I 

111TH CONGRESS 

1ST SESSION H. R. 584 

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 

JANUARY 15, 2009 

Ms. LEE of California 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 Labor, Oversight and 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 of 2009’’. 

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) The Women’s Health Initiative terminated 

10 its study of hormone therapy three years early be11 cause of findings that the combination of estrogen 

12 and progestin increases the risk of heart disease, 

13 stroke, blood clots, and breast cancer, and that es14 trogen alone increases the risk of stroke and, in 

15 women over 65 years of age, increases the risk of de16 mentia. 

17 (2) The National Institutes of Health has stat18 ed unequivocally that while menopause is a natural 


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1 process in women’s lives, some women at midlife ex2 perience hot flashes, night sweats, vaginal dryness, 

3 sleep disturbances, and mood disturbances that dis4 rupt quality of life. Women who have hade meno5 pause induced by surgery, chemotherapy, or radi6 ation are more likely to experience these symptoms. 

7 (3) Women deserve relief from menopause-re8 lated symptoms. 

9 (4) The National Institutes of Health have stat10 ed that while estrogen and progestin have been 

11 found to be effective remedies for these symptoms, 

12 these remedies are not without risk. 

13 (5) Concerned about these risks, women seek 

14 alternative types of treatments for symptoms that 

15 disrupt quality of life, such as hot flashes, night 

16 sweats, vaginal dryness, sleep disturbances, and 

17 mood disturbances. 

18 (6) The National Institutes of Health have 

19 found that although there are many alternatives to 

20 synthetic hormones available, including bio-identical 

21 or ‘‘natural’’ hormones as well as herbal remedies 

22 and food supplements, the effectiveness and long23 term safety of these products need to be rigorously 

24 studied in diverse populations. 


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1 (7) Government insurance programs, such as 

2 Medicare, Medicaid, the Federal Employees Health 

3 Benefits Program (FEHBP), and the Department 

4 of Veterans Affairs, do not cover non-prescription al5 ternative treatments for menopause-related symp6 toms because of a lack of demonstrated safety and 

7 efficacy of these products. 

8 (8) Most private health insurance coverage does 

9 not cover non-prescription alternative treatments for 

10 menopause-related symptoms because of a lack of 

11 demonstrated safety and efficacy of these products. 

12 SEC. 3. MEDICARE COVERAGE OF MENOPAUSAL HORMONE 

13 REPLACEMENT THERAPY AND ALTERNATIVE 

14 TREATMENTS FOR MENOPAUSAL HORMONE 

15 REPLACEMENT THERAPY. 

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

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

18 (1) by striking ‘‘and’’ at the end of subpara19 graph (DD); 

20 (2) by adding ‘‘and’’ at the end of subpara21 graph (EE); and 

22 (3) by adding at the end the following new sub23 paragraph: 

24 ‘‘(FF)(i) hormone replacement therapy for 

25 treatment of menopausal symptoms; and 


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1 ‘‘(ii) an alternative therapy for hormone re2 placement therapy for treatment of menopausal 

3 symptoms if the therapy is recommended by a health 

4 care provider who is licensed, accredited, or certified 

5 under State law, if it has been proven safe and effec6 tive in peer-reviewed scientific studies, and if it is 

7 administered only after the health care provider ob8 tains the informed consent of the patient to receive 

9 it;’’. 

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

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

12 after the date of the enactment of this Act. 

13 SEC. 4. MEDICAID COVERAGE OF ALTERNATIVE TREAT14 MENTS FOR MENOPAUSAL HORMONE RE15 PLACEMENT THERAPY. 

16 (a) REQUIREMENT FOR COVERAGE.—Section 

17 1902(a)(10) of the Social Security Act (42 U.S.C. 

18 1396a(a)(10)) is amended— 

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

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

21 (21), and (28)’’; and 

22 (2) in subparagraph (C)(iv)— 

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

24 ‘‘, (17), and (28)’’; and 


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1 (B) by striking ‘‘through (24)’’ and insert2 ing ‘‘through (28)’’. 

3 (b) DESCRIPTION OF COVERED THERAPIES.—Sec4 tion 1905(a) of such Act (42 U.S.C. 1396d(a)) is amend5 ed— 

6 (1) by striking ‘‘and’’ at the end of paragraph 

7 (27) 

8 (2) by redesignating paragraph (28) as para9 graph (29); and 

10 (3) by inserting after paragraph (27) the fol11 lowing new paragraph: 

12 ‘‘(28) an alternative therapy for hormone re13 placement therapy for treatment of menopausal 

14 symptoms if the therapy is recommended by a health 

15 care provider who is licensed, accredited, or certified 

16 under State law, if it has been proven safe and effec17 tive in peer-reviewed scientific studies, and if it is 

18 administered only after the health care provider ob19 tains the informed consent of the patient to receive 

20 it; and’’. 

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

22 this section apply to therapies furnished on or after the 

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

24 whether or not final regulations to carry out such amend25 ments have been promulgated by such date. 


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1 SEC. 5. COVERAGE OF MENOPAUSAL HORMONE REPLACE2 MENT THERAPY AND ALTERNATIVE TREAT3 MENTS FOR MENOPAUSAL HORMONE RE4 PLACEMENT THERAPY UNDER GROUP 

5 HEALTH PLANS AND INDIVIDUAL HEALTH IN6 SURANCE COVERAGE. 

7 (a) GROUP HEALTH PLANS.— 

8 (1) PUBLIC HEALTH SERVICE ACT AMEND9 MENTS.— 

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

11 title XXVII of the Public Health Service Act is 

12 amended by adding at the end the following 

13 new section: 

14 ‘‘SEC. 2708. STANDARD RELATING TO COVERAGE OF MENO15 PAUSAL HORMONE REPLACEMENT THERAPY 

16 AND ALTERNATIVE TREATMENTS FOR MENO17 PAUSAL HORMONE REPLACEMENT THERAPY. 

18 ‘‘(a) REQUIREMENTS.— 

19 ‘‘(1) MENOPAUSAL HORMONE REPLACEMENT

20 THERAPY.—If a group health plan, or a health in21 surance issuer offering group health insurance cov22 erage, provides benefits for outpatient prescription 

23 drugs, the plan or coverage may not exclude or re24 strict benefits for hormone replacement therapy for 

25 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.—A group health plan under this part 

19 shall comply with the notice requirement under section 

20 714(b) of the Employee Retirement Income Security Act 

21 of 1974 with respect to the requirements of this section 

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

23 (B) CONFORMING AMENDMENT.—Section 

24 2723(c) of such Act (42 U.S.C. 300gg–23(c)) is 


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1 amended by striking ‘‘section 2704’’ and insert2 ing ‘‘sections 2704 and 2708’’. 

3 (2) ERISA AMENDMENTS.— 

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

5 subtitle B of title I of the Employee Retirement 

6 Income Security Act of 1974 is amended by 

7 adding at the end the following new section: 

8 ‘‘SEC. 715. STANDARD RELATING TO COVERAGE OF MENO9 PAUSAL HORMONE REPLACEMENT THERAPY 

10 AND ALTERNATIVE TREATMENTS FOR MENO11 PAUSAL HORMONE REPLACEMENT THERAPY. 

12 ‘‘(a) REQUIREMENTS.— 

13 ‘‘(1) MENOPAUSAL HORMONE REPLACEMENT

14 THERAPY.—If a group health plan, or a health in15 surance issuer offering group health insurance cov16 erage, provides benefits for outpatient prescription 

17 drugs, the plan or coverage may not exclude or re18 strict benefits for hormone replacement therapy for 

19 treatment of menopausal symptoms. 

20 ‘‘(2) ALTERNATIVE TREATMENTS FOR MENO21 PAUSAL HORMONE REPLACEMENT THERAPY.—If a 

22 group health plan, or a health insurance issuer offer23 ing group health insurance coverage, provides bene24 fits for hormone replacement therapy for treatment 

25 of menopausal symptoms, the plan or coverage may 


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1 not exclude or restrict benefits for an alternative 

2 therapy for hormone replacement therapy for treat3 ment of menopausal symptoms if— 

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

5 health care provider who is licensed, accredited, 

6 or certified under State law; 

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

8 in peer-reviewed scientific studies; and 

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

10 health care provider obtains the informed con11 sent of the patient to receive it. 

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

13 imposition of the requirement of this section shall be treat14 ed as a material modification in the terms of the plan de15 scribed in the last sentence of section 102(a), for purposes 

16 of assuring notice of such requirements under the plan; 

17 except that the summary description required to be pro18 vided under the fourth sentence of section 104(b)(1) with 

19 respect to such modification shall be provided by not later 

20 than 60 days after the first day of the first plan year in 

21 which such requirement applies.’’. 

22 (B) CONFORMING AMENDMENTS.— 

23 (i) Section 731(c) of such Act (29 U.S.C. 

24 1191(c)) is amended by striking ‘‘section 711’’ 

25 and inserting ‘‘sections 711 and 715’’. 


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

2 1191a(a)) is amended by striking ‘‘section 711’’ 

3 and inserting ‘‘sections 711 and 715’’. 

4 (iii) The table of contents in section 1 of 

5 such Act is amended by inserting after the item 

6 relating to section 714 the following new item: 

‘‘Sec. 715. Standard relating to coverage of menopausal hormone replacement 

therapy and alternative treatments for menopausal hormone replacement therapy.’’. 

7 (3) INTERNAL REVENUE CODE AMEND8 MENTS.— 

9 (A) IN GENERAL.—Subchapter B of chap10 ter 100 of the Internal Revenue Code of 1986 

11 is amended by adding at the end the following: 

12 ‘‘SEC. 9813. STANDARD RELATING TO COVERAGE OF MENO13 PAUSAL HORMONE REPLACEMENT THERAPY 

14 AND ALTERNATIVE TREATMENTS FOR MENO15 PAUSAL HORMONE REPLACEMENT THERAPY. 

16 ‘‘(a) MENOPAUSAL HORMONE REPLACEMENT THER17 APY.—If a group health plan provides benefits for out18 patient prescription drugs, the plan may not exclude or 

19 restrict benefits for hormone replacement therapy for 

20 treatment of menopausal symptoms. 

21 ‘‘(b) ALTERNATIVE TREATMENTS FOR MENOPAUSAL

22 HORMONE REPLACEMENT THERAPY.—If a group health 

23 plan provides benefits for hormone replacement therapy 

24 for treatment of menopausal symptoms, the plan may not 


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1 exclude or restrict benefits for an alternative therapy for 

2 hormone replacement therapy for treatment of meno3 pausal symptoms if— 

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

5 care provider who is licensed, accredited, or certified 

6 under State law; 

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

8 peer-reviewed scientific studies; and 

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

10 care provider obtains the informed consent of the 

11 patient to receive it.’’ 

12 (A) CONFORMING AMENDMENTS.— 

13 (i) Section 4980D(d)(1) of such Code 

14 is amended by striking ‘‘section 9811’’ and 

15 inserting ‘‘sections 9811 and 9813’’. 

16 (ii) The table of sections for sub17 chapter B of chapter 100 of such Code is 

18 amended by adding at the end the fol19 lowing new item: 

‘‘Sec. 9813. Standard relating to coverage of menopausal hormone replacement 

therapy and alternative treatments for menopausal hormone replacement therapy.’’. 

20 (4) EFFECTIVE DATE.—The amendments made 

21 by this subsection shall apply with respect to group 

22 health plans for plan years beginning on or after the 

23 date of the enactment of this Act. 

24 (b) INDIVIDUAL HEALTH INSURANCE.— 


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

2 Public Health Service Act is amended by inserting 

3 after section 2753 the following new section: 

4 ‘‘SEC. 2754. STANDARD RELATING TO COVERAGE OF MENO5 PAUSAL HORMONE REPLACEMENT THERAPY 

6 AND ALTERNATIVE TREATMENTS FOR MENO7 PAUSAL HORMONE REPLACEMENT THERAPY. 

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

9 2708(a) shall apply to health insurance coverage offered 

10 by a health insurance issuer in the individual market in 

11 the same manner as they apply to health insurance cov12 erage offered by a health insurance issuer in connection 

13 with a group health plan in the small or large group mar14 ket. 

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

16 part shall comply with the notice requirement under sec17 tion 715(b) of the Employee Retirement Income Security 

18 Act of 1974 with respect to the requirements referred to 

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

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

21 (2) CONFORMING AMENDMENT.—Section 

22 2762(b)(2) of such Act (42 U.S.C. 300gg–62(b)(2)) 

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

24 ‘‘sections 2751 and 2754’’. 


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1 (3) EFFECTIVE DATE.—The amendments made 

2 by this subsection shall apply with respect to thera3 pies furnished on or after the date of the enactment 

4 of this Act. 

5 (c) COORDINATION OF ADMINISTRATION.—The Sec6 retary of Labor, the Secretary of the Treasury, and the 

7 Secretary of Health and Human Services shall ensure, 

8 through the execution of an interagency memorandum of 

9 understanding among such Secretaries, that— 

10 (1) regulations, rulings, and interpretations 

11 issued by such Secretaries relating to the same mat12 ter over which two or more such Secretaries have re13 sponsibility under the provisions of this section (and 

14 the amendments made thereby) are administered so 

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

16 (2) coordination of policies relating to enforcing 

17 the same requirements through such Secretaries in 

18 order to have a coordinated enforcement strategy 

19 that avoids duplication of enforcement efforts and 

20 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 ‘‘(H) 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 


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