S T A T E O F N E W Y O R K
________________________________________________________________________
8316
I N S E N A T E
May 11, 2020
___________
Introduced by Sen. HARCKHAM -- read twice and ordered printed, and when
printed to be committed to the Committee on Health
AN ACT in relation to determining whether the state can claim federal
financial participation for coverage of and payment for certain
prescription digital therapeutics
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Legislative finding and declaration. New Yorkers in recov-
ery for substance and opioid use disorders and in treatment for mental
health conditions are losing access to in-person treatment under the
state's "stay at home" and social distancing orders as part of coronavi-
rus pandemic mitigation efforts. In recent news reports, experts warn
that the coronavirus pandemic may be "a national relapse trigger" for
individuals in treatment for alcohol, cocaine, methamphetamine, marijua-
na, and heroin addiction. Prescription Digital Therapeutics (PDTs) are
new, software-based disease treatments designed to directly treat
disease, tested for safety and efficacy in randomized clinical trials,
evaluated by the FDA, and prescribed by healthcare providers. These
therapies are designed and tested much like traditional prescription
drugs with one distinction: rather than swallowing a pill or taking an
injection, patients are treated with software. Certain PDTs provide
clinicians and patients with evidence-based remote treatment modalities
to treat substance and opioid use disorders, mental health, and other
diseases and conditions. However, there is no clear statutory benefit
category to allow Medicaid coverage for PDTs. In light of the promise of
PDTs for the treatment of patients with substance use and opioid use
disorders during the coronavirus pandemic, this legislation would
require that the New York state department of health seek guidance from
the Centers for Medicare and Medicaid Services relative to a coverage
and reimbursement pathway for PDTs, in order to accelerate access to
such therapies for enrollees.
§ 2. No later than 30 days from the effective date of this section,
the New York state department of health shall request guidance from the
Centers for Medicare and Medicaid Services to determine whether the
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD16257-01-0
S. 8316 2
state can claim federal financial participation for coverage of and
payment for certain prescription digital therapeutics approved by the
food and drug administration to treat substance use and opioid use
disorders.
§ 3. This act shall take effect immediately.