[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 1536 Introduced in Senate (IS)]







105th CONGRESS
  1st Session
                                S. 1536

 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 and to help women 
  make informed choices about their reproductive and post-menopausal 
  health care, and to otherwise provide for research and information 
        concerning osteoporosis and other related bone diseases.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 13, 1997

  Mr. Torricelli (for himself and Ms. Snowe) introduced the following 
 bill; which was read twice and referred to the Committee on Labor and 
                            Human Resources

_______________________________________________________________________

                                 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 and to help women 
  make informed choices about their reproductive and post-menopausal 
  health care, and to otherwise provide for research and information 
        concerning osteoporosis and other related bone diseases.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; FINDINGS.

    (a) Short Title.--This Act may be cited as the ``Early Detection 
and Prevention of Osteoporosis and Related Bone Diseases Act of 1997''.
    (b) Findings.--Congress makes the following findings:
            (1) Nature of osteoporosis.--
                    (A) Osteoporosis is a disease characterized by low 
                bone mass and structural deterioration of bone tissue 
                leading to bone fragility and increased susceptibility 
                to fractures of the hip, spine, and wrist.
                    (B) Osteoporosis has no symptoms and typically 
                remains undiagnosed until a fracture occurs.
                    (C) Once a fracture occurs, the condition has 
                usually advanced to the stage where the likelihood is 
                high that another fracture will occur.
                    (D) There is no cure for osteoporosis, but drug 
                therapy has been shown to reduce new hip and spine 
                fractures by 50 percent and other treatments, such as 
                nutrition therapy, have also proven effective.
            (2) Incidence of osteoporosis and related bone diseases.--
                    (A) 28 million Americans have (or are at risk for) 
                osteoporosis, 80 percent of which are women.
                    (B) Osteoporosis is responsible for 1.5 million 
                bone fractures annually, including more than 300,000 
                hip fractures, 700,000 vertebral fractures and 200,000 
                fractures of the wrists.
                    (C) Half of all women, and one-eighth of all men, 
                age 50 or older will have a bone fracture due to 
                osteoporosis.
                    (D) Between 3 and 4 million Americans have Paget's 
                disease, osteogenesis imperfecta, hyperparathyroidism, 
                and other related metabolic bone diseases.
            (3) Impact of osteoporosis.--The cost of treating 
        osteoporosis is significant:
                    (A) The annual cost of osteoporosis in the United 
                States is $13.8 billion and is expected to increase 
                precipitously because the proportion of the population 
                comprised of older persons is expanding and each 
                generation of older persons tends to have a higher 
                incidence of osteoporosis than preceding generations.
                    (B) The average cost in the United States of 
                repairing a hip fracture due to osteoporosis is 
                $32,000.
                    (C) Fractures due to osteoporosis frequently result 
                in disability and institutionalization of individuals.
                    (D) Because osteoporosis is a progressive condition 
                and affects primarily aging individuals, reductions in 
                the incidence or severity of osteoporosis, particularly 
                for post menopausal women before they become eligible 
                for medicare, has a significant potential of reducing 
                osteoporosis-related costs under the medicare program.
            (4) Use of bone mass measurement.--
                    (A) Bone mass measurement is the only reliable 
                method of detecting osteoporosis at an early stage.
                    (B) Low bone mass is as predictive of future 
                fractures as is high cholesterol or high blood pressure 
                of heart disease or stroke.
                    (C) Bone mass measurement is a non-invasive, 
                painless, and reliable way to diagnose osteoporosis 
                before costly fractures occur.
                    (D) Under section 4106 of the Balanced Budget Act 
                of 1997, Medicare will provide coverage, effective July 
                1, 1998, for bone mass measurement for qualified 
                individuals who are at risk of developing osteoporosis.
            (5) Research on osteoporosis and related bone diseases.--
                    (A) Technology now exists, and new technology is 
                developing, that will permit the early diagnosis and 
                prevention of osteoporosis and related bone diseases as 
                well as management of these conditions once they 
                develop.
                    (B) Funding for research on osteoporosis and 
                related bone diseases is severely constrained at key 
                research institutes, including the National Institute 
                of Arthritis and Musculoskeletal and Skin Diseases, the 
                National Institute on Aging, the National Institute of 
                Diabetics and Digestive and Kidney Diseases, the 
                National Institute of Dental Research, and the National 
                Institute of Child Health and Human Development.
                    (C) Further research is needed to improve medical 
                knowledge concerning--
                            (i) cellular mechanisms related to the 
                        processes of bone resorption and bone 
                        formation, and the effect of different agents 
                        on bone remodeling;
                            (ii) risk factors for osteoporosis, 
                        including newly discovered risk factors, risk 
                        factors related to groups not ordinarily 
                        studied (such as men and minorities), risk 
                        factors related to genes that help to control 
                        skeletal metabolism, and risk factors relating 
                        to the relationship of aging processes to the 
                        development of osteoporosis;
                            (iii) bone mass measurement technology, 
                        including more widespread and cost-effective 
                        techniques for making more precise measurements 
                        and for interpreting measurements;
                            (iv) calcium (including bioavailability, 
                        intake requirements, and the role of calcium in 
                        building heavier and denser skeletons), and 
                        vitamin D and its role as an essential vitamin 
                        in adults;
                            (v) prevention and treatment, including the 
                        efficacy of current therapies, alternative drug 
                        therapies for prevention and treatment, and the 
                        role of exercise; and
                            (vi) rehabilitation.
                    (D) Further educational efforts are needed to 
                increase public and professional knowledge of the 
                causes of, methods for avoiding, and treatment of 
                osteoporosis.

SEC. 2. REQUIRING COVERAGE OF BONE MASS MEASUREMENT UNDER HEALTH PLANS.

    (a) Group Health Plans.--
            (1) Public health service act amendments.--
                    (A) In general.--Subpart 2 of part A of title XXVII 
                of the Public Health Service Act, as amended by section 
                703(a) of Public Law 104-204, is amended by adding at 
                the end the following new section:

``SEC. 2706. STANDARDS RELATING TO BENEFITS FOR BONE MASS MEASUREMENT.

    ``(a) Requirements for Coverage of Bone Mass Measurement.--A group 
health plan, and a health insurance issuer offering group health 
insurance coverage, shall include (consistent with this section) 
coverage for bone mass measurement for beneficiaries and participants 
who are qualified individuals.
    ``(b) Definitions Relating to Coverage.--In this section:
            ``(1) Bone mass measurement.--The term `bone mass 
        measurement' means a radiologic or radioisotopic procedure or 
        other procedure approved by the Food and Drug Administration 
        performed on an individual for the purpose of identifying bone 
        mass or detecting bone loss or determining bone quality, and 
        includes a physician's interpretation of the results of the 
        procedure. Nothing in this paragraph shall be construed as 
        requiring a bone mass measurement to be conducted in a 
        particular type of facility or to prevent such a measurement 
        from being conducted through the use of mobile facilities that 
        are otherwise qualified.
            ``(2) Qualified individual.--The term `qualified 
        individual' means an individual who--
                    ``(A) is an estrogen-deficient woman at clinical 
                risk for osteoporosis;
                    ``(B) has vertebral abnormalities;
                    ``(C) is receiving chemotherapy or long-term 
                gluococorticoid (steroid) therapy;
                    ``(D) has primary hyperparathyroidism, 
                hyperthyroidism, or excess thyroid replacement; or
                    ``(E) is being monitored to assess the response to 
                or efficacy of approved osteoporosis drug therapy.
    ``(c) Limitation on Frequency Required.--Taking into account the 
standards established under section 1861(rr)(3) of the Social Security 
Act, the Secretary shall establish standards regarding the frequency 
with which a qualified individual shall be eligible to be provided 
benefits for bone mass measurement under this section. The Secretary 
may vary such standards based on the clinical and risk-related 
characteristics of qualified individuals.
    ``(d) Restrictions on Cost-Sharing.--
            ``(1) In general.--Subject to paragraph (2), nothing in 
        this section shall be construed as preventing a group health 
        plan or issuer from imposing deductibles, coinsurance, or other 
        cost-sharing in relation to bone mass measurement under the 
        plan (or health insurance coverage offered in connection with a 
        plan).
            ``(2) Limitation.--Deductibles, coinsurance, and other 
        cost-sharing or other limitations for bone mass measurement may 
        not be imposed under paragraph (1) to the extent they exceed 
        the deductibles, coinsurance, and limitations that are applied 
        to similar services under the group health plan or health 
        insurance coverage.
    ``(e) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, may not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide incentives (monetary or otherwise) to 
        individuals to encourage such individuals not to be provided 
        bone mass measurements to which they are entitled under this 
        section or to providers to induce such providers not to provide 
        such measurements to qualified individuals;
            ``(3) prohibit a provider from discussing with a patient 
        osteoporosis preventive techniques or medical treatment options 
        relating to this section; or
            ``(4) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided bone 
        mass measurements to a qualified individual in accordance with 
        this section.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to require an individual who is a participant or beneficiary 
to undergo bone mass measurement.
    ``(g) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 713(g) 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.
    ``(h) Level and Type of Reimbursements.--Nothing in this section 
shall be construed to prevent a group health plan or a health insurance 
issuer offering group health insurance coverage from negotiating the 
level and type of reimbursement with a provider for care provided in 
accordance with this section.
    ``(i) Preemption.--
            ``(1) In general.--The provisions of this section do not 
        preempt State law relating to health insurance coverage to the 
        extent such State law provides greater benefits with respect to 
        osteoporosis detection or prevention.
            ``(2) Construction.--Section 2723(a)(1) shall not be 
        construed as superseding a State law described in paragraph 
        (1).''.
                    (B) Conforming amendment.--Section 2723(c) of such 
                Act (42 U.S.C. 300gg-23(c)), as amended by section 
                604(b)(2) of Public Law 104-204, is amended by striking 
                ``section 2704'' and inserting ``sections 2704 and 
                2706''.
            (2) ERISA amendments.--
                    (A) In general.--Subpart B of part 7 of subtitle B 
                of title I of the Employee Retirement Income Security 
                Act of 1974, as amended by section 702(a) of Public Law 
                104-204, is amended by adding at the end the following 
                new section:

``SEC. 713. STANDARDS RELATING TO BENEFITS FOR BONE MASS MEASUREMENT.

    ``(a) Requirements for Coverage of Bone Mass Measurement.--A group 
health plan, and a health insurance issuer offering group health 
insurance coverage, shall include (consistent with this section) 
coverage for bone mass measurement for beneficiaries and participants 
who are qualified individuals.
    ``(b) Definitions Relating to Coverage.--In this section:
            ``(1) Bone mass measurement.--The term `bone mass 
        measurement' means a radiologic or radioisotopic procedure or 
        other procedure approved by the Food and Drug Administration 
        performed on an individual for the purpose of identifying bone 
        mass or detecting bone loss or determining bone quality, and 
includes a physician's interpretation of the results of the procedure. 
Nothing in this paragraph shall be construed as requiring a bone mass 
measurement to be conducted in a particular type of facility or to 
prevent such a measurement from being conducted through the use of 
mobile facilities that are otherwise qualified.
            ``(2) Qualified individual.--The term `qualified 
        individual' means an individual who--
                    ``(A) is an estrogen-deficient woman at clinical 
                risk for osteoporosis;
                    ``(B) has vertebral abnormalities;
                    ``(C) is receiving chemotherapy or long-term 
                gluococorticoid (steroid) therapy;
                    ``(D) has primary hyperparathyroidism, 
                hyperthyroidism, or excess thyroid replacement; or
                    ``(E) is being monitored to assess the response to 
                or efficacy of approved osteoporosis drug therapy.
    ``(c) Limitation on Frequency Required.--The standards established 
under section 2706(c) of the Public Health Service Act shall apply to 
benefits provided under this section in the same manner as they apply 
to benefits provided under section 2706 of such Act.
    ``(d) Restrictions on Cost-Sharing.--
            ``(1) In general.--Subject to paragraph (2), nothing in 
        this section shall be construed as preventing a group health 
        plan or issuer from imposing deductibles, coinsurance, or other 
        cost-sharing in relation to bone mass measurement under the 
        plan (or health insurance coverage offered in connection with a 
        plan).
            ``(2) Limitation.--Deductibles, coinsurance, and other 
        cost-sharing or other limitations for bone mass measurement may 
        not be imposed under paragraph (1) to the extent they exceed 
        the deductibles, coinsurance, and limitations that are applied 
        to similar services under the group health plan or health 
        insurance coverage.
    ``(e) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, may not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide incentives (monetary or otherwise) to 
        individuals to encourage such individuals not to be provided 
        bone mass measurements to which they are entitled under this 
        section or to providers to induce such providers not to provide 
        such measurements to qualified individuals;
            ``(3) prohibit a provider from discussing with a patient 
        osteoporosis preventive techniques or medical treatment options 
        relating to this section; or
            ``(4) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided bone 
        mass measurements to a qualified individual in accordance with 
        this section.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to require an individual who is a participant or beneficiary 
to undergo bone mass measurement.
    ``(g) Notice Under Group Health Plan.--The imposition of the 
requirements of this section shall be treated as a material 
modification in the terms of the plan described in section 102(a)(1), 
for purposes of assuring notice of such requirements under the plan; 
except that the summary description required to be provided under the 
last 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 requirements apply.
    ``(h) Preemption.--
            ``(1) In general.--The provisions of this section do not 
        preempt State law relating to health insurance coverage to the 
        extent such State law provides greater benefits with respect to 
        osteoporosis detection or prevention.
            ``(2) Construction.--Section 731(a)(1) shall not be 
        construed as superseding a State law described in paragraph 
        (1).''.
                    (B) Conforming amendments.--
                            (i) Section 731(c) of such Act (29 U.S.C. 
                        1191(c)), as amended by section 603(b)(1) of 
                        Public Law 104-204, is amended by striking 
                        ``section 711'' and inserting ``sections 711 
                        and 713''.
                            (ii) Section 732(a) of such Act (29 U.S.C. 
                        1191a(a)), as amended by section 603(b)(2) of 
                        Public Law 104-204, is amended by striking 
                        ``section 711'' and inserting ``sections 711 
                        and 713''.
                            (iii) The table of contents in section 1 of 
                        such Act is amended by inserting after the item 
relating to section 712 the following new item:

``Sec. 713. Standards relating to benefits for bone mass measurement.
    (b) Individual Health Insurance.--
            (1) In general.--Part B of title XXVII of the Public Health 
        Service Act, as amended by section 605(a) of Public Law 104-
        204, is amended by inserting after section 2751 the following 
        new section:

``SEC. 2752. STANDARDS RELATING TO BENEFITS FOR BONE MASS MEASUREMENT.

    ``(a) In General.--The provisions of section 2706 (other than 
subsection (g)) shall apply to health insurance coverage offered by a 
health insurance issuer in the individual market in the same manner as 
it applies to health insurance coverage offered by a health insurance 
issuer in connection with a group health plan in the small or large 
group market.
    ``(b) Notice.--A health insurance issuer under this part shall 
comply with the notice requirement under section 713(g) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
referred to in subsection (a) as if such section applied to such issuer 
and such issuer were a group health plan.
    ``(c) Preemption.--
            ``(1) In general.--The provisions of this section do not 
        preempt State law relating to health insurance coverage to the 
        extent such State law provides greater benefits with respect to 
        osteoporosis detection or prevention.
            ``(2) Construction.--Section 2762(a) shall not be construed 
        as superseding a State law described in paragraph (1).''.
            (2) Conforming amendments.--Section 2762(b)(2) of such Act 
        (42 U.S.C. 300gg-62(b)(2)), as added by section 605(b)(3)(B) of 
        Public Law 104-204, is amended by striking ``section 2751'' and 
        inserting ``sections 2751 and 2752''.
    (c) Effective Dates.--
            (1) Group health plans.--The amendments made by subsection 
        (a) shall apply with respect to group health plans for plan 
        years beginning on or after January 1, 1999.
            (2) Individual market.--The amendments made by subsection 
        (b) shall apply with respect to health insurance coverage 
        offered, sold, issued, renewed, in effect, or operated in the 
        individual market on or after such date.

SEC. 3. OSTEOPOROSIS RESEARCH.

    Subpart 4 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285d et seq.) is amended by adding at the end the following 
new section:

            ``research on osteoporosis and related diseases

    ``Sec. 442A. (a) Expansion of Research.--The Director of the 
Institute, the Director of the National Institute on Aging, the 
Director of the National Institute of Diabetes and Digestive and Kidney 
Diseases, the Director of the National Institute of Dental Research, 
and the Director of the National Institute of Child Health and Human 
Development shall expand and intensify research on osteoporosis and 
related bone diseases. The research shall be in addition to research 
that is authorized under any other provision of law.
    ``(b) Mechanisms for Expansion of Research.--Each of the Directors 
specified in subsection (a) shall, in carrying out such subsection, 
provide for one or more of the following:
            ``(1) Investigator-initiated research.
            ``(2) Funding for investigators beginning their research 
        careers.
            ``(3) Mentorship research grants.
    ``(c) Specialized Centers of Research.--
            ``(1) In general.--The Director of the Institute, after 
        consultation with the advisory council for the Institute, shall 
        make grants to, or enter into contracts with, public or 
        nonprofit private entities for the development and operation of 
        centers to conduct research on osteoporosis and related bone 
        diseases. Subject to the extent of amounts made available in 
        appropriations Acts, the Director shall provide for not less 
        than three such centers.
            ``(2) Activities.--Each center assisted under this 
        subsection--
                    ``(A) shall, with respect to osteoporosis and 
                related bone diseases--
                            ``(i) conduct basic and clinical research;
                            ``(ii) develop protocols for training 
                        physicians, scientists, nurses, and other 
                        health and allied health professionals;
                            ``(iii) conduct training programs for such 
                        individuals;
                            ``(iv) develop model continuing education 
                        programs for such professionals; and
                            ``(v) disseminate information to such 
                        professionals and the public;
                    ``(B) may use the funds to provide stipends for 
                health and allied health professionals enrolled in 
                training programs described in subparagraph (A)(iii); 
                and
                    ``(C) shall use the facilities of a single 
                institution, or be formed from a consortium of 
                cooperating institutions, meeting such requirements as 
                may be prescribed by the Director of the Institute.
            ``(3) Duration of support.--Support of a center under this 
        subsection may be for a period not exceeding 5 years. Such 
        period may be extended for one or more additional periods not 
        exceeding 5 years if the operations of such center have been 
        reviewed by an appropriate technical and scientific peer review 
        group established by the Director and if such group has 
        recommended to the Director that such period should be 
        extended.
    ``(d) Definition of Related Bone Diseases.--For purposes of this 
section, the term `related bone diseases' includes--
            ``(1) Paget's disease, a bone disease characterized by 
        enlargement and loss of density with bowing and deformity of 
        the bones;
            ``(2) osteogenesis imperfecta, a familial disease marked by 
        extreme brittleness of the long bones;
            ``(3) hyperparathyroidism, a condition characterized by the 
        presence of excess parathormone in the body resulting in 
        disturbance of calcium metabolism with loss of calcium from 
        bone and renal damage;
            ``(4) hypoparathyroidism, a condition characterized by the 
        absence of parathormone resulting in disturbances of calcium 
        metabolism;
            ``(5) renal bone disease, a disease characterized by 
        metabolic disturbances from dialysis, renal transplants, or 
        other renal disturbances;
            ``(6) primary or postmenopausal osteoporosis and secondary 
        osteoporosis, such as that induced by corticosteroids; and
            ``(7) other general diseases of bone and mineral metabolism 
        including abnormalities of vitamin D.
    ``(e) Authorizations of Appropriations.--
            ``(1) National institute of arthritis and musculoskeletal 
        and skin diseases.--For the purpose of carrying out this 
        section through the National Institute of Arthritis and 
        Musculoskeletal and Skin Diseases, there are authorized to be 
        appropriated $17,000,000 for each of the fiscal years 1999 
        through 2001, and such sums as may be necessary for each 
        subsequent fiscal year.
            ``(2) National institute on aging.--For the purpose of 
        carrying out this section through the National Institute on 
        Aging, there are authorized to be appropriated $10,000,000 for 
        each of the fiscal years 1999 through 2001, and such sums as 
        may be necessary for each subsequent fiscal year.
            ``(3) National institute of diabetes and digestive and 
        kidney diseases.--For the purpose of carrying out this section 
        through the National Institute of Diabetes and Digestive and 
        Kidney Diseases, there are authorized to be appropriated 
        $10,000,000 for each of the fiscal years 1999 through 2001, and 
        such sums as may be necessary for each subsequent fiscal year.
            ``(4) National institute of dental research.--For the 
        purpose of carrying out this section through the National 
        Institute of Dental Research, there are authorized to be 
        appropriated $5,000,000 for each of the fiscal years 1999 
        through 2001, and such sums as may be necessary for each 
        subsequent fiscal year.
            ``(5) National institute of child health and human 
        development.--For the purpose of carrying out this section 
        through the National Institute of Child Health and Human 
        Development, there are authorized to be appropriated $5,000,000 
        for each of the fiscal years 1999 through 2001, and such sums 
        as may be necessary for each subsequent fiscal year.
            ``(6) Specialized centers of research.--For the purpose of 
        carrying out subsection (c), there are authorized to be 
        appropriated $3,000,000 for each of the fiscal years 1999 
        through 2001, and such sums as may be necessary for each 
        subsequent fiscal year.
            ``(7) Relation to other provisions.--Authorizations of 
        appropriations under this subsection are in addition to amounts 
        authorized to be appropriated for biomedical research relating 
        to osteoporosis and related bone diseases under any other 
        provision of law.''.

SEC. 4. FUNDING FOR INFORMATION CLEARINGHOUSE ON OSTEOPOROSIS, PAGET'S 
              DISEASE, AND RELATED BONE DISORDERS.

    Section 409A(d) of the Public Health Service Act (42 U.S.C. 
284e(d)) is amended by adding at the end the following sentence: ``In 
addition to other authorizations of appropriations available for the 
purpose of the establishment and operation of the information 
clearinghouse under subsection (c), there are authorized to be 
appropriated for such purpose $1,000,000 for fiscal year 1999, and such 
sums as may be necessary for each of the fiscal years 2000 and 2001.''.
                                 <all>