The 21st Century Cures Act is Full of Medical Horrors. Not only does it nullify our protected right of Informed Consent by allowing unannounced clinical trials if fewer than 8000 people are involved, it also deprives people of safe, secure, cost-effective treatments. Here is a personal account of that nightmare.
Rima E. Laibow, MD August 8, 2017
Laura B. Coleman, PhD, has a rare genetic disorder. As she explains in the article below, she can be, and prospers when she is, treated at home with an infusion pump. The 21st Century Cures Act, which Natural Solutions Foundation warned against last year, contains provision after provision which violate your rights and mine – and Dr. Coleman’s. Not only that, common sense and fiscal logic are violated.
On top of all of that, the any time a pharmaceutical company wants to conduct a clinical trial, if they carefully keep their test population to 7,999 or below, they do not need to tell the people they are experimenting on that they have been ‘enrolled’ in a clinical trial. Most clinical trials are less than 8000 people in size.
Read what Dr. Coleman has to say:
As the nation considers the important issues related to access to healthcare, there is one issue impacting Medicare beneficiary access to lifesaving therapies that requires immediate action to fix to a problem created late last year as part of the 21st Century Cures Act.
I have a rare, chronic condition known as a primary immunodeficiency disease (PI). This means my immune system doesn’t work like most people’s do. In order to protect myself from infections, I rely on medication known as immunoglobulin or Ig replacement therapy to replace the antibodies my body does not produce.
In my case, I receive my Ig replacement therapy in my home by using an infusion pump to inject the medication subcutaneously or just under my skin. Known as SCIG, this method allows me to infuse my medication more regularly for shorter periods of time than what would be required if I received treatment intravenously.
I have been taking the same medication via home infusion since my diagnosis nearly a decade ago and have been doing very well, but will need to continue on this therapy for the rest of my life to stay healthy.
Unfortunately, under a change to the law governing how Medicare pays for such therapies that was enacted late last year, I was informed on March 2, 2017 that my home infusion provider will no longer supply me (or other Medicare Part B beneficiaries) with my prescribed treatment.
In December as part of the 21st Century Cures Act, Congress changed the mechanism used for Medicare reimbursement for treatments like SCIG delivered using a pump or other type of durable medical equipment. This change immediately reduced the provider payment for these services.
In the same law, Congress did establish a new home infusion benefit that will institute a reimbursement payment for the essential services of training and monitoring patients to self-infuse safely and bring Medicare into line with policies that have long been the norm for private insurers.
However, while payments were reduced as of January 1, 2017, the new home infusion reimbursement benefit is not scheduled to start until 2021. The consequences of reducing the reimbursement of infusible drugs without instituting at the same time a reimbursement for the necessary professional services to train and monitor patients for self-administration of the drugs are happening right now.
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