[Congressional Record Volume 165, Number 206 (Thursday, December 19, 2019)]
[Senate]
[Pages S7211-S7212]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Ms. COLLINS (for herself, Mr. Jones, Ms. McSally, and Mr. 
        Menendez):
  S. 3116. A bill to enable States to better provide access to whole 
genome sequencing clinical services for certain undiagnosed children 
under the Medicaid program, and for other purposes; to the Committee on 
Finance.
  Ms. COLLINS. Mr. President, I rise today to introduce the Ending the 
Diagnostic Odyssey Act. This legislation gives States the option of 
providing whole genome sequencing WSG clinical services through 
Medicaid for children with a disease that is suspected to have a 
genetic cause, at an enhanced Federal matching rate for 3 years. I am 
pleased to be joined by Senators Jones, McSally, and Menendez.
  Children with rare diseases will spend on average 5 to 7 years on 
diagnostic odyssey, and 30 percent of those children will not survive 
beyond the age of 5 years old. The average patient sees seven different 
physicians in that time. The wait to find a cause--nevermind a cure--
can be excruciating. Parents try to project a calm and reassuring 
presence for their child while facing a whirlwind of doctor 
appointments, hospital visits, and unanswered questions.
  Undeniably, we are making progress in both accelerating research 
funding for rare diseases as well as in the development of diagnostics. 
In 2014, the National Institutes of Health, NIH launched a program 
called the Undiagnosed Disease Network UDN. In its first 20 months, the 
UDN accepted 601 participants undiagnosed by traditional medical 
practices. Of those who completed their UDN evaluation during this 
time, 35 percent were given a diagnosis. Many of these diagnoses were 
rare genetic diseases, including 31 previously unknown syndromes.
  In May, the Director of the National Institutes of Health, Dr. 
Francis Collins, wrote a blog post on how whole genome sequencing--
combined with artificial intelligence, AI--can now be used to diagnose 
genetic diseases in seriously ill babies in fewer than 24 hours. Dr. 
Collins writes: ``I would submit that there is no other technology in 
the history of planet Earth that has experienced this degree of 
progress in speed and affordability.''
  For parents of children with an undiagnosed illness, answers cannot 
come soon enough. There are approximately 7,000 rare diseases known 
today. Approximately 80 percent of rare diseases are genetic, and about 
one-half of all rare diseases affect children. For example, Alstrom 
syndrome is an extremely rare and complex genetic disorder. 
Approximately 1,200 affected individuals have been identified 
worldwide, which makes a obtaining a correct diagnosis challenging. 
Characteristics of Alstrom syndrome include vision disturbances, 
sensorineural hearing impairment, cardiomyopathy, obesity, kidney 
dysfunction, and diabetes.
  Robin Marshall, executive director of the Alstrom Syndrome 
International, located in Mount Desert Islanas, ME, has said that 
``whole Genome Sequencing has changed the lives of those we represent 
by enabling earlier and more accurate diagnosis, fostering more timely 
and appropriate medical care, and unlocking a host of social services 
to combat the educational and psycho-social complications that our 
children confront.''
  By giving States an incentive to provide whole genome sequencing for 
eligible children through Medicaid my legislation will ensure that more 
children and their families can obtain the right diagnosis and 
treatment the start. The Ending the Diagnostic Odyssey Act has the 
support of more than 100 patient advocacy organizations, including 
Alstrom Syndrome International, the Genetic Alliance, the Personalized 
Medicine Coalition, and many others. I urge my colleagues to support 
this legislation.
                                 ______
                                 
      By Mr. MANCHIN (for himself and Mrs. Capito):
  S. 3147. A bill to require the Secretary of Veterans Affairs to 
submit to Congress reports on patient safety and quality of care at 
medical centers of the Department of Veterans Affairs, and for other 
purposes; considered and passed.

                                S. 3147

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Improving Safety and 
     Security for Veterans Act of 2019''.

     SEC. 2. DEPARTMENT OF VETERANS AFFAIRS REPORTS ON PATIENT 
                   SAFETY AND QUALITY OF CARE.

       (a) Report on Patient Safety and Quality of Care.--
       (1) In general.--Not later than 30 days after the date of 
     the enactment of this Act, the Secretary of Veterans Affairs 
     shall submit to the Committee on Veterans' Affairs of the 
     Senate and the Committee on Veterans' Affairs of the House of 
     Representatives a report regarding the policies and 
     procedures of the Department relating to patient safety and 
     quality of care and the steps that the Department has taken 
     to make improvements in patient safety and quality of care at 
     medical centers of the Department.
       (2) Elements.--The report required by paragraph (1) shall 
     include the following:
       (A) A description of the policies and procedures of the 
     Department and improvements made by the Department with 
     respect to the following:
       (i) How often the Department reviews or inspects patient 
     safety at medical centers of the Department.
       (ii) What triggers the aggregated review process at medical 
     centers of the Department.
       (iii) What controls the Department has in place for 
     controlled and other high-risk substances, including the 
     following:

       (I) Access to such substances by staff.
       (II) What medications are dispensed via automation.
       (III) What systems are in place to ensure proper matching 
     of the correct medication to the correct patient.
       (IV) Controls of items such as medication carts and pill 
     bottles and vials.
       (V) Monitoring of the dispensing of medication within 
     medical centers of the Department, including monitoring of 
     unauthorized dispensing.

       (iv) How the Department monitors contact between patients 
     and employees of the Department, including how employees are 
     monitored and tracked at medical centers of the Department 
     when entering and exiting the room of a patient.
       (v) How comprehensively the Department uses video 
     monitoring systems in medical centers of the Department to 
     enhance patient safety, security, and quality of care.
       (vi) How the Department tracks and reports deaths at 
     medical centers of the Department at the local level, 
     Veterans Integrated Service Network level, and national 
     level.
       (vii) The procedures of the Department to alert local, 
     regional, and Department-wide leadership when there is a 
     statistically abnormal number of deaths at a medical center 
     of the Department, including--

       (I) the manner and frequency in which such alerts are made; 
     and
       (II) what is included in such an alert, such as the nature 
     of death and where within the medical center the death 
     occurred.

       (viii) The use of root cause analyses with respect to 
     patient deaths in medical centers of the Department, 
     including--

       (I) what threshold triggers a root cause analysis for a 
     patient death;

[[Page S7212]]

       (II) who conducts the root cause analysis; and
       (III) how root cause analyses determine whether a patient 
     death is suspicious or not.

       (ix) What triggers a patient safety alert, including how 
     many suspicious deaths cause a patient safety alert to be 
     triggered.
       (x) The situations in which an autopsy report is ordered 
     for deaths at hospitals of the Department, including an 
     identification of--

       (I) when the medical examiner is called to review a patient 
     death; and
       (II) the official or officials that decide such a review is 
     necessary.

       (xi) The method for family members of a patient who died at 
     a medical center of the Department to request an 
     investigation into that death.
       (xii) The opportunities that exist for family members of a 
     patient who died at a medical center of the Department to 
     request an autopsy for that death.
       (xiii) The methods in place for employees of the Department 
     to report suspicious deaths at medical centers of the 
     Department.
       (xiv) The steps taken by the Department if an employee of 
     the Department is suspected to be implicated in a suspicious 
     death at a medical center of the Department, including--

       (I) actions to remove or suspend that individual from 
     patient care or temporarily reassign that individual and the 
     speed at which that action occurs; and
       (II) steps taken to ensure that other medical centers of 
     the Department and other non-Department medical centers are 
     aware of the suspected role of the individual in a suspicious 
     death.

       (xv) In the case of the suspicious death of an individual 
     while under care at a medical center of the Department, the 
     methods used by the Department to inform the family members 
     of that individual.
       (xvi) The policy of the Department for communicating to the 
     public when a suspicious death occurs at a medical center of 
     the Department.
       (B) A description of any additional authorities or 
     resources needed from Congress to implement any of the 
     actions, changes to policy, or other matters included in the 
     report required under paragraph (1)
       (b) Report on Deaths at Louis A. Johnson Medical Center.--
       (1) In general.--Not later than 60 days after the date on 
     which the Attorney General indicates that any investigation 
     or trial related to the suspicious deaths of veterans at the 
     Louis A. Johnson VA Medical Center in Clarksburg, West 
     Virginia, (in this subsection referred to as the 
     ``Facility'') that occurred during 2017 and 2018 has 
     sufficiently concluded, the Secretary of Veterans Affairs 
     shall submit to the Committee on Veterans' Affairs of the 
     Senate and the Committee on Veterans' Affairs of the House of 
     Representatives a report describing--
       (A) the events that occurred during that period related to 
     those suspicious deaths; and
       (B) actions taken at the Facility and throughout the 
     Department of Veterans Affairs to prevent any similar 
     reoccurrence of the issues that contributed to those 
     suspicious deaths.
       (2) Elements.--The report required by paragraph (1) shall 
     include the following:
       (A) A timeline of events that occurred at the Facility 
     relating to the suspicious deaths described in paragraph (1) 
     beginning the moment those deaths were first determined to be 
     suspicious, including any notifications to--
       (i) leadership of the Facility;
       (ii) leadership of the Veterans Integrated Service Network 
     in which the Facility is located;
       (iii) leadership at the central office of the Department; 
     and
       (iv) the Office of the Inspector General of the Department 
     of Veterans Affairs.
       (B) A description of the actions taken by leadership of the 
     Facility, the Veterans Integrated Service Network in which 
     the Facility is located, and the central office of the 
     Department in response to the suspicious deaths, including 
     responses to notifications under subparagraph (A).
       (C) A description of the actions, including root cause 
     analyses, autopsies, or other activities that were conducted 
     after each of the suspicious deaths.
       (D) A description of the changes made by the Department 
     since the suspicious deaths to procedures to control access 
     within medical centers of the Department to controlled and 
     non-controlled substances to prevent harm to patients.
       (E) A description of the changes made by the Department to 
     its nationwide controlled substance and non-controlled 
     substance policies as a result of the suspicious deaths.
       (F) A description of the changes planned or made by the 
     Department to its video surveillance at medical centers of 
     the Department to improve patient safety and quality of care 
     in response to the suspicious deaths.
       (G) An analysis of the review of sentinel events conducted 
     at the Facility in response to the suspicious deaths and 
     whether that review was conducted consistent with policies 
     and procedures of the Department.
       (H) A description of the steps the Department has taken or 
     will take to improve the monitoring of the credentials of 
     employees of the Department to ensure the validity of those 
     credentials, including all employees that interact with 
     patients in the provision of medical care.
       (I) A description of the steps the Department has taken or 
     will take to monitor and mitigate the behavior of employee 
     bad actors, including those who attempt to conceal their 
     mistreatment of veteran patients.
       (J) A description of the steps the Department has taken or 
     will take to enhance or create new monitoring systems that--
       (i) automatically collect and analyze data from medical 
     centers of the Department and monitor for warnings signs or 
     unusual health patterns that may indicate a health safety or 
     quality problem at a particular medical center; and
       (ii) automatically share those warnings with other medical 
     centers of the Department, relevant Veterans Integrated 
     Service Networks, and officials of the central office of the 
     Department.
       (K) A description of the accountability actions that have 
     been taken at the Facility to remove or discipline employees 
     who significantly participated in the actions that 
     contributed to the suspicious deaths.
       (L) A description of the system-wide reporting process that 
     the Department will or has implemented to ensure that 
     relevant employees are properly reported, when applicable, to 
     the National Practitioner Data Bank of the Department of 
     Health and Human Services, the applicable State licensing 
     boards, the Drug Enforcement Administration, and other 
     relevant entities.
       (M) A description of any additional authorities or 
     resources needed from Congress to implement any of the 
     recommendations or findings included in the report required 
     under paragraph (1).
       (N) Such other matters as the Secretary considers 
     necessary.
                                 ______
                                 
      By Mr. JOHNSON (for himself, Mr. Cotton, Mr. Cassidy, Mrs. 
        Blackburn, Ms. Ernst, Mr. Braun, Mr. Alexander, Mr. McConnell, 
        and Mr. Lankford):
  S. 3148. A bill to amend the Controlled Substances Act to list 
fentanyl-related substances as schedule I controlled substances; read 
the first time.

                                S. 3148

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Stopping Overdoses of 
     Fentanyl Analogues Act''.

     SEC. 2. FENTANYL-RELATED SUBSTANCES.

       Section 202(c) of the Controlled Substances Act (21 U.S.C. 
     812) is amended--
       (1) by adding at the end of subsection (b) of Schedule I 
     the following:
       ``(23) Isobutyryl fentanyl.
       ``(24) Para-Methoxybutyrylfentanyl.
       ``(25) Valeryl fentanyl.
       ``(26) Cyclopentyl fentanyl.
       ``(27) Para-Chloroisobutyryl fentanyl.''; and
       (2) by adding at the end of Schedule I the following:
       ``(e)(1) Unless specifically exempted or unless listed in 
     another schedule, any material, compound, mixture, or 
     preparation which contains any quantity of fentanyl-related 
     substances, or which contains their salts, isomers, and salts 
     of isomers whenever the existence of such salts, isomers, and 
     salts of isomers is possible within the specific chemical 
     designation.
       ``(2) In paragraph (1), the term `fentanyl-related 
     substances' includes the following:
       ``(A) Any substance that is structurally related to 
     fentanyl by one or more of the following modifications:
       ``(i) By replacement of the phenyl portion of the phenethyl 
     group by any monocycle, whether or not further substituted in 
     or on the monocycle.
       ``(ii) By substitution in or on the phenethyl group with 
     alkyl, alkenyl, alkoxy, hydroxy, halo, haloalkyl, amino or 
     nitro groups.
       ``(iii) By substitution in or on the piperidine ring with 
     alkyl, alkenyl, alkoxy, ester, ether, hydroxy, halo, 
     haloalkyl, amino or nitro groups.
       ``(iv) By replacement of the aniline ring with any aromatic 
     monocycle whether or not further substituted in or on the 
     aromatic monocycle.
       ``(v) By replacement of the N-propionyl group by another 
     acyl group.
       ``(B) 4'-Methyl acetyl fentanyl.
       ``(C) Crotonyl fentanyl.
       ``(D) 2'-Fluoro ortho-fluorofentanyl.
       ``(E) Ortho-Methyl acetylfentanyl.
       ``(F) Thiofuranyl fentanyl.
       ``(G) Ortho-Fluorobutyryl fentanyl.
       ``(H) Ortho-Fluoroacryl fentanyl.
       ``(I) Beta-Methyl fentanyl.
       ``(J) Phenyl fentanyl.
       ``(K) Para-Methylfentanyl.
       ``(L) Beta'-Phenyl fentanyl.
       ``(M) Benzodioxole fentanyl.''.
       This act shall take effect one day after the date of 
     enactment.

                          ____________________