A special thanks to all of you who responded to my first post on the rare disease Advocacy/Policy blog. I heard some incredibly heartbreaking stories this week, including one about a boy who passed away on his 6th birthday from complications of three different genetic disorders. That little boy had a compromised immune system and scarred lungs, and also respiratory syncytial virus (RSV). A vaccine was available which may have helped… However, the vaccine has not been tested on older children or children with weakened immune systems, and so it is only offered to children under the age of 3 years old. This little boy’s life could have been saved. There’s still so much work to be done.
There has been quite a bit of discussion about strides being made in clinical research and orphan drugs. But we all know there is also a whole other component for families who have been impacted by a rare disease diagnosis: quality of life.
Buried in the Federal health reform was the Community Living Assistance Services and Supports (CLASS) Act. Little information has been shared thus far on implementation of the CLASS Act, though the Kaiser Family Foundation has started to offer a few issue briefs on it in the last couple of weeks. Those of you who know me, know I have been a Ted Kennedy Democrat – in support of his work from community health centers to AmeriCorps and National Service programs. The Class Act is yet another legacy of Senator Kennedy, which essentially sets up a long-term care insurance program that people can pay for through their employers (there is an opportunity to “opt-out”). This program helps to supplement Medicaid, Social Security and other benefit programs, but does not replace them. Adults who have been paying premiums for a minimum of 5 years will become eligible to receive a cash benefit of at least $50 per day to purchase non-medical services and supports. This benefit may be used to pay for things such as home health care, adult day care, respite care, transportation services, and home modifications for improved mobility. Moreover, the benefit can be used to offset the costs of assisted living facilities or nursing homes. The program starts January 1, 2011.
My question for you is what impact do you think the CLASS Act will have on you and your family? One of my concerns, and this has not been clarified yet, is that this benefit may not be used for dependents? What about the potential impact on those of you who have rare disorders but are still able to work? Will you opt-in to this program? What about the period between now and the 5 years before you are eligible to receive benefits – how have you been getting by?
Different elements of the CLASS act are interesting for a variety of reasons, such as the ability to pay for home modifications. Thomas Maeder shared a blog post as “Man of the Month” in Disruptive Women in Health Care, an author, educator and consultant who has written on rare disease before, about medical devices (see excerpt below). While the CLASS Act can only be used for “non-medical services and supports”, does it open the door to provide incentives for the medical device community to partner with other groups to help improve quality of life? Maybe, maybe not. I see a continuum here, from direct medical care and pharma to medical devices to home modifications – and bridging things like this together to meet all the needs an individual might have is an important concept.
One unfortunate omission in the Orphan Drug Act was the field of medical devices, which were not given the same incentives as pharmaceuticals. FDA’s device regulations do provide for what are called “custom devices” – variants of a commercially marketed device that are prescribed for an individual patient, like prosthetics or dental implants. In the early 1980s, Cook Medical, an Indiana device company that manufactured a bladder stent for ureteral obstructions, custom produced a diminutive version for use in fetuses. Cook sold this device at cost, as it was an effective way to treat an otherwise fatal condition affecting 200 fetuses each year. When the number reached 680, FDA decided that the stents were no longer custom devices, but manufactured products, whether sold at a profit or not. Cook successfully lobbied for new legislation, and the Safe Medical Devices Act of 1990 included provisions for a Humanitarian Device Exemption. Alas, Cook won the battle but lost the war, because the exemption applies only for conditions affecting fewer than 4,000 Americans per year, explicitly bars manufacturers from making any profit, and provides incentives too paltry to encourage and facilitate the sort of robust R&D projects seen in the orphan drug world.
As we discuss health care and health care reform, how often is something like the carpentry for a rail in the shower of an elderly or person with disability not considered “health care” (or the corporatized “healthcare”)? Does the CLASS Act help to move us closer to the understanding that quality of life, and meeting the needs of our patients through “patient centered medical homes” concepts, is more than just exercise, nutrition and pharmaceuticals? One of the first things I learned in the community health center world is the story of the patient with diabetes and how misdirected sometimes our focus on clinical components can be:
There was a woman whose diabetes was not in control; her nutrition was poor, she was not adhering to treatment protocol for her medications, etc. None of her medical providers had spent enough time with her. Finally a community health worker sat down with her and asked her about her life within a broader context. What was her story? Finally they discovered that what the patient really needed was assistance with getting her drivers license… How does this relate to her health care? Well, she did not have access to farmers markets or quality grocery stores for fresh produce, with no car and limited access to public transportation. She therefore relied on fast food nearby or loading up on processed frozen food which could hold the family over for an extended period of time. She had trouble with transportation to a pharmacy to access her medications. Getting this woman and her family healthy started with getting them access to transportation and empowering them with something as simple as a drivers license.
What do you need to be an effective caregiver? What do you need to be in more control over your own life? What might help you attain a higher quality of life? What can I do to help you as an advocate? I’m looking for programs and legislation that will support you and your family; have you been working with Congressmen on a bill in your State that we should be paying more attention to on the National level.