I 

113TH CONGRESS 

2D SESSION H. R. 5808 

To amend title XVIII of the Social Security Act in order to strengthen 

rules applied in case of competition for diabetic testing strips, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 8, 2014 

Ms. DEGETTE (for herself and Mr. REED) 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 in order 

to strengthen rules applied in case of competition for 

diabetic testing strips, and for other purposes. 

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 ‘‘Protecting Access to 

5 Diabetes Supplies of 2014’’. 


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1 SEC. 2. STRENGTHENING RULES APPLIED IN CASE OF COM2 PETITION FOR DIABETIC TESTING STRIPS. 

3 (a) SPECIAL RULE APPLIED IN CASE OF COMPETI4 TION FOR DIABETIC TESTING STRIPS.— 

5 (1) IN GENERAL.—Paragraph (10) of section 

6 1847(b) of the Social Security Act (42 U.S.C. 

7 1395w–3(b)) is amended— 

8 (A) in subparagraph (A), by striking the 

9 second sentence and inserting the following new 

10 sentence: ‘‘The volume for such types of prod11 ucts shall be determined through the use of 

12 multiple sources of data that measure consump13 tion and utilization of diabetic testing strips 

14 among individuals in the United States.’’; and 

15 (B) by adding at the end the following new 

16 subparagraphs: 

17 ‘‘(C) DEMONSTRATION OF ABILITY TO

18 FURNISH TYPES OF DIABETIC TESTING

19 STRIPS.—With respect to the program de20 scribed in subparagraph (A), the Secretary shall 

21 reject a bid submitted by an entity if the entity 

22 does not, as part of the demonstration to the 

23 Secretary described in such subparagraph sub24 mitted by the entity, demonstrate that the enti25 ty has an ability to furnish the types of diabetic 

26 testing strips included in its bid, including an 


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1 ability to obtain and maintain an inventory of 

2 such strips by volume in a manner consistent 

3 with its bid. 

4 ‘‘(D) USE OF UNLISTED TYPES IN CAL5 CULATION OF PERCENTAGE.—In determining 

6 under subparagraph (A) whether a bid sub7 mitted by an entity under such subparagraph 

8 covers 50 percent (or such higher percentage as 

9 the Secretary may specify) of all types of dia10 betic testing strip products, the Secretary may 

11 not attribute a percentage to types of diabetic 

12 testing strips that the Secretary does not pro13 vide the entity with the option to identify by 

14 type and market share volume. 

15 ‘‘(E) CONTRACT REQUIREMENT.—Any con16 tract entered into with an entity for diabetic 

17 testing strips under the competition conducted 

18 pursuant to paragraph (1) shall include a re19 quirement that the entity offers, makes avail20 able to, and maintains in inventory of (or other21 wise has ready access to, such as through pur22 chasing contracts) each of the types of diabetic 

23 testing strip products that is included in the bid 

24 submitted by the entity. In the case that an en25 tity enters into such a contract with the SecVerDate Sep 11 2014 02:15 Dec 09, 2014 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.IH H5808

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1 retary and fails to fulfill the requirement de2 scribed in the preceding sentence, the Secretary 

3 shall terminate such contract. 

4 ‘‘(F) MONITORING ADHERENCE TO DEM5 ONSTRATION.—The Secretary shall establish a 

6 process to monitor, on an ongoing basis, the ex7 tent to which an entity that enters into a con8 tract with the Secretary for diabetic testing 

9 strips under the competition conducted pursu10 ant to paragraph (1) adheres to the demonstra11 tion that the entity provided to the Secretary 

12 under subparagraph (A).’’. 

13 (2) CONFORMING AMENDMENT.—Section 

14 1847(b)(3)(A) of the Social Security Act (42 U.S.C. 

15 1395w–3(b)(3)(A)) is amended by adding at the end 

16 the following new sentence: ‘‘In the case that such 

17 a contract is for diabetic testing strips, such con18 tract shall include the information required under 

19 paragraph (10)(E).’’ 

20 (b) CODIFYING AND EXPANDING ANTI-SWITCHING

21 RULE.—Section 1847(b) of the Social Security Act (42 

22 U.S.C. 1395w–3(b)), as amended by subsection (a)(1), is 

23 further amended— 

24 (1) by redesignating paragraph (11) as para25 graph (12); and 


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1 (2) by inserting after paragraph (10) the fol2 lowing new paragraph: 

3 ‘‘(11) ADDITIONAL SPECIAL RULE IN CASE OF

4 COMPETITION FOR DIABETIC TESTING STRIPS.— 

5 ‘‘(A) IN GENERAL.—With respect to dia6 betic testing strips furnished by an entity to an 

7 individual under the competitive acquisition 

8 program established under this section, the en9 tity shall furnish to the individual the brand of 

10 such strips that is compatible with the home 

11 blood glucose monitor selected by the individual. 

12 ‘‘(B) PROHIBITION ON INFLUENCING AND

13 INCENTIVIZING.—An entity described in sub14 paragraph (A) may not attempt to influence or 

15 incentivize the individual described in such sub16 paragraph to switch the brand of glucose mon17 itor or testing strips selected by the individual, 

18 including by— 

19 ‘‘(i) persuading, pressuring, or advis20 ing the individual to switch such brand; or 

21 ‘‘(ii) furnishing information about al22 ternative brands to the individual in the 

23 case that the individual has not requested 

24 such information. 


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1 ‘‘(C) PROVISION OF INFORMATION.—An 

2 entity described in subparagraph (A) may not 

3 communicate directly to an individual described 

4 in such subparagraph until the entity has ver5 bally provided the individual with standardized 

6 information, to be supplied to the entity by the 

7 Secretary, that describes the rights of the indi8 vidual with respect to the entity. The informa9 tion described in the preceding sentence shall 

10 include information regarding— 

11 ‘‘(i) the requirements established in 

12 subparagraphs (A) and (B); 

13 ‘‘(ii) the right of the individual to con14 tact other mail order suppliers of diabetic 

15 testing strips or to purchase such strips at 

16 a retail pharmacy in the case that the enti17 ty is not able to furnish the brand of such 

18 strips that is compatible with the home 

19 blood glucose monitor selected by the indi20 vidual; and 

21 ‘‘(iii) the right of the individual de22 scribed in subparagraph (D) to reject dia23 betic testing strips furnished to the indi24 vidual by the entity. 


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1 ‘‘(D) INDIVIDUALS ALLOWED TO SWITCH

2 FROM UNWANTED PRODUCTS.— 

3 ‘‘(i) IN GENERAL.—The Secretary 

4 shall establish a process under which an 

5 individual furnished with diabetic testing 

6 strips under the competitive acquisition 

7 program established under this section 

8 may reject the strips by notification, in9 cluding notification by telephone or elec10 tronic mail, to the supplier and to the Sec11 retary. 

12 ‘‘(ii) CONSEQUENCES OF REJEC13 TION.—In the case that an individual re14 jects diabetic testing strips under clause 

15 (i)— 

16 ‘‘(I) any payment made to the 

17 supplier under this title for a portion 

18 of such strips furnished for use during 

19 the period beginning with the date on 

20 which the individual rejects the strips 

21 shall be recovered by the Secretary; 

22 and 

23 ‘‘(II) the individual may obtain 

24 different diabetic testing strips from a 

25 supplier, and the Secretary shall procVerDate Sep 11 2014 02:15 Dec 09, 2014 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.IH H5808

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1 ess a claim for such different diabetic 

2 testing strips without regard to any 

3 benefit or coverage limitations arising 

4 from the fact that a claim has already 

5 been submitted and payment made for 

6 the rejected diabetic testing strips. 

7 ‘‘(iii) PROHIBITION ON FUTURE

8 CLAIMS.—In the case that an individual re9 jects diabetic testing strips under clause 

10 (i), the supplier who supplied the rejected 

11 diabetic testing strips to the individual 

12 may not submit additional claims for pay13 ment on behalf of the individual for the 

14 type or brand of diabetic testing strips so 

15 rejected by the individual, unless the indi16 vidual makes a separate expression of con17 sent to the supplier to be furnished with 

18 such type or brand of diabetic testing 

19 strips by the supplier.’’. 

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

21 this section shall apply with respect to diabetic testing 

22 strips furnished on or after July 1, 2016. 

Æ 


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