I 
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 de-
termined 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 Representa-
tives 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’’. 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
SEC. 
2. 
CREATING 
INCENTIVES 
FOR 
INNOVATIVE 
DIAGNOSTICS. 
(a) IMPROVEMENTS TO PROCESS FOR DETERMINING 
FEE SCHEDULE AMOUNTS FOR NEW TESTS.— 
(1) CLARIFYING
FACTORS
FOR
RATE-SET-
TING.—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 ‘‘Sec-
retary’’) shall take into account, as applicable and 
available, the following factors with respect to such 
a new test: 
(A) IMPACT ON PATIENT CARE.—The im-
pact 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. 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
(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
RECOMMENDA-
TIONS.—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 AD-
VISORY
PANEL.—The Secretary shall convene 
an independent advisory panel from which the 
Secretary shall request information and rec-
ommendations regarding any new test (as re-
ferred 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 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
made under such section, including technical, 
clinical, and quality information. 
(B) COMPOSITION OF INDEPENDENT ADVI-
SORY
PANEL.—Subject to subparagraph (D), 
the independent advisory panel shall be com-
prised of 19 members, including— 
(i) 7 individuals with expertise and ex-
perience 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, in-
cluding 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 tech-
nology assessment; and 
(vi) 2 individuals with expertise on the 
impact of new tests on quality of patient 
care, including genetic counselors. 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
(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
EX-
PERTS.—Insofar as the Secretary determines 
with respect to a new test that there are an in-
sufficient number of members of the panel with 
expertise with respect to that specific test, the 
Secretary may appoint individuals who have ex-
pertise pertaining to the new test involved to 
serve on the panel. 
(E) OPEN MEETINGS.—The Secretary shall 
receive or review the findings and recommenda-
tions of the independent advisory panel with re-
spect to the new tests described in subpara-
graph (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 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
appropriate Medicare administrative contrac-
tors. 
(3) JUSTIFICATION FOR PAYMENT DETERMINA-
TIONS.— 
(A) INITIAL JUSTIFICATION.—With respect 
to decisions regarding payments made under 
the clinical laboratory fee schedule for new clin-
ical diagnostic laboratory tests, the Secretary 
shall publicly provide a justification for the pay-
ment basis and payment rate determination, in-
cluding a detailed summary of the information 
submitted to, or obtained by, the Secretary re-
garding 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 recon-
sideration to receive any appeal of the deter-
mination and to evaluate any additional infor-
mation received regarding the justification and 
the factors specified in paragraph (1). 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
(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 addi-
tional information was evaluated during the re-
consideration and how such information was 
taken into account with respect to the final de-
termination. Nothing in this paragraph shall be 
construed as authorizing the Secretary to reveal 
proprietary information which is otherwise pro-
hibited from disclosure under law. 
(b) PROCESS
FOR ASSIGNMENT
OF TEMPORARY 
CODES FOR DIAGNOSTIC TESTS.—The Secretary shall es-
tablish a process for application for the assignment of a 
temporary national HCPCS code to uniquely identify a di-
agnostic 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 quar-
terly 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 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
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 deter-
mining payment amounts for new clinical diagnostic lab-
oratory tests under section 1833(h)(8) of the Social Secu-
rity Act. Taking into account the changes made by this 
section, the Secretary shall identify further changes to im-
prove 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 other-
wise, and how to ensure that the process is informed by 
appropriate expertise and proceeds in a transparent and 
accountable manner. The Secretary shall implement im-
provements in the process, insofar as these are possible 
under the law through regulations, after public notice and 
opportunity for comment. For changes the Secretary de-
termines 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: 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS
(1) NEW
CLINICAL
DIAGNOSTIC
LABORATORY 
TESTS.—The term ‘‘new clinical diagnostic labora-
tory 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 enact-
ment of this Act and shall apply with respect to new 
clinical diagnostic laboratory tests. 
(2) APPLICATION OF JUSTIFICATIONS TO CUR-
RENT
RATE
DETERMINATIONS.—Subsection (a)(3) 
shall apply to payment basis and payment rate de-
terminations made on or after January 1, 2013. 
Æ 
VerDate Mar 15 2010 
22:38 May 24, 2013
Jkt 029200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6301
E:\BILLS\H2085.IH
H2085
tkelley on DSK3SPTVN1PROD with BILLS