Short title

This Act may be cited as the

21st Century Health Information Act of 2005

Findings; purpose

(a)

Findings

(1)According to the Institute for Safe Medication Practices, pharmacists make over 150 million calls to physicians for clarification of illegible prescriptions each year and electronic prescribing can reduce follow-up calls between pharmacists and doctors by over 50 percent. (2)A study by the Journal of the American Medical Association found that laboratory and radiology results, letters, and medical histories were missing during 13.6 percent of 1,614 patient visits. In 44 percent of these cases, doctors felt that the missing information had the potential to adversely affect a patient’s well-being. (3)A study by the Rand Corporation found that patients only receive recommended care about 55 percent of the time. (4)A study of emerging infectious diseases finds that preventable health care acquired infections cost $4.5 billion per year and contributed to more than 88,000 deaths — one death every 6 minutes. (5)The Centers for Disease Control and Prevention reports that United States patients are prescribed improper medications in about 1 out of every 12 physician visits. An estimated 16.7 million physician visits for the elderly result in prescription errors per year. (6)A March 2001 Institute of Medicine (IOM) study called Crossing the Quality Chasm: A New Health System for the 21st Century concludes that in order to improve quality, the Nation must have a national commitment to building an information infrastructure to support health care delivery, consumer health, quality measurement and improvement, public accountability, clinical and health services research, and clinical education. (7)An October 2003 Government Accountability Office report found that the benefits of an electronic health care information system included improved quality of care, reduced costs associated with medication errors, more accurate and complete medical documentation, more accurate capture of codes and charges, and improved communication among providers enabling them to respond more quickly to patients' needs. (8)In January 2004, the President stated that by computerizing health records, we can avoid dangerous medical mistakes, reduce costs, and improve care and outlined a plan to ensure that most Americans have electronic health records within the next 10 years. (b)

Purpose

The Secretary of Health and Human Services shall implement this Act for the purpose of developing interoperable regional health information networks and promoting the adoption of health information technology products.

Health information technology grants

(a)

Grant authorization

(1)

In general

The Secretary may make not more than 20 grants to regional health information organizations to enable each grantee to develop and implement over a 3-year period a regional health information technology plan that provides for— (A)a health information network that will serve a geographic area that— (i)is located in 1 or more States; and (ii)does not include any area to be served by the health information network of any other grantee under this section; (B)a plan to finance acquisition and implementation of technology by health care providers as needed to allow participation by the providers in the network; and (C)a plan to use the network to improve patient safety, quality, and efficiency within the health care system. (2)

Use of funds

The Secretary may not make a grant to a regional health information organization under this section unless the organization agrees to use the grant— (A)to develop and implement a regional health information technology plan described in paragraph (3) for submission to the Secretary under paragraph (4); and (B)to begin implementation of the plan not later than the beginning of the second year of the grant. (3)

Regional health information technology plan

(A)

In general

A regional health information technology plan shall provide for— (i)the establishment and implementation in a specified geographic area of a regional health information network that— (I)allows the seamless, secure, electronic sharing of health information among health care providers, health plans, and other authorized users; (II)provides consumers with secure, electronic access to their own health information; (III)meets data standards for interoperability adopted by the Secretary, including any standards providing for interoperability among regional health information networks; (IV)provides for interoperability with any health information technology product certified by the certification entity described in section 4(a); (V)meets the privacy requirements of subsection (b); (VI)gives patients the option of allowing only designated health care providers to access their individually identifiable information concerning diagnosis and treatment of sexually transmitted diseases, addiction, and mental illnesses; (VII)provides such public health reporting capability as the Secretary requires; (VIII)allows for such reporting of, and access to, health information for purposes of research (other than individually identifiable patient health information) as the Secretary requires; and (IX)allows for the reporting of provider-specific health information (other than individually identifiable patient health information) required for the calculation of any voluntary consensus standard endorsed by the National Quality Forum; (ii)the financing and technical assistance required to allow health care providers, especially small physician groups, to acquire and implement electronic medical records or other technology necessary to participate in the regional health information network; and (iii)agreements among health care stakeholders regarding data reporting, reimbursement practices, or other mechanisms to use the regional health information network to improve patient safety, quality, and efficiency within the health care system. (B)

Contents

A regional health information technology plan shall— (i)be developed with the participation and widespread support of all health care stakeholders of the geographic area to be served by the grantee's health information network, including but not limited to hospitals, practicing physicians (including those from small physician groups), nursing facilities and skilled nursing facilities, other health care providers, health plans, employers, and patient groups; (ii)describe the governance structure of the health information network; (iii)describe the technologies and systems, including interoperability data standards, that will be used to establish a health information network consistent with paragraph (A)(i); (iv)explain what information will be able to be accessed, transferred, or exchanged through the health information network and what capabilities the network will have to include other types of information in the future; (v)describe plans to ensure network reliability, expected frequency of network interruptions, and backup procedures in the event of network interruptions; (vi)describe sources of initial financing for the development of the health information network and a financing model for long-term sustainability of the network; (vii)describe sources of financing the acquisition, implementation, and maintenance of technology necessary to allow health care providers, especially small physician groups, to participate in the health information network; (viii)describe how the health information network will be used to improve health care quality and the health outcomes of patients; (ix)establish how administrative and clinical savings resulting from widespread use of the new health information network will be accounted for and allocated; (x)explain how the regional health information organization involved will ensure widespread participation by health care providers (especially small physician groups) in the grantee’s health information network and what support and assistance will be available to physicians seeking to integrate health information technologies into their practices; (xi)describe how patients and caregivers who are not health care providers will be able to access and utilize the health information network; (xii)explain how the grantee’s health information network will protect patient privacy and maintain security; and (xiii)explain how the grantee will ensure the participation of health care providers serving minority communities, including communities in which English is not the primary language spoken. (4)

Approval of plan

(A)

Submission by grantees

Not later than the end of the first year for which a regional health information organization receives a grant under this subsection, the organization shall submit its regional health information technology plan to the Secretary. (B)

Submission by other organizations

A regional health information organization that has not received a grant under this subsection may, at its discretion, submit a regional health information technology plan to the Secretary. (C)

Approval

The Secretary shall approve or disapprove each regional health information technology plan submitted to the Secretary under this paragraph based on whether the plan complies with the requirements of this subsection. (D)

Effect of failure to approve

The Secretary may not make any payment under this subsection to a regional health information organization for the second or third year for which the organization receives a grant unless the Secretary has approved the organization’s regional health information technology plan. (E)

Geographic exclusivity

The Secretary may not approve a regional health information technology plan under this paragraph if the plan applies to a geographic area for which the Secretary has already approved a regional health information technology plan under this paragraph, irrespective of whether the approved regional health information technology plan was submitted by a grantee under subparagraph (A) or by an organization under subparagraph (B). (5)

Selection

In selecting grant recipients under this section, the Secretary shall take into account— (A)existing technological and organizational infrastructure upon which the health information network can build; (B)the extent of stakeholder participation; (C)health care provider participation commitments; (D)capacity to measure quality and efficiency improvements; (E)replicability; (F)the extent of the opportunity for a plan to improve health care quality and the health outcomes of patients in the region to be served; (G)the extent to which an applicant intends to develop a regional health information technology plan that covers a complete medical market area (as defined by the Secretary); (H)the extent to which an applicant’s proposed network will allow the exchange of machine-computable data among providers; (I)geographical diversity of grantees; and (J)such other factors as the Secretary considers relevant. (b)

Privacy protections

(1)

In general

Any health information network funded in whole or in part under this section shall— (A)comply with the privacy protections of regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033); and (B)allow patients to exclude their health information from the health information network. (2)

Unauthorized disclosure

In the event of the unauthorized access to or disclosure of individually identifiable patient health information by or through a health information network funded in whole or in part under this section, the operator of such network shall— (A)report the conditions of such unauthorized access or disclosure to the Secretary in such manner as the Secretary requires; and (B)provide notice to any individuals whose patient health information may have been compromised in violation of this subsection as a result of such unauthorized access or disclosure. (c)

Application

To seek a grant under this section, an applicant shall submit an application to the Secretary in such form, in such manner, and containing such information and assurances as the Secretary may require. (d)

Technical assistance

(1)

In general

The Secretary shall provide to regional health information organizations such technical assistance as the Secretary deems appropriate to carry out this section, including assistance relating to questions of governance, financing, and technological approaches to the creation of health information networks. (2)

National technical assistance Center

(A)

Establishment

The Director of the Agency for Healthcare Research and Quality shall by contract or grant establish and maintain a national technical assistance center to provide assistance to physicians described in subparagraph (B) to facilitate successful adoption of health information technologies and participation in the development and implementation of regional health information technology plans by such physicians. (B)

Physicians

The national technical assistance center shall provide assistance to physicians in geographical areas served by a health information network that has been accredited or provisionally accredited under subsection (e). (C)

Priority

In providing assistance to physicians under this paragraph, the national technical assistance centers shall— (i)give priority to physicians in small physician groups; and (ii)as resources allow, provide assistance to physicians in larger groups. (D)

Requirements

Technical assistance provided under this paragraph shall, at a minimum, include the following: (i)A clearinghouse of best practices, guidelines, and implementation strategies directed at the small medical practices that plan to adopt electronic medical records, electronic prescribing, and other health information technologies. (ii)A change management tool kit to enable physicians and their office staffs to successfully prepare practice workflows for adoption of electronic medical records and electronic prescribing, to receive guidance in the selection of vendors of health information technology products and services that are appropriate within the context of the individual practice and the community setting, to implement health information technology solutions and manage the project at the practice level, and to address the ongoing need for upgrades, maintenance, and security of office-based health information technologies. (iii)The capability to provide consultations and advice to small medical practices to facilitate adoption of health information technologies. (e)

Accreditation

(1)

In general

Not later than the date that is 1 year after the date of the enactment of this Act, the Secretary shall establish a program of accrediting health information networks that are in compliance with the requirements of subparagraph (A) of subsection (a)(3), subsection (b), and any other requirements of the national health information infrastructure as established by the Secretary. (2)

Provisional accreditation

The program under this subsection shall include a process for provisional accreditation of networks that are in the process of being implemented. Approval of a regional health information technology plan by the Secretary under subsection (a)(4) is deemed to constitute initial provisional accreditation of the health information network described in the plan. (f)

Prohibition

No funds under this section may be used for the establishment of a national database of individually identifiable patient health information. (g)

Report by GAO

Not later than 4 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit a report to the Congress on the progress of the regional health information organizations in realizing the purposes of this Act, with particular attention to the following: (1)The capacity to exchange health information between and among regional health information networks. (2)Rates of health information technology usage and provider participation in regional health information networks. (3)The security and privacy of regional health information networks. (4)The differing approaches of regional health information organizations to implementing the purposes of this Act and common characteristics of successful efforts. (5)The impact of health information networks on health care quality, health outcomes of patients, and health care costs. (h)

Authorization of appropriations

(1)

In general

To carry out the provisions of this section other than subsection (d)(2), there are authorized to be appropriated for grants under subsection (a), $50,000,000 for fiscal year 2006 and such sums as may be necessary for each of fiscal years 2007, 2008, 2009, and 2010. (2)

Technical assistance

(A)

In general

Of the amount appropriated to carry out this section for a fiscal year, not more than than 10 percent of such amount or $5,000,000, whichever is lesser, may be used to provide technical assistance under subsection (d)(1). (B)

National technical assistance Center

To carry out subsection (d)(2), there is authorized to be appropriated $2,500,000 for each of fiscal years 2006 through 2010.

Interoperability

(a)

Purchase of health information technology products

(1)

Requirement

No Federal funds may be made available to any entity under this Act for the purchase of a health information technology product, unless— (A)for any period during which there is a certification entity described in paragraph (2)— (i)the product is certified by the entity; or (ii)if a certification process has not yet been developed for the product by the entity, the Federal department or agency involved has determined that the product incorporates, to the extent feasible, appropriate interoperability data standards and compliance criteria adopted by the entity for another product; and (B)for any period for which the Secretary (or the Secretary’s designee) adopts applicable standards and criteria under paragraph (4), the product complies with such standards and criteria. (2)

Certification entity

The certification entity described in this paragraph is— (A)for any period during which the Certification Commission for Healthcare Information Technology is accredited by the American National Standards Institute or approved by the Secretary under paragraph (3), the Certification Commission for Healthcare Information Technology; and (B)for any other period, the private entity, if any, designated by the Secretary under paragraph (4)(A)(ii) or, as applicable, paragraph (4)(B). (3)

Approval of Commission by Secretary

For any period during which the Certification Commission for Healthcare Information Technology is not accredited by the American National Standards Institute, the Secretary of Health and Human Services— (A)shall examine biannually the Commission’s certification processes; (B)shall approve the Commission for purposes of this subsection if the Secretary determines that— (i)the Commission’s certification processes— (I)are open to input from all affected parties, including providers, patients, vendors, and regional health information organizations; (II)reflect the prevailing opinion among the affected parties; and (III)promote quality, safety, and efficiency in health care; and (ii)the Commission’s governance procedures ensure effective representation of and accountability to affected stakeholder groups and transparent decision-making processes; (C)shall disapprove the Commission for purposes of this subsection if the Secretary determines that the Commission’s certification processes or governance procedures do not satisfy clause (i) or (ii), respectively, of subparagraph (B); and (D)if the Secretary disapproves the Commission under this paragraph, shall provide specific recommendations to the Commission on changes that may be implemented by the Commission in order to obtain approval under this paragraph. (4)

Interoperability standards; alternative certification entity

(A)

In general

For any period during which the Certification Commission for Healthcare Information Technology is not accredited by the American National Standards Institute and the Secretary disapproves such Commission under paragraph (3)(C), the Secretary— (i)shall adopt interoperability standards and compliance criteria for health information technology products, including electronic medical records; or (ii)shall designate a private entity with certification and governance processes in accordance with paragraph (3)(B) to adopt such standards and criteria and to certify such products. (B)

Nine-month deadline

If the Certification Commission for Healthcare Information Technology is accredited by the American National Standards Institute or approved by the Secretary under paragraph (3)(B) but fails to adopt interoperability standards and compliance criteria for electronic medical records by the date that is 9 months after the date of the enactment of this Act, the Secretary may adopt such standards and criteria, or designate a private entity with certification and governance processes in accordance with paragraph (3)(B) to adopt such standards and criteria and to certify such products. (C)

Consultation

In adopting standards and criteria under subparagraph (A)(i) or (B), the Secretary shall take into consideration the recommendations (if any) of the National Committee on Vital and Health Statistics. In making such recommendations, the National Committee on Vital and Health Statistics shall consult with all affected parties, including health care providers, patients, vendors, health plans, and regional health information organizations. (5)

Effect of failure to seek accreditation by ANSI

In determining whether to approve the Certification Commission for Healthcare Information Technology under paragraph (3)(B), the Secretary shall not give any negative weight to a decision by the Commission to forgo seeking accreditation by the American National Standards Institute. (b)

Technical standards and compliance criteria

The Secretary shall adopt such technical standards and compliance criteria for the organization and content of health information networks under section 3 as the Secretary deems appropriate to ensure that health information data can be exchanged among such networks and between health information networks and Federal agencies. The Secretary may delegate the authority to adopt such standards and criteria to a private entity, if— (1)the entity is accredited by the American National Standards Institute; or (2)the Secretary biannually certifies that the entity’s processes for adoption of standards and— (A)compliance criteria— (i)are open to input for all affected parties, including health care providers, patients, vendors, and health plans regional health information organizations; (ii)reflect the prevailing opinion among the affected parties; and (iii)promote quality, safety, and efficiency in health care; (B)governance procedures ensure effective representation of and accountability to affected stakeholder groups and transparent decision-making processes.

Loans

(a)

In general

The Secretary may make loans to any regional health information organization with a health information network that is accredited or provisionally accredited under section 3(e) to finance investments in network infrastructure and technology acquisition, training, and workflow engineering for physicians. (b)

Terms and conditions

Each loan under this section shall be subject to such terms and conditions as the Secretary deems appropriate, except that— (1)the repayment period of each such loan may not exceed 10 years; (2)no funds from the loan may be used to acquire a health information technology product for which the Certification Commission for Healthcare Information Technology has established a certification process unless such health information technology product has been so certified; (3)any technology investments paid for in whole or in part with funds from the loan must comply with the privacy requirements of section 3(b); and (4)the Secretary shall require the regional health information organization involved to provide to the Secretary an annual accounting of loan funds.

Safe harbor for equipment and services provided for the development or implementation of a health information network

(a)

In general

Paragraph (3) of section 1128B(b) of the Social Security Act (42 U.S.C. 1320a–7b(b)) is amended— (1)by striking the period at the end of the first subparagraph (H) and inserting a semicolon; (2)by redesignating the second subparagraph (H) as subparagraph (I); (3)by striking the period at the end of subparagraph (I) (as so redesignated) and inserting ; and; and (4)by adding at the end the following:

(J)the provision of any equipment or services that are appropriate for the development or implementation of a regional health information technology plan approved by the Secretary under section 3 of the 21st Century Health Information Act of 2005, including the provision of hardware, software, and services necessary to participate in a health information network so long as— (i)any patient data and information that is accessible to recipients of such equipment and services is also accessible to other appropriate persons or entities through a regional health information network accredited or provisionally accredited under section 3(e) of the 21st Century Health Information Act of 2005; (ii)any such equipment or services provided are capable of and intended to be used to access, transfer, and exchange patient data and information with other participants in a regional health information network accredited or provisionally accredited under section 3(e) of the 21st Century Health Information Act of 2005; and (iii)any such equipment or services are not provided in a manner that takes into account the volume or value of referrals or other business generated between the parties.

(b)

Additional safe harbor

(1)Subject to paragraph (2), the Secretary shall consider the establishment of a safe harbor under subsection (a) of section 1128C of the Social Security Act (42 U.S.C. 1320a–7c) to permit the provision of equipment or services intended to permit the exchange of health care information to improve health care quality, reduce medical errors, reduce health care costs, or improve the coordination of health care services. (2)Insofar as the Secretary develops a safe harbor under paragraph (1)_ (A)such safe harbor may only apply to geographic areas that are not covered by a regional health information network accredited by the Secretary under section 3(e) of the 21st Century Health Information Act of 2005; (B)any equipment or services provided pursuant to the safe harbor are not provided in a manner that takes into account the volume or value of referrals or other business generated between the parties involved; and (C)any such equipment or services shall comply with data standards for interoperability adopted by the certification entity described in section 4 of the 21st Century Health Information Act of 2005.

Exception to medicare limitations on physician self-referral

(a)

In general

Section 1877(e) of the Social Security Act (42 U.S.C. 1395nn(e)) is amended by adding at the end the following new paragraph:

(9)

Development or implementation of a health information network

The provision of any equipment or services that are appropriate for the development or implementation of a regional health information technology plan approved by the Secretary under section 3 of the 21st Century Health Information Act of 2005, including the provision of hardware, software, and services necessary to participate in a health information network so long as— (A)any patient data and information that is accessible to recipients of such equipment and services is also accessible to other appropriate persons or entities through a regional health information network accredited or provisionally accredited under section 3(e) of the 21st Century Health Information Act of 2005; (B)any such equipment or services provided are capable of and intended to be used to access, transfer, and exchange patient data and information with other participants in a regional health information network accredited or provisionally accredited under section 3(e) of the 21st Century Health Information Act of 2005; and (C)any such equipment or services are not provided in a manner that takes into account the volume or value of referrals or other business generated between the parties.

(b)

Advisory opinion

(1)Subject to paragraph (2), the Secretary shall consider the issuance of an advisory opinion under subsection (g)(6) of section 1877 of the Social Security Act (42 U.S.C. 1395nn) to permit the provision of equipment or services intended to permit the exchange of health care information to improve health care quality, reduce medical errors, reduce health care costs, or improve the coordination of health care services. (2)Insofar as the Secretary develops an advisory opinion under paragraph (1)_ (A)such advisory opinion may only apply to geographic areas that are not covered by a regional health information network accredited by the Secretary under section 3(e) of the 21st Century Health Information Act of 2005; (B)any equipment or services provided pursuant to the advisory opinion are not provided in a manner that takes into account the volume or value of referrals or other business generated between the parties involved; and (C)any such equipment or services shall comply with data standards for interoperability adopted by the certification entity described in section 4 of the 21st Century Health Information Act of 2005.

Adjustments to medicare payments to providers of service and suppliers participating in health information networks

(a)

In general

The Secretary shall establish a methodology for making adjustments in payment amounts under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) made to providers of services and suppliers who furnish items or services for which payment is made under that title who— (1)participate in a health information network accredited or provisionally accredited by the Secretary under section 3(e); and (2)in the course of furnishing items and services for which payment may be made under such title, use health information technology with patient-specific applications that the Secretary determines improve the quality and accuracy of clinical decision-making (such as electronic medical records, electronic prescribing, and computerized physician order entry with clinical decision-support capabilities) . (b)

Establishment and modification of codes

The methodology under subsection (a) shall— (1)include the establishment of new codes, modification of existing codes, and adjustment of evaluation and management modifiers to such codes that take into account the costs of acquiring, using, and maintaining health information technology with patient-specific applications; and (2)take into account estimated aggregate annual savings in overall payments under such title XVIII attributable to the use of health information technology with patient-specific applications. (c)

Duration

The Secretary may reduce or eliminate adjustments established made to subsection (a) as payment methodologies under title XVIII of the Social Security Act are adjusted to reflect provider quality and efficiency. (d)

Rule of construction

In making national coverage determinations under section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)) with respect to maintaining health information technology with patient-specific applications, in determining whether the health information technology is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, the Secretary shall consider whether the health information technology improves clinical outcomes or cost-effectiveness of treatment. (e)

Definitions

In this section: (1)

Provider of services

The term provider of services has the meaning given such term under section 1861(u) of the Social Security Act (42 U.S.C. 1395x(u)). (2)

Supplier

The term supplier has the meaning given such term under section 1861(d) of such Act (42 U.S.C. 1395x(d)).

Medicaid payments for information infrastructure for health information network and information technology

In the case of a State that provides funding under a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) for the development and implementation of a regional health information technology plan approved by the Secretary under section 3, the Secretary shall make matching payments to States under section 1903(a) of such Act (42 U.S.C. 1396b(a)) for such funding— (1)to the extent such funding supports development of the health information network and is reasonably related to the Medicaid population’s share of the applicable region's patient population or to Medicaid’s share of the applicable region’s health care costs; or (2)to the extent such funding directly or indirectly assists community health centers or other Medicaid providers acquire and implement technology in order to participate in the network.

10.

Definitions

In this Act: (1)The term community health center means a health center eligible for assistance under section 330 of the Public Health Service Act (42 U.S.C. 254b). (2)The term health care provider means an entity involved in consultation, prevention, diagnosis, and treatment, including but not limited to a physician group, physician in individual practice, psychologist or other mental health clinician licensed by the State, hospital, community health center, community mental health center, nursing facility, skilled nursing facility, laboratory, imaging center, or pharmacy. (3)The term health information network means a health information network described in section 3(a)(3)(A)(i). (4)The term health information technology means products, devices, or systems that allow for the electronic collection, storage, exchange, or management of patient information. (5)The term health plans means a group health plan or a health insurance issuer that is offering health insurance coverage. (6)The terms health insurance coverage and health insurance issuer have the meanings given such terms under paragraphs (1) and (2), respectively, of section 733(b) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191b(b)). (7)The term group health plan has the meaning given that term in section 733(a)(1) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191b(a)(1)). (8)The term physician has the meaning given to that term in section 1861(r) of the Social Security Act (42 U.S.C. 1395x(r)). (9)The term regional health information organization means an organization or consortium of organizations that— (A)facilitates the drafting and implementation of a regional health information network plan for a given geographic area in 1 or more States; (B)includes representatives of health plans and other third party payers, government health care programs, employers, physicians, hospitals, other health care providers, and health care consumers; and (C)may include representatives of organized labor. (10)The term small physician group means a physician practice group of 10 or fewer physicians. (11)The term State includes the 50 States and the District of Columbia.