I 

109TH CONGRESS 

1ST SESSION H. R. 1410 

To provide for coverage of hormone replacement therapy for treatment of 

menopausal symptoms, and for coverage of an alternative therapy for 

hormone replacement therapy for such symptoms, under the Medicare 

and Medicaid Programs, group health plans and individual health insurance coverage, and other Federal health insurance programs. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 17, 2005 

Ms. LEE (for herself, Mr. PAYNE, and Mr. OWENS) introduced the following 

bill; which was referred to the Committee on Energy and Commerce, and 

in addition to the Committees on Ways and Means, Education and the 

Workforce, Government Reform, and Veterans’ Affairs, 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 provide for coverage of hormone replacement therapy 

for treatment of menopausal symptoms, and for coverage 

of an alternative therapy for hormone replacement therapy for such symptoms, under the Medicare and Medicaid Programs, group health plans and individual health 

insurance coverage, and other Federal health insurance 

programs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Menopausal Hormone Replacement Therapies and Alter4 native Treatments and Fairness Act’’. 

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

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Medicare coverage of menopausal hormone replacement therapy and alternative treatments for menopausal hormone replacement 

therapy. 

Sec. 4. Medicaid coverage of alternative treatments for menopausal hormone replacement therapy. 

Sec. 5. Coverage of menopausal hormone replacement therapy and alternative 

treatments for menopausal hormone replacement therapy under 

group health plans and individual health insurance coverage. 

Sec. 6. Coverage of menopausal hormone replacement therapy and alternative 

treatments for menopausal hormone replacement therapy under 

FEHBP. 

Sec. 7. Coverage of alternative treatments for menopausal hormone replacement 

therapy under Department of Veterans Affairs health care system. 

7 SEC. 2. FINDINGS. 

8 Congress finds the following: 

9 (1) 50 million women in the United States suf10 fer from symptoms or conditions related to meno11 pause, including osteoporosis, hot flashes, heart dis12 ease, and depression. 

13 (2) The Women’s Health Initiative terminated 

14 its study on the synthetic version of hormone re15 placement therapy (HRT) three years early due to 

16 findings that the combination of estrogen and pro17 gestin increases the risk of heart disease, stroke, 

18 blood clots, and breast cancer. 
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1 (3) Only 35 percent of women in the United 

2 States who are undergoing menopause take pre3 scribed synthetic HRT for treatment of menopausal 

4 symptoms. 

5 (4) Natural estrogen and progestin, which may 

6 not be available by prescription, could be useful in 

7 treating menopause symptoms and related condi8 tions. 

9 (5) 33 percent of women in the United States 

10 who are undergoing menopause routinely use alter11 native treatments for menopausal symptoms, such as 

12 Soy, Black Cohosh, Chasteberry, Pro-Gest, Hops, 

13 Red Clover, Dong Quai, Evening Primose Oil, Vita14 min E, Flax Seed Oil, Ginseng, and natural DHEA. 

15 (6) Women deserve relief from ailments relating 

16 to menopause. 

17 (7) Government insurance programs such as 

18 medicare, medicaid, the Federal Employees Health 

19 Benefits Program (FEHBP), and the Department 

20 of Veterans’ Affairs do not cover non-prescription al21 ternative HRT treatments. 

22 (8) Most private insurance does not cover non23 prescription alternative HRT treatments. 
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1 SEC. 3. MEDICARE COVERAGE OF MENOPAUSAL HORMONE 

2 REPLACEMENT THERAPY AND ALTERNATIVE 

3 TREATMENTS FOR MENOPAUSAL HORMONE 

4 REPLACEMENT THERAPY. 

5 (a) IN GENERAL.—Section 1861(s)(2) of the Social 

6 Security Act (42 U.S.C. 1395x(s)(2)) is amended— 

7 (1) by striking ‘‘and’’ at the end of subpara8 graph (Y); 

9 (2) by adding ‘‘and’’ at the end of subpara10 graph (Z); and 

11 (3) by adding at the end the following new sub12 paragraph: 

13 ‘‘(AA)(i) hormone replacement therapy for 

14 treatment of menopausal symptoms and (ii) an al15 ternative therapy for hormone replacement therapy 

16 for treatment of menopausal symptoms if the ther17 apy is recommended by a health care provider who 

18 is licensed, accredited, or certified under State law, 

19 if it has been proven safe and effective in peer-re20 viewed scientific studies, and if it is administered 

21 only after the health care provider obtains the in22 formed consent of the patient to receive it;’’. 

23 (b) EFFECTIVE DATE.—The amendments made by 

24 subsection (a) shall apply to therapies furnished on or 

25 after the date of the enactment of this Act. 
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1 SEC. 4. MEDICAID COVERAGE OF ALTERNATIVE TREAT2 MENTS FOR MENOPAUSAL HORMONE RE3 PLACEMENT THERAPY. 

4 (a) REQUIREMENT FOR COVERAGE.—Section 

5 1902(a)(10) of the Social Security Act (42 U.S.C. 

6 1396a(a)(10)) is amended— 

7 (1) in subparagraph (A) in the matter before 

8 clause (i), by striking ‘‘and (21)’’ and inserting ‘‘, 

9 (21), and (27)’’; and 

10 (2) in subparagraph (C)(iv)— 

11 (A) by striking ‘‘and (17)’’ and inserting 

12 ‘‘, (17), and (27)’’; and 

13 (B) by striking ‘‘through (24)’’ and insert14 ing ‘‘through (28)’’. 

15 (b) DESCRIPTION OF COVERED THERAPIES.—Sec16 tion 1905(a) of such Act (42 U.S.C. 1396d(a)) is amend17 ed— 

18 (1) by redesignating paragraph (28) as para19 graph (29); and 

20 (2) by inserting after paragraph (27) the fol21 lowing new paragraph: 

22 ‘‘(28) an alternative therapy for hormone re23 placement therapy for treatment of menopausal 

24 symptoms if the therapy is recommended by a health 

25 care provider who is licensed, accredited, or certified 

26 under State law, if it has been proven safe and effec-
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1 tive in peer-reviewed scientific studies, and if it is 

2 administered only after the health care provider ob3 tains the informed consent of the patient to receive 

4 it; and’’. 

5 (c) EFFECTIVE DATE.—The amendments made by 

6 this section apply to therapies furnished on or after the 

7 date of the enactment of this Act, without regard to 

8 whether or not final regulations to carry out such amend9 ments have been promulgated by such date. 

10 SEC. 5. COVERAGE OF MENOPAUSAL HORMONE REPLACE11 MENT THERAPY AND ALTERNATIVE TREAT12 MENTS FOR MENOPAUSAL HORMONE RE13 PLACEMENT THERAPY UNDER GROUP 

14 HEALTH PLANS AND INDIVIDUAL HEALTH IN15 SURANCE COVERAGE. 

16 (a) GROUP HEALTH PLANS.— 

17 (1) PUBLIC HEALTH SERVICE ACT AMEND18 MENTS.—(A) Subpart 2 of part A of title XXVII of 

19 the Public Health Service Act is amended by adding 

20 at the end the following new section: 

21 ‘‘SEC. 2707. STANDARD RELATING TO COVERAGE OF MENO22 PAUSAL HORMONE REPLACEMENT THERAPY 

23 AND ALTERNATIVE TREATMENTS FOR MENO24 PAUSAL HORMONE REPLACEMENT THERAPY. 

25 ‘‘(a) REQUIREMENTS.— 
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1 ‘‘(1) MENOPAUSAL HORMONE REPLACEMENT

2 THERAPY.—If a group health plan, or a health in3 surance issuer offering group health insurance cov4 erage, provides benefits for outpatient prescription 

5 drugs, the plan or coverage may not exclude or re6 strict benefits for hormone replacement therapy for 

7 treatment of menopausal symptoms. 

8 ‘‘(2) ALTERNATIVE TREATMENTS FOR MENO9 PAUSAL HORMONE REPLACEMENT THERAPY.—If a 

10 group health plan, or a health insurance issuer offer11 ing group health insurance coverage, provides bene12 fits for hormone replacement therapy for treatment 

13 of menopausal symptoms, the plan or coverage may 

14 not exclude or restrict benefits for an alternative 

15 therapy for hormone replacement therapy for treat16 ment of menopausal symptoms if— 

17 ‘‘(A) the therapy is recommended by a 

18 health care provider who is licensed, accredited, 

19 or certified under State law; 

20 ‘‘(B) it has been proven safe and effective 

21 in peer-reviewed scientific studies; and 

22 ‘‘(C) it is administered only after the 

23 health care provider obtains the informed con24 sent of the patient to receive it. 
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1 ‘‘(b) NOTICE.—A group health plan under this part 

2 shall comply with the notice requirement under section 

3 714(b) of the Employee Retirement Income Security Act 

4 of 1974 with respect to the requirements of this section 

5 as if such section applied to such plan.’’. 

6 (B) Section 2723(c) of such Act (42 U.S.C. 

7 300gg–23(c)) is amended by striking ‘‘section 2704’’ 

8 and inserting ‘‘sections 2704 and 2707’’. 

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

10 part 7 of subtitle B of title I of the Employee Re11 tirement Income Security Act of 1974 is amended by 

12 adding at the end the following new section: 

13 ‘‘SEC. 714. STANDARD RELATING TO COVERAGE OF MENO14 PAUSAL HORMONE REPLACEMENT THERAPY 

15 AND ALTERNATIVE TREATMENTS FOR MENO16 PAUSAL HORMONE REPLACEMENT THERAPY. 

17 ‘‘(a) REQUIREMENTS.— 

18 ‘‘(1) MENOPAUSAL HORMONE REPLACEMENT

19 THERAPY.—If a group health plan, or a health in20 surance issuer offering group health insurance cov21 erage, provides benefits for outpatient prescription 

22 drugs, the plan or coverage may not exclude or re23 strict benefits for hormone replacement therapy for 

24 treatment of menopausal symptoms. 
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1 ‘‘(2) ALTERNATIVE TREATMENTS FOR MENO2 PAUSAL HORMONE REPLACEMENT THERAPY.—If a 

3 group health plan, or a health insurance issuer offer4 ing group health insurance coverage, provides bene5 fits for hormone replacement therapy for treatment 

6 of menopausal symptoms, the plan or coverage may 

7 not exclude or restrict benefits for an alternative 

8 therapy for hormone replacement therapy for treat9 ment of menopausal symptoms if— 

10 ‘‘(A) the therapy is recommended by a 

11 health care provider who is licensed, accredited, 

12 or certified under State law; 

13 ‘‘(B) it has been proven safe and effective 

14 in peer-reviewed scientific studies; and 

15 ‘‘(C) it is administered only after the 

16 health care provider obtains the informed con17 sent of the patient to receive it. 

18 ‘‘(b) NOTICE UNDER GROUP HEALTH PLAN.—The 

19 imposition of the requirement of this section shall be treat20 ed as a material modification in the terms of the plan de21 scribed in section 102(a)(1), for purposes of assuring no22 tice of such requirements under the plan; except that the 

23 summary description required to be provided under the 

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

25 modification shall be provided by not later than 60 days 
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1 after the first day of the first plan year in which such 

2 requirement apply.’’. 

3 (B) Section 731(c) of such Act (29 U.S.C. 

4 1191(c)) is amended by striking ‘‘section 711’’ and 

5 inserting ‘‘sections 711 and 714’’. 

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

7 1191a(a)) is amended by striking ‘‘section 711’’ and 

8 inserting ‘‘sections 711 and 714’’. 

9 (D) The table of contents in section 1 of such 

10 Act is amended by inserting after the item relating 

11 to section 713 the following new item: 

‘‘714. Standard relating to coverage of menopausal hormone replacement therapy and alternative treatments for menopausal hormone replacement therapy.’’. 

12 (3) INTERNAL REVENUE CODE AMEND13 MENTS.— 

14 (A) IN GENERAL.—Subchapter B of chap15 ter 100 of the Internal Revenue Code of 1986 

16 is amended— 

17 (i) in the table of sections, by insert18 ing after the item relating to section 9812 

19 the following new item: 

‘‘9813. Standard relating to coverage of menopausal hormone replacement therapy and alternative treatments for menopausal hormone replacement therapy.’’ 

20 ; and 

21 (ii) by inserting after section 9812 the 

22 following: 
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1 ‘‘SEC. 9813. STANDARD RELATING TO COVERAGE OF MENO2 PAUSAL HORMONE REPLACEMENT THERAPY 

3 AND ALTERNATIVE TREATMENTS FOR MENO4 PAUSAL HORMONE REPLACEMENT THERAPY. 

5 ‘‘(a) MENOPAUSAL HORMONE REPLACEMENT THER6 APY.—If a group health plan provides benefits for out7 patient prescription drugs, the plan may not exclude or 

8 restrict benefits for hormone replacement therapy for 

9 treatment of menopausal symptoms. 

10 ‘‘(b) ALTERNATIVE TREATMENTS FOR MENOPAUSAL

11 HORMONE REPLACEMENT THERAPY.—If a group health 

12 plan provides benefits for hormone replacement therapy 

13 for treatment of menopausal symptoms, the plan may not 

14 exclude or restrict benefits for an alternative therapy for 

15 hormone replacement therapy for treatment of meno16 pausal symptoms if— 

17 ‘‘(1) the therapy is recommended by a health 

18 care provider who is licensed, accredited, or certified 

19 under State law; 

20 ‘‘(2) it has been proven safe and effective in 

21 peer-reviewed scientific studies; and 

22 ‘‘(3) it is administered only after the health 

23 care provider obtains the informed consent of the 

24 patient to receive it.’’ 

25 (B) CONFORMING AMENDMENT.—Section 

26 4980D(d)(1) of such Code is amended by strik-
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1 ing ‘‘section 9811’’ and inserting ‘‘sections 

2 9811 and 9813’’. 

3 (b) INDIVIDUAL HEALTH INSURANCE.—(1) Part B 

4 of title XXVII of the Public Health Service Act is amend5 ed by inserting after section 2752 the following new sec6 tion: 

7 ‘‘SEC. 2753. STANDARD RELATING TO COVERAGE OF MENO8 PAUSAL HORMONE REPLACEMENT THERAPY 

9 AND ALTERNATIVE TREATMENTS FOR MENO10 PAUSAL HORMONE REPLACEMENT THERAPY. 

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

12 2707(a) shall apply to health insurance coverage offered 

13 by a health insurance issuer in the individual market in 

14 the same manner as they apply to health insurance cov15 erage offered by a health insurance issuer in connection 

16 with a group health plan in the small or large group mar17 ket. 

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

19 part shall comply with the notice requirement under sec20 tion 714(b) of the Employee Retirement Income Security 

21 Act of 1974 with respect to the requirements referred to 

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

23 and such issuer were a group health plan.’’. 
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1 (2) Section 2762(b)(2) of such Act (42 U.S.C. 

2 300gg–62(b)(2)) is amended by striking ‘‘section 2751’’ 

3 and inserting ‘‘sections 2751 and 2753’’. 

4 (c) EFFECTIVE DATE.—The amendments made by 

5 this section shall apply with respect to therapies furnished 

6 on or after the date of the enactment of this Act. 

7 (d) COORDINATION OF ADMINISTRATION.—The Sec8 retary of Labor, the Secretary of the Treasury, and the 

9 Secretary of Health and Human Services shall ensure, 

10 through the execution of an interagency memorandum of 

11 understanding among such Secretaries, that— 

12 (1) regulations, rulings, and interpretations 

13 issued by such Secretaries relating to the same mat14 ter over which two or more such Secretaries have re15 sponsibility under the provisions of this section (and 

16 the amendments made thereby) are administered so 

17 as to have the same effect at all times; and 

18 (2) coordination of policies relating to enforcing 

19 the same requirements through such Secretaries in 

20 order to have a coordinated enforcement strategy 

21 that avoids duplication of enforcement efforts and 

22 assigns priorities in enforcement. 
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1 SEC. 6. COVERAGE OF MENOPAUSAL HORMONE REPLACE2 MENT THERAPY AND ALTERNATIVE TREAT3 MENTS FOR MENOPAUSAL HORMONE RE4 PLACEMENT THERAPY UNDER FEHBP. 

5 (a) IN GENERAL.—Section 8902 of title 5, United 

6 States Code, is amended by adding at the end the fol7 lowing new subsection: 

8 ‘‘(p)(1) If a contract or plan provides benefits for out9 patient prescription drugs, the contract or plan may not 

10 exclude or restrict benefits for hormone replacement ther11 apy for treatment of menopausal symptoms. 

12 ‘‘(2) If a contract or plan provides benefits for hor13 mone replacement therapy for treatment of menopausal 

14 symptoms, the contract or plan may not exclude or restrict 

15 benefits for an alternative therapy for hormone replace16 ment therapy for treatment of menopausal symptoms if— 

17 ‘‘(A) the therapy is recommended by a health 

18 care provider who is licensed, accredited, or certified 

19 under State law; 

20 ‘‘(B) it has been proven safe and effective in 

21 peer-reviewed scientific studies; and 

22 ‘‘(C) it is administered only after the health 

23 care provider obtains the informed consent of the 

24 patient to receive it.’’. 

25 (b) EFFECTIVE DATE.—The amendment made by 

26 this section shall apply with respect to contracts made and 
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1 plans approved on or after the date of the enactment of 

2 this Act. 

3 SEC. 7. COVERAGE OF ALTERNATIVE TREATMENTS FOR 

4 MENOPAUSAL HORMONE REPLACEMENT 

5 THERAPY UNDER DEPARTMENT OF VET6 ERANS AFFAIRS HEALTH CARE SYSTEM. 

7 (a) IN GENERAL.—Section 1701(6) of title 38, 

8 United States Code, is amended by adding at the end the 

9 following new subparagraph: 

10 ‘‘(G) An alternative therapy for hormone re11 placement therapy for treatment of menopausal 

12 symptoms if the therapy is recommended by a health 

13 care provider who is licensed, accredited, or certified 

14 under State law, if the therapy has been proven safe 

15 and effective in peer-reviewed scientific studies, and 

16 if it is administered only after the health care pro17 vider obtains the informed consent of the patient to 

18 receive it.’’. 

19 (b) EFFECTIVE DATE.—The amendment made by 

20 subsection (a) shall apply to therapies furnished on or 

21 after the date of the enactment of this Act. 

Æ