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.
(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.
(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.
(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.
(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:
(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.
(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.
(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.
(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.
END
