Facts Are Stubborn Things: The Medicare Part B Experiment, a Patient Advocate's Perspective (Part I)

Debra Madden is a 2-time cancer survivor who was diagnosed with Hodgkin’s lymphoma as a young adult and breast cancer nearly 20 years later, which was thought to be secondary to the radiation she had received for her original cancer treatment. Debra became an active Cancer Research Advocate following her second cancer diagnosis at the age of 42 years. She is currently a member of the ECOG/ACRIN Cancer Research Group and the Patient-Centered Outcomes Research Institute’s Advisory Panel on the Assessment of Prevention, Diagnosis, and Treatment Options. She also serves on multiple grant review panels, including the Congressionally Directed Medical Research Program Breast Cancer Research Program. Debra blogs at “Musings of a Cancer Research Advocate,” (https://draemadden.wordpress.com/) and you can follow her on Twitter at @AdvocateDebM.
Why this patient advocate is concerned about the newly proposed Medicare Part B model regarding its level of transparency and the evidence.
“Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence.” ~John Adams, from The Portable John Adams

As a young adult cancer survivor, an active cancer research advocate, and an American citizen, I’ve become increasingly concerned as I watch our country slide deeper into contentious, complex, and combative debates about healthcare access, coverage, and cost. When CMS recently announced a plan to test new payment models for Medicare Part B prescription drugs in an attempt to lower costs, this served to further fan the flames for many, including myself, where my alarm grew on 2 important fronts:
  1. The proposed “demonstration project” to randomize the amount paid for Part B prescription medications to the clinicians administering these drugs based on zip codes, and to track drug usage patterns and costs, yet not to assess patient benefit
  2. The reaction to CMS’ proposed approaches to “value-based” pricing, where cost varies for a particular drug based on its different levels of clinical effectiveness for different disease indications
Both areas have generated a tremendous amount of controversy—with many clinician organizations, hospitals, and patient advocacy groups expressing adamant opposition to the CMS initiative overall.  I share this deep concern regarding the first part of the proposal. Today, when Part B drugs are administered for patients, CMS typically pays providers the Average Sales Price (“ASP”) plus a 6% add-on. But with this proposed demonstration project, CMS will geographically randomize clinicians, testing whether decreasing the add-on payment to 2.5% plus a flat fee of $16.80 per drug per day impacts prescribing incentives and clinicians’ prescribing patterns. In contrast, as noted above, my concern regarding the value-based portion of the proposal is the reaction to that proposal. Although this may seem contradictory, the basis of my concern is actually the same: the level of transparency and evidence that underlie both.

An Experiment to Reduce Costs
Let me begin with the proposed change to the ASP payments to those providers who are treating patients with prescription Part B medications in the clinic, including infused oncology drugs. My misgivings are many, including that:
  • The purpose of this non-voluntary demonstration project—which is more accurately termed a mandatory, real-world experiment—appears to be tracking drug utilization patterns and focusing on decreasing Medicare costs only, rather than on assessing patient benefit and quality of care.
  • Importantly, in addition to the ASP payment change described above, these payments would be further reduced by the mandatory 2% sequester cut to Part B drugs based on current law. Yet nowhere is this further 2% reduction discussed in the Federal Register’s announcement of this proposed rule.  (The Federal Register is described as “The Daily Journal of the United States Government.”) This noteworthy omission demonstrates a tremendous lack of transparency, resulting in what could be termed a misrepresentation of the true reduction in reimbursement rates that physicians will receive for Part B drugs.
  • This CMS experiment may well prevent an increasing number of community-based oncologists from being able to provide optimal cancer care based on their expert clinical judgment—through potentially reduced use of certain drugs that may be most appropriate and effective for specific patients, increased closure of community oncology practices or their consolidation with larger healthcare systems, and increased transition of patient treatment to much costlier hospital settings (which in turn may lead to reduced access and treatment disparities).
  • CMS apparently developed this proposal without seeking any direct input from critical stakeholders, including clinicians, clinician groups, patients, and patient organizations, and without providing them (i.e., us) with any knowledge of this experiment—again demonstrating a breathtaking lack of transparency.


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