[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1368 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 1368

To establish a program to provide financial incentives to encourage the 
        adoption and use of interactive personal health records.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 7, 2007

 Mr. Kennedy (for himself, Mr. Reichert, and Mr. Smith of Washington) 
 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 to encourage the 
        adoption and use 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 2007''.

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 use of interactive qualifying personal 
health records by 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 $3 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), or authorized 
        representative, uses the QPHR for 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), or authorized 
        representative or a QPHR service provider (as defined in 
        subsection (e)(2)), 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.
            (3) The physician (or provider), or authorized 
        representative, uses the QPHR as appropriate and authorized by 
        the patient to communicate appropriate patient education and 
        care management messages.
            (4) 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.
            (5) 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); QPHR Service 
Provider.--
            (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) Access to the record.--
                            (i) Access rights.--Access to 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) Termination rights.--The record allows 
                        a patient (or the patient's authorized 
                        representative) 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 QPHR service 
                        provider. Nothing in this clause shall require 
                        a health care provider to eliminate a patient's 
                        personal health information included in the 
                        QPHR that is in a medical record maintained by 
                        the provider.
                            (iii) Transportability.--The patient's 
                        rights to control access to 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 (3), and the QPHR service provider complies 
                with any security and privacy standards, policies, and 
                practices adopted under such paragraph.
                    (C) Interoperability.--The record is capable of 
                exchanging standards-based clinical and patient data 
                with other sources and users of health data, including 
                other QPHRs, electronic health records used by 
                hospitals and physicians and other providers, 
                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 QPHR service provider is capable of 
                        sending patient-specific patient education, 
                        reminders, and clinical messages to patients 
                        based upon data in the QPHR, but such messages 
                        shall not be sent unless such messages comply 
                        with standards adopted under paragraph (4). 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 QPHR service provider 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 (4).
                            (iii) Fund partner messages.--Subject to 
                        clause (v), the QPHR service provider 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 (4). A fund partner may 
                        not send a message to a patient about a product 
                        or service unless that product or service has 
                        already been prescribed or recommended to the 
                        patient by a health care provider.
                            (iv) Health plan notification.--The QPHR 
                        service provider notifies, no less frequently 
                        than quarterly, each Fund partner that operates 
                        a health benefit plan of the individuals who 
                        have received messages sent on behalf of the 
                        Fund partner under this section.
                            (v) Limitation on commercial 
                        solicitation.--The QPHR service provider does 
                        not allow messages to be sent to patients 
                        unless--
                                    (I) the patient is a patient or 
                                beneficiary of the sender or source of 
                                the message, uses the sender's or 
                                source's product with a prescription or 
                                recommendation of a provider, or has 
                                some other pre-existing relationship 
                                (as defined by the Secretary) with the 
                                sender or source, or the sender or 
                                source is a public health agency;
                                    (II) the message contains 
                                information directly related to the 
                                patient's health or health care and 
                                does not include marketing or 
                                commercial solicitations;
                                    (III) the message complies with 
                                standards adopted under paragraph (3); 
                                and
                                    (IV) the message clearly identifies 
                                the source of the content and the 
                                sender of the message.
                            (vi) Patient opt-out.--The QPHR service 
                        provider allows 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 QPHR 
                service provider 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 
                QPHRs.
                    (G) Authentication.--The record includes 
                functionality to authenticate the patient's identity 
                prior to the record's use to receive electronic data 
                feeds of personal health information (other than actual 
                authentication information) from third party sources, 
                such as pharmacies, pharmacy benefit managers, 
                laboratories, and health plans, including the Medicare 
                program.
            (2) QPHR service provider defined.--For purposes of this 
        section, the term ``QPHR service provider'' means an entity 
        that operates or administers a QPHR or part of a QPHR and has 
        access to patients' individually identifiable health 
        information contained in the QPHR.
            (3) 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. Such 
                standards shall include a required plain language 
                notice of patients' privacy rights with respect to 
                personal health records.
                    (B) Treatment of qphr service provider as covered 
                entity.--A QPHR service provider shall be treated as a 
                covered entity for purposes of applying the HIPAA 
                regulations referred to in subparagraph (A).
                    (C) 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.
                    (D) Notification of breach.--A QPHR service 
                provider must disclose any breach of the security of 
                individually identifiable personal health information 
                contained in a QPHR to any individual whose 
                individually identifiable personal health information 
                was, or is reasonably believed to have been, acquired 
                by an unauthorized person and to the Secretary in a 
                manner to be specified by the Secretary.
                    (E) Availability of individual health information 
                in electronic form.--Effective beginning on January 1, 
                2010, an individual who requests a copy of the 
                individual's individually identifiable health 
                information pursuant to the HIPAA regulations referred 
                to in subparagraph (A) shall be entitled to receive 
                that information in electronic form capable of being 
                imported into a QPHR, if such information was 
                maintained in electronic form by the entity from which 
                the information is requested.
            (4) 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 messages by Fund partners for commercial solicitations or 
        marketing. Such standards shall incorporate existing standards 
        governing communications to consumers 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 $3 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 $3 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 $3 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 the level of patient engagement in their QPHR, 
        patients' management of their health (including adherence to 
        prescribed medications and recommended preventive care), 
        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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