This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives. STORAGE NAME: h1099a.FFS DATE: 1/21/2022 HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: CS/HB 1099 Living Organ Donors in Insurance Policies SPONSOR(S): Finance & Facilities Subcommittee, Latvala TIED BILLS: IDEN./SIM. BILLS: SB 1026 REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Finance & Facilities Subcommittee 14 Y, 0 N, As CS Calixte Lloyd 2) Appropriations Committee 3) Health & Human Services Committee SUMMARY ANALYSIS Organ donation is the process of surgically removing an organ or tissue from one person (the donor) and transplanting it into another person (the recipient). Transplanting in such cases is necessary because the recipient’s organ has failed or has been damaged by disease or injury. Transplantable organs include the liver, kidneys, pancreas, heart, lung, and intestine. Transplantable tissue includes skin, bone, heart valves, tendons, veins, and corneas. Despite advances in medicine and technology, and increased awareness of organ donation and transplantation, more donors are needed to meet the demand for transplants. As of January 2022, 120,000 children and adults are waiting for a life-saving organ transplant, including 5,000 Floridians. Although most organ donations occur after death of the donor, some donations come from living organ donors. A living-donor transplant is a surgical procedure to remove an organ or portion of an organ from a living person and place it another person whose organ is no longer functioning. Based on the limited data available on the long-term risks of living organ donors currently available, the overall risks are considered to be low and differ among donors depending on the organ donated. The bill prohibits insurers of life insurance policies, industrial life insurance policies, group life insurance policies, credit life and credit disability insurance policies, and long-term care insurance policies from discriminating against living organ donors, or prospective donors, in coverage or eligibility solely on their status as a living organ donor. The bill has no fiscal impact on state or local government. The bill provides an effective date of July 1, 2022. STORAGE NAME: h1099a.FFS PAGE: 2 DATE: 1/21/2022 FULL ANALYSIS I. SUBSTANTIVE ANALYSIS A. EFFECT OF PROPOS ED CHANGES: Background Organ and Tissue Donation Organ and tissue donation is the process of surgically removing an organ or tissue from one person (the donor) and transplanting it into another person (the recipient). Transplanting in such cases is necessary because the recipient’s organ has failed or has been damaged by disease or injury. 1 Transplantable organs include the liver, kidneys, pancreas, heart, lung, intestine. 2 Transplantable tissue include skin used as a temporary dressing for burns, serious abrasions and other exposed areas; bone is used in orthopedic surgery to facilitate healing of fractures or prevent amputation; heart valves are used to replace defective valves; tendons are used to repair torn ligaments on knees or other joints; veins are used in cardiac by-pass surgery; and corneas can restore sight. 3 A single organ donor can save up to eight lives and over seventy-five more can be improved through organ donation. 4 Despite advances in medicine and technology, and increased awareness of organ donation and transplantation, more donors are needed to meet the demand for transplants. 5 As of January 2022, 120,000 children and adults are waiting for a life-saving organ transplant, including 5,000 Floridians. 6 In 2021, 41,354 organ transplants were performed in the United States, reflecting an increase of 5.9 percent from 2020. 7 Living donor transplants on the other hand significantly decreased in 2020 due to COVID-19. While they increased in 2021, the numbers remain lower than in previous years. In 2021, a total of 6,541 living donor transplants were performed nationwide. Living Organ Donation Although most organ donations occur after the death of the donor, some donations come from living organ donors. A living-donor transplant is a surgical procedure to remove an organ or portion of an organ from a living person and place it in another person whose organ is no longer functioning properly. 8 Kidney and liver transplants are the most common living-organ procedures, though a living organ donor can also donate tissues for transplants such as skin, bone marrow, and stem cells to replace organs or tissue that have been damaged or destroyed by disease, drugs or radiation. 9 Based on the limited data available on the long-term risks of living organ donors currently available, the overall risks are considered to be low and differ among donors depending on the organ donated. 10 Short-term risks of living organ donation involve risks associated with anesthesia and major surgeries, 1 Cleveland Clinic, Organ Donation and Transplantation, https://my.clevelandclinic.org/health/articles/11750-organ- donation-and- transplantation#:~:text=Organ%20donation%20is%20the%20process%20of%20surgically%20removing,one%20of%20the %20great%20advances%20in%20modern%20medicine (last visited Jan. 4, 2022). 2 Id. 3 Donate Life Florida, Frequently Asked Questions, https://www.donatelifeflorida.org/categories/donation/ (last visited Jan. 14, 2022). 4 Health Resources and Services Administration, What Can Be Donated, https://www.organdonor.gov/learn/what-can-be- donated (last visited January 14, 2022). https://optn.transplant.hrsa.gov/data/ (last visited Jan. 14, 2022). 5 U.S. Department of Health and Human Services, Organ Procurement and Transplantation Network, All-time records again set in 2021 for organ transplants, organ donation from deceased donors - OPTN (hrsa.gov) (last visited Jan. 18, 2022). 6 Supra, note 3. 7 Supra, note 5. 8 Mayo Clinic, Living-donor transplant, https://www.mayoclinic.org/tests-procedures/living-donor-transplant/about/pac- 20384787 (last visited Jan. 14, 2022). 9 Id. 10 Unos, How do I become a living donor?, https://unos.org/transplant/living-donation/ (last visited Jan. 14, 2022). STORAGE NAME: h1099a.FFS PAGE: 3 DATE: 1/21/2022 including pain, infection, blood loss, blood clots, allergic reactions to anesthesia, pneumonia, injury to surrounding tissue or organs, and death. 11 For kidney donors, there is only a one percent lifetime increase in the donor’s own risk of kidney failure. 12 Long-term risks in kidney donation may include: high-blood pressure, reduced kidney function, organ impairment or failure that may lead to the need of dialysis, and death. Liver donations carry a greater risk for both the donor and the recipient than a kidney transplantation. 13 Possible risks associated with donating a lobe of the liver may include: infections, hernia, abdominal bleeding, bile leakage, narrowing of the bile duct, intestinal problems including blockages and tears, and organ impairment or failure that leads to the need for transplantation. 14 National Organ Transplant Act of 1984 The National Organ Transplant Act of 1984, which regulates organ donations including living organ donors, prohibits the buying and selling of organs. 15 Living donation of an organ must be voluntary and the donor cannot receive payment. Although, the organ recipient’s health insurances cover medical expenses such as evaluation, surgery, and limited follow-up test and medical appointments depending on the particular insurance, the recipient’s insurance will not cover transportation, lodging, long distance phone calls, childcare, or lost wages. 16 In addition, treatment for conditions discovered during the evaluation portion of the donation process and some post-donation follow-up expenses are not covered. 17 Furthermore, UNOS warns that some donors reported, “difficulty in getting, affording, or keeping health, disability, or life insurance.” 18 Living Organ Donors and Insurance The Florida Office of Insurance Regulation The Office of Insurance Regulation (OIR) licenses and regulates the activities of life, health, property, and casualty insurers, health maintenance organizations (HMOs), and other risk-bearing entities. The OIR is an office within the Financial Services Commission (FSC). The FSC is composed of the Governor, the Attorney General, the Chief Financial Officer, and the Commissioner of Agriculture. The FSC members serve as the agency head for purposes of rulemaking under ss. 120.536-120.565, F.S. 19 Obtaining and Affording Insurance In 2014, the American Journal of Transplantation published a study of 1,046 donors who underwent living kidney donation at Johns Hopkins Hospital. Of these donors, 25 percent of those who reported 11 Id. 12 American Transplant Foundation, Risks to Donor, https://www.americantransplantfoundation.org/about-transplant/living- donation/about-living-donation/ (last visited Jan. 14, 2022). 13 Id. 14 Id. 15 National Organ Transplant Act, 42 U.S.C. s. 274. 16 UNOS, Financial and Insurance Factors to Consider, https://unos.org/transplant/living-donation/ (last visited Jan.17, 2022). 17 Id. 18 Id. 19 S. 20.232(3), F.S. STORAGE NAME: h1099a.FFS PAGE: 4 DATE: 1/21/2022 attempting to obtain new or revised life insurance policies post-procedure reported difficulty in doing so. The difficulties reported included outright denials in obtaining coverage, higher premiums, and the notation of a pre-existing condition relating to the kidney donation. The same survey also noted that of the surveyed donors who reported attempting to obtain new or revised health insurance policies post- procedure, seven percent reported difficulties in doing so. 20 Another study, also published in the American Journal of Transplantation (in 2007), which reviewed different studies over a 35-year period, concluded that a significant number of living kidney donors encounter difficulties in obtaining or maintaining insurance (with anywhere between three percent to eleven percent of those surveyed reporting difficulties). 21 That same study also found that insurability issues caused significant stress for between 11 percent and 13 percent of kidney donors and that “insurability may negatively influence one’s decision to become a living organ donor.” 22 This same study also found that these insurability issues are not isolated to kidney donors. 23 The National Kidney Foundation also advises potential donors, in assessing the risk of donation, that “some donors have reported difficulty in getting, affording, or keeping disability or life insurance.” There is some evidence that these increased difficulties and costs in obtaining life insurance is not always based on the actual additional loss risk that organ donation presents. A 2015 study of living kidney donors found that such donation “does not appear to increase long-term mortality compared with controls;” however, the study did advise that it was limited in scope and more research was needed. 24 A study of living kidney donors in Korea, published in 2019, found that,“ the risk of all-cause mortality was comparable between live kidney donors and matched non-donor healthy controls with similar health status.” 25 A 2012 study of live liver donors found that while 90-day mortality rates were elevated for such donors, the rates of long-term mortality were essentially the same for live liver donors, for live kidney donors, and for healthy controls. 26 The Affordable Care Act The Affordable Care Act (ACA), previously known as the Patient Protection and Affordable Care Act PP(ACA), signed into law in 2010 made sweeping changes to the U.S. health insurance system. 27 The ACA imposes extensive requirements on health insurance and health insurance policies relating to required benefits, rating and underwriting standards, review of rate increase, and other requirements. 28 The ACA further prohibits health insurance to deny coverage on the basis of a pre-existing condition and without basing premiums on health related factors. 29 Effect of the Bill HB 1099 prohibits insurers of life insurance, industrial life insurance, group life insurance, credit life insurance policies, group life insurance policies, credit life and credit disability insurance policies, and long-term care insurance policies from discriminating against an individual solely on their status of as a living organ donor. It makes living organ donor insurance discrimination an unfair insurance trade practice. Specifically, the bill prohibits an insurer from: 20 B.j. Boyarsky, et al, Experiences Obtaining Insurance After Live Kidney Donation, 14(9) AM J Transplant. 2168-72 (2014). 21 2 Health Resources Services Administration, Organ Donation Frequently Asked Questions, available at https://www.organdonor.gov/learn/faq (last visited Jan. 13, 2022). 22 R.C. Yang, et al, Insurability of Living Organ Donors: A Systematic Review, 7(6) AM J TRANSPLANT. 1547-48 (2007). 23 Id. and Nissing MH & Hayashi PH, Right hepatic lobe donation adversely affects donor life insurability up to one year after donation, 11 LIVER TRANSPL 843–847 (2005). 24 K.L. Lentine & A. Patel, Risks and outcomes of living donation, 19(4) ADV CHRONIC KIDNEY DIS. 220-8 (2012). 25 Y. Kim, et al, Long-term Mortality Risks Among Living Kidney Donors in Korea. 75(6) Am J Kidney Dis. 925 (2019). 26 1 A.D. Muzaale, et al, Estimates of early death, acute liver failure, and long-term mortality among live liver donors, 142(2) Gastroenterology 273-80 (2012). 27 Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148, March 23, 2010, 124 Stat 119. 28 Most of the insurance regulatory provisions in PPACA amend Title XXVII of the Public Health Service Act (PHSA), 42 U.S.C. 300gg et seq. 29 5 ACA s. 1201; PHSA s. 2704 (42 U.S.C. 300gg-3). STORAGE NAME: h1099a.FFS PAGE: 5 DATE: 1/21/2022 Declining or limiting coverage of a person solely due to the individual’s status as a living organ donor; Precluding an insured person or subscriber from donating all, or part of, an organ as a condition to continuing to receive coverage under that person’s insurance policy; or Otherwise discriminating in the offering, issuance, cancellation, coverage, premium, or any other condition of a person’s policy without any additional actuarial risk, and based solely on that person’s status as a living organ donor. Penalties for Violations The bill further provides the Financial Services Commission with the authority to adopt rules and to enforce these provisions. A person is subject to a fine of up to $ 5,000 for each nonwillful violation and up to $40, 000 for each willful violation. 30 Insurers may be fined an aggregate amount of up to $20,000 for all nonwillful violations arising out of the same action or an aggregate amount of up to $20,000 for all willful violations arising out of the same action. These specified fines any be imposed in addition to any specified penalty elsewhere in the law. B. SECTION DIRECTORY: Section 1: Creates s. 626.97075, F.S., relating to life insurance, disability insurance, and long-term care insurance; discrimination against living organ donors prohibited. Section 2: Provides an effective date of July 1, 2022. II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT A. FISCAL IMPACT ON STATE GOVERNMENT: 1. Revenues: None. 2. Expenditures: None. 31 B. FISCAL IMPACT ON LOCAL GOVERNMENTS: 1. Revenues: None. 2. Expenditures: None. C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR: None identified. D. FISCAL COMMENTS: None. 30 S. 626.9521, F.S. 31 OIR states that the fiscal impact of rulemaking required by the bill can be absorbed within current resources. Florida Office of Insurance Regulation, Agency Analysis of 2022 HB 1099, p. 4 (Nov. 29, 2021). STORAGE NAME: h1099a.FFS PAGE: 6 DATE: 1/21/2022 III. COMMENTS A. CONSTITUTIONAL ISSUES: 1. Applicability of Municipality/County Mandates Provision: Not applicable. The bill does not appear to affect county or municipal governments. 2. Other: None. B. RULE-MAKING AUTHORITY: The bill provides OIR sufficient rulemaking authority to implement the bill. C. DRAFTING ISSUES OR OTHER COMMENTS: None. IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES On January 20, 2022, the Finance & Facilities Subcommittee adopted one amendment and reported the bill favorably as a committee substitute. The amendment removes the portions of the bill related to healthcare insurance and makes living organ donor insurance discrimination an unfair insurance trade practice. This analysis is drafted to the committee substitute as passed by the Finance & Facilities Subcommittee.