I 

110TH CONGRESS 

1ST SESSION H. R. 1321 

To amend title XVIII of the Social Security Act to improve payments under 

the Medicare clinical laboratory fee schedule. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2007 

Mr. RUSH 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 amend title XVIII of the Social Security Act to improve 

payments under the Medicare clinical laboratory fee schedule. 

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 AND TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Medicare Advanced Laboratory Diagnostics Act of 

6 2007’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 

Sec. 1. Short title and table of contents. 


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TITLE I—NEAR-TERM CHANGES 

Sec. 101. Fee schedule and national limitation amounts for clinical diagnostic 

laboratory tests. 

Sec. 102. Issuance of regulations on gap-filling for medicare fee schedule for 

clinical diagnostic laboratory tests. 

Sec. 103. Increased transparency of process for determining fee schedule 

amounts for new tests. 

Sec. 104. Advance notice of clinical diagnostic laboratory test amounts being 

considered for adjustment under inherent reasonableness authority. 

TITLE II—FUTURE REFORM 

Sec. 201. Establishment of medicare demonstration project to evaluate new approaches to coding and payment for certain molecular diagnostic tests. 

1 TITLE I—NEAR-TERM CHANGES 

2 SEC. 101. FEE SCHEDULE AND NATIONAL LIMITATION 

3 AMOUNTS FOR CLINICAL DIAGNOSTIC LAB4 ORATORY TESTS. 

5 (a) IN GENERAL.—Section 1833(h) of the Social Se6 curity Act (42 U.S.C. 1395l(h)) is amended by adding at 

7 the end the following new paragraph: 

8 ‘‘(9)(A) For purposes of this paragraph: 

9 ‘‘(i) The term ‘an amount determined under 

10 this subsection’ means, with respect to a clinical lab11 oratory test, the fee schedule amount determined 

12 under paragraph (2)(A)(i) for the test or the limita13 tion amount determined under paragraph (4)(B) for 

14 the test. 

15 ‘‘(ii) The terms ‘appropriate medicare adminis16 trative contractor’ and ‘medicare administrative con17 tractor’ have the meaning given to such terms under 

18 section 1874A(a)(3). 


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1 ‘‘(iii) The term ‘erroneous decision’ means, with 

2 respect to the determination of an amount deter3 mined under this subsection, any decision, calcula4 tion, judgment or other action by the Secretary or 

5 a medicare administrative contractor that, based 

6 upon consideration of currently known facts, needs 

7 to be modified to produce a fair and equitable pay8 ment amount, except that such term does not in9 clude typographical or clerical errors. 

10 ‘‘(iv) The term ‘non-governmental party’ in11 cludes— 

12 ‘‘(I) a provider of services (as defined in 

13 section 1861(u)) that furnishes clinical diag14 nostic laboratory tests for which payment may 

15 be made under this subsection; 

16 ‘‘(II) a supplier (as defined in section 

17 1861(d)) that furnishes such tests; and 

18 ‘‘(III) a manufacturer of a test or of any 

19 supplies or equipment that are used in per20 forming such test. 

21 ‘‘(B) An amount determined under this subsection 

22 may be changed solely on the basis of— 

23 ‘‘(i) in the case of a change other than a change 

24 to correct an erroneous decision in determining such 

25 amount, the authority provided by the preceding 


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1 provisions of this subsection, section 1842(b)(8), or 

2 any regulations, manual instructions, or other regu3 latory guidance implementing such provisions; or 

4 ‘‘(ii) in the case of a change to correct an erro5 neous decision in determining such an amount, the 

6 authority provided by subparagraphs (C), (D), and 

7 (E). 

8 ‘‘(C) Any erroneous decision in determining an 

9 amount under this subsection may be corrected only if— 

10 ‘‘(i) a non-governmental party submits a re11 quest under subparagraph (D) or (E) for correction 

12 of the erroneous decision; and 

13 ‘‘(ii) such party demonstrates, to an appro14 priate medicare administrative contractor under sub15 paragraph (D) or the Secretary under subparagraph 

16 (E), that an erroneous decision clearly was made. 

17 ‘‘(D)(i) Any non-governmental party may request (in 

18 such form and manner as the Secretary may require) that 

19 the appropriate medicare administrative contractor change 

20 a fee schedule amount determined under paragraph 

21 (2)(A)(i) to correct an erroneous decision in determining 

22 such amount. 

23 ‘‘(ii) Any request under this subparagraph shall in24 clude a statement of the basis for the non-governmental 

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1 termining such amount, together with supporting evidence 

2 and a description of any additional data (other than data 

3 already in the possession of the appropriate medicare ad4 ministrative contractor) that— 

5 ‘‘(I) is or may be in the possession of the Sec6 retary or another medicare administrative con7 tractor; and 

8 ‘‘(II) is necessary to demonstrate that such an 

9 erroneous decision exists. 

10 ‘‘(iii) If the Secretary or another medicare adminis11 trative contractor is identified as possessing or potentially 

12 possessing additional data identified by a non-govern13 mental party in a request under this subparagraph, the 

14 Secretary or such contractor, as the case may be, shall 

15 make available to the non-governmental party within 30 

16 days after the date of the submission of the request any 

17 data in their possession that meet the description of the 

18 additional data identified in such request, with appro19 priate safeguards to protect confidential and proprietary 

20 information. 

21 ‘‘(iv) If additional data are made available to a non22 governmental party under clause (iii), such party may 

23 amend its request under this subparagraph to incorporate 

24 such data within 30 days after the date such data are 

25 made available to such party. 


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1 ‘‘(v) An appropriate medicare administrative con2 tractor to which a request is submitted under this sub3 paragraph shall make a determination with respect to 

4 whether to correct the decision that is identified as erro5 neous in the request not later than 60 days after the date 

6 of the submission of such request, or if later, the date of 

7 the submission of an amended request under clause (iv). 

8 Such contractor shall determine that the non-govern9 mental party submitting the request— 

10 ‘‘(I) has demonstrated that an erroneous deci11 sion clearly was made, correct such erroneous deci12 sion, and increase the fee schedule amount as of the 

13 first day of the next calendar quarter to reflect the 

14 correction of such erroneous decision; or 

15 ‘‘(II) has failed to demonstrate that an erro16 neous decision clearly was made and decline to 

17 change the fee schedule amount, 

18 and shall provide to the non-governmental party a written 

19 explanation of the basis for such determination. 

20 ‘‘(vi) An appropriate medicare administrative con21 tractor to which a request is submitted under this sub22 paragraph may not reduce a fee schedule amount pursu23 ant to such request, and may reduce such an amount only 

24 pursuant to section 1842(b)(8). 


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1 ‘‘(E)(i) Any non-governmental party may request (in 

2 such form and manner as the Secretary may require) that 

3 the Secretary— 

4 ‘‘(I) reverse a determination of a medicare ad5 ministrative contractor under subparagraph (D) that 

6 is adverse to the non-governmental party requesting 

7 it; 

8 ‘‘(II) correct an erroneous decision in the deter9 mination of a limitation amount under paragraph 

10 (4)(B); or 

11 ‘‘(III) reverse a determination referred to in 

12 subclause (I) and correct an erroneous decision re13 ferred to in subclause (II). 

14 ‘‘(ii) Any request under this subparagraph shall in15 clude a statement of the basis for the non-governmental 

16 party’s belief that an erroneous decision was made in de17 termining such amount, together with supporting evidence 

18 and a description of any additional data (other than data 

19 already in the possession of the Secretary or the appro20 priate medicare administrative contractor reviewing the 

21 request under subparagraph (D)) that– 

22 ‘‘(I) are or may be in the possession of the Sec23 retary or another medicare administrative con24 tractor; and 


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1 ‘‘(II) are necessary to demonstrate that such an 

2 erroneous decision exists. 

3 ‘‘(iii) If the Secretary or another medicare adminis4 trative contractor is identified as possessing or potentially 

5 possessing additional data identified by a non-govern6 mental party in a request under this subparagraph, the 

7 Secretary or such contractor, as the case may be, shall 

8 make available to the non-governmental party within 30 

9 days after the date of the submission of the request any 

10 data in their possession that meet the description of the 

11 additional data identified in such request, with appro12 priate safeguards to protect confidential and proprietary 

13 information. 

14 ‘‘(iv) If additional data are made available to a non15 governmental party under clause (iii), such party may 

16 amend its request under this subparagraph to incorporate 

17 such data within 30 days after the date such data are 

18 made available to such party. 

19 ‘‘(v) The Secretary shall make a determination of 

20 whether to correct the erroneous decision that is the sub21 ject of a request submitted under this subparagraph not 

22 later than 60 days after the date of the submission of such 

23 request, or if later, the submission of an amended request 

24 under clause (iv). The Secretary shall determine that the 

25 non-governmental party submitting the request— 


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1 ‘‘(I) has demonstrated that an erroneous deci2 sion clearly was made, correct such erroneous deci3 sion, and increase the fee schedule amount as of the 

4 first day of the next calendar quarter to reflect the 

5 correction of such erroneous decision; or 

6 ‘‘(II) has failed to demonstrate that an erro7 neous decision clearly was made and decline to 

8 change the fee schedule amount or national limita9 tion amount, as the case may be, 

10 and shall provide to the non-governmental party with a 

11 written explanation of the basis for such determination. 

12 ‘‘(vi) The Secretary may not reduce a fee schedule 

13 amount pursuant to a request under this subparagraph 

14 and may reduce such an amount only pursuant to section 

15 1842(b)(8). 

16 ‘‘(F)(i) There shall be no administrative or judicial 

17 review under section 1869, 1878, or otherwise of any de18 termination made under subparagraph (D) or (E). 

19 ‘‘(ii) Nothing in this paragraph shall be construed as 

20 precluding administrative or judicial review of determina21 tions of the amount of benefits that are available to a 

22 Medicare beneficiary in a particular case.’’. 

23 (b) EFFECTIVE DATE.—The amendment made by 

24 subsection (a) shall take effect on the date of the enact25 ment of this Act and shall apply to requests for corrections 


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1 submitted on or after such date, without regard to whether 

2 final regulations to carry out such amendment have been 

3 issued. 

4 SEC. 102. ISSUANCE OF REGULATIONS ON GAP-FILLING 

5 FOR MEDICARE FEE SCHEDULE FOR CLIN6 ICAL DIAGNOSTIC LABORATORY TESTS. 

7 Not later than one year after the date of the enact8 ment of this Act, the Secretary of Health and Human 

9 Services shall issue final regulations specifying how an ap10 propriate medicare administrative contractor (as defined 

11 in section 1874A(a)(3)(B) of the Social Security Act (42 

12 U.S.C. 1395kk–1(a)(3)(B)) shall apply a gap-filling meth13 odology in determining fee schedule amounts established 

14 under section 1833(h)(2)(A)(i) of such Act (42 U.S.C. 

15 1395l(h)(2)(A)(i)). Such regulations shall specify— 

16 (1) a process for ensuring that the resulting fee 

17 schedule amounts are fair, including a description of 

18 the types of data to be collected for use in such 

19 methodology and the minimum requirements such 

20 data shall meet in order to ensure that the data are 

21 valid, meaningful, and unbiased; 

22 (2) the principles to be employed to ensure that 

23 such data are statistically significant and alter24 natives to follow if statistically significant data are 

25 unavailable; 


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1 (3) the principles to be followed in using data 

2 to calculate fee schedule amounts, including prin3 ciples for excluding data that do not meet the re4 quirements of paragraph (1) and (2); 

5 (4) the methods the Secretary will use to over6 see the application of a gap filling methodology by 

7 such contractors and the remedies that will be avail8 able in cases in which such a contractor fails to com9 ply with regulatory requirements; and 

10 (5) a process that provides opportunities for the 

11 public to participate in the development of fee sched12 ule amounts through the application of gap-filling 

13 methodologies, including release to the public of data 

14 collection protocols and the data derived from such 

15 protocols with an opportunity for public comment 

16 thereon. 

17 SEC. 103. INCREASED TRANSPARENCY OF PROCESS FOR 

18 DETERMINING FEE SCHEDULE AMOUNTS 

19 FOR NEW TESTS. 

20 Section 1833(h)(8) of the Social Security Act (42 

21 U.S.C. 1395l(h)(8) is amended— 

22 (1) in subparagraph (B)(iii), by inserting ‘‘to be 

23 conducted in an inter-active format,’’ after ‘‘meet24 ing,’’; 

25 (2) in subparagraph (B)(iv)— 


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1 (A) by inserting ‘‘(I)’’ after ‘‘meeting,’’; 

2 (B) by striking ‘‘determination,’’ and in3 serting ‘‘determination and’’; and 

4 (C) by striking ‘‘a request for’’ and insert5 ing ‘‘(II) publishes in the Federal Register a 

6 notice of a period of not less than 60 days dur7 ing which the Secretary will receive’’; and 

8 (3) in subparagraph (C), by striking ‘‘Under 

9 the procedures’’ and inserting ‘‘In the regulations’’. 

10 SEC. 104. ADVANCE NOTICE OF CLINICAL DIAGNOSTIC LAB11 ORATORY TEST AMOUNTS BEING CONSID12 ERED FOR ADJUSTMENT UNDER INHERENT 

13 REASONABLENESS AUTHORITY. 

14 (a) LIMIT ON INHERENT REASONABLENESS AU15 THORITY.—Section 1842(b)(9)(A) of the Social Security 

16 Act (42 U.S.C. 1395u(b)(9)(A)) is amended by adding at 

17 the end the following: ‘‘Before publishing a proposed no18 tice under subparagraph (B) with respect to any clinical 

19 diagnostic laboratory test being considered for adjustment 

20 under paragraph (8), advance notice that such test is 

21 being considered for such an adjustment shall be provided 

22 to non-governmental parties (as defined in section 

23 1833(h)(9)(A)(iv)) at the meeting required by section 

24 1833(h)(8)(B)(iii), together with an opportunity for such 

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1 ments on the appropriateness of such an adjustment for 

2 such test.’’. 

3 (b) CONFORMING CHANGE.—Section 1833(h)(8)(B) 

4 of such Act (42 U.S.C. 1395l(h)(8)(B)) is amended by 

5 adding at the end the following: 

6 ‘‘At the meeting required by clause (iii), the Secretary 

7 shall provide advance notice of inherent reasonableness ad8 justments under section 1842(b)(8) that are being consid9 ered for clinical diagnostic laboratory tests, and afford an 

10 opportunity for non-governmental parties (as defined 

11 1833(h)(9)(A)(iv)) at the meeting to comment orally on 

12 the appropriateness of such an adjustment.’’. 

13 (c) EFFECTIVE DATE.—The amendments made by 

14 this section shall become effective on January 1, 2008, 

15 and shall apply to inherent reasonableness adjustments 

16 that have not been proposed as of such date. 

17 TITLE II—FUTURE REFORM 

18 SEC. 201. ESTABLISHMENT OF MEDICARE DEMONSTRATION 

19 PROJECT TO EVALUATE NEW APPROACHES 

20 TO CODING AND PAYMENT FOR CERTAIN MO21 LECULAR DIAGNOSTIC TESTS. 

22 (a) ESTABLISHMENT OF DEMONSTRATION.— 

23 (1) DEMONSTRATION OF NEW APPROACHES TO

24 CODING AND PAYMENT.—The Secretary of Health 

25 and Human Services (in this section referred to as 


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1 the ‘‘Secretary’’) shall establish a demonstration 

2 project under this section (in this section referred to 

3 as the ‘‘demonstration’’) to evaluate new approaches 

4 to coding and payment under the medicare program 

5 for clinical diagnostic laboratory tests included in 

6 the demonstration (in this section referred to as ‘‘in7 cluded tests’’). 

8 (2) DURATION.—The demonstration and any 

9 payment amounts assigned under the demonstration 

10 shall apply solely to claims submitted for included 

11 tests during the 12-calendar-quarter period that be12 gins with the first day of the first calendar quarter 

13 to begin at least 250 days after the date of the en14 actment of this Act. 

15 (3) SCOPE.—The demonstration shall apply on 

16 a national basis to included tests in all settings for 

17 which payment for such tests would (but for the 

18 demonstration) be made under the fee schedules and 

19 limitation amounts established under section 

20 1833(h) of the Social Security Act (42 U.S.C. 

21 1395l(h)). 

22 (4) ISSUANCE OF TEMPORARY HCPCS CODES; 

23 CONTINUED APPLICATION OF SUCH CODES.—The 

24 Secretary shall issue a temporary code or codes 

25 under the Health Care Procedure Coding System 


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1 (HCPCS) when needed for an included test, and 

2 such code or codes— 

3 (A) shall continue to apply to the test until 

4 a permanent code or codes is assigned; and 

5 (B) shall not cease to apply solely because 

6 the demonstration ends. 

7 (b) INCLUDED TESTS.— 

8 (1) ELIGIBLE TESTS.—A clinical diagnostic lab9 oratory test is eligible to be an included test under 

10 the demonstration if— 

11 (A) the test is a new or existing molecular 

12 diagnostic test that (but for its inclusion in the 

13 demonstration) could be paid under the fee 

14 schedules and national limitation amount estab15 lished under section 1833(h) of the Social Secu16 rity Act (42 U.S.C. 1395l(h)) for the test; and 

17 (B) there is the prospect— 

18 (i) for wide usage of the test in mul19 tiple geographic areas; and 

20 (ii) that development of a new code, 

21 or payment, or both, for the test under the 

22 demonstration will result in reduced ad23 ministrative complexity and improved effi24 ciency. 


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1 (2) INCLUDED TESTS.—A clinical diagnostic 

2 laboratory test shall be treated as an included test 

3 if— 

4 (A) an interested party submits a request 

5 to the standing panel established under sub6 section (c) that the test be included in the dem7 onstration; and 

8 (B) the standing panel determines that the 

9 test is an eligible test under paragraph (1); or 

10 (3) DEFINITIONS.—For purposes of this sec11 tion— 

12 (A) the term ‘‘molecular diagnostic test’’ 

13 means a clinical diagnostic laboratory test per14 formed on deoxyribonucleic (DNA), ribonucleic 

15 acid (RNA), or protein that is drawn from a 

16 human being or from a disease-causing orga17 nism for genomic or proteomic analysis; and 

18 (B) the term ‘‘interested party’’ means, 

19 with respect to a request for inclusion of molec20 ular diagnostic test in the demonstration, an in21 dividual entitled to benefits under title XVIII of 

22 the Social Security Act, a manufacturer of the 

23 test, a clinical laboratory offering the test, a 

24 professional society, the Centers for Medicare & 

25 Medicaid Services, a private payer for such test, 


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1 and a physician or other health care practi2 tioner. 

3 (c) STANDING PANEL.— 

4 (1) APPOINTMENT.—Not later than 60 days 

5 after the date of the enactment of this section, the 

6 Secretary shall appoint a standing panel (in this sec7 tion referred to as the ‘‘standing panel’’ or ‘‘panel’’) 

8 to determine whether a test is an included test and 

9 make recommendations to the Secretary on the ap10 propriate coding of, and payment for, designated 

11 clinical diagnostic laboratory tests under the dem12 onstration. 

13 (2) COMPOSITION OF PANEL.— 

14 (A) IN GENERAL.—The standing panel 

15 shall be comprised of 12 members. Two of such 

16 members shall be non-voting representatives of 

17 the Administrator of the Centers for Medicare 

18 & Medicaid Services. The Secretary shall ap19 point the other 10 members from— 

20 (i) organizations representing large 

21 clinical laboratories; 

22 (ii) organizations representing small 

23 clinical laboratories; 


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1 (iii) organizations representing physi2 cians with expertise in clinical diagnostic 

3 laboratory tests; 

4 (iv) organizations representing non5 physician laboratorians with expertise in 

6 such tests; 

7 (v) organizations representing manu8 facturers of such tests; 

9 (vi) organizations representing indi10 viduals entitled to benefits under title 

11 XVIII of the Social Security Act; 

12 (vii) organizations representing pri13 vate payers for such tests (but not more 

14 than one member may be appointed to rep15 resent such organizations); 

16 (viii) individuals with expertise in 

17 measuring resource utilization by clinical 

18 laboratories in performing tests; and 

19 (ix) individuals with other relevant ex20 pertise. 

21 (B) TERMS OF OFFICE.—Each member of 

22 the panel shall be appointed for the life of the 

23 panel, except that any individual appointed to 

24 fill a vacancy shall be appointed for the remain25 der of the term of the individual who is being 


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1 replaced. Any vacancy shall be filled in the 

2 same manner, and with a representative of the 

3 same category under subparagraph (A), as the 

4 individual being replaced. 

5 (3) RULES GOVERNING PANEL.— 

6 (A) IN GENERAL.—The panel shall elect its 

7 chair. A quorum shall be required to conduct 

8 the business of the panel, and eight members of 

9 the panel shall constitute a quorum. 

10 (B) COMPENSATION.—While serving on 

11 the business of the panel (including travel 

12 time), a member of the panel shall be entitled 

13 to compensation at the per diem equivalent rate 

14 provided for level IV of the Executive Schedule 

15 under section 5315 of title 5, United States 

16 Code, and while so serving away from home and 

17 the member’s regular place of business, a mem18 ber may be allowed travel expenses as author19 ized by the chair of the panel. 

20 (C) STAFFING.— 

21 (i) DETAILING.—The panel may seek 

22 such assistance and support of its duties 

23 from appropriate Federal Departments 

24 and agencies. 


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1 (ii) OUTSIDE EXPERTS.—The panel 

2 may retain the services of such outside ex3 perts as are necessary for the evaluation of 

4 a request under this section, and such ex5 perts shall not be voting members of the 

6 panel. 

7 (D) MEETINGS.—The panel shall meet at 

8 the call of the chair and at such intervals 

9 (which shall not be less than quarterly) as may 

10 be necessary for the conduct of its business. 

11 The agenda of each meeting and a notice of its 

12 date shall be published at least 30 days before 

13 the date the meeting occurs, and, except as pro14 vided in subparagraph (E), meetings of the 

15 panel shall be open to the public. 

16 (E) FACA.—The Federal Advisory Com17 mittee Act (5 U.S.C. App.) shall not apply to 

18 the panel, but the panel may close any portion 

19 of a meeting that could be closed if such Act 

20 applied. 

21 (F) TERMINATION OF PANEL.—The panel 

22 shall terminate not more than 180 days after 

23 the close of the demonstration. 

24 (d) FORM AND CONTENT OF REQUESTS FOR INCLU25 SION IN THE DEMONSTRATION.—A request for inclusion 


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1 of a clinical diagnostic laboratory test in the demonstra2 tion shall be submitted in such form, and shall contain 

3 such information as the standing panel may require, in4 cluding at least— 

5 (1) any coding and payment determinations re6 quested with respect to the test; and 

7 (2) any documentation in support of— 

8 (A) the eligibility of the test for inclusion 

9 in the demonstration; and 

10 (B) any coding and payment determina11 tions requested with respect to the test, includ12 ing data on the typical resources necessary to 

13 perform the test. 

14 The Secretary shall cause to have published in the 

15 Federal Register and on an appropriate internet site 

16 public notice of each such request. Such information 

17 shall be supplied to the Secretary by the standing 

18 panel. 

19 (e) CRITERIAFOR EVALUATING REQUESTS FOR DE20 TERMINATIONS IN CODING AND PAYMENT.— 

21 (1) IN GENERAL.—In determining whether a 

22 requested payment determination should be granted, 

23 and what the new payment amount for a test should 

24 be, the standing panel (in making its recommenda25 tions to the Secretary) and the Secretary (in deterVerDate Aug 31 2005 05:26 Mar 07, 2007 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H1321.IH H1321

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1 mining whether to grant such a determination) shall 

2 take into account typical resources necessary to per3 form the test, the expected impact of the test on, 

4 and value of the test to, patient care management, 

5 and such other factors as the standing panel and the 

6 Secretary, respectively, determine to be relevant to 

7 the determination. 

8 (2) STANDING PANEL.—Not later than 180 

9 days after the appointment of all of the members of 

10 the panel, the panel shall, after consultation with the 

11 Secretary, establish and make available to the pub12 lic— 

13 (A) standards and parameters for deter14 mining whether to recommend to the Secretary 

15 a coding or payment determination specified in 

16 a request for inclusion of a test in the dem17 onstration, which shall include a listing of data 

18 elements necessary to support a request and a 

19 standardized procedure for collecting and sub20 mitting data to the panel on typical resources 

21 necessary to perform a test; 

22 (B) policies and procedures for protecting 

23 the confidentiality of financial and other propri24 etary data submitted to the panel in support of 

25 a request; and 


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1 (C) resource intervals or resource bands 

2 (as described in subsection (g)(1)) that the 

3 panel recommends that the Secretary should 

4 use for the assignment of included tests under 

5 the demonstration. 

6 (3) SECRETARIAL DETERMINATIONS.—The Sec7 retary shall develop and make available to public on 

8 an internet site guidance documents on the stand9 ards and parameters that will be applied in making 

10 Secretarial determinations and on the resource inter11 vals or resource bands to be used under the dem12 onstration and on whether to grant a request for a 

13 payment or coding determination. Such guidance 

14 documents shall be developed, which shall be made 

15 available to the public at least 10 days before the be16 ginning of the demonstration, in a manner similar to 

17 the manner in which guidance documents are devel18 oped under section 701(h) of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 371(h)). 

20 (4) AUTHORITY TO RECOMMEND REVISIONS TO, 

21 AND TO REVISE, RESOURCE INTERVALS OR RE22 SOURCE BANDS.—Nothing in this section shall be 

23 construed as limiting the authority of the standing 

24 panel to recommend, or the Secretary to adopt, new 


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1 resource intervals or resource bands to accommodate 

2 changes in technology. 

3 (f) REVIEW PROCESS.— 

4 (1) REQUESTS FOR INCLUSION IN DEMONSTRA5 TION.—An interested party may submit a request 

6 for inclusion of a test in the demonstration to the 

7 standing panel at any time during a calendar year 

8 for which the demonstration is in effect, except that 

9 the standing panel may decline to review and make 

10 recommendations or determinations with respect to 

11 any request that would result in a requested coding 

12 or payment determination being effective for a pe13 riod of less than 4 calendar quarters. 

14 (2) RECOMMENDATIONS OF STANDING

15 PANEL.—The standing panel shall review each re16 quest for a coding or payment determination that is 

17 made with respect to an included test. Applying the 

18 standards and parameters developed under sub19 section (e)(2)(A), the panel shall make a rec20 ommendation to the Secretary with respect to each 

21 requested determination. 

22 (3) SECRETARIAL DETERMINATIONS.— 

23 (A) QUARTERLY DETERMINATIONS.—The 

24 Secretary shall make determinations on whether 

25 to grant requested coding and payment deterVerDate Aug 31 2005 05:26 Mar 07, 2007 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H1321.IH H1321

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1 minations on a quarterly basis, but is not re2 quired to make such a determination for every 

3 request made (or with respect to which a rec4 ommendation is received from the standing 

5 panel) during a particular quarter. 

6 (B) TIME FRAMES FOR DETERMINA7 TIONS.—Determinations of the Secretary shall 

8 be made in a timely manner in accordance with 

9 time frames developed by the standing panel 

10 taking into account factors such as when a re11 quest (and a recommendation with respect to 

12 the request) is made during a quarter, the par13 ticular type of test involved, and the staffing 

14 and resources that may be required to review 

15 the request. 

16 (g) PAYMENT METHODOLOGY.— 

17 (1) IN GENERAL.—Included tests shall be paid 

18 in accordance with a methodology, developed by the 

19 standing panel, that establishes resource intervals or 

20 resource bands in a manner similar to those that are 

21 used as new technology ambulatory payment classi22 fication groups for hospital outpatient services under 

23 section 1833(t) of the Social Security Act (42 

24 U.S.C. 1395l(t)), with a test being assigned to the 

25 interval or band that most closely approximates the 


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1 typical resources necessary for a laboratory to per2 form the test. Tests that are included tests for pur3 poses of this section shall be excluded from any dem4 onstration project under section 1847(e) of such Act 

5 (42 U.S.C. 1395w–3(e)). 

6 (2) PANEL RECOMMENDATIONS; SECRETARIAL

7 DETERMINATIONS.— 

8 (A) RECOMMENDATIONS; SECRETARIAL

9 DETERMINATIONS.—The standing panel shall 

10 recommend to the Secretary a resource interval 

11 or resource band to which an included test 

12 should be assigned, and the Secretary may as13 sign such test to such band or interval or to an14 other band or interval the Secretary determines 

15 to more closely approximate the typical re16 sources necessary to perform the test. 

17 (B) EXPLANATION OF DETERMINATION

18 THAT DIFFERS FROM RECOMMENDATION.—If 

19 the Secretary assigns a test to an interval or 

20 band other than that recommended by the 

21 standing panel, the Secretary shall provide a 

22 detailed written explanation of the reasons for 

23 determining that such other interval or band is 

24 more appropriate. 


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1 (3) EFFECTIVE DATE OF SECRETARIAL DETER2 MINATION.—A determination by the Secretary with 

3 respect to a coding or payment determination for an 

4 included test shall become effective as of the first 

5 day of the calendar quarter following the calendar 

6 quarter in which the determination is made. 

7 (4) PERIODIC LOOK-BACKS OF INTERVAL OR

8 BAND ASSIGNMENTS.—At the request of the inter9 ested party that submitted the initial request for a 

10 test to be included in the demonstration or of a 

11 member of the standing panel, the standing panel 

12 may review the appropriateness of the payment in13 terval or band to which the test is assigned and 

14 make a recommendation to the Secretary that the 

15 assignment be changed. The Secretary may accept 

16 or reject such recommendation, and if the rec17 ommendation is rejected, the Secretary shall provide 

18 a detailed explanation of the reasons for such rejec19 tion. 

20 (5) PUBLICATION OF DETERMINATIONS.—The 

21 Secretary shall publish determinations under this 

22 subsection in a timely manner on an appropriate 

23 internet site. 

24 (h) REPORTS TO CONGRESS.— 


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1 (1) IN GENERAL.—The Secretary shall submit 

2 interim and final reports on the demonstration to 

3 the Committees on Ways and Means and Energy 

4 and Commerce of the House of Representatives and 

5 the Committee on Finance of the Senate. The in6 terim report shall be submitted not later than the 

7 close of the second year of the demonstration, and 

8 the final report shall be submitted not later than 

9 180 days after the close of the demonstration. 

10 (2) CONTENT OF REPORTS.—The reports sub11 mitted under paragraph (1) shall include interim 

12 and final— 

13 (A) determinations on whether coding and 

14 payment assignments under the demonstration 

15 provide for— 

16 (i) more equitable and accurate pay17 ment for included tests; and 

18 (ii) reduced administrative complexity, 

19 improved efficiency, and improved access 

20 to care; and 

21 (B) recommendations on— 

22 (i) whether the alternative mechanism 

23 for determining payment and coding for in24 cluded tests should be continued for such 


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1 tests beyond the 12-calendar-quarter pe2 riod the demonstration is in effect; and 

3 (ii) whether the application of such 

4 mechanism should be expanded to include 

5 other new clinical diagnostic laboratory 

6 tests for which payment would otherwise 

7 be made under the fee schedules and limits 

8 established under section 1833(h) of the 

9 Social Security Act (42 U.S.C. 1395l(h)). 

10 (3) COMMENTS BY STANDING PANEL.—The 

11 standing panel shall submit comments to the com12 mittees referred to in paragraph (1) on the interim 

13 and final reports of the Secretary. 

14 (i) AUTHORIZATION OF APPROPRIATIONS.—There 

15 are authorized to be appropriated for each of fiscal years 

16 2008 through 2013, such sums as may be necessary to 

17 carry out this section. 

Æ 


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