Regulatory Updates

September 30, 2017

A GAO report faults CMS policy on durable medical equipment, and the diaTribe Foundation convenes a daylong session to guide the FDA on how future drugs and devices should be evaluated for measures beyond A1C.

A recent report from the Government Accountability Office (GAO) calls for a review of Medicare’s policies for covering durable medical equipment (DME), and asks CMS to consider changes that would extend coverage to novel devices and encourage innovation. The report became public July 17, 2017.1

Historically, Medicare will not pay for devices that don’t meet the DME test: the device must serve a medical purpose, can withstand repeated use, and have an expected life of 3 years. As technology advances, however, the lines are blurring between durable and disposable technology. Some devices that combine the 2, with potential to help patients achieve better glycemic control or greatly improved sleep, will fall outside current definitions. In the report, GAO predicts missed opportunities to keep patients healthy, and thus wants to review DME payment policies. Allowing payment for disposable medical equipment—or asking Congress to create a new benefit category—might prevent situations like a decision the report cites: Earlier this year, CMS made a breakthrough policy change when it ruled that certain seniors with diabetes could have a Dexcom G5 continuous glucose monitor (CGM).2

But then a Medicare administrative contractor said seniors could only be reimbursed if they didn’t use the Dexcom monitor with their smartphone.3 That ruling, reported by The American Journal of Managed Care®, was specifically cited by GAO as an example of how “CMS has already faced issues accommodating new technology.”1

The report found that CMS’ challenges with technology will only increase as devices, such as new versions of the artificial pancreas or next-generation CGM, get closer to completion. Increasingly, traditional medical device companies are working with technology giants like Google and Apple4,5 to create products that require minimal interaction from patients with diabetes and chronic disease.

For example, Dexcom CEO Kevin Sayer said last year that the company is working with Verily, a division of Google, on a CGM transmitter that functions like Band-Aid, which patients “can peel off and throw away.”4

The goal: if medical devices have the usability of smartphones and Band-Aids, patients will stick with them and stay healthy, while feeding data to their doctors and health systems. Thus, devices will easily track progress at both the individual and population health level. For several years now, device and technology companies have formed partnerships with these goals in mind. Devices will become smaller and cheaper,6 which should also appeal to Medicare.

GAO’s report examined several types of devices: durable and disposable insulin pumps, infusion pumps, and blood glucose monitors. Insulin pumps that have both durable and disposable components present the current challenge, because Medicare has refused to pay for at least 1 popular pump (which appears to be Insulet’s Omnipod based on the description in the report) after ruling its insulin delivery mechanism is disposable even though the bulk of the device lasts more than 3 years. This is the type of hair-splitting where GAO sees future problems. Six of 21 stakeholders interviewed for the report said medical device technology is advancing, and 5 “specifically cited CMS’ definition of DME as a disincentive to technological innovation, such as the development of disposable substitutes.”

“As advancing technology results in changes to the functionality of devices, including the development of disposable substitutes, CMS will likely have to consider how its benefit coverage policies will apply to them,” the report stated.

Disposable substitutes for DME can have certain advantages: some disposable models are lighter and quieter; with certain patients, disposable products can promote adherence if it’s not necessary to clean and transport supplies, as it is for durable products. In some care settings, disposal products reduce nurses’ workloads and prevent infection. On the downside, DME varieties are preferred when dosing needs to be highly specific.

The GAO report goes into detail on several potential DME substitutes, with their potential benefits and limitations; it outlines the current incentives and disincentives for developing disposable DME substitutes. Lack of Medicare reimbursement for disposable equipment topped the list of barriers. What can be done? The GAO recommended the following:

• CMS should evaluate the possibility of paying for disposable devices, including the potential for overall cost savings.

• If necessary, CMS should ask Congress to authorize a new benefit category if the current options would be inadequate to pay for disposable equipment.

GAO reports that HHS, which includes CMS, believes this type of evaluation is premature. But GAO says it “continues to believe an evaluation is needed to help HHS anticipate and plan for significant changes using a forward-looking process.”

“Beyond A1C” Pinpoints the Metrics That Matter to Patients in the FDA Process

In Diabetes Care , glycated hemoglobin (A1C), which reflects a 3-month average of blood glucose levels, is the benchmark for tracking everything from how well a patient is doing on a diabetes care regimen to how well a health system is caring for its population.

For the FDA, A1C is the gold standard for measuring whether therapies or devices help people with diabetes manage the disease. But for patients, it’s not the whole story: A1C tells nothing about how they are doing throughout the day. If FDA is to weigh other metrics, however, what would they be? Could professional groups agree on standards? How would these new measures be put into practice?

On July 21, 2017, the dia-Tribe Foundation convened luminaries in diabetes research, regulation, and advocacy for a daylong session, “Glycemic Outcomes Beyond A1C: Standardization and Implementation.” The session, led by diaTribe founder and chair, Kelly Close, was a follow-up to a 2016 summer workshop, which then-FDA Commissioner Robert M. Califf, MD, attended in person.1

There’s consensus that the FDA should measure how well drugs and devices control hypoglycemia and time in range. Based on the meeting, there’s growing support for using continuous glucose monitoring (CGM) to gather data in clinical trials. Attendees also discussed whether the FDA should measure patients’ ability to get more consecutive hours of sleep, since artificial pancreas technology offers this promise. “We all know the very high dangers of hypoglycemia, but only by speaking with 1 voice—as researchers, clinicians, and patients, with leaders from different professional organizations—can we stay ahead of those dangers,” Close said in an e-mail to Evidence-Based Diabetes Management™. “To achieve that, we hope that CGM is used more often in clinical trials and then that information is used to guide care for patients. If our goal is to improve outcomes at lower costs—and minimize hypoglycemia—that path will take us there.”

Not only does reducing hypoglycemia and improving time in range lead to improved health and safety outcomes, but these factors matter to patients and caregivers and could lead to better quality of life. Richard Wood of dQ&A, a diabetes market research firm, presented data from 3455 patients who have either type 1 diabetes (T1D) or type 2 diabetes (T2D), including patients who used insulin and those who did not. Across the board, reports on quality of life were dismal. “Fewer than a third of the patients feel their diabetes care is very successful,” Wood said. “It’s clear we have a lot of work to do, despite all the therapies we have today.” As one patient said in the survey, “Time in range defines my daily experience.”

This hardly means that A1C is meaningless. As Robert Ratner, MD, FACP, FACE, retired chief scientific and medical officer of the American Diabetes Association (ADA), explained, the landmark Diabetes Control and Complications Trial found that a 2% reduction in A1C was associated with a 60% reduction in retinopathy, nephropathy, and neuropathy.2 But as has been seen in subsequent trials, reductions in A1C don’t always translate into macrovascular benefits.

More recently, with the DEVOTE trial, a cardiovascular (CV) trial that compared insulin glargine and insulin degludec (Tresiba),3 “How you achieve A1C lowering become critically important,” Ratner said. This head-to-head trial showed that both insulins were safe from a CV standpoint, but insulin degludec offered a larger drop in severe hypoglycemia, especially at night.

The meeting featured researchers and regulators from Europe, as diaTribe seeks to foster alignment between the FDA and the European Medicines Agency (EMA), so pharmaceutical and medical device companies developing new metrics will have a common set of standards. The rising role of technology was clear. ADA’s chief scientific and medical officer William T. Cefalu, MD, said that the 2018 Standards of Medical Care in Diabetes will include a separate chapter on technology for the first time.

Philip Home, DPhil, of Newcastle University in the United Kingdom, said if CGM is to be used in research, issues arise about ensuring it is calibrated. If hypoglycemia is a metric, how do regulators define an event? If there are several within a short span, do they count as single incident?

Bart Van der Schueren, PhD, of the EMA, discussed that agency’s efforts to update metrics and said there is definitely a preference for including CGM data with applications, not just for T1D approvals. Even a week’s worth of data for T2D approvals offers insight about glucose variability he said.

The EMA is still exploring patient-reported outcomes, Van der Shueren said, but has not yet seen a validated measure it’s ready to adopt. The need for alignment isn’t about pleasing pharmaceutical companies. “We want companies to please patients,” he said. To hold down costs and speed development, “There is a need to align internationally.”

Afternoon sessions were set up as workshops to discuss the future of clinical trials and make concrete recommendations to the FDA. Questions debated included: (1) should hypoglycemia be an efficacy outcome, instead of a safety outcome, for US regulators? (2) Should CGM be required for an entire trial or just for 14-day periods at the beginning and the end? (3) What is the definition of nonsevere hypoglycemia? (4) What can be done about patients with hypoglycemia unawareness?

Dexcom, Ascensia to Partner on Medicare Diabetes Bundle

Ascensia Diabetes Care and Dexcom reached an agreement on July 10 to speed delivery of Dexcom’s G5 continuous glucose monitoring (CGM) system to eligible Medicare beneficiaries.1 The deal gives Dexcom a partner for creating the “bundle” of a CGM and blood glucose monitoring system, which will meet Medicare shipping requirements and give access to those who meet CMS criteria for the system.

Earlier this year, Medicare announced it would pay for the Dexcom G5 for beneficiaries with diabetes who take insulin, use a home blood glucose monitoring system (BGMS), and perform For those who rely on CGM, this was historic news. Previously, turning 65 meant paying for the device out-of-pocket or giving up a tool that had helped bring unprecedented levels of glycemic control. Dexcom, and advocacy groups like JDRF, had worked for years on the policy change, which began with a July 2016 FDA hearing to show that it was safe to use the Dexcom G5 for dosing decisions. The Dexcom model is the only one approved by FDA for therapeutic use, which cleared the way for it to be covered by Medicare.3

The good news hit a snag, however, when Medicare suppliers refused to ship the Dexcom G5.4 They wanted to know how to follow rules that require diabetes supplies to be shipped in a set, or “bundle.” Because Dexcom doesn’t make the BGMS needed to calibrate a CGM, it had to find a partner to meet requirements.

According to a statement from Ascensia, “The complete bundle will be available to people who are covered by Medicare and qualify for therapeutic CGM.” Ascensia Diabetes Care’s Contour Next One BGMS will be included in the bundle. While separate blood glucose tests are no longer needed for each dosing decision, they are still needed twice a day to calibrate the CGM.

“For those people with diabetes who are eligible to receive the G5 through Medicare, Ascensia is thrilled to become the partner of choice for calibration of the Dexcom G5 CGM system,” said Robert Schumm, vice president and managing director of Ascensia Diabetes Care. “We believe this combination will help improve diabetes management for people on Medicare who are eligible for therapeutic CGM.”

Dexcom hailed the agreement as well. “In Ascensia, we saw a business partner that matches our own commitment to best-in-class products and services for people with diabetes. With this agreement, we are pleased to begin offering a complete bundle to Medicare-eligible patients, enabling access to the Dexcom G5 CGM system as efficiently as possible.”

References, GAO Report

1. Government Accountability Office. Medicare: CMS should evaluate providing coverage for disposable medical devices that could substitute for durable medical equipment. GAO-17-600. www.gao.gov/products/GAO-17-600#. Published and accessed July 17, 2017.

2. Medicare announces criteria covering Dexcom G5 Mobile CGM for all people with diabetes on intensive insulin therapy [press release]. San Diego, CA: Dexcom; March 24, 2017. www.dexcom.com/news/medicareannounces-criteria-covering-dexcom-g5-mobile-cgm-for-all-people-withdiabetes-on-intensive-insulin. Accessed July 20, 2017.

3. Caffrey M. Medicare issues rules for CGM coverage—no smartphones allowed. The American Journal of Managed Care® website. www.ajmc.com/newsroom/medicare-issues-rules-for-cgm-coverage-no-smartphonesallowed. Published March 28, 2017. Accessed July 20, 2017.

4. Lawrence S. Google’s Verily, Dexcom aim to launch mini glucose monitor by 2018, with next-gen by 2021. www.fiercebiotech.com/medical-devices/google-s-verily-dexcom-aim-to-launch-mini-glucose-monitor-2018-nextgen-by-2021. Published February 24, 2016. Accessed July 20, 2017.

5. Farr C. Apple has a secret team working on the holy grail for treating diabetes. CNBC.com. www.cnbc.com/2017/04/12/apple-working-onglucose-sensors-diabetes-treatment.html. Published April 12, 2017. Accessed July 20, 2017.

6. Gabbay R. Dr Robert Gabbay highlights 3 exciting areas of developing diabetes technology. The American Journal of Managed Care® website. www.ajmc.com/conferences/ada-2017/dr-robert-gabbay-highlights-3-excitingareas-of-developing-diabetes-technology. Published June 10, 2017. Accessed July 20, 2017.

References, Beyond A1C

1. Caffrey M. FDA to ask: what outcomes matter besides A1C? The American Journal of Managed Care® website. ajmc.com/newsroom/fda-to-ask-whatoutcomes-matter-besides-a1c. Published August 22, 2016. Accessed July 26, 2017.

2. Nathan DM, Genuth S, Lachin S, et al; Diabetes Control and Complications Trial Study Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulindependent diabetes mellitus. N Engl J Med. 1993;329(14):977-986. doi: 10.1056/NEJM1993093032991401.

3. Marso SP, McGuire DK, Zinman B, et al. for the DEVOTE study group. Efficacy and safety of degludec versus glargine in type 2 diabetes [published online June 12, 2017]. N Engl J Med. 2017. doi: 10.1056/NEJMoa1615692.

Refererences, Dexcom and Ascensia

1. Ascensia Diabetes Care announces commercial agreement to include Contour Next One BGMS with Dexcom G5 continuous glucose monitoring system for patients covered by Medicare [press release]. Parsippany, NJ: PR Newswire; July 10, 2017. prnewswire.com/news-releases/ascensia-diabetescare-announces-commercial-agreement-with-dexcom-inc-to-include-contournext- one-bgms-with-the-dexcom-g5-continuous-glucose-monitoringsystem-for-patients-covered-by-medicare-633586963.html. Accessed July 11, 2017.

2. Caffrey M. Medicare issues rules for CGM coverage—no smartphones allowed. The American Journal of Managed Care® website. ajmc.com/newsroom/medicare-issues-rules-for-cgm-coverage-no-smartphones-allowed. Published March 28, 2017. Accessed July 20, 2017.

3. FDA approval of Dexcom’s non-adjunctive indication triggers a new era in diabetes management [press release]. San Diego, CA: Business Wire; December 20, 2016. businesswire.com/news/home/20161220005992/en/FDA-Approval-Dexcom%E2%80%99s-Non-Adjunctive-Indication-Triggers-EraSnag story. Accessed July 26, 2017.