[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 804 Introduced in Senate (IS)]

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.

    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 2015''.

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 senses or 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, 2016.
            (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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