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I
113th CONGRESS
1st Session
H. R. 2363
IN THE HOUSE OF REPRESENTATIVES
June 13, 2013
Mr. Honda introduced
the following bill; which was referred to the
Committee on Energy and
Commerce, and in addition to the Committees on
Ways and Means and
Small Business, 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 foster further innovation and entrepreneurship in the
health information technology sector.
1.
Short title
This Act may be cited as the
Health Care Innovation and Marketplace
Technologies Act of 2013.
2.
Health information
technology placed in service by medical care provider
(a)
In
general
Part VI of subchapter B of chapter 1 of the Internal
Revenue Code of 1986 is amended by adding at the end the following:
200.
Health IT
placed in service by medical care provider
(a)
In
general
In the case of a medical care provider, there shall be
allowed as a deduction an amount equal to the amount paid or incurred by the
medical care provider for qualified health information technology placed in
service by the provider during the taxable year.
(b)
Limitation
The
amount allowed as a deduction to a medical care provider by subsection (a) for
a taxable year shall not exceed $250,000.
(c)
Definitions
For
purposes of this section—
(1)
Medical care
provider
The term
medical care provider means—
(A) a provider of
services (as defined in section 1861(u) of the Social Security Act (42 U.S.C.
1395x(u)),
(B) a provider of
medical or health services (as defined in section 1861(s) of the Social
Security Act (42 U.S.C. 1395x(s)), and
(C) any other person
who furnishes, bills, or is paid for health care in the normal course of
business.
(2)
Qualified health
information technology
The
term qualified health information technology means the application
of information processing involving both computer hardware and software that
deals with the storage, retrieval, sharing, and use of health care information,
data, and knowledge for communication and decisionmaking. Such term does not
include certified EHR technology.
(d)
Special
rules
(1)
Pass-thru
entities
In the case of a partnership or S corporation, this
section shall be applied at the entity level and at the partner or similar
level.
(2)
Coordination
with other deductions
Any amount taken into account under
subsection (a) shall not be allowed as a deduction under any other section of
this chapter.
(e)
Termination
This section shall not apply to amounts
paid or incurred after December 31,
2018.
.
(b)
Clerical
amendment
The table of sections for part VI of subchapter B of
chapter 1 of such Code is amended by adding at the end the following new
item:
Sec. 200. Health IT placed in service by medical care
provider.
.
(c)
Effective
date
The amendments made by this section shall apply to taxable
years beginning after December 31, 2013.
3.
Small business
health information technology financing program
The Small Business Act (15 U.S.C. 631 et
seq.) is amended by redesignating sections 45, 46, and 47 as sections 46, 47,
and 48, respectively, and by inserting the following new section after section
44:
45.
Loan guarantees
for health information technology
(a)
Definitions
As
used in this section:
(1) The term
health information technology means computer hardware, software,
services, and related technology that is purchased by an eligible professional
to aid in the provision of health care in a health care setting and that
provides for—
(A) enhancement of
continuity of care for patients through electronic storage, transmission, and
exchange of relevant personal health data and information, such that this
information is accessible at the times and places where clinical decisions will
be or are likely to be made;
(B) enhancement of
communication between patients and health care providers;
(C) improvement of
quality measurement by eligible professionals enabling them to collect, store,
measure, and report on the processes and outcomes of individual and population
performance and quality of care;
(D) improvement of
evidence-based decision support;
(E) enhancement of
consumer and patient empowerment; or
(F) services that assist with workflow
redesign, training, system configuration, human change management and other
similar services focused on getting the best value from existing technology
that has already been purchased.
Such term
shall not include information technology whose sole use is financial
management, maintenance of inventory of basic supplies, or appointment
scheduling.
(2) The term
eligible professional means any of the following:
(A) A physician (as
defined in section 1861(r) of the Social Security Act (42 U.S.C.
1395x(r))).
(B) A practitioner
described in section 1842(b)(18)(C) of that Act.
(C) A physical or
occupational therapist or a qualified speech-language pathologist.
(D) A qualified
audiologist (as defined in section 1861(ll)(3)(B)) of that Act.
(E) A State-licensed
pharmacist.
(F) A State-licensed,
a State-certified, or a nationally accredited home health care provider.
(3) The term
qualified eligible professional means an eligible professional
whose office can be classified as a small business concern by the Administrator
for purposes of this Act under size standards established under section 3 of
this Act.
(b)
Loan guarantees
for qualified eligible professionals
(1)
In
general
Subject to paragraph (2), the Administrator may guarantee
up to 90 percent of the amount of a loan made to a qualified eligible
professional to be used for the acquisition of health information technology
for use in such eligible professional’s medical practice and for the costs
associated with the installation of such technology. Except as otherwise
provided in this section, the terms and conditions that apply to loans made
under section 7(a) of this Act shall apply to loan guarantees made under this
section.
(2)
Limitations on
guarantee amounts
The maximum amount of loan principal guaranteed
under this subsection may not exceed—
(A) $250,000 with
respect to any single qualified eligible professional; and
(B) $500,000 with
respect to a single group of affiliated qualified eligible
professionals.
(c)
Fees
(1) The Administrator may
impose a guarantee fee on the borrower for the purpose of reducing the cost (as
defined in section 502(5) of the Federal Credit Reform Act of 1990) of the
guarantee to zero in an amount not to exceed 2 percent of the total guaranteed
portion of any loan guaranteed under this section. The Administrator may also
impose annual servicing fees on lenders not to exceed 0.5 percent of the
outstanding balance of the guarantees on lenders’ books.
(2) No service fees,
processing fees, origination fees, application fees, points, brokerage fees,
bonus points, or other fees may be charged to a loan applicant or recipient by
a lender in the case of a loan guaranteed under this section.
(d)
Deferral
period
Loans guaranteed under this section shall carry a deferral
period of not less than 1 year and not more than 3 years. The Administrator
shall have the authority to subsidize interest during the deferral
period.
(e)
Effective
date
No loan may be guaranteed under this section after the date
that is 6 months after the date of enactment of this section.
(f)
Sunset
No loan may be guaranteed under this
section after the date that is 10 years after the date that is 6 months after
the date of enactment of this section.
(g)
Authorization of
appropriations
There are authorized to be appropriated such sums
as are necessary for the cost (as defined in section 502(5) of the Federal
Credit Reform Act of 1990) of guaranteeing $25,000,000 in loans under this
section. The Administrator shall determine such program cost separately and
distinctly from other programs operated by the
Administrator.
.
4.
Challenge grant
program; Disruptive technologies prize program
(a)
In
general
Subtitle B of title
XXX of the Public Health Service Act (42 U.S.C. 300jj–31 et. seq.) is
amended—
(1) by redesignating
sections 3017 and 3018 as sections 3019 and 3020, respectively; and
(2) by inserting after
section 3016 the following new sections:
3017.
Challenge
grant program
(a)
In
general
Subject to the
availability of appropriations, the Secretary, acting through the National
Coordinator, shall award competitive grants to eligible entities to carry out
the activities described in subsection (d).
(b)
Eligible entity
defined
In this section, the term eligible entity
means any individual or entity, except for an entity that—
(1) has 500 or more employees; and
(2) has an annual
revenue of $7,000,000 or more.
(c)
Application
An eligible entity seeking a grant under
this section shall submit an application to the National Coordinator at such
time, in such manner, and containing such information as the National
Coordinator may require, including a description of the product, process, or
structure described in subsection (d) for which the entity intends to use the
grant.
(d)
Uses of
funds
An eligible entity that receives a grant under this section
shall use such funds to develop an effective product, process, or structure
that enhances the use, particularly by patients, of health information
technology, by—
(1) integrating more
than one aspect of health information;
(2) performing a medical consultation using
technology;
(3) providing health information to physicians
or patients;
(4) allowing better coordination during the
delivery and follow-up after the delivery of health care; or
(5) addressing any of the three areas that the
Commission established under section 3018(e)(1) has identified pursuant to its
duties under section 3018(e)(2)(A).
(e)
Prohibited use
of funds
An eligible entity that receives a grant under this
section may not use such grant to develop a product, process, or structure that
meets only the requirements that are necessary to be a certified EHR
technology.
(f)
Grant
amount
A grant awarded under
this section may not be greater than $75,000.
(g)
Report
Not later than one year after the date of
receipt of a grant under this section, an eligible entity shall submit to the
National Coordinator and the Administrator of the Centers for Medicare &
Medicaid Services a report that describes—
(1) the progress that the entity has made on
the product, process, or structure funded by the grant; and
(2) how patients,
health care providers, and other individuals and entities involved in the
delivery of healthcare, including the Centers for Medicare & Medicaid
Services, could use the product, process, or structure funded by the grant to
enhance the delivery of and reduce the cost of health care.
(h)
Authorization of
Appropriations
There is authorized to be appropriated to carry
out this section $5,000,000 for each of fiscal years 2015 through 2017.
3018.
Disruptive
technologies prize program
(a)
Prize program
authorized
For purposes of
rewarding innovation in health information technology, the Secretary, acting
through the National Coordinator, shall carry out a program to award one prize
competitively in each of the three areas identified by the Commission under
subsection (e)(2)(A) using the benchmarks developed under subsection (e)(2)(B)
to select the prize recipient in each category.
(b)
Administration
of Program
In carrying out
the program under subsection (a), the following shall apply:
(1)
Advertising
The
National Coordinator shall widely advertise the prize competition to encourage
broad participation.
(2)
Requirements and
Registration
The National Coordinator shall publish a notice in
the Federal Register announcing—
(A) the rules for being eligible to participate
in the competition;
(B) the process for
participants to register for the competition;
(C) the areas of
health information technology that the Commission develops under subsection
(e)(2)(A) for each prize; and
(D) the benchmarks
that the Commission develops under subsection (e)(2)(B) based on which a winner
will be selected in each such area.
(c)
Eligibility
To be eligible to win a prize under this
section, an individual or entity—
(1) shall register to
participate in the competition in accordance with any rules promulgated by the
National Coordinator under subsection (b)(2);
(2) in the case of an
entity, shall be incorporated in and maintain a primary place of business in
the United States, and in the case of an individual, whether participating
singly or in a group, shall be a citizen or permanent resident of the United
States; and
(3) may not be a
Federal entity or Federal employee acting within the scope of their employment;
and
(4) shall submit an
application that includes an explanation of the anticipated market viability of
the technology that such individual or entity would develop with funds received
under the prize program.
(d)
Prize
amount
(1)
In
general
Subject to paragraph (2), a prize awarded under this
section shall be in the amount of $10,000,000.
(2)
Alternative
rule
In the case that the amount made available for prize awards
under this section is less than $33,000,000, the National Coordinator may
reserve not more than 10 percent for the administrative costs of carrying out
this section, and shall divide the remaining amount equally for the three
prizes awarded under this section.
(e)
Commission
(1)
In
general
There is established a commission to carry out the
activities described in paragraph (2) (referred to in this section as the
Commission).
(2)
Duties
(A)
Areas of health
information technology
For
the purposes of the prize program under subsection (a), the Commission shall
identify three areas within the field of health information technology that are
not adequately addressed by certified EHR technologies and the use of such
technologies. Each area identified shall be an area that will promote the
development of technologies that would be widely useful, would help decrease
the cost of health care, and would improve the quality of health care,
particularly for patients.
(B)
Benchmarks
The
Commission shall develop the benchmarks that the National Coordinator shall use
to determine the prize recipient in each area identified under subparagraph
(A). The Commission shall identify such benchmarks with the goals of—
(i) attracting participants from outside the
health information technology field that will take new approaches to addressing
the areas identified by the Commission under subparagraph (A);
(ii) solving such challenges; and
(iii) promoting the development of technologies
that will be widely adopted, particularly by patients.
(C)
Restriction of
prize award
The Commission shall determine how to restrict the
prize recipients’ use of the funds awarded as a prize under this section, with
respect to the development of health information technology, in order to ensure
that the prize recipients use such funds to further develop the technologies
for which such prize was awarded.
(3)
Members
(A)
Number and
appointment
The Commission shall be composed of 10 members
appointed by the National Coordinator not later than 90 days after the date of
the enactment of this Act.
(B)
Composition
Each
member of the Commission shall be appointed to represent one of the following
four categories:
(i) The varied
disciplines within the health information technology field.
(ii) The varied
disciplines within the medical field that are not described in clause
(i).
(iii) Individuals
who—
(I) represent a
patient-led, patient-centered organization with a patient constituency;
(II) have experience
with health information technology and privacy; and
(III) are trained,
knowledgeable, and prepared to participate in the decisionmaking process
regarding health information technology.
(iv) Officers or
employees of the Federal Government.
(C)
Representation
of membership categories
At least two members of the Commission
shall represent each of the categories described in subparagraph (B).
(D)
Travel
expenses
Each member shall receive travel expenses, including per
diem in lieu of subsistence, in accordance with applicable provisions under
subchapter I of chapter 57 of title 5, United States Code.
(E)
First
meeting
The Commission shall
hold its first meeting not later than 180 days after the date of the enactment
of this Act.
(4)
Report to the
National Coordinator
Not
later than one year after the date of enactment of this Act, the Commission
shall submit to the National Coordinator a report containing the areas,
benchmarks, and restrictions on the uses of prize awards that the Commission
identifies for the prize program under paragraph (2).
(5)
Termination
The Commission shall terminate upon
submitting its report to the National Coordinator under paragraph (4).
(f)
Authorization of
Appropriations
In addition to sums authorized to be appropriated
to carry out this subtitle under section 3020, there is authorized to be
appropriated to carry out this section $33,000,000 for fiscal year
2015.
.
(b)
Conforming
Amendments
(1) Section 3011 of
such Act (42 U.S.C. 300jj–31) is amended—
(A) in subsection (a),
by striking section 3018 and inserting section
3020; and
(B) in subsection (c),
by striking section 3018 and inserting section
3020.
(2) Section 3020 of such Act (as so
redesignated) is amended by inserting except for section 3018,
after For purposes of carrying out this subtitle,.
5.
Establishment of the
Office of Wireless Health Technology
Chapter X of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the
following new section:
1013.
Office of
Wireless Health Technology
(a)
Establishment
There is established within the Office of
the Commissioner an office to be known as the Office of Wireless Health
Technology (referred to in this section as the Office), which
shall be headed by a director.
(b)
Appointment of
first Director
The first Director of the Office shall be
appointed by the Commissioner not later than 90 days after the date of
enactment of this section.
(c)
Duties
The
Director of the Office shall—
(1) through public meetings and other forms of
communication with individuals and entities that design, produce, disseminate,
or have a prevailing interest in wireless health technology, receive and
analyze recommendations with respect to ways that existing regulations
regarding wireless health technology might be made more reasonable and
predictable, including ways that such regulations could be clarified and
simplified;
(2) coordinate with Federal agencies, offices,
institutes, and centers involved in the regulation of wireless health
technology, including the Federal Communications Commission, the Office of the
National Coordinator for Health Information Technology, the Centers for
Medicare & Medicaid Services, the Agency for Healthcare Research and
Quality, the National Institute of Standards and Technology, the Health
Resources and Services Administration, and the National Institutes of Health,
regarding activities of such agencies, offices, institutes, and centers that
can be improved so as to make such regulation more robust, predictable, and
easily understood and navigated by individuals and entities that design,
produce, disseminate, or have a prevailing interest in wireless health
technology;
(3) provide information to individuals and
entities that design, produce, disseminate, or have a prevailing interest in
wireless health technology on how to design, produce, or disseminate wireless
health technology in accordance with existing law; and
(4) publish and make available on the public
Internet Web site of the Food and Drug Administration in a searchable format an
annual report that—
(A) explains how the Food and Drug
Administration implemented regulations regarding wireless health technology
during the prior year;
(B) analyzes the effectiveness of—
(i) such regulations;
and
(ii) other wireless
health-related efforts by the Food and Drug Administration; and
(C) provides specific recommendations on how
the Food and Drug Administration should improve its practices with regard to
wireless health technology (in a manner that ensures consistency within the
Food and Drug Administration regarding the application of its regulatory
approach without compromising patient safety or privacy) in order to—
(i) remove barriers to
innovations in such technology; and
(ii) align such practices with the practices of
other Federal agencies.
(d)
Consultation
with working groups and commissions
In carrying out the duties specified in
subsection (c), the Director of the Office may consult with any working groups
or commissions, including any working group or commission convened for a
purpose related to the regulation of wireless health technology.
(e)
Definition of
wireless health technology
For purposes of this section, the term
wireless health technology has such meaning as specified by the
Commissioner pursuant to regulation, but in no case shall include technology
this is not regulated under the provisions of this Act (other than this
section).
(f)
Authorization of
appropriations
There is
authorized to be appropriated to carry out this section $1,000,000 for each of
fiscal years 2015 through
2019.
.
6.
Mobile health
software application technology responsibilities of the Health Information
Technology Research Center
Section 3012 of the Public Health Service
Act (42 U.S.C. 300jj–32) is amended—
(1) in subsection (b),
by adding at the end the following new paragraph:
(4)
Encouragement of
design, production, and dissemination of mobile health software application
technology
(A)
In
general
In addition to the purposes under paragraph (3), the
Center shall—
(i) establish an educational Web site
repository and a response mechanism (such as a national telephone number) to
provide timely responses to questions in order to make information available
and provide direct support to individuals and entities that design, produce,
disseminate, or have a prevailing interest in mobile health software
application technology regarding the actions such individuals and entities must
take in order to ensure that such technology is designed, produced, and
disseminated in accordance with Federal law; and
(ii) publish and make available on the public
Internet Web site of the Department in a searchable format an annual report
that—
(I) highlights and explains the laws and
regulations that commonly impede efforts by individuals and entities to design,
produce, or disseminate mobile health software application technology;
and
(II) discusses the
work the Center has completed in the past year with regard to mobile health
software application technology, including accomplishments by the Center and
challenges that may require more work or outside support in order for the
Center to accomplish the objectives outlined in this subparagraph.
(B)
Definition of
mobile health software application technology
For purposes of subparagraph (A), the term
mobile health software application technology means a software
program that—
(i) offers health-related services and runs on
a mobile device; or
(ii) enables
health-related services through other portals associated with the use of a
mobile device.
(C)
Authorization of
appropriations
There is
authorized to be appropriated to carry out this paragraph $500,000 for each of
fiscal years 2015 through 2019.
;
and
(2) in subsection
(c)(8), by deleting paragraph (3) and inserting
paragraphs (3) and (4).
7.
Workforce Retraining
Grants
(a)
In
General
The National
Coordinator for Health Information Technology may award to eligible entities
grants to be used for training health care workers in health information
technology (in this section referred to as HIT).
(b)
Period of
Grant
The period of a grant under this section shall be 24
months.
(c)
Eligible
Entities
In this section, eligible entities means
entities that provide clinical health care services to individuals within the
United States.
(d)
Job
Transition
As a condition on
receipt of a grant under this section, a grantee shall ensure that each
employee whose HIT training is funded by that grant assumes expanded duties
with the grantee, either in the form of a new employment position or revised
duties within such employee’s existing employment position, that requires the
use of HIT, not more than 1 year after the employee completes the
training.
(e)
Reporting
Each grantee shall submit a report not
later than 24 months after receipt of a grant to the National
Coordinator for Health Information Technology including the following:
(1) The number of employees who received
training pursuant to the grant.
(2) The HIT skills
covered during such training or trainings.
(3) Documentation that each trained employee
commenced or will commence work in a new position that satisfies the condition
set forth in subsection (d).
(f)
Authorization of
Appropriations
There are
authorized to be appropriated to carry out this section $10,000,000 for each of
fiscal years 2015 through 2019.