II 

114TH CONGRESS 

2D SESSION S. 4 

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

rules in case of competition for diabetic testing strips, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 16, 2016 

Mr. COATS (for himself and Mr. WARNER) introduced the following bill; which 

was read twice and referred to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act in order 

to strengthen rules 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 Act of 2016’’. 

6 SEC. 2. STRENGTHENING RULES IN CASE OF COMPETITION 

7 FOR DIABETIC TESTING STRIPS. 

8 (a) SPECIAL RULE IN CASE OF COMPETITION FOR

9 DIABETIC TESTING STRIPS.— 

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

2 1847(b) of the Social Security Act (42 U.S.C. 

3 1395w–3(b)) is amended— 

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

5 second sentence and inserting the following new 

6 sentence: ‘‘With respect to bids to furnish such 

7 types of products on or after January 1, 2019, 

8 the volume for such types of products shall be 

9 determined by the Secretary through the use of 

10 multiple sources of data, including market 

11 based data measuring sales of diabetic testing 

12 strip products described in section 1861(n) that 

13 are not exclusively sold by, and marketed under 

14 the name of, a single retailer that is not the 

15 manufacturer of such products, from mail 

16 order, non-mail order, Medicare, and non-Medi17 care markets.’’; and 

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

19 subparagraphs: 

20 ‘‘(C) DEMONSTRATION OF ABILITY TO

21 FURNISH TYPES OF DIABETIC TESTING STRIP

22 PRODUCTS.—With respect to bids to furnish di23 abetic testing strip products on or after Janu24 ary 1, 2019, under the program described in 

25 subparagraph (A), the Secretary shall reject a 

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1 bid submitted by an entity if the entity does not 

2 attest to the Secretary and demonstrate, 

3 through letters of intent with manufacturers, 

4 wholesalers, or other suppliers, or other evi5 dence as the Secretary may specify, that the en6 tity has the ability to obtain an inventory of the 

7 types and quantities of diabetic testing strip 

8 products that will allow the entity to furnish 

9 such products in a manner consistent with its 

10 bid. 

11 ‘‘(D) USE OF UNLISTED TYPES IN CAL12 CULATION OF PERCENTAGE.—With respect to 

13 bids to furnish diabetic testing strip products 

14 on or after January 1, 2019, in determining 

15 under subparagraph (A) whether a bid sub16 mitted by an entity under such subparagraph 

17 covers 50 percent (or such higher percentage as 

18 the Secretary may specify) of all types of dia19 betic testing strip products, the Secretary may 

20 not attribute a percentage to types of diabetic 

21 testing strip products that the Secretary does 

22 not identify by brand, model, and market share 

23 volume. 

24 ‘‘(E) ADHERENCE TO DEMONSTRATION.— 

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1 ‘‘(i) IN GENERAL.—In the case of an 

2 entity that is furnishing diabetic testing 

3 strip products on or after January 1, 

4 2019, under a contract entered into under 

5 the competition conducted pursuant to 

6 paragraph (1), the Secretary shall estab7 lish a process to monitor, on an ongoing 

8 basis, the extent to which such entity con9 tinues to cover the product types included 

10 in the entity’s bid. 

11 ‘‘(ii) TERMINATION.—If the Secretary 

12 determines that an entity described in 

13 clause (i) fails to maintain in inventory, or 

14 otherwise maintain ready access to through 

15 requirements contracts or otherwise, a type 

16 of product included in the entity’s bid, the 

17 Secretary may terminate such contract un18 less the Secretary finds that the failure of 

19 the entity to maintain inventory of, or 

20 ready access to, the product is the result of 

21 the discontinuation of the product by the 

22 product manufacturer or a market-wide 

23 shortage of the product.’’. 

24 (b) CODIFYING AND EXPANDING ANTI-SWITCHING

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

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

2 further amended— 

3 (1) by redesignating paragraph (11) as para4 graph (12); and 

5 (2) by inserting after paragraph (10) the fol6 lowing new paragraph: 

7 ‘‘(11) ADDITIONAL SPECIAL RULES IN CASE OF

8 COMPETITION FOR DIABETIC TESTING STRIPS.— 

9 ‘‘(A) IN GENERAL.—With respect to an en10 tity that is furnishing diabetic testing strip 

11 products to individuals under a contract entered 

12 into under the competitive acquisition program 

13 established under this section, the entity shall 

14 furnish to each individual a brand of such 

15 strips that is compatible with the home blood 

16 glucose monitor selected by the individual. 

17 ‘‘(B) PROHIBITION ON INFLUENCING AND

18 INCENTIVIZING.—An entity described in sub19 paragraph (A) may not attempt to influence or 

20 incentivize an individual to switch the brand of 

21 glucose monitor or diabetic testing strip product 

22 selected by the individual, including by— 

23 ‘‘(i) persuading, pressuring, or advis24 ing the individual to switch; or 

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1 ‘‘(ii) furnishing information about al2 ternative brands to the individual where 

3 the individual has not requested such in4 formation. 

5 ‘‘(C) PROVISION OF INFORMATION.— 

6 ‘‘(i) STANDARDIZED INFORMATION.— 

7 Not later than January 1, 2019, the Sec8 retary shall develop and make available to 

9 entities described in subparagraph (A) 

10 standardized information that describes 

11 the rights of an individual with respect to 

12 such an entity. The information described 

13 in the preceding sentence shall include in14 formation regarding— 

15 ‘‘(I) the requirements established 

16 under subparagraphs (A) and (B); 

17 ‘‘(II) the right of the individual 

18 to purchase diabetic testing strip 

19 products from another mail order sup20 plier of such products or a retail phar21 macy if the entity is not able to fur22 nish the brand of such product that is 

23 compatible with the home blood glu24 cose monitor selected by the indi25 vidual; and 

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1 ‘‘(III) the right of the individual 

2 to return diabetic testing strip prod3 ucts furnished to the individual by the 

4 entity. 

5 ‘‘(ii) REQUIREMENT.—With respect to 

6 diabetic testing strip products furnished on 

7 or after the date on which the Secretary 

8 develops the standardized information 

9 under clause (i), an entity described in 

10 subparagraph (A) may not communicate 

11 directly to an individual until the entity 

12 has verbally provided the individual with 

13 such standardized information. 

14 ‘‘(D) ORDER REFILLS.—With respect to 

15 diabetic testing strip products furnished on or 

16 after January 1, 2019, the Secretary shall re17 quire an entity furnishing diabetic testing strip 

18 products to an individual to contact and receive 

19 a request from the individual for such products 

20 not more than 14 days prior to dispensing a re21 fill of such products to the individual.’’. 

22 (c) IMPLEMENTATION; NON-APPLICATION OF THE

23 PAPERWORK REDUCTION ACT.— 

24 (1) IMPLEMENTATION.—Notwithstanding any 

25 other provision of law, the Secretary of Health and 

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1 Human Services may implement the provisions of, 

2 and amendments made by, this section by program 

3 instruction or otherwise. 

4 (2) NON-APPLICATION OF THE PAPERWORK RE5 DUCTION ACT.—Chapter 35 of title 44, United 

6 States Code (commonly referred to as the ‘Paper7 work Reduction Act of 1995’) shall not apply to this 

8 section or the amendments made by this section. 

Æ 

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