S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   3642
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 28, 2021
                                ___________
 
 Introduced  by  M.  of  A. L. ROSENTHAL -- read once and referred 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.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD01006-01-1

 A. 3642                             2
 
   §  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
 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.