metabolites, that de16 tects genotypes, mutations, or chromosomal 

17 changes. 

18 (B) EXCEPTIONS.—The term ‘‘genetic 

19 test’’ does not mean an analysis of proteins or 

20 metabolites that does not detect genotypes, 

21 mutations, or chromosomal changes. 

22 SEC. 202. EMPLOYER PRACTICES. 

23 (a) DISCRIMINATION BASED ON GENETIC INFORMA24 TION.—It shall be an unlawful employment practice for 

25 an employer— 
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1 (1) to fail or refuse to hire, or to discharge, any 

2 employee, or otherwise to discriminate against any 

3 employee with respect to the compensation, terms, 

4 conditions, or privileges of employment of the em5 ployee, because of genetic information with respect 

6 to the employee; or 

7 (2) to limit, segregate, or classify the employees 

8 of the employer in any way that would deprive or 

9 tend to deprive any employee of employment oppor10 tunities or otherwise adversely affect the status of 

11 the employee as an employee, because of genetic in12 formation with respect to the employee. 

13 (b) ACQUISITION OF GENETIC INFORMATION.—It 

14 shall be an unlawful employment practice for an employer 

15 to request, require, or purchase genetic information with 

16 respect to an employee or a family member of the em17 ployee except— 

18 (1) where an employer inadvertently requests or 

19 requires family medical history of the employee or 

20 family member of the employee; 

21 (2) where— 

22 (A) health or genetic services are offered 

23 by the employer, including such services offered 

24 as part of a bona fide wellness program; 
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1 (B) the employee provides prior, knowing, 

2 voluntary, and written authorization; 

3 (C) only the employee (or family member 

4 if the family member is receiving genetic serv5 ices) and the licensed health care professional 

6 or board certified genetic counselor involved in 

7 providing such services receive individually iden8 tifiable information concerning the results of 

9 such services; and 

10 (D) any individually identifiable genetic in11 formation provided under subparagraph (C) in 

12 connection with the services provided under 

13 subparagraph (A) is only available for purposes 

14 of such services and shall not be disclosed to 

15 the employer except in aggregate terms that do 

16 not disclose the identity of specific employees; 

17 (3) where an employer requests or requires 

18 family medical history from the employee to comply 

19 with the certification provisions of section 103 of the 

20 Family and Medical Leave Act of 1993 (29 U.S.C. 

21 2613) or such requirements under State family and 

22 medical leave laws; 

23 (4) where an employer purchases documents 

24 that are commercially and publicly available (includ25 ing newspapers, magazines, periodicals, and books, 
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1 but not including medical databases or court 

2 records) that include family medical history; 

3 (5) where the information involved is to be used 

4 for genetic monitoring of the biological effects of 

5 toxic substances in the workplace, but only if— 

6 (A) the employer provides written notice of 

7 the genetic monitoring to the employee; 

8 (B)(i) the employee provides prior, know9 ing, voluntary, and written authorization; or 

10 (ii) the genetic monitoring is required by 

11 Federal or State law; 

12 (C) the employee is informed of individual 

13 monitoring results; 

14 (D) the monitoring is in compliance with— 

15 (i) any Federal genetic monitoring 

16 regulations, including any such regulations 

17 that may be promulgated by the Secretary 

18 of Labor pursuant to the Occupational 

19 Safety and Health Act of 1970 (29 U.S.C. 

20 651 et seq.), the Federal Mine Safety and 

21 Health Act of 1977 (30 U.S.C. 801 et 

22 seq.), or the Atomic Energy Act of 1954 

23 (42 U.S.C. 2011 et seq.); or 

24 (ii) State genetic monitoring regula25 tions, in the case of a State that is imple-
144 

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1 menting genetic monitoring regulations 

2 under the authority of the Occupational 

3 Safety and Health Act of 1970 (29 U.S.C. 

4 651 et seq.); and 

5 (E) the employer, excluding any licensed 

6 health care professional or board certified ge7 netic counselor that is involved in the genetic 

8 monitoring program, receives the results of the 

9 monitoring only in aggregate terms that do not 

10 disclose the identity of specific employees; or 

11 (6) where the employer conducts DNA analysis 

12 for law enforcement purposes as a forensic labora13 tory, includes such analysis in the Combined DNA 

14 Index System pursuant to section 210304 of the 

15 Violent Crime Control and Law Enforcement Act of 

16 1994 (42 U.S.C. 14132), and requests or requires 

17 genetic information of such employer’s employees, 

18 but only to the extent that such genetic information 

19 is used for analysis of DNA identification markers 

20 for quality control to detect sample contamination. 

21 (c) PRESERVATION OF PROTECTIONS.—In the case 

22 of information to which any of paragraphs (1) through 

23 (6) of subsection (b) applies, such information may not 

24 be used in violation of paragraph (1) or (2) of subsection 
145 

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1 (a) or treated or disclosed in a manner that violates sec2 tion 206. 

3 SEC. 203. EMPLOYMENT AGENCY PRACTICES. 

4 (a) DISCRIMINATION BASED ON GENETIC INFORMA5 TION.—It shall be an unlawful employment practice for 

6 an employment agency— 

7 (1) to fail or refuse to refer for employment, or 

8 otherwise to discriminate against, any individual be9 cause of genetic information with respect to the indi10 vidual; 

11 (2) to limit, segregate, or classify individuals or 

12 fail or refuse to refer for employment any individual 

13 in any way that would deprive or tend to deprive any 

14 individual of employment opportunities, or otherwise 

15 adversely affect the status of the individual as an 

16 employee, because of genetic information with re17 spect to the individual; or 

18 (3) to cause or attempt to cause an employer to 

19 discriminate against an individual in violation of this 

20 title. 

21 (b) ACQUISITION OF GENETIC INFORMATION.—It 

22 shall be an unlawful employment practice for an employ23 ment agency to request, require, or purchase genetic infor24 mation with respect to an individual or a family member 

25 of the individual except— 
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1 (1) where an employment agency inadvertently 

2 requests or requires family medical history of the in3 dividual or family member of the individual; 

4 (2) where— 

5 (A) health or genetic services are offered 

6 by the employment agency, including such serv7 ices offered as part of a bona fide wellness pro8 gram; 

9 (B) the individual provides prior, knowing, 

10 voluntary, and written authorization; 

11 (C) only the individual (or family member 

12 if the family member is receiving genetic serv13 ices) and the licensed health care professional 

14 or board certified genetic counselor involved in 

15 providing such services receive individually iden16 tifiable information concerning the results of 

17 such services; and 

18 (D) any individually identifiable genetic in19 formation provided under subparagraph (C) in 

20 connection with the services provided under 

21 subparagraph (A) is only available for purposes 

22 of such services and shall not be disclosed to 

23 the employment agency except in aggregate 

24 terms that do not disclose the identity of spe25 cific individuals; 
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1 (3) where an employment agency requests or re2 quires family medical history from the individual to 

3 comply with the certification provisions of section 

4 103 of the Family and Medical Leave Act of 1993 

5 (29 U.S.C. 2613) or such requirements under State 

6 family and medical leave laws; 

7 (4) where an employment agency purchases 

8 documents that are commercially and publicly avail9 able (including newspapers, magazines, periodicals, 

10 and books, but not including medical databases or 

11 court records) that include family medical history; or 

12 (5) where the information involved is to be used 

13 for genetic monitoring of the biological effects of 

14 toxic substances in the workplace, but only if— 

15 (A) the employment agency provides writ16 ten notice of the genetic monitoring to the indi17 vidual; 

18 (B)(i) the individual provides prior, know19 ing, voluntary, and written authorization; or 

20 (ii) the genetic monitoring is required by 

21 Federal or State law; 

22 (C) the individual is informed of individual 

23 monitoring results; 

24 (D) the monitoring is in compliance with— 
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1 (i) any Federal genetic monitoring 

2 regulations, including any such regulations 

3 that may be promulgated by the Secretary 

4 of Labor pursuant to the Occupational 

5 Safety and Health Act of 1970 (29 U.S.C. 

6 651 et seq.), the Federal Mine Safety and 

7 Health Act of 1977 (30 U.S.C. 801 et 

8 seq.), or the Atomic Energy Act of 1954 

9 (42 U.S.C. 2011 et seq.); or 

10 (ii) State genetic monitoring regula11 tions, in the case of a State that is imple12 menting genetic monitoring regulations 

13 under the authority of the Occupational 

14 Safety and Health Act of 1970 (29 U.S.C. 

15 651 et seq.); and 

16 (E) the employment agency, excluding any 

17 licensed health care professional or board cer18 tified genetic counselor that is involved in the 

19 genetic monitoring program, receives the results 

20 of the monitoring only in aggregate terms that 

21 do not disclose the identity of specific individ22 uals. 

23 (c) PRESERVATION OF PROTECTIONS.—In the case 

24 of information to which any of paragraphs (1) through 

25 (5) of subsection (b) applies, such information may not 
149 

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1 be used in violation of paragraph (1), (2), or (3) of sub2 section (a) or treated or disclosed in a manner that vio3 lates section 206. 

4 SEC. 204. LABOR ORGANIZATION PRACTICES. 

5 (a) DISCRIMINATION BASED ON GENETIC INFORMA6 TION.—It shall be an unlawful employment practice for 

7 a labor organization— 

8 (1) to exclude or to expel from the membership 

9 of the organization, or otherwise to discriminate 

10 against, any member because of genetic information 

11 with respect to the member; 

12 (2) to limit, segregate, or classify the members 

13 of the organization, or fail or refuse to refer for em14 ployment any member, in any way that would de15 prive or tend to deprive any member of employment 

16 opportunities, or otherwise adversely affect the sta17 tus of the member as an employee, because of ge18 netic information with respect to the member; or 

19 (3) to cause or attempt to cause an employer to 

20 discriminate against a member in violation of this 

21 title. 

22 (b) ACQUISITION OF GENETIC INFORMATION.—It 

23 shall be an unlawful employment practice for a labor orga24 nization to request, require, or purchase genetic informa-
150 

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1 tion with respect to a member or a family member of the 

2 member except— 

3 (1) where a labor organization inadvertently re4 quests or requires family medical history of the 

5 member or family member of the member; 

6 (2) where— 

7 (A) health or genetic services are offered 

8 by the labor organization, including such serv9 ices offered as part of a bona fide wellness pro10 gram; 

11 (B) the member provides prior, knowing, 

12 voluntary, and written authorization; 

13 (C) only the member (or family member if 

14 the family member is receiving genetic services) 

15 and the licensed health care professional or 

16 board certified genetic counselor involved in 

17 providing such services receive individually iden18 tifiable information concerning the results of 

19 such services; and 

20 (D) any individually identifiable genetic in21 formation provided under subparagraph (C) in 

22 connection with the services provided under 

23 subparagraph (A) is only available for purposes 

24 of such services and shall not be disclosed to 

25 the labor organization except in aggregate 
151 

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1 terms that do not disclose the identity of spe2 cific members; 

3 (3) where a labor organization requests or re4 quires family medical history from the members to 

5 comply with the certification provisions of section 

6 103 of the Family and Medical Leave Act of 1993 

7 (29 U.S.C. 2613) or such requirements under State 

8 family and medical leave laws; 

9 (4) where a labor organization purchases docu10 ments that are commercially and publicly available 

11 (including newspapers, magazines, periodicals, and 

12 books, but not including medical databases or court 

13 records) that include family medical history; or 

14 (5) where the information involved is to be used 

15 for genetic monitoring of the biological effects of 

16 toxic substances in the workplace, but only if— 

17 (A) the labor organization provides written 

18 notice of the genetic monitoring to the member; 

19 (B)(i) the member provides prior, knowing, 

20 voluntary, and written authorization; or 

21 (ii) the genetic monitoring is required by 

22 Federal or State law; 

23 (C) the member is informed of individual 

24 monitoring results; 

25 (D) the monitoring is in compliance with— 
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1 (i) any Federal genetic monitoring 

2 regulations, including any such regulations 

3 that may be promulgated by the Secretary 

4 of Labor pursuant to the Occupational 

5 Safety and Health Act of 1970 (29 U.S.C. 

6 651 et seq.), the Federal Mine Safety and 

7 Health Act of 1977 (30 U.S.C. 801 et 

8 seq.), or the Atomic Energy Act of 1954 

9 (42 U.S.C. 2011 et seq.); or 

10 (ii) State genetic monitoring regula11 tions, in the case of a State that is imple12 menting genetic monitoring regulations 

13 under the authority of the Occupational 

14 Safety and Health Act of 1970 (29 U.S.C. 

15 651 et seq.); and 

16 (E) the labor organization, excluding any 

17 licensed health care professional or board cer18 tified genetic counselor that is involved in the 

19 genetic monitoring program, receives the results 

20 of the monitoring only in aggregate terms that 

21 do not disclose the identity of specific members. 

22 (c) PRESERVATION OF PROTECTIONS.—In the case 

23 of information to which any of paragraphs (1) through 

24 (5) of subsection (b) applies, such information may not 

25 be used in violation of paragraph (1), (2), or (3) of sub-
153 

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1 section (a) or treated or disclosed in a manner that vio2 lates section 206. 

3 SEC. 205. TRAINING PROGRAMS. 

4 (a) DISCRIMINATION BASED ON GENETIC INFORMA5 TION.—It shall be an unlawful employment practice for 

6 any employer, labor organization, or joint labor-manage7 ment committee controlling apprenticeship or other train8 ing or retraining, including on-the-job training pro9 grams— 

10 (1) to discriminate against any individual be11 cause of genetic information with respect to the indi12 vidual in admission to, or employment in, any pro13 gram established to provide apprenticeship or other 

14 training or retraining; 

15 (2) to limit, segregate, or classify the applicants 

16 for or participants in such apprenticeship or other 

17 training or retraining, or fail or refuse to refer for 

18 employment any individual, in any way that would 

19 deprive or tend to deprive any individual of employ20 ment opportunities, or otherwise adversely affect the 

21 status of the individual as an employee, because of 

22 genetic information with respect to the individual; or 

23 (3) to cause or attempt to cause an employer to 

24 discriminate against an applicant for or a partici-
154 

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1 pant in such apprenticeship or other training or re2 training in violation of this title. 

3 (b) ACQUISITION OF GENETIC INFORMATION.—It 

4 shall be an unlawful employment practice for an employer, 

5 labor organization, or joint labor-management committee 

6 described in subsection (a) to request, require, or purchase 

7 genetic information with respect to an individual or a fam8 ily member of the individual except— 

9 (1) where the employer, labor organization, or 

10 joint labor-management committee inadvertently re11 quests or requires family medical history of the indi12 vidual or family member of the individual; 

13 (2) where— 

14 (A) health or genetic services are offered 

15 by the employer, labor organization, or joint 

16 labor-management committee, including such 

17 services offered as part of a bona fide wellness 

18 program; 

19 (B) the individual provides prior, knowing, 

20 voluntary, and written authorization; 

21 (C) only the individual (or family member 

22 if the family member is receiving genetic serv23 ices) and the licensed health care professional 

24 or board certified genetic counselor involved in 

25 providing such services receive individually iden-
155 

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1 tifiable information concerning the results of 

2 such services; and 

3 (D) any individually identifiable genetic in4 formation provided under subparagraph (C) in 

5 connection with the services provided under 

6 subparagraph (A) is only available for purposes 

7 of such services and shall not be disclosed to 

8 the employer, labor organization, or joint labor9 management committee except in aggregate 

10 terms that do not disclose the identity of spe11 cific individuals; 

12 (3) where the employer, labor organization, or 

13 joint labor-management committee requests or re14 quires family medical history from the individual to 

15 comply with the certification provisions of section 

16 103 of the Family and Medical Leave Act of 1993 

17 (29 U.S.C. 2613) or such requirements under State 

18 family and medical leave laws; 

19 (4) where the employer, labor organization, or 

20 joint labor-management committee purchases docu21 ments that are commercially and publicly available 

22 (including newspapers, magazines, periodicals, and 

23 books, but not including medical databases or court 

24 records) that include family medical history; 
156 

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1 (5) where the information involved is to be used 

2 for genetic monitoring of the biological effects of 

3 toxic substances in the workplace, but only if— 

4 (A) the employer, labor organization, or 

5 joint labor-management committee provides 

6 written notice of the genetic monitoring to the 

7 individual; 

8 (B)(i) the individual provides prior, know9 ing, voluntary, and written authorization; or 

10 (ii) the genetic monitoring is required by 

11 Federal or State law; 

12 (C) the individual is informed of individual 

13 monitoring results; 

14 (D) the monitoring is in compliance with— 

15 (i) any Federal genetic monitoring 

16 regulations, including any such regulations 

17 that may be promulgated by the Secretary 

18 of Labor pursuant to the Occupational 

19 Safety and Health Act of 1970 (29 U.S.C. 

20 651 et seq.), the Federal Mine Safety and 

21 Health Act of 1977 (30 U.S.C. 801 et 

22 seq.), or the Atomic Energy Act of 1954 

23 (42 U.S.C. 2011 et seq.); or 

24 (ii) State genetic monitoring regula25 tions, in the case of a State that is imple-
157 

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1 menting genetic monitoring regulations 

2 under the authority of the Occupational 

3 Safety and Health Act of 1970 (29 U.S.C. 

4 651 et seq.); and 

5 (E) the employer, labor organization, or 

6 joint labor-management committee, excluding 

7 any licensed health care professional or board 

8 certified genetic counselor that is involved in 

9 the genetic monitoring program, receives the re10 sults of the monitoring only in aggregate terms 

11 that do not disclose the identity of specific indi12 viduals; or 

13 (6) where the employer conducts DNA analysis 

14 for law enforcement purposes as a forensic labora15 tory, includes such analysis in the Combined DNA 

16 Index System pursuant to section 210304 of the 

17 Violent Crime Control and Law Enforcement Act of 

18 1994 (42 U.S.C. 14132), and requests or requires 

19 genetic information of such employer’s apprentices 

20 or trainees, but only to the extent that such genetic 

21 information is used for analysis of DNA identifica22 tion markers for quality control to detect sample 

23 contamination. 

24 (c) PRESERVATION OF PROTECTIONS.—In the case 

25 of information to which any of paragraphs (1) through 
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1 (6) of subsection (b) applies, such information may not 

2 be used in violation of paragraph (1), (2), or (3) of sub3 section (a) or treated or disclosed in a manner that vio4 lates section 206. 

5 SEC. 206. CONFIDENTIALITY OF GENETIC INFORMATION. 

6 (a) TREATMENT OF INFORMATION AS PART OF CON7 FIDENTIAL MEDICAL RECORD.—If an employer, employ8 ment agency, labor organization, or joint labor-manage9 ment committee possesses genetic information about an 

10 employee or member, such information shall be main11 tained on separate forms and in separate medical files and 

12 be treated as a confidential medical record of the employee 

13 or member. An employer, employment agency, labor orga14 nization, or joint labor-management committee shall be 

15 considered to be in compliance with the maintenance of 

16 information requirements of this subsection with respect 

17 to genetic information subject to this subsection that is 

18 maintained with and treated as a confidential medical 

19 record under section 102(d)(3)(B) of the Americans With 

20 Disabilities Act (42 U.S.C. 12112(d)(3)(B)). 

21 (b) LIMITATION ON DISCLOSURE.—An employer, em22 ployment agency, labor organization, or joint labor-man23 agement committee shall not disclose genetic information 

24 concerning an employee or member except— 
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1 (1) to the employee or member of a labor orga2 nization (or family member if the family member is 

3 receiving the genetic services) at the written request 

4 of the employee or member of such organization; 

5 (2) to an occupational or other health re6 searcher if the research is conducted in compliance 

7 with the regulations and protections provided for 

8 under part 46 of title 45, Code of Federal Regula9 tions; 

10 (3) in response to an order of a court, except 

11 that— 

12 (A) the employer, employment agency, 

13 labor organization, or joint labor-management 

14 committee may disclose only the genetic infor15 mation expressly authorized by such order; and 

16 (B) if the court order was secured without 

17 the knowledge of the employee or member to 

18 whom the information refers, the employer, em19 ployment agency, labor organization, or joint 

20 labor-management committee shall inform the 

21 employee or member of the court order and any 

22 genetic information that was disclosed pursuant 

23 to such order; 
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1 (4) to government officials who are inves2 tigating compliance with this title if the information 

3 is relevant to the investigation; or 

4 (5) to the extent that such disclosure is made 

5 in connection with the employee’s compliance with 

6 the certification provisions of section 103 of the 

7 Family and Medical Leave Act of 1993 (29 U.S.C. 

8 2613) or such requirements under State family and 

9 medical leave laws. 

10 (c) RELATIONSHIP TO HIPAA REGULATIONS.—With 

11 respect to the regulations promulgated by the Secretary 

12 of Health and Human Services under part C of title XI 

13 of the Social Security Act (42 U.S.C. 1320d et seq.) and 

14 section 264 of the Health Insurance Portability and Ac15 countability Act of 1996 (42 U.S.C. 1320d–2 note), this 

16 title does not prohibit a covered entity under such regula17 tions from any use or disclosure of health information that 

18 is authorized for the covered entity under such regula19 tions. The previous sentence does not affect the authority 

20 of such Secretary to modify such regulations. 

21 SEC. 207. REMEDIES AND ENFORCEMENT. 

22 (a) EMPLOYEES COVERED BY TITLE VII OF THE

23 CIVIL RIGHTS ACT OF 1964.— 

24 (1) IN GENERAL.—The powers, remedies, and 

25 procedures provided in sections 705, 706, 707, 709, 
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1 710, and 711 of the Civil Rights Act of 1964 (42 

2 U.S.C. 2000e–4 et seq.) to the Commission, the At3 torney General, or any person, alleging a violation of 

4 title VII of that Act (42 U.S.C. 2000e et seq.) shall 

5 be the powers, remedies, and procedures this title 

6 provides to the Commission, the Attorney General, 

7 or any person, respectively, alleging an unlawful em8 ployment practice in violation of this title against an 

9 employee described in section 201(2)(A)(i), except as 

10 provided in paragraphs (2) and (3). 

11 (2) COSTS AND FEES.—The powers, remedies, 

12 and procedures provided in subsections (b) and (c) 

13 of section 722 of the Revised Statutes of the United 

14 States (42 U.S.C. 1988), shall be powers, remedies, 

15 and procedures this title provides to the Commis16 sion, the Attorney General, or any person, alleging 

17 such a practice. 

18 (3) DAMAGES.—The powers, remedies, and pro19 cedures provided in section 1977A of the Revised 

20 Statutes of the United States (42 U.S.C. 1981a), in21 cluding the limitations contained in subsection (b)(3) 

22 of such section 1977A, shall be powers, remedies, 

23 and procedures this title provides to the Commis24 sion, the Attorney General, or any person, alleging 

25 such a practice (not an employment practice specifi-
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1 cally excluded from coverage under section 

2 1977A(a)(1) of the Revised Statutes of the United 

3 States). 

4 (b) EMPLOYEES COVERED BY GOVERNMENT EM5 PLOYEE RIGHTS ACT OF 1991.— 

6 (1) IN GENERAL.—The powers, remedies, and 

7 procedures provided in sections 302 and 304 of the 

8 Government Employee Rights Act of 1991 (42 

9 U.S.C. 2000e–16b, 2000e–16c) to the Commission, 

10 or any person, alleging a violation of section 

11 302(a)(1) of that Act (42 U.S.C. 2000e–16b(a)(1)) 

12 shall be the powers, remedies, and procedures this 

13 title provides to the Commission, or any person, re14 spectively, alleging an unlawful employment practice 

15 in violation of this title against an employee de16 scribed in section 201(2)(A)(ii), except as provided 

17 in paragraphs (2) and (3). 

18 (2) COSTS AND FEES.—The powers, remedies, 

19 and procedures provided in subsections (b) and (c) 

20 of section 722 of the Revised Statutes of the United 

21 States (42 U.S.C. 1988), shall be powers, remedies, 

22 and procedures this title provides to the Commis23 sion, or any person, alleging such a practice. 

24 (3) DAMAGES.—The powers, remedies, and pro25 cedures provided in section 1977A of the Revised 
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1 Statutes of the United States (42 U.S.C. 1981a), in2 cluding the limitations contained in subsection (b)(3) 

3 of such section 1977A, shall be powers, remedies, 

4 and procedures this title provides to the Commis5 sion, or any person, alleging such a practice (not an 

6 employment practice specifically excluded from cov7 erage under section 1977A(a)(1) of the Revised 

8 Statutes of the United States). 

9 (c) EMPLOYEES COVERED BY CONGRESSIONAL AC10 COUNTABILITY ACT OF 1995.— 

11 (1) IN GENERAL.—The powers, remedies, and 

12 procedures provided in the Congressional Account13 ability Act of 1995 (2 U.S.C. 1301 et seq.) to the 

14 Board (as defined in section 101 of that Act (2 

15 U.S.C. 1301)), or any person, alleging a violation of 

16 section 201(a)(1) of that Act (42 U.S.C. 1311(a)(1)) 

17 shall be the powers, remedies, and procedures this 

18 title provides to that Board, or any person, alleging 

19 an unlawful employment practice in violation of this 

20 title against an employee described in section 

21 201(2)(A)(iii), except as provided in paragraphs (2) 

22 and (3). 

23 (2) COSTS AND FEES.—The powers, remedies, 

24 and procedures provided in subsections (b) and (c) 

25 of section 722 of the Revised Statutes of the United 
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1 States (42 U.S.C. 1988), shall be powers, remedies, 

2 and procedures this title provides to that Board, or 

3 any person, alleging such a practice. 

4 (3) DAMAGES.—The powers, remedies, and pro5 cedures provided in section 1977A of the Revised 

6 Statutes of the United States (42 U.S.C. 1981a), in7 cluding the limitations contained in subsection (b)(3) 

8 of such section 1977A, shall be powers, remedies, 

9 and procedures this title provides to that Board, or 

10 any person, alleging such a practice (not an employ11 ment practice specifically excluded from coverage 

12 under section 1977A(a)(1) of the Revised Statutes 

13 of the United States). 

14 (4) OTHER APPLICABLE PROVISIONS.—With re15 spect to a claim alleging a practice described in 

16 paragraph (1), title III of the Congressional Ac17 countability Act of 1995 (2 U.S.C. 1381 et seq.) 

18 shall apply in the same manner as such title applies 

19 with respect to a claim alleging a violation of section 

20 201(a)(1) of such Act (2 U.S.C. 1311(a)(1)). 

21 (d) EMPLOYEES COVERED BY CHAPTER 5 OF TITLE

22 3, UNITED STATES CODE.— 

23 (1) IN GENERAL.—The powers, remedies, and 

24 procedures provided in chapter 5 of title 3, United 

25 States Code, to the President, the Commission, the 
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1 Merit Systems Protection Board, or any person, al2 leging a violation of section 411(a)(1) of that title, 

3 shall be the powers, remedies, and procedures this 

4 title provides to the President, the Commission, such 

5 Board, or any person, respectively, alleging an un6 lawful employment practice in violation of this title 

7 against an employee described in section 

8 201(2)(A)(iv), except as provided in paragraphs (2) 

9 and (3). 

10 (2) COSTS AND FEES.—The powers, remedies, 

11 and procedures provided in subsections (b) and (c) 

12 of section 722 of the Revised Statutes of the United 

13 States (42 U.S.C. 1988), shall be powers, remedies, 

14 and procedures this title provides to the President, 

15 the Commission, such Board, or any person, alleging 

16 such a practice. 

17 (3) DAMAGES.—The powers, remedies, and pro18 cedures provided in section 1977A of the Revised 

19 Statutes of the United States (42 U.S.C. 1981a), in20 cluding the limitations contained in subsection (b)(3) 

21 of such section 1977A, shall be powers, remedies, 

22 and procedures this title provides to the President, 

23 the Commission, such Board, or any person, alleging 

24 such a practice (not an employment practice specifi25 cally excluded from coverage under section 
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1 1977A(a)(1) of the Revised Statutes of the United 

2 States). 

3 (e) EMPLOYEES COVERED BY SECTION 717 OF THE

4 CIVIL RIGHTS ACT OF 1964.— 

5 (1) IN GENERAL.—The powers, remedies, and 

6 procedures provided in section 717 of the Civil 

7 Rights Act of 1964 (42 U.S.C. 2000e–16) to the 

8 Commission, the Attorney General, the Librarian of 

9 Congress, or any person, alleging a violation of that 

10 section shall be the powers, remedies, and proce11 dures this title provides to the Commission, the At12 torney General, the Librarian of Congress, or any 

13 person, respectively, alleging an unlawful employ14 ment practice in violation of this title against an em15 ployee or applicant described in section 

16 201(2)(A)(v), except as provided in paragraphs (2) 

17 and (3). 

18 (2) COSTS AND FEES.—The powers, remedies, 

19 and procedures provided in subsections (b) and (c) 

20 of section 722 of the Revised Statutes of the United 

21 States (42 U.S.C. 1988), shall be powers, remedies, 

22 and procedures this title provides to the Commis23 sion, the Attorney General, the Librarian of Con24 gress, or any person, alleging such a practice. 
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1 (3) DAMAGES.—The powers, remedies, and pro2 cedures provided in section 1977A of the Revised 

3 Statutes of the United States (42 U.S.C. 1981a), in4 cluding the limitations contained in subsection (b)(3) 

5 of such section 1977A, shall be powers, remedies, 

6 and procedures this title provides to the Commis7 sion, the Attorney General, the Librarian of Con8 gress, or any person, alleging such a practice (not an 

9 employment practice specifically excluded from cov10 erage under section 1977A(a)(1) of the Revised 

11 Statutes of the United States). 

12 (f) DEFINITION.—In this section, the term ‘‘Commis13 sion’’ means the Equal Employment Opportunity Commis14 sion. 

15 SEC. 208. DISPARATE IMPACT. 

16 (a) GENERAL RULE.—Notwithstanding any other 

17 provision of this division, ‘‘disparate impact’’, as that term 

18 is used in section 703(k) of the Civil Rights Act of 1964 

19 (42 U.S.C. 2000e–2(k)), on the basis of genetic informa20 tion does not establish a cause of action under this divi21 sion. 

22 (b) COMMISSION.—On the date that is 6 years after 

23 the date of enactment of this Act, there shall be estab24 lished a commission, to be known as the Genetic Non25 discrimination Study Commission (referred to in this sec-
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1 tion as the ‘‘Commission’’) to review the developing 

2 science of genetics and to make recommendations to Con3 gress regarding whether to provide a disparate impact 

4 cause of action under this division. 

5 (c) MEMBERSHIP.— 

6 (1) IN GENERAL.—The Commission shall be 

7 composed of eight members, of which— 

8 (A) one member shall be appointed by the 

9 Majority Leader of the Senate; 

10 (B) one member shall be appointed by the 

11 Minority Leader of the Senate; 

12 (C) one member shall be appointed by the 

13 Chairman of the Committee on Health, Edu14 cation, Labor, and Pensions of the Senate; 

15 (D) one member shall be appointed by the 

16 ranking minority member of the Committee on 

17 Health, Education, Labor, and Pensions of the 

18 Senate; 

19 (E) one member shall be appointed by the 

20 Speaker of the House of Representatives; 

21 (F) one member shall be appointed by the 

22 Minority Leader of the House of Representa23 tives; 
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1 (G) one member shall be appointed by the 

2 Chairman of the Committee on Education and 

3 Labor of the House of Representatives; and 

4 (H) one member shall be appointed by the 

5 ranking minority member of the Committee on 

6 Education and Labor of the House of Rep7 resentatives. 

8 (2) COMPENSATION AND EXPENSES.—The 

9 members of the Commission shall not receive com10 pensation for the performance of services for the 

11 Commission, but shall be allowed travel expenses, in12 cluding per diem in lieu of subsistence, at rates au13 thorized for employees of agencies under subchapter 

14 I of chapter 57 of title 5, United States Code, while 

15 away from their homes or regular places of business 

16 in the performance of services for the Commission. 

17 (d) ADMINISTRATIVE PROVISIONS.— 

18 (1) LOCATION.—The Commission shall be lo19 cated in a facility maintained by the Equal Employ20 ment Opportunity Commission. 

21 (2) DETAIL OF GOVERNMENT EMPLOYEES.— 

22 Any Federal Government employee may be detailed 

23 to the Commission without reimbursement, and such 

24 detail shall be without interruption or loss of civil 

25 service status or privilege. 
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1 (3) INFORMATION FROM FEDERAL AGENCIES.— 

2 The Commission may secure directly from any Fed3 eral department or agency such information as the 

4 Commission considers necessary to carry out the 

5 provisions of this section. Upon request of the Com6 mission, the head of such department or agency 

7 shall furnish such information to the Commission. 

8 (4) HEARINGS.—The Commission may hold 

9 such hearings, sit and act at such times and places, 

10 take such testimony, and receive such evidence as 

11 the Commission considers advisable to carry out the 

12 objectives of this section, except that, to the extent 

13 possible, the Commission shall use existing data and 

14 research. 

15 (5) POSTAL SERVICES.—The Commission may 

16 use the United States mails in the same manner and 

17 under the same conditions as other departments and 

18 agencies of the Federal Government. 

19 (e) REPORT.—Not later than 1 year after all of the 

20 members are appointed to the Commission under sub21 section (c)(1), the Commission shall submit to Congress 

22 a report that summarizes the findings of the Commission 

23 and makes such recommendations for legislation as are 

24 consistent with this division. 
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1 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to the Equal Employ3 ment Opportunity Commission such sums as may be nec4 essary to carry out this section. 

5 SEC. 209. CONSTRUCTION. 

6 (a) IN GENERAL.—Nothing in this title shall be con7 strued to— 

8 (1) limit the rights or protections of an indi9 vidual under any other Federal or State statute that 

10 provides equal or greater protection to an individual 

11 than the rights or protections provided for under 

12 this title, including the protections of an individual 

13 under the Americans with Disabilities Act of 1990 

14 (42 U.S.C. 12101 et seq.) (including coverage af15 forded to individuals under section 102 of such Act 

16 (42 U.S.C. 12112)), or under the Rehabilitation Act 

17 of 1973 (29 U.S.C. 701 et seq.); 

18 (2)(A) limit the rights or protections of an indi19 vidual to bring an action under this title against an 

20 employer, employment agency, labor organization, or 

21 joint labor-management committee for a violation of 

22 this title; or 

23 (B) provide for enforcement of, or penalties for 

24 violation of, any requirement or prohibition applica25 ble to any employer, employment agency, labor orga-
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1 nization, or joint labor-management committee the 

2 enforcement of which, or penalties for which, are 

3 provided under the amendments made by title I; 

4 (3) apply to the Armed Forces Repository of 

5 Specimen Samples for the Identification of Remains; 

6 (4) limit or expand the protections, rights, or 

7 obligations of employees or employers under applica8 ble workers’ compensation laws; 

9 (5) limit the authority of a Federal department 

10 or agency to conduct or sponsor occupational or 

11 other health research that is conducted in compli12 ance with the regulations contained in part 46 of 

13 title 45, Code of Federal Regulations (or any cor14 responding or similar regulation or rule); 

15 (6) limit the statutory or regulatory authority 

16 of the Occupational Safety and Health Administra17 tion or the Mine Safety and Health Administration 

18 to promulgate or enforce workplace safety and 

19 health laws and regulations; or 

20 (7) require any specific benefit for an employee 

21 or member or a family member of an employee or 

22 member under any group health plan or health in23 surance issuer offering group health insurance cov24 erage in connection with a group health plan. 
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1 (b) GENETIC INFORMATION OF A FETUS OR EM2 BRYO.—Any reference in this title to genetic information 

3 concerning an individual or family member of an indi4 vidual shall— 

5 (1) with respect to such an individual or family 

6 member of an individual who is a pregnant woman, 

7 include genetic information of any fetus carried by 

8 such pregnant woman; and 

9 (2) with respect to an individual or family 

10 member utilizing an assisted reproductive tech11 nology, include genetic information of any embryo le12 gally held by the individual or family member. 

13 SEC. 210. MEDICAL INFORMATION THAT IS NOT GENETIC 

14 INFORMATION. 

15 An employer, employment agency, labor organization, 

16 or joint labor-management committee shall not be consid17 ered to be in violation of this title based on the use, acqui18 sition, or disclosure of medical information that is not ge19 netic information about a manifested disease, disorder, or 

20 pathological condition of an employee or member, includ21 ing a manifested disease, disorder, or pathological condi22 tion that has or may have a genetic basis. 
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1 SEC. 211. REGULATIONS. 

2 Not later than 1 year after the date of enactment 

3 of this title, the Commission shall issue final regulations 

4 to carry out this title. 

5 SEC. 212. AUTHORIZATION OF APPROPRIATIONS. 

6 There are authorized to be appropriated such sums 

7 as may be necessary to carry out this title (except for sec8 tion 208). 

9 SEC. 213. EFFECTIVE DATE. 

10 This title takes effect on the date that is 18 months 

11 after the date of enactment of this Act. 

12 TITLE III—MISCELLANEOUS 

13 PROVISIONS 

14 SEC. 301. GUARANTEE AGENCY COLLECTION RETENTION. 

15 Clause (ii) of section 428(c)(6)(A) of the Higher 

16 Education Act of 1965 (20 U.S.C. 1078(c)(6)(A)) is 

17 amended to read as follows: 

18 ‘‘(ii) an amount equal to 23 percent of 

19 such payments for use in accordance with sec20 tion 422B, except that beginning October 1, 

21 2007, and ending September 30, 2008, this 

22 subparagraph shall be applied by substituting 

23 ‘22 percent’ for ‘23 percent’.’’. 

24 SEC. 302. SEVERABILITY. 

25 If any provision of this division, an amendment made 

26 by this division, or the application of such provision or 
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1 amendment to any person or circumstance is held to be 

2 unconstitutional, the remainder of this division, the 

3 amendments made by this division, and the application of 

4 such provisions to any person or circumstance shall not 

5 be affected thereby. 

Passed the House of Representatives March 5, 

2008. 

Attest: 

Clerk. 
110TH CONGRESS 

2D SESSION H. R. 1424 

AN ACT 

To amend section 712 of the Employee Retirement 

ance and employment, and for other purposes. genetic information with respect to health insurplans, to prohibit discrimination on the basis of related disorder benefits under group health in the provision of mental health and substanceInternal Revenue Code of 1986 to require equity Public Health Service Act, section 9812 of the Income Security Act of 1974, section 2705 of the