SENATE  .  .  .  .  .  .  .  .  .  .  .  .  .  .  No. 2512

 

 

The Commonwealth of Massachusetts

 

_______________

In the One Hundred and Ninety-Third General Court
(2023-2024)

_______________

 

in section 21, by inserting, in line 196, after the word “drugs”, the following words:- 

“, continuous glucose monitoring system components, all components of the continuous glucose monitoring system of which the component is a part, and, when applicable, delivery devices,”; and

in said section 21, by adding, in line 413, after the word “barriers.”, the following words: 

“This section shall also apply to selected continuous glucose monitoring system components, all components of the continuous glucose monitoring system of which the component is a part, and delivery devices, when applicable.”; and

in section 39, by inserting, in line 627, after the word “all”, the following words:- 

“continuous glucose monitoring system components, all components of the continuous glucose monitoring system of which the component is a part, and”; and 

in section 41, by adding, after the definition of “Brand name drug”, the following definitions:-

““Continuous glucose monitoring system”, a system to continuously sense, transmit, and display blood glucose levels. 

“Continuous glucose monitoring system component”, a component of a system to continuously monitor blood glucose levels such as a sensor, transmitter, or display.”; and

in said section 41, by adding, after the definition of “Delivery device”, the following definition:-

““Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose monitors for use by the legally blind, visual magnifying aids for use by the legally blind; provided further that “associated supplies” shall not include a brand name drug, a generic drug, a continuous glucose monitoring system component, or a delivery device.”; and 

in said section 41, by inserting, in line 691, after the word “color”, the following words:- 

“; provided, however, that for diabetes, the commission shall also select a continuous glucose monitoring system component”; and 

in said section 41, by striking out, in lines 699 to 700, the words “and delivery device, when applicable”; and 

in said section 41, by striking out subsection (d) and inserting in place thereof the following subsection:- 

“(d) The continuous glucose monitoring system component shall be selected in the same manner in which the 1 generic drug and 1 brand name drug are selected.”; and 

in said section 41, by striking out subsection (e) and inserting in place thereof the following subsection:-

“(e)(1) The commission shall provide coverage for the brand name drugs and generic drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name drugs from being reduced below the amount specified in this section. 

(2) If use of a brand name drug or generic drug that the commission selects requires a separate delivery device, the commission shall select a delivery device for that drug in accordance with the factors established in subsection (c) for selecting brand name drugs and generic drugs, to the extent possible. The commission shall provide coverage for the delivery device, and the delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(3) The commission shall provide coverage for the continuous glucose monitoring system component selected pursuant to subsection (b), and all components of the blood glucose monitoring system of which the selected component is a part. All components of the applicable continuous glucose monitoring system shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(4) The commission shall provide coverage for necessary diabetes treatment supplies. Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.” and;

in said section 41, by striking out, in lines 743 to 744, the sentence “When applicable this subsection shall apply to delivery devices.”, and inserting in place thereof the following sentence:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and  

in said section 41, by adding, in line 755, after the words “subsection (b).”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”

in said section 41, by inserting, in line 758, after the word “drug”, the following words:- 

“, continuous glucose monitoring system component”; and 

in said section 41, by striking out, in line 759, the words “subsection (d)”, and inserting in place thereof the following words:- 

“subsection (e)”; and 

in said section 41, by striking out, in lines 767 and 769, the words “and delivery devices” each time those words appear; and 

in said subsection 41, by adding, in line 772, after the word “made.”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices, in the same manner in which it applies to drugs.”; and 

in said section 41, by striking out, in line 773, the words “drugs and delivery devices”, and inserting in place thereof the following words:- 

“drugs, continuous glucose monitoring system components, all components of the system of which the component is a part and delivery devices”; and 

in section 44, by adding, after the definition of “Brand name drug”, the following definitions:-

““Continuous glucose monitoring system”, a system to continuously sense, transmit, and display blood glucose levels. 

“Continuous glucose monitoring system component”, a component of a system to continuously monitor blood glucose levels such as a sensor, transmitter, or display.”; and 

in said section 44, by adding, after the definition of “Delivery device”, the following definition:-

““Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose monitors for use by the legally blind, visual magnifying aids for use by the legally blind; provided further that “associated supplies” shall not include a brand name drug, a generic drug, a continuous glucose monitoring system component, or a delivery device.”; and 

in said section 44, by inserting, in line 891, after the word “color”, the following words:- 

“; provided, however, that for diabetes, the division shall also select a continuous glucose monitoring system component”; and 

in said section 44, by striking out subsection (d) and inserting in place thereof the following subsection:- 

“(d) The continuous glucose monitoring system component shall be selected in the same manner in which the 1 generic drug and 1 brand name drug are selected.”; and 

in said section 44, by striking out subsection (e) and inserting in place thereof the following subsection:-

“(e)(1) The division shall provide coverage for the brand name drugs and generic drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name drugs from being reduced below the amount specified in this section. 

(2) If use of a brand name drug or generic drug that the division selects requires a separate delivery device, the division shall select a delivery device for that drug in accordance with the factors established in subsection (c) for selecting brand name drugs and generic drugs, to the extent possible. The division shall provide coverage for the delivery device, and the delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(3) The division shall provide coverage for the continuous glucose monitoring system component selected pursuant to subsection (b), and all components of the blood glucose monitoring system of which the selected component is a part. All components of the applicable continuous glucose monitoring system shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(4) The division shall provide coverage for necessary diabetes treatment supplies. Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.”; and

in said section 44, by striking out, in lines 944 to 945, the sentence “When applicable this subsection shall apply to delivery devices.”, and inserting in place thereof the following sentence:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and  

in said section 44, by adding, in line 958, after the words “subsection (b).”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and

in said section 44, by inserting, in line 960, after the word “drug”, the following words:- 

“, continuous glucose monitoring system component”; and 

in said section 44, by striking out, in line 961, the words “subsection (d)”, and inserting in place thereof the following words:- 

“subsection (e)”; and 

in said section 44, by striking out, in lines 972, the words “and delivery devices”; and 

in said subsection 44, by adding, in line 975, after the word “made.”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices, in the same manner in which it applies to drugs.”; and 

in said section 44, by striking out, in line 976, the words “drugs and delivery devices”, and inserting in place thereof the following words:- 

“drugs, continuous glucose monitoring system components, all components of the system of which the component is a part and delivery devices”; and 

in section 45, by adding, after the definition of “Brand name drug”, the following definitions:-

““Continuous glucose monitoring system”, a system to continuously sense, transmit, and display blood glucose levels. 

“Continuous glucose monitoring system component”, a component of a system to continuously monitor blood glucose levels such as a sensor, transmitter, or display.”; and 

in said section 45, by adding, after the definition of “Delivery device”, the following definition:-

““Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose monitors for use by the legally blind, visual magnifying aids for use by the legally blind; provided further that “associated supplies” shall not include a brand name drug, a generic drug, a continuous glucose monitoring system component, or a delivery device.”; and 

in said section 45, by inserting, in line 1012, after the word “color”, the following words:- 

“; provided, however, that for diabetes, the carrier shall also select a continuous glucose monitoring system component”; and 

in said section 45, by striking out subsection (d) and inserting in place thereof the following subsection:- 

“(d) The continuous glucose monitoring system component shall be selected in the same manner in which the 1 generic drug and 1 brand name drug are selected.”; and 

in said section 45, by striking out subsection (e) and inserting in place thereof the following subsection:-

“(e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name drugs from being reduced below the amount specified in this section. 

(2) If use of a brand name drug or generic drug that the carrier selects requires a separate delivery device, the carrier shall select a delivery device for that drug in accordance with the factors established in subsection (c) for selecting brand name drugs and generic drugs, to the extent possible. The carrier shall provide coverage for the delivery device, and the delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(3) The carrier shall provide coverage for the continuous glucose monitoring system component selected pursuant to subsection (b), and all components of the blood glucose monitoring system of which the selected component is a part. All components of the applicable continuous glucose monitoring system shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.”; and

in said section 45, by striking out, in lines 1064, the sentence “When applicable this subsection shall apply to delivery devices.”, and inserting in place thereof the following sentence:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and  

in said section 45, by adding, in line 1075, after the words “subsection (b).”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and

in said section 45, by inserting, in line 1077, after the word “drug”, the following words:- 

“, continuous glucose monitoring system component”; and 

in said section 45, by striking out, in line 1079, the words “subsection (d)”, and inserting in place thereof the following words:- 

“subsection (e)”; and 

in said section 45, by striking out, in lines 1087 and 1089, the words “and delivery devices”, each time they appear; and 

in said subsection 45, by adding, in line 1092, after the word “made.”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices, in the same manner in which it applies to drugs.”; and 

in said section 45, by striking out, in line 1093, the words “drugs and delivery devices”, and inserting in place thereof the following words:- 

“drugs, continuous glucose monitoring system components, all components of the system of which the component is a part and delivery devices”; and 

in section 47, by adding, after the definition of “Brand name drug”, the following definitions:-

““Continuous glucose monitoring system”, a system to continuously sense, transmit, and display blood glucose levels. 

“Continuous glucose monitoring system component”, a component of a system to continuously monitor blood glucose levels such as a sensor, transmitter, or display.”; and 

in said section 47, by adding, after the definition of “Delivery device”, the following definition:-

““Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose monitors for use by the legally blind, visual magnifying aids for use by the legally blind; provided further that “associated supplies” shall not include a brand name drug, a generic drug, a continuous glucose monitoring system component, or a delivery device.”; and 

in said section 47, by adding, in line 1144, after the word “conditions”, the following words:- 

“: (i) diabetes; (ii) asthma; and (iii) heart conditions, including, but not limited to, those conditions that disproportionately impact a particular demographic group, including people of color; provided, however, that for diabetes, the carrier shall also select a continuous glucose monitoring system component”; and 

in said section 47, by striking out subsection (d) and inserting in place thereof the following subsection:- 

“(d) The continuous glucose monitoring system component shall be selected in the same manner in which the 1 generic drug and 1 brand name drug are selected.”; and 

in said section 47, by striking out subsection (e) and inserting in place thereof the following subsection:-

“(e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name drugs from being reduced below the amount specified in this section. 

(2) If use of a brand name drug or generic drug that the carrier selects requires a separate delivery device, the carrier shall select a delivery device for that drug in accordance with the factors established in subsection (c) for selecting brand name drugs and generic drugs, to the extent possible. The carrier shall provide coverage for the delivery device, and the delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(3) The carrier shall provide coverage for the continuous glucose monitoring system component selected pursuant to subsection (b), and all components of the blood glucose monitoring system of which the selected component is a part. All components of the applicable continuous glucose monitoring system shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.”; and

in said section 47, by striking out, in line 1196, the sentence “When applicable this subsection shall apply to delivery devices”, and inserting in place thereof the following sentence:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and  

in said section 47, by adding, in line 1207, after the words “subsection (b).”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and

in said section 47, by inserting, in line 1209, after the word “drug”, the following words:- 

“, continuous glucose monitoring system component”; and 

in said section 47, by striking out, in line 1211, the words “subsection (d)”, and inserting in place thereof the following words:- 

“subsection (e)”; and 

in said section 47, by striking out, in lines 1219 and 1221, the words “and delivery devices” each time they appear; and 

in said subsection 47, by adding, in line 1224, after the word “made.”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices, in the same manner in which it applies to drugs.”; and 

in said section 47, by striking out, in line 1225, the words “drugs and delivery devices”, and inserting in place thereof the following words:- 

“drugs, continuous glucose monitoring system components, all components of the system of which the component is a part and delivery devices”; and 

in section 48, by adding, after the definition of “Brand name drug”, the following definitions:-

““Continuous glucose monitoring system”, a system to continuously sense, transmit, and display blood glucose levels. 

“Continuous glucose monitoring system component”, a component of a system to continuously monitor blood glucose levels such as a sensor, transmitter, or display.”; and 

in said section 48, by adding, after the definition of “Delivery device”, the following definition:-

““Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose monitors for use by the legally blind, visual magnifying aids for use by the legally blind; provided further that “associated supplies” shall not include a brand name drug, a generic drug, a continuous glucose monitoring system component, or a delivery device.”; and 

in said section 48, by inserting, in line 1261, after the word “color”, the following words:- 

“; provided, however, that for diabetes, the carrier shall also select a continuous glucose monitoring system component”; and 

in said section 48, by striking out subsection (d) and inserting in place thereof the following subsection:- 

“(d) The continuous glucose monitoring system component shall be selected in the same manner in which the 1 generic drug and 1 brand name drug are selected.”; and 

in said section 48, by striking out subsection (e) and inserting in place thereof the following subsection:-

“(e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name drugs from being reduced below the amount specified in this section. 

(2) If use of a brand name drug or generic drug that the carrier selects requires a separate delivery device, the carrier shall select a delivery device for that drug in accordance with the factors established in subsection (c) for selecting brand name drugs and generic drugs, to the extent possible. The carrier shall provide coverage for the delivery device, and the delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(3) The carrier shall provide coverage for the continuous glucose monitoring system component selected pursuant to subsection (b), and all components of the blood glucose monitoring system of which the selected component is a part. All components of the applicable continuous glucose monitoring system shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.”; and

in said section 48, by striking out, in lines 1313, the sentence “When applicable this subsection shall apply to delivery devices”, and inserting in place thereof the following sentence:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices”; and  

in said section 48, by adding, in line 1324, after the words “subsection (b).”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”

in said section 48, by inserting, in line 1326, after the word “drug”, the following words:- 

“, continuous glucose monitoring system component”; and 

in said section 48, by striking out, in line 1328, the words “subsection (d)”, and inserting in place thereof the following words:- 

“subsection (e)”; and 

in said section 48, by striking out, in lines 1336 and 1338, the words “and delivery devices” each time they appear; and 

in said subsection 48, by adding, in line 1341, after the word “made.”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices, in the same manner in which it applies to drugs.”; and 

in said section 48, by striking out, in line 1342, the words “drugs and delivery devices”, and inserting in place thereof the following words:- 

“drugs, continuous glucose monitoring system components, all components of the system of which the component is a part and delivery devices”; and 

in section 52, by adding, after the definition of “Brand name drug”, the following definitions:-

““Continuous glucose monitoring system”, a system to continuously sense, transmit, and display blood glucose levels. 

“Continuous glucose monitoring system component”, a component of a system to continuously monitor blood glucose levels such as a sensor, transmitter, or display.”; and 

in said section 52, by adding, after the definition of “Delivery device”, the following definition:-

““Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose monitors for use by the legally blind, visual magnifying aids for use by the legally blind; provided further that “associated supplies” shall not include a brand name drug, a generic drug, a continuous glucose monitoring system component, or a delivery device.”; and 

in said section 52, by inserting, in line 1394, after the word “color”, the following words:- 

“; provided, however, that for diabetes, the carrier shall also select a continuous glucose monitoring system component”; and 

in said section 52, by striking out subsection (d) and inserting in place thereof the following subsection:- 

“(d) The continuous glucose monitoring system component shall be selected in the same manner in which the 1 generic drug and 1 brand name drug are selected.”; and 

in said section 52, by striking out subsection (e) and inserting in place thereof the following subsection:-

“(e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name drugs from being reduced below the amount specified in this section. 

(2) If use of a brand name drug or generic drug that the carrier selects requires a separate delivery device, the carrier shall select a delivery device for that drug in accordance with the factors established in subsection (c) for selecting brand name drugs and generic drugs, to the extent possible. The carrier shall provide coverage for the delivery device, and the delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(3) The carrier shall provide coverage for the continuous glucose monitoring system component selected pursuant to subsection (b), and all components of the blood glucose monitoring system of which the selected component is a part. All components of the applicable continuous glucose monitoring system shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.

(4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any deductible.”; and

in said section 52, by striking out, in line 1446, the sentence “When applicable this subsection shall apply to delivery devices.”, and inserting in place thereof the following sentence:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”; and  

in said section 52, by adding, in line 1457, after the words “subsection (b).”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices.”

in said section 52, by inserting, in line 1459, after the word “drug”, the following words:- 

“, continuous glucose monitoring system component”; and 

in said section 52, by striking out, in line 1441, the words “subsection (d)”, and inserting in place thereof the following words:- 

“subsection (e)”; and 

in said section 52, by striking out, in lines 1469 and 1471, the words “and delivery devices” each time they appear; and 

in said subsection 52, by adding, in line 1474, after the word “made.”, the following words:- 

“This subsection shall apply to continuous glucose monitoring system components and, when applicable, delivery devices, in the same manner in which it applies to drugs.”; and 

in said section 52, by striking out, in line 1475, the words “drugs and delivery devices”, and inserting in place thereof the following words:- 

“drugs, continuous glucose monitoring system components, all components of the system of which the component is a part and delivery devices”; and 

in section 61, by adding, in line 1790, after the word “website.”, the following words:- 

“This section shall also apply to selected continuous glucose monitoring system components and, when applicable, delivery devices.”