II

106TH CONGRESS

1ST SESSION S. 1641

To amend the Employee Retirement Income Security Act of 1974, Public

Health Service Act, and the Internal Revenue Code of 1986 to require

that group and individual health insurance coverage and group health

plans provide coverage of cancer screening.

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 24, 1999

Mrs. FEINSTEIN introduced the following bill; which was read twice and

referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Employee Retirement Income Security Act

of 1974, Public Health Service Act, and the Internal

Revenue Code of 1986 to require that group and individual health insurance coverage and group health plans

provide coverage of cancer screening.

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

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Cancer Screening Cov5 erage Act of 1999’’.

6 SEC. 2. CANCER SCREENING COVERAGE.

7 (a) GROUP HEALTH PLANS.—
2

•S 1641 IS

1 (1) PUBLIC HEALTH SERVICE ACT AMEND2 MENTS.—

3 (A) IN GENERAL.—Subpart 2 of part A of

4 title XXVII of the Public Health Service Act

5 (42 U.S.C. 300gg–4 et seq.) is amended by

6 adding at the end the following new section:

7 ‘‘SEC. 2707. COVERAGE OF CANCER SCREENING.

8 ‘‘(a) REQUIREMENT.—A group health plan, and a

9 health insurance issuer offering group health insurance

10 coverage, shall provide coverage and payment under the

11 plan or coverage for the following items and services under

12 terms and conditions that are no less favorable than the

13 terms and conditions applicable to other screening benefits

14 otherwise provided under the plan or coverage:

15 ‘‘(1) MAMMOGRAMS.—In the case of a female

16 participant or beneficiary who is 40 years of age or

17 older, or is under 40 years of age but is at high risk

18 (as defined in subsection (e)) of developing breast

19 cancer, an annual mammography (as defined in sec20 tion 1861(jj) of the Social Security Act) conducted

21 by a facility that has a certificate (or provisional cer22 tificate) issued under section 354 of the Public

23 Health Service Act.

24 ‘‘(2) CLINICAL BREAST EXAMINATIONS.—In the

25 case of a female participant or beneficiary who—
3

•S 1641 IS

1 ‘‘(A)(i) is 40 years of age or older or (ii)

2 is at least 20 (but less than 40) years of age

3 and is at high risk of developing breast cancer,

4 an annual clinical breast examination; or

5 ‘‘(B) is at least 20, but less than 40, years

6 of age and who is not at high risk of developing

7 breast cancer, a clinical breast examination

8 each 3 years.

9 ‘‘(3) PAP TESTS AND PELVIC EXAMINATIONS.—

10 In the case of a female participant or beneficiary

11 who is 18 years of age or older, or who is under 18

12 years of age and is or has been sexually active—

13 ‘‘(A) an annual diagnostic laboratory test

14 (popularly known as a ‘pap smear’) consisting

15 of a routine exfoliative cytology test (Papani16 colaou test) provided to a woman for the pur17 pose of early detection of cervical or vaginal

18 cancer and including an interpretation by a

19 qualified health professional of the results of

20 the test; and

21 ‘‘(B) an annual pelvic examination.

22 ‘‘(4) COLORECTAL CANCER SCREENING PROCE23 DURES.—In the case of a participant or beneficiary

24 who is 50 years of age or older, or who is under 50

25 years of age and is at high risk of developing
4

•S 1641 IS

1 colorectal cancer, the procedures described in section

2 1861(pp)(1) of the Social Security Act (42 U.S.C.

3 1395x(pp)(1)) or section 4104(a)(2) of the Balanced

4 Budget Act of 1997 (111 Stat. 362), shall be fur5 nished to the individual for the purpose of early de6 tection of colorectal cancer. The group health plan

7 or health insurance issuer shall provide coverage for

8 the method and frequency of colorectal cancer

9 screening determined to be appropriate by a health

10 care provider treating such participant or bene11 ficiary, in consultation with the participant or bene12 ficiary.

13 ‘‘(5) PROSTATE CANCER SCREENING.—In the

14 case of a participant or beneficiary who is 50 years

15 of age or older, or who is a male who is at high risk

16 for prostate cancer (such as an African American or

17 a male who has a history of prostate cancer in close

18 family members), an annual test consisting of any

19 (or all) of the procedures described in section

20 1861(oo)(2) of Social Security Act (42 U.S.C.

21 1395x(oo)(2)) provided for the purpose of early de22 tection of prostate cancer.

23 ‘‘(6) OTHER TESTS AND PROCEDURES.—Such

24 other tests or procedures for the detection of cancer,

25 and modifications to the tests and procedures, with
5

•S 1641 IS

1 such frequency, as the Secretary determines to be

2 appropriate, in consultation with appropriate organi3 zations and agencies, for the diagnosis or detection

4 of cancer.

5 ‘‘(b) PROHIBITIONS.—A group health plan, and a

6 health insurance issuer offering group health insurance

7 coverage in connection with a group health plan, shall

8 not—

9 ‘‘(1) deny to an individual eligibility, or contin10 ued eligibility, to enroll or to renew coverage under

11 the terms of the plan, solely for the purpose of

12 avoiding the requirements of this section;

13 ‘‘(2) provide monetary payments or rebates to

14 individuals to encourage such individuals to accept

15 less than the minimum protections available under

16 this section;

17 ‘‘(3) penalize or otherwise reduce or limit the

18 reimbursement of a provider because such provider

19 provided care to an individual participant or bene20 ficiary in accordance with this section; or

21 ‘‘(4) provide incentives (monetary or otherwise)

22 to a provider to induce such provider to provide care

23 to an individual participant or beneficiary in a man24 ner inconsistent with this section.

25 ‘‘(c) RULES OF CONSTRUCTION.—
6

•S 1641 IS

1 ‘‘(1) Nothing in this section shall be construed

2 to require an individual who is a participant or bene3 ficiary to undergo a procedure, examination, or test

4 described in subsection (a).

5 ‘‘(2) Nothing in this section shall be construed

6 as preventing a group health plan or issuer from im7 posing deductibles, coinsurance, or other cost-shar8 ing in relation to benefits described in subsection (a)

9 consistent with such subsection, except that such co10 insurance or other cost-sharing shall not discrimi11 nate on any basis related to the coverage required

12 under this section.

13 ‘‘(d) NOTICE.—A group health plan under this part

14 shall comply with the notice requirement under section

15 714(d) of the Employee Retirement Income Security Act

16 of 1974 with respect to the requirements of this section

17 as if such section applied to such plan.

18 ‘‘(e) HIGH RISK DEFINED.—For purposes of this

19 section, an individual is considered to be at ‘high risk’ of

20 developing a particular type of cancer if, under guidelines

21 developed or recognized by the Secretary based upon sci22 entific evidence, the individual—

23 ‘‘(1) has one or more close family members who

24 have developed that type of cancer;

25 ‘‘(2) has previously had that type of cancer;
7

•S 1641 IS

1 ‘‘(3) has the presence of an appropriate recog2 nized gene marker that is identified as putting the

3 individual at a higher risk of developing that type of

4 cancer; or

5 ‘‘(4) has other predisposing factors that signifi6 cantly increases the risk of the individual con7 tracting that type of cancer.

8 For purposes of this subsection, the term ‘type of cancer’

9 includes other types of cancer that the Secretary recog10 nizes as closely related for purposes of establishing risk.’’.

11 (B) TECHNICAL AMENDMENT.—Section

12 2723(c) of the Public Health Service Act (42

13 U.S.C. 300gg–23(c)) is amended by striking

14 ‘‘section 2704’’ and inserting ‘‘sections 2704

15 and 2707’’.

16 (2) ERISA AMENDMENTS.—

17 (A) IN GENERAL.—Subpart B of part 7 of

18 subtitle B of title I of the Employee Retirement

19 Income Security Act of 1974 (29 U.S.C. 1185

20 et seq.) is amended by adding at the end the

21 following new section:

22 ‘‘SEC. 714. COVERAGE OF CANCER SCREENING.

23 ‘‘(a) REQUIREMENT.—A group health plan, and a

24 health insurance issuer offering group health insurance

25 coverage, shall provide coverage and payment under the
8

•S 1641 IS

1 plan or coverage for the following items and services under

2 terms and conditions that are no less favorable than the

3 terms and conditions applicable to other screening benefits

4 otherwise provided under the plan or coverage:

5 ‘‘(1) MAMMOGRAMS.—In the case of a female

6 participant or beneficiary who is 40 years of age or

7 older, or is under 40 years of age but is at high risk

8 (as defined in subsection (e)) of developing breast

9 cancer, an annual mammography (as defined in sec10 tion 1861(jj) of the Social Security Act) conducted

11 by a facility that has a certificate (or provisional cer12 tificate) issued under section 354 of the Public

13 Health Service Act.

14 ‘‘(2) CLINICAL BREAST EXAMINATIONS.—In the

15 case of a female participant or beneficiary who—

16 ‘‘(A)(i) is 40 years of age or older or (ii)

17 is at least 20 (but less than 40) years of age

18 and is at high risk of developing breast cancer,

19 an annual clinical breast examination; or

20 ‘‘(B) is at least 20, but less than 40, years

21 of age and who is not at high risk of developing

22 breast cancer, a clinical breast examination

23 each 3 years.

24 ‘‘(3) PAP TESTS AND PELVIC EXAMINATIONS.—

25 In the case of a female participant or beneficiary
9

•S 1641 IS

1 who is 18 years of age or older, or who is under 18

2 years of age and is or has been sexually active—

3 ‘‘(A) an annual diagnostic laboratory test

4 (popularly known as a ‘pap smear’) consisting

5 of a routine exfoliative cytology test (Papani6 colaou test) provided to a woman for the pur7 pose of early detection of cervical or vaginal

8 cancer and including an interpretation by a

9 qualified health professional of the results of

10 the test; and

11 ‘‘(B) an annual pelvic examination.

12 ‘‘(4) COLORECTAL CANCER SCREENING PROCE13 DURES.—In the case of a participant or beneficiary

14 who is 50 years of age or older, or who is under 50

15 years of age and is at high risk of developing

16 colorectal cancer, the procedures described in section

17 1861(pp)(1) of the Social Security Act (42 U.S.C.

18 1395x(pp)(1)) or section 4104(a)(2) of the Balanced

19 Budget Act of 1997 (111 Stat. 362), shall be fur20 nished to the individual for the purpose of early de21 tection of colorectal cancer. The group health plan

22 or health insurance issuer shall provided coverage

23 for the method and frequency of colorectal cancer

24 screening determined to be appropriate by a health

25 care provider treating such participant or bene-
10

•S 1641 IS

1 ficiary, in consultation with the participant or bene2 ficiary.

3 ‘‘(5) PROSTATE CANCER SCREENING.—In the

4 case of a participant or beneficiary who is 50 years

5 of age or older, or who is a male who is at high risk

6 for prostate cancer (such as an African American or

7 a male who has a history of prostate cancer in close

8 family members), an annual test consisting of any

9 (or all) of the procedures described in section

10 1861(oo)(2) of Social Security Act (42 U.S.C.

11 1395x(oo)(2)) provided for the purpose of early de12 tection of prostate cancer.

13 ‘‘(6) OTHER TESTS AND PROCEDURES.—Such

14 other tests or procedures for the detection of cancer,

15 and modifications to the tests and procedures, with

16 such frequency, as the Secretary determines to be

17 appropriate, in consultation with appropriate organi18 zations and agencies, for the diagnosis or detection

19 of cancer.

20 ‘‘(b) PROHIBITIONS.—A group health plan, and a

21 health insurance issuer offering group health insurance

22 coverage in connection with a group health plan, may

23 not—

24 ‘‘(1) deny to an individual eligibility, or contin25 ued eligibility, to enroll or to renew coverage under
11

•S 1641 IS

1 the terms of the plan, solely for the purpose of

2 avoiding the requirements of this section;

3 ‘‘(2) provide monetary payments or rebates to

4 individuals to encourage such individuals to accept

5 less than the minimum protections available under

6 this section;

7 ‘‘(3) penalize or otherwise reduce or limit the

8 reimbursement of a provider because such provider

9 provided care to an individual participant or bene10 ficiary in accordance with this section; or

11 ‘‘(4) provide incentives (monetary or otherwise)

12 to a provider to induce such provider to provide care

13 to an individual participant or beneficiary in a man14 ner inconsistent with this section.

15 ‘‘(c) RULES OF CONSTRUCTION.—

16 ‘‘(1) Nothing in this section shall be construed

17 to require an individual who is a participant or bene18 ficiary to undergo a procedure, examination, or test

19 described in subsection (a).

20 ‘‘(2) Nothing in this section shall be construed

21 as preventing a group health plan or issuer from im22 posing deductibles, coinsurance, or other cost-shar23 ing in relation to benefits described in subsection (a)

24 consistent with such subsection, except that such co25 insurance or other cost-sharing shall not discrimi-
12

•S 1641 IS

1 nate on any basis related to the coverage required

2 under this section.

3 ‘‘(d) NOTICE UNDER GROUP HEALTH PLAN.—The

4 imposition of the requirement of this section shall be treat5 ed as a material modification in the terms of the plan de6 scribed in section 102(a)(1), for purposes of assuring no7 tice of such requirements under the plan; except that the

8 summary description required to be provided under the

9 last sentence of section 104(b)(1) with respect to such

10 modification shall be provided by not later than 60 days

11 after the first day of the first plan year in which such

12 requirement apply.

13 ‘‘(e) HIGH RISK DEFINED.—For purposes of this

14 section, an individual is considered to be at ‘high risk’ of

15 developing a particular type of cancer if, under guidelines

16 developed or recognized by the Secretary based upon sci17 entific evidence, the individual—

18 ‘‘(1) has one or more close family members who

19 have developed that type of cancer;

20 ‘‘(2) has previously had that type of cancer;

21 ‘‘(3) has the presence of an appropriate recog22 nized gene marker that is identified as putting the

23 individual at a higher risk of developing that type of

24 cancer; or
13

•S 1641 IS

1 ‘‘(4) has other predisposing factors that signifi2 cantly increases the risk of the individual con3 tracting that type of cancer.

4 For purposes of this subsection, the term ‘type of cancer’

5 includes other types of cancer that the Secretary recog6 nizes as closely related for purposes of establishing risk.’’.

7 (B) TECHNICAL AMENDMENTS.—

8 (i) Section 731(c) of the Employee

9 Retirement Income Security Act of 1974

10 (29 U.S.C. 1191(c)) is amended by strik11 ing ‘‘section 711’’ and inserting ‘‘sections

12 711 and 714’’.

13 (ii) Section 732(a) of the Employee

14 Retirement Income Security Act of 1974

15 (29 U.S.C. 1191a(a)) is amended by strik16 ing ‘‘section 711’’ and inserting ‘‘sections

17 711 and 714’’.

18 (iii) The table of contents in section 1

19 of the Employee Retirement Income Secu20 rity Act of 1974 is amended by inserting

21 after the item relating to section 713 the

22 following new item:

‘‘Sec. 714. Coverage of cancer screening.’’.

23 (3) INTERNAL REVENUE CODE AMEND24 MENTS.—Subchapter B of chapter 100 of the Inter25 nal Revenue Code of 1986 is amended—
14

•S 1641 IS

1 (A) in the table of sections, by inserting

2 after the item relating to section 9812 the fol3 lowing new item:

‘‘Sec. 9813. Coverage of cancer screening.’’; and

4 (B) by inserting after section 9812 the fol5 lowing:

6 ‘‘SEC. 9813. COVERAGE OF CANCER SCREENING.

7 ‘‘(a) REQUIREMENT.—A group health plan shall pro8 vide coverage and payment under the plan for the fol9 lowing items and services under terms and conditions that

10 are no less favorable than the terms and conditions appli11 cable to other screening benefits otherwise provided under

12 the plan:

13 ‘‘(1) MAMMOGRAMS.—In the case of a female

14 participant or beneficiary who is 40 years of age or

15 older, or is under 40 years of age but is at high risk

16 (as defined in subsection (d)) of developing breast

17 cancer, an annual mammography (as defined in sec18 tion 1861(jj) of the Social Security Act) conducted

19 by a facility that has a certificate (or provisional cer20 tificate) issued under section 354 of the Public

21 Health Service Act.

22 ‘‘(2) CLINICAL BREAST EXAMINATIONS.—In the

23 case of a female participant or beneficiary who—

24 ‘‘(A)(i) is 40 years of age or older or (ii)

25 is at least 20 (but less than 40) years of age
15

•S 1641 IS

1 and is at high risk of developing breast cancer,

2 an annual clinical breast examination; or

3 ‘‘(B) is at least 20, but less than 40, years

4 of age and who is not at high risk of developing

5 breast cancer, a clinical breast examination

6 each 3 years.

7 ‘‘(3) PAP TESTS AND PELVIC EXAMINATIONS.—

8 In the case of a female participant or beneficiary

9 who is 18 years of age or older, or who is under

10 18 years of age and is or has been sexually active—

11 ‘‘(A) an annual diagnostic laboratory test

12 (popularly known as a ‘pap smear’) consisting

13 of a routine exfoliative cytology test (Papani14 colaou test) provided to a woman for the pur15 pose of early detection of cervical or vaginal

16 cancer and including an interpretation by a

17 qualified health professional of the results of

18 the test; and

19 ‘‘(B) an annual pelvic examination.

20 ‘‘(4) COLORECTAL CANCER SCREENING PROCE21 DURES.—In the case of a participant or beneficiary

22 who is 50 years of age or older, or who is under 50

23 years of age and is at high risk of developing

24 colorectal cancer, the procedures described in section

25 1861(pp)(1) of the Social Security Act (42 U.S.C.
16

•S 1641 IS

1 1395x(pp)(1)) or section 4104(a)(2) of the Balanced

2 Budget Act of 1997 (111 Stat. 362), shall be fur3 nished to the individual for the purpose of early de4 tection of colorectal cancer. The group health plan

5 or health insurance issuer shall provide coverage for

6 the method and frequency of colorectal cancer

7 screening determined to be appropriate by a health

8 care provider treating such participant or bene9 ficiary, in consultation with the participant or bene10 ficiary.

11 ‘‘(5) PROSTATE CANCER SCREENING.—In the

12 case of a participant or beneficiary who is 50 years

13 of age or older, or who is a male who is at high risk

14 for prostate cancer (such as an African American or

15 a male who has a history of prostate cancer in close

16 family members), an annual test consisting of any

17 (or all) of the procedures described in section

18 1861(oo)(2) of Social Security Act (42 U.S.C.

19 1395x(oo)(2)) provided for the purpose of early de20 tection of prostate cancer.

21 ‘‘(6) OTHER TESTS AND PROCEDURES.—Such

22 other tests or procedures for the detection of cancer,

23 and modifications to the tests and procedures, with

24 such frequency, as the Secretary determines to be

25 appropriate, in consultation with appropriate organi-
17

•S 1641 IS

1 zations and agencies, for the diagnosis or detection

2 of cancer.

3 ‘‘(b) PROHIBITIONS.—A group health plan may not—

4 ‘‘(1) deny to an individual eligibility, or contin5 ued eligibility, to enroll or to renew coverage under

6 the terms of the plan, solely for the purpose of

7 avoiding the requirements of this section;

8 ‘‘(2) provide monetary payments or rebates to

9 individuals to encourage such individuals to accept

10 less than the minimum protections available under

11 this section;

12 ‘‘(3) penalize or otherwise reduce or limit the

13 reimbursement of a provider because such provider

14 provided care to an individual participant or bene15 ficiary in accordance with this section; or

16 ‘‘(4) provide incentives (monetary or otherwise)

17 to a provider to induce such provider to provide care

18 to an individual participant or beneficiary in a man19 ner inconsistent with this section.

20 ‘‘(c) RULES OF CONSTRUCTION.—

21 ‘‘(1) Nothing in this section shall be construed

22 to require an individual who is a participant or bene23 ficiary to undergo a procedure, examination, or test

24 described in subsection (a).
18

•S 1641 IS

1 ‘‘(2) Nothing in this section shall be construed

2 as preventing a group health plan from imposing

3 deductibles, coinsurance, or other cost-sharing in re4 lation to benefits described in subsection (a) con5 sistent with such subsection, except that such coin6 surance or other cost-sharing shall not discriminate

7 on any basis related to the coverage required under

8 this section.

9 ‘‘(d) HIGH RISK DEFINED.—For purposes of this

10 section, an individual is considered to be at ‘high risk’ of

11 developing a particular type of cancer if, under guidelines

12 developed or recognized by the Secretary based upon sci13 entific evidence, the individual—

14 ‘‘(1) has one or more close family members who

15 have developed that type of cancer;

16 ‘‘(2) has previously had that type of cancer;

17 ‘‘(3) has the presence of an appropriate recog18 nized gene marker that is identified as putting the

19 individual at a higher risk of developing that type of

20 cancer; or

21 ‘‘(4) has other predisposing factors that signifi22 cantly increases the risk of the individual con23 tracting that type of cancer.
19

•S 1641 IS

1 For purposes of this subsection, the term ‘type of cancer’

2 includes other types of cancer that the Secretary recog3 nizes as closely related for purposes of establishing risk.’’.

4 (b) INDIVIDUAL HEALTH INSURANCE.—

5 (1) IN GENERAL.—Part B of title XXVII of the

6 Public Health Service Act is amended by inserting

7 after section 2752 (42 U.S.C. 300gg–52) the fol8 lowing new section:

9 ‘‘SEC. 2753. STANDARD RELATING PATIENT FREEDOM OF

10 CHOICE.

11 ‘‘(a) IN GENERAL.—The provisions of section 2707

12 (other than subsection (d)) shall apply to health insurance

13 coverage offered by a health insurance issuer in the indi14 vidual market with respect to an enrollee under such cov15 erage in the same manner as they apply to health insur16 ance coverage offered by a health insurance issuer in con17 nection with a group health plan in the small or large

18 group market to a participant or beneficiary in such plan.

19 ‘‘(b) NOTICE.—A health insurance issuer under this

20 part shall comply with the notice requirement under sec21 tion 714(d) of the Employee Retirement Income Security

22 Act of 1974 with respect to the requirements referred to

23 in subsection (a) as if such section applied to such issuer

24 and such issuer were a group health plan.’’.
20

•S 1641 IS

1 (2) TECHNICAL AMENDMENT.—Section

2 2762(b)(2) of such Act (42 U.S.C. 300gg–62(b)(2))

3 is amended by striking ‘‘section 2751’’ and inserting

4 ‘‘sections 2751 and 2753’’.

5 (c) EFFECTIVE DATES.—

6 (1) GROUP HEALTH PLANS.—Subject to para7 graph (3), the amendments made by subsection (a)

8 shall apply with respect to group health plans for

9 plan years beginning on or after January 1, 2000.

10 (2) INDIVIDUAL PLANS.—The amendment made

11 by subsection (b) shall apply with respect to health

12 insurance coverage offered, sold, issued, renewed, in

13 effect, or operated in the individual market on or

14 after such date.

15 (3) COLLECTIVE BARGAINING AGREEMENT.—In

16 the case of a group health plan maintained pursuant

17 to 1 or more collective bargaining agreements be18 tween employee representatives and 1 or more em19 ployers ratified before the date of enactment of this

20 Act, the amendments made to subsection (a) shall

21 not apply to plan years beginning before the later

22 of—

23 (A) the date on which the last collective

24 bargaining agreements relating to the plan ter25 minates (determined without regard to any ex-
21

•S 1641 IS

1 tension thereof agreed to after the date of en2 actment of this Act), or

3 (B) January 1, 2000.

4 For purposes of subparagraph (A), any plan amend5 ment made pursuant to a collective bargaining

6 agreement relating to the plan which amends the

7 plan solely to conform to any requirement added by

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

9 of such collective bargaining agreement.

10 (d) COORDINATED REGULATIONS.—Section 104(1)

11 of Health Insurance Portability and Accountability Act of

12 1996 is amended by striking ‘‘this subtitle (and the

13 amendments made by this subtitle and section 401)’’ and

14 inserting ‘‘the provisions of part 7 of subtitle B of title

15 I of the Employee Retirement Income Security Act of

16 1974, the provisions of parts A and C of title XXVII of

17 the Public Health Service Act, and chapter 100 of the In18 ternal Revenue Code of 1986’’.

19 (e) MODIFICATION OF COVERAGE.—

20 (1) IN GENERAL.—The Secretary of Health and

21 Human Services may, by regulation, modify the cov22 erage requirements applicable pursuant to the

23 amendments made by this Act to reflect changes in

24 medical practice or new scientific knowledge, on the
22

•S 1641 IS

1 Secretary’s own initiative or upon petition of an in2 dividual or organization.

3 (2) CONSULTATION.—In modifying coverage re4 quirements under paragraph (1), the Secretary of

5 Health and Human Services shall consult with ap6 propriate organizations, experts, and agencies.

7 (3) PETITIONS.—The Secretary of Health and

8 Human Services may issue requirements for the pe9 titioning process under paragraph (1), including re10 quirements that the petition be in writing and in11 clude scientific or medical bases for the modification

12 sought. Upon receipt of such a petition, the Sec13 retary shall respond to the petitioner and decide

14 whether to propose a regulation proposing a change

15 within 90 days of such receipt. If a regulation is re16 quired, the Secretary shall propose such regulation

17 within 6 months of such determination. The Sec18 retary shall provide the petitioner the reasons for

19 the decision of the Secretary. The Secretary may

20 make changes requested by a petitioner in whole or

21 in part.

Æ