I 

112TH CONGRESS 

1ST SESSION H. R. 383 

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 20, 2011 

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 the Workforce, 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 2011’’. 

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 had 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 (EE); 

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

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

24 ‘‘(GG)(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 (28)’’ and inserting ‘‘, 

21 (28), and (29)’’; and 

22 (2) in subparagraph (C)(iv)— 

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

24 ‘‘, (17), and (29)’’; and 


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1 (B) by striking ‘‘through (24)’’ and insert2 ing ‘‘through (29)’’. 

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 (28); 

8 (2) by redesignating paragraph (29) as para9 graph (30); and 

10 (3) by inserting after paragraph (28) the fol11 lowing new paragraph: 

12 ‘‘(29) 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) PUBLIC HEALTH SERVICE ACT AMENDMENTS.— 

8 (1) IN GENERAL.—Title XXVII of the Public 

9 Health Service Act is amended by inserting after 

10 section 2728 of such Act (42 U.S.C. 300gg–28), as 

11 redesignated by section 1001(2) of the Patient Pro12 tection and Affordable Care Act (Public Law 111– 

13 148), the following new section: 

14 ‘‘SEC. 2729. 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 or individual health in22 surance coverage, provides benefits for outpatient 

23 prescription drugs, the plan or coverage may not ex24 clude or restrict benefits for hormone replacement 

25 therapy for 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 or individual health insurance coverage, 

5 provides benefits for hormone replacement therapy 

6 for treatment of menopausal symptoms, the plan or 

7 coverage may not exclude or restrict benefits for an 

8 alternative therapy for hormone replacement therapy 

9 for treatment 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 

20 716(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. A health insurance 

23 issuer under this part shall comply with the notice require24 ment under such section with respect to the requirements 


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1 of this section as if such section applied to such issuer 

2 and such issuer were a group health plan. 

3 ‘‘(c) EFFECTIVE DATE.—Notwithstanding any other 

4 provision of law, this section shall apply with respect to 

5 plan years beginning on or after the date of the enactment 

6 of the Menopausal Hormone Replacement Therapies and 

7 Alternative Treatments and Fairness Act of 2011 and 

8 with respect to health insurance coverage issued on or 

9 after such date.’’. 

10 (2) CONFORMING AMENDMENT.—Section 

11 2724(c) of such Act (42 U.S.C. 300gg–23(c)), as re12 designated by sections 1001(4) and 1563(c)(14)(B) 

13 of the Patient Protection and Affordable Care Act 

14 (Public Law 111–148) is amended by striking ‘‘sec15 tion 2704’’ and inserting ‘‘sections 2704 and 2729’’. 

16 (3) APPLICATION RULE.—For purposes of ap17 plying section 2729 of the Public Health Service 

18 Act, as inserted by paragraph (1), to individual 

19 health insurance coverage before 2014, the provi20 sions of such section shall be treated as also in21 cluded under part B of title XXVII of the Public 

22 Health Service Act. 

23 (b) ERISA AMENDMENTS.— 

24 (1) IN GENERAL.—Subpart B of part 7 of sub25 title B of title I of the Employee Retirement Income 


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1 Security Act of 1974 is amended by adding at the 

2 end the following new section: 

3 ‘‘SEC. 716. STANDARD RELATING TO COVERAGE OF MENO4 PAUSAL HORMONE REPLACEMENT THERAPY 

5 AND ALTERNATIVE TREATMENTS FOR MENO6 PAUSAL HORMONE REPLACEMENT THERAPY. 

7 ‘‘(a) REQUIREMENTS.— 

8 ‘‘(1) MENOPAUSAL HORMONE REPLACEMENT

9 THERAPY.—If a group health plan, or a health in10 surance issuer offering group health insurance cov11 erage, provides benefits for outpatient prescription 

12 drugs, the plan or coverage may not exclude or re13 strict benefits for hormone replacement therapy for 

14 treatment of menopausal symptoms. 

15 ‘‘(2) ALTERNATIVE TREATMENTS FOR MENO16 PAUSAL HORMONE REPLACEMENT THERAPY.—If a 

17 group health plan, or a health insurance issuer offer18 ing group health insurance coverage, provides bene19 fits for hormone replacement therapy for treatment 

20 of menopausal symptoms, the plan or coverage may 

21 not exclude or restrict benefits for an alternative 

22 therapy for hormone replacement therapy for treat23 ment of menopausal symptoms if— 


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

2 health care provider who is licensed, accredited, 

3 or certified under State law; 

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

5 in peer-reviewed scientific studies; and 

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

7 health care provider obtains the informed con8 sent of the patient to receive it. 

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

10 imposition of the requirement of this section shall be treat11 ed as a material modification in the terms of the plan de12 scribed in the last sentence of section 102(a), for purposes 

13 of assuring notice of such requirements under the plan; 

14 except that the summary description required to be pro15 vided under the fourth sentence of section 104(b)(1) with 

16 respect to such modification shall be provided by not later 

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

18 which such requirement applies.’’. 

19 (2) CONFORMING AMENDMENTS.— 

20 (A) Section 731(c) of such Act (29 U.S.C. 

21 1191(c)) is amended by striking ‘‘section 711’’ 

22 and inserting ‘‘sections 711 and 716’’. 

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

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

25 and inserting ‘‘sections 711 and 716’’. 


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

2 such Act is amended by inserting after the item 

3 relating to section 714 the following new item: 

‘‘Sec. 716. Standard relating to coverage of menopausal hormone replacement 

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

4 (c) INTERNAL REVENUE CODE AMENDMENTS.— 

5 (1) IN GENERAL.—Subchapter B of chapter 

6 100 of the Internal Revenue Code of 1986 is amend7 ed by adding at the end the following: 

8 ‘‘SEC. 9816. STANDARD RELATING TO COVERAGE OF MENO9 PAUSAL HORMONE REPLACEMENT THERAPY 

10 AND ALTERNATIVE TREATMENTS FOR MENO11 PAUSAL HORMONE REPLACEMENT THERAPY. 

12 ‘‘(a) MENOPAUSAL HORMONE REPLACEMENT THER13 APY.—If a group health plan provides benefits for out14 patient prescription drugs, the plan may not exclude or 

15 restrict benefits for hormone replacement therapy for 

16 treatment of menopausal symptoms. 

17 ‘‘(b) ALTERNATIVE TREATMENTS FOR MENOPAUSAL

18 HORMONE REPLACEMENT THERAPY.—If a group health 

19 plan provides benefits for hormone replacement therapy 

20 for treatment of menopausal symptoms, the plan may not 

21 exclude or restrict benefits for an alternative therapy for 

22 hormone replacement therapy for treatment of meno23 pausal symptoms if— 


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

2 care provider who is licensed, accredited, or certified 

3 under State law; 

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

5 peer-reviewed scientific studies; and 

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

7 care provider obtains the informed consent of the 

8 patient to receive it.’’ 

9 (2) CONFORMING AMENDMENTS.— 

10 (A) Section 4980D(d)(1) of such Code is 

11 amended by striking ‘‘section 9811’’ and insert12 ing ‘‘sections 9811 and 9816’’. 

13 (B) The table of sections for subchapter B 

14 of chapter 100 of such Code is amended by 

15 adding at the end the following new item: 

‘‘Sec. 9816. Standard relating to coverage of menopausal hormone replacement 

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

16 (d) COORDINATION OF ADMINISTRATION.—The Sec17 retary of Labor, the Secretary of the Treasury, and the 

18 Secretary of Health and Human Services shall ensure, 

19 through the execution of an interagency memorandum of 

20 understanding among such Secretaries, that— 

21 (1) regulations, rulings, and interpretations 

22 issued by such Secretaries relating to the same mat23 ter over which two or more such Secretaries have re24 sponsibility under the provisions of this section (and 


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1 the amendments made thereby) are administered so 

2 as 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) EFFECTIVE DATE.—The amendments made by 

9 subsections (b) and (c) shall apply with respect to group 

10 health plans for plan years beginning on or after the date 

11 of the enactment of this Act. 

12 SEC. 6. COVERAGE OF MENOPAUSAL HORMONE REPLACE13 MENT THERAPY AND ALTERNATIVE TREAT14 MENTS FOR MENOPAUSAL HORMONE RE15 PLACEMENT THERAPY UNDER FEHBP. 

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

17 States Code, is amended by adding at the end the fol18 lowing new subsection: 

19 ‘‘(p)(1) If a contract or plan provides benefits for out20 patient prescription drugs, the contract or plan may not 

21 exclude or restrict benefits for hormone replacement ther22 apy for treatment of menopausal symptoms. 

23 ‘‘(2) If a contract or plan provides benefits for hor24 mone replacement therapy for treatment of menopausal 

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


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1 benefits for an alternative therapy for hormone replace2 ment therapy for treatment of menopausal symptoms if— 

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

4 care provider who is licensed, accredited, or certified 

5 under State law; 

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

7 peer-reviewed scientific studies; and 

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

9 care provider obtains the informed consent of the 

10 patient to receive it.’’. 

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

12 this section shall apply with respect to contracts made and 

13 plans approved on or after the date of the enactment of 

14 this Act. 

15 SEC. 7. COVERAGE OF ALTERNATIVE TREATMENTS FOR 

16 MENOPAUSAL HORMONE REPLACEMENT 

17 THERAPY UNDER DEPARTMENT OF VET18 ERANS AFFAIRS HEALTH CARE SYSTEM. 

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

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

21 following new subparagraph: 

22 ‘‘(H) An alternative therapy for hormone 

23 replacement therapy for treatment of meno24 pausal symptoms if the therapy is recommended 

25 by a health care provider who is licensed, acVerDate Mar 15 2010 22:19 Jan 21, 2011 Jkt 099200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H383.IH H383

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1 credited, or certified under State law, if the 

2 therapy has been proven safe and effective in 

3 peer-reviewed scientific studies, and if it is ad4 ministered only after the health care provider 

5 obtains the informed consent of the patient to 

6 receive it.’’. 

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

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

9 after the date of the enactment of this Act. 

Æ 


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