Short title; table of contents

(a)

Short title

This Act may be cited as the

Immunization Improvement Act of 2009

. (b)

Table of contents

The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

Sec. 3. State authority to purchase recommended vaccines for adults.

Sec. 4. Demonstration program to improve immunization coverage.

Sec. 5. Reauthorization of immunization program.

Sec. 6. Inclusion of recommended immunizations under part B of the Medicare program with no beneficiary cost-sharing.

Sec. 7. Medicaid coverage of recommended adult immunizations.

Sec. 8. Vaccine administration fees.

Sec. 9. Health insurance coverage for recommended immunizations.

Sec. 10. Immunization information systems.

Sec. 11. Reports.

Findings

Congress makes the following findings: (1)Immunizations recommended for routine use have been proven to be clinically effective in improving health and preventing the spread of disease. Routine childhood immunizations prevent over 14,000,000 cases of disease and over 33,500 deaths over the lifetime of children born in any given year. In addition to protecting individuals from disease, immunization provides population-based (herd) immunity. (2)An economic evaluation of the impact of seven vaccines routinely given as part of the childhood immunization schedule found that the vaccines are cost-effective. Over the lifetime of children born in any given year, these immunizations result in an annual cost savings of $10,000,000,000 in direct medical costs and over $40,000,000,000 in indirect societal costs. (3)There are significant and persistent gaps in public and private health insurance coverage of immunizations. About 11 percent of young children and 21 percent of adolescents are underinsured for immunizations. Among adults, 59 percent are underinsured and 17 percent are completely uninsured for immunizations. According to the Institute of Medicine, even those with insurance increasingly have to pay higher deductibles and copayments for immunizations. (4)Each year, vaccine-preventable diseases cause the deaths of more than 42,000 people and hundreds of thousands cases of illness. (5)In 2003, the Institute of Medicine's Committee on the Evaluation of Vaccine Purchase Financing made the following conclusions: (A)Current public and private financing strategies for immunization have had substantial success, especially in improving immunization rates for young children. However, significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations. (B)Many young children, adolescents, and high-risk adults have no or limited insurance for recommended vaccines. Gaps and fragmentation in insurance benefits create barriers for both vulnerable populations and clinicians that can contribute to lower immunization rates.

State authority to purchase recommended vaccines for adults

Section 317 of the Public Health Service Act (42 U.S.C. 247b) is amended by adding at the end the following:

(l)

Authority To purchase recommended vaccines for adults

(1)

In general

The Secretary may negotiate and enter into contracts with manufacturers of vaccines for the purchase and delivery of vaccines for adults otherwise provided vaccines under grants under this section. (2)

State purchase

A State may obtain adult vaccines (subject to amounts specified to the Secretary by the State in advance of negotiations) through the purchase of vaccines from manufacturers at the applicable price negotiated by the Secretary under this subsection.

Demonstration program to improve immunization coverage

Section 317 of the Public Health Service Act (42 U.S.C. 247b), as amended by section 3, is further amended by adding at the end the following:

(m)

Demonstration program To improve immunization coverage

(1)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a demonstration program to award grants to States to improve the provision of recommended immunizations for children, adolescents, and adults through the use of evidence-based, population-based interventions for high-risk populations. (2)

State plan

To be eligible for a grant under paragraph (1), a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a State plan that describes the interventions to be implemented under the grant and how such interventions match with local needs and capabilities, as determined through consultation with local authorities. (3)

Use of funds

Funds received under a grant under this subsection shall be used to implement interventions that are recommended by the Task Force on Community Preventive Services (as established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) or other evidence-based interventions, including— (A)providing immunization reminders or recalls for target populations of clients, patients, and consumers; (B)educating targeted populations and health care providers concerning immunizations in combination with one or more other interventions; (C)reducing out-of-pocket costs for families for vaccines and their administration; (D)carrying out immunization-promoting strategies for participants or clients of public programs, including assessments of immunization status, referrals to health care providers, education, provision of on-site immunizations, or incentives for immunization; (E)providing for home visits that promote immunization through education, assessments of need, referrals, provision of immunizations, or other services; (F)providing reminders or recalls for immunization providers; (G)conducting assessments of, and providing feedback to, immunization providers; or (H)any combination of one or more interventions described in this paragraph. (4)

Consideration

In awarding grants under this subsection, the Secretary shall consider any reviews or recommendations of the Task Force on Community Preventive Services. (5)

Evaluation

Not later than 3 years after the date on which a State receives a grant under this subsection, the State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage rates among high-risk populations within the State. (6)

Report to Congress

Not later than 4 years after the date of enactment of the Immunization Improvement Act of 2009, the Secretary shall submit to Congress a report concerning the effectiveness of the demonstration program established under this subsection together with recommendations on whether to continue and expand such program. (7)

Authorization of appropriations

There is authorized to be appropriated to carry out this subsection, such sums as may be necessary for each of fiscal years 2010 through 2014.

Reauthorization of immunization program

Section 317(j) of the Public Health Service Act (42 U.S.C. 247b(j)) is amended— (1)in paragraph (1), by striking for each of the fiscal years 1998 through 2005; and (2)in paragraph (2), by striking after October 1, 1997,.

Inclusion of recommended immunizations under part B of the Medicare program with no beneficiary cost-sharing

(a)

In general

Paragraph (10) of section 1861(s) of the Social Security Act (42 U.S.C. 1395x(s)) is amended to read as follows:

(10)vaccines recommended for routine use by the Advisory Committee on Immunization Practices (an advisory committee established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) and their administration;

(b)

Conforming amendments

(1)Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended, in each of subsections (a)(1)(B), (a)(2)(G), (a)(3)(A), (b)(1), by striking 1861(s)(10)(A) or 1861(s)(10)(B) and inserting 1861(s)(10) each place it appears. (2)Section 1842(o)(1)(A)(iv) of the Social Security Act (42 U.S.C. 1395u(o)(1)(A)(iv)) is amended by striking subparagraph (A) or (B) of. (3)Section 1847A(c)(6) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)) is amended by striking subparagraph (G). (4)Section 1860D–2(e)(1) of the Social Security Act (42 U.S.C. 1395w–102(e)(1)) is amended by striking a vaccine and all that follows through its administration) and. (5)Section 1861(ww)(2)(A) of the Social Security Act (42 U.S.C. 1395x(ww)(2)(A)) is amended by striking Pneumococcal, influenza, and hepatitis B and inserting Any. (6)Section 1866(a)(2)(A) of the Social Security Act (42 U.S.C. 1395cc(a)(2)(A)) is amended by striking 1861(s)(10)(A) and inserting 1861(s)(10). (c)

Effective date

The amendments made by this section shall apply to vaccines administered on or after January 1, 2010.

Medicaid coverage of recommended adult immunizations

(a)

Mandatory coverage of recommended immunizations for adults

Section 1905(a)(4) of the Social Security Act (42 U.S.C. 1396d(a)(4)) is amended— (1)by striking and before (C); and (2)by inserting after the semicolon the following: and (D) with respect to an adult individual, vaccines recommended for routine use by the Advisory Committee on Immunization Practices (an advisory committee established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) and their administration;. (b)

Prohibition on cost-sharing

(1)

In general

Section 1916 of the Social Security Act (42 U.S.C. 1396o), as amended by section 5006(a)(1)(A) of division B of Public Law 111–5, is amended— (A)in subsection (a), by striking and (j) and inserting , (j), and (k); and (B)by adding at the end the following:

(k)The State plan shall require that no provider participating under the State plan may impose a copayment, cost-sharing charge, or similar charge for vaccines or their administration that the State is required to provide under sections 1902(a)(10)(A) and 1905(a)(4)(D).

(2)

Technical and conforming amendment

The second sentence of section 1916A(a)(1) of such Act (42 U.S.C. 1396o–1(a)(1)) is amended by striking or (i) and inserting (i), (j), or (k). (c)

Allowing for Medicaid rebates

Section 1927(k)(2)(B) of such Act (42 U.S.C. 1396r–8(k)(2)(B)) is amended by striking , other than a vaccine and inserting (including vaccines described in section 1905(a)(4)(D) but excluding qualified pediatric vaccines under section 1928). (d)

Effective date

(1)

In general

Except as provided in paragraphs (2) and (3), the amendments made by this section take effect on October 1, 2010. (2)

Extension of effective date for state law amendment

In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) which the Secretary of Health and Human Services determines requires State legislation in order for the plan to meet the additional requirements imposed by the amendments made by this section, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session is considered to be a separate regular session of the State legislature. (3)

Medicaid rebates

The amendment made by subsection (c) takes effect on October 1, 2010, and applies to rebate agreements entered into under section 1927 of the Social Security Act (42 U.S.C. 1396r–8) on or after that date.

Vaccine administration fees

(a)

Review of federally established maximum allowable administrative fees

Not later than October 1, 2010, the Administrator of the Centers for Medicare & Medicaid Services and the Director of the Centers for Disease Control and Prevention, jointly shall— (1)review the regional maximum charge for vaccine administration for each State established under the Vaccines for Children program under section 1928 of the Social Security Act (42 U.S.C. 1396s) to determine the appropriateness and adequacy of such rates; and (2)update such rates, as appropriate, based on the results of such review and taking into account all appropriate costs related to the administration of vaccines under that program. (b)

Federal reimbursement for vaccine administration for non-Medicaid vaccine-eligible children

(1)

In general

Section 1928 of the Social Security Act (42 U.S.C. 1396s) is amended— (A)in subsection (a)(1)(B), by inserting and is entitled to receive reimbursement for any fee imposed by the provider for the administration of such vaccine consistent with subsection (c)(2)(C) (not to exceed the amount applicable under clause (iv) of such subsection) to a federally vaccine-eligible child who is described in clause (ii), (iii), or (iv) of subsection (b)(2), after delivery to the provider,; (B)in subsection (a)(2), by adding at the end the following new subparagraph:

(D)

Reimbursement for vaccine administration for non-Medicaid eligible children

The Secretary shall pay each State such amounts as are necessary for the State to reimburse each program-registered provider in the State for an administration fee imposed consistent with subsection (c)(2)(C) (not to exceed the amount applicable under clause (iv) of such subsection) for the administration of a qualified pediatric vaccine to a federally vaccine-eligible child who is described in clause (ii), (iii), or (iv) of subsection (b)(2).

;

(C)in subsection (c)(2)(C), by adding at the end the following new clause:

(IV)In the case of a federally vaccine-eligible child who is described in clause (ii), (iii), or (iv) of subsection (b)(2), the State shall pay the provider an amount equal to the administration fee established under the State plan approved under this title for the administration of a qualified pediatric vaccine to a medicaid-eligible child.

; and

(D)by striking subsection (g). (2)

Conforming amendments

Section 1928 of such Act (42 U.S.C. 1396s), as amended by paragraph (1), is amended— (A)by redesignating subsection (h) as subsection (g); (B)in subsection (a)(1)(A), by striking (h)(8) and inserting (g)(8); and (C)in subsection (b)(2)(A)(iv), by striking (h)(3) and inserting (g)(3).

Health insurance coverage for recommended immunizations

(a)

Amendments to the Public Health Service Act

(1)

Group health coverage

Subpart 2 of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–4 et seq.) is amended by adding at the end the following:

2708.

Coverage of recommended immunizations

A group health plan, and a health insurance issuer offering group health insurance coverage, shall provide for coverage, without the application of deductibles, coinsurance, or copayments, of vaccines recommended for routine use by the Advisory Committee on Immunization Practices (as established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) and their administration.

(2)

Individual health insurance coverage

Subpart 2 of part B of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–51 et seq.) is amended by adding at the end the following:

2754.

Coverage of recommended immunizations

The provisions of section 2708 shall apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner as such provisions apply 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)

Amendments to ERISA

(1)

In general

Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 is amended by adding at the end the following:

715.

Coverage of recommended immunizations

(2)

Technical amendments

(A)Section 732(a) of such Act (29 U.S.C. 1191a(a)) is amended by striking section 711 and inserting sections 711 and 715. (B)The table of contents in section 1 of such Act is amended by inserting after the item relating to section 713 the following new item:

Sec. 715. Coverage of recommended immunizations.

(c)

Internal revenue code amendments

(1)

In general

Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended— (A)in the table of sections, by inserting after the item relating to section 9813 the following new item:

Sec. 9814. Coverage of recommended immunizations.

;

and

(B)by inserting after section 9813 the following:

9814.

Coverage of recommended immunizations

(d)

Exception for collective bargaining agreements

Nothing in this section shall be construed to preempt any provision of a collective bargaining agreement that is in effect on the date of enactment of this section. (e)

Effective date

The amendments made by this section shall apply to plan years beginning with the first plan year during which the Congressional Budget Office determines that any health reform legislation enacted by Congress will provide health insurance coverage to 95 percent or more of the population of the United States.

10.

Immunization information systems

(a)

Health information technology infrastructure

Section 3011(a) of the Public Health Service Act (as added by section 13301 of the American Recovery and Reinvestment Act of 2009) is amended by adding at the end the following:

(8)Improvement and expansion of immunization information systems (as defined in section 3000), including activities to— (A)support the integration and linkage of such systems with electronic birth records, health care providers, other preventive health services information systems, and health information exchanges; (B)support interstate data exchange; (C)ensure that such systems are interoperable with electronic health record systems; (D)provide technical support, such as training, data reporting, data quality and completeness review, and decision support, to immunization providers to integrate the use of such systems; (E)develop, in consultation with manufacturers, vendors, and specialty professional organizations, continuing education materials relating to the use of such systems; (F)ensure that such systems can provide complete and accurate data to monitor immunization coverage, uptake, and the impact of shortages in the population served within their jurisdiction; and (G)ensure the privacy, confidentiality, and security of all data and data exchanges with such systems.

(b)

State grants

Section 3013(d) of the Public Health Service Act (as added by section 13301 of the American Recovery and Reinvestment Act of 2009) is amended— (1)in paragraph (9), by striking and at the end; (2)by redesignating paragraph (10) as paragraph (11); and (3)by inserting after paragraph (9), the following:

(10)improving and expanding immunization information systems (as defined in section 3000); and

(c)

Definition

Section 3000 of the Public Health Service Act (as added by section 13301 of the American Recovery and Reinvestment Act of 2009) is amended— (1)by redesignating paragraphs (9) through (14) as paragraphs (10) through (15), respectively; and (2)by inserting after paragraph (8), the following:

(9)

Immunization information system

The term immunization information system means an immunization registry or a confidential, population-based, computerized information system that collects vaccination data within a geographic area, consolidates vaccination records from multiple health care providers, generates reminder and recall notifications, and is capable of exchanging immunization information with health care providers.

11.

Reports

(a)

Costs of public and private vaccine administration

Not later than 5 years after the date of enactment of this Act, and every 5 years thereafter, the Director of the Centers for Disease Control and Prevention jointly with the Administrator of the Centers for Medicare & Medicaid Services shall collect and publish data relating to the costs associated with public and private vaccine administration, including the costs associated with the delivery of vaccines, activities such as reporting data to immunization registries, and maintenance of appropriate storage requirements for vaccines. (b)

Section 317 Immunization Program

Not later than February 1, 2010, and each February 1 thereafter, the Director of the Centers for Disease Control and Prevention shall submit to Congress a report concerning the size and scope of the appropriations needed for each fiscal year for vaccine purchases, vaccination infrastructure, vaccine administration, and vaccine safety under section 317 of the Public Health Service Act (42 U.S.C. 247b). (c)

Annual publication of State-established administrative fees under Medicaid

Beginning October 1, 2009, and annually thereafter, the Administrator of the Centers for Medicare & Medicaid Services and the Director of the Centers for Disease Control and Prevention jointly shall make publicly available the administrative fee established under each State Medicaid program for administering a qualified pediatric vaccine to a vaccine-eligible child under the Vaccines for Children program under section 1928 of the Social Security Act (42 U.S.C. 1396s) with the State and Federal contribution for such fee separately identified.