Where are you Medicare? The elephant was not in the room



This was the question burning in people’s mind and passionately talked about yesterday and today at the General Sessions of the AACE/ACE Consensus Conference on Glucose Monitoring, an event to bring together in Washington, DC all relevant stakeholders to outline possible solutions to assure patients’ access to high-quality glucose monitoring systems.

Participants on the General Sessions of the conference represented FDA (who did a great job in the face of the fair amount criticism they received in connection with post-market enforcement), patient advocacy groups, every medical, scientific, professional, and educational societies, industry representatives, and payers like Aetna, Humana, and UnitedHealthcare. Yet the Centers for Medicare and Medicaid Services (CMS) was not represented. We were told that “No one at CMS was available.”

You know me: I am always smiling, a very positive person. But I was very upset to not see Medicare at the General Sessions during the consensus conference. Because at the heart of a lot of problems currently faced by the 29 million people with diabetes in the US (almost 40% of whom are of Medicare age) are directly a consequence of Medicare actions or inactions.

Examples of inadequate coverage by Medicare include two items in the toolkits of people with diabetes:

  • One is the lack of coverage for Continuous Glucose Monitoring (CGM) for people with type 1 diabetes who meet criteria. To address this shortsighted approach by Medicare, JDRF along with a coalition of partners is working very hard to get bills S. 2689 and H.R. 5644 passed.
  • Another one is the effort to increase access to diabetes self-management education and support (DSMES) by having Medicare authorize credentialed diabetes educators (as defined in the legislation) to be directly reimbursed to provide DSMES within a Medicare accredited program (either by an ADA recognized program or AADE accredited program), AADE, other organizations and the diabetes community are working to increase this access by getting bills S. 945 and H.R. 1274 passed.

In both cases, valuable advocacy time and energy is being spent to have Congress turn into law benefits for people with diabetes that Medicare should be covering anyway.

Another example is the deeply flawed implementation of a Competitive Bidding process for Durable Medical Equipment (DME, which includes blood glucose monitoring devices) that was implemented largely as a black-box, as Kelly Close said.

The competitive bidding process lacked transparency and allowed things such as non-binding bids: some bidders artificially deflated the average bid and were able to walk away from the process. Medicare claims that the program has been a success, while observations made by groups such as AADE have found clear evidence that Medicare beneficiaries are consistently not receiving access to blood glucose monitoring systems in the way that Medicare claims they do.

On day two of the conference, the attendees split into pillars. I participated in the Patient/Lay Organizations Pillar on behalf of DHF, along with Cynthia Rice from JDRF; Kelly Close from Diatribe; Jeff Hitchcock from Children with Diabetes; Bennet Dunlap from StripSafely; Larry Smith and Larry Ellingson, from the National Diabetes Volunteer Leadership Council; and others.

In fairness, Medicare sent Dr. William Rogers, to participate in the Government, Regulatory, Payers, and Employers Pillar (a small sub-set of the attendees), but after the pillar small meetings were over, he was gone… Engaging with the larger group, including patients, being a TRUE part of the conversation with ALL stakeholders is badly needed from Medicare.

May today be the last time that CMS avoids facing all the other stakeholders: we need them at the table, we need everyone to stand up to their responsibility, and they have an important part to play to help us address this crisis.

In the meantime, I invite you to take action and act on the CGM and Diabetes Advocacy bills mentioned earlier, and also take action and contact your legislators about the bill sponsored by AACE that would result in the creation of a National Diabetes Care Commission, so that the left and the right hand in our government begin to coordinate policy for the greater benefit of people with diabetes, and we don’t see any more gaps like the ones we are trying to remedy today.

  • Thanks for sharing this, Manny. Unbelievable action on the part of CMS.

  • Mike Hoskins

    Agreed, that CMS needs to be there. But as a devil’s advocate, think of it from their perspective: Last time they attended a D-event with patient engagement, they were yelled at. And those familiar with CMS from the inside say they aren’t like the FDA in contemporary patient engagement. We need to be honest with them, but at the same time, have to make sure it’s done constructively in a way that doesn’t flat out scare them away from being involved. That’s the challenge we as a community face — to get that real dialogue established the way we’ve been able to with the FDA. Thanks for being a part of that and helping to make it happen, Manny.

  • Richard Vaughn

    I have too many lows, some of which I do not feel, and caused by my not having coverage for a CGM. This can be a major problem when it happens during the night. I have written letters to my Senator and my Congressman, and I did receive polite replies, but no further follow-up. I am tired of testing 15 times per day, while trying to compensate for lack of a CGM. Even frequent testing does not prevent the occasional lows, sometimes as low as 35. Many of my long term type 1 friends have the same experience, with no coverage from Medicare. We are being ignored by Medicare, and this has to stop!

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  • Dan Kraft

    Case No. 13-CV-990 Whitcomb v Sylvia Burwell Secretary of Health & Human Services. Medicare Cannot Deny Coverage for CGM … http://www.leagle.com/decision/In%20FDCO%2020150601648/WHITCOMB%20v.%20BURWELL

    Not only has a judge in the Medicare Office of Hearings and Appeals found coverage for CGM was appropriate, but the District Court of Wisconsin has ruled that claims cannot be denied. A remand sentence-four 42 U.S.C. § 405(g) reverses the Medicare Appeals Counsel’s decision and is a “victory for the Plaintiff and terminates the litigation”. In the present matter the Federal Court’ ruling recognizes that goverment’s refusal to cover a Continuous Glucose Monitor for the management of Whitcomb’s diabetes was not supported in law or fact.

    [Decision page 4] Determination regarding whether a certain item or service is covered by Medicare, coverage “decisions are made based on the individual’s particular factual situation,” 68 Fed. Reg. 63692, 63693 (citing Heckler v. Ringer, 466 U.S. 602, 617 (1984)), “and whether the item or service is reasonable and necessary, Almy, 749 F. Supp. 2d at 320.”

    [Decision page 7] “the Secretary, through the Medicare Appeals Council, erred when it concluded that A47238 is incorporated into LCD L27231. Nothing in LCD L27231 attempts to incorporate A47238”… which unambiguously states that continuous glucose monitors are considered precautionary and not covered by Medicare.

    [Decision page 8] “If the reference to the continuous glucose monitors contained in the Article had been included in the LCD, the outcome of this case likely would be different. But the fact that the LCD is silent as to whether continuous glucose monitors are covered is not a matter the court can overlook. Looking to Articles for coverage determinations would undermine
    Section 522 of BIPA, whereby Congress created the right for certain beneficiaries to challenge coverage language contained in LCDs. See 68 Fed. Reg. 63692, 63693”.

    On May 26, 2015, the District Court for the Eastern District of Wisconsin ruled that the Secretary of Health and Human Services cannot deny coverage of a continuous glucose monitor based on a statement in an Article that such monitors are “precautionary.” The case reflects the arduous path that Type 1 diabetic Medicare beneficiaries endure while trying to secure coverage for a medical device that is considered the standard of care for Type 1 diabetics with hypoglycemic unawareness – a device widely deemed necessary to prevent life-threatening hypoglycemic events. The Medicare beneficiary had sought coverage from United Healthcare’s Secure Horizon’s Medicare Advantage Plan. Although United Healthcare covers CGM on a limited basis for non-Medicare beneficiaries, it does not cover CGM for Medicare beneficiaries.

    Through every phase of the multi-step Medicare administrative appeals process, the Plaintiff appealed the denial of a CGM that she got in April 2011. Although statutory regulations provide that an administrative law judge should issue a decision within 90 days of a request for an administrative hearing, 231 days passed until the Plaintiff received a favorable administrative law judge decision, i.e., February 2013. United Healthcare appealed the favorable decision and the Medicare Appeals Council reversed the decision asserting that the Medicare contractor’s local coverage determination (“LCD”) incorporated a Medicare Article that deemed CGM to be “precautionary.” Although Medicare regulations require the Council to issue a decision within 90 days of a request for review, the Council took approximately six months to render a decision, i.e., August 2013.

    The District Court, however, found that the LCD did not incorporate the Article by reference nor vise versa. Further, the Court noted the distinction between LCDs (which indicate whether a device is reasonable and necessary) and Articles (which address non-coverage information such as coding and payment). The Court reasoned that if a Medicare contractor could issue a
    coverage decision in an Article, it would subvert the LCD development process and would undermine Medicare beneficiaries’ ability to challenge a non-coverage policy as envisioned by Congress under Section 522 of BIPA.

    The Court remanded the matter to the Medicare Appeals Council to determine the Medicare beneficiary’s need for CGM based on her individual medical condition, i.e., without reference to the Article. The case underscores the challenges faced by Medicare beneficiaries seeking coverage of a device that is the standard of care, and the Office of Medicare Hearings and Appeals’ and Council’s failure to meet statutory deadlines, even for Medicare beneficiaries.