Advocacy is important to people with bleeding disorders. Many chapters have advocacy days, where members visit the state capitol to educate legislators on important issues. While advocacy can be empowering for constituents, it can also be frustrating, especially for people new to the lengthy processes by which laws are made.
Kristin Marema, board member and advocacy chair of the Midwest Hemophilia Association (MHA) in Kansas City, Missouri, has a son with mild hemophilia and knows this firsthand. She was instrumental in the passage of HB 552, a Missouri state bill that creates new standards of care for pharmacies supplying clotting factor to people with bleeding disorders. The bill passed in 2011, after five years of work from dedicated volunteers from both the MHA and the Gateway Hemophilia Association (GHA), based in Manchester, Missouri.
HB 522 is based on NHF’s Medical and Scientific Advisory Council’s (MASAC) recommendation #188, which outlines standards for specialty pharmacies that dispense clotting factor. Although many pharmacies have self-reported compliance with MASAC standards, states can enact laws to ensure that standards are met. Marema says her experience and that of other families showed that pharmacies weren’t meeting expectations. “Parents were concerned about auto-shipping. Some weren’t getting their factor on time,” she says. “And when they would call the 800 number of their pharmacy benefits manager, they had to explain what hemophilia was.”
Marema joined forces with Mary Fleming from GHA, and for two years, the two women—on behalf of their respective chapters—worked on getting sponsors for a standards of care bill that would turn the MASAC recommendations into law. They initially found a sponsor in the Missouri legislature, but the bill was never introduced on the floor. Eventually, MHA realized that getting the bill passed would require money.
A grant from CSL Behring enabled the chapter to hire a lobbyist and covered the costs of families who traveled to Jefferson City to meet with legislators. Rep. Chris Molendorp agreed to sponsor the bill. “His son is in Boy Scouts with another boy who has hemophilia, so he was familiar with it,” says Marema. Molendorp was also chair of the state House of Representatives Health Insurance Committee. “With his help and hard work, it all came together,” Marema says.
The law requires that the Missouri state board of pharmacy create and put into action the rules governing the standards of care for pharmacies dispensing blood-clotting therapies. Among its stipulations are shipments of factor to existing patients must arrive within 48 hours, and a window of 72 hours or less for new patients, except in cases of emergency. Further, all patients must be notified within 24 hours of medical recalls for products and ancillary equipment. In addition, all pharmacies will be required to have a licensed pharmacist either on site or on call 24 hours a day, 7 days a week, every day of the year to fill prescriptions.
Still, even though the bill was signed into law in 2011, it has not yet been implemented. The Missouri Board of Pharmacy (BOP) is writing the rules that pharmacies must follow to comply with the law.
MHA, GHA and NHF have attended hearings, provided comments and met with the BOP director to provide guidance and offer suggestions on the rules. As of September 2012, the organizations had met five times in the past year but still had not finalized the rules. “The rules process takes a long time,” sometimes 12 to 18 months, Marema says.
Now with a greater understanding of state BOPs, Marema and MHA are working to enact a similar set of standards in Kansas by going directly to that state’s BOP, bypassing the legislature. This could mean faster results for chapters, without hiring lobbyists.
When the rules are finalized and go into effect, Marema wants to make sure all of those with bleeding disorders in Missouri are aware of the standards. “It made me want to work hard to give these moms a voice and do whatever I can to make their lives a little bit better.”