NY State Senate Bill 2019-S5403

Senate Bill S5403

2019-2020 Legislative Session

Relates to designated suppliers and authorized distributors of nonprescription blood glucose self-testing equipment, devices and supplies

download bill text pdf

Archive: Last Bill Status - In Senate Committee Higher Education Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 08, 2020	referred to higher education
Apr 29, 2019	referred to higher education

2019-S5403 (ACTIVE) - Details

See Assembly Version of this Bill:: A7582
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Add §6808-c, Ed L
Versions Introduced in Other Legislative Sessions:: 2021-2022: S5667, A3253
2023-2024: S3541

2019-S5403 (ACTIVE) - Summary

Requires manufacturer of nonprescription blood glucose self-testing equipment, devices and supplies to submit to the New York State Board of Pharmacy a comprehensive list of designated suppliers and authorized distributors of nonprescription blood glucose self-testing equipment, devices and supplies; and prohibits pharmacists from distributing nonprescription blood glucose self-testing equipment, devices, and supplies or seeking reimbursement therefor when the pharmacist knows or has reason to know that the equipment did not come through an authorized supplier or distributor.

2019-S5403 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S5403

SPONSOR: BRESLIN
 
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.

2019-S5403 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   5403
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                              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 self-
   testing equipment, devices and supplies

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, 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  WITH-
 OUT 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 FEDER-
 AL 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 PHAR-
 MACY  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 INFOR-
 MATION,  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  PHARMA-
 CIST  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 MANUFAC-
 TURER  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.

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