II 

113TH CONGRESS 

2D SESSION S. 2689 

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 

JULY 30, 2014 

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 2014’’. 

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 mon18 itors and trends glucose levels in body fluid. 

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

20 ‘‘(i) as a stand-alone product; 

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

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

23 medical device cleared or approved by the Food and 

24 Drug Administration, such as artificial pancreas de25 vice systems. 


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

2 device that is described in clause (ii) or (iii) of subpara3 graph (B), the Secretary shall treat an insulin pump or 

4 other medical device that has a continuous glucose moni5 toring device as an integrated or integral component as 

6 a single medical device. 

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

8 and supplies that are necessary and related to the oper9 ation of the class III medical device, such as sensors, 

10 transmitters, receivers, and requisite software. 

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

12 of the following: 

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

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

15 treatment regimen that consists of 3 or more 

16 insulin injections per day or the use of a sub17 cutaneous insulin infusion pump; 

18 ‘‘(ii) subject to paragraph (3), whose at19 tending physician certifies that the individual’s 

20 condition cannot be safely and effectively man21 aged with self-monitoring of blood glucose; and 

22 ‘‘(iii) who— 

23 ‘‘(I) has been unable to achieve opti24 mum glycemic control in accordance with 

25 evidence-based guidelines; or 


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1 ‘‘(II) has experienced hypoglycemia 

2 unawareness or frequent hypoglycemic epi3 sodes. 

4 ‘‘(B) An individual not described in subpara5 graph (A) who meets such other medical criteria as 

6 the Secretary may specify for the furnishing of a 

7 continuous glucose monitoring device based on avail8 able medical evidence and taking into account any 

9 anticipated pathway to the development of artificial 

10 pancreas device systems. 

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

12 regularly using a continuous glucose monitoring de13 vice before becoming entitled to, or enrolling in, part 

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

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

16 physician described in paragraph (2)(A)(ii), such certifi17 cation shall not be required more frequently than once 

18 every 3 years.’’. 

19 (b) PAYMENT.— 

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

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

22 amended— 

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

24 (B) by inserting before the semicolon at 

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


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1 to continuous glucose monitoring devices under 

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

3 be an amount equal to 80 percent of the 

4 amount determined under the fee schedule es5 tablished under section 1834(p)’’. 

6 (2) CONFORMING AMENDMENT.—Section 1834 

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

8 amended by adding at the end the following new 

9 subsection: 

10 ‘‘(p) FEE SCHEDULE FOR CONTINUOUS GLUCOSE

11 MONITORING DEVICES.— 

12 ‘‘(1) ESTABLISHMENT.— 

13 ‘‘(A) IN GENERAL.—With respect to con14 tinuous glucose monitoring devices (as defined 

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

16 the amount of payment under this part for such 

17 devices shall be determined under a fee schedule 

18 established by the Secretary in accordance with 

19 this subsection. 

20 ‘‘(B) CLARIFICATION OF APPLICATION OF

21 FEE SCHEDULE TO DEVICES HAVING CGM AS AN

22 INTEGRAL COMPONENT.—Payment shall be cal23 culated and made under the fee schedule estab24 lished under this subsection for any insulin 

25 pump or other medical device that has a continVerDate Mar 15 2010 23:35 Aug 05, 2014 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2689.IS S2689

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1 uous glucose monitoring device as an integrated 

2 or integral component. 

3 ‘‘(2) INITIAL PAYMENT RATE.— 

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

5 distinct type of continuous glucose monitoring 

6 device, the Secretary shall establish an initial 

7 payment rate under the fee schedule established 

8 under this subsection for the first year, which 

9 may be a partial year, during which payment 

10 may be made for such continuous glucose moni11 toring device under this part. 

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

13 glucose monitoring device, the initial payment 

14 rate under subparagraph (A) shall— 

15 ‘‘(i) reflect market rates for such de16 vice; and 

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

18 available data on prices for such device. 

19 ‘‘(C) ACCOUNTING FOR DIFFERENCES IN

20 FUNCTIONALITIES AMONG VARIOUS CGM DE21 VICES.—For purposes of the initial payment 

22 rates established under subparagraph (A), the 

23 Secretary shall establish a new HCPCS code for 

24 each distinct type of class III medical device 

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1 ministration that includes a continuous glucose 

2 monitoring device, such as a medical device de3 scribed in clause (ii) or (iii) of section 

4 1861(iii)(1)(B). Such HCPCS codes shall dis5 tinguish among the different functionalities of 

6 such devices in a manner that reflects the clas7 sifications of the Food and Drug Administra8 tion in clearing or approving such devices. 

9 ‘‘(3) UPDATES TO PAYMENT RATES.—With re10 spect to each year beginning after the year, or par11 tial year, referred to in paragraph (2)(A) during 

12 which an initial payment rate is established for a 

13 distinct continuous glucose monitoring device, the 

14 Secretary shall provide for annual updates to the 

15 payment rate under the fee schedule established 

16 under this subsection for each such device for the 

17 preceding year by the percentage increase in the 

18 consumer price index for all urban consumers 

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

20 ending with June of the preceding year. 

21 ‘‘(4) ADJUSTMENT FOR GEOGRAPHIC VARI22 ATIONS.—The Secretary shall provide for adjust23 ments to the payment rates under the fee schedule 

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1 count geographic variations in the prices of contin2 uous glucose monitoring devices.’’. 

3 (c) ENSURING BENEFICIARY ACCESS TO APPRO4 PRIATE COMPONENTS.—Section 1847(a) of the Social Se5 curity Act (42 U.S.C. 1395w–3(a)) is amended by adding 

6 at the end the following new paragraph: 

7 ‘‘(8) ENSURING BENEFICIARY ACCESS TO AP8 PROPRIATE COMPONENTS.— 

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

10 programs under this section with respect to glu11 cose meters required for continuous glucose 

12 monitoring devices (as defined in section 

13 1861(iii)(1)) that are furnished to CGM quali14 fied individuals (as defined in section 

15 1861(iii)(2)), the Secretary shall ensure that 

16 such CGM qualified individuals are furnished 

17 the brand of diabetic testing supplies (as de18 fined in subparagraph (B)) that function with 

19 such continuous glucose monitoring devices, 

20 such as in the case where there is only one 

21 brand of glucose meter that is compatible with 

22 a particular continuous glucose monitoring de23 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, 2015. 

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 

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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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