Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 - Sets forth additional factors for the Secretary of Health and Human Services (HHS) to consider in determining the payment amount for new clinical diagnostic laboratory tests under gapfilling procedures which are used when no comparable existing test is available.
Directs the Secretary to convene an independent advisory panel to inform and make recommendations to the Secretary regarding any new test.
Requires the Secretary to justify publicly the basis and rate determination for any payments made under the clinical laboratory fee schedule for new clinical diagnostic laboratory tests, including a detailed summary of information received regarding the additional factors considered.
Requires the Secretary then, after publishing such justification, to provide for a reasonable period of reconsideration to: (1) receive any appeal of the payment determination, and (2) evaluate any additional information received regarding the justification and the factors considered.
Requires the Secretary, following the period of reconsideration, to make a final payment basis and payment rate determination, providing a justification for it with an explanation of what additional information was evaluated during reconsideration and how it was taken into account.
Directs the Secretary to: (1) establish a process for application for the assignment of a temporary national HCPCS (Healthcare Common Procedure Coding System) code to uniquely identify a diagnostic test until a permanent national HCPCS code is available for assignment to that test, (2) analyze the process used for the gapfilling procedures used in determining payment amounts for new clinical diagnostic laboratory tests, and (3) implement improvements in the process after public notice and opportunity for comment.
Applies this Act to payment basis and payment rate determinations made on or after January 1, 2013.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2085 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 2085
To create incentive for innovative diagnostics by improving the process
for determining Medicare payment rates for new tests.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 22, 2013
Mr. Roskam (for himself, Mr. Neal, Mr. Lance, Mr. Kind, Mr. Guthrie,
Mr. Paulsen, and Mr. Tiberi) 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 create incentive for innovative diagnostics by improving the process
for determining Medicare payment rates for new tests.
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 ``Diagnostic Innovation Testing and
Knowledge Advancement Act of 2013''.
SEC. 2. CREATING INCENTIVES FOR INNOVATIVE DIAGNOSTICS.
(a) Improvements To Process for Determining Fee Schedule Amounts
for New Tests.--
(1) Clarifying factors for rate-setting.--In determining
the payment amount under gapfilling procedures (as described in
section 414.508(b) of title 42, Code of Federal Regulations, or
any successor regulation to such section) for new clinical
diagnostic laboratory tests under section 1833(h)(8) of the
Social Security Act (42 U.S.C. 1395l(h)(8)), the Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') shall take into account, as applicable and
available, the following factors with respect to such a new
test:
(A) Impact on patient care.--The impact of the new
test on patient care, patient management, or patient
treatment.
(B) Technical characteristics.--The technical
characteristics of the new test, and the resources
required to develop, validate, and perform the new
test.
(C) Claims data.--Data from claims for which
payment is made under part B of title XVIII of the
Social Security Act.
(D) Laboratory charges.--Amounts charged by
laboratories to self-pay patients for the new test.
(E) Private insurance rates.--Amounts paid to
laboratories for such new test under private health
insurance coverage offered in the group market and the
individual market.
(F) Advisory panel recommendations.--The findings
and recommendations of the independent advisory panel
convened under paragraph (2) with respect to that new
test and any comments received during the open meeting
of the advisory panel.
(G) Additional factors.--Such other factors as the
Secretary may specify.
(2) Input from patients, clinicians, and technical
experts.--
(A) Requirement for independent advisory panel.--
The Secretary shall convene an independent advisory
panel from which the Secretary shall request
information and recommendations regarding any new test
(as referred to under subparagraph (A) of section
1833(h)(8) of the Social Security Act (42 U.S.C.
1395l(h)(8))) for which payment is made under such
section, including technical, clinical, and quality
information.
(B) Composition of independent advisory panel.--
Subject to subparagraph (D), the independent advisory
panel shall be comprised of 19 members, including--
(i) 7 individuals with expertise and
experience with clinical diagnostic laboratory
tests including expertise in the technical
characteristics of the new test as well as
expertise in the requirements to develop,
validate, and perform the new test;
(ii) 3 representatives of patients,
including a patient representative for rare
disorders;
(iii) 3 clinicians who use results of the
new test in patient care;
(iv) 2 laboratorians;
(v) 2 individuals with expertise in the
area of pharmacoeconomics or health technology
assessment; and
(vi) 2 individuals with expertise on the
impact of new tests on quality of patient care,
including genetic counselors.
(C) Terms.--Subject to subparagraph (D), a member
of the panel shall be appointed to serve a term of 6
years, except with respect to the members first
appointed, whose terms of appointment shall be
staggered evenly over 2-year increments.
(D) Temporary appointment of experts.--Insofar as
the Secretary determines with respect to a new test
that there are an insufficient number of members of the
panel with expertise with respect to that specific
test, the Secretary may appoint individuals who have
expertise pertaining to the new test involved to serve
on the panel.
(E) Open meetings.--The Secretary shall receive or
review the findings and recommendations of the
independent advisory panel with respect to the new
tests described in subparagraph (A) involved during a
meeting open to the public and provide opportunity for
public comment.
(F) Clarification of authority of secretary to
consult carriers.--Nothing in this section shall be
construed as affecting the authority of the Secretary
to consult with appropriate Medicare administrative
contractors.
(3) Justification for payment determinations.--
(A) Initial justification.--With respect to
decisions regarding payments made under the clinical
laboratory fee schedule for new clinical diagnostic
laboratory tests, the Secretary shall publicly provide
a justification for the payment basis and payment rate
determination, including a detailed summary of the
information submitted to, or obtained by, the Secretary
regarding the factors specified in paragraph (1), such
that interested stakeholders can readily understand the
Secretary's rationale for the payment basis and rate
determinations.
(B) Reconsideration period.--After providing such
justification for a payment basis and payment rate
determination, the Secretary shall provide for a
reasonable period of reconsideration to receive any
appeal of the determination and to evaluate any
additional information received regarding the
justification and the factors specified in paragraph
(1).
(C) Final determination.--After the period of
reconsideration the Secretary shall make a final
payment basis and payment rate determination and
provide a justification for such final determination
explaining what additional information was evaluated
during the reconsideration and how such information was
taken into account with respect to the final
determination. Nothing in this paragraph shall be
construed as authorizing the Secretary to reveal
proprietary information which is otherwise prohibited
from disclosure under law.
(b) Process for Assignment of Temporary Codes for Diagnostic
Tests.--The Secretary shall establish a process for application for the
assignment of a temporary national HCPCS code to uniquely identify a
diagnostic test until a permanent national HCPCS code is available for
assignment to that test. Assignments of a temporary national HCPCS code
shall occur on a quarterly basis. The Secretary shall provide public
notice through the Centers for Medicare & Medicaid Services Web site of
applications made for such temporary national HCPCS codes. Upon
assignment of a temporary code under this process, the Secretary shall
treat such test as a new test for purposes of section 1833(h)(8) of the
Social Security Act.
(c) Development of Further Improvements in Rate-Setting
Processes.--The Secretary shall analyze the process used for the
gapfilling procedure used in determining payment amounts for new
clinical diagnostic laboratory tests under section 1833(h)(8) of the
Social Security Act. Taking into account the changes made by this
section, the Secretary shall identify further changes to improve the
accuracy and appropriateness of resulting rates and the openness,
transparency, and predictability of the process. The Secretary shall
examine what and how many entities should perform gapfilling, under
contract or otherwise, and how to ensure that the process is informed
by appropriate expertise and proceeds in a transparent and accountable
manner. The Secretary shall implement improvements in the process,
insofar as these are possible under the law through regulations, after
public notice and opportunity for comment. For changes the Secretary
determines would require a change in law, the Secretary shall transmit
recommendations to the Speaker of the House and the President of the
Senate not later than July 1, 2014.
(d) Definitions.--For purposes of this section:
(1) New clinical diagnostic laboratory tests.--The term
``new clinical diagnostic laboratory test'' means a clinical
diagnostic laboratory test--
(A) that is assigned a new or substantially revised
code on or after January 1, 2013; or
(B) for which a temporary national HCPCS code is
granted under subsection (b) on or after January 1,
2014.
(2) Self-pay patient.--The term ``self-pay patient'' means,
with respect to a health care item or service, an individual
who pays out of pocket for such item or service and who does
not have health insurance coverage for such item or service.
(e) Effective Date.--
(1) In general.--Subject to paragraph (2), this section
shall take effect on the date of enactment of this Act and
shall apply with respect to new clinical diagnostic laboratory
tests.
(2) Application of justifications to current rate
determinations.--Subsection (a)(3) shall apply to payment basis
and payment rate determinations made on or after January 1,
2013.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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