Alabama House OKs Alabama Farmers Federation health plans
Rep. David Faulkner, R-Mountain Brook, speaks on the floor of the Alabama House of Representatives on April 25, 2024 at the Alabama Statehouse in Montgomery, Alabama. The Alabama House on Thursday approved a bill sponsored by Faulkner to allow the Alabama Farmers Federation to sell health insurance plans. (Brian Lyman/Alabama Reflector)
The Alabama House of Representatives Thursday voted to allow the Alabama Farmers Federation to offer health insurance for its members.
The chamber approved HB 477, sponsored by Rep. David Faulkner, R-Mountain Brook, by a vote of 98-1. It allows an organization fitting the description of the Alabama Farmers Federation (Alfa) to offer a health care plan that exists outside of state regulations and is only available to people who are members of the nonprofit.
'The rising cost of health care is a significant burden for our farmers,' Faulkner said when he introduced his legislation on the floor. 'As legislators, there is little we can do about fertilizer costs, or the price of cotton. But we can make a difference in one of the largest household costs for many farmer families and other citizens in Alabama regarding their health care coverage.'
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Faulker's proposal was introduced last week at the Alabama House Health Committee when the committee hosted a public hearing, and members of the public voiced several concerns regarding the bill.
Members of the committee considered the legislation once again Wednesday, and several lawmakers on the committee introduced amendments to the bill even though the sponsor did not always agree with all the proposals.
Two days later, Faulker's bill was approved in the House and passed onto the Senate.
The bill allows Alfa to offer health plans that include outpatient services and hospital visits; visits to the emergency room; mental health and substance abuse services and prescription drug benefits.
Members enrolled in the plan cannot be denied coverage because of a pre-existing medical condition. The plan cannot be cancelled because of a medical event.
If someone enrolled in the plan must visit a provider that is not in the network, Alfa will pay that provider the median amount of the in-network rate or 80% of the maximum allowed charge for the service.
Only members of the Alabama Farmers Federation can enroll in the health care plan, and only after they certify that they are not able to enroll in a health plan sponsored by their employer or that enrolling in the plan is too expensive.
Under the bill, only insurance agents authorized by Alfa can market and sell the plan. The Alabama Department of Insurance may also review and comment on any complaint that a person enrolled in the plan files which will then be forwarded to the third party responsible for addressing the complaint.
Several people during a public hearing on April 3 expressed concerns regarding the legislation prior to lawmakers introducing amendments to change the bill in committee. They said that it lacks several protections afforded to patients that are in the Affordable Care Act.
'We believe this bill threatens those protections by allowing the sale of health plans that are not required to cover essential health benefits… and can discriminate against individuals with pre-existing conditions, including cancer,' said Jane Adams during the public hearing, government relations director for the American Cancer Society Cancer Action Network (ACS CAN) in Alabama, during the public hearing last Wednesday.
Numerous changes were made to the bill after several lawmakers in the committee during Wednesday's meeting submitted amendments to include the other benefits, such as prescription drug coverage and mental health and substance abuse and allow for greater oversight by the Alabama Department of Insurance.
On the House floor Thursday, Rep. Paul Lee, R-Dothan, the chair of the House Health Committee, proposed an amendment setting the annual limit on the benefits of the health plan at least $2 million.
'We want to make sure that our farmers are taken care of,' Lee said. 'I am the first generation away from a dependence on farming, so I understand it, growing up in it. So, I know the hard times, the late nights, getting up and looking for a cloud in the sky. I understand that. We want to make sure that farmers get the best thing, and anything we can get in this bill.'
The Alabama Hospital Association proposed the provision to lawmakers.
Much of the debate circled around an amendment proposed by Rep. Frances Holk-Jones, R-Foley, and approved in committee that said the Alabama Department of Insurance 'shall enforce this act.'
Faulkner, who opposed the amendment, moved to remove it from the bill Thursday, saying it was 'very confusing.'
'The state's Department of Insurance does not regulate self-funded plans,' he said. 'And the federal regulation that applies to self-funded plans does not have any application to our bill. Our bill is far more comprehensive, and so it doesn't make sense for that to be on there.'
The debate over the move took two hours.
'These amendments, this one in particular, that says the plan will be enforced by the Department of Insurance, it is just a precaution,' said Holk-Jones, who has worked in the insurance industry for the past 40 years. 'It is a precaution for those individuals who have this policy. I call it a prenup. While we are in love with each other, and while we are agreeing to everything, that is when we want the prenup.'
The chamber voted to remove the language.
The bill moves to the Senate.
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U.S. FDA Grants Approval for Jivi® Antihemophilic Factor (Recombinant), PEGylated-aucl in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A (Congenital Factor VIII Deficiency)
Not intended for media outside the U.S. WHIPPANY, N.J., May 19, 2025--(BUSINESS WIRE)--Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi®, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency). The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi's safety and efficacy in children aged 7 to under 12 years with severe hemophilia A. This significant milestone reflects Bayer's ongoing commitment to providing effective treatment options for the hemophilia community. Jivi was first granted approval by the FDA in August 2018 for use in previously treated adults 12 years of age and older with hemophilia A for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes. 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Injuries can have severe consequences if not treated appropriately, as the blood clots more slowly in hemophilia patients than in healthy individuals. Based on a study that used data collected on patients receiving care in federally funded hemophilia treatment centers during the period 2012–2018, about 33,000 males in the United States are living with the disorder.2 About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. © 2025 BayerBAYER, the Bayer Cross and Jivi are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to confirm them to future events or developments. References:1. Jivi® [antihemophilic factor (recombinant), PEGylated-aucl] [Prescribing Information]. Whippany, NJ: Bayer 20252. Centers for Disease Control and Prevention. About Hemophilia. Last Reviewed: May 2025. PP-JIV-US-2365- 1 May 2025 View source version on Contacts Media Jennifer May+1 412 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
19-05-2025
- Business Wire
U.S. FDA Grants Approval for Jivi ® Antihemophilic Factor (Recombinant), PEGylated-aucl in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A (Congenital Factor VIII Deficiency)
BUSINESS WIRE)--Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi ®, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency). The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi's safety and efficacy in children aged 7 to under 12 years with severe hemophilia A. This significant milestone reflects Bayer's ongoing commitment to providing effective treatment options for the hemophilia community. Jivi was first granted approval by the FDA in August 2018 for use in previously treated adults 12 years of age and older with hemophilia A for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes. Jivi is not indicated for use in: Children <7 years of age due to a greater risk for hypersensitivity reactions and/or loss of efficacy. Previously untreated patients (PUPs). Treatment of von Willebrand disease. "Bayer remains dedicated to meeting the needs of the hemophilia A community," stated Jessica Charlet, Scientific Director. 'The FDA's approval for pediatric patients 7 to <12 years of age is reflective of Bayer's commitment to the hemophilia A community and underscores our commitment to supporting families through their treatment journey.' Bayer continues to prioritize support for the hemophilia community, and we are excited to offer Jivi as a treatment option for patients and their families. About Jivi ® [antihemophilic factor (recombinant), PEGylated-aucl] Jivi is approved for the routine prophylactic treatment of hemophilia A in previously treated adult and pediatric patients 7 years of age or older. Jivi's initial recommended dosing for children 7 to under 12 years of age is 60 IU/kg twice weekly. Adjust the dose based on the patient's clinical response and/or recovery. The recommended initial dosage regimen for adults and adolescents is (30-40 IU/kg) twice weekly with the ability to dose every five days (45-60 IU/kg) and further individually adjust to less or more frequent dosing based on bleeding episodes. Jivi is also approved for on-demand treatment and the perioperative management of bleeding in the same population. 1 To learn more about Jivi, visit INDICATION JIVI ® is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes. Perioperative management of bleeding. Routine prophylaxis to reduce the frequency of bleeding episodes. Limitations of use JIVI is not indicated for use in: Children <7 years of age due to a greater risk for hypersensitivity reactions and/or loss of efficacy. Previously untreated patients (PUPs). Treatment of von Willebrand disease. IMPORTANT SAFETY INFORMATION JIVI is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product. Hypersensitivity reactions, including severe allergic reactions, have occurred with JIVI. Monitor patients for hypersensitivity symptoms. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. If hypersensitivity reactions occur, immediately discontinue administration and initiate appropriate treatment. JIVI may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins. Hypersensitivity reactions may also be related to antibodies against polyethylene glycol (PEG). Neutralizing antibody (inhibitor) formation has occurred following administration of JIVI. Carefully monitor patients for development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor (neutralizing antibody). An immune response associated with IgM anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has occurred with JIVI administration. In the clinical trials, the IgM anti-PEG antibodies disappeared within 4-6 weeks. No immunoglobulin class switching from IgM to IgG has been observed. A low post-infusion Factor VIII level, in absence of detectable Factor VIII inhibitors, may be due to loss of treatment effect related to high titers of anti-PEG IgM antibodies. In these cases, discontinue JIVI and switch patients to a different anti-hemophilic product. A reduced recovery of Factor VIII after start of JIVI treatment may be due to transient low titers of anti-PEG IgM antibodies. In these cases, increase the dose of JIVI until recovery of Factor VIII returns to expected levels. The most common (incidence ≥5%) adverse reactions in clinical trials in previously treated patients (PTPs) ≥7 years of age were headache, fever, cough, and abdominal pain. For additional important risk and use information, please see the full Prescribing Information. About Alfa-PROTECT Study A multi-center, prospective, single-arm, study to evaluate the safety of Jivi infusions for prophylaxis and treatment of bleeding in previously treated pediatric patients 7 to <12 years of age with severe hemophilia A. The study evaluated the potential risk of hypersensitivity and loss of drug effect associated with an immune response to polyethylene glycol (PEG) during the first 4 exposure days to Jivi. A total of 35 patients with a median age of 8 years (range: 7 to 11) were enrolled and treated prophylactically for a minimum of 50 EDs and 26 weeks. The patients received a treatment regimen of Jivi twice weekly (40-60 IU/kg) at investigator's discretion. Thirty-two patients completed the treatment phase and were offered continuation in an 18 month extension study. A key secondary endpoint was the annualized bleed rate (ABR) About PROTECT Kids Study A multi-center, prospective, single-arm trial to evaluate the pharmacokinetics, safety, and efficacy of Jivi for prophylaxis and treatment of bleeding in previously treated pediatric patients <12 years of age with severe hemophilia A. The primary efficacy endpoint was the annualized bleed rate (ABR). About Hemophilia A Hemophilia affects approximately 400,000 people around the world and is a largely inherited disorder in which one of the proteins needed to form blood clots is missing or reduced. Hemophilia A is the most common type of hemophilia, in which blood clotting is impaired because there is a lack or defect of coagulation FVIII. Patients repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage over time. Injuries can have severe consequences if not treated appropriately, as the blood clots more slowly in hemophilia patients than in healthy individuals. Based on a study that used data collected on patients receiving care in federally funded hemophilia treatment centers during the period 2012–2018, about 33,000 males in the United States are living with the disorder. 2 About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. © 2025 Bayer BAYER, the Bayer Cross and Jivi are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to confirm them to future events or developments. References: 1. Jivi ® [antihemophilic factor (recombinant), PEGylated-aucl] [Prescribing Information]. Whippany, NJ: Bayer 2025 2. Centers for Disease Control and Prevention. About Hemophilia. Last Reviewed: May 2025.
