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 Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend title XVIII of the Social Security Act to specify 
coverage of continuous glucose monitoring devices, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare CGM Access 
Act of 2014’’. 
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SEC. 2. MEDICARE COVERAGE OF CONTINUOUS GLUCOSE 
MONITORING DEVICES. 
(a) IN GENERAL.—Section 1861 of the Social Secu-
rity Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
(A) in subparagraph (EE), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (FF), by adding 
‘‘and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(GG) continuous glucose monitoring devices 
(as defined in subsection (iii)(1)) furnished to a 
CGM qualified individual (as defined in subsection 
(iii)(2));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘Continuous Glucose Monitoring Device; CGM Qualified 
Individual 
‘‘(iii)(1)(A) The term ‘continuous glucose monitoring 
device’ means a class III medical device approved by the 
Food and Drug Administration that continuously mon-
itors and trends glucose levels in body fluid. 
‘‘(B) Such term applies to such medical device— 
‘‘(i) as a stand-alone product; 
‘‘(ii) when integrated with an insulin pump; or 
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‘‘(iii) as an integral component of any other 
medical device cleared or approved by the Food and 
Drug Administration, such as artificial pancreas de-
vice systems. 
‘‘(C) With respect to a continuous glucose monitoring 
device that is described in clause (ii) or (iii) of subpara-
graph (B), the Secretary shall treat an insulin pump or 
other medical device that has a continuous glucose moni-
toring device as an integrated or integral component as 
a single medical device. 
‘‘(D) Such term includes components, accessories, 
and supplies that are necessary and related to the oper-
ation of the class III medical device, such as sensors, 
transmitters, receivers, and requisite software. 
‘‘(2) The term ‘CGM qualified individual’ means any 
of the following: 
‘‘(A) An individual with Type I diabetes— 
‘‘(i) who is following an intensive insulin 
treatment regimen that consists of 3 or more 
insulin injections per day or the use of a sub-
cutaneous insulin infusion pump; 
‘‘(ii) subject to paragraph (3), whose at-
tending physician certifies that the individual’s 
condition cannot be safely and effectively man-
aged with self-monitoring of blood glucose; and 
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‘‘(iii) who— 
‘‘(I) has been unable to achieve opti-
mum glycemic control in accordance with 
evidence-based guidelines; or 
‘‘(II) has experienced hypoglycemia 
unawareness or frequent hypoglycemic epi-
sodes. 
‘‘(B) An individual not described in subpara-
graph (A) who meets such other medical criteria as 
the Secretary may specify for the furnishing of a 
continuous glucose monitoring device based on avail-
able medical evidence and taking into account any 
anticipated pathway to the development of artificial 
pancreas device systems. 
‘‘(C) An individual with diabetes who has been 
regularly using a continuous glucose monitoring de-
vice before becoming entitled to, or enrolling in, part 
A, or enrolling in part B, or both. 
‘‘(3) For purposes of a certification by an attending 
physician described in paragraph (2)(A)(ii), such certifi-
cation shall not be required more frequently than once 
every 3 years.’’. 
(b) PAYMENT.— 
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(1) IN GENERAL.—Section 1833(a)(1) of the 
Social Security Act (42 U.S.C. 1395l(a)(1)) is 
amended— 
(A) by striking ‘‘and’’ before ‘‘(Z)’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘, and (AA) with respect 
to continuous glucose monitoring devices under 
section 1861(s)(2)(GG)), the amount paid shall 
be an amount equal to 80 percent of the 
amount determined under the fee schedule es-
tablished under section 1834(r)’’. 
(2) CONFORMING AMENDMENT.—Section 1834 
of the Social Security Act (42 U.S.C. 1395m) is 
amended by adding at the end the following new 
subsection: 
‘‘(r) FEE SCHEDULE FOR CONTINUOUS GLUCOSE 
MONITORING DEVICES.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN GENERAL.—With respect to con-
tinuous glucose monitoring devices (as defined 
in section 1861(iii)(1)) furnished during a year, 
the amount of payment under this part for such 
devices shall be determined under a fee schedule 
established by the Secretary in accordance with 
this subsection. 
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‘‘(B) CLARIFICATION OF APPLICATION OF 
FEE SCHEDULE TO DEVICES HAVING CGM AS AN 
INTEGRAL COMPONENT.—Payment shall be cal-
culated and made under the fee schedule estab-
lished under this subsection for any insulin 
pump or other medical device that has a contin-
uous glucose monitoring device as an integrated 
or integral component. 
‘‘(2) INITIAL PAYMENT RATE.— 
‘‘(A) IN GENERAL.—With respect to each 
distinct type of continuous glucose monitoring 
device, the Secretary shall establish an initial 
payment rate under the fee schedule established 
under this subsection for the first year, which 
may be a partial year, during which payment 
may be made for such continuous glucose moni-
toring device under this part. 
‘‘(B) DATA.—With respect to a continuous 
glucose monitoring device, the initial payment 
rate under subparagraph (A) shall— 
‘‘(i) reflect market rates for such de-
vice; and 
‘‘(ii) take into account the most recent 
available data on prices for such device. 
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‘‘(C) ACCOUNTING FOR DIFFERENCES IN 
FUNCTIONALITIES
AMONG
VARIOUS
CGM
DE-
VICES.—For purposes of the initial payment 
rates established under subparagraph (A), the 
Secretary shall establish a new HCPCS code for 
each distinct type of class III medical device 
cleared or approved by the Food and Drug Ad-
ministration that includes a continuous glucose 
monitoring device, such as a medical device de-
scribed in clause (ii) or (iii) of section 
1861(iii)(1)(B). Such HCPCS codes shall dis-
tinguish among the different functionalities of 
such devices in a manner that reflects the clas-
sifications of the Food and Drug Administra-
tion in clearing or approving such devices. 
‘‘(3) UPDATES TO PAYMENT RATES.—With re-
spect to each year beginning after the year, or par-
tial year, referred to in paragraph (2)(A) during 
which an initial payment rate is established for a 
distinct continuous glucose monitoring device, the 
Secretary shall provide for annual updates to the 
payment rate under the fee schedule established 
under this subsection for each such device for the 
preceding year by the percentage increase in the 
consumer price index for all urban consumers 
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(United States city average) for the 12-month period 
ending with June of the preceding year. 
‘‘(4) ADJUSTMENT
FOR
GEOGRAPHIC
VARI-
ATIONS.—The Secretary shall provide for adjust-
ments to the payment rates under the fee schedule 
established under this subsection to take into ac-
count geographic variations in the prices of contin-
uous glucose monitoring devices.’’. 
(c) ENSURING BENEFICIARY ACCESS
TO APPRO-
PRIATE COMPONENTS.—Section 1847(a) of the Social Se-
curity Act (42 U.S.C. 1395w–3(a)) is amended by adding 
at the end the following new paragraph: 
‘‘(8) ENSURING BENEFICIARY ACCESS TO AP-
PROPRIATE COMPONENTS.— 
‘‘(A) IN GENERAL.—In carrying out the 
programs under this section with respect to glu-
cose meters required for continuous glucose 
monitoring devices (as defined in section 
1861(iii)(1)) that are furnished to CGM quali-
fied 
individuals 
(as 
defined 
in 
section 
1861(iii)(2)), the Secretary shall ensure that 
such CGM qualified individuals are furnished 
the brand of diabetic testing supplies (as de-
fined in subparagraph (B)) that function with 
such continuous glucose monitoring devices, 
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such as in the case where there is only one 
brand of glucose meter that is compatible with 
a particular continuous glucose monitoring de-
vice. 
‘‘(B) DEFINITION.—In this paragraph, the 
term ‘diabetic testing supplies’ means glucose 
meters and diabetic testing strips.’’. 
(d) EFFECTIVE DATE; RULEMAKING.— 
(1) EFFECTIVE DATE.—The amendments made 
by this section shall apply to items and services fur-
nished on or after January 1, 2015. 
(2) RULEMAKING.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services (in this paragraph 
referred to as the ‘‘Secretary’’) shall implement 
the amendments made by this section through 
notice and comment rulemaking. 
(B) CONSULTATION.—As part of the rule-
making process under subparagraph (A), the 
Secretary shall consult with national organiza-
tions representing individuals with diabetes, 
physicians with relevant clinical expertise in en-
docrinology, and other relevant stakeholders to 
develop clinical criteria for the determination of 
whether an individual qualifies as having Type 
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I diabetes under section 1861(iii)(2)(A) of the 
Social Security Act, as added by subsection 
(a)(2). Not later than 60 days after the date of 
enactment of this Act, the Secretary shall con-
vene a meeting of those stakeholders to develop 
consensus recommendations for such clinical 
criteria. The Secretary shall take such rec-
ommendations into account in implementing the 
amendments made by this section. 
Æ 
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