Bill Text: NJ S344 | 2018-2019 | Regular Session | Introduced


Bill Title: Requires hospital laboratories and bio-analytical or clinical laboratories to offer test for hepatitis C to certain individuals; authorizes certain laboratories to perform rapid tests for hepatitis C.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced - Dead) 2018-01-09 - Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee [S344 Detail]

Download: New_Jersey-2018-S344-Introduced.html

SENATE, No. 344

STATE OF NEW JERSEY

218th LEGISLATURE

 

PRE-FILED FOR INTRODUCTION IN THE 2018 SESSION

 


 

Sponsored by:

Senator  NILSA CRUZ-PEREZ

District 5 (Camden and Gloucester)

 

 

 

 

SYNOPSIS

     Requires hospital laboratories and bio-analytical or clinical laboratories to offer test for hepatitis C to certain individuals; authorizes certain laboratories to perform rapid tests for hepatitis C.

 

CURRENT VERSION OF TEXT

     Introduced Pending Technical Review by Legislative Counsel.

  


An Act concerning hepatitis C testing and supplementing Title 26 and Title 45 of the Revised Statutes.

 

     Be It Enacted by the Senate and General Assembly of the State of New Jersey:

 

      1.   The Legislature finds and declares that:

      a.   According to the federal Centers for Disease Control and Prevention (CDC), approximately 75 percent of the 3.2 million people chronically infected with hepatitis C in the United States were born between 1945 and 1965.  The CDC estimates that people born during these years are five times more likely than other adults to be infected with hepatitis C.

      b.   The CDC notes that hepatitis C is the leading cause of both liver cancer and liver transplants, and estimates that people born between 1945 and 1965 account for 73 percent of all hepatitis C-related mortality.

      c.   Studies suggest that between 45 percent and 85 percent of people infected with hepatitis C are unaware they are infected, and as many as 50 percent of hepatitis C infections may go undetected under the current hepatitis C risk factor screening standards.

      d.   The CDC recommends one-time testing of all people born between 1945 and 1965 for hepatitis C infection, suggesting that this testing is likely to identify approximately 800,000 people infected with hepatitis C.

      e.   Proactively testing for hepatitis C infection among persons born between 1945 and 1965 may help stop progression of the disease, increase the effectiveness of treatment, and reduce the duration of therapy for those infected, potentially resulting in improved health outcomes and significant cost reductions associated with treating liver disease.

      f.    New Jersey can help promote efforts to diagnose and treat hepatitis C infection by facilitating access to hepatitis C screening tests at certain points of care for persons born between 1945 and 1965.

 

     2.    a.  As used in this section:

     "Carrier" means a carrier as defined in section 2 of P.L.1997, c.192 (C.26:2S-2).

     "Health benefits plan" means a health benefits plan as defined in section 2 of P.L.1997, c.192 (C.26:2S-2), the State Health Benefits Program established pursuant to the "State Health Benefits Program Act," P.L.1961, c.49 (C.52:14-17.25 et seq.), and the School Employees' Health Benefits Program established pursuant to the "School Employees' Health Benefits Program Act," sections 31 through 41 of P.L.2007, c.103 (C.54:14-17.46.1 through C.52:14-17.46.11).

     "Hepatitis C screening test" means a test approved by the federal Food and Drug Administration that detects the presence of hepatitis C virus antibodies in the blood.

     b.    Pursuant to a standing order issued by its chief medical officer, a general hospital licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.), when providing laboratory services on an outpatient basis to an individual who was born between January 1, 1945 and December 31, 1965, shall, upon registration, provide the individual with a verbal and written statement of CDC policy regarding hepatitis C screening, and offer to provide a hepatitis C screening test to that individual.  If the individual consents to undergo a hepatitis C screening test pursuant to this subsection, the hospital laboratory shall perform the hepatitis C screening test and transmit the test results to the health care provider rendering the referral for laboratory services.  The standing order shall designate a process for an appropriate member of the hospital staff to contact an individual who tests positive for hepatitis C in a screening test performed pursuant to this subsection, so as to advise the individual of the test results and encourage the individual to seek appropriate follow-up care.

     c.     Pursuant to a standing order issued by its chief medical officer or an equivalent officer, a bio-analytical or clinical laboratory, when providing laboratory services to an individual born between January 1, 1945 and December 31, 1965 who was referred for laboratory services by a health care professional licensed pursuant to Title 45 of the Revised Statutes, shall, upon registration, provide the individual with a verbal and written statement of CDC policy regarding Hepatitis C screening and offer to provide a hepatitis C screening test to that individual.  If the individual consents to undergo a hepatitis C screening test pursuant to this subsection, the laboratory shall perform the hepatitis C screening test and transmit the test results to the health care professional who provided the referral for laboratory services.

     d.    This section shall not affect the scope of practice of any health care professional or diminish any authority or legal or professional obligation of any health care professional to offer a hepatitis C screening test, or to provide services or health care for the individual who is subject to a hepatitis C screening test.

     e.     A hospital, bio-analytical, or clinical laboratory shall not be required to provide an individual with a statement of CDC policy regarding hepatitis C screening and offer to provide a hepatitis C screening test to the individual pursuant to this section if, upon a review of the laboratory's records, it is determined the individual has already been tested for hepatitis C.

     f.     (1)  In the event that a laboratory that performs a hepatitis C screening test pursuant to subsection b. or c. of this section is out-of-network with respect to a covered person's health benefits plan, the carrier shall reimburse the laboratory for the cost of the screening test at the carrier's in-network rate, or in any other reasonable amount as agreed upon by the laboratory and the carrier, less any applicable copayment, coinsurance, or deductible.  In no case shall the laboratory bill the covered person for the screening test, except for the covered person's applicable copayment, coinsurance, or deductible. 

     (2)   Paragraph (1) of this subsection shall not apply to a hepatitis C screening test that is performed on a covered person in the event that, prior to the performance of the screening test:

     (a)   a check of laboratory records pursuant to subsection e. of this section determines that the covered person was previously tested for hepatitis C;

     (b)   the covered person is advised that, because the person was previously tested for hepatitis C, the person may be liable for all or part of the cost of the screening test in the event the person's health benefits plan does not provide coverage for the test; and

     (c)   the person, voluntarily and in writing, requests or agrees to undergo the hepatitis C screening test.

     g.    The Commissioner of Health shall evaluate the impact of the provisions of this section with respect to the number of individuals who are screened for hepatitis C and the number of individuals who have accessed care following a positive test.  No later than one year after the effective date of this act, the Commissioner of Health shall submit a report of the evaluation to the Governor and, pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1), to the Legislature.

 

     3.    The Commissioner of Health, in consultation with the Public Health Council in the Department of Health, shall adopt regulations, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), to permit any laboratory site that has a current Clinical Laboratory Improvement Amendments Certificate of Waiver issued by the federal Centers for Medicare & Medicaid Services to perform rapid point-of-care tests for hepatitis C virus licensed by the federal Food and Drug Administration.

 

     4.    The Commissioner of Health, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), shall adopt rules and regulations necessary to effectuate the purposes of this act.

 

     5.    This act shall take effect on the first day of January next following the date of enactment, except that the Commissioner of Health may take such anticipatory administrative action in advance of the effective date as shall be necessary for the implementation of this act.  Section 1 of this act shall expire and be deemed repealed on January 1 of the fifth year next following the date of enactment.

STATEMENT

 

     This bill sets forth certain requirements for hepatitis C screenings for individuals born between January 1, 1945 and December 31, 1965 who, according to the federal Centers for Disease Control and Prevention (CDC), are at increased risk for hepatitis C infection and associated liver diseases. 

     Specifically, pursuant to a standing order issued by its chief medical officer, a general hospital will be required, when providing laboratory services on an outpatient basis to an individual born between 1945 and 1965, to provide, upon registration, the individual with a verbal and written statement of CDC policy regarding Hepatitis C screening, and offer to provide the individual with a hepatitis C screening test.  If the individual consents to a hepatitis C screening test, the hospital laboratory will be required to perform the test and transmit the test results to the health care provider who referred the individual for laboratory services.  The standing order is to designate a process for an appropriate member of the hospital staff to contact individuals who test positive for hepatitis C, so as to advise the individual of the test results and encourage the individual to seek appropriate follow-up care.

     Similarly, when providing laboratory services to an individual born between 1945 and 1965 upon referral by a health care professional, a bio-analytical or clinical laboratory, pursuant to a standing order issued by its chief medical officer or an equivalent officer, will be required to provide the individual, upon registration, with a verbal and written statement of CDC policy regarding Hepatitis C screening and offer to provide the individual with a hepatitis C screening test. If the individual consents to a hepatitis C screening test, the laboratory is to perform the test and transmit the test results to the health care professional who provided the referral for laboratory services.

     The requirement for laboratories to provide individuals with a statement of CDC policy regarding hepatitis C screening and offer to provide a hepatitis C screening test will not apply if a check of laboratory records indicates the individual has already been tested for hepatitis C.

     The bill provides that, in the event that a laboratory is out-of-network with respect to an individual's health benefits plan, the person's health benefits carrier is to reimburse the laboratory at the carrier's in-network rate, or in any other reasonable amount as agreed upon by the laboratory and the carrier, less any applicable copayment, coinsurance, or deductible, and the laboratory will be prohibited from billing the covered person for the screening test, other than for the applicable copayment, coinsurance, or deductible.  This prohibition will not apply in situations in which: (1) the laboratory checks its records and determines that the covered person was previously screened for hepatitis C; (2) the person is advised that, because of the prior test, the person may be liable for the full cost of a subsequent test if the person's health benefits plan does not provide coverage for the test; (3) and the person, voluntarily and in writing, requests or agrees to undergo the subsequent test.

     Nothing in the bill will affect the scope of practice of any health care professional or diminish any authority or legal or professional obligation of any health care professional to offer a hepatitis C screening or diagnostic test, or to provide services or health care for the individual who is subject to a hepatitis C test.

     The commissioner will be required to evaluate the impact of the bill with respect to the number of hepatitis C screenings and the number of individuals who access care following a positive test, and submit a report of the evaluation to the Governor and to the Legislature within one year of the effective date of the bill.

     The commissioner will also be required to adopt regulations, in consultation with the Public Health Council in the Department of Health, to permit any laboratory site that has a current Clinical Laboratory Improvement Amendments Certificate of Waiver issued by the federal Centers for Medicare & Medicaid Services to perform rapid point-of-care tests for hepatitis C virus licensed by the federal Food and Drug Administration.

     The bill will take effect on the first day of January next following the date of enactment, and the provisions concerning the hepatitis C screening requirements will expire and be deemed repealed on January 1 of the fifth year next following the date of enactment.

     The CDC has suggested that one-time testing of persons born between 1945 and 1965 for hepatitis C will help identify additional cases of hepatitis C infection that may otherwise go undetected, potentially improving health care outcomes and reducing the impact of liver disease among this population.

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