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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Diagnostic Innovation 

5 Testing and Knowledge Advancement Act of 2013’’. 


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1 SEC. 2. CREATING INCENTIVES FOR INNOVATIVE 

2 DIAGNOSTICS. 

3 (a) IMPROVEMENTS TO PROCESS FOR DETERMINING

4 FEE SCHEDULE AMOUNTS FOR NEW TESTS.— 

5 (1) CLARIFYING FACTORS FOR RATE-SET6 TING.—In determining the payment amount under 

7 gapfilling procedures (as described in section 

8 414.508(b) of title 42, Code of Federal Regulations, 

9 or any successor regulation to such section) for new 

10 clinical diagnostic laboratory tests under section 

11 1833(h)(8) of the Social Security Act (42 U.S.C. 

12 1395l(h)(8)), the Secretary of Health and Human 

13 Services (in this section referred to as the ‘‘Sec14 retary’’) shall take into account, as applicable and 

15 available, the following factors with respect to such 

16 a new test: 

17 (A) IMPACT ON PATIENT CARE.—The im18 pact of the new test on patient care, patient 

19 management, or patient treatment. 

20 (B) TECHNICAL CHARACTERISTICS.—The 

21 technical characteristics of the new test, and 

22 the resources required to develop, validate, and 

23 perform the new test. 

24 (C) CLAIMS DATA.—Data from claims for 

25 which payment is made under part B of title 

26 XVIII of the Social Security Act. 


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1 (D) LABORATORY CHARGES.—Amounts 

2 charged by laboratories to self-pay patients for 

3 the new test. 

4 (E) PRIVATE INSURANCE RATES.— 

5 Amounts paid to laboratories for such new test 

6 under private health insurance coverage offered 

7 in the group market and the individual market. 

8 (F) ADVISORY PANEL RECOMMENDA9 TIONS.—The findings and recommendations of 

10 the independent advisory panel convened under 

11 paragraph (2) with respect to that new test and 

12 any comments received during the open meeting 

13 of the advisory panel. 

14 (G) ADDITIONAL FACTORS.—Such other 

15 factors as the Secretary may specify. 

16 (2) INPUT FROM PATIENTS, CLINICIANS, AND

17 TECHNICAL EXPERTS.— 

18 (A) REQUIREMENT FOR INDEPENDENT AD19 VISORY PANEL.—The Secretary shall convene 

20 an independent advisory panel from which the 

21 Secretary shall request information and rec22 ommendations regarding any new test (as re23 ferred to under subparagraph (A) of section 

24 1833(h)(8) of the Social Security Act (42 

25 U.S.C. 1395l(h)(8))) for which payment is 


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1 made under such section, including technical, 

2 clinical, and quality information. 

3 (B) COMPOSITION OF INDEPENDENT ADVI4 SORY PANEL.—Subject to subparagraph (D), 

5 the independent advisory panel shall be com6 prised of 19 members, including— 

7 (i) 7 individuals with expertise and ex8 perience with clinical diagnostic laboratory 

9 tests including expertise in the technical 

10 characteristics of the new test as well as 

11 expertise in the requirements to develop, 

12 validate, and perform the new test; 

13 (ii) 3 representatives of patients, in14 cluding a patient representative for rare 

15 disorders; 

16 (iii) 3 clinicians who use results of the 

17 new test in patient care; 

18 (iv) 2 laboratorians; 

19 (v) 2 individuals with expertise in the 

20 area of pharmacoeconomics or health tech21 nology assessment; and 

22 (vi) 2 individuals with expertise on the 

23 impact of new tests on quality of patient 

24 care, including genetic counselors. 


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1 (C) TERMS.—Subject to subparagraph 

2 (D), a member of the panel shall be appointed 

3 to serve a term of 6 years, except with respect 

4 to the members first appointed, whose terms of 

5 appointment shall be staggered evenly over 2- 

6 year increments. 

7 (D) TEMPORARY APPOINTMENT OF EX8 PERTS.—Insofar as the Secretary determines 

9 with respect to a new test that there are an in10 sufficient number of members of the panel with 

11 expertise with respect to that specific test, the 

12 Secretary may appoint individuals who have ex13 pertise pertaining to the new test involved to 

14 serve on the panel. 

15 (E) OPEN MEETINGS.—The Secretary shall 

16 receive or review the findings and recommenda17 tions of the independent advisory panel with re18 spect to the new tests described in subpara19 graph (A) involved during a meeting open to 

20 the public and provide opportunity for public 

21 comment. 

22 (F) CLARIFICATION OF AUTHORITY OF

23 SECRETARY TO CONSULT CARRIERS.—Nothing 

24 in this section shall be construed as affecting 

25 the authority of the Secretary to consult with 


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1 appropriate Medicare administrative contrac2 tors. 

3 (3) JUSTIFICATION FOR PAYMENT DETERMINA4 TIONS.— 

5 (A) INITIAL JUSTIFICATION.—With respect 

6 to decisions regarding payments made under 

7 the clinical laboratory fee schedule for new clin8 ical diagnostic laboratory tests, the Secretary 

9 shall publicly provide a justification for the pay10 ment basis and payment rate determination, in11 cluding a detailed summary of the information 

12 submitted to, or obtained by, the Secretary re13 garding the factors specified in paragraph (1), 

14 such that interested stakeholders can readily 

15 understand the Secretary’s rationale for the 

16 payment basis and rate determinations. 

17 (B) RECONSIDERATION PERIOD.—After 

18 providing such justification for a payment basis 

19 and payment rate determination, the Secretary 

20 shall provide for a reasonable period of recon21 sideration to receive any appeal of the deter22 mination and to evaluate any additional infor23 mation received regarding the justification and 

24 the factors specified in paragraph (1). 


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1 (C) FINAL DETERMINATION.—After the 

2 period of reconsideration the Secretary shall 

3 make a final payment basis and payment rate 

4 determination and provide a justification for 

5 such final determination explaining what addi6 tional information was evaluated during the re7 consideration and how such information was 

8 taken into account with respect to the final de9 termination. Nothing in this paragraph shall be 

10 construed as authorizing the Secretary to reveal 

11 proprietary information which is otherwise pro12 hibited from disclosure under law. 

13 (b) PROCESS FOR ASSIGNMENT OF TEMPORARY

14 CODES FOR DIAGNOSTIC TESTS.—The Secretary shall es15 tablish a process for application for the assignment of a 

16 temporary national HCPCS code to uniquely identify a di17 agnostic test until a permanent national HCPCS code is 

18 available for assignment to that test. Assignments of a 

19 temporary national HCPCS code shall occur on a quar20 terly basis. The Secretary shall provide public notice 

21 through the Centers for Medicare & Medicaid Services 

22 Web site of applications made for such temporary national 

23 HCPCS codes. Upon assignment of a temporary code 

24 under this process, the Secretary shall treat such test as 


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1 a new test for purposes of section 1833(h)(8) of the Social 

2 Security Act. 

3 (c) DEVELOPMENT OF FURTHER IMPROVEMENTS IN

4 RATE-SETTING PROCESSES.—The Secretary shall analyze 

5 the process used for the gapfilling procedure used in deter6 mining payment amounts for new clinical diagnostic lab7 oratory tests under section 1833(h)(8) of the Social Secu8 rity Act. Taking into account the changes made by this 

9 section, the Secretary shall identify further changes to im10 prove the accuracy and appropriateness of resulting rates 

11 and the openness, transparency, and predictability of the 

12 process. The Secretary shall examine what and how many 

13 entities should perform gapfilling, under contract or other14 wise, and how to ensure that the process is informed by 

15 appropriate expertise and proceeds in a transparent and 

16 accountable manner. The Secretary shall implement im17 provements in the process, insofar as these are possible 

18 under the law through regulations, after public notice and 

19 opportunity for comment. For changes the Secretary de20 termines would require a change in law, the Secretary 

21 shall transmit recommendations to the Speaker of the 

22 House and the President of the Senate not later than July 

23 1, 2014. 

24 (d) DEFINITIONS.—For purposes of this section: 


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1 (1) NEW CLINICAL DIAGNOSTIC LABORATORY

2 TESTS.—The term ‘‘new clinical diagnostic labora3 tory test’’ means a clinical diagnostic laboratory 

4 test— 

5 (A) that is assigned a new or substantially 

6 revised code on or after January 1, 2013; or 

7 (B) for which a temporary national 

8 HCPCS code is granted under subsection (b) on 

9 or after January 1, 2014. 

10 (2) SELF-PAY PATIENT.—The term ‘‘self-pay 

11 patient’’ means, with respect to a health care item 

12 or service, an individual who pays out of pocket for 

13 such item or service and who does not have health 

14 insurance coverage for such item or service. 

15 (e) EFFECTIVE DATE.— 

16 (1) IN GENERAL.—Subject to paragraph (2), 

17 this section shall take effect on the date of enact18 ment of this Act and shall apply with respect to new 

19 clinical diagnostic laboratory tests. 

20 (2) APPLICATION OF JUSTIFICATIONS TO CUR21 RENT RATE DETERMINATIONS.—Subsection (a)(3) 

22 shall apply to payment basis and payment rate de23 terminations made on or after January 1, 2013. 

Æ 


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