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House File 387 - IntroducedA Bill ForAn Act 1creating the better caths for Iowa Act including a
2review of the use and reimbursement of certain catheters
3under the Medicaid program.
4BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. SHORT TITLE. This Act shall be known as the
2“Better Caths for Iowa Act”.
3 Sec. 2. FINDINGS. The general assembly finds all of the
4following:
51. Di(2-ethylhexyl)phthalate (DEHP) belongs to a family
6of chemicals called phthalates: toxic, endocrine-disrupting
7chemicals which are added to certain plastic products to
8increase their flexibility. There is no question that the use
9of DEHP in medical devices harms patients. The evidence of
10patient exposure to DEHP and other toxins during the course
11of clinical care is well established and science continues to
12demonstrate the need to reduce patient risk from such exposure.
132. Exposure to phthalates like DEHP can do lasting harm
14to child brain development and increases children’s risks for
15learning, attention, and behavior disorders.
163. A pregnant woman’s exposure to phthalates, which is
17known to decrease fetal testosterone, can harm reproductive
18tract development in male babies which may have lifelong
19consequences.
204. Phthalates in medical devices like catheters have been
21shown to leach into soft tissue from the plastic, a reason
22phthalates have been banned in children’s toys by the United
23States food and drug administration (FDA) as children often
24hold toys or put them in their mouths for long periods of time.
255. Exposure to phthalates can come from multiple sources
26simultaneously, including from food and food contact substances
27and other products. Therefore, assessing risks from individual
28phthalates may underestimate the health risks from exposure to
29mixtures of phthalates.
306. Research shows that women have higher exposure to
31phthalates found in care products than men.
327. Studies have shown that African American and Latina women
33have higher exposure to certain phthalates compared with white
34women.
358. In a nationally representative sample, African
-1-1American women had higher exposures to a real-world mixture of
2hormonally active phthalates compared with white women.
39. Studies have shown that people with disabilities who use
4catheters experience bladder cancer at four times the national
5average.
610. A population-based retrospective cohort study published
7in September 2021 in Ontario, Canada, proves the correlation
8between long-term catheterization and bladder cancer incidence
9and mortality. In that study, thirty-six thousand nine hundred
10three patients with long-term catheterization were compared
11to one hundred ten thousand seven hundred nine patients
12without a history of catheterization using HealthCanada
13records. Patients in the catheter group develop bladder cancer
14four times more often than the noncatheter group. Bladder
15cancer-specific death was more than eight times higher among
16the patients who were long-term catheter users than the
17noncatheter group.
1811. Cancer is the third leading cause of death in
19individuals with spinal cord injury or disorder (SCI/D), and
20bladder cancer is the second most common cancer type in these
21individuals.
2212. Urinary bladder cancer in SCI/D patients differs
23considerably from urinary bladder cancer in able-bodied
24patients. SCI/D patients show a significantly higher
25proportion of the more aggressive squamous cell carcinoma than
26that of the general population. Consequently, the survival
27rate is extremely unfavorable.
2813. Exposure to phthalates including DEHP, butyl benzyl
29phthalate (BBzP), and Diisobutyl phthalate (DiBP) has been
30positively associated with prostate cancer in men.
3114. Human and rodent data suggest that DEHP induces cancer
32through multiple molecular signals, including DNA damage.
3315. The European Union has determined that DEHP is a
34reproductive toxicant and endocrine disruptor, and in 2017
35adopted regulations requiring a benefit-risk assessment before
-2-1certain phthalates, including DEHP, can be used in medical
2devices.
316. The state of California has determined that DEHP is a
4reproductive and developmental toxicant and a carcinogen, and
5advises patients to request devices that do not contain DEHP
6when undergoing medical treatment.
717. In 2002, based on the FDA’s 2001 safety assessment,
8the FDA recommended that health care providers consider
9alternatives to DEHP when conducting procedures on high-risk
10patients.
1118. The American medical association passed an
12organizational resolution for members encouraging alternatives
13to DEHP products.
1419. The American public health association issued a policy
15statement discouraging the use of DEHP and other phthalates in
16facilities that serve vulnerable populations.
1720. American patients receiving care in hospitals and other
18settings are overexposed to dangerous levels of phthalates.
19This critical patient safety issue has been the subject of
20extensive research over the last few decades, but thus far the
21guidance to protect patients from these harmful chemicals has
22done very little to actually reduce the use of these chemicals
23in health care settings.
2421. Despite these findings and the growing body of evidence
25that has confirmed earlier research and identified additional
26risks of adverse health effects on vulnerable patients, there
27has been minimal progress in the United States over the last
28twenty years in reducing the use of DEHP in medical devices.
2922. Since 2018, the office of inspector general of the
30United States department of health and human services has
31recommended a significant reduction in reimbursement amounts by
32the centers for Medicare and Medicaid services of the United
33States department of health and human services (CMS) for
34intermittent catheters as the Medicare and Medicaid programs
35have paid substantially more than commercial payors for
-3-1intermittent urinary catheters.
223. Each of the three billing categories of intermittent
3catheters, straight tip, curved tip, and sterile kit, show
4large differences between Medicare payments and acquisition
5costs, which indicates a potential for substantial savings
6both to the Medicare program and Medicare beneficiaries who
7share responsibility for payment of the Medicare-allowed
8reimbursement amount.
924. Nearly twenty years after the FDA’s first guidance
10was issued on phthalates, the time has finally come to take
11aggressive and necessary steps forward to protect the lives of
12Iowa Medicaid patients.
1325. At the very least, the Iowa Medicaid program should
14not reimburse medical device manufacturers, distributors, or
15suppliers for catheters that are made with the known carcinogen
16DEHP.
17 Sec. 3. REVIEW OF CATHETERS — REIMBURSEMENT SUSPENSION
18PENDING COMPLETION OF REVIEW — MEDICAID PROGRAM.
191. The Medicaid program shall not reimburse claims for
20catheters made with Di(2-ethylhexyl)phthalate (DEHP) until
21after the completion and pending the results of the review
22under this section that includes the Medicaid director’s
23recommendation regarding which catheters should be reimbursable
24under the Medicaid program.
252. Pending completion of the review under this section, all
26of the following shall also apply:
27a. Notwithstanding any provision of law to the contrary,
28the use of catheters made with DEHP is deemed unsafe for Iowa
29Medicaid recipients.
30b. Any rules previously adopted prescribing the conditions
31under which any catheter made with DEHP may be safely used are
32void, and shall have no force or effect.
33c. The Medicaid director shall object to any notification of
34an intended use of catheters made with DEHP and shall not adopt
35rules prescribing any conditions under which any catheter made
-4-1with DEHP may be safely used as an invasive medical device.
2d. In establishing the safety of alternatives to catheters
3made with DEHP that may be used and reimbursed under the Iowa
4Medicaid program, the Medicaid director shall consider, in
5addition to criteria under section 409 of the federal Food,
6Drug, and Cosmetic Act, 21 U.S.C.§348, potential adverse
7effects of exposure to an alternative substance on vulnerable
8populations, including pregnant women, infants, children,
9persons with disabilities, the elderly, and populations with
10high exposure, including workers who are exposed through
11production practices or clinical handling of the final product.
12e. The Medicaid director shall inform Medicaid providers
13and recipients of the prohibition against reimbursement of
14catheters made with DEHP during the pendency of the review and
15shall make available to Medicaid providers and recipients a
16list of alternative products that are not made with DEHP and
17that are reimbursable under Medicaid when provided to Medicaid
18recipients during the pendency of the review.
193. The Medicaid director shall cause a review to be
20conducted by the university of Iowa public policy center
21or other appropriate state entity that includes all of the
22following:
23a. A historical records review of Medicaid recipients who
24used catheters made with phthalate chemicals like DEHP which
25are subject to regulation by the United States food and drug
26administration to determine whether Iowa Medicaid recipients
27who use these medical devices made with phthalate chemicals
28have a higher incidence rate of bladder cancer than the general
29population.
30b. Identification of the brands of catheters with DEHP
31that are correlated with higher levels of bladder cancer in
32the Iowa Medicaid population of catheter users by comparing
33the diagnosis codes associated with bladder cancer against
34individual patient-level data that includes catheter billing
35at the stock keeping unit level to determine the DEHP
-5-1concentration of these devices.
2c. A comparison of the average lifetime cost of care for a
3Medicaid recipient who uses catheters with the average lifetime
4cost of care of a Medicaid recipient who has bladder cancer
5treatment.
6d. Consideration of the disproportionate exposure of
7invasive medical devices containing phthalate chemicals on
8members of communities of color and with disabilities, and the
9health effects of such exposure on members of such communities,
10including any increased risk of cancer, endocrine disruption,
11effects on reproductive health, and other risks to human
12health.
134. No later than July 1, 2025, the Medicaid director shall
14issue a report on the findings of the review, submit the report
15to the governor and the general assembly, and post the report
16on the department of health and human services internet site.
17The report shall include the Medicaid director’s recommendation
18as to which catheters should be reimbursed under the Medicaid
19program, including specifically whether catheters made with
20DEHP should be reimbursed under the Medicaid program.
215. For the purposes of this section, catheters include
22intermittent and indwelling catheters.
23EXPLANATION
24The inclusion of this explanation does not constitute agreement with
25the explanation’s substance by the members of the general assembly.
26This bill relates to the use and reimbursement of certain
27catheters under the Medicaid program.
28The bill shall be known as the “Better Caths for Iowa Act”.
29The bill includes findings relating to the use of
30phthalates, a family of toxic endocrine-disrupting chemicals
31that include Di(2-ethylhexyl)phthalate or DEHP, that when
32added to certain plastic products increase their flexibility.
33These products include catheters. The findings include
34that American patients receiving care in hospitals and other
35settings are overexposed to dangerous levels of phthalates;
-6-1exposure to phthalates can do lasting harm to child brain
2development and increases children’s risks for learning,
3attention, and behavior disorders; a pregnant woman’s exposure
4to phthalates can harm reproductive tract development in
5male babies which may have lifelong consequences; phthalates
6have been banned from use in children’s toys in the United
7States; women have higher exposure to phthalates found in
8care products than men; African American and Latina women
9have higher exposure to certain phthalates compared with
10white women; persons with disabilities who use catheters
11experience bladder cancer at four times the national average;
12little has been done to protect patients from these harmful
13chemicals to actually reduce the use of these chemicals in
14health care settings; that the three billing categories of
15intermittent catheters, straight tip, curved tip, and sterile
16kit, show large differences between Medicare payments and
17acquisition costs, indicating the potential for substantial
18savings both to the Medicare program and Medicare beneficiaries
19who share responsibility for payment of the Medicare-allowed
20reimbursement amount; and that at the very least, the
21Iowa Medicaid program should not reimburse medical device
22manufacturers, distributors, or suppliers for catheters that
23are made with the known carcinogen DEHP.
24The bill provides the Medicaid program shall not reimburse
25claims for catheters made with DEHP, until after the completion
26and the results of the review required under the bill including
27the recommendation of the Medicaid director regarding
28reimbursement of catheters under the Medicaid program.
29Pending completion of the review under the bill, the use of
30catheters made with DEHP is deemed unsafe for Iowa Medicaid
31recipients; any rules previously adopted prescribing the
32conditions under which any catheter made with DEHP may be
33safely used are void, and shall have no force or effect;
34the Medicaid director shall object to any notification of an
35intended use of catheters made with DEHP and shall not adopt
-7-1rules prescribing any conditions under which any catheter
2made with DEHP may be safely used as an invasive medical
3device; and in establishing the safety of alternatives to
4catheters made with DEHP that may be used and reimbursed
5under the Iowa Medicaid program, the Medicaid director shall
6consider, in addition to criteria provided under federal law,
7the potential adverse effects of exposure to an alternative
8substance on vulnerable populations, including pregnant women,
9infants, children, persons with disabilities, the elderly,
10and populations with high exposure, including workers who are
11exposed through production practices or clinical handling of
12the final product. The Medicaid director is required to inform
13Medicaid providers and recipients of the prohibition against
14reimbursement of catheters made with DEHP during the pendency
15of the review and make available to Medicaid recipients and
16providers a list of alternative products that are not made with
17DEHP and that are reimbursable under Medicaid when provided to
18Medicaid recipients during the pendency of the review.
19The Medicaid director shall cause a review to be conducted of
20catheters, including a historical records review of Medicaid
21recipients who used catheters made with phthalate chemicals
22including DEHP, to determine whether Iowa Medicaid recipients
23who use these medical devices have a higher incidence rate of
24bladder cancer than the general population; identification of
25the brands of catheters with DEHP that are correlated with
26higher levels of bladder cancer in the Iowa Medicaid population
27of catheter users; a comparison of the average lifetime cost
28of care for a Medicaid recipient who uses catheters with the
29average lifetime cost of care for a Medicaid recipient who has
30bladder cancer treatment; consideration of the disproportionate
31exposure of invasive medical devices containing phthalate
32chemicals on members of communities of color and with
33disabilities, and the health effects of such exposure on
34members of such communities, including any increased risk of
35cancer, endocrine disruption, effects on reproductive health,
-8-1and other risks to human health. No later than July 1, 2025,
2the Medicaid director shall issue a report on the findings of
3the review, submit the report to the governor and the general
4assembly, and post the report on the department of health and
5human services internet site. The report shall include a
6recommendation as to whether catheters made with DEHP should be
7reimbursed under the Medicaid program.
8Under the bill, catheters include intermittent and
9indwelling catheters.
-9-pf/rh
2review of the use and reimbursement of certain catheters
3under the Medicaid program.
4BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. SHORT TITLE. This Act shall be known as the
2“Better Caths for Iowa Act”.
3 Sec. 2. FINDINGS. The general assembly finds all of the
4following:
51. Di(2-ethylhexyl)phthalate (DEHP) belongs to a family
6of chemicals called phthalates: toxic, endocrine-disrupting
7chemicals which are added to certain plastic products to
8increase their flexibility. There is no question that the use
9of DEHP in medical devices harms patients. The evidence of
10patient exposure to DEHP and other toxins during the course
11of clinical care is well established and science continues to
12demonstrate the need to reduce patient risk from such exposure.
132. Exposure to phthalates like DEHP can do lasting harm
14to child brain development and increases children’s risks for
15learning, attention, and behavior disorders.
163. A pregnant woman’s exposure to phthalates, which is
17known to decrease fetal testosterone, can harm reproductive
18tract development in male babies which may have lifelong
19consequences.
204. Phthalates in medical devices like catheters have been
21shown to leach into soft tissue from the plastic, a reason
22phthalates have been banned in children’s toys by the United
23States food and drug administration (FDA) as children often
24hold toys or put them in their mouths for long periods of time.
255. Exposure to phthalates can come from multiple sources
26simultaneously, including from food and food contact substances
27and other products. Therefore, assessing risks from individual
28phthalates may underestimate the health risks from exposure to
29mixtures of phthalates.
306. Research shows that women have higher exposure to
31phthalates found in care products than men.
327. Studies have shown that African American and Latina women
33have higher exposure to certain phthalates compared with white
34women.
358. In a nationally representative sample, African
-1-1American women had higher exposures to a real-world mixture of
2hormonally active phthalates compared with white women.
39. Studies have shown that people with disabilities who use
4catheters experience bladder cancer at four times the national
5average.
610. A population-based retrospective cohort study published
7in September 2021 in Ontario, Canada, proves the correlation
8between long-term catheterization and bladder cancer incidence
9and mortality. In that study, thirty-six thousand nine hundred
10three patients with long-term catheterization were compared
11to one hundred ten thousand seven hundred nine patients
12without a history of catheterization using HealthCanada
13records. Patients in the catheter group develop bladder cancer
14four times more often than the noncatheter group. Bladder
15cancer-specific death was more than eight times higher among
16the patients who were long-term catheter users than the
17noncatheter group.
1811. Cancer is the third leading cause of death in
19individuals with spinal cord injury or disorder (SCI/D), and
20bladder cancer is the second most common cancer type in these
21individuals.
2212. Urinary bladder cancer in SCI/D patients differs
23considerably from urinary bladder cancer in able-bodied
24patients. SCI/D patients show a significantly higher
25proportion of the more aggressive squamous cell carcinoma than
26that of the general population. Consequently, the survival
27rate is extremely unfavorable.
2813. Exposure to phthalates including DEHP, butyl benzyl
29phthalate (BBzP), and Diisobutyl phthalate (DiBP) has been
30positively associated with prostate cancer in men.
3114. Human and rodent data suggest that DEHP induces cancer
32through multiple molecular signals, including DNA damage.
3315. The European Union has determined that DEHP is a
34reproductive toxicant and endocrine disruptor, and in 2017
35adopted regulations requiring a benefit-risk assessment before
-2-1certain phthalates, including DEHP, can be used in medical
2devices.
316. The state of California has determined that DEHP is a
4reproductive and developmental toxicant and a carcinogen, and
5advises patients to request devices that do not contain DEHP
6when undergoing medical treatment.
717. In 2002, based on the FDA’s 2001 safety assessment,
8the FDA recommended that health care providers consider
9alternatives to DEHP when conducting procedures on high-risk
10patients.
1118. The American medical association passed an
12organizational resolution for members encouraging alternatives
13to DEHP products.
1419. The American public health association issued a policy
15statement discouraging the use of DEHP and other phthalates in
16facilities that serve vulnerable populations.
1720. American patients receiving care in hospitals and other
18settings are overexposed to dangerous levels of phthalates.
19This critical patient safety issue has been the subject of
20extensive research over the last few decades, but thus far the
21guidance to protect patients from these harmful chemicals has
22done very little to actually reduce the use of these chemicals
23in health care settings.
2421. Despite these findings and the growing body of evidence
25that has confirmed earlier research and identified additional
26risks of adverse health effects on vulnerable patients, there
27has been minimal progress in the United States over the last
28twenty years in reducing the use of DEHP in medical devices.
2922. Since 2018, the office of inspector general of the
30United States department of health and human services has
31recommended a significant reduction in reimbursement amounts by
32the centers for Medicare and Medicaid services of the United
33States department of health and human services (CMS) for
34intermittent catheters as the Medicare and Medicaid programs
35have paid substantially more than commercial payors for
-3-1intermittent urinary catheters.
223. Each of the three billing categories of intermittent
3catheters, straight tip, curved tip, and sterile kit, show
4large differences between Medicare payments and acquisition
5costs, which indicates a potential for substantial savings
6both to the Medicare program and Medicare beneficiaries who
7share responsibility for payment of the Medicare-allowed
8reimbursement amount.
924. Nearly twenty years after the FDA’s first guidance
10was issued on phthalates, the time has finally come to take
11aggressive and necessary steps forward to protect the lives of
12Iowa Medicaid patients.
1325. At the very least, the Iowa Medicaid program should
14not reimburse medical device manufacturers, distributors, or
15suppliers for catheters that are made with the known carcinogen
16DEHP.
17 Sec. 3. REVIEW OF CATHETERS — REIMBURSEMENT SUSPENSION
18PENDING COMPLETION OF REVIEW — MEDICAID PROGRAM.
191. The Medicaid program shall not reimburse claims for
20catheters made with Di(2-ethylhexyl)phthalate (DEHP) until
21after the completion and pending the results of the review
22under this section that includes the Medicaid director’s
23recommendation regarding which catheters should be reimbursable
24under the Medicaid program.
252. Pending completion of the review under this section, all
26of the following shall also apply:
27a. Notwithstanding any provision of law to the contrary,
28the use of catheters made with DEHP is deemed unsafe for Iowa
29Medicaid recipients.
30b. Any rules previously adopted prescribing the conditions
31under which any catheter made with DEHP may be safely used are
32void, and shall have no force or effect.
33c. The Medicaid director shall object to any notification of
34an intended use of catheters made with DEHP and shall not adopt
35rules prescribing any conditions under which any catheter made
-4-1with DEHP may be safely used as an invasive medical device.
2d. In establishing the safety of alternatives to catheters
3made with DEHP that may be used and reimbursed under the Iowa
4Medicaid program, the Medicaid director shall consider, in
5addition to criteria under section 409 of the federal Food,
6Drug, and Cosmetic Act, 21 U.S.C.§348, potential adverse
7effects of exposure to an alternative substance on vulnerable
8populations, including pregnant women, infants, children,
9persons with disabilities, the elderly, and populations with
10high exposure, including workers who are exposed through
11production practices or clinical handling of the final product.
12e. The Medicaid director shall inform Medicaid providers
13and recipients of the prohibition against reimbursement of
14catheters made with DEHP during the pendency of the review and
15shall make available to Medicaid providers and recipients a
16list of alternative products that are not made with DEHP and
17that are reimbursable under Medicaid when provided to Medicaid
18recipients during the pendency of the review.
193. The Medicaid director shall cause a review to be
20conducted by the university of Iowa public policy center
21or other appropriate state entity that includes all of the
22following:
23a. A historical records review of Medicaid recipients who
24used catheters made with phthalate chemicals like DEHP which
25are subject to regulation by the United States food and drug
26administration to determine whether Iowa Medicaid recipients
27who use these medical devices made with phthalate chemicals
28have a higher incidence rate of bladder cancer than the general
29population.
30b. Identification of the brands of catheters with DEHP
31that are correlated with higher levels of bladder cancer in
32the Iowa Medicaid population of catheter users by comparing
33the diagnosis codes associated with bladder cancer against
34individual patient-level data that includes catheter billing
35at the stock keeping unit level to determine the DEHP
-5-1concentration of these devices.
2c. A comparison of the average lifetime cost of care for a
3Medicaid recipient who uses catheters with the average lifetime
4cost of care of a Medicaid recipient who has bladder cancer
5treatment.
6d. Consideration of the disproportionate exposure of
7invasive medical devices containing phthalate chemicals on
8members of communities of color and with disabilities, and the
9health effects of such exposure on members of such communities,
10including any increased risk of cancer, endocrine disruption,
11effects on reproductive health, and other risks to human
12health.
134. No later than July 1, 2025, the Medicaid director shall
14issue a report on the findings of the review, submit the report
15to the governor and the general assembly, and post the report
16on the department of health and human services internet site.
17The report shall include the Medicaid director’s recommendation
18as to which catheters should be reimbursed under the Medicaid
19program, including specifically whether catheters made with
20DEHP should be reimbursed under the Medicaid program.
215. For the purposes of this section, catheters include
22intermittent and indwelling catheters.
23EXPLANATION
24The inclusion of this explanation does not constitute agreement with
25the explanation’s substance by the members of the general assembly.
26This bill relates to the use and reimbursement of certain
27catheters under the Medicaid program.
28The bill shall be known as the “Better Caths for Iowa Act”.
29The bill includes findings relating to the use of
30phthalates, a family of toxic endocrine-disrupting chemicals
31that include Di(2-ethylhexyl)phthalate or DEHP, that when
32added to certain plastic products increase their flexibility.
33These products include catheters. The findings include
34that American patients receiving care in hospitals and other
35settings are overexposed to dangerous levels of phthalates;
-6-1exposure to phthalates can do lasting harm to child brain
2development and increases children’s risks for learning,
3attention, and behavior disorders; a pregnant woman’s exposure
4to phthalates can harm reproductive tract development in
5male babies which may have lifelong consequences; phthalates
6have been banned from use in children’s toys in the United
7States; women have higher exposure to phthalates found in
8care products than men; African American and Latina women
9have higher exposure to certain phthalates compared with
10white women; persons with disabilities who use catheters
11experience bladder cancer at four times the national average;
12little has been done to protect patients from these harmful
13chemicals to actually reduce the use of these chemicals in
14health care settings; that the three billing categories of
15intermittent catheters, straight tip, curved tip, and sterile
16kit, show large differences between Medicare payments and
17acquisition costs, indicating the potential for substantial
18savings both to the Medicare program and Medicare beneficiaries
19who share responsibility for payment of the Medicare-allowed
20reimbursement amount; and that at the very least, the
21Iowa Medicaid program should not reimburse medical device
22manufacturers, distributors, or suppliers for catheters that
23are made with the known carcinogen DEHP.
24The bill provides the Medicaid program shall not reimburse
25claims for catheters made with DEHP, until after the completion
26and the results of the review required under the bill including
27the recommendation of the Medicaid director regarding
28reimbursement of catheters under the Medicaid program.
29Pending completion of the review under the bill, the use of
30catheters made with DEHP is deemed unsafe for Iowa Medicaid
31recipients; any rules previously adopted prescribing the
32conditions under which any catheter made with DEHP may be
33safely used are void, and shall have no force or effect;
34the Medicaid director shall object to any notification of an
35intended use of catheters made with DEHP and shall not adopt
-7-1rules prescribing any conditions under which any catheter
2made with DEHP may be safely used as an invasive medical
3device; and in establishing the safety of alternatives to
4catheters made with DEHP that may be used and reimbursed
5under the Iowa Medicaid program, the Medicaid director shall
6consider, in addition to criteria provided under federal law,
7the potential adverse effects of exposure to an alternative
8substance on vulnerable populations, including pregnant women,
9infants, children, persons with disabilities, the elderly,
10and populations with high exposure, including workers who are
11exposed through production practices or clinical handling of
12the final product. The Medicaid director is required to inform
13Medicaid providers and recipients of the prohibition against
14reimbursement of catheters made with DEHP during the pendency
15of the review and make available to Medicaid recipients and
16providers a list of alternative products that are not made with
17DEHP and that are reimbursable under Medicaid when provided to
18Medicaid recipients during the pendency of the review.
19The Medicaid director shall cause a review to be conducted of
20catheters, including a historical records review of Medicaid
21recipients who used catheters made with phthalate chemicals
22including DEHP, to determine whether Iowa Medicaid recipients
23who use these medical devices have a higher incidence rate of
24bladder cancer than the general population; identification of
25the brands of catheters with DEHP that are correlated with
26higher levels of bladder cancer in the Iowa Medicaid population
27of catheter users; a comparison of the average lifetime cost
28of care for a Medicaid recipient who uses catheters with the
29average lifetime cost of care for a Medicaid recipient who has
30bladder cancer treatment; consideration of the disproportionate
31exposure of invasive medical devices containing phthalate
32chemicals on members of communities of color and with
33disabilities, and the health effects of such exposure on
34members of such communities, including any increased risk of
35cancer, endocrine disruption, effects on reproductive health,
-8-1and other risks to human health. No later than July 1, 2025,
2the Medicaid director shall issue a report on the findings of
3the review, submit the report to the governor and the general
4assembly, and post the report on the department of health and
5human services internet site. The report shall include a
6recommendation as to whether catheters made with DEHP should be
7reimbursed under the Medicaid program.
8Under the bill, catheters include intermittent and
9indwelling catheters.
-9-pf/rh