II 

114TH CONGRESS 

1ST SESSION S. 804 

To amend title XVIII of the Social Security Act to specify coverage of 

continuous glucose monitoring devices, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 19, 2015 

Ms. COLLINS (for herself and Mrs. SHAHEEN) 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 to specify 

coverage of continuous glucose monitoring devices, 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 ‘‘Medicare CGM Access 

5 Act of 2015’’. 

6 SEC. 2. MEDICARE COVERAGE OF CONTINUOUS GLUCOSE 

7 MONITORING DEVICES. 

8 (a) IN GENERAL.—Section 1861 of the Social Secu9 rity Act (42 U.S.C. 1395x) is amended— 

10 (1) in subsection (s)(2)— 


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1 (A) in subparagraph (EE), by striking 

2 ‘‘and’’ at the end; 

3 (B) in subparagraph (FF), by adding 

4 ‘‘and’’; and 

5 (C) by adding at the end the following new 

6 subparagraph: 

7 ‘‘(GG) continuous glucose monitoring devices 

8 (as defined in subsection (iii)(1)) furnished to a 

9 CGM qualified individual (as defined in subsection 

10 (iii)(2));’’; and 

11 (2) by adding at the end the following new sub12 section: 

13 ‘‘Continuous Glucose Monitoring Device; CGM Qualified 

14 Individual 

15 ‘‘(iii)(1)(A) The term ‘continuous glucose monitoring 

16 device’ means a class III medical device approved by the 

17 Food and Drug Administration that continuously senses 

18 or continuously monitors and trends glucose levels in body 

19 fluid. 

20 ‘‘(B) Such term applies to such medical device— 

21 ‘‘(i) as a stand-alone product; 

22 ‘‘(ii) when integrated with an insulin pump; or 

23 ‘‘(iii) as an integral component of any other 

24 medical device cleared or approved by the Food and 


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1 Drug Administration, such as artificial pancreas de2 vice systems. 

3 ‘‘(C) With respect to a continuous glucose monitoring 

4 device that is described in clause (ii) or (iii) of subpara5 graph (B), the Secretary shall treat an insulin pump or 

6 other medical device that has a continuous glucose moni7 toring device as an integrated or integral component as 

8 a single medical device. 

9 ‘‘(D) Such term includes components, accessories, 

10 and supplies that are necessary and related to the oper11 ation of the class III medical device, such as sensors, 

12 transmitters, receivers, and requisite software. 

13 ‘‘(2) The term ‘CGM qualified individual’ means any 

14 of the following: 

15 ‘‘(A) An individual with Type I diabetes— 

16 ‘‘(i) who is following an intensive insulin 

17 treatment regimen that consists of 3 or more 

18 insulin injections per day or the use of a sub19 cutaneous insulin infusion pump; 

20 ‘‘(ii) subject to paragraph (3), whose at21 tending physician certifies that the individual’s 

22 condition cannot be safely and effectively man23 aged with self-monitoring of blood glucose; and 

24 ‘‘(iii) who— 


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1 ‘‘(I) has been unable to achieve opti2 mum glycemic control in accordance with 

3 evidence-based guidelines; or 

4 ‘‘(II) has experienced hypoglycemia 

5 unawareness or frequent hypoglycemic epi6 sodes. 

7 ‘‘(B) An individual not described in subpara8 graph (A) who meets such other medical criteria as 

9 the Secretary may specify for the furnishing of a 

10 continuous glucose monitoring device based on avail11 able medical evidence and taking into account any 

12 anticipated pathway to the development of artificial 

13 pancreas device systems. 

14 ‘‘(C) An individual with diabetes who has been 

15 regularly using a continuous glucose monitoring de16 vice before becoming entitled to, or enrolling in, part 

17 A, or enrolling in part B, or both. 

18 ‘‘(3) For purposes of a certification by an attending 

19 physician described in paragraph (2)(A)(ii), such certifi20 cation shall not be required more frequently than once 

21 every 3 years.’’. 

22 (b) PAYMENT.— 

23 (1) IN GENERAL.—Section 1833(a)(1) of the 

24 Social Security Act (42 U.S.C. 1395l(a)(1)) is 

25 amended— 


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1 (A) by striking ‘‘and’’ before ‘‘(Z)’’; and 

2 (B) by inserting before the semicolon at 

3 the end the following: ‘‘, and (AA) with respect 

4 to continuous glucose monitoring devices under 

5 section 1861(s)(2)(GG)), the amount paid shall 

6 be an amount equal to 80 percent of the 

7 amount determined under the fee schedule es8 tablished under section 1834(r)’’. 

9 (2) CONFORMING AMENDMENT.—Section 1834 

10 of the Social Security Act (42 U.S.C. 1395m) is 

11 amended by adding at the end the following new 

12 subsection: 

13 ‘‘(r) FEE SCHEDULE FOR CONTINUOUS GLUCOSE

14 MONITORING DEVICES.— 

15 ‘‘(1) ESTABLISHMENT.— 

16 ‘‘(A) IN GENERAL.—With respect to con17 tinuous glucose monitoring devices (as defined 

18 in section 1861(iii)(1)) furnished during a year, 

19 the amount of payment under this part for such 

20 devices shall be determined under a fee schedule 

21 established by the Secretary in accordance with 

22 this subsection. 

23 ‘‘(B) CLARIFICATION OF APPLICATION OF

24 FEE SCHEDULE TO DEVICES HAVING CGM AS AN

25 INTEGRAL COMPONENT.—Payment shall be calVerDate Sep 11 2014 07:10 Mar 25, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S804.IS S804

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1 culated and made under the fee schedule estab2 lished under this subsection for any insulin 

3 pump or other medical device that has a contin4 uous glucose monitoring device as an integrated 

5 or integral component. 

6 ‘‘(2) INITIAL PAYMENT RATE.— 

7 ‘‘(A) IN GENERAL.—With respect to each 

8 distinct type of continuous glucose monitoring 

9 device, the Secretary shall establish an initial 

10 payment rate under the fee schedule established 

11 under this subsection for the first year, which 

12 may be a partial year, during which payment 

13 may be made for such continuous glucose moni14 toring device under this part. 

15 ‘‘(B) DATA.—With respect to a continuous 

16 glucose monitoring device, the initial payment 

17 rate under subparagraph (A) shall— 

18 ‘‘(i) reflect market rates for such de19 vice; and 

20 ‘‘(ii) take into account the most recent 

21 available data on prices for such device. 

22 ‘‘(C) ACCOUNTING FOR DIFFERENCES IN

23 FUNCTIONALITIES AMONG VARIOUS CGM DE24 VICES.—For purposes of the initial payment 

25 rates established under subparagraph (A), the 


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1 Secretary shall establish a new HCPCS code for 

2 each distinct type of class III medical device 

3 cleared or approved by the Food and Drug Ad4 ministration that includes a continuous glucose 

5 monitoring device, such as a medical device de6 scribed in clause (ii) or (iii) of section 

7 1861(iii)(1)(B). Such HCPCS codes shall dis8 tinguish among the different functionalities of 

9 such devices in a manner that reflects the clas10 sifications of the Food and Drug Administra11 tion in clearing or approving such devices. 

12 ‘‘(3) UPDATES TO PAYMENT RATES.—With re13 spect to each year beginning after the year, or par14 tial year, referred to in paragraph (2)(A) during 

15 which an initial payment rate is established for a 

16 distinct continuous glucose monitoring device, the 

17 Secretary shall provide for annual updates to the 

18 payment rate under the fee schedule established 

19 under this subsection for each such device for the 

20 preceding year by the percentage increase in the 

21 consumer price index for all urban consumers 

22 (United States city average) for the 12-month period 

23 ending with June of the preceding year. 

24 ‘‘(4) ADJUSTMENT FOR GEOGRAPHIC VARI25 ATIONS.—The Secretary shall provide for adjustVerDate Sep 11 2014 07:10 Mar 25, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S804.IS S804

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1 ments to the payment rates under the fee schedule 

2 established under this subsection to take into ac3 count geographic variations in the prices of contin4 uous glucose monitoring devices.’’. 

5 (c) ENSURING BENEFICIARY ACCESS TO APPRO6 PRIATE COMPONENTS.—Section 1847(a) of the Social Se7 curity Act (42 U.S.C. 1395w–3(a)) is amended by adding 

8 at the end the following new paragraph: 

9 ‘‘(8) ENSURING BENEFICIARY ACCESS TO AP10 PROPRIATE COMPONENTS.— 

11 ‘‘(A) IN GENERAL.—In carrying out the 

12 programs under this section with respect to glu13 cose meters required for continuous glucose 

14 monitoring devices (as defined in section 

15 1861(iii)(1)) that are furnished to CGM quali16 fied individuals (as defined in section 

17 1861(iii)(2)), the Secretary shall ensure that 

18 such CGM qualified individuals are furnished 

19 the brand of diabetic testing supplies (as de20 fined in subparagraph (B)) that function with 

21 such continuous glucose monitoring devices, 

22 such as in the case where there is only one 

23 brand of glucose meter that is compatible with 

24 a particular continuous glucose monitoring de25 vice. 


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1 ‘‘(B) DEFINITION.—In this paragraph, the 

2 term ‘diabetic testing supplies’ means glucose 

3 meters and diabetic testing strips.’’. 

4 (d) EFFECTIVE DATE; RULEMAKING.— 

5 (1) EFFECTIVE DATE.—The amendments made 

6 by this section shall apply to items and services fur7 nished on or after January 1, 2016. 

8 (2) RULEMAKING.— 

9 (A) IN GENERAL.—The Secretary of 

10 Health and Human Services (in this paragraph 

11 referred to as the ‘‘Secretary’’) shall implement 

12 the amendments made by this section through 

13 notice and comment rulemaking. 

14 (B) CONSULTATION.—As part of the rule15 making process under subparagraph (A), the 

16 Secretary shall consult with national organiza17 tions representing individuals with diabetes, 

18 physicians with relevant clinical expertise in en19 docrinology, and other relevant stakeholders to 

20 develop clinical criteria for the determination of 

21 whether an individual qualifies as having Type 

22 I diabetes under section 1861(iii)(2)(A) of the 

23 Social Security Act, as added by subsection 

24 (a)(2). Not later than 60 days after the date of 

25 enactment of this Act, the Secretary shall conVerDate Sep 11 2014 07:10 Mar 25, 2015 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S804.IS S804

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1 vene a meeting of those stakeholders to develop 

2 consensus recommendations for such clinical 

3 criteria. The Secretary shall take such rec4 ommendations into account in implementing the 

5 amendments made by this section. 

Æ 


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