Medicare CGM Access Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to provide Medicare coverage of continuous glucose monitoring (CGM) devices furnished to a CGM qualified individual.
Directs the Secretary of Health and Human Services (HHS) to establish a fee schedule and ensure that CGM qualified individuals are furnished with appropriate device components.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5644 Introduced in House (IH)]
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.
Be it enacted by the Senate and House of Representatives 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''.
SEC. 2. MEDICARE COVERAGE OF CONTINUOUS GLUCOSE MONITORING DEVICES.
(a) In General.--Section 1861 of the Social Security 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 subsection:
``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 monitors 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
``(iii) as an integral component of any other medical
device cleared or approved by the Food and Drug Administration,
such as artificial pancreas device systems.
``(C) With respect to a continuous glucose monitoring device that
is described in clause (ii) or (iii) of subparagraph (B), the Secretary
shall treat an insulin pump or other medical device that has a
continuous glucose monitoring 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 operation 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 subcutaneous insulin
infusion pump;
``(ii) subject to paragraph (3), whose attending
physician certifies that the individual's condition
cannot be safely and effectively managed with self-
monitoring of blood glucose; and
``(iii) who--
``(I) has been unable to achieve optimum
glycemic control in accordance with evidence-
based guidelines; or
``(II) has experienced hypoglycemia
unawareness or frequent hypoglycemic episodes.
``(B) An individual not described in subparagraph (A) who
meets such other medical criteria as the Secretary may specify
for the furnishing of a continuous glucose monitoring device
based on available 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 device 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 certification shall not be
required more frequently than once every 3 years.''.
(b) Payment.--
(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 established 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 continuous
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.
``(B) Clarification of application of fee schedule
to devices having cgm as an integral component.--
Payment shall be calculated and made under the fee
schedule established under this subsection for any
insulin pump or other medical device that has a
continuous 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
monitoring 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 device;
and
``(ii) take into account the most recent
available data on prices for such device.
``(C) Accounting for differences in functionalities
among various cgm devices.--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 Administration that
includes a continuous glucose monitoring device, such
as a medical device described in clause (ii) or (iii)
of section 1861(iii)(1)(B). Such HCPCS codes shall
distinguish among the different functionalities of such
devices in a manner that reflects the classifications
of the Food and Drug Administration in clearing or
approving such devices.
``(3) Updates to payment rates.--With respect to each year
beginning after the year, or partial 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 (United States city average) for the 12-month period
ending with June of the preceding year.
``(4) Adjustment for geographic variations.--The Secretary
shall provide for adjustments to the payment rates under the
fee schedule established under this subsection to take into
account geographic variations in the prices of continuous
glucose monitoring devices.''.
(c) Ensuring Beneficiary Access to Appropriate Components.--Section
1847(a) of the Social Security Act (42 U.S.C. 1395w-3(a)) is amended by
adding at the end the following new paragraph:
``(8) Ensuring beneficiary access to appropriate
components.--
``(A) In general.--In carrying out the programs
under this section with respect to glucose meters
required for continuous glucose monitoring devices (as
defined in section 1861(iii)(1)) that are furnished to
CGM qualified 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 defined in subparagraph
(B)) that function with such continuous glucose
monitoring devices, such as in the case where there is
only one brand of glucose meter that is compatible with
a particular continuous glucose monitoring device.
``(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 furnished 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 rulemaking
process under subparagraph (A), the Secretary shall
consult with national organizations representing
individuals with diabetes, physicians with relevant
clinical expertise in endocrinology, and other relevant
stakeholders to develop clinical criteria for the
determination of whether an individual qualifies as
having Type 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 convene a meeting of
those stakeholders to develop consensus recommendations
for such clinical criteria. The Secretary shall take
such recommendations into account in implementing the
amendments made by this section.
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Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
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