House File 387 - Introduced HOUSE FILE 387 BY TUREK A BILL FOR An Act creating the better caths for Iowa Act including a 1 review of the use and reimbursement of certain catheters 2 under the Medicaid program. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 1822YH (10) 90 pf/rh
H.F. 387 Section 1. SHORT TITLE. This Act shall be known as the 1 Better Caths for Iowa Act. 2 Sec. 2. FINDINGS. The general assembly finds all of the 3 following: 4 1. Di(2-ethylhexyl)phthalate (DEHP) belongs to a family 5 of chemicals called phthalates: toxic, endocrine-disrupting 6 chemicals which are added to certain plastic products to 7 increase their flexibility. There is no question that the use 8 of DEHP in medical devices harms patients. The evidence of 9 patient exposure to DEHP and other toxins during the course 10 of clinical care is well established and science continues to 11 demonstrate the need to reduce patient risk from such exposure. 12 2. Exposure to phthalates like DEHP can do lasting harm 13 to child brain development and increases childrens risks for 14 learning, attention, and behavior disorders. 15 3. A pregnant womans exposure to phthalates, which is 16 known to decrease fetal testosterone, can harm reproductive 17 tract development in male babies which may have lifelong 18 consequences. 19 4. Phthalates in medical devices like catheters have been 20 shown to leach into soft tissue from the plastic, a reason 21 phthalates have been banned in childrens toys by the United 22 States food and drug administration (FDA) as children often 23 hold toys or put them in their mouths for long periods of time. 24 5. Exposure to phthalates can come from multiple sources 25 simultaneously, including from food and food contact substances 26 and other products. Therefore, assessing risks from individual 27 phthalates may underestimate the health risks from exposure to 28 mixtures of phthalates. 29 6. Research shows that women have higher exposure to 30 phthalates found in care products than men. 31 7. Studies have shown that African American and Latina women 32 have higher exposure to certain phthalates compared with white 33 women. 34 8. In a nationally representative sample, African 35 -1- LSB 1822YH (10) 90 pf/rh 1/ 9
H.F. 387 American women had higher exposures to a real-world mixture of 1 hormonally active phthalates compared with white women. 2 9. Studies have shown that people with disabilities who use 3 catheters experience bladder cancer at four times the national 4 average. 5 10. A population-based retrospective cohort study published 6 in September 2021 in Ontario, Canada, proves the correlation 7 between long-term catheterization and bladder cancer incidence 8 and mortality. In that study, thirty-six thousand nine hundred 9 three patients with long-term catheterization were compared 10 to one hundred ten thousand seven hundred nine patients 11 without a history of catheterization using HealthCanada 12 records. Patients in the catheter group develop bladder cancer 13 four times more often than the noncatheter group. Bladder 14 cancer-specific death was more than eight times higher among 15 the patients who were long-term catheter users than the 16 noncatheter group. 17 11. Cancer is the third leading cause of death in 18 individuals with spinal cord injury or disorder (SCI/D), and 19 bladder cancer is the second most common cancer type in these 20 individuals. 21 12. Urinary bladder cancer in SCI/D patients differs 22 considerably from urinary bladder cancer in able-bodied 23 patients. SCI/D patients show a significantly higher 24 proportion of the more aggressive squamous cell carcinoma than 25 that of the general population. Consequently, the survival 26 rate is extremely unfavorable. 27 13. Exposure to phthalates including DEHP, butyl benzyl 28 phthalate (BBzP), and Diisobutyl phthalate (DiBP) has been 29 positively associated with prostate cancer in men. 30 14. Human and rodent data suggest that DEHP induces cancer 31 through multiple molecular signals, including DNA damage. 32 15. The European Union has determined that DEHP is a 33 reproductive toxicant and endocrine disruptor, and in 2017 34 adopted regulations requiring a benefit-risk assessment before 35 -2- LSB 1822YH (10) 90 pf/rh 2/ 9
H.F. 387 certain phthalates, including DEHP, can be used in medical 1 devices. 2 16. The state of California has determined that DEHP is a 3 reproductive and developmental toxicant and a carcinogen, and 4 advises patients to request devices that do not contain DEHP 5 when undergoing medical treatment. 6 17. In 2002, based on the FDAs 2001 safety assessment, 7 the FDA recommended that health care providers consider 8 alternatives to DEHP when conducting procedures on high-risk 9 patients. 10 18. The American medical association passed an 11 organizational resolution for members encouraging alternatives 12 to DEHP products. 13 19. The American public health association issued a policy 14 statement discouraging the use of DEHP and other phthalates in 15 facilities that serve vulnerable populations. 16 20. American patients receiving care in hospitals and other 17 settings are overexposed to dangerous levels of phthalates. 18 This critical patient safety issue has been the subject of 19 extensive research over the last few decades, but thus far the 20 guidance to protect patients from these harmful chemicals has 21 done very little to actually reduce the use of these chemicals 22 in health care settings. 23 21. Despite these findings and the growing body of evidence 24 that has confirmed earlier research and identified additional 25 risks of adverse health effects on vulnerable patients, there 26 has been minimal progress in the United States over the last 27 twenty years in reducing the use of DEHP in medical devices. 28 22. Since 2018, the office of inspector general of the 29 United States department of health and human services has 30 recommended a significant reduction in reimbursement amounts by 31 the centers for Medicare and Medicaid services of the United 32 States department of health and human services (CMS) for 33 intermittent catheters as the Medicare and Medicaid programs 34 have paid substantially more than commercial payors for 35 -3- LSB 1822YH (10) 90 pf/rh 3/ 9
H.F. 387 intermittent urinary catheters. 1 23. Each of the three billing categories of intermittent 2 catheters, straight tip, curved tip, and sterile kit, show 3 large differences between Medicare payments and acquisition 4 costs, which indicates a potential for substantial savings 5 both to the Medicare program and Medicare beneficiaries who 6 share responsibility for payment of the Medicare-allowed 7 reimbursement amount. 8 24. Nearly twenty years after the FDAs first guidance 9 was issued on phthalates, the time has finally come to take 10 aggressive and necessary steps forward to protect the lives of 11 Iowa Medicaid patients. 12 25. At the very least, the Iowa Medicaid program should 13 not reimburse medical device manufacturers, distributors, or 14 suppliers for catheters that are made with the known carcinogen 15 DEHP. 16 Sec. 3. REVIEW OF CATHETERS REIMBURSEMENT SUSPENSION 17 PENDING COMPLETION OF REVIEW MEDICAID PROGRAM. 18 1. The Medicaid program shall not reimburse claims for 19 catheters made with Di(2-ethylhexyl)phthalate (DEHP) until 20 after the completion and pending the results of the review 21 under this section that includes the Medicaid directors 22 recommendation regarding which catheters should be reimbursable 23 under the Medicaid program. 24 2. Pending completion of the review under this section, all 25 of the following shall also apply: 26 a. Notwithstanding any provision of law to the contrary, 27 the use of catheters made with DEHP is deemed unsafe for Iowa 28 Medicaid recipients. 29 b. Any rules previously adopted prescribing the conditions 30 under which any catheter made with DEHP may be safely used are 31 void, and shall have no force or effect. 32 c. The Medicaid director shall object to any notification of 33 an intended use of catheters made with DEHP and shall not adopt 34 rules prescribing any conditions under which any catheter made 35 -4- LSB 1822YH (10) 90 pf/rh 4/ 9
H.F. 387 with DEHP may be safely used as an invasive medical device. 1 d. In establishing the safety of alternatives to catheters 2 made with DEHP that may be used and reimbursed under the Iowa 3 Medicaid program, the Medicaid director shall consider, in 4 addition to criteria under section 409 of the federal Food, 5 Drug, and Cosmetic Act, 21 U.S.C. 348, potential adverse 6 effects of exposure to an alternative substance on vulnerable 7 populations, including pregnant women, infants, children, 8 persons with disabilities, the elderly, and populations with 9 high exposure, including workers who are exposed through 10 production practices or clinical handling of the final product. 11 e. The Medicaid director shall inform Medicaid providers 12 and recipients of the prohibition against reimbursement of 13 catheters made with DEHP during the pendency of the review and 14 shall make available to Medicaid providers and recipients a 15 list of alternative products that are not made with DEHP and 16 that are reimbursable under Medicaid when provided to Medicaid 17 recipients during the pendency of the review. 18 3. The Medicaid director shall cause a review to be 19 conducted by the university of Iowa public policy center 20 or other appropriate state entity that includes all of the 21 following: 22 a. A historical records review of Medicaid recipients who 23 used catheters made with phthalate chemicals like DEHP which 24 are subject to regulation by the United States food and drug 25 administration to determine whether Iowa Medicaid recipients 26 who use these medical devices made with phthalate chemicals 27 have a higher incidence rate of bladder cancer than the general 28 population. 29 b. Identification of the brands of catheters with DEHP 30 that are correlated with higher levels of bladder cancer in 31 the Iowa Medicaid population of catheter users by comparing 32 the diagnosis codes associated with bladder cancer against 33 individual patient-level data that includes catheter billing 34 at the stock keeping unit level to determine the DEHP 35 -5- LSB 1822YH (10) 90 pf/rh 5/ 9
H.F. 387 concentration of these devices. 1 c. A comparison of the average lifetime cost of care for a 2 Medicaid recipient who uses catheters with the average lifetime 3 cost of care of a Medicaid recipient who has bladder cancer 4 treatment. 5 d. Consideration of the disproportionate exposure of 6 invasive medical devices containing phthalate chemicals on 7 members of communities of color and with disabilities, and the 8 health effects of such exposure on members of such communities, 9 including any increased risk of cancer, endocrine disruption, 10 effects on reproductive health, and other risks to human 11 health. 12 4. No later than July 1, 2025, the Medicaid director shall 13 issue a report on the findings of the review, submit the report 14 to the governor and the general assembly, and post the report 15 on the department of health and human services internet site. 16 The report shall include the Medicaid directors recommendation 17 as to which catheters should be reimbursed under the Medicaid 18 program, including specifically whether catheters made with 19 DEHP should be reimbursed under the Medicaid program. 20 5. For the purposes of this section, catheters include 21 intermittent and indwelling catheters. 22 EXPLANATION 23 The inclusion of this explanation does not constitute agreement with 24 the explanations substance by the members of the general assembly. 25 This bill relates to the use and reimbursement of certain 26 catheters under the Medicaid program. 27 The bill shall be known as the Better Caths for Iowa Act. 28 The bill includes findings relating to the use of 29 phthalates, a family of toxic endocrine-disrupting chemicals 30 that include Di(2-ethylhexyl)phthalate or DEHP, that when 31 added to certain plastic products increase their flexibility. 32 These products include catheters. The findings include 33 that American patients receiving care in hospitals and other 34 settings are overexposed to dangerous levels of phthalates; 35 -6- LSB 1822YH (10) 90 pf/rh 6/ 9
H.F. 387 exposure to phthalates can do lasting harm to child brain 1 development and increases childrens risks for learning, 2 attention, and behavior disorders; a pregnant womans exposure 3 to phthalates can harm reproductive tract development in 4 male babies which may have lifelong consequences; phthalates 5 have been banned from use in childrens toys in the United 6 States; women have higher exposure to phthalates found in 7 care products than men; African American and Latina women 8 have higher exposure to certain phthalates compared with 9 white women; persons with disabilities who use catheters 10 experience bladder cancer at four times the national average; 11 little has been done to protect patients from these harmful 12 chemicals to actually reduce the use of these chemicals in 13 health care settings; that the three billing categories of 14 intermittent catheters, straight tip, curved tip, and sterile 15 kit, show large differences between Medicare payments and 16 acquisition costs, indicating the potential for substantial 17 savings both to the Medicare program and Medicare beneficiaries 18 who share responsibility for payment of the Medicare-allowed 19 reimbursement amount; and that at the very least, the 20 Iowa Medicaid program should not reimburse medical device 21 manufacturers, distributors, or suppliers for catheters that 22 are made with the known carcinogen DEHP. 23 The bill provides the Medicaid program shall not reimburse 24 claims for catheters made with DEHP, until after the completion 25 and the results of the review required under the bill including 26 the recommendation of the Medicaid director regarding 27 reimbursement of catheters under the Medicaid program. 28 Pending completion of the review under the bill, the use of 29 catheters made with DEHP is deemed unsafe for Iowa Medicaid 30 recipients; any rules previously adopted prescribing the 31 conditions under which any catheter made with DEHP may be 32 safely used are void, and shall have no force or effect; 33 the Medicaid director shall object to any notification of an 34 intended use of catheters made with DEHP and shall not adopt 35 -7- LSB 1822YH (10) 90 pf/rh 7/ 9
H.F. 387 rules prescribing any conditions under which any catheter 1 made with DEHP may be safely used as an invasive medical 2 device; and in establishing the safety of alternatives to 3 catheters made with DEHP that may be used and reimbursed 4 under the Iowa Medicaid program, the Medicaid director shall 5 consider, in addition to criteria provided under federal law, 6 the potential adverse effects of exposure to an alternative 7 substance on vulnerable populations, including pregnant women, 8 infants, children, persons with disabilities, the elderly, 9 and populations with high exposure, including workers who are 10 exposed through production practices or clinical handling of 11 the final product. The Medicaid director is required to inform 12 Medicaid providers and recipients of the prohibition against 13 reimbursement of catheters made with DEHP during the pendency 14 of the review and make available to Medicaid recipients and 15 providers a list of alternative products that are not made with 16 DEHP and that are reimbursable under Medicaid when provided to 17 Medicaid recipients during the pendency of the review. 18 The Medicaid director shall cause a review to be conducted of 19 catheters, including a historical records review of Medicaid 20 recipients who used catheters made with phthalate chemicals 21 including DEHP, to determine whether Iowa Medicaid recipients 22 who use these medical devices have a higher incidence rate of 23 bladder cancer than the general population; identification of 24 the brands of catheters with DEHP that are correlated with 25 higher levels of bladder cancer in the Iowa Medicaid population 26 of catheter users; a comparison of the average lifetime cost 27 of care for a Medicaid recipient who uses catheters with the 28 average lifetime cost of care for a Medicaid recipient who has 29 bladder cancer treatment; consideration of the disproportionate 30 exposure of invasive medical devices containing phthalate 31 chemicals on members of communities of color and with 32 disabilities, and the health effects of such exposure on 33 members of such communities, including any increased risk of 34 cancer, endocrine disruption, effects on reproductive health, 35 -8- LSB 1822YH (10) 90 pf/rh 8/ 9
H.F. 387 and other risks to human health. No later than July 1, 2025, 1 the Medicaid director shall issue a report on the findings of 2 the review, submit the report to the governor and the general 3 assembly, and post the report on the department of health and 4 human services internet site. The report shall include a 5 recommendation as to whether catheters made with DEHP should be 6 reimbursed under the Medicaid program. 7 Under the bill, catheters include intermittent and 8 indwelling catheters. 9 -9- LSB 1822YH (10) 90 pf/rh 9/ 9