S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9324
 
                           I N  A S S E M B L Y
 
                             February 29, 2024
                                ___________
 
 Introduced by M. of A. PAULIN -- read once and referred to the Committee
   on Health
 
 AN  ACT  to  amend  the  social services law, in relation to payment for
   rapid whole genome sequencing
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1. The social services law is amended by adding a new section
 367-y to read as follows:
   § 367-Y. PAYMENT FOR RAPID WHOLE GENOME SEQUENCING. 1. FOR PURPOSES OF
 THIS SECTION, "RAPID WHOLE GENOME SEQUENCING" MEANS AN INVESTIGATION  OF
 THE  ENTIRE  HUMAN  GENOME,  INCLUDING CODING AND NON-CODING REGIONS AND
 MITOCHONDRIAL DEOXYRIBONUCLEIC ACID, TO IDENTIFY DISEASE-CAUSING GENETIC
 CHANGES THAT RETURNS THE PRELIMINARY POSITIVE RESULTS WITHIN SEVEN  DAYS
 AND  FINAL  RESULTS  WITHIN FIFTEEN DAYS FROM THE DATE OF RECEIPT OF THE
 SAMPLE BY THE LAB PERFORMING THE TEST. "RAPID WHOLE  GENOME  SEQUENCING"
 INCLUDES  PATIENT-ONLY  WHOLE  GENOME  SEQUENCING AND DUO AND TRIO WHOLE
 GENOME SEQUENCING OF THE PATIENT AND BIOLOGICAL PARENT OR PARENTS.
   2. ONE YEAR AFTER THE EFFECTIVE DATE OF THIS SECTION, AND  SUBJECT  TO
 ANY REQUIRED APPROVAL OF THE CENTERS FOR MEDICARE AND MEDICAID SERVICES,
 THE COMMISSIONER SHALL AUTHORIZE THE PAYMENT OF MEDICAL ASSISTANCE FUNDS
 FOR RAPID WHOLE GENOME SEQUENCING WHEN THE BENEFICIARY:
   (A) IS UNDER TWENTY-ONE YEARS OF AGE;
   (B)  HAS  A  COMPLEX OR ACUTE ILLNESS OF UNKNOWN ETIOLOGY, THAT IS NOT
 CONFIRMED TO BE CAUSED BY AN ENVIRONMENTAL  EXPOSURE,  TOXIC  INGESTION,
 INFECTION WITH NORMAL RESPONSE TO THERAPY, OR TRAUMA; AND
   (C)  IS RECEIVING HOSPITAL SERVICES IN AN INTENSIVE CARE UNIT OR OTHER
 HIGH ACUITY CARE UNIT WITHIN A HOSPITAL.
   3. PAYMENT PROVIDED PURSUANT TO THIS SECTION MAY BE SUBJECT TO  APPLI-
 CABLE  EVIDENCE-BASED  MEDICAL NECESSITY CRITERIA THAT SHALL BE BASED ON
 ALL OF THE FOLLOWING:
   (A) THE PATIENT HAS SYMPTOMS THAT SUGGEST A BROAD DIFFERENTIAL DIAGNO-
 SIS THAT WOULD REQUIRE AN EVALUATION BY MULTIPLE GENETIC TESTS IF  RAPID
 WHOLE GENOME SEQUENCING IS NOT PERFORMED;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD13237-02-4
              

 A. 9324                             2
 
   (B)  THE  PATIENT'S  TREATING  HEALTHCARE PROVIDER HAS DETERMINED THAT
 TIMELY IDENTIFICATION OF A MOLECULAR DIAGNOSIS  IS  NECESSARY  TO  GUIDE
 CLINICAL  DECISION-MAKING AND TESTING RESULTS MAY GUIDE THE TREATMENT OR
 MANAGEMENT OF THE PATIENT'S CONDITION; AND
   (C)  THE  PATIENT  HAS  A COMPLEX OR ACUTE ILLNESS OF UNKNOWN ETIOLOGY
 INCLUDING AT LEAST ONE OF THE FOLLOWING CONDITIONS:
   (I) CONGENITAL ANOMALIES INVOLVING  AT  LEAST  TWO  ORGAN  SYSTEMS  OR
 COMPLEX/MULTIPLE CONGENITAL ANOMALIES IN ONE ORGAN SYSTEM;
   (II)  SPECIFIC  ORGAN  MALFORMATIONS  HIGHLY  SUGGESTIVE  OF A GENETIC
 ETIOLOGY;
   (III)  ABNORMAL  LABORATORY  TESTS  OR  ABNORMAL  CHEMISTRY   PROFILES
 SUGGESTING  THE  PRESENCE OF A GENETIC DISEASE, COMPLEX METABOLIC DISOR-
 DER, OR INBORN ERROR OF METABOLISM;
   (IV) REFRACTORY OR SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA;
   (V) ABNORMAL RESPONSE TO THERAPY  RELATED  TO  AN  UNDERLYING  MEDICAL
 CONDITION AFFECTING VITAL ORGANS OR BODILY SYSTEMS;
   (VI) SEVERE MUSCLE WEAKNESS, RIGIDITY, OR SPASTICITY;
   (VII) REFRACTORY SEIZURES;
   (VIII)  A  HIGH-RISK STRATIFICATION ON EVALUATION FOR A BRIEF RESOLVED
 UNEXPLAINED EVENT WITH ANY OF THE FOLLOWING:
   (A) A RECURRENT EVENT WITHOUT RESPIRATORY INFECTION;
   (B) A RECURRENT WITNESSED SEIZURE-LIKE EVENT; OR
   (C) A RECURRENT CARDIOPULMONARY RESUSCITATION EVENT;
   (IX) ABNORMAL CARDIAC DIAGNOSTIC TESTING RESULTS SUGGESTIVE OF  POSSI-
 BLE  CHANNELOPATHIES,  ARRHYTHMIAS,  CARDIOMYOPATHIES,  MYOCARDITIS,  OR
 STRUCTURAL HEART DISEASE;
   (X) ABNORMAL  DIAGNOSTIC  IMAGING  STUDIES  SUGGESTIVE  OF  UNDERLYING
 GENETIC CONDITION;
   (XI) ABNORMAL PHYSIOLOGIC FUNCTION STUDIES SUGGESTIVE OF AN UNDERLYING
 GENETIC ETIOLOGY; OR
   (XII) FAMILY GENETIC HISTORY RELATED TO THE PATIENT'S CONDITION.
   4. THE COMMISSIONER MAY ADD CONDITIONS TO THOSE CONTAINED IN PARAGRAPH
 (C) OF SUBDIVISION THREE OF THIS SECTION BASED UPON NEW MEDICAL EVIDENCE
 AND MAY PROVIDE COVERAGE FOR RAPID WHOLE GENOME SEQUENCING OR OTHER NEXT
 GENERATION  SEQUENCING  AND  GENETIC TESTING IN ADDITION TO THE COVERAGE
 REQUIRED UNDER THIS SECTION.
   5. (A) EXCEPT AS PROVIDED IN PARAGRAPH (B) OF THIS SUBDIVISION, GENET-
 IC DATA GENERATED AS A RESULT OF PERFORMING RAPID WHOLE GENOME  SEQUENC-
 ING COVERED PURSUANT TO THIS SECTION SHALL HAVE A PRIMARY USE OF ASSIST-
 ING  THE  ORDERING  HEALTH  CARE  PROFESSIONAL AND TREATING CARE TEAM TO
 DIAGNOSE AND TREAT THE PATIENT, AND AS PROTECTED HEALTH  INFORMATION  IT
 SHALL  BE  SUBJECT  TO  THE  REQUIREMENTS APPLICABLE TO PROTECTED HEALTH
 INFORMATION AS SET FORTH  IN  THE  HEALTH  INFORMATION  PORTABILITY  AND
 ACCOUNTABILITY  ACT  ("HIPAA"),  THE  HEALTH  INFORMATION TECHNOLOGY FOR
 ECONOMIC AND CLINICAL HEALTH ACT, THEIR ATTENDANT REGULATIONS, INCLUDING
 BUT NOT LIMITED TO THE HIPAA PRIVACY RULE AS PROMULGATED AT 45 CFR  PART
 160 AND SUBPARTS A AND E OF 45 CFR PART 164, AND ANY APPLICABLE STATE OR
 LOCAL LAW.
   (B) GENETIC DATA GENERATED FROM RAPID WHOLE GENOME SEQUENCING, COVERED
 PURSUANT  TO THIS SECTION, CAN BE USED IN SCIENTIFIC RESEARCH IF CONSENT
 FOR SUCH USE OF THE DATA HAS BEEN EXPRESSLY GIVEN BY THE PATIENT, OR THE
 PATIENT'S LEGAL GUARDIAN IN THE  CASE  OF  A  MINOR.  THE  PATIENT,  THE
 PATIENT'S LEGAL GUARDIAN IN THE CASE OF A MINOR, OR THE PATIENT'S HEALTH
 CARE  PROVIDER  WITH  THE  PATIENT'S  CONSENT, MAY REQUEST ACCESS TO THE
 RESULTS OF THE TESTING COVERED BY THIS SECTION FOR USE IN OTHER CLINICAL
 SETTINGS. A HEALTH CARE PROVIDER MAY ONLY CHARGE A FEE  TO  THE  PATIENT
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 BASED ON THE DIRECT COSTS OF PRODUCING THE RESULTS IN A FORMAT USABLE IN
 OTHER  CLINICAL  SETTINGS. A PATIENT, OR PATIENT'S LEGAL GUARDIAN IN THE
 CASE OF A MINOR, SHALL HAVE THE RIGHT TO RESCIND THE ORIGINAL CONSENT TO
 THE USE OF THE DATA IN SCIENTIFIC RESEARCH AT ANY TIME, AND UPON RECEIPT
 OF A WRITTEN REVOCATION OF THE CONSENT THE HEALTH CARE PROVIDER OR OTHER
 ENTITY USING THE DATA SHALL CEASE USE AND EXPUNGE THE DATA FROM ANY DATA
 REPOSITORY WHERE IT IS HELD.
   6.  THE COMMISSIONER SHALL TAKE ANY ACTIONS NECESSARY TO IMPLEMENT THE
 PROVISIONS OF THIS SECTION, INCLUDING, BUT NOT LIMITED TO:
   (A) PROMULGATING RULES AND REGULATIONS TO PROVIDE FOR PAYMENT PURSUANT
 TO THIS SECTION;
   (B) SUBMITTING TO THE CENTERS FOR MEDICARE AND MEDICAID  SERVICES  ANY
 NEW  WAIVER  APPLICATION,  AMENDMENT  TO AN EXISTING WAIVER, OR MEDICAID
 STATE PLAN AMENDMENT NECESSARY TO ENSURE FEDERAL FINANCIAL PARTICIPATION
 FOR MEDICAID COVERAGE PURSUANT TO THIS SECTION; AND
   (C) ANY OTHER ADMINISTRATIVE ACTION  DETERMINED  TO  BE  NECESSARY  TO
 IMPLEMENT THE REQUIREMENTS OF THIS SECTION.
   § 2. This act shall take effect immediately.