National Clinical Care Commission: “Laser-like” Review of Diabetes Programs, Policies
Legislation to improve diabetic health, whether through better management of the government’s resources or to appropriate funds to support public health institutions, has been having a rough go of it lately.
As far back as 2011, Congressman Pete Olson (R-TX) and Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) have championed legislation to create an office within the federal public health apparatus to focus exclusively on fostering diabetes research and improving access to quality care. Last fall, in the 115th Congress, they succeeded, with final passage in the House on October 11 of Senate Bill 920, signed into law on November 2, tasking a panel of public health officials and diabetes care experts to examine existing prevention and treatment programs in search of greater efficiency and effectiveness. The final bill reflected changes that had been negotiated in committees of both chambers and in the conference to agree to the Senate amendment.
Adopting the changes – restating the Commission’s task to review programs serving those with complex metabolic or autoimmune diseases, striking “Diabetes” from the Commission’s name, and no longer limiting the non-government officer membership to clinical endocrinologists and related physician specialties – cannot be distilled from the committee reports or the Congressional Record. Health care professionals we consulted in preparation of this story either saw the changes as distinctions without a difference or possibly the result of compromises to disarm opponents. In search of the rationale, we reached out in December and again in January to Collins, Olson, and Shaheen staff members. Senator Shaheen’s policy staff told us this:
Regarding the bill’s evolution to the enacted form, bills work their ways through committee, or are reintroduced in a new Congress, where changes to update the legislation certainly will happen. With regard to the Shaheen-Collins-Olson legislation, updates to the bill were made, in part, to simplify the legislation and to ensure that all diabetes stakeholders’ voices were heard.
Legislation to improve diabetic health, whether through better management of the government’s resources or to appropriate funds to support public health institutions, has been having a rough go of it lately. For example, bills sponsored by members of caucuses in each chamber during the 114th Congress to mandate Medicare coverage for continuous glucose monitors were unsuccessful. But recent decisions rendered within the Medicare benefit appeal process, and a change in the way CGM – insulin pump combinations are categorized, opened the possibility of broader coverage under the original Medicare plans and under supplemental plans offered by commercial insurors. Earlier this month the Centers for Medicare and Medicaid Services (CMS) issued guidance to Medicare Part D insurors to carry that into effect. Ironically, Medicare beneficiaries opting to purchase or upgrade CGMs under the FDA’s recently relaxed requirements – for CGM calibration by finger stick and meter – are still finding themselves up against coverage limitations on their resupply of meter test strips. Currently one in three Medicare benefit dollars is paid out for diabetes care.
The docket of the 115th Congress, as of publication time, shows eighty bills or resolutions relating directly, or in companion bills, to diabetic health care which have made it beyond committee consideration; of these, the Senate has one and the House four. Two bearing directly on diabetes care (three if 21st Century Cures Act from the 114th Congress could be counted in the win column) have made it into law – the Clinical Care Commission Act and provisions of the 2017 Consolidated Appropriations Act which fund the National Institutes of Health.
The Clinical Care Commission will be charged during the three years of its existence to examine the operations of all federal public health and medical benefit programs serving people with insulin-related metabolic or autoimmune diseases. The commission will then submit an action to the DHHS secretary and to Congress for consolidating duplicative or overlapping prevention and treatment programs and for improving the efficiency and effectiveness of the government’s scientific activities and funding mechanisms. The measure originated in nearly identical bills introduced in each house of Congress this session, HR 309 and S 920, and gained passage when the Senate version was adopted on October 11 after crossing over to the House.
Commission’s voting membership will consist of the heads of eleven executive branch agencies including the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Food and Drug Administration (FDA), and the department of Defense (DOD) and Veterans’ Affairs (VA). Twelve additional voting members are to be appointed from among the medical professions and professions allied to public health administration and patient advocacy.
The 2017-2018 Senate sponsors Shaheen and Collins, joined by Senator Patty Smith (D-WA), are members of the Senate Diabetes Caucus, founded by Collins when she entered the Senate in 2007, and which she co-chairs with Shaheen. Representative Olson has been a member of the Congressional Caucus on Diabetes, founded in 1996, since entering Congress nine years ago. Over the years, members from the two groups have filed and co-sponsored successful legislation to increase NIH funding for diabetes research, for Native American clinical services, and to improve access to testing supplies, among other initiatives.
But still hanging in the balance on Friday evening, as a divided Congress lurched toward passing a continuing resolution to fund the government, were two initiatives of the Special Diabetes Program: NIH funding to maintain diabetes care services for native Americans and Alaskan Eskimo patients, and CHIPS (the Children’s’ Health Insurance Program), although the House had extended CHIPS beyond its October expiration and its version of the continuing resolution would keep that program funded for six years. That appropriation appears to be alive for a vote if the Senate reconvenes today.
In remarks appearing in the Congressional Record last January 9, when his bill came on for consideration in the House, and again when the Shaheen-Collins-Murray bill came before the House on October 11, Olson observed that Congress’s investment over more than a decade into diabetes research and health care services had failed to reverse the prevalence of obesity, prediabetes, diabetes, and associated cardiovascular illnesses among Americans.
“When I first came to Congress in 2009, it was crystal clear that we had a big problem. The benefits of all the federal research dollars going into diseases were simply not making their way to patients. Researchers at the NIH, the CDC, the DOD, the VA, and the FDA weren’t sharing diabetes research. It was clear to me then, and it is clear today, that we need a laser-like focus on improving patient care by pursuing a strong Federal focus on research.”
Language in the various bills introduced unsuccessfully in Congress between 2010 and 2016 to create the Commission stated that as many as 35 federal agencies or programs had some role in diabetes research carried on within the government, or in funding of research by academic or non-profit institutions, direct care to minority and underserved patients, or financing of hospital and physician care.
As noted earlier, bills filed in each body in the 112th, 113th, and 114th terms of Congress to create a National Diabetes Clinical Care Commission were never passed, although the bill introduced by Olson 2015 (HR 1192, 114th Congress) did clear the House on World Diabetes Day 2016 after redrafting in committee. The committee’s changes dropped the term “diabetes” from the name of the Commission and re-defined the scope of the the Commission’s work from research and patient care for pre-diabetes, diabetes, and chronic diseases and conditions that are complications of or caused by diabetes to at least one but not more than two complex metabolic or autoimmune diseases resulting from issues related to insulin. The 114th Congress adjourned before the Senate took action, but Olsen’s bill became the template for the ultimately successful effort last fall at passage in the Senate.
During debate in the House to pass the Senate’s Clinical Care Commission bill, Rep. Michael Burgess (R-TX), a physician, remarked that “Mr. Olson’s long and arduous journey now will be completed…and we should all look forward to that.” In the circumstances, the Clinical Care Commission and 21st Century Cures legislation probably couldn’t have passed at a better time.
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