increased in patient adverse events, including higher mortality rates and hospitalizations

Medicare Competitive Bidding Program Under Fire

WASHINGTON — A new Medicare competitive bidding program for durable medical equipment has made it more difficult for diabetic beneficiaries to get the supplies they need, according to endocrinologists and diabetes advocates.

“As implemented, Medicare has used the Competitive Bidding Program to significantly reduce the cost of diabetes testing supplies by restricting access to improved technology devices and limiting choice for patients and healthcare professionals based primarily on cost,” George Grunberger, MD, president of the American Association of Clinical Endocrinologists, wrote in a letter to senators Orrin Hatch (R-Utah) and Ron Wyden (D-Ore.) leaders of the Senate Finance Committee. “The result has been an increase in patient adverse events, including higher mortality rates and hospitalizations, which ironically have led to overall higher Medicare costs.”

“The goal of competitive bidding was to reduce costs for both patients and the American taxpayer and to ensure access to quality products and services,” wrote members of the National Diabetes Volunteer Leadership Council, a group of former board members of the American Diabetes Association, in a letter to Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services (CMS). “For diabetes testing supplies, the program has failed on both of its objectives.”

Medicare’s competitive bidding program was established under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Round 2 of the program, which included a mail-order component for diabetes supplies, was fully implemented in July 2013 after several years of testing.

“Importantly, the program has maintained beneficiary access to quality products from accredited suppliers in all competitive bidding areas,” CMS said in a press release issued March 15th. “Extensive real-time monitoring data have shown successful implementation with very few beneficiary complaints and no negative impact on beneficiary health status based on measures such as hospitalizations, length of hospital stay, and number of emergency room visits compared to non-competitive bidding areas.”

But that’s not the conclusion reached by Christopher Parkin, MS, of CGParkin Communications, in Boulder City, Nev., and colleagues. They published results from a 4-year, retrospective, longitudinal study which examined 2009-2012 data on nearly 530,000 Medicare beneficiaries who were insulin users. The study appeared online March 18th in Diabetes Care.

The authors noted that Medicare reimburses for the acquisition of three glucose test strips per day for insulin-dependent beneficiaries.

“Based on that reimbursement schedule, full procurement of self-monitoring blood glucose supplies is defined here as the purchase of diabetes testing strips so that, from the date of the first purchase, the beneficiary continued to acquire testing supplies, resulting in their purchasing enough blood glucose testing supplies to allow them to test their blood glucose three times per day more than 80% of the year,” they explained.

“Any beneficiary who scored 80% or higher on this … scale was considered full [supply] acquisition; any beneficiary who scored less than 80% was defined as partial/no [supply] acquisition.”

The study found that use of the competitive bidding system in nine test markets resulted in a 23% increase in beneficiaries getting partial or no diabetes supplies, as opposed to a 1.7% increase among the beneficiaries in the nontest markets. In addition, “4-year survival was negatively associated” with partial or no supply acquisition among both groups (P<0.0001), the investigators said.

“The results indicate that the system implemented to reduce cost was associated with a disruption of acquisition of [diabetes] supplies,” the authors wrote. “These findings are particularly concerning, given the predominant use of short-acting insulin and rapid-acting insulin analogs by Medicare beneficiaries, who are at significantly greater risk for hypoglycemia than younger individuals with insulin-treated diabetes.”

“Based on our findings,” they continued, “policy makers should consider suspending the competitive bidding program until CMS can demonstrate its ability to effectively monitor the effects of the program and ensure that Medicare beneficiaries, a population that is most vulnerable to both the acute and chronic complications of diabetes, are protected from harm.”

Howard Lando, MD, a member of the AACE board of directors and chair of the association’s Legislative and Regulatory Committee, agreed that the program has caused problems for diabetes patients. “The unintended consequences of the competitive bidding program are restricted access to improved technology devices — e.g. high-quality brand-name blood glucose meters — and limited choice of monitors and test strips for patients and healthcare professionals,” he said in an email to MedPage Today.

“Patients have received meters and strips different from those they used prior to the competitive bidding program’s implementation that did not have user instructions, which led to the inability to download or read data,” wrote Lando, an endocrinologist in Alexandria, Va. “Alarmingly, neither the patients nor their physicians neither approved nor were notified of these switches in advance. Furthermore, lower quality non-branded devices can provide inaccurate or inconsistent readings, which have led to patients experiencing adverse medical events, such as hypoglycemia.”

The competitive bidding program should be suspended for diabetes testing supplies “until it can be determined that patient safety is not at risk,” he continued. “AACE is also advocating for passage of H.R. 771, ‘Protecting Access to Diabetes Supplies Act of 2015,’ legislation that will enhance patient protections by strengthening and enforcing program safeguards that, as currently implemented, have been ineffective in protecting patient access to preferred diabetes testing supplies.”

CMS was contacted for this story but declined to comment.

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