[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6289 Introduced in House (IH)]








109th CONGRESS
  2d Session
                                H. R. 6289

    To establish a program to provide financial incentives for the 
         establishment of interactive personal health records.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 29, 2006

 Mr. Kennedy of Rhode Island introduced the following bill; which was 
 referred to the Committee on Energy and Commerce, and in addition to 
   the Committee on Ways and Means, 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 establish a program to provide financial incentives for the 
         establishment of interactive personal health records.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Personalized Health Information Act 
of 2006''.

SEC. 2. PERSONAL HEALTH RECORD (PHR) INCENTIVE PROGRAM.

    (a) Establishment.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall establish a 
program (in this section referred to as the ``program'') to provide 
financial incentives for the establishment of interactive qualifying 
personal health records for Medicare and other patients and their 
health care providers in order to--
            (1) provide patients (or their authorized representatives) 
        access to and control over their personal health data and 
        information and educational information so as to become 
        healthier and more informed and engaged health care consumers;
            (2) make available to authorized health care providers a 
        more accurate minimum data set of patient information at all 
        points of care;
            (3) protect patient security and privacy;
            (4) improve patients' adherence to evidence-based care 
        guidelines, preventive care, and screening protocols, thereby 
        improving health outcomes and lowering health care costs;
            (5) improve medication adherence by patients, thereby 
        improving health outcomes and lowering health care costs;
            (6) provide patients with more accurate, timely, and 
        appropriate information related to their health care benefits 
        and related administrative information;
            (7) improve the quality and efficiency of communication 
        between health care providers and patients;
            (8) create a direct communications channel to patients in 
        the event of health emergencies; and
            (9) provide access with appropriate privacy safeguards to 
        de-identified health care information to evaluate and advance 
        public health and health research goals.
    (b) Incentive Payments.--
            (1) In general.--Under the program, each qualified 
        physician (as defined in subsection (c)) that has a qualifying 
        patient (as defined in subsection (d)) shall receive an 
        incentive payment from the PHR Incentive Fund established under 
        subsection (f). In the case of such a patient of more than one 
        physician, each such physician (who does not share in the same 
        group practice, as defined by the Secretary, with another 
        qualifying physician of that patient) may receive such a 
        payment.
            (2) Amount of payment.--
                    (A) In general.--Except as otherwise provided, the 
                amount of the incentive payment to a qualifying 
                physician under the program shall be at least $2 per 
                year for each qualifying patient of the physician.
                    (B) Adjustment; limitation.--The Secretary shall 
                annually retrospectively set the incentive payment 
                amount based on the amount of the contributions into 
                the PHR Incentive Fund. The Secretary shall pay PHR 
                incentives payments only from such Fund.
                    (C) Annual limitation.--The Secretary shall 
                establish a maximum annual payment under this section 
                to any qualifying physician.
            (3) Duration.--Payments shall be made under the program 
        during a 3-year period beginning on the date of implementation 
        of the program, except that the Secretary may continue the 
        program for an additional two years if the Secretary determines 
        that continuation of the program for such period would be a 
        cost-effective way of achieving the goals of this Act.
            (4) Program education.--
                    (A) Publication of names qualifying physicians.--In 
                order to assist patients in identifying health care 
                providers that use qualifying personal health records, 
                Secretary shall publish on the official website for the 
                Centers for Medicare & Medicaid Services (CMS), or 
                other online locations of the Secretary's choosing, a 
                list of qualifying physicians who participate in the 
                Medicare program and who have received incentive 
                payments under this section.
                    (B) Education.--
                            (i) Patient education.--The Secretary 
                        shall, in consultation with appropriate 
                        organizations that represent health care 
                        consumers, take steps to educate Medicare 
                        beneficiaries and other patients about the 
                        health and convenience benefits of qualifying 
                        personal health records.
                            (ii) Provider education.--The Secretary 
                        shall take steps to educate Medicare providers 
                        about the patient, provider and overall health 
                        care benefits of using qualifying personal 
                        health records.
    (c) Qualified Physician Defined.--For purposes of this section, the 
term ``qualified physician'' means a licensed physician (or other 
licensed health care provider, such as a clinic, designated by the 
Secretary) that meets the following requirements, with respect to a 
qualifying patient of that physician and the qualifying personal health 
record of that patient:
            (1) The physician (or provider) uses the QPHR for 
        electronic patient registration for encounters, including 
        taking demographic information, insurance information, 
        medication list, problems list, family history, and other 
        information included within the QPHR.
            (2) The physician (or provider) implements policies to 
        authenticate the patient's identities pursuant to standards 
        established by the Secretary in order to enable the QPHR to 
        receive electronic data feeds from appropriate third party 
        sources, such as pharmacies, pharmacy benefit managers, 
        laboratories, and health plans, including the Medicare program.
            (3) The physician (or provider), or authorized 
        representative, updates the diagnosis and medication list 
        (including all current medications and new medications 
        prescribed or provided as samples) in the QPHR after each 
        patient encounter, if appropriate and authorized by the 
        patient, either by direct entry or through a data sharing 
        arrangement using an appropriate electronic means, such as an 
        electronic medical record or e-prescribing.
            (4) The physician (or provider) uses the QPHR as 
        appropriate and authorized by the patient to communicate 
        appropriate patient education and care management messages.
            (5) There is submitted to the Secretary by the physician 
        (or by the administrator of the QPHR on the physician's behalf) 
        on a regular basis, but no less frequently than annually, a 
        report documenting the number of such qualifying patients of 
        the physician (or provider) and the use of QPHRs of such 
        patients.
            (6) The physician (or provider) meets other requirements as 
        the Secretary may establish.
    (d) Qualifying Patient Defined.--For purposes of this section, the 
term ``qualifying patient'' means an individual for whom a qualifying 
personal health record has been established and is in operation under 
the program and who is a Medicare beneficiary or is covered under a 
health benefits or other plan the sponsor of which is participating as 
a Fund partner under this section.
    (e) Qualifying Personal Health Record (QPHR).--
            (1) Definition.--For purposes of this section, the terms 
        ``qualifying personal health record'' and ``QPHR'' mean a 
        record of health care related information that meets the 
        following requirements:
                    (A) Control.--
                            (i) In general.--The record is controlled 
                        solely by the patient (or the patient's 
                        authorized representative), with the patient 
                        (or the patient's authorized representative) 
                        able to access online, print, copy to 
                        electronic media, or provide online access to 
                        authorized third parties, including health care 
                        providers, to all individually identifiable 
                        health information held in the record at any 
                        time.
                            (ii) Access rights.--The record guarantees 
                        the control of the patient (or the patient's 
                        authorized representative) over who accesses 
                        the patient's individually identifiable 
                        information contained in the record.
                            (iii) Termination rights.--The record 
                        allows a patient to terminate the further use 
                        of the record service at any time, including 
                        elimination of the patient's personal health 
                        information in the control of the administrator 
                        of the record. Nothing in this clause shall 
                        require a health care provider to eliminate a 
                        patient's personal health information that is 
                        in a medical record maintained by the provider.
                            (iv) Transportability.--The patient's 
                        rights to control of the record under this 
                        subparagraph are not affected by changes in 
                        relationships with particular providers or 
                        health plans.
                    (B) Security.--The record meets minimum security 
                standards, including the rules promulgated under 
                section 264(c) of the Health Insurance Portability and 
                Accountability Act of 1996 (HIPAA) and other such 
                minimum standards as identified by the Secretary under 
                paragraph (2), and the administrator of the record 
                complies with any security and privacy standards, 
                policies, and practices adopted under such paragraph.
                    (C) Interoperability.--The record complies with 
                interoperability data standards specified by the 
                Secretary, to ensure the capability to integrate with 
                other QPHRs and other sources of individual data, such 
                as electronic health records, pharmacies, pharmacy 
                benefit managers, and health plans.
                    (D) Web-based.--The record is web-based and capable 
                of sharing information between patients and their 
                providers, and enabling patient-provider communication.
                    (E) Messaging capabilities.--
                            (i) Education reminders.--Subject to clause 
                        (v), the record is capable of sending patient-
                        specific patient education, reminders, and 
                        clinical messages to patients based upon data 
                        in the record, but such messages shall not be 
                        sent unless such messages comply with standards 
                        adopted under paragraph (3). The Secretary 
                        shall work with the Secretary of Homeland 
                        Security and the Director of the Centers for 
                        Disease Control and Prevention to optimize the 
                        public health and emergency response 
                        capabilities of the networks created by QPHRs.
                            (ii) Federal reminders.--Subject to clause 
                        (v), the record provides for the sending on 
                        behalf of Federal agencies of objective, 
                        accurate, patient-specific messages to patients 
                        concerning their health care or benefits, but 
                        such messages shall not be sent unless the 
                        messages comply with standards adopted under 
                        paragraph (3).
                            (iii) Fund partner messages.--Subject to 
                        clause (v), the record provides for the 
                        sending, on behalf of Fund partners who 
                        contribute to the Fund, appropriate patient-
                        specific messages to consumers (with whom such 
                        partners have pre-existing relationships) 
                        concerning the patients' health care, 
                        medications, treatments, medical devices or 
                        benefits, but such messages shall not be sent 
                        unless such messages comply with standards 
                        adopted under paragraph (3).
                            (iv) Health plan notification.--The QPHR 
                        service notifies, no less frequently than 
                        quarterly, each Fund partner that administers a 
                        health benefit plan of the individuals who are 
                        enrolled in the plan and who have a QPHR 
                        established.
                            (v) Limitation on commercial 
                        solicitation.--The record does not allow any 
                        commercial solicitations, marketing, or 
                        messages to patients unless the patient is a 
                        patient or beneficiary of the sender, uses the 
                        sender's product with a prescription or 
                        recommendation of a provider, or has some other 
                        pre-existing relationship (as defined by the 
                        Secretary), or other messages that do not 
                        comply with standards adopted under paragraph 
                        (3), and the record ensures that every message 
                        clearly identifies the source of the content.
                            (vi) Patient opt-out.--The record allow a 
                        patient (or patient's authorized 
                        representative) to opt out of receiving 
                        messages entirely or from particular sources.
                    (F) Public health analysis and research.--The 
                record is capable of providing de-identified data for 
                public health analysis and for research purposes. The 
                Secretary shall consult with the Commissioner of the 
                Food and Drug Administration, the Director of the 
                National Institutes of Health, the Director of the 
                Centers for Disease Control and Prevention, and the 
                Administrator of the Agency for Healthcare Research and 
                Quality to optimize the public health and post-market 
                surveillance capabilities of the networks created by 
                QPHRs.
            (2) Privacy and consumer protection standards.--
                    (A) In general.--The Secretary shall set minimum 
                security, privacy and data use standards for QPHRs, in 
                addition to such standards as required under 
                regulations promulgated under section 264(c) of the 
                Health Insurance Portability and Accountability Act of 
                1996 (HIPAA), in order to optimally protect and 
                safeguard patient health care information.
                    (B) Consumer protection board.--The Secretary shall 
                establish a consumer protection board, a majority of 
                whose members represent health care consumers, 
                including individuals with chronic diseases and with 
                mental and addictive disorders. Such board shall--
                            (i) recommend to the Secretary minimum 
                        standards to protect patient-identifiable 
                        information stored in or transmitted from a 
                        QPHR;
                            (ii) recommend procedures to ensure the 
                        objectivity, relevance, and accuracy of 
                        messages sent to patients via their QPHRs; and
                            (iii) have the right to request and review 
                        the security and privacy capabilities, policies 
                        and practices of those entities administering 
                        QPHRs.
            (3) Message standards.--The Secretary shall establish 
        minimum standards to ensure the objectivity, accuracy and 
        relevance of messages sent to individual patients under 
        paragraph (1)(E) from a QPHR and to protect against the use of 
        such records by Fund partners for commercial solicitations or 
        marketing. Such standards shall incorporate existing standards 
        established by the Food and Drug Administration or other 
        Federal agencies.
    (f) PHR Incentive Fund.--
            (1) In general.--The Secretary shall establish a PHR 
        Incentive Fund (in this section referred to as the ``PHR 
        Incentive Fund'' or ``Fund''). The Fund may receive 
        contributions from Fund partners for the sole purpose of paying 
        PHR incentives under subsection (a), conducting annual studies 
        under subsection (g), and otherwise carrying out the program.
            (2) Funding partners.--
                    (A) In general.--The Secretary may enter into 
                contracts with public or private payers, drug 
                manufacturers, device manufacturers, or other public or 
                private entities (in this section referred to as ``Fund 
                partners'') to allow the Fund to receive contributions 
                in accordance with this subsection and other terms 
                determined by the Secretary.
                    (B) Federal partners.--The Secretary shall seek the 
                involvement and contributions of the Food and Drug 
                Administration, the Centers for Disease Control and 
                Prevention, the Agency for Healthcare Research and 
                Quality, and the Department of Homeland Security to 
                maximize the effectiveness of the QPHRs in meeting the 
                health, national security, emergency response, 
                biosurveillance, and research goals of the Federal 
                government in a manner consistent with this Act.
                    (C) Partner accounts.--The Fund shall include an 
                account for each Fund partner, including Medicare, 
                separately accounting for each Fund partner's 
                contributions to the Fund. Incentive payments shall be 
                debited from each account in accordance with this 
                subsection. Amounts in the account of a Fund partner 
                that are not paid in fiscal year remain available for 
                payment from such account in the subsequent fiscal 
                year.
                    (D) Contribution levels.--Contribution levels to 
                the Fund by Fund partners shall be set annually by the 
                Secretary, except that the contribution level for the 
                first year shall be as follows:
                            (i) Medicare contribution.--The Secretary 
                        shall contribute $2 for each Medicare 
                        beneficiary for whom any PHR incentive payment 
                        is made during such year by transferring the 
                        appropriate amount from the Medicare trust 
                        funds under parts A and B of the Medicare 
                        program, in such proportion as the Secretary 
                        may specify.
                            (ii) FDA-messaging contributions.--Each 
                        manufacturer shall contribute $2 for each 
                        qualifying patient for each medication 
                        adherence program for which one or more 
                        messages are sent under subsection 
                        (e)(1)(E)(iii) in the year.
                            (iii) Other contributions.--Any other fund 
                        partner shall contribute $2 for each qualifying 
                        patient for whom a PHR incentive payment is 
                        made, except that the Secretary may establish 
                        other contribution levels for device 
                        manufacturers or other Fund partners that 
                        employ messages sent under subsection 
                        (e)(1)(D)(iii).
                    (E) Charging fund partners.--Each Fund partner's 
                account shall be debited according to the same formula 
                with which contributions were determined. In the event 
                that a Fund partner's account does not have a 
                sufficient balance to cover the Fund partner's 
                liability, the Fund partner shall make a supplemental 
                contribution to the Fund to cover the shortfall plus 
                such penalty as the Secretary may assess.
                    (F) Limitation on benefits.--Contributions by a 
                Fund partner to the Fund shall confer no preferential 
                access to data or information or any other benefit to 
                the partner other than public acknowledgment under 
                paragraph (5) and the ability to have messages sent to 
                qualifying patients under subsection (e)(1)(D)(iii).
            (3) Publication of fund contributors.--The Secretary shall 
        publish on the official website of the Centers for Medicare & 
        Medicaid Services a list of Fund partners that have contributed 
        to the Fund.
    (g) Annual Study.--
            (1) In general.--The Secretary shall provide for an annual 
        study to assess changes patient engagement in their QPHR, 
        behavior changes, changes in health outcomes, and cost savings 
        resulting from implementation of the program. The study shall 
        include collection of aggregate data documenting the number of 
        qualifying patient, number and kind of messages sent to 
        patients, the percentage of messages opened by patients, and 
        other measures of the program's effectiveness.
            (2) Funding.--There are available from the PHR Incentive 
        Fund not to exceed $2,000,000 each year to pay for the annual 
        study under paragraph (1). Amounts so used shall be debited 
        from each Fund partner's account on a pro-rata basis.
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