Diabetes on Capitol Hill The Hot Trends in Washington

Transcription

1 Diabetes on Capitol Hill The Hot Trends in Washington Howard S. Blank, M.D. Associated Endocrinologists, P.C. Oakland University William Beaumont School of Medicine

2 Objectives Review the current federal government make-up Review current national political issues in type 1 diabetes National Clinical Care Commission Act of 2017 Special Diabetes Program (SDP) 21 st Century Cures Act Continuous Glucose Monitoring Americans with Disabilities Act (ADA) Affordable Care Act (ACA) American Health Care Act (AHCA) and subsequent actions Unfortunately I cannot cover every aspect of legislation in Washington and it seems to change by the day!

3 Disclosure / conflict I have no conflicts of interest I am a member of the American Association of Clinical Endocrinologists (AACE) Legislative and Regulatory Committee and serve on board of directors of AACEPAC.

4 JDRF Advocacy SDP Access to Type 1 diabetes therapy and technologies CGM coverage in Medicare In early 2017 U.S. Centers for Medicare & Medicaid Services (CMS) announced coverage Using a home blood glucose monitor and checking 4 times per day Insulin treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump Requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results Support low and predictable out of pocket costs Reduce barriers of care Eliminate exclusions for pre-existing conditions

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8 The Federal Government President Trump (R) Supreme Court 9 justices Slightly more conservative than liberal Congress House has 435 members 238 Republicans (including several variations of conservatism), 193 Democrats (4 vacancies). 16 human medical professionals Senate has 100 members + Vice President Pence (R) 51 Republicans, 47 Democrats and 2 independents (who caucus with Democrats). 3 physicians More than 80% are men

9 I have been told that Congress does not like single disease legislation

10 Congressional Diabetes Caucus: Advocates for patients with diabetes Legislators with shared common goals Goal: educate members of Congress and their staff about diabetes mellitus and support legislation that will improve diabetes research, education, and treatment Two hundred sixty-four members from both houses (of 535 total Congressmen and Congresswomen) One of the largest caucuses in Congress

11 Senate Diabetes Caucus Chaired by Senator Susan Collins (R-ME) and Senator Jeanne Shaheen (D-NH) Thirty-seven members 21 Democrats / Independents 16 Republicans Senator Debbie Stabenow (D-MI) 2018 seat election

12 House Diabetes Caucus Chaired by Congresswoman Diana DeGette (D-CO) and Congressman Tom Reed (R-NY) Two hundred seventy members 148 Democrats 122 Republicans

13 Michigan Members of House Diabetes Caucus Ms. Debbie Dingell (12 th - D) south of Detroit Mr. Bill Huizenga (2 nd - R) west and north of Grand Rapids Ms. Brenda Lawrence (14 th - D) Southfield / Oakland county Mr. Sander Levin (9 th D) (retiring) Oakland and Macomb counties Mr. Dan Kildee (5 th D) Flint area Mr. Fred Upton (6 th -R) southwest Michigan / Kalamazoo Mr. John Conyers (13 th - D)- former member

14 Who is NOT a member from Michigan? Senator Gary Peters (D) Mr. Jack Bergman (1 st R) including U.P and northern Mitten Mr. Justin Amash (3 nd R) including Grand Rapid and north, east and southeast of Grand Rapids Mr. John Moolenaar (4 th - R) including north of Lansing Mr. Tim Walberg (7 th R) including south of Jackson and Ann Arbor to the state line Mr. Mike Bishop (8 th R) including south and east of Lansing to north and east of Pontiac Mr. Paul Mitchell (10 th R) including the Thumb Mr. Dave Trott (11 th R) including western Wayne and Oakland counties (retiring)

15 Call them now! Voters have power call your members of Congress Ask why they are not members of this important group. THANK those who are this is really powerful.

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17 National (Diabetes) Clinical Care Commission Act of 2017 Creates a public private Commission to improve the coordination and implementation of federal diabetes programs spread across 35 agencies Chaired by clinical endocrinologist Goal is to streamline federal diabetes activities and support clinicians in providing high quality care to people with diabetes and pre-diabetes, new technology and treatment Evaluate and expand education and awareness activities provided to health care professionals, outreach Must submit an operating plan to HHS and Congress within 90 days of its first meeting. The commission is terminated after it submits a final report, but not later than the end of FY2021.

18 National (Diabetes) Clinical Care Commission Act of 2017 Complex metabolic or autoimmune disease, diabetes, or complications caused by such diseases. Identifying current activities and gaps in federal efforts to support clinicians in providing integrated care Endorsed by more than 40 organizations representing physicians, allied health professionals, patients, community health organizations and industry JDRF, AACE, ADA, AADE, ACC, AMA, Endocrine Society, YMCA of USA, NKF

19 I went to Washington to advocate for patients

20 National (Diabetes) Clinical Care Commission Act of th Congress ( ) Status update In the 114 th Congress, it passed the House but died in the Lame Duck session of the Senate Passed House on January 9, 2017 without amendment On April 26, Senate Health, Education, Labor and Pensions (HELP) Committee approved by a voice vote On September 6, passed by the Senate with amendments On October 11, 2017 passed by the House The bill became law on November 2, 2017 as it was signed by President Trump Administration is working on seating the commission, ideally by summer

21 National (Diabetes) Clinical Care Commission Act of th Congress ( ) The commission membership includes heads of: CMS, AHRQ, CDC, IHS, VA, NIH, FDA, DoD, Agriculture, Office of Minority Health, Health Resources and Services Administration Additional 12 members Commission is seated for 3 years

22 Special Diabetes Program (SDP) Advocacy cornerstone of the JDRF advocacy campaign Advance type 1 diabetes research at NIH Prevention therapies (American Indian and Native Alaskans) Beta-cell replacement Type 1 diabetes outcomes

23 SDP Supported Programs Artificial pancreas Glucose control Diabetes kidney disease Diabetes related eye disease (retinopathy) Environmental triggers of diabetes Immune therapies for diabetes

24 Special Diabetes Program (SDP) Bipartisan support in Senators 356 Congress members Expired 9/30/17 Renewed 2/9/18 as part of general budget bill Senate passed 71 to 28 House passed 240 to 186 Expires 9/30/19 Provides $150 million per year for type 1 diabetes research Provided $750 million since 2010, $2.5 billion since 1998 Contact your elected members of Congress now and thank them!

25 Continuous Glucose Monitoring (CGM) CGM coverage in Medicare In early 2017 U.S. Centers for Medicare & Medicaid Services (CMS) announced coverage Using a home blood glucose monitor and checking 4 times per day Insulin treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump Requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results

26 Continuous Glucose Monitoring (CGM) Dexcom G5 Approved in March 2017 Cannot use smart phone / IOS / Android device Loss of use if CMS / Medicare learns that patient is using these devices FreeStyle Libre system Approved in January 2018 Device, 3 sensors per month, and test strips Medical supplier and not pharmacy

27 Thank your Congress member Thank them for supporting S.804 / HR1427 These were the bills for Medicare coverage of CGMS However CMS made the decision first The effort was started by the co-chairs of the House Diabetes Caucus

28 21 st Century Cures Act of 2016 Supported by JDRF but not diabetes specific: Making patient input a greater factor in FDA s regulatory decisions Establishing an FDA review pathway for biomarkers and other drug development tools Enabling novel clinical trial designs in the regulatory process Increasing the scientific expertise at the FDA by improving processes to recruit and retain needed personnel $500 million for FDA over a 10-year period to accomplish the key components mentioned above and many others. Sponsored by Hon. Fred Upton (MI-6) in House; 94-5 in Senate $6.3 billion

29 Americans with Disabilities Act of 1990 Federal law - prohibits discrimination against qualified individuals with disabilities Disability: limits a major life activity, have a record (or history) of a substantially limiting impairment, or are regarded as having a disability Provides protections for students with diabetes and also parents of children with diabetes Public schools and private schools receiving funding

30 Federal Action on the cost of insulin Washington Post, 6/22/17

31 Federal Action on the cost of insulin The answer is not much! Leaders of Congressional Diabetes Caucus Rep. Diana DeGette (D-CO) Rep. Tom Reed (R-NY) Sen. Bernie Sanders (I-NH) Rep. Elijah Cummings (D-MD) I suggest that you contact your elected officials

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33 Patient Protection and Affordable Care Act of 2010 (ACA) Also known as Obamacare Ultimate Goal To increase the quality of life for many and reduce the most common cause of bankruptcy in the U.S. Allow citizens to be more job mobile

34 Affordable Care Act (ACA) Signed into law in 2010 Survived legal challenge at the Supreme Court in 2012 Individual Mandate requiring all individuals purchase health insurance or pay penalty Aims to increase insurance coverage Increase Medicaid eligibility to persons living 138% of poverty level ($33,948 for family of four) Michigan is an expansion state State-based marketplace where individuals can purchase insurance Federal subsidy to those living under 400% of poverty level ($98,400 for family of four)

35 Standards of Health Insurance Plans Community rating Ban on dropping members who become ill Ban on price discrimination based on pre-existing conditions or gender (underwriting) Children and dependents can stay on plan until becoming 26 years old Ban on lifetime / annual caps of coverage

36 ACA essential health benefits Outpatient and emergency care Hospitalization Pregnancy and newborn care, post-partum care Mental health and substance use treatment prescription drugs Rehabilitative care Laboratory services Preventative / wellness care Pediatric services, including oral and vision care (but adult dental and vision coverage aren t essential health benefits) Birth control / nursing services

37 Medicare Part D Instituted under President George W. Bush Medicare insurance coverage of medications Created a gap in coverage well known as the Donut Hole No coverage between $2850 and $4950 ACA instituted a gradual closing of the donut hole Elimination by 2020; replacement with 25% copay on medications Approximately $5000 annual personal savings Medications for diabetes, high blood pressure, and high cholesterol are among the costliest to seniors currently

38 Complaint of ACA Lack of Access: Complaints related to high deductible plans Lack of physician availability Marketplace insurance programs are disappearing Insurance companies are not finding profit in the plans are withdrawing Over $1 trillion cost over 10 years However may result in $100 billion in deficit savings

39 American Health Care Act (AHCA) of 2017 First efforts to repeal the ACA started with executive order by President Trump on Inauguration Day 1/20/2017 Failed to achieve enough votes in 2017 Mr. Paul Ryan: Obamacare will prevail for the foreseeable future

40 Congressional Budget Office Score of AHCA Not a repeal of ACA Increase the number of uninsured by 24 million people Lower federal deficit by $337 billion over 10 years Decrease Medicaid expansion Eliminates the penalty for not having health insurance Decreases financial assistance for health marketplace Estimates employer sponsored plans decline 2 million by 2020 and 7 million by 2026

41 Effect of AHCA on Medicaid Patients with diabetes represent a disproportionate percentage of Medicaid use (15% of all patients with diabetes in 2003) Over 10 years, decline in funding of $840 billion (decline from 90% to 50-75%); states get more if there is a work requirement Medicaid covers 70 million Americans; CBO estimates loss of 14 million covered 50% of childbirths 2/3 rd of nursing home care

42 Medicaid and Diabetes Interesting study from The number of Medicaid-enrolled patients with newly identified diabetes increased by 23% (14,625 vs. 18,020 patients) in the 26 states (and District of Columbia) that expanded Medicaid Compare to increase of 0.4% (11,612 vs. 11,653 patients) in the 24 states that did not expand Medicaid during this period. Similar differences were observed in younger and older adults and for both men and women. Kaufman et al, 2015

43 American Health Care Act of 2017 May 4, 2017 House passes the AHCA by vote (all Democrats and 20 Republicans voted against the bill Shifts power to states Allows states to apply for waivers to pull from ACA May allow employers to pull from ACA Eliminates subsidies and replaces with tax credits (2020) Eliminates tax on wealthy, device manufacturers and tanning parlors Repeals funding for prevention and public health Higher health saving accounts limits Late enrollment penalty of 30% - or heath status rating

44 AHCA and Pre-existing conditions The concern is for people living in OPT-OUT states May be subject to higher premiums based on health conditions States may have to cover part of the difference in the cost of care May result in higher premiums for those with pre-existing conditions and less expensive for those without No change for people who do not have interruption of coverage for more than 62 days May not exclude coverage for people with pre-existing conditions

45 AHCA - High Risk Pool The idea is that states set up high risk pools for patients Federal government contribution underwrites some of the cost of higher premiums The Upton (R-MI) Amendment Added $8 billion to the $100 billion and $15 billion allotted to the high risk pools Supported by Mr. Trump and helped gain moderate Republicans

46 The McArthur Amendment (R-NJ) States would be permitted to partially waive the community rating rule of ACA Insurers would be allowed to charge differently based on health if there is a 63 day gap in coverage in the last year Health status rating would replace the 30 percent premium surcharge that would otherwise be imposed on people without continuous coverage under the AHCA States can allow rating ratio above 5:1 States can determine their own essential health benefits

47 AHCA Individual Mandate The mandate to have health care remains However there is no longer a tax penalty Late enrollment (30% of premium) penalty for non-continuous coverage (63 consecutive days) changed by the new amendment May allow for medical underwriting (state issue) If this were a change in the ACA rules, it would not be a budget bill; waivers allow for Senate to rule without 60 votes

48 AHCA modified premium tax credits Increases the tax credits for young adults Decreases tax credits for older adults Will not provide tax credit to cover plans which cover abortion This is a replacement of ACA cost sharing subsidy

49 ACHA age rating Plans may charge higher rates for people who are older ACA allowed for a 3:1 difference in cost AHCA allows for 5:1 difference in cost of plans as people become older The premiums will be less for younger patients compared with ACA The premiums will be more for older patients compared with ACA Breakpoint age 39 The AHCA may affect older lower income patients especially living in expensive areas

50 AHCA essential health benefits The ACA rules still apply to all EHB However states may apply to OPT OUT Preventative benefits still are required

51 After passage of AHCA by the House After passage of the House bill, the bill died in the Senate for several reasons. The Senate created its own bill

52 Organizations who support AHCA National Taxpayers Union Americans for Tax Reform Association of Mature American Citizens Center of the American Experiment Council for Citizens Against Government Waste Independent Women s Voice Institute for Liberty Log Cabin Republicans Market Institute Obamacare Repeal Coalition Six Degrees Project Small Business and Entrepreneurship Counsel Speaker.gov

53 Organizations who opposed the AHCA JDFR ADA AACE Endocrine Society ACP AAFP ACOG AOA AMA ALA AARP

54 JDRF response In another statement, the JDRF encouraged supporters to contact their senators. On behalf of the 1.25 million Americans with type 1 diabetes and their families who rely on affordable, comprehensive health insurance, JDRF is deeply upset that the House of Representatives has passed a health reform bill that would allow insurance companies to charge people with [type 1 diabetes] more money for coverage and deeply cut Medicaid, on which many low-income people with [type 1 diabetes] rely, Derek Rapp, JDRF president and chief executive officer, stated in the release. We will spend the coming weeks working with Senators across the political spectrum to ensure any health care reform legislation will protect people with preexisting conditions and provide access to affordable, comprehensive coverage for everyone including the [type 1 diabetes] community.

55 The AHCA did not become law

56 Senate bill: Better Care and Reconciliation Act Created by 13 men No women were in the draft production Sen. Susan Collins of the Diabetes caucus was excluded CBO estimated 15 million would immediately lose insurance and 7 million more would lose insurance in the following 4 years Sen. Cruz amendment allowed insurers to create plans which did not provide minimal coverage as long as other plans by the company did Allows for age rating and higher charges for pre-existing conditions Allows large employers to drop insurance offering Eliminated the individual mandate

57 After BCRA of 2017 Bill in the Senate was blocked by Sen. Collins and Sen. (Dr.) Paul Two other senators announced they would block the bill Sen. John McCain became ill Pres. Trump announced his desire to instead promote the Obamacare Repeal Reconciliation Act and let the marketplace fall apart This was not passed Several subsequent measures were attempted including Graham- Cassidy effort for block grants to states Pres. Trump signed executive order allowing for interstate insurance plans and extend the length of short-term plans

58 Tax Cuts and Jobs Act of 2017 This is the tax bill signed by Pres. Trump in December 2017 It repealed the individual mandate CBO previously noted repeal would: Save more than $300 billion over 10 years Raise premiums by 10% Lead to loss of insurance for 13 million over 10 years

59 New Challenges to ACA February 2018 President Trump promotes short term health coverage from 3 months to 12 months December 2017 the tax bill eliminates the individual mandate Enrollment in 2017 decline by about 5% although enrollment was shorter and outreach funding was down 90%

60 Please call your legislators. Promote your cause. Support diabetes patients. Follow up with them frequently

61 Thank you.

62 References I utilized incredible resources: Wall Street Journal, Harvard Business Review, NPR, NY Times, Washington Post, podcasts of WSJ, NY Times, Brookings Institute and images from aoc.gov Brown DS and McBride TD. Impact of the affordable care act on access to care for US adults with diabetes Prev Chronic Dis 2015; 12: Burge MR and Schade DS. Diabetes and the affordable care act. Diabetes Technology & Therapeutics. 214; 16: Kaufman H, Chen Z, Fonseca V, and McPhaul M. Surge in newly identified diabetes among medicaid patients in 2014 within medicaid expansion states under the affordable care act. Diabetes Care 2015 May; 38(5): Summary of the American Health Care Act by Kaiser Family Foundation. Thanks to Ms. Sara Milo of AACE.