I 

111TH CONGRESS 

1ST SESSION H. R. 716 

To amend the Public Health Service Act, the Employee Retirement Income 

Security Act of 1974, and the Internal Revenue Code of 1986 to require 

group and individual health insurance coverage and group health plans 

to provide coverage for individuals participating in approved cancer clinical trials. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 27, 2009 

Mr. ISRAEL (for himself, Mrs. MYRICK, and Mrs. CAPPS) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor and 

Ways and Means, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

A BILL 

To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal 

Revenue Code of 1986 to require group and individual 

health insurance coverage and group health plans to 

provide coverage for individuals participating in approved 

cancer clinical trials. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


hsrobinson on PROD1PC76 with BILLS
2 

HR 716 IH 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Access to Cancer Clin3 ical Trials Act of 2009’’. 

4 SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

5 APPROVED CANCER CLINICAL TRIALS. 

6 (a) GROUP HEALTH PLANS.— 

7 (1) PUBLIC HEALTH SERVICE ACT AMEND8 MENTS.—Subpart 2 of part A of title XXVII of the 

9 Public Health Service Act is amended by adding at 

10 the end the following new section: 

11 ‘‘SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING 

12 IN APPROVED CANCER CLINICAL TRIALS. 

13 ‘‘(a) COVERAGE.— 

14 ‘‘(1) IN GENERAL.—If a group health plan (or 

15 a health insurance issuer offering health insurance 

16 coverage in connection with the plan) provides cov17 erage to a qualified individual (as defined in sub18 section (b)), the plan or issuer— 

19 ‘‘(A) may not deny the individual partici20 pation in the clinical trial referred to in sub21 section (b)(2); 

22 ‘‘(B) subject to subsection (c), may not 

23 deny (or limit or impose additional conditions 

24 on) the coverage of routine patient costs for 

25 items and services furnished in connection with 

26 participation in the trial; and 


hsrobinson on PROD1PC76 with BILLS
3 

HR 716 IH 

1 ‘‘(C) may not discriminate against the in2 dividual on the basis of the individual’s partici3 pation in such trial. 

4 ‘‘(2) EXCLUSION OF CERTAIN COSTS.— 

5 ‘‘(A) IN GENERAL.—For purposes of para6 graph (1)(B), subject to subparagraph (B), rou7 tine patient costs include all items and services 

8 provided in the clinical trial that are otherwise 

9 generally available to the qualified individual, 

10 except— 

11 ‘‘(i) in the cases of drugs and devices, 

12 the investigational item or service, itself; or 

13 ‘‘(ii) items and services that are pro14 vided solely to satisfy data collection and 

15 analysis needs and that are not used in the 

16 direct clinical management of the patient. 

17 ‘‘(B) INCLUSIONS.—Such routine patient 

18 costs include costs for the following: 

19 ‘‘(i) CONVENTIONAL CARE.—Items or 

20 services that are typically provided absent 

21 a clinical trial. 

22 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items 

23 or services required solely for the provision 

24 of the investigational item or service (such 

25 as the administration of a noncovered 


hsrobinson on PROD1PC76 with BILLS
4 

HR 716 IH 

1 chemotherapeutic agent), the clinically ap2 propriate monitoring of the effects of the 

3 item or service, or the prevention of com4 plications. 

5 ‘‘(iii) REASONABLE AND NECESSARY

6 CARE.—Items or services needed for rea7 sonable and necessary care arising from 

8 the provision of an investigational item or 

9 service, including the diagnosis or treat10 ment of complications. 

11 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one 

12 or more participating providers is participating in a 

13 clinical trial, nothing in paragraph (1) shall be con14 strued as preventing a plan or issuer from requiring 

15 that a qualified individual participate in the trial 

16 through such a participating provider if the provider 

17 will accept the individual as a participant in the 

18 trial. 

19 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur20 poses of subsection (a), the term ‘qualified individual’ 

21 means an individual who is a participant or beneficiary 

22 in a group health plan and who meets the following condi23 tions: 

24 ‘‘(1)(A) The individual has been diagnosed with 

25 cancer. 


hsrobinson on PROD1PC76 with BILLS
5 

HR 716 IH 

1 ‘‘(B) The individual is eligible to participate in 

2 an approved clinical trial according to the trial pro3 tocol with respect to treatment of such illness. 

4 ‘‘(2) Either— 

5 ‘‘(A) the referring physician is a partici6 pating health care professional and has con7 cluded that the individual’s participation in 

8 such trial would be appropriate based upon the 

9 individual meeting the conditions described in 

10 paragraph (1); or 

11 ‘‘(B) the participant or beneficiary pro12 vides medical and scientific information estab13 lishing that the individual’s participation in 

14 such trial would be appropriate based upon the 

15 individual meeting the conditions described in 

16 paragraph (1). 

17 ‘‘(c) PAYMENT.— 

18 ‘‘(1) IN GENERAL.—Under this section a group 

19 health plan (or health insurance issuer offering 

20 health insurance coverage in connection with the 

21 plan) shall provide for payment for routine patient 

22 costs described in subsection (a)(2) but is not re23 quired to pay for costs of items and services that are 

24 customarily provided by the research sponsors free 

25 of charge for individuals participating in the trial. 


hsrobinson on PROD1PC76 with BILLS
6 

HR 716 IH 

1 ‘‘(2) PAYMENT RATE.—In the case of covered 

2 items and services provided by— 

3 ‘‘(A) a participating provider, the payment 

4 rate shall be at the agreed upon rate, or 

5 ‘‘(B) a nonparticipating provider, the pay6 ment rate shall be at the rate the plan would 

7 normally pay for comparable items and services 

8 under subparagraph (A). 

9 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.— 

10 ‘‘(1) IN GENERAL.—In this section, the term 

11 ‘approved clinical trial’ means a clinical research 

12 study or clinical investigation that relates to the 

13 treatment of cancer (including related symptoms) 

14 and is described in any of the following subpara15 graphs: 

16 ‘‘(A) FEDERALLY FUNDED TRIALS.—The 

17 study or investigation is approved or funded 

18 (which may include funding through in-kind 

19 contributions) by one or more of the following: 

20 ‘‘(i) NIH.—The National Institutes of 

21 Health. 

22 ‘‘(ii) CDC.—The Centers for Disease 

23 Control and Prevention. 

24 ‘‘(iii) AHRQ.—The Agency for Health 

25 Care Research and Quality. 


hsrobinson on PROD1PC76 with BILLS
7 

HR 716 IH 

1 ‘‘(iv) CMS.—The Centers for Medi2 care & Medicaid Services. 

3 ‘‘(v) COOPERATIVE CENTER.—A coop4 erative group or center of any of the enti5 ties described in clauses (i) through (iv) or 

6 the Departments of Defense or Veterans 

7 Affairs. 

8 ‘‘(vi) CENTER SUPPORT GRANTEES.— 

9 A qualified non-governmental research en10 tity identified in the guidelines issued by 

11 the National Institutes of Health for cen12 ter support grants. 

13 ‘‘(vii) DOD; VA; DOE.—Any of the fol14 lowing if the conditions described in para15 graph (2) are met: 

16 ‘‘(I) The Department of Veterans 

17 Affairs. 

18 ‘‘(II) The Department of De19 fense. 

20 ‘‘(III) The Department of En21 ergy. 

22 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The 

23 study or investigation is conducted under an in24 vestigational new drug application reviewed by 

25 the Food and Drug Administration. 


hsrobinson on PROD1PC76 with BILLS
8 

HR 716 IH 

1 ‘‘(C) EXEMPT DRUG TRIAL.—The study or 

2 investigation is a drug trial that is exempt from 

3 having such an investigational new drug appli4 cation. 

5 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The 

6 conditions described in this paragraph, for a study 

7 or investigation conducted by a Department, are 

8 that the study or investigation has been reviewed 

9 and approved through a system of peer review that 

10 the Secretary determines— 

11 ‘‘(A) to be comparable to the system of 

12 peer review of studies and investigations used 

13 by the National Institutes of Health, and 

14 ‘‘(B) assures unbiased review of the high15 est scientific standards by qualified individuals 

16 who have no interest in the outcome of the re17 view. 

18 ‘‘(e) CONSTRUCTION.—Nothing in this section shall 

19 be construed to limit a plan’s or issuer’s coverage with 

20 respect to clinical trials.’’. 

21 (2) ERISA AMENDMENTS.—(A) Subpart B of 

22 part 7 of subtitle B of title I of the Employee Re23 tirement Income Security Act of 1974 is amended by 

24 adding at the end the following new section: 


hsrobinson on PROD1PC76 with BILLS
9 

HR 716 IH 

1 ‘‘SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

2 APPROVED CANCER CLINICAL TRIALS. 

3 ‘‘(a) COVERAGE.— 

4 ‘‘(1) IN GENERAL.—If a group health plan (or 

5 a health insurance issuer offering health insurance 

6 coverage in connection with the plan) provides cov7 erage to a qualified individual (as defined in sub8 section (b)), the plan or issuer— 

9 ‘‘(A) may not deny the individual partici10 pation in the clinical trial referred to in sub11 section (b)(2); 

12 ‘‘(B) subject to subsection (c), may not 

13 deny (or limit or impose additional conditions 

14 on) the coverage of routine patient costs for 

15 items and services furnished in connection with 

16 participation in the trial; and 

17 ‘‘(C) may not discriminate against the in18 dividual on the basis of the individual’s partici19 pation in such trial. 

20 ‘‘(2) EXCLUSION OF CERTAIN COSTS.— 

21 ‘‘(A) IN GENERAL.—For purposes of para22 graph (1)(B), subject to subparagraph (B), rou23 tine patient costs include all items and services 

24 provided in the clinical trial that are otherwise 

25 generally available to the qualified individual, 

26 except— 


hsrobinson on PROD1PC76 with BILLS
10 

HR 716 IH 

1 ‘‘(i) in the cases of drugs and devices, 

2 the investigational item or service, itself; or 

3 ‘‘(ii) items and services that are pro4 vided solely to satisfy data collection and 

5 analysis needs and that are not used in the 

6 direct clinical management of the patient. 

7 ‘‘(B) EXCLUSION.—Such routine patient 

8 costs do include costs for the following: 

9 ‘‘(i) CONVENTIONAL CARE.—Items or 

10 services that are typically provided absent 

11 a clinical trial. 

12 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items 

13 or services required solely for the provision 

14 of the investigational item or service (such 

15 as the administration of a noncovered 

16 chemotherapeutic agent), the clinically ap17 propriate monitoring of the effects of the 

18 item or service, or the prevention of com19 plications. 

20 ‘‘(iii) REASONABLE AND NECESSARY

21 CARE.—Items or services needed for rea22 sonable and necessary care arising from 

23 the provision of an investigational item or 

24 service, including the diagnosis or treat25 ment of complications. 


hsrobinson on PROD1PC76 with BILLS
11 

HR 716 IH 

1 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one 

2 or more participating providers is participating in a 

3 clinical trial, nothing in paragraph (1) shall be con4 strued as preventing a plan or issuer from requiring 

5 that a qualified individual participate in the trial 

6 through such a participating provider if the provider 

7 will accept the individual as a participant in the 

8 trial. 

9 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur10 poses of subsection (a), the term ‘qualified individual’ 

11 means an individual who is a participant or beneficiary 

12 in a group health plan and who meets the following condi13 tions: 

14 ‘‘(1)(A) The individual has been diagnosed with 

15 cancer. 

16 ‘‘(B) The individual is eligible to participate in 

17 an approved clinical trial according to the trial pro18 tocol with respect to treatment of such illness. 

19 ‘‘(2) Either— 

20 ‘‘(A) the referring physician is a partici21 pating health care professional and has con22 cluded that the individual’s participation in 

23 such trial would be appropriate based upon the 

24 individual meeting the conditions described in 

25 paragraph (1); or 


hsrobinson on PROD1PC76 with BILLS
12 

HR 716 IH 

1 ‘‘(B) the participant or beneficiary pro2 vides medical and scientific information estab3 lishing that the individual’s participation in 

4 such trial would be appropriate based upon the 

5 individual meeting the conditions described in 

6 paragraph (1). 

7 ‘‘(c) PAYMENT.— 

8 ‘‘(1) IN GENERAL.—Under this section a group 

9 health plan (or health insurance issuer offering 

10 health insurance coverage in connection with the 

11 plan) shall provide for payment for routine patient 

12 costs described in subsection (a)(2) but is not re13 quired to pay for costs of items and services that are 

14 customarily provided by the research sponsors free 

15 of charge for individuals participating in the trial. 

16 ‘‘(2) PAYMENT RATE.—In the case of covered 

17 items and services provided by— 

18 ‘‘(A) a participating provider, the payment 

19 rate shall be at the agreed upon rate, or 

20 ‘‘(B) a nonparticipating provider, the pay21 ment rate shall be at the rate the plan would 

22 normally pay for comparable items and services 

23 under subparagraph (A). 

24 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.— 


hsrobinson on PROD1PC76 with BILLS
13 

HR 716 IH 

1 ‘‘(1) IN GENERAL.—In this section, the term 

2 ‘approved clinical trial’ means a clinical research 

3 study or clinical investigation that relates to the 

4 treatment of cancer (including related symptoms) 

5 and is described in any of the following subpara6 graphs: 

7 ‘‘(A) FEDERALLY FUNDED TRIALS.—The 

8 study or investigation is approved or funded 

9 (which may include funding through in-kind 

10 contributions) by one or more of the following: 

11 ‘‘(i) NIH.—The National Institutes of 

12 Health. 

13 ‘‘(ii) CDC.—The Centers for Disease 

14 Control and Prevention. 

15 ‘‘(iii) AHRQ.—The Agency for Health 

16 Care Research and Quality. 

17 ‘‘(iv) CMS.—The Centers for Medi18 care & Medicaid Services. 

19 ‘‘(v) COOPERATIVE CENTER.—A coop20 erative group or center of any of the enti21 ties described in clauses (i) through (iv) or 

22 the Departments of Defense or Veterans 

23 Affairs. 

24 ‘‘(vi) CENTER SUPPORT GRANTEES.— 

25 A qualified non-governmental research enVerDate Nov 24 2008 23:16 Jan 28, 2009 Jkt 079200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H716.IH H716

hsrobinson on PROD1PC76 with BILLS
14 

HR 716 IH 

1 tity identified in the guidelines issued by 

2 the National Institutes of Health for cen3 ter support grants. 

4 ‘‘(vii) DOD; VA; DOE.—Any of the fol5 lowing if the conditions described in para6 graph (2) are met: 

7 ‘‘(I) The Department of Veterans 

8 Affairs. 

9 ‘‘(II) The Department of De10 fense. 

11 ‘‘(III) The Department of En12 ergy. 

13 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The 

14 study or investigation is conducted under an in15 vestigational new drug application reviewed by 

16 the Food and Drug Administration. 

17 ‘‘(C) EXEMPT DRUG TRIAL.—The study or 

18 investigation is a drug trial that is exempt from 

19 having such an investigational new drug appli20 cation. 

21 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The 

22 conditions described in this paragraph, for a study 

23 or investigation conducted by a Department, are 

24 that the study or investigation has been reviewed 


hsrobinson on PROD1PC76 with BILLS
15 

HR 716 IH 

1 and approved through a system of peer review that 

2 the Secretary determines— 

3 ‘‘(A) to be comparable to the system of 

4 peer review of studies and investigations used 

5 by the National Institutes of Health, and 

6 ‘‘(B) assures unbiased review of the high7 est scientific standards by qualified individuals 

8 who have no interest in the outcome of the re9 view. 

10 ‘‘(e) CONSTRUCTION.—Nothing in this section shall 

11 be construed to limit a plan’s or issuer’s coverage with 

12 respect to clinical trials.’’. 

13 (B) Section 732(a) of such Act (29 U.S.C. 

14 1191a(a)) is amended by striking ‘‘section 711’’ and 

15 inserting ‘‘sections 711 and 714’’. 

16 (C) The table of contents in section 1 of such 

17 Act is amended by inserting after the item relating 

18 to section 713 the following new item: 

‘‘Sec. 714. Coverage for individuals participating in approved cancer clinical 

trials.’’. 

19 (3) INTERNAL REVENUE CODE AMEND20 MENTS.— 

21 (A) IN GENERAL.—Subchapter B of chap22 ter 100 of the Internal Revenue Code of 1986 

23 is amended— 


hsrobinson on PROD1PC76 with BILLS
16 

HR 716 IH 

1 (i) in the table of sections, by insert2 ing after the item relating to section 9812 

3 the following new item: 

‘‘Sec. 9813. Coverage for individuals participating in approved cancer clinical 

trials.’’; 

4 and 

5 (ii) by inserting after section 9812 the 

6 following: 

7 ‘‘SEC. 9813. COVERAGE FOR INDIVIDUALS PARTICIPATING 

8 IN APPROVED CANCER CLINICAL TRIALS. 

9 ‘‘(a) COVERAGE.— 

10 ‘‘(1) IN GENERAL.—If a group health plan pro11 vides coverage to a qualified individual (as defined in 

12 subsection (b)), the plan— 

13 ‘‘(A) may not deny the individual partici14 pation in the clinical trial referred to in sub15 section (b)(2); 

16 ‘‘(B) subject to subsection (c), may not 

17 deny (or limit or impose additional conditions 

18 on) the coverage of routine patient costs for 

19 items and services furnished in connection with 

20 participation in the trial; and 

21 ‘‘(C) may not discriminate against the in22 dividual on the basis of the individual’s partici23 pation in such trial. 

24 ‘‘(2) EXCLUSION OF CERTAIN COSTS.— 


hsrobinson on PROD1PC76 with BILLS
17 

HR 716 IH 

1 ‘‘(A) IN GENERAL.—For purposes of para2 graph (1)(B), subject to subparagraph (B), rou3 tine patient costs include all items and services 

4 provided in the clinical trial that are otherwise 

5 generally available to the qualified individual, 

6 except— 

7 ‘‘(i) in the cases of drugs and devices, 

8 the investigational item or service, itself; or 

9 ‘‘(ii) items and services that are pro10 vided solely to satisfy data collection and 

11 analysis needs and that are not used in the 

12 direct clinical management of the patient. 

13 ‘‘(B) EXCLUSION.—Such routine patient 

14 costs do include costs for the following: 

15 ‘‘(i) CONVENTIONAL CARE.—Items or 

16 services that are typically provided absent 

17 a clinical trial. 

18 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items 

19 or services required solely for the provision 

20 of the investigational item or service (such 

21 as the administration of a noncovered 

22 chemotherapeutic agent), the clinically ap23 propriate monitoring of the effects of the 

24 item or service, or the prevention of com25 plications. 


hsrobinson on PROD1PC76 with BILLS
18 

HR 716 IH 

1 ‘‘(iii) REASONABLE AND NECESSARY

2 CARE.—Items or services needed for rea3 sonable and necessary care arising from 

4 the provision of an investigational item or 

5 service, including the diagnosis or treat6 ment of complications. 

7 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one 

8 or more participating providers is participating in a 

9 clinical trial, nothing in paragraph (1) shall be con10 strued as preventing a plan from requiring that a 

11 qualified individual participate in the trial through 

12 such a participating provider if the provider will ac13 cept the individual as a participant in the trial. 

14 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur15 poses of subsection (a), the term ‘qualified individual’ 

16 means an individual who is a participant or beneficiary 

17 in a group health plan and who meets the following condi18 tions: 

19 ‘‘(1)(A) The individual has been diagnosed with 

20 cancer. 

21 ‘‘(B) The individual is eligible to participate in 

22 an approved clinical trial according to the trial pro23 tocol with respect to treatment of such illness. 

24 ‘‘(2) Either— 


hsrobinson on PROD1PC76 with BILLS
19 

HR 716 IH 

1 ‘‘(A) the referring physician is a partici2 pating health care professional and has con3 cluded that the individual’s participation in 

4 such trial would be appropriate based upon the 

5 individual meeting the conditions described in 

6 paragraph (1); or 

7 ‘‘(B) the participant or beneficiary pro8 vides medical and scientific information estab9 lishing that the individual’s participation in 

10 such trial would be appropriate based upon the 

11 individual meeting the conditions described in 

12 paragraph (1). 

13 ‘‘(c) PAYMENT.— 

14 ‘‘(1) IN GENERAL.—Under this section a group 

15 health plan shall provide for payment for routine pa16 tient costs described in subsection (a)(2) but is not 

17 required to pay for costs of items and services that 

18 are customarily provided by the research sponsors 

19 free of charge for individuals participating in the 

20 trial. 

21 ‘‘(2) PAYMENT RATE.—In the case of covered 

22 items and services provided by— 

23 ‘‘(A) a participating provider, the payment 

24 rate shall be at the agreed upon rate, or 


hsrobinson on PROD1PC76 with BILLS
20 

HR 716 IH 

1 ‘‘(B) a nonparticipating provider, the pay2 ment rate shall be at the rate the plan would 

3 normally pay for comparable items and services 

4 under subparagraph (A). 

5 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.— 

6 ‘‘(1) IN GENERAL.—In this section, the term 

7 ‘approved clinical trial’ means a clinical research 

8 study or clinical investigation that relates to the 

9 treatment of cancer (including related symptoms) 

10 and is described in any of the following subpara11 graphs: 

12 ‘‘(A) FEDERALLY FUNDED TRIALS.—The 

13 study or investigation is approved or funded 

14 (which may include funding through in-kind 

15 contributions) by one or more of the following: 

16 ‘‘(i) NIH.—The National Institutes of 

17 Health. 

18 ‘‘(ii) CDC.—The Centers for Disease 

19 Control and Prevention. 

20 ‘‘(iii) AHRQ.—The Agency for Health 

21 Care Research and Quality. 

22 ‘‘(iv) CMS.—The Centers for Medi23 care & Medicaid Services. 

24 ‘‘(v) COOPERATIVE CENTER.—A coop25 erative group or center of any of the entiVerDate Nov 24 2008 23:16 Jan 28, 2009 Jkt 079200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H716.IH H716

hsrobinson on PROD1PC76 with BILLS
21 

HR 716 IH 

1 ties described in clauses (i) through (iv) or 

2 the Departments of Defense or Veterans 

3 Affairs. 

4 ‘‘(vi) CENTER SUPPORT GRANTEES.— 

5 A qualified non-governmental research en6 tity identified in the guidelines issued by 

7 the National Institutes of Health for cen8 ter support grants. 

9 ‘‘(vii) DOD; VA; DOE.—Any of the fol10 lowing if the conditions described in para11 graph (2) are met: 

12 ‘‘(I) The Department of Veterans 

13 Affairs. 

14 ‘‘(II) The Department of De15 fense. 

16 ‘‘(III) The Department of En17 ergy. 

18 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The 

19 study or investigation is conducted under an in20 vestigational new drug application reviewed by 

21 the Food and Drug Administration. 

22 ‘‘(C) EXEMPT DRUG TRIAL.—The study or 

23 investigation is a drug trial that is exempt from 

24 having such an investigational new drug appli25 cation. 


hsrobinson on PROD1PC76 with BILLS
22 

HR 716 IH 

1 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The 

2 conditions described in this paragraph, for a study 

3 or investigation conducted by a Department, are 

4 that the study or investigation has been reviewed 

5 and approved through a system of peer review that 

6 the Secretary determines— 

7 ‘‘(A) to be comparable to the system of 

8 peer review of studies and investigations used 

9 by the National Institutes of Health, and 

10 ‘‘(B) assures unbiased review of the high11 est scientific standards by qualified individuals 

12 who have no interest in the outcome of the re13 view. 

14 ‘‘(e) CONSTRUCTION.—Nothing in this section shall 

15 be construed to limit a plan’s coverage with respect to clin16 ical trials.’’. 

17 (B) CONFORMING AMENDMENT.—Section 

18 4980D(d)(1) of such Code is amended by strik19 ing ‘‘section 9811’’ and inserting ‘‘sections 

20 9811 and 9813’’. 

21 (b) INDIVIDUAL HEALTH INSURANCE.—Part B of 

22 title XXVII of the Public Health Service Act is amended— 

23 (1) by redesignating the first subpart 3 (relat24 ing to other requirements) as subpart 2; and 


hsrobinson on PROD1PC76 with BILLS
23 

•HR 716 IH

1 (2) by adding at the end of subpart 2 the fol2 lowing new section: 

3 ‘‘SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING 

4 IN APPROVED CANCER CLINICAL TRIALS. 

5 ‘‘The provisions of section 2707 shall apply to health 

6 insurance coverage offered by a health insurance issuer 

7 in the individual market in the same manner as they apply 

8 to health insurance coverage offered by a health insurance 

9 issuer in connection with a group health plan in the small 

10 or large group market.’’. 

11 (c) EFFECTIVE DATES.— 

12 (1) GROUP HEALTH PLANS AND GROUP

13 HEALTH INSURANCE COVERAGE.—Subject to para14 graph (3), the amendments made by subsection (a) 

15 apply with respect to group health plans for plan 

16 years beginning on or after January 1, 2010. 

17 (2) INDIVIDUAL HEALTH INSURANCE COV18 ERAGE.—The amendment made by subsection (b) 

19 applies with respect to health insurance coverage of20 fered, sold, issued, renewed, in effect, or operated in 

21 the individual market on or after such date. 

22 (3) COLLECTIVE BARGAINING EXCEPTION.—In 

23 the case of a group health plan maintained pursuant 

24 to one or more collective bargaining agreements be25 tween employee representatives and one or more emVerDate Nov 24 2008 03:10 Jan 29, 2009 Jkt 079200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H716.IH H716

hsrobinson on PROD1PC76 with BILLS
24 

•HR 716 IH

1 ployers ratified before the date of the enactment of 

2 this Act, the amendments made by subsection (a) 

3 shall not apply to plan years beginning before the 

4 later of— 

5 (A) the date on which the last collective 

6 bargaining agreements relating to the plan ter7 minates (determined without regard to any ex8 tension thereof agreed to after the date of the 

9 enactment of this Act), or 

10 (B) January 1, 2010. 

11 For purposes of subparagraph (A), any plan amend12 ment made pursuant to a collective bargaining 

13 agreement relating to the plan which amends the 

14 plan solely to conform to any requirement added by 

15 subsection (a) shall not be treated as a termination 

16 of such collective bargaining agreement. 

17 (d) COORDINATION OF ADMINISTRATION.—The Sec18 retary of Labor, the Secretary of the Treasury, and the 

19 Secretary of Health and Human Services shall ensure, 

20 through the execution of an interagency memorandum of 

21 understanding among such Secretaries, that— 

22 (1) regulations, rulings, and interpretations 

23 issued by such Secretaries relating to the same mat24 ter over which two or more such Secretaries have re25 sponsibility under the provisions of this Act (and the 


hsrobinson on PROD1PC76 with BILLS
25 

HR 716 IH 

1 amendments made thereby) are administered so as 

2 to have the same effect at all times; and 

3 (2) coordination of policies relating to enforcing 

4 the same requirements through such Secretaries in 

5 order to have a coordinated enforcement strategy 

6 that avoids duplication of enforcement efforts and 

7 assigns priorities in enforcement. 

8 (e) STUDY AND REPORT.— 

9 (1) STUDY.—The Secretary of Health and 

10 Human Services, jointly with the Secretaries of 

11 Labor and the Treasury, shall study the impact on 

12 group health plans and health insurance issuers of 

13 requiring group health plans and health insurance 

14 coverage to cover routine patient care costs for indi15 viduals with serious and life threatening diseases 

16 other than cancer. 

17 (2) REPORT TO CONGRESS.—Not later than 

18 January 1, 2013, such Secretary shall submit a re19 port to Congress that contains an assessment of— 

20 (A) any incremental cost to group health 

21 plans and health insurance issuers resulting 

22 from the provisions of this section; and 

23 (B) a projection of expenditures of such 

24 plans and issuers if coverage of routine patient 

25 care costs in an approved clinical trial program 


hsrobinson on PROD1PC76 with BILLS
26 

HR 716 IH 

1 were extended to individuals entitled to benefits 

2 under such plans or health insurance coverage 

3 who have a diagnosis other than cancer. 

Æ 


hsrobinson on PROD1PC76 with BILLS