I 

108TH CONGRESS 

2D SESSION H. R. 4154 

To amend the Public Health Service Act and Employee Retirement Income 

Security Act of 1974 to require that group and individual health insurance coverage and group health plans provide coverage for qualified 

individuals for bone mass measurement (bone density testing) to prevent 

fractures associated with osteoporosis. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 2, 2004 

Mrs. MALONEY (for herself and Ms. HART) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on Education and the Workforce, 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 amend the Public Health Service Act and Employee Retirement Income Security Act of 1974 to require that 

group and individual health insurance coverage and 

group health plans provide coverage for qualified individuals for bone mass measurement (bone density testing) 

to prevent fractures associated with osteoporosis. 

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; FINDINGS. 

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

3 ‘‘Osteoporosis Early Detection and Prevention Act of 

4 2004’’. 

5 (b) FINDINGS.—Congress makes the following find6 ings: 

7 (1) NATURE OF OSTEOPOROSIS.— 

8 (A) Osteoporosis is a disease characterized 

9 by low bone mass and structural deterioration 

10 of bone tissue leading to bone fragility and in11 creased susceptibility to fractures of the hip, 

12 spine, and wrist. 

13 (B) Osteoporosis has no symptoms and 

14 typically remains undiagnosed until a fracture 

15 occurs. 

16 (C) Once a fracture occurs, the condition 

17 has usually advanced to the stage where the 

18 likelihood is high that another fracture will 

19 occur. 

20 (D) There is no cure for osteoporosis, but 

21 drug therapy has been shown to reduce new hip 

22 and spine fractures by 50 percent and other 

23 treatments, such as nutrition therapy, have also 

24 proven effective. 

25 (2) INCIDENCE OF OSTEOPOROSIS.— 

26 Osteoporosis is a common condition: 
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1 (A) Of the 44 million Americans who have 

2 (or are at risk for) osteoporosis, 80 percent are 

3 women. 

4 (B) Annually there are 1.5 million bone 

5 fractures attributable to osteoporosis. 

6 (C) Half of all women, and one-fourth of 

7 all men, age 50 or older will have a bone frac8 ture due to osteoporosis. 

9 (3) IMPACT OF OSTEOPOROSIS.—The cost of 

10 treating osteoporosis is significant: 

11 (A) The annual cost of osteoporosis in the 

12 United States was $17 billion in 2001. 

13 (B) The average cost in the United States 

14 of repairing a hip fracture due to osteoporosis 

15 is $37,000, while the average cost of an 

16 osteoporosis screening test ranges from $59 to 

17 $300. 

18 (C) Fractures due to osteoporosis fre19 quently result in disability and institutionaliza20 tion of individuals. 

21 (D) Because osteoporosis is a progressive 

22 condition causing fractures primarily in aging 

23 individuals, preventing fractures particularly in 

24 post menopausal women before they become eli25 gible for medicare, has a significant potential of 
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1 reducing osteoporosis-related costs under the 

2 medicare program. 

3 (4) USE OF BONE MASS MEASUREMENT.— 

4 (A) Bone mass measurement is a non5 invasive, painless, and reliable way to diagnose 

6 osteoporosis before costly fractures occur. 

7 (B) Low bone mass is as predictive of fu8 ture fractures as is high cholesterol or high 

9 blood pressure of heart disease or stroke. 

10 (C) Bone mass measurement is the only 

11 reliable method of detecting osteoporosis at an 

12 early stage. 

13 (D) Under section 4106 of the Balanced 

14 Budget Act of 1997, medicare provides cov15 erage, effective July 1, 1998, for bone mass 

16 measurement for qualified individuals who are 

17 at risk of developing osteoporosis. 

18 SEC. 2. REQUIRING COVERAGE OF BONE MASS MEASURE19 MENT UNDER HEALTH PLANS. 

20 (a) GROUP HEALTH PLANS.— 

21 (1) PUBLIC HEALTH SERVICE ACT AMEND22 MENTS.—(A) Subpart 2 of part A of title XXVII of 

23 the Public Health Service Act is amended by adding 

24 at the end the following new section: 
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1 ‘‘SEC. 2707. STANDARDS RELATING TO BENEFITS FOR BONE 

2 MASS MEASUREMENT. 

3 ‘‘(a) REQUIREMENTS FOR COVERAGE OF BONE MASS

4 MEASUREMENT.—A group health plan, and a health in5 surance issuer offering group health insurance coverage, 

6 shall include (consistent with this section) coverage for 

7 bone mass measurement for beneficiaries and participants 

8 who are qualified individuals. 

9 ‘‘(b) DEFINITIONS RELATING TO COVERAGE.—In 

10 this section: 

11 ‘‘(1) BONE MASS MEASUREMENT.—The term 

12 ‘bone mass measurement’ means a radiologic or 

13 radioisotopic procedure or other procedure approved 

14 by the Food and Drug Administration performed on 

15 an individual for the purpose of identifying bone 

16 mass or detecting bone loss or determining bone 

17 quality, and includes a physician’s interpretation of 

18 the results of the procedure. Nothing in this para19 graph shall be construed as requiring a bone mass 

20 measurement to be conducted in a particular type of 

21 facility or to prevent such a measurement from 

22 being conducted through the use of mobile facilities 

23 that are otherwise qualified. 

24 ‘‘(2) QUALIFIED INDIVIDUAL.—The term ‘quali25 fied individual’ means an individual who— 
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1 ‘‘(A) is at clinical risk for osteoporosis, in2 cluding an estrogen-deficient woman; 

3 ‘‘(B) has vertebral abnormalities; 

4 ‘‘(C) is receiving chemotherapy or long5 term gluococorticoid (steroid) therapy; 

6 ‘‘(D) has primary hyperparathyroidism, 

7 hyperthyroidism, or excess thyroid replacement; 

8 or 

9 ‘‘(E) is being monitored to assess the re10 sponse to or efficacy of approved osteoporosis 

11 drug therapy. 

12 ‘‘(c) LIMITATION ON FREQUENCY REQUIRED.—Tak13 ing into account the standards established under section 

14 1861(rr)(3) of the Social Security Act, the Secretary shall 

15 establish standards regarding the frequency with which a 

16 qualified individual shall be eligible to be provided benefits 

17 for bone mass measurement under this section. The Sec18 retary may vary such standards based on the clinical and 

19 risk-related characteristics of qualified individuals. 

20 ‘‘(d) RESTRICTIONS ON COST-SHARING.— 

21 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

22 nothing in this section shall be construed as pre23 venting a group health plan or issuer from imposing 

24 deductibles, coinsurance, or other cost-sharing in re25 lation to bone mass measurement under the plan (or 
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1 health insurance coverage offered in connection with 

2 a plan). 

3 ‘‘(2) LIMITATION.—Deductibles, coinsurance, 

4 and other cost-sharing or other limitations for bone 

5 mass measurement may not be imposed under para6 graph (1) to the extent they exceed the deductibles, 

7 coinsurance, and limitations that are applied to simi8 lar services under the group health plan or health 

9 insurance coverage. 

10 ‘‘(e) PROHIBITIONS.—A group health plan, and a 

11 health insurance issuer offering group health insurance 

12 coverage in connection with a group health plan, may 

13 not— 

14 ‘‘(1) deny to an individual eligibility, or contin15 ued eligibility, to enroll or to renew coverage under 

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

17 avoiding the requirements of this section; 

18 ‘‘(2) provide incentives (monetary or otherwise) 

19 to individuals to encourage such individuals not to 

20 be provided bone mass measurements to which they 

21 are entitled under this section or to providers to in22 duce such providers not to provide such measure23 ments to qualified individuals; 
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1 ‘‘(3) prohibit a provider from discussing with a 

2 patient osteoporosis preventive techniques or medical 

3 treatment options relating to this section; or 

4 ‘‘(4) penalize or otherwise reduce or limit the 

5 reimbursement of a provider because such provider 

6 provided bone mass measurements to a qualified in7 dividual in accordance with this section. 

8 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec9 tion shall be construed to require an individual who is a 

10 participant or beneficiary to undergo bone mass measure11 ment. 

12 ‘‘(g) NOTICE.—A group health plan under this part 

13 shall comply with the notice requirement under section 

14 714(g) of the Employee Retirement Income Security Act 

15 of 1974 with respect to the requirements of this section 

16 as if such section applied to such plan. 

17 ‘‘(h) LEVEL AND TYPE OF REIMBURSEMENTS.— 

18 Nothing in this section shall be construed to prevent a 

19 group health plan or a health insurance issuer offering 

20 group health insurance coverage from negotiating the level 

21 and type of reimbursement with a provider for care pro22 vided in accordance with this section. 

23 ‘‘(i) PREEMPTION.— 

24 ‘‘(1) IN GENERAL.—The provisions of this sec25 tion do not preempt State law relating to health in-
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1 surance coverage to the extent such State law pro2 vides greater benefits with respect to osteoporosis 

3 detection or prevention. 

4 ‘‘(2) CONSTRUCTION.—Section 2723(a)(1) shall 

5 not be construed as superseding a State law de6 scribed in paragraph (1).’’. 

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

8 300gg–23(c)) is amended by striking ‘‘section 2704’’ 

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

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

11 part 7 of subtitle B of title I of the Employee Re12 tirement Income Security Act of 1974 is amended by 

13 adding at the end the following new section: 

14 ‘‘SEC. 714. STANDARDS RELATING TO BENEFITS FOR BONE 

15 MASS MEASUREMENT. 

16 ‘‘(a) REQUIREMENTS FOR COVERAGE OF BONE MASS

17 MEASUREMENT.—A group health plan, and a health in18 surance issuer offering group health insurance coverage, 

19 shall include (consistent with this section) coverage for 

20 bone mass measurement for beneficiaries and participants 

21 who are qualified individuals. 

22 ‘‘(b) DEFINITIONS RELATING TO COVERAGE.—In 

23 this section: 

24 ‘‘(1) BONE MASS MEASUREMENT.—The term 

25 ‘bone mass measurement’ means a radiologic or 
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1 radioisotopic procedure or other procedure approved 

2 by the Food and Drug Administration performed on 

3 an individual for the purpose of identifying bone 

4 mass or detecting bone loss or determining bone 

5 quality, and includes a physician’s interpretation of 

6 the results of the procedure. Nothing in this para7 graph shall be construed as requiring a bone mass 

8 measurement to be conducted in a particular type of 

9 facility or to prevent such a measurement from 

10 being conducted through the use of mobile facilities 

11 that are otherwise qualified. 

12 ‘‘(2) QUALIFIED INDIVIDUAL.—The term ‘quali13 fied individual’ means an individual who— 

14 ‘‘(A) is at clinical risk for osteoporosis, in15 cluding an estrogen-deficient woman; 

16 ‘‘(B) has vertebral abnormalities; 

17 ‘‘(C) is receiving chemotherapy or long18 term gluococorticoid (steroid) therapy; 

19 ‘‘(D) has primary hyperparathyroidism, 

20 hyperthyroidism, or excess thyroid replacement; 

21 or 

22 ‘‘(E) is being monitored to assess the re23 sponse to or efficacy of approved osteoporosis 

24 drug therapy. 
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1 ‘‘(c) LIMITATION ON FREQUENCY REQUIRED.—The 

2 standards established under section 2707(c) of the Public 

3 Health Service Act shall apply to benefits provided under 

4 this section in the same manner as they apply to benefits 

5 provided under section 2707 of such Act. 

6 ‘‘(d) RESTRICTIONS ON COST-SHARING.— 

7 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

8 nothing in this section shall be construed as pre9 venting a group health plan or issuer from imposing 

10 deductibles, coinsurance, or other cost-sharing in re11 lation to bone mass measurement under the plan (or 

12 health insurance coverage offered in connection with 

13 a plan). 

14 ‘‘(2) LIMITATION.—Deductibles, coinsurance, 

15 and other cost-sharing or other limitations for bone 

16 mass measurement may not be imposed under para17 graph (1) to the extent they exceed the deductibles, 

18 coinsurance, and limitations that are applied to simi19 lar services under the group health plan or health 

20 insurance coverage. 

21 ‘‘(e) PROHIBITIONS.—A group health plan, and a 

22 health insurance issuer offering group health insurance 

23 coverage in connection with a group health plan, may 

24 not— 
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1 ‘‘(1) deny to an individual eligibility, or contin2 ued eligibility, to enroll or to renew coverage under 

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

4 avoiding the requirements of this section; 

5 ‘‘(2) provide incentives (monetary or otherwise) 

6 to individuals to encourage such individuals not to 

7 be provided bone mass measurements to which they 

8 are entitled under this section or to providers to in9 duce such providers not to provide such measure10 ments to qualified individuals; 

11 ‘‘(3) prohibit a provider from discussing with a 

12 patient osteoporosis preventive techniques or medical 

13 treatment options relating to this section; or 

14 ‘‘(4) penalize or otherwise reduce or limit the 

15 reimbursement of a provider because such provider 

16 provided bone mass measurements to a qualified in17 dividual in accordance with this section. 

18 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec19 tion shall be construed to require an individual who is a 

20 participant or beneficiary to undergo bone mass measure21 ment. 

22 ‘‘(g) NOTICE UNDER GROUP HEALTH PLAN.—The 

23 imposition of the requirements of this section shall be 

24 treated as a material modification in the terms of the plan 

25 described in section 102(a)(1), for purposes of assuring 
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1 notice of such requirements under the plan; except that 

2 the summary description required to be provided under the 

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

4 modification shall be provided by not later than 60 days 

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

6 requirements apply. 

7 ‘‘(h) PREEMPTION.— 

8 ‘‘(1) IN GENERAL.—The provisions of this sec9 tion do not preempt State law relating to health in10 surance coverage to the extent such State law pro11 vides greater benefits with respect to osteoporosis 

12 detection or prevention. 

13 ‘‘(2) CONSTRUCTION.—Section 731(a)(1) shall 

14 not be construed as superseding a State law de15 scribed in paragraph (1).’’. 

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

17 1191(c)) is amended by striking ‘‘section 711’’ and 

18 inserting ‘‘sections 711 and 714’’. 

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

20 1191a(a)) is amended by striking ‘‘section 711’’ and 

21 inserting ‘‘sections 711 and 714’’. 

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

23 Act is amended by inserting after the item relating 

24 to section 712 the following new item: 

‘‘714. Standards relating to benefits for bone mass measurement.’’. 
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1 (b) INDIVIDUAL HEALTH INSURANCE.—(1) Part B 

2 of title XXVII of the Public Health Service Act is amend3 ed by inserting after section 2752 the following new sec4 tion: 

5 ‘‘SEC. 2753. STANDARDS RELATING TO BENEFITS FOR BONE 

6 MASS MEASUREMENT. 

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

8 (other than subsection (g)) shall apply to health insurance 

9 coverage offered by a health insurance issuer in the indi10 vidual market in the same manner as it applies to health 

11 insurance coverage offered by a health insurance issuer 

12 in connection with a group health plan in the small or 

13 large group market. 

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

15 part shall comply with the notice requirement under sec16 tion 714(g) of the Employee Retirement Income Security 

17 Act of 1974 with respect to the requirements referred to 

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

19 and such issuer were a group health plan. 

20 ‘‘(c) PREEMPTION.— 

21 ‘‘(1) IN GENERAL.—The provisions of this sec22 tion do not preempt State law relating to health in23 surance coverage to the extent such State law pro24 vides greater benefits with respect to osteoporosis 

25 detection or prevention. 
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1 ‘‘(2) CONSTRUCTION.—Section 2762(a) shall 

2 not be construed as superseding a State law de3 scribed in paragraph (1).’’. 

4 (2) Section 2762(b)(2) of such Act (42 U.S.C. 

5 300gg–62(b)(2)) is amended by striking ‘‘section 2751’’ 

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

7 (c) EFFECTIVE DATES.—(1) The amendments made 

8 by subsection (a) shall apply with respect to group health 

9 plans for plan years beginning on or after January 1, 

10 2005. 

11 (2) The amendments made by subsection (b) shall 

12 apply with respect to health insurance coverage offered, 

13 sold, issued, renewed, in effect, or operated in the indi14 vidual market on or after such date. 

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