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Medicare & You: Diabetes
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May 26, 2015 Federal Court rules Medicare cannot deny coverage for CGM… Medicare Denying CGM for the management of diabetes “was not supported in law or fact”.
See Case No. 13-CV-990 Whitcomb v Sylvia Burwell Secretary of Health & Human Services. http://www.leagle.com/decision/In%20FDCO%2020150601648/WHITCOMB%20v.%20BURWELL
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”.
Under Federal Law, a prevailing litigant in a case against the United States Government is entitled to recover its attorney fees and costs, when the position asserted by the government was not substantially justified. 28 U.S.C. § 2412. “In the present matter this Court ruling recognizes that the government’s refusal to cover a medical device for the management of Whitcomb’s diabetes was not supported in law or fact”.
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 based on the Article stating CGM is precautionary and therefore not covered…
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.
The Secretary denying CGM on a one-line sentence that is unsupported in law or fact stating the CGM is “precautionary” … Since the majority of these life threating hypo-events requiring external assistance for recovery would be avoided… Not including the $800+ EMT rescue service and transportation fee. “The American Journal of Managed Care say” the costs for hypoglycemia visits were $17,564 for an inpatient admission, $1,387 for an ER visit.” Doing the math: Costs about $640 million a year.
On July 27, 2015 the Secretary did not file an Appeal within the statutory deadline with the Supreme Court. Fewer then 10% of appeals filed with the Supreme Court are even reviewed. The scope of the Supreme Court is to support the District Court’s decision and making it law.
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.
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This video is very misleading bordering on propagating mis-information. For glucose test strips and glucometers you need Medicare part B. Part D (prescription service) does not include any test supplies. And the test strips are only available from pre-screened suppliers. They really should make this more obvious.
Civil Remedies Division Docket No. C-15-1021 Decision No. CR4596: On April 29, 2016, a judge in Medicare’s Civil Remedies Division struck down the policy that CGMs are precautionary and therefore not durable medical equipment (“DME”) eligible for coverage under Medicare. The judge noted:“The contractor [NHIC] and CMS have not produced any record in the form of peer-reviewed literature, medical opinions, or even an analysis from an individual with a medical background that supports a conclusion that CGM is never reasonable and necessary irrespective of the beneficiary’s condition. . . There is simply no evidence before me that explains how CGM does not meet DME requirements or why CGM cannot ever be reasonable and necessary under [the Medicare Act].” Accordingly, the judge found that the policy statement that CGM is precautionary and therefore not covered under Medicare’s DME benefit to be invalid under the reasonableness standard. The judge reviewed each of the statutory elements for DME and how CGM satisfied those elements. Neither the Medicare contractor nor CMS submitted a single document or proposed a single witness in support of the position that CGM is precautionary.
What I just found out was the office visit isn’t free if you HAVE diabetes. So Medicare will pay to check people to see if they have diabetes, but not help to control diabetes. Bottom line, This video made me think my screening was covered, but I guess this is government so I shouldn’t get dragged in by the BS.
Finigan v Burwell Secretary of HHS. Ms. Burrell CGM is covered by Medicare what part of that do you not understand? Research proves CGM saves the taxpayers money WHAT part of that do you not understand Ms. Burwell? https://cases.justia.com/federal/district-courts/massachusetts/madce/1:2015cv12246/171124/30/0.pdf
On May 26, 2015 the Federal Court gave the Secretary the opportunity to correct the “error in the novel” but failed to do so. On Nov 8, 2016 (election day) the Secretary violated Whitcomb’s civil rights by refusing to cover a Continuous Glucose Monitor for the management of Whitcomb’s diabetes will now cost the US Government millions of dollars in damages. In the present matter the Federal Court’ ruling recognizes that government’s refusal to cover a Continuous Glucose Monitor for the management of Whitcomb’s diabetes was not supported in law or fact. See Case No. 13-CV-990 Whitcomb v Burwell Secretary of Health & Human Services.