Mary Jo Lawyer Spano Mesothelioma Patient Registry Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 1824 To amend the Public Health Service Act to provide for the establishment of a mesothelioma patient registry, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 18, 2019 Mr. KATKO (for himself and Mr. KENNEDY) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to provide for the establishment of a mesothelioma patient registry, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Mary Jo Lawyer Spano 4 Mesothelioma Patient Registry Act of 2019’’. 5 SEC. 2. PATIENT REGISTRY FOR MESOTHELIOMA DATA 6 COLLECTION AND RESEARCH. 7 Title III of the Public Health Service Act is amended 8 by inserting after section 399V–6 of such Act (42 U.S.C. 9 280g–17) the following: 10 VerDate Sep 11 2014 04:59 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1824.IH H1824 kjohnson on DSK79L0C42 with BILLS 2 •HR 1824 IH ‘‘SEC. 399V–7. PATIENT REGISTRY FOR MESOTHELIOMA 1 DATA COLLECTION AND RESEARCH. 2 ‘‘(a) IN GENERAL.—The Secretary, acting through 3 the Administrator of the Agency for Toxic Substances and 4 Disease Registry, shall develop a patient registry to collect 5 data on mesothelioma, including information with respect 6 to the incidence and prevalence of the disease in the 7 United States. 8 ‘‘(b) USES.—The Secretary shall use the registry 9 under subsection (a)— 10 ‘‘(1) to enhance and expand infrastructure and 11 activities for tracking the epidemiology of mesothe- 12 lioma patients; 13 ‘‘(2) to collect, consolidate, and report on health 14 information on patients who have been diagnosed 15 with mesothelioma, including with respect to— 16 ‘‘(A) treatment outcomes, including patient 17 longevity; and 18 ‘‘(B) the number of patients receiving 19 treatment for mesothelioma disaggregated by 20 hospital; 21 ‘‘(3) to better describe the incidence and preva- 22 lence of mesothelioma in the United States; 23 ‘‘(4) to facilitate further research on mesothe- 24 lioma; 25 VerDate Sep 11 2014 04:59 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1824.IH H1824 kjohnson on DSK79L0C42 with BILLS 3 •HR 1824 IH ‘‘(5) to examine factors, such as environmental 1 and occupational factors, that may be associated 2 with mesothelioma; 3 ‘‘(6) to better outline key demographic factors 4 (such as age, race or ethnicity, gender, and family 5 history) associated with mesothelioma; and 6 ‘‘(7) to make the information in such registry, 7 other than individually identifiable information, 8 available to the public to facilitate and enhance re- 9 search on, and prevention and treatment of, meso- 10 thelioma. 11 ‘‘(c) CONTENT.—In carrying out this section, the 12 Secretary— 13 ‘‘(1) shall provide for the collection and storage 14 of information on the incidence and prevalence of 15 mesothelioma in the United States; 16 ‘‘(2) when scientifically possible, shall provide 17 for the collection and storage of other available in- 18 formation on mesothelioma, such as information con- 19 cerning— 20 ‘‘(A) demographics and other information 21 associated or possibly associated with mesothe- 22 lioma, such as age, race, ethnicity, sex, geo- 23 graphic location, and family history; 24 VerDate Sep 11 2014 04:59 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1824.IH H1824 kjohnson on DSK79L0C42 with BILLS 4 •HR 1824 IH ‘‘(B) risk factors associated or possibly as- 1 sociated with mesothelioma, including genetic 2 and environmental risk factors; and 3 ‘‘(C) diagnosis and progression markers; 4 and 5 ‘‘(3) may provide for the collection and storage 6 of information relevant to analysis on mesothelioma, 7 such as information concerning— 8 ‘‘(A) the epidemiology of the disease; 9 ‘‘(B) the natural history of the disease; 10 ‘‘(C) the prevention of the disease; 11 ‘‘(D) the detection, management, and 12 treatment approaches for the disease; and 13 ‘‘(E) the development of outcomes meas- 14 ures. 15 ‘‘(d) CONSULTATION.—In carrying out this section, 16 the Secretary shall consult with individuals with appro- 17 priate expertise, including non-Federal mesothelioma ex- 18 perts including— 19 ‘‘(1) epidemiologists with experience in disease 20 surveillance or registries; 21 ‘‘(2) representatives of national voluntary asso- 22 ciations that focus on mesothelioma or have dem- 23 onstrated experience in research, care, or patient 24 service for mesothelioma; 25 VerDate Sep 11 2014 04:59 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1824.IH H1824 kjohnson on DSK79L0C42 with BILLS 5 •HR 1824 IH ‘‘(3) health information technology experts or 1 other information management specialists; 2 ‘‘(4) clinicians with expertise in mesothelioma; 3 and 4 ‘‘(5) research scientists with experience con- 5 ducting translational research or utilizing surveil- 6 lance systems for scientific research purposes. 7 ‘‘(e) COORDINATION WITH OTHER FEDERAL AGEN- 8 CIES.—The Secretary shall make information in and anal- 9 ysis derived from the registry under this section available, 10 as appropriate, to Federal departments and agencies, such 11 as the National Institutes of Health, the Food and Drug 12 Administration, the Centers for Medicare & Medicaid 13 Services, the Agency for Healthcare Research and Quality, 14 the Department of Veterans Affairs, and the Department 15 of Defense. 16 ‘‘(f) PUBLIC ACCESS.—Subject to subsection (g), the 17 Secretary shall make information in, and analysis derived 18 from, the registry under this section available, as appro- 19 priate, to the public, including researchers. 20 ‘‘(g) PRIVACY.—The Secretary shall ensure that pri- 21 vacy and security protections applicable to the registry 22 under this section are at least as stringent as the privacy 23 and security protections under HIPAA privacy and secu- 24 rity law (as defined in section 3009). 25 VerDate Sep 11 2014 04:59 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1824.IH H1824 kjohnson on DSK79L0C42 with BILLS 6 •HR 1824 IH ‘‘(h) REPORTS TO CONGRESS.— 1 ‘‘(1) INITIAL REPORT.—Not later than 18 2 months after the date of enactment of the Mary Jo 3 Lawyer Spano Mesothelioma Patient Registry Act of 4 2019, the Secretary shall submit to the Congress a 5 report that— 6 ‘‘(A) shall outline— 7 ‘‘(i) the findings in the mesothelioma 8 patient registry under subsection (a); 9 ‘‘(ii) future plans for expansion or re- 10 vision of such registry; and 11 ‘‘(iii) the scope of such registry; and 12 ‘‘(B) may include a description of the ac- 13 tivities undertaken by the Secretary to establish 14 partnerships with research and patient advocacy 15 communities to expand such registry. 16 ‘‘(2) SUBSEQUENT REPORT.—Not later than 4 17 years after the date of enactment of the Mary Jo 18 Lawyer Spano Mesothelioma Patient Registry Act of 19 2019, the Secretary shall submit a report to the 20 Congress concerning the implementation of this sec- 21 tion. Such report should include information on— 22 ‘‘(A) the development and maintenance of 23 the mesothelioma patient registry under sub- 24 section (a); 25 VerDate Sep 11 2014 04:59 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1824.IH H1824 kjohnson on DSK79L0C42 with BILLS 7 •HR 1824 IH ‘‘(B) the type of information collected and 1 stored in the registry; 2 ‘‘(C) the use and availability of such infor- 3 mation, including guidelines for such use; and 4 ‘‘(D) the use and coordination of databases 5 that collect or maintain information on meso- 6 thelioma.’’. 7 Æ VerDate Sep 11 2014 04:59 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H1824.IH H1824 kjohnson on DSK79L0C42 with BILLS