I 

113TH CONGRESS 

2D SESSION H. R. 5644 

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

continuous glucose monitoring devices, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 18, 2014 

Mr. REED (for himself, Ms. DEGETTE, and Mr. WHITFIELD) 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 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’’. 


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1 SEC. 2. MEDICARE COVERAGE OF CONTINUOUS GLUCOSE 

2 MONITORING DEVICES. 

3 (a) IN GENERAL.—Section 1861 of the Social Secu4 rity Act (42 U.S.C. 1395x) is amended— 

5 (1) in subsection (s)(2)— 

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

7 ‘‘and’’ at the end; 

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

9 ‘‘and’’; and 

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

11 subparagraph: 

12 ‘‘(GG) continuous glucose monitoring devices 

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

14 CGM qualified individual (as defined in subsection 

15 (iii)(2));’’; and 

16 (2) by adding at the end the following new sub17 section: 

18 ‘‘Continuous Glucose Monitoring Device; CGM Qualified 

19 Individual 

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

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

22 Food and Drug Administration that continuously mon23 itors and trends glucose levels in body fluid. 

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

25 ‘‘(i) as a stand-alone product; 

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


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

2 medical device cleared or approved by the Food and 

3 Drug Administration, such as artificial pancreas de4 vice systems. 

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

6 device that is described in clause (ii) or (iii) of subpara7 graph (B), the Secretary shall treat an insulin pump or 

8 other medical device that has a continuous glucose moni9 toring device as an integrated or integral component as 

10 a single medical device. 

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

12 and supplies that are necessary and related to the oper13 ation of the class III medical device, such as sensors, 

14 transmitters, receivers, and requisite software. 

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

16 of the following: 

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

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

19 treatment regimen that consists of 3 or more 

20 insulin injections per day or the use of a sub21 cutaneous insulin infusion pump; 

22 ‘‘(ii) subject to paragraph (3), whose at23 tending physician certifies that the individual’s 

24 condition cannot be safely and effectively man25 aged with self-monitoring of blood glucose; and 


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1 ‘‘(iii) who— 

2 ‘‘(I) has been unable to achieve opti3 mum glycemic control in accordance with 

4 evidence-based guidelines; or 

5 ‘‘(II) has experienced hypoglycemia 

6 unawareness or frequent hypoglycemic epi7 sodes. 

8 ‘‘(B) An individual not described in subpara9 graph (A) who meets such other medical criteria as 

10 the Secretary may specify for the furnishing of a 

11 continuous glucose monitoring device based on avail12 able medical evidence and taking into account any 

13 anticipated pathway to the development of artificial 

14 pancreas device systems. 

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

16 regularly using a continuous glucose monitoring de17 vice before becoming entitled to, or enrolling in, part 

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

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

20 physician described in paragraph (2)(A)(ii), such certifi21 cation shall not be required more frequently than once 

22 every 3 years.’’. 

23 (b) PAYMENT.— 


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

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

3 amended— 

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

5 (B) by inserting before the semicolon at 

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

7 to continuous glucose monitoring devices under 

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

9 be an amount equal to 80 percent of the 

10 amount determined under the fee schedule es11 tablished under section 1834(r)’’. 

12 (2) CONFORMING AMENDMENT.—Section 1834 

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

14 amended by adding at the end the following new 

15 subsection: 

16 ‘‘(r) FEE SCHEDULE FOR CONTINUOUS GLUCOSE

17 MONITORING DEVICES.— 

18 ‘‘(1) ESTABLISHMENT.— 

19 ‘‘(A) IN GENERAL.—With respect to con20 tinuous glucose monitoring devices (as defined 

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

22 the amount of payment under this part for such 

23 devices shall be determined under a fee schedule 

24 established by the Secretary in accordance with 

25 this subsection. 


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1 ‘‘(B) CLARIFICATION OF APPLICATION OF

2 FEE SCHEDULE TO DEVICES HAVING CGM AS AN

3 INTEGRAL COMPONENT.—Payment shall be cal4 culated and made under the fee schedule estab5 lished under this subsection for any insulin 

6 pump or other medical device that has a contin7 uous glucose monitoring device as an integrated 

8 or integral component. 

9 ‘‘(2) INITIAL PAYMENT RATE.— 

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

11 distinct type of continuous glucose monitoring 

12 device, the Secretary shall establish an initial 

13 payment rate under the fee schedule established 

14 under this subsection for the first year, which 

15 may be a partial year, during which payment 

16 may be made for such continuous glucose moni17 toring device under this part. 

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

19 glucose monitoring device, the initial payment 

20 rate under subparagraph (A) shall— 

21 ‘‘(i) reflect market rates for such de22 vice; and 

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

24 available data on prices for such device. 


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1 ‘‘(C) ACCOUNTING FOR DIFFERENCES IN

2 FUNCTIONALITIES AMONG VARIOUS CGM DE3 VICES.—For purposes of the initial payment 

4 rates established under subparagraph (A), the 

5 Secretary shall establish a new HCPCS code for 

6 each distinct type of class III medical device 

7 cleared or approved by the Food and Drug Ad8 ministration that includes a continuous glucose 

9 monitoring device, such as a medical device de10 scribed in clause (ii) or (iii) of section 

11 1861(iii)(1)(B). Such HCPCS codes shall dis12 tinguish among the different functionalities of 

13 such devices in a manner that reflects the clas14 sifications of the Food and Drug Administra15 tion in clearing or approving such devices. 

16 ‘‘(3) UPDATES TO PAYMENT RATES.—With re17 spect to each year beginning after the year, or par18 tial year, referred to in paragraph (2)(A) during 

19 which an initial payment rate is established for a 

20 distinct continuous glucose monitoring device, the 

21 Secretary shall provide for annual updates to the 

22 payment rate under the fee schedule established 

23 under this subsection for each such device for the 

24 preceding year by the percentage increase in the 

25 consumer price index for all urban consumers 


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

2 ending with June of the preceding year. 

3 ‘‘(4) ADJUSTMENT FOR GEOGRAPHIC VARI4 ATIONS.—The Secretary shall provide for adjust5 ments to the payment rates under the fee schedule 

6 established under this subsection to take into ac7 count geographic variations in the prices of contin8 uous glucose monitoring devices.’’. 

9 (c) ENSURING BENEFICIARY ACCESS TO APPRO10 PRIATE COMPONENTS.—Section 1847(a) of the Social Se11 curity Act (42 U.S.C. 1395w–3(a)) is amended by adding 

12 at the end the following new paragraph: 

13 ‘‘(8) ENSURING BENEFICIARY ACCESS TO AP14 PROPRIATE COMPONENTS.— 

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

16 programs under this section with respect to glu17 cose meters required for continuous glucose 

18 monitoring devices (as defined in section 

19 1861(iii)(1)) that are furnished to CGM quali20 fied individuals (as defined in section 

21 1861(iii)(2)), the Secretary shall ensure that 

22 such CGM qualified individuals are furnished 

23 the brand of diabetic testing supplies (as de24 fined in subparagraph (B)) that function with 

25 such continuous glucose monitoring devices, 


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1 such as in the case where there is only one 

2 brand of glucose meter that is compatible with 

3 a particular continuous glucose monitoring de4 vice. 

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

6 term ‘diabetic testing supplies’ means glucose 

7 meters and diabetic testing strips.’’. 

8 (d) EFFECTIVE DATE; RULEMAKING.— 

9 (1) EFFECTIVE DATE.—The amendments made 

10 by this section shall apply to items and services fur11 nished on or after January 1, 2015. 

12 (2) RULEMAKING.— 

13 (A) IN GENERAL.—The Secretary of 

14 Health and Human Services (in this paragraph 

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

16 the amendments made by this section through 

17 notice and comment rulemaking. 

18 (B) CONSULTATION.—As part of the rule19 making process under subparagraph (A), the 

20 Secretary shall consult with national organiza21 tions representing individuals with diabetes, 

22 physicians with relevant clinical expertise in en23 docrinology, and other relevant stakeholders to 

24 develop clinical criteria for the determination of 

25 whether an individual qualifies as having Type 


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

2 Social Security Act, as added by subsection 

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

4 enactment of this Act, the Secretary shall con5 vene a meeting of those stakeholders to develop 

6 consensus recommendations for such clinical 

7 criteria. The Secretary shall take such rec8 ommendations into account in implementing the 

9 amendments made by this section. 

Æ 


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