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We Interviewed the Diabetes Researcher Who Found Competitive Bidding Increased Mortality – Here’s What He Said

Posted on in HME Government Issues

By: Collin Brecher, VGM Government Relations

A study recently published in Diabetes Care, “The Impact of CMS Competitive Bidding Program on Medicare Beneficiary Safety and Access to Diabetes Testing Supplies: A Retrospective, Longitudinal Analysis”, brought forth findings that the Competitive Bidding Program is putting Medicare beneficiaries at risk. The National Minority Quality Forum (NMQF) authored the study headed by Gary A. Puckrein, Ph.D., president and CEO of the NMQF along with other health and research experts. Among those contributors was Christopher Parkin.

Parkin is president of CGParkin Communications, a consulting firm that specializes in diabetes education development. He has been involved in many aspects of the diabetic industry for more than 30 years. Parkin’s specialties range from educational programs, device studies and continuing education. And, over the past seven years he has become involved in research studies. We recently had the opportunity to speak with Parkin and discuss the findings of the NMQF study and the impacts of competitive bidding on the entire HME and CRT industries.

CONNECT: What was the original motivation to conduct this study?

Christopher Parkin: The competitive bidding program had been questioned quite a bit before the implementation process began in the nine markets back in 2011, so there was good reason to suspect there may be problems created by this approach. Just the economic modeling that (CMS) used was unheard of. There was a white paper by Brett Katzman published back in 2004 that found significant flaws in just the design of the (competitive bidding) program itself. CMS has continuously asserted that access to supplies has not been disrupted, there were no adverse health events associated with it, and there were significant cost savings involved. We essentially said, “Okay, let’s see if this is true,” in order to find out what the real impact was of competitive bidding in the area of diabetes.

CONNECT: What were the essential findings of the study?

CP: Following a group of patients from 2009 to 2012, we saw a significant change occur in the nine original test markets by the end of 2011. There was a significant shift in where people were getting their test strips. It used to be a 50/50 split between mail-order and pharmacy, and in 2011 that went entirely out of whack. We saw that competitive bidding had disrupted access by the fact that most people were no longer getting their supplies through mail-order, which is a clear sign of disruption. We also saw that patients had stopped adhering to their prescribed regiment. This led to the conclusion that there was a direct increase in mortality, because we had more people going into the high-risk group. With these increases was a doubling of hospitalization rates and a doubling of hospitalization costs. What CMS has looked at is only the Part D portion, so they saw cost savings because a lot of people stopped buying strips, but they did not report the significant increase in hospitalization that shows up in Medicare Part B.

CONNECT: Who exactly was the sample population and where did this data come from?

CP: We wanted to carve out the population people with full, self-monitoring of blood glucose from a Medicare beneficiary database to ask what were these patients doing prior to the implementation of competitive bidding and what were they doing after it was implemented. We took a longitudinal approach, contrary to what Medicare is doing, and it is basically the same thing as clinical research. You have a group of people that you know what they are doing before you intervene, you initiate the intervention, and then you look at what happens, meaning did those people change in any way? We found a group of patients in the nine markets that were matched to a completely identical control and intervention group in the non-test markets in which we ended up with about 40,000 patients in each group.

CONNECT: What kind of requirements or scrutiny do these kinds of studies face in order to be put into a peer-reviewed journal such as Diabetes Care?

CP: I have published almost 100 articles in the past years, and I have never undergone such scrutiny as we had for the competitive bidding paper. We went through five rounds of reviews, and had to respond to reviewers because this issue has such high visibility and is such a controversial subject. I have never been under such a magnify glass, which was good because it only strengthened our findings. People just could not believe that the government was doing this. We had to explain many times that this wasn’t even our data, this is using entirely CMS data. All that we did was look at the data and definitions in a true, scientific way, and this was what we found.

CONNECT: Recently, CMS issued a fact sheet on competitive bidding claiming the program “has been a great success for beneficiaries and the taxpayers.” Do you believe, based on the findings in the diabetic category of your extensive studies, that this is the case for other competitively bid products?

CP: Yes, I do, and I think to varying degrees. If you get into products such as oxygen, for example, people need this in order to live. So, the impact on mortality would have significant health impacts that would be seen in those product categories that are directly related to survival and are needed on a continuous basis. If you get into other areas, such as wheelchairs and those types of products, then you get into impacts of people’s lifestyle and ultimately quality of life goes down. This program will impact virtually every product category that I can imagine. What that impact is will vary upon how a particular product impacts survival, mortality and hospitalization.

CONENCT: Do you believe that competitive bidding, as currently being conducted, has a positive or negative impact on providers and patients?

CP: I will tell you right now, if this program had been a clinical trial with an institutional review board’s oversight, the minute that these signals started popping up, it would have been stopped immediately. Because ethically, scientists cannot proceed with a study when harm is being detected, even if they don’t know where the harm is coming from. This has not been the case with CMS. In fact, CMS has completely ignored the signals of disruption, and these signals have been going on all along. I am really worried about what the patients are saying and what the physicians are saying. At the end of the day, Medicare is responsible for providing quality health care to everyone over the age of 65, and they just are not doing it.

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Please visit the VGM Action Center, and encourage your patients to reach out to their members of Congress to support H.R. 5210 and S. 2736, the Patient Access to Durable Medical Equipment Act.

If you are interested in learning more about this peer-reviewed study and to view the names of the other contributors to the study, please visit the American Diabetes Association website by clicking here.

 

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