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 insur-
ance 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 Gov-
ernment Reform, and Veterans’ Affairs, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions 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 ther-
apy for such symptoms, under the Medicare and Med-
icaid Programs, group health plans and individual health 
insurance coverage, and other Federal health insurance 
programs. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Menopausal Hormone Replacement Therapies and Alter-
native Treatments and Fairness Act of 2011’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
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 al-
ternative treatments for menopausal hormone replacement 
therapy. 
Sec. 4. Medicaid coverage of alternative treatments for menopausal hormone re-
placement 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 sys-
tem. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) The Women’s Health Initiative terminated 
its study of hormone therapy three years early be-
cause of findings that the combination of estrogen 
and progestin increases the risk of heart disease, 
stroke, blood clots, and breast cancer, and that es-
trogen alone increases the risk of stroke and, in 
women over 65 years of age, increases the risk of de-
mentia. 
(2) The National Institutes of Health has stat-
ed unequivocally that while menopause is a natural 
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process in women’s lives, some women at midlife ex-
perience hot flashes, night sweats, vaginal dryness, 
sleep disturbances, and mood disturbances that dis-
rupt quality of life. Women who have had meno-
pause induced by surgery, chemotherapy, or radi-
ation are more likely to experience these symptoms. 
(3) Women deserve relief from menopause-re-
lated symptoms. 
(4) The National Institutes of Health have stat-
ed that while estrogen and progestin have been 
found to be effective remedies for these symptoms, 
these remedies are not without risk. 
(5) Concerned about these risks, women seek 
alternative types of treatments for symptoms that 
disrupt quality of life, such as hot flashes, night 
sweats, vaginal dryness, sleep disturbances, and 
mood disturbances. 
(6) The National Institutes of Health have 
found that although there are many alternatives to 
synthetic hormones available, including bio-identical 
or ‘‘natural’’ hormones as well as herbal remedies 
and food supplements, the effectiveness and long- 
term safety of these products need to be rigorously 
studied in diverse populations. 
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(7) Government insurance programs, such as 
Medicare, Medicaid, the Federal Employees Health 
Benefits Program (FEHBP), and the Department 
of Veterans Affairs, do not cover non-prescription al-
ternative treatments for menopause-related symp-
toms because of a lack of demonstrated safety and 
efficacy of these products. 
(8) Most private health insurance coverage does 
not cover non-prescription alternative treatments for 
menopause-related symptoms because of a lack of 
demonstrated safety and efficacy of these products. 
SEC. 3. MEDICARE COVERAGE OF MENOPAUSAL HORMONE 
REPLACEMENT THERAPY AND ALTERNATIVE 
TREATMENTS FOR MENOPAUSAL HORMONE 
REPLACEMENT THERAPY. 
(a) IN GENERAL.—Section 1861(s)(2) of the Social 
Security Act (42 U.S.C. 1395x(s)(2)) is amended— 
(1) by striking ‘‘and’’ at the end of subpara-
graph (EE); 
(2) by adding ‘‘and’’ at the end of subpara-
graph (FF); and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(GG)(i) hormone replacement therapy for 
treatment of menopausal symptoms; and 
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‘‘(ii) an alternative therapy for hormone re-
placement therapy for treatment of menopausal 
symptoms if the therapy is recommended by a health 
care provider who is licensed, accredited, or certified 
under State law, if it has been proven safe and effec-
tive in peer-reviewed scientific studies, and if it is 
administered only after the health care provider ob-
tains the informed consent of the patient to receive 
it;’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to therapies furnished on or 
after the date of the enactment of this Act. 
SEC. 4. MEDICAID COVERAGE OF ALTERNATIVE TREAT-
MENTS FOR MENOPAUSAL HORMONE RE-
PLACEMENT THERAPY. 
(a) 
REQUIREMENT
FOR
COVERAGE.—Section 
1902(a)(10) of the Social Security Act (42 U.S.C. 
1396a(a)(10)) is amended— 
(1) in subparagraph (A) in the matter before 
clause (i), by striking ‘‘and (28)’’ and inserting ‘‘, 
(28), and (29)’’; and 
(2) in subparagraph (C)(iv)— 
(A) by striking ‘‘and (17)’’ and inserting 
‘‘, (17), and (29)’’; and 
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(B) by striking ‘‘through (24)’’ and insert-
ing ‘‘through (29)’’. 
(b) DESCRIPTION OF COVERED THERAPIES.—Sec-
tion 1905(a) of such Act (42 U.S.C. 1396d(a)) is amend-
ed— 
(1) by striking ‘‘and’’ at the end of paragraph 
(28); 
(2) by redesignating paragraph (29) as para-
graph (30); and 
(3) by inserting after paragraph (28) the fol-
lowing new paragraph: 
‘‘(29) an alternative therapy for hormone re-
placement therapy for treatment of menopausal 
symptoms if the therapy is recommended by a health 
care provider who is licensed, accredited, or certified 
under State law, if it has been proven safe and effec-
tive in peer-reviewed scientific studies, and if it is 
administered only after the health care provider ob-
tains the informed consent of the patient to receive 
it; and’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section apply to therapies furnished on or after the 
date of the enactment of this Act, without regard to 
whether or not final regulations to carry out such amend-
ments have been promulgated by such date. 
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SEC. 5. COVERAGE OF MENOPAUSAL HORMONE REPLACE-
MENT THERAPY AND ALTERNATIVE TREAT-
MENTS FOR MENOPAUSAL HORMONE RE-
PLACEMENT 
THERAPY 
UNDER 
GROUP 
HEALTH PLANS AND INDIVIDUAL HEALTH IN-
SURANCE COVERAGE. 
(a) PUBLIC HEALTH SERVICE ACT AMENDMENTS.— 
(1) IN GENERAL.—Title XXVII of the Public 
Health Service Act is amended by inserting after 
section 2728 of such Act (42 U.S.C. 300gg–28), as 
redesignated by section 1001(2) of the Patient Pro-
tection and Affordable Care Act (Public Law 111– 
148), the following new section: 
‘‘SEC. 2729. STANDARD RELATING TO COVERAGE OF MENO-
PAUSAL HORMONE REPLACEMENT THERAPY 
AND ALTERNATIVE TREATMENTS FOR MENO-
PAUSAL HORMONE REPLACEMENT THERAPY. 
‘‘(a) REQUIREMENTS.— 
‘‘(1) MENOPAUSAL
HORMONE
REPLACEMENT 
THERAPY.—If a group health plan, or a health in-
surance issuer offering group or individual health in-
surance coverage, provides benefits for outpatient 
prescription drugs, the plan or coverage may not ex-
clude or restrict benefits for hormone replacement 
therapy for treatment of menopausal symptoms. 
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‘‘(2) ALTERNATIVE
TREATMENTS
FOR
MENO-
PAUSAL HORMONE REPLACEMENT THERAPY.—If a 
group health plan, or a health insurance issuer offer-
ing group or individual health insurance coverage, 
provides benefits for hormone replacement therapy 
for treatment of menopausal symptoms, the plan or 
coverage may not exclude or restrict benefits for an 
alternative therapy for hormone replacement therapy 
for treatment of menopausal symptoms if— 
‘‘(A) the therapy is recommended by a 
health care provider who is licensed, accredited, 
or certified under State law; 
‘‘(B) it has been proven safe and effective 
in peer-reviewed scientific studies; and 
‘‘(C) it is administered only after the 
health care provider obtains the informed con-
sent of the patient to receive it. 
‘‘(b) NOTICE.—A group health plan under this part 
shall comply with the notice requirement under section 
716(b) of the Employee Retirement Income Security Act 
of 1974 with respect to the requirements of this section 
as if such section applied to such plan. A health insurance 
issuer under this part shall comply with the notice require-
ment under such section with respect to the requirements 
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of this section as if such section applied to such issuer 
and such issuer were a group health plan. 
‘‘(c) EFFECTIVE DATE.—Notwithstanding any other 
provision of law, this section shall apply with respect to 
plan years beginning on or after the date of the enactment 
of the Menopausal Hormone Replacement Therapies and 
Alternative Treatments and Fairness Act of 2011 and 
with respect to health insurance coverage issued on or 
after such date.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
2724(c) of such Act (42 U.S.C. 300gg–23(c)), as re-
designated by sections 1001(4) and 1563(c)(14)(B) 
of the Patient Protection and Affordable Care Act 
(Public Law 111–148) is amended by striking ‘‘sec-
tion 2704’’ and inserting ‘‘sections 2704 and 2729’’. 
(3) APPLICATION RULE.—For purposes of ap-
plying section 2729 of the Public Health Service 
Act, as inserted by paragraph (1), to individual 
health insurance coverage before 2014, the provi-
sions of such section shall be treated as also in-
cluded under part B of title XXVII of the Public 
Health Service Act. 
(b) ERISA AMENDMENTS.— 
(1) IN GENERAL.—Subpart B of part 7 of sub-
title B of title I of the Employee Retirement Income 
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Security Act of 1974 is amended by adding at the 
end the following new section: 
‘‘SEC. 716. STANDARD RELATING TO COVERAGE OF MENO-
PAUSAL HORMONE REPLACEMENT THERAPY 
AND ALTERNATIVE TREATMENTS FOR MENO-
PAUSAL HORMONE REPLACEMENT THERAPY. 
‘‘(a) REQUIREMENTS.— 
‘‘(1) MENOPAUSAL
HORMONE
REPLACEMENT 
THERAPY.—If a group health plan, or a health in-
surance issuer offering group health insurance cov-
erage, provides benefits for outpatient prescription 
drugs, the plan or coverage may not exclude or re-
strict benefits for hormone replacement therapy for 
treatment of menopausal symptoms. 
‘‘(2) ALTERNATIVE
TREATMENTS
FOR
MENO-
PAUSAL HORMONE REPLACEMENT THERAPY.—If a 
group health plan, or a health insurance issuer offer-
ing group health insurance coverage, provides bene-
fits for hormone replacement therapy for treatment 
of menopausal symptoms, the plan or coverage may 
not exclude or restrict benefits for an alternative 
therapy for hormone replacement therapy for treat-
ment of menopausal symptoms if— 
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‘‘(A) the therapy is recommended by a 
health care provider who is licensed, accredited, 
or certified under State law; 
‘‘(B) it has been proven safe and effective 
in peer-reviewed scientific studies; and 
‘‘(C) it is administered only after the 
health care provider obtains the informed con-
sent of the patient to receive it. 
‘‘(b) NOTICE UNDER GROUP HEALTH PLAN.—The 
imposition of the requirement of this section shall be treat-
ed as a material modification in the terms of the plan de-
scribed in the last sentence of section 102(a), for purposes 
of assuring notice of such requirements under the plan; 
except that the summary description required to be pro-
vided under the fourth sentence of section 104(b)(1) with 
respect to such modification shall be provided by not later 
than 60 days after the first day of the first plan year in 
which such requirement applies.’’. 
(2) CONFORMING AMENDMENTS.— 
(A) Section 731(c) of such Act (29 U.S.C. 
1191(c)) is amended by striking ‘‘section 711’’ 
and inserting ‘‘sections 711 and 716’’. 
(B) Section 732(a) of such Act (29 U.S.C. 
1191a(a)) is amended by striking ‘‘section 711’’ 
and inserting ‘‘sections 711 and 716’’. 
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(C) The table of contents in section 1 of 
such Act is amended by inserting after the item 
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 re-
placement therapy.’’. 
(c) INTERNAL REVENUE CODE AMENDMENTS.— 
(1) IN
GENERAL.—Subchapter B of chapter 
100 of the Internal Revenue Code of 1986 is amend-
ed by adding at the end the following: 
‘‘SEC. 9816. STANDARD RELATING TO COVERAGE OF MENO-
PAUSAL HORMONE REPLACEMENT THERAPY 
AND ALTERNATIVE TREATMENTS FOR MENO-
PAUSAL HORMONE REPLACEMENT THERAPY. 
‘‘(a) MENOPAUSAL HORMONE REPLACEMENT THER-
APY.—If a group health plan provides benefits for out-
patient prescription drugs, the plan may not exclude or 
restrict benefits for hormone replacement therapy for 
treatment of menopausal symptoms. 
‘‘(b) ALTERNATIVE TREATMENTS FOR MENOPAUSAL 
HORMONE REPLACEMENT THERAPY.—If a group health 
plan provides benefits for hormone replacement therapy 
for treatment of menopausal symptoms, the plan may not 
exclude or restrict benefits for an alternative therapy for 
hormone replacement therapy for treatment of meno-
pausal symptoms if— 
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‘‘(1) the therapy is recommended by a health 
care provider who is licensed, accredited, or certified 
under State law; 
‘‘(2) it has been proven safe and effective in 
peer-reviewed scientific studies; and 
‘‘(3) it is administered only after the health 
care provider obtains the informed consent of the 
patient to receive it.’’ 
(2) CONFORMING AMENDMENTS.— 
(A) Section 4980D(d)(1) of such Code is 
amended by striking ‘‘section 9811’’ and insert-
ing ‘‘sections 9811 and 9816’’. 
(B) The table of sections for subchapter B 
of chapter 100 of such Code is amended by 
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 re-
placement therapy.’’. 
(d) COORDINATION OF ADMINISTRATION.—The Sec-
retary of Labor, the Secretary of the Treasury, and the 
Secretary of Health and Human Services shall ensure, 
through the execution of an interagency memorandum of 
understanding among such Secretaries, that— 
(1) regulations, rulings, and interpretations 
issued by such Secretaries relating to the same mat-
ter over which two or more such Secretaries have re-
sponsibility under the provisions of this section (and 
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the amendments made thereby) are administered so 
as to have the same effect at all times; and 
(2) coordination of policies relating to enforcing 
the same requirements through such Secretaries in 
order to have a coordinated enforcement strategy 
that avoids duplication of enforcement efforts and 
assigns priorities in enforcement. 
(e) EFFECTIVE DATE.—The amendments made by 
subsections (b) and (c) shall apply with respect to group 
health plans for plan years beginning on or after the date 
of the enactment of this Act. 
SEC. 6. COVERAGE OF MENOPAUSAL HORMONE REPLACE-
MENT THERAPY AND ALTERNATIVE TREAT-
MENTS FOR MENOPAUSAL HORMONE RE-
PLACEMENT THERAPY UNDER FEHBP. 
(a) IN GENERAL.—Section 8902 of title 5, United 
States Code, is amended by adding at the end the fol-
lowing new subsection: 
‘‘(p)(1) If a contract or plan provides benefits for out-
patient prescription drugs, the contract or plan may not 
exclude or restrict benefits for hormone replacement ther-
apy for treatment of menopausal symptoms. 
‘‘(2) If a contract or plan provides benefits for hor-
mone replacement therapy for treatment of menopausal 
symptoms, the contract or plan may not exclude or restrict 
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benefits for an alternative therapy for hormone replace-
ment therapy for treatment of menopausal symptoms if— 
‘‘(A) the therapy is recommended by a health 
care provider who is licensed, accredited, or certified 
under State law; 
‘‘(B) it has been proven safe and effective in 
peer-reviewed scientific studies; and 
‘‘(C) it is administered only after the health 
care provider obtains the informed consent of the 
patient to receive it.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply with respect to contracts made and 
plans approved on or after the date of the enactment of 
this Act. 
SEC. 7. COVERAGE OF ALTERNATIVE TREATMENTS FOR 
MENOPAUSAL 
HORMONE 
REPLACEMENT 
THERAPY 
UNDER 
DEPARTMENT 
OF 
VET-
ERANS AFFAIRS HEALTH CARE SYSTEM. 
(a) IN GENERAL.—Section 1701(6) of title 38, 
United States Code, is amended by adding at the end the 
following new subparagraph: 
‘‘(H) An alternative therapy for hormone 
replacement therapy for treatment of meno-
pausal symptoms if the therapy is recommended 
by a health care provider who is licensed, ac-
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