What's happening
This bill requires manufacturers to list authorized suppliers of nonprescription blood glucose testing supplies and prohibits pharmacists from dispensing or billing unauthorized products.
Why it matters
Aims to prevent "gray market" or potentially counterfeit diabetes testing supplies. by ensuring only products from manufacturer-approved suppliers and distributors can be sold or reimbursed—helping protect consumers from unreliable or unsafe equipment.
Requires public transparency. Manufacturers must provide updated lists of authorized suppliers and distributors to the state board of pharmacy, which will be posted online, making it easier for pharmacists and consumers to verify product legitimacy.
Holds pharmacists accountable. Pharmacists could face disciplinary action for dispensing or billing for products from unauthorized sources, increasing professional standards and potentially reducing insurance fraud or improper billing.
May impact product availability and pharmacy operations. Some pharmacies might need to change suppliers or adjust inventory practices, which could temporarily affect access or pricing for certain diabetes self-testing supplies.
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Who cares
Headline styles
Regulate Diabetes Test Suppliers
Plain English, a few words. Used as the page title.
Sponsors
No co-sponsors yet.
History
- Referred to higher education
- Referred to higher education
Companion bill
The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.
Regulate Diabetes Test Suppliers
In Assembly Committee · Higher Education · Sponsor John T. McDonald III
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
5403
2019-2020 Regular Sessions
IN SENATE
April 29, 2019
Introduced by Sen. BRESLIN -- read twice and ordered printed, and when printed to be committed to the Committee on Higher Education
AN ACT to amend the education law, in relation to designated suppliers and authorized distributors of nonprescription blood glucose selftesting equipment, devices and supplies
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. The education law is amended by adding a new section 6808-c to read as follows:
§ 6808-c. Suppliers and authorized distributors of nonprescription blood glucose self-testing equipment, devices and supplies. 1. As used in this section, "nonprescription blood glucose self-testing equipment, devices and supplies" means blood glucose monitors, continuous glucose monitors (CGM), blood glucose test strips, lancet devices and lancets, glucose control solutions for checking the accuracy of testing equipment and test strips, supply allowance for therapeutic continuous glucose monitors (CGM), including all supplies and accessories for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and are labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
2. Within one hundred eighty days of the effective date of this section, each manufacturer of nonprescription blood glucose self-testing equipment, devices and supplies shall submit to the state board of pharmacy a comprehensive list of designated suppliers and authorized distributors of nonprescription blood glucose self-testing equipment, devices and supplies. Such manufacturers shall update the state board of pharmacy when there are any changes to the list of designated suppliers and authorized distributors. Within ninety days of receiving that information, such board shall post the names of designated suppliers and authorized distributors on the department's website.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD11356-01-9
S. 5403 2
3. It shall be unprofessional conduct for a pharmacist to:
a. dispense nonprescription blood glucose self-testing equipment, devices and supplies received from a person or entity that the pharmacist knew or reasonably should have known was not a manufacturer's designated supplier or authorized distributor; or
b. submit a reimbursement claim for nonprescription blood glucose self-testing equipment, devices and supplies to a pharmaceutical benefit manager, health insurer, government agency, or other third-party payor when the pharmacist knew or reasonably should have known that the diabetes test device was not purchased either directly from the manufacturer or from the nonprescription blood glucose self-testing equipment, devices and supplies manufacturer's designated supplier or authorized distributor.
§ 2. This act shall take effect immediately.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
An act to amend the education law, in relation to designated suppliers and authorized distributors of nonprescription blood glucose self-testing equipment, devices and supplies
Summary of specific provisions
Section 1 adds a new section 6808-c to create a definition for nonpres- cription blood glucose self-testing equipment, devices, and supplies and requires manufacturers to submit a list of designated supplies and authorized distributors to the New York State Board of Pharmacy to post publicly on the NYS Education Department website and to keep the list updated as changes occur. The new section also finds that it shall be unprofessional conduct for a pharmacist to dispense nonprescription blood glucose self-testing equipment, devices, and supplies that they knew or reasonably should have known are not from a designated supplier or authorized distributor or to submit a reimbursement claim for such nonprescription blood glucose self-testing equipment, devices, and supplies if the pharmacist knew or reasonably should have known that the device was not purchased from a designated supplier or authorized distributor.
Section 2 provides for an immediate effective date.
Justification
When using diabetes testing devices, supplies, and equipment (i.e. Blood Glucose Testing Supplies (BGTS) or Continuous Glucose Monitoring (CGM)), patients make therapeutic decisions based on prescribers protocols to manage diabetes. These decisions result in changes in dosing of insulin by as little as 1-2 units of insulin and an incorrect adjustment can lead to hypoglycemia or hyperglycemia, negatively impacting a patient's health. Consistency of product is crucial in overall diabetes manage- ment.
It has been widely reported regarding the growth of the illicit market for diabetes testing supplies and equipment, especially glucose strips. The Albany Times Union in 2012 cited a growing diabetic population fuel- ing the underground market. In April 2019, the U.S. Food and Drug Administration issued a safety alert warning that sellers are marketing pre-owned test strips or test strips not authorized for sale in the United State leading to inaccurate test results, infections, and increased risk of serious patient injury, including death.
This bill seeks to address this issue by providing information regarding authorized distributors and designated suppliers on the NYS Education Department website to allow ease of access to the information and to provide penalties in the event that a pharmacist chooses to sell diabetes testing equipment that is not from a designated supplier or authorized distributor. This is an important consumer protection and safety issue that will protect those who are managing diabetes, an ever growing population.
Prior legislative history
New bill.
Fiscal implications
None.
Effective date
This act shall take effect immediately.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.