ASSEMBLY, No. 3909

STATE OF NEW JERSEY

217th LEGISLATURE

 

INTRODUCED SEPTEMBER 8, 2016

 


 

Sponsored by:

Assemblyman  HERB CONAWAY, JR.

District 7 (Burlington)

Assemblywoman  ANGELA V. MCKNIGHT

District 31 (Hudson)

 

 

 

 

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

     As introduced.

  


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, “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 inpatient or outpatient basis to an individual who was born between January 1, 1945 and December 31, 1965, shall 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.

      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 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 or diagnostic test, or to provide services or health care for the individual who is subject to a hepatitis C screening or diagnostic test.

 

     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 inpatient or outpatient basis to an individual born between 1945 and 1965, to provide 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. 

      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 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.

      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 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.