URGENT MEDICARE PATIENTS: 21st Century Care Act section 5004, became law on 12/13/16, known as the “Cures” Act. Passed by the House on 11/30/16, passed by Senate on 12/7/16. The patient organizations were well aware of the law and did make this public until legitimate PI patients went public until legitimate PI patients took to social media on 12/20/16. The law goes into effect 1/1/17: ASP Reimbursement to Begin on January 1, 2017 Without Dela
Of all times, that we need the support of each other and the advocacy of PID groups is now! Working together, and not divided, is in the PI communities best interest.
The law does effect supplies and pumps (DME), which effects the patients who infuse immunoglobulin (igg) subcutaneously. SCIG brands including: Hizentra, Gammagard, Hyquvia, Gamunex c and Gammagard. Although, many Specialty Pharmacies (SP) are attempting to meet the needs of their patients, in light of this law, which is admirable that they are keeping patients needs first. Many SPs will continue to address patient concerns as information is provided to them.
The DME (Durable Medical Equipment) supplies that we use to infuse igg, are one specific area of concern. Medicare appears to pay under cost to supply the scig IGGs above. Thereby, Specialty Pharmacies May discharge patients, due to lack of reimbursement for the medication and supplies (cost prohibitive) since all DME are excluded (infusion of biologicals) in Part B., although many SPs are scrambling, and attempting to provide for patients impacted. At this point, I would suggest to advocate, stay informed of the facts (i.e. 21st Century Cure Cares Act section 5004), and voice your concerns. Sadly, this was not a one size fits all law, that stated, keep informed!
In the meanwhile, prepare in anyway you can. This will impact MANY people. Where were the PI advocate groups in lobbying against this, or keeping their purported population base on their radar to advocate or lobby against this? Instead, 700 organizations supported this mismatched law. PI patients will be directly impacted. I do believe, that it is in our best interest to explore all groups that advocate for PI patients, and not divide, that would be extremely detrimental at this time.
Other groups that supported the law for example, may benefit by bringing medicine to market faster, such as arthritis, Alzheimer’s, etc. However, for our subset of population this can and will lead to unnecessary illnesses, and potentially worse. The plasma derived from human beings, and the igg extracted that keep us alive, should not by any means be compromised by a generic version–as there is not one. The biosimilars development, now FDA has less restrictions and emphasis on bringing new biosimilars, without adequate testing is a certain nightmare, made for human disaster.
Does not matter, protect yourself and warn everyone that you know that this will effect.21st century Cure Care Act Section 5004 law as of 12/13/16
Further complicating matters: SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.; addresses Home Infusion Therapy, and its amendments per Cures. However, as written, “(3) EXCLUSION FROM HOME HEALTH SERVICES.—Section 1861(m) of the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the first sentence, by inserting the following before the period at the end: “and home infusion therapy (as defined in subsection (iii)(i))”.
I am dissecting this law to clarify these changes in understandable english. Will post updates soon.
More importantly is that we attempt to close this four year gap: (waiting confirmation on what steps are needed next)
(d) Effective Date for section 5012—The amendments made by this section shall apply to items and services furnished on or after January 1, 2021.
Lead sponsors of the Bill: Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO).
The National Home Infusion Association is reported to have lobbied against this law. The shift in PI patients loyalties need to be geared toward the truth in who are Advocating for us: WWW.NHIA.ORG, and others.
#cures2015 #cures #pipunited